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Start Preamble Start Printed Page 39104 Centers for Medicare symbicort turbohaler 400 12 http://onetracktrainers.com/member/blog/horse-profiles/ &. Medicaid Services (CMS), Health and Human Services (HHS). Proposed rule symbicort turbohaler 400 12. This major proposed rule addresses. Changes to the physician fee schedule (PFS).

Other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in symbicort turbohaler 400 12 the statute. Medicare Shared Savings Program requirements. Updates to the Quality Payment Program symbicort turbohaler 400 12. Medicare coverage of opioid use disorder services furnished by opioid treatment programs. Updates to certain Medicare provider enrollment policies.

Requirements for prepayment and post-payment medical symbicort turbohaler 400 12 review activities. Requirement for electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan, or a Medicare Advantage Prescription Drug (MA-PD) plan. Updates to the Medicare Ground Ambulance Data Collection symbicort turbohaler 400 12 System. Changes to the Medicare Diabetes Prevention Program (MDPP) expanded model. And amendments to the physician self-referral law regulations.

To be assured consideration, comments must be received at one of the addresses provided below, symbicort turbohaler 400 12 no later than 5 p.m. On September 13, 2021. In commenting, please refer to file code CMS-1751-P symbicort turbohaler 400 12. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed). 1.

Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions. 2. By regular mail.

You may mail written comments to the following address ONLY. Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention. CMS-1751-P, P.O. Box 8016, Baltimore, MD 21244-8016.

Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY. Centers for Medicare &.

Medicaid Services, Department of Health and Human Services, Attention. CMS-1751-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. Start Further Info DivisionofPractitionerServices@cms.hhs.gov, for any issues not identified below. Michael Soracoe, (410) 786-6312, for issues related to practice expense, work RVUs, conversion factor, and PFS specialty-specific impacts. Larry Chan, (410) 786-6864, for issues related to potentially misvalued services under the PFS.

Donta Henson, (410) 786-1947, Patrick Sartini, (410) 786-9252, and Larry Chan, (410) 786-6864, for issues related to telehealth services and other services involving communications technology. Julie Adams, (410) 786-8932, for issues related to payment for anesthesia services. Sarah Leipnik, (410) 786-3933, for issues related to split (or shared) services. Christiane LaBonte, (410) 786-7237, for issues related to indirect practice expense, PFS payment for critical care services, and PFS payment for teaching physician services. DivisionofPractitionerServices@cms.hhs.gov, for issues related to payment for treatment administration services.

Regina Walker-Wren, (410) 786-9160, for issues related to billing for services of physician assistants. Pamela West, (410) 786-2302, for issues related to PFS payment for therapy services, medical nutrition therapy services, and services of registered dieticians and nutrition professionals. Liane Grayson, (410) 786-6583, and Donta Henson, (410) 786-1947, for issues related to coinsurance for certain colorectal cancer screening services. Lisa Parker, (410) 786-4949, for issues related to RHCs and FQHCs. Laura Kennedy, (410) 786-3377, for issues related to drugs payable under Part B.

Heather Hostetler, (410) 786-4515, and Elizabeth Truong, 410-786-6005, for issues related to removal of select national coverage determinations. Sarah Fulton, (410) 786-2749, for issues related to Appropriate Use Criteria for Advanced Diagnostic Imaging (AUC). And Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac Rehabilitation. Rachel Katonak, (410) 786-8564, for issues related to Medical Nutrition Therapy. Fiona Larbi, (410) 786-7224, for issues related to the Medicare Shared Savings Program (Shared Savings Program) Quality performance standard and quality reporting requirements.

Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518, or SharedSavingsProgram@cms.hhs.gov, for issues related to Shared Savings Program beneficiary assignment, repayment mechanism requirements, and benchmarking methodology. Naseem Tarmohamed, (410) 786-0814, or SharedSavingsProgram@cms.hhs.gov, for inquiries related to Shared Savings Program application, compliance and beneficiary notification requirements. Amy Gruber, AmbulanceDataCollection@cms.hhs.gov, for issues related to the Medicare Ground Ambulance Data Collection System. Juliana Tiongson, (410) 786-0342, for issues related to the Medicare Diabetes Prevention Program (MDPP). Laura Ashbaugh, (410) 786-1113, for issues related to Clinical Laboratory Fee Schedule.

Laboratory Specimen Collection and Travel Allowance and Use of Electronic Travel Logs. Frank Whelan, (410) 786-1302, for issues related to Medicare provider enrollment regulation updates. Thomas J. Kessler, (410) 786-1991, for issues related to provider and supplier prepayment and post-payment medical review requirements. Lindsey Baldwin, (410) 786-1694, and Michele Franklin, (410) 786-9226, for issues related to Medicare coverage of opioid use disorder treatment services furnished by opioid treatment programs.

Lisa O. Wilson, (410) 786-8852, or Meredith Larson, (410) 786-7923, for inquiries related to the physician self-referral law. Joella Roland, (410) 786-7638, for issues related to requirement for electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or an MA-PD plan. Kathleen Ott, (410) 786-4246, for issues related to open payments.Start Printed Page 39105 Molly MacHarris, (410) 786-4461, for inquiries related to Merit-based Incentive Payment System (MIPS). Brittany LaCouture, (410) 786-0481, for inquiries related to Alternative Payment Models (APMs).

End Further Info End Preamble Start Supplemental Information Inspection of Public Comments. All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received. Http://www.regulations.gov. Follow the search instructions on that website to view public comments.

CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments. Addenda Available Only Through the Internet on the CMS Website. The PFS Addenda along with other supporting documents and tables referenced in this proposed rule are available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​index.html.

Click on the link on the left side of the screen titled, “PFS Federal Regulations Notices” for a chronological list of PFS Federal Register and other related documents. For the CY 2022 PFS proposed rule, refer to item CMS-1751-P. Readers with questions related to accessing any of the Addenda or other supporting documents referenced in this proposed rule and posted on the CMS website identified above should contact DivisionofPractitionerServices@cms.hhs.gov. CPT (Current Procedural Terminology) Copyright Notice. Throughout this proposed rule, we use CPT codes and descriptions to refer to a variety of services.

We note that CPT codes and descriptions are copyright 2020 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply. I.

Executive Summary This major proposed rule proposes to revise payment polices under the Medicare PFS and makes other policy changes, including proposals to implement certain provisions of the Consolidated Appropriations Act, 2021 (CAA, 2021) (Pub. L. 116-260, December 27, 2020), Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018) and the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT Act) (Pub.

L. 115-271, October 24, 2018), related to Medicare Part B payment. In addition, this major proposed rule includes proposals regarding other Medicare payment policies described in sections III. And IV. A.

Summary of the Major Provisions The statute requires us to establish payments under the PFS, based on national uniform relative value units (RVUs) that account for the relative resources used in furnishing a service. The statute requires that RVUs be established for three categories of resources. Work, practice expense (PE), and malpractice (MP) expense. In addition, the statute requires that we establish each year by regulation the payment amounts for physicians' services paid under the PFS, including geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas. In this major proposed rule, we are proposing to establish RVUs for CY 2022 for the PFS to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute.

This proposed rule also includes discussions and provisions regarding several other Medicare Part B payment policies. Specifically, this proposed rule addresses. Practice Expense RVUs (section II.B.) Potentially Misvalued Services Under the PFS (section II.C.) Telehealth and Other Services Involving Communications Technology (section II.D.) Valuation of Specific Codes (section II.E.) Evaluation and Management Visits (section II.F.) Billing for Physician Assistant Services (section II.G.) Therapy Services (section II.H.) Changes to Beneficiary Coinsurance for Additional Procedures Furnished During the Same Clinical Encounter as Certain Colorectal Cancer Screening Tests (section II.I.) treatment Administration Services (section II.J.) Payment for Medical Nutrition Therapy Services and Related Services (section II.K.) Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) (sections III.A., III.B., and III.C.) Requiring Certain Manufacturers to Report Drug Pricing Information for Part B and Determination of ASP for Certain Self-administered Drug Products (sections III.D.1. And 2.) Medicare Part B Drug Payment for Drugs Approved under Section 505(b)(2) of the Federal Food, Drug, &. Cosmetic Act (section III.E.) Appropriate Use Criteria for Advanced Diagnostic Imaging (section III.F.) Removal of Select National Coverage Determinations (section III.G.) Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac Rehabilitation (section III.H.) Medical Nutrition Therapy (section III.I.) Medicare Shared Savings Program (section III.J.) Medicare Ground Ambulance Data Collection System (section III.K.) Medicare Diabetes Prevention Program (MDPP) (section III.L.) Clinical Laboratory Fee Schedule.

Laboratory Specimen Collection and Travel Allowance for Clinical Diagnostic Laboratory Tests and Use of Electronic Travel Logs (section III.M.) Medicare Provider and Supplier Enrollment Changes (section III.N.1.) Provider/Supplier Medical Review Requirements. Addition of Provider/Supplier Requirements related to Prepayment and Post-payment Reviews (section III.N.2.) Modifications Related to Medicare Coverage for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs) (section III.O.) Updates to the Physician Self-Referral Regulations (section III.P.) Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D Drug under a Prescription Drug Plan or an MA-PD Plan (section 2003 of the SUPPORT Act) (section III.Q.) Open Payments (section III.R.) Updates to the Quality Payment Program (section IV.) Collection of Information Requirements (section V.) Response to Comments (section VI.) Regulatory Impact Analysis (section VII.)Start Printed Page 39106 3. Summary of Costs and Benefits We have determined that this proposed rule is economically significant. For a detailed discussion of the economic impacts, see section VII., Regulatory Impact Analysis, of this proposed rule. II.

Provisions of the Proposed Rule for the PFS A. Background Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Social Security Act (the Act), “Payment for Physicians' Services.” The PFS relies on national relative values that are established for work, practice expense (PE), and malpractice (MP), which are adjusted for geographic cost variations. These values are multiplied by a conversion factor (CF) to convert the relative value units (RVUs) into payment rates. The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act of 1989 (OBRA '89) (Pub. L.

101-239, December 19, 1989), and the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) (Pub. L. 101-508, November 5, 1990). The final rule published in the November 25, 1991 Federal Register (56 FR 59502) set forth the first fee schedule used for payment for physicians' services. We note that throughout this proposed rule, unless otherwise noted, the term “practitioner” is used to describe both physicians and nonphysician practitioners (NPPs) who are permitted to bill Medicare under the PFS for the services they furnish to Medicare beneficiaries.

1. Development of the RVUs a. Work RVUs The work RVUs established for the initial fee schedule, which was implemented on January 1, 1992, were developed with extensive input from the physician community. A research team at the Harvard School of Public Health developed the original work RVUs for most codes under a cooperative agreement with the Department of Health and Human Services (HHS). In constructing the code-specific vignettes used in determining the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the federal government, and obtained input from numerous physician specialty groups.

As specified in section 1848(c)(1)(A) of the Act, the work component of physicians' services means the portion of the resources used in furnishing the service that reflects physician time and intensity. We establish work RVUs for new, revised and potentially misvalued codes based on our review of information that generally includes, but is not limited to, recommendations received from the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), the Health Care Professionals Advisory Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), and other public commenters. Medical literature and comparative databases. As well as a comparison of the work for other codes within the Medicare PFS, and consultation with other physicians and health care professionals within CMS and the federal government. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters, and the rationale for their recommendations.

In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalk to key reference or similar codes, and magnitude estimation. More information on these issues is available in that rule. B. Practice Expense RVUs Initially, only the work RVUs were resource-based, and the PE and MP RVUs were based on average allowable charges. Section 121 of the Social Security Act Amendments of 1994 (Pub.

L. 103-432, October 31, 1994), amended by section 1848(c)(2)(C)(ii) of the Act and required us to develop resource-based PE RVUs for each physicians' service beginning in 1998. We were required to consider general categories of expenses (such as office rent and wages of personnel, but excluding MP expenses) comprising PEs. The PE RVUs continue to represent the portion of these resources involved in furnishing PFS services. Originally, the resource-based method was to be used beginning in 1998, but section 4505(a) of the Balanced Budget Act of 1997 (BBA `97) (Pub.

L. 105-33, August 5, 1997) delayed implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA `97 provided for a 4-year transition period from the charge-based PE RVUs to the resource-based PE RVUs. We established the resource-based PE RVUs for each physicians' service in the November 2, 1998 final rule (63 FR 58814), effective for services furnished in CY 1999. Based on the requirement to transition to a resource-based system for PE over a 4-year period, payment rates were not fully based upon resource-based PE RVUs until CY 2002.

This resource-based system was based on two significant sources of actual PE data. The Clinical Practice Expert Panel (CPEP) data. And the AMA's Socioeconomic Monitoring System (SMS) data. These data sources are described in greater detail in the CY 2012 PFS final rule with comment period (76 FR 73033). Separate PE RVUs are established for services furnished in facility settings, such as a hospital outpatient department (HOPD) or an ambulatory surgical center (ASC), and in nonfacility settings, such as a physician's office.

The nonfacility RVUs reflect all of the direct and indirect PEs involved in furnishing a service described by a particular HCPCS code. The difference, if any, in these PE RVUs generally results in a higher payment in the nonfacility setting because in the facility settings some resource costs are borne by the facility. Medicare's payment to the facility (such as the outpatient prospective payment system (OPPS) payment to the HOPD) would reflect costs typically incurred by the facility. Thus, payment associated with those specific facility resource costs is not made under the PFS. Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) (Pub.

L. 106-113, November 29, 1999) directed the Secretary of Health and Human Services (the Secretary) to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule (65 FR 25664) that set forth the criteria for the submission of these supplemental PE survey data. The criteria were modified in response to comments received, and published in the Federal Register (65 FR 65376) as part of a November 1, 2000 final rule. The PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended the period during which we would accept these supplemental data through March 1, 2005.

In the CY 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating direct PE RVUs from the top-down to the bottom-up methodology beginning in CY 2007. We adopted a 4-year transition to the new PE RVUs. This transition was completed for CY 2010. In the CY 2010 PFS final rule with Start Printed Page 39107comment period, we updated the practice expense per hour (PE/HR) data that are used in the calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, we began a 4-year transition to the new PE RVUs using the updated PE/HR data, which was completed for CY 2013.

C. Malpractice RVUs Section 4505(f) of the BBA `97 amended section 1848(c) of the Act to require that we implement resource-based MP RVUs for services furnished on or after CY 2000. The resource-based MP RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and physician-owned insurers' MP insurance premium data from all the states, the District of Columbia, and Puerto Rico. D.

Refinements to the RVUs Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no less often than every 5 years. Prior to CY 2013, we conducted periodic reviews of work RVUs and PE RVUs independently from one another. We completed 5-year reviews of work RVUs that were effective for calendar years 1997, 2002, 2007, and 2012. Although refinements to the direct PE inputs initially relied heavily on input from the RUC Practice Expense Advisory Committee (PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to the use of the updated PE/HR data in CY 2010 have resulted in significant refinements to the PE RVUs in recent years. In the CY 2012 PFS final rule with comment period (76 FR 73057), we finalized a proposal to consolidate reviews of work and PE RVUs under section 1848(c)(2)(B) of the Act and reviews of potentially misvalued codes under section 1848(c)(2)(K) of the Act into one annual process.

In addition to the 5-year reviews, beginning for CY 2009, CMS and the RUC identified and reviewed a number of potentially misvalued codes on an annual basis based on various identification screens. This annual review of work and PE RVUs for potentially misvalued codes was supplemented by the amendments to section 1848 of the Act, as enacted by section 3134 of the Affordable Care Act, that require the agency to periodically identify, review and adjust values for potentially misvalued codes. E. Application of Budget Neutrality to Adjustments of RVUs As described in section VII. Of this proposed rule, the Regulatory Impact Analysis, in accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs cause expenditures for the year to change by more than $20 million, we will make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.

2. Calculation of Payments Based on RVUs To calculate the payment for each service, the components of the fee schedule (work, PE, and MP RVUs) are adjusted by geographic practice cost indices (GPCIs) to reflect the variations in the costs of furnishing the services. The GPCIs reflect the relative costs of work, PE, and MP in an area compared to the national average costs for each component. Please refer to the CY 2020 PFS final rule for a discussion of the last GPCI update (84 FR 62615 through 62623). RVUs are converted to dollar amounts through the application of a CF, which is calculated based on a statutory formula by CMS' Office of the Actuary (OACT).

The formula for calculating the Medicare PFS payment amount for a given service and fee schedule area can be expressed as. Payment = [(RVU work × GPCI work) + (RVU PE × GPCI PE) + (RVU MP × GPCI MP)] × CF 3. Separate Fee Schedule Methodology for Anesthesia Services Section 1848(b)(2)(B) of the Act specifies that the fee schedule amounts for anesthesia services are to be based on a uniform relative value guide, with appropriate adjustment of an anesthesia CF, in a manner to ensure that fee schedule amounts for anesthesia services are consistent with those for other services of comparable value. Therefore, there is a separate fee schedule methodology for anesthesia services. Specifically, we establish a separate CF for anesthesia services and we utilize the uniform relative value guide, or base units, as well as time units, to calculate the fee schedule amounts for anesthesia services.

Since anesthesia services are not valued using RVUs, a separate methodology for locality adjustments is also necessary. This involves an adjustment to the national anesthesia CF for each payment locality. B. Determination of PE RVUs 1. Overview Practice expense (PE) is the portion of the resources used in furnishing a service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages, but excluding MP expenses, as specified in section 1848(c)(1)(B) of the Act.

As required by section 1848(c)(2)(C)(ii) of the Act, we use a resource-based system for determining PE RVUs for each physicians' service. We develop PE RVUs by considering the direct and indirect practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service-specific PE RVUs.

We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detailed explanation of the PE methodology. 2. Practice Expense Methodology a. Direct Practice Expense We determine the direct PE for a specific service by adding the costs of the direct resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing that service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are generally based on our review of recommendations received from the RUC and those provided in response to public comment periods.

For a detailed explanation of the direct PE methodology, including examples, we refer readers to the 5-year review of work RVUs under the PFS and proposed changes to the PE methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629). B. Indirect Practice Expense per Hour Data We use survey data on indirect PEs incurred per hour worked, in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the PE/HR by specialty that was obtained from the AMA's SMS. The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS).

The PPIS is a multispecialty, Start Printed Page 39108nationally representative, PE survey of both physicians and NPPs paid under the PFS using a survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and health care professional groups. We believe the PPIS is the most comprehensive source of PE survey information available. We used the PPIS data to update the PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that participated in the survey. When we began using the PPIS data in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE/HR data are used in that methodology.

We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we transitioned its use over a 4-year period from the previous PE RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), the transition to the PPIS data was complete for CY 2013. Therefore, PE RVUs from CY 2013 forward are developed based entirely on the PPIS data, except as noted in this section. Section 1848(c)(2)(H)(i) of the Act requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services.

Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data. Supplemental survey data on independent labs from the College of American Pathologists were implemented for payments beginning in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments beginning in CY 2007. Neither IDTFs, nor independent labs, participated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data.

Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for these specialties were updated to CY 2006 using the Medicare Economic Index (MEI) to put them on a comparable basis with the PPIS data. We also do not use the PPIS data for reproductive endocrinology and spine surgery since these specialties currently are not separately recognized by Medicare, nor do we have a method to blend the PPIS data with Medicare-recognized specialty data. Previously, we established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead used the PPIS-based PE/HR. We use crosswalks for specialties that did not participate in the PPIS.

These crosswalks have been generally established through notice and comment rulemaking and are available in the file titled “CY 2022 PFS proposed rule PE/HR” on the CMS website under downloads for the CY 2022 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. For CY 2022, we have incorporated the available utilization data for two new specialties, each of which became a recognized Medicare specialty during 2020. These specialties are Micrographic Dermatologic Surgery (MDS) and Adult Congenital Heart Disease (ACHD). We are proposing to use proxy PE/HR values for these new specialties, as there are no PPIS data for these specialties, by crosswalking the PE/HR as follows from specialties that furnish similar services in the Medicare claims data. Micrographic Dermatologic Surgery (MDS) from Dermatology.

And Adult Congenital Heart Disease (ACHD from Cardiology. These updates are reflected in the “CY 2022 PFS proposed rule PE/HR” file available on the CMS website under the supporting data files for the CY 2022 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. c. Allocation of PE to Services To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service. (1) Direct Costs The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing each of the services.

The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service. (2) Indirect Costs We allocate the indirect costs at the code level based on the direct costs specifically associated with a code and the greater of either the clinical labor costs or the work RVUs. We also incorporate the survey data described earlier in the PE/HR discussion. The general approach to developing the indirect portion of the PE RVUs is as follows.

For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. That is, the initial indirect allocator is calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE RVUs for a given service is 2.00 and direct costs, on average, represent 25 percent of total costs for the specialties that furnish the service, the initial indirect allocator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00). Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator.

In our example, if this service had a work RVU of 4.00 and the clinical labor portion of the direct PE RVU was 1.50, we would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial indirect allocator of 6.00 to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, Start Printed Page 39109the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service. Then, we incorporate the specialty-specific indirect PE/HR data into the calculation. In our example, if, based on the survey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service with an indirect allocator of 5.00, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.

(3) Facility and Nonfacility Costs For procedures that can be furnished in a physician's office, as well as in a facility setting, where Medicare makes a separate payment to the facility for its costs in furnishing a service, we establish two PE RVUs. Facility and nonfacility. The methodology for calculating PE RVUs is the same for both the facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. In calculating the PE RVUs for services furnished in a facility, we do not include resources that would generally not be provided by physicians when furnishing the service. For this reason, the facility PE RVUs are generally lower than the nonfacility PE RVUs.

(4) Services With Technical Components and Professional Components Diagnostic services are generally comprised of two components. A professional component (PC). And a technical component (TC). The PC and TC may be furnished independently or by different providers, or they may be furnished together as a global service. When services have separately billable PC and TC components, the payment for the global service equals the sum of the payment for the TC and PC.

To achieve this, we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs. That is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global.) (5) PE RVU Methodology For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746). We also direct readers to the file titled “Calculation of PE RVUs under Methodology for Selected Codes” which is available on our website under downloads for the CY 2022 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. This file contains a table that illustrates the calculation of PE RVUs as described in this proposed rule for individual codes.

(a) Setup File First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific PE/HR data calculated from the surveys. (b) Calculate the Direct Cost PE RVUs Sum the costs of each direct input. Step 1. Sum the direct costs of the inputs for each service.

Step 2. Calculate the aggregate pool of direct PE costs for the current year. We set the aggregate pool of PE costs equal to the product of the ratio of the current aggregate PE RVUs to current aggregate work RVUs and the projected aggregate work RVUs. Step 3. Calculate the aggregate pool of direct PE costs for use in ratesetting.

This is the product of the aggregate direct costs for all services from Step 1 and the utilization data for that service. Step 4. Using the results of Step 2 and Step 3, use the CF to calculate a direct PE scaling adjustment to ensure that the aggregate pool of direct PE costs calculated in Step 3 does not vary from the aggregate pool of direct PE costs for the current year. Apply the scaling adjustment to the direct costs for each service (as calculated in Step 1). Step 5.

Convert the results of Step 4 to a RVU scale for each service. To do this, divide the results of Step 4 by the CF. Note that the actual value of the CF used in this calculation does not influence the final direct cost PE RVUs as long as the same CF is used in Step 4 and Step 5. Different CFs would result in different direct PE scaling adjustments, but this has no effect on the final direct cost PE RVUs since changes in the CFs and changes in the associated direct scaling adjustments offset one another. (c) Create the Indirect Cost PE RVUs Create indirect allocators.

Step 6. Based on the survey data, calculate direct and indirect PE percentages for each physician specialty. Step 7. Calculate direct and indirect PE percentages at the service level by taking a weighted average of the results of Step 6 for the specialties that furnish the service. Note that for services with TCs and PCs, the direct and indirect percentages for a given service do not vary by the PC, TC, and global service.

We generally use an average of the 3 most recent years of available Medicare claims data to determine the specialty mix assigned to each code. Codes with low Medicare service volume require special attention since billing or enrollment irregularities for a given year can result in significant changes in specialty mix assignment. We finalized a policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use the most recent year of claims data to determine which codes are low volume for the coming year (those that have fewer than 100 allowed services in the Medicare claims data). For codes that fall into this category, instead of assigning specialty mix based on the specialties of the practitioners reporting the services in the claims data, we use the expected specialty that we identify on a list developed based on medical review and input from expert stakeholders. We display this list of expected specialty assignments as part of the annual set of data files we make available as part of notice and comment rulemaking and consider recommendations from the RUC and other stakeholders on changes to this list on an annual basis.

Services for which the specialty is automatically assigned based on previously finalized policies under our established methodology (for example, “always therapy” services) are unaffected by the list of expected specialty assignments. We also finalized in the CY 2018 PFS final rule (82 FR 52982 through 59283) a policy to apply these service-level overrides for both PE and MP, rather than one or the other category. Step 8. Calculate the service level allocators for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components.

The direct PE RVUs. The clinical labor PE RVUs. And the work RVUs. For most services the indirect allocator is. Indirect PE percentage * (direct PE RVUs/direct percentage) + work RVUs.

There are two situations where this formula is modified. If the service is a global service (that is, a service with global, professional, and technical components), then the indirect PE allocator is. Indirect percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs + work RVUs. If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect Start Printed Page 39110allocator is. Indirect PE percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs.

(Note. For global services, the indirect PE allocator is based on both the work RVUs and the clinical labor PE RVUs. We do this to recognize that, for the PC service, indirect PEs would be allocated using the work RVUs, and for the TC service, indirect PEs would be allocated using the direct PE RVUs and the clinical labor PE RVUs. This also allows the global component RVUs to equal the sum of the PC and TC RVUs.) For presentation purposes, in the examples in the download file titled “Calculation of PE RVUs under Methodology for Selected Codes”, the formulas were divided into two parts for each service. The first part does not vary by service and is the indirect percentage (direct PE RVUs/direct percentage).

The second part is either the work RVU, clinical labor PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step). Apply a scaling adjustment to the indirect allocators. Step 9. Calculate the current aggregate pool of indirect PE RVUs by multiplying the result of step 8 by the average indirect PE percentage from the survey data. Step 10.

Calculate an aggregate pool of indirect PE RVUs for all PFS services by adding the product of the indirect PE allocators for a service from Step 8 and the utilization data for that service. Step 11. Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so that the aggregate indirect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8. Calculate the indirect practice cost index. Step 12.

Using the results of Step 11, calculate aggregate pools of specialty-specific adjusted indirect PE allocators for all PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the utilization data for that service. Step 13. Using the specialty-specific indirect PE/HR data, calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the work time for the service, and the specialty's utilization for the service across all services furnished by the specialty. Step 14. Using the results of Step 12 and Step 13, calculate the specialty-specific indirect PE scaling factors.

Step 15. Using the results of Step 14, calculate an indirect practice cost index at the specialty level by dividing each specialty-specific indirect scaling factor by the average indirect scaling factor for the entire PFS. Step 16. Calculate the indirect practice cost index at the service level to ensure the capture of all indirect costs. Calculate a weighted average of the practice cost index values for the specialties that furnish the service.

(Note. For services with TCs and PCs, we calculate the indirect practice cost index across the global service, PCs, and TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by the PC, TC, and global service.) Step 17. Apply the service level indirect practice cost index calculated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE RVUs. (d) Calculate the Final PE RVUs Step 18.

Add the direct PE RVUs from Step 5 to the indirect PE RVUs from Step 17 and apply the final PE budget neutrality (BN) adjustment. The final PE BN adjustment is calculated by comparing the sum of steps 5 and 17 to the aggregate work RVUs scaled by the ratio of current aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in the PFS account for the fact that certain specialties are excluded from the calculation of PE RVUs but included in maintaining overall PFS budget neutrality. (See “Specialties excluded from ratesetting calculation” later in this final rule.) Step 19. Apply the phase-in of significant RVU reductions and its associated adjustment.

Section 1848(c)(7) of the Act specifies that for services that are not new or revised codes, if the total RVUs for a service for a year would otherwise be decreased by an estimated 20 percent or more as compared to the total RVUs for the previous year, the applicable adjustments in work, PE, and MP RVUs shall be phased in over a 2-year period. In implementing the phase-in, we consider a 19 percent reduction as the maximum 1-year reduction for any service not described by a new or revised code. This approach limits the year one reduction for the service to the maximum allowed amount (that is, 19 percent), and then phases in the remainder of the reduction. To comply with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure that the total RVUs for all services that are not new or revised codes decrease by no more than 19 percent, and then apply a relativity adjustment to ensure that the total pool of aggregate PE RVUs remains relative to the pool of work and MP RVUs. For a more detailed description of the methodology for the phase-in of significant RVU changes, we refer readers to the CY 2016 PFS final rule with comment period (80 FR 70927 through 70931).

(e) Setup File Information Specialties excluded from ratesetting calculation. For the purposes of calculating the PE and MP RVUs, we exclude certain specialties, such as certain NPPs paid at a percentage of the PFS and low-volume specialties, from the calculation. These specialties are included for the purposes of calculating the BN adjustment. They are displayed in Table 1. Start Printed Page 39111 Crosswalk certain low volume physician specialties.

Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties. Physical therapy utilization. Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy. Identify professional and technical services not identified under the usual TC and 26 modifiers. Flag the services that are PC and TC services but do not use TC and 26 modifiers (for example, electrocardiograms).

This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads. Interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads. With interpretation and report). Payment modifiers.

Payment modifiers are accounted for in the creation of the file consistent with current payment policy as implemented in claims processing. For example, services billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that service. Therefore, the utilization file is modified to only account for 16 percent of any service that contains the assistant at surgery modifier. Similarly, for those services to which volume adjustments are made to account for the payment modifiers, time adjustments are applied as well. For time adjustments to surgical services, the intraoperative portion in the work time file is used.

Where it is not present, the intraoperative percentage from the payment files used by contractors to process Medicare claims is used instead. Where neither is available, we use the payment adjustment ratio to adjust the time accordingly. Table 2 details the manner in which the modifiers are applied. Start Printed Page 39112 We also make adjustments to volume and time that correspond to other payment rules, including special multiple procedure endoscopy rules and multiple procedure payment reductions (MPPRs). We note that section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments for multiple imaging procedures and multiple therapy services from the BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act.

These MPPRs are not included in the development of the RVUs. Beginning in CY 2022, section 1834(v)(1) of the Act requires that we apply a 15 percent payment reduction for outpatient occupational therapy services and outpatient physical therapy services that are provided, in whole or in part, by a physical therapist assistant (PTA) or occupational therapy assistant (OTA). Section 1834(v)(2)(A) of the Act required CMS to establish modifiers to identify these services, which we did in the CY 2019 PFS final rule (83 FR 59654 through 59661), creating the CQ and CO payment modifiers for services provided in whole or in part by PTAs and OTAs, respectively. These payment modifiers are required to be used on claims for services with dates of service beginning January 1, 2020, as specified in the CY 2020 PFS final rule (84 FR 62702 through 62708). We will apply the 15 percent payment reduction to therapy services provided by PTAs (using the CQ modifier) or OTAs (using the CO modifier), as required by statute.

Under sections 1834(k) and 1848 of the Act, payment is made for outpatient therapy services at 80 percent of the lesser of the actual charge or applicable fee schedule amount (the allowed charge). The remaining 20 percent is the beneficiary copayment. For therapy services to which the new discount applies, payment will be made at 85 percent of the 80 percent of allowed charges. Therefore, the volume discount factor for therapy services to which the CQ and CO modifiers apply is. (0.20 + (0.80* 0.85), which equals 88 percent.

For anesthesia services, we do not apply adjustments to volume since we use the average allowed charge when simulating RVUs. Therefore, the RVUs as calculated already reflect the payments as adjusted by modifiers, and no volume adjustments are necessary. However, a time adjustment of 33 percent is made only for medical direction of two to four cases since that is the only situation where a single practitioner is involved with multiple beneficiaries concurrently, so that counting each service without regard to the overlap with other services would overstate the amount of time spent by the practitioner furnishing these services. Work RVUs. The setup file contains the work RVUs from this final rule.

(6) Equipment Cost per Minute The equipment cost per minute is calculated as. (1/(minutes per year * usage)) * price * ((interest rate/(1−(1/((1 + interest rate)∧ life of equipment)))) + maintenance) Where. Minutes per year = maximum minutes per year if usage were continuous (that is, usage = 1). Generally 150,000 minutes. Usage = variable, see discussion below in this proposed rule.

Price = price of the particular piece of equipment. Life of equipment = useful life of the particular piece of equipment. Maintenance = factor for maintenance. 0.05. Interest rate = variable, see discussion below in this proposed rule.

Usage. We currently use an equipment utilization rate assumption of 50 percent for most equipment, with the exception of expensive diagnostic imaging equipment, for which we use a 90 percent assumption as required by section 1848(b)(4)(C) of the Act. Useful Life. In the CY 2005 PFS final rule we stated that we updated the useful life for equipment items primarily based on the AHA's “Estimated Useful Lives of Depreciable Hospital Assets” guidelines (69 FR 66246). The most recent edition of these guidelines was published in 2018.

This reference material provides an estimated useful life for hundreds of different types of equipment, the vast majority of which fall in the range of 5 to 10 years, and none of which are lower than 2 years in duration. We believe that the updated editions of this reference material remain the most accurate source for estimating the useful life of depreciable medical equipment.Start Printed Page 39113 In the CY 2021 PFS final rule, we finalized a proposal to treat equipment life durations of less than 1 year as having a duration of 1 year for the purpose of our equipment price per minute formula. In the rare cases where items are replaced every few months, we noted that we believe it is more accurate to treat these items as disposable supplies with a fractional supply quantity as opposed to equipment items with very short equipment life durations. For a more detailed discussion of the methodology associated with very short equipment life durations, we refer readers to the CY 2021 PFS final rule (85 FR 84482 through 84483). Maintenance.

We finalized the 5 percent factor for annual maintenance in the CY 1998 PFS final rule with comment period (62 FR 33164). As we previously stated in the CY 2016 PFS final rule with comment period (80 FR 70897), we do not believe the annual maintenance factor for all equipment is precisely 5 percent, and we concur that the current rate likely understates the true cost of maintaining some equipment. We also noted that we believe it likely overstates the maintenance costs for other equipment. When we solicited comments regarding sources of data containing equipment maintenance rates, commenters were unable to identify an auditable, robust data source that could be used by CMS on a wide scale. We noted that we did not believe voluntary submissions regarding the maintenance costs of individual equipment items would be an appropriate methodology for determining costs.

As a result, in the absence of publicly available datasets regarding equipment maintenance costs or another systematic data collection methodology for determining a different maintenance factor, we did not propose a variable maintenance factor for equipment cost per minute pricing as we did not believe that we have sufficient information at present. We noted that we would continue to investigate potential avenues for determining equipment maintenance costs across a broad range of equipment items. Interest Rate. In the CY 2013 PFS final rule with comment period (77 FR 68902), we updated the interest rates used in developing an equipment cost per minute calculation (see 77 FR 68902 for a thorough discussion of this issue). The interest rate was based on the Small Business Administration (SBA) maximum interest rates for different categories of loan size (equipment cost) and maturity (useful life).

The Interest rates are listed in Table 3. We are not proposing any changes to the equipment interest rates for CY 2022. 3. Changes to Direct PE Inputs for Specific Services This section focuses on specific PE inputs. The direct PE inputs are included in the CY 2022 direct PE input public use files, which are available on the CMS website under downloads for the CY 2022 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

a. Standardization of Clinical Labor Tasks As we noted in the CY 2015 PFS final rule with comment period (79 FR 67640 through 67641), we continue to make improvements to the direct PE input database to provide the number of clinical labor minutes assigned for each task for every code in the database instead of only including the number of clinical labor minutes for the preservice, service, and post service periods for each code. In addition to increasing the transparency of the information used to set PE RVUs, this level of detail would allow us to compare clinical labor times for activities associated with services across the PFS, which we believe is important to maintaining the relativity of the direct PE inputs. This information would facilitate the identification of the usual numbers of minutes for clinical labor tasks and the identification of exceptions to the usual values. It would also allow for greater transparency and consistency in the assignment of equipment minutes based on clinical labor times.

Finally, we believe that the detailed information can be useful in maintaining standard times for particular clinical labor tasks that can be applied consistently to many codes as they are valued over several years, similar in principle to the use of physician preservice time packages. We believe that setting and maintaining such standards would provide greater consistency among codes that share the same clinical labor tasks and could improve relativity of values among codes. For example, as medical practice and technologies change over time, changes in the standards could be updated simultaneously for all codes with the applicable clinical labor tasks, instead of waiting for individual codes to be reviewed. In the CY 2016 PFS final rule with comment period (80 FR 70901), we solicited comments on the appropriate standard minutes for the clinical labor tasks associated with services that use digital technology. After consideration of comments received, we finalized standard times for clinical labor tasks associated with digital imaging at 2 minutes for “Availability of prior images confirmed”, 2 minutes for “Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist”, 2 minutes for “Review examination with interpreting MD”, and 1 minute for “Exam documents scanned into PACS” and “Exam completed in RIS system to generate billing process and to populate images into Radiologist work queue.” In the CY 2017 PFS final rule (81 FR 80184 through 80186), we finalized a policy to establish a range of appropriate standard minutes for the clinical labor activity, “Technologist QCs images in PACS, checking for all images, reformats, and dose page.” These standard minutes will be applied to new and revised Start Printed Page 39114codes that make use of this clinical labor activity when they are reviewed by us for valuation.

We finalized a policy to establish 2 minutes as the standard for the simple case, 3 minutes as the standard for the intermediate case, 4 minutes as the standard for the complex case, and 5 minutes as the standard for the highly complex case. These values were based upon a review of the existing minutes assigned for this clinical labor activity. We determined that 2 minutes is the duration for most services and a small number of codes with more complex forms of digital imaging have higher values. We also finalized standard times for a series of clinical labor tasks associated with pathology services in the CY 2016 PFS final rule with comment period (80 FR 70902). We do not believe these activities would be dependent on number of blocks or batch size, and we believe that the finalized standard values accurately reflect the typical time it takes to perform these clinical labor tasks.

In reviewing the RUC-recommended direct PE inputs for CY 2019, we noticed that the 3 minutes of clinical labor time traditionally assigned to the “Prepare room, equipment and supplies” (CA013) clinical labor activity were split into 2 minutes for the “Prepare room, equipment and supplies” activity and 1 minute for the “Confirm order, protocol exam” (CA014) activity. We proposed to maintain the 3 minutes of clinical labor time for the “Prepare room, equipment and supplies” activity and remove the clinical labor time for the “Confirm order, protocol exam” activity wherever we observed this pattern in the RUC-recommended direct PE inputs. Commenters explained in response that when the new version of the PE worksheet introduced the activity codes for clinical labor, there was a need to translate old clinical labor tasks into the new activity codes, and that a prior clinical labor task was split into two of the new clinical labor activity codes. CA007 (Review patient clinical extant information and questionnaire) in the preservice period, and CA014 (Confirm order, protocol exam) in the service period. Commenters stated that the same clinical labor from the old PE worksheet was now divided into the CA007 and CA014 activity codes, with a standard of 1 minute for each activity.

We agreed with commenters that we would finalize the RUC-recommended 2 minutes of clinical labor time for the CA007 activity code and 1 minute for the CA014 activity code in situations where this was the case. However, when reviewing the clinical labor for the reviewed codes affected by this issue, we found that several of the codes did not include this old clinical labor task, and we also noted that several of the reviewed codes that contained the CA014 clinical labor activity code did not contain any clinical labor for the CA007 activity. In these situations, we continue to believe that in these cases, the 3 total minutes of clinical staff time would be more accurately described by the CA013 “Prepare room, equipment and supplies” activity code, and we finalized these clinical labor refinements. For additional details, we direct readers to the discussion in the CY 2019 PFS final rule (83 FR 59463 and 59464). Following the publication of the CY 2020 PFS proposed rule, a commenter expressed concern with the published list of common refinements to equipment time.

The commenter stated that these refinements were the formulaic result of the applying refinements to the clinical labor time and did not constitute separate refinements. The commenter requested that CMS no longer include these refinements in the table published each year. In the CY 2020 PFS final rule, we agreed with the commenter that these equipment time refinements did not reflect errors in the equipment recommendations or policy discrepancies with the RUC's equipment time recommendations. However, we believed that it was important to publish the specific equipment times that we were proposing (or finalizing in the case of the final rule) when they differed from the recommended values due to the effect that these changes can have on the direct costs associated with equipment time. Therefore, we finalized the separation of the equipment time refinements associated with changes in clinical labor into a separate table of refinements.

For additional details, we direct readers to the discussion in the CY 2020 PFS final rule (84 FR 62584). Historically, the RUC has submitted a “PE worksheet” that details the recommended direct PE inputs for our use in developing PE RVUs. The format of the PE worksheet has varied over time and among the medical specialties developing the recommendations. These variations have made it difficult for both the RUC's development and our review of code values for individual codes. Beginning with its recommendations for CY 2019, the RUC has mandated the use of a new PE worksheet for purposes of their recommendation development process that standardizes the clinical labor tasks and assigns them a clinical labor activity code.

We believe the RUC's use of the new PE worksheet in developing and submitting recommendations will help us to simplify and standardize the hundreds of different clinical labor tasks currently listed in our direct PE database. As we did in previous calendar years, to facilitate rulemaking for CY 2022, we are continuing to display two versions of the Labor Task Detail public use file. One version with the old listing of clinical labor tasks, and one with the same tasks crosswalked to the new listing of clinical labor activity codes. These lists are available on the CMS website under downloads for the CY 2022 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. B.

Technical Corrections to Direct PE Input Database and Supporting Files For CY 2022, we are proposing to address the following. Following the publication of the CY 2021 PFS proposed rule, several commenters questioned the proposed RVUs associated with several occupational therapy evaluation procedures (CPT codes 97165 through 97167). Commenters stated that the PE valuation for these codes appeared to be illogical as it was counterintuitive for the PE RVU to go down as the level of complexity increased. Commenters stated that the distribution of code usage has not changed in any manner to justify a reduction in the code values and that all three evaluation codes should reimburse at the same rate. In response to the commenters, we noted that although the three codes in question shared the same work RVU and the same direct PE inputs, they did not share the same specialty distribution in the claims data and therefore would not necessarily receive the same allocation of indirect PE.

In the CY 2021 PFS final rule (85 FR 84490), we finalized the implementation of a technical change intended to ensure that these three services received the same allocation of indirect PE. We agreed with commenters that it was important to avoid a potential rank order anomaly in which the simple case for a service was valued higher than the complex case. After the publication of the CY 2021 PFS final rule, stakeholders stated their appreciation for the technical change made in the final rule to ensure that the indirect PE allocation was the same for all three levels of occupational therapy evaluation codes. However, stakeholders expressed concern that the PE RVUs we finalized for CPT codes Start Printed Page 3911597165-97167 decreased as compared to the PE RVUs we proposed for CY 2021. Stakeholders stated that nothing had occurred in the past year that would account for a reduction to the proposed PE for these codes, especially in a year where the proposed PE increased for the corresponding physical therapy evaluation procedures (CPT codes 97161-97163), and stakeholders questioned whether there had been an error in applying the indirect PE methodology.

We reviewed the indirect PE allocation for CPT codes 97165-97167 in response to the stakeholder inquiry and we do not agree that there was an error in applying the indirect PE methodology. We finalized a technical change in the CY 2021 PFS final rule intended to ensure that these three services received the same allocation of indirect PE, which achieved its desired goal of assigning equivalent indirect PE to these three services. However, by forcing CPT codes 97165-97167 to have the same indirect PE allocation, the indirect PE values for these codes no longer relied on the claims data, which ended up affecting the indirect practice cost index for the wider occupational therapy specialty. Because CPT codes 97165-97167 are high volume services, this resulted in a lower indirect practice cost index for the occupational therapy specialty and a smaller allocation of indirect PE for CY 2021 than initially proposed. We are addressing this issue for CY 2022 by proposing to assign all claims data associated with CPT codes 97165-97167 to the occupational therapy specialty.

This should ensure that CPT codes 97165-97167 would always receive the same indirect PE allocation as well as preventing any fluctuations to the indirect practice cost index for the wider occupational therapy specialty. This proposal is intended to avoid a potential rank order anomaly in which the simple case for a service is valued higher than the complex case. As the utilization for CPT codes 97165-97167 is overwhelmingly identified as performed by occupational therapists, we do not anticipate that assigning all of the claims data for these codes to the occupational therapy specialty will have a noticeable effect on their valuation. We are soliciting public comments regarding this proposal, and specifically on what commenters suggest as the most appropriate method of assigning indirect PE allocation for these services. In the CY 2020 PFS final rule (84 FR 63102 through 63104), we created two new HCPCS G codes, G2082 and G2083, effective January 1, 2020 on an interim final basis for the provision of self-administered esketamine.

In the CY 2021 PFS final rule, we finalized a proposal to refine the values for HCPCS codes G2082 and G2083 using a building block methodology that summed the values associated with several codes (85 FR 84641 through 84642). Following the publication of the CY 2021 PFS final rule, stakeholders expressed their concern that the finalized PE RVU had decreased for HCPCS codes G2082 and G2083 as compared to the proposed valuation and as compared to the previous CY 2020 interim final valuation. Stakeholders questioned whether there had been an error in the PE allocation since CMS had finalized increases in the direct PE inputs for the services. We reviewed the indirect PE allocation for HCPCS codes G2082 and G2083 in response to the stakeholder inquiry and discovered a technical change that was applied in error. Specifically, we inadvertently assigned a different physician specialty than we intended (“All Physicians”) to HCPCS codes G2082 and G2083 for indirect PE allocation in our ratesetting process during valuation of these codes in the CY 2020 PFS final rule, and continued that assignment into the CY 2021 PFS proposed rule.

This specialty assignment caused the PE value for these services to be higher than anticipated for CY 2020. We intended to revise the assigned physician specialty for these codes to “General Practice” in the CY 2021 PFS final rule. However, we neglected to discuss this change in the course of PFS rulemaking for CY 2021. Since we initially applied this technical change in the CY 2021 PFS final rule without providing an explanation, we issued a correction notice (86 FR 14690) to remove this change from the CY 2021 PFS final rule, and to instead maintain the All Physicians specialty assignment through CY 2021. We apologize for any confusion this may have caused.

For CY 2022, we are proposing to maintain the currently assigned physician specialty for indirect PE allocation for HCPCS codes G2082 and G2083. We are proposing to assign these two services to the All Physicians specialty for indirect PE allocation which will maintain payment consistency with the rates published in the CY 2020 PFS final rule and the CY 2021 PFS proposed rule. Although we had previously intended to assign the General Practice specialty to these codes, stakeholders have provided additional information about these services suggesting that maintaining the All Physicians specialty assignment for these codes will help maintain payment stability and preserve access to this care for beneficiaries. We are soliciting public comments to help us discern which specialty would be the most appropriate to use for indirect PE allocation for HCPCS codes G2082 and G2083. We note that the PE methodology, which relies on the allocation of indirect costs based on the magnitude of direct costs, should appropriately reflect the typical costs for the specialty the commenters suggest.

For example, we do not believe it would be appropriate to assign the Psychiatry specialty for these services given that HCPCS codes G2082 and G2083 include the high direct costs associated with esketamine supplies. The Psychiatry specialty is an outlier compared to most other specialties, allocating indirect costs at a 15:1 ratio based on direct costs because psychiatry services typically have very low direct costs. Assignment of most other specialties would result in allocation of direct costs at roughly a 3:1 ratio. We request that commenters explain in their comments how the indirect PE allocation would affect the payment for these services. Specifically, to ensure appropriate payment for HCPCS codes G2082 and G2083, we would like to get a better understanding of the indirect costs associated with these services, relative to other services furnished by the suggested specialty.

A stakeholder contacted us regarding a potential error involving the intraservice work time for CPT code 35860 (Exploration for postoperative hemorrhage, thrombosis or . Extremity). The stakeholder stated that the RUC recommended an intraservice work time of 90 minutes for this code when it was last reviewed in the CY 2012 PFS final rule and we finalized the work time without refinement at 60 minutes (76 FR 73131). The stakeholder requested that the intraservice work time for CPT code 35860 should be updated to 90 minutes. We reviewed the intraservice work time for CPT code 35860 and found that the RUC inadvertently recommended a time of 60 minutes for the code, which we proposed and finalized without comment in rulemaking for the CY 2012 PFS.

As a result, we do not believe that this is a technical error on our part. However, since the stakeholder has clarified that the RUC intended to recommend 90 minutes of intraservice work time for CPT code 35860 based on the surveyed median time, we are proposing to update the intraservice work time to 90 minutes to match the survey results.Start Printed Page 39116 c. Updates to Prices for Existing Direct PE Inputs In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a process to act on public requests to update equipment and supply price and equipment useful life inputs through annual rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2022, we are proposing to update the price of six supplies and two equipment items in response to the public submission of invoices. Since this is the final year of the supply and equipment pricing update, the new pricing for each of these supply and equipment items will take effect for CY 2022 as there are no remaining years of the transition.

The six supply and equipment items with proposed updated prices are listed in the valuation of specific codes section of the preamble under Table 16. CY 2022 Invoices Received for Existing Direct PE Inputs. (1) Market-Based Supply and Equipment Pricing Update Section 220(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93, April 1, 2014) provides that the Secretary may collect or obtain information from any eligible professional or any other source on the resources directly or indirectly related to furnishing services for which payment is made under the PFS, and that such information may be used in the determination of relative values for services under the PFS.

Such information may include the time involved in furnishing services. The amounts, types and prices of PE inputs. Overhead and accounting information for practices of physicians and other suppliers, and any other elements that would improve the valuation of services under the PFS. As part of our authority under section 1848(c)(2)(M) of the Act, we initiated a market research contract with StrategyGen to conduct an in-depth and robust market research study to update the PFS direct PE inputs (DPEI) for supply and equipment pricing for CY 2019. These supply and equipment prices were last systematically developed in 2004-2005.

StrategyGen submitted a report with updated pricing recommendations for approximately 1300 supplies and 750 equipment items currently used as direct PE inputs. This report is available as a public use file displayed on the CMS website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. The StrategyGen team of researchers, attorneys, physicians, and health policy experts conducted a market research study of the supply and equipment items currently used in the PFS direct PE input database. Resources and methodologies included field surveys, aggregate databases, vendor resources, market scans, market analysis, physician substantiation, and statistical analysis to estimate and validate current prices for medical equipment and medical supplies. StrategyGen conducted secondary market research on each of the 2,072 DPEI medical equipment and supply items that CMS identified from the current DPEI.

The primary and secondary resources StrategyGen used to gather price data and other information were. Telephone surveys with vendors for top priority items (Vendor Survey). Physician panel validation of market research results, prioritized by total spending (Physician Panel). The General Services Administration system (GSA). An aggregate health system buyers database with discounted prices (Buyers).

Publicly available vendor resources, that is, Amazon Business, Cardinal Health (Vendors). The Federal Register, current DPEI data, historical proposed and final rules prior to CY 2018, and other resources. That is, AMA RUC reports (References). StrategyGen prioritized the equipment and supply research based on current share of PE RVUs attributable by item provided by CMS. StrategyGen developed the preliminary Recommended Price (RP) methodology based on the following rules in hierarchical order considering both data representativeness and reliability.

(1) If the market share, as well as the sample size, for the top three commercial products were available, the weighted average price (weighted by percent market share) was the reported RP. Commercial price, as a weighted average of market share, represents a more robust estimate for each piece of equipment and a more precise reference for the RP. (2) If no data were available for commercial products, the current CMS prices were used as the RP. GSA prices were not used to calculate the StrategyGen recommended prices, due to our concern that the GSA system curtails the number and type of suppliers whose products may be accessed on the GSA Advantage website, and that the GSA prices may often be lower than prices that are available to non-governmental purchasers. After reviewing the StrategyGen report, we proposed to adopt the updated direct PE input prices for supplies and equipment as recommended by StrategyGen.

StrategyGen found that despite technological advancements, the average commercial price for medical equipment and supplies has remained relatively consistent with the current CMS price. Specifically, preliminary data indicated that there was no statistically significant difference between the estimated commercial prices and the current CMS prices for both equipment and supplies. This cumulative stable pricing for medical equipment and supplies appears similar to the pricing impacts of non-medical technology advancements where some historically high-priced equipment (that is, desktop PCs) has been increasingly substituted with current technology (that is, laptops and tablets) at similar or lower price points. However, while there were no statistically significant differences in pricing at the aggregate level, medical specialties would experience increases or decreases in their Medicare payments if we were to adopt the pricing updates recommended by StrategyGen. At the service level, there may be large shifts in PE RVUs for individual codes that happened to contain supplies and/or equipment with major changes in pricing, although we note that codes with a sizable PE RVU decrease would be limited by the requirement to phase in significant reductions in RVUs, as required by section 1848(c)(7) of the Act.

The phase-in requirement limits the maximum RVU reduction for codes that are not new or revised to 19 percent in any individual calendar year. We believe that it is important to make use of the most current information available for supply and equipment pricing instead of continuing to rely on pricing information that is more than a decade old. Given the potentially significant changes in payment that would occur, both for specific services and more broadly at the specialty level, in the CY 2019 PFS proposed rule we proposed to phase in our use of the new direct PE input pricing over a 4-year period using a 25/75 percent (CY 2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021), and 100/0 percent (CY 2022) split between new and old pricing. This approach is consistent with how we have previously incorporated significant new data into the calculation of PE RVUs, such as the 4-year transition period finalized in CY 2007 PFS final rule with comment period when changing to the “bottom-Start Printed Page 39117up” PE methodology (71 FR 69641). This transition period will not only ease the shift to the updated supply and equipment pricing, but will also allow interested parties an opportunity to review and respond to the new pricing information associated with their services.

We proposed to implement this phase-in over 4 years so that supply and equipment values transition smoothly from the prices we currently include to the final updated prices in CY 2022. We proposed to implement this pricing transition such that one quarter of the difference between the current price and the fully phased-in price is implemented for CY 2019, one third of the difference between the CY 2019 price and the final price is implemented for CY 2020, and one half of the difference between the CY 2020 price and the final price is implemented for CY 2021, with the new direct PE prices fully implemented for CY 2022. An example of the transition from the current to the fully-implemented new pricing is provided in Table 4. For new supply and equipment codes for which we establish prices during the transition years (CYs 2019, 2020 and 2021) based on the public submission of invoices, we proposed to fully implement those prices with no transition since there are no current prices for these supply and equipment items. These new supply and equipment codes would immediately be priced at their newly established values.

We also proposed that, for existing supply and equipment codes, when we establish prices based on invoices that are submitted as part of a revaluation or comprehensive review of a code or code family, they will be fully implemented for the year they are adopted without being phased in over the 4-year pricing transition. The formal review process for a HCPCS code includes a review of pricing of the supplies and equipment included in the code. When we find that the price on the submitted invoice is typical for the item in question, we believe it would be appropriate to finalize the new pricing immediately along with any other revisions we adopt for the code valuation. For existing supply and equipment codes that are not part of a comprehensive review and valuation of a code family and for which we establish prices based on invoices submitted by the public, we proposed to implement the established invoice price as the updated price and to phase in the new price over the remaining years of the proposed 4-year pricing transition. During the proposed transition period, where price changes for supplies and equipment are adopted without a formal review of the HCPCS codes that include them (as is the case for the many updated prices we proposed to phase in over the 4-year transition period), we believe it is important to include them in the remaining transition toward the updated price.

We also proposed to phase in any updated pricing we establish during the 4-year transition period for very commonly used supplies and equipment that are included in 100 or more codes, such as sterile gloves (SB024) or exam tables (EF023), even if invoices are provided as part of the formal review of a code family. We would implement the new prices for any such supplies and equipment over the remaining years of the proposed 4-year transition period. Our proposal was intended to minimize any potential disruptive effects during the proposed transition period that could be caused by other sudden shifts in RVUs due to the high number of services that make use of these very common supply and equipment items (meaning that these items are included in 100 or more codes). We believed that implementing the proposed updated prices with a 4-year phase-in would improve payment accuracy, while maintaining stability and allowing stakeholders the opportunity to address potential concerns about changes in payment for particular items. Updating the pricing of direct PE inputs for supplies and equipment over a longer timeframe will allow more opportunities for public comment and submission of additional, applicable data.

We welcomed feedback from stakeholders on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration. We received many comments regarding the market-based supply and equipment pricing proposal following the publication of the CY 2019 PFS proposed rule. For a full discussion of these comments, we direct readers to the CY 2019 PFS final rule (83 FR 59475 through 59480). In each instance in which a commenter raised questions about the accuracy of a supply or equipment code's recommended price, the StrategyGen contractor conducted further research on the item and its price with special attention to ensuring that the recommended price was based on the correct item in question and the clarified unit of measure. Based on the commenters' requests, the StrategyGen contractor conducted an extensive examination of the pricing of any supply or equipment items that any commenter identified as requiring additional review.

Invoices submitted by multiple commenters were greatly appreciated and ensured that medical equipment and supplies were re-examined and clarified. Multiple researchers reviewed these specified supply and equipment codes for accuracy and proper pricing. In most cases, the contractor also reached out to a team of nurses and their physician panel to further validate the accuracy of the data and pricing information. In some cases, the pricing for individual items needed further clarification due to a lack of information or due to significant variation in packaged items. After consideration of the comments and this additional price research, we updated the recommended prices for approximately 70 supply and equipment codes identified by the commenters.

Table 9 in the CY 2019 PFS final rule lists the supply and equipment codes with price changes based on feedback from the commenters and the resulting additional research into pricing (83 FR 59479 through 59480). After consideration of the public comments, we finalized our proposals Start Printed Page 39118associated with the market research study to update the PFS direct PE inputs for supply and equipment pricing. We continue to believe that implementing the updated prices with a 4-year phase-in will improve payment accuracy, while maintaining stability and allowing stakeholders the opportunity to address potential concerns about changes in payment for particular items. We continue to welcome feedback from stakeholders on the updated supply and equipment pricing, including the submission of additional invoices for consideration. For CY 2022, we received invoice submissions from stakeholders for approximately half a dozen supply and equipment codes as part of the fourth year of the market-based supply and equipment pricing update.

We used these submitted invoices in many cases to supplement the pricing originally proposed for the CY 2019 PFS rule cycle. We reviewed the invoices, as well as our own data for the relevant supply/equipment codes to make sure the item in the invoice was representative of the supply/equipment item in question and aligned with past research. Based on this review, we are proposing to update the prices of six supply items listed in the valuation of specific codes section of the preamble under Table 16. CY 2022 Invoices Received for Existing Direct PE Inputs. Since this is the final year of the supply and equipment pricing update, the new pricing for each of these supply and equipment items would take effect immediately for CY 2022.

The proposed prices for the supply and equipment items listed in Table 16 of CY 2022 were generally calculated following our standard methodology of averaging together the prices on the submitted invoices. In the case of the Liquid coverslip (Ventana 650-010) (SL479) supply, we are proposing a price of $0.051 based on the median invoice due to the presence of an outlier invoice that substantially increased the pricing when using an average. We believe that the proposed price of $0.051 would be more typical for the SL479 supply based on the pricing information contained on the other submitted invoices. We also received several invoices for the 3C patch system (SD343) supply. However, since we established a price of $625.00 for this supply in last year's CY 2021 PFS final rule and the submitted invoices had an average price of $612.50, we are not proposing to update the price.

We believe that the submitted invoices confirm that the current pricing of $625.00 is typical for the SD343 supply. (2) Invoice Submission The full list of updated supply and equipment pricing as implemented over the 4-year transition period will be made available as a public use file displayed on the CMS website under downloads for the CY 2022 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. We routinely accept public submission of invoices as part of our process for developing payment rates for new, revised, and potentially misvalued codes. Often these invoices are submitted in conjunction with the RUC-recommended values for the codes. To be included in a given year's proposed rule, we generally need to receive invoices by the same February 10th deadline we noted for consideration of RUC recommendations.

However, we will consider invoices submitted as public comments during the comment period following the publication of the PFS proposed rule, and would consider any invoices received after February 10th or outside of the public comment process as part of our established annual process for requests to update supply and equipment prices. Stakeholders are encouraged to submit invoices with their public comments or, if outside the notice and comment rulemaking process, via email at PE_Price_Input_Update@cms.hhs.gov. (3) Autologous Platelet-Rich Plasma (HCPCS Code G0460) Supply Inputs We did not make any proposals associated with HCPCS code G0460 (Autologous platelet rich plasma for chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures, administration and dressings, per treatment) in the CY 2021 PFS proposed rule. Following publication of the rule, stakeholders contacted CMS regarding the creation of a new 3C patch system supply, which is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically-debrided wounds. Stakeholders first sought clarification on how CMS calculated the underlying nonfacility PE RVUs for HCPCS code G0460.

Stakeholders also stated that autologous platelet rich plasma administration procedures furnished in clinical trials (including the new 3C patch system) are reported using HCPCS code G0460 and requested that CMS revalue the service to reflect the PEs associated with the new patch system supply. The stakeholders stated that the use of the new 3C patch system will represent the typical case for HCPCS code G0460, and suggested that, therefore, the cost inputs for this supply should be used to establish the RVUs for this code, as the current PFS payment rate is substantially less than the amount it costs to furnish the 3C patch. We want to clarify that the direct PE inputs for HCPCS code G0460 increased for CY 2021 as a result of the ongoing market-based supply and equipment pricing update. However, there was also a minor decrease in the indirect PE allocation associated with this service for CY 2021, with the net result that the proposed PE RVU coincidentally ended up remaining the same as in the previous year. We also clarify that HCPCS code G0460 is not included in the Anticipated Specialty Assignment for Low Volume Services list, and therefore, was unaffected by low utilization in the claims data.

In addition, as a contractor priced service, HCPCS code G0460 is unaffected by inclusion or exclusion from this list. We share the concerns of the stakeholders that patient access to the 3C patch could be materially impacted if CMS maintains the current PE RVUs for HCPCS G0460. In the CY 2021 PFS final rule, we established contractor pricing for HCPCS code G0460 for CY 2021. We believe that the use of contractor pricing again for CY 2022 will allow us additional time to consider the most appropriate resource inputs and PE RVUs for HCPCS code G0460. We also added the 3C patch system to our supply database under supply code SD343 at a price of $625.00 based on an average of the submitted invoices.

We are proposing to maintain contractor pricing for CY 2022 for HCPCS code G0460 as we do not currently have sufficient information to establish national pricing. It remains unclear to us what the typical supply inputs would be for HCPCS code G0460 and whether they would include the use of the new 3C patch system. We believe that it would be more appropriate to maintain contractor pricing for the service, which will allow for more flexibility in pricing. We are soliciting any additional information that commenters can supply that CMS should consider to establish national payment for HCPCS code G0460. D.

Clinical Labor Pricing Update Section 220(a) of the PAMA provides that the Secretary may collect or obtain information from any eligible professional or any other source on the resources directly or indirectly related to furnishing services for which payment is made under the PFS, and Start Printed Page 39119that such information may be used in the determination of relative values for services under the PFS. Such information may include the time involved in furnishing services. The amounts, types and prices of PE inputs. Overhead and accounting information for practices of physicians and other suppliers, and any other elements that would improve the valuation of services under the PFS. Since 2019, we have been updating the supply and equipment prices used for PE as part of a market-based pricing transition.

CY 2022 will be the final year of this 4-year transition. We initiated a market research contract with StrategyGen to conduct an in-depth and robust market research study to update the supply and equipment pricing for CY 2019, and we finalized a policy in CY 2019 to phase in the new pricing over a period of 4 years. However, we did not propose to update the clinical labor pricing, and the pricing for clinical labor has remained unchanged during this pricing transition. Clinical labor rates were last updated for CY 2002 using Bureau of Labor Statistics (BLS) data and other supplementary sources where BLS data were not available. We refer readers to the full discussion in the CY 2002 PFS final rule for additional details (66 FR 55257 through 55262).

Stakeholders have raised concerns that the long delay since clinical labor pricing was last updated has created a significant disparity between CMS' clinical wage data and the market average for clinical labor. In recent years, a number of stakeholders have suggested that certain wage rates are inadequate because they do not reflect current labor rate information. Some stakeholders have also stated that updating the supply and equipment pricing without updating the clinical labor pricing could create distortions in the allocation of direct PE. Since the pool of aggregated direct PE inputs is budget neutral, if these rates are not routinely updated, clinical labor may become undervalued over time relative to equipment and supplies, especially since the supply and equipment prices are in the process of being updated. There has been considerable stakeholder interest in updating the clinical labor rates, and when we solicited comment on this topic in past rules, such as in the CY 2019 PFS final rule (83 FR 59480), stakeholders supported the idea.

Therefore, we are proposing to update the clinical labor pricing for CY 2022, in conjunction with the final year of the supply and equipment pricing update. We believe it is important to update the clinical labor pricing to maintain relativity with the recent supply and equipment pricing updates. We are proposing to use the methodology outlined in the CY 2002 PFS final rule (66 FR 55257), which draws primarily from BLS wage data, to calculate updated clinical labor pricing. As we stated in the CY 2002 PFS final rule, the BLS' reputation for publishing valid estimates that are nationally representative led to the choice to use the BLS data as the main source. We believe that the BLS wage data continues to be the most accurate source to use as a basis for clinical labor pricing and this data will appropriately reflect changes in clinical labor resource inputs for purposes of setting PE RVUs under the PFS.

We used the most current BLS survey data (2019) as the main source of wage data for this proposal. We recognize that the BLS survey of wage data does not cover all the staff types contained in our direct PE database. Therefore, we crosswalked or extrapolated the wages for several staff types using supplementary data sources for verification whenever possible. In situations where the price wages of clinical labor types were not referenced in the BLS data, we have used the national salary data from the Salary Expert, an online project of the Economic Research Institute that surveys national and local salary ranges and averages for thousands of job titles using mainly government sources. (A detailed explanation of the methodology used by Salary Expert to estimate specific job salaries can be found at www.salaryexpert.com).

We previously used Salary Expert information as the primary backup source of wage data during the last update of clinical labor pricing in CY 2002. If we did not have direct BLS wage data available for a clinical labor type, we used the wage data from Salary Expert as a reference for pricing, then crosswalked these clinical labor types to a proxy BLS labor category rate that most closely matched the reference wage data, similar to the crosswalks used in our PE/HR allocation. For example, there is no direct BLS wage data for the Mammography Technologist (L043) clinical labor type. We used the wage data from Salary Expert as a reference and identified the BLS wage data for Respiratory Therapists as the best proxy category. We calculated rates for the “blend” clinical labor categories by combining the rates for each labor type in the blend and then dividing by the total number of labor types in the blend.

As in the CY 2002 clinical labor pricing update, the proposed cost per minute for each clinical staff type was derived by dividing the average hourly wage rate by 60 to arrive at the per minute cost. In cases where an hourly wage rate was not available for a clinical staff type, the proposed cost per minute for the clinical staff type was derived by dividing the annual salary (converted to 2021 dollars using the Medicare Economic Index) by 2080 (the number of hours in a typical work year) to arrive at the hourly wage rate and then again by 60 to arrive at the per minute cost. To account for the employers' cost of providing fringe benefits, such as sick leave, we used the same benefits multiplier of 1.366 as employed in CY 2002. As an example of this process, for the Physical Therapy Aide (L023A) clinical labor type, the BLS data reflected an average hourly wage rate of $14.03, which we multiplied by the 1.366 benefits modifier and then divided by 60 minutes to arrive at the proposed per-minute rate of $0.32. Table 5 lists our proposed updates to the clinical labor prices.

The BLS occupational code used as a source of wage data is listed for each clinical labor type. For the “blend” clinical labor types, this may include multiple BLS occupational codes and other clinical labor types which were calculated separately and then averaged together. Clinical labor types without a direct BLS labor category where we are employing a proxy BLS wage rate are indicated with an asterisk in Table 5. Start Printed Page 39120 We are proposing to use the 75th percentile of the average wage data for the Medical Physicist (L152A) clinical labor type because we believe this level Start Printed Page 39121would most closely fit with the historic wage data for this clinical labor type. A Medical Physicist is a specific type of physicist, and the available BLS wage data describes the more general category of physicist which is paid at a lower rate.

In this specific case, the 75th percentile more accurately describes the clinical labor type in question based on how it has historically been paid. We are also proposing to maintain the current clinical labor pricing for the Behavioral Health Care Manager (L057B) clinical labor type rather than update it. Although the BLS data reflected a decreased clinical labor rate for the Behavioral Health Care Manager labor type, we do not believe that the typical wages have decreased for this clinical labor type given that every other clinical labor type has increased over the past 5 years since the Behavioral Health Care Manager clinical labor type was created. The Behavioral Health Care Manager labor type was initially established in the CY 2017 PFS final rule (81 FR 80350). It seems more likely that we misidentified the proper BLS category for this clinical labor type than that wages have decreased since 2017.

We believe that the clinical labor rate for the Behavioral Health Care Manager should be held constant for CY 2022 pending additional public feedback. We are soliciting comments on the proposed updated clinical labor pricing. We are particularly interested in additional wage data for the clinical labor types for which we lacked direct BLS wage data and made use of proxy labor categories for pricing. We understand that the clinical labor undertaken by, for example, a Histotechnologist (L037B) is not the same as the clinical labor provided by the Health Information Technologist category of BLS wage data that we employed as a proxy for pricing. Although these occupations are not directly analogous to each other in terms of the work they do, we nonetheless believe that the proposed crosswalks are appropriate in terms of the resulting hourly wage data.

We appreciate any additional information that commenters can supply both in terms of direct wage data, as well as identifying the most accurate types of BLS categories that could be used as proxies to update pricing for clinical labor types that lack direct BLS wage data. We isolated the anticipated effects of the clinical labor pricing update on specialty payment impacts by comparing the proposed CY 2022 PFS rates with and without the clinical labor pricing updates in place. Start Printed Page 39122 Start Printed Page 39123 The potential effects of the clinical labor pricing update on specialty payment impacts are largely driven by the share that labor costs represent of the direct PE inputs for each specialty. Specialties with a substantially lower or higher than average share of direct costs attributable to labor would experience significant declines or increases, respectively, if this proposal is finalized. For example, the Family Practice specialty has a higher share of direct costs associated with clinical labor, and payments to services comprising the specialty would be expected to increase as a result of this clinical labor pricing update.

In contrast, Diagnostic Testing Facilities have a lower share of direct costs that are associated with clinical labor, and payments to services comprising the specialty would be expected to decrease. Other specialty-level payment impacts for the proposed clinical labor pricing changes are driven by changes in wage rates for a clinical labor category that affects a given specialty more than average. One such example would be the proposed increase of 11 percent for Oncology nurses as opposed to the average increase for nurses of 63 percent. We emphasize that these are not the projected impacts by specialty of all the policies we are proposing in this proposed rule for CY 2022, only the anticipated effect of the isolated clinical labor pricing update, should this clinical labor pricing update be finalized as proposed. When updates to our payment methodology based on new data produce significant shifts in payment, we often consider whether it would be appropriate to implement the updates through a phased transition across several calendar years.

For example, we utilized a 4-year transition for the market-based supply and equipment pricing update concluding in CY 2022. We are considering the use of a similar 4-year transition to implement the clinical labor pricing update. A multi-year transition could smooth out the increases and decreases in payment caused by the pricing update for affected stakeholders, promoting payment stability. However, a phased transition would delay the full implementation of updated pricing and continue to rely in part on outdated data for clinical labor pricing. We discuss a potential 4-year transition for the clinical labor pricing update as an alternative considered in the Regulatory Impact Analysis (section VII.I) of this rule.

E. Proposal To Establish Values for Remote Retinal Imaging (CPT Code 92229), Comment Solicitation for Fractional Flow Reserve Derived From Computed Tomography (CPT Code 0503T), and Comment Solicitation for Codes Involving Innovative Technology Rapid advances in innovative technology are having a profound effect on every facet of the economy, including in the delivery of health care. Emerging and evolving technologies are introducing advances in treatment options that have the potential to increase access to care for Medicare beneficiaries, improve outcomes, and reduce overall costs to the program. While new services have emerged over the last several years, it is possible that the anti inflammatory drugs public health emergency (PHE) could be accelerating the supply and demand for these innovations. Emerging and evolving technologies could be useful tools for improving disparities in care that have been exacerbated by the PHE.

Some of these new applications have codes for which innovative technology is substituting for and/or augmenting physician work. For example, the CPT Editorial Panel created CPT code 92229 (Imaging of retina for detection or monitoring of disease. Point-of-care automated analysis and report, unilateral or bilateral), a diagnostic test for diabetic retinopathy that uses a software algorithm, and the RUC provided valuation recommendations which included a retinal camera and an analysis fee for remote imaging. In the CY 2021 PFS final rule (85 FR 84629 through 84630), we considered CPT code 92229 to be a diagnostic service under the PFS, contractor-priced it, and stated that we would have ongoing conversations with stakeholders. The following section will discuss proposed policies to establish RVUs for CPT code 92229, solicit feedback to establish RVUs for CPT code 0503T (Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery disease.

Analysis of fluid dynamics and simulated maximal coronary hyperemia, and generation of estimated FFR model), and solicit feedback to help us better understand the resource costs for services involving the use of innovative technologies such as software algorithms and artificial intelligence (AI). In our discussion of CPT code 92229 in the CY 2021 PFS final rule (85 FR 84629 through 84630), we wrote that as the data used in our PE methodology have aged, and more services have begun to include innovative technology such as software algorithms and AI, these innovative applications are not well accounted for in our PE methodology. As described earlier in this section, PE resources involved in furnishing services are characterized as either direct or indirect costs. Direct costs of the PE resources involved in furnish a service are estimated for each code and include clinical labor, medical supplies, and medical equipment. Indirect costs include administrative labor, office expenses, and all other expenses.

Indirect PE is allocated to each service based on physician work, direct costs, and a specialty-specific indirect percentage. The source of the specialty specific indirect percentage was the Physician Practice Information Survey (PPIS), last administered in 2007 and 2008, when emerging technologies that rely primarily on software, licensing, and analysis fees, with minimal costs in equipment and hardware may not have been typical. Thus, these costs are not well accounted for in the PE methodology. Consistent with our PE methodology and as we have stated in past PFS rulemaking (83 FR 59557), we have considered most computer software and associated analysis and licensing fees to be indirect costs tied to costs for associated hardware that is considered to be medical equipment. In the case of CPT code 92229, the hardware is a retinal camera used for remote imaging.

Given that indirect costs are based on physician work, direct costs, and Start Printed Page 39124specialty-specific indirect percentages that can include high-cost equipment, our concern is that if we were to consider an analysis fee to be a supply cost, as was recommended by the RUC, it is possible that we would inadvertently allocate too many indirect costs for a supply item that may not require additional indirect expenses. Unlike a piece of equipment, such as the retinal camera, an analysis fee for software does not require physical space in an office or administrative staff hours to maintain it. However, increasingly, stakeholders have routinely expressed concerns with our policy to consider analysis fees as indirect costs, especially for evolving technologies that rely primarily on these fees with minimal costs in equipment or hardware. In comments in the CY 2021 PFS final rule (85 FR 84629 through 84630) responding to our proposal to price the analysis fee for remote imaging as an indirect cost, stakeholders stated that there would be no service if the software was not used. There are two aspects that distinguish CPT code 92229 from other services.

First, most of the RUC's recommended resource costs for CPT code 92229 were for the analysis fee, rather than high-cost equipment or other supplies that require commensurate indirect costs to accommodate for space or administrative labor. Second, the innovative technology incorporated into the service is a software algorithm, which interprets data collected during the test, either augmenting the work of the physician or NPP performing the test, or in some cases replacing at least some work that a physician would typically furnish. In general, it is possible that physician work time and intensity of furnishing care to patients could be affected as more services that involve innovative technologies such as software algorithms or AI become available. We finalized a policy to establish contractor pricing for CPT code 92229 (85 FR 84629 through 84630) because analysis fees for software algorithms and AI applications are not well accounted for our PE methodology, and to recognize that practitioners do incur resource costs for purchase and ongoing use of the software. We stated that we would continue to seek out new data sources and have ongoing conversations with stakeholders while also considering other approaches to reflect overall resource costs for these technologies in our PE methodology.

As we described in the CY 2021 PFS final rule (85 FR 84498 through 84499), the RAND Corporation is currently studying potential improvements to CMS' PE allocation methodology and the data that underlie it. RAND has found that the PPIS data last collected in 2007-2008 may no longer reflect the resource allocation, staffing arrangements, and cost structures that describe practitioners' resource requirements in furnishing services to Medicare beneficiaries, and consequently may not accurately capture the indirect PE resources required to furnish services to Medicare FFS beneficiaries. Our experience with the challenge of accurately accounting for resource costs for innovative and emerging technologies such as ongoing service-specific software costs that are included in CPT code 92229 is another reason we continue to be interested in potentially refining the PE methodology and updating the data used to establish RVUs and payment rates under the PFS. We commonly employ a crosswalk to recognize resource costs when we lack the inputs that we would need to calculate work, PE, and/or malpractice RVUs for a service otherwise. When we use a crosswalk to value a service, we substitute the established RVUs for other services with similar resource costs in the physician office setting to set RVUs and the national payment rates for that particular service.

For CY 2022, we are proposing to establish values for CPT code 92229 using our crosswalk approach, and thus this service would no longer be contractor-priced. We continue to believe that the software algorithm present in the analysis fee for CPT code 92229 is not well accounted for in our PE methodology. However, we recognize that practitioners are incurring resource costs for purchase of the software and its ongoing use. We are proposing to use a crosswalk that reflects the overall relative resource costs for this service while we continue to consider potentially refining the PE methodology and updating the data we use to establish PE RVUs under the PFS. Specifically, we are proposing a crosswalk to CPT code 92325 (Modification of contact lens (separate procedure), with medical supervision of adaptation), a PE-only code used for the eye, as we believe it reflects overall resource costs for CPT code 92229 in the physician office setting.

We recognize that the services described by CPT code 92325 are not the same as the services in CPT code 92229. However, we believe that the total resource costs would be similar across these two codes. We believe that crosswalking the RVUs for CPT code 92229 to a code with similar resource costs allows CMS to recognize that practitioners are incurring resource costs for the purchase and ongoing use of the software employed in CPT code 92229, which would not typically be considered direct PE under our current methodology. We are also soliciting comments on our proposal to crosswalk CPT code 92229 to CPT code 92325, and whether other codes would provide a more appropriate crosswalk in terms of resource costs. In addition, as discussed in section II.E of this proposed rule, we are proposing to use our crosswalk approach for CPT code 77X01 (Trabecular bone score (TBS), structural condition of the bone microarchitecture.

Using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk) and CPT code 77X03 (Trabecular bone score (TBS), structural condition of the bone microarchitecture. Using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk, technical calculation only). We are aware of other services that use similar innovative technologies to those used for the diagnostic test for diabetic retinopathy and trabecular bone score, and that those technologies also are not well-accounted for in our PE methodology. For CY 2018, the AMA CPT Editorial Panel established four new Category III CPT codes for fractional flow reserve derived from computed tomography (FFRCT). CPT code 0501T (Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery disease.

Data preparation and transmission, analysis of fluid dynamics and simulated maximal coronary hyperemia, generation of estimated FFR model, with anatomical data review in comparison with estimated FFR model to reconcile discordant data, interpretation and report) CPT code 0502T (Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery disease. Data preparation and transmission). CPT code 0503T (Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic Start Printed Page 39125simulation software analysis of functional data to assess the severity of coronary artery disease. Analysis of fluid dynamics and simulated maximal coronary hyperemia, and generation of estimated FFR model). And CPT code 0504T (Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery disease.

Anatomical data review in comparison with estimated FFR model to reconcile discordant data, interpretation and report). FFRCT is a noninvasive diagnostic service that allows physicians to measure coronary artery disease in a patient through coronary CT scans. It uses a proprietary data analysis process performed at a central facility to develop a three-dimensional image of a patient's coronary arteries, which allows physicians to identify the fractional flow reserve to assess whether or not patients should undergo further invasive testing or treatment (typically, a coronary angiogram). We understand that FFRCT can show through non-invasive imaging whether a beneficiary has coronary artery disease thereby potentially avoiding an invasive coronary procedure. Medicare began payment for CPT code 0503T in the hospital outpatient department setting under the Outpatient Prospective Payment System (OPPS) in CY 2018 (82 FR 59284).

For the PFS, we typically assign contractor pricing for Category III codes since they are temporary codes assigned to emerging technology and services. We followed this established process for Category III codes by assigning and listing them as contractor pricing in Appendix B in the CY 2018 PFS final rule (available at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices-Items/​CMS-1676-F). We have since been trying to understand the costs of the PE resource inputs for CPT code 0503T in the physician office setting. In the CY 2021 PFS final rule, we stated that we found FFRCT to be similar to other technologies that use algorithms, artificial intelligence, or other innovative forms of analysis to determine a course of treatment, where the analysis portion of the service cannot adequately be reflected under the PE methodology. And that our recent reviews for the overall cost of CPT code 0503T have shown the costs in the physician office setting to be similar to costs reflected in payment under the OPPS (85 FR 84630).

For the CY 2021 OPPS/ASC final rule, we found that the geometric mean cost reported by hospital outpatient departments for the service was $804.35 (85 FR 85943). We believe the costs reported under the OPPS are instructive as they reflect actual costs that hospitals incurred in furnishing the service described by CPT code 0503T to Medicare beneficiaries, and, as we stated in the CY 2021 PFS final rule, we believe that these costs would be similar in the physician office setting. Using the geometric mean costs under the OPPS as a proxy, we then searched for services paid under the PFS that could potentially serve as a crosswalk. Specifically, we looked for services paid under the PFS that include only a technical component because CPT code 0503T is a technical component-only service, and that have similar total costs to CPT code 0503T. We identified the following potential crosswalks, and seek public comment on which, if any of them, would be appropriate.

CPT code 93455 (Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation. With catheter placement(s) in bypass graft(s) (internal mammary, free arterial, venous grafts) including intraprocedural injection(s) for bypass graft angiography) and CPT code 93458 (Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation. With left heart catheterization including intraprocedural injection(s) for left ventriculography, when performed). We are also seeking comment on whether other codes would provide a more appropriate crosswalk in terms of resource costs. We are also more broadly soliciting public comment to help us better understand the resource costs for services involving the use of innovative technologies, including but not limited to software algorithms and AI.

Specifically, we are requesting commenters consider the following questions. To what extent are services involving innovative technologies such as software algorithms and/or AI substitutes and/or supplements for physician work?. To what extent do these services involving innovative technology inform, augment, or replace physician work?. For example, CPT code 92229 is a PE-only code in which the software algorithm may be substituting for some work of an ophthalmologist to diagnose/detect diabetic retinopathy. CPT code 77X01 is a service in which the trabecular bone score software may be supplementing physician work to predict and detect fracture risk.

CPT code 0503T may be both substituting for, and supplementing physician work to detect coronary artery disease. How has innovative technology such as software algorithms and/or AI affected physician work time and intensity of furnishing services involving the use of such technology to Medicare beneficiaries?. For example, if a new software algorithm or AI technology for a diagnostic test results in a reduction in the amount of time that a practitioner spends reviewing and interpreting the results of a diagnostic test that previously did not involve such software algorithm or AI technology, and if the software algorithm or AI could be considered in part a substitute for at least some physician work, it may follow that the intensity of the service decreases. It is also possible that a software algorithm for a diagnostic test that is supplementing other tests to establish a diagnosis or treatment pathway for a particular condition could result in an increase in the amount of time that a practitioner spends explaining the test to a patient and then reviewing the results. How is innovative technology such as software algorithms and/or AI changing cost structures in the physician office setting?.

As discussed previously, the PPIS data that underlie the PE methodology were last collected in 2007 and 2008, which was prior to the widespread adoption of electronic health records and services that involve care management, non-face-to-face and/or asynchronous remote care. The need to use electronic clinical quality measure data to support quality improvement, disparity identification and resolution, and value based payment. And the emergence of software algorithms and/or AI and other technologies that use data to inform, augment, or replace physician work in the delivery of health care. Do costs for innovative technology such as software algorithms and/or AI to furnish services to patients involve a one-time investment and/or recurring costs?. How should CMS consider costs for software algorithms and/or AI that use patient data that were previously collected as part of another service?.

As technology adoption grows, do these costs decrease over time?. How is innovative technology affecting beneficiary access to Medicare-covered services?. How are services involving software algorithms and/or AI being furnished to Medicare beneficiaries and what is important for Start Printed Page 39126CMS to understand as it considers how to accurately pay for services involving software algorithms and/or AI?. For example, it is possible that services that involve software algorithms and/or AI may allow a practitioner to more efficiently furnish care to more Medicare beneficiaries, potentially increasing access to care. Additionally, to what extent have services that involve innovative technology such as software algorithms and/or AI affected access to Medicare-covered services in rural and/or underserved areas, or for beneficiaries that may face barriers (homelessness, lack of access to transportation, lower levels of health literacy, lower rates of internet access, mental illness, having a high number of chronic conditions/frailty, etc.) in obtaining health care?.

Compared to other services paid under the PFS, are services that are driven by or supported by innovative technology such as software algorithms and/or AI at greater risk of overutilization or more subject to fraud, waste, and abuse?. As we are considering appropriate payment for services enabled by new technologies, there are considerations for program integrity. For example, section 218(b) of the PAMA required that we establish an Appropriate Use Criteria Program to promote appropriate use of advanced diagnostic imaging services provided to Medicare beneficiaries.[] To what extent do services involving innovative technology require mechanisms such as appropriate use criteria to guard against overutilization, fraud, waste, or abuse?. Compared to other services paid under the PFS, are services driven by or supported by innovative technology such as software algorithms and/or AI associated with improvements in the quality of care or improvements in health equity?. For example, increased access to services to detect diabetic retinopathy such as the service described by CPT code 92229 could eventually lead to fewer beneficiaries losing their vision.

Because CPT code 92229 can be furnished in a primary care practice's office and may not require the specialized services of an ophthalmologist, more beneficiaries could have access to a test, including those who live in areas with fewer ophthalmologists. Additionally, taking into consideration that a software algorithm and/or AI may introduce bias into clinical decision making that could influence outcomes for racial and ethnic minorities and people who are socioeconomically disadvantaged, are there guardrails, such as removing the source of bias in a software algorithm and/or AI, that Medicare should require as part of considering payment amounts for services enabled by software algorithm and/or AI?. Our proposals to use crosswalks to set values for codes describing diabetic retinopathy and trabecular bone score would allow us to account for overall resource costs involved in furnishing the services. The possible crosswalks for FFRCT may also account for overall resource costs involved in furnishing the service. We also believe it is important to accurately account for resource costs for innovative and emerging technologies such as ongoing service-specific software costs and, as explained above, such costs are not well accounted for in the PE methodology.

We continue to be interested in potentially refining the PE methodology and updating the underlying data, including the PPIS data that are the data source that underpins the indirect PE allocation. How might CMS consider updating such data to reflect ongoing advances in technology so that we could establish appropriate relative values without resorting to crosswalks?. The RAND Corporation laid out a number of issues for CMS to consider in two reports. We refer readers to RAND's first phase of research, available at https://www.rand.org/​pubs/​research_​reports/​RR2166.html, and RAND's second phase of research, available at https://www.rand.org/​pubs/​research_​reports/​RR3248.html. C.

Potentially Misvalued Services Under the PFS 1. Background Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the relative value units (RVUs) established under the PFS. Section 1848(c)(2)(K) of the Act requires the Secretary to periodically identify potentially misvalued services using certain criteria and to review and make appropriate adjustments to the relative values for those services. Section 1848(c)(2)(L) of the Act also requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments. As discussed in section II.E.

Of this proposed rule, Valuation of Specific Codes, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the American Medical Association (AMA) Resource-Based Relative Value Scale (RVS) Update Committee (RUC), the Medicare Payment Advisory Commission (MedPAC), and other stakeholders. For many years, the RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a code-by-code basis and consider these recommendations in conjunction with analyses of other data, such as claims data, to inform the decision-making process as authorized by statute. We may also consider analyses of work time, work RVUs, or direct PE inputs using other data sources, such as Department of Veteran Affairs (VA), National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based Incentive Payment System (MIPS) data. In addition to considering the most recently available data, we assess the results of physician surveys and specialty recommendations submitted to us by the RUC for our review.

We also consider information provided by other stakeholders. We conduct a review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available and requires us to take into account the results of consultations with organizations representing physicians who provide the services. In accordance with section 1848(c) of the Act, we determine and make appropriate adjustments to the RVUs. In its March 2006 Report to the Congress (http://www.medpac.gov/​docs/​default-source/​reports/​Mar06_​Ch03.pdf?.

€‹sfvrsn=​0), MedPAC discussed the importance of appropriately valuing physicians' services, noting that misvalued services can distort the market for physicians' services, as well as for other health care services that physicians order, such as hospital services. In that same report, MedPAC postulated that physicians' services under the PFS can become misvalued over time. MedPAC stated, “When a new service is added to the physician fee schedule, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work Start Printed Page 39127required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it.” We believe services can also become overvalued when PE costs decline. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently than is estimated in the PE methodology, reducing its cost per use.

Likewise, services can become undervalued when physician work increases or PE costs rises. As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/​docs/​default-source/​reports/​march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since MedPAC made the initial recommendations, CMS and the RUC have taken several steps to improve the review process. Also, section 1848(c)(2)(K)(ii) of the Act augments our efforts by directing the Secretary to specifically examine, as determined appropriate, potentially misvalued services in the following categories. Codes that have experienced the fastest growth. Codes that have experienced substantial changes in PE.

Codes that describe new technologies or services within an appropriate time-period (such as 3 years) after the relative values are initially established for such codes. Codes which are multiple codes that are frequently billed in conjunction with furnishing a single service. Codes with low relative values, particularly those that are often billed multiple times for a single treatment. Codes that have not been subject to review since implementation of the fee schedule. Codes that account for the majority of spending under the PFS.

Codes for services that have experienced a substantial change in the hospital length of stay or procedure time. Codes for which there may be a change in the typical site of service since the code was last valued. Codes for which there is a significant difference in payment for the same service between different sites of service. Codes for which there may be anomalies in relative values within a family of codes. Codes for services where there may be efficiencies when a service is furnished at the same time as other services.

Codes with high intraservice work per unit of time. Codes with high PE RVUs. Codes with high cost supplies. Codes as determined appropriate by the Secretary. Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services.

In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including using existing processes for consideration of coding changes) that may include consolidation of individual services into bundled codes for payment under the PFS. 2.

Progress in Identifying and Reviewing Potentially Misvalued Codes To fulfill our statutory mandate, we have identified and reviewed numerous potentially misvalued codes as specified in section 1848(c)(2)(K)(ii) of the Act, and we intend to continue our work examining potentially misvalued codes in these areas over the upcoming years. As part of our current process, we identify potentially misvalued codes for review, and request recommendations from the RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The RUC, through its own processes, also identifies potentially misvalued codes for review. Through our public nomination process for potentially misvalued codes established in the CY 2012 PFS final rule with comment period, other individuals and stakeholder groups submit nominations for review of potentially misvalued codes as well. Individuals and stakeholder groups may submit codes for review under the potentially misvalued codes initiative to CMS in one of two ways.

Nominations may be submitted to CMS via email or through postal mail. Email submissions should be sent to the CMS emailbox MedicarePhysicianFeeSchedule@cms.hhs.gov, with the phrase “Potentially Misvalued Codes” and the referencing CPT code number(s) and/or the CPT descriptor(s) in the subject line. Physical letters for nominations should be sent via the U.S. Postal Service to the Centers for Medicare &. Medicaid Services, Mail Stop.

C4-01-26, 7500 Security Blvd., Baltimore, Maryland 21244. Envelopes containing the nomination letters must be labeled “Attention. Division of Practitioner Services, Potentially Misvalued Codes”. Nominations for consideration in our next annual rule cycle should be received by our February 10th deadline. Since CY 2009, as a part of the annual potentially misvalued code review and Five-Year Review process, we have reviewed over 1,700 potentially misvalued codes to refine work RVUs and direct PE inputs.

We have assigned appropriate work RVUs and direct PE inputs for these services as a result of these reviews. A more detailed discussion of the extensive prior reviews of potentially misvalued codes is included in the Medicare Program. Payment Policies Under the Physician Fee Schedule, Five-Year Review of Work Relative Value Units, Clinical Laboratory Fee Schedule. Signature on Requisition, and Other Revisions to Part B for CY 2012. Final rule (76 FR 73052 through 73055) (hereinafter referred to as the “CY 2012 PFS final rule with comment period”).

In the CY 2012 PFS final rule with comment period (76 FR 73055 through 73958), we finalized our policy to consolidate the review of physician work and PE at the same time, and established a process for the annual public nomination of potentially misvalued services. In the Medicare Program. Revisions to Payment Policies Under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013 (77 FR 68892) (hereinafter referred to as the “CY 2013 PFS final rule with comment period”), we built upon the work we began in CY 2009 to review potentially misvalued codes that have not been reviewed since the implementation of the PFS (so-called “Harvard-valued codes”). In the Medicare Program. Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009.

And Revisions to the Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions. Proposed Rule (73 FR 38589) (hereinafter referred to as Start Printed Page 39128the “CY 2009 PFS proposed rule”), we requested recommendations from the RUC to aid in our review of Harvard-valued codes that had not yet been reviewed, focusing first on high-volume, low intensity codes. In the fourth Five-Year Review (76 FR 32410), we requested recommendations from the RUC to aid in our review of Harvard-valued codes with annual utilization of greater than 30,000 services. In the CY 2013 PFS final rule with comment period, we identified specific Harvard-valued services with annual allowed charges that total at least $10,000,000 as potentially misvalued. In addition to the Harvard-valued codes, in the CY 2013 PFS final rule with comment period we finalized for review a list of potentially misvalued codes that have stand-alone PE (codes with physician work and no listed work time and codes with no physician work that have listed work time).

We continue each year to consider and finalize a list of potentially misvalued codes that have or will be reviewed and revised as appropriate in future rulemaking. 3. CY 2022 Identification and Review of Potentially Misvalued Services In the CY 2012 PFS final rule with comment period (76 FR 73058), we finalized a process for the public to nominate potentially misvalued codes. In the CY 2015 PFS final rule with comment period (79 FR 67606 through 67608), we modified this process whereby the public and stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation by February 10th of each year. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may include the following.

Documentation in peer reviewed medical literature or other reliable data that demonstrate changes in physician work due to one or more of the following. Technique, knowledge and technology, patient population, site-of-service, length of hospital stay, and work time. An anomalous relationship between the code being proposed for review and other codes. Evidence that technology has changed physician work. Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.

Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation. Prices for certain high cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information. Analyses of work time, work RVU, or direct PE inputs using other data sources (for example, VA, NSQIP, the STS National Database, and the MIPS data). National surveys of work time and intensity from professional and management societies and organizations, such as hospital associations. We evaluate the supporting documentation submitted with the nominated codes and assess whether the nominated codes appear to be potentially misvalued codes appropriate for review under the annual process.

In the following year's PFS proposed rule, we publish the list of nominated codes and indicate for each nominated code whether we agree with its inclusion as a potentially misvalued code. The public has the opportunity to comment on these and all other proposed potentially misvalued codes. In that year's final rule, we finalize our list of potentially misvalued codes. A. Public Nominations In this proposed rule, we are soliciting comments regarding the potentially misvalued codes nominated by the public to inform our decision on whether to establish the codes as potentially misvalued in the CY 2022 PFS final rule.

We received public nominations for potentially misvalued codes by February 10th. We display these public nominations on our public website, including the submitter's name and their associated organization to provide full transparency. Among the public nominations that we received this year, one was a request for CMS to review a PE-related input for a code. We refer readers to section II.B. Of this proposed rule, Determination of PE RVUs, for further discussion on the PE-related submission.

The summary of this year's submissions under the potentially misvalued code initiative are discussed below. A stakeholder nominated CPT code 22551 (Fusion of spine bones with removal of disc at upper spinal column, anterior approach, complex) “and common related services” as potentially misvalued. Citing the CY 2021 PFS final rule (84 FR 84501) where CMS agreed with the public nomination of CPT code 22867 (Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar. Single level) as potentially misvalued, and discussed the relationship between CPT code 22867 and CPT code 63047 (Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [e.g., spinal or lateral recess stenosis]), single vertebral segment. Lumbar), this stakeholder suggests that there are additional CPT code values related to spine procedures that are in need of contemporaneous review with CPT code 22867.

The stakeholder believes that CMS has an interest in reviewing associated anterior cervical discectomy and fusion (ACDF) procedures as well, and suggests that CPT code 22551 “and common related services” can result in cumulative RVUs that do not sufficiently reflect physician work, time, or outcomes. In their submission, the stakeholder expressed concern that there is a discrepancy between the typical total RVUs for codes billed for vertebral fusion procedures performed using three synthetic cage devices with plate and vertebral fusion procedures performed using three allografts with plate. Both methods of vertebral fusion are described by CPT code 22551 (includes a 90-day global period), which has a work RVU of 25.00. Both methods of vertebral fusion involve two units of CPT code 22552 (Arthrodesis, anterior interbody, including disc space preparation, discectomy, osteophytectomy and decompression of spinal cord and/or nerve roots. Cervical below C2, each additional interspace (List separately in addition to code for primary procedure) (ZZZ global period)) with a total work RVU of 13.00 (6.50 × 2).

And both methods of vertebral fusion involve 1 unit of CPT code 22846 (Anterior instrumentation. 4 to 7 vertebral segments (List separately in addition to code for primary procedure) (ZZZ global period)) with a work RVU of 12.40. The vertebral fusion method employing three synthetic cage devices with a plate would involve CPT code 22853 (Insertion of interbody biomechanical device (s) (e.g., synthetic cage, mesh) with integral anterior instrumentation for device anchoring (e.g., screws, flanges), when performed, to intervertebral disc space in conjunction with interbody arthrodesis, each interspace (List separately in addition to code for primary procedure) (ZZZ global period)) for the insertion of synthetic cage devices for a total work RVU of 12.75 (4.25 × 3), and CPT code 20930 (Allograft, morselized, or Start Printed Page 39129placement of osteopromotive material, for spine surgery only (List separately in addition to code for primary procedure)) with a work RVU of 0.00 (because Medicare considers this code to be bundled into codes for other services). The stakeholder stated that the total work RVUs for the typical vertebral fusion employing three synthetic cage devices with plate would be 63.15 work RVUs. In contrast, the stakeholder asserted that the vertebral fusion method employing three allografts with plate involves the same set of services and codes (CPT code 22551 (090 global period) and CPT code 22846 (ZZZ global period)), but instead of CPT codes 22853 or 20930, involve CPT code 20931 (Allograft, structural, for spine surgery only (List separately in addition to code for primary procedure) (ZZZ global period) with a work RVU of 1.81.

Altogether, the total work RVUs for CPT codes involved in this vertebral fusion method is 52.21. The stakeholder suggested that this difference in total work RVUs, 63.15 versus 52.21, is evidence that these services are misvalued, and that the total work RVUs do not reflect the differences in the amount of work, resources, and intensity between the two vertebral fusion methods. This stakeholder's description of the potential misvaluation of CPT code 22551 “and common related services” differs from the CMS approach to identifying potentially misvalued services by using certain criteria, as described in the beginning of this section. Our determination that one or more codes are potentially misvalued generally revolves around the specific RVUs assigned to an individual code, or several codes within a family of codes. CMS generally does not examine the summed differences in total RVUs based on billing patterns using different codes in different scenarios, representing different physician work, and then comparing the two methods of a procedure, in this case, the use or non-use, of the synthetic cage devices in the vertebral fusion with removal of the disc in the upper spinal column.

We do not believe that the stakeholder has provided support for the premise that CPT code 22551 alone is misvalued, or that any of the codes identified as common related services are misvalued. Therefore, we are not inclined to propose this code as potentially misvalued. However, we welcome additional comment, including any analysis or studies demonstrating that one or more of these codes meet the criteria listed above under “Identification and Review of Potentially Misvalued Services,” particularly in regard to any changes in the resources to providing a service, or are otherwise potentially misvalued. A stakeholder nominated CPT code 49436 (Delayed creation of exit site from embedded subcutaneous segment of intraperitoneal cannula or catheter) as potentially misvalued, as it has not been valued for payment in the non-facility/office setting. This stakeholder did not include in their submission detailed recommendations for the items, quantities, and unit costs for the supplies, equipment types, and clinical labor (if any), that might be incurred in the non-facility/office setting, all of which are key factors when determining potential valuation or mis-valuation of a service.

Medicare claims data for 2018, 2019, and 2020 show that CPT code 49436 is solely performed in the facility ambulatory surgical center (ASC) setting. We are not inclined to propose this code as potentially misvalued. However, we welcome additional comment, including any analysis or studies demonstrating that this code meets the criteria listed above under “Identification and Review of Potentially Misvalued Services,” particularly in regard to any changes in the resources to providing a service, or is otherwise potentially misvalued. A stakeholder nominated CPT code 55880 (Ablation of malignant prostate tissue, transrectal, with high intensity-focused uasound (HIFU), including uasound guidance) as potentially misvalued, as it has not been valued in the non-facility/office setting. This stakeholder also did not include in their submission detailed recommendations for items, quantities, and unit costs for the supplies, equipment types, and clinical labor (if any), that might be incurred in the non-facility/office setting, all of which are key factors when determining valuation or mis-valuation.

This stakeholder stated that the advances in High Intensity Focused Uasound (HIFU) technology toward the destruction of cancerous tissues in the prostate gland have matured to the point where this procedure is now equally as effective and as safe as the cryoablation procedure described by CPT code 55873 (Cryosurgical ablation of the prostate (includes uasonic guidance and monitoring)), which is currently valued in the non-facility/office setting (186.69 total RVUs, approximately $6,514) and has been for approximately 10 years. We note that CPT code 55880 was reviewed and valued in the CY 2021 PFS final rule (85 FR 84614 through 84615) in the facility setting only. Accordingly, we do not have enough claims data for this code to make accurate comparisons to similar codes that may be furnished in non-facility settings. There is no case presented here that constitutes a misvaluation of CPT code 55880, and therefore, we are not inclined to put this code forward as potentially misvalued for CY 2022. However, we welcome additional comment, including any analysis or studies demonstrating that this code meets the criteria listed above under “Identification and Review of Potentially Misvalued Services,” particularly in regard to any changes in the resources to providing a service, or is otherwise potentially misvalued.

A stakeholder nominated CPT code 59200 (Insertion cervical dilator (e.g., laminaria, prostaglandin) as potentially misvalued because the direct PE inputs do not include the supply item, Dilapan-S. This stakeholder had sought to establish a Level II HCPCS code for Dilapan-S, but CMS did not find sufficient evidence to support that request. The stakeholder now submits Dilapan-S to be considered as PE supply input to a Level I CPT code(s). This stakeholder seeks to add Dilapan-S to the nonfacility/office PE inputs for CPT code 59200. Specifically, the stakeholder recommends adding 4 rods of Dilapan-S at $80.00 per unit, for a total of $320.00, as a replacement for the current PE supply item, laminaria tent (a small rod of dehydrated seaweed that when inserted in the cervix, rehydrates, absorbing the water from the surrounding tissue in the woman's body), which is currently listed at $4.0683 per unit, with a total of 3 units, for a total of $12.20.

We welcome additional comment, including any analysis or studies demonstrating that this code meets the criteria listed above under “Identification and Review of Potentially Misvalued Services,” particularly in regard to any changes in the resources to providing a service, or is otherwise potentially misvalued. A stakeholder nominated CPT codes 66982 through 66986 as potentially misvalued, as they have not been valued in the non-facility/office setting. This stakeholder did not submit other details or reasoning to support their nomination. We note that some of these cataract-related procedures were initially reviewed and valued in CY 2020 PFS final rule (84 FR 62751), and that presently, additional codes in this family are scheduled to be reviewed and valued in this CY 2022 PFS proposed rule (we refer readers to section II.E. Of this proposed rule, Valuation of Specific Codes).

The highest utilization of these cataract codes are CPT code 66982 (Extracapsular cataract removal with insertion of intraocular lens prosthesis Start Printed Page 39130(1-stage procedure), manual or mechanical technique (e.g., irrigation and aspiration or phacoemulsification), complex, requiring devices or techniques not generally used in routine cataract surgery (e.g., iris expansion device, suture support for intraocular lens, or primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage. Without endoscopic cyclophotocoagulation) and CPT code 66984 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage procedure), manual or mechanical technique (e.g., irrigation and aspiration or phacoemulsification). Without endoscopic cyclophotocoagulation). In 2018 and 2019, these services were almost all performed in the ASC facility setting, but based on 2020 claims, the most common setting appears to have shifted to the hospital inpatient or hospital outpatient facility setting. There is no case presented here that constitutes a misvaluation of CPT codes 66982 to 66986, and therefore, we are not inclined to put this code family forward as potentially misvalued for CY 2022.

However, we welcome additional comment, including any analysis or studies demonstrating that one or more of these codes meet the criteria listed above under “Identification and Review of Potentially Misvalued Services,” particularly in regard to any changes in the resources to providing a service, or are otherwise potentially misvalued. D. Telehealth and Other Services Involving Communications Technology, and Interim Final Rule With Comment Period for Coding and Payment of Virtual Check-In Services—Payment for Medicare Telehealth Services Under Section 1834(m) of the Act As discussed in prior rulemaking, several conditions must be met for Medicare to make payment for telehealth services under the PFS. See further details and full discussion of the scope of Medicare telehealth services in the CY 2018 PFS final rule (82 FR 53006) and CY 2021 PFS final rule (85 FR 84502) and in 42 CFR 410.78 and 414.65. 1.

Payment for Medicare Telehealth Services Under Section 1834(m) of the Act a. Proposed Changes to the Medicare Telehealth Services List In the CY 2003 PFS final rule with comment period (67 FR 79988), we established a regulatory process for adding services to or deleting services from the Medicare telehealth services list in accordance with section 1834(m)(4)(F)(ii) of the Act (42 CFR 410.78(f)). This process provides the public with an ongoing opportunity to submit requests for adding services, which are then reviewed by us and assigned to categories established through notice and comment rulemaking. Specifically, we assign any submitted request to add to the Medicare telehealth services list to one of the following two categories. Category 1.

Services that are similar to professional consultations, office visits, and office psychiatry services that are currently on the Medicare telehealth services list. In reviewing these requests, we look for similarities between the requested and existing telehealth services for the roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the distant site and, if necessary, the telepresenter, a practitioner who is present with the beneficiary in the originating site. We also look for similarities in the telecommunications system used to deliver the service. For example, the use of interactive audio and video equipment. Category 2.

Services that are not similar to those on the current Medicare telehealth services list. Our review of these requests includes an assessment of whether the service is accurately described by the corresponding code when furnished via telehealth and whether the use of a telecommunications system to furnish the service produces demonstrated clinical benefit to the patient. Submitted evidence should include both a description of relevant clinical studies that demonstrate the service furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings, and a list and copies of published peer reviewed articles relevant to the service when furnished via telehealth. Our evidentiary standard of clinical benefit does not include minor or incidental benefits. Some examples of other clinical benefits that we would consider include the following.

Ability to diagnose a medical condition in a patient population without access to clinically appropriate in-person diagnostic services. Treatment option for a patient population without access to clinically appropriate in-person treatment options. Reduced rate of complications. Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process). Decreased number of future hospitalizations or physician visits.

More rapid beneficial resolution of the disease process treatment. Decreased pain, bleeding, or other quantifiable symptom. Reduced recovery time. Category 3. In the CY 2021 PFS final rule (85 FR 84507), we created a third category of criteria for adding services to the Medicare telehealth services list on a temporary basis following the end of the PHE for the anti inflammatory drugs symbicort.

This new category describes services that were added to the Medicare telehealth services list during the PHE for which there is likely to be clinical benefit when furnished via telehealth, but there is not yet sufficient evidence available to consider the services for permanent addition under the Category 1 or Category 2 criteria. Services added on a temporary, Category 3 basis would ultimately need to meet the criteria under Category 1 or 2 in order to be permanently added to the Medicare telehealth services list. To add specific services on a Category 3 basis, we conducted a clinical assessment to identify those services for which we could foresee a reasonable potential likelihood of clinical benefit Start Printed Page 39131when furnished via telehealth. We considered the following factors. ++ Whether, outside of the circumstances of the PHE for anti inflammatory drugs, there are concerns for patient safety if the service is furnished as a telehealth service.

++ Whether, outside of the circumstances of the PHE for anti inflammatory drugs, there are concerns about whether the provision of the service via telehealth is likely to jeopardize quality of care. ++ Whether all elements of the service could fully and effectively be performed by a remotely located clinician using two-way, audio/video telecommunications technology. In the CY 2021 PFS final rule (85 FR 84507), we also temporarily added several services to the Medicare telehealth services list using the Category 3 criteria described above. In this proposed rule, we are considering additional requests to add services to the Medicare telehealth services list on a Category 3 basis using the previously described Category 3 criteria. The Medicare telehealth services list, including the additions described later in this section, is available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​index.html.

Beginning in CY 2019, we stated that for CY 2019 and onward, we intend to accept requests through February 10, consistent with the deadline for our receipt of code valuation recommendations from the RUC (83 FR 59491). For CY 2022, requests to add services to the Medicare telehealth services list must have been submitted and received by February 10, 2021. Each request to add a service to the Medicare telehealth services list must have included any supporting documentation the requester wishes us to consider as we review the request. Because we use the annual PFS rulemaking process as the vehicle to make changes to the Medicare telehealth services list, requesters are advised that any information submitted as part of a request is subject to public disclosure for this purpose. For more information on submitting a request in the future to add services to the Medicare telehealth services list, including where to mail these requests, see our website at https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​index.html.

B. Requests To Add Services to the Medicare Telehealth Services List for CY 2022 Under our current policy, we add services to the Medicare telehealth services list on a Category 1 basis when we determine that they are similar to services on the existing Medicare telehealth services list for the roles of, and interactions among, the beneficiary, physician (or other practitioner) at the distant site and, if necessary, the telepresenter. As we stated in the CY 2012 PFS final rule with comment period (76 FR 73098), we believe that the Category 1 criteria not only streamline our review process for publicly requested services that fall into this category, but also expedite our ability to identify codes for the Medicare telehealth services list that resemble those services already on the Medicare telehealth services list. We received several requests to permanently add various services to the Medicare telehealth services list effective for CY 2022. We found that none of the requests we received by the February 10th submission deadline met our Category 1 or Category 2 criteria for permanent addition to the Medicare telehealth services list.

The requested services are listed in Table 8. Start Printed Page 39132 Start Printed Page 39133 We remind stakeholders that the criterion for adding services to the Medicare telehealth list under Category 1 is that the requested services are similar to professional consultations, office visits, and office psychiatry services that are currently on the Medicare telehealth services list, and that the criterion for adding services under Category 2 is that there is evidence of clinical benefit if provided as telehealth. As explained below, we find that none of the requested services met the Category 1 criterion. We received a request to permanently add CPT code 51741 (Complex uroflowmetry (e.g., calibrated electronic equipment)) to the Medicare telehealth services list. This CPT code describes the acquisition of uroflowmetric information and analysis of that information.

The code includes a technical component and a professional component. The technical component describes the acquisition of the uroflowmetric information when billed as a standalone service. The professional component describes the analysis for the uroflowmetric information when it is billed as a standalone service. As we have explained in previous rulemaking (see 83 FR 59483), the remote interpretation of diagnostic tests is not considered to be a telehealth service under section 1834(m) of the Act or our regulation at § 410.78. We do not believe that the technical component, which would include acquisition of the uroflowmetric Start Printed Page 39134information, would meet the criterion to be added on a Category 1 basis because it is not similar to other services on the Medicare telehealth list.

Moreover, we do not believe the uroflowmetric information can be accurately and effectively collected using two-way, audio/video communication technology to the degree that would make the results clinically useful. We believe the patient would need to be in the same location as the equipment. Thus, making it impracticable to achieve via telehealth. Due to these concerns, we do not believe that the submitted information demonstrates sufficient clinical benefit to support the addition of CPT code 51741 to the Medicare telehealth services list. We received a request to permanently add several biofeedback, services, CPT codes 90901, 90912, and 90913, to the Medicare telehealth services list.

We do not believe these services are similar to Category 1 services on the Medicare telehealth list in that these services describe the application of electrodes directly to the patient's skin and using them to monitor the patient's response. Therefore, we do not believe they meet the criterion for addition to the Medicare telehealth services list on a Category 1 basis. We also believe that proper application of electrodes and monitoring of the patient's response would require the furnishing practitioner to be in the same physical location as the beneficiary. As such, we do not believe these services would meet the criteria for addition to the Medicare telehealth list on a Category 2 basis. When we reviewed these biofeedback services on a Category 2 basis, we found that the information supplied with the requests was not detailed enough to determine if the objective functional outcomes (that is, Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs) of the telehealth patients) were similar to that of patients treated in person.

Moreover, we believe that the ADLs/IADLs alone are not sufficient to determine if these services, when performed via telehealth, demonstrate a clinical benefit to a patient. We would request that stakeholders supply a more comprehensive set of objective data in order to fully illustrate any benefits, to better enable us to evaluate all outcomes. We received requests to permanently add Neuropsychological/Psychological Testing services, CPT codes 96130-96133 and 96136-96139, to the Medicare telehealth services list. We separately reviewed each of the services in these two code families. In prior years' rulemaking, we have declined to add these services on a Category 1 basis because, in contrast to other services on the telehealth list these services require close observation by the furnishing practitioner to monitor how a patient responds and progresses through the testing (see 81 FR 80197).

We continue to believe that this is the case. All of these codes describe services that involve a very thorough observation and testing process, and require the tester to observe the following. Speed of responses. The ability to adjust focus. Written, sometimes manual tasks.

Following tasks that display the patients' visuospatial mapping abilities, pattern recognition, abstraction, calculation—all while appreciating that the patient may be distracted or aided by environmental cues. The tester must also maintain some subjective amount of flexibility to allow the patient to be in their environment. Additionally, the tester has to maintain professional scrutiny through dynamic tasks. Given all of the above, remote observation by the furnishing practitioner to accomplish the testing in question seems impractical and potentially creates the risk of inaccuracies in diagnosis and subsequent treatment. We note that the information supplied by stakeholders did not address these concerns, and as such, we have concerns over patient safety and the ability of these services to be accurately and thoroughly performed via telehealth to demonstrate a clinical benefit to Medicare beneficiaries.

Therefore, we do not believe these services meet the Category 2 criteria for permanent addition to the Medicare telehealth list of services. Consequently, we are not proposing to add these services to the Medicare telehealth services list. We encourage stakeholders to submit information addressing the concerns we have stated in any future requests to have these services added to the Medicare telehealth list of services. We received requests to add Therapy Procedures, CPT codes 97110, 97112, 97116, 97150, and 97530. Physical Therapy Evaluations, CPT codes 97161-97164.

Therapy Personal Care services, CPT codes 97535, 97537, and 97542. And Therapy Tests and Measurements services, CPT codes 97750, 97755, and 97763, to the Medicare telehealth services list. In the CY 2017 PFS final rule (81 FR 80198), we noted that section 1834(m)(4)(E) of the Act specifies the types of practitioners who may furnish and bill for Medicare telehealth services as those practitioners under section 1842(b)(18)(C) of the Act. Physical therapists (PTs), occupational therapists (OTs), and speech-language pathologists (SLPs) are not among the practitioners identified in section 1842(b)(18)(C) of the Act. We also stated in the CY 2017 PFS final rule that, because these services are predominantly furnished by PTs, OTs, and SLPs, we did not believe it would be appropriate to add them to the Medicare telehealth services list at that time.

In a subsequent request to consider adding these services for 2018, the original requester suggested that we might propose these services be added to the Medicare telehealth services list so that payment can be made for them when furnished via telehealth by physicians or practitioners who can serve as distant site practitioners. We stated that, since the majority of the codes are furnished over 90 percent of the time by therapy professionals who are not included on the statutory list of eligible distant site practitioners, we believed that adding therapy services to the Medicare telehealth services list could result in confusion about who is authorized to furnish and bill for these services when furnished via telehealth. We continue to believe this to be true. However, we reviewed each therapy service separately, and have categorized them together here for convenience as the same set of information accompanied the request for each of these services. We determined that these services did not meet the Category 1 criteria for addition to the Medicare telehealth services because they are therapeutic in nature and in many instances involve direct physical contact between the practitioner and the patient.

In assessing the evidence that was supplied by stakeholders in support of adding these services to the Medicare telehealth services list on a Category 2 basis, we concluded that it did not provide sufficient detail to determine whether all of the necessary elements of the service could be furnished remotely, and whether the objective functional outcomes of ADL and IADL for the telehealth patients were similar to those of patients receiving the services in person. As we stated above when discussing the request to add certain biofeedback services to the telehealth list, we do not believe ADLs and IADLS alone are sufficient to demonstrate clinical benefit to a Medicare beneficiary. We have enumerated above some examples of the types of clinical benefits we would consider when evaluating services using the Category 2 criterion. Therefore, we do not believe the supplied information demonstrates that the services meet either the Category 1 or the Category 2 criteria. We are not Start Printed Page 39135proposing to add these services to the Medicare telehealth services list.

We continue to encourage commenters to supply sufficient data for us to be able to see all measurements/parameters performed, so that we may evaluate all outcomes. We received requests to add the services in Table 9, and we note that these services are generally not separately payable under the Medicare PFS. Given that these services are not separately payable when furnished in-person, they would not be separately payable when furnished as telehealth. Section 1834(m)(2)(A) of the Act provides that payment for a service when furnished as a telehealth services is equal to the payment when the service is furnished in person. CPT code 90849 has a restricted payment status, indicating that claims must be adjudicated on a case-by-case basis when furnished in-person.

Accordingly, any separate payment for that service would require special consideration and not be routine. Therefore, we do not believe this service should be added to the Medicare telehealth list. CPT codes 98960-98962 are bundled services, and therefore, payment for these services is always bundled into payment of other services. For that reason, we are not proposing to add them to the Medicare list of telehealth services. We received requests to temporarily add Neurostimulators, CPT codes 95970-95972, and Neurostimulators, Analysis-Programming services, CPT codes 95983 and 95984, to the Medicare telehealth services list using the Category 3 criteria (see Table 10).

In their submission, the requestor noted they would conduct a future study and would submit the study data to CMS at a later date. These services are on the expanded telehealth services list for the PHE, but were not added by CMS on a category 3 basis in the CY 2021 PFS final rule. We do not yet have sufficient information to adjudicate whether these services are likely to meet the category 1 or category 2 criteria given additional time on the Medicare telehealth services list, without having evaluated the full data, and we encourage commenters to submit all available information, when available, for future consideration. As a result, we are not proposing to add these services to the Medicare telehealth list of services on a Category 3 basis at this time. Start Printed Page 39136 c.

Revised Timeframe for Consideration of Services Added to the Telehealth List on a Temporary Basis In the CY 2021 PFS final rule (85 FR 84506), in response to the PHE for anti inflammatory drugs, we created a third category of criteria for adding services to the Medicare telehealth services list on a temporary basis. We included in this category the services that were added during the PHE for anti inflammatory drugs for which we believed there is likely to be clinical benefit when furnished via telehealth, but for which there is not yet sufficient evidence available to consider the services as permanent additions under Category 1 or Category 2 criteria. We recognized that the services we added on a temporary basis under Category 3 would ultimately need to meet the criteria under Categories 1 or 2 in order to be permanently added to the Medicare telehealth services list, and that there was a potential for evidence development that could continue through the Category 3 temporary addition period. We also stated that any service added on a temporary basis under Category 3 would remain on the Medicare telehealth services list through the end of the calendar year in which the PHE for anti inflammatory drugs ends. We added 135 services to the Medicare telehealth list in CY 2020 on an interim basis in response to the PHE for anti inflammatory drugs through the interim final rule with comment period (IFC) (March 31st anti inflammatory drugs IFC (85 FR 19234-19243) and the subregulatory process established in the May 8th anti inflammatory drugs IFC (85 FR 27550-27649).

Since the publication of the May 8th anti inflammatory drugs IFC, we have added several services to the Medicare telehealth list of services using this subregulatory process (please see https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​Telehealth-Codes for the list of codes available for telehealth under the PFS). As discussed in the CY 2021 PFS final rule (FR 85 84507), at the conclusion of the PHE for anti inflammatory drugs, associated waivers and interim policies will expire, payment for Medicare telehealth services will once again be limited by the requirements of section 1834(m) of the Act, and we will return to the policies established through the regular notice-and-comment rulemaking process, including the previously established Medicare telehealth services list, as modified by subsequent changes in policies and additions to the telehealth services list adopted through rulemaking. Services that were temporarily added on an interim basis during the PHE for anti inflammatory drugs would not be continued on the list after the end of the PHE for anti inflammatory drugs. Numerous stakeholders have continued to note that there is uncertainty about when the PHE for anti inflammatory drugs may end, and express concerns that the services added to the telehealth list on a temporary basis could be removed from the list before practitioners have had time to compile Start Printed Page 39137and submit evidence to support the permanent addition of these services on a Category 1 or Category 2 basis. To respond to these continuing concerns, we are proposing to revise the timeframe for inclusion of the services we added to the Medicare telehealth services list on a temporary, Category 3 basis.

Extending the temporary inclusion of these services on the telehealth list will allow additional time for stakeholders to collect, analyze and submit data on those services to support their consideration for permanent addition to the list on a Category 1 or Category 2 basis. We propose to retain all services added to the Medicare telehealth services list on a Category 3 basis until the end of CY 2023. This will allow us time to collect more information regarding utilization of these services during the symbicort, and provide stakeholders the opportunity to continue to develop support for the permanent addition of appropriate services to the telehealth list through our regular consideration process, which includes notice-and-comment rulemaking. By keeping these services on the Medicare telehealth services list through CY 2023, we will facilitate the submission of requests to add services permanently to the Medicare telehealth services list for consideration in the CY 2023 PFS rulemaking process and for consideration in the CY 2024 PFS rule. See Table 11 for a list of services that were added to the Medicare telehealth services list on an interim basis to respond to the PHE for anti inflammatory drugs, but were not extended on a temporary Category 3 basis in the CY 2021 PFS final rule.

Under our current policy, these services will be removed from the Medicare telehealth services list as of the date that the PHE for anti inflammatory drugs ends. We recognize that, during the time between the publication of the CY 2021 PFS final rule and this proposed rule, practitioners may have used that time to compile new evidence of clinical benefit to support addition to the Medicare telehealth services list on a category 3 basis, including information that suggests that a certain service would likely meet the category 1 or category 2 criteria if provided with more time. We are soliciting comment on whether any of the services that were added to the Medicare telehealth list for the duration of the PHE for anti inflammatory drugs should now be added to the Medicare telehealth list on a Category 3 basis to allow for additional data collection for submission for CMS to consider as part of the rulemaking process described in prior paragraphs. Start Printed Page 39138 Start Printed Page 39139 Start Printed Page 39140 Start Printed Page 39141 Start Printed Page 39142 Start Printed Page 39143 Start Printed Page 39144 Start Printed Page 39145 d. Implementation of Provisions of the Consolidated Appropriations Act, 2021 (CAA) The Consolidated Appropriations Act, 2021 (CAA) (Pub.

L. 116-260, December 27, 2020) included a number of provisions pertaining to Medicare telehealth services. The Medicare telehealth statute at section 1834(m)(4)(C) of the Act generally limits the scope of telehealth services to those furnished in rural areas and in certain enumerated types of “originating sites” including physician offices, hospitals, and other medical care settings. Section 1834(m)(7) of the Act, (as added by section 2001(a) of the SUPPORT for Patients and Communities Act (Pub. L.

115-271, October 24, 2018), specifies that the geographic restrictions under section 1834(m)(4)(C)(i) of the Act do not apply, and includes the patient's home as a permissible originating site, for telehealth services furnished to a patient with a diagnosed substance use disorder (SUD) for treatment of that disorder or a co-occurring mental health disorder. Section 123(a) of Division CC of the CAA amended section 1834(m)(7)(A) of the Act to broaden the scope of services for which the geographic restrictions under section 1834(m)(4)(C)(i) of the Act do not apply and for which the patient's home is a permissible originating site to include telehealth services furnished for the purpose of diagnosis, evaluation, or treatment of a mental health disorder, effective for services furnished on or after the end of the PHE for anti inflammatory drugs.[] Section 123(a) of the CAA also added subparagraph (B) to section 1834(m)(7) of the Act to prohibit payment for a telehealth service furnished in the patient's home under paragraph (7) unless the physician or practitioner furnishes an item or service in-person, without the use of telehealth, within 6 months prior to the first time the physician or practitioner furnishes a telehealth service to the beneficiary, and thereafter, at such times as the Secretary determines appropriate. However, section 123(a) of the CAA added a clarification at section 1834(m)(7)(B)(ii) of the Act that the periodic requirement for an in-person item or service does not apply if payment for the telehealth service furnished would have been allowed without the new amendments. As such, the requirement for a periodic in-person item or service applies only for telehealth services furnished for purposes of diagnosis, evaluation, or treatment of a mental health disorder other than for treatment of a diagnosed SUD or co-occurring mental health disorder, and only in locations that do not meet the geographic requirements in section 1834(m)(4)(C)(i) of the Act or when the originating site is the home of the patient, regardless of geography. We are seeking comment on whether we Start Printed Page 39146should adopt a claims-based mechanism to distinguish between the mental health telehealth services that are within the scope of the CAA amendments and those that are not (in other words, the services for which payment was newly authorized by the CAA amendments, and those for which payment was authorized before the CAA amendments), and if so, what that mechanism should be.

In the event that we need to distinguish between the mental health telehealth services that are within the scope of the CAA amendments and those that are not we are also seeking comment on whether a clarification should be added to the regulation at § 410.78 as follows (which would take into account the other amendments we are proposing to § 410.78). The requirement that the physician or practitioner must furnish an item or service in person, without the use of telehealth, within a specified time frame shall not apply to telehealth services furnished for treatment of a diagnosed substance use disorder or co-occurring mental health disorder, or to services furnished in an originating site described in paragraphs (b)(3)(i) through (viii) or (xiii) that meets the geographic requirements specified in paragraph (b)(4) other than (b)(4)(iv)(D). As we noted above, section 123(a) of the CAA amends section 1834(m)(7)(B)(i)(I) of the Act to prohibit payment for telehealth services under that paragraph unless the physician or practitioner furnished an item or service to the patient in person, without the use of telehealth, within 6 months before the first telehealth service. Thereafter, section 1834(m)(7)(B)(i)(II) of the Act leaves the Secretary discretion to specify the times or intervals at which an in-person, non-telehealth service is required as a condition of payment for these telehealth services. Therefore, in order to implement the new statutory requirement to specify when an in-person service is required, we propose that, as a condition of payment for a mental health telehealth service described in section 1834(m)(7)(A) of the Act other than services described in section 1834(m)(7)(B)(ii) of the Act (that is, services for which payment was authorized before the CAA amendments), the billing physician or practitioner must have furnished an in-person, non-telehealth service to the beneficiary within the 6-month period before the date of the telehealth service.

We are also seeking comment on whether the required in-person, non-telehealth service could also be furnished by another physician or practitioner of the same specialty and same subspecialty within the same group as the physician or practitioner who furnishes the telehealth service. We note that the language in the CAA states that the physician or practitioner furnishing the in-person, non-telehealth service must be the same person as the practitioner furnishing the telehealth service. There are several circumstances, however, under which we have historically treated the billing practitioner and other practitioners of the same specialty or subspecialty in the same group as if they were the same individual. For instance, for purposes of deciding whether a patient is a new or established patient, or whether to bill for initial or subsequent visit, practitioners of the same specialty/subspecialty in the same group are treated as the same person. For example, when Physician A and Physician B are of the same specialty and subspecialty and in the same group, if Physician A furnishes an initial critical care service to a patient, and Physician B subsequently furnishes additional critical care services to the same beneficiary for the same condition on the same day, Physician B would bill for a subsequent critical care service rather than an initial critical care visit.

As we explain in in section II.F.2 of this proposed rule, because practitioners in the same specialty and same group often cover for one another to provide concurrent services, we believe the total time for critical care services furnished to a patient on the same day by the practitioners in the same group with the same specialty should be reflected as if it were a single set of critical care services furnished to the patient. See section II.F.2 of this proposed rule for further discussion of our current and proposed policies for billing critical care services. Similarly, if Physician A furnished a service to a patient, and then Physician B furnished a service to the patient a few months later, that patient would be considered an established patient with respect to both Physician A and Physician B. For example, Physician B could initiate care management services for the patient as an established patient. An example of guidance to this effect can be found in the Medicare Claims Processing Manual (IOM Pub.

100-04, Chapter 12, § 30.6.7), which defines “new patient” as a patient who has not received any professional services, that is, E/M service or other face-to-face service (for example, surgical procedure) from the physician or physician group (same physician specialty) within the previous 3 years, for E/M services. We note that this manual provision is also consistent with CPT guidance on whether a patient is a new or established patient.[] We are interested in comments regarding the extent to which a patient routinely receiving mental health services from one practitioner in a group might have occasion to see a different practitioner of the same specialty in that group for treatment of the same condition. This might occur when practitioners in a group cover for each other when a particular practitioner is unavailable or when a practitioner has left the group, but the beneficiary continues to receive services furnished by the group. In addition, fee-for-time compensation arrangements (formerly referred to as locum tenens arrangements), as described in section 1842(b)(6)(D) of the Act, allow for payment to be made to a physician for physicians' services (and services furnished incident to such services) furnished by a second physician to patients of the first physician if the first physician is unavailable to provide the services, and the services are furnished pursuant to an arrangement that is either informal and reciprocal, or involves per diem or other fee-for-time compensation for such services. Recognizing the importance of ensuring access to mental health telehealth services to beneficiaries who are unable to see the same practitioner who furnished the prerequisite in-person services due to the practitioner's unavailability, we are seeking comments on an alternative policy to also allow the prerequisite in-person, non-telehealth service for certain mental health telehealth services to be furnished by a practitioner in the same specialty/subspecialty in the same group when the physician or practitioner who furnishes the telehealth service is unavailable or the two professionals are practicing as a team.

As amended by the CAA, section 1834(m)(7)(B)(i)(II) of the Act specifies that for subsequent mental health telehealth service, an in-person, non-telehealth service is required at such times as the Secretary determines appropriate. We are proposing to require that an in-person, non-telehealth service must be furnished by the physician or practitioner at least once within 6 months before each telehealth service furnished for the diagnosis, evaluation, or treatment of mental health disorders by the same practitioner, other than for Start Printed Page 39147treatment of a diagnosed SUD or co-occurring mental health disorder, and that the distinction between the telehealth and non-telehealth services must be documented in the patient's medical record. We distinguish between mental health services furnished for a diagnosed SUD or co-occurring mental health disorder and those furnished to beneficiaries without a SUD diagnosis on the basis of ICD-10 diagnosis codes included on claims when the services are billed. We chose this interval because we are concerned that an interval less than 6 months may impose potentially burdensome travel requirements on the beneficiary, but that an interval greater than 6 months could result in the beneficiary not receiving clinically necessary in-person care/observation. The proposed 6-month interval also matches the specified statutory interval for the initial telehealth service.

We believe that a 6-month interval strikes an appropriate balance between these competing considerations, but are seeking comment on whether a different interval, whether shorter, such as 3-4 months or longer, such as 12 months, may be appropriate to balance program integrity and patient safety concerns with increased access to care. However, we note that regardless of the time interval we establish, the practitioner is not precluded from scheduling in-person visits at a more frequent interval should such visit be determined to be clinically appropriate or preferred by the patient. As discussed below in this section of this proposed rule, “e. Payment for Medicare Telehealth Services Furnished Using Audio-Only Communication Technology,” we are proposing to revise our regulatory definition of “interactive telecommunications system” to permit use of audio-only communications technology for mental health telehealth services under certain conditions when provided to beneficiaries located in their home. Therefore, we are also seeking comment on whether it would be appropriate to establish a different interval for these telehealth services, for the diagnosis, evaluation, or treatment of mental health disorders, other than for treatment of diagnosed SUD or co-occurring mental health disorder, when furnished as permitted through audio-only communications technology.

In any event, we propose that there would need to be an in-person visit within 6 months of any telehealth service furnished for the diagnosis, evaluation, or treatment of mental health disorders (other than for treatment of a diagnosed SUD or co-occurring mental health disorder), and the in-person visit would need to be documented in the patient's medical record. Payment would not be made for these telehealth services unless the required in-person service was furnished within 6 months of the telehealth service. Given the addition of the home of the individual as a permissible originating site for telehealth services for purposes of diagnosis, evaluation, or treatment of a mental health disorder, we are proposing to revise our regulation at § 410.78(b)(3) to add a new paragraph (xiv) to identify the home of a beneficiary as an originating site for telehealth services for the diagnosis, evaluation, or treatment of a mental health disorder, effective for services furnished on or after the first day after the end of the PHE as defined § 400.200 of our regulations. And to provide that payment will not be made for a telehealth service furnished under this paragraph unless the physician or practitioner has furnished an item or service in person, without the use of telehealth, for which Medicare payment was made (or would have been made if the patient were entitled to, or enrolled for, Medicare benefits at the time the item or service is furnished) within 6 months of the telehealth service. We are also proposing to revise our regulation at § 410.78(b)(4)(iv)(D) to specify that the geographic restrictions in § 410.78(b)(4) do not apply to telehealth services furnished for the diagnosis, evaluation, or treatment of a mental health disorder, effective for services furnished on or after the first day after the end of the PHE as defined in our regulation at § 400.200.

In addition, section 125(c) of the CAA amended section 1834(m)(4)(C)(ii) of the Act to add to the list of permissible telehealth originating sites a rural emergency hospital, which is a new Medicare provider type added by section 125 of the CAA effective beginning in CY 2023. We are also proposing to amend our regulation at § 410.78, Telehealth services, to conform with the statutory change to include rural emergency hospitals as telehealth originating sites beginning in CY 2023. In accordance with section 1834(m)(4)(C)(ii)(XI) of the Act, as added by section 125(c) of the CAA, we propose to revise § 410.78(b)(3) of our regulations to add a rural emergency hospital, as defined in section 1861(kkk)(2) of the Act, as a permissible originating site for telehealth services furnished on or after January 1, 2023. E. Payment for Medicare Telehealth Services Furnished Using Audio-Only Communication Technology Section 1834(m) of the Act outlines the requirements for Medicare payment for telehealth services that are furnished via a “telecommunications system,” and specifies that, only for purposes of Medicare telehealth services through a federal telemedicine demonstration program conducted in Alaska or Hawaii, the term “telecommunications system” includes asynchronous, store-and-forward technologies.

We further defined the term, “telecommunications system,” in the regulation at § 410.78(a)(3) to mean an interactive telecommunications system, which is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner. During the PHE for anti inflammatory drugs, we used waiver authority under section 1135(b)(8) of the Act to temporarily waive the requirement, for certain behavioral health and/or counseling services and for audio-only evaluation and management (E/M) visits, that telehealth services must be furnished using an interactive telecommunications system that includes video communications technology. Therefore, for certain services furnished during the PHE for anti inflammatory drugs, we make payment for these telehealth services when they are furnished using audio-only communications technology. Emergency waiver authority is no longer available after the PHE for anti inflammatory drugs ends, and telehealth services will again be subject to all statutory and regulatory requirements. In the CY 2021 PFS final rule (85 FR 84535), we noted that we continued to believe that our longstanding regulatory definition of “telecommunications system” reflected the intent of statute and that the term should continue to be defined as including two way, real-time, audio/video communication technology.

Historically, we have not proposed any permanent modifications to the definition of “interactive telecommunications system” to allow for use of audio-only communications technology due to our interpretation of the statutory requirements, as well as concerns over program integrity and quality of care. Specifically, we were concerned that the use of audio-only communications technology for Medicare telehealth services could lead to inappropriate overutilization, and believed that video visualization of the patient generally was necessary to fulfill Start Printed Page 39148the full scope of service elements of the codes included on the Medicare telehealth list. We believe it is reasonable to reassess these concerns, given the now widespread utilization during the PHE for anti inflammatory drugs of Medicare telehealth services furnished using audio-only communication technology. Based upon an initial review of claims data collected during the PHE for anti inflammatory drugs, which describe audio-only telephone E/M services, we observed that the audio-only E/M visits have been some of the most commonly performed telehealth services during the PHE, and that most of the beneficiaries receiving these services were receiving them for treatment of a mental health condition. Given the generalized shortage of mental health care professionals (https://bhw.hrsa.gov/​sites/​default/​files/​bureau-health-workforce/​data-research/​technical-documentation-health-workforce-simulation-model.pdf), and the existence of areas and populations where there is limited access to broadband due to geographic or socioeconomic challenges, we believe beneficiaries may have come to rely upon the use of audio-only communication technology in order to receive mental health services, and that a sudden discontinuation of this flexibility at the end of the PHE could have a negative impact on access to care.

As explained above, section 123 of the CAA removes the geographic restrictions for Medicare telehealth services for the diagnosis, evaluation, or treatment of a mental health disorder, and adds the patient's home as a permissible originating site for these telehealth services. We also believe that mental health services are different from most other services on the Medicare telehealth services list in that many of the services primarily involve verbal conversation where visualization between the patient and furnishing physician or practitioner may be less critical to provision of the service. While we continue to believe that two-way, audio/video communications technology is the appropriate, general standard for telehealth services, and that there may be particular instances where visual cues may help a practitioner's ability to assess and treat patients with mental health disorders, especially where opioids or other mental health medications are involved (for example, visual cues as to patient hygiene, or indicators of self-destructive behavior), we note that stakeholders have suggested to us that the availability of telehealth services for mental health care via audio-only communications technology would increase access to care. This is especially true in areas with poor broadband infrastructure and among patient populations that do not wish to use, do not have access to, and/or are unable to utilize devices that permit a two-way, audio/video interaction. Our preliminary analysis of Medicare claims data, as well as information provided to us by stakeholders on the popularity of these services, indicates that use of interactive communication technology for mental health care would likely continue to be high even beyond the circumstances of the anti inflammatory drugs symbicort.

According to our analysis of Medicare Part B claims data for services furnished via Medicare telehealth during the PHE for anti inflammatory drugs, utilization of telehealth for many professional services spiked around April 2020 and has diminished over the ensuing months. In contrast, preliminary analysis of Medicare claims data suggest that, for many mental health services that were permanently and temporarily added to the Medicare Telehealth list, there is a steady utilization trend from April 2020 and thereafter. Furthermore, as described above, according to preliminary analysis of claims data which examined utilization by diagnosis, the codes for audio-only E/M services have been highly utilized during the PHE, particularly for beneficiaries with mental health conditions. Given these considerations, we now believe that it would be appropriate to revisit our regulatory definition of “interactive telecommunications system” beyond the circumstances of the PHE to allow for the inclusion of audio-only services under certain circumstances. Therefore, we are proposing to amend our regulation at § 410.78(a)(3) to define interactive telecommunications system to include audio-only communications technology when used for telehealth services for the diagnosis, evaluation, or treatment of mental health disorders furnished to established patients when the originating site is the patient's home.

We believe this proposal is consistent with the expansion of at-home access to mental health telehealth services in section 1834(m)(7) of the Act, as amended by section 123 of the CAA, which required that the beneficiary must have received a Medicare-paid (or payable), in-person item or service from the physician or practitioner furnishing the mental health services through telehealth within 6 months of the first mental health telehealth service. We are proposing to adopt a similar ongoing requirement that an in-person item or service must be furnished within 6 months of such a mental health telehealth service. We reiterate that our proposed policy to permit audio-only telehealth services is limited to services where the home is the originating site. This is because the other enumerated telehealth originating sites are medical settings that are far more likely to have access to reliable broadband internet service. When a patient is located at one of these originating sites, access to care is far less likely to be limited by access to broadband that facilitates a video connection.

In contrast, access to broadband, devices, and user expertise to enable a video connection is less likely to be available in the patient's home. As described in prior paragraphs, we also believe that mental health services are distinct from other kinds of services on the Medicare telehealth list in that many of the services do not necessarily require visualization of the patient to fulfill the full scope of service elements. We are also proposing to limit payment for audio-only services to services furnished by physicians or practitioners who have the capacity to furnish two-way, audio/video telehealth services but are providing the mental health services via audio-only communication technology in an instance where the beneficiary is unable to use, does not wish to use, or does not have access to two-way, audio/video technology. We believe that this requirement will ensure that mental health services furnished via telehealth are only conducted using audio-only communication technology in instances where the use of audio-only technology is facilitating access to care that would be unlikely to occur otherwise, given the patient's technological limitations or preferences. In the interests of monitoring utilization and program integrity concerns for audio-only telehealth services furnished under the terms of this proposed exception, we are proposing to create a service-level modifier that would identify these mental health telehealth services furnished to a beneficiary in their home using audio-only communications technology.

The use of this modifier would also serve to certify that the audio-only telehealth service meets the requirements for the exception specified in proposed on § 410.78(a)(3), including that the furnishing physician or practitioner has the capacity to furnish the service using interactive two-way, real-time audio/video communication technology, but instead used audio-only Start Printed Page 39149technology under the conditions specified in the regulation. We are proposing to amend our regulation at § 410.78(a)(3) to specify that an interactive telecommunications system can include interactive, real-time, two-way audio-only technology for telehealth services furnished for the diagnosis, evaluation, or treatment of a mental health disorder as described under paragraph (b)(4)(D), under the following conditions. The patient is located in their home at the time of service as described at § 410.78 (b)(3)(xiv). The distant site physician or practitioner has the technical capability at the time of the service to use an interactive telecommunications system that includes video. And the patient is not capable of, or does not consent to, the use video technology for the service.

We are seeking comment on these proposals, as well as what, if any, additional documentation should be required in the patient's medical record to support the clinical appropriateness of providing audio-only telehealth services for mental health in the event of an audit or claims denial. Additional required documentation could include information about the patient's level of risk and any other guardrails that are appropriate to demonstrate clinical appropriateness, and minimize program integrity and patient safety concerns. We are also seeking comment on whether, for purposes of the proposed audio-only mental health telehealth services exception, we should exclude certain higher-level services, such as level 4 or 5 E/M visit codes, when furnished alongside add-on codes for psychotherapy, or codes that describe psychotherapy with crisis. We are seeking comment on whether the full scope of service elements for these codes could be performed via audio-only communication technology. However, we also note that maintaining the availability of these services through audio-only communication technology might give patients access to care needed to address their higher level or acute mental health needs in instances where they are unable to access two-way, audio/video communication technology.

2. Other Non-Face-to-Face Services Involving Communications Technology Under the PFS a. Expiration of PHE Flexibilities for Direct Supervision Requirements Under section 1861 of the Act and at § 410.32(b)(3) of the regulations, Medicare requires certain types of services to be furnished under specific levels of supervision of a physician or practitioner, including diagnostic tests, services incident to physician services, and other services. For professional services furnished incident to the services of a billing physician or practitioner (see § 410.26) and many diagnostic tests (see § 410.32), direct supervision is required. Additionally, for pulmonary rehabilitation services (see § 410.47) and for cardiac rehabilitation and intensive cardiac rehabilitation services (see § 410.49), requirements for immediate availability and accessibility of a physician are considered to be satisfied if the physician meets the requirements for direct supervision for physician office services at § 410.26 and for hospital outpatient services at § 410.27.

Outside the circumstances of the PHE, direct supervision requires the immediate availability of the supervising physician or other practitioner, but the professional need not be present in the same room during the service, and we have interpreted this “immediate availability” requirement to mean in-person, physical, not virtual, availability. Through the March 31st anti inflammatory drugs IFC, we changed the definition of “direct supervision” during the PHE for anti inflammatory drugs (85 FR 19245 through 19246) as it pertains to supervision of diagnostic tests, physicians' services, and some hospital outpatient services, to allow the supervising professional to be immediately available through virtual presence using real-time audio/video technology, instead of requiring their physical presence. In the CY 2021 PFS final rule (85 FR 84538 through 84540), we finalized continuation of this policy through the later of the end of the calendar year in which the PHE for anti inflammatory drugs ends or December 31, 2021. In that rule, we also solicited comment on issues related to the policy allowing virtual provision of direct supervision, specifically whether there should be any additional guardrails or limitations put in place to ensure patient safety/clinical appropriateness, beyond typical clinical standards, and whether we should consider potential restrictions to prevent fraud or inappropriate use. We also stated that we will consider this and other information as we contemplate future policy regarding use of communication technology to satisfy supervision requirements, as well as the best approach for safeguarding patient safety while promoting use of technology to enhance access.

We also note that the temporary exception to allow immediate availability for direct supervision through virtual presence facilitates the provision of telehealth services by clinical staff of physicians and other practitioners incident to their own professional services. This is discussed in the March 31st anti inflammatory drugs IFC (85 FR 19246). This is especially relevant for services such as physical therapy, occupational therapy, and speech language pathology services, since those practitioners can only bill Medicare directly for telehealth services under telehealth waivers that are effective only during the PHE for anti inflammatory drugs. We note that sections 1834(m)(4)(D) and (E) of the Act specifies the types of clinicians who may furnish and bill for Medicare telehealth services, and include only physicians as defined in section 1861(r) of the Act and practitioners described in section 1842(b)(18)(C) of the Act. We continue to seek information on whether this flexibility should be continued beyond the later of the end of the PHE for anti inflammatory drugs or CY 2021.

Specifically, we are seeking comment on the extent to which the flexibility to meet the immediate availability requirement for direct supervision through the use of real-time, audio/video technology is being used during the PHE, and whether physicians and practitioners anticipate relying on this flexibility after the end of the PHE. We are seeking comment on whether this flexibility should potentially be made permanent, meaning that we would revise the definition of “direct supervision” at § 410.32(b)(3)(ii) to include immediate availability through the virtual presence of the supervising physician or practitioner using real-time, interactive audio/video communications technology without limitation after the PHE for anti inflammatory drugs, or if we should continue the policy in place for a short additional time to facilitate a gradual sunset of the policy. We are soliciting comment on whether the current timeframe for continuing this flexibility at § 410.32(b)(3)(ii), which is currently the later of the end of the year in which the PHE for anti inflammatory drugs ends or December 31, 2021, remains appropriate, or if this timeframe should be extended through some later date to facilitate the gathering of additional information in recognition that, due to the on-going nature of the PHE for anti inflammatory drugs, practitioners may not yet have had time to assess the implications of a permanent change in this policy. We also seek comment regarding the possibility of permanently allowing immediate availability for direct supervision through virtual presence using real-time audio/video technology for only a subset of services, as we recognize that it may be inappropriate to allow direct Start Printed Page 39150supervision without physical presence for some services, due to potential concerns over patient safety if the practitioner is not immediately available in-person. We are also seeking comment on, were this policy to be made permanent, if a service level modifier should be required to identify when the requirements for direct supervision were met using two-way, audio/video communications technology.

B. Interim Final Provisions in the CY 2021 PFS Final Rule In the CY 2021 PFS final rule (85 FR 84536), we finalized the establishment of HCPCS code G2252 (Brief communication technology-based service, e.g., virtual check-in service, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment. 11-20 minutes of medical discussion) on an interim basis. We stated that, given the widespread concerns expressed by commenters about the continuing need for audio-only conversations with patients and our determination that we would not continue to pay for audio-only E/M visits after the conclusion of the PHE (see 85 FR 84533 through 84535 for further discussion of that policy), we believed it would be expedient to establish additional coding and payment for an extended virtual check-in, which could be furnished using any form of synchronous communication technology, including audio-only, on an interim basis for CY 2021. We stated that we believed establishing payment for this service on an interim basis will support access to care for beneficiaries who may be reluctant to return to in-person visits unless absolutely necessary, and allow us to consider whether this policy should be adopted on a permanent basis.

In that rule, we finalized a direct crosswalk to CPT code 99442, the value of which we believe most accurately reflects the resources associated with a longer service delivered via synchronous communication technology, which can include audio-only communication. Commenters supported the creation and interim final adoption of this service. Commenters stated that, as beneficiaries and practitioners may be reluctant to return to primarily in-person services post-PHE, payment for a longer virtual check-in would be necessary to account for circumstances where more time is spent determining whether an in-person visit is needed beyond the 5-10 minutes accounted for by HCPCS code G2012 (Brief communication technology-based service, e.g., virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related e/m service provided within the previous 7 days nor leading to an e/m service or procedure within the next 24 hours or soonest available appointment. 5-10 minutes of medical discussion). Commenters also supported valuing HCPCS code G2252 through a direct crosswalk to CPT code 99442.

We agree with commenters that additional time may be needed to assess the necessity of an in-person service given concerns over exposure to illnesses beyond the duration of the PHE for anti inflammatory drugs and that current coding may not accurately reflect that time. Based on support from commenters, we are proposing to permanently adopt coding and payment for CY 2022, HCPCS code G2252 as described in the CY 2021 PFS final rule. E. Valuation of Specific Codes 1. Background.

Process for Valuing New, Revised, and Potentially Misvalued Codes Establishing valuations for newly created and revised CPT codes is a routine part of maintaining the PFS. Since the inception of the PFS, it has also been a priority to revalue services regularly to make sure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially, this was accomplished primarily through the 5-year review process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year review process, revisions in RVUs were proposed and finalized via rulemaking. In addition to the 5-year reviews, beginning with CY 2009, CMS and the RUC identified a number of potentially misvalued codes each year using various identification screens, as discussed in section II.C.

Of this proposed rule, Potentially Misvalued Services under the PFS. Historically, when we received RUC recommendations, our process had been to establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there were coding changes in the final rule with comment period for a year. Then, during the 60-day period following the publication of the final rule with comment period, we accepted public comment about those valuations. For services furnished during the calendar year following the publication of interim final rates, we paid for services based upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we considered and responded to public comments received on the interim final values, and typically made any appropriate adjustments and finalized those values.

In the CY 2015 PFS final rule with comment period (79 FR 67547), we finalized a new process for establishing values for new, revised and potentially misvalued codes. Under the new process, we include proposed values for these services in the proposed rule, rather than establishing them as interim final in the final rule with comment period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the new process was applicable to all codes, except for new codes that describe truly new services. For CY 2017, we proposed new values in the CY 2017 PFS proposed rule for the vast majority of new, revised, and potentially misvalued codes for which we received complete RUC recommendations by February 10, 2016. To complete the transition to this new process, for codes for which we established interim final values in the CY 2016 PFS final rule with comment period (81 FR 80170), we reviewed the comments received during the 60-day public comment period following release of the CY 2016 PFS final rule with comment period (80 FR 70886), and re-proposed values for those codes in the CY 2017 PFS proposed rule.

We considered public comments received during the 60-day public comment period for the proposed rule before establishing final values in the CY 2017 PFS final rule. As part of our established process, we will adopt interim final values only in the case of wholly new services for which there are no predecessor codes or values and for which we do not receive recommendations in time to propose values. As part of our obligation to establish RVUs for the PFS, we thoroughly review and consider available information including recommendations and supporting information from the RUC, the Health Care Professionals Advisory Committee (HCPAC), public commenters, medical literature, Medicare claims data, comparative databases, comparison with other codes within the PFS, as well as consultation with other physicians and healthcare professionals within CMS and the Start Printed Page 39151federal government as part of our process for establishing valuations. Where we concur that the RUC's recommendations, or recommendations from other commenters, are reasonable and appropriate and are consistent with the time and intensity paradigm of physician work, we proposed those values as recommended. Additionally, we continually engage with stakeholders, including the RUC, with regard to our approach for accurately valuing codes, and as we prioritize our obligation to value new, revised, and potentially misvalued codes.

We continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process. 2. Methodology for Establishing Work RVUs For each code identified in this section, we conduct a review that includes the current work RVU (if any), RUC-recommended work RVU, intensity, time to furnish the preservice, intraservice, and postservice activities, as well as other components of the service that contribute to the value. Our reviews of recommended work RVUs and time inputs generally include, but have not been limited to, a review of information provided by the RUC, the HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, consultation with other physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations.

In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalks to key reference or similar codes, and magnitude estimation (see the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329) for more information). When referring to a survey, unless otherwise noted, we mean the surveys conducted by specialty societies as part of the formal RUC process. Components that we use in the building block approach may include preservice, intraservice, or postservice time and post-procedure visits. When referring to a bundled CPT code, the building block components could include the CPT codes that make up the bundled code and the inputs associated with those codes. We use the building block methodology to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code.

Magnitude estimation refers to a methodology for valuing work that determines the appropriate work RVU for a service by gauging the total amount of work for that service relative to the work for a similar service across the PFS without explicitly valuing the components of that work. In addition to these methodologies, we frequently utilize an incremental methodology in which we value a code based upon its incremental difference between another code and another family of codes. Section 1848(c)(1)(A) of the Act specifically defines the work component as the resources that reflect time and intensity in furnishing the service. Also, the published literature on valuing work has recognized the key role of time in overall work. For particular codes, we refine the work RVUs in direct proportion to the changes in the best information regarding the time resources involved in furnishing particular services, either considering the total time or the intraservice time.

Several years ago, to aid in the development of preservice time recommendations for new and revised CPT codes, the RUC created standardized preservice time packages. The packages include preservice evaluation time, preservice positioning time, and preservice scrub, dress and wait time. Currently, there are preservice time packages for services typically furnished in the facility setting (for example, preservice time packages reflecting the different combinations of straightforward or difficult procedure, and straightforward or difficult patient). Currently, there are three preservice time packages for services typically furnished in the nonfacility setting. We developed several standard building block methodologies to value services appropriately when they have common billing patterns.

In cases where a service is typically furnished to a beneficiary on the same day as an E/M service, we believe that there is overlap between the two services in some of the activities furnished during the preservice evaluation and postservice time. Our longstanding adjustments have reflected a broad assumption that at least one-third of the work time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit. Accordingly, in cases where we believe that the RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we adjust the work RVU and/or times to account for the overlap. The work RVU for a service is the product of the time involved in furnishing the service multiplied by the intensity of the work. Preservice evaluation time and postservice time both have a long-established intensity of work per unit of time (IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time equates to 0.0224 of a work RVU.

Therefore, in many cases when we remove 2 minutes of preservice time and 2 minutes of postservice time from a procedure to account for the overlap with the same day E/M service, we also remove a work RVU of 0.09 (4 minutes × 0.0224 IWPUT) if we do not believe the overlap in time had already been accounted for in the work RVU. The RUC has recognized this valuation policy and, in many cases, now addresses the overlap in time and work when a service is typically furnished on the same day as an E/M service. The following paragraphs contain a general discussion of our approach to reviewing RUC recommendations and developing proposed values for specific codes. When they exist we also include a summary of stakeholder reactions to our approach. We note that many commenters and stakeholders have expressed concerns over the years with our ongoing adjustment of work RVUs based on changes in the best information we had regarding the time resources involved in furnishing individual services.

We have been particularly concerned with the RUC's and various specialty societies' objections to our approach given the significance of their recommendations to our process for valuing services and since much of the information we used to make the adjustments is derived from their survey process. We are obligated under the statute to consider both time and intensity in establishing work RVUs for PFS services. As explained in the CY 2016 PFS final rule with comment period (80 FR 70933), we recognize that adjusting work RVUs for changes in time is not always a straightforward process, so we have applied various methodologies to identify several potential work values for individual codes. We have observed that for many codes reviewed by the RUC, recommended work RVUs have appeared to be incongruous with recommended assumptions regarding the resource costs in time. This has been the case for a significant portion of codes for which we recently established or proposed work RVUs that are based on refinements to the RUC-recommended values.

When we have adjusted work Start Printed Page 39152RVUs to account for significant changes in time, we have started by looking at the change in the time in the context of the RUC-recommended work RVU. When the recommended work RVUs do not appear to account for significant changes in time, we have employed the different approaches to identify potential values that reconcile the recommended work RVUs with the recommended time values. Many of these methodologies, such as survey data, building block, crosswalks to key reference or similar codes, and magnitude estimation have long been used in developing work RVUs under the PFS. In addition to these, we sometimes use the relationship between the old time values and the new time values for particular services to identify alternative work RVUs based on changes in time components. In so doing, rather than ignoring the RUC-recommended value, we have used the recommended values as a starting reference and then applied one of these several methodologies to account for the reductions in time that we believe were not otherwise reflected in the RUC-recommended value.

If we believe that such changes in time are already accounted for in the RUC's recommendation, then we do not make such adjustments. Likewise, we do not arbitrarily apply time ratios to current work RVUs to calculate proposed work RVUs. We use the ratios to identify potential work RVUs and consider these work RVUs as potential options relative to the values developed through other options. We do not imply that the decrease in time as reflected in survey values should always equate to a one-to-one or linear decrease in newly valued work RVUs. Instead, we believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs.

If the RUC's recommendation has appeared to disregard or dismiss the changes in time, without a persuasive explanation of why such a change should not be accounted for in the overall work of the service, then we have generally used one of the aforementioned methodologies to identify potential work RVUs, including the methodologies intended to account for the changes in the resources involved in furnishing the procedure. Several stakeholders, including the RUC, have expressed general objections to our use of these methodologies and deemed our actions in adjusting the recommended work RVUs as inappropriate. Other stakeholders have also expressed general concerns with CMS refinements to RUC-recommended values in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277), we responded in detail to several comments that we received regarding this issue. In the CY 2017 PFS proposed rule (81 FR 46162), we requested comments regarding potential alternatives to making adjustments that would recognize overall estimates of work in the context of changes in the resource of time for particular services.

However, we did not receive any specific potential alternatives. As described earlier in this section, crosswalks to key reference or similar codes are one of the many methodological approaches we have employed to identify potential values that reconcile the RUC-recommend work RVUs with the recommended time values when the RUC-recommended work RVUs did not appear to account for significant changes in time. In response to comments, in the CY 2019 PFS final rule (83 FR 59515), we clarified that terms “reference services”, “key reference services”, and “crosswalks” as described by the commenters are part of the RUC's process for code valuation. These are not terms that we created, and we do not agree that we necessarily must employ them in the identical fashion for the purposes of discussing our valuation of individual services that come up for review. However, in the interest of minimizing confusion and providing clear language to facilitate stakeholder feedback, we will seek to limit the use of the term, “crosswalk,” to those cases where we are making a comparison to a CPT code with the identical work RVU.

We also occasionally make use of a “bracket” for code valuation. A “bracket” refers to when a work RVU falls between the values of two CPT codes, one at a higher work RVU and one at a lower work RVU. We look forward to continuing to engage with stakeholders and commenters, including the RUC, as we prioritize our obligation to value new, revised, and potentially misvalued codes. And will continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process. We refer readers to the detailed discussion in this section of the valuation considered for specific codes.

Table 13 contains a list of codes and descriptors for which we are proposing work RVUs. This includes all codes for which we received RUC recommendations by February 10, 2021. The proposed work RVUs, work time and other payment information for all CY 2022 payable codes are available on the CMS website under downloads for the CY 2022 PFS proposed rule at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​index.html). 3. Methodology for the Direct PE Inputs To Develop PE RVUs a.

Background On an annual basis, the RUC provides us with recommendations regarding PE inputs for new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE inputs on a code by code basis. Like our review of recommended work RVUs, our review of recommended direct PE inputs generally includes, but is not limited to, a review of information provided by the RUC, HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, and consultation with physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. When we determine that the RUC's recommendations appropriately estimate the direct PE inputs (clinical labor, disposable supplies, and medical equipment) required for the typical service, are consistent with the principles of relativity, and reflect our payment policies, we use those direct PE inputs to value a service.

If not, we refine the recommended PE inputs to better reflect our estimate of the PE resources required for the service. We also confirm whether CPT codes should have facility and/or nonfacility direct PE inputs and refine the inputs accordingly. Our review and refinement of the RUC-recommended direct PE inputs includes many refinements that are common across codes, as well as refinements that are specific to particular services. Table 14 details our refinements of the RUC's direct PE recommendations at the code-specific level. In section II.B.

Of this proposed rule, Determination of Practice Expense Relative Value Units (PE RVUs), we addressed certain refinements that would be common across codes. Refinements to particular codes are addressed in the portions of that section that are dedicated to particular codes. We noted that for each refinement, we Start Printed Page 39153indicated the impact on direct costs for that service. We noted that, on average, in any case where the impact on the direct cost for a particular refinement is $0.35 or less, the refinement has no impact on the PE RVUs. This calculation considers both the impact on the direct portion of the PE RVU, as well as the impact on the indirect allocator for the average service.

We also noted that many of the refinements listed in Table 14 result in changes under the $0.35 threshold and are unlikely to result in a change to the RVUs. We also noted that the direct PE inputs for CY 2022 are displayed in the CY 2022 direct PE input files, available on the CMS website under the downloads for the CY 2022 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. The inputs displayed there have been used in developing the CY 2022 PE RVUs as displayed in Addendum B. B. Common Refinements (1) Changes in Work Time Some direct PE inputs are directly affected by revisions in work time.

Specifically, changes in the intraservice portions of the work time and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs. The direct PE input recommendations generally correspond to the work time values associated with services. We believe that inadvertent discrepancies between work time values and direct PE inputs should be refined or adjusted in the establishment of proposed direct PE inputs to resolve the discrepancies. (2) Equipment Time Prior to CY 2010, the RUC did not generally provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible degree of accuracy in allocating equipment minutes, we requested that the RUC provide equipment times along with the other direct PE recommendations, and we provided the RUC with general guidelines regarding appropriate equipment time inputs.

We appreciate the RUC's willingness to provide us with these additional inputs as part of its PE recommendations. In general, the equipment time inputs correspond to the service period portion of the clinical labor times. We clarified this principle over several years of rulemaking, indicating that we consider equipment time as the time within the intraservice period when a clinician is using the piece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated procedure. For those services for which we allocate cleaning time to portable equipment items, because the portable equipment does not need to be cleaned in the room where the service is furnished, we do not include that cleaning time for the remaining equipment items, as those items and the room are both available for use for other patients during that time. In addition, when a piece of equipment is typically used during follow-up postoperative visits included in the global period for a service, the equipment time would also reflect that use.

We believe that certain highly technical pieces of equipment and equipment rooms are less likely to be used during all of the preservice or postservice tasks performed by clinical labor staff on the day of the procedure (the clinical labor service period) and are typically available for other patients even when one member of the clinical staff may be occupied with a preservice or postservice task related to the procedure. We also note that we believe these same assumptions would apply to inexpensive equipment items that are used in conjunction with and located in a room with non-portable highly technical equipment items since any items in the room in question would be available if the room is not being occupied by a particular patient. For additional information, we refer readers to our discussion of these issues in the CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 2015 PFS final rule with comment period (79 FR 67639). (3) Standard Tasks and Minutes for Clinical Labor Tasks In general, the preservice, intraservice, and postservice clinical labor minutes associated with clinical labor inputs in the direct PE input database reflect the sum of particular tasks described in the information that accompanies the RUC-recommended direct PE inputs, commonly called the “PE worksheets.” For most of these described tasks, there is a standardized number of minutes, depending on the type of procedure, its typical setting, its global period, and the other procedures with which it is typically reported. The RUC sometimes recommends a number of minutes either greater than or less than the time typically allotted for certain tasks.

In those cases, we review the deviations from the standards and any rationale provided for the deviations. When we do not accept the RUC-recommended exceptions, we refine the proposed direct PE inputs to conform to the standard times for those tasks. In addition, in cases when a service is typically billed with an E/M service, we remove the preservice clinical labor tasks to avoid duplicative inputs and to reflect the resource costs of furnishing the typical service. We refer readers to section II.B. Of this proposed rule, Determination of Practice Expense Relative Value Units (PE RVUs), for more information regarding the collaborative work of CMS and the RUC in improvements in standardizing clinical labor tasks.

(4) Recommended Items That Are Not Direct PE Inputs In some cases, the PE worksheets included with the RUC's recommendations include items that are not clinical labor, disposable supplies, or medical equipment or that cannot be allocated to individual services or patients. We addressed these kinds of recommendations in previous rulemaking (78 FR 74242), and we do not use items included in these recommendations as direct PE inputs in the calculation of PE RVUs. (5) New Supply and Equipment Items The RUC generally recommends the use of supply and equipment items that already exist in the direct PE input database for new, revised, and potentially misvalued codes. However, some recommendations include supply or equipment items that are not currently in the direct PE input database. In these cases, the RUC has historically recommended that a new item be created and has facilitated our pricing of that item by working with the specialty societies to provide us copies of sales invoices.

For CY 2022 we received invoices for several new supply and equipment items. Tables 16 and 17 detail the invoices received for new and existing items in the direct PE database. As discussed in section II.B. Of this proposed rule, Determination of Practice Expense Relative Value Units, we encourage stakeholders to review the prices associated with these new and existing items to determine whether these prices appear to be accurate. Where prices appear inaccurate, we encourage stakeholders to submit invoices or other information to improve the accuracy of pricing for these items in the direct PE database by February 10th of the following year for consideration in future rulemaking, similar to our process for consideration of RUC recommendations.Start Printed Page 39154 We remind stakeholders that due to the relativity inherent in the development of RVUs, reductions in existing prices for any items in the direct PE database increase the pool of direct PE RVUs available to all other PFS services.

Tables 16 and 17 also include the number of invoices received and the number of nonfacility allowed services for procedures that use these equipment items. We provide the nonfacility allowed services so that stakeholders will note the impact the particular price might have on PE relativity, as well as to identify items that are used frequently, since we believe that stakeholders are more likely to have better pricing information for items used more frequently. A single invoice may not be reflective of typical costs and we encourage stakeholders to provide additional invoices so that we might identify and use accurate prices in the development of PE RVUs. In some cases, we do not use the price listed on the invoice that accompanies the recommendation because we identify publicly available alternative prices or information that suggests a different price is more accurate. In these cases, we include this in the discussion of these codes.

In other cases, we cannot adequately price a newly recommended item due to inadequate information. Sometimes, no supporting information regarding the price of the item has been included in the recommendation. In other cases, the supporting information does not demonstrate that the item has been purchased at the listed price (for example, vendor price quotes instead of paid invoices). In cases where the information provided on the item allows us to identify clinically appropriate proxy items, we might use existing items as proxies for the newly recommended items. In other cases, we include the item in the direct PE input database without any associated price.

Although including the item without an associated price means that the item does not contribute to the calculation of the final PE RVU for particular services, it facilitates our ability to incorporate a price once we obtain information and are able to do so. (6) Service Period Clinical Labor Time in the Facility Setting Generally speaking, our direct PE inputs do not include clinical labor minutes assigned to the service period because the cost of clinical labor during the service period for a procedure in the facility setting is not considered a resource cost to the practitioner since Medicare makes separate payment to the facility for these costs. We address code-specific refinements to clinical labor in the individual code sections. (7) Procedures Subject to the Multiple Procedure Payment Reduction (MPPR) and the OPPS Cap We note that the list of services for the upcoming calendar year that are subject to the MPPR on diagnostic cardiovascular services, diagnostic imaging services, diagnostic ophthalmology services, and therapy services. And the list of procedures that meet the definition of imaging under section 1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap.

Are displayed in the public use files for the PFS proposed and final rules for each year. The public use files for CY 2022 are available on the CMS website under downloads for the CY 2022 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. For more information regarding the history of the MPPR policy, we refer readers to the CY 2014 PFS final rule with comment period (78 FR 74261 through 74263). Effective January 1, 2007, section 5102(b)(1) of the Deficit Reduction Act of 2005 (Pub. L.

109-171) (DRA) amended section 1848(b)(4) of the Act to require that, for imaging services, if—(i) The technical component (including the technical component portion of a global fee) of the service established for a year under the fee schedule without application of the geographic adjustment factor, exceeds (ii) The Medicare OPD fee schedule amount established under the prospective payment system (PPS) for hospital outpatient department services under section 1833(t)(3)(D) of the Act for such service for such year, determined without regard to geographic adjustment under paragraph (t)(2)(D) of such section, the Secretary shall substitute the amount described in clause (ii), adjusted by the geographic adjustment factor [under the PFS], for the fee schedule amount for such technical component for such year. As required by the section 1848(b)(4)(A) of the statute, for imaging services furnished on or after January 1, 2007, we cap the TC of the PFS payment amount for the year (prior to geographic adjustment) by the Outpatient Prospective Payment System (OPPS) payment amount for the service (prior to geographic adjustment). We then apply the PFS geographic adjustment to the capped payment amount. Section 1848(b)(4)(B) of the Act defines imaging services as “imaging and computer-assisted imaging services, including X-ray, uasound (including echocardiography), nuclear medicine (including PET), magnetic resonance imaging (MRI), computed tomography (CT), and fluoroscopy, but excluding diagnostic and screening mammography.” For more information regarding the history of the cap on the TC of the PFS payment amount under the DRA (the “OPPS cap”), we refer readers to the CY 2007 PFS final rule with comment period (71 FR 69659 through 69662). For CY 2022, we identified new and revised codes to determine which services meet the definition of “imaging services” as defined above for purposes of this cap.

Beginning for CY 2022, we are proposing to include the following services on the list of codes to which the OPPS cap applies. CPT codes 0633T (Computed tomography, breast, including 3D rendering, when performed, unilateral. Without contrast material), 0634T (Computed tomography, breast, including 3D rendering, when performed, unilateral. With contrast material(s)), 0635T (Computed tomography, breast, including 3D rendering, when performed, unilateral. Without contrast, followed by contrast material(s)), 0636T (Computed tomography, breast, including 3D rendering, when performed, bilateral.

Without contrast material(s)), 0637T (Computed tomography, breast, including 3D rendering, when performed, bilateral. With contrast material(s)), 0638T (Computed tomography, breast, including 3D rendering, when performed, bilateral. Without contrast, followed by contrast material(s)), 0648T (Quantitative magnetic resonance for analysis of tissue composition (e.g., fat, iron, water content), including multiparametric data acquisition, data preparation and transmission, interpretation and report, obtained without diagnostic MRI examination of the same anatomy (e.g., organ, gland, tissue, target structure) during the same session), 0649T (Quantitative magnetic resonance for analysis of tissue composition (e.g., fat, iron, water content), including multiparametric data acquisition, data preparation and transmission, interpretation and report, obtained with diagnostic MRI examination of the same anatomy (e.g., organ, gland, tissue, target structure) (List separately in addition to code for primary procedure)), 77X01 (Trabecular bone score (TBS), structural condition of the bone microarchitecture. Using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk), 77X02 Start Printed Page 39155(Trabecular bone score (TBS), structural condition of the bone microarchitecture. Using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk, technical preparation and transmission of data for analysis to be performed elsewhere), 77X03 (Trabecular bone score (TBS), structural condition of the bone microarchitecture.

Using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk, technical calculation only), 77X04 (Trabecular bone score (TBS), structural condition of the bone microarchitecture. Using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk interpretation and report on fracture risk only, by other qualified health care professional), 9111X (Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), colon, with interpretation and report), and 933X0 (3D echocardiographic imaging and postprocessing during transesophageal echocardiography or transthoracic echocardiography for congenital cardiac anomalies for the assessment of cardiac structure(s) (e.g., cardiac chambers and valves, left atrial appendage, intraterial septum, interventricular septum) and function, when performed). We believe these codes meet the definition of imaging services under section 1848(b)(4)(B) of the Act, and thus, should be subject to the OPPS cap. 4. Proposed Valuation of Specific Codes for CY 2022 (1) Anesthesia for Cardiac Electrophysiologic Procedures (CPT Code 00537) In October 2019, the RUC reviewed CPT code 00537 (Anesthesia for cardiac electrophysiologic procedures including radiofrequency ablation) and recommended that the code be surveyed for the October 2020 meeting.

This service was identified by the RUC via the high volume growth screen for services with total Medicare utilization of 10,000 or more that have increased by at least 100 percent from 2009 through 2014. Additionally, at the October 2019 RUC meeting, the RUC approved an anesthesia reference service list (RSL) and a method to assess the relativity among services on the anesthesia fee schedule that uses a revised building block methodology and a regression line analysis. The RUC has stated that the revised building block methodology generates “proxy RVUs” that are then compared against the RSL regression line to assess relativity among anesthesia services. The RUC has indicated that their primary and approved method for anesthesia base unit valuation continues to be the anesthesia survey results, and that the building block and regression line analysis are used as a supplemental validation measure. The RUC recommended a valuation of 12 base units for CPT code 00537.We disagree with the RUC-recommended valuation of 12 base units for CPT code 00537.

After performing a RUC database search of codes with similar total times and post-induction period procedure anesthesia (PIPPA) times, 12 base units appears to be on the very high range. We are proposing a valuation of 10 base units supported by reference codes CPT code 00620 (anesthesia for procedures on the thoracic spine and cord, not otherwise specified) and CPT code 00600 (Anesthesia for procedures on cervical spine and cord. Not otherwise specified), which both have a valuation of 10 base units. CPT code 00620 has a very similar total time of 235 minutes and CPT code 00600 has a higher total time of 257 minutes and the same base unit value of 10, which indicates that this is an appropriate valuation. Additionally, we note that the survey total time for CPT code 00537 increased from 150 to 238 minutes, resulting in a survey result 25th percentile valuation of 10 base units.

We are proposing the RUC-recommended direct PE inputs for CPT code 00537. (2) Anesthesia Services for Image-Guided Spinal Procedures (CPT Codes 01XX2, 01XX3, 01XX4, 01XX5, 01XX6, and 01XX7) In 2017, the RUC identified CPT code 01936 (Anesthesia for percutaneous image guided procedures on the spine and spinal cord. Therapeutic) as possibly needing refinement due to inaccurate reporting via the high volume growth screen. The Relativity Assessment Workgroup reviewed data on what procedures were reported with this anesthesia code. In October 2019, the Workgroup reviewed this service and recommended that it be referred to the CPT Editorial Panel to create more granular codes.

In October 2020, the CPT Editorial Panel replaced CPT codes 01935 and 01936 with six new codes to report percutaneous image-guided spine and spinal cord anesthesia procedures. These CPT codes are 01XX2 (Anesthesia for percutaneous image-guided injection, drainage or aspiration procedures on the spine or spinal cord. Cervical or thoracic), 01XX3 (Anesthesia for percutaneous image guided injection, drainage or aspiration procedures on the spine or spinal cord. Lumbar or sacral), 01XX4 (Anesthesia for percutaneous image guided destruction procedures by neurolytic agent on the spine or spinal cord. Cervical or thoracic), 01XX5 (Anesthesia for percutaneous image guided destruction procedures by neurolytic agent on the spine or spinal cord.

Lumbar or sacral), 01XX6 (Anesthesia for percutaneous image guided neuromodulation or intravertebral procedures (e.g., Kyphoplasty, vertebroplasty) on the spine or spinal cord. Cervical or thoracic) and 01XX7 (Anesthesia for percutaneous image guided neuromodulation or intravertebral procedures (e.g., Kyphoplasty, vertebroplasty) on the spine or spinal cord. Lumbar or sacral). We are proposing the RUC-recommended valuation of 4 base units for CPT codes 01XX2, 01XX3, 01XX4, and 01XX5. We disagree with the RUC-recommend valuation of 6 base units for CPT codes 01XX6 and 01XX7.

After performing a RUC database search of codes with similar total times and post-induction period procedure anesthesia (PIPPA) times, 6 base units for CPT codes 01XX6 and 01XX7 appears to be a high valuation. We are proposing a valuation of 5 base units for both codes supported by a reference code, CPT code 00813 (Anesthesia for combined upper and lower gastrointestinal endoscopic procedures, endoscope introduced both proximal to and distal to the duodenum). CPT code 00813 has a valuation of 5 base units with a higher PIPPA time of 40 minutes as well as a higher total time of 70 minutes. The RUC notes that CPT codes 01XX6 and 01XX7 should have a higher base unit valuation than the other similar codes within this family due to the complex nature of these procedures that have a more intensive anesthesia process. The RUC supports their recommendation with a crosswalk code, CPT code 00732 (Anesthesia for upper gastrointestinal endoscopic procedures, endoscope introduced proximal to duodenum.

Endoscopic retrograde cholangiopancreatography (ECRP)). CPT code 00732 has a valuation of 6 base units, a total time of 100 minutes, and a PIPPA time of 65 minutes. CPT codes 01XX6 and 01XX7 have a total time of 58 minutes and a PIPPA time of 20 minutes. We agree that a more complex procedure may require a higher base unit valuation within a code family. However, given the disparity in total and PIPPA time, we disagree with the use of Start Printed Page 39156this crosswalk code to support a valuation of 6 base units and instead propose a valuation of 5 base units supported by reference CPT code 00813, which has higher times and the same base unit valuation.

We are proposing the RUC-recommended direct PE inputs for all six codes in the family. (3) Closed Treatment of Nasal Bone Fracture (CPT Codes 21315 and 21320) We agree with the RUC's recommendation to change CPT codes 21315 (Closed treatment of nasal bone fracture. Without stabilization) and 21320 (Closed treatment of nasal bone fracture. With stabilization) to 000-day global period codes from 010-day global period codes to account for the degree of swelling within 10 days post-procedure, and because the patient can remove their own splint at home for CPT code 21320. For CPT codes 21315 and 21320, we disagree with the RUC-recommended work RVUs of 2.00 and 2.33, respectively, as we believe these values do not adequately reflect the surveyed reductions in physician time and the change to a 000-day global period from a 010-day global period for these CPT codes.

We are proposing a work RVU of 0.96 for CPT code 21315 and 1.59 for CPT code 21320 based on the reverse building block methodology to remove the RVUs associated with the 010-day global period and the surveyed reductions in physician time. We believe that the proposed work RVU of 0.96 for CPT code 21315 adequately accounts for the 50 percent decrease in intraservice and postservice time, a 31-minute decrease in total time, and a change to a 000-day global period which will allow for separately billable E/M visits as medically necessary. We believe that the proposed work RVU of 1.59 for CPT code 21320 adequately accounts for the 5-minute decrease in intraservice time, 3-minute decrease in total time, and 48 percent decrease in postservice time. Absent an explicitly stated rationale for an intensity increase for CPT codes 21315 and 21320, we are proposing to adjust the work RVU to reflect significant decreases in surveyed physician time. The global period changes from 010-day to 000-day allow for separately billable E/M visits relating to CPT codes 21315 and 21320, therefore we removed RVUs that we believed were attributable to the currently bundled E/M visits totaling 1.30 RVUs for CPT code 21315 and 0.35 RVUs for CPT code 21320.

CPT code 21315 is currently bundled with one post-operative follow up office visit, CPT code 99213 (Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and low level of medical decision making. When using time for code selection, 20-29 minutes of total time is spent on the date of the encounter). CPT code 21320 is currently bundled with half of a post-operative follow up office visit, CPT code 99212 (Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and straightforward medical decision making. When using time for code selection, 10-19 minutes of total time is spent on the date of the encounter). We do not believe the RUC adequately accounted for the loss of these E/M visits in their recommended work RVUs for CPT codes 21315 and 21320.

The RUC's recommendations also seem to dismiss the significant changes in surveyed physician time, without a persuasive explanation of a significant increase in IWPUT that results from the RUC's recommended work RVUs for CPT codes 21315 and 21320. We believe the surveyed decreases in physician time in conjunction with the loss of the post-operative visits for CPT codes 21315 and 21320 merit decreases in the work RVUs from the current work RVUs. We considered using a modified total time ratio methodology given the age and potentially flawed methodology used to arrive at the current valuation. The modified total time ratio calculation does not include the loss of 8 minutes of post-operative time attributable to the change from a 010-day global period to a 000-day global period for CPT code 21320 and loss of 23 minutes of post-operative time for CPT code 23215. This modified time ratio methodology reflects how the physician time is changing in the pre-, intra-, and postservice periods when a code's global period is changing, given that E/M services can be billed as medically necessary and appropriate for a 000-day global code.

The total time ratio between the current and proposed total times for CPT code 21315, excluding the 23 minutes of post-operative time in the current total time, equals 1.64. We arrived at 1.64 by modifying the original total time ratio equation to equal the proposed new total time divided by the current time, less any time attributable to the post-operative global period, then multiplied by the current work RVU. The current total time for CPT code 21315 without the 23 minutes of post-operative time that will be lost by going from a 010-day to a 000-day global period code is 76 minutes, therefore, the modified total time ratio = (68 minutes/(99 minutes−23 minutes)) * 1.83 = 1.64. When using the original total time ratio methodology for CPT code 21315, it shows a 31 percent decrease in total time [(68 minutes−99 minutes)/99 minutes = −0.31], whereas the modified methodology shows that there is only an 11 percent decrease in newly proposed pre-, intra-, and postservice time from the current times [(68 minutes−76 minutes)/76 minutes = −0.11]. The same modified total time ratio methodology could be applicable to CPT code 21320.

The current total time for CPT code 21320 without the 8 minutes of post-operative time that will be lost by going from a 010-day to a 000-day global period code is 70 minutes, therefore, the modified total time ratio = (75 minutes/(78 minutes−8 minutes) * 1.88 = 2.01. The modified methodology shows that the pre-, intra-, and postservice time is increasing by 7 percent for CPT code 21320, whereas the original methodology, which accounts for the loss of the 8 post-operative minutes in the total time ratio, shows a 4 percent decrease in total time that would indicate the need for a work RVU decrease. We recognize that we have not previously used a modified total time approach to consider work RVU values when there is a change in the global period for a service in conjunction with significant surveyed changes to the pre-, intra-, and postservice times. Therefore, we are seeking comment on application of the modified total time ratio approach to value services that have a global period change and significant surveyed physician time changes. We believe this methodology may account for the loss of post-operative visits and the surveyed changes in the pre-, intra-, and postservice times in this unique situation, given the potentially flawed methodology used to arrive at the current valuations for CPT codes 21315 and 21320 that are used in the total time ratios.

We are also proposing the RUC-recommended direct PE inputs without refinements and the surveyed physician times for CPT codes 21315 and 21320. (4) Insertion of Interlaminar/Interspinous Device (CPT Code 22867) We are proposing the RUC-recommended work RVU of 15.00 for CPT code 22867 (Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar. Single level). The RUC is not recommending changes to the current Start Printed Page 39157PE inputs, and CMS is not proposing any changes to the current PE inputs. (5) Treatment of Foot (CPT Codes 28001, 28002, and 28003) Through a screen of codes with 010-day global period service with more than one post-operative follow-up office visit, the RUC identified this family of major surgical codes that did not have consistent global periods.

The RUC conducted a survey of these codes as 000-day globals for their April 2020 meeting, and the review was postponed until October 2020. CPT code 28001 (Incision and drainage, bursa, foot) (work RVU of 2.78 with 31 minutes of intraservice time) currently has a 010-day global period with one post-operative follow-up office visit, CPT code 99212 (Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components. A problem focused history. A problem focused examination. Straightforward medical decision making.

Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are self limited or minor. Typically, 10 minutes are spent face-to-face with the patient and/or family). Survey results from podiatrists and orthopedic surgeons yielded a median work RVU of 2.00 with 17 minutes of preservice evaluation time, 3 minutes of preservice positioning time, 5 minutes of preservice scrub/dress/wait time, 20 minutes intraservice time, and 15 minutes immediate postservice time for a total of 60 minutes total time. We are proposing the RUC-recommended work RVU of 2.00 and the surveyed physician times for this 000-day global code.

CPT code 28002 (Incision and drainage below fascia, with or without tendon sheath involvement, foot. Single bursal space) (work RVU of 5.34 with 30 minutes of intraservice time) currently has a 010-day global period with two post-operative follow-up office visits, CPT code 99213 (Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components. An expanded problem focused history. An expanded problem focused examination. Medical decision making of low complexity.

Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of low to moderate severity. Typically, 15 minutes are spent face-to-face with the patient and/or family). And a half day hospital discharge CPT code 99238 (Hospital discharge day management. 30 minutes or less).

For CPT code 28002, the RUC recommended 30 minutes of preservice evaluation time, 5 minutes of preservice positioning time, 15 minutes of preservice scrub/dress/wait time, 30 minutes of intraservice time, and 20 minutes of immediate postservice time, for a total of 100 minutes total time. The RUC recommended a work RVU of 3.50 and the surveyed physician times for this 000-day global code. We note that the result from the survey's 50th percentile work RVU was 3.73 and that the survey's 25th percentile work RVU was 2.80. As this CPT code is converting from a 010-day global to a 000-day global we find the reference CPT code 43193 (Esophagoscopy, rigid, transoral. With biopsy, single or multiple) as a more suitable value of 2.79 work RVUs with a similar 30 minutes of intraservice physician time and 106 minutes of total time.

We are proposing a work RVU of 2.79 for CPT code 28002 and we are proposing the RUC surveyed physician times for this 000-day global code. CPT code 28003 (Incision and drainage below fascia, with or without tendon sheath involvement, foot. Multiple areas) currently has a 090-day global period with two post-operative follow-up office visits, CPT code 99212 (Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components. A problem focused history. A problem focused examination.

Straightforward medical decision making. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are self limited or minor. Typically, 10 minutes are spent face-to-face with the patient and/or family). Three post-operative follow-up office visits, CPT code 99213 (Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components.

An expanded problem focused history. An expanded problem focused examination. Medical decision making of low complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of low to moderate severity.

Typically, 15 minutes are spent face-to-face with the patient and/or family.). One post-operative CPT code 99231 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components. A problem focused interval history. A problem focused examination. Medical decision making that is straightforward or of low complexity.

Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is stable, recovering or improving. Typically, 15 minutes are spent at the bedside and on the patient's hospital floor or unit). One post-operative CPT code 99232 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components. An expanded problem focused interval history.

An expanded problem focused examination. Medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is responding inadequately to therapy or has developed a minor complication. Typically, 25 minutes are spent at the bedside and on the patient's hospital floor or unit), and one hospital discharge CPT code 99238 (Hospital discharge day management.

30 minutes or less), for a total of eight post op follow-up visits, across five types of E/M and hospital care codes. For CPT code 28003, the RUC recommends 40 minutes of preservice evaluation time, 10 minutes of preservice positioning time, 15 minutes of preservice scrub/dress/wait time, 45 minutes of intraservice time, and 20 minutes of immediate postservice time, for a total time of 130 minutes. We are proposing the RUC-recommended work RVU of 5.28 and surveyed physician times for this 000-day global code. In order to complete the adjustments for making these Treatment of Foot codes consistent as 000-day global codes, the RUC adjusted the PE inputs for these codes to reflect their proposed global periods from 010 and 090-day globals to 000-day global, and to reflect the use of more typical supplies, equipment, and clinical labor Start Printed Page 39158employed now, than what was necessary a decade ago. Some relatively small valued supply items were removed, while other items were added, and clinical labor times were largely adjusted to remove minutes from the post-operative follow-up office visit times in the 010 and 090-day global codes.

We are proposing all of the PE refinements as recommended by the RUC for these codes, which can be found in section II.B. Of this proposed rule, under the Determination of Practice Expense RVUs. (6) Percutaneous Cerebral Embolic Protection (CPT Codes 33XXX) CPT code 33XXX (Transcatheter placement and subsequent removal of cerebral embolic protection device(s), including arterial access, catheterization, imaging, and radiological supervision and interpretation, percutaneous (List separately in addition to code for primary procedure)) was created in October 2020, by the CPT Editorial Panel as a new add-on code to report transcatheter placement and subsequent removal of cerebral embolic protection device(s). The CPT Editorial Panel also added instructions to report the new code in the Aortic Valve guidelines. The RUC reviewed the survey results for the new add-on code and noted that the survey respondents likely overvalued the physician work involved in performing this service, with a 25th percentile work value of 3.43.

The RUC recommends a work RVU of 2.50 for CPT code 33XXX. We are proposing the RUC-recommended work RVU of 2.50 for CPT code 33XXX. This is a facility-based add-on code with no direct PE inputs. (7) Exclusion of Left Atrial Appendage (CPT Codes 33XX3, 33XX4, and 33XX5) In May 2020, the CPT Editorial Panel approved the creation of three new codes to describe open and thoracoscopic left atrial appendage management procedures when performed as stand-alone procedures or in conjunction with other procedures. The codes represent new technology and surgical techniques that may be used to treat atrial fibrillation at the time of another surgical procedure and include CPT code 33XX3 (Exclusion of left atrial appendage, open, any method (e.g., excision, isolation via stapling, oversewing, ligation, plication, clip), CPT code 33XX4 (Exclusion of left atrial appendage, open, performed at the time of other sternotomy or thoracotomy procedure(s), any method (e.g., excision, isolation via stapling, oversewing, ligation, plication, clip) (List separately in addition to code for primary procedure)), and CPT code 33XX5 (Exclusion of left atrial appendage, thoracoscopic, any method (e.g., excision, isolation via stapling, oversewing, ligation, plication, clip).

CPT codes 33XX3 and 33XX5 are 090-day global codes while CPT code 33XX4 is a ZZZ global code. In October 2020, the RUC reviewed and recommended work and PE values for the three new codes. Recommended work values include 18.50 RVUs for CPT code 33XX3, 2.50 work RVUs for CPT code 33XX4, and 14.31 work RVUs for CPT code 33XX5. We are proposing the RUC-recommended work RVUs for the three new codes. We are also proposing the RUC-recommended direct PE inputs for CPT codes 33XX3 and 33XX5.

We note that CPT code 33XX4 has no direct PE inputs. (8) Endovascular Repair of Aortic Coarctation (CPT Codes 338X1, 338X2, and 338X0) In October 2020, the CPT Editorial Panel created CPT codes 338X1 (Endovascular stent repair of coarctation of the ascending, transverse, or descending thoracic or abdominal aorta, involving stent placement. Across major side branches) and 338X2 (Endovascular stent repair of coarctation of the ascending, transverse, or descending thoracic or abdominal aorta, involving stent placement. Not crossing major side branches) to report endovascular stent repair of coarctation of the thoracic or abdominal aorta. And CPT code 338X0 (Percutaneous transluminal angioplasty of native or recurrent coarctation of the aorta) to report trans-liminal angioplasty for repair of native or recurrent percutaneous coarctation of the aorta.

For CY 2022, the RUC recommended a work RVU of 21.70 for CPT code 338X1, a work RVU 17.97 for CPT code 338X2, and a work RVU 14.00 for CPT code 338X0. We disagree with the RUC-recommended work RVUs for the CPT code family of 338X1, 338X2, and 338X0. We found that the recommended work RVUs for these CPT codes were high when compared to other codes with similar time values. Therefore, we are proposing the RUC survey 25th percentile of 18.27 as the work RVU for 338X1, we are proposing a work RVU of 14.54 for 338X2, and we are proposing a work RVU of 10.81 for 338X0. When we reviewed CPT code 338X1, we found that the recommended work RVU was high compared to other codes with similar time values.

The RUC survey 25th percentile of 18.27 falls within the range of RVUs with similar intra service time. This is supported by the reference CPT codes we compared to CPT code 338X1 with intra service time similar to the 134 minutes of intra service time for CPT code 338X1. Reference CPT code 37231 (Revascularization, endovascular, open or percutaneous, tibial, peroneal artery, unilateral, initial vessel. With transluminal stent placement(s) and atherectomy, includes angioplasty within the same vessel, when performed) has a work RVU of 14.75 with 135 minutes of intra service time, and CPT code 93590 (Percutaneous transcatheter closure of paravalvular leak. Initial occlusion device, mitral valve) has a work RVU of 21.70 with 135 minutes of intra service time.

We note that the RUC-recommended RVU of 21.70 is a crosswalk from CPT code 93590 and is the highest value code within the range of reference codes we reviewed with similar intra service time. Again, we believe the RUC survey 25th percentile of 18.27 is a more appropriate value overall than 21.70 when compared to the range of codes with similar intra service time. The RUC-recommended RVU of 17.97 for CPT code 338X2 was higher than other codes with the same 120 minutes of intra service time and similar total time. Although we disagree with the RUC-recommended work RVU for 338X2, we concur that the relative difference in work between CPT codes 338X1 and 338X2 is equivalent to the RUC-recommended interval of 3.73 RVUs. We believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within a family of codes where it is important to maintain an appropriate intra-family relativity.

Therefore, we are proposing a work RVU of 14.54 for CPT code 338X2, based on the RUC-recommended interval of 3.73 RVUs below our proposed work RVU of 18.27 for CPT code 338X1. The RUC-recommended work RVU of 14.00 for CPT code 338X0 was higher than other codes with the same 90 minutes of intra service time and similar total time and we believe it would be more accurate to propose a work RVU that maintains the 3.73 incremental difference between the codes in this family. Therefore, for CPT code 338X0, we propose a work RVU of 10.81 which also continues the 3.73 incremental difference used between CPT codes 338X1 and 338X2, instead of the RUC incremental difference of 3.97 between CPT codes 338X2 and 338X0. Although Start Printed Page 39159the work RVU of 10.81 we are proposing for CPT code 338X0 is lower than the RUC recommendation, the 3.73 incremental difference between CPT codes 338X2 and 338X0 we are proposing is more generous than the RUC incremental difference of 3.97 between CPT codes 338X2 and 338X0. We are proposing no direct PE inputs for the CPT code family of 338X1, 338X2, and 338X0, as recommended by the RUC.

These services are provided exclusively in the facility setting. (9) Harvest of Upper Extremity Artery (CPT Codes 35XX0 and 35600) In May 2020, the CPT Editorial Panel created CPT code 35XX0 (Harvest of upper extremity artery, 1 segment, for coronary artery bypass procedure, endoscopic) to describe endoscopic radial artery harvest via an endoscopic approach, and CPT code 35600 (Harvest of upper extremity artery, 1 segment, for coronary artery bypass procedure, open) was modified to only include an open approach for the upper extremity harvesting procedure. The RUC also stated that CPT codes 35XX0 and 35600 are almost always exclusively performed in conjunction with coronary artery bypass grafting (CABG) procedures. For CY 2022, the RUC-recommended a work RVU of 3.75 for CPT code 35XX0 and a work RVU of 4.00 for CPT code 35600. We disagree with the RUC-recommended RVUs for the CPT code family of 35XX0 and 35600.

We found that the recommended work RVUs for these CPT codes were high when compared to other codes with similar time values. Therefore, we are proposing 3.34 as the work RVU for 35XX0 and we are proposing a work RVU of 3.59 for 35600. We disagree with the RUC-recommended work RVU for CPT code 35XX0 and are proposing an RVU of 3.34 which is a direct work RVU crosswalk from CPT code 35686 (Creation of distal arteriovenous fistula during lower extremity bypass surgery (non-hemodialysis) (List separately in addition to code for primary procedure)). The RUC-recommended value of 3.75 is higher than other codes with similar intra service time and total time. This is supported by the reference CPT codes we compared to CPT code 35XX0 with the same 35 minutes of intra service time and 35 minutes of total time as CPT code 35XX0.

Reference CPT code 74713 (Magnetic resonance (e.g., proton) imaging, fetal, including placental and maternal pelvic imaging when performed. Each additional gestation (List separately in addition to code for primary procedure)) has a work RVU of 1.85, and CPT code 35686 has a work RVU of 3.34. Although we disagree with the RUC-recommended work RVU for CPT code 35600, we concur that the relative difference in work between CPT codes 35XX0 and 35600 is equivalent to the RUC-recommended interval of 0.25 RVUs. We believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within a family of codes where it is important to maintain an appropriate intra-family relativity. Therefore, we are proposing a work RVU of 3.59 for CPT code 35600, based on the RUC-recommended interval of 0.25 RVUs above our proposed work RVU of 3.34 for CPT code 35XX0.

We are proposing no direct PE inputs for the CPT code family of 35XX0 and 35600 as recommended by the RUC. These services are provided exclusively in the facility setting. The RUC acknowledged that CPT codes 35XX0 and 35600 are almost always exclusively performed in conjunction with coronary artery bypass grafting (CABG) procedures. Such codes are designated as add-on procedures and are assigned a ZZZ-day global period (that is, code related to another service and is always included in the global period of the other service). The RUC also requested that the global period for both CPT codes 35XX0 and 35600 be an XXX-day global period (that is, global concept does not apply) and not a ZZZ-day global period as is customary for add-on codes.

The RUC stated that an XXX-day global period would allow the individual that performs the harvest of upper extremity artery procedure (often separate from the surgeon performing the base CABG procedure) to report it under their own provider number. The RUC noted that it is often a nurse practitioner (NP) or physician's assistant (PA) who performs the harvest procedure. However, the RUC surveyed CPT codes 35XX0 and 35600 using reference codes with the ZZZ-day global period. Therefore, we believe it is appropriate to use that same ZZZ-day global period for CPT codes 35XX0 and 35600, and we are proposing to assign the ZZZ-day global period to CPT codes 35XX0 and 35600 for CY 2022. Through our scrutiny of comparing the code descriptions of codes with matching intra service times, we find much more clinically coherent similarities with codes with a ZZZ-day global period (procedures complementary, and sometimes necessary, to complete a larger procedure) than codes with an XXX-day global period.

However, we are compelled to understand more about the billing circumstances presented by the RUC and stakeholders that have presented this approach for CPT codes 35XX0 and 35600 to CMS for consideration. We are seeking comments and requesting information that may inform why CPT codes 35XX0 and 35600 should have an XXX-day global period instead of the ZZZ-day global period that is customary for add-on codes. (10) Needle Biopsy of Lymph Nodes (CPT Code 38505) CPT code 38505 (Biopsy or excision of lymph node(s). By needle, superficial (e.g., cervical, inguinal, axillary)) was identified in October 2019 as Harvard Valued with a utilization of over 30,000 claims. In January 2020, the RUC recommended that the code be surveyed for October 2020 RUC meeting.

The RUC recommended increasing the work RVU to 1.59 which is the survey 25th percentile, acknowledging a change in the service, which now involves larger tissue samples as well as a change in technology, and a change in the dominant specialty now reporting the service. We are proposing the RUC-recommended work RVU of 1.59 for CPT code 38505. We are also proposing the RUC-recommended direct PE inputs for this code. (11) Drug Induced Sleep Endoscopy (CPT Codes 42XXX) CPT code 42XXX (Drug induced sleep endoscopy. With dynamic evaluation of velum, pharynx, tongue base, and larynx for evaluation of sleep disordered breathing.

Flexible, diagnostic) is a new code created to report drug induced sleep endoscopy (DISE) flexible, diagnostic. The RUC recommended, and we agree, that the survey 25th percentile for the work RVU of 1.90 accurately reflects the typical physician work necessary to perform this service. Since this is a drug induced sleep endoscopy, we are proposing CPT code 31575 (Diagnostic laryngoscopy) as the endoscopic base code for CPT code 42XXX because the description of the proposed CPT code is the same as what is described for CPT code 31575 with the additional component of the patient being sedated. The procedure is performed with a flexible endoscope or laryngoscope. CPT code 42XXX is not an add-on code, it has a 0-day global period.

The endoscopic base code that it is using is a specific type of multiple procedure discount that applies to some endoscopy codes. We are proposing the RUC-recommended work RVU of 1.90 for Start Printed Page 39160CPT code 42XXX. We are also proposing the RUC-recommended direct PE inputs for this code. (12) Per-Oral Endoscopic Myotomy (POEM) (CPT Codes 434XX) In May 2020, the CPT Editorial Panel created a new CPT code 434XX (Lower esophageal myotomy, transoral (i.e., peroral endoscopic myotomy [POEM])) to describe a Per-Oral Endoscopic Myotomy (POEM), which involves the visualization and dissection of the esophageal muscle layers via an endoscope to treat esophageal motility disorders such as achalasia. This procedure accomplishes a comparable myotomy to what traditional open and laparoscopic myotomy (Heller) accomplishes.

POEM utilizes an endoscope and specially designed dissecting, cutting, and cauterizing instruments to create a long submucosal tunnel beginning in the mid-esophagus and extending several centimeters into the cardia. For CY 2022, the RUC recommended a work RVU of 15.50 for CPT code 434XX. We disagree with the RUC-recommended work RVU for CPT code 434XX and are proposing a work RVU of 13.29 based on a direct work RVU crosswalk from CPT code 36819 (Arteriovenous anastomosis, open. By upper arm basilic vein transposition). CPT code 36819 has the same 120 minutes of intra service time as CPT code 434XX, and has 283 minutes of total time, which is 2 minutes more than the 281 minutes of total time than for 434XX.

The RUC used CPT codes 43279 (Laparoscopy, surgical, esophagomyotomy (Heller type), with fundoplasty, when performed) and 43180 (Esophagoscopy, rigid, transoral with diverticulectomy of hypopharynx or cervical esophagus (e.g., Zenker's diverticulum), with cricopharyngeal myotomy, includes use of telescope or operating microscope and repair, when performed) as reference codes for CPT code 434XX. However, the intra service time of 150 minutes and total time of 404 minutes for the RUC reference CPT code 43279, and intra service time of 60 minutes and total time of 201 minutes for the RUC reference CPT code 43180, are not adequate comparisons since they do not have similar time values to those of CPT code 434XX. Therefore, we believe the proposed work RVU of 13.29 for CPT code 434XX based on a direct work RVU crosswalk from CPT code 36819 is a better representation of the work being performed and is more appropriate based on the same intra service time and similar total time. We are proposing the RUC-recommended direct PE inputs for CPT code 434XX without refinement. (13) Placement-Removal of Seton (CPT Codes 46020 and 46030) For CPT codes 46020 (Placement of seton) and 46030 (Removal of anal seton, other marker), we disagree with the RUC-recommended work RVUs of 3.50 and 2.00, respectively, as we believe these values do not adequately reflect the surveyed reductions in physician time for CPT code 46020 and the change to a 000-day global period from a 010-day global period for these CPT codes.

Instead, we are proposing a work RVU of 1.86 for CPT code 46020 and 1.48 for CPT code 46030 based on a reverse building block methodology. The survey showed that total time and intraservice time are decreasing for CPT code 46020 by 26 minutes and 5 minutes, respectively. We believe the surveyed decreases in physician time in conjunction with the loss of the post-operative visits for CPT code 46020 merit a decrease in work RVU from the current work RVU. We note that the proposed work RVU of 1.48 for CPT code 46030 falls between CPT code 57410 (Pelvic examination under anesthesia (other than local)), which has a work RVU of 1.75, and CPT code 64487 (Transversus abdominis plane (TAP) block (abdominal plane block, rectus sheath block) unilateral. By continuous infusion(s) (includes imaging guidance, when performed)), which has a work RVU of 1.48.

Both of these bracketing reference codes have identical intraservice times and similar total time values. While we understand that total time is going up for CPT code 46030, this increase is a result of significant increases to evaluation, positioning, and scrub, dress, wait preservice times, which is mostly low-intensity physician work. We agree with the RUC's recommendation to change CPT codes 46020 and 46030 to 000-day global period codes from 010-day global period codes to account for the highly variable follow-up care for these services, but we note that the differences in RUC-recommended work RVUs and our proposed work RVUs largely reflect the change in global period and loss of physician time to provide the E/M services. The global period changes from 010-day to 000-day allow for separately billable E/M visits relating to CPT codes 46020 and 46030, therefore we removed RVUs that we believed were attributable to the currently bundled E/M visits totaling 2.04 RVUs for CPT code 46020 and 0.35 RVUs for CPT code 46030. CPT code 46020 is currently bundled with two post-operative follow up office visits, CPT code 99212 (Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and straightforward medical decision making.

When using time for code selection, 10-19 minutes of total time is spent on the date of the encounter), and a half hospital discharge CPT code 99238 (Hospital discharge day management. 30 minutes or less). CPT code 46030 is currently bundled with half of a post-operative follow up office visit, CPT code 99212 (Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and straightforward medical decision making. When using time for code selection, 10-19 minutes of total time is spent on the date of the encounter). We do not believe the RUC adequately accounted for the loss of these E/M visits in their recommended work RVUs for CPT codes 46020 and 46030.

The RUC proposed the standard 090-day preservice times for the clinical labor activities CA001, CA002, CA003, CA004, and CA005 for CPT code 46020 in the facility. We note that the RUC recommended 090-day preservice clinical labor times despite surveying the service as a 000-day service. We disagree with the RUC-recommended 090-day preservice clinical labor times as we believe 000-day services should have times consistent with 000-day services, not 090-day services. However, we recognize there is time needed to coordinate this service. Therefore, we are proposing the following standard clinical labor times for extensive use of clinical staff for a 000-day global code.

Complete preservice diagnostic and referral forms (CA001) 5 minutes. Coordinate pre-surgery services (including test results) (CA002) 10 minutes. Schedule space and equipment in facility (CA003) 5 minutes. Provide preservice education/obtain consent (CA004) 7 minutes. Complete pre-procedure phone calls and prescription (CA005) 3 minutes.

We are also proposing to refine the direct PE input for Coordinate post-procedure services (CA038) to 0 minutes from the RUC-recommended 3 minutes to align with 000-day standards instead of 090-day standards for CPT code 46020. For CPT code 46030, the RUC recommended the standard 000-day Start Printed Page 39161extensive use of clinical staff preservice times for clinical activities CA001, CA002, CA003, CA004, and CA005 in the facility and non-facility settings. Preservice times for 000-day codes are presumed to be zero unless there is sufficient justification that preservice time is warranted. We do not agree that sufficient justification was presented to warrant preservice time in the non-facility setting, therefore, we are proposing the following standard clinical labor times for use of clinical staff in the non-facility setting. We are also proposing the standards for minimal use of clinical staff in the facility setting, as we recognize there is time needed to coordinate this service for CPT code 46030.

Complete preservice diagnostic and referral forms (CA001) 0 minutes for non-facility and 3 minutes for facility. Coordinate pre-surgery services (including test results) (CA002) 0 minutes for non-facility and 3 minutes for facility. Schedule space and equipment in facility (CA003) 0 minutes for non-facility and 3 minutes for facility. Provide preservice education/obtain consent (CA004) 0 minutes for non-facility and 3 minutes for facility. Complete pre-procedure phone calls and prescription (CA005) 0 minutes for non-facility and 3 minutes for facility.

We are also proposing to refine the direct PE input for Coordinate post-procedure services (CA038) to 0 minutes from the RUC-recommended 3 minutes to align with 000-day standards instead of 090-day standards for CPT code 46030. (14) Periurethral Balloon Continence Device Procedures (CPT Codes 53XX1, 53XX2, 53XX3, and 53XX4) In October 2020, the CPT Editorial Panel replaced four CPT Category III codes with four new CPT Category I codes to report periurethral adjustable balloon continence devices. Given the low utilization and the low survey response rate for the four new codes, the RUC recommended that CMS assign contractor pricing to these procedures. We agree with the RUC and we are proposing contractor pricing for all four codes in the family, CPT codes 53XX1 (Periurethral transperineal adjustable balloon continence device. Bilateral insertion, including cystourethroscopy and imaging guidance), 53XX2 (Periurethral transperineal adjustable balloon continence device.

Unilateral insertion, including cystourethroscopy and imaging guidance), 53XX3 (Periurethral transperineal adjustable balloon continence device. Removal, each balloon) and 53XX4 (Periurethral transperineal adjustable balloon continence device. Percutaneous adjustment of balloon(s) fluid volume). (15) Intracranial Laser Interstitial Thermal Therapy (LITT) (CPT Codes 617X1 and 617X2) In October 2020, the CPT Editorial Panel approved the addition of two codes to report laser interstitial thermal therapy (LITT) of lesion, intracranial, including burr hole(s), with magnetic resonance (MR) imaging guidance for a single trajectory for 1 simple lesion and multiple trajectories for multiple or complex lesion(s). LITT is a novel procedure that involves multiple steps and movements of the patient through the hospital for different stages of the procedure.

The typical facility does not have an interoperative MRI suite (a small minority of academic medical centers may), so patient transport is necessary. The RUC recommended a work RVU of 20.00 for CPT code 617X1 (Laser interstitial thermal therapy (LITT) of lesion, intracranial, including burr hole(s), with magnetic resonance imaging guidance, when performed. Single trajectory for 1 simple lesion) based on the survey median response. CPT code 617X1 was surveyed with having one subsequent hospital visit, CPT code 99232 (sbsq hospital care/day 25 minutes) and 40 minutes of immediate postservice time. The RUC noted that although the survey median immediate postservice time was 40 minutes, for 617X1, the CMS 23-Hour Stay Outpatient Surgical Services with Subsequent Hospital Visits Policy was applied which resulted in the 99232 visit being removed and its 20 minutes of intraservice time being applied to the 40 minutes of immediate postservice time resulting in 60 minutes of immediate postservice time.

See the 2011 PFS final rule (75 FR 73226) for an in-depth explanation of the 23-hour policy. We believe the RUC partially applied the 23-hr policy when it applied the policy to the immediate post service time but not to the work RVU. We believe the 23-hour policy in its entirety should be applied to 671X1, which includes the work RVUs along with the immediate postservice time. Following the valuation methodology we established for 23-hour stay services in the CY 2011 PFS final rule, 617X1 would have a work RVU of 19.06. The steps are as follows.

Step (1). CPT code 617X1 does not have a hospital discharge day management service. Therefore, we would skip this step. Step (2). 20 − 1.39** = 18.61.

Step (3). 18.61 + (20 minutes × 0.0224)*** = 19.06 RVUs. * Value associated with 1/2 hospital discharge day management service. ** Value associated with an inpatient hospital visit, CPT code 99232. *** Value associated with the reallocated intraservice time multiplied by the postservice intensity of the 23-hour stay code.

Therefore, for CY 2022 we are proposing a work RVU of 19.06 for CPT code 671X1. In reviewing the RUC-recommended direct PE inputs for 671X1 we noticed the RUC proposed the standard 090-day preservice times for the following clinical labor activities. Complete preservice diagnostic and referral forms (CA001) 5 minutes. Coordinate pre-surgery services (including test results) (CA002) 20 minutes. Schedule space and equipment in facility (CA003) 8 minutes.

Provide preservice education/obtain consent (CA004) 20 minutes. Complete pre-procedure phone calls and prescription (CA005) 7 minutes. We note that the RUC recommended 090-day preservice times despite surveying the service as a 000-day service. We disagree with the RUC-recommended 090-day times as we believe this is a 000-day service and should have times consistent with 000-day services. However, we recognize there is time needed to coordinate this service.

Therefore, for CY 2022 we are proposing the following standard clinical labor times for a 000-day extensive. Complete preservice diagnostic and referral forms (CA001) 5 minutes. Coordinate pre-surgery services (including test results) (CA002) 10 minutes. Schedule space and equipment in facility (CA003) 5 minutes. Provide preservice education/obtain consent (CA004) 7 minutes.

Complete pre-procedure phone calls and prescription (CA005) 3 minutes. For CPT code 617X2 (Laser interstitial thermal therapy (LITT) of lesion, intracranial, including burr hole(s), with magnetic resonance imaging guidance, when performed. Multiple trajectories for multiple or complex lesion(s)), the RUC recommended a work RVU of 24.00 which is the survey median. The RUC's recommendation also included 40 minutes of immediate postservice time and one hospital visit, CPT code 99233 (sbsq hospital care/day visit 35 minutes). We believe it would be appropriate to apply the 23-hr policy to CPT code 617X2 as well.Start Printed Page 39162 The steps are as follows.

Step (1). CPT code 617X2 does not have a hospital discharge day management service. Therefore, we would skip this step. Step (2). 24 − 2** = 22 Step (3).

22 + (30 minutes × 0.0224)*** = 22.67 RVUs * Value associated with 1/2 hospital discharge day management service. ** Value associated with an inpatient hospital visit, CPT code 99233. *** Value associated with the reallocated intraservice time multiplied by the postservice intensity of the 23-hour stay code. This results in a work RVU of 22.67, and an immediate post service time of 70 minutes. Therefore, for CY 2022 we a proposing a work RVU of 22.67 and 70 minutes of immediate postservice time for CPT code 617X2.

For the direct PE, the RUC proposed identical preservice times for CPT codes 617X1 and 617X2. For the reasons stated above concerning the direct PE inputs for CPT code 671X1, we are proposing the standard clinical labor times associated with a 000-day extensive for CPT code 617X2 for CY 2022. (16) Arthrodesis Decompression (CPT Codes 630XX and 630X1) For CPT codes 630XX (Laminectomy, facetectomy, or foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s] [eg, spinal or lateral recess stenosis]), during posterior interbody arthrodesis, lumbar. Single vertebral segment (List separately in addition to code for primary procedure)) and 630X1 (Laminectomy, facetectomy, or foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s] [eg, spinal or lateral recess stenosis]), during posterior interbody arthrodesis, lumbar. Each additional segment (List separately in addition to code for primary procedure)), we disagree with the RUC-recommended work RVUs of 5.55 and 4.44, respectively, because these values are anomalously high in comparison to other similar add-on codes that have longer intraservice times, and we are proposing a work RVU of 3.08 for CPT code 630XX and a work RVU of 2.31 for CPT code 630X1.

CPT codes 630XX and 630X1 are new add-on codes to report decompression when performed in conjunction with posterior interbody arthrodesis at the same interspace. The proposed work RVU for CPT code 630XX is based on an intraservice time ratio between the proposed 40 minutes of intraservice time for CPT code 630XX and the 45 minutes of intraservice time for CPT code 63048 (Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment. Each additional segment, cervical, thoracic, or lumbar (List separately in addition to code for primary procedure)). We believe that CPT code 63048 is a stronger reference code for CPT code 630XX than the RUC-recommended reference CPT codes 33924 (Ligation and takedown of a systemic-to-pulmonary artery shunt, performed in conjunction with a congenital heart procedure (List separately in addition to code for primary procedure)) and 22614 (Arthrodesis, posterior or posterolateral technique, single level. Each additional vertebral segment (List separately in addition to code for primary procedure)) because of the similarities in the long descriptors, physician time, and intensity of intraservice work for CPT codes 630XX and 63048.

The intraservice time ratio between CPT codes 63048 and 630XX equals a work RVU of 3.08 for CPT code 630XX ((40 minutes/45 minutes) * 3.47 = 3.08). Therefore, we are proposing a work RVU of 3.08 for CPT code 630XX. The intraservice time ratio between CPT codes 63048 and 630XX was selected to value CPT code 630XX because of the similarities in the descriptions of intraservice work provided in the RUC's summary of recommendations for CPT code 630XX and the RUC Database for CPT code 63048. We are proposing a work RVU of 2.31 for CPT code 630X1 based on an intraservice time ratio between the proposed 30 minutes of intraservice time for CPT code 630X1 and the proposed 40 minutes of intraservice time for CPT code 630XX ((30 minutes/40 minutes) * 3.08 = 2.31), given that the RUC contends that there are some efficiencies in providing an additional level of decompression, evidenced by the 10 minutes less of intraservice time for CPT code 630X1 compared to CPT code 630XX. These work RVU proposals are further supported by brackets of other 30 and 40 minute ZZZ codes.

We note that the proposed work RVU for CPT code 630XX falls between CPT code 19294 (Preparation of tumor cavity, with placement of a radiation therapy applicator for intraoperative radiation therapy (IORT) concurrent with partial mastectomy (List separately in addition to code for primary procedure)), which has a work RVU of 3.00, and CPT code 37185 (Primary percutaneous transluminal mechanical thrombectomy, noncoronary, non-intracranial, arterial or arterial bypass graft, including fluoroscopic guidance and intraprocedural pharmacological thrombolytic injection(s). Second and all subsequent vessel(s) within the same vascular family (List separately in addition to code for primary mechanical thrombectomy procedure)), which has a work RVU of 3.28. Both of these bracketing reference codes have identical intraservice times as CPT code 630XX. The proposed work RVU for CPT code 630X1 falls between CPT code 43273 (Endoscopic cannulation of papilla with direct visualization of pancreatic/common bile duct(s) (List separately in addition to code(s) for primary procedure)), which has a work RVU of 2.24, and CPT code 22870 (Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar. Second level (List separately in addition to code for primary procedure)), which has a work RVU of 2.34.

Both of these bracketing reference codes have identical intraservice times as CPT code 630X1. When we compared the RUC-recommended work RVU of 5.55 for CPT code 630XX and 4.44 for CPT code 630X1 to other spinal add-on codes in the 63000 CPT code series in the RUC database, we found that CPT code 630XX would have the highest work RVU and the second shortest intraservice time (with CPT code 630X1 having the shortest intraservice time), and CPT code 630X1 would have the third highest work RVU and shortest intraservice time compared to the 10 other nationally-priced spinal add-on codes in the 63000 CPT code series. We do not agree that decompression when performed in conjunction with posterior interbody arthrodesis at the same interspace should have an anomalously high work value in comparison to other similar add-on codes that have longer intraservice times. We believe that our proposed work RVUs of 3.08 for CPT code 630XX and 2.31 for CPT code 630X1 better serve the interests of relativity. We note that the specialty societies did not survey the two new add-on codes with the base codes, which is a standard to provide assurance that the respondents followed instruction to only consider the work of the add-on codes.

CPT codes 630XX and 630X1 were reviewed again with their base codes at the April 2021 RUC meeting. There were also revisions to the base codes' definitions, guidelines, and parenthetical instructions, which Start Printed Page 39163were approved by the CPT Editorial Panel for CY 2022. The RUC did not recommend any direct PE inputs for these codes and we are not proposing any direct PE inputs. (17) Hypoglossal Nerve Stimulator Services (CPT Codes 645X1, 645X2, and 645X3) In October 2020, the CPT Editorial Panel added three new CPT Category I codes to report open implantation, revision or replacement, and removal of hypoglossal nerve stimulator array. These new CPT codes replaced three CPT Category III codes which were reported with CPT codes 64568 (Incision for implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator), 64569 (Revision or replacement of cranial nerve (eg, vagus nerve) neurostimulator electrode array, including connection to existing pulse generator) and 64570 (Removal of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator).

CPT code 645X1 (Open implantation of hypoglossal nerve neruostimulator array, pulse generator, and distal respiratory sensor electrode or electrode array) was previously reported using the now deleted Category III CPT code 0466T (Insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator (List separately in addition to code for primary procedure)) along with CPT code 64568. We are not proposing the RUC-recommendation to use the survey median work RVU of 16.00 for CPT code 645X1. We are proposing a work RVU of 14.00 based on the intraservice time ratio of CPT code 64568 compared to the RUC-recommended intraservice time for CPT code 645X1. CPT code 64568 has a work RVU of 9.00, intraservice time of 90 minutes and total time of 275 minutes. CPT code 645X1 has a RUC-recommended work RVU of 16.00, intraservice time of 140 minutes and total time of 294 minutes.

Additionally, when we reviewed CPT code 645X1, we found that the RUC-recommended work RVU was higher than other global 90-day codes with similar time values. We do not agree that it would be typical to value this code so much higher than services with similar work time values. Additionally, we note that the proposed work RVU of 14.00 is also the survey 25th percentile. Therefore, as previously stated, we believe 14.00 is a more appropriate value overall than 16.00 when compared to the range of codes with similar work times. We are not proposing the RUC-recommended work value of 16.50 for CPT code 645X2 (Revision or replacement of hypoglossal nerve neruostimulator array and distal respiratory sensor electrode or electrode array, including connection to an existing pulse generator), rather we are proposing a work RVU of 14.50.

Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 645X1 and 645X2 is equivalent to the recommended increment of 0.50 RVUs. Therefore, we are proposing a work RVU of 14.50 for CPT code 645X2 based on the recommended increment of 0.50 additional RVUs above our proposed work RVU of 14.00 for CPT code 645X1. We believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within a family of codes where it is important to maintain an appropriate intra-family relativity. Additionally, we note that the proposed work RVU of 14.50 is also nearly identical to the 25th percentile survey value for CPT code 645X2 of 14.63. Therefore, as previously stated, we believe 14.50 is a more appropriate value than 16.50 to maintain an appropriate intra-family relativity.

We are not proposing the RUC-recommended work value of 14.00 for CPT code 645X3 (Removal of hypoglossal nerve neruostimulator array, pulse generator, and distal respiratory sensor electrode or electrode array), rather we are proposing a work RVU of 12.00. Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 645X1 and 645X3 is equivalent to the recommended increment of −2.0 RVUs. We believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within a family of codes where it is important to maintain an appropriate intra-family relativity. Therefore, we are proposing a work RVU of 12.00 for CPT code 645X3 based on the recommended increment of 2.0 RVUs below our proposed work RVU of 14.00 for CPT code 645X1. Additionally, we note that the proposed work RVU of 12.00 is also the RUC 25th percentile survey value for CPT code 645X3.

We are proposing the RUC-recommended direct PE inputs without refinements for CPT codes 645X1, 645X2 and 645X3. (18) Destruction by Neurolytic Agent (CPT Codes 64633, 64634, 64635, and 64636) In September 2014, the Relativity Assessment Workgroup identified a work neutrality issue for CPT codes 64633 (Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT). Cervical or thoracic, single facet joint), 64634 (Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT). Cervical or thoracic, each additional facet joint (List separately in addition to code for primary procedure)), 64635 (Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT). Lumbar or sacral, single facet joint), and 64636 (Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT).

Lumbar or sacral, each additional facet joint (List separately in addition to code for primary procedure)) related to incorrect coding relative to how the services were originally valued. In May 2015, the CPT Editorial Panel revised the parenthetical instructions for the five codes describing paravertebral facet joint nerve destruction to clarify that these codes are reported per joint, not nerve. Due to the extensive growth and original incorrect assumptions about distribution of reporting, the RUC recommended that CPT codes 64633-64636 be surveyed. We are proposing the RUC-recommended work RVU of 1.32 for CPT code 64634 and the RUC-recommended work RVU of 1.16 for CPT code 64636. For CPT codes 64633 and 64635, we are not proposing the RUC-recommended work RVU of 3.42 for both codes, as we believe this value understates the decrease in physician work time for these codes.

An analysis of all 010-day global period codes indicates that these proposed values would place these codes among the highest valued for codes with similar time values. We are instead using a total-time ratio methodology to propose work RVUs of 3.31 for CPT code 64633 and 3.32 for CPT code 64635. We support these values by noting that they fall between CPT codes 54164 (Frenulotomy of penis), with a work RVU of 2.82, and CPT code 68371 (Harvesting conjunctival allograft, living donor), with a work RVU of 5.09. These reference codes have total time values that are similar to, and intraservice time values that are identical to those recommended for CPT codes 64633 and 64635.Start Printed Page 39164 We are proposing the RUC-recommended direct PE inputs without refinement. (19) Destruction of Intraosseous Basivertebral Nerve (CPT Codes 646X0 and 646X1) In October 2020, the CPT Editorial Panel added two Category I codes to report thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance for the first two vertebral bodies (lumbar or sacral) and for each additional vertebral body (lumbar or sacral).

We are not proposing the RUC-recommended work value of 8.25 for CPT code 646X0 (Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance. First two vertebral bodies, lumbar or sacral). When we reviewed CPT code 646X0, we found that the RUC-recommended work RVU was higher than codes with the same 10-day global period, same intraservice time and similar total times. The RUC-recommended work RVU of 8.25 would value CPT code 646X0 at the 90th percentile of comparable 10-day globals and we do not agree that it would be typical to value this code so much higher than services with similar work time values. We believe it would be more accurate to propose a work RVU of 7.15 based on a crosswalk to CPT code 63650 (Percutaneous implantation of neurostimulator electrode array, epidural) with a work RVU of 7.15, identical intraservice time of 60, and similar total time of 170.

We believe the crosswalk to CPT code 63650 serves as a more accurate valuation for CPT code 646X0. We also are not proposing the RUC-recommended work value of 4.87 for CPT code 646X1 (Thermal destruction of intraosseous basivertebral nerve, inclusive of all imaging guidance. Each additional vertebral body, lumbar or sacral (List separately in addition to code for primary procedure)). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 646X0 and 646X1 is equivalent to the recommended increment of −3.38 RVUs. However, since the recommended work RVU of code 646X0 was higher than other codes with the same 10-day global period, same intraservice time, and similar total times, we refined the work RVU for code 646X1 to preserve the incremental difference between the two codes.

We believe that these refinements maintain the relationship between the two codes in the family while better preserving relativity with other similar 10-day global codes on the wider PFS. We believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within a family of codes where it is important to maintain an appropriate intra-family relativity. Therefore, we are proposing a work RVU of 3.77 for CPT code 646X1 based on the recommended increment of 3.38 RVUs below our proposed work RVU of 7.15 for CPT code 646X0. We are proposing the RUC-recommended direct PE inputs without refinements for CPT code 646X0. CPT code 646X1 is an add-on code and does not have any direct PE inputs.

(20) Dilation of Aqueous Outflow Canal (CPT Codes 66174 and 66175) These services were identified through the New Technology/New Services List. In January 2020, the specialty societies submitted an action plan and the RUC recommended referral to the CPT Editorial Panel in 2020 to possibly revise the descriptor and add exclusionary parentheticals for CPT code 66174 (Transluminal dilation of aqueous outflow canal. Without retention of device or stent). In October 2020, the CPT Editorial Panel revised this code to add a parenthetical to restrict reporting this code in conjunction with CPT code 65820 (Goniotomy). We are not proposing the RUC-recommended work RVUs of 8.53 for CPT code 66174 and 10.25 for CPT code 66175 (Transluminal dilation of aqueous outflow canal.

With retention of device or stent), as we believe these values do not adequately reflect the surveyed reductions in physician time. These RVUs would rank these codes among the highest valued 090-day global period codes of similar time values. We are proposing a work RVU of 9.34 for CPT code 66175 using a reverse building block methodology. We then subtract the incremental difference between the two RUC-recommended work RVUs, an increment of 1.72, from our proposed work RVU of 9.34 for CPT code 66175 to propose a work RVU of 7.62 for CPT code 66174. We believe this approach is consistent with the RUC's assumption that the intensity and complexity of CPT code 66174 is the same as that of CPT code 66175, the only difference between the two procedures being the additional intraservice time associated with placement of the stent.

As further support for these values, we note that they fall between CPT code 66984 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1 stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification). Without endoscopic cyclophotocoagulation), with 7.35 work RVUs, and CPT code 15150 (Tissue cultured skin autograft, trunk, arms, legs. First 25 sq cm or less), with 9.39 work RVUs. We are proposing the RUC-recommended PE inputs without refinement. (21) Cataract Removal With Drainage Device Insertion (CPT Codes 669X1, 669X2, 66982, 66984, 66987, 66988, and 0X12T) The RUC identified CPT code 0191T (Insertion of anterior segment aqueous drainage device, without extraocular reservoir, internal approach, into the trabecular meshwork.

Initial insertion) via the Category III codes with High Utilization screen (2018 estimated Medicare utilization over 1,000). In January 2020, the RUC recommended that the specialty societies develop a coding application for Category I status for CPT code 0191T and CPT code 0376T (each additional device insertion (List separately in addition to code for primary procedure). In October 2020, the CPT Editorial Panel replaced two Category III codes (CPT codes 0191T and 0376T) with two new codes, CPT codes 669X1 and 669X2, to report extracapsular cataract removal with insertion of intraocular lens prosthesis and one Category III code to report insertion of anterior segment aqueous drainage device without concomitant cataract removal. The RUC recommended a work RVU of 12.13 for CPT code 669X1 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification), complex, requiring devices or techniques not generally used in routine cataract surgery (eg, iris expansion device, suture support for intraocular lens, or primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage. With insertion of intraocular (eg, trabecular meshwork, supraciliary, suprachoroidal) anterior segment aqueous drainage device, without extraocular reservoir, internal approach, one or more) based on the survey 25th percentile.

In its recommendation, the RUC noted that the recommended intraservice time of 28 minutes for CPT code 669X1 is 2 minutes less than the intraservice time of 30 minutes associated with CPT code 66982 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage procedure), manual Start Printed Page 39165or mechanical technique (eg, irrigation and aspiration or phacoemulsification), complex, requiring devices or techniques not generally used in routine cataract surgery (eg, iris expansion device, suture support for intraocular lens, or primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage. Without endoscopic cyclophotocoagulation). The RUC further noted this should not be the case, as the insertion of the intraocular lens prosthesis should take the same amount of time and be represented by the same relative work for both procedures and that it is counterintuitive that the intraservice time for CPT code 669X1 would be lower than the intraservice time for CPT code 66982, as CPT code 669X1 includes both complex cataract surgery and the insertion of the intraocular anterior segment aqueous drainage device. The specialty society that surveyed the codes explained that this is likely because the early adopters of this new technology service are highly skilled surgeons who would likely perform these procedures quickly. They stated that as this procedure diffuses into the wider population of ophthalmologic surgeons over the next few years, the intraservice time will likely rise above the intraservice time associated with CPT codes 66982 and 66984 and will come in line for both CPT codes 669X1 and 669X2.

CPT code 69982 has a work RVU of 10.25, 125 minutes of total time and 30 minutes of intraservice time. CPT code 669X1 has a RUC-recommended work RVU of 12.13, 176 minutes of total time and 28 minutes of intraservice time. We agree with the RUC assessment that both procedures, CPT code 66982 and CPT code 669X1, are almost identical in time and intensity. However, we disagree with the RUC-recommended work RVU of 12.13 for CPT code 669X1 noting that CPT code 66982 has a work RUV of 10.25. We are proposing a work RVU of 10.31 based on the current total time ratio of CPT code 66982 compared to the RUC-recommended total time for CPT code 669X1.

For CPT code 669X2, the RUC recommended a work RVU of 9.23. The RUC determined that it would be appropriate to use the increment between the 25th percentile work RVU value for CPT code 669X1 and the current RUC-reviewed work RVU value for CPT code 66982 to build a work RVU recommendation for CPT code 669X2. The RUC determined that the increment between the 25th percentile work RVU value for CPT code 669X1 (work RVU = 12.13) and the current RUC-reviewed work RVU value for CPT code 66982 (work RVU = 10.25) would yield an increment between those two codes of 1.88. The RUC added the 1.88 increment to 7.35, the current work RVU for 66984, which yields a RUC-recommended work RVU value of 9.23. This comparison results in a work RVU recommendation of 9.23 for CPT code 669X2.

We are proposing a work RVU of 7.41, which is the increment between the current RUC-reviewed work RVU value for CPT code 66982 and CPT code 66984. The increment between CPT code 66982 (work RVU = 10.25) and CPT code 66984 (work RVU = 7.35) yields a work RUV of 2.90. We subtracted this 2.90 increment from 10.31, to determine our proposed work RVU of 7.41 for CPT code 669X1. We are proposing the RUC-recommended indirect PE values for CPT codes 669X1 and 669X2. We are not proposing any new valuations but reaffirming the work RVUs and direct PE inputs that we previously finalized for CPT codes 66982 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification), complex, requiring devices or techniques not generally used in routine cataract surgery (eg, iris expansion device, suture support for intraocular lens, or primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage.

Without endoscopic cyclophotocoagulation) and 66984 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1 stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification). Without endoscopic cyclophotocoagulation). For CPT codes 66987 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification), complex, requiring devices or techniques not generally used in routine cataract surgery (eg, iris expansion device, suture support for intraocular lens, or primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage. With endoscopic cyclophotocoagulation) and 66988 (Extracapsular cataract removal with insertion of intraocular lens prosthesis (1 stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification). With endoscopic cyclophotocoagulation) we continue to believe these services should be contractor priced.

(22) Retinal Detachment Prophylaxis (CPT Codes 67141 and 67145) CPT code 67145 (Prophylaxis of retinal detachment (eg, retinal break, lattice degeneration) without drainage, 1 or more sessions. Photocoagulation (laser or xenon arc)) was identified in October 2019 as a Harvard Valued service with utilization over 30,000. In January 2020, the RUC agreed with the specialty societies that surveyed the service and recommended that CPT code 67145, as well as its parent CPT code 67141 (Prophylaxis of retinal detachment (eg, retinal break, lattice degeneration) without drainage, 1 or more sessions. Cryotherapy, diathermy), be referred to the CPT Editorial Panel for a descriptor and global period change. The codes were edited to remove the reference to “1 or more sessions” so that the services may be valued as a 010-day procedure versus the current 090-day global.

At the May 2020 CPT Editorial Panel meeting, the Panel approved revision of the two codes to remove “1 or more sessions” from the descriptors and deletion of the Eye and Ocular Adnexa Prophylaxis guidelines. For CY 2022, we are proposing the RUC-recommended work RVU of 2.53 for CPT codes 67141 and 67145. We are also proposing the RUC-recommended direct PE inputs without refinements. (23) Strabismus Surgery (CPT Codes 67311, 67312, 67314, 67316, 67318, 67320, 67331, 67332, 67334, 67335, and 67340) In April 2020, The RUC recommend that add-on CPT codes 67320, 67331, 67332, 67334, 67335, and 67340 be surveyed along with the base codes in which these services are typically reported (CPT codes 67311, 67312, 67314, 67316 and 67318). When AMA staff compiled a list of 010-day and 090-day services for increases in physician work and time during the surgical global period, they noticed that several low volume codes that were converted to ZZZ global periods in 1999 still included office visits (specifically CPT codes 67320, 67331, 67332, 67334, 67340).

It appeared that these office visits may not be appropriate for these services. This issue was deferred until October 2020. We are proposing the RUC-recommended work RVUs for all base codes within this family. This includes a work RVU of 5.93 for CPT code 67311 (Strabismus surgery, recession or resection procedure. 1 horizontal muscle), 9.50 for CPT code 67312 Start Printed Page 39166(Strabismus surgery, recession or resection procedure.

2 horizontal muscles), 5.93 for CPT code 67314 (Strabismus surgery, recession or resection procedure. 1 vertical muscle (excluding superior oblique), 10.31 for CPT code 67316 (Strabismus surgery, recession or resection procedure. 2 or more vertical muscles (excluding superior oblique)), and 9.80 for CPT code 67318 (Strabismus surgery, any procedure, superior oblique muscle). We are also proposing the RUC-recommend work RVUs for all of the add-on codes within this family. This includes a work RVU of 3.00 for CPT code 67320 (Transposition procedure (eg, for paretic extraocular muscle), any extraocular muscle (specify) (List separately in addition to code)), 2.00 for CPT code 67331 (Strabismus surgery on patient with previous eye surgery or injury that did not involve the extraocular muscles (List separately in addition to code for primary procedure)), 3.50 for CPT code 67332 (Strabismus surgery on patient with scarring of extraocular muscles (eg, prior ocular injury, strabismus or retinal detachment surgery) or restrictive myopathy (eg, dysthyroid opthalmopathy) (List separately in addition to code for primary procedure)), 2.06 for CPT code 67334 (Strabismus surgery by posterior fixation suture technique, with or without muscle recession (List separately in addition to code for primary procedure)), 3.23 for CPT code 67335 (Strabismus surgery by posterior fixation suture technique, with or without muscle recession (List separately in addition to code for primary procedure)), and 5.00 for CPT code 67340 (Strabismus surgery by posterior fixation suture technique, with or without muscle recession (List separately in addition to code for primary procedure)).

We are proposing the RUC-recommended direct PE inputs for this code family without refinements. (24) Lacrimal Canaliculus Drug Eluding Implant Insertion (CPT Codes 68XXX) CPT code 68XXX (Insertion of drug-eluting implant, including punctal dilation, when performed, into lacrimal canaliculus, each) was recommended for RUC review in October 2020 since the CPT Editorial Panel replaced CPT Category III (temporary) code 0356T with a new CPT Category I code to report the insertion of a drug eluting implant into the lacrimal canaliculus. We are proposing the RUC-recommended work RVU of 0.49 for CPT code 68XXX. For the direct PE inputs, we are proposing to refine the equipment time for the “lane, screening (oph)” (EL006) from the RUC-recommended 9 minutes of equipment time to the 5 minute equipment standard for CPT code 68XXX. Five minutes is the standard equipment time associated with EL006 for this procedure.

The recommended materials for this code family from the RUC state that the screening lane is used for the duration of setup, procedure, cleaning, and counselling post procedure and that the standard formulas are applied. We believe that the RUC inadvertently failed to update the equipment time associated with this procedure when CPT code 68XXX was reviewed. The recommended materials for CPT code 68XXX state the standard equipment time formula would be typical for this service, which would be 5 minutes in this case (the CA013 and CA024 equipment times are included but not the CA035 equipment time). We are proposing to refine the equipment time for the equipment item lane, screening (oph) (EL006) from 9 minutes to 5 minutes to match this change in equipment time and are seeking additional comment from stakeholders regarding the RUC-recommended non-standard equipment time of 9 minutes. We do not agree that it would be typical for CPT code 68XXX to require an additional 4 minutes of equipment time totaling 9 minutes.

(25) Transcutaneous Passive Implant-Temporal Bone (CPT Codes 69714, 69717, 69X50, 69X51, 69X52, and 69X53) In October 2020, the CPT Editorial Panel deleted two codes used for mastoidectomy and replaced them with four new codes for magnetic transcutaneous attachment to external speech processor. The CPT Editorial Panel made additional revisions to differentiate implantation, removal, and replacement of the implants. We are proposing the RUC-recommended work RVU for all six of the codes in this family. We are proposing a work RVU of 8.69 for CPT code 69714 (Implantation, osseointegrated implant, skull. With percutaneous attachment to external speech processor), a work RVU of 9.77 for CPT code 69X50 (Implantation, osseointegrated implant, skull.

With magnetic transcutaneous attachment to external speech processor), a work RVU of 8.80 for CPT code 69717 (Revision/replacement (including removal of existing device), osseointegrated implant, skull. With percutaneous attachment to external speech processor), a work RVU of 9.77 for CPT code 69X51 (Revision/replacement (including removal of existing device), osseointegrated implant, skull. With magnetic transcutaneous attachment to external speech processor), a work RVU of 5.93 for CPT code 69X52 (Removal, osseointegrated implant, skull. With percutaneous attachment to external speech processor), and a work RVU of 7.13 for CPT code 69X53 (Removal, osseointegrated implant, skull. With magnetic transcutaneous attachment to external speech processor).

For the direct PE inputs, we are proposing to refine the clinical labor time for the “Post-operative visits (total time)” (CA039) activity from the RUC-recommended 108 minutes to 99 minutes for CPT codes 69714 and 69717. 99 minutes is the clinical labor time associated with one Level 2 postoperative office visit and two Level 3 postoperative office visits. We believe that the RUC inadvertently failed to update the clinical labor time associated with these postoperative office visits when CPT codes 69714 and 69717 were reviewed. We are also proposing to refine the equipment time for all equipment items other than the basic instrument pack (EQ137) from 108 minutes to 99 minutes to match this change in clinical labor time. (26) X-Rays at Surgery Add-On (CPT Code 74301) The RUC recommended that CPT code 74301 (Cholangiography and/or pancreatography.

Additional set intraoperative, radiological supervision and interpretation (List separately in addition to code for primary procedure)) be deleted for October 2020. The specialty societies that typically bill for this service submitted a code change application to delete CPT code 74301 at the February 2020 CPT meeting. However, the specialty societies withdrew the deletion request after receiving feedback from the dominant provider of CPT code 74301 (general surgery), indicating the code is still necessary and should not be deleted. The RUC recommended to maintain the work RVU of 0.21 for CPT code 74301. The specialty societies did not resurvey CPT code 74301 due to its low utilization (2019 Medicare utilization = 63) and the difficulty of obtaining 30 survey responses from providers with experience in the past 12 months.

Since there was no survey done, there is no new information and the RUC recommended to maintain the current value. The work RVU suggested by the RUC is a reaffirmation of the current value. We are proposing the RUC-recommended work RVU of 0.21 for Start Printed Page 39167CPT code 74301. This is an add-on code with no direct PE inputs. (27) Trabecular Bone Score (TBS) (CPT Codes 77X01, 77X02, 77X03, and 77X04) We are proposing the RUC-recommended work RVUs of 0.20 for CPT codes 77X01 (Trabecular bone score (TBS), structural condition of the bone microarchitecture.

Using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk) and 77X04 (Trabecular bone score (TBS), structural condition of the bone microarchitecture. Using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture risk interpretation and report on fracture risk only, by other qualified health care professional). CPT codes 77X02 (Trabecular bone score (TBS), structural condition of the bone microarchitecture. Technical preparation and transmission of data for analysis to be performed elsewhere) and 77X03 (Trabecular bone score (TBS), structural condition of the bone microarchitecture. Technical calculation only) are PE only codes.

The RUC did not recommend and we are not proposing a work RVU for these codes. The RUC PE recommendations for CPT codes 77X01 and 77X03 include a new “TBS iNsight Software” supply input. The submitted invoice for this supply indicates that it is a licensing fee associated with the use of the software, which is not typically considered to be a form of direct PE under our methodology. Historically, we have considered most computer software and associated licensing fees to be indirect costs tied to associated costs for hardware considered to be medical equipment. However, as we noted in section II.B.

Of this proposed rule (the PE section), stakeholders have routinely expressed concerns with this policy, especially for evolving technologies that rely primarily on software and licensing fees with minimal costs in equipment or hardware. Most of the recommended resource costs for CPT codes 77X01 and 77X03 are for this analysis fee and these costs are not well accommodated by the PE methodology since these sorts of technological applications did not exist when the data that underlie the PE allocation was last collected in 2007 through 2008. We are therefore proposing to value the PE for CPT codes 77X01 and 77X03 through the use of a crosswalk to a comparable service, CPT code 71101 (Radiologic examination, ribs, unilateral. Including posteroanterior chest, minimum of 3 views), which, for CY 2021, had a PE RVU of 0.94. We are proposing that the PE RVU for CPT code 77X03 equals the PE RVU from code 77X01 minus the PE RVU from codes 77X02 and 77X04 so that the three codes sum to the valuation of code 77X01.

(CPT code 77X01 is the global code in this family and CPT codes 77X02, 77X03, and 77X04 must sum together to equal the value of 77X01.) CPT code 71101 is another type of bone imaging procedure that we believe reflects codes 77X01 and 77X03 similar direct PE resource costs as CPT codes 77X01 and 77X03. We recognize that the services being performed in this crosswalk code are not the same as the services in CPT codes 77X01 and 77X03, however we believe that the direct resource costs would typically be analogous across these codes. We believe that this is the most accurate way to incorporate the costs of the software employed in CPT codes 77X01 and 77X03 which would not typically be considered direct PE under our current methodology. We are soliciting comments, both on the specific proposal for the Trabecular Bone Score codes as well as our broader discussion of this topic in section II.B. Of this proposed rule.

(28) Pathology Clinical Consult (CPT Codes 80XX0, 80XX1, 80XX2, and 80XX3) The Relativity Assessment Workgroup identified CPT code 80500 (Clinical pathology consultation. Limited, without review of patient's history and medical records) via the CMS/Other source codes with the Medicare utilization over 20,000 screen. In October 2019, the RUC referred this issue to the CPT Editorial Panel to define this service more specifically as the current descriptor is vague. In October 2020, the CPT Editorial Panel replaced CPT codes 80500 and 80502 (Clinical pathology consultation. Comprehensive, for a complex diagnostic problem, with review of patient's history and medical records) with four new codes, CPT codes 80XX0 (Pathology clinical consultation.

For a clinical problem with limited review of patient's history and medical records and straightforward medical decision making. When using time for code selection, 5-20 minutes of total time is spent on the date of the consultation. (For consultations involving the examination and evaluation of the patient, see 99241, 99242, 99243, 99244, 99245, 99251, 99252, 99253, 99254, 99255)), 80XX1 (for a moderately complex clinical problem, with review of patient's history and medical records and moderate level of medical decision making. When using time for code selection, 21-40 minutes of total time is spent on the date of the consultation), 80XX2 (for a highly complex clinical problem, with comprehensive review of patient's history and medical records and high level of medical decision making. When using time for code selection, 41-60 minutes of total time is spent on the date of the consultation), and 80XX3 (prolonged service, each additional 30 minutes (List separately in addition to code for primary procedure) (Use 80XX3 in conjunction with 80XX2) (Do not report 80XX0, 80XX1, 80XX2, 80XX3 in conjunction with 88321, 88323, 88325) (Prolonged pathology clinical consultation service of less than 15 additional minutes is not reported separately) (For consultations involving the examination and evaluation of the patient, see 99241-99255)) to report pathology clinical consultation and creation of guidelines to select and document the appropriate level of service.

The RUC recommended a work RVU of 0.50 for CPT code 80XX0 based on the 25th percentile of the survey. The RUC-recommended 15 minutes of intraservice and total times for CPT code 80XX0 are 2 minutes above the current instraservice and total times for CPT code 80500. This represents a 15 percent increase in the respective times. However, the RUC-recommended work RVU of 0.50 is 35 percent higher than the current work RVU of 0.37 for CPT code 80500. We believe that the increase or decrease in times should be commensurate with the increase or decrease in the work RVU.

Therefore, we are proposing a work RVU of 0.43. This represents the ratio of total time between the current total time of CPT code 80500 and the proposed total time of CPT code 80XX0 (0.15) applied to the current value of CPT code 80500 (0.37 × 0.15 = 0.43). We are proposing the RUC-recommended work RVU of 0.91 without refinements for CPT code 80XX1. The RUC recommended a work RVU of 1.80 for CPT code 80XX2 based on the 25th percentile of the survey. The current intraservice and total times for CPT code 80502 are 42 minutes.

The RUC-recommended times for CPT code 80XX2 are 54 minutes. Similar to the scenario described above for CPT code 80XX0, the intraservice and total times for CPT code 80XX2 increased 28.6 percent while the work RVU increased 35 percent. As stated above, we believe the increase or decrease in time should be commensurate with the increase or Start Printed Page 39168decrease in the work RVU. Therefore, for CPT code 80XX2 we are proposing a work RVU of 1.71, which is the current total time ratio of CPT code 80502 compared to the RUC-recommended total time for CPT code 80XX2. We are proposing the RUC-recommended work RVU of 0.80 for CPT code 80XX3 without refinement.

For the direct PE inputs of CPT codes 80XX0, 80XX1, and 80XX2, we are proposing to refine the time associated with the clinical labor activity PA001 (Accession and enter information) from the RUC-recommended time of 4 minutes to 0 minutes as we believe the time is duplicative with clinical labor activity PA008 (File specimen, supplies, and other materials). The RUC recommended 15, 30, 54, and 30 minutes of equipment time for EP024 (microscope, compound) for CPT codes 80XX0, 80XX1, 80XX2, and 80XX3, respectively. We note that there is no indication from the code descriptors that the pathologist is reviewing physical slides. The code descriptor and description of work indicate that the pathologist is reviewing paper records and/or EHR and therefore we are proposing to remove the equipment time associated with EP024 (microscope, compound) from CPT codes 80XX0, 80XX1, 80XX2, and 80XX3. Additionally, the proposed Levels of Decision Making for Table for Pathology Clinical Consult codes includes “Assessment requiring an independent historian(s)” as an element of “Amount and/or Complexity of Data to be Reviewed and Analyzed *—Each unique test, order, or document contributes to the combination of 2 or combination of 3 in Category 1 below.” Neither the code descriptors nor the descriptions of work indicate that this type of assessment is typical in a pathology clinical consult as was discussed for the office visit Levels of Decision Making table.

For these reasons, CMS proposes that this element not be included as an element that CMS would recognize as an element of medical decision making. We note that CMS will monitor the use of these replacement codes per our usual practice to ensure appropriate billing and inform future rulemaking as needed. We are also seeking comment on how these replacement codes would most typically be billed relative to use of existing pathology coding. Such information would also inform future rulemaking as needed. (29) Revaluing End Stage Renal Disease (ESRD) Monthly Capitation Payment Services (MCP) (CPT Code 90954) In the CY 2021 PFS final rule (85 FR 84551 through 84554), we revalued most, but not all, of the ESRD MCP services.

We finalized an increase in valuations for those ESRD MCP codes with values tied to the values of Outpatient/Office Evaluation and Management (O/O E/M) codes. We did not revalue CPT code 90954 (End-stage renal disease (ESRD) related services monthly, for patients 2-11 years of age to include monitoring for the adequacy of nutrition, assessment of growth and development, and counseling of parents. With 4 or more face-to-face visits by a physician or other qualified health care professional per month) because it was originally valued by a crosswalk. Stakeholders stated that CPT code 90954 was different from the other ESRD MCP codes. Rather than using an O/O E/M code building block methodology as had been used originally to value the other ESRD MCP codes, CPT code 90954 was valued based upon a crosswalk to CPT code 99293 (Inpatient pediatric critical care provided for children age 29 days through 24 months old, per day).

When CPT code 99293 was deleted, the value of CPT code 90954 was crosswalked to a replacement code, CPT code 99471 (Initial inpatient pediatric critical care, per day, for the evaluation and management of a critically ill infant or young child, 29 days through 24 months of age). By crosswalking CPT code 90954 to CPT code 99471, the rank order across the ESRD MCP code family at that time was preserved. Since we finalized the revalued ESRD MCP values for CY 2021, stakeholders have requested that we revalue CPT code 90954 because by not updating it, we created a rank order anomaly for work RVUs and time within the ESRD MCP code family. A stakeholder suggested that we address the rank order anomaly by revaluing CPT code 90954 based upon a new crosswalk to CPT code 33977 (Removal of a ventricular assist device. Extracorporeal, single ventricle).

The stakeholder stated that CPT code 33977 more appropriately represented the time and effort of the service provided over one month than the existing crosswalk to CPT code 99471 relative to the revalued services within the MCP code family. In response to stakeholder requests to update the value of CPT code 90954, we are proposing to increase the value of CPT code 90954, a global code with a current work RVU of 15.98, by crosswalking it to CPT code 33977, a 090-day procedural code with a work RVU of 20.86 to preserve relativity within the ESRD MCP family. We are also seeking comment on our proposal to increase the value of CPT code 90954. (30) Colon Capsule Endoscopy (CPT Codes 91110, 91111, and 9111X) In October 2020, the CPT Editorial Panel replaced Category III code 0355T (Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), colon, with interpretation and report) with a new Category I code 9111X (Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), colon, with interpretation and report) to report gastrointestinal tract imaging. CPT codes 91110 (Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), esophagus through ileum, with interpretation and report) and 91111 (Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), esophagus with interpretation and report) were added as part of the family and surveyed for the January 2021 RUC meeting.

We are proposing the RUC-recommended work RVU for two of the codes in this family. We are proposing a work RVU of 2.24 for CPT code 91110 and a work RVU of 2.41 for CPT code 9111X as recommended by the RUC in both cases. For CPT code 91111, we disagree with the RUC-recommended work RVU of 1.00 and we are proposing a work RVU of 0.90 based on a crosswalk to CPT code 95923 (Testing of autonomic nervous system function. Sudomotor, including 1 or more of the following. Quantitative sudomotor axon reflex test (QSART), silastic sweat imprint, thermoregulatory sweat test, and changes in sympathetic skin potential).

CPT code 95923 is an autonomic nervous system testing procedure that shares the identical intraservice work time of 15 minutes with CPT code 91111 and has 5 additional minutes of immediate postservice work time. When we reviewed CPT code 91111, we noted that the surveyed intraservice work time had decreased by 3 minutes, from 18 minutes to 15 minutes, while the RUC recommended maintaining the current work RVU of 1.00. Although we do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, decreases in time should typically be reflected in decreases to work RVUs. In the case of CPT code 91111, we believe that it would be more accurate to propose a work RVU of 0.90 based on a crosswalk Start Printed Page 39169to CPT code 95923 to account for these decreases in the surveyed work time. For the direct PE inputs, we are proposing to refine the clinical labor time for the “Prepare, set-up and start IV, initial positioning and monitoring of patient” (CA016) activity from the RUC-recommended 9 minutes to 6 minutes for CPT code 91111.

The recommended materials for this code family state that the 6 minutes for the CA016 activity are used to connect the equipment, fit belt to patient, put data recorder on patient, and sync capsule to each sensor on belt. This description of this clinical labor activity is identical for CPT codes 91110 and 9111X and each code has the same recommended time of 6 minutes. However, the recommended materials for CPT code 91111 state that 6 minutes are used to connect the equipment, fit belt, put data recorder on patient, sync capsule to each sensor and then an additional 3 minutes are used to position the patient (assist patient onto table lying down on right side and then into a sitting position after the capsule is swallowed). We do not agree that it would be typical for CPT code 91111 to require an additional 3 minutes for positioning as compared with the other codes in the family, particularly in light of the clinical similarities between these services. We are refining the clinical labor time to 6 minutes for CPT code 91111 to maintain relativity within the family.

We are also proposing to refine the equipment time for the capsule endoscopy recorder kit (EQ146) from 64 minutes to 61 minutes and the exam table (EF023) from 44 minutes to 41 minutes to match this change in clinical labor time for CPT code 91111. (31) External Cardiovascular Device Monitoring (CPT Codes 93228 and 93229) For CPT code 93228 (External mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days. Review and interpretation with report by a physician or other qualified health care professional), we disagree with the RUC-recommended work RVU of 0.52, and we are proposing a work RVU of 0.43. The proposed work RVU is based on an intraservice time ratio between the current and RUC-recommended intraservice times for CPT code 93228 ((10 minutes/12 minutes)*0.52), yielding a work RVU of 0.43. This proposed work RVU reflects the decrease in total time and is a direct work RVU crosswalk to CPT code 93290 (Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter.

Implantable cardiovascular physiologic monitor system, including analysis of 1 or more recorded physiologic cardiovascular data elements from all internal and external sensors). CPT code 93290 has the same pre-, intra-, and postservice times as the survey times for CPT code 93228 and was reviewed in October 2016. While we recognize that the number of ECG tracings and daily reports have increased because of the increase in average wear time from 14 days to 20 days, the specialty societies and the RUC contend that this is offset by technology advancements, integrations with EHRs, and online portals that make it easier to manage and review the data in a chronological and efficient manner. Therefore, we are recommending a work RVU that accounts for decrease in total time to provide this service, given that the increased tracings and daily reports are offset by the efficiencies gained by technological advancements. The RUC recommended 10 minutes for “Provide education/obtain consent” (CA011) for CPT code 93228, based on a direct crosswalk and duplication of CPT code 93229 (External mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days.

Review and interpretation with report by a physician or other qualified health care professional). We disagree with the RUC-recommended duplication of clinical labor to provide education that the patient will hear for a second time from the IDTF technician. While we understand that the duplication is by design, we do not agree with a direct crosswalk from CPT code 93229, because the provider of CPT code 93229 will likely have more in-depth education, specific to the patient, including materials and instructions for the patient to review. Therefore, we are proposing the standard 2 minutes for CA011 in the non-facility for CPT code 93228. The RUC recommended the addition of 24 minutes for quality assurance “overread” done by a second, senior technician, Clinical Activity Code CA021, Line 67 on the RUC-recommended PE Spreadsheet, for CPT code 93229.

This is a new clinical activity for CPT code 93228, and we are seeking public comment about the typicality of a second senior technician. We are requesting additional information about the IDTF's current quality assurance measures and parameters within the ECG recording program that should act as some degree of quality assurance. We are also seeking additional information from IDTFs about the current error rate for improperly transmitted tracings to the physician that would indicate that it is typical for a second, senior technician to perform “overread.” We are proposing 0 minutes for Clinical Activity Code CA021, Line 67 on the RUC-recommended PE Spreadsheet, unless commenters can provide compelling information that a second, senior technician typically performs quality assurance measures. Otherwise, we agree with the RUC-recommended direct PE inputs and are proposing the refinements as recommended. In addition to the proposed work RVU and direct PE input refinements, we are requesting additional information about the acquisition costs for equipment item EQ340 Patient Worn Telemetry System.

Due to the proprietary nature of this equipment, invoices were unattainable to update this equipment item. Substantial technological improvements have been made to these devices since the last update in 2008, but they are proprietary devices, owned and manufactured for each IDTF. We are seeking public comment on the manufacturing costs and other information to help update the equipment item for CY 2022. Second, we are requesting additional information about the useful lifetime of EQ340. CMS currently assigns 3 years of useful life to EQ340, but the RUC notes that this is the only equipment item and CPT code 93228 is the only CPT code with an equipment item that has more than 500 minutes of equipment time and a useful life of 3 years or less.

We are seeking public comment to help update the useful life of EQ340, as it has not been updated since 2008, and the device has experienced significant technological changes. (32) Electrophysiologic Evaluation (CPT Code 93621) In October 2019, the RUC identified CPT code 93621 (Comprehensive electrophysiologic evaluation including insertion and repositioning of multiple electrode catheters with induction or attempted induction of arrhythmia. With left atrial pacing and recording from coronary sinus or left atrium (List separately in addition to code for Start Printed Page 39170primary procedure) as a high-growth service. It is an add-on code that can be used with several different procedures—base codes or other add-on codes, diagnostic as well as therapeutic. CPT code 93621 is furnished in the facility only and thus has no direct PE inputs.

We disagree with the RUC-recommended work RVU of 1.75 based on a crosswalk to CPT code 36483 (Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (eg, cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous. Subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure). We are proposing a work RVU of 1.50 based on a crosswalk to CPT code 16036 (Escharotomy. Each additional incision). CPT code 16036 is also an add-on code for a surgical incision that shares both an identical intraservice work time and a total time of 20 minutes with CPT code 93621.

While the RUC's recommended crosswalk code also has 20 minutes of intraservice and total time, CPT code 36483 is more intense than CPT code 93621, whereas CPT code 16036 has a similar level of intensity as CPT code 93621. The RUC did not recommend and we are not proposing any direct PE inputs for CPT code 93621. (33) Cardiac Ablation Services Bundling (CPT Codes 93653, 93654, 93655, 93656, and 93657) The technologies and clinical practices associated with Cardiac Ablation Services have changed enough over the past decade (since 2011 when they were first developed) that the specialty societies recommended referring theses codes to CPT Editorial Panel to have the code descriptors for Cardiac Ablation Services updated to create new and more complete descriptors reflecting the fact that many of these services are commonly performed together and should be incorporated and bundled. In October 2020, the CPT Editorial Panel revised the three existing cardiac ablation codes to be bundled with 3D mapping and to include “induction or attempted induction of an arrhythmia with right atrial pacing and recording, and catheter ablation of arrhythmogenic focus,” and “left atrial pacing and recording from coronary sinus or left atrium” and “intracardiac echocardiography including imaging supervision and interpretation” into their descriptors. A survey of the Cardiac Ablation Services was sent out using the newly revised CPT code descriptors asking cardiac electrophysiologists about the revised language in the existing CPT codes.

From the survey results, the RUC advisory committee believes that many of the survey respondents may not have realized that the code descriptors had been substantially revised and that they may not have read the updated code descriptors thoroughly enough to understand that services that are separately billed, were now combined into the existing codes (since CPT did not issue new codes for the revised descriptors). The RUC recommended that these services be valued as interim to allow for re-survey and subsequent review at the April 2021 RUC meeting. CPT code 93653 (Comprehensive electrophysiologic evaluation with insertion and repositioning of multiple electrode catheters, induction or attempted induction of an arrhythmia with right atrial pacing and recording, and catheter ablation of arrhythmogenic focus, including intracardiac electrophysiologic 3-dimensional mapping, right ventricular pacing and recording, left atrial pacing and recording from coronary sinus or left atrium, and His bundle recording, when performed. Treatment of supraventricular tachycardia by ablation of fast or slow atrioventricular pathway, accessory atrioventricular connection, cavo-tricuspid isthmus or other single atrial focus or source of atrial re-entry) (previous work RVU of 14.75 with 000-day global) is now bundled with the add-on CPT codes 93613 (Intracardiac electrophysiologic 3-dimensional mapping (List separately in addition to code for primary procedure))(work RVU of 5.23 with 90 minutes of intraservice time) and the add-on CPT code 93621 (Comprehensive electrophysiologic evaluation including insertion and repositioning of multiple electrode catheters with induction or attempted induction of arrhythmia. With left atrial pacing and recording from coronary sinus or left atrium (List separately in addition to code for primary procedure))(work RVU of 2.10 with 30 minutes of intraservice time).

The RUC-recommended work RVU for CPT code 93653 is 18.49, with 40 minutes of preservice evaluation, 3 minutes of preservice positioning, 15 minutes of preservice scrub/dress/wait time, 125 minutes of intraservice time and 30 minutes of immediate postservice time. Since the two add-on codes are combined with the primary CPT code 93653, one would expect the intraservice time to have increased or remained similar to the current 180 minutes. Instead, the RUC-recommended intraservice time has decreased to 125 minutes. Accounting for changes in technologies and clinical practices from over 10 years since this code family's last review, we would expect better efficiencies and reductions in work times, but with the addition of two add-on codes whose work is mostly, if not all, added to the intraservice time, one would not expect a net decrease in minutes. This is not what the collected responses from this survey show and it is a concern.

Some of CPT code 93653 add-on service times may have shifted over to the increases in preservice times, but there does appear to be a collective misunderstanding in the survey's work RVUs and physician work time responses. In light of the RUC's intention to resurvey and re-review CPT code 93653 (and this family of codes) at the April 2021 RUC meeting, and to resolve any flaws from the initial survey, such as survey respondents probably not realizing that a new descriptor describing the inclusion of services is now bundled to the existing CPT code (and not a newly issued CPT code), we are proposing to maintain the current physician times and current work RVU of 14.75, until the AMA RUC returns with a more definitive and accurate valuation. For CPT code 93654 (Comprehensive electrophysiologic evaluation with insertion and repositioning of multiple electrode catheters, induction or attempted induction of an arrhythmia with right atrial pacing and recording, and catheter ablation of arrhythmogenic focus, including intracardiac electrophysiologic 3-dimensional mapping, right ventricular pacing and recording, left atrial pacing and recording from coronary sinus or left atrium, and His bundle recording, when performed. With treatment of ventricular tachycardia or focus of ventricular ectopy including left ventricular pacing and recording, when performed) (work RVU of 19.75), the RUC recommends 40 minutes of preservice evaluation, 3 minutes of preservice positioning, 20 minutes of preservice scrub/dress/wait time, 240 minutes of intraservice time and 33 minutes of immediate postservice time for a total of 336 minutes, an increase to the code's current 309 total minutes. Unlike CPT codes 93653 and 93656, CPT code 93654 already accounts for the work RVUs and physician times for 3-dimensional mapping of add-on CPT code 93613.

The RUC recommended maintaining the current work RVU Start Printed Page 39171value of 19.75. We are proposing the RUC-recommended updates to the physician times (net increase in total minutes) and to maintain the same work RVUs for CPT code 93654 for CY 2022. CPT code 93655 (Intracardiac catheter ablation of a discrete mechanism of arrhythmia which is distinct from the primary ablated mechanism, including repeat diagnostic maneuvers, to treat a spontaneous or induced arrhythmia (List separately in addition to code for primary procedure)) has a current work RVU of 7.50 with a physician intraservice time of 90 minutes. The RUC recommended a revised intraservice time of 60 minutes and 6.50 work RVUs. The primary change to CPT code 93655 is the reduction of the intraservice time of about 67 percent, which we use as a guide to determine a work RVU.

We compare add-on CPT code 22854 (Insertion of intervertebral biomechanical device(s) (e.g., synthetic cage, mesh) with integral anterior instrumentation for device anchoring (e.g., screws, flanges), when performed, to vertebral corpectomy(ies) (vertebral body resection, partial or complete) defect, in conjunction with interbody arthrodesis, each contiguous defect (List separately in addition to code for primary procedure)) also with 60 minutes of intraservice and total time and a work RVU of 5.50 to CPT code 93655 and we believe that this is a more accurate valuation than the RUC's work RVU crosswalk to CPT code 34709 (Placement of extension prosthesis(es) distal to the common iliac artery(ies) or proximal to the renal artery(ies) for endovascular repair of infrarenal abdominal aortic or iliac aneurysm, false aneurysm, dissection, penetrating ulcer, including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, and treatment zone angioplasty/stenting, when performed, per vessel treated (List separately in addition to code for primary procedure)) with a work RVU of 6.50 and an intraservice and total time of 60 minutes because the proportional reduction in physician time should also reflect a similar proportional reduction in work RVUs. We are proposing the RUC-recommended 60 minutes of intraservice and total time, but instead propose a work RVU of 5.50 for CPT code 93655. CPT code 93656 (Comprehensive electrophysiologic evaluation including transseptal catheterizations, insertion and repositioning of multiple electrode catheters with intracardiac catheter ablation of atrial fibrillation by pulmonary vein isolation, including intracardiac electrophysiologic 3-dimensional mapping, intracardiac echocardiography including imaging supervision and interpretation, induction or attempted induction of an arrhythmia including left or right atrial pacing/recording, right ventricular pacing/recording, and His bundle recording, when performed) is now bundled with the add-on CPT codes 93613 (Intracardiac electrophysiologic 3-dimensional mapping (List separately in addition to code for primary procedure)) (work RVU of 5.23 with 90 minutes of intraservice time) and the add-on CPT code 93662 (Intracardiac echocardiography during therapeutic/diagnostic intervention, including imaging supervision and interpretation (List separately in addition to code for primary procedure) (work RVU currently carrier-priced with 25 minutes of intraservice time) which previously were separately reported add-on services, similar to above CPT code 93653 and its add-on codes. The RUC-recommended work RVU for CPT code 93656 is 20.00, with 40 minutes of preservice evaluation, 3 minutes of preservice positioning, 20 minutes of preservice scrub/dress/wait time, 210 minutes of intraservice time and 33 minutes of immediate postservice time, for a total of 306 minutes. The current physician times for CPT code 93656 are 23 minutes of preservice evaluation, 1 minutes of preservice positioning, 5 minutes of preservice scrub/dress/wait time, 240 minutes of intraservice time, and 40 minutes of immediate postservice time, for a total of 309 minutes, which is a net difference of 3 minutes less in the total proposed minutes, and the RUC is recommending a work RVU of 20.00, which is 0.23 more work RVUs than the current work RVU of 19.77.

In light of the RUC's intention to resurvey and review CPT code 93653 (and this family of codes) with its new bundling at their April 2021 RUC meeting to resolve any flaws from the initial survey, where many of the survey respondents may not have realized that the code descriptors had been substantially revised and that they may not have read the updated code descriptors thoroughly enough to respond correctly, we believe CPT code 93656 is in the same situation with its new bundling thus, we are proposing the RUC-recommended updates to the physician times (a net decrease of 3 minutes in total time) and to maintain the current work RVU of 19.77. From the survey of CPT code 93657 (Additional linear or focal intracardiac catheter ablation of the left or right atrium for treatment of atrial fibrillation remaining after completion of pulmonary vein isolation (List separately in addition to code for primary procedure)), a value of 8.00 work RVUs was obtained at the 25th percentile for this add-on code. The RUC recommended a work RVU of 6.50, for the 60 minutes of intraservice and total physician time. The current work RVU is 7.50, for 90 minutes of intraservice and total physician time. We compare add-on CPT code 22854 (Insertion of intervertebral biomechanical device(s) (e.g., synthetic cage, mesh) with integral anterior instrumentation for device anchoring (e.g., screws, flanges), when performed, to vertebral corpectomy(ies) (vertebral body resection, partial or complete) defect, in conjunction with interbody arthrodesis, each contiguous defect (List separately in addition to code for primary procedure)) with 60 minutes of intraservice and total time and 5.50 work RVUs to CPT code 93657 and we believe that this is a more accurate valuation, since the primary change to CPT code 93657 is the reduction of the intraservice time of about 67 percent, which we use as a guide to determining a work RVU.

The RUC-recommended work RVU is crosswalked from CPT code 34709 (Placement of extension prosthesis(es) distal to the common iliac artery(ies) or proximal to the renal artery(ies) for endovascular repair of infrarenal abdominal aortic or iliac aneurysm, false aneurysm, dissection, penetrating ulcer, including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, and treatment zone angioplasty/stenting, when performed, per vessel treated (List separately in addition to code for primary procedure)) with a work RVU of 6.50 and an intraservice and total time of 60 minutes, does not reflect the proportional reductions to the intraservice time and work. For CPT code 93657, we are proposing the RUC-recommended 60 minutes of intraservice and total time, and a work RVU of 5.50, crosswalked from CPT code 22854. There are no direct PE inputs for these facility-only CPT codes. (34) 3D Imaging of Cardiac Structures (CPT Codes 933X0) In May 2020, the CPT Editorial Panel created one new add-on code to describe the 3D echocardiographic imaging and postprocessing during transesophageal or transthoracic echocardiography for congenital cardiac anomalies for the assessment of cardiac Start Printed Page 39172structure(s). The 3D imaging could be performed as a follow-up to a 2D transthoracic echocardiogram.

We are proposing the RUC-recommended work RVU of 0.50 for CPT code 93XX0 (3D echocardiographic imaging and postprocessing during transesophageal echocardiography, or during transthoracic echocardiography for congenital cardiac anomalies, for the assessment of cardiac structure(s) (eg, cardiac chambers and valves, left atrial appendage, interatrial septum, interventricular septum) and function, when performed (List separately in addition to code for echocardiographic imaging). While we are proposing no refinements to the direct PE inputs, we are requesting additional information about the 3D echocardiography probe equipment item. The RUC recommended that a 3D probe was required in addition to the base echocardiography machine. We received an invoice for $31,754.30 for this equipment item. It was unclear if the invoice reflected both the 3D probe and the base echocardiography machine or only the probe itself.

We are seeking additional information to know if this equipment item reflected both the 3D probe and the base echocardiography machine or only the probe. (35) Cardiac Catheterization for Congenital Defects (CPT Codes 93X1X, 93X2X, 93X3X, 93X4X, 93X5X, and 93X6X) In May 2020, the CPT Editorial Panel replaced a family of four cardiac catheterization codes with five new codes (CPT codes 93X1X-93X5X) to describe cardiac catheterization for congenital cardiac defect(s). The CPT Editorial Panel also replaced two cardiac output measurement codes with one new add-on code (CPT code 93X6X) to report cardiac output measurement(s), performed during cardiac catheterization for congenital cardiac defects. We are proposing the RUC-recommended work RVU for two of the codes in this family. We are proposing a work RVU of 3.99 for CPT code 93X1X (Right heart catheterization for congenital heart defect(s) including imaging guidance by the proceduralist to advance the catheter to the target zone.

Normal native connections) and a work RVU of 6.10 for CPT code 93X2X (Right heart catheterization for congenital heart defect(s) including imaging guidance by the proceduralist to advance the catheter to the target zone. Abnormal native connections) as recommended by the RUC in both cases. For CPT code 93X3X (Left heart catheterization for congenital heart defect(s) including imaging guidance by the proceduralist to advance the catheter to the target zone, normal or abnormal native connections), we disagree with the RUC-recommended work RVU of 6.00 and we are instead proposing a work RVU of 5.50 based on a crosswalk to CPT code 32607 (Thoracoscopy. With diagnostic biopsy(ies) of lung infiate(s) (eg, wedge, incisional), unilateral). CPT code 32607 is a thorascopy procedure with three fewer minutes of intraservice work time (45 minutes) than CPT code 93X3X but a higher total work time of 178 minutes.

CPT code 93X3X has similar surveyed work time to CPT code 93X1X but the RUC recommended a work RVU of 3.99 for the first code in the family as compared to 6.00 for CPT code 93X3X. While we agree that CPT code 93X3X is a more intensive procedure, we do not agree that it should be valued more than two full RVUs higher as compared to the first code in the family. We believe that it would be more accurate to propose a work RVU of 5.50 based on the aforementioned crosswalk to CPT code 32607. We note that the intensity of CPT code 93X3X remains higher than the first two codes in the family at the proposed work RVU of 5.50. For CPT code 93X4X (Right and left heart catheterization for congenital heart defect(s) including imaging guidance by the proceduralist to advance the catheter to the target zone(s).

Normal native connections), we disagree with the RUC-recommended work RVU of 7.91 and we are instead proposing a work RVU of 6.84 based on a crosswalk to CPT code 32608 (Thoracoscopy. With diagnostic biopsy(ies) of lung nodule(s) or mass(es) (eg, wedge, incisional), unilateral). CPT code 32608 is another thorascopy procedure from the same family as CPT code 32607, with the same 60 minutes of intraservice work time as CPT code 93X4X and a higher total work time of 195 minutes. In the same fashion as the previous code, CPT code 93X4X has similar surveyed work time to CPT code 93X2X but the RUC recommended a work RVU of 6.10 for the second code in the family as compared to 7.91 for CPT code 93X4X. While we agree that CPT code 93X4X is a more intensive procedure, we do not agree that it should be valued almost two full RVUs higher as compared to the second code in the family.

We believe that it would be more accurate to propose a work RVU of 6.84 based on the aforementioned crosswalk to CPT code 32608. We note that the intensity of CPT code 93X4X remains the highest among the first four codes in the family at the proposed work RVU of 6.84. We believe that our proposed RVUs for CPT codes 93X3X and 93X4X better preserve relativity both within the family and also with other services on the PFS. For CPT code 93X5X (Right and left heart catheterization for congenital heart defect(s) including imaging guidance by the proceduralist to advance the catheter to the target zone(s). Abnormal native connections), we disagree with the RUC-recommended work RVU of 9.99 and we are instead proposing a work RVU of 8.88 based on the median work RVU from the survey.

The RUC's recommendation of a work RVU of 9.99, based on maintaining the prior work RVU of deleted CPT code 93532 (Combined right heart catheterization and transseptal left heart catheterization through intact septum with or without retrograde left heart catheterization, for congenital cardiac anomalies), was nearly equal to the 75th percentile work RVU from the survey at 10.00. Since the RUC recommended the survey median work RVU for the other four non-measurement codes in the family, we do not understand the recommendation of a value for CPT code 93X5X that sits within 0.01 RVUs of the survey 75th percentile. The survey for CPT code 93X5X also revealed that it typically requires far less work time to perform as compared with predecessor code 93532 (83 minutes of intraservice work time as compared to 175 minutes for the predecessor code). Although we agree that CPT code 93X5X is a more intensive procedure than its predecessor code, we do not believe that the work RVU should remain unchanged given the greatly reduced work time in the new procedure. Since the two components of work are time and intensity, we believe that decreases in time should typically be reflected in decreases to work RVUs.

We are therefore proposing a work RVU of 8.88 for CPT code 93X5X based on the survey median outcome. We believe that our proposed RVU more accurately accounts for these changes in surveyed work time and better preserves relativity with the rest of the family. For CPT code 93X6X (Cardiac output measurement(s), thermodilution or other indicator dilution method, performed during cardiac catheterization for the evaluation of congenital heart defects), we disagree with the RUC-recommended work RVU of 1.75 and we are instead proposing a work RVU of 1.44 based on a crosswalk Start Printed Page 39173to CPT code 37253 (Intravascular uasound (noncoronary vessel) during diagnostic evaluation and/or therapeutic intervention, including radiological supervision and interpretation. Each additional noncoronary vessel). CPT code 37253 is an intravascular uasound procedure that shares the same intraservice work time of 20 minutes as CPT code 93X6X and has 1 additional minute of immediate postservice time.

We note that the intensity of CPT code 93X6X as recommended by the RUC at a work RVU of 1.75 would be the second-highest in the family, higher than CPT code 93X5X for example. We do not agree that this cardiac output measurement code would typically be more intensive to perform than the two types of heart catheterization taking place in CPT code 93X5X. We also note that the recommended work RVU for CPT code 93X6X was higher than the sum of its two predecessor codes. Former CPT codes 93561 (Indicator dilution studies such as dye or thermodilution, including arterial and/or venous catheterization. With cardiac output measurement) and 93562 (Indicator dilution studies such as dye or thermodilution, including arterial and/or venous catheterization.

Subsequent measurement of cardiac output) had CY 2021 work RVUs of 0.95 and 0.77 respectively. These two codes sum together to a work RVU of 1.72 which would be lower than the RUC's recommendation of 1.75 for CPT code 93X6X. The RUC's recommendation suggests that there would be no efficiencies gained or savings created in the process of creating CPT code 93X6X. We believe that the survey for the new code indicates otherwise, as the predecessor codes had work times of 15 minutes and 12 minutes respectively (27 minutes total) as compared to 20 minutes of surveyed work time for the new code. This lower work time suggests that the creation of CPT code 93X6X has led to greater efficiencies in the service which, under the resource-based nature of the RVU system, lends further support for a reduction in the work RVU as compared to a sum of the predecessor codes.

We therefore believe that it would be more accurate to propose a work RVU of 1.44 based on the aforementioned crosswalk to CPT code 37253. The RUC did not recommend any direct PE inputs for these six codes and we are not proposing any direct PE inputs. (36) Outpatient Pulmonary Rehabilitation Services (CPT Codes 946X1 and 946X2) CPT code 946X1 (Physician or other qualified health care professional services for outpatient pulmonary rehabilitation. Without continuous oximetry monitoring (per session)) and CPT code 946X2 (Physician or other qualified health care professional services for outpatient pulmonary rehabilitation. With continuous oximetry monitoring (per session) (Do not report 946X1, 946X2 in conjunction with 94760, 94761)) are two new codes created by the CPT Editorial Panel to take the place of the HCPCS G-code G0424 (Pulmonary rehabilitation, including exercise (includes monitoring), one hour, per session, up to two sessions per day) which was created in 2010.

The RUC recommended work RVUs for CPT codes 946X1 and 946X2 of 0.55 and 0.69 respectively. We disagree with the RUC-recommended work RVUs for both CPT code 946X1 and 946X2. Although the pulmonary rehab service as described by these new codes have not changed, the RUC recommendation included an increase in intraservice and total time for the services. As the survey time increased for the pulmonary rehabilitation codes, an increase in work value may be appropriate. Based on a comparison of intraservice time for the current code relative the recommended values, we are proposing a work RVU of 0.36 for CPT code 946X1 and a work RVU of 0.56 for CPT code 946X2, which is an increase to the work RVU from the HCPCS G-code G0424 that these two codes are replacing and reflects a commensurate increase in work relative to the increase in intraservice time.

For the direct PE inputs, we are proposing to refine the clinical labor time for the “Provide education/obtain consent” (CA011) activity from the RUC-recommended 15 minutes to 2 minutes for both CPT codes 946X1 and 946X2. The recommended materials for this code family state that the 15 minutes for the CA011 activity are used for education which is an integral component of pulmonary rehabilitation programs. There is education provided at each separate session following a curriculum outlined in the guideline and covers both educational topics concerning self-management and educational topics concerning advance care planning which is different at every session. We do not agree that it would be typical for CPT codes 946X1 and 946X2 to require an additional 13 minutes for education and consent given the patient is seen two to three times a week for pulmonary rehabilitation and the education can be covered during those sessions. We are refining the clinical labor time to 2 minutes for both CPT codes 946X1 and 946X2 to maintain relativity, particularly in light of the clinical similarities between these services.

The education would be done during the “Perform procedure/service—NOT directly related to physician work time” (CA021), as stated above, as the patient is seen two to three times a week for pulmonary rehabilitation. We are also proposing to refine the equipment time and lower the pulse oximeter w-printer (EQ211) and exercise equipment (treadmill, bike, stepper, UBE, pulleys, balance board) (EQ118) equipment times from 93 minutes to 80 minutes to match this change in clinical labor time for CPT codes 946X1 and 946X2. Additionally, we are proposing to revise the utilization that we would use to set rates for CPT code 946X2 to reflect our understanding that pulmonary rehabilitation is always done with pulse oximetry. Thus, we are proposing to update our analytic crosswalk to reflect our belief that 100 percent of the utilization for the pulmonary rehabilitation services currently billed using HCPCS code G0424 will now be billed using CPT code 946X2. We believe that it is unlikely that these services would typically be billed using CPT code 946X1 since it is our understanding that pulmonary rehabilitation is typically provided with pulse oximetry, and therefore, we expect little to no utilization for CPT code 946X1.

We are seeking comment from stakeholders on our understanding and proposal to revise the utilization as stated. (37) Remote Therapeutic Monitoring (CPT Codes 989X1, 989X2, 989X3, 989X4, and 989X5) Remote Therapeutic Monitoring (RTM) is a family of five codes created by the CPT Editorial Panel in October 2020 and valued by the RUC at its January 2021 meeting. The RTM family includes three PE-only codes and two codes that include professional work. In recent years, we have finalized seven codes in the Remote Physiological Monitoring (RPM) family that include services similar to the new RTM codes. (See the CY 2021 PFS final rule at 85 FR 84542 through 84546 for more information.) Based upon our analysis, the services and code structure of RTM resemble those of RPM.

For example, the RTM codes reflect similar staff and Start Printed Page 39174physician work, although the specific equipment used is different. While there are notable similarities between the two sets of code descriptors, there are two primary differences. One difference is that according to RUC documents, primary billers of RTM codes are projected to be nurses and physical therapists. Stakeholders have suggested that the new RTM coding was created to allow practitioners who cannot bill RPM codes to furnish and bill for services that look similar to those of RPM. RPM services are considered to be E/M services and physical therapists, for example, are practitioners who cannot bill E/M services.

The RTM codes, instead, are general medicine codes. In our review of the new codes, we identified an issue that disallows physical therapists and other practitioners, who are not physicians or NPPs, to bill the RTM codes. By modeling the new RTM codes on the RPM codes, “incident to” services became part of the three direct practice expense-only (PE-only) codes (that is, CPT codes 989X1, 989X2, and 989X3) as well as the two professional work codes (that is, CPT codes 989X4 and 989X5). As a result, the RTM codes as constructed currently cannot be billed by, for example, physical therapists. We describe “incident to” services in the CMS Medicare Benefit Policy Manual, Chapter 15, beginning at section 60 and note that only physicians and certain other practitioners are authorized to furnish and bill “incident to” services.

Incident to services are. An integral, although incidental, part of the physician's professional service (see § 60.1). Commonly rendered without charge or included in the physician's bill (see § 60.1A). Of a type that are commonly furnished in physician's offices or clinics (see § 60.1A). And Furnished by the physician or by auxiliary personnel under the physician's direct supervision (see § 60.1B).

Additionally, we designated the treatment management RPM codes (that is, CPT codes 99457 and 99458) as care management services (84 FR 62697 through 62698), which allow general supervision rather than direct supervision for incident to services. The treatment management RTM codes (CPT codes 989X4 and 989X5), because they are not E/M codes, cannot be designated as care management services. As a result, we are seeking comment on how we might remedy the issues related to the RTM code construction in order to permit practitioners who are not physicians or NPPs to bill the RTM codes. The second primary difference between the RTM and RPM codes is the nature of the data to be collected and how it is collected. According to the code descriptors, RTM codes monitor health conditions, including musculoskeletal system status, respiratory system status, therapy (medication) adherence, and therapy (medication) response, and as such, allow non-physiologic data to be collected.

Reportedly, data also can be self-reported as well as digitally uploaded. RPM requires that data be physiologic and be digitally uploaded. We note that, for both sets of codes, the device used must meet the FDA definition of a medical device as described in section 201(h) of the Federal Food, Drug and Cosmetic Act (FFDCA). We are seeking comment on the typical type of device(s) and associated costs of the device(s) that might be used to collect the various kinds of data included in the code descriptors (for example, respiratory system status, musculoskeletal status, medication adherence, pain) for the RTM services. For CY 2022, we are proposing the RUC-recommended work RVU of 0.62 for CPT code 989X4 (Remote therapeutic monitoring treatment management services, physician/other qualified health care professional time in a calendar month requiring at least one interactive communication with the patient/caregiver during the calendar month.

First 20 minutes) and the RUC-recommended work RVU of 0.61 for its add-on code, CPT code 989X5 (Remote therapeutic monitoring treatment management services, physician/other qualified health care professional time in a calendar month requiring at least one interactive communication with the patient/caregiver during the calendar month. Each additional 20 minutes (List separately in addition to code for primary procedure)) as a means of maintaining parity with the two RPM treatment management codes (CPT codes 99457 and 99458) upon which the two RTM codes are based. We also are proposing the RUC-recommended direct PE inputs for the two treatment management codes, CPT codes 989X4 and 989X5, without refinement. We are proposing to refine the direct PE inputs for the three PE-only codes. CPT code 989X1 (Remote therapeutic monitoring (e.g., respiratory system status, musculoskeletal system status, therapy adherence, therapy response).

Initial set-up and patient education on use of equipment), CPT code 989X2 (Remote therapeutic monitoring (e.g., respiratory system status, musculoskeletal system status, therapy adherence, therapy response). Device(s) supply with scheduled (e.g., daily) recording(s) and/or programmed alert(s) transmission to monitor respiratory system, each 30 days), and CPT code 989X3 (Remote therapeutic monitoring (e.g., respiratory system status, musculoskeletal system status, therapy adherence, therapy response). Device(s) supply with scheduled (e.g., daily) recording(s) and/or programmed alert(s) transmission to monitor musculoskeletal system, each 30 days). We are proposing to value the PE for CPT code 989X1 by crosswalking to the PE RVU for RPM code 99453 upon which the new RTM code was based. We also are proposing to value the PE for CPT codes 989X2 and 989X3 by crosswalking to the PE RVU for comparable RPM code 99454, a code that includes payment for the medical device used to collect and transmit data.

We note that the only input to CPT code 989X2 is a monthly fee of $25, which would not be paid as a direct cost under the PFS. Historically, we have considered most computer software and associated licensing fees to be indirect costs. However, as we noted in section II.B. Of this proposed rule (the PE section), stakeholders have routinely expressed concerns with this policy, especially for evolving technologies that rely primarily on software and licensing fees with minimal costs in equipment or hardware. (38) Principal Care Management and Chronic Care Management (CPT Codes 99490, 99439, 99491, 99X21, 99487, 99489, 99X22, 99X23, 99X24, and 99X25) In recent years, we have engaged in efforts to update and improve the relative value of care management and coordination services within the PFS by identifying gaps in payment and coding.

One of those PFS services is Chronic Care Management (CCM). CCM services, which include management and support services provided by clinical staff under the supervision of a physician or NPP or services provided personally by a physician or NPP, have received ongoing refinements related to payment and coding since CY 2013. Beginning in the CY 2014 PFS final rule (78 FR 74414 through 74427), we noted that physicians and NPPs who furnish care to patients with multiple chronic conditions require greater resources than are required to support patient care in a typical E/M service. In response, we finalized a separately payable HCPCS code, GXXX1 (Chronic Care Management (CCM) services Start Printed Page 39175furnished to patients with multiple (2 or more) chronic condition expected to last at least 12 months, or until the death of the patient. 20 minutes or more per in 30 days of chronic care management services provided by clinical staff and directed by a physician or other qualified health care practitioner).

For CY 2015 (79 FR 67715 through 67730), we refined aspects of the existing CCM policies and adopted separate payment for CCM services under CPT code 99490 (Chronic care management services (CCM), at least 20 minutes of clinical staff time directed by a physician or other qualified health professional, per calendar month, with the following required elements. Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient. Chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. Comprehensive care plan established, implemented, revised, or monitored). For CY 2017 (81 FR 80244), we adopted CPT codes 99487 (Complex chronic care management (CCCM) services with the following required elements.

Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, comprehensive care plan established, implemented, revised, or monitored, moderate or high complexity medical decision making. First 60 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month) and 99489 (Complex chronic care management (CCCM) services with the following required elements. Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, comprehensive care plan established, implemented, revised, or monitored, moderate or high complexity medical decision making. Each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure)). Then, in the CY 2019 PFS final rule (83 FR 59577), we adopted a new CPT code, 99491 (Chronic care management services, provided personally by a physician or other qualified health care professional, at least 30 minutes of physician or other qualified health care professional time, per calendar month, with the following required elements.

Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient. Chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. Comprehensive care plan established, implemented, revised, or monitored), to describe at least 30 minutes of CCM services performed personally by a physician or NPP. In the CY 2020 PFS final rule (84 FR 62690), we established payment for an add-on code to CPT code 99490 by creating HCPCS code G2058 (Chronic care management services, each additional 20 minutes of clinical staff time directed by a physician or other qualified healthcare professional, per calendar month). We also created two new HCPCS G codes, G2064 and G2065 (84 FR 62692 through 62694), representing comprehensive services for a single high-risk disease (that is, principal care management).

In the CY 2021 PFS final rule (85 FR 84639), we finalized a RUC-recommended replacement code for HCPCS code G2058, CPT code 99439, which was given the same valuation and the identical descriptor as G2058. For CY 2022, the RUC resurveyed the CCM code family, including Complex Chronic Care Management (CCCM) and Principal Care Management (PCM), and added five new CPT codes. 99X21 (Chronic care management services each additional 30 minutes by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure)), 99X22 (Principal care management services for a single high-risk disease first 30 minutes provided personally by a physician or other qualified health care professional, per calendar month), 99X23 (Principal care management services for a single high-risk disease each additional 30 minutes provided personally by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure), 99X24 (Principal care management services, for a single high-risk disease first 30 minutes of clinical staff time directed by physician or other qualified health care professional, per calendar month), and 99X25 (Principal care management services, for a single high-risk disease each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure)). The CCM/CCCM/PCM code family now includes five sets of codes, each set with a base code and an add-on code. The sets vary by the degree of complexity of care (that is, CCM, CCCM, or PCM), who furnishes the care (that is, clinical staff or the physician or NPP), and the time allocated for the services.

The RUC-recommended values for work RVUs and direct PE inputs for CY 2022 derive from the recent RUC specialty society survey (see Table 12). We reviewed the RUC-recommended values for the 10 codes in the CCM family and are proposing to accept the recommended work values for the codes. We are proposing the RUC-recommended direct PE inputs without refinements. We believe that proposing to accept these updated values is consistent with our goals of ensuring continued and consistent access to these crucial care management services and acknowledges our longstanding concern about undervaluation of care management under the PFS. We are seeking comment, however, on whether keeping professional PCM and CCM at the same value creates an incentive to bill CCM instead of billing PCM when appropriate.

In addition to the proposals on the values for CCM codes, we are interested in understanding more about the standard practice used by practitioners to obtain beneficiary consent for these services. We have received questions from stakeholders regarding the consent requirements for CCM services. We believe that these questions have arisen because of the many flexibilities allowed in response to the PHE for anti inflammatory drugs. In particular, during the PHE for anti inflammatory drugs, we allowed stakeholders to obtain beneficiary consent for certain services under general supervision (85 FR 19230, April 6, 2020). Before the PHE for anti inflammatory drugs, we required that beneficiary consent be obtained either by or under the direct supervision of the primary care practitioner.

This requirement is consistent with the conditions of payment for this service under the PFS. As we consider what policies implemented during the PHE for anti inflammatory drugs should remain in effect beyond the PHE, we are interested in understanding how billing practitioners furnishing CCM at different service sites (for example, physician office settings, RHCs, FQHCs) have been obtaining beneficiary consent over the past year and how different levels of supervision impact this activity. We welcome public comment on the issue, specifically on what levels of supervision are necessary to obtain beneficiary consent when furnishing CCM services and will Start Printed Page 39176consider such comments in future rulemaking. We also are proposing to adopt CPT codes 99X22 (PCM First 30 minutes provided personally by a physician or other qualified health care professional, per calendar month) and 99X24 (PCM First 30 minutes of clinical staff time directed by physician or other qualified health care professional, per calendar month) to replace HCPCS codes G2064 and G2065 in the calculation of the rate for HCPCS code G0511 for General Care Management services billed by RHCs and FQHCs. The payment rate for HCPCS code G0511 is calculated based on the average of the national non-facility PFS payment rate for care management and general behavioral health integration codes (CPT codes 99484, 99487, 99490, and 99491) as well as HCPCS codes G2064 and G2065 which describe PCM services billed under the PFS.

The payment rate for HCPCS code G0511 is updated annually based on the PFS amounts for these codes. (39) Moderate Sedation (HCPCS Code G0500) Following the publication of the CY 2021 PFS final rule, a stakeholder contacted us regarding what they believed to be an error in the intraservice work time for HCPCS code G0500 (Moderate sedation services provided by the same physician or other qualified health care professional performing a gastrointestinal endoscopic service that sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient's level of consciousness and physiological status. Initial 15 minutes of intra-service time. Patient age 5 years or older (additional time may be reported with 99153, as appropriate)). We established HCPCS code G0500 in CY 2017 to more accurately capture the work of administering moderate sedation for gastrointestinal endoscopic procedures for patients 5 years of age or older.

We based the physician work and time for HCPCS code G0500 on data from the 100 gastroenterologists who completed the survey of CPT code 99152 (Moderate sedation services provided by the same physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient's level of consciousness and physiological status. Initial 15 minutes of intraservice time, patient age 5 years or older) presented at the October 2015 RUC meeting. The survey data for CPT code 99152 showed a significant bimodal distribution with data from gastroenterologists performing endoscopic procedures demonstrating a markedly different and lesser amount of physician work for moderate sedation compared to other specialties. The stakeholder stated that the finalization of 12 minutes of intraservice work time for HCPCS G0500 appeared to be an error and asked CMS to correct it to reflect the 5 minutes of intraservice work time indicated by survey data when gastroenterologists performed endoscopic procedures. While we appreciate the feedback from the stakeholder, we disagree that the finalization of 12 minutes of intraservice work time for HCPCS code G0500 (matching CPT code 99152) was an error.

The work time for HCPCS code G0500 was proposed and finalized at 12 minutes in CY 2017, with the intention that it would match the work time for CPT code 99152. This was the rationale behind the descriptor for HCPCS code G0500 listing that the code was intended for the initial 15 minutes of intraservice time. Furthermore, several commenters questioned the work time for HCPCS code G0500 in the CY 2017 PFS final rule (81 FR 80341) and we stated in response that we expected that practitioners would report the appropriate CPT or HCPCS code that most accurately described the services performed during a patient encounter, including those services performed concurrently and in support of a procedural service consistent with CPT guidance. We noted that the commenters referred to the time for moderate sedation in the survey data, while the time thresholds for the moderate sedation codes were intended to match the intraservice time of the procedure itself. For a full discussion of this topic, we refer readers to the CY Start Printed Page 391772017 PFS final rule (81 FR 80339 through 80349).

Although we are not proposing a change in the work time for HCPCS code G0500, we are soliciting comments on this issue in the interest of gaining additional information about the typical use of this procedure. (40) Payment for Synthetic Skin Substitutes (HCPCS Codes GXXAB, GXXAC, GXXAD, GXXAE, GXXAF, GXXAG, GXXAH, and GXXAI) On July 1, 2020, Medicare implemented HCPCS code C1849 (Skin substitute, synthetic, resorbable, per square centimeter) and made it payable under the OPPS. In the CY 2021 OPPS final rule (85 FR 86064 through 86067) Medicare finalized payment for C1849—and the associated synthetic skin substitute products—allowing it to be billed with graft skin substitute procedure CPT codes 15271 through 15278. We note that under the OPPS, payment for C1849 is packaged into the payment for the graft skin substitute procedure, and its costs are reflected in the development of the payment rates for those services. The creation of the C-code and the CY 2021 OPPS rulemaking addressed the need for a mechanism to pay for graft skin substitute application services performed with synthetic graft substitute products in the outpatient hospital setting, which is comparable to how Medicare pays for graft skin substitute application services performed with graft skin substitutes that are regulated by the Food and Drug Administration (FDA) under its regulatory framework at section 361 of the Public Health Service (PHS) Act for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

We want to clarify that the availability of a HCPCS code for a particular HCT/P does not mean that the product is appropriately regulated solely under section 361 of the PHS Act and the FDA regulations in 21 CFR part 1271. Manufacturers of HCT/Ps should consult with the FDA Tissue Reference Group (TRG) or obtain a determination through a Request for Designation (RFD) on whether their HCT/Ps are appropriately regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271 (85 FR 86058). We note that in a response to the CY 2021 OPPS proposal, a commenter noted that the use of a C-code meant that synthetic graft skin substitute products would only be payable under the OPPS, and would not be able to be reported for graft skin substitute services using a synthetic product in the physician office setting (85 FR 86066). Currently, graft skin substitute application services are paid separately from the (HCT/Ps) skin substitutes under the PFS. Specifically, when a physician or NPP furnishes a surgical service to apply a (HCT/Ps) skin substitute in a non-facility setting, they may bill Medicare for the surgical service (as described by CPT codes 15271 through 15278), and separately bill for the (HCT/Ps) skin substitute.

For CY 2022, in order to reconcile the gap in payment for synthetic products in the physician office setting, we are proposing to create eight HCPCS codes (parallel to the aforementioned existing surgical codes) that would include the synthetic graft skin substitute product as a supply cost in determining the PFS rate. We believe that it would be appropriate to consider these products as incident to supplies in the office setting, and as such they should be built in as a supply cost in calculating the PFS rate. Therefore, we are proposing to consider these products as incident to supplies in the office setting. The codes and long descriptors for the proposed synthetic graft skin substitute services are. HCPCS Code GXXAB.

Application of synthetic skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm, including provision of synthetic skin substitute. First 25 sq cm or less wound surface area. HCPCS Code GXXAC. Application of synthetic skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm, including provision of synthetic skin substitute. Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure).

HCPCS Code GXXAD. Application of synthetic skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm, including provision of synthetic skin substitute. First 100 sq cm wound surface area, or 1% of body area of infants and children. HCPCS Code GXXAE. Application of synthetic skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm, including provision of synthetic skin substitute.

Each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure). HCPCS Code GXXAF. Application of synthetic skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm, including provision of synthetic skin substitute. First 25 sq cm or less wound surface area. HCPCS Code GXXAG.

Application of synthetic skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm, including provision of synthetic skin substitute. Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure). HCPCS Code GXXAH. Application of synthetic skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm, including provision of synthetic skin substitute. First 100 sq cm wound surface area, or 1% of body area of infants and children.

HCPCS Code GXXAI. Application of synthetic skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm, including provision of synthetic skin substitute. Each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure). We are proposing contractor pricing for these codes for CY 2022. We note that there is limited data available on the cost of synthetic skin substitute products in physician offices, so we are also seeking comment and documentation regarding the appropriate values for these services for consideration of national pricing in future rulemaking.

Though we are proposing contractor pricing in the interim, we also considered an alternative approach that would use crosswalks to value these services in the physician office setting in a way that is commensurate with the rates paid under the OPPS. Though limited data exists on the cost of graft synthetic skin substitute products in physician offices, hospitals began reporting costs associated with synthetic skin substitute products in CY 2020 after C1849 became effective and payable under the OPPS starting in July, 2020. We analyzed CY 2020 OPPS claims data and estimate hospital outpatient department costs for graft synthetic skin substitute products averaged $1,500. We note that under the OPPS, outpatient departments are paid separately for the primary surgical application codes (CPT codes 15271, 15273, 15275, 15277), and the costs associated with the synthetic products Start Printed Page 39178as well as the add-on services (described by CPT codes 15272, 15274, 15276, 15278) are packaged into the payment for the primary procedure. Under this alternative, we considered following an approach similar to that under the OPPS where the cost of the supply would be included in the primary codes (described by HCPCS GXXAB, GXXAD, GXXAF, and GXXAH) and not the add-on codes (described by HCPCS GXXAC, GXXAE, GXXAG, and GXXAI), though the add-on would continue to be reported and paid separately.

Specifically, we would use direct crosswalks for the work RVUs, MP RVUs, and facility PE RVUs from the current surgical application codes (that is, CPT codes 15271 through 15278) as we believe that these payment components for the synthetic graft skin substitute services, described by the aforementioned HCPCS codes, would be similar. However, with regards to the non-facility PE RVUs, we recognize that there are significant supply costs associated with synthetic skin substitute products. As described previously, we estimate that hospitals face average costs associated with synthetic skin substitute products of $1,500. We note that the PE methodology, which relies on the allocation of indirect costs based on the magnitude of direct costs, may not be appropriate for these types of services because the specialists that typically furnish these types of services do not typically have significant supply costs within the methodology. As such, we used the hospital reported costs and we looked to other codes where specialists frequently have similarly high supply costs in order to crosswalk the non-facility PE RVUs.

We considered services that have a significant proportion of supply costs and are furnished by specialists who typically have higher supply costs as potential crosswalks for the non-facility PE RVUs. For example, we considered a crosswalk to CPT code 21461 (Open treatment of mandibular fracture. Without interdental fixation) for HCPCS codes GXXAB and GXXAF, and a crosswalk to CPT code 21462 (Open treatment of mandibular fracture. With interdental fixation) for HCPCS codes GXXAD and GXXAH. As an estimate of non-facility PE, we believe these would be appropriate codes for crosswalking non-facility PE RVUs.

As previously discussed, for the purposes of the work RVUs, MP RVUs, and facility PE RVUs, we believe direct crosswalks to the current surgical application codes would be appropriate as those values would generally not be impacted by the addition of a synthetic skin substitute product. We realize this alternative considered would follow a similar coding and payment approach established under the OPPS, and that potential adoption of this alternative would mean that the cost of the products is included in the primary codes and not included in the add-on codes. We welcome feedback on our proposal to treat synthetic skin substitute products as incident to supplies in the physician office, the proposal to have contractor pricing for these codes, and other ways we could obtain detailed and reliable cost information on synthetic skin substitutes that are furnished in the non-facility setting. We are also seeking comment on the alternative approach that we considered (using crosswalks to value these services in the physician office setting). Additionally, we are seeking comment on potential ways to reconcile these coding and payment differences across settings to yield a more consistent and rational payment approach for synthetic and HCT/P graft skin substitutes.

(41) External Extended ECG Monitoring (CPT Codes 93241, 93242, 93243, 93244, 93245, 93246, 93247, and 93248) In the CY 2021 PFS proposed rule (85 FR 50164), we proposed to adopt the RUC recommendations for CPT codes 93241 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage. Includes recording, scanning analysis with report, review and interpretation), 93242 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage. Recording (includes connection and initial recording)), 93243 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage. Scanning analysis with report), 93244 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage. Review and interpretation), 93245 (External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage.

Includes recording, scanning analysis with report, review and interpretation), 93246 (External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage. Recording (includes connection and initial recording)), 93247 (External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage. Scanning analysis with report), and 93248 (External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage. Review and interpretation). We noted that the recommendations for this family of codes contain one new supply item, the “extended external ECG patch, medical magnetic tape recorder” (SD339).

We did not receive a traditional invoice to establish a price for this supply item. Instead we received pricing information from two sources. A weighted median of claims data with the cost of the other direct PE inputs removed, and a top-down approach calculating the cost of the supply per service based on summing the total costs of the health care provider and dividing by the total number of tests furnished. The former methodology yielded a supply price of approximately $440 while the latter methodology produced an estimated supply price of $416.85. Stakeholders also submitted a series of invoices from the clinical study marketplace with a price of $595, which we rejected as we typically require an invoice representative of commercial market pricing to establish a national price for a new supply or equipment item.

After consideration of the information, we proposed to employ a crosswalk to an existing supply for use as a proxy price until we received pricing information to use for the “extended external ECG patch, medical magnetic tape recorder” item. We proposed to use the “kit, percutaneous neuro test stimulation” (SA022) supply as our proxy item at a price of $413.24. We believed the kit to be the closest match from a pricing perspective to employ as a proxy until we would be able to arrive at an invoice that is representative of commercial market pricing. We welcomed the submission of invoices or other additional information for use in pricing the “extended external ECG patch, medical magnetic tape recorder” supply. In response to our proposal, we received conflicting information from commenters and in the CY 2021 PFS final rule (85 FR 84631), we ultimately finalized contractor pricing for CY 2021 for the four codes that include this supply input (CPT codes 93241, 93243, 93245, and 93247) to allow additional time to receive more pricing information.

We note that stakeholders have continued to engage with CMS and the MACs on payment for this service. We remain concerned that we continue to hear that the supply costs as initially considered in our CY 2021 PFS proposal are much higher than they should be. At the same time we also have heard that Start Printed Page 39179the resource costs, as reflected in the contractor based payments do not adequately cover the incurred cost for the SD339 supply that is used to furnish these services. In consideration of continued access to these services for Medicare beneficiaries, we are once again seeking public comment and information to support CMS' future rulemaking to establish a uniform national payment that appropriately reflects the PE that are used to furnish these services. As previously stated, invoices or other additional information, including for example, which proxy supply items could be used to establish cost for the SD339 supply, information on use/application and potential alternatives (as appropriate) to the supply items, would be ideal for us to use in establishing fair and stable pricing for these services.

We note that in the absence of such additional and actionable information (that is, information that provides further context to information that has already been considered) we are proposing to maintain contractor pricing for these services. (42) Comment Solicitation for Impact of Infectious Disease on Codes and Ratesetting During the PHE for anti inflammatory drugs, several stakeholders have contacted CMS with concerns about the additional costs borne by physician and NPPs due to the symbicort that may impact the professional services furnished to Medicare beneficiaries. For example, we have heard from stakeholders about higher costs due to additional supplies, such as personal protective equipment, and increased time that physicians, NPPs and their clinical staff may spend with patients to mitigate further spread of when, for example, stakeholders are working to rule out a anti inflammatory drugs , or furnishing other services to a patient with a confirmed anti inflammatory drugs . While costs such as these may diffuse into Medicare payment rates over a period of time, our payment systems, including the PFS, are not generally designed to accommodate more acute increases in resource costs, even if they are widespread. We acknowledge the circumstances stakeholders have identified that may lead to additional costs borne by physicians and NPPs during the PHE, and we have developed and implemented policies, as appropriate and where possible, to maintain beneficiary access to necessary services during the PHE.

CMS is continuing to think broadly about the concerns raised, and specifically about the types of resource costs that may not be fully reflected in payment rates for existing services, or costs that could be accounted for by establishing new payment rates for new services. We are interested in feedback from stakeholders about additional strategies to account for PHE-related costs, including feedback on the specific types of services and costs that may benefit from further review, such as infectious disease control measures, research-related activities and services, or PHE-related preventive or therapeutic counseling services. We are interested in detailed feedback from stakeholders to help inform whether we should consider making changes to payments for services or develop separate payments for such services in future rulemaking. (43) Comment Solicitation on Separate PFS Coding and Payment for Chronic Pain Management Adequate treatment of pain is a significant public health challenge. Centers for Disease Control and Prevention (CDC) data indicate 50 million adults in the United States have chronic daily pain, with nearly 20 million experiencing high impact pain that interferes with daily life or work.

Pain is the most common reason individuals seek medical care, and more than 20 percent of office visits are associated with pain.[] In the United States, 42.6 percent of adults report having pain on some days in the past 6 months,[] and chronic pain and high-impact chronic pain are experienced by 20.4 percent and 8 percent of adults, respectively.[] The high prevalence of pain exacts a substantial economic toll. Medical expenditures and lost productivity related to pain result in a cost to the United States estimated at up to $635 billion.[] In 2010, HHS, through the National Institutes of Health (NIH), contracted with the Institute of Medicine to make recommendations “to increase the recognition of pain as a significant public health problem in the United States.” In its 2011 report entitled Relieving Pain in America. A Blueprint for Transforming Prevention, Care, Education, and Research, the Institute of Medicine, through a study mandated by Congress, recommended significant improvements in pain prevention, care, education, and research and development of a population health-level strategy to address pain care.[] The report described that the unique experience of pain requires a combination of person-centered therapies and coping techniques influenced by genes, cultural attitudes, stress, depression, ability to understand health information, and other behavioral, cultural, and emotional factors. It noted that individualized care can require adequate extra time to counsel patients and caregivers, promote self-management, and consult with other providers, but current reimbursement systems are not designed to efficiently pay for this approach. HHS subsequently convened an expert committee to oversee creation of the National Pain Strategy (NPS), issued in 2016.[] The NPS addressed six key areas of care.

Population research, prevention and care, disparities, service delivery and payment, professional education and training, and public education/communication. In this report, NPS' vision is to “decrease the prevalence of pain across its continuum from acute to high-impact chronic pain and its associated morbidity and disability across the lifespan,” and aim “to reduce the burden of pain for individuals, their families, and society as a whole.” This work was followed by HHS's 2019 release of its Pain Management Best Practices Inter-Agency Task Force Report. Updates, Gaps, Inconsistencies, and Recommendations (PMTF Report).[] The PMTF Report focuses on the development of patient-centered pain treatment plans to establish diagnosis and set measurable outcomes such as improvements in quality of life, function, and activities of daily living. It emphasized multi-modal, multi-disciplinary approaches that include various modalities for acute and chronic pain. The PMTF Report also identified five broad treatment categories.

Medications including opioids and non-opioids, restorative therapies, interventional approaches, behavioral approaches, and complementary and integrative health. It stressed the importance of special populations including older adults and persons with Start Printed Page 39180relapsing conditions, Veterans, and people who receive palliative care. The PMTF Report recognized the importance of proper opioid stewardship for individuals who need opioids to effectively manage their pain. As the Task Force noted, there are ongoing concerns regarding suicide and suicidal ideation due to pain, and a lack of access to pain treatment, including appropriate access to opioid medications. The PMTF Report noted that management of pain conditions often requires multidisciplinary coordination among health care professionals, and that the experience of pain can intensify other health issues such as delayed recovery from surgery, or exacerbate behavioral health conditions.

Many health care professionals, including primary care providers, have opted out entirely in treating pain, worsening an existing shortage of pain specialists and making chronic pain care hard to access, including for people who frequently experience disparities in pain care such as rural dwellers, racial/ethnic minorities, and people with disabilities. The anti inflammatory drugs Public Health Emergency has also had an impact on the ability of many older adults and people with disabilities' access to care, although telehealth modalities have shown promise in broadening access to services and supports. At the same time individuals are experiencing difficulties finding pain care, the country is also coping with a worsening opioid and SUD crisis. The current environment involves shifting “waves” of overdose deaths associated with heroin, synthetic opioids, and prescription drugs, and intensifying stimulant and polysubstance use. Preliminary Centers for Disease Control and Prevention data released in April 2021 show a 29 percent rise in overdose deaths from October 2019 through September 2020—the most recent data available—compared with the previous 12-month period.[] Illicitly manufactured fentanyl and other synthetic opioids were the primary drivers, although many fatal overdoses have also involved stimulant drugs, particularly methamphetamine.

In December 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a preliminary report from its Drug Abuse Warning Network, which captures data on emergency department (ED) visits related to recent substance use and misuse such as alcohol use, illicit drug use, suicide attempts, and nonmedical use of pharmaceuticals. Most commonly associated with ED visits in the participating hospitals are illicit substances and central nervous system agents. Among illicit drugs, stimulants (including methamphetamine and illicit amphetamine) are the most common, followed by cannabinoids (including marijuana and synthetic cannabinoids).[] The PMTF Report urged clinicians to use a comprehensive, individualized, person-centered approach to the diagnosis and treatment of pain featuring multiple therapeutic modalities. The uptake of this approach is an urgent concern as growing numbers of older adults are enrolling in Medicare. Some estimates indicate about half of older adults have pain that interferes with function.

Primary care clinicians and specialists are already facing challenges in treating pain and associated chronic disease in the Medicare population, where conditions such as arthritis, bone/joint disorders, back and neck pain, cancer and other conditions that inform and at times inhibit employing the full spectrum of pain management therapies are common. We believe untreated and inappropriately treated pain may translate to increased costs to the Medicare program as more beneficiaries experience functional decline, incapacitation, and frailty. Additional risks in untreated pain include individuals using illicit drugs such as cannabis. Inadequate treatment of mental disorders such as depression and anxiety, misuse of prescription drugs, alcohol and other drug use disorder, and increased suicide risk and suicide. In 2019 HHS issued the Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics (the Guide) to support the thoughtful, deliberative, and measured discontinuation of long-term opioid analgesics, and mitigate harm and risk to patients who are working with their clinicians to undergo appropriate tapering or discontinuation.[] The Guide notes that decisions to continue or reduce opioid medications for pain should be collaborative and based on the individual patient's goals and circumstances and clinicians should consider, for example, whether opioid medications continue to support patients meeting treatment goals.

If opioids are exposing the person to an increased risk for serious adverse events or an opioid use disorder. And whether benefits continue to outweigh risks of opioids. Whether or not opioids are used in treatment, safe and effective non-opioid treatments can be integrated into patients' pain management plans based on an individualized assessment of benefits and risks, and considering the patient's diagnosis, goals and circumstances.[] Unique needs and coordination across the health care team is critical and clinicians and care teams have a responsibility to provide, or arrange for, coordinated management of patients' pain including any medication-related issues. The system of care should not ultimately result in patient abandonment. The FDA issued a safety announcement in 2019, advising that health care professionals should not abruptly discontinue opioids in patients who are physically dependent and that patient-specific plans should be created to gradually taper off opioids, in part due to the risk of adverse events including abrupt withdrawal symptoms, increased pain, mood changes, mental health impact, psychosocial impact, and importantly, suicide risk.[] In 2020 the National Academy of Medicine, as part of its “Action Collaborative to Countering the U.S.

Opioid Epidemic,” began an effort to understand more about the state of chronic pain management, and to bring greater awareness to any intended and unintended consequences of opioid prescribing metrics as they pertain to the delivery, access, and coordination of chronic pain management and care. CMS is one of the sponsors of this work. The aim of this project is to visually illustrate the chronic pain management journey and accelerate the uptake of a range of pain treatments by outlining approaches to effective communication that leads to strong clinical relationships and optimal quality of life for people with pain.[] The SUPPORT Act (Pub. L. 115-271, October 24, 2018) outlines national strategies to help address America's opioid and substance use disorders (SUD) crisis, and advances policies to improve the treatment of pain and SUD.

The SUPPORT Act recognizes the importance of opioid-related medication management, as well as the overall need to identify SUD in the Medicare Start Printed Page 39181beneficiary population. Sections 2002 and 6086 of the SUPPORT Act are of particular importance regarding pain management. For beneficiaries with chronic pain, section 2002 of the SUPPORT Act amended sections 1861(ww) and (hhh)(2) of the Act to include a review of any current opioid prescriptions in conjunction with the initial preventive physical examination (the “Welcome to Medicare” visit) and annual wellness visit (AWV). The opioid prescription review is to include a review of the potential risk factors to the individual for opioid use disorder, an evaluation of the individual's pain severity and current treatment plan, the provision of information on non-opioid treatment options, and referral to a specialist, if appropriate. Section 2002 also amended sections 1861(ww) and (hhh)(2) of the Act to add a screening for potential SUDs to the Welcome to Medicare visit and the AWV, and to add referral to a specialist, as appropriate, to the AWV.

Section 6086 of the SUPPORT Act, the Dr. Todd Graham Pain Management Study, will provide HHS and CMS with key information about services delivered to Medicare beneficiaries with acute or chronic pain, help in understanding the current landscape of pain relief options for Medicare beneficiaries, and inform decisions around payment and coverage for pain management interventions, including those that minimize the risk of SUD. CMS has worked with the Agency for Healthcare Research and Quality, which has undertaken three topic briefs and two systematic reviews to inform Medicare coverage for the treatment of acute and chronic pain. CMS has also worked with HHS's Office of the Secretary for Planning and Evaluation to write a Report on the Study, which will be submitted to Congress. CMS will post a completed copy of the Report on our website.

The Report will address questions regarding coverage and payment for evidence-based interventions for acute and chronic pain in Medicare, barriers to access, costs and benefits of expanding or revising benefits not currently covered, and legislative and administrative options to improve pain interventions. We believe it is important to highlight the role of a person-centered approach to pain care. The National Quality Forum, which as its core work defines measures and health care practices as the best, evidence-based approaches to improving care, has defined person-centered planning as “a facilitated, individual-directed, positive approach to the planning and coordination of a person's services and supports based on individual aspirations, needs, preferences, and values,” and stated that the “goal of person-centered planning is to create a plan that would optimize the person's self-defined quality of life, choice, and control, and self-determination through meaningful exploration and discovery of unique preferences and needs and wants in areas including, but not limited to, health and well-being, relationships, safety, communication, residence, technology, community, resources, and assistance.” [] These general principles should also apply in the treatment of individuals with pain, where clinicians confirm and affirm the individual's recovery and/or maintenance goals, and focus on those, where treatment is a means to an end.[] For example, one goal might be to not rely on aiming to reduce a simple pain score, such as a numeric or visual score, but to evaluate function for example, through a tool such as the Defense and Veterans Pain Rating scale,[] which integrates functional status, and then aim to optimize physical function and mental function in the beneficiary with chronic pain. We recognize that there are no existing codes that specifically describe the work of the clinician involved in performing the tasks necessary to perform pain management care. We believe there are complexities in treating pain management patients that could include lifestyle discussion, ongoing medication management (such as opioid tapering or discontinuation, when appropriate), behavioral health care, preparation and updating of a care plan, consideration of federal and other opioid prescribing limits and guidelines, Prescription Drug Monitoring Program checks, electronic prescribing requirements, special licensing requirements (controlled substance licenses.

Buprenorphine “X-waivers”), interdisciplinary interactions, prescription drug coverage, CMS high-prescriber oversight, consideration of out-of-pocket costs, and other issues. As one example, decreasing or discontinuing opioid treatment requires careful, person-centered consideration of all of these aspects of providing care. These unique challenges often adversely impact the delivery of care, and subsequent access to care, for beneficiaries with chronic pain. Current Medicare payment methodologies such as Chronic Care Management (CCM) support chronic disease management, though may not provide adequate payment to health care providers or systems to holistically care for beneficiaries with chronic pain. We believe the complexity and resources required for safe and effective pain management may not be adequately captured and paid through these codes.

We believe that creating separate or add-on payment for care and management for people with pain might provide opportunities to better leverage services furnished using telecommunications technology and non face-to-face care while expanding access to treatment for pain. Such an additional payment could potentially be effective in preventing or reducing the need for acute services such as fall avoidance, and reduce the need for treatment for mental disorders such as depression, anxiety, and sleep disorders which may occur in some individuals with pain. There is also reason to believe that addressing chronic pain (for example, pain that lasts more than 3 months) early in its course may result in averting the development of “high-impact” chronic pain in some individuals, where they experience at least one major activity restriction (for example, unable to work, go to school, perform household chores). These individuals report more severe pain, more difficulty with self-care, and higher health care use than others with chronic pain. From a social determinants of health perspective, Blacks, Native Americans, persons of Asian/Indian descent, older adults, and people with less education, and single individuals report more high impact chronic pain.[] In 2019, 12.2 million individuals were enrolled in both Medicaid and Medicare, including people age 65 and older and younger beneficiaries with disabilities.

Many have multiple chronic conditions, physical disabilities, behavioral health conditions, and cognitive impairments and on average, use more services and supports than those enrolled in only Medicaid or Medicare, with higher per capita costs. Dually eligible beneficiaries often have multiple social risk factors such as housing insecurity and homelessness, food insecurity, inadequate access to transportation, and low health literacy. A 2019 study [] on dually eligible beneficiaries using “high dose” opioids to treat pain between 2006 through 2015 Start Printed Page 39182indicated that the common conditions in beneficiaries studied were chronic pain, migraine, rheumatoid arthritis, osteoporosis, HIV/AIDS, viral hepatitis, and SUD.[] We are soliciting comment on whether we should consider creating separate coding and payment for medically necessary activities involved with chronic pain management and achieving safe and effective dose reduction of opioid medications when appropriate, or whether the resources involved in furnishing these services are appropriately recognized in current coding and payment. These activities could include, but are not limited to the following. Diagnosis.

Assessment and monitoring. Administration of a validated rating scale(s). Development and maintenance of a person-centered care plan. Overall treatment management. Facilitation and coordination of any needed behavioral health treatment.

Medication management. Patient education and self-management. Crisis care. Specialty care coordination such as complementary and integrative pain care, and SUD care. And Other aspects of pain and/or behavioral health services, including care rendered through telehealth modalities.

We are interested in feedback regarding whether the resource costs involved in furnishing these activities would be best captured through an add-on code to be billed with an E/M visit or a standalone code. To price such a code, we could consider using a crosswalk to the valuation and inputs for reference codes such as CPT code 99483 (Assessment of and care planning for a patient with cognitive impairment), HCPCS code G2064 (Comprehensive care management services for a single high-risk disease, e.g., principal care management, at least 30 minutes of physician or other qualified health care professional time per calendar month), HCPCS code G0108 (Diabetes outpatient self-management training services, individual, per 30 minutes), or other services paid under the PFS with similar resource costs. We also seek information on which healthcare settings and stages in treatment these transitions from opioid dependence are occurring, as well as what types of practitioners furnish these services. We are soliciting comments on whether the specific activities we identify above are appropriate, and whether there are other activities that should be included. We are interested in stakeholder feedback regarding how we could define and value separate coding or an E/M add-on code.

We also seek comment on whether any components of the service could be provided “incident to” the services of the billing physician who is managing the beneficiary's overall care similar to the structure of the Behavioral Health Integration (BHI) codes, which can include BHI services that are not delivered personally by the billing practitioner and delivered by other members of the care team (except the beneficiary), under the direction of the billing practitioner on an incident to basis (as an integral part of services delivered by the billing practitioner), subject to applicable state law, licensure, and scope of practice. The other care team members are either employees or working under contract to the practitioner who bills for BHI services. We welcome feedback from stakeholders and the public on potential separate coding or an E/M add-on code for chronic pain management for our consideration for CY 2022 or for future rulemaking. Start Printed Page 39183 Start Printed Page 39184 Start Printed Page 39185 Start Printed Page 39186 Start Printed Page 39187 Start Printed Page 39188 Start Printed Page 39189 Start Printed Page 39190 Start Printed Page 39191 Start Printed Page 39192 Start Printed Page 39193 Start Printed Page 39194 Start Printed Page 39195 Start Printed Page 39196 Start Printed Page 39197 Start Printed Page 39198 Start Printed Page 39199 Start Printed Page 39200 Start Printed Page 39201 Start Printed Page 39202 Start Printed Page 39203 F. Evaluation and Management (E/M) Visits Over the past several years, CMS has engaged with the AMA and other stakeholders in a process to update coding and payment for office/outpatient evaluation and management (E/M) visits, with recent changes taking effect January 1, 2021 (see 85 FR 84548 through 84574).

In light of these changes, we are engaged in an ongoing review of other E/M visit code sets and are proposing a number of refinements to our current policies. The following section will discuss proposed policies regarding split (or shared) visits, critical care services, and teaching physician visits. 1. Split (or Shared) Visits a. Background A split (or shared) visit refers to an E/M visit that is performed (“split” or “shared”) by both a physician and a NPP who are in the same group.

Because the Medicare statute provides a higher PFS payment rate for services furnished by physicians than services furnished by NPPs, we need to address whether and when the physician can bill for split (or shared) visits. For visits in the non-facility (for example, office) setting for which the physician and NPP each perform portions of the visit, the physician can bill for the visit rather than the NPP as long as the visit meets the conditions of payment in our regulations at § 410.26(b)(1) for services furnished “incident to” a physician's professional services. However, for visits furnished under similar circumstances in facility settings (for example, in a hospital), our current regulations provide for payment only to the physician or NPP who personally performs all elements of the service, and no payment is made for services furnished “incident to” the billing professional's services. As stated in our regulation at § 410.26(b)(1), Medicare Part B pays for services and supplies furnished “incident to” a physician's (or other practitioner's) professional services if those services and supplies are furnished in a noninstitutional setting to noninstitutional patients. In certain institutional (or “facility”) settings, our longstanding split (or shared) billing Start Printed Page 39204policy allows a physician to bill for an E/M visit when both the billing physician and an NPP in their group each perform portions of the visit, but only if the physician performs a substantive portion of the visit.

When the physician bills for such a split (or shared) visit, in accordance with section 1833(a)(1)(N) of the Act, the Medicare Part B payment is equal to 80 percent of the payment basis under the PFS which, under section 1848(a)(1) of the Act, is the lesser of the actual charge or the fee schedule amount for the service. In contrast, if the physician does not perform a substantive portion of such a split (or shared) visit and the NPP bills for it, in accordance with section 1833(a)(1)(O) of the Act, the Medicare Part B payment is equal to 80 percent of the lesser of the actual charge or 85 percent of the fee schedule rate. Previously, our policy for billing these split (or shared) visits was reflected in several provisions of our Medicare Claims Policy Manual (sections 30.6.1(B), 30.6.12, and 30.6.13(H)) which were withdrawn effective May 9, 2021, in response to a petition under the Department's Good Guidance regulations at 45 CFR 1.5 (see Transmittal 10742 available on the CMS website at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Transmittals/​Transmittals/​r10742cp). In the absence of these manual provisions, the Medicare statute and various broadly applicable regulations continue to apply. In addition to withdrawing the manual provisions, we issued our response to the petition and an accompanying enforcement instruction on May 26, 2021, available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​Evaluation-and-Management-Visits).

In those documents, we indicated that we intend to address split (or shared) visits and critical care services (addressed below) through rulemaking. And that until we do, we will limit review to the applicable statutory and regulatory requirements for purposes of assessing payment compliance. The list of applicable statutory and regulatory requirements includes the CY 2021 PFS final rule (85 FR 84549), where CMS generally adopted new CPT prefatory language and code descriptors for office/outpatient E/M visits. The new CPT guidelines for E/M services introduced a CPT definition of a split (or shared) visit for the first time, effective January 1, 2021. This new CPT definition was part of CPT's new guidelines indicating how to select the visit level based on time, which can be done for all office/outpatient E/M visits starting in 2021.

The CPT guidelines that we are referring to are published in the CPT Codebook, in a section titled “Evaluation and Management Services (E/M) Guidelines.” [] In this section of our proposed rule, we use the term “CPT E/M Guidelines” to refer to this material. In the CY 2021 PFS final rule (85 FR 84549), we stated that we are generally adopting the CPT E/M Guidelines for the new office/outpatient E/M visit codes. However, the CPT E/M Guidelines do not address many issues that arise in the context of PFS payment for split (or shared) visits, such as which practitioner should report the visit when elements of the visit are performed by different practitioners. Whether a substantive portion of the visit must be performed by the billing practitioner. Whether practitioners must be in the same group to bill for a split (or shared) visit.

Or the settings of care where split (or shared) visits may be furnished and billed. The CPT E/M Guidelines simply state, “A split or shared visit is defined as a visit in which a physician and other qualified health care professional(s) jointly provide the face-to-face and non-face-to-face work related to the visit. When time is being used to select the appropriate level of services for which time-based reporting of shared or split visits is allowed, the time personally spent by the physicians and other qualified health care professional(s) assessing and managing the patient on the date of the encounter is summed to define total time. Only distinct time should be summed for split or shared visits (that is, when two or more individuals jointly meet with or discuss the patient, only the time of one individual should be counted).” [] In contrast, to ensure appropriate PFS payment, our policy for split (or shared) visits, as expressed in the recently withdrawn manual provisions, is that the physician may bill for a split (or shared) visit only if they perform a substantive portion of the visit, and the practitioners must be in the same group and furnishing the visit in specified settings in order to bill for a split (or shared) visit. Our manual also limited billing for split (or shared) visits to services furnished to established patients.

In this proposed rule, we are making a number of proposals to address the recently withdrawn manual sections and improve transparency and clarity regarding our policies on billing for split (or shared) visits, to update them to account for recent revisions to E/M visit coding and payment, and to revise our regulations to reflect these policies. B. Definition of Split (or Shared) Visits We are proposing to define a split (or shared) visit as an E/M visit in the facility setting that is performed in part by both a physician and an NPP who are in the same group, in accordance with applicable laws and regulations. We propose to add this definition to a new section of our regulations at § 415.140. Additionally, we propose to define split (or shared) visits as those that.

Are furnished in a facility setting by a physician and an NPP in the same group, where the facility setting is defined as an institutional setting in which payment for services and supplies furnished incident to a physician or practitioner's professional services is prohibited under our regulation at § 410.26(b)(1). Are furnished in accordance with applicable law and regulations, including conditions of coverage and payment, such that the E/M visit could be billed by either the physician or the NPP if it were furnished independently by only one of them in the facility setting (rather than as a split (or shared) visit). We are proposing to revise our regulations at § 415.140 to codify this definition. We believe that limiting the definition of split (or shared) visits to include only E/M visits in institutional settings, for which “incident to” payment is not available, will allow for improved clarity, and clearly distinguish, the policies applicable to split (or shared) visits, from the policies applicable to services furnished incident to the professional services of a physician. We do not see a need for split (or shared) visit billing in the office setting, because the “incident to” regulations govern situations where an NPP works with a physician who bills for the visit, rather than billing under the NPP's own provider number.

We are also proposing to modify our policy to allow physicians and NPPs to bill for split (or shared) visits for both new and established patients, and for critical care and certain Skilled Nursing Facility/Nursing Facility (SNF/NF) E/M visits. We are proposing these modifications to the current policy and conditions of payment for split (or shared) visits, discussed below, to account for changes that have occurred in medical practice patterns, including Start Printed Page 39205the evolving role of NPPs as part of the medical team. C. Definition of Substantive Portion (1) More Than Half of the Total Time As stated earlier, only the physician or NPP who performs the substantive portion of the split (or shared) visit would bill for the visit. We are proposing to define “substantive portion” as more than half of the total time spent by the physician and non-physician practitioner performing the visit.

We note that our withdrawn manual instructions contained a few definitions of “substantive portion.” For example, one section defined substantive portion as any face-to-face portion of the visit, while another section defined it as one of the three key components of an E/M visit—either the history of present illness (HPI), physical exam, and/or medical decision-making (MDM). Given recent changes in the CPT E/M Guidelines, HPI and physical exam are no longer necessarily included in all E/M visits, because as noted above, for office/outpatient E/M visits, the visit level can now be selected based on either MDM or time, and history and exam are performed only as medically appropriate. Accordingly, defining “substantive portion” as one of these three key components is no longer a viable approach. Similarly, MDM is not easily attributed to a single physician or NPP when the work is shared, because MDM is not necessarily quantifiable and can depend on patient characteristics (for example, risk). We believe that time is a more precise factor than MDM to use as a basis for deciding which practitioner performs the substantive portion of the visit.

We also do not believe it would be appropriate to consider the performance of any portion of the visit—with or without direct patient contact—as a substantive portion. For instance, we do not believe it would be appropriate to consider a brief or minor interaction, with or without direct patient contact, such as where the physician merely “pokes their head” into the room, to be a substantive portion of the visit. Therefore, we are proposing to define “substantive portion” as more than half of the total time spent by the physician and NPP performing the split (or shared) visit. We are proposing to revise our regulation at § 415.140 to codify this definition. We recognize that the billing practitioner, who would be the practitioner providing the substantive portion of the visit, could select the level for the split (or shared) visit based on MDM, but we nonetheless propose to base the definition of substantive portion on the amount of time spent by the physician and NPP providing the visit.

We recognize that this policy would necessitate the practitioners' tracking and documenting the time they spent for these visits. However, we believe that practitioners are likely to increasingly time their visits for purposes of visit level selection independent of our split (or shared) visit policies, given recent changes to the CPT E/M Guidelines, and the fact that critical care visits are already timed. Accordingly, we do not believe this would comprise a substantial new burden. (2) Distinct Time We propose that the distinct time of service spent by each physician or NPP furnishing a split (or shared) visit would be summed to determine total time and who provided the substantive portion (and therefore bills for the visit). This would be consistent with the CPT E/M Guidelines stating that, for split (or shared) visits, when two or more individuals jointly meet with or discuss the patient, only the time of one individual should be counted).[] For example, if the NPP first spent 10 minutes with the patient and the physician then spent another 15 minutes, their individual time spent would be summed to equal a total of 25 minutes.

The physician would bill for this visit since they spent more than half of the total time (15 of 25 total minutes). If, in the same situation, the physician and NPP met together for five additional minutes (beyond the 25 minutes) to discuss the patient's treatment plan, that overlapping time could only be counted once for purposes of establishing total time and who provided the substantive portion of the visit. The total time would be 30 minutes, and the physician would bill for the visit since they spent more than half of the total time (20 of 30 total minutes). (3) Qualifying Time Drawing on the CPT E/M Guidelines, we are proposing a listing of activities that could count toward total time for purposes of determining the substantive portion. For visits that are not critical care services, we are proposing the same listing of activities that can count when time is used to select E/M visit level, specifically the following activities, when performed and regardless of whether or not they involve direct patient contact.

Preparing to see the patient (for example, review of tests). Obtaining and/or reviewing separately obtained history. Performing a medically appropriate examination and/or evaluation. Counseling and educating the patient/family/caregiver. Ordering medications, tests, or procedures.

Referring and communicating with other health care professionals (when not separately reported). Documenting clinical information in the electronic or other health record. Independently interpreting results (not separately reported) and communicating results to the patient/family/caregiver. Care coordination (not separately reported). Practitioners would not count time spent on the following.

The performance of other services that are reported separately. Travel. Teaching that is general and not limited to discussion that is required for the management of a specific patient.[] Since critical care services can include additional activities that are bundled into the critical care visit code(s), we are proposing a different listing of qualifying activities, discussed in our section below on split (or shared) critical care services. Additionally, we are seeking public comment on whether there should be a different listing of qualifying activities for purposes of determining the total time and substantive portion of split (or shared) emergency department visits, since those visits also have a unique construct. (4) Application to Prolonged Services For office/outpatient E/M visits, as discussed in our CY 2021 PFS final rule (85 FR 84572), HCPCS code G2212 can be used to report prolonged services in 15-minute increments of time beyond the maximum time for a level 5 office/outpatient E/M visit.

For all other E/M visits (except critical care and emergency department visits), CPT codes 99354-9 can be used to report prolonged time with or without direct patient contact, when required time increments above the typical time is spent (see CY 2017 PFS final rule, 81 FR 80228-80230 and the Medicare Claims Processing Manual (Pub. 100-02), chapter 12, section 30.6.15 available on our website at https://www.cms.gov/​Start Printed Page 39206Regulations-and-Guidance/​Guidance/​Manuals/​Downloads/​clm104c12.pdf). Our withdrawn manual provisions instructed that practitioners cannot bill prolonged services as a split (or shared) visit. Having reviewed this policy, we believe that codes that are billed as add-on codes for prolonged service time for an E/M visit, which could be furnished and billed as a split (or shared) visit under our proposed policy, should be considered to be part of that E/M visit. Therefore, we are proposing to change our policy to allow a practitioner to bill for a prolonged E/M visit as a split (or shared) visit.

Specifically, the physician or practitioner who spent more than half the total time (that is, performed the substantive portion described above) would bill for the primary E/M visit and the prolonged service code(s) when the service is furnished as a split (or shared) visit, if all other requirements to bill for the services were met. The physician and NPP would sum their time together, and whomever furnished more than half of the total time, including prolonged time, (that is, the substantive portion) would report both the primary service code and the prolonged services add-on code(s), assuming the time threshold for reporting prolonged services is met. We note that for critical care visits, the practitioner would not bill prolonged E/M services because the practitioners would instead aggregate their time, as proposed below, to report additional units of critical care services. D. New and Established Patients, and Initial and Subsequent Visits Our withdrawn manual provisions stated that when an E/M service is furnished as a split or shared encounter, between a physician and an NPP (that is, an NP, PA, CNS or CNM), the service is considered to have been performed “incident to” if the requirements for “incident to” are met and the patient is an established patient.

This provision was generally interpreted to mean that split (or shared) visits cannot be billed for new patients. The withdrawn manual provisions also did not specify whether the practitioner who bills for the split or shared visit could bill for initial, versus subsequent, split (or shared) visits in the facility setting. After conducting an internal review, including consulting our medical officers, we believe that the practice of medicine has evolved toward a more team-based approach to care, and greater integration in the practice of physicians and NPPs, particularly when care is furnished by practitioners in the same group in the facility setting. Given this evolution in medical practice, the concerns that may have been present when we issued the manual instructions may no longer be as relevant. We understand that there have been changes in the practice of medicine over the past several years, some facilitated by the advent of electronic health records (EHRs) and other systems, toward a more team-based approach to care.

There has also been an increase in alternative payment models that employ a more team-based approach to care. After considering and reevaluating our policy, we see no reason to preclude the physician or NPP from billing for split (or shared) visits for a new patient, in addition to an established patient, or for initial and subsequent split (or shared) visits. Therefore, we are proposing to permit the physician or NPP to bill for split (or shared) visits for both new and established patients, as well as for initial and subsequent visits. We believe this approach is also consistent with the CPT E/M Guidelines for split (or shared) visits, which does not exclude these types of visits from being billed when furnished as split (or shared) services. E.

Settings of Care The concept of split (or shared) visits was developed as an analog in the facility setting to payment policies for services and supplies furnished incident to a physician's or an NPP's professional services in the non-institutional setting. Section 410.26(a)(6) of our regulations defines the non-institutional setting as all settings other than a hospital or SNF. We are proposing to allow billing of split (or shared) visits, including critical care visits, when they are performed in any institutional setting and are proposing to codify the definition of facility setting in the regulation at § 415.140. We discuss our proposals regarding billing for critical care split (or shared) E/M services below (see section II.F. Of this proposed rule).

Our withdrawn manual provisions did not allow practitioners to bill for split (or shared) visits that are critical care services or SNF/NF visits. The manual stated that the split (or shared) E/M policy did not apply to critical care services or procedures, and that a split (or shared) E/M service performed by a physician and a qualified NPP of the same group (or employed by the same employer) cannot be reported as a critical care service. It also stated that a split (or shared) E/M visit cannot be reported in the SNF/NF setting. We propose to define split (or shared) visits to be limited to services furnished in institutional settings, as discussed above. As discussed below, we do not see any reason to preclude billing for split (or shared) visits for critical care services, although we are seeking public comment on this issue in particular.

We understand that there have been changes in the practice of medicine over the past several years, some facilitated by the advent of EHRs and other systems, toward a more team-based approach to care. There has also been an increase in alternative payment models that employ a more team-based approach to care. Where a physician and NPP in the same group take a team approach to furnishing care, as would be the case for split (or shared) visits, even for new patients, initial visits, critical care visits, or SNF/NF visits, we are less concerned about potential disruptions in continuity of care than we might once have been. Rather, we believe that when a visit is shared between a physician and an NPP in the same group, there would be close coordination and an element of collaboration in providing care to the beneficiary. We do not see any reason to preclude billing for split (or shared) visits for the subset of SNF/NF visits that are not required by our regulations to be performed in their entirety by a physician.

Under our current policy, no E/M services can be furnished and billed as split (or shared) visits in the SNF setting. We refer readers to our Conditions of Participation in 42 CFR 483.30 for information regarding the SNF/NF visits that are required to be performed in their entirety by a physician. That regulation requires that certain SNF/NF visits must be furnished directly and solely by a physician. If finalized, our proposal would not apply to the SNF/NF visits that are required to be performed in their entirety by a physician. Any SNF/NF visit that is required to be performed in its entirety by a physician cannot and would not be able to be billed as a split (or shared) visit.

However, for other visits to which the regulation at § 483.30 does not apply, there is no requirement for a physician to directly and solely perform the visit. We propose that those visits could be furnished and billed as split (or shared) visits. F. Same Group In accordance with the current policy outlined in the withdrawn manual provisions, we are proposing that a physician and NPP must be in the same group in order for the physician and NPP to bill for a split (or shared) visit. We believe that in circumstances when a split or (shared) visit is appropriately billed, a physician and NPP are working jointly to furnish all of the work related to the visit with the patient.

However, if a physician and NPP are in different groups, we would expect the physician Start Printed Page 39207and NPP to bill independently, and only for the services they specifically and fully furnish. Further, consistent with our withdrawn manual guidance, we note that Medicare does not pay for partial physician's visits, so CPT modifier −52 (reduced services) could not be used to report split (or shared) visits. Thus, if a physician and an NPP who are in different groups each furnish part of an E/M service, but not all of it, then we would not consider either service to be a billable service. Similarly, if two physicians, each in their own private practice, both saw the same patient in the hospital, but neither one fully furnished a billable service—there would be no basis on which to combine their efforts or minutes of service into one billable E/M visit. We are seeking public comment on whether we should further define “group” for purposes of split (or shared) visit billing.

While we are not proposing a definition in this proposed rule, we have considered several options, such as requiring that the physician and NPP must be in the same clinical specialty, in which case we would use the approach outlined in the CPT E/M Guidelines. That is the NPP is considered to be in the same specialty and subspecialty as the physician with whom they are working.[] We are also considering an approach under which we would align the definition of “group” with the definition of “physician organization” at § 411.351. The term “physician organization” is defined at § 411.351 for purposes of section 1877 of the Act and our regulations in 42 CFR part 411, subpart J (collectively, the physician self-referral law), and explained further in frequently asked questions available on the CMS website at https://www.cms.gov/​Medicare/​Fraud-and-Abuse/​PhysicianSelfReferral/​Downloads/​FAQs-Physician-Self-Referral-Law.pdf. Another approach would be to consider practitioners with the same billing tax identification number as being in the same group. We are concerned that this particular approach may be too broad in multi-specialty groups or health care systems that include many practitioners who do not typically work together to furnish care to patients in the facility setting.

We note that some of these approaches may not align with the definition of “group” used for purposes of Medicare enrollment. G. Medical Record Documentation To ensure program integrity and quality of care, we are proposing that documentation in the medical record must identify the two individual practitioners who performed the visit. The individual who performed the substantive portion (and therefore bills the visit) would be required to sign and date the medical record. We are proposing to revise our regulation at § 415.140 to reflect the conditions of payment for split (or shared) visits as discussed in this section.

H. Claim Identification We are proposing to create a modifier to describe split (or shared) visits, and we are proposing to require that the modifier must be appended to claims for split (or shared) visits, whether the physician or NPP bills for the visit. Currently, we cannot identify through claims that a visit was performed as a split (or shared) visit, which means that we could know that a visit was performed as a split (or shared) visit only through medical record review. We believe it is important for program integrity and quality considerations to have a way to identify who is providing which E/M services, and how often we are paying at the physician rate for services provided in part by NPPs. (Please see the documentation section below for additional information).

The proposed modifier, if finalized, would give CMS insight, directly through our claims data instead of only through medical record review, into the specific circumstances under which these split (or shared) visits are furnished. Such information would be helpful to CMS for program integrity purposes, and could be instructive in considering whether we may need to offer additional clarification to the public, or further revise the policy for these E/M visits in future rulemaking. We are proposing to revise our regulation at § 415.140 to reflect the conditions of payment for split (or shared) visits as discussed in this section. Consistent with our current policy, Medicare does not pay for partial E/M visits for which all elements of the service are not furnished. Therefore, we are proposing that the modifier identified by CPT for purposes of reporting partial services (modifier −52 (reduced services)) could not be used to report partial E/M visits, including any partial services furnished as split (or shared) visits.

We are also considering whether it is necessary to amend our regulations to explicitly state that Medicare does not pay for partial E/M visits and are interested in public comments on this issue. 2. Critical Care Services (CPT Codes 99291-99292) As stated previously, in light of updates that we previously finalized for coding and payment for office/outpatient E/M visits, we are proposing a number of refinements to other E/M code sets. Historically, our policy for billing critical care services was reflected in several provisions of the Medicare Claims Processing Manual (sections 30.6.1(B), 30.6.12, and 30.6.13(H)) which were withdrawn effective May 9, 2021, in response to a petition under the Department's Good Guidance regulation at 45 CFR 1.5 (see Transmittal 10742 available on the CMS website at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Transmittals/​Transmittals/​r10742cp). In the absence of these manual provisions, the Medicare statute and various broadly applicable regulations continue to apply.

In addition to withdrawing the manual provisions, we issued our response to the petition and accompanying enforcement instruction issued on May 26, 2021, available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​Evaluation-and-Management-Visits. In those documents, we indicated that we intend to address split (or shared) visits (addressed above) and critical care services (addressed below) through rulemaking. And that until we do, we will limit review to the applicable statutory and regulatory requirements for purposes of assessing payment compliance. The list of applicable statutory and regulatory requirements includes the CY 2021 PFS final rule (85 FR 84549), where CMS generally adopted new CPT prefatory language and code descriptors for office/outpatient E/M visits. Therefore, in this section of the proposed rule, we are proposing to update our critical care E/M visit policies to improve transparency and clarity, and to account for recent revisions to E/M visit coding and payment.

The CPT 2021® Professional Codebook (hereafter, CPT Codebook) provides guidelines for critical care services in the CPT E/M Guidelines on pp. 5-9 and in prefatory language, code descriptors, and parentheticals on pp. 31-33. We are proposing to adopt the CPT prefatory language for critical care services as currently described in the CPT Codebook, except as otherwise specified in this section of the proposed rule. Should CPT make changes to the guidance for critical care services in a Start Printed Page 39208subsequent edition of the CPT Codebook, we could revisit these policies in future rulemaking.

We are also proposing to clarify our definition of critical care visits, and the requirements governing how critical care visits are reported when more than one practitioner or specialty is involved in furnishing critical care services to a patient. Further, we are proposing to prohibit a practitioner that reports critical care services furnished to a patient from also reporting any other E/M visit for that same patient on the same calendar day that the critical care services are furnished to that patient, and vice versa. Additionally, we are proposing to prohibit practitioners from reporting critical care visits during the same time-period as a procedure with a global surgical period. A. Definition of Critical Care Critical care visits are described by CPT codes 99291 (Critical care, evaluation and management of the critically ill or critically injured patient.

First 30-74 minutes) and 99292 (each additional 30 minutes (List separately in addition to code for primary service). As stated above, the CPT Codebook defines critical care services in prefatory language on pp. 31-33. Critical care services were defined in the withdrawn provisions of the Medicare Claims Processing Manual, and that definition tracked closely with the CPT prefatory language regarding critical care services. To improve transparency and clarity, we are proposing to adopt the CPT prefatory language as the definition of critical care services.

The CPT prefatory language states that critical care is the direct delivery by a physician(s) or other qualified healthcare professional (QHP) of medical care for a critically ill/injured patient in which there is acute impairment of one or more vital organ systems, such that there is a probability of imminent or life-threatening deterioration of the patient's condition.[] It involves high complexity decision-making to treat single or multiple vital organ system failure and/or to prevent further life-threatening deterioration of the patient's condition. We continue to believe that the CPT Codebook appropriately delineates coding and definitions for critical care services in order to distinguish them as more intense services that are valued relatively higher than other E/M services. Thus, we are proposing to adopt the CPT prefatory language as the definition of critical care services, and refer readers to the CPT Codebook for additional details. Under current Medicare policy, a QHP is an individual who is qualified by education, training, licensure/regulation (when applicable), facility privileging (when applicable), and the applicable Medicare benefit category to perform a professional service within their scope of practice and independently report that service (see, for example, 80 FR 70957. 85 FR 84543, 84593).

Because the CPT Codebook provides that critical care services can be delivered by a physician or QHP, we are proposing that critical care services may be reported by a physician or NPP who is a QHP as explained above. The CPT prefatory language specifies that critical care may be furnished on multiple days, and is typically furnished in a critical care area, which can include an intensive care unit or emergency care facility. CPT prefatory language also states that critical care requires the full attention of the physician or NPP, and therefore, for any given time-period spent providing critical care services, the practitioner cannot provide services to any other patient during the same period of time. We are proposing to adopt this CPT prefatory language to improve transparency and clarity of our policy for this service for Medicare billing purposes. CPT prefatory language and billing and coding guidance bundles several services into critical care visits furnished by a given practitioner when performed during the critical period by the practitioners providing critical care.

We are proposing to adopt CPT's listing of bundled services that are part of critical care visits to improve transparency and clarity of our policy for this service. Therefore, we are proposing that the following services would be bundled into critical care visits. Interpretation of cardiac output measurements (93561, 93562), chest X rays (71045, 71046), pulse oximetry (94760, 94761, 94762), blood gases, and collection and interpretation of physiologic data (for example, ECGs, blood pressures, hematologic data). Gastric intubation (43752, 43753). Temporary transcutaneous pacing (92953).

Ventilator management (94002-94004, 94660, 94662). And vascular access procedures. As a result, these codes would not be separately billable by a practitioner during the time-period when the practitioner is providing critical care for a given patient. We are also proposing to adopt the CPT prefatory language stating that time spent performing separately reportable procedures or services should be reported separately and should not be included in the time reported as critical care time. B.

Critical Care by a Single Physician or NPP Our withdrawn manual provisions and the prefatory language in the CPT Codebook cited above both describe the time duration for the correct reporting of critical care services by a single physician or NPP. To improve transparency and clarity of our policy for this service, we are proposing to adopt the CPT prefatory language. Under our proposal, the physician or NPP would report CPT code 99291 for the first 30-74 minutes of critical care services provided to a patient on a given date. Thereafter, they would report CPT code 99292 for additional 30-minute time increments provided to the same patient. We refer readers to the CPT Codebook for examples of the total duration of critical care visits.[] The prefatory language states that CPT codes 99291 and 99292 are used to report the total duration of time spent by the physician or QHP providing critical care services to a critically ill or critically injured patient, even if the time spent by the practitioner on that date is not continuous.

And that non-continuous time for medically necessary critical care services may be aggregated. The CPT Codebook indicates that CPT code 99291 is used to report the first 30-74 minutes of critical care on a given date, and that the code should be used only once per date even if the time spent by the practitioner is not continuous on that date. We are proposing to adopt this rule for critical care services furnished by a single physician or NPP. We note that the prefatory language does not indicate how practitioners should report critical care when a service lasts beyond midnight. We are seeking comment about how practitioners should report CPT codes 99291 and 99292 when a service extends beyond midnight to the following calendar day.

C. Critical Care Services Furnished Concurrently by Different Specialties The CPT Codebook does not provide any special instructions regarding how to report critical care furnished by more than one physician or practitioner, whether in a split (or shared) visit context or other contexts that might be relevant given the unique nature of critical care and the long timeframes over which patients may receive these services. The CPT E/M Guidelines state broadly that concurrent care is the provision of similar services (for Start Printed Page 39209example, hospital visits) to the same patient by more than one physician or other QHP on the same day. The CPT E/M Guidelines state that when concurrent care is provided, no special reporting is required.[] The CPT E/M Guidelines also state broadly that when time is being used to select the appropriate level of services for which time-based reporting of split (or shared) visits is allowed, the time personally spent by the physician and other QHP(s) assessing and managing the patient on the date of the encounter is summed to define total time. And that only distinct time should be summed for split (or shared) visits (that is, when two or more individuals jointly meet with or discuss the patient, only the time of one individual should be counted).[] In the context of critical care services, our withdrawn manual provisions provided guidance on concurrent care, and stated that there are situations where physicians or NPPs within a group provide coverage or follow-on care for one another on a single day.

The manual also stated that critically ill or injured patients may require the care of more than one practitioner from more than one specialty (regardless of group affiliation), and this work could transpire simultaneously or overlap. Consistent with our current policy, and to improve transparency and clarity of our policy for critical care services, we are proposing that concurrent care occurs where more than one physician or qualified NPP furnishes services to the same patient on the same day. In general, concurrent care is covered when the services of each practitioner are medically necessary, and not duplicative. For example, concurrent care may be medically necessary because of the existence of more than one medical condition requiring diverse specialized medical services, that is, more than one specialty (which can include a qualified NPP as a specialty). In the context of critical care services, a critically ill patient may have more than one medical condition requiring diverse specialized medical services and thus requiring more than one practitioner having different specialties to play an active role in the patient's treatment.

Thus, we are proposing that critical care services may be furnished as concurrent care (or concurrently) to the same patient on the same day by more than one practitioner in more than one specialty (for example, an internist and a surgeon, allergist and a cardiologist, neurosurgeon and NPP), regardless of group affiliation, if the service meets the definition of critical care and is not duplicative of other services. However, as for most Medicare-covered services, these critical care services would need to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. We are seeking comment on this proposal to better understand current clinical practice for critical care, and when it would be appropriate for more than one physician or NPP of the same or different specialties, and within the same or a different group, to provide critical care services. D. Critical Care Furnished Concurrently by Practitioners in the Same Specialty and Same Group (Follow-Up Care) Physician(s) or NPP(s) in the same specialty and in the same group may provide concurrent follow-up care, such as a critical care visit subsequent to another practitioner's critical care visit.

This may be as part of continuous staff coverage or follow-up care to critical care services furnished earlier in the day on the same calendar date. According to CPT coding and billing conventions that we generally acknowledge, a practitioner who furnishes a timed service such as critical care would typically need to report the primary service or procedure code before reporting an add-on code. However, we are proposing that when critical care is furnished concurrently by two or more practitioners in the same specialty and in the same group to the same patient on the same day, the individual physician(s) or NPP(s) providing the follow-up or subsequent care would report their time using the code for subsequent time intervals (CPT code 99292), and would not report the primary service code (CPT code 99291). CPT code 99291 would not be reported more than once for the same patient on the same day by these practitioners. This proposal recognizes that multiple practitioners in the same specialty and the same group can maintain continuity of care by providing follow-up care for the same patient on the same day, and is consistent with our current policy as described in the withdrawn manual provisions.

Because practitioners in the same specialty and same group cover for one another to provide concurrent critical care services, we believe the total time for critical care services furnished to a patient on the same day by the practitioners in the same group with the same specialty should be reflected as if it were a single set of critical care services furnished to the patient. The practitioner furnishing the initial critical care service would report CPT code 99291, and the practitioner(s) reporting subsequent critical care service time would report CPT code 99292. Under our current policy, the initial critical care service must be performed by a single physician or qualified NPP. In considering and reevaluating this policy, we believe it would better reflect current medical practice to allow critical care service time spent by more than one practitioner in the same group with the same specialty to be added together for the purposes of meeting the time requirement to bill for the initial critical care service using CPT code 99291. We are proposing this policy for two main reasons.

First, we believe this proposal would appropriately recognize that multiple practitioners in the same specialty and group can concurrently furnish critical care services to a patient on a single day. Second, this proposal would conform our policy for the initial critical care service with our proposal described above for multiple practitioners in the same specialty and same group to report CPT code 99292 for their cumulative critical care service time. Thus, we are proposing that where one practitioner begins furnishing the initial critical care service but does not meet the time required to report CPT code 99291, and another practitioner in the same specialty and group continues to deliver critical care to the same patient on the same day, the time spent by those practitioners could be aggregated to meet the time requirement to bill CPT code 99291. Under our proposal, once the cumulative required critical care service time is met to report CPT code 99291, CPT code 99292 would not be reported by the practitioner or another practitioner in the same specialty and group unless and until an additional 30 minutes of critical care services are furnished to the same patient on the same day (114 total minutes). Finally, consistent with our current policy, we are proposing that the aggregated time spent on critical care visits must be medically necessary and each visit must meet the definition of critical care in order to add the times for purposes of meeting the time requirement to bill CPT code 99291.

We are seeking comment on this proposal to better understand current clinical practice for critical care, and when it would be appropriate for more than one physician or NPP of the same or different specialties, and within the same or a different group, to provide Start Printed Page 39210critical care services to a patient on a single day. E. Split (or Shared) Critical Care Services Under current CMS policy, critical care services cannot be billed as split (or shared) E/M services. As previously discussed in section II.F.1. Of this proposed rule for split (or shared) visits, we believe the practice of medicine has evolved toward a more team-based approach to care, and greater integration in the practice of physicians and NPPs, particularly when care is furnished by clinicians in the same group in the facility setting.

Given this evolution in medical practice, the concerns that may have been present when we issued current policy may no longer be as relevant. We understand that there have been changes in the practice of medicine over the past several years, some facilitated by the advent of EHRs and other systems, toward a more team-based approach to care. There has also been an increase in alternative payment models that employ a more team-based approach to care. In considering and reevaluating this policy, we believe it would be appropriate to revise our policy to allow critical care services to be reported when furnished as split (or shared) services. Therefore, we are proposing that critical care visits may be furnished as split (or shared) visits.

The proposals described in section II.F.1. Of this proposed rule for split (or shared) visits would apply (with one exception discussed below), and service time would be counted for CPT code 99292 in the same way as for prolonged E/M services. In other words, we are proposing that the total critical care service time provided by a physician and NPP in the same group on a given calendar date to a patient would be summed, and the practitioner who furnishes the substantive portion of the cumulative critical care time would report the critical care service(s). In section II.F.1. Of this proposed rule, drawing on the CPT E/M Guidelines, we proposed a list of activities that could count toward total time for purposes of determining the substantive portion.

We stated that since critical care services can include additional activities that are bundled into the critical care visits code(s), we are proposing a different listing of qualifying activities for split (or shared) critical care. These qualifying activities are described in prefatory language on pp. 31-32 of the CPT Codebook. Thus, when critical care services are furnished as a split (or shared) visit, we are proposing to define the substantive portion as more than half the cumulative total time in qualifying activities that are included in CPT codes 99291 and 99292. Additionally, the billing practitioner would first report CPT code 99291 and, if 75 or more cumulative total minutes were spent providing critical care, one or more units of CPT code 99292.

We would require practitioners to include the proposed split (or shared) visit modifier on the claim, and we are proposing that the documentation and other rules proposed in section II.F.1. Of this proposed rule for split (or shared) visits would apply to split critical care services. We note that, in contrast to our proposals regarding concurrent critical care services above, we are proposing that when a critical care service is furnished as a split (or shared) visit, when two or more practitioners spend time jointly meeting with or discussing the patient, the time may be counted only once for purposes of reporting the split (or shared) critical care visit. This proposed policy accords with our proposed policy for all split (or shared) visits. It also accords with the CPT E/M Guidelines stating that, for split (or shared) visits, when two or more individuals jointly meet with or discuss the patient, only the time of one individual should be counted).[] We are seeking comment on these proposals to ensure they reflect a clinically appropriate approach, and intend to assess whether we should instead require that an individual physician or NPP directly perform the entirety of each critical care visit.

We are seeking comment on this proposal to better understand current clinical practice for critical care, and when it would be appropriate for more than one physician or NPP of the same or different specialties, and within the same or a different group, to provide critical care to a patient. F. Critical Care Visits and Same-Day Emergency Department, Inpatient or Office/Outpatient Visits The CPT Codebook states that critical care and other E/M services may be provided to the same patient on the same date by the same individual. However, our general policy as described in the Medicare Claims Processing Manual states that physicians in the same group who are in the same specialty must bill and be paid for services under the PFS as though they were a single physician. If more than one E/M visit is provided on the same day to the same patient by the same physician, or by more than one physician in the same specialty in the same group, only one E/M service may be reported unless the E/M services are for unrelated problems.

Instead of billing separately, the physicians should select a level of service representative of the combined visits and submit the appropriate code for that level.[] This policy is intended to ensure that multiple E/M visits for a patient on a single day are medically necessary and not duplicative. With respect to office/outpatient E/M visits specifically, our current manual instructs, “As for all other E/M services except where specifically noted, the Medicare Administrative Contractors (MACs) may not pay two E/M office visits billed by a physician (or physician of the same specialty from the same group) for the same beneficiary on the same day unless the physician documents that the visits were for unrelated problems in the office, off campus-outpatient hospital, or on campus-outpatient hospital setting which could not be provided during the same encounter.” [] With respect to hospital visits, hospital ED visits, and critical care services furnished on the same day, the Medicare Claims Processing Manual states, “When a hospital inpatient or office/outpatient E/M service are furnished on a calendar date at which time the patient does not require critical care and the patient subsequently requires critical care both the critical care services (CPT codes 99291 and 99292) and the previous E/M service may be paid on the same date of service. Hospital ED services are not paid for the same date as critical care services when provided by the same physician to the same patient.” [] We are concerned that adopting the CPT rule that critical care and other E/M visits may be furnished to the same patient on the same date by the same practitioner could have unintended consequences for the Medicare program. We have previously expressed concerns that multiple E/M visits by the same practitioner, or by practitioners in the same specialty within a group, on the same day as another E/M service ordinarily would not be medically necessary (83 FR 59639). It is possible that adopting the CPT rule allowing billing for critical care and other E/M Start Printed Page 39211visits on the same day, by practitioners in the same group and of the same specialty, could lead to duplicative payment, particularly given the frequently long duration of critical care services, the CPT prefatory language indicating that time spent furnishing critical care may be non-continuous, and the relatively higher valuation of critical care services compared to other E/M services.

Thus, we are proposing that no other E/M visit can be billed for the same patient on the same date as a critical care service when the services are furnished by the same practitioner, or by practitioners in the same specialty in the same group. There are possible alternative approaches to address our concerns about medical necessity and duplicative payment for E/M services furnished to a patient on the same day by the same practitioner or a practitioner in the same group. We have previously considered a Multiple Procedure Payment Reduction (MPPR) for standalone office/outpatient E/M visits that occur on the same day as a procedure to address efficiencies (for example, in preservice and postservice clinician work and PE) that are not accounted for in the current payment rates (83 FR 59639). These visits could be identified on the claim with modifier −25 (significant, separately identifiable E/M service by the same physician on the same day of the procedure or other service) and CMS could assign a reduced payment rate to one of the visits. CMS could also use documentation requirements to support the medical necessity and non-duplicative nature of a claim for critical care services on the same calendar date as another E/M visit provided to a patient by the same practitioner or practitioner of the same specialty in a group.

We also recognize that our proposal not to allow an E/M visit to be billed for the same patient on the same date as a critical care service when the services are furnished by the same practitioner, or by practitioners in the same specialty within a group, may be appropriate only in certain clinical situations. For example, it may be possible that a patient would not require critical care services at the time of an ED visit, but then be admitted to the hospital on the same calendar date as the ED visit and require care that meets the definition of critical care services. It may also be possible that the practitioner who furnished the ED visit later provided critical care services to the same patient on the same calendar date. Thus, we are seeking comment on this proposal to better understand clinical practice for critical care, whether and how CMS could pay for E/M services furnished on the same date as critical care services when provided by the same practitioner, or practitioners in the same specialty within a group, while also reducing the potential for duplicative payment. G.

Critical Care Visits and Global Surgery Critical care services may be needed on the on the same calendar date as a procedure code with a global surgical period. In many cases, preoperative and postoperative critical care visits are included in procedure codes that have a global surgical period. In the CY 2015 PFS final rule, we discussed the challenges of accurately accounting for the number of visits included in the valuation of 10- and 90-day global packages (79 FR 67548, 67582). The 10- and 90-day global packages can include critical care visits. We finalized a policy to change all global periods to 0-day global periods, and to allow separate payment for post-operative E/M visits.

Our concerns were based on a number of key points including. The lack of sufficient data on the number of visits typically furnished during the global periods, questions about whether we will be able to adjust values on a regular basis to reflect changes in the practice of medicine and health care delivery, and concerns about how our global payment policies could affect the services that are actually furnished. Section 1848(c)(8)(B) of the Act, which was added by section 523(a) of the Medicare Access and CHIP Reauthorization Act (MACRA), required us to collect data to value surgical services. Because critical care visits are included in some 10- and 90-day global packages, we are proposing to bundle critical care visits with procedure codes that have a global surgical period. We note that this proposal contrasts with the current policy as described in the Medicare Claims Processing Manual which states that critical care visits are unbundled from procedures with a global surgical period as long as the critical care service was unrelated to the procedure.[] As we have made clear in previous rulemaking, we are continuing to assess values for global surgery procedures (84 FR 2452), including in particular the number and level of preoperative and postoperative visits, which can include critical care services.

Because this work is still ongoing, we are proposing to bundle critical care visits with procedure codes that have a global surgical period. H. Documentation Requirements Because critical care is a time-based service, we are proposing to require practitioners to document in the medical record the total time that critical care services were provided by each reporting practitioner (not necessarily start and stop times). The documentation would also need to indicate that the services furnished to the patient, including any concurrent care by the practitioners, were medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. To support coverage and payment determinations regarding concurrent care, services would need to be sufficiently documented to allow a medical reviewer to determine the role each practitioner played in the patient's care (that is, the condition or conditions for which the practitioner treated the patient).

To support coverage and payment determinations regarding split (or shared) critical care services, the documentation requirements proposed above for all split (or shared) E/M visits would also apply to critical care visits (see section II.F. Of this proposed rule). 3. Payment for the Services of Teaching Physicians As part of the CPT office/outpatient E/M visit coding framework that we finalized beginning for CY 2021 (85 FR 84548 through 84574), practitioners can select the office/outpatient E/M visit level to bill, based either on the total time personally spent by the reporting practitioner or MDM. Stakeholders have asked us how teaching physicians who involve residents in furnishing care should consider time spent by the resident in selecting the office/outpatient E/M visit level.

For teaching physicians, section 1842(b) of the Act specifies that in the case of physicians' services furnished to a patient in a hospital with a teaching program, the Secretary shall not provide payment for such services unless the physician renders sufficient personal and identifiable physicians' services to the patient to exercise full, personal control over the management of the portion of the case for which payment is sought. Regulations regarding PFS payment for teaching physician services are codified in 42 CFR part 415. In general, under § 415.170, payment is made under the PFS for services furnished in a teaching hospital setting if the services are personally furnished by a physician Start Printed Page 39212who is not a resident, or the services are furnished by a resident in the presence of a teaching physician, with exceptions as specified in subsequent regulatory provisions in part 415. Medicare separately pays for the time spent by the resident through direct graduate medical education (GME) under Medicare Part A. A.

General Policy for Evaluation and Management Visits Under our regulation at § 415.172 and absent a public health emergency (PHE), if a resident participates in a service furnished in a teaching setting, a teaching physician can bill for the service only if they are present for the key or critical portion of the service. For residency training sites that are located outside a metropolitan statistical area, PFS payment may also be made if a teaching physician is present through audio/video real-time communications technology (that is, “virtual presence”). In the case of E/M services, the teaching physician must be present during the portion of the service that determines the level of service billed. We are proposing that when total time is used to determine the office/outpatient E/M visit level, only the time that the teaching physician was present can be included. We believe it is appropriate to include only the time of the teaching physician because the Medicare program makes separate payment for the program's share of the resident's graduate medical training program, which includes time spent by a resident furnishing services with a teaching physician, under Medicare Part A.

During the PHE, the time of the teaching physician when they are present through audio/video real-time communications technology may also be included in the total time considered for visit level selection. We note that, outside the circumstances of the anti inflammatory drugs PHE, the teaching physician presence requirement can be met virtually, through audio/video real-time communications technology, only in residency training sites that are located outside of a metropolitan statistical area. This proposal is consistent with our previously finalized policy that practitioners can use total time personally spent by the reporting practitioner to select office/outpatient E/M visit level. It is also consistent with our regulation at § 415.172 that states that PFS payment is made when a teaching physician involves a resident in providing care only if the teaching physician is present for the key or critical portions of the service, including the portion that is used to select the visit level. B.

Primary Care Exception Policy The regulation at §  415.174 sets forth an exception to the conditions for PFS payment for services furnished in teaching settings in the case of certain E/M services furnished in certain primary care centers. Under the so-called “primary care exception,” Medicare makes PFS payment in certain teaching hospital primary care centers for certain services of lower and mid-level complexity furnished by a resident without the physical presence of a teaching physician. We expanded the list of services that residents could furnish without the physical presence of the teaching physician for the duration of the PHE to include all levels of an office/outpatient E/M visit, among other services. Upon the conclusion of the PHE, levels 4-5 office/outpatient E/M visits will no longer be included in the primary care exception (85 FR 84585 through 84590). Section 415.174(a)(3) requires that the teaching physician must not direct the care of more than four residents at a time, and must direct the care from such proximity as to constitute immediate availability (that is, provide direct supervision), and must review with each resident during or immediately after each visit, the beneficiary's medical history, physical examination, diagnosis, and record of tests and therapies.

Section 415.174(a)(3) also requires that the teaching physician must have no other responsibilities at the time, assume management responsibility for the beneficiaries seen by the residents, and ensure that the services furnished are appropriate. We are proposing that under the primary care exception, only MDM can be used to select office/outpatient E/M visit level. The intent of the primary care exception as described in §  415.174 is that E/M visits of lower and mid-level complexity furnished by residents are simple enough to permit a teaching physician to be able to direct and manage the care of up to four residents at any given time and direct the care from such proximity as to constitute immediate availability. In the context of teaching hospital primary care centers that are staffed by residents and teaching physicians, we believe that MDM would be a more accurate indicator of the complexity of the visit as opposed to time. Because residents are in training, they may need more time than is reflected in the code descriptor to furnish a visit that has a low-level of medical decision making.

For example, CPT code 99213 (Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and low level of medical decision making. When using time for code selection, 20-29 minutes of total time is spent on the date of the encounter) involves a low level of MDM and between 20-29 minutes of total time. If time was used for level selection instead of MDM, it is possible that residents may need more than 20-29 minutes of time, including any conferring with the teaching physician, to furnish CPT code 99213. Thus, residents may be less efficient relative to a teaching physician in furnishing care. Office/outpatient E/M visits requiring 30 or more minutes of total time are described by visit levels 4-5.

After the expiration of the anti inflammatory drugs PHE, office/outpatient levels 4-5 will no longer be included in the primary care exception. In the CY 2021 PFS final rule, we expressed concern that the teaching physician may not be able to maintain sufficient personal involvement in all of the care to warrant PFS payment for the services being furnished by up to four residents when some or all of the residents might be furnishing services that are more than lower and mid-level complexity. We noted that when the teaching physician is directing the care of a patient that requires moderate or higher medical decision-making, the ability to be immediately available to other residents could be compromised, potentially putting patients at risk (85 FR 84586). Thus, to guard against the possibility of residents furnishing visits that are of more than lower and mid-level complexity, we are proposing that only MDM may be used for office/outpatient E/M visit level selection for services furnished by residents under the primary care exception. We acknowledge that under the new CPT office/outpatient E/M visit coding framework, it is possible that time is an accurate indicator of the complexity of the visit.

Thus, we are seeking comment on this proposal, including our assumption that MDM is a more accurate indicator of the appropriate level of the visit relative to time in the context of the primary care exception for services furnished by residents and billed by teaching physicians in primary care centers. We are also seeking comment on whether time is an accurate indicator of the complexity of the visit and how teaching physicians might select office/outpatient E/M visit level using time when directing the care of a patient that is being furnished by a resident in the context of the primary care exception.Start Printed Page 39213 G. Billing for Physician Assistant (PA) Services Under the respective Medicare statutory benefit categories for services of Physician assistants (PAs), nurse practitioners (NPs), and clinical nurse specialists (CNSs), these practitioners are authorized to furnish services that would be physicians' services if they were furnished by a physician, and which they are legally authorized to perform by the state in which the services are furnished. And such services that are furnished incident to the practitioners' professional services (but only if no facility or other provider charges or is paid any amount for the services). Additionally, the payment amount for the services of PAs, NPs, and CNSs, as specified under section 1833(a)(1)(O) of the Act, is equal to 80 percent of the lesser of the practitioner's actual charge or 85 percent of the amount that would be paid to a physician under the PFS.

However, while NPs and CNSs are authorized to bill the Medicare program and be paid directly for their professional services, section 1842(b)(6)(C)(i) of the Act has required since the inception of the PA benefit (with a narrow exception not relevant here) that payment for PA services must be made to the PA's employer. Accordingly, our regulation at § 410.74(a)(2)(v) specifies that PA services are covered under Medicare Part B only when billed by the PA's employer. Our regulation that addresses to whom Medicare Part B payment is made, at § 410.150(b)(15), further provides that payment is made to the qualified employer of a PA, and specifies that the PA could furnish services under a W-2 employment relationship, an employer-employee relationship, or as an independent contractor through a 1099 employment relationship. The regulation also specifies that a group of PAs that incorporate to bill for their services is not a qualified employer. Given the statutory requirement that we make payment to the PA's employer, PAs are precluded from directly billing the Medicare program and receiving payment for their services, and do not have the ability to reassign Medicare payment rights for their services to any employer, facility, or billing agent.

Section 403 of the Consolidated Appropriations Act, 2021 (CAA) (Pub. L. 116-260, December 27, 2020), amends section 1842(b)(6)(C)(i) of the Act to remove the requirement to make payment for PA services only to the employer of a PA effective January 1, 2022. With the removal of this requirement, PAs will be authorized to bill the Medicare program and be paid directly for their services in the same way that NPs and CNSs do. Effective with this amendment, PAs also may reassign their rights to payment for their services, and may choose to incorporate as a group comprised solely of practitioners in their specialty and bill the Medicare program, in the same way that NPs and CNSs may do.

We note that the amendment made by section 403 of the CAA changed only the statutory billing construct for PA services. It neither changed the statutory benefit category for PA services, including the requirement that PA services are performed under physician supervision, at section 1861(s)(2)(K)(i) of the Act, nor did it change the statutory payment percentage applicable to PA services specified in section 1833(a)(1)(O) of the Act. We are proposing to amend pertinent sections of our regulations to reflect the amendment made by section 403 of the CAA. Specifically, we are proposing to amend § 410.74(a)(2)(v) to specify that the current requirement that PA services must be billed by the PA's employer in order to be covered under Medicare Part B is effective only until January 1, 2022. We are also proposing to amend § 410.150(b) to redesignate the current requirements in paragraph (b)(15) as § 410.150(b)(15)(i), and to amend that paragraph to provide that Medicare payment is made for PA services to the qualified employer of the PA for services furnished prior to January 1, 2022.

In § 410.150, we further propose to add a new paragraph (b)(15)(ii) to state that, effective for services furnished on or after January 1, 2022, payment is made to a PA for their professional services, including services and supplies furnished incident to their services. We would conform this new paragraph with the regulation at § 410.150(b)(16) regarding to whom payment is made for NP or CNS services. As such, the proposed new paragraph at § 410.150(b)(15)(ii) would provide that payment will be made to a PA for professional services furnished by a PA in all settings in both rural and non-rural areas. And that payment is made only if no facility or other provider charges or is paid any amount for services furnished by a PA. We also intend to update our program manual instructions to reflect the statutory change made by section 403 of the CAA and the changes to our regulations.

H. Therapy Services We are implementing the third and final part of the amendments made by section 53107 of the Bipartisan Budget Act (BBA of 2018) (Pub. L. 115-123, February 9, 2018). The BBA of 2018 added a new section 1834(v) of the Act.

Section 1834(v)(1) of the Act requires CMS to make a reduced payment for physical therapy and occupational therapy services furnished in whole or in part by physical therapist assistants (PTAs) and occupational therapy assistants (OTAs) at 85 percent of the otherwise applicable Part B payment for the service, effective January 1, 2022. Section 1834(v)(2) of the Act requires that. (1) By January 1, 2019, CMS must establish a modifier to indicate that a therapy service was furnished in whole or in part by a PTA or OTA. And, (2) beginning January 1, 2020, each claim for a therapy service furnished in whole or in part by a PTA or an OTA must include the modifier. Section 1834(v)(3) of the Act requires CMS to implement these amendments through notice and comment rulemaking.

In the CY 2019 PFS final rule (83 FR 59654 through 59660), we established the CQ and CO modifiers that were required to be used by the billing practitioner or therapy provider to identify therapy services provided in whole or in part by PTAs and OTAs, respectively, beginning January 1, 2020. We require these payment modifiers to be appended on claims for therapy services, alongside the GP and GO therapy modifiers which are used to indicate the services are furnished under a physical therapy or occupational therapy plan of care, respectively. The payment modifiers are defined as follows. CQ modifier. Physical therapy services furnished in whole or in part by PTAs.

CO modifier. Occupational therapy services furnished in whole or in part by OTAs. In the CY 2019 PFS final rule (83 FR 59654 through 59660), we did not finalize our proposed definition of “furnished in whole or in part by a PTA or OTA” as a service for which any minute of a therapeutic service is furnished by a PTA or OTA. Instead, in response to public comments, we finalized a de minimis standard under which a service is considered to be furnished in whole or in part by a PTA or OTA when more than 10 percent of the service is furnished by the PTA or OTA. In the CY 2019 PFS proposed and final rules (83 FR 35850 through 35852, and 83 FR 59654 through 59660, respectively), we explained that the CQ and CO modifiers would not apply to claims for outpatient therapy services that are furnished by, or incident to, the services of, physicians or NPPs including NPs, PAs, and CNSs.

This is because our outpatient physical and Start Printed Page 39214occupational therapy services regulations require that the individual who performs outpatient therapy services incident to the services of a physician or NPP must meet the qualifications and standards for a therapist (other than state licensure). As such, only therapists, and not therapy assistants, can perform outpatient therapy services incident to the services of a physician or NPP (83 FR 59655 through 59656). And the modifiers to describe services furnished in whole or in part by a PTA or OTA are not applicable to the claim for a therapy service billed by a physician or NPP incident to their professional services. We indicated that we would add this distinction in the provision of the Medicare Benefit Policy Manual (MBPM) Chapter 15 that discusses therapy services furnished incident to the physician's or NPP's services at section 230.5, as well as the sections that discuss PTA and OTA services at sections 230.1 and 230.2, respectively. In the CY 2020 PFS proposed and final rules (84 FR 40558 through 40564 and 62702 through 62708, respectively), we explained that the CQ/CO modifiers and the de minimis policy would apply to both untimed and timed codes.

The untimed codes are evaluation and reevaluation codes, group therapy and supervised modalities, and when these are billed, only one unit is reflected in the “units” portion of the claim. When the PTA/OTA provides more than 10 percent of the service, the code is billed with a CQ/CO modifier. For timed codes, that is, those codes defined in 15-minute increments, the services are typically performed in multiple units of the same and/or different codes for a patient on one treatment day. We explained that under our policy, the therapist or therapy assistant needs to find the total time of all these 15-minute timed codes in order to determine the number of units that can be billed for that day. For example, if the PT/OT and/or the PTA/OTA, as appropriate, furnished between 8 minutes through 22 minutes, one unit can be billed.

If 23 minutes through 37 minutes are provided, 2 units can be billed. If 38 minutes through 52 minutes are furnished, 3 units can be billed. Once the total number of units to bill is determined, the qualified professional (therapist or assistant) then needs to decide whether the CQ/CO modifier is applicable. In the CY 2020 PFS proposed rule (84 FR 40558 through 40564), we proposed that the time the PTA/OTA spent together with the PT/OT in performing a service, as well as the time the PTA/OTA spent independent of the PT/OT treating the patient, is considered time for which the service is furnished in whole or in part by the PTA/OTA. As explained in the CY 2020 PFS final rule (84 FR 62702 through 62708), many commenters objected to our proposal to include as time that the therapy service is furnished “in whole or in part” by the PTA/OTA both the minutes spent by the PTA/OTA concurrently with and separately from the therapist.

These commenters also expressed concerns that this policy would unfairly discount services that are fully furnished by therapists, and in which the therapy assistant supports them while they provide a service. We were persuaded by commenters to finalize a policy to not include as minutes furnished in whole or in part by a PTA/OTA the minutes in which the PTA/OTA worked concurrently with the PT/OT. We agreed with the commenters that when a therapy assistant and therapist furnish care to a patient at the same time, the patient requires both professionals, and this reflects a clinical scenario where the assistant is helping the therapist to provide a highly skilled procedure or one in which both professionals are needed for safety reasons. We modified our proposed regulation text at §§ 410.59 (outpatient occupational therapy), 410.60 (physical therapy), and 410.105 (for PT and OT CORF services) accordingly. For purposes of deciding whether the 10 percent de minimis standard is exceeded, we offered two different ways to compute this.

The simple method. Divide the total of the PTA/OTA + PT/OT minutes by 10, round to the nearest integer then add 1 minute to get the number of minutes needed to exceed the de minimis standard at and above which the CQ/CO modifier applies. The percentage method. Divide the PTA/OTA minutes by the sum of the PTA/OTA and therapist minutes and then multiply this number by 100 to calculate the percentage of the service that involves the PTA/OTA, if this number is greater than 10 percent the CQ/CO modifier applies. Hypothetical examples of each of these methods are included later in this section.

In response to our proposal that all the units of one service needed to be considered when determining if the de minimis is applied, commenters requested that we consider each 15-minute unit instead—noting that they would be able to apply the CQ/CO modifier on one claim line for a service that was provided by the PTA/OTA and report another claim line without the CQ/CO for the service provided by the PT/OT. We were persuaded by stakeholders, and finalized a policy under which the de minimis standard is applied for each 15-minute unit of a service. This allows the separate reporting, on two different claim lines, of the number of 15-minute units of a code to which the therapy assistant modifiers do not apply, and the number of 15-minute units of a code to which the therapy assistant modifiers do apply. However, we neglected to modify the text of our regulations to reflect this final policy for applying the de minimis standard. Therefore, we are proposing to revise our regulation text to specify that the de minimis rule is applied to each 15-minute unit of a service, rather than to all the units of a service at §§ 410.59(a)(4)(iii)(B), 410.60(a)(4)(iii)(B), and 410.105(d)(3)(ii).

The specific proposed revisions are discussed below. To recap, we finalized a de minimis standard to identify when the CQ/CO modifiers apply and when they do not apply as follows. Portions of a service furnished by the PTA/OTA independent of the physical therapist/occupational therapist, as applicable, that do not exceed 10 percent of the total service (or 15-minute unit of a service) are not considered to be furnished in whole or in part by a PTA/OTA, so are not subject to the payment reduction. Portions of a service that exceed 10 percent of the total service (or 15-minute unit of a service) when furnished by the PTA/OTA independent of the therapist must be reported with the CQ/CO modifier, alongside of the corresponding GP/GO therapy modifier. Are considered to be furnished in whole or in part by a PTA/OTA, and are subject to the payment reduction.

And Portions of a service provided by the PTA/OTA together with the physical therapist/occupational therapist are considered for this purpose to be services provided by the therapist. In the CY 2020 PFS proposed rule (84 FR 40558 through 40564), we proposed to adopt a documentation requirement that a short phrase or statement must be added to the daily treatment note to explain whether the therapy assistant modifier was or was not appended for each therapy service furnished. We also sought comment on whether it would be appropriate to also require documentation of the minutes spent by the therapist or therapy assistant along with the CQ/CO modifier explanation as a means to avoid possible additional burden associated with a contractor's medical review process conducted for these services. Many commenters stated that. (1) The statute does not require documentation to explain why a Start Printed Page 39215modifier was or was not applied for each code.

(2) the proposed documentation requirements are exceedingly burdensome and conflict with the agency's “Patients over Paperwork Initiative”. (3) the proposed documentation requirement that calls for a narrative phrase in the treatment note and requires documentation of the minutes is duplicative of current requirements that requires adding the total timed code minutes and total treatment time (includes timed and untimed codes) to the daily treatment note. And, (4) the Medicare Benefit Policy Manual (MBPM) already includes extensive documentation requirements. In response to the feedback, we did not finalize the proposed documentation requirement. Nor did we finalize a requirement that the therapist and therapy assistant minutes be included in the documentation.

Instead, we reminded therapists and therapy providers that correct billing requires sufficient documentation in the medical record to support the codes and units reported on the claim, including those reported with and without an assistant modifier. Further, in agreement with many commenters, we clarified that we would expect the documentation in the medical record to be sufficient to know whether a specific service was furnished independently by a therapist or a therapist assistant, or was furnished “in part” by a therapist assistant, in sufficient detail to permit the determination of whether the 10 percent standard was exceeded. In the CY 2020 PFS proposed rule, we also provided multiple typical clinical billing scenarios to illustrate when the CQ/CO modifier would and would not be applicable. Because these clinical scenarios did not convey our finalized policies as modified in response to public comments, we indicated in the CY 2020 PFS final rule that we would provide further detail regarding the clinical scenario examples to illustrate how to use the therapy assistant modifiers through information we would post on the cms.gov website. We clarified that our revised finalized policy applied generally in the same way as illustrated in those examples, except for the difference in the minutes of time that are counted toward the 10 percent standard (not counting the minutes furnished together by a therapist and therapy assistant), the application of the 10 percent standard to each billed unit of a timed code rather than to all billed units of a timed code, and the billing on two separate claim lines of the units of a timed code to which the therapy assistant modifiers do and do not apply.

In early March 2021, we posted on our Therapy Services website at https://www.cms.gov/​Medicare/​Billing/​TherapyServices general guidance on how to assign the CQ/CO modifiers for multiple billing scenarios. In the guidance, we provided general examples for 8 different billing scenarios in which multiple units of 15-minute codes are provided by PTs/OTs and PTAs/OTAs and one billing example that used the untimed code for group therapy performed for equal minutes by a PT and a PTA. We noted that prior to applying our rules to determine appropriate application of the CQ/CO modifiers, the PTA/OTA or PT/OT first needs to determine how many 15-minute units can be billed in a single treatment day for a patient. For information on this topic, we referred readers to the chart in section 20.2.C of Chapter 5 of the Medicare Claims Processing Manual (MCPM) that describes how to count minutes for timed codes defined by 15-minute units, since the therapist or assistant should use the same counting rule, commonly known as the “8-minute rule,” that they have used previously. Once the therapist or therapy assistant has identified the number of 15-minute units that can be billed for a patient on a single treatment day, we provided the following information to clarify how to apply our policy for application of the CQ and CO modifiers, as follows.

Step 1. Identify the Timed HCPCS Codes Furnished for 15 Minutes or More. List the code numbers of each of the services furnished along with the number of minutes in total done by the PT, PTA, OT, or OTA. When a PT, PTA, OT, or OTA provides at least 15 minutes and less than 30 minutes of a service on a single treatment day, assign 1 unit. When multiples of 15 minutes are furnished, for example, 30 minutes (assign 2 units) and 45 minutes (assign 3 units), etc.

This needs to be the first step whenever it is applicable to the billing scenario. When any of these services, that is, full 15-minute increments, are provided by a PTA/OTA, the CQ/CO modifiers apply. Step 2. Identify Services for Which the PT/OT and PTA/OTA Provide Minutes of the Same HCPCS Code. After applying Step 1, where applicable, identify any minutes (including remaining minutes from Step 1) performed by a PT/OT and PTA/OTA for the same service/code.

Add the minutes furnished by the PT/OT and the PTA/OTA together, then divide the total by 10 and round to the nearest integer—this is the 10 percent de minimis time standard. Then add 1 minute to get the fewest number of minutes performed by the PTA/OTA that would exceed the 10 percent time standard for that service—if the PTA/OTA minutes meet or exceed this number, the CQ/CO modifier would be appended. This is the “simple” method for calculating the de minimis number of minutes. Step 3. Identify Services Where the PT/OT and PTA/OTA Furnish Services of Two Different Timed HCPCS Codes.

After applying Step 1 for each service, compare the remaining minutes furnished by the PT/OT for one service with the remaining minutes furnished by the PTA/OTA for a different service. Assign the CQ/CO modifier to the service provided by the PTA/OTA when the time they spent is greater than the time spent by the PT/OT performing the different service. The CQ/CO modifier does not apply when the minutes spent delivering a service by the PT/OT are greater than the minutes spent by the PTA/OTA delivering a different service. Step 4. Identify the Different HCPCS Codes Where the PT/OT and the PTA/OTA Each Independently Furnish the Same Number of Minutes.

Once Step 1 is completed for each service (when applicable), and when the remaining minutes for each service—one provided by the PT/OT and the other provided by the PTA/OTA—are the same, either service may be billed. If the service provided by the PT/OT is billed, the CQ/CO modifier does not apply. However, if the service provided by the PTA/OTA is billed, the CQ/CO modifier does apply. The below two examples are taken from our guidance on the CMS website. These are examples of when the PT and PTA provide minutes of the same service.

Example #1 PTA—23 minutes 97110 PT—13 minutes 97110 PT—30 minutes 97140 Total = 66 minutes—qualifies for billing 4 units (53 minutes through 67 minutes). Billing Explanation. First Step. Assign units to services based on those that have at least 15 minutes or codes that were provided in multiples of 15 minutes. For 97110, assign one unit of 97110 with the CQ modifier because the PTA furnished at least 15 minutes of 97110 (therapeutic exercise).

Then, assign two units of 97140 without the modifier, because the PT furnished the full 30 minutes of manual therapy. Second Step. Determine if the PTA furnished more than 10 percent of the remaining minutes of the 97110 service. To do this via the simple method. Add Start Printed Page 39216the PTA's 8 remaining minutes to the PT's 13 minutes for a total time of 21 minutes.

Divide the total by 10 to get 2.1 minutes and round to the nearest integer, which is 2 minutes (the 10 percent time standard for this service). Add 1 minute to find the threshold number of minutes that would exceed the de minimis standard, which in this example is 3 minutes. Using the percentage method, divide the PTA's remaining 8 minutes by the total 21 minutes of the service (8 PTA + 13 PT = 21 minutes) to get 0.38, then multiply the result × 100 = 38 percent. Final Step. Because 8 minutes meets or exceeds the 3-minute threshold, and 38 percent is greater than 10 percent, a second unit of 97110 is billed with the CQ modifier.

Example #2 PTA—19 minutes of 97110 PT—10 minutes of 97110 Total = 29 minutes—two units of 97110 can be billed (23 minutes through 37 minutes). Billing Explanation. First Step. Bill one unit of 97110 with the CQ modifier because a full 15 minutes was provided by the PTA, with 4 minutes remaining. Second Step.

Determine if the PTA's 4 remaining minutes exceed the 10 percent de minimis standard. Simple method. Add together the PTA's 4 remaining minutes and the 10 PT minutes to get the total time of 14 minutes and divide by ten to get 1.4 minutes and round to the nearest integer = 1 minute to get the 10 percent de minimis standard. Then add 1 minute to get a threshold minimum of 2 minutes for PTA time. If the PTA minutes are at or above the threshold, the CQ modifier applies.

Percentage method. Divide the PTA's 4 remaining minutes by the total time of 14 to get 0.29 then multiply by 100 = 29 percent. If the resulting percentage is greater than 10 percent, the PTA modifier applies. Final Step. Bill another unit of 97110 with the CQ modifier since 4 minutes is greater than the 2-minute threshold minimum and 29 percent is greater than 10 percent.

After reviewing the information posted on the CMS Therapy Services web page, therapy stakeholders reached out to CMS to express concern that certain aspects of the billing scenarios described in the guidance contradict their interpretation of our de minimis policy, especially as it applies to a final unit of a multiple-unit timed service. The therapy stakeholders suggested that the guidance we offered would lead to confusion for the same-service billing scenarios (including examples #1 and #2 above). We consider the unit of measure for a timed therapy service code to be 15 minutes. In billing scenarios with multiple units, we would consider the combined time for same or different services in 15-minute unit increments. The stakeholders agree that the de minimis standard is applied to the last unit of a timed therapy service code in two separate cases.

The first case happens when the PTA/OTA and the PT/OT each furnish less than 8 minutes for that final unit of a service. For example, if the PTA/OTA provided 7 minutes and the PT/OT furnished 5 minutes—using the simple method. 12 minutes divided by 10 equals 1.2, rounded to the nearest integer is 1, plus 1 equals 2—if the PTA/OTA provides 2 or more minutes, the CQ/CO modifier is applied. The second case occurs when the PTA/OTA provides 8 or more minutes and the PT/OT furnishes less than 8 minutes—in which event, the de minimis standard is exceeded and the CQ/CO modifier is applied. We note that the therapy stakeholders' interpretation of when the de minimis policy applies for a final 15-minute unit of a multiple unit timed service is based on what is commonly termed the “8-minute rule” which recognizes a unit of a 15-minute timed therapy service code as 8 minutes (more than the midpoint of the service or 7.5 minutes), but only when it applies to the final unit billed.

Applied to the above two examples, the stakeholders informed us that they believe the second unit of CPT code 97110 in both examples should not be billed with an assistant modifier because the therapist provided enough minutes of the service on their own, that is, 8 minutes or more, to bill for the last unit without the assistant's additional minutes. The stakeholders indicated that the therapist would have a financial incentive to not have the PTA/OTA provide the additional minutes at all if the CQ or CO modifier would apply. We note that, in addition to the two cases discussed above, there is another billing scenario to address in the context of our de minimis policy—specifically, where the PT/OT and PTA/OTA each furnish between 9 and 14 minutes of a 15-minute timed service when the total time of therapy services furnished in combination by the PTA/OTA and PT/OT is at least 23 but no more than 28 minutes, and there are two remaining units left to be billed. These “two remaining unit” cases with time ranges between 9 and 14 minutes include the following PTA/OTA:PT/OT (or vice versa) time splits. 9:14, 10:13, 11:12, 12:12, 12:13, 12:14, 13:13.

13:14. And 14:14. We believe that the stakeholder's interpretation of the de minimis standard is not consistent with the de minimis policy we finalized in the CY 2020 PFS final rule (84 FR 62702 through 62708). However, in working through the billing scenarios with the stakeholders, we identified where we could make refinements to our policy to address some of the confusion and concerns expressed by stakeholders and to address the “two remaining unit” cases noted above. These refinements may also avoid implementing a payment policy that could be perceived to penalize the provision of additional care by a therapy assistant when those minutes of service would lead to a reduced payment for a unit of a service.

The stakeholders criticized the finalized de minimis policy because they believed it provides an inherent financial incentive for the therapist to ensure that PTAs/OTAs provide services in exactly 15-minute intervals—to avoid any leftover PTA/OTA minutes that could necessitate application of the CQ/CO modifier, and reduced payment, for the service that the therapist is also providing—without regard to the clinical needs of the individual patient. The stakeholders suggested that if we were to recognize their “8-minute rule” and recommended policy, we would remove the incentive for the therapist to avoid providing appropriate minutes of therapy services performed by the PTA/OTA. To address the concerns expressed by the stakeholders and the “two remaining unit” cases we identified in our review, we propose to modify our existing policy, specifically for billing scenarios when only one unit of a timed therapy service remains to be billed (the majority of all billing scenarios) and the “two remaining unit” cases described above. As shown in Table 19, this proposal would require application of the CQ/CO modifier when the PTA/OTA provides at least 8 minutes or more and the PT/OT provides less than 8 minutes of the service. Or, when both the PT/OT and the PTA/OTA provide less than 8 minutes of the same service.

Start Printed Page 39217 Under this proposed modification, the CQ/CO modifier would not apply when the PT/OT furnishes 8 minutes or more, or both the PT/OT and the PTA/OTA furnish 8 minutes or more, of a timed service. This proposed “midpoint rule” policy was suggested to us by the therapy stakeholders. We agree that since, in this circumstance, the PT/OT provided enough minutes of the service on their own to bill the last unit of the service, the additional minutes of service performed by the PTA/OTA are not material, and thus, should be disregarded, as shown in the examples in Table 20. With these proposed policy adjustments, the CQ/CO modifiers apply when the PTA/OTA provides all the minutes of a timed service, and to some services (as illustrated in Table 19) when the PTA/OTA and PT/OT each, independent of the other, furnish portions of the same timed service. The CQ/CO modifiers also apply if the portion of an untimed code furnished by the PTA/OTA exceeds the de minimis standard.

The CQ/CO modifiers do not apply when the PTA/OTA and the PT/OT furnish different services. Time spent by the PT/OT and PTA/OTA providing services together is considered time spent by the PT/OT for purposes of applying the de minimis standard. Finally, we propose to modify our policy so that the CQ/CO modifiers would not apply when the PT/OT provides enough minutes of the service on their own to bill for the last unit of a timed service, (more minutes than the midpoint or 8 minutes of a 15-minute timed code) regardless of any additional minutes for the service provided by the PTA/OTA. Examples of Billing Scenarios using the CQ/CO modifiers when the de minimis standard applies, and the proposed policy for the last billed unit of a service. Example #A.

PTA—10 minutes of 97110 PT—5 minutes of 97110 Total = 15 minutes—qualifies to bill one 15-minute unit (8 minute to 22 minutes). Analysis. Bill one unit of 97110 with the CQ modifier because the PTA provided 8 minutes or more and the PT provided less than 8 minutes. The de minimis standard applies in these cases. Example #B.

PTA—5 minutes of 97110 PT—6 minutes of 97110 Total = 11 minutes—qualifies to bill one 15-minute unit (8 minute through 22 minutes). Analysis. Bill one unit of 97110 with the CQ modifier because the PTA and the PT both provided less than 8 minutes. In this case, the PT provided 6 minutes and the PTA furnished 5 minutes independent of each other. The de minimis standard applies in these cases.

Example #C. PTA-22 minutes of 97110 PT—23 minutes of 97110 Total = 45 minutes—qualifies to bill three 15-minute units (38 minutes through 52 minutes). Analysis. Apply Step One of the general policy rules and bill one unit of 97110 with the CQ modifier because the PTA provided 15 full minutes with 7 minutes remaining. Apply Step One to the PT's 23 minutes and bill one unit without the assistant modifier with 8 minutes remaining.

The third unit of 97110 is billed without the assistant modifier because the therapist provided enough minutes (8 or more minutes) without the PTAs minutes to bill the final unit.Start Printed Page 39218 Example #D—also see the below regulatory proposal using this `two remaining unit' example. PT—12 minutes of 97110 PTA—14 minutes of 97110 PT—20 minutes of 97140 Total = 46 minutes—qualifies to bill three units (38 minutes through 52 minutes). Analysis. Apply Step One of the general policy rules and bill one unit of 97140 without the CQ modifier because the PT provided 15 full minutes of one unit with 5 minutes remaining. Two units remain to be billed and the PT and the PTA each provided between 9 and 14 minutes independent of one another with a total time between 23 and 28 minutes—in these “two remaining unit” scenarios, one unit is billed with the CQ modifier for the PTA and the other unit is billed without it for the PT.

The PT's 5 remaining minutes of 97140 are counted towards the total timed minutes but are not billable in this scenario. Example #E OTA—11 minutes of 97535 OT—11 minutes of 97530 Total = 22 minutes—qualifies to bill one (1) unit (8 minutes through 22 minutes). Billing Analysis. Since two different services were furnished for an equal number of minutes—the “tie-breaker” scenario applies. Either code 97530 by the OT or code 97535 by the OTA can be billed in accordance with a billing example in the MCPM, Chapter 5, section 20.2.C.

Either one unit of 97530 is billed without the CO modifier or one unit of 97535 is billed with the CO modifier. Example #F. Untimed code—1 unit is billed for all untimed codes including evaluations, reevaluations, supervised modalities, and group therapy. OTA—20 minutes 97150 independent of the OT OT—20 minutes 97150 independent of the OTA Total = 40 minutes of Group Therapy = 1 unit of 97150 is billed for each group member. Billing Analysis.

One unit of group therapy 97150 is billed with the CO modifier because the OTA provided more than the 10 percent time standard in this example. Either method can be used to determine if the OTA's time exceeded the 10 percent time standard for this clinical scenario, see below. The simple method. First add the OTA's 20 minutes to the OT's 20 minutes to get 40, then divide by 10 to get 4.0 and add 1 to equal 5 minutes. The OTA's 20 minutes is equal to or greater than 5 minutes so the CO modifier is required on the claim.

The percentage method. Divide the number of minutes that an OTA independently furnished a service by the total number of minutes the service was furnished as a whole—20 divided by 40 equals 0.50. Then multiple by 100 to get 50 percent, which is greater than 10 percent. The CO modifier is applied to 97150. Tie breaker.

The tie breaker does not apply in this scenario because the example does not contain two different timed codes described in 15-minute intervals. For “tie breaker” see Example #F above. As noted above and illustrated in Example #D, there are a finite number of cases where there are two 15-minute units left to bill. In these “two remaining unit” cases, the PTA/OTA and the PT/OT each provide between 9 and 14 minutes with a total time of at least 23 minutes through 28 minutes. Under our proposed policy, one unit of the service would be billed with the CQ/CO modifier for the minutes furnished by the PTA/OTA (who furnished between 9 and 14 minutes of the service), and one unit would be billed without the CQ/CO modifier for the service provided by the PT/OT (who also furnished between 9 and 14 minutes of the same service).

This is because the PTA/OTA and the PT/OT each independently furnished part of each unit of the same service, and these cases are not addressed by the proposed midpoint rule that would apply when there is only one single unit left to bill. We are proposing to amend our regulation to address the scenario where there are two remaining 15-minute units of the same service for which the PTA/OTA and the PT/OT each provided between 9 and 14 minutes with a total time of at least 23 minutes and no more than 28 minutes. In this scenario, we propose that one unit of the service would be billed with the CQ/CO modifier and the other unit of the service would be billed without the assistant modifier. We are proposing to add this policy to our regulations at §§ 410.59(a)(4)(v) and 410.60(a)(4)(v) for outpatient occupational therapy and physical therapy services, respectively and at § 410.105(d)(3)(iv) for Comprehensive Outpatient Rehabilitation Facility (CORF) services. As noted above, when we finalized the policy to consider each 15-minute unit of a service for purposes of determining whether the de minimis standard applies, we neglected to revise our regulations at §§ 410.59, 410.60 and 410.105 to reflect this change.

As such, we are proposing to amend the regulations at §§ 410.59(a)(4)(iii)(B) and 410.60(a)(4)(iii)(B) for outpatient occupational therapy and physical therapy services, respectively, and at § 410.105(d)(3)(ii) for CORF services to specify that we consider a service to be furnished in part by a PTA or an OTA when the PTA/OTA furnishes a portion of a service, or in the case of a 15-minute timed code, a portion of a unit of a service, separately from the portion of the service or unit of service furnished by the therapist such that the minutes for that portion of a service or a unit of a service furnished by the PTA/OTA exceed 10 percent of the total minutes for that service or unit of a service. To accommodate the proposed refinement of the de minimis policy, we are proposing to amend the same regulations at §§ 410.59(a)(4)(iv) and 410.60(a)(4)(iv) for outpatient occupational therapy and physical therapy services, respectively, and at § 410.105(d)(3)(iii) for CORF services to provide that, for the final 15-minute unit billed for a patient for a date of service, when the PT/OT provides more than the midpoint (at least 8 minutes) of a service such that they could bill for the service without any additional minutes being furnished by the PTA/OTA, the service may be billed without a CQ or CO modifier, and any remaining minutes of service furnished by the PTA/OTA are considered immaterial. Beginning January 1, 2022, therapy services furnished in whole or in part by a PTA or OTA will be identified based on the inclusion by the billing therapy services provider (whether a therapist in private practice or therapy provider) of the CQ or CO modifier, respectively, on claim lines for therapy services, and the payment for those services will be adjusted as required by section 1834(v)(1) of the Act. Per our usual system update process, we plan to issue instructions in a change request to prepare our shared systems and Medicare Administrative Contractors (MACs) to pay the reduced amount for therapy services furnished in whole or in part by a PTA or OTA. We will issue an MLN article once the CR is released, after the CY 2022 PFS final rule is issued.

We are seeking comment on all of our proposals. I. Changes to Beneficiary Coinsurance for Additional Procedures Furnished During the Same Clinical Encounter as Certain Colorectal Cancer Screening Tests Section 122 of the Consolidated Appropriations Act (CAA) of 2021, Waiving Medicare Coinsurance for Start Printed Page 39219Certain Colorectal Cancer Screening Tests, amends section 1833(a) of the Act to offer a special coinsurance rule for screening flexible sigmoidoscopies and screening colonoscopies, regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure, that is furnished in connection with, as a result of, and in the same clinical encounter as the colorectal cancer screening test. The reduced coinsurance will be phased-in beginning January 1, 2022. Currently, the addition of any procedure beyond a planned colorectal cancer screening test (for which there is no coinsurance), results in the beneficiary having to pay coinsurance.

Section 1861(pp) of the Act defines “colorectal cancer screening tests” and, under sections 1861(pp)(1)(B) and (C) of the Act, identifies “screening flexible sigmoidoscopy” and “screening colonoscopy” as two of the recognized procedures. During the course of either one of these two procedures, removal of tissue or other matter may become necessary for diagnostic purposes. Among other things, section 1861(pp)(1)(D) of the Act authorizes the Secretary to include in the definition other tests or procedures and modifications to the tests and procedures described under this subsection, with such frequency and payment limits as the Secretary determines appropriate, in consultation with appropriate organizations. Section 1861(s)(2)(R) of the Act includes colorectal cancer screening tests in the definition of the medical and other health services that fall within the scope of Medicare Part B benefits described in section 1832(a)(1) of the Act. Section 1861(ddd)(3) of the Act includes colorectal cancer screening tests within the definition of “preventive services.” In addition, section 1833(a)(1)(Y) of the Act provides for payment for a preventive service under the PFS at 100 percent of the lesser of the actual charge or the fee schedule amount for these colorectal cancer screening tests, and under the OPPS at 100 percent of the OPPS payment amount, when the preventive service is recommended by the United States Preventive Services Task Force (USPSTF) with a grade of A or B.

As such, there is no beneficiary coinsurance for recommended colorectal cancer screening tests as defined in section 1861(pp)(1) of the Act. Under these statutory provisions, we have issued regulations governing payment for colorectal cancer screening tests at § 410.152(l)(5). We pay 100 percent of the Medicare payment amount established under the applicable payment methodology for the setting for providers and suppliers, and beneficiaries are not required to pay Part B coinsurance for colorectal cancer screening tests (except for barium enemas, which are not recommended by the USPSTF with a grade of A or B).[] In addition to colorectal cancer screening tests, which typically are furnished to patients in the absence of signs or symptoms of illness or injury, Medicare also covers various diagnostic tests (see § 410.32). In general, diagnostic tests must be ordered by the physician or practitioner who is treating the beneficiary and who uses the results of the diagnostic test in the management of the patient's specific medical condition. Under Part B, Medicare may cover flexible sigmoidoscopies and colonoscopies as diagnostic tests when those tests are reasonable and necessary as specified in section 1862(a)(1)(A) of the Act.

When these services are furnished as diagnostic tests rather than as screening tests, patients are responsible for the Part B coinsurance (20 or 25 percent depending upon the setting) associated with these services. We define colorectal cancer screening tests in our regulation at § 410.37(a)(1) to include “flexible screening sigmoidoscopies” and “screening colonoscopies, including anesthesia furnished in conjunction with the service.” Under our current regulations, we exclude from the definition of colorectal screening services, colonoscopies and sigmoidoscopies that begin as screening services, but where a polyp or other growth is found and removed as part of the procedure. The exclusion of these services from the definition of colorectal cancer screening tests is based upon longstanding provisions under sections 1834(d)(2)(D) and (d)(3)(D) of the Act dealing with the detection of lesions or growths during procedures (see CY 1998 PFS final rule at 62 FR 59048, 59082 for a more detailed explanation). Prior to the enactment of section 122 of the CAA, section 1834(d)(2)(D) of the Act provided that if, during the course of a screening flexible sigmoidoscopy, a lesion or growth is detected which results in a biopsy or removal of the lesion or growth, payment under Medicare Part B shall not be made for the screening flexible sigmoidoscopy, but shall be made for the procedure classified as a flexible sigmoidoscopy with such biopsy or removal. Similarly, prior to the recent legislative change, section 1834(d)(3)(D) of the Act provided that if, during the course of a screening colonoscopy, a lesion or growth is detected that results in a biopsy or removal of the lesion or growth, payment under Medicare Part B shall not be made for the screening colonoscopy but shall be made for the procedure classified as a colonoscopy with such biopsy or removal.

In these situations, Medicare pays for the flexible sigmoidoscopy and colonoscopy tests as diagnostic tests rather than as screening tests and the 100 percent payment rate for recommended preventive services under section 1833(a)(1)(Y) of the Act, as codified in our regulation at § 410.152(l)(5), has not applied. As such, beneficiaries currently are responsible for the usual coinsurance that applies to the services (20 or 25 percent of the cost of the services depending upon the setting). Under section 1833(b) of the Act, before making payment under Medicare Part B for expenses incurred by a beneficiary for covered Part B services, beneficiaries must first meet the applicable deductible for the year. Section 4104 of the Affordable Care Act (that is, the Patient Protection and Affordable Care Act (Pub L. 111-148, March 23, 2010), and the Health Care and Education Reconciliation Act of 2010 (Pub.

L. 111-152, March 30, 2010), collectively referred to as the “Affordable Care Act”) amended section 1833(b)(1) of the Act to make the deductible inapplicable to expenses incurred for certain preventive services that are recommended with a grade of A or B by the USPSTF, including colorectal cancer screening tests as defined in section 1861(pp) of the Act. Section 4104 of the Affordable Care Act also added a sentence at the end of section 1833(b)(1) of the Act specifying that the exception to the deductible shall apply with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as the screening test. Although amendments made by the Affordable Care Act addressed the applicability of the deductible in the case of a colorectal cancer screening test that involves biopsy or tissue removal, they did not alter the coinsurance provision in section 1833(a) of the Act for such procedures. Public commenters encouraged the agency to eliminate the coinsurance in these circumstances.

Start Printed Page 39220however, the agency found that statute did not provide for elimination of the coinsurance (75 FR 73170 at 73431). Beneficiaries have continued to contact us noting their concern that a coinsurance percentage applies (20 or 25 percent depending upon the setting) under circumstances where they expected to receive only a colorectal screening test to which coinsurance does not apply. Instead, these beneficiaries received what Medicare considers to be a diagnostic procedure because, for example, polyps were discovered and removed during the procedure. Similarly, physicians have expressed concern about the reactions of beneficiaries when they are informed that they will be responsible for coinsurance if polyps are discovered and removed during a procedure that they had expected to be a screening procedure to which coinsurance does not apply. Section 122 of the CAA addresses this coinsurance issue by successively reducing, over a period of years, the percentage amount of coinsurance for which the beneficiary is responsible.

Ultimately, for services furnished on or after January 1, 2030, the coinsurance will be zero. To implement the amendments made by section 122 of the CAA, we are proposing to modify our regulations to reflect the changes to Medicare statute. As amended, the statute effectively provides that, for services furnished on or after January 1, 2022, a flexible sigmoidoscopy or a colonoscopy can be considered a screening flexible sigmoidoscopy or a screening colonoscopy test even if an additional procedure is furnished to remove tissue or other matter during the screening test. Specifically, section 122(a)(3) of the CAA added a sentence to the end of section 1833(a) of the Act to include as colorectal screening tests described in section 1833(a)(1)(Y) of the Act, a colorectal cancer screening test, regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as the screening test. We note that only flexible screening sigmoidoscopies and screening colonoscopies are recognized currently as colorectal cancer screening tests that might involve removal of tissue or other matter.

This new sentence added under section 1833(a) of the Act uses the same language that was used to amend the statute at section 1833(b)(1) of the Act and to broaden the scope of colorectal cancer screening tests to which a deductible does not apply. Section 122(b)(1) of the CAA then limits application of the 100 percent Medicare payment rate (that is, no beneficiary coinsurance) under section 1833(a)(1)(Y) of the Act for the additional colorectal cancer screening tests (those that are not screening tests “but for” the new sentence at the end of section 1833(a) of the Act) by making payment for them subject to a new section 1833(dd) of the Act. Section 1833(dd) of the Act provides for a series of increases in the Medicare payment rate percentage for those services over successive periods of years through CY 2029. Thereafter, section 1833(dd) of the Act has no effect, so payment for all colorectal cancer screening tests would be made at 100 percent under section 1833(a)(1)(Y) of the Act. To codify the amendments made by section 122 of the CAA in our regulations, we are proposing to make two modifications to current regulations.

At § 410.37, we propose to modify our regulation where we define conditions for and limitations on coverage for colorectal cancer screening tests by adding a new paragraph (j). That paragraph would provide that, effective January 1, 2022, when a planned colorectal cancer screening test, that is, screening flexible sigmoidoscopy or screening colonoscopy test, requires a related procedure, including removal of tissue or other matter, furnished in connection with, as a result of, and in the same clinical encounter as the screening test, it is considered to be a colorectal cancer screening test. At § 410.152(l)(5), we also propose to modify our regulation. Here we describe payment for colorectal cancer screening tests. Effective January 1, 2022, we propose to provide for an increase in the Medicare payment percentage that is phased in over time.

As the Medicare payment percentage increases, the beneficiary coinsurance percentage decreases. We propose to revise § 410.152(l)(5) to provide that Medicare payment in a specified year is equal to a specified percent of the lesser of the actual charge for the service or the amount determined under the fee schedule that applies to the test. The phased in Medicare payment percentages for colorectal cancer screening services described in the proposed regulation at § 410.37(j) (and the corresponding reduction in coinsurance) are as follows. 80 percent payment for services furnished during CY 2022 (with coinsurance equal to 20 percent). 85 percent payment for services furnished during CY 2023 through CY 2026 (with coinsurance equal to 15 percent).

90 percent payment for services furnished during CY 2027 through CY 2029 (with coinsurance equal to 10 percent). And 100 percent payment for services furnished from CY 2030 onward (with coinsurance equal to zero percent). Thus, between CYs 2022 and 2030, the coinsurance required of Medicare beneficiaries for planned colorectal cancer screening tests that result in additional procedures furnished in the same clinical encounter will be reduced over time from the current 20 or 25 percent to zero percent in CY 2030 and will remain at zero percent for these services furnished beginning in CY 2030 and thereafter. J. treatment Administration Services.

Comment Solicitation. Medicare Payments for Administering Preventive treatments On January 31, 2020, under section 319 of the Public Health Service (PHS) Act (42 U.S.C. 247d), the Secretary of the Department of Health and Human Services (the Secretary) determined that a public health emergency (PHE) as a result of confirmed cases of 2019 Novel anti-inflammatories exists nationwide and has existed since January 27, 2020 (hereafter referred to as the PHE for anti inflammatory drugs). The Secretary has since renewed this declaration for successive 90-day periods, the latest on April 15, 2021. The PHE for anti inflammatory drugs has reinforced the important and positive impact that preventive treatments can have on the health of Medicare beneficiaries and the broader public.

At the time of publishing this proposed rule, the PHE for anti inflammatory drugs declaration is still in effect and the United States is in the middle of a national effort to vaccinate as many people against anti inflammatory drugs as quickly as possible. This national effort has at least temporarily altered the landscape for treatments and treatment administration by, for example, encouraging existing providers and suppliers to dramatically expand their vaccination capabilities and by encouraging new (and new types) of providers and suppliers to furnish treatments. Over the past several years, stakeholders have expressed concerns about the reduction in Medicare payment rates for the service to administer preventive treatments covered by Medicare Part B under section 1861(s)(10) of the Act, including the influenza, pneumococcal, and hepatitis B symbicort (HBV) treatments. In the last two PFS rulemaking cycles (that is, for CY 2020 and CY 2021), we have attempted Start Printed Page 39221to address some of these concerns and these efforts are discussed in more detail below. However, CY 2021 payment rates for administration of these treatments by suppliers including physicians, NPPs, and mass immunizers remain the same as in CY 2019.

A national average rate of $16.94, which is geographically adjusted. In this section, we are seeking feedback on how we should update the payment rate for administration of these preventive treatments under Medicare Part B. 1. Medicare Part B Payment for treatments Under section 1861(s)(10) of the Act, Medicare Part B covers both the treatment and its administration for the preventive treatments specified—the influenza, pneumococcal, HBV, and anti inflammatory drugs treatments. Under sections 1833(a)(1)(B) and (b)(1) of the Act, there is no applicable beneficiary coinsurance, and the annual Part B deductible does not apply for these vaccinations or the services to administer them.

In CY 2021, payment for these treatments is based on 95 percent of the Average Wholesale Price (AWP) for a particular treatment product except where furnished in the settings for which payment is based on reasonable cost, such as a hospital outpatient department, rural health clinic (RHC), or federally qualified health center (FQHC). For example, for the 2020-2021 influenza season, payment limits for adult influenza treatment products range from about $19 to $61 per adult dose. We note that most other preventive treatments not specified for Medicare Part B coverage under section 1861(s)(10) of the Act, such as the shingles treatment, are covered and paid for under Medicare Part D. Section 3713 of the anti-inflammatories Aid, Relief, and Economic Security Act (CARES Act) (Pub. L.

116-136) added the anti inflammatory drugs treatment and its administration to section 1861(s)(10)(A) of the Act in the same subparagraph as the influenza and pneumococcal treatments and their administration. To implement this section, we issued an interim final rule with comment period (November 4th anti inflammatory drugs IFC (85 FR 71145 through 71150)) which established that payments for anti inflammatory drugs treatments and treatment administration would be made in the same manner as payments for the influenza and pneumococcal treatments. The IFC specifically amended §§ 414.707(a)(2)(iii) and 414.904(e)(1) to include the anti inflammatory drugs treatment in the list of treatments with payment limits calculated using 95 percent of the AWP (85 FR 71147). We note that Medicare does not pay providers and suppliers for the treatment product when the federal government purchases it and gives it to the provider or suppliers for free, as has been the case for all anti inflammatory drugs treatments as of the publication of this proposed rule. We note that the treatment administration services described under 1861(s)(10) of the Act are not technically valued or paid under the PFS, as they are not included within the statutory definition of physicians' services in section 1848(j)(3) of the Act.

Despite this, we have historically based payment rates for the administration of these preventive treatments by suppliers such as physicians, NPPs, and mass immunizers on an evaluation of the resource costs involved in furnishing the service, which is similar to the methodology that we use to establish payment rates for the PFS. We note further that we also assign a payment rate for administering these preventive treatments under the Outpatient Prospective Payment System (OPPS), and those payment rates are for hospitals and home health agencies for preventive treatment administration. Certain other types of providers and suppliers, such as RHCs, FQHCs and critical access hospitals (CAHs), are paid based on reasonable cost for treatment administration. We also note that these payments are geographically adjusted based on the provider's wage index. As discussed in the CY 2021 PFS proposed rule (85 CFR 50162), many stakeholders raised concerns about the reductions in payment rates for the preventive treatment administration services that had occurred over the past several years.

We generally have established payment rates for the three Healthcare Common Procedural Coding System (HCPCS) codes G0008, G0009, and G0010—which describe the services to administer an influenza, pneumococcal and HBV treatments, respectively, based on a direct crosswalk to the PFS payment rate for CPT code 96372 (Therapeutic, prophylactic, or diagnostic injection (specify substance or drug). Subcutaneous or intramuscular). Because we proposed and finalized reductions in valuation for that code for CY 2018, the payment rate for the treatment administration codes was concurrently reduced. Further, because the reduction in RVUs for CPT code 96372 was significant enough to be required to be phased in over several years under section 1848(c)(7) of the Act, the reductions in overall valuation for the treatment administration codes were likewise subject to reductions over several years. As noted in Table 21, the national payment rate for administering these preventive treatments has declined more than 30 percent since 2015.

Start Printed Page 39222 We have attempted to address the reduction in payment rates for these treatment administration HCPCS codes in the last two PFS rulemaking cycles. In the CY 2020 PFS final rule, we acknowledged that it is in the public interest to ensure appropriate resource costs are reflected in the valuation of the immunization administration services that are used to deliver these treatments, and noted that we planned to review the valuations for these services in future rulemaking. For CY 2020, we maintained the CY 2019 national payment amount for immunization administration services described by HCPCS codes G0008, G0009 and G0010. In the CY 2021 PFS proposed rule, we proposed to crosswalk G0008, G0009 and G0010 to CPT code 36000 (Introduction of needle or intracatheter, vein) (85 FR 50163). In the proposed rule, we noted that CPT code 36000 is a service with a similar clinical vignette, and that the additional clinical labor, supply, and equipment resources associated with furnishing CPT code 36000 were similar to costs associated with these treatment administration codes.

We also noted that this crosswalk would have resulted in payment rates for treatment administration services at a rate that is approximately the same as the CY 2017 rate (as noted in Table 21) that was in place prior to the revaluation of CPT code 96372 (the original crosswalk code). In the CY 2021 PFS final rule, we did not finalize the proposed policy, and instead finalized a policy to maintain the CY 2019 payment amount for G0008, G0009 and G0010 (85 FR 84628). In the final rule, we also noted that we continued to seek additional information that specifically identifies the resource costs and inputs that should be considered to establish payment for treatment administration services on a long-term basis. As noted above, section 3713 of the CARES Act added the anti inflammatory drugs treatment and its administration to the preventive treatments covered under Medicare Part B under section 1861(s)(10)(A) of the Act in the same subparagraph as the influenza and pneumococcal treatments and their administration. Section 3713 of the CARES Act allows us to implement the amendments made by that section through “program instruction or otherwise.” In the November 4th anti inflammatory drugs IFC (85 FR 71147) implementing section 3713 of the CARES Act, we indicated that we would establish specific coding and payment rates for the anti inflammatory drugs treatment and treatment administration through technical direction to Medicare Administrative Contractors (MACs) and information posted publicly on CMS' website.

In December 2020, we publicly posted the applicable CPT codes for the Pfizer-BioNTech and Moderna anti inflammatory drugs treatments and initial Medicare payment rates for administration of these treatments upon the FDA's authorization of these treatments. We announced an initial Medicare payment rate for anti inflammatory drugs treatment administration of $28.39 to administer single-dose treatments. For a anti inflammatory drugs treatment requiring a series of two or more doses—for example, for both the Pfizer-BioNTech and Moderna products—we announced a payment rate for administration of the initial dose(s) of $16.94, which was based on the Medicare payment rate for administering the other preventive treatments under section 1861(s)(10) of the Act. We also announced a payment rate for administering the second dose of $28.39, which was based on the payment rate that was proposed, but not finalized, for administration of the other preventive treatments under section 1861(s)(10) of the Act in the CY 2021 PFS proposed rule, discussed in more detail above. On March 15, 2021, we announced an increase in the payment rate for administering a anti inflammatory drugs treatment to $40 per dose, effective for doses administered on or after March 15, 2021, which means the payment rate is $40 to administer a single dose product, and $40 each to administer the first and second dose in a two-dose regime ($80 total).

Start Printed Page 39223 As discussed above, payment rates for suppliers such as physicians, NPPs, and mass immunizers for administering the Part B covered preventive treatments have generally been based on a direct crosswalk to CPT code 96372 (Therapeutic, prophylactic, or diagnostic injection (specify substance or drug). Subcutaneous or intramuscular). This crosswalk code is paid under the PFS, and Medicare's process to value codes under the PFS relies in part on recommended resource inputs provided by the AMA RUC and steps to translate those recommended inputs into national RVUs. In 2020, the RUC resubmitted its 2009 valuation recommendation for treatment administration services described by CPT codes, including CPT codes 90460 (Administration of first treatment or toxoid component through 18 years of age with counseling), 90471 (Administration of 1 treatment), and 90473 (Administration of 1 nasal or oral treatment). The AMA RUC also recently provided valuation recommendations for the CPT codes that describe the service to administer the anti inflammatory drugs treatments.

As noted earlier, we also assign a payment rate for administering preventive treatments under the OPPS by assigning an ambulatory payment classification (APC) to each service based on clinical and resource cost similarity to other services assigned to the APC. Geometric mean costs, which are generally used in establishing the prospective OPPS payments for each APC, are calculated using historical claims and cost report information. In CY 2021, CMS assigned HCPCS codes G0008, G0009 and G0010 to APC 5691 (level 1 drug administration), which has a national payment rate of $40 for CY 2021. Our practice of setting payment rates for preventive treatment administration services described by HCPCS codes G0008, G0009 and G0010 for physicians, NPPs, and mass immunizers by using the PFS approach (for example, a crosswalk to an existing CPT code) means that costs incorporated into the rate primarily reflect costs of furnishing the service in a physician office setting. It also means that the payment rate can be affected by other aspects of the PFS rate-setting methodology, such as the allocation of indirect PE, and broader changes to PFS codes and rates, including the multi-year phase-in of significant reductions in RVUs discussed earlier.

We note that we have not historically collected or used information from other providers and suppliers, including pharmacies which are commonly enrolled as mass immunizers to furnish treatments and treatment administration services, for purposes of establishing a rate for these codes. We are requesting feedback from stakeholders that would support the development of an accurate and stable payment rate for administration of the preventive treatments described in section 1861(s)(10) of the Act for physicians, NPPs, mass immunizers and certain other providers and suppliers. We are interested in detailed feedback on the following questions, which we believe would assist us in establishing payment rates for these services that could be appropriate for use on a long-term basis. What are the different types of providers and suppliers that furnish preventive treatments, and have these types of providers/suppliers changed as a result of the PHE for anti inflammatory drugs?. (We note that our claims data reflect the type of Medicare enrollment for those billing for the treatment administration, but we are particularly interested in understanding additional, specific characteristics of the providers and suppliers that may not be distinguishable under the more general Medicare enrollment data.) We are also interested in whether different providers and suppliers furnish different aspects of the treatment administration for the same beneficiary.

What are the differences in incurred costs of furnishing flu, pneumonia and HBV treatments compared to furnishing anti inflammatory drugs treatments?. Are there differences in the costs (per dose or otherwise) of furnishing a one-dose treatment product vs. A two-dose treatment product?. Also, are there differences in cost of administering preventive treatments furnished under the Part D benefit, such as the shingles treatments, compared to those furnished under Part B?. What are the resource costs that physicians, NPPs, mass immunizers and certain other suppliers incur when furnishing treatments safely and effectively?.

We are interested in specific information on costs related to staffing/labor, infrastructure, patient onboarding/enrollment, treatment storage and handling, treatment procurement and coordination, supplies, CDC and state reporting requirements, patient counseling about safety and efficacy, and other costs we may not have considered. We are also interested in specific resource costs per treatment dose within each cost category, if that is available. What are the impacts of the PHE for anti inflammatory drugs on resource costs incurred by vaccination providers, and do stakeholders envision that these impacts will continue after the PHE has ended?. Following the end of the PHE, do you expect that the same types of vaccination providers and suppliers will continue to administer treatments, or do you envision that this will change (if so, how, and what would be the primary factors driving the change)?. As described previously, Medicare has generally relied on the PFS methodology for setting payment rates for HCPCS codes G0008, G0009 and Start Printed Page 39224G0010.

How should Medicare assess costs associated with furnishing these preventive treatments outside of the physician office setting, such as in pharmacies, mass immunization sites, mobile treatment clinics or other locations?. In addition, we understand that there could be administrative burden associated with the routine collection of cost data to support more accurate rate-setting for suppliers that are vaccinating patients. Are there other ways to update and validate costs for a broader range of entities using existing data?. Payment rates for treatment administration currently vary by setting. For HCPCS codes G0008, G0009 and G0010, the CY 2021 national average payment rate for physicians, practitioners and other suppliers is $16.94, which is geographically adjusted, while for hospital outpatient departments it is $40.

However, for anti inflammatory drugs treatment administration, Medicare now pays $40 per administration in all settings, unless the treatment in administered under certain circumstances in the beneficiary's home or residence (as discussed in more detail below). Should Medicare continue to pay differently for non-anti inflammatory drugs preventive treatments furnished in certain settings or under certain conditions?. If not, what factors contribute to higher costs for administration of non-anti inflammatory drugs treatments that are not currently reflected in the Medicare payment rates?. Should CMS use a different process to update the payment rates for administration of the preventive treatments described in section 1861(s)(10) of the Act on an annual basis?. In the last few years we have also crosswalked treatment administration CPT codes 90460 (Administration of first treatment or toxoid component through 18 years of age with counseling), 90461 (Administration of treatment or toxoid component through 18 years of age with counseling), 90471 (Administration of 1 treatment), 90472 (Administration of treatment), 90473 (Administration of 1 nasal or oral treatment), and 90474 (Administration of nasal or oral treatment) to the same rate used by G0008, G0009 and G0010.

How should Medicare address payment rates for these CPT codes under the PFS?. Are there major differences between what Medicare pays physicians, NPPs and mass immunizers for non-anti inflammatory drugs preventive treatment administration and what commercial insurers pay?. To the extent possible we are also interested in feedback on specific rates used by other insurers. 2. Payment for anti inflammatory drugs treatment Administration in the Home Effective June 8, 2021, we announced a new add-on payment with a national rate of $35.50 when a anti inflammatory drugs treatment is administered in the beneficiary's home.[] Under this new policy, providers and suppliers that administer a anti inflammatory drugs treatment in a beneficiary's home under certain circumstances can bill Medicare for one of the existing anti inflammatory drugs treatment administration CPT codes (0001A, 0002A, 0011A, 0012A, 0031A) along with HCPCS code M0201 (anti inflammatory drugs treatment administration inside a patient's home.

Reported only once per individual home per date of service when only anti inflammatory drugs treatment administration is performed at the patient's home). Providers and suppliers administering a anti inflammatory drugs treatment in the home will be paid a national average payment $75.50 dollars per dose ($40 for anti inflammatory drugs treatment administration and $35.50 for the additional payment for administration in the home, and both payments are geographically adjusted). In establishing the additional payment for anti inflammatory drugs treatment administration in the beneficiary's home, we also established certain conditions for the add-on payment described by HCPCS code M0201. More specifically, for purposes of this additional payment for administration of the anti inflammatory drugs treatment in the beneficiary's home, we established that Medicare will make this payment when either of these situations applies. The patient has difficulty leaving the home to get the treatment, which could mean any of these.

(1) They have a condition, due to an illness or injury, that restricts their ability to leave home without a supportive device or help from a paid or unpaid caregiver. (2) They have a condition that makes them more susceptible to contracting a symbicort disease like anti inflammatory drugs. Or (3) They are generally unable to leave the home, and if they do leave home, it requires a considerable and taxing effort. The patient is hard-to-reach because they have a disability or face clinical, socioeconomic, or geographical barriers to getting a anti inflammatory drugs treatment in settings other than their home. These patients face challenges that significantly reduce their ability to get vaccinated outside the home, such as challenges with transportation, communication, or caregiving.

We also specified that payment is made for HCPCS code M0201 if the sole purpose of the visit is to administer the anti inflammatory drugs treatment. However, Medicare will not pay the additional amount if the provider or supplier furnished another Medicare covered service in the same home on the same date. For purposes of this add-on payment for in-home anti inflammatory drugs treatment administration, we announced that a home can be a private residence temporary lodging (for example, a hotel or motel, campground, hostel, or homeless shelter), an apartment in an apartment complex or a unit in an assisted living facility or group home, or a patient's home that is made provider-based to a hospital during the PHE for anti inflammatory drugs. As such, a home may be a domiciliary or rest home, meaning a facility, which provides room, board, and other personal assistance services (for example, an assisted living facility). We also announced that the following locations are not considered to be the patient's home for purposes of the add-on payment for anti inflammatory drugs treatment administration.

Communal spaces of a multi-unit living arrangement. Hospitals. Medicare SNFs, and Medicaid NFs, regardless of whether they are the patient's permanent residence. Assisted living facilities participating in the CDC's Pharmacy Partnership for Long-Term Care Program when their residents are vaccinated through this program. We are clarifying that an institution is not considered to be a patient's home if the institution meets the requirements of sections 1861(e)(1), 1819(a)(1), or 1919(a)(1) of the Act, which includes hospitals and skilled nursing facilities, as well as most nursing facilities under Medicaid.[] Additionally, we established that assisted living facilities participating in the CDC Pharmacy Partnership for Long-Term Care Program partnership would not be eligible for this higher payment for anti inflammatory drugs treatment administration in the home when their residents were vaccinated through this program.

In addition, the anti inflammatory drugs treatment administration service must be furnished inside an individual's home. An individual unit in a multi-dwelling building is considered a home. For example, an individual apartment in an apartment complex or an individual bedroom inside an assisted living facility or group home is considered a home. We established that communal spaces of, or related to, congregate living arrangements (such as a communal area of an apartment or condominium complex, assisted living facility, group Start Printed Page 39225home) are not considered a home for purposes of this add-on payment because multiple people could be vaccinated and monitored either simultaneously or in tandem in such communal spaces. As noted in the code descriptor for HCPCS code M0201, this code can be billed only once per individual home per date of service.

In situations where more than one Medicare beneficiary lives in the same individual home, the additional payment for anti inflammatory drugs treatment administration in the home is limited to one time in that home on that day, while any additional anti inflammatory drugs treatment administration services for other individuals in that same home would be paid at the generally applicable rate of approximately $40 without the additional in-home add-on payment amount. We established the payment amount for HCPCS code M0201 for in-home vaccination to reflect the additional costs associated with administering the treatment in the home, such as upfront administration costs like scheduling, the additional clinical time needed for post administration monitoring of a single patient, and public health reporting requirements. To identify an appropriate payment rate for HCPCS code M0201, we used the home health low utilization payment adjustment add-on factor for skilled nursing as a proxy for the increased resource costs, above those reflected in the base payment rate for anti inflammatory drugs treatment administration, involved in arranging and furnishing anti inflammatory drugs treatment administration services in the home. For home health services, we make a low utilization payment adjustment (LUPA) when, during a 30-day period of home health care (or prior to January 1, 2020, a 60-day episode of home health care) a patient receives minimal services (less visits than a predetermined threshold) and the home health agency is paid per visit rather than the full 30-day (previously 60-day) bundled payment amount (see 42 CFR 484.230). As stated in the CY 2008 HH PPS proposed rule, after the HH PPS went into effect we received comments and correspondence stating that the LUPA per-visit payment rates do not adequately account for the front-loading of costs in an episode.

Commenters suggested that because of the small number of visits in a LUPA episode, HHAs have little opportunity to spread the costs of lengthy initial visits over a full episode (72 FR 25424). As such, under the Medicare home health payment system, LUPA add-on payments are made to account for the upfront fixed costs and prolonged visit lengths in a LUPA period/episode compared to those for non-LUPA periods/episodes. We believe the LUPA add-on factor for skilled nursing is an appropriate proxy for the upfront fixed costs and prolonged visit lengths that exemplify and constitute the increased resource costs involved in arranging and furnishing anti inflammatory drugs treatment administration services in the home. The CY 2021 LUPA add-on factor for skilled nursing is 1.8451, and we applied this to the base rate for anti inflammatory drugs treatment administration of $40 per dose (effective March 15, 2021). This calculation results in a total proxy payment rate for in-home anti inflammatory drugs treatment administration of approximately $74.

Subtracting the $40 base rate for anti inflammatory drugs treatment administration, which applies across most other settings, results in an additional proxy payment rate of roughly $34. To expedite access to this service and ensure consistency in payment rates for HCPCS code M0201 between health care professionals, other suppliers, and institutional providers, we established a payment rate that corresponds to the proxy we calculated based on the LUPA add-on factor using a reference to another proxy payment rate under the hospital OPPS. Specifically, we looked to APC payment amounts under the hospital OPPS that were similar to the $34 proxy amount and could be implemented with speed under the anti inflammatory drugs treatment benefit (which relies on both institutional and professional claims processing systems). We identified New Technology APC 1494 under the hospital OPPS with a national payment rate of $35.50 as an appropriate reference payment amount for this service for most providers and suppliers, and established that amount as the national payment rate for HCPCS code M0201. That is, the national payment rate for HCPCS code M0201 is $35.50 for all providers and suppliers not paid reasonable cost.

In announcing the add-on payment for in-home anti inflammatory drugs treatment administration, we noted that we established these policies on a “preliminary basis to ensure access to anti inflammatory drugs treatments during the public health emergency” and that “we continue to evaluate the needs of Medicare patients and these policies, and will address them in the future, as needed”.[] We are using this proposed rule as a way to collect feedback on these policies and potential future changes. We are interested in feedback on our requirements, including the definition of the “home” and the types of clinical and non-clinical circumstances that make it difficult for a beneficiary to receive a anti inflammatory drugs treatment outside the home. Do these requirements strike the appropriate balance of ensuring access to treatments for vulnerable beneficiaries while also protecting against potential fraud?. Should we maintain these requirements during the PHE as-is, and if not, what changes should we consider?. Outside of the circumstances of the PHE that create a need for beneficiaries to be vaccinated as quickly and broadly as possible, under what circumstances do health care providers, suppliers, or others find particular need to vaccinate people at home rather than periodically in association with routine in-person visits?.

As noted, we established an add-on payment of $35.50, which is based on applying the LUPA add-on factor for skilled nursing to the national $40 payment rate for the base service as a proxy to reflect the additional resources involved in furnishing services in the home setting. We are interested in detailed feedback on the costs associated with furnishing anti inflammatory drugs treatments in the home, and how these costs differ from costs of furnishing treatments in traditional locations, such as a physician's office or mass immunization site. What other steps should we take related to program integrity and beneficiary protection with this new add-on payment for administering the anti inflammatory drugs treatment in the home?. What documentation should providers and suppliers that furnish treatments in the home be required to maintain and/or provide?. We note that this add-on payment of $35.50 only applies when providers or suppliers furnish the anti inflammatory drugs treatment in the beneficiary's home, and is not billable when providers and suppliers furnish a different preventive treatment (influenza, pneumonia, HBV) in the home.

We believe the additional payment is only appropriate for anti inflammatory drugs treatments due to the unique circumstances of the PHE, as well as the upfront fixed costs and prolonged visit lengths that exemplify and constitute the increased resource costs involved in arranging and furnishing anti inflammatory drugs treatment administration services in the home. However, we are interested in feedback on whether the same barriers that could prevent a beneficiary from obtaining a anti inflammatory drugs treatment would also prevent them from obtaining other preventive treatments, whether Medicare should make a similar add-on treatment administration payment in those Start Printed Page 39226circumstances, and whether the costs to furnish other preventive treatments in the beneficiary's home would be consistent with the costs to furnish the anti inflammatory drugs treatment. 3. Monoclonal Antibodies Used To Treat anti inflammatory drugs On November 10, 2020, the FDA issued an Emergency Use Authorization (EUA) for bamlanivimab monotherapy.[] On November 21, 2020 the FDA issued an EUA for casirivimab and imdevimab, which are administered together.[] On February 9, 2021, the FDA issued an EUA for bamlanivimab and etesevimab, which are also administered together.[] On April 16, 2021, the FDA revoked the EUA for bamlanivimab monotherapy.[] On May 26, 2021, the FDA issued an EUA for sotrovimab monotherapy.[] On June 3, 2021, the FDA revised the EUA for casirivimab and imdevimab, which revised the dosing regimen from 2400mg (1200 mg of casirivimab and 1200 mg of imdevimab) to 1200mg (600 mg of casirivimab and 600 mg of imdevimab), authorized the addition of a new presentation consisting of a single vial of casirivimab and imdevimab co-formulated in a 1:1 ratio, and also authorized casirivimab and imdevimab to be administered together via subcutaneous injection in certain limited circumstances.[] On June 24, 2021, the FDA issued an EUA for tocilizumab monotherapy.[] Under the EUAs, for all of these products except for tocilizumab, they can be used for certain high-risk patients with mild-to-moderate anti inflammatory drugs with the goal of preventing further deterioration and hospitalization. Tocilizumab is authorized for hospitalized patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

When these products were authorized during the PHE for anti inflammatory drugs, we made the determination to cover and pay for them under the anti inflammatory drugs treatment benefit in section 1861(s)(10) of the Act. When we announced this approach, we also indicated that we would address “potential refinements to payment for administering monoclonal antibody products to treat anti inflammatory drugs through future notice-and-comment rulemaking”.[] We make a separate payment for the products (when not given to the provider or supplier for free by the government) and for the service to administer them. We note that as of June 30, 2021, the monoclonal antibody products authorized by the FDA under an EUA include two products involving drugs administered together, casirivimab and imdevimab and bamlanivimab and etesevimab, the sotrovimab monotherapy, and the tocilizumab monotherapy. All four products may be administered through intravenous (IV) infusion, and casirivimab and imdevimab may be administered via subcutanoues injection in certain limited circumstances under the updated June 3rd EUA. Initially, we established a national payment rate of $309.10 for the service to administer (through IV infusion only at the time) these products, which was based on one hour of infusion and post-infusion monitoring in the hospital outpatient setting.

We note that while these products are typically infused over a period of roughly one hour, the EUA for casirivimab and imdevimab allows the product to be infused over a shorter time-period, such as 20 minutes, when appropriate. We note that, as of June 15, 2021, the EUAs require at least one hour of post infusion monitoring for all of the products available. On May 6, 2021, we increased the payment rate for administration to $450.00 and established a separate payment rate of $750.00 when a monoclonal antibody product used to treat anti inflammatory drugs is administered in a home or residence.[] The decision to cover and pay for monoclonal antibody products used to treat anti inflammatory drugs under the anti inflammatory drugs treatment benefit prioritized access to these products during the anti inflammatory drugs symbicort by allowing almost all Medicare enrolled providers and suppliers, as permitted by state law and consistent with the terms of the EUA, to furnish and bill for administering these products across settings of care. Covering and paying for these services under the anti inflammatory drugs treatment benefit also means that beneficiaries are not responsible for any cost sharing for the product or the service to administer it. We note that Medicare considers other monoclonal antibody products—that is, monoclonal antibody products used in the treatment of other health conditions—“biologicals” and pays for them based on the methodology in section 1847A of the Act when they are furnished in physician offices, ambulatory infusion clinics and under a similar methodology under the hospital OPPS.

We also note that, for these care settings, we typically rely on the applicable AMA CPT codes to describe and pay for drug administration services performed by providers and suppliers. As noted above, bamlanivimab monotherapy and casirivimab and imdevimab, administered together, were authorized in late 2020, we made the determination to cover and pay for them under the treatment benefit in section 1861(s)(10) of the Act, and this decision prioritized beneficiary access for purposes of addressing the PHE for anti inflammatory drugs. Since that time, the EUA for bamlanivimab monotherapy has been revoked, the EUA for casirivimab and imdevimab administered together has been revised to include a new presentation, a new dosing regimen, and a new route of administration (in certain limited circumstances), the sotrovimab monotherapy has been authorized and the tocilizumab monotherapy has been authorized. It is also becoming clear that, as more products enter the market, the federal government may not purchase them for distribution to providers and suppliers for free, as is the case with sotrovimab monotherapy and tocilizumab monotherapy. Given these fast-moving changes, we are seeking feedback on our approach to coverage and payment for anti inflammatory drugs monoclonal antibody products under the anti inflammatory drugs treatment benefit.

We are considering whether we should align payment and coverage for these products with our approach for other monoclonal antibody products following the end of the PHE. We believe that the context in which these products are furnished to beneficiaries after the end of the PHE may more closely resemble the circumstances under which similar drugs and biologics are ordinarily furnished, specifically to a more targeted patient population outside of a symbicort. Outside the context of the PHE, we believe treating these products like other drugs and biologics paid under section 1847A of the Act may better align Medicare coverage and payment policies for anti inflammatory drugs monoclonal antibody products with other monoclonal antibody products, which are purchased by providers and suppliers through Start Printed Page 39227similar channels and administered using similar modalities. As noted above, coverage and payment for anti inflammatory drugs monoclonal antibodies under the anti inflammatory drugs treatment benefit has meant that Medicare beneficiaries are not responsible for any cost-sharing, which is typically 20 percent of the allowed amount in most settings. We note that if Medicare were to pay for anti inflammatory drugs monoclonal antibody products under the methodologies in 1847A of the Act, it would mean that beneficiary co-insurance would apply, similar to how it applies to other drugs and biologics that are not paid for under a preventive treatment benefit.

We also note that tocilizumab—typically sold under the brand name Actemra—was previously approved by the FDA for several indications.[] As a result, during the PHE for anti inflammatory drugs, Medicare has separate coding and payment rules for tocilizumab when it is furnished to patients with anti inflammatory drugs and in a manner consistent with the terms of the EUA, and for when tocilizumab is used for other clinical purposes. This may be confusing for hospital providers and we believe that treating these monoclonal antibody products like other drugs and biologics paid under section 1847A of the Act may help clarify these inconsistencies. We are interested in feedback on these issues. We are also interested in additional feedback on the resource costs to administer anti inflammatory drugs monoclonal antibody products, such as costs associated with infrastructure, clinical labor, and equipment, including personal protective equipment. We recognize that administering monoclonal antibodies used to treat anti inflammatory drugs may be complex due the need to interact with beneficiaries that have active s and manage the potential for spreading disease.

We are interested in information on how the costs to furnish monoclonal antibodies used to treat anti inflammatory drugs compare with infusions of other complex biologics, and how the costs to furnish these products may be different when these products are administered in the home. 4. Summary We have taken several steps to promote timely access to anti inflammatory drugs treatments including monoclonal antibody products during the PHE for anti inflammatory drugs. As explained above, we increased the payment rates we initially established for services to administer a anti inflammatory drugs injected treatment and a anti inflammatory drugs infused or injected monoclonal antibody product. We also developed specific payment rates when these products are administered in the beneficiary's home.

Taken together, these efforts signal our understanding of the importance of anti inflammatory drugs treatments for the health of the individual beneficiary and the public. We also believe these efforts, and the PHE broadly, provide an opportunity to consider a more rational payment framework for the other preventive treatments covered under Medicare Part B. We are encouraged by stakeholder engagement on these important issues and continue to seek information that reflects the resource costs that we should consider for treatment administration services. We are interested in detailed feedback and verifiable data from the public to help inform whether we should consider making changes to payments for administering preventive treatments, or develop separate payments for treatment administration in the home. We appreciate feedback from the public on these important issues regarding preventive treatment administration, treatment administration in the home, and monoclonal antibodies used to treat anti inflammatory drugs.

K. Payment for Medical Nutrition Therapy Services and Related Services Section 105 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554, December 21, 2000) added section 1861(vv)(1) to the Act which provided Medicare coverage under Part B for Medical Nutrition Therapy (MNT) services when performed by registered dietitians and nutrition professionals pursuant to a referral from a physician. Under section 1842(b)(18)(C) of the Act, registered dietitians and nutrition professionals are included in the list of NPPs that may bill Medicare and be paid directly for their services, effective January 1, 2002.

To submit claims for MNT services, the registered dietitian or nutrition professional must enroll as such in accordance with our regulations at 42 CFR 414.64 and 424.510. Like other NPPs listed in section 1842(b)(18)(C) of the Act, registered dietitians and nutrition professionals who are employees or independent contractors of hospitals or physician groups may reassign their benefits to that hospital or physician group, as appropriate. The Medicare specialty code for “dietitian/nutritionist” is 71. Under section 1833(a)(1)(T) of the Act, we were originally required to pay for MNT services at 80 percent of the lesser of the actual charge for the services or 85 percent of the amount determined under the PFS for the same services if the services had been furnished by a physician. We established payment regulations for MNT in our regulation at § 414.64 in the CY 2002 PFS final rule (66 FR 55278 through 55281 and 55332).

MNT services are defined as services that are furnished by a registered dietitian or nutrition professionals. These practitioners use three CPT® codes to bill for MNT assessment and intervention services with the referral of a physician. In cases where there is a second physician referral for MNT for the same patient within a calendar year (for example, based on a change in the patient's condition, diagnosis, or treatment regimen), the furnishing practitioner uses two other HCPCS codes to report these episodes. We have worked with stakeholders over the years to establish values for the services described by the five MNT codes. The importance of MNT services for managing diabetes or renal disease, as well as the underutilization of the benefit by Medicare beneficiaries is discussed in this proposed rule at section III.H.

More recently, stakeholders who are concerned about the low utilization rate for the services have requested that CMS make changes geared toward making MNT services more accessible to Medicare beneficiaries. These stakeholders believe the underutilization of MNT services is due to multiple factors. Some of these factors and our proposal to address them are discussed elsewhere in this rule (see section III.H.), including proposals to remove the requirement that the MNT referral be made by the “treating physician” and update the glomerular fiation rate (GFR) to reflect current medical practice. And, some factors are being considered here. First, stakeholders recommend that we modify the Medicare Claims Processing Manual (MCPM) to increase the visibility of MNT services by moving the provisions that address these services to appear near the provisions addressing other preventive services.

(We note that MNT services are included in the definition of preventive services under section 1861(ddd)(3)(A) of the Act). Second, the stakeholders recommend that we revise our Medicare Benefit Policy Manual to address registered dietitians and nutrition professionals, and the MNT services they furnish, in a way that aligns with the provisions addressing other types of practitioners and the services they furnish.Start Printed Page 39228 We established the MNT regulations in the CY 2002 PFS final rule at § 410.130 through § 410.134 and § 414.64. There have since been two significant changes to payment for MNT services, which are discussed in more detail below. (1) We added MNT services to the Medicare telehealth services list and recognized that registered dietitians and nutrition professionals can furnish and bill for these services as distant site practitioners. And (2) section 4104 of the Affordable Care Act (ACA) amended the statute to remove application of the Medicare Part B deductible and coinsurance for MNT services effective January 1, 2011.

In the CY 2006 PFS final rule (70 FR 70155 through 70157), we amended our regulation to add registered dietitians and nutrition professionals to the list of distant site practitioners for telehealth services at § 410.78(b)(2)(viii), and to add the three individual MNT services to the Medicare telehealth services list by adding “individual medical nutrition therapy” to § 414.65(a)(1). In the CY 2011 PFS final rule, we also added one of the group MNT codes (97804) to the Medicare telehealth services list (75 FR 73314 through 73315). In the CY 2011 PFS final rule, (75 FR 73412 through 73430), we implemented the amendments made by section 4104 of the ACA, which were designed to remove financial barriers that may have prevented beneficiaries from obtaining certain preventive services. Section 4104 of the ACA amended section 1833(a)(1) of the Act by adding a new subparagraph (Y), which provides for Medicare Part B payment at 100 percent for preventive services described in section 1861(ddd)(3)(A) of the Act that are recommended with a grade of A or B by the United States Preventive Services Task Force (USPSTF). And, amended section 1833(b)(1) of the Act to specify that the annual Medicare Part B deductible does not apply to preventive services with a recommended grade of A or B by the USPSTF.

Section 1861(ddd)(3) of the Act defines “preventive services” and includes MNT services as a preventive service through a cross references section 1861(ww)(2) of the Act. Additionally, section 4104 of the ACA amended section 1833(a)(1)(T) of the Act to specify that Medicare Part B payment is made at 100 percent (instead of 80 percent) of the lesser of the actual charge or 85 percent of the PFS payment amount for these services if they are recommended with an A or B rating by the USPSTF, thereby removing beneficiary coinsurance for these services. In the CY 2011 PFS final rule, we listed all preventive services and their recommended ratings from the USPSTF in Table 66 (66 FR 73420 through 73430), noting that all 5 MNT services received a grade of B from the USPSTF. And the last column in the table noted that the coinsurance and deductible are not applicable to these services beginning January 1, 2011. We codified the coinsurance exception for MNT services at § 410.152(l)(7) to indicate that Medicare Part B pays 100 percent of the Medicare payment amount, and the exception for the Medicare Part B deductible at § 410.160(b)(11).

At that time, the preventive services coinsurance and deductible changes were implemented through Change Request 7012 (Transmittal 864). However, we neglected to update the payment regulation for MNT services at § 414.64(a). As a result, we are now proposing to modify to the requirement at § 414.64(a) for payment of MNT services to reflect that MNT services, with their USPSTF recommended B rating, are paid at 100 percent of the lesser of the actual charges or 85 percent of the PFS amount. Because the registered dietitian and nutrition professional are the only practitioners listed at section 1842(b)(18)(C) of the Act without a specific regulatory provision addressing them as a type of practitioner and specifying payment policies for their services, we are proposing to create a new section at § 410.72 to reflect these policies. We are proposing to include in the regulation at § 410.72 a cross reference to the regulation at § 410.134 that addresses the qualifications for registered dietitians and nutrition professionals.

For covered services described at § 410.72(b), we are proposing as a condition of coverage to refer to medical nutrition therapy services as defined at § 410.130, and also to refer to the conditions for coverage of MNT services at § 410.132(a). Section 410.132(a) requires a referral for MNT services from a physician (an M.D. Or D.O.), and that MNT services are personally performed by the registered dietitian or nutrition professional in a face-to-face encounter except when those services are furnished as a telehealth service as provided in § 410.78 of our regulations. Because registered dietitians and nutrition professionals are also the primary specialty that furnishes diabetes self-management training (DSMT) services, we are proposing to include DSMT at § 410.72(b)(2) as an “other service” that registered dietitians and nutrition professionals can provide in cases where the registered dietitian or nutrition professional is a certified provider of DSMT services as specified at section 1861(qq)(2)(A) of the Act. And they have submitted necessary documentation to, and are accredited by, a CMS-approved accreditation organization, as specified in § 410.141(e) for DSMT services.

We also propose to address in the regulation at § 410.72(b)(2) the current requirement that, as specified in the regulation at § 410.141(b)(1), DSMT services require a referral from the physician or qualified NPP (as defined in § 410.32(a)(2)) who is treating the beneficiary's diabetes condition. We also propose to specify in the regulation at § 410.72(b)(3) that MNT and DSMT services cannot be furnished together on the same date of service as detailed in the national coverage determination for MNT services (see https://www.cms.gov/​medicare-coverage-database/​details/​ncd-details.aspx?. €‹ncdid=​252). And, that neither MNT nor DSMT services can be furnished incident to the professional services of a physician or other practitioner. For MNT services, we are proposing to clarify that MNT services cannot be provided incident to the services of a billing physician.

As a distinct, stand-alone benefit under Medicare Part B at section 1861(s)(2)(V) of the Act, MNT services cannot be furnished incident to a physician's professional service that is separately specified at section 1861(s)(2)(A) of the Act. Further, if a physician also meets the qualifications to bill Medicare as a registered dietitian or nutrition professional (although not necessarily enrolled as one), they would have to personally provide any MNT services as explained above, meaning that those services could not be furnished by auxiliary personnel incident to their own professional services. For DSMT services, we are also proposing to clarify that DSMT services cannot be provided incident to the services of a billing physician or practitioner. DSMT is a distinct benefit under Medicare Part B, as specified in a stand-alone statutory provision at section 1861(s)(2)(S) of the Act. Approved DSMT entities are separately recognized programs, rather than individuals or practitioners, that provide DSMT services in accordance with their accreditation from a CMS-approved organization under § 410.142, indicating that the entity meets a set of quality standards described in § 410.144.

Even when the DSMT services are billed by a physician or other practitioner, such as the DSMT certified provider, the physician or other practitioner could not provide Start Printed Page 39229DSMT services directly, unless they themselves are also an approved DSMT entity. If a physician or practitioner is an approved entity, the DSMT services must be provided in accordance with the requirements to furnish such services. For these reasons, we are adding at § 410.72(b)(3)(ii) that neither MNT nor DSMT may be furnished and billed incident to the professional services of a physician or practitioner, where applicable. As such, we are proposing to add at 410.72(d) that the registered dietitian or nutrition professional can be paid for their professional services only if those services have been personally performed by them. Section 1861(vv) of the Act clearly indicates that MNT services are only provided by registered dietitians and nutrition professionals.

And this was reiterated at § 410.134 in the CY 2002 PFS final rule (66 FR 55331). In addition, in the CY 2002 PFS final rule, we established a regulation at § 410.132(a) that requires registered dietitians and nutrition professionals to provide MNT services and that those services consist of face-to-face nutritional assessments and interventions in accordance with nationally accepted dietary or nutritional protocols. Both of these provisions were codified in our regulations at §§ 410.132(a) and 410.134. In the CY 2001 PFS final rule, we discussed that registered dietitians and nutrition professionals who are enrolled in Medicare could furnish services in various settings including private practices and outpatient hospitals, but that payment for MNT services would not be made when beneficiaries are inpatients in Part A stays in hospitals and skilled nursing facilities (SNFs) (66 FR 55279). We explained that our payment to hospitals and SNFs includes payment for MNT services.

We established these regulations at § 414.64(c). We are proposing to add these rules to our regulation at § 410.72(c)(1) and (2), as on payment for services of registered dietitians and nutrition professionals when beneficiaries are inpatients of hospitals and SNFs. Also, in the CY 2001 PFS final rule, we finalized, in accordance with section 1861(s)(2)(V)(ii) of the Act, that there is no coverage for MNT services available for beneficiaries who are receiving maintenance dialysis for which payment is made under section 1881 of the Act, that is, services from an end-stage renal disease (ESRD) facility. This was codified at § 410.132(b). We are proposing to add this non-covered service to our regulation at § 410.72(c)(3) and note its cross reference to § 410.132(b).

In accordance with section 1842(b)(18)(B) of the Act, the registered dietitian or nutrition professional must accept assignment, meaning that they must accept the payment amount Medicare approves as payment in full and collect nothing from the beneficiaries for those services for which Medicare pays 100 percent of the Medicare approved amount or only collect the difference between the Medicare approved amount and the Medicare Part B payment in accordance with § 424.55. We are proposing to add at § 410.72(f) that the services of a registered dietitian or nutrition professional are provided on an assignment-related basis. Because Medicare pays 100 percent of the Medicare approved amount for MNT covered services, this means that beneficiaries cannot be billed any amount for MNT covered services. For other services, including DSMT, for which the Medicare Part B coinsurance percentage is 20 percent, a registered dietitian or nutrition professional must not collect amounts in excess of the limits specified in § 424.55 of our regulation, and if they do, they must refund the full amount of the impermissible charge to the beneficiary. Finally, we note that the proposed regulatory text for § 410.72(f) is consistent with the text in existing §§ 410.74(d)(2), 410.75(e)(2), 410.76(e)(2) and 410.77(d)(2).

We are also considering whether alternate regulatory text that cross-refers to the assignment requirements in § 424.55 would provide additional clarity. Specifically, we are considering whether to specify restrictions at § 410.72(f) to specify that the services of a registered dietitian or nutrition professional are provided on an assignment-related basis, and the registered dietitian or nutrition professional may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55. In addition, if a beneficiary has made payment for a service in excess of these limits, the registered dietitian or nutrition professional must refund the full amount of the impermissible charge to the beneficiary. To ensure maximum consistency in our regulations, if we finalize the alternate regulatory text for § 410.72(f), we would also make corresponding revisions to §§ 410.74(d)(2), 410.75(e)(2), 410.76(e)(2) and 410.77(d)(2). We seek public comments on the clearest language to describe the assignment requirements.

We are seeking comment on our proposals. III. Other Provisions of the Proposed Rule A. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) 1. Background a.

RHC and FQHC Payment Methodologies As discussed in 42 CFR part 405, subpart X, RHC and FQHC visits generally are face-to-face encounters between a patient and one or more RHC or FQHC practitioners during which one or more RHC or FQHC qualifying services are furnished. RHC and FQHC practitioners are physicians, nurse practitioners (NPs), physician assistants (PA), certified nurse midwives (CNMs), clinical psychologists (CPs), and clinical social workers, and under certain conditions, a registered nurse or licensed practical nurse furnishing care to a homebound RHC or FQHC patient in an area with a shortage of home health agencies. A Transitional Care Management (TCM) service can also be an RHC or FQHC visit. In addition, a Diabetes Self-Management Training (DSMT) service or a Medical Nutrition Therapy (MNT) service furnished by a certified DSMT or MNT program may also be considered an FQHC visit. Only medically necessary medical, mental health, or qualified preventive health services that require the skill level of an RHC or FQHC practitioner are RHC or FQHC billable visits.

Services furnished by auxiliary personnel (for example, nurses, medical assistants, or other clinical personnel acting under the supervision of the RHC or FQHC practitioner) are considered incident to the visit and are included in the per-visit payment. RHCs generally are paid an all-inclusive rate (AIR) for all medically necessary medical and mental health services and qualified preventive health services furnished on the same day (with some exceptions). The AIR is subject to a payment limit, meaning that an RHC will not receive any payment beyond the specified limit amount. As of April 1, 2021, all RHCs are subject to a payment limit for the AIR, and this limit will be determined for each RHC in accordance with section 130 of the Consolidated Appropriations Act, 2021, described below. FQHCs were paid under the same AIR methodology until October 1, 2014.

Beginning that date, in accordance with section 1834(o) of the Act (as added by section 10501(i)(3) of the Affordable Start Printed Page 39230Care Act), they began to transition to an FQHC PPS system in which they are paid based on the lesser of the FQHC PPS rate or their actual charges. The FQHC PPS rate is adjusted for geographic differences in the cost of services by the FQHC PPS geographic adjustment factor (GAF). The rate is increased by 34 percent when an FQHC furnishes care to a patient that is new to the FQHC, or to a beneficiary receiving an initial preventive physical examination (IPPE) or has an annual wellness visit (AWV). Both the RHC AIR and FQHC PPS payment rates were designed to reflect the cost of all services and supplies that an RHC or FQHC furnishes to a patient in a single day. The rates are not adjusted for the complexity of the patient health care needs, the length of the visit, or the number or type of practitioners involved in the patient's care.

2. Payment Methodology for RHCs a. Background As we discussed previously, under Medicare Part B, payment to RHCs for services (defined in § 405.2411) furnished to beneficiaries is made on the basis of an all-inclusive payment methodology subject to a maximum payment per-visit (discussed in section III.A.3. Of this proposed rule) and annual reconciliation. Our regulations, at § 405.2470 provides that RHCs are required to submit cost reports to allow the Medicare Administrative Contractor (MAC) to determine payment in accordance with 42 CFR part 405, subpart X, and instructions issued by CMS.

The statutory payment requirements for RHC services are set forth at section 1833(a)(3) of the Act, (as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 [] ), which states that RHCs are paid reasonable costs “* * * less the amount a provider may charge as described in clause of section 1866(a)(2)(A), but in no case may the payment exceed 80 percent of such costs. The beneficiary is responsible for the Medicare Part B deductible and coinsurance amounts. Section 1866(a)(2)(A)(ii) of the Act and implementing regulations at § 405.2410(b) establish beneficiary coinsurance at an amount not to exceed 20 percent of the clinic's reasonable charges for covered services. We explain in § 405.2464(a) the AIR is determined by the MAC at the beginning of the cost reporting period. The MAC calculates the AIR that will apply for the upcoming cost reporting period for each RHC by dividing the estimated total allowable costs by estimated total visits for RHC services.

The MAC also periodically reviews the AIR throughout the cost reporting period to assure that payments approximate actual allowable costs and visits and may adjust the rate. Productivity, payment limits, and other factors are also considered in the calculation. Allowable costs must be reasonable and necessary and may include practitioner compensation, overhead, equipment, space, supplies, personnel, and other costs incident to the delivery of RHC services (§ 405.2468). Medicare payment for RHC services are ultimately determined at cost report settlement. That is, during the annual reconciliation as explained in § 405.2466, MACs determine the total reimbursement amount due the RHC for covered services furnished to Medicare beneficiaries based on the reporting period.

The total reimbursement amount due is compared with total payments made to the RHC for the reporting period, and the difference constitutes the amount of the reconciliation. If the total reimbursement due the RHC exceeds the payments made for the reporting period, the MAC makes a lump-sum payment to the RHC to bring total payments into agreement with total reimbursement due the RHC. If the total payments made to an RHC for the reporting period exceed the total reimbursement due the RHC for the period, the MAC arranges with the RHC for repayment. In the event a new RHC is in its initial reporting period, and the MAC does not have a cost report to set its AIR, the RHC provides the MAC an estimate of what it expects its costs to be for its initial reporting period. In the Provider Reimbursement Manual (Pub.

15-2), chapter 46, section 4600,[] we explain that for an RHC's initial reporting period, the clinic completes the cost report's worksheets with estimates of costs and visits and other information required by the reports. The MAC uses these estimates to determine an interim rate of payment for the RHC. This interim rate may be adjusted throughout the reporting period. Following the end of the RHC's reporting period, the RHC is required to submit its worksheets, using data based on its actual experience for the reporting period. The AIR for the following year will then be based on the RHC's actual experience.

As discussed in Pub. 100-02, Chapter 13, section 80.2,[] when RHCs are part of the same organization with more than one RHC, they may elect to file consolidated cost reports rather than individual cost reports. Under this type of reporting, each RHC in the organization need not file individual cost reports. Rather, the group of RHCs may file a single report that accumulates the costs and visits for all RHCs in the organization. In order to qualify for consolidation reporting, all RHCs in the group must be owned, leased, or through any other agreement, controlled by one organization.

3. RHC Payment Limit Per-Visit a. Background Prior to the Balanced Budget Act of 1997 [] (BBA), the payment methodology for an RHC depended on whether it was “provider-based” or “independent.” Specifically, payment to provider-based RHCs for services furnished to Medicare beneficiaries was made on a reasonable cost basis by the provider's MAC in accordance with the regulations at 42 CFR part 413. Whereas payment to independent RHCs for services furnished to Medicare beneficiaries was made on the basis of a uniform all-inclusive rate payment methodology in accordance with 42 CFR part 405, subpart X. In addition, payment to independent RHCs also was subject to a maximum payment per visit (also referred to as a “payment limit per-visit”, “upper payment limit per-visit”, or “cap”) as set forth in section 1833(f) of the Act.

This national statutory payment limit was set at $46 and was adjusted annually based on the Medicare Economic Index (MEI) described in section 1842(b)(3) of the Act. Section 1833(f) of the Act was further amended by section 4205(a) of the BBA) (Pub. L. 105-33) to permit an exception to the national statutory payment limit for RHCs based in rural hospitals with less than 50 beds. Our guidance directed Medicare intermediaries to use the bed definition at § 412.105(b) and the rural definition at § 412.62(f)(1) to determine which RHCs are eligible for the exception.

The hospital bed definition was based on available bed days and the rural definition was based on the Office of Management and Budget's Start Printed Page 39231metropolitan statistical area (MSA) method. Section 224 of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 (Appendix F of Consolidated Appropriations Act of 2001) (BIPA) [] (Pub. L. 106-554, December 21, 2000) further amended section 1833(f) of the Act by expanding the eligibility criteria for receiving an exception to the national statutory payment limit for RHCs. Specifically, this section of BIPA extended the exemption to RHCs based in small, urban hospitals.

Effective July 1, 2001, all hospitals of less than 50 beds were eligible to receive an exception from the per visit payment limit for their RHCs. As discussed in Change Request 1958, Transmittal A-01-138 issued on December 6, 2001, following the implementation of the BBA provision, CMS announced an alternative bed size definition for very rural, sole community hospitals with seasonal fluctuations in patient census. The MAC reviews the number of beds twice a year to determine whether the provider-based RHC meets the exception, during the Desk Review process and during the interim rate process (that is, determining the RHC's AIR). The provider-based RHC continues to receive the exception until the hospital which they are affiliated with submits a cost report with more than 50 beds. However, in the May 8, 2020 Federal Register, in response to the PHE for anti inflammatory drugs, we published the “Medicare and Medicaid Programs, Basic Health Program, and Exchanges.

Additional Policy and Regulatory Revisions in Response to the anti inflammatory drugs Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program” interim final rule with comment period (85 FR 27550) (May 8, 2020 IFC). In the May 8, 2020 IFC, we implemented, on an interim basis, a change to the period of time used to determine the number of beds in a hospital at § 412.105(b) for purposes of determining which provider-based RHCs are subject to the payment limit (85 FR 27569). That is, for the duration of the PHE, we adopted an interim final policy to use the number of beds from the cost reporting period prior to the start of the PHE as the official hospital bed count for application of this policy. As such, RHCs with provider-based status that were exempt from the national statutory payment limit in the period prior to the effective date of the PHE (January 27, 2020) would continue to be exempt from the bed count requirement for the duration of the PHE for the anti inflammatory drugs symbicort, as defined at § 400.200, even if the hospital raised its bed count above 50. Once the PHE for anti inflammatory drugs ends, hospitals need to lower their bed count to less than 50 beds to utilize an RHC policy that has such a requirement.

B. Section 130 of the Consolidated Appropriations Act, 2021 Section 130 of the Consolidated Appropriations Act, 2021 (CAA 2021) (Pub. L. 116-260, December 27, 2020) updated section 1833(f) of the Act by restructuring the payment limits for RHCs beginning April 1, 2021. We note that section 2 of H.R.

1868 (Pub. L. 117-7), enacted April 14, 2021, provided a technical correction to section 1833(f) of the Act. The amendments made by this technical correction take effect as if included in the enactment of the Consolidated Appropriations Act of 2021 (Pub. L.

116-260). Section 1833(f)(2) of the Act, as added by section 130 of the CAA 2021, states that beginning April 1, 2021, RHCs will begin to receive an increase in their payment limit per visit over an 8-year period, with a prescribed amount for each year from 2021 through 2028. Then, in a subsequent year, at the limit established for the previous year increased by the percentage increase in the MEI applicable to primary care services furnished as of the first of such subsequent year. This provision also subjects all new RHCs (including provider-based RHCs in a hospital with less than 50 beds and enrolled in Medicare after December 31, 2020) to the national statutory payment limit. The national statutory payment limit for RHCs over an 8-year period is as follows.

In 2021, after March 31, at $100 per visit. In 2022, at $113 per visit. In 2023, at $126 per visit. In 2024, at $139 per visit. In 2025, at $152 per visit.

In 2026, at $165 per visit. In 2027, at $178 per visit. And In 2028, at $190 per visit. Beginning April 1, 2021, provider-based RHCs that meet the qualifications in section 1833(f)(3)(B) of the Act, as added by section 130 of the CAA 2021 and amended by Public Law 117-7, are entitled to special payment rules, as described in section 1833(f)(3)(B) of the Act. That is, a provider-based RHC must meet the following criteria to have its payment limit established based on its per visit payment amount (or AIR).

As of December 31, 2020, was in a hospital with less than 50 beds and after December 31, 2020 in a hospital that continues to have less than 50 beds (not taking into account any increase in the number of beds pursuant to a waiver during the PHE for anti inflammatory drugs). And one of the following circumstances. ++ As of December 31, 2020, was enrolled in Medicare (including temporary enrollment during the PHE for anti inflammatory drugs). Or ++ Submitted an application for enrollment in Medicare (or a request for temporary enrollment during the PHE for anti inflammatory drugs) that was received not later than December 31, 2020. Specifically, beginning April 1, 2021, for provider-based RHCs that had a per visit payment amount (or AIR) established for services furnished in 2020, the payment limit per visit shall be set at an amount equal to the greater of.

(1) The per visit payment amount applicable to such RHC for services furnished in 2020, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of 2021. Or (2) the national statutory payment limit for RHCs per visit. The details of the most recent MEI rebasing and revising is discussed in the CY 2011 PFS final rule with comment period (75 FR 73262). The MEI increase for an update year is based on historical data through the second quarter of the prior calendar year. For example, the 2021 update reflects data through the second quarter 2020.

We note that the MEI percentage increase for CY 2021 is 1.4 percent, which reflects historical MEI data through the 2nd quarter 2020 and historical multifactor productivity (MFP) data through 2019. IGI is a nationally recognized economic and financial forecasting firm with which we contract to forecast the components of the MEI and other CMS market baskets, https://ihsmarkit.com/​index.html. In a subsequent year (that is, after 2021), the provider-based RHC's payment limit per visit shall be set at an amount equal to the greater of. (1) The payment limit per visit established for the previous year, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of such subsequent year. Or (2) the national statutory payment limit for RHCs.

The proposed CY 2022 MEI update is 1.8 percent based on the IGI 1st quarter 2021 forecast of the MEI and productivity adjustment, which reflects historical MEI data through 4th quarter 2020 and historical MFP data through 2019. As is our general practice, we are Start Printed Page 39232proposing that if more recent data become available after the publication of this proposed rule and before the publication of the final rule (for example, a more recent estimate of the MEI percentage increase or productivity adjustment), we would use such data, if appropriate, to determine the final CY 2022 MEI update. For provider-based RHCs that meet certain requirements, but did not have a per visit payment amount (or AIR) established for services furnished in 2020, the payment limit per visit shall be at an amount equal to the greater of. (1) The per visit payment amount applicable to the provider-based RHC for services furnished in 2021. Or (2) the national statutory payment limit for RHCs.

In a subsequent year (that is, after 2022), the provider-based RHCs payment limit per visit will be the greater of. (1) The payment limit per visit established for the previous year, increased by the percentage increase in MEI applicable to primary care services furnished as of the first day of such subsequent year. Or (2) the national statutory payment limit for RHCs. A provider-based RHC that meets the qualifications of section 1833(f)(3)(B) of the Act, as corrected by Public Law 117-7 will lose this designation if the hospital does not continue to have less than 50 beds, beyond the exemptions provided for the PHE for anti inflammatory drugs. If this occurs, the provider-based RHC will be subject to the statutory payment limit per visit applicable for such year and not able to regain the specified provider-based payment limit.

Provider-based RHCs that are newly enrolled beginning January 1, 2021, and after are subject to the national statutory payment limit applicable for such year for RHCs. C. Implementation of Section 130 of the Consolidated Appropriations Act, 2021 As we stated above, RHCs began to receive an increase in the national statutory payment limit over an 8-year period, with a prescribed amount for each year from 2021 through 2028. Prior to this legislation, the CY 2020 national statutory payment limit for RHCs was $86.31. Then for calendar year 2021, there are two sets of payment rules for RHCs.

For the period before March 31, 2021, independent RHCs and provider-based RHCs that did not meet specified requirements were subject to the payment limit of $87.52 that CMS announced in Change Request 12035, Transmittal 10413 issued on October 29, 2020.[] Provider-based RHCs that met specified requirements were not subject to a payment limit for the first quarter of calendar year 2021. However, beginning April 1, 2021, in accordance with section 130 of the CAA 2021, all RHCs are now subject to a payment limit. For example, beginning April 1, 2021 through December 31, 2021 the national statutory payment limit for RHCs is $100.00. To prepare for this change in payment limits during the calendar year, Change Request 12185, Transmittal 10679 was issued on March 16, 2021, to implement an increase in the RHC statutory payment limit per visit and establish the provider-based RHC payment limits per visit, which went in effect on April 1, 2021. We note, Change Request 12185, Transmittal 10679 was rescinded and replaced by Transmittal 10780 issued on May 4, 2021 to reflect the technical corrections in section 2 of H.R.

1868 (Pub. L. 117-7). We also note that this provision does not impact the way beneficiary coinsurance is calculated as described in § 405.2410(b)(1). I.

Specified Provider-Based RHCs In section III.A.3.b. Of this proposed rule, we discuss the qualifications specified in section 1833(f)(3)(B) of the Act, as amended by Public Law 117-7, that determine if a provider-based RHC is entitled to the special payment rules described in section 1833(f)(3)(A) of the Act. To determine if an RHC was in a hospital with less than 50 beds as of December 31, 2020, we will review each provider-based RHC using the existing bed count review process, as described above, to determine if this criterion is met. In addition, this process generally includes ongoing review by the MACs two times a year. The beds to be counted for purposes of this criterion are described in § 412.105(b), in accordance with existing policy.

In continuing with our existing policy and in accordance with section 1833(f)(3)(B)(i) of the Act which states that “as of December 31, 2020, was in a hospital with less than 50 beds and after such date such hospital continues to have less than 50 beds” an RHC will retain its specified provider-based status until the hospital which they are affiliated submits a cost report with more than 50 beds. An RHC will no longer retain its specified provider-based status nor be eligible for specified status in the future once the hospital which they are affiliated submits a cost report with more than 50 beds. However, in response to the PHE for anti inflammatory drugs and in accordance with section 1833(f)(3)(B)(I) of the Act, we will apply the policy that allows for increased hospital bed counts, as described in the May 8, 2020 IFC, for purposes of determining this bed count criterion for specified provider-based RHC status. That policy specifies that for the duration of the PHE, we will use the number of beds from the cost reporting period prior to the start of the PHE as the official hospital bed count. We note that the criteria specified in section 1833(f)(3)(B)(i) of the Act specifies “in a hospital with less than 50 beds” therefore, beginning April 1, 2021, we will apply the bed definition at § 412.105(b) exclusively.

Section 1833(f)(3)(B)(ii) of the Act, as added by section 2 of Public Law 117-7, requires that these specified provider-based RHCs as of December 31, 2020 are “enrolled under 1866(j) (including temporary enrollment during such emergency period for such emergency period),” or “submitted an application for enrollment under section 1866(j) of the Act (or a request for such a temporary enrollment for such emergency period) that was received not later than December 31, 2020.” We propose that the RHC's effective date of enrollment (as established under existing regulations) would be used in our determination as to whether an RHC is enrolled under section 1866(j) of the Act as of December 31, 2020. In addition, with regard to an application for enrollment under section 1866(j) of the Act or a request for temporary enrollment, we propose to use the date an application or request was received to determine if the RHC met the qualification. RHCs that established temporary locations for the purpose of responding to the PHE for anti inflammatory drugs, in accordance with their state symbicort response plan, are permitted to enroll and receive temporary Medicare billing privileges. When the PHE for anti inflammatory drugs ends, an RHC that had been temporarily enrolled under the flexibilities described above must submit a complete CMS-855 enrollment application in order to establish full Medicare billing privileges. Failure to do so will result in the deactivation of the RHC's temporary billing privileges.

No payments can be made for services provided while the temporary billing privileges are deactivated. For RHCs enrolled through the temporary enrollment process that will need to submit a complete CMS-855 enrollment application, we propose, regardless of when the temporarily enrolled RHC is fully enrolled, that the RHC would be entitled to the special payment rules as long as it was Start Printed Page 39233temporarily enrolled as of December 31, 2020 or a temporary enrollment request was received by December 31, 2020, and it meets the bed count requirement. As stated above, section 1833(f)(3)(A) of the Act instructs Medicare to set payment limits per visit for these specified provider-based RHCs under certain payment rules. Specifically, beginning April 1, 2021, a payment limit per visit shall be set at an amount equal to the greater of. (1) The per visit payment amount applicable to such RHC for services furnished in 2020, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of 2021.

Or (2) the statutory payment limit per visit as described in section 1833(f)(2) of the Act. For subsequent years, in accordance with section 1833(f)(3)(A)(ii) of the Act, that payment amount is increased by the percentage increase in the MEI or the statutory payment limit described in section 1833(f)(2) of the Act, whichever is greater. We interpret the “per visit payment amount” to align with the interim rate process the MACs use in determining an RHC's AIR (discussed above in section III.A.2. Of this proposed rule). That is, as explained in § 405.2464(a) the AIR is determined by the MAC using the most recently available cost report.

Therefore, with regard to “services furnished in 2020” we interpret this to mean the period at which the services were furnished in 2020 and that costs for those services were reported. We understand that there may be more than one cost report that reports costs for services furnished in calendar year 2020. However, since section 130 of the CAA 2021 states that the “per visit payment amount” is to be increased by the CY 2021 MEI, if a provider has a cost reporting period that differs from a calendar year time-period then the MACs should use data based on the relevant cost report period ending in 2020. Finally, we understand that certain RHCs file consolidated cost reports, as described above. For specified provider-based RHCs, existing RHCs that are independent, and existing RHCs that are in a hospital with greater than 50 beds, we will continue to use the parent RHCs' cost reports to determine the payment limit per visit (for multi-facility RHC systems), as consolidated cost reporting reduces the reporting burden and cost report preparation time for RHCs.

Combining multiple individual RHC cost reports into a consolidated cost report allows RHCs to take advantage of administrative efficiencies and economies of scale that do not exist otherwise. However, in accordance with section 1833(f)(2) of the Act, all new provider-based RHCs and independent RHCs enrolled, as of January 1, 2021, shall have a payment limit established at the national statutory payment limit for RHCs. Therefore, beginning with RHCs enrolled in Medicare as of January 1, 2021, we will no longer allow new RHCs to file consolidated cost reports. Ii. All Other RHCs While there are criteria that allow for specified provider-based RHCs to be eligible for certain payment rules, all other RHCs are subject to payment limits as described in section 1833(f)(2) of the Act.

While there may be new RHCs that are “in a hospital with less than 50 beds” and “enrolled under section 1866(j)”, they will not have met these criteria by December 31, 2020. Thus, any new RHCs will also be subject to the national statutory payment limits as described in section 1833(f)(2) of the Act. Though the payment limit is described, these RHCs will still have an AIR per visit determined based on their allowable costs for each year going forward. However, the payment limit that is established will be the maximum amount that an RHC will be paid by Medicare per visit. As discussed above, at the time of reconciliation, if an RHC's costs per visit are above the AIR, they will be paid an amount that reflects these additional costs, not to exceed the payment limit.

If an RHC's costs per visit are below the AIR, then CMS will collect any overpayment for that visit. To implement this provision beginning April 1, 2021, CMS instructed the MACs to increase the payment limits to $100 per visit. Although the payment limit per-visit as set forth in section 1833(f) of the Act has already been implemented in administrative instructions issued to the MACs in Change Request 12185, we are proposing revisions to § 405.2462 to reflect the provisions set forth in section 1833(f)(2) and (3) of the Act. We solicit comment on these revisions and on our proposals regarding the implementation of section 130 of the CAA 2021. 3.

Payment for Attending Physician Services Furnished by RHCs or FQHCs to Hospice Patients a. Background In the Fiscal Year (FY) 2021 Hospice Payment Rate Update final rule (85 FR 47070) we explain that hospice care is a comprehensive, holistic approach to treatment that recognizes the impending death of a terminally ill individual and warrants a change in the focus from curative care to palliative care for relief of pain and for symptom management. Palliative care is at the core of hospice philosophy and care practices, and is a critical component of the Medicare hospice benefit. The goal of hospice care is to help terminally ill individuals continue life with minimal disruption to normal activities while remaining primarily in the home environment. A hospice uses an interdisciplinary approach to deliver medical, nursing, social, psychological, emotional, and spiritual services through a collaboration of professionals and other caregivers, with the goal of making the beneficiary as physically and emotionally comfortable as possible.

As referenced in our regulations at § 418.22(b)(1), to be eligible for Medicare hospice services, the patient's attending physician (if any) and the hospice medical director must certify that the individual is “terminally ill,” as defined in section 1861(dd)(3)(A) of the Act and our regulations at § 418.3. That is, the individual's prognosis is for a life expectancy of 6 months or less if the terminal illness runs its normal course. Section 1861(dd)(3)(B) of the Act defines the term “attending physician” to mean, with respect to an individual, the physician, the NP or PA who may be employed by a hospice program, whom the individual identifies as having the most significant role in the determination and delivery of medical care to the individual at the time the individual makes an election to receive hospice care. As explained in Pub. 100-02, chapter 9, section 20.1,[] the attending physician is a doctor of medicine or osteopathy who is legally authorized to practice medicine or surgery by the state in which he or she performs that function, an NP, or PA, and is identified by the individual, at the time he or she elects to receive hospice care, as having the most significant role in the determination and delivery of the individual's medical care.

An NP is defined as a registered nurse who performs such services as legally authorized to perform (in the state in which the services are performed) in accordance with state law (or state regulatory mechanism provided by state law) and who meets training, education, and experience requirements described in § 410.75. A PA is defined as a professional who has graduated from an accredited PA educational program who Start Printed Page 39234performs such services as he or she is legally authorized to perform (in the state in which the services are performed) in accordance with state law (or state regulatory mechanism provided by state law) and who meets the training, education, and experience requirements as the Secretary may prescribe. The PA qualifications for eligibility for furnishing services under the Medicare program can be found in the regulations at § 410.74 (c). RHCs and FQHCs are not authorized under the statute to serve in the role of an attending physician. However, a physician, NP, or PA who works for an RHC or FQHC may provide hospice attending physician services during a time when they are not working for the RHC or FQHC (unless prohibited by their RHC or FQHC contract or employment agreement).

These services would not be considered RHC or FQHC services, since they are not being provided by an RHC or FQHC practitioner during RHC or FQHC hours. The physician, NP, or PA would bill for services under Part B using their own provider number/NPI. In addition, any service provided to a hospice beneficiary by an RHC or FQHC practitioner must comply with Medicare prohibitions on commingling. Further information regarding commingling is available in Pub. 100-02, Chapter 13, section 100.[] b.

Section 132 of the Consolidated Appropriations Act 2021 Section 132 of the CAA 2021 amended section 1834(o) of the Act and added a new section 1834(y) to the Act, to provide the authority for both FQHCs and RHCs, respectively, to receive payment for hospice attending physician services. Specifically, when a designated attending physician employed by or working under contract with an FQHC or RHC furnishes hospice attending physician services (as described in section 1812(d)(2)(A)(ii) of the Act) on or after January 1, 2022, the FQHC or RHC is eligible to receive payment under the FQHC PPS or RHC AIR, respectively. Therefore, beginning January 1, 2022, a physician, NP, or PA who is employed by or working under contract with an RHC or FQHC may provide hospice attending physician services during a time when they are working for the RHC or FQHC. The RHC or FQHC would bill for these services as they would for any other qualified service to be paid the RHC AIR or the FQHC PPS rate, respectively. When the RHC/FQHC furnishes a hospice attending physician service that has a technical component, the provider furnishing the technical component would go to the hospice for payment as discussed in the Medicare Claims Processing Manual at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Manuals/​Downloads/​clm104c11.pdf.

We propose to codify the new statutory provisions as described in section 132 of the CAA 2021 in 42 CFR 405, subpart X, specifically. At § 405.2411, Scope of benefits, we are amending § 405.2411(b) to reflect that hospice attending physician services are covered when furnished during a patient's hospice election only when provided by an RHC/FQHC physician, NP, or PA designated by the patient at the time of hospice election as his or her attending physician and employed or under contract with the RHC or FQHC at the time the services are furnished. At § 405.2446, Scope of services, we are amending § 405.2446(c) to include that FQHC services are covered when they are hospice attending physician services furnished during a hospice election. 4. Concurrent Billing for Chronic Care Management Services (CCM) and Transitional Care Management (TCM) Services for RHCs and FQHCs a.

Background In the CY 2013 PFS final rule (77 FR 68978 through 68994), Medicare payment for TCM services furnished by an RHC or FQHC practitioner was effective January 1, 2013, consistent with the effective date of payment for TCM services under the PFS. We adopted two CPT codes (99495 and 99496) to report physician or qualifying NPP care management services for a patient following a discharge from an inpatient hospital or SNF, an outpatient hospital stay for observation or partial hospitalization services, or partial hospitalization in a community mental health center. As a condition for receiving TCM payment, a face-to-face visit was required. In the CY 2016 PFS final rule with comment period (80 FR 71080 through 71088), we finalized policies for payment of CCM services in RHCs and FQHCs. Payment for CCM services in RHCs and FQHCs was effective beginning on January 1, 2016, for RHCs and FQHCs that furnish a minimum of 20 minutes of qualifying CCM services during a calendar month to patients with multiple (two or more) chronic conditions that are expected to last at least 12 months or until the death of the patient, and that would place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline.

Payment was made for CCM services when CPT code 99490 was billed alone or with other payable services on an RHC or FQHC claim, and the rate was based on the PFS national average non-facility payment rate. The requirement that RHC or FQHC services be furnished face-to-face was waived for CCM services furnished to an RHC or FQHC patient because CCM describes non face-to-face services. In the CY 2018 PFS final rule, (82 FR 53172 through 53180), we finalized payment for CCM, general Behavioral Health Integration (BHI), and the psychiatric collaborative care model (CoCM) services furnished by RHCs or FQHCs on or after January 1, 2018, described by HCPCS codes G0511 and G0512. HCPCS code G0511 is a General Care Management code for use by RHCs or FQHCs when at least 20 minutes of qualified CCM or general BHI services are furnished to a patient in a calendar month. HCPCS code G0512 is a psychiatric CoCM code for use by RHCs or FQHCs when at least 70 minutes of initial psychiatric CoCM services or 60 minutes of subsequent psychiatric CoCM services are furnished to a patient in a calendar month.

The payment amount for HCPCS code G0511 is set at the average of the three national non-facility PFS payment rates for the CCM and general BHI codes and updated annually based on the PFS rates. The three codes are CPT code 99490 (20 minutes or more of CCM services), CPT code 99487 (60 minutes or more of complex CCM services), and CPT code 99484 (20 minutes or more of BHI services). The payment amount for HCPCS code G0512 is set at the average of the two national non-facility PFS payment rates for the CoCM codes and is updated annually based on the PFS rates. The two codes are CPT code 99492 (70 minutes or more of initial psychiatric CoCM services) and CPT code 99493 (60 minutes or more of subsequent psychiatric CoCM services). In the CY 2019 PFS final rule (83 FR 59687), we finalized that effective January 1, 2019, the payment rate for HCPCS code G0511 (General Care Management Services) is set at the average of the national non-facility PFS payment rates for CPT codes 99490, 99487, 99484, and 99491.

In the CY 2020 PFS final rule with comment period (84 FR 62692), we added HCPCS code G2064 (30 minutes of PCM services furnished by physicians or NPPs) and G2065 (30 minutes or more of PCM services furnished by Start Printed Page 39235clinical staff under the direct supervision of a physician or NPP) as a general care management service and included it in the calculation of HCPCS code G0511. Beginning January 1, 2021, the payment for HCPCS code G0511 is set at the average of the national non-facility PFS payment rates for CPT codes 99490, 99487, 99484, and 99491, and HCPCS codes G2064 and G2065, and is updated annually based on the PFS rates. Additional information on CCM requirements is available on the CMS Care Management web page [] and on the CMS RHC [] and FQHC [] web pages. Currently, RHCs and FQHCs may not bill for TCM services for a beneficiary if another practitioner or facility has already billed for CCM services for the same beneficiary during the same time-period. B.

Concurrent Billing for Chronic Care Management Services and TCM Services for RHCs and FQHCs In the CY 2020 PFS final rule (84 FR 62687), we finalized a policy allowing suppliers paid under the PFS to concurrently bill care management codes that were previously restricted from being billed with TCM for services billed under the PFS. This included allowing concurrent billing of TCM with 14 HCPCS codes, as well as CPT codes 99490 and 99491, which describe CCM services furnished under the PFS. However, we did not extend this policy to care management services furnished in RHCs or FQHCs at that time. Consistent with changes made in the CY 2020 PFS final rule for care management services billed under the PFS, for CY 2022, we are proposing to allow RHCs and FQHCs to bill for TCM and other care management services furnished for the same beneficiary during the same service period, provided that all requirements for billing each code are met. This would include the services described by HCPCS codes G0511 (General Care Management for RHCs and FQHCs only) and G0512 (Psychiatric CoCM code for RHCs and FQHCs only), which both describe a service period of one calendar month.

We believe that when medically necessary, these services may complement each other rather than substantially overlapping or duplicating services since TCM services are furnished once within 30 days of a patient's discharge, whereas CCM services require a more comprehensive care management plan, care coordination and ongoing clinical care, and CoCM services describe care management services specifically for behavioral health conditions. We note that under this proposal, time and effort could not be counted more than once. 4. Proposed Conforming Technical Changes to 42 CFR 405.2466 In the November 6, 2020 Federal Register, we published the “Additional Policy and Regulatory Revisions in Response to the anti inflammatory drugs Public Health Emergency” interim final rule with request for comment (85 FR 71145 through 71147) (hereinafter referred to as the November 6, 2020 IFC). In the November 6, 2020 IFC, we implemented section 3713 of the CARES Act (Pub.

L 116-136, March 27, 2020), which established Medicare Part B coverage and payment for a anti inflammatory drugs treatment and its administration. As we discussed in that rule (85 FR 71147), section 3713 of the CARES Act added the anti inflammatory drugs treatment and administration to section 1861(s)(10)(A) of the Act in the same subparagraph as the influenza and pneumococcal treatments and their administration. Therefore, the Medicare allowed amount and billing processes for anti inflammatory drugs vaccinations are similar to those in place for influenza and pneumococcal vaccinations across provider/supplier settings. The amendments made to section 1861(s)(10)(A) of the Act were effective on the date of enactment, that is, March 27, 2020, and apply to a anti inflammatory drugs treatment beginning on the date that such treatment is licensed under section 351 of the PHS Act (42 U.S.C. 262).

A list of treatments and their effective dates are updated as they are available and located on the CMS website at https://www.cms.gov/​medicare/​medicare-part-b-drug-average-sales-price/​anti inflammatory drugs-treatments-and-monoclonal-antibodies. Although there were regulations updated to reflect the changes set forth by the CARES Act, we inadvertently did not revise the specific regulation text that applies to RHCs and FQHCs. Therefore, consistent with the changes described above, we are proposing to make conforming technical changes to the applicable RHC and FQHC regulations in 42 CFR part 405, subpart X, specifically. At § 405.2466, Annual reconciliation, we are proposing to amend paragraph (b)(1)(iv) to include the anti inflammatory drugs treatment in the list of treatments and their administration that would be paid at 100 percent of Medicare reasonable cost. B.

Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)—Telecommunications Technology 1. Revising the Definition of an RHC and FQHC Mental Health Visit a. Payment Rules for RHC and FQHC Visits and for Medicare Telehealth Services Section 1861(aa)(1) of the Act defines RHC services as physicians' services and such services and supplies that are furnished as an incident to a physician's professional service, and items and services as well as certain treatments and their administration. It also includes services furnished by a PA, NP, clinical psychologist, or clinical social worker and services and supplies furnished as incident to these services as would otherwise be covered if furnished by a physician or incident to a physician's service. In the case of an RHC in an area with a home health agency shortage, part-time or intermittent nursing care and related medical supplies may be furnished by a registered professional nurse or licensed practical nurse to a homebound individual under certain conditions.

Section 1861(aa)(3) of the Act defines FQHC services to include the specified RHC services and preventive services as well as required primary preventive health services. As previously stated, RHC and FQHC visits are defined as medically-necessary, face-to-face encounters between a patient and an RHC or FQHC practitioner, during which time one or more RHC or FQHC qualifying services are furnished. Services furnished must be within the practitioner's state scope of practice, and only services that require the skill level of the RHC or FQHC practitioner are considered RHC or FQHC visits. The RHC and FQHC payment is based on the costs of all services, except in certain circumstances, such as treatments and their administration. RHCs are paid an all-inclusive rate (AIR) for medically-necessary primary health care services, and qualified preventive health services, furnished by an RHC practitioner.

Medicare pays 80 percent of the RHC AIR, subject to a payment limit. Services furnished incident to an RHC professional service are included in the AIR and are not billed as a separate visit. The professional component of a procedure is usually a covered service, but is not a stand-alone billable visit. The costs of covered services provided incident to a Start Printed Page 39236billable visit may be included on the RHC cost report. FQHCs are paid 80 percent of the lesser of the FQHC's charge or the FQHC PPS payment rate.

Except for grandfathered tribal FQHCs, the FQHC PPS payment rate reflects a base rate that is the same for all FQHCs, a geographic adjustment based on the location where services are furnished, and other applicable adjustments. The FQHC PPS rate was established based on the aggregate of FQHC total costs, and is updated yearly by the FQHC market basket. Under the PFS, Medicare makes payment to professionals and other suppliers for physician's services, certain diagnostic tests, and some preventive services. Section 1834(m) of the Act specifies for Medicare telehealth services paid under the PFS, the payment amounts and circumstances under which Medicare makes payment for a discrete set of services, all of which must ordinarily be furnished in-person, when they are instead furnished using interactive, real-time telecommunication technology. When furnished under the telehealth rules, many of these specified Medicare telehealth services are still reported using codes that describe “face-to-face” services but are furnished using audio/video, real-time communication technology instead of in-person (82 FR 53006).

Section 1834(m) of the Act also specifies conditions related to which professionals can be paid by Medicare for their professional services furnished via telehealth (referred to as distant site practitioners) and the originating site (both setting of care and geography) where a beneficiary is located while receiving telehealth services furnished remotely by the physician or practitioner through a telecommunications system. The regulation text at 42 CFR 410.78 describes a process for adding or deleting services to the list of Medicare telehealth services through the annual PFS rulemaking process and defines what technology may be used to furnish the service. Under the permanent authority provided under section 1834(m)(4)(C)(ii) of the Act, RHCs and FQHCs, like hospitals, physician offices, and other sites, are authorized to serve as originating sites for eligible telehealth services. As defined in section 1834(m)(4)(C)(i) of the Act, the originating site is where the eligible telehealth individual is located at the time the service is furnished via a telecommunications system. As defined in section 1834(m)(4)(A) of the Act, the distant site is where the physician or practitioner is located at the time the service is provided via a telecommunications system.

Originating sites are paid an originating site facility fee that is billed using HCPCS code Q3014 and is assigned a rate of $27.02 for CY 2021. Section 3704 of the anti-inflammatories Aid, Relief, and Economic Security Act (the CARES Act) (Pub. L. 116-136, March 27, 2020) directs the Secretary to establish Medicare payment for telehealth services when RHCs and FQHCs serve as the distant site during the public health emergency (PHE) for anti inflammatory drugs. Separately, section 3703 of the CARES Act expanded CMS' emergency waiver authority to allow for a waiver of any of the statutory telehealth payment requirements under section 1834(m) of the Act for telehealth services furnished during the PHE.

Specifically, section 1834(m)(8)(B) of the Act, as added by the CARES Act, requires that the Secretary develop and implement payment methods for FQHCs and RHCs that serve as a distant site during the PHE for the anti inflammatory drugs symbicort. The payment methodology outlined in the CARES Act requires that rates shall be based on rates that are similar to the national average payment rates for comparable telehealth services under the Medicare PFS. CMS established rates based on the average amount for all PFS telehealth services on the telehealth list, weighted by volume. RHCs and FQHCs bill for these Medicare telehealth services using HCPCS code G2025 and the rate for CY 2021 is $99.45. The temporary authority under section 1834(m)(8) of the Act to pay RHCs and FQHCs for furnishing distant site Medicare telehealth services expires when the PHE for the anti inflammatory drugs symbicort is terminated.

While they will continue to be able to serve as an originating site for Medicare telehealth services, the payment mechanism for the professional services of RHC and FQHC practitioners will be FQHC and RHC payments under the established methodology, that is the RHC AIR or the FQHC PPS. B. Adoption of Telehealth Technologies for Mental Health Care While not specific to RHC and FQHC telehealth services provided during the PHE, according to MedPAC's report, Telehealth in Medicare after the anti-inflammatories Public Health Emergency,[] there were 8.4 million telehealth services paid under the PFS in April 2020, compared with 102,000 in February 2020. MedPAC also reported that during focus groups held in the summer of 2020, clinicians and beneficiaries supported continued access to telehealth visits with some combination of in-person visits. They cited benefits of telehealth, including improved access to care for those with physical impairments, increased convenience from not traveling to an office, and increased access to specialists outside of a local area.

In their annual beneficiary survey, over 90 percent of respondents who had a telehealth visit reported being “somewhat” or “very satisfied” with their video or audio visit, and nearly two-thirds reported being “very satisfied.” Widespread use of telecommunications technology to furnish services during the PHE has illustrated interest within the medical community and among Medicare beneficiaries in furnishing and receiving care through the use of technology beyond the PHE. During the PHE for anti inflammatory drugs symbicort, RHCs and FQHCs, much like other provider types, have had to change how they furnish care in order to meet the needs of their patients, and use of the temporary authority to bill Medicare for PFS telehealth services has been widely utilized by RHCs and FQHCs during the PHE. This shift in how care is furnished has prompted us to reevaluate the regulations regarding visit requirements for encounters between an RHC or FQHC patient and an RHC or FQHC practitioner to ensure that they reflect contemporary medical practice. Recently enacted legislation modified the circumstances under which Medicare makes payment for mental health services furnished via telehealth technology under the PFS following the PHE. Division CC, section 123 of the Consolidated Appropriations Act of 2021 (CAA) (Pub.

L. 116-260, December 27, 2020) removed the domestic geographic originating site restrictions and added the home of the individual as a permissible originating site for telehealth services billed under the PFS when furnished for the purposes of diagnosis, evaluation, or treatment of a mental health disorder. This change correlates with a growing acceptance of the use of technology in the provision of mental health care. Clinicians furnishing telepsychiatry services at Massachusetts General Hospital Department of Psychiatry during the PHE observed several advantages of the virtual format for furnishing psychiatric services, noting that patients with psychiatric pathologies that interfere with their ability to leave home (for example, immobilizing depression, Start Printed Page 39237anxiety, agoraphobia, and/or time-consuming obsessive-compulsive rituals) were able to access care more consistently since eliminating the need to travel to a psychiatry clinic can increase privacy, and therefore, decrease stigma-related barriers to treatment, potentially bringing care to many more patients in need, as well as enhanced ease of scheduling, decreased rate of no-shows, increased understanding of family and home dynamics, and protection for patients and practitioners with underlying health conditions.[] These findings are consistent with our analysis of Medicare claims data that indicate that use of interactive communication technology for mental health care is likely to continue to be in broad use beyond the circumstances of the symbicort. According to our analysis of Medicare Part B claims data for services furnished via Medicare telehealth under the PFS during the PHE, use of telehealth for many professional services spiked in utilization around April 2020 and diminished over time.

However, utilization was still higher than it was prior to the PHE. In contrast, Medicare claims data suggests that for mental health services both permanently and temporarily added to the Medicare Telehealth list, subsequent to April 2020, the trend is toward maintaining a steady state of usage over time. Given this information, broad acceptance in the public and medical community, and the relatively stable Medicare utilization of services during the entire anti inflammatory drugs symbicort, we believe use of interactive communication technology in furnishing mental health care is becoming an established part of medical practice, very likely to persist well after the anti inflammatory drugs symbicort, and available across the country under Medicare statute for the range of professionals furnishing mental health care and paid under the PFS. C. Revising the Definition of an RHC and FQHC Mental Health Visit We believe beneficiaries receiving mental health services from RHC and FQHC practitioners should have the same access to mental health care delivered via telecommunications technology as beneficiaries receiving services from practitioners paid under the PFS.

We also believe that disruptions in access to mental health care from trusted practitioners can be particularly problematic for Medicare beneficiaries, especially when it results in fragmented care. However, absent changes in the definition of mental health visits, RHCs and FQHCs would no longer be paid by Medicare for mental health care services delivered via telecommunications technology and would likely resume furnishing solely in-person, face-to-face mental health visits after the PHE, thereby removing the ability for beneficiaries to be able to receive these services from RHC/FQHC practitioners if furnished via interactive communication technology. Because the definitions of RHC and FQHC services, as specified in sections 1861(aa)(1) and (3) of the Act, respectively, refer specifically to physicians' services, and services that would be physicians' services, but are instead furnished by certain other types of practitioners, we believe it would be consistent to align policies to provide access to services furnished by RHCs and FQHCs similar to PFS services, where appropriate and within statutory requirements. To ensure that beneficiaries can access services furnished by RHCs and FQHCs in a manner similar to mental health services under the PFS after the PHE, we believe it is appropriate to consider modifying our regulatory definition of a mental health visit to provide for remote access to RHC and FQHC services. Therefore, to avoid both the inequities in access to modes of care, and to avoid potentially problematic interruptions to care or the negative consequences of fragmented care, for CY 2022, we are proposing to revise the regulatory requirement that an RHC or FQHC mental health visit must be a face-to-face (that is, in person) encounter between an RHC or FQHC patient and an RHC or FQHC practitioner to also include encounters furnished through interactive, real-time telecommunications technology, but only when furnishing services for the purposes of diagnosis, evaluation, or treatment of a mental health disorder.

Additionally, similar to the discussion of proposals for mental health services furnished under the PFS, as described in section II.D. Of this proposed rule, we believe that mental health telehealth services furnished via audio-only communications technology would increase access to care, especially in areas with poor broadband infrastructure and among patient populations that either are not capable of, or do not consent to, the use of devices that permit a two-way, audio/video interaction. Therefore, in order to align with proposals related to use of audio-only telecommunications technology to furnish similar mental health services under the PFS, we are proposing to allow RHCs and FQHCs to furnish mental health visits using audio-only interactions in cases where beneficiaries are not capable of, or do not consent to, the use of devices that permit a two-way, audio/video interaction. We note that the decision related to a service being furnished via telecommunications technology should be a patient-centered choice and that providers/practitioners should not force or impose services being furnished via telecommunications technology on beneficiaries who prefer to receive the services in-person. Additionally, some patients may prefer a hybrid whereby some mental health services are in person, but other times they are done using telecommunications technology.

We believe that this decision should be based on the clinical judgment of the practitioner, in consideration of patient needs and preferences. This proposed change would allow RHCs and FQHCs to report and be paid for mental health visits furnished via real-time, telecommunication technology in the same way they currently do when these services are furnished in-person. This proposed expansion of payable modes of mental health services furnished by RHCs and FQHCs corresponds with the expanded availability for professionals paid for Medicare Telehealth services under the PFS authorized by section 123 of the CAA and using the technology available for use for corollary services when paid under the PFS. This proposed revision would not allow RHCs or FQHCs to report visits furnished using asynchronous communications like email exchanges. Rather, RHCs and FQHCs would continue to report and be paid for furnishing medically necessary virtual communications services in accordance with the requirements for HCPCS code G0071 (83 FR 59686).

Also, this proposed change would not allow RHCs and FQHCs to report Medicare telehealth services under section 1834(m) of the Act or be paid under the PFS since RHCs and FQHCs are not authorized to serve as distant site practitioners for Medicare telehealth services once the PHE for the anti inflammatory drugs symbicort has been terminated. In order to track utilization of mental health visits furnished using communication technology, we are proposing that RHCs and FQHCs would append the 95 modifier (Synchronous Telemedicine Service Rendered via Real-Time Interactive Audio and Video Telecommunications System) in instances where the service was furnished using audio-video communication technology or a new Start Printed Page 39238service level modifier in cases where the service was furnished audio-only. Additionally, we note that section 123 of the CAA also requires that there be an in-person service within 6 months prior to the furnishing of the telehealth service and at intervals thereafter as specified by the Secretary for mental health services furnished via Medicare telehealth under the PFS. We are seeking comment on whether we should consider a similar requirement for mental health services furnished by RHCs and FQHCs via telecommunications technology, or whether this requirement may be especially burdensome for beneficiaries receiving treatment at RHCs and FQHCs, particularly in rural areas. If we were to establish a similar requirement for RHC and FQHC mental health services, we could consider the proposal for Medicare telehealth services described in section II.D.

Of this proposed rule that there be an in-person service within 6 months prior to the furnishing of the telecommunications service and that an in-person service (without the use of telecommunications technology) be provided at least every 6 months while the beneficiary is receiving services furnished via telecommunications technology for diagnosis, evaluation, or treatment of mental health disorders, which would be documented in the patient's medical record, or whether we should defer to the clinical judgment of the practitioner on how often an in-person visit would be appropriate. D. Regulatory Changes We are proposing to revise the regulation at § 405.2463, to revise paragraph (a)(1)(i) to state that a mental health visit is a face-to-face (that is, in person) encounter (or, for mental health visits only, an encounter that meets the requirements under paragraph (b)(3)) between an RHC patient and an RHC practitioner. We are proposing to revise paragraph (b)(3) to define a mental health visit as a face-to-face encounter or an encounter where services are furnished using interactive, real-time, audio and video telecommunications technology or audio-only interactions in cases where beneficiaries are not capable of, or do not consent to, the use of devices that permit a two-way, audio/video interaction for the purposes of diagnosis, evaluation or treatment of a mental health disorder. We are also proposing to revise § 405.2469, FQHC supplemental payments, to revise paragraph (d) by adding that a supplemental payment required under this section is made to the FQHC when a covered face-to-face (that is, in-person) encounter or an encounter where services are furnished using interactive, real-time, telecommunications technology or audio-only interactions in cases where beneficiaries do not wish to use or do not have access to devices that permit a two-way, audio/video interaction for the purposes of diagnosis, evaluation or treatment of a mental health disorder occurs between a MA enrollee and a practitioner as set forth in § 405.2463.

C. Federally Qualified Health Centers (FQHCs) Payment for Tribal FQHCs—Comment Solicitation 1. Health Services to American Indians and Alaska Natives (AI/AN) There is a special government-to-government relationship between the federal government and federally recognized tribes based on U.S. Treaties, laws, Supreme Court decisions, Executive Orders and the U.S. Constitution.

This government-to-government relationship forms the basis for federal health services to American Indians/Alaska Natives (AI/AN) in the U.S. In 1976, the Indian Health Care Improvement Act (IHCIA) (Pub. L. 94-437, September 30, 1976) amended the statute to permit payment by Medicare and Medicaid for services provided to AI/ANs in Indian Health Service (IHS) and tribal health care facilities that meet the applicable requirements. Under this authority, Medicare services to AI/ANs may be furnished by IHS operated facilities and programs and tribally-operated facilities and programs under Title I or Title V of the Indian Self Determination Education Assistance Act, as amended (ISDEAA) (Pub.

L 93-638, January 4, 1975). According to the IHS Profile,[] the IHS healthcare delivery system currently consists of 46 hospitals, with 24 of those hospitals operated by the IHS and 22 of them operated by tribes under the ISDEAA, as well as 492 health centers, 75 operated by IHS and 417 operated by tribes under the ISDEAA. Payment rates for outpatient medical care (also referred to as outpatient hospital services) furnished by the IHS and tribal facilities is set annually by the IHS under the authority of sections 321(a) and 322(b) of the Public Health Service Act (the PHS Act) (42 U.S.C. 248 and 249(b)) (Pub. L.

83-568 (42 U.S.C. 2001(a)), and the IHCIA, based on the previous year cost reports from federal and tribal hospitals. The IHCIA provided the authority for CMS (then HCFA) to pay IHS and tribal facilities for its outpatient hospital services to Medicare eligible patients, using an outpatient per visit rate (also referred to as the Medicare all-inclusive payment rate (AIR). 2. Federally Qualified Health Centers (FQHCs) Prospective Payment System (PPS) FQHCs were established in 1990 by section 4161 of the Omnibus Budget Reconciliation Act of 1990 (OBRA 90) (Pub.

L. 101- 508, November 5, 1990), and were effective beginning on October 1, 1991. They are facilities that furnish services that are typically furnished in an outpatient clinic setting. There are many FQHCs operated by IHS and tribes. The statutory requirements that FQHCs must meet to furnish services to Medicare beneficiaries are in section 1861(aa)(4) of the Act.

All FQHCs are subject to Medicare regulations at 42 CFR part 405, subpart X, and 42 CFR part 491. Based on these provisions, the following three types of organizations that are eligible to enroll in Medicare as FQHCs. Health Center Program grantees. Organizations receiving grants under section 330 of the PHS Act (42 U.S.C. 254b).

Health Center Program “lookalikes”. Organizations that have been identified by the Health Resources and Services Administration as meeting the requirements to receive a grant under section 330 of the PHS Act, but which do not receive section 330 grant funding. Outpatient health programs or facilities operated by a Tribe or tribal organization under the ISDEAA, or by an urban Indian organization receiving funds under Title V of the IHCIA. FQHCs are also entities that were treated by the Secretary, for purposes of Medicare Part B, as a comprehensive federally funded health center as of January 1, 1990 (see section 1861(aa)(4)(C) of the Act). Section 1834 of the Act was amended in 2010 by section 10501(i)(3)(A) of the Affordable Care Act by adding a new subsection (o), “Development and Implementation of Prospective Payment System” for FQHCs.

Section 1834(o)(1)(A) of the Act requires that the system include a process for appropriately describing the services furnished by FQHCs, and establish payment rates based on such descriptions of services, taking into account the type, intensity, and duration of services furnished by FQHCs. It also stated that the new system may include adjustments (such as geographic adjustments) as determined appropriate by the Secretary. Section 1833(a)(1)(Z) of the Act, as added by the Affordable Care Start Printed Page 39239Act, requires that Medicare payment for FQHC services under section 1834(o) of the Act be 80 percent of the lesser of the actual charge or the PPS amount determined under section 1834(o) of the Act. In accordance with the requirements in the statute, as amended by the Affordable Care Act, beginning on October 1, 2014, payment to FQHCs is based on the lesser of the national encounter-based FQHC PPS rate, or the FQHC's total charges, for primary health services and qualified preventive health services furnished to Medicare beneficiaries. The FQHC PPS rate is adjusted by the FQHC geographic adjustment factor (GAF), which is based on the Geographic Practice Cost Index used under the PFS.

The FQHC PPS rate is also adjusted when the FQHC furnishes services to a patient that is new to the FQHC, and when the FQHC furnishes an IPPE or an AWV. Payment to the FQHC for a Medicare visit is the lesser of the FQHC's charges (as established by the G-code), or the PPS rate. The CY 2021 FQHC PPS rate is $176.45. 3. Grandfathered Tribal FQHCs In the November 16, 2015 Federal Register, we published a final rule, entitled “Medicare Program.

Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016 (referred to as CY 2016 PFS final rule). In that rule, we discuss the payment methodology and requirements finalized for grandfathered tribal FQHCs (80 FR 71089 through 71096). We stated that tribal facilities that met the conditions of § 413.65(m) on or before April 7, 2000, and had a change in their status on or after April 7, 2000, from IHS to tribal operation, or vice versa, or the realignment of a facility from one IHS or tribal hospital to another IHS or tribal hospital, such that the organization no longer met the Medicare Conditions of Participation (CoPs) for Medicare-participating hospitals at § 482.12, the “governing body” of the facility could nevertheless seek to become certified as a grandfathered tribal FQHC. In CY 2016 PFS final rule, we explained that a different structure was needed to maintain access to care for AI/AN populations served by the hospitals and clinics impacted by the provider-based rules at § 413.65, while also ensuring that the tribal clinics are in compliance with our health and safety rules. We recognized that a tribal clinic billing under an IHS hospital's CMS Certification Number (CCN), without any additional administrative or clinical relationship with the IHS hospital, could put that hospital at risk for noncompliance with their CoPs because the clinic had a separate governing body although still provider-based.

We explained that the FQHC program provided an alternative structure that met the needs of these tribal clinics and the populations they served, while also ensuring the IHS hospitals were not at risk of being cited for non-compliance with the requirements with their CoPs (80 FR 71090). As stated in § 405.2462(d)(1) a “grandfathered tribal FQHC” is a FQHC that is operated by a tribe or tribal organization under the ISDEAA. Was billing as if it were provider-based to an IHS hospital on or before April 7, 2000 and is not currently operating as a provider-based department of an IHS hospital. We refer to these tribal FQHCs as “grandfathered tribal FQHCs” to distinguish them from freestanding tribal FQHCs that are currently being paid the lesser of their charges or the adjusted national FQHC PPS rate, and from provider-based tribal clinics that may have begun operations subsequent to April 7, 2000. There are 7 “grandfathered tribal FQHCs”.

Under the authority in section 1834(o) of the Act to include adjustments determined appropriate by the Secretary, we revised §§ 405.2462 and 405.2464 to pay these grandfathered tribal FQHCs on the Medicare outpatient per visit rate as set annually by the IHS, that is, the AIR and not the FQHC PPS payment rates (80 FR 71089). Payment rates for outpatient medical care (also referred to as outpatient hospital services) furnished by the IHS and tribal facilities is set annually by the IHS under the authority of sections 321(a) and 322(b) of the Public Health Service Act (the PHS Act) (42 U.S.C. 248 and 249(b)) (Pub. L. 83-568 (42 U.S.C.

2001(a)), and the IHCIA, based on the previous year cost reports from federal and tribal hospitals. The outpatient per visit rate is only applicable for those IHS or tribal facilities that meet the definition of a provider-based department as described at § 413.65(m), or a “grandfathered” tribal FQHC as described at § 405.2462(d)(1). There is an outpatient per visit AIR for Medicare visits in Alaska and a separate outpatient per visit AIR for Medicare visits in the lower 48 states. For CY 2021, the outpatient per visit rate for Medicare visits in Alaska is $662 and $414 in the lower 48 states (85 FR 86940). There are no grandfathered tribal FQHCs in Alaska because the tribes operate the hospitals, not IHS.

We note that IHS does not operate any hospitals or facilities in Hawaii or the territories, and thus no rates are set, in those localities. As we discussed in CY 2016 PFS final rule, the payment rate is not adjusted by the FQHC GAF. For new patients, annual wellness visits, or initial preventive physical examinations. Or annually by the FQHC PPS market basket, as further adjustments would be unnecessary and/or duplicative of adjustments already made by IHS in deriving the rate. Comparatively, the FQHC PPS rate established by CMS is $176.45.

The reimbursement is the lesser of the charges or the IHS AIR rate. We stated as part of the CY 2016 PFS final rule that we would monitor future costs and claims data of these tribal clinics and reconsider options as appropriate. 4. Paying all IHS- and Tribally-Operated Outpatient Clinics the AIR CMS established a Tribal Technical Advisory Group (TTAG) in 2004 to provide advice and input to CMS on policy and program issues impacting AI/AN populations served by CMS programs. Although not a substitute for formal consultation with Tribal leaders, the TTAG enhances the government-to-government relationship and improves increased understanding between CMS and Tribes.

The TTAG has subject specific subcommittees that meet on a regular basis in order to be more effective and perform in-depth analysis of Medicare, Medicaid, CHIP, and the Health Insurance Marketplace policies that have Tribal implications. The TTAG is comprised of 17 representatives. An elected Tribal leader, or an appointed representative from each of the 12 geographic areas of the IHS delivery system and a representative from each of the national Indian organizations headquartered in Washington DC—the National Indian Health Board, the National Congress of American Indians, and the Tribal Self-Governance Advisory Group. The American Recovery and Reinvestment Act of 2009 section 5006(e)(1), which became effective July 1, 2009, mandates that TTAG shall be maintained within CMS and added two new representative's positions. A representative and alternate from a national urban Indian health organization (National Council of Urban Indian Health) and a representative and alternate from the IHS.

The TTAG has requested [] that CMS amend its Medicare regulations to make all IHS and tribally-operated outpatient Start Printed Page 39240facilities eligible for payment at the IHS Medicare outpatient per visit rate/AIR. The TTAG explained that outpatient clinics, which are otherwise similar to grandfathered tribal FQHCs, are paid at different rates depending upon whether they meet the requirements as a “provider based facility,” a “grandfathered tribal FQHC,” a non-grandfathered tribal FQHC, or none of the above. They believe that the rates vary based on the Medicare regulatory definition, rather than the actual costs of the outpatient clinic. There are varying payment differentials among Medicare enrolled providers and suppliers under the authorities of the SSA. For example, Ambulatory Surgical Centers are paid differently than hospital outpatient departments.

Which are paid differently whether they're under the under the outpatient prospective payments system or a located in a critical access hospital. The TTAG also questioned the need for grandfathered tribal FQHCs to file cost reports. Specifically, the TTAG stated that the FQHC cost reports have no relationship to the IHS Medicare outpatient per visit rate/AIR paid to grandfathered tribal FQHCs, as they use hospital cost reports in setting the rate. Therefore, they stated, the FQHCs should only need to file a cost report to the extent necessary to support payment for non-FQHC services that are reimbursed outside the Medicare outpatient per visit rate/AIR. We note that under section 1815(a) of the Act, providers participating in the Medicare program are required to submit financial and statistical information to achieve settlement of costs relating to health care services rendered to Medicare beneficiaries.

Under the FQHC PPS, Medicare payment for FQHC services is the lesser of the FQHC PPS rate or the charges on the claim. In the establishment of the FQHC PPS, the statute does not exempt FQHCs from submitting cost reports. In addition, Medicare payments for the reasonable costs of the influenza and pneumococcal treatments and their administration, allowable graduate medical education costs, and bad debts are determined and paid through the cost report. The FQHC market basket also uses information from the FQHC cost report to determine the cost share weights, which reflect the relative costs of input expenses that FQHCs face in order to provide FQHC services. Having a full picture of the costs of providing care by grandfathered FQHCs is important so that CMS can be sure that payments are adequate.

5. Comment Solicitation We appreciate the TTAG's concerns with ensuring that CMS make appropriate payments among the clinics for similar services and the impact this has on tribal Medicare beneficiaries and ensuring that access to healthcare is available and equitable and we take these concerns seriously. However, we have insufficient information necessary to evaluate the costs and benefits of potential changes to these policies. Therefore, we would like to solicit comment on the TTAG's request for CMS to amend its Medicare regulations to make all IHS- and tribally-operated outpatient facilities/clinics eligible for payment at the Medicare outpatient per visit rate/AIR, regardless of whether they were owned, operated, or leased by IHS. We seek information on the kinds of and number of facilities or clinics that could potentially enroll in Medicare as an FQHC, or are already an FQHC paid under the FQHC PPS, and if these clinics are freestanding or provider-based to expand on information provided by the IHS Profile.

We seek information regarding the relative operating costs of IHS- and tribally-operated outpatient clinics compared to non-tribal FQHCs, stakeholder feedback and supporting evidence to address whether or why payment set at the IHS AIR would be more appropriate than payment rate under the FQHC PPS. Further, we seek comment on how the IHS AIR, which is based upon a limited number of hospital cost reports, relates to costs in such clinics and the kinds of services that the clinics furnish. Finally, we seek comment on the concerns that the AI/AN community may have on issues regarding access or inequity care in situations where a payment differential exists. While, we have information on grandfathered tribal FQHCs and the outpatient hospital cost reports, we do not have any information specific to the composition of IHS and tribal facilities. For example, if the facility is not enrolled in Medicare as an FQHC or is not provider based to a hospital, is it a physician practice?.

It would be helpful to know how the facilities are organized and related. Are there other options for enrolling as different types of providers or suppliers?. As increasing the rate would increase payments from the Medicare Trust Fund, we are also seeking comment on the magnitude of that payment change and whether any program integrity concerns would be present with the increased payment. We also request comments on FQHC services that are paid through the cost report, like influenza, pneumococcal, and anti inflammatory drugs vaccinations and GME and how that impacts the request to not file cost reports. As stated above, having a full picture of the costs of providing care is important so that CMS can be sure that payments are adequate.

Are these services included in the IHS/AIR?. We are also seeking input on other potential uses of the adjustment authority under section 1834(o)(1)(A) of the Act which provides that the FQHC PPS may include adjustments determined appropriate by the Secretary. For example, we could consider TTAG's request on the expansion of the payment policy finalized in the CY 2016 PFS final rule for grandfathered tribal FQHCs to all Tribally-operated outpatient clinics. Alternatively, we could develop a payment adjustment applicable to IHS- and tribally-operated outpatient clinics based on the cost differential reported in their cost reports when compared to non-IHS outpatient clinics, or non-provider-based clinics, if such differentials exist and would be interested in specific comments about appropriate adjustments to the FQHC PPS rate for clinics that are enrolled as FQHCs. We seek comment on other potential ways to determine whether the costs associated with furnishing services to AI/AN are uniquely greater than other clinics within the confines of the FQHC PPS outlined in section 1834(o)(1) of the Act.

D. Requiring Certain Manufacturers To Report Drug Pricing Information for Part B and Determination of ASP for Certain Self-Administered Drug Products 1. Requiring Certain Manufacturers To Report Drug Pricing Information for Part B (§§ 414.802 and 414.806) a. Overview and Summary Section 1927(b)(3)(A)(iii)(I) of the Act requires manufacturers with a Medicaid drug rebate agreement to report Average Sales Price (ASP) data as specified in section 1847A of the Act. Some manufacturers without Medicaid drug rebate agreements voluntarily submit ASP data for their single source drugs or biologicals that are payable under Part B.

However, other manufacturers without Medicaid drug rebate agreements do not voluntarily submit such data. Without manufacturer reported ASP data, CMS cannot calculate the ASP payment limit, and consequently, payment is typically based on Wholesale Acquisition Cost (WAC). Consistent with section 1847A(c)(3) of the Act and our regulations at Start Printed Page 39241§ 414.804(a)(2), the ASP is net of price concessions. However, consistent with the definition of WAC at section 1847A(c)(6)(B) of the Act, the WAC is not net of price concessions, and thus, is nearly always, and sometimes, significantly, higher than ASP. Drugs with payment allowances based on WAC may have greater “spreads” between acquisition costs and payment than drugs for which there is an ASP-based payment allowance, which, in turn, may.

(1) Incent the use of the drug based on its spread rather than on purely clinical considerations. (2) result in increased payments under Medicare Part B. And (3) increase beneficiary cost sharing. Section 401 of Division CC, Title IV of the CAA, 2021 (for the purposes of this section of this proposed rule, hereinafter is referred to as “section 401”) amended section 1847A of the Act to add new section 1847A(f)(2) of the Act, which requires manufacturers without a Medicaid drug rebate agreement to report ASP information to CMS for calendar quarters beginning on January 1, 2022, for drugs or biologicals payable under Medicare Part B and described in sections 1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of the Act, including items, services, supplies, and products that are payable under Part B as a drug or biological. Section 401(b)(2) also amended section 1847A(c)(6)(A) of the Act to permit the Secretary to exclude repackagers [] from the definition of “manufacturer” for purposes of the ASP reporting requirement in section 1847A(f)(2) of the Act, if the Secretary determines appropriate.

Section 401(b)(1) also adds provisions to section 1847A of the Act addressing confidentiality, audit and verification provisions. Civil money penalties for misrepresentation, late reporting, and reporting of false information. And increasing oversight and enforcement provisions. These provisions largely track the statutory provisions in section 1927(b) of the Act that apply to the reporting of ASP by manufacturers with Medicaid drug rebate agreements. Additionally, section 401(d) requires HHS Office of the Inspector General (OIG) to submit a report on the accuracy of ASP submissions to Congress by January 1, 2023.

Finally, section 401 amended section 1927(b) of the Act to clarify that for Part B ASP reporting, drugs would include items, services, supplies, and products that are payable under Medicare Part B as a drug or biological. We are proposing regulatory changes to implement the new reporting requirements at 42 CFR, part 414, subpart J. B. Reporting Requirements for Manufacturers Without a Medicaid Drug Rebate Agreement Starting with calendar quarters beginning on January 1, 2022, manufacturers will be required to report ASP for drugs and biologicals payable under Medicare Part B consistent with the statutory requirements of section 1847A(f) of the Act, regardless of whether they have Medicaid drug rebate agreements. Our existing regulations at 42 CFR part 414, subpart J implement the ASP reporting requirements referenced in section 1847A(f)(1) of the Act, that is, the requirements of section 1927(b)(3) of the Act.

Thus, the existing regulations at 42 CFR part 414, subpart J already set forth requirements for manufacturers with Medicaid drug rebate agreements to report their ASP information (and if required to make payment, WAC) each quarter. Many manufacturers without Medicaid drug rebate agreements voluntarily submit ASP data consistent with these requirements. Whether obligated to report or voluntarily reporting, manufacturers are accustomed to the existing regulatory requirements at 42 CFR part 414 subpart J, and indeed, the methodology for reporting ASP reflected in these regulations does not currently distinguish between manufacturers with Medicaid drug rebate agreements and those without these agreements. Because new section 1847A(f)(2) of the Act, as noted previously, largely parallels section 1927(b)(3) of the Act, and thus both manufacturers with Medicaid drug rebate agreements, as well as those without such agreements, will be subject to requirements already reflected in the existing regulations at subpart J, we do not believe it is necessary to propose substantial changes to the regulation text. For these reasons, our proposal to amend the regulations to reflect the new requirements of section 1847A(f)(2) of the Act seeks to preserve the status quo to the extent possible.

C. Definitions As noted previously, the new section 1847A(f)(2) of the Act, as added by section 401(a), requires manufacturers without a Medicaid drug rebate agreement to report ASP information to CMS for calendar quarters beginning on January 1, 2022 for drugs or biologicals payable under Medicare Part B and described in sections 1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of the Act, including items, services, supplies, and products that are payable under Part B as a drug or biological. Section 401 also made a conforming amendment to the ASP reporting requirements applicable to manufacturers with Medicaid drug rebate agreements at section 1927(b)(3)(A)(iii) of the Act to specify that those reporting requirements also apply to items, services, supplies, and products that are payable under Part B as a drug or biological. To implement this change, we propose to amend the definition of the term “drug” at § 414.802 to mean a drug or biological, and includes an item, service, supply, or product that is payable under Medicare Part B as a drug or biological. Section 1847A(c)(6)(A) of the Act incorporates the definition of manufacturer at section 1927(k)(5) of the Act, except that section 401(b)(2) permits the Secretary to exempt repackagers from the definition of manufacturer, as determined appropriate, for purposes of section 1847A(f)(2) of the Act.

However, no such exemption is provided for manufacturers with Medicaid drug rebate agreements (see the definition of manufacturer at § 447.502). Consequently, the current ASP data reporting includes submissions by repackagers. To confirm the Medicare Payment Advisory Commission's (MedPAC's) assertion in their June 2017 report (available at http://medpac.gov/​docs/​default-source/​reports/​jun17_​ch2.pdf) that many repackagers currently do not report ASP data, and thus inform our consideration of whether we should propose to exclude repackagers from the definition of manufacturers for purposes of section 1847A(f)(2) of the Act, we conducted an analysis to estimate the proportion of repackaged products in our existing ASP data. If our existing ASP data do not contain an appreciable Start Printed Page 39242proportion of repackaged products, it may be appropriate to exclude repackagers from the definition of manufacturer for this limited purpose. However, if repackaged products comprise an appreciable proportion of our existing ASP data, we would reasonably anticipate this trend to follow under the new requirements, and in such a scenario, it would not be appropriate to exclude repackagers from the definition of manufacturer for purposes of section 1847A(f)(2) of the Act because excluding their sales could distort the ASP.

To effectuate this analysis, we obtained a list of National Drug Codes (NDCs) of repackaged drugs from the United States Food and Drug Administration (FDA).[] We also obtained a list of labeler codes for which the manufacturers have Medicaid drug rebate agreements.[] We then performed a crosswalk both of these to our composite file of ASP data submissions to segregate our composite file of ASP data submissions into four categories. (1) Repackaged products for which ASP data submissions were required (that is, manufacturers with Medicaid drug rebate agreements). (2) Repackaged products for which ASP data submissions were voluntary (that is, for manufacturers without Medicaid drug rebate agreements). (3) Non-repackaged products for which ASP data submissions were required. And (4) Non-repackaged products for which ASP data submissions were voluntary.

We estimate that, of all 6319 products for which we currently receive ASP data submissions (the sum of categories (1)-(4) above), repackaged products accounted for 271 (4.29 percent) of these products. Additionally, repackaged products accounted for 137 (2.51 percent of) products for which ASP data submissions were required, and 134 (15.23 percent of) products for which ASP data were voluntarily submitted. Additionally, we conducted another analysis to estimate. (1) The number of new ASP submissions we can expect as a result of the new requirements under section 401. And (2) the proportion of those submissions that involve repackaged products.

To effectuate this analysis, we obtained a crosswalk of NDCs and Healthcare Common Procedure Coding System (HCPCS) codes that includes the NDCs and HCPCS codes of items for which ASP reporting is not currently required.[] We supplemented this crosswalk by adding HCPCS codes with NDCs that are payable under Part B, but not already reflected in the crosswalk.[] We then identified [] and removed from the crosswalk all of the products contained in our composite file of ASP data submissions and those HCPCS codes that are non-covered under Medicare Part B. Adding the results of this analysis to the results of categories two and four from the prior analysis (that is, repackaged and non-repackaged products for which ASP submissions were voluntary), we estimate there will be 6994 total products for which manufacturers will now be required to submit ASP data. We then compared this number to the FDA's list of repackaged products in the previous analysis, and found that of the 6994 products for which manufacturers will be required to submit ASP data, 223 (3.19 percent) are repackaged products. Further, we estimate 6114 products for which their manufacturers did not previously (voluntarily) submit ASP data and will now be required to do so under the new reporting requirements of section 401. Of these, 89 (1.46 percent) are repackaged products.

These data do not persuade us that it is necessary to exempt repackagers from the new reporting requirements under section 401 at this time. Our current operational process to verify the accuracy of manufacturers' reported ASP data does not distinguish. (1) Products on the basis of repackaging, and (2) manufacturers who are required to report ASP data from those who do so voluntarily. Each month, CMS reviews ASP data submissions at the NDC level (and for products without NDCs, the manufacturer's product code). Previously, we have not required manufacturers to identify which products are repackaged as part of these submissions.

Exempting repackagers from the new requirements of section 1847A(f)(2) of the Act would significantly increase our administrative burden because we would have to undergo an additional quality check for each NDC from a different database for which data are submitted as part of our operational process to verify the accuracy of manufacturers' reported ASP data. Moreover, for products without NDCs, our ability to determine if these products are repackaged (without manufacturer attestation) to that effect is significantly limited. Finally, any such attestation would require a data source for us to verify the accuracy of the attestation, and no such data source currently exists. These additional checks could, in turn, significantly increase the time it takes for us to calculate and display on our website the volume-weighted ASP payment limits. Additionally, we are concerned that exempting repackagers from the new reporting requirements could lead to a gap in ASP reporting, meaning that ASPs could be distorted to the extent that certain sales are carved out of the reporting requirement through the use of repackagers.

Consequently, in order to maintain consistency and integrity of the ASP data for those manufacturers with and without Medicaid drug rebate agreements, we do not believe it is appropriate to exclude repackagers from the requirements of section 401 at this time. However, we may propose to exempt repackagers in the future, if warranted. We solicit comment on this approach. In summary, we propose to modify the definition of drug at § 414.802 to include any item, service, supply or product that is payable under Part B as a drug or biological. We are not proposing to exclude repackagers from the definition of manufacturer for purposes of the reporting requirements at section 1847A(f)(2) of the Act.

D. Civil Money Penalties As amended by section 401(b), section 1847A(d)(4)(A) of the Act specifies the penalties associated with misrepresentations in the reporting of the manufacturer's ASP for a drug or biological. Consistent with our existing regulation at § 414.806, if the Secretary determines that a manufacturer has made a misrepresentation in the reporting of ASP data, a civil money penalty in an amount of up to $10,000 may be applied for each price misrepresentation and for each day in which the price misrepresentation was applied. New sections 1847A(d)(4)(B) and (C) of the Act, as added by section 401(b), Start Printed Page 39243apply civil money penalties for failure to report timely and accurate ASP data for manufacturers without Medicaid drug rebate agreements, consistent with the civil money penalties found at sections 1927(b)(3)(C)(i) and (ii) of the Act for manufacturers with Medicaid drug rebate agreements. Our current regulations at § 414.806 refer to section 1927(b)(3)(C) of the Act, as amended by section 303(i)(4) of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 (Pub.

L. 108-173, December 8, 2003), as specifying the penalties associated with a manufacturer's failure to submit timely information or the submission of false information. We propose to amend § 414.806 to reflect the new provisions specifying penalties for manufacturers without Medicaid drug rebate agreements and to provide some technical changes to streamline the regulations text. Specifically, we propose to do the following. Add paragraph (a), labeled as “Misrepresentation”, moving the existing regulatory language at § 414.806 specific to misrepresentation to this paragraph.

Remove the sentence which reads, “If the Secretary determines that a manufacturer has made a misrepresentation in the reporting of ASP data, a civil money penalty in an amount of up to $10,000 may be applied for each price misrepresentation and for each day in which the price misrepresentation was applied,” since the previous sentence in the regulations text already references the statutory provision for this language. Add paragraph (b), labeled as “Failure to provide timely information or the submission of false information”. Add paragraph (b)(1) to clarify that the existing language at § 414.806 regarding civil money penalties for failure to submit timely information or for the submission of false information applies to manufacturers with a Medicaid drug rebate agreement. Remove the phrase “as amended by section 303(i)(4) of the MMA”. And Add paragraph (b)(2) to reflect new sections 1847A(d)(4)(B) and (C) of the Act regarding civil money penalties for failure to submit timely information or for the submission of false information for manufacturers without a Medicaid drug rebate agreement.

We welcome comments on these proposals. E. Summary of all Proposals In summary, to implement the new reporting requirements for manufacturers without Medicaid drug rebate agreements, we are proposing to modify. The definition of drug at § 414.802. And The regulations describing civil money penalties at § 414.806.

We welcome comments on these proposals. 2. Determination of ASP for Certain Self-Administered Drug Products (§ 414.904) a. Background Drugs and biologicals payable under Medicare Part B fall into three general categories. Those furnished incident to a physician's services (hereinafter referred to as “incident to”) (section 1861(s)(2) of the Act), those administered via a covered item of durable medical equipment (DME) (section 1861(s)(6) of the Act), and others as specified by statute (for example, certain treatments described in sections 1861(10)(A) and (B) of the Act).

Payment limits for most drugs and biologicals separately payable under Medicare Part B are determined using the methodology in section 1847A of the Act, and in many cases, payment is based on the Average Sales Price (ASP) plus a statutorily mandated 6 percent add-on. Most drugs payable under Part B are paid under the “incident to” benefit under section 1861(s)(2) of the Act, which includes drugs and biologicals not usually self-administered by the patient. Paragraphs (4)(A) and (6) of sections 1847A(b) of the Act require that the Medicare Part B payment amount for a single-source drug or biological be determined using all of the NDCs assigned to it. Section 1847A(b)(5) of the Act further states that the payment limit shall be determined without regard to any special packaging, labeling, or identifiers on the dosage form or product or package. In 2007, CMS issued a program instruction (available at https://www.cms.gov/​Medicare/​Coding/​MedHCPCSGenInfo/​Downloads/​051807_​coding_​annoucement.pdf), as permitted under section 1847A(c)(5)(C) of the Act, stating that the payment limit for a single source drug or biological will be based on the pricing information for products produced or distributed under the applicable FDA approval (such as a New Drug Application (NDA) or Biologics License Application (BLA)).

Therefore, all versions of a single source drug or biological product (or NDCs) marketed under the same FDA approval number (for example, NDA or BLA, including supplements) are considered the same drug or biological, for payments made under section 1847A of the Act and are crosswalked to the same billing and payment code. This means that a self-administered version marketed under the same FDA approval is subject to the ASP reporting requirements and is not excluded from the payment limit calculation, even though Medicare does not make separate Part B payment for it. This is consistent with our longstanding policy on the scope of the ASP reporting requirements. (Please see our final rule titled, “Medicare Program. Revisions to Payment Policies, Five-Year Review of Work Relative Value Units, Changes to the Practice Expense Methodology Under the Physician Fee Schedule, and Other Changes to Payment Under Part B.

Revisions to the Payment Policies of Ambulance Services Under the Fee Schedule for Ambulance Services. And Ambulance Inflation Factor Update for CY 2007,” published in the December 1, 2006 Federal Register (71 FR 69675)). The price of a drug or biological product that may be administered by the patient (that is, self-administered) may differ from versions that are administered incident to a physician's service, which may affect the ASP-based payment limit for drug or biological product's billing and payment code. The HHS OIG conducted studies []  [] of payment-limit calculations for certain drugs paid under section 1847A of the Act. The OIG identified two highly utilized biological products for which there are both Part-B-covered (versions administered incident to a physician's service) and non-covered versions (those identified to be self-administered) for which the NDCs were marketed under the same FDA approval number.

OIG's studies found that when the ASPs of the self-administered versions are included in the payment limit calculation, the resulting payment limit is substantially higher than if the ASPs of only the incident-to versions had been included. The OIG studies concluded that as a result, Medicare payment amounts were inflated, causing the program and its beneficiaries to pay an additional $366 million from 2014 through 2016 and $497 million from 2017 through 2018. They recommended that legislative changes be made to provide CMS the flexibility to determine when certain versions of a drug identified to be self-administered should be included in ASP payment limit calculations. Section 405 of Division CC, Title IV of the CAA, 2021, amended section 1847A of the Act by redesignating Start Printed Page 39244existing subsection (g) as subsection (h) and adding new subsection (g), which describes the Medicare Part B ASP payment-limit adjustment for certain drugs and biological products for which NDCs have been identified by the OIG to be self-administered and not covered under Medicare Part B. The new section 1847A(g)(1) of the Act directs OIG to conduct periodic studies to identify NDCs for drug or biological products that are identified to be self-administered for which payment may not be made under Part B pursuant to section 1861(s)(2) of the Act and that OIG determines should be excluded from the determination of the payment amount under section 1847A of the Act.

New section 1847A(g)(2) of the Act specifies that if the OIG identifies an NDC under section 1847A(g)(1) of the Act, it must inform the Secretary at such times as the Secretary may specify. Then the Secretary shall, to the extent appropriate, apply as the payment limit for the applicable billing and payment code the lesser of. (1) The payment allowance that would be determined under section 1847A of the Act if the NDC for the identified drug or biological product were excluded from the calculation. Or (2) the payment limit otherwise determined under section 1847A of the Act without application of section 1847A(g) of the Act. In other words, the Medicare payment limit for a drug or biological product's billing and payment code in these circumstances would be the lesser of the payment limit determined including the NDCs identified to be self-administered and the payment limit determined after excluding the NDCs identified to be self-administered (hereinafter referred to as the “lesser-of payment methodology”).

Although section 1847A(g)(1) of the Act provides us with discretion in whether to apply the lesser-of methodology to billing and payment codes that include self-administered versions identified by the OIG (because we are directed to apply the methodology to the extent deemed appropriate), new section 1847A(g)(3) of the Act, requires the application of the lesser-of methodology to the two billing and payment codes identified in the OIG's July 2020 report titled, “Loophole in Drug Payment Rule Continues To Cost Medicare and Beneficiaries Hundreds of Millions of Dollars,” (available at https://oig.hhs.gov/​oei/​reports/​OEI-BL-20-00100.asp) (hereinafter referred to as “OIG's July 2020 report”)) beginning July 1, 2021. To meet the implementation date required by this provision, we applied the lesser-of methodology to the payment limit calculations for the billing and payment codes representing Cimzia® (certolizumab pegol) and Orencia® (abatacept), details on these calculations are described in this section. In a memorandum providing supplemental information on the OIG July 2020 report, the OIG provided specific NDCs that the report identified. 00003-2188-11, 00003-2188-51, 00003-2814-11, 00003-2818-11, 50474-0710-79, 50474-0710-81. The lesser-of methodology was applied to these billing and payment codes for the July 2021 ASP Drug Pricing Files and crosswalks along with program instructions in a change request (CR) at https://www.cms.gov/​medicare/​medicare-part-b-drug-average-sales-price/​2021-asp-drug-pricing-files.

We propose to codify the new requirements of section 1847A(g) of the Act at § 414.904. Our proposals described in the next section specify when the application of the lesser-of methodology would be appropriate, describe how we will apply the lesser-of payment methodology to billing and payment codes that OIG has identified pursuant to studies described in section 1847A(g)(1) of the Act, and codify the approach we used for the certolizumab pegol and abatacept billing and payment codes. B. Identification of Billing and Payment Codes to Which the Lesser-of Policy Will Be Applied As noted previously, section 1847A(g)(1) of the Act directs OIG to conduct periodic studies to identify NDCs for drug or biological products that are self-administered and for which payment is not made under Part B. Section 1847A(g)(2) of the Act specifies that if OIG makes an identification under section 1847A(g)(1) of the Act, OIG informs CMS at such times as we may specify, and in such an event, we apply the lesser-of methodology to the extent deemed appropriate.

We propose that when the OIG conducts a periodic study, OIG informs us at the time the study becomes are publicly available. CMS will obtain the NDCs identified by the OIG study described in section 1847A(g)(1) of the Act. However, if the specific NDCs are not available in the OIG study report, we will request OIG provide documentation of the identified NDCs to CMS. To allow operational time for assessment and application of the lesser-of methodology, we believe it is reasonable that the application of the lesser-of methodology be reflected beginning in the ASP pricing file two quarters following the OIG study publication. For example, if the OIG study becomes available to the public in the first quarter of the calendar year, the lesser-of methodology would be applied to the payment limit calculation of the applicable billing and payment code in the third quarter ASP pricing file (in other words, the July ASP pricing file) and each quarter thereafter.

C. Calculation of Payment Allowance Using the Lesser-of Payment Methodology Sections 1847A(g)(2) and (g)(3) of the Act set forth the lesser-of payment methodology for applicable billing and payment codes with NDCs for certain drug or biological products identified by the OIG as self-administered products for which payment may not be made under this part because such products are not covered under section 1861(s)(2) of the Act. In this section, we describe how we propose to apply the lesser-of methodology. We propose to codify this methodology, which we currently use for the billing and payment codes that describe certolizumab pegol and abatacept, and which we propose to use for billing and payment codes for which OIG identifies a drug or biological product with NDCs identified to be self-administered as described in section 1847A(g)(1) of the Act. The ASP payment limit calculation is described in section 1847A(b)(6) of the Act and codified at § 414.904(b)(2)(ii) and (c)(2)(ii), which specifies that for a billing and payment code, the volume-weighted average of the average sales prices reported by the manufacturer is determined by.

Computing the sum of the products (for each NDC assigned to such drug products) of. ++ The manufacturer's average sales price determined by the Secretary without dividing such price by the total number of billing units for the NDC for the billing and payment code. And ++ The total number of units sold. And Dividing the sum determined under (A) by the sum of by the sum of the products (for each NDC assigned to such drug products) of ++ The total number of units specified sold. And ++ The total number of billing units for the NDC for the billing and payment code.

When applying the lesser-of methodology described in 1847A(g)(2) and (g)(3) of the Act, we propose to make two calculations as described in section 1847A(b)(6) of the Act. (1) The ASP payment limit for the billing and payment code, excluding the NDCs that have been identified by the OIG study (that is, excluding the ASPs for those NDCs as well as the units of such NDCs Start Printed Page 39245sold in the quarter). And (2) the ASP payment limit for the billing and payment code, including such NDCs' ASPs and units sold. The calculation resulting in the lower payment limit will be used as the payment limit for the applicable billing and payment code for that quarter's ASP pricing files. We propose to apply the lesser-of methodology to the billing and payment codes containing OIG-identified products each quarter when determining ASP payment limits.

New section 1847A(g) of the Act does not change ASP reporting requirements, and consistent with section 1847A(f)(1) of the Act and, beginning January 1, 2022, section 1847A(f)(2) of the Act, manufacturers must continue to report ASP data for all NDCs of the drug or biological product. Under new section 1847A(g) of the Act, ASP data for all NDCs under the same FDA approval application (for example, NDA or BLA, including any supplements) are required to carry out the lesser-of calculations for the purposes of determining the payment limit for the billing and payment code. Even if the resulting payment limit does not reflect the ASPs or units sold of self-administered versions of a product identified by the OIG, the manufacturer must continue to report those versions' ASPs and units sold to the Secretary. The implementation of the lesser-of methodology is not expected to be associated with substantial administrative costs. We plan to incorporate methodology in the current operational process that is used to determine ASP payment limits each quarter.

The OIG found that Medicare and its beneficiaries would have saved a combined $497 million on certolizumab pegol and abatacept over 2 years (2017-2018) if such a methodology had been in place. D. Exceptions We further propose that the application of the lesser-of methodology is deemed appropriate in all cases in which OIG identifies a drug or biological product in a periodic study described in section 1847A(g)(1) of the Act and made publicly available, unless the drug or biological product is in short supply.[] As stated in the OIG's July 2020 report, CMS expressed concern about potential impact on beneficiary access if certain versions identified to be self-administered were excluded from the ASP payment limit calculation. Because of potential for drug shortages that may affect patient care, beneficiary and provider access, and drug prices for providers, we would consider it not appropriate to apply the lesser-of methodology when a product is in short supply. Similar to the average manufacturer price (AMP) price substitution provision in section 1847A(d)(3)(C) of the Act (codified in §  414.904(d)(3)), we propose to add § 414.904(d)(4)(ii) to specify that we will not apply the lesser-of methodology (that is, we will determine the payment allowance including all NDCs of the drug or biological product) if the drug and dosage form(s) represented by the billing and payment code are reported by the Drug Shortage list established under section 506E of the Federal Food, Drug, and Cosmetic Act (FFDCA) at the time that ASP payment limits are being finalized for the next quarter.

However, we propose that this exception to the application of the lesser-of methodology would not apply in the case of the billing and payment codes for certolizumab pegol and abatacept because section 1847A(g)(3) of the Act does not provide us with the same discretion as section 1847A(g)(2) of the Act. Thus, for these applicable billing and payment codes we will always apply the lesser-of methodology. We recognize that NDCs identified by an OIG study described in section 1847A(g)(1) or (g)(3) of the Act may change, for example, because of a manufacturer change. In the event that the manufacturer of an OIG-identified product simply redesignates the NDC for its product, we believe the new NDC also would meet the same criteria defined in the OIG study. In this circumstance, we expect that the product labeling would not contain substantial changes regarding the redesignated NDC.

Therefore, we propose to add § 414.904(d)(4)(iv) to codify the application of the lesser-of methodology such that the manufacturer-reported pricing data associated with redesignated NDCs will be used in the lesser-of methodology in the same way as the original OIG-identified NDC. Once an OIG study identifies self-administered versions of a drug or biological product, there may be subsequent FDA approvals of other products with the same active ingredient, such as new syringe sizes, new types of injector syringes, generic formulations, biosimilar biological products, or interchangeable biological products. For example, this would include the situation in which the current manufacturer of certolizumab pegol or abatacept obtains a supplemental FDA approval for a new version of the product. Similarly, this would also include the situation in which another manufacturer gains FDA approval of a product with the same active ingredient as an OIG-identified self-administered version. We believe that provisions at new section 1847A(g) of the Act would require a new OIG study as described in section 1847A(g)(1) of the Act in order for us to apply the lesser-of methodology to the drug or biological product.

E. Summary In summary, to implement new section 1847A(g) of the Act, we are proposing to. Add § 414.904(d)(4) to codify the lesser-of payment methodology and define when the application of the lesser-of methodology would first be reflected in the ASP pricing file following the OIG study publication. And Describe the lesser of methodology at § 414.904(d)(4)(iv). Describe exceptions to application of the lesser-of methodology at § 414.904(d)(4)(ii).

Clarify application of the lesser-of methodology for billing and payment code described under section 1847A(g)(3) of the Act at § 414.904(d)(4)(iii). Describe the application of the lesser-of methodology to redesignated NDCs of those identified in the OIG studies at § 414.904(d)(4)(v). We welcome comments on these proposals. E. Medicare Part B Payment for Drugs Approved Through the Pathway Established Under Section 505(b)(2) of the Federal Food, Drug, &.

Cosmetic Act 1. Background For most drugs that are payable under Medicare Part B, payment-limit amounts are determined using the methodology in section 1847A of the Act. In many cases, the payment-limit amount is based on the Average Sales Price (ASP) plus a statutorily mandated 6 percent add-on. Additionally, small molecule drugs payable under Medicare Part B using the methodology in section 1847A of the Act fall into two broad, mutually exclusive categories. (1) Multiple source drugs, and (2) single source drugs.

These terms are defined in sections 1847A(c)(6)(C) and (D) of the Act, respectively.Start Printed Page 39246 In most cases, the distinction between multiple source drugs and single source drugs is straightforward. We published program instructions in 2007 (available at https://www.cms.gov/​Medicare/​Coding/​MedHCPCSGenInfo/​Downloads/​051807_​coding_​annoucement.pdf) that address how these distinctions are made. However, a subset of drugs that are approved by the FDA under New Drug Applications (NDAs) are approved through the pathway established under section 505(b)(2) of the FFDCA (Pub. L. 75-717, June 25, 1938) (hereinafter referred to as “section 505(b)(2) drug products”).

For section 505(b)(2) drug products, the distinction between multiple source drugs and single source drugs can be less straightforward. The drug approval pathway established under section 505(b)(2) of the FFDCA (hereinafter referred to as “the section 505(b)(2) pathway”) provides an avenue for applications that contain full reports of investigations of safety and effectiveness, where at least some of the information needed for an approval comes from studies not conducted by or for the applicant, and for which the applicant has not obtained a right of reference or use.[] An application submitted under the section 505(b)(2) pathway (hereinafter referred to as a “section 505(b)(2) application”) may rely either on the FDA's findings of safety, effectiveness, or both, for an already-FDA-approved drug product or on published literature, provided that. (1) Such reliance is scientifically justified, and (2) the section 505(b)(2) application complies with applicable statutory and regulatory requirements, including, but not limited to, patent certification, if appropriate. Unlike a generic drug product approved under an Abbreviated New Drug Application (ANDA), a section 505(b)(2) drug product is not required to have the same FDA-approved labeling as the labeling for the already-FDA-approved drug product(s) upon which the section 505(b)(2) application relied. (For more information, see the FDA's May 2019 guidance titled, “Determining Whether to Submit an ANDA or a 505(b)(2) Application,” available at https://www.fda.gov/​media/​124848/​download.) The number of section 505(b)(2) drug products approved each year has been growing, from about 40 per year from 2011 to 2016, to about 60 to 70 per year from 2017 to 2020.

Approximately 10 to 20 percent of these section 505(b)(2) drug products are payable under Medicare Part B. Of these, some section 505(b)(2) drug products share substantial portions of the FDA-approved labeling with the approved drug product(s) upon which the section 505(b)(2) application relied, for example prescribing information on safety, efficacy, and pharmacokinetics. In some cases, the section 505(b)(2) drug product even shares substantial portions of labeling with generic drug products that are payable under Part B as multiple source drugs. Medicare Part B claims data from 2020 indicate that spending for some of these section 505(b)(2) drug products (that is, those that could be assigned to a multiple source drug code under the framework described below, but are instead currently assigned to a single source drug code) is substantially greater than that for the corresponding generic drug products assigned to a multiple source drug code. One example is a sterile injectable drug that was first approved as a lyophilized powder for reconstitution in a vial and later was approved through the section 505(b)(2) pathway as a concentrated liquid in a vial.

Another example is a drug available as a lyophilized powder for reconstitution in a vial that was then approved through the section 505(b)(2) pathway as a ready-to-use intravenous (IV) solution in a bag. Analysis of 2020 claims data for the separately coded section 505(b)(2) drug product (that is, the ready-to-use IV solution) shows that Medicare spending per service unit was approximately eight times that of the corresponding products in the multiple source drug code. Moreover, in the July 2021 ASP Pricing File (available at https://www.cms.gov/​medicare/​medicare-part-b-drug-average-sales-price/​2021-asp-drug-pricing-files), the payment limit for the section 505(b)(2) drug product is 17.2 times the payment limit for the multiple source code, when adjusted for the different dose descriptors of each code. In another example, there were approximately 7.54 million allowed service units, representing approximately $1.38 million of allowed charges, for a multiple source drug code, but for the separately coded section 505(b)(2) drug product, over the same time-period there were approximately 1.08 million allowed service units, representing approximately $2.13 million in allowed charges. Calculating the allowed charges per allowed service unit, each service unit of the section 505(b)(2) drug product cost Medicare 10.78 times that of the corresponding products assigned to the multiple source drug code, costing Medicare an additional $1.93 million.

In the July 2021 ASP Pricing File, the payment limit for the section 505(b)(2) drug product is 21.3 times the payment limit for the multiple source code. Based on these observed data points, we are planning an additional analysis of spending on section 505(b)(2) drug products and potential savings to Medicare and Medicare beneficiaries that may be realized if certain section 505(b)(2) drug products were to be assigned to multiple source drug codes based on the framework described in section 3 of this preamble. 2. CY 2021 Proposal In the CY 2021 PFS proposed rule, we proposed to codify our long-standing approach to determine whether a section 505(b)(2) drug product is described by an existing multiple source drug code, or if the section 505(b)(2) drug product would be assigned to a single source drug code. In that proposal, we explained generally how information about the section 505(b)(2) drug product's active ingredient(s), drug product name (this refers to nomenclature of the drug product as found in the United States Pharmacopeia—National Formulary (USP-NF) and nomenclature as found in title of the FDA-approved labeling), and description.

Labeling information. And ordering (prescribing) and clinical use would factor into a determination. Commenters on our proposal in the CY 2021 PFS proposed rule (primarily manufacturers) stated that the proposal conflicted with both the Medicare statute and the FDA's therapeutic equivalence (TE) ratings,[] and would impair access for patients, underpay providers, and stifle innovation. Several commenters from beneficiary advocate and provider organizations generally repeated the same points, although some commenters expressed support for curbing drug prices, particularly if the proposal did not affect patient access. Several commenters appeared to take a middle ground that conditionally supported the proposals, particularly if more detail could be provided and if effects on patient access were considered.

Several commenters supported the proposals without conditions. Several commenters expressed that we should provide more Start Printed Page 39247detail about the decision framework and the determination process. Some commenters on the CY 2021 PFS proposed rule requested that we provide more details about the process by which certain section 505(b)(2) drug products would be assigned to multiple source drug codes. Commenters requested that we include more detail on how factors described in the CY 2021 PFS proposal, (for example, differences in the active ingredient and labeling) may be interpreted and which drug products might be affected. Commenters also requested that we provide the public more time to assess a more detailed proposal as well as an opportunity, such as through future rulemaking, for public input both on the proposal and on decisions about specific drug products.

Several commenters stated that if we move forward with the CY 2021 proposal, we should exclude products with “meaningful differences” from the policy and encouraged us to continue an approach “that allows for innovation, competition, and ultimately more therapeutic choices for Medicare beneficiaries.” We recognize that some section 505(b)(2) drug products have clear differences in factors such as safety, efficacy, or pharmacokinetics, which would not result in the assignment of the product to the existing multiple source drug code. The framework discussed in the next section would address situations in which a section 505(b)(2) drug product is not described by an existing multiple source drug code, and therefore, would not be assigned to the existing multiple source drug code. In response to commenters' requesting more detail about our proposed approach and to delay finalizing a decision, we did not finalize our proposals in the CY 2021 PFS proposed rule regarding section 505(b)(2) drug products. We stated that the delay would allow time for CMS to further consider this issue. As part of our further consideration, we are soliciting comment on a more detailed framework (hereinafter referred to as “the framework”) for determining when a section 505(b)(2) drug product is a multiple source drug under section 1847A(c)(6)(C) of the Act.

The framework is consistent with program instruction published in 2007, which addressed how we would assign “single source drugs” and “biological products” using a multi-step process. However, this program instruction did not expressly address how we would assign multiple source drugs. The program instruction uses the term “drug” at the billing and payment code level when discussing single source drugs in the same way that the discussion in this preamble uses the term “drug” in reference to multiple source drugs. Development of standards for identifying multiple source drugs (that is, the framework) would add to the 2007 program instruction and provide detail about an approach to Medicare Part B payment for section 505(b)(2) drug products. The framework described in the next section aims to build off the current CMS policy for assigning drug products to billing and payment codes by describing detailed standards for determining whether a section 505(b)(2) drug product corresponds to an existing multiple source drug code.

We are not proposing to adopt the framework at this time. Rather, we are seeking comment on the framework to inform future policy making. 3. The Framework The framework is a determination process to identify when section 505(b)(2) drug products without an FDA TE rating to an existing drug product payable under Part B correspond to an existing multiple source drug code for the purpose of payment under Medicare Part B. The framework would provide additional detail about the decision-making process and increase transparency about potential determinations resulting from the framework.

The first portion of the framework would compare certain qualities of the section 505(b)(2) drug product with drug products already assigned to an existing multiple source drug code.[] This includes comparison of the. (1) Active ingredient(s). (2) dosage form (if part of the drug product name). (3) salt form. And (4) other ingredients in the drug product formulation.

The drug product assessment could result in a match or non-match designation. Section 505(b)(2) drug products receiving a match designation in the first portion of the framework would continue to a verification step. This step would compare the pharmacokinetic and clinical studies of the section 505(b)(2) drug product's FDA-approved labeling with those of the drug products already assigned to an existing multiple source code. Finally, a determination would be made as to whether the section 505(b)(2) drug product could be assigned to the existing multiple source code. For full details on the framework, please see https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.

We are soliciting comment on. The framework and how it aligns with the statutory definitions of single source and multiple source drugs in section 1847A(c)(6)(C) and (D) of the Act, respectively. How the framework distinguishes situations in which a section 505(b)(2) drug product is not described by an existing multiple source drug code. And The potential impacts of the framework on Medicare beneficiaries, the government, and other stakeholders. F.

Appropriate Use Criteria for Advanced Diagnostic Imaging Section 218(b) of the Protecting Access to Medicare Act (Pub. L. 113-93, April 1, 2014) (PAMA) amended Title XVIII of the Act to add section 1834(q) of the Act directing us to establish a program to promote the use of appropriate use criteria (AUC) for advanced diagnostic imaging services. We have taken steps to implement this program over several years, and codified the AUC program in our regulations at 42 CFR 414.94. In CY 2020, we began conducting an educational and operations testing period for the claims-based reporting of AUC consultation information, which has been extended through CY 2021.

The CY 2016 PFS final rule with comment period (80 FR 70886) addressed the initial component of the new Medicare AUC program, specifying applicable AUC. In the CY 2016 PFS final rule with comment period, we established an evidence-based process and transparency requirements for the development of AUC, defined provider-led entities (PLEs) and established the process by which PLEs may become qualified to develop, modify or endorse AUC. The first list of qualified PLEs was posted on the CMS website at the end of June 2016 at which time their AUC libraries became specified applicable AUC for purposes of section 1834(q)(2)(A) of the Act. The CY 2017 PFS final rule (81 FR 80170) addressed the second component of this program, specification of qualified clinical decision support mechanisms (CDSMs). In the CY 2017 PFS final rule, we defined CDSM, identified the requirements CDSMs must meet for qualification, including preliminary qualification for mechanisms documenting how and when each requirement is reasonably Start Printed Page 39248expected to be met, and established a process by which CDSMs may become qualified.

We also defined applicable payment systems under this program, specified the first list of priority clinical areas, and identified exceptions to the requirement that ordering professionals consult specified applicable AUC when ordering applicable imaging services. The first list of qualified CDSMs was posted on the CMS website in July 2017. The CY 2018 PFS final rule (82 FR 53190) addressed the third component of this program, the consultation and reporting requirements. In the CY 2018 PFS final rule, we established the start date of January 1, 2020 for the Medicare AUC program for advanced diagnostic imaging services. Specifically, for services ordered on and after January 1, 2020, we established that ordering professionals must consult specified applicable AUC using a qualified CDSM when ordering applicable imaging services, and furnishing professionals must report AUC consultation information on the Medicare claim.

We further specified that the AUC program will begin on January 1, 2020 with a year-long educational and operations testing period during which time AUC consultation information is expected to be reported on claims, but claims would not be denied for failure to include proper AUC consultation information. We also established a voluntary period from July 2018 through the end of 2019 that ordering professionals who are ready to participate in the AUC program may consult specified applicable AUC through qualified CDSMs and communicate the results to furnishing professionals. And furnishing professionals who are ready to do so may report AUC consultation information on the claim at https://www.cms.gov/​Outreach-and-Education/​Medicare-Learning-Network-MLN/​MLNMattersArticles/​Downloads/​MM10481.pdf. Additionally, to incentivize early use of qualified CDSMs to consult AUC, we established in the CY 2018 Updates to the Quality Payment Program. And Quality Payment Program.

Extreme and Uncontrollable Circumstances Policy for the Transition Year final rule with comment period and interim final rule (hereinafter “CY 2018 Quality Payment Program final rule”), a high-weight improvement activity for ordering professionals who consult specified AUC using a qualified CDSM for the Merit-based Incentive Payment System (MIPS) performance period that began January 1, 2018 (82 FR 54193). In the CY 2019 PFS final rule (83 FR 59452), we made further additions and clarifications to the AUC program requirements. We added independent diagnostic testing facility (IDTF) to the definition of applicable settings under § 414.94(b). We also clarified that the furnishing professionals (including provider or supplier entities furnishing advanced diagnostic imaging services in an applicable setting, paid for under an applicable payment system) are required to report AUC consultation information on the claims as specified under § 414.94(k). We established significant hardship exception criteria and process under § 414.94(i)(3) to be specific to the AUC program and independent of other Medicare programs.

We specified under § 414.94(j)(2) that when delegated by the ordering professional, clinical staff under the direction of the ordering professional may perform the AUC consultation with a qualified CDSM. Finally, we announced our intention to use G-codes and modifiers to report AUC consultation information on the Medicare claims. In 2020, in response to the Public Health Emergency (PHE) for the anti-inflammatories Disease 2019 (anti inflammatory drugs) (PHE for anti inflammatory drugs), the educational and operations testing period was extended through CY 2021. 1. Background AUC present information in a manner that links a specific clinical condition or presentation.

One or more services. And an assessment of the appropriateness of the service(s). Evidence-based AUC for imaging can assist clinicians in selecting the imaging study that is most likely to improve health outcomes for patients based on their individual clinical presentation. For purposes of this program, AUC is a set or library of individual AUC. Each individual criterion is an evidence-based guideline for a particular clinical scenario based on a patient presenting symptoms or condition.

AUC need to be integrated as seamlessly as possible into the clinical workflow. CDSMs are the electronic portals through which clinicians access the AUC during the patient workup. They can be standalone applications that require direct entry of patient information, but may be more effective when they are integrated into electronic health records (EHRs). Ideally, practitioners would interact directly with the CDSM through their primary user interface, thus minimizing interruption to the clinical workflow. 2.

Statutory Authority Section 218(b) of the PAMA added a new section 1834(q) of the Act entitled, “Recognizing Appropriate Use Criteria for Certain Imaging Services,” which directed the Secretary to establish a program to promote the use of AUC. Section 1834(q)(4) of the Act requires ordering professionals to consult with specified applicable AUC through a qualified CDSM for applicable imaging services furnished in an applicable setting and paid for under an applicable payment system. And payment for such service may only be made if the claim for the service includes information about the ordering professional's consultation of specified applicable AUC through a qualified CDSM. 3. Discussion of Statutory Requirements There are four major components of the AUC program under section 1834(q) of the Act, and each component has its own implementation date.

(1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of the Act). (2) identification of mechanisms for consultation with AUC by April 1, 2016 (section 1834(q)(3) of the Act). (3) AUC consultation by ordering professionals, and reporting on AUC consultation by January 1, 2017 (section 1834(q)(4) of the Act). And (4) annual identification of outlier ordering professionals for services furnished after January 1, 2017 (section 1834(q)(5) of the Act). We did not identify mechanisms for consultation by April 1, 2016.

Therefore, we did not require ordering professionals to consult CDSMs or furnishing professionals to report information on the consultation by the January 1, 2017 date. A. Establishment of AUC In the CY 2016 PFS final rule with comment period, we addressed the first component of the Medicare AUC program under section 1834(q)(2) of the Act—the requirements and process for establishment and specification of applicable AUC, along with relevant aspects of the definitions under section 1834(q)(1) of the Act. This included defining the term “provider-led entity” and finalizing requirements for the rigorous, evidence-based process by which a PLE would develop AUC, upon which qualification is based, as provided in section 1834(q)(2)(B) of the Act and in the CY 2016 PFS final rule with comment period. Using this process, once a PLE is qualified by us, the AUC that are developed, modified or endorsed by the qualified PLE are considered to be specified applicable AUC under section 1834(q)(2)(A) of the Act.

We defined PLE to include national professional medical societies, health systems, hospitals, clinical practices and collaborations of such entities such as the High Value Healthcare Collaborative or the National Comprehensive Cancer Network. Start Printed Page 39249Qualified PLEs may collaborate with third parties that they believe add value to their development of AUC, provided such collaboration is transparent. We expect qualified PLEs to have sufficient infrastructure, resources, and the relevant experience to develop and maintain AUC according to the rigorous, transparent, and evidence-based processes detailed in the CY 2016 PFS final rule with comment period. In the same rule, we established a timeline and process under § 414.94(c)(2) for PLEs to apply to become qualified. Qualified PLEs are listed at https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Appropriate-Use-Criteria-Program/​PLE.html (OMB Control Number 0938-1288).

B. Mechanism for AUC Consultation In the CY 2017 PFS final rule, we addressed the second major component of the Medicare AUC program—the specification of qualified CDSMs for use by ordering professionals for consultation with specified applicable AUC under section 1834(q)(3) of the Act, along with relevant aspects of the definitions under section 1834(q)(1) of the Act. This included defining the term CDSM and finalizing functionality requirements of mechanisms, upon which qualification is based, as provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS final rule. We defined CDSM as an interactive, electronic tool for use by clinicians that communicates AUC information to the user and assists them in making the most appropriate treatment decision for a patient's specific clinical condition. Tools may be modules within or available through certified EHR technology (as defined in section 1848(o)(4) of the Act) or private sector mechanisms independent from certified EHR technology or a mechanism established by the Secretary.

In the CY 2017 PFS final rule, we established a timeline and process in § 414.94(g)(2) for CDSM developers to apply to have their CDSMs qualified. Qualified CDSMs are listed at https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Appropriate-Use-Criteria-Program/​CDSM.html (OMB Control Number 0938-1315). C. AUC Consultation and Reporting In the CY 2018 PFS final rule, we addressed the third major component of the Medicare AUC program—consultation with applicable AUC by the ordering professional and reporting of such consultations under section 1834(q)(4) of the Act. We established a January 1, 2020 effective date for the AUC consultation and reporting requirements for this program.

We also established a voluntary period during which early adopters could begin reporting limited consultation information on Medicare claims from July 2018 through December 2019. During the voluntary period, there is no requirement for ordering professionals to consult AUC or furnishing professionals to report information related to the consultation. On January 1, 2020, the program began with an educational and operations testing period and during this time, we have continued to pay claims whether or not they correctly include AUC consultation information. Ordering professionals must consult specified applicable AUC through qualified CDSMs for applicable imaging services furnished in an applicable setting, paid for under an applicable payment system and ordered on or after January 1, 2020. And furnishing professionals must report the AUC consultation information on the Medicare claim for these services ordered on or after January 1, 2020.

Consistent with section 1834(q)(4)(B) of the Act, we also established that the following information must be reported on Medicare claims for advanced diagnostic imaging services as specified in section 1834(q)(1)(C) of the Act and defined in § 414.94(b), furnished in an applicable setting as defined in section 1834(q)(1)(D) of the Act, paid for under an applicable payment system as defined in section 1834(q)(4)(D) of the Act, and ordered on or after January 1, 2020. (1) The qualified CDSM consulted by the ordering professional. (2) whether the service ordered would or would not adhere to specified applicable AUC, or whether the specified applicable AUC consulted was not applicable to the service ordered. And (3) the NPI of the ordering professional (if different from the furnishing professional). Section 1834(q)(4)(C) of the Act provides for exceptions to the AUC consultation and reporting requirements in the case of.

A service ordered for an individual with an emergency medical condition, a service ordered for an inpatient and for which payment is made under Medicare Part A, and a service ordered by an ordering professional for whom the Secretary determines that consultation with applicable AUC would result in a significant hardship. In the CY 2017 PFS final rule, we adopted a regulation at § 414.94(h)(1)(i) to specify the circumstances under which AUC consultation and reporting requirements are not applicable and in the CY 2019 PFS final rule, we updated the significant hardship exception criteria to be specific to the AUC program and independent of other programs. An ordering professional experiencing any of the following when ordering an advanced diagnostic imaging service is not required to consult AUC using a qualified CDSM, and the claim for the applicable imaging service is not required to include AUC consultation information. Significant hardship exceptions under § 414.94(i)(3) include. Insufficient internet access.

EHR or CDSM vendor issues. Or extreme and uncontrollable circumstances. We remind readers that, consistent with section 1834(q)(4)(A) of the Act, ordering professionals must consult AUC for every applicable imaging service furnished in an applicable setting and paid under an applicable payment system unless a statutory exception applies. Section 1834(q)(4)(D) of the Act specifies the applicable payment systems for which AUC consultation and reporting requirements apply. In the CY 2017 PFS final rule, we defined applicable payment system to reflect the statutory requirements in § 414.94(b) as.

(1) The PFS established under section 1848(b) of the Act. (2) the PPS for hospital outpatient department services under section 1833(t) of the Act. And (3) the ambulatory surgical center payment system under section 1833(i) of the Act. Section 1834(q)(1)(D) of the Act specifies the applicable settings in which AUC consultation and reporting requirements apply. A physician's office, a hospital outpatient department (including an emergency department), an ambulatory surgical center, and any other “provider-led outpatient setting determined appropriate by the Secretary.” In the CY 2017 PFS final rule, we added this definition to § 414.94(b).

As noted above, we expanded that definition to add an IDTF in the CY 2019 PFS final rule. D. Identification of Outliers The fourth component of the Medicare AUC program is specified in section 1834(q)(5) of the Act, Identification of Outlier Ordering Professionals. The identification of outlier ordering professionals under this paragraph facilitates a prior authorization requirement that applies for outlier professionals beginning January 1, 2020, as specified under section 1834(q)(6) of the Act. Because we established a start date of January 1, 2020 for AUC consultation and reporting requirements, we did not identify any outlier ordering professionals by that date.

As such, Start Printed Page 39250implementation of the prior authorization component is delayed. However, we did finalize in the CY 2017 PFS final rule the first list of priority clinical areas to guide identification of outlier ordering professionals as follows. Coronary artery disease (suspected or diagnosed). Suspected pulmonary embolism. Headache (traumatic and non-traumatic).

Hip pain. Low back pain. Shoulder pain (to include suspected rotator cuff injury). Cancer of the lung (primary or metastatic, suspected or diagnosed). Cervical or neck pain.

We will use future rulemaking to establish the methodology for the identification of outlier ordering professionals who would eventually be subject to a prior authorization process when ordering advanced diagnostic imaging services. 4. Proposals for Continuing Implementation a. Proposed Clarification of AUC Program Scope i. Modified Orders Updates or modifications to orders for advanced diagnostic imaging services may be warranted in certain situations once the beneficiary is under the care of the furnishing professional.

Unless they are also serving as the ordering professional, furnishing professionals may not consult AUC on behalf of or in place of the ordering professional. The Medicare Benefit Policy Manual (BPM) (Pub. L. 100-02) addresses situations where the furnishing professional performs imaging services that differ from ordered services in chapter 15, sections 80.6.1-4. These BPM sections on modified orders state that when an interpreting physician determines that a different or additional imaging service not included on the order should be performed, the interpreting physician or testing facility generally may not perform the test until a new order from the treating physician/practitioner has been received.

If the treating physician/practitioner cannot be reached to change or obtain a new order, the interpreting physician or testing facility may furnish the additional imaging service under the following circumstances, as documented in the patient's medical record. The treating physician/practitioner could not be reached, the ordered test is performed and an additional diagnostic test is medically necessary because of the abnormal result of that test, delaying performance of the additional test would have an adverse effect on the patient's care, the result of the additional test is communicated to and used by the treating physician/practitioner in the patient's treatment, and the interpreting physician/practitioner documents in the report the reasons for the additional testing. When the furnishing professional performs additional imaging services not reflected on the order under these circumstances, we do not believe it would be appropriate to consider them to be acting as an ordering professional such that an AUC consultation would be needed. Instead, we believe the furnishing professional in these situations is the interpreting physician/practitioner who is exercising their professional judgment to provide the ordering professional with additional diagnostic test results for use in managing the patient's care. Additionally, they are doing so only because, after performing the ordered test and determining that additional testing is expedient given the results of that test, the ordering professional cannot be reached to request a modified or additional order.

Given the conditions under which these additional imaging services are performed, we propose that when the furnishing professional for an advanced diagnostic imaging service performs one or more additional services under the circumstances described in chapter 15, section 80.6.2-4 of the BPM, neither the ordering professional nor the furnishing professional are required to consult AUC for the additional service(s). In these situations, the AUC consultation information from the original order is to be reported on the claim line for the additional service(s). Where the furnishing professional modifies the order for an advanced diagnostic imaging service without obtaining a new order from the ordering professional, the AUC consultation information provided by the ordering professional with the original order should be reflected on the Medicare claim to demonstrate that the requisite AUC consultation occurred. Because the BPM instructions state that the interpreting physician or testing facility generally may not perform a modified or new test until a new order from the treating physician/practitioner has been received, we expect situations where AUC consultations do not occur for new or modified orders to be infrequent. Ii.

Extreme and Uncontrollable Circumstances Hardship Exception In the CY 2019 PFS final rule, we describe extreme and uncontrollable circumstances to include disasters, natural or man-made, that have a significant negative impact on healthcare operations, area infrastructure or communication systems. We also explain these may include areas where events occur that have been designated by FEMA as a major disaster or a public health emergency declared by the Secretary. To further clarify, these circumstances are events that are entirely outside the control of the ordering professional that prevent the ordering professional from consulting AUC through a qualified CDSM. We believe the hardship criteria under this program are similar to other programs such as the Promoting Interoperability performance category of the Merit-based Incentive Payment System (MIPS), particularly the flexibility that is given to clinicians to identify what they consider to be extreme and uncontrollable circumstances. The PHE for anti inflammatory drugs has been in effect since January 27, 2020.

Stakeholders have described challenges in continuing to prepare for the payment penalty phase of the AUC program due to resource reallocation resulting from the PHE. Some stakeholders have explained that all health technology projects unrelated to the PHE were halted, including projects that impact establishing or updating health IT systems that enable AUC consultation through qualified CDSMs. Stakeholders have also indicated that human resources were reallocated to focus on responding to the PHE. Additionally, we recognize that practitioners have been heavily impacted in their own practice of medicine to respond to the PHE and provide treatment to patients which may have prevented them from focusing on and participating in the educational and operations testing period to prepare for the payment penalty phase. While we are continuing to move forward in implementing the AUC program, we want to assure stakeholders that they may attest to a significant hardship under the AUC program due to extreme and uncontrollable circumstances due to the PHE for anti inflammatory drugs, and such an attestation may be used as needed by ordering practitioners throughout the PHE.

Furthermore, as the AUC program progresses into the payment penalty phase, self-attestation for a significant hardship exception will continue to be available for ordering professionals experiencing extreme and uncontrollable circumstances due to the PHE. We also recognize that ordering professionals may experience significant Start Printed Page 39251hardships related to or resulting from the PHE that extend beyond the date the PHE expires and note that AUC program exceptions will continue to be available for such significant hardships as defined at § 414.94(i)(3). B. Claims Processing As we move ahead to implement the payment penalty phase of this program, we must address additional operational and administrative issues. We explain these issues here, and our assessments and proposals for addressing them.

We are soliciting comments on whether additional scenarios require our consideration, and whether the proposed solutions adequately address issues raised by stakeholders. We are soliciting any additional information stakeholders may offer to assist us in developing claims processing system edits or other measures to ensure that only appropriate claims are subject to AUC claims processing edits. The AUC program will be fully implemented when we have the necessary edits established in the claims processing system and we begin using those edits to deny Medicare claims that fail to report the required AUC consultation information. Therefore, we need to find workable solutions that allow the AUC program to accurately pay and deny claims using the information available on Medicare claims, while working within the limitations of the Medicare claims processing system. The identification of claims that are or are not subject to the Medicare AUC Program must be precise to avoid inadvertently denying claims that should be paid.

Because implementation of this program establishes edits for advanced diagnostic imaging claims, the inadvertent denial of claims would disproportionately impact radiologists, hospital outpatient departments and freestanding imaging centers. Also, as we have noted previously, the AUC program is unique in that the burden of consulting AUC and providing AUC consultation information to the furnishing professional falls on the ordering professional, yet the claims that are denied for failing to report AUC consultation information are for services furnished and billed by the professionals and facilities that furnish advance diagnostic imaging. Two main Medicare claim types are subject to claims processing edits in the AUC program. These are the CMS-1500 and its electronic equivalent (referred to here as the practitioner claim) submitted by physicians and practitioners, ASCs, and IDTFs, and the UB-04, also called the CMS-1450, (referred to here as the institutional claim) submitted by hospital outpatient departments and on-campus and off-campus provider-based departments. These claim types differ in the data elements they contain.

Therefore, claims processing edits will not be identical across claim types. We have already issued partial claims processing instructions (CR11268, Transmittal 2404) [] to support the educational and operations testing period. We established HCPCS Level III G-codes for furnishing professionals to report which CDSM was consulted. We also established HCPCS modifiers for furnishing professionals to report adherence, non-adherence and not applicable AUC consultation responses on the same claim line as the corresponding G-code. Both G-codes and modifiers are applicable to practitioner and institutional claims.

We established additional HCPCS modifiers for furnishing professionals to report situations in which the ordering professional is not required to consult AUC. These modifiers are reported on the same claim line as the code for the advanced diagnostic imaging procedure since a G-code would not be reported. We also established a procedure code list that identifies the advanced diagnostic imaging codes that are subject to the AUC program. Based on a review of CY 2020 Medicare claims (noting for readers that during this year the AUC program was only in the education and operations testing phase with no payment penalties), we estimate between 9-10 percent of all claims subject to the AUC program reported information sufficient to be considered compliant with the program, which means that 90-91 percent of claims would not be considered compliant with AUC program requirements. In other words, if the claims processing systems edits had been in place for the payment penalty phase, only 9-10 percent of claims subject to the AUC program would have been paid as opposed to being denied or rejected.

An additional 6-7 percent of claims subject to the AUC program included some relevant information, which demonstrates an awareness of the AUC program among these billing entities. But the claims did not include all of the necessary AUC consultation information that will ultimately be required for the claim to be paid. I. Ordering Professional NPI There are locations on both the practitioner and institutional claim types to report the NPI of the ordering professional. The institutional claim uses the K3 segment and the practitioner claim uses the referring professional field.

However, to fully implement the AUC program, we must establish a claims processing edit to require these fields to be populated on all advanced diagnostic imaging claims subject to the AUC program. In addition, there currently are situations in which multiple advanced diagnostic imaging services ordered by more than one ordering professional may be reported on a single claim. This would not be workable for purposes of reporting AUC consultation information because the referring professional field is reported at the claim-level and not at the claim line- or service-level for professional claims. Therefore, the furnishing professional will need to submit separate claims for the services ordered by each referring or ordering professional. In other words, only one ordering professional can be reported per claim.

Ii. Critical Access Hospitals As discussed in the CY 2018 PFS final rule with comment period (82 FR 53192), advanced diagnostic imaging services furnished in an outpatient department of a critical access hospital (CAH) are not subject to the AUC program because, in accordance with section 1833(q)(1)(D) of the Act, a CAH is not an applicable setting under the program. Therefore, we must identify these advanced diagnostic imaging services and allow them to bypass the AUC program claims processing edits. For institutional claims, we intend to apply the AUC program claims processing edits to type of bill 13x, which is used only for outpatient hospital settings. CAHs submit outpatient claims using type of bill 85x, rather than type of bill 13x.

In the CY 2019 PFS final rule (83 FR 59694), we further explained that because section 1834(q)(4)(B) of the Act clearly includes all claims paid under applicable payment systems without exclusion, the claims from both furnishing professionals and facilities must include AUC consultation information. We revised our regulation at § 414.94(k) to specify that AUC consultation information must be reported on Medicare claims for advanced diagnostic imaging services furnished in an applicable setting and paid under an applicable payment system. Prior to this revision, § 414.94(k) required furnishing professionals to report AUC consultation on the claim, without also specifying that facility claims must include the AUC consultation Start Printed Page 39252information. In the CY 2019 PFS final rule, we explained that the AUC consultation information would be included on the practitioner's claim for the professional component (PC) of the service and on the provider's or supplier's claim for the facility portion or technical component (TC) of the service. Under § 414.94(k), the requirement to report AUC consultation information on the claim applies to both the PC and TC of the imaging services that are furnished in an applicable setting and paid under an applicable payment system.

Section 1834(q)(4)(B) of the Act further specifies that the requirement to report AUC consultation information is specific to claims for advanced diagnostic imaging services furnished in an applicable setting and paid under an applicable payment system. We believe that all claims for advanced diagnostic imaging services, both the PC and TC, must include the AUC consultation information when they are furnished both in an applicable setting and paid under an applicable payment system. However, if advanced diagnostic imaging services are not entirely furnished in an applicable setting, we believe that neither the PC nor TC claim should be required to include AUC consultation information. This ensures consistent application of the AUC consultation requirements across claims submitted for advanced diagnostic imaging services even when the PC and TC components of the service are furnished by different furnishing professionals. As such, we propose that claims submitted by physicians or practitioners for the PC of an advanced diagnostic imaging service when the TC was not furnished in an applicable setting would not be subject to the AUC program since the setting where the TC of the imaging service is furnished is not subject to the AUC program consultation and reporting requirements.

If a physician or practitioner submits a claim for the PC of an advanced imaging service for which the TC was performed as an outpatient CAH service, there currently is not a systems-based way for us to recognize that the TC of the service was furnished by a CAH. Place of service codes reported on practitioner claims are not specific enough. We have not yet identified a way to segregate these claims and automatically allow them to bypass AUC program claims processing edits. Therefore, as discussed below, we propose to establish a separate HCPCS modifier that will be used to identify practitioner claims for advanced diagnostic imaging services that are not subject to the AUC program and that are not otherwise identified using the other AUC program modifiers designated to identify specific situations where the claims are not subject to the AUC program. Iii.

Maryland Total Cost of Care Model Section 1834(q)(4)(D) of the Act specifies that the applicable payment systems for which AUC consultation and reporting requirements apply are the PFS, the hospital OPPS and the ambulatory surgical center payment system. We define applicable payment system consistent with statute at § 414.94(b) and, as noted above, require AUC consultation information to be reported on Medicare claims for advanced diagnostic imaging services, both the PC and TC, furnished in an applicable setting and paid under an applicable payment system at § 414.94(k). Section 1834(q)(4)(B) of the Act specifies that the requirement to report AUC consultation information is specific to claims for advanced diagnostic imaging services furnished in an applicable setting and paid under an applicable payment system. We believe that all claims for the advanced diagnostic imaging services, both the PC and TC, must include the AUC consultation information when they are furnished both in an applicable setting and paid under an applicable payment system. Therefore, if both the PC and TC for advanced diagnostic imaging services are not paid under an applicable payment system, neither the PC nor TC claim is required to include AUC consultation information.

This ensures consistent application of the AUC consultation requirements across claims submitted for advanced diagnostic imaging services even when the PC and TC components of the service are furnished by different furnishing professionals. Similar to claims for the PC of services for which the TC is furnished outside of an applicable setting, and because both practitioner and institutional claims are subject to the AUC program as discussed above, when the practitioner or institutional claim for the advanced imaging service is not subject to the AUC program (for example, payment is not made under an applicable payment system), the corresponding practitioner or institutional claim for the same imaging service is also not subject to the AUC program. Stakeholders alerted CMS to concerns about whether advanced diagnostic imaging services furnished in hospitals participating in the Maryland Total Cost of Care Model would be subject to the AUC program. We appreciate that this has been brought to our attention and we seek comments on other models. Advanced diagnostic imaging services furnished in outpatient departments of Maryland hospitals that participate in the Hospital Payment Program within the Maryland Total Cost of Care Model are not subject to the AUC program because these services are not paid under an applicable payment system (Maryland hospitals that receive payments under the Hospital Payment Program within the Maryland Total Cost of Care Model are not paid under the OPPS).

Because these services are not subject to the AUC program requirements when furnished in a hospital paid under the Hospital Payment Program within the Maryland Total Cost of Care Model, as opposed to an applicable payment system, we propose that the PCs of these advanced diagnostic imaging services, when billed separately, are also not required to include AUC consultation information. We believe we can identify all institutional claims from a hospital that is paid under the Hospital Payment Program within the Maryland Total Cost of Care Model based on their CMS Certification Number (CCN) and allow those claims to bypass AUC program claims processing edits. We understand that when the TC and PC of advanced diagnostic imaging services are billed separately, the professional claim must identify in box 32 the location where the TC of the imaging service was furnished to the patient. Therefore, we believe we will have the ability to identify situations in which the imaging service was furnished in a hospital that is paid under the Hospital Payment Program within the Maryland Total Cost of Care Model and exclude those claims from being subject to AUC program claims processing edits. We believe this can be accomplished by using the CCN and will continue to work to determine if a list of CCNs can be used as the source of our edits in addition to determining the frequency that the list will be updated.

Note that advanced diagnostic imaging services furnished in applicable settings in the state of Maryland and paid under an applicable payment system are subject to the AUC program—the above discussion applies only to the outpatient departments of hospitals that are paid under the Hospital Payment Program within the Maryland Total Cost of Care Model. Iv. Inpatients Converted to Outpatients While uncommon, there are situations in which a beneficiary's hospital inpatient status is changed to outpatient. Certain criteria must be met for this to occur and, if met, condition Start Printed Page 39253code 44 (inpatient admission changed to outpatient) is appended to the institutional claim (https://www.cms.gov/​regulations-and-guidance/​guidance/​transmittals/​downloads/​r299cp.pdf). We propose to allow institutional claims with condition code 44 to bypass AUC claims processing edits.

We make this proposal because, at the time advanced diagnostic imaging services were ordered and furnished, they were ordered for and furnished to a beneficiary who was in inpatient status. As such, the AUC consultation requirement would not have applied at that time. We believe that any professional claims would include place of service code 21 (inpatient hospital) since the expectation, until just prior to discharge, would be that the patient is in an inpatient status. We expect less than half of one percent of claims will include condition code 44. V.

Deny or Return Claims That Fail AUC Claims Processing Edits As discussed above, claims that do not properly include AUC consultation information will not be paid once we fully implement the AUC claims processing edits. We are considering whether claims that do not pass the AUC claims processing edits, and therefore will not be paid, should be initially returned to the health care provider so they can be corrected and resubmitted, or should be denied so they can be appealed. On one hand, we expect there will be some errors in reporting AUC consultation information on claims, especially early on, and health care providers might find it helpful to have the opportunity to correct claims. However, there may be situations in which the health care provider would prefer the claim be denied so they have an earlier opportunity to appeal. We are requesting comments to help us better understand which path would be most appropriate once we fully implement the AUC program claims edits.

Additionally, we are requesting comments on whether the payment penalty phase should begin first with returning claims and then transition to denying claims after a period of time, which may be helpful to furnishing professionals and facilities as they become more proficient in submitting claims under the AUC program. Vi. Medicare as a Secondary Payer We understand based on feedback from stakeholders that, in some EHRs, the primary payer information is readily available and known to the ordering professional. However, secondary payer information typically is not available. Additionally, it is possible that when Medicare is the secondary payer that no Medicare payment would be made at all after the primary payer makes payment.

Medicare is reported as the secondary payer for approximately 1.5 percent of advanced diagnostic imaging services that are subject to the AUC program. Because the secondary payer information for a patient generally is not available to the ordering professional, and because no Medicare payment may be involved at all when Medicare is the secondary payer, we propose to exclude claims that identify Medicare as the secondary payer from application of the AUC consultation and reporting requirements. Specifically, we propose to allow claims that identify Medicare as the secondary payer (using block 1 or the electronic equivalent of the practitioner claims and using FL 50/51 or the electronic equivalent of institutional claims) to bypass the AUC program claims processing edits. Vii. Date of Service and Date of Order We will specify a start date for the AUC program claims processing edits to take effect.

Medicare claims include a date of service but do not allow for the date of an imaging order to be recorded. Because we cannot identify the order date for an advanced imaging service based on claims, we propose that the AUC program claims processing edits for the payment penalty phase will be applicable for advanced imaging services furnished on or after the effective date of the claims edits. For imaging services ordered prior to, but furnished on or after the effective date of the AUC program claims processing edits, the furnishing professional would apply the separate HCPCS modifier discussed in section III.F.4.b.ii. (Critical Access Hospitals) of this proposed rule to indicate that the claim is not subject to the AUC claims processing edits. Viii.

HCPCS Modifiers We established two primary sets of HCPCS modifiers for this program. One set is to be included on the same claim line as the G-code identifying the CDSM that was consulted, and reports whether the imaging service adheres to the AUC (modifier ME), does not adhere to the AUC (modifier MF), or the qualified CDSM does not contain AUC that applies to the order (modifier MG). We intend for these modifiers to continue to be used when the program enters the payment penalty phase. Additionally, reporting of these modifiers should be limited to one per qualified CDSM G-code since these modifiers are mutually exclusive. The second set of HCPCS modifiers is available for use when the ordering professional does not consult a qualified CDSM.

On these claims, providers would not add a G-code for a CDSM because a consultation did not take place, and the HCPCS modifier would be included on the same line as the procedure code for the advanced diagnostic imaging service that was furnished. These HCPCS modifiers include the three that were created to describe significant hardship exceptions (insufficient internet access (modifier MB), EHR or CDSM vendor issues (modifier MC) and extreme and uncontrollable circumstances (modifier MD)). Additionally, section 1834(q)(4)(C) of the Act includes an exception for services ordered for an individual with an emergency medical condition and modifier MA is available to identify claims for patients with a suspected or confirmed emergency medical condition. This set of codes is mutually exclusive and we expect only one to be reported per procedure code-level claim line. Modifier QQ was created for use during the voluntary period, before more detailed modifiers and codes were created, to indicate that an ordering professional consulted a qualified CDSM for the service and related data was provided to the furnishing professional.

The descriptor for this code explains that the ordering professional consulted a qualified CDSM for this service and the related information was provided to the furnishing professional. Modifier QQ continues to be available for use through the educational and operations testing period, but we intend to end the use of that modifier and not carry it forward into the payment penalty phase since we have established and will require the use of distinct modifiers to communicate specific AUC consultation information. Modifier MH was created for use during the educational and operations testing phase to identify claims for which AUC consultation information was not provided to the furnishing professional and furnishing facility. When the AUC program enters the payment penalty phase, we will no longer have a need for this modifier because claims will be required to include AUC consultation information or indicate a reason the information is not required in order to avoid AUC program claims processing edits. Beginning for services furnished on and after the effective date of the AUC program claims processing edits, we propose to redefine modifier MH to describe situations in which the Start Printed Page 39254ordering professional is not required to consult AUC and the claim is not required to report AUC consultation information.

For example, we would repurpose modifier MH to be used in the scenarios described in sections III.F.4.b.ii. (Critical Access Hospitals), III.F.4.b.iii (Maryland Total Cost of Care Model) if other options to identify claims are not feasible, and III.F.4.b.vii. (Date of Service and Date of Order) of this proposed rule as those scenarios would fall outside the scope of the AUC program requirements. Ix. Additional Claims Processing Information Section 1834(q)(1)(D) of the Act specifies the applicable settings for the AUC program as a physician's office, a hospital outpatient department (including an emergency department), and ambulatory surgical center and any other provider-led outpatient setting determined appropriate by the Secretary.

As discussed in the CY 2019 PFS final rule (83 FR 59690 and 59691), we added IDTFs to the definition of applicable setting at § 414.94(b) to the three applicable settings specified in statute because it is a provider-led outpatient setting in which advanced diagnostic imaging services are furnished by licensed, certified nonphysician personnel under appropriate physician supervision. To identify these settings through the Medicare claims system we evaluated type of bill and place of service codes to identify those aligned with applicable settings under the AUC program. For institutional claims, we propose to limit AUC program claims processing edits to apply only to type of bill 13x (hospital outpatient). This claim type code encompasses the hospital outpatient department and the emergency department which represent all applicable settings under the program that would bill Medicare using institutional claims. For practitioner claims, we propose to limit the edits to claims with place of service codes 11 (office), 15 (mobile unit), 19 (off campus outpatient hospital), 22 (on campus outpatient hospital), 23 (emergency room) and 24 (ASC).

These place of service codes should encompass all applicable settings under the AUC program as defined at § 414.94(b). Because these type of bill and place of service codes reflect the applicable settings within which advanced diagnostic imaging services must be furnished to be subject to the AUC program requirements, we believe setting these parameters will allow us to more accurately pay claims while avoiding the need for other types of professionals and facilities to append modifiers to their claims. X. Claims Processing Summary We have presented above some of the scenarios that CMS and stakeholders have identified as being potentially challenging or impracticable for application of the AUC program claims processing edits for purposes of the payment penalty phase. We request feedback on whether additional scenarios require consideration and whether the proposed claims processing solutions will adequately address the issues raised.

We also request feedback on areas that stakeholders believe need more education to inform our ongoing outreach and education efforts. While much of the discussion is about identifying claims that are not subject to the AUC program, we note that physicians and other practitioners, or providers submitting claims for advanced imaging services that are not subject to the AUC program can voluntarily report AUC consultation information. We intend to allow those claims to process through the system. We request commenters to provide additional information to assist us in developing edits that ensure only appropriate claims are subject to AUC claims processing edits. C.

Timing of Payment Penalties We have previously announced in August 2020, via the CMS AUC website, that the education and operations testing period of the AUC program would be extended through 2021 and the payment penalty phase would begin in January 2022. However, given the many complexities around the scope and application of AUC program claims processing edits, we believe that notice and comment rulemaking is the most appropriate means for us to discuss the implementation and claims processing issues, the start date of the payment penalty phase, and to obtain stakeholder feedback before subsequently finalizing a course of action in the final rule. This process will help ensure that we will appropriately identify claims for denial when the payment penalty phase of the program begins. In addition, we acknowledge the circumstances of physicians and other practitioners, and providers, due to the PHE for anti inflammatory drugs and that additional time may be needed to prepare for the payment penalty phase given the challenges and practice disruptions they have experienced while responding to the PHE. The earliest that our claims processing system can begin screening claims using the AUC program claims processing edits for the payment penalty phase is October 2022.

This is because it would not be possible for us to finalize implementation and claims processing plans in this final rule (typically published on or before November 1) and make those decisions effective any earlier than the 3rd calendar quarter of 2022. Implementing the types of claims processing edits necessary for this program generally requires a long lead time. However, we note that an effective date for the claims processing edits in October 2022 may be misaligned with typical annual updates to the systems used by the health care providers that are subject to the AUC program such as EHR, CDSM or claims submission systems. Therefore, we believe the earliest practicable effective date for the AUC program claims processing edits and payment penalty phase is January 1, 2023. While the above date takes into account technical system and programming concerns, it does not expressly take into the account the impact that the PHE for anti inflammatory drugs has had, and may yet have, on practitioners, providers and beneficiaries.

Therefore, we are proposing a flexible effective date for AUC program claims processing edits and payment penalty phase to begin the later of January 1, 2023, or the January 1 that follows the declared end of the PHE for anti inflammatory drugs. We acknowledge that the AUC program has been significantly delayed. We seek public comment on this proposal for the payment penalty phase to begin, and whether we have appropriately taken into account the PHE for anti inflammatory drugs and other factors. We recognize that some practitioners and institutions have already invested in qualified CDSMs, while others have had to redirect their resources during the PHE. We seek information from the public on the state of readiness of practitioners, facilities, and EHR and CDSM vendors.

5. Summary In summary, we are providing clarifications and proposals around the scope of the AUC program specifically pertaining to updates or modifications to orders for advanced diagnostic imaging services and the extreme and uncontrollable circumstances significant hardship exception. We are also proposing several claims processing solutions to ensure accurate identification of claims that are and are not subject to the AUC program requirements. These proposals address special circumstances related to. Services furnished by a CAH, services paid under the Maryland Total Cost of Start Printed Page 39255Care Model, inpatients converted to outpatients, situations when Medicare is the secondary payer, and imaging services ordered prior to the payment penalty phase but furnished on or after the start of the payment penalty phase.

We also discuss identifying the ordering professional on practitioner claims for the imaging service and request feedback on whether it is more appropriate to deny or return claims that fail AUC claims processing edits. We are also proposing to begin the AUC claims processing systems edits and payment penalty phase of the program on the later of January 1, 2023, or the January 1 of the year after the year in which the PHE for anti inflammatory drugs ends. We invite the public to submit comments on these clarifications and proposals. We will continue to post information on our website for this program, accessible at www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Appropriate-Use-Criteria-Program/​index.html. G.

Removal of Selected National Coverage Determinations CMS periodically identifies and removes National Coverage Determinations (NCDs) that no longer contain clinically pertinent and current information, in other words those items and services that no longer reflect current medical practice, or that involve items or services that are used infrequently by beneficiaries. Clinical science and technology evolves and items and services that were once considered state-of-the-art or cutting edge and experimental may be established as reasonable and necessary for Medicare beneficiaries or replaced by more beneficial technologies or clinical paradigms. In the CY 2021 PFS final rule (85 FR 84472), we established rulemaking as an appropriate vehicle for receiving public comment on removing outdated NCDs, replacing the prior subregulatory administrative process used on two occasions in 2013 and 2015. Using rulemaking under section 1871(a)(2) of the Act allows us to consider removal of several NCDs at once as compared to the public comment process established in section 1862(l) of the Act, to be used in making and reconsidering individual NCDs. Eliminating an NCD that provides national coverage for items and services means that the item or service will no longer be automatically covered by Medicare (42 CFR 405.1060).

Instead, the initial coverage determinations for those items and services will be made by local Medicare Administrative Contractors (MACs). On the other hand, removing an NCD that bars coverage for an item or service under title XVIII (that is, national noncoverage NCD), allows MACs to cover the item or service if the MAC determines that such action is appropriate under the statute. Removing a national non-coverage NCD may permit more immediate access to technologies that may now be beneficial for some uses. As the scientific community continues to conduct research, which produces new evidence, the evidence base we previously reviewed may have evolved to support other policy conclusions. In the CY 2021 PFS final rule, we did not establish an exclusive list of criteria that we would use for identifying and evaluating NCDs for removal.

Instead, based on recommendations in public comments, and to be more flexible and nimble, we added considerations to the six factors established in 2013 to guide our decision making process. In addition to the six factors listed below, we also consider the general age of an NCD, changes in medical practice/standard of care, the pace of medical technology development since the last determination, and availability and quality of clinical evidence and information to support removal of an NCD. We would consider proposing the removal of an NCD if. We believe that allowing local contractor discretion to make a coverage decision better serves the needs of the Medicare program and its beneficiaries. The technology is generally acknowledged to be obsolete and is no longer marketed.

In the case of a noncoverage NCD based on the experimental status of an item or service, the item or service in the NCD is no longer considered experimental. The NCD has been superseded by subsequent Medicare policy. The national policy does not meet the definition of an “NCD” as defined in sections 1862(l) or 1869(f) of the Act. The benefit category determination is no longer consistent with a category in the statute. When we evaluate particular NCDs for removal, we take into account information gathered from stakeholders, the claims data for those items and services, and factors such as whether there may be documentation requirements within the NCD that are outdated and create a barrier to coverage.

The rulemaking process provides an opportunity to consider public input before the NCD would be removed. We could decide to retain those NCDs after considering public comments. In Table 23, we list the NCDs that we propose to remove. In addition to conducting an internal review to identify appropriate NCDs for removal, we receive removal requests from a variety of external stakeholders, such as medical specialty societies, device manufacturers, beneficiaries, physicians and providers, and other interested individuals. Additionally, sometimes topics are brought to our attention by the MAC medical directors.

Also, we received comments to the NCD Removal proposal in response to the CY 2021 PFS proposed rule suggesting another seven NCDs for CMS to consider removing. After reviewing those comments and considering other available evidence and information, we are proposing to remove one of those seven NCDs in this rulemaking cycle. We have opened a national coverage analysis (NCA) using the NCD process for one and believe the other five NCDs should be retained. We solicit comment on the two NCDs discussed in Table 23, as well as comments recommending other NCDs for CMS to consider for removal in a future rulemaking or through the NCD process. The following outlines each NCD and provides a summary of the rationale for removal.

Each of the current NCDs below is available in the Medicare National Coverage Determinations Manual located at https://www.cms.gov/​Start Printed Page 39256Regulations-and-Guidance/​Guidance/​Manuals/​internet-Only-Manuals-IOMs-Items/​CMS014961. 1. NCD 180.2 Enteral and Parenteral Nutritional Therapy (July 11, 1984) Circumstances/Factor. We believe that allowing local contractor discretion to make a coverage decision better serves the needs of the Medicare program and its beneficiaries. Rationale.

External stakeholders suggested that portions of this NCD are outdated. Enteral nutrition is the delivery of food to a patient with a functioning gastrointestinal tract who, due to pathology to, or non-function of the structures that normally permit food to reach the digestive tract, cannot maintain weight and strength. Enteral nutrition is provided through a nasogastric, jejunostomy, or gastrostomy tube. Parenteral nutrition is provided intravenously to the patient with pathology of the alimentary tract severe enough, that it does not allow for absorption of sufficient nutrients. This NCD does not provide as a matter of course, for pharmacy prepared parental solutions, which would increase patient safety.

It also unnecessarily adds to patient and provider burden as it requires repeated reviews of medical necessity for those individuals who need enteral or parenteral nutrition services as a result of chronic diseases that affect the ability to eat or to digest/absorb nutrition. Local contractors have proposed LCDs that, if finalized, would provide parenteral and enteral nutrition coverage for certain Medicare beneficiaries. Therefore, we believe that removing this NCD would better serve the needs of the Medicare program and its beneficiaries. 2. NCD 220.6 Positron Emission Tomography (PET) Scans (September 3, 2013) Circumstances/Factor.

We believe that allowing local contractor discretion to make a coverage decision better serves the needs of the Medicare program and its beneficiaries. Rationale. External stakeholders suggested this NCD may be outdated. NCD 220.6 established broad national non-coverage for non-oncologic indications of PET and was established in 2000. Thus we required that every non-oncologic indication for PET must have its own NCD in order to receive coverage.

In 2013, we reconsidered the NCD to allow coverage for diagnostic PET imaging for oncologic uses not already determined by an NCD, to be made at the discretion of local Medicare administrative contractors (MACs), due to “various improvements in the technical, regulatory and professional aspects of PET imaging for diagnosis.” Since the 2013 reconsideration, new non-oncologic PET agents have been approved by the FDA and multiple professional medical societies have published guidelines relevant to appropriate use of these agents. We believe that local contractor discretion provides an immediate avenue to potential coverage in appropriate candidates for non-oncologic indications. Therefore, we are proposing to eliminate subsection 220.6 to remove the broad national bar to coverage of PET scans for non-oncologic indications, thus allowing local Medicare contractors to make a coverage determination under section 1862(a)(1)(A) of the Act for beneficiaries. We believe this framework better serves the needs of the Medicare program and its beneficiaries. For clarity, we are not proposing to change any other subsections of 220.6.

Thus, the NCDs listed at 220.6.1 through 220.6.20 would not be changed by this proposal. In summary, we solicit comment on the proposal to remove the two NCDs, as well as comments recommending other NCDs for CMS to consider for future removal. We request commenters include a rationale to support their comments. We will use the public comments to help inform our decision to take one of three actions on the three NCDs proposed for removal. Remove the NCD, as proposed, allowing for coverage to be determined by the MACs.

Retain the current policy as an NCD. Reconsider the NCD by opening a National Coverage Analysis. Comments suggesting that the NCD should be revised, rather than eliminated, should include new evidence that was not previously available at the time of the original NCD or at the time the NCD was last reconsidered, in order to support a change in national coverage. H. Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac Rehabilitation Conditions of coverage for pulmonary rehabilitation (PR), cardiac rehabilitation (CR) and intensive cardiac rehabilitation (ICR) are codified at 42 CFR 410.47 and 410.49.

We are proposing revisions to the PR and CR/ICR regulations to emphasize that though one program treats a respiratory disease and one treats cardiac conditions, both types of programs aim to improve quality of life for their participants using similar methods. Because many components are shared between PR and CR/ICR, we strive to ensure consistency in the regulatory language used for these therapeutic programs. Additionally, we are proposing to more closely conform the PR and CR regulations by removing a PR requirement, and to add anti inflammatory drugs as a covered condition for PR for certain beneficiaries. As discussed by Fleg and colleagues (2020),[] CR and PR continue to be severely underutilized despite clear benefits on clinical and patient-centered outcomes. In fact Million Hearts® 2022, a national initiative co-led by the Centers for Disease Control and Prevention (CDC) and CMS to prevent 1 million heart attacks and strokes within 5 years, has incorporated a goal for increasing CR utilization.

Million Hearts® worked with CR professionals to set a goal of 70 percent CR participation for eligible patients.[] With these proposals to improve accuracy and consistency of the regulatory language specifying Medicare conditions of coverage for PR and CR/ICR, we hope to assist programs to better understand the PR and CR/ICR conditions of coverage. 1. Statutory Authority Section 144(a) of the Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275, July 15, 2008) (MIPPA) amended Title XVIII to add new section 1861(eee) of the Act to provide coverage of CR and ICR under Medicare part B, as well as new section 1861(fff) to provide coverage of PR under Medicare part B.

The statute specified certain conditions for coverage of these services and an effective date of January 1, 2010. Conditions of coverage for PR, CR and ICR consistent with the statutory provisions of section 144(a) of the MIPPA were codified in §§ 410.47 and 410.49 respectively through the CY 2010 PFS final rule with comment period (74 FR 61872 through 61886 and 62002 through 62003 (PR) 62004 through 62005 (CR/ICR)). 2. Background Under § 410.47(b), Medicare part B covers PR for beneficiaries with moderate to very severe chronic obstructive pulmonary disease (COPD) Start Printed Page 39257(defined as GOLD classification II, III and IV), when referred by the physician treating the chronic respiratory disease and allows additional medical indications to be established through a national coverage determination (NCD). We have not expanded coverage of PR further using the NCD process.

The conditions of coverage for CR and ICR set forth in MIPPA were codified in § 410.49 through the CY 2010 PFS final rule with comment period. In 2014, we expanded coverage of CR through the NCD process (NCD 20.10.1, Cardiac Rehabilitation Programs for Chronic Heart Failure (Pub. 100-03) to beneficiaries with stable, chronic heart failure. Section 51004 of the Bipartisan Budget Act (Pub. L.

115-123, February 9, 2018) (BBA of 2018), amended section 1861(eee)(4)(B) of the Act to expand coverage of ICR to include patients with stable, chronic heart failure. Section 410.49 was updated to codify this expansion through the CY 2020 PFS final rule (84 FR 62897 through 62899 and 63188). Under § 410.49(b), Medicare part B covers CR and ICR for beneficiaries who have experienced one or more of the following. (1) An acute myocardial infarction within the preceding 12 months. (2) a coronary artery bypass surgery.

(3) current stable angina pectoris. (4) heart valve repair or replacement. (5) percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting. (6) a heart or heart-lung transplant. (7) stable, chronic heart failure defined as patients with left ventricular ejection fraction of 35 percent or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least 6 weeks, on or after February 18, 2014 for cardiac rehabilitation and on or after February 9, 2018 for intensive cardiac rehabilitation.

Or (8) other cardiac conditions as specified through an NCD. The NCD process may also be used to specify non-coverage of a cardiac condition for ICR if coverage is not supported by clinical evidence. As set forth in statute, PR, CR and ICR are programs furnishing physician-supervised items and services that may be furnished in a physician's office or hospital outpatient setting or in other settings determined appropriate by the Secretary.[] When items and services are furnished under these programs, a physician must be immediately available and accessible for medical consultation and medical emergencies. PR, CR and ICR programs must include. Physician-prescribed exercise, psychosocial assessment, outcomes assessment, cardiac risk factor modification (for CR/ICR) and education or training (for PR), and individualized treatment plans (ITPs) established, reviewed and signed by a physician every 30 days.

The statute also includes physician requirements for PR and CR/ICR programs. Namely, section 1861(eee)(5) of the Act requires that the Secretary establish standards to ensure that a physician with expertise in the management of individuals with cardiac pathophysiology is responsible for the CR/ICR program and that such physician, in consultation with appropriate staff, is involved substantially in directing the progress of individual in the program. Section 1861(fff)(3) of the Act similarly requires the Secretary establish standards that ensure that a physician with expertise in the management of individuals with respiratory pathophysiology is responsible for the PR program and, in consultation with appropriate staff, is involved substantially in directing the progress of individual in the program. We established physician standards for PR at § 410.47 and for CR/ICR at § 410.49. Under the statute, PR and CR/ICR programs include individualized treatment that is furnished under a written plan established, reviewed, and signed by a physician every 30 days.

We codified this requirement in §§ 410.47 and 410.49 by defining and describing the ITP which must be established, reviewed, and signed by a physician every 30 days. Because the statute requires a plan to be established, reviewed, and signed by a physician every 30 days, we cannot alter this requirement. Stakeholders have indicated to us that it is very challenging for a program to fulfill these tasks on each patient's first day of PR or CR/ICR. Stakeholders have also expressed concerns that there is not separate and additional payment for medical directors or other physicians to develop and sign the ITPs. In response to these concerns, we note that the medical director and any staff physician(s) working in the PR or CR/ICR program who is involved in the patient's care and has knowledge related to the patient's condition, or the patient's treating and/or referring physician, may establish, review and sign ITPs.

When appropriate and when all billing requirements are met, a separately billable evaluation and management (E/M) service may be furnished by the medical director or other PR or CR/ICR staff physician(s) working in the program in connection with establishing and signing the ITP on or before the first day of PR or CR/ICR. Additionally, physicians treating patients for their cardiovascular or respiratory conditions, but who are not staff of the PR or CR/ICR programs, are not precluded from developing and signing ITPs for their patients before they begin PR or CR/ICR programs. While the CY 2010 PFS final rule for PR (74 FR at 61883) stated that the PR physician must review and sign the ITP prior to initiation of PR even if the plan was developed by a different physician, we recognize that this imposes greater burden and may potentially delay treatment. ITPs developed and signed on or before the first day of PR by a physician who is treating the patient's respiratory condition outside of the PR program will not require an additional signature from the PR medical director (or any other physician working in the program) on or before the first day of PR. Similarly, ITPs developed and signed on or before the first day of CR/ICR by a physician outside of the CR/ICR program treating the patient's cardiovascular condition, do not require an additional signature from the CR/ICR medical director (or other physician working in the program) on or before the first day of CR/ICR.

The PR and CR/ICR medical director and other appropriate staff would review these ITPs on or before the first day services are furnished. The medical director or other physician working in the program, in consultation with staff, may revise the ITP as needed to ensure the plan is appropriately individualized, regardless of which physician establishes and signs the plan. 3. Proposed Revisions As described above, PR and CR/ICR programs are subject to many of the same statutory requirements. Despite the consistency in requirements set forth in statute, we recognize that some of the conditions of coverage codified in regulation are not identical across both programs.

We are proposing conforming changes to the regulatory text for both PR and CR/ICR to establish consistency in terminology, definitions and requirements where appropriate which will result in clearer and more streamlined regulatory text. We are also proposing to adjust the regulatory structure of § 410.47 to align with § 410.49. The proposed revisions will also enable stakeholders with interest in both PR and CR/ICR programs to more easily compare requirements and implement programs.Start Printed Page 39258 a. Definitions We are proposing revisions to six PR definitions at § 410.47(a), including individualized treatment plan, medical director, outcomes assessment, physician-prescribed exercise, psychosocial assessment and supervising physician. And revisions to three CR/ICR definitions at § 410.49(a), including medical director, outcomes assessment, and physician-prescribed exercise.

Specifically, the proposed revisions to the PR definitions of ITP, psychosocial assessment and supervising physician align with the definitions of the same terms for CR/ICR. The proposed revisions to the PR definition of physician-prescribed exercise align with the definition of physician-prescribed exercise for CR/ICR and also include revisions to provide examples of physical activities appropriate to the patient population (which were relocated from the PR components section (previously § 410.47(c)). Similar revisions are proposed for the CR/ICR definition of physician-prescribed exercise. We are proposing to modify language in the PR definition of medical director to align with the CR/ICR definition of medical director to more specifically describe the role of the PR medical director. We are proposing conforming changes to the CR/ICR definition of medical director.

Proposed revisions to the PR and CR/ICR definitions of outcomes assessment remove and revise redundant and unnecessary language. Also, we are proposing to clearly state that outcome assessments may be performed by either the physician or the PR or CR/ICR program staff and that all results of these evaluations performed by program staff must be considered by the physician in the development and/or review of ITPs. These proposals are consistent with descriptions provided in the CY 2010 PFS proposed rule (74 FR at 33608, 33613) which state that PR and CR/ICR staff must provide outcomes assessments to the physician and serve to clearly communicate the important supportive role program staff may play to the physicians of these rehabilitation programs. The proposed conforming changes are designed to more accurately define the existing terms and ensure consistency in definitions used for the same terms across PR and CR/ICR programs. We chose to largely maintain the CR/ICR regulatory text and align the PR regulatory text with CR/ICR based on stakeholder feedback and questions regarding the PR requirements.

Aligning PR with CR/ICR, as opposed to aligning CR/ICR with PR requirements, better addresses stakeholder feedback and improves consistency in terminology, definitions and descriptions of conditions of coverage. With the proposed revisions and increased consistency, we also aim to improve program efficiency in implementing the conditions of coverage. B. Covered Conditions The definition for PR at § 410.47(a) specifies that PR is a physician-supervised program for COPD and certain other chronic respiratory diseases. The CDC uses the term post-anti inflammatory drugs conditions to describe health issues that persist more than 4 weeks after first being infected with the causative symbicort [] indicating that this timeframe provides a rough approximation of effects that occur beyond the acute period.

Similarly, the National Institute for Health and Care Excellence (NICE), the Scottish Intercollegiate Guidelines Network (SIGN) and the Royal College of General Practitioners (RCGP) have jointly used 4 weeks to differentiate the acute symptoms of anti inflammatory drugs from `long anti inflammatory drugs,' the signs and symptoms that continue or develop after acute anti inflammatory drugs.[] Based on the information from the CDC, NICE, SIGN and RCGP, we consider anti inflammatory drugs to be chronic when symptoms persist for more than 4 weeks. Symptoms include dyspnea, depression and anxiety which can impair physical function and cause incapacitation.[] We are proposing to cover PR for Medicare beneficiaries who have been diagnosed with severe manifestations of anti inflammatory drugs, defined as requiring hospitalization in the ICU or otherwise, and who experience continuing symptomatology, including respiratory dysfunction, for at least 4 weeks post discharge. Management of anti inflammatory drugs post-acute syndrome is an evolving issue in the health of our beneficiaries. We recognize that there is limited evidence available assessing the benefits that PR may provide for patients who were diagnosed with anti inflammatory drugs. However, early research and consensus statements emphasize the restorative role that PR will likely play in the patient recovering from anti inflammatory drugs.[] We are soliciting comments regarding the appropriateness of the coverage criteria for PR for beneficiaries diagnosed with anti inflammatory drugs, including both the characteristics of the patients for whom PR is covered and the timing of their symptoms as presented above.

C. Components We are proposing revisions to the description of each of the five PR components under § 410.47(b)(2) (previously § 410.47(c)). Proposed revisions to the descriptions of physician prescribed exercise, psychosocial assessment and outcomes assessment include removing language already used in the definition of each term or references to the definitions in § 410.47(a). The inclusion of already established definition language is redundant and therefore unnecessary. Proposed revisions to the education or training component more concisely explain, but do not change, the existing requirements for meeting this component.

Proposed revisions to the description of the ITP align with the description used for the CR/ICR ITP. As noted in the section above, we largely align the PR regulatory text with CR/ICR to better address stakeholder feedback and improve consistency in terminology, definitions and descriptions of conditions of coverage to assist in improving program efficiency in implementing the conditions of coverage. D. Settings We are proposing minor edits to align the PR setting text in § 410.47(b)(3)(i) (previously § 410.47(d)(1)) with the CR/ICR setting text and reorganize this section to move and update, consistent with the corresponding CR/ICR section, the requirement that all settings must have a physician immediately available and accessible for medical consultations and emergencies. E.

Physician Standards We are proposing revisions to align regulatory text regarding the standards for the PR medical director and the supervising physician found at Start Printed Page 39259§ 410.47(c) and (d) (previously § 410.47(e)) with the corresponding CR/ICR medical director and supervising physician text and minor conforming changes to CR/ICR language § 410.49(d) and (e). These revisions will not only align similar requirements for PR and CR/ICR programs, but also more accurately describe the roles and responsibilities of physicians in PR programs, and thereby address stakeholder feedback requesting more specificity around the roles and standards for the physicians involved in PR programs. Specifically, we are proposing to replace the existing PR “physician standards” section with two separate sections. The first, entitled “medical director standards” delineates requirements for the PR medical director, and the second, “supervising physician standards” delineates requirements for physicians fulfilling the supervising physician role when PR items and services are furnished. These revisions also include removing language that is redundant to the definition for medical director already set forth in § 410.47(a) and the requirement that a physician have “direct patient contact related to the periodic review of his or her treatment plan.” We are proposing to remove the direct patient contact language because this requirement is overly burdensome and unnecessary since a physician is already required to, in consultation with staff, review patient ITPs every 30 days.

Direct physician-patient contact can be written into an ITP for patients who require such attention. However, it is not necessary for every patient and the need for it should instead be specified by the clinician. Furthermore, while we believe direct physician-patient contact within the PR program every 30 days is not necessary for every PR patient, we note that patients are seen by PR staff and their progress is tracked at each session where staff are able to identify the need for direct physician-patient contact as appropriate. Additionally, patients participating in PR generally continue to have ongoing interactions with their treating physicians outside of PR. Because the need for direct physician-patient contact is individualized and patients continue to engage with their treating physicians outside of PR, we are proposing to remove the requirement for direct physician-patient contact within the PR program every 30 days.

We are requesting public comment on whether removing the regulatory requirement for direct physician-patient contact every 30 days would be potentially detrimental to PR patients by eliminating a critical physician interaction, or if necessary interactions are already occurring outside of the PR program at appropriate intervals as determined by a physician treating the patient for his or her respiratory condition. These proposed revisions and clearer delineations of the roles and standards for the PR medical director and, separately, the supervising physician, are important to address stakeholder feedback and reduce burden on PR programs, physicians and patients while ensuring treatment is truly individualized as directed by statute. As these proposed revisions, more accurately describe and delineate the roles and standards for the medical director and the supervising physician, please note that the PR or CR/ICR medical director may serve as a supervising physician if he or she also meets the requirements for a supervising physician. Two different physicians are not necessarily required, as long as the definitions and descriptions in §§ 410.47 and 410.49 are met. F.

Limitations We are proposing conforming changes to § 410.47(e) (previously § 410.47(f)) and § 410.49(f) to improve clarity of these sections and more closely align the descriptions for session duration, number of sessions covered and time-period over which sessions must be provided. 4. Summary To improve consistency and accuracy across PR and CR/ICR conditions of coverage, we are proposing largely conforming changes throughout §§ 410.47 and 410.49. We are also proposing to add coverage of PR for beneficiaries who were hospitalized with a anti inflammatory drugs diagnosis and experience persistent symptoms, including respiratory dysfunction, for least 4 weeks after hospital discharge and to remove a PR program requirement that is overly burdensome and unnecessary for all PR patients which was also not expressly required in statute. We believe these proposals result in clearer and more streamlined regulatory text and better assist stakeholders in understanding and implementing PR, CR and ICR programs.

We look forward to public comments on our proposals, in particular our proposals to remove the PR direct physician-patient contact requirement and to add coverage of PR for beneficiaries who were hospitalized with a anti inflammatory drugs diagnosis and experience persistent symptoms, including respiratory dysfunction, for at least 4 weeks after hospital discharge. I. Medical Nutrition Therapy Medical nutrition therapy became a distinct Medicare benefit under section 1861(s)(2) of the Act pursuant to section 105 of the Medicare, Medicaid, and SCHIP Benefits Improvement Protection Act of 2000 (BIPA). Medicare beneficiaries with diabetes or renal disease can receive individualized medical nutrition therapy (MNT) provided by a registered dietitian or nutrition professional, pursuant to a referral by a physician (as defined in section 1861(r)(1) of the Act), with no cost to the beneficiary. Currently, 42 CFR 410.132(c), further requires that the referral must be made by the treating physician.

The treating physician was defined as the primary care physician or specialist, coordinating care for the beneficiary with diabetes or renal disease. The regulation also specifically defines renal disease as including chronic renal insufficiency based on glomerular fiation rate (GFR) eligibility criteria. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Kidney Foundation and Academy of Nutrition and Dietetics support MNT for adults with chronic kidney disease (CKD). The National Kidney Foundation and the Academy of Nutrition and Dietetics' Clinical Practice Guideline on Nutrition in Chronic Kidney Disease [] acknowledges that the goals of MNT are to optimize nutritional status, and to minimize risks imposed by comorbid conditions and alterations in metabolism on the progression of kidney disease and on adverse clinical outcomes. The authors recognize that patients with CKD have changing needs according to their disease stage and they recommended MNT for each stage of CKD.

In addition, evidence supports the use of MNT as a component of quality diabetes care, including its integration into the medical management of diabetes. Nutrition therapy that includes the development of an eating plan designed to improve blood glucose, blood pressure, and lipid profiles is important in the management of diabetes and can lower the risk of cardiovascular disease, coronary heart disease, and stroke. Despite these findings and endorsement by leading clinical societies, including the American Diabetes Association, American College of Cardiology and the Start Printed Page 39260National Kidney Foundation, less than 1 percent of the estimated 14 million eligible Medicare beneficiaries have accessed MNT. Over the years, we have heard from several stakeholder groups requesting that we update the MNT regulations to improve beneficiary access. In this proposed rule, we provide background on the MNT services, discuss the MNT regulation revisions, and make proposals to implement these modifications.

We are proposing to make changes to the treating physician requirements and update the chronic renal insufficiency GFR criteria in order to improve access and utilization of the MNT benefit. The statute expressly requires the order of a physician. Therefore, we are unable to extend referral privileges to NPPs. 1. Background.

MNT MNT is defined in sections 1861(s)(2)(V) and 1861(vv)(1) of the Act and codified in 42 CFR 410.130 (definitions), § 410.132 (MNT), and § 410.134 (provider qualifications). A. Definitions (§ 410.130) In 42 CFR subpart G, we define the following definitions that apply to MNT at § 410.130. Chronic renal insufficiency. Diabetes.

Episode of care. Medical nutrition therapy services. Physician. Renal disease. Treating physician.

b. Medical Nutrition Therapy (§ 410.132) In § 410.132(a), we outline the conditions for coverage of MNT services. That is, Medicare Part B pays for MNT services provided by a registered dietitian or nutrition professional as defined in § 410.134 when the beneficiary is referred for the service by the treating physician. Services covered consist of face-to-face nutritional assessments and interventions in accordance with nationally-accepted dietary or nutritional protocols. The regulation contains an exception that permits MNT services to be provided as telehealth services under § 410.78.

In § 410.132(b), we outline the limitations on coverage of MNT services. First, the MNT services based on a diagnosis of renal disease as described in 42 CFR subpart G are not covered for beneficiaries receiving maintenance dialysis for which payment is made under section 1881 of the Act. Also, a beneficiary may only receive the maximum number of hours covered under the DSMT benefit for both DSMT and MNT during the initial DSMT training period unless additional hours are determined to be medically necessary under the national coverage determination (NCD) process. In years when the beneficiary is eligible for MNT and follow-up DSMT, Medicare will cover the maximum number of hours covered under MNT unless additional hours are determined to be medically necessary under the NCD process. Under the current MNT NCD (NCD 180.1), Medicare covers 3 hours of MNT the initial year of referral and up to 2 hours of MNT for subsequent years.

In addition, if a beneficiary has both diabetes and renal disease, Medicare will cover the maximum number of hours covered under the renal MNT benefit in one episode of care unless he or she is receiving initial DSMT services, in which case the beneficiary would receive whichever is greater. Finally, an exception to the maximum number of hours described here may be made when the treating physician determines that there is a change of diagnosis, medical condition, or treatment regimen related to diabetes or renal disease that requires a change in MNT during an episode of care. At § 410.132(c), we discuss that a referral may only be made by the treating physician when the beneficiary has been diagnosed with diabetes or renal disease as defined in 42 CFR subpart G with documentation maintained by the referring physician in the beneficiary's medical record. We also note that referrals must be made for each episode of care and any additional assessments or interventions required by a change of diagnosis, medical condition, or treatment regimen during an episode of care. C.

Provider Qualifications (§ 410.134) For Medicare Part B coverage of MNT, only a registered dietitian or nutrition professional may provide the services. At § 410.134, we define registered dietitian or nutrition professional as an individual who, on or after December 22, 2000. (1) Holds a bachelor's or higher degree granted by a regionally accredited college or university in the United States (or an equivalent foreign degree) with completion of the academic requirements of a program in nutrition or dietetics accredited by an appropriate national accreditation organization recognized for this purpose. (2) has completed at least 900 hours of supervised dietetics practice under the supervision of a registered dietitian or nutrition professional. And (3) is licensed or certified as a dietitian or nutrition professional by the state in which the services are performed.

In a state that does not provide for licensure or certification, the individual will be deemed to have met this requirement if he or she is recognized as a registered dietitian by the Commission on Dietetic Registration or its successor organization. However, a dietitian or nutritionist licensed or certified in a state as of December 21, 2000 is not required to hold a bachelor's or higher degree granted by a regionally accredited college or university in the United States (or an equivalent foreign degree) with completion of the academic requirements of a program in nutrition or dietetics accredited by an appropriate national accreditation organization recognized for this purpose. (2) and need not complete at least 900 hours of supervised dietetics practice under the supervision of a registered dietitian or nutrition professional. In addition, a registered dietitian in good standing, as recognized by the Commission of Dietetic Registration or its successor organization, is deemed to have met these requirements. 2.

Proposal for MNT Revisions a. Removal of the Treating Physician Restriction For CY 2022, we are proposing to revise the regulations at §§ 410.130 and 410.132. Sections 1861(s)(2)(V) and 1861(vv)(1)) of the Act define MNT services as nutritional diagnostic, therapy, and counseling services for the purpose of disease management which are furnished by a registered dietitian or nutrition professional pursuant to a referral by a physician (either an M.D. Or D.O.) (as defined in section 1861(r)(1) of the Act). The current regulation further provides that Medicare pays for MNT services when the beneficiary is referred for the service by the treating physician, which is defined as the primary care physician or specialist coordinating care for the beneficiary with diabetes or renal disease.

As discussed above in section III.I.2. Of this proposed rule and codified at § 410.132(c), we required referrals only by the treating physician when the beneficiary has been diagnosed with diabetes or a renal disease, with documentation maintained by the referring physician in the beneficiary's medical record. In the CY 2002 PFS final rule (66 FR 55246, November 1, 2001), we believed the treating physician requirement was necessary to ensure coordination of care by the primary care physician or specialist for beneficiaries with chronic diseases in order to assure quality (66 FR 55277). Start Printed Page 39261This relatively narrow definition, however, is now believed to have contributed to the low uptake of referrals to MNT services, although we note that few studies have examined MNT use. We are proposing to eliminate the requirement that the referral be made by the treating physician and, consistent with the language of the statute, require MNT services to be pursuant to a referral by a physician (as defined in section 1861(r)(1) of the Act) at § 410.130 and § 410.132.

It would be reasonable for any physician to refer a beneficiary to MNT. The treating physician restriction is no longer necessary to expect care to be coordinated. Care coordination between the hospital or post-acute care provider and the primary care provider is the goal and a standard of care in today's medical environment. We have worked to improve, through various efforts, the exchange of patient information between healthcare settings, and that a patient's healthcare information follows them after discharge from a hospital or post-acute care provider. Such improved transitions of care and exchange of information helps to assure that Medicare beneficiaries will continue to receive quality services.

We are proposing to delete the term treating and the definition of treating physician, as there is a separate definition for physician within this provision. Therefore, we are not proposing any change to Medicare's definition of treating physician and the deletion of treating physician only applies to this provision. B. Update the GFR Eligibility Criteria for Patients With CKD We are proposing to revise the regulations at § 410.130. Section 1861(s)(2)(V) of the Act states that MNT services are available to beneficiaries with diabetes or a renal disease.

In 2001, we established the definition of chronic renal insufficiency for the purpose of the MNT benefit using definitions from the Institute of Medicine report, “The Role of Nutrition in Maintaining Health in the Nation's Elderly.” [] The definitions and staging of chronic kidney disease have evolved since the release of the report and stakeholders have noted that our definition does not reflect current medical practice. Therefore, we are proposing to update the GFR eligibility criteria so that it aligns with up to date accepted standards for CKD stage III through stage V, specifically GFR 15-59 mL/min/1.73m2. The accepted CKD staging system separates stage III into two parts. Stage III-a. And Stage III-b.

Stage III-a is GFR 45-59. The existing regulatory upper limit of 50 is mid stage III-a and does not meet the widely accepted standard of when a person is diagnosed with moderate kidney disease. The NIDDK and National Kidney Foundation's staging of CKD align with the proposed change in GFR criteria.[] 3. Proposed Regulatory Text Changes We are proposing to make changes to the treating physician requirements and GFR eligibility criteria outlined in § § 410.130 and 410.132, consistent with statutory limitations. We propose to revise § 410.130 (definitions) and § 410.132 (MNT) by.

(1) Revising the chronic renal insufficiency definition. (2) striking the treating physician definition. And (3) revising conditions for coverage of MNT services, limitations on coverage of MNT services, and referrals. (1) Definition of Chronic Renal Insufficiency We propose to revise § 410.130 by revising the chronic renal insufficiency definition by removing the GFR eligibility criteria of 13—50 ml/min/1.73m2 and replacing with 15—59 ml/min/1.73m2. (2) Definition of Treating Physician We propose to revise § 410.130 by removing the definition of treating physician.

(3) Proposed Changes to Conditions for Coverage of MNT Services, Limitations on Coverage of MNT Services, and Referrals At § 410.132, we are proposing to revise conditions for coverage of MNT services, limitations on coverage of MNT services, and referrals by removing the terms “the” and “treating,” and replacing them with “a,” at paragraphs (a), (b)(5), and (c). In paragraph (c), we are also proposing to strike the term, “maintained,” and replace it with the term, “noted.” 4. Summary The MNT services may help reduce illnesses and improve quality of life for people with diabetes or renal disease. We believe the proposed changes to the treating physician requirements and GFR eligibility criteria are in the best interest of the Medicare program and its beneficiaries. The physician requirement change will increase the capacity and availability of physicians who can refer beneficiaries to MNT, which would alleviate some of the demand on primary care physicians as the usual source to perform this particular function.

We note that stakeholders have contacted CMS and suggested such flexibility in the past. We recognize that MNT is not a highly utilized service and we believe these revisions will allow for Medicare patients to gain greater access to MNT services. We look forward to receiving public comment on these proposals. J. Medicare Shared Savings Program On March 23, 2010, the Patient Protection and Affordable Care Act (Pub.

L. 111-148) was enacted, followed by enactment of the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) on March 30, 2010, which amended certain provisions of the Patient Protection and Affordable Care Act (hereinafter collectively referred to as “the Affordable Care Act”). Section 3022 of the Affordable Care Act amended Title XVIII of the Act (42 U.S.C.

1395 et seq.) by adding section 1899 to the Act to establish the Medicare Shared Savings Program (Shared Savings Program) to facilitate coordination and cooperation among healthcare providers to improve the quality of care for Medicare fee-for-service (FFS) beneficiaries and reduce the rate of growth in expenditures under Medicare Parts A and B. (See 42 U.S.C. 1395jjj.) Eligible groups of providers and suppliers, including physicians, hospitals, and other healthcare providers, may participate in the Shared Savings Program by forming or participating in an Accountable Care Organization (ACO). Under the Shared Savings Program, providers of services and suppliers that participate in an ACO continue to receive traditional Medicare FFS payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. Section 1899 of the Act has been amended through subsequent legislation.

The requirements for assignment of Medicare FFS beneficiaries to ACOs participating under the program were amended by the 21st Century Cures Act (the CURES Act) (Pub. L. 114-255, December 13, 2016). The Bipartisan Budget Act of 2018 (Pub. L.

115-123, February 9, 2018), further Start Printed Page 39262amended section 1899 of the Act to provide for the following. Expanded use of telehealth services by physicians or practitioners participating in an applicable ACO to furnish services to prospectively assigned beneficiaries, greater flexibility in the assignment of Medicare FFS beneficiaries to ACOs by allowing ACOs in tracks under retrospective beneficiary assignment a choice of prospective assignment for the agreement period. Permitting Medicare FFS beneficiaries to voluntarily identify an ACO professional as their primary care provider and requiring that such beneficiaries be notified of the ability to make and change such identification, and mandating that any such voluntary identification will supersede claims-based assignment. And allowing ACOs under certain two-sided models to establish CMS-approved beneficiary incentive programs. The Shared Savings Program regulations are codified at 42 CFR part 425.

The final rule establishing the Shared Savings Program appeared in the November 2, 2011 Federal Register (Medicare Program. Medicare Shared Savings Program. Accountable Care Organizations. Final rule (76 FR 67802) (hereinafter referred to as the “November 2011 final rule”)). A subsequent major update to the program rules appeared in the June 9, 2015 Federal Register (Medicare Program.

Medicare Shared Savings Program. Accountable Care Organizations. Final rule (80 FR 32692) (hereinafter referred to as the “June 2015 final rule”)). The final rule entitled, “Medicare Program. Medicare Shared Savings Program.

Accountable Care Organizations—Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial Calculations,” which addressed changes related to the program's financial benchmark methodology, appeared in the June 10, 2016 Federal Register (81 FR 37950) (hereinafter referred to as the “June 2016 final rule”). A final rule, “Medicare Program. Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019. Medicare Shared Savings Program Requirements. Quality Payment Program.

Medicaid Promoting Interoperability Program. Quality Payment Program—Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year. Provisions From the Medicare Shared Savings Program—Accountable Care Organizations—Pathways to Success. And Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act”, appeared in the November 23, 2018 Federal Register (83 FR 59452) (hereinafter referred to as the “November 2018 final rule” or the “CY 2019 PFS final rule”). In the November 2018 final rule, we finalized a voluntary 6-month extension for existing ACOs whose participation agreements would otherwise expire on December 31, 2018.

Allowed beneficiaries greater flexibility in designating their primary care provider and in the use of that designation for purposes of assigning the beneficiary to an ACO if the clinician they align with is participating in an ACO. Revised the definition of primary care services used in beneficiary assignment. Provided relief for ACOs and their clinicians impacted by extreme and uncontrollable circumstances in performance year 2018 and subsequent years. Established a new Certified Electronic Health Record Technology (CEHRT) use threshold requirement. And reduced the Shared Savings Program quality measure set from 31 to 23 measures (83 FR 59940 through 59990 and 59707 through 59715).

A final rule redesigning the Shared Savings Program appeared in the December 31, 2018 Federal Register (Medicare Program. Medicare Shared Savings Program. Accountable Care Organizations—Pathways to Success and Uncontrollable Circumstances Policies for Performance Year 2017. Final rule) (83 FR 67816) (hereinafter referred to as the “December 2018 final rule”). In the December 2018 final rule, we finalized a number of policies for the Shared Savings Program, including a redesign of the participation options available under the program to encourage ACOs to transition to two-sided models.

New tools to support coordination of care across settings and strengthen beneficiary engagement. And revisions to ensure rigorous benchmarking. In the interim final rule with comment period (IFC) entitled “Medicare and Medicaid Programs. Policy and Regulatory Revisions in Response to the anti inflammatory drugs Public Health Emergency”, which was effective on the March 31, 2020 date of display and appeared in the April 6, 2020 Federal Register (85 FR 19230) (hereinafter referred to as the “March 31, 2020 anti inflammatory drugs IFC”), we removed the restriction which prevented the application of the Shared Savings Program extreme and uncontrollable circumstances policy for disasters that occur during the quality reporting period if the reporting period is extended, to offer relief under the Shared Savings Program to all ACOs that may be unable to completely and accurately report quality data for 2019 due to the Public Health Emergency (PHE) for anti inflammatory drugs (85 FR 19267 and 19268). In the IFC entitled “Medicare and Medicaid Programs.

Basic Health Program, and Exchanges. Additional Policy and Regulatory Revisions in Response to the anti inflammatory drugs Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program” which was effective on May 8, 2020, and appeared in the May 8, 2020 Federal Register (85 FR 27573 through 27587) (hereinafter referred to as the “May 8, 2020 anti inflammatory drugs IFC”), we modified Shared Savings Program policies to. (1) Allow ACOs whose current agreement periods expire on December 31, 2020, the option to extend their existing agreement period by 1-year, and allow ACOs in the BASIC track's glide path the option to elect to maintain their current level of participation for performance year 2021. (2) adjust program calculations to remove payment amounts for episodes of care for treatment of anti inflammatory drugs. And (3) expand the definition of primary care services for purposes of determining beneficiary assignment to include telehealth codes for virtual check-ins, e-visits, and telephonic communication.

We also clarified the applicability of the program's extreme and uncontrollable circumstances policy to mitigate shared losses for the period of the PHE for anti inflammatory drugs starting in January 2020. We have also made use of the annual CY PFS rules to address quality reporting for the Shared Savings Program and certain other issues. Refer to the CY 2020 PFS proposed rule for a summary of policies finalized in prior PFS rules (84 FR 40705). In the CY 2021 PFS final rule, we finalized new Shared Savings Program quality reporting requirements that align with the Alternative Payment Model (APM) Performance Pathway (APP) under the Quality Payment Program and revised the quality performance standard for performance years beginning on or after January 1, 2021, to reduce reporting burden and focus on patient outcomes. We also finalized a policy that waived the requirement that ACOs administer the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for ACOs survey for performance year 2020.

In addition, we finalized updates to the definition of primary care services used Start Printed Page 39263for beneficiary assignment, and policies to reduce burden associated with repayment mechanisms. In the CY 2021 PFS final rule, we also finalized the Shared Savings Program provisions included in the March 31, 2020 anti inflammatory drugs IFC and the May 8, 2020 anti inflammatory drugs IFC, with several modifications in response to public comments received. Policies applicable to Shared Savings Program ACOs for purposes of reporting for other programs have also continued to evolve based on changes in the statute. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L.

114-10, April 16, 2015) established the Quality Payment Program. In the CY 2017 Quality Payment Program final rule with comment period (81 FR 77008), we established regulations for the Merit-Based Incentive Payment System (MIPS) and Advanced APMs and related policies applicable to eligible clinicians who participate in APMs, including the Shared Savings Program. As a general summary, in this proposed rule, we are proposing to. Clarify the Application of the CAHPS for MIPS Survey sampling policies, including the CAHPS for MIPS minimum sampling thresholds, for Shared Savings Program ACOs. Amend the reporting requirements under the APM Performance Pathway (APP) for performance year 2022 and performance year 2023.

++ Solicit comments on addressing health disparities and promoting health equity. ++ Solicit comments on the feasibility of TIN level reporting and sampling for eCQMs/MIPS CQMs. ++ Solicit comments on reporting options for specialist providers within an ACO. ++ Update the APM Performance Pathway (APP) measure set to remove the Risk-Standardized, All-Cause Unplanned Admissions for Multiple Chronic Conditions (MCC) for ACOs and replace it with the Risk Standardized, All-Cause Unplanned Admissions for Multiple Chronic Conditions for MIPS. Amend the quality performance standard for performance year 2023 by freezing the quality performance standard at the 30th percentile MIPS Quality performance category score.

++ Solicit comments on publicly displaying prior year performance scores that equate to the 30th or 40th percentile MIPS Quality performance category scores. Revise the extreme and uncontrollable circumstances policy to align with the proposal to freeze the quality performance standard at the 30th percentile MIPS Quality performance category score for performance year 2023. Update the definition of primary care services used in beneficiary assignment at § 425.400(c). Revise the repayment mechanism arrangement policy in the following manner. ++ To reduce the percentages used in the existing methodology for determining the repayment mechanism amount and to specify the number of assigned beneficiaries used as a multiplier in the calculations, such that the ACO's repayment mechanism amount would be calculated as the lesser of the following.

(1) One-half percent of the total per capita Medicare Parts A and B FFS expenditures for the ACO's assigned beneficiaries, based on expenditures and the number of assigned beneficiaries for the most recent calendar year for which 12 months of data are available. Or (2) 1 percent of the total Medicare Parts A and B FFS revenue of its ACO participants, based on revenue for the most recent calendar year for which 12 months of data are available, and based on the ACO's number of assigned beneficiaries for the most recent calendar year for which 12 months of data are available. ++ To specify how we identify the number of assigned beneficiaries used in the repayment mechanism amount calculation and the annual repayment mechanism amount recalculation. ++ To allow a one-time opportunity for certain ACOs that established a repayment mechanism to support their participation in a two-sided model beginning on July 1, 2019, January 1, 2020, or January 1, 2021, to elect to decrease the amount of their existing repayment mechanisms. ++ To revise the threshold for determining whether an increase in the repayment mechanism amount is required.

Streamline the application process by revising requirements concerning the disclosure of prior participation in the Shared Savings Program by the ACO, ACO participants, and ACO providers/suppliers, in light of other requirements that consider an ACO's prior participation. Reduce the frequency and circumstances under which ACOs submit sample ACO participant agreements and executed ACO participant agreements to CMS. Amend the beneficiary notification requirement as it applies to ACOs under prospective assignment and ACOs under preliminary prospective assignment with retrospective reconciliation. Solicit comments on considerations related to the use of regional FFS expenditures in the Shared Savings Program's benchmarking methodology. 1.

Quality and Other Reporting Requirements a. Background Section 1899(b)(3)(C) of the Act states that the Secretary shall establish quality performance standards to assess the quality of care furnished by ACOs and seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both. As we stated in the November 2011 final rule establishing the Shared Savings Program (76 FR 67872), our principal goal in selecting quality measures for ACOs has been to identify measures of success in the delivery of high-quality health care at the individual and population levels, with a focus on outcomes. In the November 2011 final rule, we adopted a quality measure set spanning four domains. Patient experience of care, care coordination/patient safety, preventative health, and at-risk population (76 FR 67872 through 67891).

We subsequently updated the measures comprising the quality performance measure set for the Shared Savings Program through rulemaking in the CY 2015, 2016, 2017, and 2019 PFS final rules (79 FR 67907 through 67920, 80 FR 71263 through 71268, 81 FR 80484 through 80489, and 83 FR 59707 through 59715 respectively). Between performance years 2017 (the first performance year under MIPS) and 2020, eligible clinicians who were participating in an ACO and who were subject to MIPS (MIPS eligible clinicians) were scored under the APM scoring standard under MIPS (81 FR 77260). These clinicians include any MIPS eligible clinicians who were participating in an ACO in a track, or payment model within a track (Track 1 and Levels A through D of the BASIC track) of the Shared Savings Program that is not an Advanced APM, as well as those MIPS eligible clinicians participating in an ACO in a track, or payment model within a track (Track 2, Level E of the BASIC track, and the ENHANCED track, or the Medicare ACO Track 1+ Model (Track 1+ Model)) that is an Advanced APM, but who do not become Qualifying APM Participants (QPs) as specified in § 414.1425, and are not otherwise excluded from MIPS. In the CY 2021 PFS final rule, CMS finalized modifications to the Shared Savings Program quality reporting Start Printed Page 39264requirements and quality performance standard for PY 2021 and subsequent performance years (85 FR 84720 through 84736). For performance year 2021 and subsequent years, ACOs are required to report quality data via the APP.

In addition, CMS finalized a phase-in approach to the new Shared Savings Program quality performance standard that ACOs must achieve in order to be eligible to share in savings or avoid maximum losses. This phase-in allows for a gradual increase of the quality performance standard from a quality performance score that is equivalent to or higher than the 30th percentile across all MIPS Quality performance category scores in performance years 2021 and 2022 to a quality performance score that is equivalent to or higher than the 40th percentile across all MIPS Quality performance category scores in performance year 2023 and subsequent years. B. Clarification of the Application of CAHPS for MIPS Sampling Policies to Shared Savings Program ACOs In the CY 2021 PFS final rule (85 FR 84722), we finalized that beginning in performance year (PY) 2021, Shared Savings Program Accountable Care Organizations (ACOs) are required to report quality data via the Alternative Payment Model (APM) Performance Pathway (APP). As part of the APP, ACOs are required to administer the CAHPS for MIPS survey (85 FR 84730 through 84732).

In the CY 2021 PFS final rule, we noted, in response to public comments, that the CAHPS for MIPS survey uses the same survey instrument to assess the same patient experience domains (or Summary Survey Measures (SSMs)) as the CAHPS for ACO survey. We noted that both the CAHPS for MIPS and the CAHPS for ACOs survey use the same shortened, streamlined version of the survey that we implemented for both CAHPS for ACOs and CAHPS for MIPS in 2018, reflecting efforts by CMS to reduce the number of questions. Moreover, in 2019, the two programs used identical survey instruments. As discussed in the CY 2021 PFS final rule, we conducted analyses to assess the impact of aligning CAHPS scoring and benchmarking using 2019 CAHPS for ACOs and CAHPS for MIPS data. The results of these analyses indicate that scoring ACOs using the MIPS methodology resulted in ACOs having a similar distribution of quality points as MIPS groups.

This distribution was wider than the distribution of quality points using the ACO scoring methodology largely due to differences across the two programs in the approach to benchmarking (85 FR 84731). In addition, we clarified that beneficiaries assigned to an ACO or MIPS group, who are eligible for the CAHPS for MIPS or CAHPS for ACOs survey, are randomly selected for inclusion in the sample. Samples are drawn at the ACO level for CAHPS for ACOs and at the TIN level for MIPS groups. Therefore, each ACO or MIPS group sample is representative of the ACO or group population. We stated that due to the alignment of CAHPS for ACOs with CAHPS for MIPS, we will use the benchmarking and scoring methodology for CAHPS for MIPS to assess ACOs' performance on the CAHPS survey measures.

We explained that a single set of benchmarks will be calculated using data from all applicable CAHPS for MIPS reporters. We score the CAHPS for MIPS survey as one quality measure, which is a different scoring approach from the Shared Savings Program quality scoring methodology, which scored the 10 CAHPS for ACOs SSMs in one patient/caregiver experience quality domain. As described in the CY 2017 Quality Payment Program final rule (81 FR 77284), each scored SSM has an individual benchmark and is scored individually and compared against the benchmark to establish the number of points earned. The CAHPS score is the average number of points across scored SSMs. As stated in the CY 2021 PFS final rule (85 FR 84731), eligible beneficiaries assigned to an ACO or MIPS group are randomly selected to be included in the sample for the CAHPS for ACOs or CAHPS for MIPS survey.

In the CY 2021 PFS final rule, we explained that the target sample size for CAHPS samples for all participating ACOs, groups, and virtual groups is 860. For ACOs, groups, and virtual groups with 860 or more survey-eligible patients, a random sample of 860 patients is drawn. We also noted that groups and virtual groups with fewer than 860 survey-eligible patients are eligible to participate in the CAHPS for MIPS if they meet the minimum sampling thresholds for CAHPS for MIPS. Large groups or virtual groups with 100 or more eligible clinicians. 416 eligible patients.

Medium groups or virtual groups with 25-99 eligible clinicians. 255 eligible patients. Small groups or virtual groups with 2-24 eligible clinicians. 125 eligible patients. These minimum sampling thresholds are necessary to ensure that groups have an adequate sample size to ensure that the survey responses will be representative of the care furnished by the clinicians in the group.

Groups that do not have an adequate sample size would be at risk for not receiving enough survey responses to be representative of the care provided. In the CY 2021 PFS final rule, we stated that we will continue to draw the CAHPS survey samples for Shared Savings Program ACOs administering the CAHPS for MIPS survey at the Shared Savings Program ACO level, with a target sample size of 860 going forward. Although we did not specifically state in the CY 2021 PFS final rule that the MIPS minimum sampling thresholds would also apply to ACOs participating in the Shared Savings Program, we want to clarify that they do apply for performance year 2021 and subsequent years. As explained in the CY 2021 PFS final rule, under the APP we are replacing the CAHPS for ACOs that was previously used in the Shared Savings Program with the CAHPS for MIPS. Because our intent in including the CAHPS for MIPS in the APP was to align reporting requirements under the Shared Savings Program with MIPS, we believe that the discussion surrounding the CAHPS for MIPS minimum sampling thresholds for groups and virtual groups can be reasonably understood to indicate that the CAHPS for MIPS minimum sampling thresholds would also apply to Shared Savings Program ACOs.

We note that we received stakeholder feedback after the publication of the CY 2021 PFS final rule asking whether the CAHPS for MIPS minimum sampling thresholds would also apply to Shared Savings Program ACOs. From the feedback received, we determined that it was necessary to clarify that the minimum sampling threshold will apply. As discussed previously in this section, minimum sampling thresholds are necessary to ensure that ACOs have an adequate sample size to ensure that the survey responses will be representative of the care furnished by the ACO clinicians. In addition, we do not want ACOs to be required to contract with a vendor to administer the survey if there is a high risk that the ACO will not have a sufficient sample size to generate a response rate for the survey that will be sufficient to reliably calculate a score for the CAHPS for MIPS survey. Aligning the minimum sampling thresholds for ACOs with the CAHPS for MIPS minimum sampling thresholds allows for consistency across all entities reporting the CAHPS for MIPS.

Furthermore, we believe applying the CAHPS for MIPS minimum Start Printed Page 39265sampling thresholds does not negatively impact Shared Savings Program ACOs because, as discussed below, only a few ACOs would potentially be impacted by these minimum sampling thresholds. Based on the analysis of proxy data from 2020, nearly all ACOs will fall into the large size classification. That is, they will have 100 or more eligible clinicians that have assigned their billing to TINs participating in the ACO. To quantify the actual number of eligible clinicians associated with each ACO, we used the latest available reassignment and claims data from an internal file that is regularly created twice each performance year to identify the number of individual providers (NPIs) associated with each ACO's participant TINs. We conducted an analysis with proxy ACO sampling frames from 2020 and 44 ACOs fell into the medium size category of 25-99 eligible clinicians, and no ACOs were determined to have fewer than 24 eligible clinicians.

Based on this analysis, we estimate that few ACOs would not be able to administer the CAHPS for MIPS due to sample size. All ACOs classified as medium-sized had more than 860 beneficiaries eligible for sampling. However, based on our analysis, one large-sized ACO would not have been able to administer the CAHPS survey for PY 2020, if we had required ACOs to administer a CAHPS for MIPS survey in performance year 2020 and these sampling rules had applied at that time because the sample size requirements would not have been met. Two additional large-sized ACOs were close to the minimum sampling threshold and would have been at risk for not being able to administer the CAHPS for MIPS survey for performance year 2020. We note that in both cases, these ACOs would have been eligible for CAHPS sampling based on their counts of assigned, quality-eligible [] beneficiaries with 2 visits during the performance year.

However, a large proportion (over 50 percent) of the beneficiaries assigned to these ACOs were residing in nursing homes and institutionalized beneficiaries are excluded from CAHPS for MIPS sampling. Given that the minimum sampling sizes are set to ensure that groups or ACOs receive enough responses to be representative of the care their clinicians provide, we believe it is important that we should not burden ACOs that fall below the thresholds with the cost of hiring a vendor and fielding a CAHPS for MIPS survey that may not produce enough responses to calculate the CAHPS for MIPS score. Accordingly, we will inform any ACO that is at risk of falling below the minimum sampling threshold that it may not have enough beneficiaries to field a CAHPS for MIPS survey prior to the deadline for contracting with a CAHPS for MIPS survey vendor. An ACO that does not meet the minimum sampling threshold to administer the survey will not receive a score for the CAHPS for MIPS survey under the APP. When an ACO fails to meet the sampling threshold and is unable to administer the survey, the ACO's measure set will be scored accordingly, and the number of measures included in the calculation of the ACO's quality performance score will be reduced from 10 to 9 measures or from 6 to 5 measures in the APP for PY 2021.

This means that the denominator used to calculate the quality score will be lower, such that an ACO that falls below the minimum threshold will not be penalized for its inability to administer a CAHPS for MIPS survey. We seek comment on this clarification that the CAHPS for MIPS Minimum Sampling Thresholds also apply to Shared Savings Program ACOs. In section IV.A.3.d. Of this proposed rule, we discuss proposals related to the CAHPS for MIPS survey. In section IV.A.3.d, the term “performance period” is used to describe the time-period over which quality performance is assessed under MIPS, which is a full calendar year (January 1 through December 31) (except as otherwise specified for administrative claims-based measures in the MIPS final list of quality measures).

In contrast, the Shared Savings Program uses the term “performance year” to describe each period for which ACOs' quality performance is assessed. For performance year 2021 and subsequent performance years, the relevant period is also the full calendar year. Therefore, while the terminology used in the Shared Savings Program and MIPS differs, the period of time for which quality performance is assessed under the APP is the same for both programs. C. Amending the Reporting Requirements Under the APM Performance Pathway for Performance Years 2022 and 2023 In the CY 2021 PFS final rule, we finalized a change to the quality reporting requirements for purposes of the Shared Savings Program (85 FR 84720 through 84734).

Effective for performance year 2021 and subsequent performance years, Shared Savings Program ACOs are required to report quality data via the APP. The quality reporting requirements under the Shared Savings Program align with the requirements that apply under the APP under the Quality Payment Program. Under this new approach, ACOs only need to report one set of quality metrics via the APP to satisfy the quality reporting requirements under both the Shared Savings Program and the MIPS. The quality measures reported via the APP for purposes of the MIPS Quality performance category will also be used to determine the quality performance of the ACO for purposes of determining eligibility for shared savings and calculating shared losses, where applicable. We refer readers to Table 40 of the CY 2021 PFS final rule (85 FR 84733) for a list of the measures included in the final APP measure set for performance year 2021.

Under the policies adopted in the CY 2021 PFS final rule. For performance year 2021, ACOs are required to report quality data via the APP, and can choose to actively report either the 10 measures under the CMS Web Interface or the 3 eCQM/MIPS CQM measures. In addition, ACOs are required to field the CAHPS for MIPS survey, and CMS will calculate 2 measures using administrative claims data. For performance year 2022 and subsequent performance years, ACOs are required to actively report quality data on the 3 eCQM/MIPS CQM measures via the APP. In addition, ACOs are required to field the CAHPS for MIPS survey, and CMS will calculate two measures using administrative claims data.

All 6 measures will be included in the calculation of the ACO's quality performance score for purposes of the Shared Savings Program. Our initial proposal in the CY 2021 PFS proposed rule included the removal of the CMS Web Interface collection type and a requirement that ACOs report quality data via the eCQM/MIPS CQM collection type starting in PY 2021. Public comments on our proposal expressed concerns about moving ACOs away from a collection type under which they report quality data on a sample of their assigned Medicare beneficiary population to a collection type that requires ACOs to report quality data on a broader, all-payer population. For example, we received public comments expressing concerns about the increased burden of reporting eCQM/MIPS CQM measures, as ACOs would be responsible for aggregating the data across multiple ACO participant Taxpayer Identification Numbers (TINs) and submitting this data to CMS. In Start Printed Page 39266addition, commenters expressed concerns about the increased cost of modifying existing electronic health record (EHR) technology, obtaining new EHR interfaces and aggregation tools, and updating performance dashboards.

Also, there was concern that vendors and developers would need additional lead time to update and test systems, train staff and configure tools and measurement algorithms to aggregate data at an ACO level, in order to handle the wave of new entities reporting using eCQM/MIPS CQM measures. In the CY 2021 PFS final rule (85 FR 84730), we noted that while the three eCQM/MIPS CQM measures are based on all payer data, we believe they are appropriate for assessing the quality of care furnished by ACOs, as required by section 1899(b)(3) of the Act. These measures focus on the management of chronic health conditions that are a high priority and have high prevalence among Medicare beneficiaries. To the extent that these conditions are also prevalent among other populations of patients that receive services from the eligible clinicians participating in an ACO, we believe it is relevant to consider the quality of care that is furnished by ACO participants across all of their patients as part of assessing the overall quality of care furnished by the ACO. We also noted that measuring care delivery to all patients is appropriate because improving care processes and practices is expected to improve care for all patients (for example, improvements to an electronic health record would be expected to improve care for all patients, not just Medicare patients).

Additionally, we explained that CMS would not want ACOs participating in the Shared Savings Program to improve care for Medicare beneficiaries by reducing care quality for non-Medicare beneficiaries. Thus, looking at the overall quality of care furnished to all patients is consistent with the goal of improving care furnished by ACOs, by ensuring that care delivery is improving across all patients, rather than encouraging ACOs to focus disproportionately on improving measure performance for Medicare beneficiaries. However, in light of the concerns raised during the public comment period for the CY 2021 PFS proposed rule, in the CY 2021 PFS final rule, we decided to extend the use of the CMS Web Interface as a collection type under the APP for performance year 2021. We believed that this additional year would allow ACOs the time needed to make the necessary changes to begin reporting quality data via eCQMs/MIPS CQMs. Since the CY 2021 PFS final rule was issued, stakeholders have continued to express concerns about requiring ACOs to report eCQMs/MIPS CQMs via the APP, due to the cost of purchasing and implementing a system wide infrastructure to aggregate data from multiple ACO participant TINs and varying EHR systems.

We note that for performance years beginning on or after January 1, 2019, ACOs are required to certify that they meet the CEHRT use requirements as specified at § 425.506(f). Specifically, ACOs in a track that. Does not meet the financial risk standard to be an Advanced APM must certify that the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds 50 percent. Or Meets the financial risk standard to be an Advanced APM must certify that the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the threshold established under § 414.1415(a)(1)(i). We define CEHRT for purposes of the Shared Savings Program at § 425.20 and the term has the same meaning as provided under § 414.1305 for purposes of the Quality Payment Program.

For 2019 and subsequent years, CEHRT is defined to mean EHR technology that meets the 2015 Edition Base EHR definition and that has been certified to the 2015 Edition health IT certification criteria necessary to report on applicable objectives and measures specified for the MIPS Promoting Interoperability performance category and includes clinical quality measure certification criteria that support the calculation and reporting of clinical quality measures that can be electronically accepted by CMS. Health IT certified to clinical quality measure certification criteria can help to support ACOs' efforts to meet quality measure reporting requirements. According to a recent National Association of Accountable Care Organizations (NAACOS) survey [] regarding the readiness of ACOs to report eCQM/MIPS CQM data, NAACOS noted that 77 percent of respondents indicated they do not have the infrastructure in place to aggregate data on behalf of their ACO participant TINs on quality performance across all payers starting in 2022. On average, an ACO has 36 ACO participant TINs and the largest Shared Savings Program ACO has 436 ACO participant TINs. The NAACOS survey also noted that almost 40 percent of ACOs have more than 15 EHR systems.

Additionally, stakeholders have raised privacy and other concerns about reporting eCQMs/MIPS CQMs on all-payer populations, rather than a sample of assigned Medicare beneficiaries, as required for the CMS web interface measures. These concerns focus on perceived HIPAA Privacy Rule limitations on sharing protected health information (PHI) for non-Medicare beneficiaries with an ACO. Furthermore, we have heard concerns from ACOs that are acting as business associates of their health care provider ACO participants regarding their ability to update their business associate agreements (BAAs) to include the PHI of patients who are not covered by Medicare. Stakeholders have indicated that current agreements may only address sharing the PHI of Medicare beneficiaries. Therefore, they have raised concerns that reporting all payer eCQMs would violate their BAAs as well as the HIPAA Privacy Rule business associate requirements at 45 CFR 164.502(a) and 164.504(e).

To report eCQMs successfully, health care providers must adhere to the requirements identified by the CMS quality program in which they intend to participate. For purposes of reporting eCQMs/MIPS CQMs under MIPS, clinicians are expressly required under § 414.1340(a) to submit data on the applicable percentage of patients that meet the measure's denominator criteria, regardless of payer. Under § 414.1380(b)(1)(i)(B)(1)(iii), failure to meet this requirement may result in the clinician receiving zero points for the measure, which may adversely impact their MIPS final score and payment adjustment. As such, we believe the disclosure of all-payer data to CMS as required by § 414.1340(a) would be permitted by the HIPAA Privacy Rule under the provision that permits disclosures of PHI as “required by law.” [] Under this provision, a HIPAA covered entity, or its business associate when authorized by its BAA, may use or disclose PHI to the extent that such use or disclosure is required by law and the use or disclosure complies with and is limited to the relevant requirements of such law. We note that the HIPAA Privacy Rule minimum necessary Start Printed Page 39267standard does not apply to uses or disclosures that are required by law.[] Furthermore, the HIPAA Privacy Rule generally permits a covered entity to disclose PHI to a business associate and to allow a business associate to create, receive, maintain, or transmit PHI on its behalf, provided that the parties have a BAA that meets the requirements of 45 CFR 164.504(e) and permits the business associate to use or disclose PHI only as permitted or required by its BAA or as required by law.

The BAA must, among other things, establish the permitted and required uses and disclosures of PHI by the business associate. ACO providers and suppliers that are MIPS eligible clinicians will need to review and update any relevant BAAs as necessary to include the disclosure of all-payer data, in addition to data for Medicare beneficiaries to the ACO. We believe that ACO providers/suppliers should be able to update those agreements, in consultation with their legal counsel as necessary, to reflect the need to share data for patients covered by all payers with the ACO, in order to permit the ACO to completely and accurately report data on eCQM/MIPS CQM measures consistent with the MIPS reporting requirements. In addition, we want to correct a statement from the CY 2021 PFS final rule (85 FR 84730). In that final rule, we provided an example of how an ACO could aggregate eCQM measure data.

In this example, we stated that an ACO could, on behalf of its ACO participants, combine the results from all the ACO participant TIN QRDA 3 files, by adding numerators, denominators, etc. And create an aggregate QRDA 3 file (or other compliant file format) and submit as an ACO to CMS. However, this example did not take into account the potential for duplicate patients for a given measure across the ACO participant TINs within an ACO. It also did not take into account that two of the three eCQMs require that the most recent blood pressure or HgbA1c be captured to assess performance for those measures. Accordingly, we want to clarify that an ACO that submits eCQM quality data to CMS must de-duplicate the patient level measures data across its ACO providers/suppliers to ensure that the aggregated QRDA 3 file that is submitted to CMS incorporates only quality data that meets the intent of the measure.

Based on the feedback we received, we are convinced that ACOs and their ACO participants, Health IT vendors, and developers need additional time to prepare for reporting all-payer eCQM/MIPS CQM measures. We believe the updates we are proposing to the reporting requirements under the APP are responsive to stakeholder requests to delay the requirement that ACOs report all-payer eCQM/MIPS CQM measures, while still providing incentives for ACOs that are ready report to eCQM/MIPS CQM measures. As discussed in section IV.A.3.d.(1)(d) of this proposed rule, we are proposing to extend the CMS Web Interface as a collection type for the Quality Payment Program for PY 2022 for MIPS Groups, Virtual groups, and Shared Savings Program ACOs reporting under the APP. For PY 2023, we are proposing that the CMS Web Interface would be a collection type under the APP only for Shared Savings Program ACOs. Accordingly, we are proposing to modify the quality measure set that must be reported by Shared Savings Program ACOs under the APP, as discussed in this section and section IV.A.3.c.(2)(a) of this proposed rule.

To further address stakeholder feedback about ACOs' readiness to report all-payer measures, and in particular the concerns regarding aggregation of eCQM/MIPS CQM data across multiple ACO participant TINs using multiple different electronic health record (EHR) technology, while also providing incentives for ACOs to take the steps necessary to report all-payer measures, we are proposing that. For performance year 2022. An ACO would be required to report on either. ++ The ten CMS Web Interface measures and administer a CAHPS for MIPS survey and CMS would calculate the two claims based measures included under the APP, or ++ The three eCQM/MIPS CQM measures and administer a CAHPS for MIPS survey and CMS would calculate the two claims based measures included under the APP. If an ACO selects this option, meets the data completeness requirement at § 414.1340 and the case minimum requirement at § 414.1380 for all three eCQM/MIPS CQM measures, and achieves a quality performance score equivalent to or higher than the 30th percentile of the performance benchmark on at least one measure in the APP measure set, the ACO would meet the quality performance standard used to determine eligibility for shared savings and to avoid maximum shared losses, if applicable, for that performance year.

We believe that allowing ACOs that report eCQM/MIPS CQM measures to meet the quality performance standard if they achieve a score that is equivalent to or higher than the 30th percentile benchmark on one measure in the APP measure set would provide an incentive to ACOs to report the eCQM/MIPS CQM measures, while allowing them time to gauge their performance on the eCQM/MIPS CQM measures before full reporting of these measures is required beginning in PY 2024. If an ACO chooses this option, its performance on all three eCQM/MIPS CQM measures would be used for purposes of MIPS scoring under the APP. If an ACO decides to report both the ten CMS Web Interface measures and the three eCQM/MIPS CQM measures, it will receive the higher of the two quality scores for purposes of the MIPS Quality performance category. Please note, as indicated in Tables 25 and 40, three of the CMS Web Interface measures (Statin Therapy for the Prevention and Treatment of Cardiovascular Disease (Quality ID# 438). Depression Remission at Twelve Months (Quality ID# 370), and Preventive Care and Screening.

Tobacco Cessation. Screening and Cessation Intervention (Quality ID# 236)) do not have benchmarks for performance year 2022, and therefore, will not be scored. However, these measures are required to be reported in order to complete the CMS Web Interface dataset. Based on the ACO's chosen reporting option, either 6 (three eCQMs/MIPS CQMs + two claims based measures + CAHPS for MIPs Survey measure) or 10 measures (seven CMS Web Interface measures + two claims based measures + CAHPS for MIPS Survey measure) will be included in the calculation of the ACO's quality performance score. If an ACO does not report any of the ten CMS Web Interface measures or any of the three eCQM/MIPS CQM measures and does not administer a CAHPS for MIPS survey under the APP, the ACO will not meet the quality performance standard.

For performance year 2023. The ACO would be required to report on either. ++ The ten CMS Web Interface measures, at least one eCQM/MIPS CQM measure, and administer a CAHPS for MIPS survey and CMS would calculate the two claims-based measures included under the APP or ++ The three eCQM/MIPS CQM measures and administer a CAHPS for MIPS survey and CMS would calculate the two claims based measures included under the APP. If an ACO selects this option, meets the data completeness requirement at § 414.1340 and the case minimum requirement at § 414.1380 for all three eCQM/MIPS CQM measures, and achieves a quality performance score equivalent to or higher than the 30th percentile of the performance benchmark on at least one measure in Start Printed Page 39268the APP measure set, the ACO would meet the quality performance standard used to determine eligibility for shared savings and to avoid maximum shared losses, if applicable, for that performance year. If an ACO chooses this option, its performance on all three eCQM/MIPS CQM measures would be used for purposes of MIPS scoring under the APP.

If an ACO decides to report both the ten CMS Web Interface measures and the three eCQM/MIPS CQM measures, it will receive the higher of the two quality scores for purposes of the MIPS Quality performance category. If an ACO does not report at least one eCQM/MIPS CQM measure in the APP measure set, the ACO would not meet the quality performance standard. For performance year 2024 and subsequent performance years. The ACO would be required to report the three eCQM/MIPS CQM measures and administer a CAHPS for MIPS survey and CMS would calculate the two claims based measures included under the APP. If an ACO does not report any of the three eCQM/MIPS CQM measures and does not administer a CAHPS for MIPS survey under the APP, the ACO would not meet the quality performance standard.

Finally, for the first performance year of an ACO's first agreement period under the Shared Savings Program, if the ACO meets MIPS data completeness and case minimum requirements we are proposing that the ACO would meet the quality performance standard, if. For performance year 2022. The ACO reports the ten CMS Web Interface measures or the three eCQM/MIPS CQM measures and administers a CAHPS for MIPS survey under the APP. For performance year 2023. The ACO reports the ten CMS Web Interface measures and at least one eCQM/MIPS CQM measure or reports the three eCQM/MIPS CQM measures, and administers a CAHPS for MIPS survey under the APP.

For performance year 2024 and subsequent performance years. The ACO reports on the three eCQM/MIPS CQM measures and administers a CAHPS for MIPS survey under the APP. The proposed changes are summarized in Table 24. We are proposing changes to the regulation at § 425.512(a) to reflect these changes to the quality reporting requirements for performance years 2022 and 2023. We note that as part of these proposed changes, we are also proposing to update the provision at § 425.512(a)(2), which applies to new ACOs that are in the first performance year of their first agreement under the Shared Savings Program and are able to meet the quality performance standard under the Shared Savings if they completely and accurately report all required measures via the APP, to reflect the proposed changes to the quality reporting requirements for performance years 2022 and 2023.

Start Printed Page 39269 We seek comment on these proposed updates to the reporting requirements under the APP for performance year 2022 and subsequent years. In addition, we are seeking comment on whether we should extend the CMS Web Interface collection type for more than the 2 years proposed above. We believe the proposed 2-year extension would provide sufficient time to allow ACOs and their ACO participants to take the necessary steps to address the concerns raised by stakeholders, but are interested in hearing if stakeholders believe additional time would be needed to enable ACOs and their ACO participants to prepare for eCQM/MIPS CQM reporting. (1) Solicitation of Comments on Addressing Health Disparities and Promoting Health Equity We note that we continue to believe the move to eCQM/MIPS CQM measures is the appropriate next step for ACO quality measurement. For many years, ACOs have only reported on a sample of their assigned Medicare beneficiary population, as the CMS Web Interface Start Printed Page 39270only requires that ACOs report on 248 consecutively ranked beneficiaries for each measure in the CMS Web Interface measure set.

As we move forward with reporting under the APP and increasing the quality performance standard as described above, we believe that looking at the overall quality of care furnished to all patients is consistent with the goal of improving care furnished by ACOs by ensuring that care delivery is improving across all patients, rather than encouraging ACOs to focus disproportionately on improving measure performance for Medicare beneficiaries. We also believe that assessing Shared Savings Program ACO quality performance on a broader population can have a positive impact on the quality of care for all groups, including Medicare beneficiaries. We also expect the transition to all-payer eCQM/MIPS CQM measures will help to address health disparities and promote health equity by promoting a single standard of care across all patients receiving care from practices participating in Shared Savings Program ACOs regardless of location or racial/ethnic group. However, we are seeking comments and recommendations on how ACOs can utilize their resources to ensure that patients, regardless of racial/ethnic group, geographic location and/or income status, have access to equal care and how ACOs can improve the quality of care provided to certain communities, while addressing the disparities that currently exist in healthcare. We are also seeking comments and recommendations on how we can encourage health care providers serving vulnerable populations to participate in ACOs and other value-based care initiatives, including whether any adjustments should be made to quality measure benchmarks to take into account ACOs serving vulnerable populations.

(2) Solicitation of Comments on Feasibility of TIN Level Reporting and Sampling for eCQMs/MIPS CQMs To assist ACOs in reporting eCQM/MIPS CQM measures and to address concerns regarding data aggregation across multiple TINs with multiple different EHR systems, we are seeking comment on allowing ACO providers/suppliers to submit eCQMs/MIPS CQM measures to CMS at the ACO participant TIN level. CMS would then calculate/aggregate the TIN level quality data to create an ACO level score. For example, CMS could calculate the average of the decile scores for each measure for each TIN within the ACO to create an aggregate measure level score for the ACO. Alternatively, CMS could calculate an ACO-level numerator for each measure (sum of performance met across TINs within the ACO) and an ACO-level denominator (sum of the met and performance not met across TINs within the ACO), then divide the two—numerator/denominator × 100—to obtain the ACO-level performance rate. We seek comment on these two potential approaches as well as any other suggested approaches to the aggregation of ACO participant TIN level quality data at the ACO level.

While we continue to believe that reporting on all-payer data is important to improve the quality of care furnished to all patients, including Medicare beneficiaries, we have heard from stakeholders that CMS should allow ACOs to report the eCQM/MIPS CQM measures for a smaller, more defined beneficiary population rather than the all-payer population, to serve as an intermediary step to reporting on all patients. Thus, while we believe that the move to all-payer measures is the next step in quality reporting, we acknowledge that the denominator of patients for a given quality measure for an ACO may be significantly higher, depending on ACO size and composition, than for MIPS groups. Therefore, we seek comment on how stakeholders would envision CMS determining an appropriate beneficiary population. For example, should ACOs report on a small sample size similar to the sample size for the CMS Web Interface?. Should CMS broaden the beneficiary sample to include all assigned beneficiaries that meet the denominator for a given measure?.

Should CMS provide ACOs with a bigger sample size, larger than the size that has historically been used for CMS Web Interface but smaller than all the assigned beneficiaries that meet the denominator for a given measure?. Or should CMS develop ACO-level eCQM/MIPS CQM measure sampling specifications?. We seek comment on whether CMS should create a specific sampling methodology for ACOs, alternate sampling methodologies that could be used, as well as phase-in and tiered implementation strategies. (3) Comment Solicitation for Reporting Options for Specialist Providers Within an ACO We have also heard from stakeholders that the population health/primary care focused measures in the APP are not applicable for specialist providers within an ACO. In order to address measure applicability for specialist providers, we are seeking comment on allowing ACO participant TINs to report either the eCQM/MIPS CQM measures in the APP measure set at the TIN level or the applicable MIPS Value Pathways, including how APP and MIPS Value Pathway data reported at the ACO participant TIN level could be aggregated in order to assess ACO quality performance.

In addition, we seek input on the role specialists play in ACOs and what specialty measures in the current eCQM or MIPS CQM measure set should be considered for inclusion in the Shared Savings Program quality measure set in future performance years. Alternatively, how could the existing APP measure set be used or modified to reinforce the role of specialists in ACO population health strategies?. (4) Updates to the APM Performance Pathway (APP) Measure Set In section IV.A.3.(c) of this proposed rule, we are proposing to replace the Risk-Standardized, All-Cause Unplanned Admissions for Multiple Chronic Conditions for ACOs (MCC for ACOs measure) with the Risk Standardized, All-Cause Unplanned Admissions for Multiple Chronic Conditions for MIPS (MCC for MIPS measure) for performance year 2022. We are proposing to remove the MCC for ACOs measure from the APP measure set in order to reduce the potential for confusion around performance scores and feedback for MIPS eligible clinicians who might otherwise have been scored on both measures with differing results. This proposed change would continue the transition towards alignment of the quality measures reported by MIPS eligible clinicians who are not participants in APMs, such as the Shared Savings Program, and those who are, as discussed in the CY 2021 PFS final rule (85 FR 84720).

For a detailed description of this proposal refer to section IV.A.3.(c) of this proposed rule. By removing the MCC for ACOs measure and aligning the quality measure set for the Shared Savings Program with MIPS, we would have the opportunity to align quality measurement between CMS programs. In addition, given that the Hospital-Wide, 30-day, All-Cause Unplanned Readmission (HWR) Rate for MIPS Eligible Clinician Groups measure calculated as part of the APP looks at an ACO's all Medicare population rather than just the ACO's assigned beneficiary population, we believe the proposal to move to the MCC for MIPS measure would be consistent with the approach under the APP of assessing, measuring and improving quality of care across a broader population of patients. Further details on the specifications for the MCC Start Printed Page 39271for MIPS measure can be found in Table A-5 in Appendix A of this proposed rule. Please see Table 25 for the proposed APP measure set that would be reported by Shared Savings Program ACOs for PY 2022 and subsequent performance years.

d. Shared Savings Program Quality Performance Standard (1) Proposal To Freeze the Quality Performance Standard at the 30th Percentile of All MIPS Quality Performance Category Scores for Performance Year 2023 The quality performance standard is the minimum performance level ACOs must achieve in order to be eligible to share in any savings earned, avoid maximum shared losses under certain payment tracks, and avoid quality-related compliance actions. As noted above, in the CY 2021 PFS final rule we finalized a gradual phase in of the revised quality performance standard. Specifically, an ACO would meet the quality performance standard if:Start Printed Page 39272 For performance years 2021 and 2022, the ACO achieves a quality performance score that is equivalent to or higher than the 30th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring. And For performance year 2023 and subsequent performance years, the ACO achieves a quality performance score that is equivalent to or higher than the 40th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring (85 FR 84735).

We finalized this phase-in approach to address the concerns raised by commenters about the limited time for ACOs to gain familiarity with the new quality reporting requirements under the APP and potential challenges in meeting the new quality performance standard, as well as concerns regarding the shift from a domain-based scoring approach to the original proposal to require an ACO to achieve an overall quality score equivalent to the 40th percentile across all MIPS quality performance category scores starting in PY 2021. In conjunction with the decision to phase-in the quality performance standard, we also adopted a phase-in of the reporting requirements under the APP for Shared Savings Program ACOs, as described previously. In the CY 2021 PFS final rule, we also discussed the potential impact of the final policies on ACO quality performance. We projected that, absent an improvement in quality performance by ACOs, roughly 1-in-5 ACOs, or approximately 20 percent of ACOs, could fall below the 40th percentile MIPS Quality performance category score by performance year 2023, and would not be eligible to share in savings or would owe maximum shared losses, if applicable (85 FR 85007 through 85008). For the CY 2021 rulemaking we conducted analysis, in order to understand better how well ACOs might perform once the CMS Web Interface is no longer an available collection type.

The analysis simulated ACO performance on eCQM or MIPS CQM measures, using 2018 and 2019 quality data submitted via the CMS Web Interface. Based on the analysis of the 2018 and 2019 data there were two differing estimates of the number of ACOs that would not meet the quality performance standard. The estimated percent of Shared Savings Program ACOs falling below the 40th percentile MIPS Quality performance category score was 6.5 percent based on a simulation using 2018 data and 22.9 percent based on a simulation using 2019 data. In the CY 2021 PFS final rule, we indicated that we would continue to monitor emerging performance to determine the impact of a measured increase to the quality performance standard. We stated that we might revisit the policy in future rulemaking in order to promote an attainable standard and degree of improvement based on initial performance under the new methodology (85 FR 85008).

If our proposal to extend the availability of the CMS Web Interface as a reporting mechanism under the APP is finalized, performance year 2024 would be the first year that all ACOs would be required to report all three eCQM/MIPS CQM measures and would have no option to report data via the CMS Web Interface, with data submission beginning in 2025. However, we have heard from some ACOs that they are beginning to update their systems and workflows to further develop their capacity for reporting on the eCQM/MIPS CQM measure set in performance year 2022. These ACOs are gearing up for all-payer reporting and are performing self-tests in order to understand their performance on the 3 eCQM/MIPS CQM measures. It is also important to note that some ACOs will likely report on eCQM/MIPS CQM measures beginning with the 2021 performance year. Therefore, there is an opportunity for ACOs to gain some familiarity with meeting the requirements for these measures starting in performance year 2021.

Even with all of these contingencies in place and our proposals to phase-in reporting of the eCQM/MIPS CQM measures, we still recognize that transitioning to eCQM/MIPS CQM quality data reporting and aggregation may come with unforeseen data collection and/or system operational issues. Therefore, we have concluded that it would be appropriate to freeze the quality performance at the 30th percentile MIPS Quality performance category score for an additional year. And to raise the quality performance standard in conjunction with the transition to reporting of the three eCQM/MIPS CQMs measures by all ACOs in PY 2024. Although this increase in the quality performance standard to the 40th percentile would coincide with the first full year of eCQM/MIPS CQM quality reporting, we believe our proposal to extend the CMS Web Interface for an additional 2 years and to allow for a gradual phase in of reporting the three eCQMs/MIPS CQMs is responsive to stakeholder concerns related to the transition to eCQM/MIPS CQM measures and the need for data aggregation and would provide time for both ACOs and EHR vendors to put in place processes and systems, such that ACOs will be well positioned to report eCQM/MIPS CQMs by performance year 2024. As discussed earlier in this proposed rule, as part of this gradual phase-in to full reporting of eCQMs/MIPS CQMs, we are proposing to include incentives to encourage early adoption of full eCQM/MIPS CQM reporting prior to performance year 2024.

As part of the phase-in, and in order to transition ACOs to reporting all-payer eCQM/MIPS CQM measures, for performance year 2023 we would require an ACO to report at least one eCQM/MIPS CQM measure (that meets data completeness and case minimum requirements) in addition to the CMS Web Interface measures in order to meet the quality performance standard. In addition, we are also proposing for both performance year 2022 and performance year 2023 that ACOs that elect to report all three eCQM/MIPS CQM measures and meet the data completeness requirement and case minimum requirement for all three measures would meet the quality performance standard if they achieve a quality performance score equivalent to or higher than the 30th percentile of the performance benchmark on at least one measure in the APP measure set. We believe that our proposal to freeze the quality performance standard at the 30th percentile for an additional year, is consistent with the requirement in the statute that CMS increase the quality performance standard overtime. There are two ways to increase the quality performance standard. (1) By increasing the threshold for the quality performance standard, and (2) by moving to all payer measure populations that ACOs are required to report for purposes of Shared Savings Program quality.

In this proposed rule, we are proposing to do both by requiring that ACOs begin the transition to reporting all-payer measures before increasing the quality performance standard starting in performance year 2024. Therefore, we propose to freeze the quality performance standard at the 30th percentile MIPS Quality performance category score for PY 2023, and to establish incentives to encourage ACOs to begin the transition to eCQM/MIPS CQM measure reporting in PY 2022 and PY 2022. This would mean that for all Shared Savings Program ACOs, CMS would designate the quality performance standard as the ACO reporting via the APP established under § 414.1367 of this chapter and for. Performance year 2022, if an ACO reports:Start Printed Page 39273 ++ The 10 CMS Web Interface measures and achieves a quality performance score that is equivalent to or higher than the 30th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, or ++ The three eCQM/MIPS CQM measures, meeting the data completeness requirement at § 414.1340 of this chapter and case minimum requirement at § 414.1380 of this chapter for all three measures, and achieves a quality performance score equivalent to or higher than the 30th percentile of the performance benchmark on at least one measure in the APP measure set. If the ACO does not report any of the 10 CMS Web Interface measures or any of the three eCQM/MIPS CQM measures and does not administer a CAHPS for MIPS survey, the ACO would not meet the quality performance standard.

Performance year 2023, if an ACO reports. ++ The 10 CMS Web Interface measures and at least one eCQM/MIPS CQM measure, and achieves a quality performance score that is equivalent to or higher than the 30th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, or ++ The three eCQM/MIPS CQM measures, meeting the data completeness requirement at § 414.1340 of this chapter and case minimum requirement at § 414.1380 of this chapter for all three measures, and achieves a quality performance score equivalent to or higher than the 30th percentile of the performance benchmark on at least one measure in the APP measure set. If the ACO does not report at least one eCQM/MIPS CQM, the ACO would not meet the quality performance standard. Our proposal to extend the CMS Web Interface collection type and phase-in the reporting of the eCQMs/MIPS CQMs provides the transition time that stakeholders have requested in order to be ready to submit aggregated data on eCQMs/MIPS CQMs. We believe that the transition to the all-payer eCQM/MIPS CQM measures is the future of Shared Savings Program quality performance assessment and that ACOs are well-positioned to impact the quality of care across an all-payer population not just the Medicare population given their redesigned care processes and quality improvement activities.

Ultimately, we believe that the transition time afforded ACOs by extending the availability of the CMS Web Interface as a collection type, in conjunction with the incentives to encourage early adoption of eCQM/MIPS CQM reporting, should allow ACOs to prepare for full reporting of eCQMs/MIPS CQMs as well as the incremental increase in the quality performance standard to the 40th percentile of MIPS Quality performance category score in PY 2024. Accordingly, we are proposing that for PY 2024 and all subsequent performance years, CMS would designate the quality performance standard for all Shared Savings Program ACOs, with the exception of ACOs in the first performance year of their first agreement period under the Shared Savings Program, as the ACO reporting quality data via the APP established under § 414.1367 according to the method of submission established by CMS and achieving a quality performance score that is equivalent to or higher than the 40th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring. We also propose to revise the regulation at § 425.512 to reflect the extended phase-in of the ACO quality performance standard. As we explained in the CY 2021 PFS final rule, this approach to phasing in the new, higher quality performance standard is consistent with the statutory requirement in section 1899(b)(3)(C) of the Act, which requires the Secretary to establish quality performance standards to assess the quality of care furnished by ACOs and to seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures or both for purposes of assessing such quality of care. We believe that even though we are proposing to freeze the quality performance standard at the 30th percentile MIPS Quality performance category score for an additional year, we will still be holding ACOs to a higher standard than the previous quality standard, which merely required ACOs to achieve the 30th percentile relative to national benchmarks on one measure in each domain.

We recognize the change from the CMS Web Interface collection type to the eCQM or MIPS CQM collection type, coupled with this higher quality performance standard, adds complexity for ACOs as they may need to utilize new approaches to combining data across EHR systems to allow for a new data submission type, as well as aggregating ACO participant data for submission to CMS. However, we believe that with this proposal to delay the increase in the quality performance standard, coupled with the proposal to extend the CMS Web Interface through PY2023, with incentives for e early adoption of eCQM/MIPS CQM reporting, ACOs will have ample time to prepare for the transition to full eCQM/MIPS CQM reporting in PY 2024 and the incremental increase in the quality performance standard to the 40th percentile MIPS Quality performance category score. We also believe this proposed timeline for phasing in the new quality performance requirements under the Shared Savings Program would signal to ACOs, EHR vendors, and other stakeholders that eCQM/MIPS CQM reporting is the path forward for the Shared Savings Program and clearly establish the standard that ACOs would need to achieve in order to be eligible to share in maximum savings and avoid owing the maximum shared losses, if applicable. We also considered the possibility of extending the freeze of the Shared Savings Program quality performance standard at the 30th percentile MIPS Quality performance category score for performance year 2024. This alternative would delay the incremental increase in the quality performance standard until all ACOs have at least one year of experience in reporting data for all three eCQM/MIPS CQM measures.

This delay would allow ACOs additional time to gain experience reporting on the eCQM/MIPS CQM measures and also provide CMS with more information on ACO performance on all-payer measures and the ability of ACOs to aggregate data across multiple EHR systems and multiple practices, in order to inform the quality performance standard in outlying years. However, for the reasons described previously, we believe the timeline we are proposing for phasing in the new quality reporting and quality performance requirements will provide ample time for ACOs to prepare to meet these new requirements while also satisfying the statutory requirement that we seek to improve the quality of care furnished by ACOs over time. We seek comment on our proposal to freeze the Shared Savings Program quality performance standard at the 30th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring for PY 2023 and to increase the quality performance standard to the 40th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring starting in PY 2024. In addition, we seek comment on the alternative of freezing the Shared Savings Program quality performance standard at the 30th percentile across all MIPS Quality Start Printed Page 39274performance category scores, excluding entities/providers eligible for facility-based scoring for PYs 2023 and 2024. (2) Comment Solicitation on Publicly Displaying Prior Year Performance Scores That Equate to the 30th or 40th Percentile Across MIPS Quality Performance Category Scores Stakeholders have expressed concerns regarding the lack of information on the level of quality performance that would equate to the 30th or 40th percentile MIPS Quality performance category score and that would enable an ACO to be eligible to share in savings or to avoid maximum shared losses, if applicable.

These stakeholders have expressed concern that these data are not publicly available prior to the start of a performance year and that they do not believe that ACOs have a way of determining what quality score they would need to achieve to meet the quality performance standard. For a given performance year, the 30th or 40th percentile MIPS Quality performance category score is calculated based on the distribution across all MIPS Quality performance category scores, excluding entities/providers eligible for scoring for facility-based scoring, only once MIPS final scoring is complete. Therefore, there is no information that can be provided prior to or during the performance year. However, we note that for performance year 2018 the MIPS Quality performance category score at the 30th percentile was equivalent to 83.9 and the MIPS Quality performance category score at the 40th percentile was equivalent to 93.3. For performance year 2019 the MIPS Quality performance category score at 30th percentile was equivalent to 87.9 and the MIPS Quality performance category score at the 40th percentile was equivalent to 95.7.

We seek comment on whether publicly displaying prior year performance scores that equate to the 30th or 40th MIPS Quality performance category scores would help to address ACOs' concerns regarding the lack of advance information regarding the quality performance score they must meet in order to satisfy the quality performance standard under the Shared Savings Program. We also seek comment on other ways we could address these concerns. E. Revisions to the Extreme and Uncontrollable Circumstances Policy In the CY 2021 PFS final rule (85 FR 84744 through 84747), we updated the extreme and uncontrollable circumstances policy for performance year 2021 and subsequent performance years to align with the gradual phase in of the revised quality performance standard. Specifically, we finalized that for.

PY 2021 and PY 2022, the minimum quality performance score for an ACO affected by an extreme and uncontrollable circumstance during the performance year, including the applicable quality data reporting period for the performance year, will be set equal to the 30th percentile MIPS Quality performance category score. If the ACO is able to report quality data and meets the MIPS data completeness and case minimum requirements, we will use the higher of the ACO's quality performance score or the 30th percentile MIPS Quality performance category score. If an ACO is unable to report quality data and meet the MIPS Quality data completeness and case minimum requirements due to an extreme and uncontrollable circumstance, we will apply the 30th percentile MIPS Quality performance category score. PY 2023, the minimum quality performance score for an ACO affected by an extreme and uncontrollable circumstance during the performance year, including the applicable quality data reporting period for the performance year, will be set equal to the 40th percentile MIPS Quality performance category score. If the ACO is able to report quality data and meets the MIPS data completeness and case minimum requirements, we will use the higher of the ACO's quality performance score or the 40th percentile MIPS Quality performance category score.

If an ACO is unable to report quality data and meet the MIPS Quality data completeness and case minimum requirements due to an extreme and uncontrollable circumstance, we will apply the 40th percentile MIPS Quality performance category score (85 FR 84746). As discussed in section III.J.1.d. Of this proposed rule, we are proposing to make changes to the quality performance standard for Shared Savings Program ACOs by freezing the quality performance standard at the 30th percentile for PY 2023. Therefore, we are also proposing to update the extreme and uncontrollable circumstances policy under the Shared Savings Program consistent with the proposal in section III.J.1.d. Of this proposed rule.

Specifically, we propose to set the minimum quality performance score for an ACO affected by an extreme and uncontrollable circumstance during performance year 2023, including the applicable quality data reporting period for the performance year, to equal the 30th percentile MIPS Quality performance category score across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, for the relevant performance year. For performance years 2021 and 2022, if the ACO is able to report quality data via the APP and meets the MIPS data completeness and case minimum requirements, we would use the higher of the ACO's MIPS Quality performance category score or the 30th percentile MIPS Quality performance category score. If the ACO is unable to report quality data and meet the MIPS Quality data completeness and case minimum requirements due to an extreme and uncontrollable circumstance, we would apply the 30th percentile MIPS Quality performance category score. For performance year 2023, if the ACO is able to report quality data via the APP, including at least one eCQM/MIPS CQM measure, and meets data completeness and case minimum requirements, CMS will use the higher of the ACO's quality performance score or the equivalent of the 30th percentile MIPS Quality performance category score. If the ACO is unable to report quality data and meet the MIPS Quality data completeness and case minimum requirements due to an extreme and uncontrollable circumstance, we would apply the 30th percentile MIPS Quality performance category score.

Similarly, we propose that for performance year 2024 and subsequent years, the minimum quality performance score for an ACO affected by an extreme and uncontrollable circumstance during the performance year, including the applicable quality data reporting period for the performance year, would be set equal to the 40th percentile MIPS Quality performance category score across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, for the relevant performance year. If the ACO is able to report quality data via the APP and meets the MIPS data completeness and case minimum requirements, we would use the higher of the ACO's MIPS Quality performance category score or the 40th percentile MIPS Quality performance category score. If the ACO is unable to report quality data and meet the MIPS Quality data completeness and case minimum requirements due to an extreme and uncontrollable circumstance, we would apply the 40th percentile MIPS Quality performance category score. We believe these proposed updates are appropriate to align with the proposed changes to the quality performance standard in section III.J.1.d. Of this proposed rule, and would also allow impacted ACOs to be Start Printed Page 39275eligible to share in savings at their maximum sharing rate or to avoid maximum shared losses, if applicable.

We also propose to make conforming changes to the Shared Savings Program regulations at § 425.512(b) to reflect these proposed revisions to the extreme and uncontrollable circumstances policy. We seek comment on these proposed revisions to the extreme and uncontrollable circumstances policy. 2. Revisions to the Definition of Primary Care Services Used in Shared Savings Program Beneficiary Assignment a. Background Section 1899(c)(1) of the Act, as amended by the CURES Act and the Bipartisan Budget Act of 2018, provides that for performance years beginning on or after January 1, 2019, the Secretary shall assign beneficiaries to an ACO based on their utilization of primary care services provided by a physician who is an ACO professional and all services furnished by Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).

However, the statute does not specify a list of services considered to be primary care services for purposes of beneficiary assignment. In the November 2011 final rule (76 FR 67853), we established the initial list of services, identified by Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes, that we considered to be primary care services. In that final rule, we indicated that we intended to monitor CPT and HCPCS codes and would consider making changes to the definition of primary care services to add or delete codes used to identify primary care services, if there were sufficient evidence that revisions were warranted. We have updated the list of primary care service codes in subsequent rulemaking to reflect additions or modifications to the codes that have been recognized for payment under the Medicare PFS and to incorporate other changes to the definition of primary care services for purposes of the Shared Savings Program. In the June 2015 final rule (80 FR 32746 through 32748), we expanded the definition of primary care services to include two transitional care management (TCM) codes (CPT codes 99495 and 99496), and one chronic care management (CCM) code (CPT code 99490).

As discussed in the final rule, the TCM codes were established to pay a patient's physician or practitioner to coordinate the patient's care in the 30 days following a hospital or SNF stay. Including these codes in the definition of primary care services reflects our belief that the work of community physicians and practitioners in managing a patient's care following discharge from a hospital or nursing facility (NF) to ensure better continuity of care for these patients and help reduce avoidable readmissions is a key aspect of primary care. In the CY 2016 PFS final rule (80 FR 71270 through 71273), we revised the definition of primary care services to exclude services billed under CPT codes 99304 through 99318, containing the place of service 31 modifier specifying that the service was furnished in a skilled nursing facility (SNF). We also revised the definition of primary care services to include claims submitted by Electing Teaching Amendment (ETA) hospitals. In the CY 2018 PFS final rule (82 FR 53212 and 53213), we revised the definition of primary care services to include three additional CCM service codes, 99487, 99489, and G0506, and four behavioral health integration (BHI) service codes, G0502, G0503, G0504 and G0507.

We further revised the definition of primary care services in the November 2018 final rule (also referred to as the CY 2019 PFS final rule) (83 FR 59964 through 59968), by adding new codes to the definition of primary care services (CPT codes 99497, 99498, 96160, 96161, 99354, and 99355, and HCPCS codes G0444, G0442, and G0443), and by revising how we determine whether services identified by CPT codes 99304 through 99318 were furnished in a SNF. In the May 8, 2020 anti inflammatory drugs IFC (85 FR 27582 through 27586), we revised the definition of primary care services for purposes of beneficiary assignment for the performance year starting on January 1, 2020, and for any subsequent performance year that starts during the anti inflammatory drugs PHE defined in §  400.200, to include the following additions specified in §  425.400(c)(2). (1) HCPCS code G2010 (remote evaluation of patient video/images) and HCPCS code G2012 (virtual check-in). (2) CPT codes 99421, 99422 and 99423 (online digital evaluation and management service (e-visit)). And (3) CPT codes 99441, 99442, and 99443 (telephone evaluation and management services).

In the CY 2021 PFS final rule (85 FR 84786 through 84793), we finalized the additional primary care service codes adopted in the May 8, 2020 anti inflammatory drugs IFC with modifications to allow these codes to be used in determining beneficiary assignment when the assignment window (as defined at § 425.20) for a benchmark or performance year includes any months during the PHE for anti inflammatory drugs defined in § 400.200, and to apply these additional primary care service codes to all months of the assignment window, when the assignment window includes any month(s) during the PHE for anti inflammatory drugs. In the CY 2021 PFS final rule (85 FR 84748 through 84755), we expanded the definition of primary care services for purposes of determining beneficiary assignment to include. Online digital E/M CPT codes 99421, 99422, and 99423. Assessment of and care planning for patients with cognitive impairment CPT code 99483. Chronic care management code CPT code 99491.

Exclusion of advance care planning CPT code 99497 and the add-on code 99498 when billed in an inpatient care setting. Remote evaluation of patient video/images HCPCS codes G2010. Virtual check-in HCPCS code G2012. Non-complex chronic care management HCPCS code G2058 and its replacement CPT code 99439. Principal care management HCPCS codes G2064 and G2065.

And psychiatric collaborative care model HCPCS code G2214. In this same final rule (85 FR 84755 through 84756), we finalized revisions to the existing exclusion for professional services billed under CPT codes 99304 through 99318 that are furnished in a SNF to include services reported on an FQHC or RHC claim that includes CPT codes 99304 through 99318, when those services are furnished in a SNF. For performance years beginning on January 1, 2021, and subsequent performance years, we defined primary care services in §  425.400(c)(1)(v) for purposes of assigning beneficiaries to ACOs under §  425.402 as the set of services identified by the following HCPCS/CPT codes. CPT codes. (1) 96160 and 96161 (codes for administration of health risk assessment).

(2) 99201 through 99215 (codes for office or other outpatient visit for the evaluation and management of a patient). (3) 99304 through 99318 (codes for professional services furnished in a nursing facility. Professional services or services reported on an FQHC or RHC claim identified by these codes are excluded when furnished in a SNF). (4) 99319 through 99340 (codes for patient domiciliary, rest home, or custodial care visit). (5) 99341 through 99350 (codes for evaluation and management services furnished in a patient's home for claims identified by place of service modifier 12).Start Printed Page 39276 (6) 99354 and 99355 (add-on codes, for prolonged evaluation and management or psychotherapy services beyond the typical service time of the primary procedure.

When the base code is also a primary care service code under § 425.400(c)(1)(v)). (7) 99421, 99422, and 99423 (codes for online digital evaluation and management). (8) 99439 (code for non-complex chronic care management). (9) 99483 (code for assessment of and care planning for patients with cognitive impairment). (10) 99484, 99492, 99493 and 99494 (codes for behavioral health integration services).

(11) 99487, 99489, 99490 and 99491 (codes for chronic care management). (12) 99495 and 99496 (codes for transitional care management services). (13) 99497 and 99498 (codes for advance care planning. Services identified by these codes furnished in an inpatient setting are excluded). HCPCS codes.

(1) G0402 (code for the Welcome to Medicare visit). (2) G0438 and G0439 (codes for the annual wellness visits). (3) G0442 (code for alcohol misuse screening service). (4) G0443 (code for alcohol misuse counseling service). (5) G0444 (code for annual depression screening service).

(6) G0463 (code for services furnished in Electing Teaching Amendment hospitals). (7) G0506 (code for chronic care management). (8) G2010 (code for the remote evaluation of patient video/images). (9) G2012 (code for virtual check-in). (10) G2058 (code for non-complex chronic care management).

(11) G2064 and G2065 (codes for principal care management services). (12) G2214 (code for psychiatric collaborative care model). B. Proposed Revisions (1) HCPCS and CPT Codes Used in Assignment Based on feedback from ACOs and our further review of the HCPCS and CPT codes currently recognized for payment under the PFS, we believe it would be appropriate to amend the definition of primary care services used in the Shared Savings Program assignment methodology to include certain additional codes and make other technical changes to the definition of primary care services, for use in determining beneficiary assignment for the performance year starting on January 1, 2022, and subsequent performance years. We propose to revise the definition of primary care services in the Shared Savings Program regulations to include the following additions.

(1) Chronic Care Management (CCM) CPT code 99X21, if finalized through the CY 2022 PFS rulemaking. (2) Principal Care Management (PCM) CPT codes 99X22, 99X23, 99X24, and 99X25, if finalized through the CY 2022 PFS rulemaking. (3) Prolonged office or other outpatient evaluation and management (E/M) service HCPCS code G2212. And (4) Communication Technology-Based Service (CTBS) HCPCS code G2252, if payment for this code is made permanent through the CY 2022 PFS rulemaking. The following provides additional information about the CPT codes and HCPCS codes that we are proposing to add to the definition of primary care services used in assignment.

Chronic Care Management (CCM) CPT code 99X21. For CY 2022, the American Medical Association (AMA) CPT Editorial Panel created a new CPT code that describes CCM services furnished by clinical staff under the supervision of a physician or nonphysician practitioner (NPP) who can bill E/M services, and CCM services personally furnished by a physician or NPP. Elsewhere in this proposed rule, we propose valuation of CPT code 99X21 (Chronic care management services with the following required elements. Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient. Chronic conditions that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline.

Comprehensive care plan established, implemented, revised, or monitored.. Each additional 30 minutes by a physician or other qualified health care professional, per calendar month). In earlier rulemaking, we finalized the inclusion of CCM CPT codes 99487, 99489, 99490, and 99491 (codes for chronic care management) in the definition of primary care services for the Shared Savings Program. Refer to the June 2015 final rule (80 FR 32746 through 32748), CY 2018 PFS final rule (82 FR 53212 through 53213), and CY 2021 PFS final rule (85 FR 84749 through 84750 and 84754). €œNon-complex” CCM services (CPT codes 99490 and 99491), and “complex” CCM services (CPT codes 99487 and 99489) share a common set of service elements, including the following.

(1) Initiating visit, (2) structured recording of patient information using certified electronic health record technology (EHR), (3) 24/7 access to physicians or other qualified health care professionals or clinical staff and continuity of care, (4) comprehensive care management including systematic assessment of the patient's medical, functional, and psychosocial needs, (5) comprehensive care plan including a comprehensive care plan for all health issues with particular focus on the chronic conditions being managed, and (6) management of care transitions. They differ in the amount of clinical staff service time provided, the involvement and work of the billing practitioner, and the extent of care planning performed. The CCM services that will be furnished under the new CPT code 99X21 are similar to the CCM services that are billed under the exiting CCM codes that are included in the Shared Savings Program's current definition of primary care services, which includes CCM CPT codes 99487, 99489, 99490, 99491 and HCPCS code G0506. Because the Shared Savings Program's definition of primary care services includes other CCM CPT codes and HCPCS codes, we believe it would be appropriate to include HCPCS code 99X21, if finalized through the CY 2022 PFS rulemaking, in the definition of primary care services under § 425.400(c) for the performance year starting on January 1, 2022, and subsequent performance years. Principal Care Management (PCM) services CPT Codes 99X22, 99X23, 99X24, and 99X25.

The AMA CPT Editorial Panel has created the following new CPT codes that describe PCM services furnished by clinical staff under the supervision of a physician or NPP who can bill E/M services, and PCM services personally furnished by a physician or NPP. ++ 99X22 (Principal care management services, for a single high-risk disease, with the following required elements. One complex chronic condition expected to last at least 3 months, and which places the patient at significant risk of hospitalization, acute exacerbation/decompensation, functional decline, or death, the condition requires development, monitoring, or revision of disease-specific care plan, the condition requires frequent adjustments in the medication regimen, and/or the management of the condition is unusually complex due to comorbidities. Ongoing communication and care coordination between relevant practitioners furnishing care. First 30 minutes provided personally by a physician or other qualified health care professional, per calendar month).Start Printed Page 39277 ++ 99X23 (Principal care management services, for a single high-risk disease, with the following required elements.

One complex chronic condition expected to last at least 3 months, and which places the patient at significant risk of hospitalization, acute exacerbation/decompensation, functional decline, or death. The condition requires development, monitoring, or revision of disease-specific care plan, the condition requires frequent adjustments in the medication regimen, and/or the management of the condition is unusually complex due to comorbidities. Ongoing communication and care coordination between relevant practitioners furnishing care. Additional 30 minutes provided personally by a physician or other qualified health care professional, per calendar month). ++ 99X24 (Principal care management services, for a single high-risk disease, with the following required elements.

One complex chronic condition expected to last at least 3 months, and which places the patient at significant risk of hospitalization, acute exacerbation/decompensation, functional decline, or death. The condition requires development, monitoring, or revision of disease-specific care plan. The condition requires frequent adjustments in the medication regimen, and/or the management of the condition is unusually complex due to comorbidities. Ongoing communication and care coordination between relevant practitioners furnishing care. First 30 minutes of clinical staff time directed by physician or other qualified health care professional, per calendar month.).

++ 99X25 (Principal care management services, for a single high-risk disease, with the following required elements. One complex chronic condition expected to last at least 3 months, and which places the patient at significant risk of hospitalization, acute exacerbation/decompensation, functional decline, or death. The condition requires development, monitoring, or revision of disease-specific care plan. The condition requires frequent adjustments in the medication regimen, and/or the management of the condition is unusually complex due to comorbidities. Ongoing communication and care coordination between relevant practitioners furnishing care.

Each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month). Because the Shared Savings Program's definition of primary care services already includes the temporary HCPCS codes G2064 and G2065 that will be replaced by the permanent CPT codes 99X22 and 99X24, and CPT codes 99X23 and 99X25 represent the same services furnished for a greater length of time, we believe it would be appropriate to propose to include CPT code 99X22, 99X23, 99X24, and 99X25, if finalized through the CY 2022 PFS rulemaking, in the definition of primary care services under § 425.400(c) for the performance year starting on January 1, 2022, and subsequent performance years. Although the temporary HCPCS codes G2064 and G2065 will be replaced by the permanent CPT codes, the Shared Savings Program will retain the temporary HCPCS codes in the definition of primary care services used for assignment, to be used in conducting beneficiary assignment for benchmark years. Prolonged office or other outpatient evaluation and management (E/M) service HCPCS code G2212. In the CY 2021 PFS final rule (85 FR 84573 through 84574), CMS finalized a new HCPCS code G2212 (Prolonged office or other outpatient evaluation and management service(s) beyond the maximum required time of the primary procedure which has been selected using total time on the date of the primary service.

Each additional 15 minutes by the physician or qualified healthcare professional, with or without direct patient contact (List separately in addition to CPT codes 99205, 99215 for office or other outpatient evaluation and management services) (Do not report G2212 on the same date of service as 99354, 99355, 99358, 99359, 99415, 99416). (Do not report G2212 for any time unit less than 15 minutes)) to be used when billing Medicare for prolonged office/outpatient evaluation and management (E/M) visits instead of CPT code 99417, starting in 2021. We stated our belief that the creation of HCPCS code G2212 will serve to resolve the potential differences between Medicare and other interpretations of CPT rules, and better address questions about the required times and what time may be counted toward the required time to report prolonged office/outpatient E/M visits (see the CY 2020 PFS final rule for a more detailed discussion of this issue, (84 FR 62849 through 62850)). The current definition of primary care services used in the Shared Savings Program assignment methodology includes CPT codes 99205 and 99215 (codes for office or other outpatient visit for the evaluation and management of a patient). Because HCPCS code G2212 is defined as an add-on code for those office/outpatient E/M services, representing the same underlying services being furnished for a longer period of time, we believe it would be appropriate to propose to include HCPCS code G2212 in the definition of primary care services under § 425.400(c) for the performance year starting on January 1, 2022, and subsequent performance years.

Communication Technology-Based Service (CTBS) HCPCS code G2252. In the CY 2021 PFS final rule (85 FR 84536), CMS established additional coding and payment for services delivered via synchronous communication technology, which can include audio-only communication on an interim basis for CY 2021. We stated our belief that establishing payment for a longer service (11-20 minutes) on an interim basis would support access to care for beneficiaries who may be reluctant to return to in-person visits unless absolutely necessary, and allow us to consider whether this policy should be adopted on a permanent basis. Therefore, for CY 2021, on an interim basis, we established HCPCS code G2252 (Brief communication technology-based service, e.g., virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment. 11-20 minutes of medical discussion).

Elsewhere in this proposed rule, we are proposing to pay for this service on a permanent basis starting January 1, 2022. HCPCS code G2252 is similar to G2012 (Brief communication technology-based service, e.g., virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment. 5-10 minutes of medical discussion), but allows for an extended period of medical discussion. Because G2012 is already included the definition of primary care services at § 425.400(c), we believe including G2252 in the Shared Savings Program definition of primary care services used for assignment, beginning with performance year 2022, would result in more accurate assignment of beneficiaries based on where they receive the plurality of their Start Printed Page 39278primary care services. Accordingly, we propose to include HCPCS code G2252 in the definition of primary care services under § 425.400(c) for the performance year starting on January 1, 2022, and subsequent performance years, if payment for the code is made permanent through the CY 2022 PFS rulemaking.

We propose to specify a revised definition of primary care services in a new provision of the Shared Savings Program regulations at §  425.400(c)(1)(vi) to include the list of HCPCS and CPT codes specified in §  425.400(c)(1)(v) with the proposed additional CPT codes 99X21, 99X22, 99X23, 99X24, and 99X25, and HCPCS codes G2212 and G2252, if finalized through the CY 2022 PFS rulemaking, as applicable. We propose the new provision at §  425.400(c)(1)(vi) would be applicable for use in determining beneficiary assignment for the performance year starting on January 1, 2022, and subsequent performance years. Further, we propose technical modifications to the introductory text in §  425.400(c)(1)(v) to specify the applicability of this provision for determining beneficiary assignment for the performance year starting on January 1, 2021. (2) Extending the Applicability of the Expanded Definition of Primary Care Services in Response to the anti inflammatory drugs PHE As previously described in this section III.J.2.a. Of this proposed rule, in the May 8, 2020 anti inflammatory drugs IFC (85 FR 27582 through 27586), we adopted an expanded definition of primary care services for purposes of beneficiary assignment to reflect services furnished during the anti inflammatory drugs PHE.

This expanded definition was finalized with modifications in the CY 2021 PFS final rule (85 FR 84785 through 84793). According to § 425.400(c)(2), when the assignment window (as defined in § 425.20) for a benchmark or performance year includes any month(s) during the anti inflammatory drugs PHE defined in § 400.200, in determining beneficiary assignment, we use the primary care service codes identified in § 425.400(c)(1), and additional primary care service codes as follows. CPT codes. (1) 99421, 99422, and 99423 (codes for online digital evaluation and management services). (2) 99441, 99442, and 99443 (codes for telephone evaluation and management services).

HCPCS codes. (1) G2010 (code for the remote evaluation of patient video/images). (2) G2012 (code for virtual check-in). These additional primary care services are applicable to all months of the assignment window, when the assignment window includes any month(s) during the anti inflammatory drugs PHE defined in § 400.200. In the CY 2021 PFS final rule (85 FR 84748 through 84755), we updated the definition of primary care services under §  425.400(c) permanently for purposes of determining beneficiary assignment under §  425.402 for the performance year starting on January 1, 2021, and subsequent performance years, so that the following codes would not be linked to the duration of the PHE for anti inflammatory drugs.

(1) HCPCS code G2010 (remote evaluation of patient video/images) and HCPCS code G2012 (virtual check-in). (2) CPT codes 99421, 99422 and 99423 (online digital evaluation and management service (e-visit)). In the CY 2021 PFS final rule, we noted that we did not consider including CPT codes 99441, 99442, and 99443 in the definition of primary care services at §  425.400(c) on a permanent basis (85 FR 84751). Telephone E/M services CPT codes 99441 (Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment. 5-10 minutes of medical discussion).

99442 (Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment. 11-20 minutes of medical discussion). And 99443 (Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment. 21-30 minutes of medical discussion) are non-covered services when not provided during the PHE for anti inflammatory drugs, as defined in §  400.200, and so could not be included in the definition of primary care services for purposes of assignment outside the context of the PHE. In section II.D.

Of this proposed rule, we are proposing to revise the timeframe for services added on a temporary basis to the Medicare telehealth services list to allow additional time for stakeholders to perform an adequate analysis of those services for consideration in determining whether to include them on the Medicare telehealth services list on a permanent basis. In order to remain consistent with Medicare FFS payment policies, we propose to revise our existing definition of primary care services for purposes of beneficiary assignment in order to include CPT codes 99441, 99442, and 99443 until they are no longer payable under the Medicare FFS payment policies as specified under section 1834(m) of the Act and §§ 410.78 and 414.65. We propose to specify this modification by revising § 425.400(c)(2)(i)(A)(2) to include an exception to the applicability of the expanded definition of primary care services, to extend the timeframe for use of CPT codes 99441, 99442, and 99443, and making conforming revisions to paragraphs (c)(2)(i) and (c)(2)(ii). (3) Incorporation of Replacement Codes Into the Definition of Primary Care Services To Reflect Current Coding In the June 2015 final rule (80 FR 32746 through 32748), we established a policy under which we make any revisions to the definition of primary care services for purposes of beneficiary assignment through the annual PFS rulemaking process. We established this policy in order to promote flexibility for the Shared Savings Program and to allow the definition of primary care services used for assignment in the Shared Savings Program to respond quickly to HCPCS/CPT coding changes made in the annual PFS rulemaking process.

Accordingly, as part of the PFS rulemaking process, we periodically update the definition of primary care services used for assignment to include additional codes that we designate as primary care services for purposes of the Shared Savings Program, including new HCPCS/CPT codes or revenue codes and any subsequently modified or replacement codes. On a routine basis, the CPT Editorial Panel may delete existing CPT codes and replace them with new CPT codes. In addition, one use of HCPCS G-codes is to identify professional healthcare procedures and services that may not have assigned CPT codes. Thus, the CPT Editorial Panel may also create new CPT Start Printed Page 39279codes to replace these temporary HCPCS codes. Currently, there may be a period of time between the issuance of a replacement code and the effective date of the final rule that incorporates the replacement code into the definition of primary care services, when the replacement code is not captured in the Shared Savings Program assignment methodology.

Therefore, we are proposing to incorporate into the definition of primary care services a permanent CPT code when it directly replaces another CPT code or a temporary HCPCS code (for example, a G-code) that is already included in the definition of primary care services for purposes of determining beneficiary assignment under the Shared Savings Program. In general, we would expect to determine that a code is a direct replacement for another code based either on its having a substantially similar code description or the relevant discussion in CMS rulemaking establishing payment for the replacement code. This proposed approach would help to ensure the appropriate identification of primary care services used in the Shared Savings Program's assignment methodology by allowing for the immediate inclusion of replacement CPT codes in the determination of beneficiary assignment and lead to continuity in the assignment of beneficiaries receiving those services based on current coding. This continuity would improve predictability for ACOs, while also increasing the consistency of care coordination for their assigned beneficiaries. We further propose that such replacement codes would be incorporated into the definition of the primary care services for purposes of determining beneficiary assignment for the performance year starting on January 1, 2022, and subsequent performance years, when the assignment window for a benchmark or performance year (as defined in § 425.20) includes any day on or after the effective date of the replacement code for payment purposes under FFS Medicare.

For ACOs under preliminary prospective assignment with retrospective reconciliation, CMS assigns beneficiaries in a preliminary manner at the beginning of a performance year and quarterly based on the most recent 12 months of data available. For final assignment for a 12-month benchmark year or performance year, the assignment window is the 12-month calendar year that corresponds to the performance year or benchmark year. Under this proposal, a replacement CPT code that becomes effective during a 12-month initial, quarterly, or final assignment window would be included in the definition of primary care services used to determine beneficiary assignment for the applicable performance year or benchmark year. For ACOs under prospective assignment, claims-based beneficiary assignment is determined prospectively at the beginning of each benchmark and performance year based on the beneficiary's use of primary care services in the most recent 12 months for which data are available, based on an offset assignment window before the start of the benchmark or performance year. Under this proposal, a replacement CPT code that becomes effective during the offset assignment window would be included in the definition of primary care services used to determine beneficiary assignment for the applicable performance year or benchmark year.

We anticipate that we would continue to undergo periodic notice and comment rulemaking, through the annual PFS rulemaking, to amend the list of CPT codes and HCPCS codes that make up the definition of primary care services used for assignment in the Shared Savings Program to codify the applicable replacement CPT codes. As discussed in section III.J.2.b.(1) of this proposed rule, we propose to incorporate the revised definition of primary care services used for assignment in a new provision of the Shared Savings Program regulations at §  425.400(c)(1)(vi), applicable for use in determining beneficiary assignment for the performance year starting on January 1, 2022, and subsequent performance years. As part of this revised definition, we propose to incorporate a provision in paragraph (c)(1)(vi)(C), specifying that the primary care service codes for purposes of assigning beneficiaries include a CPT code identified by CMS that directly replaces a CPT code specified in § 425.400(c)(1)(vi)(A) or a HCPCS code specified in § 425.400(c)(1)(vi)(B), when the assignment window (as defined in § 425.20) for a benchmark or performance year includes any day on or after the effective date of the replacement code for payment purposes under FFS Medicare. We seek comment on these proposed changes to the definition of primary care services used for assigning beneficiaries to Shared Savings Program ACOs for the performance year starting on January 1, 2022, and subsequent performance years. We also welcome comments on any other existing HCPCS or CPT codes, and new HCPCS or CPT codes proposed elsewhere in this proposed rule, that we should consider adding to the definition of primary care services for purposes of assignment in future rulemaking.

3. Repayment Mechanisms a. Background An ACO that will participate in a two-sided model must demonstrate that it has established an adequate repayment mechanism to provide CMS assurance of its ability to repay shared losses for which the ACO may be liable upon reconciliation for each performance year. The requirements for an ACO to establish and maintain an adequate repayment mechanism are described in § 425.204(f), and we have provided additional program guidance on repayment mechanism arrangements.[] We established the repayment mechanism requirements through earlier rulemaking,[] and recently modified the repayment mechanism requirements in the December 2018 final rule (83 FR 67928 through 67938) and the CY 2021 PFS final rule (85 FR 84756 through 84763). According to § 425.204(f)(4)(ii), for a BASIC track or ENHANCED track ACO, the repayment mechanism amount must be equal to the lesser of the following.

(1) 1 percent of the total per capita Medicare Parts A and B FFS expenditures for the ACO's assigned beneficiaries, based on expenditures for the most recent calendar year for which 12 months of data are available. Or (2) 2 percent of the total Medicare Parts A and B FFS revenue of its ACO participants, based on revenue for the most recent calendar year for which 12 months of data are available. As discussed in the December 2018 final rule (83 FR 67866), this approach allows CMS to use the same sources of revenue and expenditure data during the program's annual application cycle to estimate the ACO's repayment mechanism amount and to determine the ACO's participation options according to whether the ACO is categorized as a low revenue ACO or high revenue ACO. As specified under § 425.204(f)(4)(iii), for agreement periods beginning on or Start Printed Page 39280after July 1, 2019, CMS recalculates the ACO's repayment mechanism amount before the second and each subsequent performance year in the agreement period based on the certified ACO participant list for the relevant performance year. We require an increase in the repayment mechanism amount if the recalculated repayment mechanism amount exceeds the existing repayment mechanism amount by at least 50 percent or $1,000,000, whichever is the lesser value.

Under § 425.204(f)(4)(iii), an ACO cannot decrease the amount of its repayment mechanism during its agreement period as a result of changes in its composition. As discussed in prior rulemaking, program stakeholders have continued to identify the repayment mechanism requirement as a potential barrier for some ACOs to enter into performance-based risk tracks, particularly small, physician-only and rural ACOs that may lack access to the capital that is needed to establish a repayment mechanism with a large dollar amount (see for example, 83 FR 67929). The design of the current repayment mechanism amount calculation, which is based on a percentage of expenditures for the ACO's assigned beneficiaries or a percentage of ACO participant revenue, seeks to approximate a percentage of the ACO's maximum possible shared losses, according to the loss recoupment limits (also referred to as the loss sharing limits) applicable to ACOs under two-sided models. Comparing the calculations for determining repayment mechanism amounts to the calculations for determining the loss sharing limits indicates that repayment mechanisms cover approximately 25 percent of estimated maximum possible losses for ACOs in the BASIC track (determined by dividing 1 percent, the percentage used in the repayment mechanism amount calculation under § 425.204(f)(4)(ii)(A), by 4 percent, the percentage of the benchmark-based loss sharing limit under Level E of the BASIC track under § 425.605(d)(1)(v)(D)(2)), and 7 percent of estimated maximum possible losses for ACOs in the ENHANCED track (determined by dividing 1 percent, the percentage used in the repayment mechanism amount calculation under § 425.204(f)(4)(ii)(A), by 15 percent, the percentage of the benchmark-based loss sharing limit under the ENHANCED track under § 425.610(g)). Based on operational experience, we have found that the repayment mechanism amounts for most ACOs are much larger than needed to cover actual losses, as repayment mechanism amount calculations have been based on a percentage of an amount that approximates the ACO's loss sharing limit (which is as high as 15 percent of updated benchmark expenditures in the ENHANCED track),[] and actual historical shared losses have been much lower than the loss sharing limit, averaging 0.96 percent of the ACO's benchmark.

Some ACOs have been required to establish repayment mechanisms with amounts that are 9 times greater than their actual shared losses. Additionally, of the 35 times ACOs have owed shared losses, as determined based on reconciliation for the Shared Savings Program's first performance year concluding on December 31, 2013, through performance years (or a performance period) in 2019, only one ACO has neglected to repay CMS timely, and most ACOs chose to repay shared losses without the use of their repayment mechanism arrangements. For the one ACO that did not repay CMS, we were able to recoup more than half of the shared losses owed using the ACO's repayment mechanism, and the remaining debt was referred to the Department of Treasury for collection. Considering this experience, which suggests there may be low risk to the Shared Savings Program by allowing lower repayment mechanism amounts, and the potential reduction in burden on ACOs by lower repayment mechanism amounts, we believe it is appropriate to modify the approach to calculating repayment mechanism amounts. We believe reducing the required amounts of repayment mechanisms may allow ACOs to use these funds to improve patient care and coordination and reduce a potential barrier to entry into performance-based risk models.

In this section of this proposed rule, we discuss four proposed policy changes regarding required repayment mechanism amounts. Under the first policy, we would modify the methodology for calculating repayment mechanism amounts to reduce the required amounts. Second, we would specify how we identify the number of assigned beneficiaries used in the repayment mechanism amount calculation and the annual repayment mechanism amount recalculation. Third, we would permit eligible ACOs that established a repayment mechanism to support their participation in a two-sided model beginning on July 1, 2019, January 1, 2020, or January 1, 2021, to elect to reduce the amount of their existing repayment mechanisms if their recalculated repayment mechanism amount for performance year 2022 is lower than their existing repayment mechanism amount. Fourth, we would modify the threshold for determining whether an ACO is required to increase its repayment mechanism amount during its ACO's agreement period.

B. Proposed Revisions (1) Repayment Mechanism Amount Calculations We considered two options for modifying the calculation of repayment mechanism amounts to result in lower amounts. (1) Reducing the percentages used in the existing repayment mechanism amount calculations specified in § 425.204(f)(4)(ii). Or (2) revising the methodology to use a per beneficiary dollar amount estimation methodology. In evaluating these options, we considered the potential impact on low revenue ACOs and high revenue ACOs, as defined according to § 425.20.

We also considered a balance of factors, including whether to retain an approach similar to the existing methodology or to use an alternative approach that could simplify the repayment mechanism amount calculation to make it more predictable. We also considered the magnitude of potential decreases in the repayment mechanism amounts under each option. We propose the first option, to reduce the percentages used in the existing repayment mechanism amount calculations, but we are seeking comment on the second, alternative option we considered. We propose to lower the repayment mechanism Start Printed Page 39281amounts by reducing the percentages used in our current methodology, under which we calculate the repayment mechanism amount as the lesser of the following. (1) 1 percent of the total per capita Medicare Parts A and B FFS expenditures for the ACO's assigned beneficiaries, based on expenditures for the most recent calendar year for which 12 months of data are available.

Or (2) 2 percent of the total Medicare Parts A and B FFS revenue of its ACO participants, based on revenue for the most recent calendar year for which 12 months of data are available. Specifically, we propose to calculate the amount as the lesser of the following. (1) One-half (0.5) percent of the total per capita Medicare Parts A and B FFS expenditures for the ACO's assigned beneficiaries, based on expenditures for the most recent calendar year for which 12 months of data are available. Or (2) 1 percent of the total Medicare Parts A and B FFS revenue of its ACO participants, based on revenue for the most recent calendar year for which 12 months of data are available. Under this proposal, ACOs would receive a 50 percent decrease in their repayment mechanism amounts compared to the current methodology.

These amounts would offer lower repayment mechanism amounts for ACOs, while still reserving what we believe to be a reasonable amount in the event CMS uses an ACO's repayment mechanism funds to support recoupment of shared losses. Our review of data for ACOs under a two-sided model revealed that if this repayment mechanism amount calculation method were in place for PY 2021, the mean repayment mechanism savings would be $297,665 for low revenue ACOs and $2.31 million for high revenue ACOs. The minimum repayment mechanism savings would be $27,030 for low revenue ACOs and $78,106 for high revenue ACOs. And the maximum repayment mechanism savings would be $1.97 million for low revenue ACOs and $11.70 million for high revenue ACOs. A second, alternative option we considered would be to estimate the repayment mechanism amount using a per beneficiary dollar amount that would be based on a percentage of actual historical median per capita shared losses for Shared Savings Program ACOs, multiplied by an estimate of the size of the ACO's assigned population as identified during the annual application or annual change request cycle.

In considering this option, we analyzed data from the 35 instances when Shared Savings Program ACOs in two-sided models have ever incurred shared losses, defined as performance year expenditures above the ACO's benchmark by an amount equal to or greater than the ACO's minimum loss rate. Using data from actual historical shared losses, we determined median per beneficiary shared losses were $100.90 and calculated per beneficiary dollar amounts projected to cover 5 to 25 percent of shared losses for ACOs, as illustrated in Table 26. Under this second, alternative option, we considered using separate per beneficiary dollar amounts, for low revenue ACOs and high revenue ACOs. We believe using two separate percentages is supported for a number of reasons. Compared to high revenue ACOs, low revenue ACOs are likely to have a lower loss sharing limit in the BASIC track (determined as a percentage of ACO participant revenue not to exceed a percentage of the ACO's updated benchmark), under which eligible low revenue ACOs may participate for up to two agreement periods.

Historically, low revenue ACOs have owed shared losses less often and have had lower amounts of per beneficiary shared losses compared to high revenue ACOs. Additionally, we believe high revenue ACOs, which tend to include institutional providers and are typically larger and better capitalized, are likely better financially prepared to secure a higher amount in their repayment mechanism than low revenue ACOs, which tend to be smaller and have less capital. For low revenue ACOs, to cover 10 percent of median actual historical shared losses, rounding to the nearest $1 increment, we considered requiring a repayment mechanism amount equal to $10 per beneficiary. For high revenue ACOs, to cover 20 percent of median actual historical shared losses we considered requiring $20 per beneficiary (refer to Table 26). These amounts would offer a lower repayment mechanism amount for 99 percent of low and high revenue ACOs with existing repayment mechanisms, while still reserving what we believe to be a reasonable amount in the event CMS uses an ACO's repayment mechanism funds to support recoupment of shared losses.

Our review of data for ACOs in a two-sided model revealed that if this repayment mechanism amount calculation method were in place for PY 2021,the mean repayment mechanism savings would be $410,682 for low revenue ACOs and $3.84 million for high revenue ACOs. The minimum repayment mechanism savings would be $6,513 for low revenue ACOs and $120,491 for high revenue ACOs. And the maximum repayment mechanism savings would be $3.45 million for low revenue ACOs and $19.73 million for high revenue ACOs. We believe there are a number of advantages to the option under which we would calculate repayment Start Printed Page 39282mechanism amounts using per beneficiary dollar amounts for low revenue ACOs and high revenue ACOs. For one, low revenue ACOs would receive additional relief through lower repayment mechanism amounts, relative to high revenue ACOs, under this approach.

We believe this is appropriate considering the previously described factors. The lower potential loss liability for low revenue ACOs. Historically, low revenue ACOs have incurred shared losses less often and have had lower per beneficiary shared losses compared to high revenue ACOs. And low revenue ACOs tend to be less well capitalized and may face potential barriers to establishing repayment mechanisms. Second, this approach aligns with the existing repayment mechanism amount calculation methodology, which tends to require proportionally higher amounts for high revenue ACOs, that tend to have higher average total expenditures for ACO assigned beneficiaries and higher total ACO participant revenue, compared to low revenue ACOs.

Third, an approach that uses a per beneficiary dollar amount would simplify the method to calculate the repayment mechanism amount, compared to the existing methodology, and may help ACOs better project repayment mechanism amounts prior to entering two-sided models, either at the point of application to a new agreement period or during the ACO's agreement period within the BASIC track's glide path as ACOs transition from a one-sided model to a two-sided model. Lastly, this approach would lower the mean repayment mechanism amount for ACOs more than the reduction that would occur under our proposal to lower the percentages used in the existing amount calculation methodology. However, we have significant concerns with an approach that uses a per beneficiary dollar amount that is applied based on whether an ACO is determined to be a low revenue ACO or a high revenue ACO, which if unresolved outweigh the potential benefits of the approach. For one, there would be a significant repayment mechanism amount difference for ACOs near the 35 percent threshold that differentiates low revenue ACOs and high revenue ACOs, and this difference in repayment mechanism amount may not correlate to covering a significant additional increase in risk. Second, the determination of whether an ACO is a low revenue ACO or high revenue ACO can change during the application cycle and between performance years within an agreement period.

Although changes in ACO composition have the potential to affect required amounts determined under the existing repayment mechanism amount calculation methodology, we believe ACO composition changes could result in a greater magnitude of change in the repayment mechanism amount under an approach that applies a $10 per beneficiary amount for low revenue ACOs and a $20 per beneficiary amount for high revenue ACOs. For ACOs establishing a repayment mechanism under the per beneficiary dollar amount approach, a change in revenue determination in later stages of the application cycle or change request cycle would delay calculation of an ACO's final repayment mechanism amount. In turn, this could delay when the ACO could submit finalized repayment mechanism documentation to demonstrate it meets the repayment mechanism requirement for entering a two-sided model. We are also concerned that ACOs whose revenue determinations change from low revenue to high revenue would face a substantial increase in the required repayment mechanism amount which they could find challenging to finance. However, based on our operational experience there have been relatively few cases where an ACO's revenue determination changes during the later stages of the application review period or change request cycle.

During an ACO's agreement period, a change in the ACO's revenue determination may cause significant fluctuation in an ACO's repayment mechanism amount under an approach that calculates the repayment mechanism amount using a per beneficiary dollar amount based on whether an ACO is determined to be a low revenue ACO or a high revenue ACO. Based on our operational experience, however, few ACOs entering agreement periods beginning on July 1, 2019, and in subsequent years, have experienced a change in revenue determination during their agreement period. Section 425.600(e) specifies an approach to addressing the circumstance where an ACO that entered an agreement period under Level E of the BASIC track because it was low revenue and experienced with performance-based risk Medicare ACO initiatives, becomes high revenue during its agreement period. This approach requires the ACO to take corrective action to meet the definition of low revenue ACO, or CMS takes compliance action as specified in §§ 425.216 and 425.218, which may include termination of the participation agreement. Further, in the absence of a policy to permit decreases in the repayment mechanism amount during the ACO's agreement period, ACOs that establish a repayment mechanism based on a high revenue ACO determination and are subsequently determined to be a low revenue ACO would need to maintain a relatively higher repayment mechanism amount for the duration of their 5-year agreement period.

To resolve these concerns, we considered using a single per beneficiary dollar amount for all ACOs, based on the values described in Table 26. However, we were unable to identify a single per beneficiary dollar amount that would account for historically higher per beneficiary shared losses owed by high revenue ACOs, while resulting in lower repayment mechanism amounts compared to the existing repayment mechanism calculation approach for most low revenue ACOs. Specifically, the dollar amount that would allow for relatively lower repayment mechanism amounts for all ACOs would be $8 per beneficiary, to cover 7.5 percent of median actual historical shared losses, rounding to the nearest $1 increment, which we believe is too low for high revenue ACOs. A higher per beneficiary dollar amount, such as $15, to cover 15 percent of median actual historical shared losses, rounding to the nearest $1 increment, would be relatively disadvantageous to approximately 20 percent of low revenue ACOs. Both our proposal and the second, alternative option would lower repayment mechanism amounts and would reduce the amount available to CMS to support repayment of shared losses.

However, we believe this risk to CMS is mitigated for a number of reasons. As noted previously in this section of this proposed rule, in our analysis of repayment mechanism amounts compared to actual historical shared losses, we believe the lower amounts would continue to provide CMS with reasonable assurance of an ACO's ability to repay shared losses. Further, as discussed in earlier rulemaking (85 FR 50249), the Shared Savings Program's existing policies require ACOs to pay shared losses, in full, within 90 days of written notification from CMS of the amount owed (according to §§ 425.605(e)(3), 425.606(h)(3), 425.610(h)(3)). ACOs have an interest in fully paying the amount of shared losses owed within the 90-day payment window to remain in compliance with the Shared Savings Program's requirements and avoid compliance actions including involuntary termination from the program. CMS may terminate an ACO's participation agreement for reasons Start Printed Page 39283including, but not limited to, non-compliance with requirements in 42 CFR part 425 (§ 425.218(b)(1)), such as failure to repay shared losses owed according to the program's regulations and may take pre-termination actions as described in § 425.216(a).

Under § 425.221(b)(2)(ii)(B), an ACO under a two-sided model whose participation agreement is terminated by CMS under § 425.218 is liable for a pro-rated share of any shared losses determined for the performance year during which the termination becomes effective. ACOs must also timely repay shared losses owed to avoid accruing interest on any unpaid amounts and to avoid referral of an unpaid debt to the Department of Treasury for collection. Based on our operational experience, nearly all ACOs fully repay shared losses without use of their repayment mechanism arrangement. ACOs will continue to have the option to secure a repayment mechanism at an amount greater than the CMS required amount, if they feel that is appropriate to prepare their ACO to repay all shared losses. Furthermore, we believe that reduced repayment mechanism amounts could reduce costs for ACOs in fees charged by financial institutions for letters of credit and by insurance companies for surety bonds, although we would not anticipate a significant reduction in fees charged by banks or credit unions for establishing and maintaining escrow accounts.

For example, reducing the required repayment mechanism amount of a given ACO by $1 million, could reduce the cost of obtaining a letter of credit or surety bond by roughly 1 or 2 percent, in this example resulting from $10,000 or $20,000 in reduced fees for the ACO. We estimate that such relief, in total for all participating ACOs, could be worth $2 to $4 million annually under the proposed approach (assuming a reduction of approximately $196 million in repayment mechanism amounts, in aggregate) and $3 to $6 million annually under the second, alternative option (assuming a reduction of approximately $322 million in repayment mechanism amounts, in aggregate). In light of these considerations, we propose to revise the regulations in § 425.204(f)(4)(ii) to reduce by one-half the percentages used in the methodology for calculating repayment mechanism amounts for ACOs in a two-sided model of the BASIC track or the ENHANCED track. We propose to revise the percentage specified in § 425.204(f)(4)(ii)(A), for calculating an amount based on expenditures for the ACO's assigned beneficiaries, from 1 percent to one-half percent. We propose to revise the percentage specified in § 425.204(f)(4)(ii)(B), for calculating an amount based on ACO participant revenue, from 2 percent to 1 percent.

Under this proposed approach for calculating repayment mechanism amounts for ACOs in a two-sided model of the BASIC track or the ENHANCED track, the repayment mechanism amount would be equal to the lesser of the following. (1) One-half percent of the total per capita Medicare Parts A and B FFS expenditures for the ACO's assigned beneficiaries, based on expenditures for the most recent calendar year for which 12 months of data are available. Or (2) 1 percent of the total Medicare Parts A and B FFS revenue of its ACO participants, based on revenue for the most recent calendar year for which 12 months of data are available. We seek comment on this proposal and the second, alternative option for calculating repayment mechanism amounts using a per beneficiary dollar amount, based on a percentage of actual historical median per capita shared losses for Shared Savings Program ACOs, multiplied by an estimate of the size of the ACO's assigned population as identified during the annual application or annual change request cycle. We seek comment on applying different per beneficiary dollar amounts for low revenue ACOs and high revenue ACOs under this alternative approach.

We welcome comments to address the dollar amounts projected to cover the percentage of median actual historical shared losses that would be an appropriate basis for low revenue ACOs (such as $10) and high revenue ACOs (such as $20) under this methodology. We also seek comment on approaches for addressing our concerns about changes in revenue determinations significantly affecting an ACO's repayment mechanism amount, such as applying a single per beneficiary dollar amount to all ACOs. We also note that if we were to adopt such an approach, we would need to address with greater specificity factors including. (1) How we would identify the population of assigned beneficiaries that would be used in the calculation as a multiplier for the per beneficiary dollar amount. And (2) the frequency with which we would consider modifications to the per beneficiary dollar amount.

We welcome comments on these considerations. We propose that these modifications would be effective and applicable on January 1, 2022. We note that the Shared Savings Program's application cycle (for new, renewing and re-entering ACOs) and change request cycle (for ACOs within an agreement period) for the performance year beginning on January 1, 2022 occurs between spring and fall 2021. During this timeframe, ACOs preparing to enter two-sided models for performance year 2022 are awaiting the final repayment mechanism amount for establishing a repayment mechanism, and ACOs within two-sided models are awaiting the determination of whether their repayment mechanism amount must be increased in accordance with § 425.204(f)(4)(iii) (as discussed in section III.J.3.b.(4) of this proposed rule). If the proposed modifications to the repayment mechanism amount calculation methodology described in this section of this proposed rule are finalized, and effective and applicable on January 1, 2022, we would communicate to ACOs their final repayment mechanism amounts after the issuance of the final rule.

We are committed to ensuring that ACOs do not overfund their repayment mechanism arrangements according to the existing methodology if we finalize the proposed revisions to reduce repayment mechanism amounts. (2) Population of Assigned Beneficiaries Used in Calculating and Recalculating Repayment Mechanism Amounts We propose to amend the regulations at §§ 425.204(f)(4)(ii) and 425.204(f)(4)(iii) to specify how we identify the number of assigned beneficiaries used in calculating and recalculating the repayment mechanism amount (respectively). For context, we first describe our current approach for calculating repayment mechanism amounts under § 425.204(f)(4)(ii) (for ACOs establishing a repayment mechanism to support their participation under a two-sided model) and under § 425.204(f)(4)(iii) (the annual recalculation to determine if an ACO is required to increase the amount of its repayment mechanism). In accordance with § 425.204(f)(4)(ii), for ACOs in a two-sided model of the BASIC track, or the ENHANCED track, the repayment mechanism amount must be equal to the lesser of the following. (1) 1 percent of the total per capita Medicare Parts A and B fee-for-service expenditures for the ACO's assigned beneficiaries, based on expenditures for the most recent calendar year for which 12 months of data are available (hereinafter referred to as an expenditure-based amount).

Or (2) 2 percent of the total Medicare Parts A and B fee-for-service revenue of its ACO participants, based on revenue for the most recent calendar year for which 12 months of data are available (hereinafter referred to as a revenue-based amount).Start Printed Page 39284 Currently, we use the following steps to calculate the expenditure-based amount specified in § 425.204(f)(4)(ii)(A), which is a percentage of the total per capita Medicare Parts A and B FFS expenditures for the ACO's assigned beneficiaries, based on expenditures for the most recent calendar year for which 12 months of data are available (referred to below as the “relevant historical calendar year”). Step 1. Identify the beneficiaries that would have been assigned to the ACO for the relevant historical calendar year (determined based on the ACO participant list for the upcoming performance year submitted by the ACO for CMS' review during the application cycle or change request cycle, referred to below as the “ACO participant list for the upcoming performance year”) and multiply the number of such beneficiaries by an assignment growth factor to account for expected growth in assignment. Step 2. Determine estimated per capita FFS expenditures by calculating the total per capita Medicare Parts A and B FFS expenditures incurred during the relevant historical calendar year by the beneficiaries identified in step 1, and dividing that amount by the total number of beneficiaries identified in step 1 before the assignment growth factor is applied.

And multiplying the resulting per capita FFS expenditure amount by a dollar trend factor to account for expected growth in Medicare FFS expenditures. Step 3. Calculate the product of the number of assigned beneficiaries determined according to step 1, and the estimated per capita FFS expenditures determined according to step 2. Step 4. Calculate the repayment mechanism amount by multiplying the amount determined in step 3 by the applicable percentage (currently 1 percent).

We currently use the following steps in calculating the revenue-based amount specified in § 425.204(f)(4)(ii)(B), which is based on revenue for the most recent calendar year for which 12 months of data are available (referred to below as the “relevant historical calendar year”). Step 1. Identify the beneficiaries that would have been assigned to the ACO for the relevant historical calendar year (determined based on the ACO participant list for the upcoming performance year) and multiply the number of such beneficiaries by an assignment growth factor. Step 2. Using the ACO participant list for the upcoming performance year, determine the estimated per capita FFS revenues of ACO participants by calculating ACO participants' total Medicare Parts A and B FFS revenue based on claims for services furnished to any beneficiary by ACO participants during the relevant historical calendar year, and dividing the dollar amount by the total number of assigned beneficiaries identified in step 1 before the assignment growth factor is applied; [] and multiplying the resulting number by a dollar trend factor to account for expected growth in Medicare FFS revenue.

Step 3. Calculate the product of the number of assigned beneficiaries determined according to step 1, and the estimated per capita FFS revenues of ACO participants determined according to step 2. Step 4. Calculate the repayment mechanism amount by multiplying the amount determined in step 3 by the applicable percentage (currently 2 percent). Regardless of the ACO's selected assignment methodology, within step 1 of the expenditure-based and revenue-based repayment mechanism amount calculations, CMS uses an assigned beneficiary population identified based on preliminary prospective assignment with retrospective reconciliation as described in § 425.400(a)(2).

This ensures that the assignment window used to determine assigned beneficiaries aligns with the relevant historical calendar year used to calculate expenditures and revenue used in step 2 of the expenditure-based amount and revenue-based amount calculation. We believe there are several important reasons for using historical data for determining the assigned beneficiary population, Medicare Parts A and B FFS expenditures for the ACO's assigned beneficiaries, and ACO participants' Medicare Parts A and B FFS revenue. For one, this approach ensures CMS' timely determination of final repayment amount estimates for ACOs required to establish a repayment mechanism arrangement prior to the start of a new agreement period under a two-sided model, or prior to start of the upcoming performance year under a two-sided model (for ACOs transitioning from a one-sided to a two-sided model along the BASIC track's glide path). Second, under this approach, the data used to determine repayment mechanism amounts is consistent with the data used in making other determinations during the application cycle and annual change request cycle, including determination of whether an ACO is categorized as a low revenue ACO or high revenue ACO. In accordance with § 425.204(f)(4)(iii), for agreement periods beginning on or after July 1, 2019, CMS recalculates the ACO's repayment mechanism amount before the second and each subsequent performance year in the agreement period in accordance with § 425.204(f), based on the certified ACO participant list for the relevant performance year.

Currently, in recalculating ACOs' repayment mechanism amounts we use the same approach to calculating the expenditure-based amount and revenue-based amount in accordance with § 425.204(f)(4)(ii), as previously described in this section. That is, in recalculating the repayment amount we determine the assigned beneficiary population, Medicare Parts A and B FFS expenditures for the ACO's assigned beneficiaries, and ACO participants' Medicare Parts A and B FFS revenue, for the most recent calendar year for which 12 months of data are available. We propose to modify the methodology for the annual repayment mechanism amount recalculation. Specifically, we propose to determine the number of assigned beneficiaries that is used as a multiplier in step 3 of the expenditure-based amount and revenue-based amount calculations, based on more recently available assignment data, rather than using a population projected to be assigned to the ACO based on historical data (that is, for the most recent calendar year for which 12 months of data are available). In determining the number of beneficiaries used as a multiplier in the recalculation estimate, we propose to determine the size of the ACO's assigned population based on the number of beneficiaries assigned to the ACO at the beginning of the performance year, as specified under § 425.400(a)(2)(i) (for ACOs under preliminary prospective assignment with retrospective reconciliation) or paragraph (a)(3)(i) (for ACOs under prospective assignment).

This population of assigned beneficiaries is specified in the ACO's initial assignment list report for the performance year. For all ACOs, this population is identified based on an assignment window that is offset from the calendar year (that is, from October 1 through September 30 prior to the start of the performance year), and which is the basis for determining prospective assignment for the performance year. Under the proposed approach that uses more recent Start Printed Page 39285assignment data in determining the recalculation estimate, we would not apply an assignment growth factor as a multiplier for the population size since we would no longer be using historical data to project the size of the ACO's assigned population. We believe this proposed approach would help ensure the recalculated repayment mechanism amounts account for an ACO's composition as reflected in the size of its assigned population for the performance year for which the recalculated amount relates, and thereby provide more accurate recalculated amounts. Under this proposed approach, we anticipate performing the annual recalculation of the repayment mechanism amounts shortly before or shortly after the start of the new performance year.

CMS will perform the recalculation of the repayment mechanism once the initial assignment list report is available, which is typically delivered to ACOs in the early winter (around mid-December), prior to the start of the relevant future performance year. We also note that under the existing approach and the proposed approach to determining the assigned population used as a multiplier in the annual recalculation of the repayment mechanism amounts, the effects on ACO's amounts are varied, resulting in relatively higher or lower amounts depending on the change in the size of the population. In annually recalculating the repayment mechanism amount under this proposed approach, we would follow the previously described steps for calculating the expenditure-based amount and revenue-based amount, with the exception of the number of beneficiaries used as a multiplier in step 3 of the calculations. In step 3 of the expenditure-based amount calculation, we would calculate the product of the total number of assigned beneficiaries specified in the ACO's initial assignment list report for the relevant future performance year, and the estimated per capita FFS expenditures determined for the relevant historical calendar year (determined according to step 2). In step 3 of the revenue-based amount calculation, we would calculate the product of the total number of assigned beneficiaries specified within the ACO's initial assignment list report for the relevant future performance year, and the estimated per capita FFS revenues of ACO participants determined for the relevant historical calendar year (determined according to step 2).

Several examples illustrate the calculation and recalculation of the repayment mechanism amounts under the proposals. First, for an ACO applying to enter a two-sided model for an agreement period beginning on January 1, 2022, we will calculate the repayment mechanism amount during the application cycle which occurs during CY 2021. During this time, CY 2020 is the most recent calendar year for which 12 months of data are available, and is the relevant historical calendar year for purposes of calculating the repayment mechanism amount. As described in this illustration, the proposed approach to identifying the assigned beneficiary population, Medicare Parts A and B FFS expenditures for the ACO's assigned beneficiaries, and ACO participants' Medicare Parts A and B FFS revenue used within these calculations is consistent with our current operational approach. In step 1 of the expenditure-based amount and revenue-based amount calculations, we would identify the beneficiaries that would have been assigned to the ACO for CY 2020, determined based on the ACO participant list for PY 2022 submitted with the ACO's application, and determined using preliminary prospective assignment with retrospective reconciliation.

That is, we would determine assignment based on the 12-month assignment window from January 1, 2020, through December 31, 2020.[] We would multiply the number of such beneficiaries by an assignment growth factor. In step 2 of the expenditure-based amount calculation, we would calculate total Medicare Parts A and B FFS expenditures incurred in CY 2020 by the beneficiaries determined under step 1 to be assigned to the ACO for CY 2020. In step 2 of the revenue-based amount calculation, we would calculate ACO participants' total Medicare Parts A and B FFS revenue, based on claims for services furnished to any beneficiary by ACO participants during CY 2020. We would determine the estimated per capita FFS expenditures, and the estimated per capita FFS revenues of ACO participants, by dividing the CY 2020 dollar amounts by the number of assigned beneficiaries for CY 2020 (determined in accordance with step 1) before the assignment growth factor is applied. We would multiply the resulting numbers by a dollar trend factor.

In step 3 of the expenditure-based amount calculation, the number of assigned beneficiaries for CY 2020 would be multiplied by the estimated per capita FFS expenditures determined for CY 2020 in accordance with step 2. In step 3 of the revenue-based amount calculation, the number of assigned beneficiaries for CY 2020 would be multiplied by the estimated per capita Medicare FFS revenues of ACO participants determined for CY 2020 in accordance with step 2. In step 4, we would calculate the repayment mechanism amount by multiplying the amount determined in step 3 by the applicable percentage. Currently, that is 1 percent under the expenditure-based amount calculation, and 2 percent under the revenue-based amount calculation. Under the proposals described in section III.J.3.b.(1) of this proposed rule, the applicable percentages would be one-half percent under the expenditure-based amount calculation, and 1 percent under the revenue-based amount calculation.

Our second example illustrates how we would perform the annual recalculation of the repayment mechanism amount for performance year (PY) 2022. In step 1 of both the expenditure-based amount and revenue-based amount calculations, we use a similar method for identifying the CY 2020 assigned population as described in the first example. That is, we would identify the beneficiaries that would have been assigned to the ACO for CY 2020, determined based on the ACO's certified ACO participant list for PY 2022, and determined using preliminary prospective assignment with retrospective reconciliation. Again, we would determine assignment based on the 12-month assignment window from January 1, 2020, through December 31, 2020. In step 2 of the expenditure-based amount calculation, we would calculate total Medicare Parts A and B FFS expenditures incurred in CY 2020 by the beneficiaries determined under step 1 to be assigned to the ACO for CY 2020.

In step 2 of the revenue-based amount calculation, we would calculate ACO participants' total Medicare Parts A and B FFS revenue, based on claims for services furnished to any beneficiary by ACO participants during CY 2020, using the ACO's certified ACO participant list for PY 2022. We would determine the estimated per capita FFS expenditures, and the estimated per capita FFS revenues of ACO participants, by Start Printed Page 39286dividing the CY 2020 dollar amounts by the number of assigned beneficiaries for CY 2020 (determined in accordance with step 1). In step 3, we would identify the total number of assigned beneficiaries specified within the ACO's initial assignment list report for PY 2022. This population of assigned beneficiaries would be specified in the ACO's initial assignment list report for PY 2022, and would be the population identified based on the assignment window from October 1, 2019 through September 30, 2020, and which would be the basis for determining prospective assignment for PY 2022. Assignment would be determined based on the ACO's certified ACO participant list for PY 2022.

In step 3 of the expenditure-based amount calculation, the number of assigned beneficiaries for PY 2022 would be multiplied by the estimated per capita FFS expenditures determined for CY 2020 in accordance with step 2. In step 3 of the revenue-based amount calculation, the number of assigned beneficiaries for PY 2022 would be multiplied by the estimated per capita FFS revenues determined for CY 2020 in accordance with step 2. In step 4, we would recalculate the repayment mechanism amount by multiplying the amount determined in step 3 by the applicable percentage. Currently, that is 1 percent under the expenditure-based amount calculation, and 2 percent under the revenue-based amount calculation. Under the proposals described in section III.J.3.b.(1) of this proposed rule, the applicable percentages would be one-half percent under the expenditure-based amount calculation, and 1 percent under the revenue-based amount calculation.

We propose to modify § 425.204(f)(4)(ii) to more clearly specify the assigned population used as a multiplier in calculating the repayment mechanism amount. Under the existing regulation text at § 425.204(f)(4)(ii)(A), the potential repayment mechanism amount is a specified percentage of total per capita Medicare Parts A and B fee-for-service expenditures “for the ACO's assigned beneficiaries, based on expenditures for the most recent calendar year for which 12 months of data are available.” We propose to amend paragraph (f)(4)(ii)(A) to refer to a specified percentage of total per capita Medicare Parts A and B fee-for-service expenditures “for the ACO's assigned beneficiaries, based on expenditures and the number of assigned beneficiaries for the most recent calendar year for which 12 months of data are available” (emphasis added to reflect revised text). Under the existing regulation text at § 425.204(f)(4)(ii)(B), the potential repayment mechanism amount is a specified percentage of total Medicare Parts A and B fee-for-service revenue “of its ACO participants, based on revenue for the most recent calendar year for which 12 months of data are available.” We propose to amend paragraph (f)(4)(ii)(B) to refer to a specified percentage of total Medicare Parts A and B fee-for-service revenue “of its ACO participants, based on revenue for the most recent calendar year for which 12 months of data are available, and based on the ACO's number of assigned beneficiaries for the most recent calendar year for which 12 months of data are available” (emphasis added to reflect revised text). We also propose technical and conforming changes to the introductory text of § 425.204(f)(4)(iii). We propose to remove as unnecessary and irrelevant the text specifying that the provision applies for agreement periods beginning on or after July 1, 2019.

We propose to revise the introductory text for clarity to specify that CMS would recalculate the ACO's repayment mechanism amount “for” the second and each subsequent performance year in the agreement period, rather than “before” the second and each subsequent performance year in the agreement period. We propose to make a conforming change to the introductory text of § 425.204(f)(4)(iii) to specify that CMS' recalculation of the ACO's repayment mechanism amount would be in accordance with § 425.204(f)(4)(ii) based on the certified ACO participant list for the relevant performance year, “except that the number of assigned beneficiaries used in the calculations would be the number of beneficiaries assigned to the ACO at the beginning of the relevant performance year under § 425.400(a)(2)(i) (for ACOs under preliminary prospective assignment with retrospective reconciliation) or § 425.400(a)(3)(i) (for ACOs under prospective assignment).” We propose that these modifications would be effective and applicable on January 1, 2022. If finalized as proposed, these policies would be used in determining required repayment mechanism amounts for ACOs establishing a repayment mechanism arrangement to support their participation in a two-sided model beginning with performance year 2022, and in subsequent performance years, and in determining recalculated repayment mechanism amounts for performance year 2022 and subsequent performance years, as well as the determination that an eligible ACO has a one-time opportunity to decrease the amount of its repayment mechanism amount as described in section III.J.3.b.(3) of this proposed rule. (3) Optional One-Time Repayment Mechanism Decrease for Eligible ACOs In connection with the proposal for lowering the repayment mechanism amounts, described in section III.J.3.b.(1) of this proposed rule, we are proposing to allow certain ACOs a one-time opportunity to decrease the amount of their repayment mechanisms. The purpose of this proposal is to let any ACO that established a repayment mechanism to support its participation in a two-sided model beginning on July 1, 2019, January 1, 2020, or January 1, 2021, to decrease its repayment mechanism amount before it seeks to renew its agreement under the new proposed policy, which if finalized, would otherwise be the first opportunity for the ACO to reduce its repayment mechanism amount.

Along these lines, the one-time decrease would also avoid unnecessary burden that could result if ACOs seek to terminate their participation agreements early and apply to re-enter the program in order to reduce their required repayment mechanism amounts. As discussed in section III.J.3.b.(1) of this proposed rule, if the proposed modifications to the repayment mechanism amount calculation methodology are finalized, and effective and applicable on January 1, 2022, we would ensure that the revised methodology would be used in determining repayment mechanism amounts for ACOs establishing a repayment mechanism to support their participation in a two-sided model beginning with performance 2022. Therefore, ACOs entering a two-sided model for an agreement period beginning on January 1, 2022, and ACOs with an earlier start date participating in the BASIC track's glide path and entering a two-sided model starting on January 1, 2022, would have established repayment mechanism amounts determined according to the proposed amount calculation methodology, if finalized. Therefore, we would not consider such ACOs eligible for the proposed one-time opportunity to decrease the amount of their repayment mechanism. Under this proposal, an eligible ACO that established a repayment mechanism to support its participation in a two-sided model beginning on July 1, 2019, January 1, 2020, or January 1, 2021, may elect to decrease the amount Start Printed Page 39287of its repayment mechanism if the recalculated repayment mechanism amount for performance year 2022 is less than the existing repayment mechanism amount.

To determine if an ACO is eligible to lower its repayment mechanism amount, we propose to compare the ACO's existing repayment mechanism amount with the recalculated amount of the ACO's repayment mechanism based on its certified ACO participant list for performance year 2022, calculated in accordance with § 425.204(f)(4)(iii) (including any modifications finalized to the recalculation methodology which would be effective and applicable January 1, 2022, as discussed in this proposed rule). If the recalculated repayment mechanism amount for performance year 2022 is less than the existing repayment mechanism amount, the ACO would be eligible to decrease the amount of its repayment mechanism to the recalculated amount. Under this approach, we would permit a one-time decrease in the repayment mechanism amount even for relatively small differences in dollar amounts. We propose that CMS would notify the ACO in writing that the ACO may elect to decrease the amount of its repayment mechanism. If this proposal is finalized, we anticipate that we would notify an ACO of its opportunity to reduce its repayment mechanism amount after the start of performance year 2022.

We also propose that an ACO must submit such election, and revised repayment mechanism documentation, in a form and manner and by a deadline specified by CMS. We expect that the deadline for submitting the election and revised repayment documentation would be 30 days from the date of the written notice from CMS, although we recognize that there may be circumstances that necessitate a longer timeframe. CMS would review the revised repayment mechanism documentation and may reject the election if the repayment mechanism documentation does not comply with the requirements of § 425.204(f). We propose to amend § 425.204 to add paragraph (f)(4)(v) to establish the policy and relevant procedure that would allow eligible ACOs that established a repayment mechanism to support their participation in a two-sided model beginning on July 1, 2019, January 1, 2020, or January 1, 2021, to elect to lower the amount of their repayment mechanism arrangements. (4) Threshold for Increasing Repayment Mechanism Amounts In accordance with § 425.204(f)(4)(iii), for agreement periods beginning on or after July 1, 2019, CMS recalculates the ACO's repayment mechanism amount before the second and each subsequent performance year in the agreement period based on the certified ACO participant list for the relevant performance year.

If the recalculated repayment mechanism amount exceeds the existing repayment mechanism amount by at least 50 percent or $1,000,000, whichever is the lesser value, CMS notifies the ACO in writing that the amount of its repayment mechanism must be increased to the recalculated repayment mechanism amount. Within 90 days after receipt of such written notice from CMS, the ACO must submit for CMS approval documentation that the amount of its repayment mechanism has been increased to the amount specified by CMS. In establishing the annual repayment mechanism amount recalculation policy in earlier rulemaking (83 FR 67930), we explained the purpose of this approach was to address changes in the ACO's composition of ACO participant TINs and the individuals who bill through the participant TINs over the course of an agreement period and to ensure the adequacy of an ACO's repayment mechanism. In establishing the annual recalculation policy (83 FR 67932), we explained that a threshold of 50 percent or $1,000,000 would likely require an increased repayment mechanism amount only for ACOs that had the largest changes in their estimated repayment mechanism value (the top 5 to 10 percent of ACOs). We believed this approach would minimize an ACO's administrative burden and financial institution fees while adjusting for meaningful changes in repayment mechanism amounts that would help protect the Medicare Trust Funds.

We continue to believe that the annual repayment mechanism amount recalculation serves an important function in identifying the need for repayment mechanism increases when an ACO's composition changes. Such changes could result in higher expenditures for the ACO's assigned beneficiaries, higher ACO participant revenue, or a larger assigned beneficiary population. Each of these changes could increase the amount of potential shared losses for an ACO under a two-sided model. Based on our operational experience with the recalculation policy, we have found that ACOs whose recalculated repayment mechanism amount is at least 50 percent higher than their existing amount, but less than $1,000,000 more, tend to be low revenue ACOs with relatively smaller existing repayment mechanism amounts, typically less than $300,000. Further, based on our operational experience and input from ACOs and other program stakeholders, modifications to repayment mechanism arrangements to revise the amount are burdensome for ACOs.

These modifications are time consuming to arrange, and can result in additional fees charged by financial institutions for ACOs to modify their arrangements, in addition to requiring ACOs to set aside additional funds (such as with escrow accounts). We believe the burden for these ACOs to increase their repayment mechanism amounts is disproportional to the benefit to CMS in the availability of additional repayment mechanism arrangement funds to support repayment of losses. Further, we believe it is timely to revisit the amount increase thresholds under the repayment mechanism amount recalculation policy in light of our proposal described in section III.J.3.b.(1) of this proposed rule to reduce the amounts required for repayment mechanism arrangements. If we finalize our proposal to reduce by one-half the repayment mechanism amounts, the 50 percent threshold of the amount recalculation provision would be proportionally lower, and the burden for these ACOs to increase their repayment mechanism amounts would be even more disproportional to the benefit to CMS. We believe that requiring an increase in the repayment mechanism amount if the recalculated amount for the performance year is at least $1,000,000 greater than the existing amount balances our interest in ensuring the repayment mechanism amount accounts for significant changes in an ACO's composition during its agreement period, while avoiding burdensome repayment mechanism modifications for relatively small dollar amounts.

Therefore, we propose to amend the regulations at § 425.204(f)(4)(iii)(A) to remove the 50 percent threshold from the annual repayment mechanism increase threshold, such that if the recalculated repayment mechanism amount exceeds the existing repayment mechanism amount by at least $1,000,000, CMS would notify the ACO in writing that the amount of its repayment mechanism must be increased to the recalculated repayment mechanism amount. We anticipate this approach would reduce the number of ACOs required to annually increase their repayment mechanism amounts and would further simplify the repayment mechanism amount calculations.Start Printed Page 39288 We propose that this modification would be effective and applicable on January 1, 2022. If finalized as proposed, the revised threshold would be used in determining required repayment mechanism increases for performance year 2022, and subsequent performance years. 4. Reducing Shared Savings Program Application Burden a.

Background In order to participate in the Shared Savings Program, a prospective ACO must submit an application and certify that it satisfies the eligibility and other requirements of the Shared Savings Program, including regulatory requirements to disclose prior participation. Under § 425.204(b), an ACO must disclose in its Shared Savings Program application whether the ACO, its ACO participants, or its ACO providers/suppliers have participated in the Shared Savings Program under the same or a different name or is related to or affiliated with another Shared Savings Program ACO. The ACO must also disclose in the application whether the related participation agreement was terminated (voluntarily or involuntarily), the cause for prior termination, and what safeguards are in place to enable the ACO, ACO participant, or ACO provider/supplier to participate in the program for the full term of the participation agreement. We refer to both of these disclosure requirements as the “prior participation disclosure requirement.” Our application evaluation criteria for renewing ACOs and re-entering ACOs are designed to prevent ACOs with a history of poor performance or a history of noncompliance with the Shared Savings Program regulations from participating in the program. Under § 425.224(b), we determine whether to approve an application based on an evaluation of several criteria, including the following.

(1) Whether the ACO has a history of noncompliance with the program's requirements, including a failure to meet the quality performance standard. (2) the ACO's history of financial performance. (3) whether an ACO under a two-sided model failed to repay shared losses owed to the program. And (4) whether the ACO has demonstrated in its application that it has corrected the deficiencies that caused it to perform poorly or to be terminated. Additionally, under § 425.204(c)(6), all applicants, including initial