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Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-in Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions from the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19

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Start Preamble Start Printed Page 84472

AGENCY:

Centers for Medicare & Medicaid Services (CMS), Health and Human Services (HHS).

ACTION:

Final rule and interim final rule.

SUMMARY:

This major final 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 the statute; Medicare Shared Savings Program requirements; Medicaid Promoting Interoperability Program requirements for Eligible Professionals; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; Medicare enrollment of Opioid Treatment Programs; payment for office/outpatient evaluation and management services; Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D drug under a prescription drug plan or an MA-PD plan and Medicare Diabetes Prevention Program (MDPP) expanded model Emergency Policy. This final rule also finalizes certain provisions of the interim final rules with comment period that CMS issued on March 31, 2020, May 8, 2020, and September 2, 2020 in response to the Public Health Emergency (PHE) for the Coronavirus Disease 2019 (COVID-19). This rule also establishes coding and payment for virtual check-in services and for personal protective equipment (PPE) on an interim final basis.

DATES:

Effective Date: The regulations in the final rule are effective on January 1, 2021.

Applicability date: The policies in this final rule are applicable on January 1, 2021, except as follows:

(1) The revisions to 42 CFR 400.200 and 425.611(b)(1)(ii) are applicable retroactively to the start of the PHE for COVID-19 on January 27, 2020. (See discussions in sections II.J. and III.G.5.d.(2) of this final rule, respectively.)

(2) The revisions to 42 CFR 425.400(c)(2) are applicable retroactively for the performance year starting on January 1, 2020. (See discussion in section III.G.5.e.(3) of this final rule.)

Comment date: Comments will be accepted/considered ONLY on the “Interim Final Rule with Comment Period for Coding and Payment of Virtual Check-in Services” contained in section II.D. of the preamble of this document and “Interim Final Rule with Comment Period for Coding and Payment for Personal Protective Equipment (PPE)” contained in section II.H. of the preamble of this document. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on February 1, 2021.

ADDRESSES:

In commenting, please refer to file code CMS-1734-IFC.

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-1734-IFC,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-1734-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Jamie Hermansen, (410) 786-2064, for any issues not identified below.

Michael Soracoe, (410) 786-6312, for issues related to practice expense, work RVUs, conversion factor, PFS specialty-specific impacts, and the interim final rule with comment period for coding and payment for PPE.

Larry Chan, (410) 786-6864, for issues related to potentially misvalued services under the PFS.

Emily Yoder, (410) 786-1804, Donta Henson, (410) 786-1947, and Patrick Sartini, (410) 786-9252, for issues related to telehealth, other services involving communications technology, and interim final rule with comment period for coding and payment of virtual check-in services.

Liane Grayson, (410) 786-6583, for issues related to care management services and remote physiologic monitoring services.

Emily Yoder, (410) 786-1804, Christiane LaBonte, (410) 786-7237, Ann Marshall, (410) 786-3059, and Patrick Sartini, (410) 786-9252, for issues related to payment for office/outpatient evaluation and management visits.

Christiane LaBonte, (410) 786-7237, and Cindy Bergin, (401) 786-1176, for issues related to teaching physician services.

Roberta Epps, (410) 786-4503, and Regina Walker-Wren, (410) 786-9160, for issues related to supervision of diagnostic tests.

Ann Marshall, (410) 786-3059, for issues related to incident to pharmacist services.

Gift Tee, (410) 786-9316, for issues related to therapy services.

Sarah Leipnik, (410) 786-3933, for issues related to medical record documentation.

Lindsey Baldwin, (410) 786-1694 and Terry Simananda, (410) 786-8144, for issues related to Medicare coverage of opioid use disorder treatment services furnished by opioid treatment programs.

Laura Ashbaugh, (410) 786-1113, for issues related to Clinical Laboratory Fee Start Printed Page 84473Schedule: Revised Data Reporting Period and Phase-in of Payment Reductions

Joseph Schultz, (410) 786-2656, for issues related to opioid treatment program provider enrollment regulation updates for institutional claim submissions.

Lisa Parker, (410) 786-4949, for issues related to RHCs and FQHCs, primary care management services, and the FQHC market basket.

Rachel Katonak, (410) 786-8564, or JoAnna Baldwin (410) 786-7205, for issues related to comprehensive screenings for seniors: Section 2002 of the Substance Use-Disorder Prevention that Promote Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act).

David Koppel, (303) 844-2883, or Elizabeth LeBreton (202) 615-3816 for issues related to the Medicaid Promoting Interoperability Program.

Fiona Larbi, (410) 786-7224, or Sabrina Ahmed, (410) 786-7499, for issues related to the Medicare Shared Savings Program (Shared Savings Program) Quality performance standard, quality reporting requirements and finalization of Shared Savings Program provisions from the March 31st COVID-19 IFC.

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 finalization of Shared Savings Program provisions from the May 8th COVID-19 IFC.

Cheryl Gilbreath, (410) 786-5919, for issues related to home infusion therapy benefit.

Heather Hostetler, (410) 786-4515 for issues related to removal of selected national coverage determinations.

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.

Edmund Kasaitis, (410) 786-0477, for issues related to Part B drug payment and Food Drug & Cosmetic Act section 505(b)(2) drug products.

Elizabeth Holland, (410) 786-1309, for issues related to updates to certified electronic health record technology due to the 21st Century Cures Act.

Julia Venanzi, (410) 786-1471, for issues related to the Hospital Inpatient Quality Reporting (IQR) Program.

Cynthia Hake, (410) 786-3404, for issues related to HCPCS Level II codes.

Amanda Rhee, (410) 786-3888, for the Medicare Diabetes Prevention Program (MDPP) expanded model emergency policy.

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).

Patricia Taft, (410) 786-4561, for issues related to the Physician Self-Referral Law: Annual Update to the List of CPT/HCPCS Codes.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY 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 final 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 2021 PFS final rule, refer to item CMS-1734-F. Readers with questions related to accessing any of the Addenda or other supporting documents referenced in this final rule and posted on the CMS website identified above should contact Jamie Hermansen at (410) 786-2064.

CPT (Current Procedural Terminology) Copyright Notice: Throughout this final rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2019 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

A. Purpose

This major final rule revises payment polices under the Medicare PFS and makes other policy changes, including to the implementation of certain provisions of the 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 final rule includes provisions related to other payment policy changes that are addressed in sections III. and IV. of this final rule.

We are issuing an interim final rule with comment period (IFC) to establish coding and payment for virtual check-in services to support the continuing need for coding and payment to reflect the provision of lengthier audio-only services outside of the PHE for COVID-19, if not as substitutes for in-person services, then as a tool to determine whether an in-person visit is needed, particularly as beneficiaries may still be cautious about exposure risks associated with in-person services. We are also issuing an interim final rule with comment period to establish coding and payment for PPE as a bundled service and certain supply pricing increases in recognition of the increased market-based costs for certain types of PPE.

1. 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 by regulation each year's payment amounts for all physicians' services paid under the PFS, incorporating geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas.

In this major final rule, we are establishing RVUs for CY 2021 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 final rule also includes Start Printed Page 84474discussions and provisions regarding several other Medicare Part B payment policies.

Specifically, this final rule addresses:

  • Practice Expense RVUs (section II.B.)
  • Potentially Misvalued Services Under the PFS (section II.C.)
  • Telehealth and Other Services Involving Communications Technology, and the Interim Final Rule with Comment Period for Coding and Payment for Virtual Check-in Services (section II.D.)
  • Care Management Services and Remote Physiologic Monitoring Services (section II.E.)
  • Refinements to Values for Certain Services to Reflect Revisions to Payment for Office/Outpatient Evaluation and Management (E/M) Visits and Promote Payment Stability during the PHE for COVID-19 (section II.F.)
  • Scopes of Practice and Related Issues (section II.G.)
  • Valuation of Specific Codes, and the Interim Final rule with Comment Period for Coding and Payment for Personal Protective Equipment (PPE) (section II.H.)
  • Modifications related to Medicare Coverage for Opioid Use Disorder (OUD) Services Furnished by Opioid Treatment Programs (OTPs) (section II.I.)
  • Technical Correction to the Definition of Public Health Emergency (section II.J.)
  • Clinical Laboratory Fee Schedule (section III.A.)
  • Opioid Treatment Program Provider Enrollment Regulation Updates for Institutional Claim Submissions (section III.B.)
  • Payment for Primary Care Management Services in RHCs and FQHCs (section III.C.)
  • Changes to the Federally Qualified Health Center Prospective Payment System (FQHC PPS) for CY 2021: Rebasing and Revising of the FQHC Market Basket (section III.D.)
  • Comprehensive Screenings for Seniors: Section 2002 of the Substance Use-Disorder Prevention that Promote Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) (section III.E.)
  • Medicaid Promoting Interoperability Program Requirements for Eligible Professionals (EPs) (section III.F.)
  • Medicare Shared Savings Program (section III.G.)
  • Notification of Infusion Therapy Options Available Prior to Furnishing Home Infusion Therapy Services (section III.H.)
  • Modifications to Quality Reporting Requirements and Comment Solicitation on Modifications to the Extreme and Uncontrollable Circumstances Policy for Performance Year 2020 (section III.I.)
  • Removal of Selected National Coverage Determinations (section III.J.)
  • Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D drug under a prescription drug plan or an MA-PD plan (section III.K.)
  • Medicare Part B Drug Payment for Drugs Approved Through the Pathway Established Under Section 505(b)(2) of the Food, Drug, and Cosmetic Act (section III.L.)
  • Updates to Certified Electronic Health Record Technology Requirements in the Promoting Interoperability Program, Quality Payment Program, and Hospital Inpatient Quality Reporting Program due to the 21st Century Cures Act (section III.M.)
  • Establishing New Code Categories (section III.N.)
  • Medicare Diabetes Prevention Program (MDPP) expanded model emergency policy (section III.O.)
  • Updates to the Quality Payment Program (section IV.)
  • Physician Self-Referral Law: Annual Update to the List of CPT/HCPCS Codes (section V.)
  • Waiver of Delay in Effective Date for this Final Rule (section VI.)
  • Collection of Information Requirements (section VII.)
  • Regulatory Impact Analysis (section VIII.)

2. Provisions Related to the PHE for COVID-19

The United States is currently responding to an outbreak of respiratory disease caused by a novel (new) coronavirus. This virus has been named “severe acute respiratory syndrome coronavirus 2” (“SARS-CoV-2”), and the disease it causes has been named “coronavirus disease 2019” (“COVID-19”). On January 31, 2020, the Secretary determined that a PHE existed nationwide as a result of the consequences of the COVID-19 pandemic (hereafter referred to as the PHE for COVID-19). On March 13, 2020, President Trump declared the COVID-19 pandemic a national emergency. Effective, October 23, 2020, the Secretary renewed the January 31, 2020 determination that a PHE exists and has existed since January 27, 2020. (Note: This declaration was previously renewed on April 21, 2020 and July 25, 2020.)

As the healthcare community continues to establish and implement recommended infection prevention and control practices, regulatory agencies operating under appropriate waiver authority during the PHE for COVID-19 are also working to revise and implement regulations that support these healthcare community infection prevention and treatment practices. We addressed some of these regulations in three previous interim final rules with comment period (IFCs):

  • The “Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” IFC appeared in the April 6, 2020 Federal Register (85 FR 19230) with an effective date of March 31, 2020 (hereafter referred to as the “March 31st COVID-19 IFC”);
  • The “Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program” IFC appeared in the May 8, 2020 Federal Register (85 FR 27550) with an effective date of May 8, 2020 (hereafter referred to as the “May 8th COVID-19 IFC”); and
  • The “Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” IFC appeared in the September 2, 2020 Federal Register (85 FR 54820) with an effective date of September 2, 2020 (hereinafter referred to as the “September 2nd COVID-19 IFC).

In this final rule, we are finalizing certain provisions of the March 31st, May 8th, and September 2nd COVID-19 IFCs.

We indicated in the CY 2021 PFS proposed rule (85 FR 50140 and 50147) our intent that for certain provisions of the March 31st, May 8th, and September 2nd COVID-19 IFCs, we would respond to comments received in this final rule. In this final rule, we are responding to public comments and finalizing certain provisions of the March 31st, May 8th, and September 2nd COVID-19 IFCs.

3. Summary of Costs and Benefits

We have determined that this final rule is economically significant. For a detailed discussion of the economic impacts, see section VIII. of this final rule.

4. Waiver of the 60-Day Delay in Effective Date for the Final Rule

The United States is responding to an outbreak of respiratory disease caused by a novel (new) coronavirus that has now been detected in more than 190 Start Printed Page 84475locations internationally, including in all 50 States and the District of Columbia. The virus has been named “SARS CoV 2” and the disease it causes has been named “Coronavirus disease 2019” (abbreviated “COVID-19”).

Due to the significant devotion of resources to the COVID-19 response, as discussed in section VI. of the preamble of this final rule, we are hereby waiving the 60-day delay in the effective date for this final rule as proposed, and replacing it with a 30-day delay in the effective date for this final rule.

II. Summary of the Proposed Provisions, Analysis of and Response to Public Comments, and the Provisions of the Final 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 (Pub. L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November 5, 1990) (OBRA '90). 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 final 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, enacted on 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 (Pub. L. 105-33, enacted on August 5, 1997) (BBA `97) 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 (Pub. L. 106-113, enacted on November 29, 1999) (BBRA) 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 Start Printed Page 84476these 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 comment 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. 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 VIII. of this final 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 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 Start Printed Page 84477that 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, nationally 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 2021 PFS Final Rule PE/HR” on the CMS website under downloads for the CY 2021 PFS final rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

As noted above, we have established PE/HR values for various specialties without SMS or PPIS survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. On this note, stakeholders have raised concerns regarding the appropriate specialty crosswalk used for home PT/INR monitoring services. These services are currently classified under the independent diagnostic testing facilities (IDTF) specialty for PE/HR purposes, due to a lack of survey data for these services, and stakeholders have suggested to CMS that this specialty does not reflect the indirect costs associated with furnishing these services. Stakeholders have raised concerns that the practice pattern of PT/INR monitoring services are markedly different from that of the dominant parent specialty as most of the services are furnished remotely and require long-term relationship with beneficiaries similar to chronic therapy. Stakeholders also stated that this is a unique request due to the lack of home PT/INR monitoring supplier involvement in the last PPIS, and that payments for these services are derived from previously used supplemental survey data from the Association for Quality Imaging (AQI), blended with supplementary survey data from the American College of Radiology (ACR)—neither of which reflect indirect cost inputs for home PT/INR monitoring.

Therefore, we are solicited comment from the public regarding the most accurate specialty crosswalk to use for indirect PE when it comes to home PT/INR monitoring services. We sought information on any additional costs associated with these services that are not reflected in our currently assigned PE/HR for independent diagnostic testing facilities, as well as which specialties would best capture these costs through the use of a crosswalk.

We received public comments on our comment solicitation regarding the most accurate specialty crosswalk to use for indirect PE for home PT/INR monitoring services. The following is a summary of the comments we received and our responses.

Comment: Several commenters stated that they had numerous concerns about the labor, supplies, equipment, and utilization associated with home PT/INR monitoring services. Commenters questioned why the typical clinical staff type for these services is an RN when 95 percent of Medicare claims for HCPCS code G0248 indicate that the service is instead furnished by the IDTF provider specialty. Commenters also questioned the clinical staff labor associated with HCPCS code G0249, as the commenters stated that they did not believe that an electrodiagnostic technologist is the appropriate clinical staff type since these technologists furnish cardiac event monitoring (CEM)-related services, not PT/INR monitoring services. Commenters stated that they believed a patient education booklet is likely a duplicative supply item for HCPCS code G0248, as the patient is expected to have already received booklet(s) related to anticoagulation at previous physician visits, and a free booklet is also supplied with INR meters. Commenters also questioned the discrepancy between the description and billing rules for this code, which state that four tests are performed, and the supply details for this code, which include supplies for six tests. Commenters stated that CMS should decrease the minutes assigned to the home INR monitor (EQ031) equipment and questioned whether this frequency of physician review meets Medicare medical necessity criteria for all patients receiving such services. One commenter submitted a shipping invoice for the INR test strip (SJ055) supply.

Response: We appreciate the additional information provided by the commenters regarding the direct PE inputs and claims data utilization for home PT/INR monitoring services. However, our comment solicitation Start Printed Page 84478sought information regarding the most accurate specialty crosswalk to use for indirect PE as well as which specialties would best capture these costs through the use of a crosswalk. We did not propose to make revisions to the direct PE inputs or conduct a review of the Medicare claims data. Although we appreciate the information provided by the commenters, we are not finalizing any changes to the direct PE inputs for home PT/INR monitoring services. With regard to the shipping invoice for the INR test strip supply, we welcome the submission of invoices or other pricing information as part of our ongoing market-based supply and equipment pricing update. However, this invoice listed the transportation costs of shipping the test strips and not the price of the test strips themselves, and as a result we were unable to make use of it.

Comment: Many commenters stated that there were inherent differences between home PT/INR monitoring services and independent diagnostic testing facilities. Several commenters stated that given the significant changes to technology and associated decrease in costs since the IDTF PE/HR value was first developed, they believed that many of the indirect PE inputs originally recognized for IDTFs in 2007 no longer apply in 2020 and home PT/INR monitoring services should no longer be crosswalked to them. Several commenters stated that typical IDTF services include the use of large, capital-intensive equipment while home PT/INR monitoring services typically involve the use of equipment by a patient in his/her home, frequently intended for use for the remainder of the patient's life—more like a therapeutic device than a diagnostic one. Several commenters emphasized that PT/INR monitoring services are very different from typical imaging and scanning services provided by IDTFs, and because there are so few suppliers of home PT/INR monitoring services, the distribution of direct and indirect costs and the indirect practice cost index (IPCI) applied to IDTFs do not accurately reflect indirect resources expended by the specialty suppliers of home PT/INR monitoring.

Several commenters provided feedback regarding the most accurate specialty crosswalk to use for indirect PE when it comes to home PT/INR monitoring services. Several commenters submitted data indicating that the direct to indirect cost percentages used to furnish home PT/INR monitoring are in the range of 31:69 rather than the approximately 50:50 currently considered in determining the PE RVUs for these services as IDTFs. These commenters recommended a crosswalk to the Pathology or All Physicians specialty type based on the submitted data. One commenter stated that they were not equipped to say which specific indirect factors may be optimal for crosswalk due to a lack of information on direct and indirect cost data from the suppliers but did wish to highlight the importance of ensuring sure that home PT/INR monitoring rates are adequate to assure access. Several commenters stated that the payment rates for these services have fallen dramatically over the past several years and they were very concerned about the impact of these cuts on patient access to these critically important services.

Response: We appreciate the detailed feedback from the commenters regarding home PT/INR monitoring services and especially the submission of data associated with the direct to indirect cost percentages. We also share the concerns of the commenters regarding maintaining access to care for these services. After consideration of the comments, we are finalizing a crosswalk to the General Practice specialty to use for indirect PE when it comes to home PT/INR monitoring services (HCPCS codes G0248, G0249, and G0250). The data submitted by the commenters indicated that the direct to indirect cost percentages to furnish home PT/INR monitoring are in the range of 31:69, similar to the ratio associated with the General Practice specialty. We also share the concerns of the commenters who were uncertain which specific indirect factors may be optimal for crosswalking due to a lack of information, and we believe that the broad nature of the General Practice specialty will serve as a more accurate proxy for home PT/INR monitoring services as opposed to trying to select a more specific specialty designation.

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 on the basis of 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, the 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 Start Printed Page 84479cost 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 2021 PFS final 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 final 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.

We received public comments on the proposed list of expected specialty assignments for CY 2021. The following is a summary of the comments we received and our responses.

Comment: One commenter stated that the 2021 expected specialty assignment for the low volume services code list included a number of services that were reassigned from cardiac surgery to thoracic surgery in CY 2020. The commenter identified these services and stated that they had concerns that CMS had erroneously assigned them as thoracic surgery procedures instead of cardiac surgery procedures. The commenter requested that CMS to correct the list and permanently assign the identified codes to the requested thoracic surgery specialty assignment.

Response: We finalized a proposal in CY 2020 to update the expected specialty list to accurately reflect a previously finalized crosswalk to thoracic surgery for the services in question. As we stated at the time, we did not finalize a proposal to assign the codes in question to the cardiac surgery specialty. Instead, we finalized a proposal to update the incorrect Start Printed Page 84480documentation in our expected specialty list to accurately reflect a previously finalized crosswalk to thoracic surgery for these services. The previously finalized assignment of the cardiac specialty to these services has been in place since the CY 2012 rule cycle, and we believe that the expected specialty list should be updated to reflect the correct specialty assignment. We did not propose to make further changes to the anticipated specialty assignment of these codes for CY 2021 and we are not finalizing any changes. We direct readers to the discussion of this topic in the CY 2020 PFS final rule (84 FR 62574 through 62578) and we reiterate again that we do not anticipate this finalized proposal having a discernible effect on the valuation of the affected codes due to the similarity between the cardiac surgery and thoracic surgery specialties.

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 allocator 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 84481

  • 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 84482

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.

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 final 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 final 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.

We received public comments on equipment utilization rate assumptions. The following is a summary of the comments we received and our responses.

Comment: Several commenters requested that CMS review the utilization assumptions for equipment due to decreased practice capacity during the public health emergency (PHE) for COVID-19. Commenters stated that equipment was used less frequently than normal and that this should be reflected in the equipment utilization rate. Commenters stated that any modifications to the equipment utilization during the public health emergency also should not be subject to budget neutrality.

Response: We disagree with the commenters that utilization assumptions for equipment should be revisited as part of the public health emergency. While we agree that many services had a reduced volume of Medicare beneficiaries at times during the 2020 calendar year, we note that equipment costs under the PFS are amortized across the full useful life of the equipment which in the vast majority of cases is 5-10 years. We believe that it would distort relativity to apply a temporary decrease in utilization caused by the public health emergency to the pricing structure of the equipment's full useful life duration. We also note that we do not have statutory authority to exempt any modifications to the equipment utilization assumptions from budget neutrality calculations.

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.

In the CY 2021 PFS proposed rule, we noted that stakeholders including the RUC, specialty societies, and other commenters suggested a useful life of less than 1 year for several of the new equipment items for CY 2021, and as low as 3 months in one case. We have rarely, if ever, received requests for equipment useful life of less than one Start Printed Page 84483year in duration and note that these very short useful life durations are significantly lower than anything in our current equipment database, and if finalized would represent major outliers when compared to the rest of the equipment. Table 3 details the distribution of useful life durations of the equipment currently in our database:

As Table 3 demonstrates, the vast majority of equipment items have a useful life duration of 5 to 10 years, and only 4 out of the 777 equipment codes have a useful life duration of less than 3 years. We also noted that due to the formula used to calculate the equipment cost per minute, decreasing the useful life of any equipment item from 5 years to 3 months has the same effect as increasing the price of the equipment 20 times over. In other words, decreasing the useful life from 5 years to 0.25 years has the same multiplicative effect as increasing the price of the equipment from $5,000 to 100,000 due to the formula listed above. Since we currently do not have any equipment items in our database with a useful life of less than one year, we proposed a clarification on how to address these cases.

We disagreed that assigning a useful life at these very short durations would be typical for new equipment, especially in light of the data provided by the AHA's “Estimated Useful Lives of Depreciable Hospital Assets” reference. The equipment life durations listed in Table 3 were finalized over the last 15 years through the use of this reference material. We noted concerns that assigning very low useful life durations to equipment items would fail to maintain relativity with other equipment on the PFS, effectively assigning a much higher price than other equipment items with more typical useful life durations. We noted that we believe that equipment items with very low useful life durations represent outlier cases that are not handled appropriately by the current equipment methodology and which we clarified through this rulemaking. We also noted that the equipment cost per minute formula was designed under the assumption that each equipment item would remain in use for a period of several years and depreciate over that span of time. Our current equipment formula is not designed to address cases in which equipment is replaced multiple times per year, and we believe that applying a multi-year depreciation in these situations would not be reflective of market pricing. We noted that we did not believe that items which are replaced on a monthly basis can be accurately priced using a formula which assumes they will be in use for years at a time, and that the use of such a formula would distort relativity with the overwhelming majority of equipment items which are in use for 5-10 years.

Therefore, we proposed 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. We noted that we believe that this is the most accurate way to incorporate these short equipment life durations within the framework of our current methodology. In the rare cases where items are replaced every few months, we noted that we believe that 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 example, we proposed to establish the EECP compression equipment package (SD341) and the EECP electrical equipment package (SD342) as disposable supplies instead of equipment items as described in the Valuation of Specific Codes (section II.H. of this final rule) portion of the preamble. We noted that we expect these situations to occur only rarely, and we will evaluate them on an individual case-by-case basis. Our criteria will be based on whether or not the item in question could be more accurately classified as a disposable supply while maintaining overall relativity within our PE methodology. We welcomed additional comments from stakeholders regarding the subject of useful life durations for new equipment items with unique useful life durations as described above and any additional suggestions on alternative ways to incorporate these items into our methodology or potential wider changes to the equipment cost per minute formula more broadly.

We received public comments on our proposals associated with equipment life duration. The following is a summary of the comments we received and our responses.

Comment: A commenter stated that although they had asked CMS to use 0.75 years as the useful life duration for the radionuclide rod source set (ER044) equipment, the commenter recognized that one year was in accordance with the CMS policy to treat equipment useful life durations of less than one year as having a duration of one year.

Response: We appreciate the feedback from the commenter and the acknowledgment of our proposed policy.

After consideration of the public comments, we are finalizing our 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 that 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.

  • Maintenance: This factor for maintenance was finalized 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 Start Printed Page 84484noted 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 that 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 4.

We did not propose any changes to the equipment interest rates for CY 2021.

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 2021 direct PE input public use files, which are available on the CMS website under downloads for the CY 2021 PFS final 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 codes 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.Start Printed Page 84485

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 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 2021, 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 2021 PFS final rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

b. Equipment Recommendations for Scope Systems

During our routine reviews of direct PE input recommendations, we have regularly found unexplained inconsistencies involving the use of scopes and the video systems associated with them. Some of the scopes include video systems bundled into the equipment item, some of them include scope accessories as part of their price, and some of them are standalone scopes with no other equipment included. It is not always clear which equipment items related to scopes fall into which of these categories. We have also frequently found anomalies in the equipment recommendations, with equipment items that consist of a scope and video system bundle recommended, along with a separate scope video system. Based on our review, the variations do not appear to be consistent with the different code descriptions.

To promote appropriate relativity among the services and facilitate the transparency of our review process, during the review of the recommended direct PE inputs for the CY 2017 PFS proposed rule, we developed a structure that separates the scope, the associated video system, and any scope accessories that might be typical as distinct equipment items for each code. Under this approach, we proposed standalone prices for each scope, and separate prices for the video systems and accessories that are used with scopes.

(1) Scope Equipment

Beginning in the CY 2017 PFS proposed rule (81 FR 46176 through 46177), we proposed standardizing refinements to the way scopes have been defined in the direct PE input database. We believe that there are four general types of scopes: Non-video scopes; flexible scopes; semi-rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and rigid scopes would typically be paired with one of the scope video systems, while the non-video scopes would not. The flexible scopes can be further divided into diagnostic (or non-channeled) and therapeutic (or channeled) scopes. We proposed to identify for each anatomical application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. We proposed to classify the existing scopes in our direct PE database under this classification system, to improve the transparency of our review process and improve appropriate relativity among the services. We planned to propose input prices for these equipment items through future rulemaking.

We proposed these changes only for the reviewed codes for CY 2017 that made use of scopes, along with updated Start Printed Page 84486prices for the equipment items related to scopes utilized by these services. We did not propose to apply these policies to codes with inputs reviewed prior to CY 2017. We also solicited comment on this separate pricing structure for scopes, scope video systems, and scope accessories, which we noted we could consider proposing to apply to other codes in future rulemaking. We did not finalize price increases for a series of other scopes and scope accessories, as the invoices submitted for these components indicated that they are different forms of equipment with different product IDs and different prices. We did not receive any data to indicate that the equipment on the newly submitted invoices was more typical in its use than the equipment that we were currently using for pricing.

We did not make further changes to existing scope equipment in CY 2017 to allow the RUC's PE Subcommittee the opportunity to provide feedback. However, we believed there was some miscommunication on this point, as the RUC's PE Subcommittee workgroup that was created to address scope systems stated that no further action was required following the finalization of our proposal. Therefore, we made further proposals in the CY 2018 PFS proposed rule (82 FR 33961 through 33962) to continue clarifying scope equipment inputs, and sought comments regarding the new set of scope proposals. We considered creating a single scope equipment code for each of the five categories detailed in this rule: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. Under the current classification system, there are many different scopes in each category depending on the medical specialty furnishing the service and the part of the body affected. We stated our belief that the variation between these scopes was not significant enough to warrant maintaining these distinctions, and we believed that creating and pricing a single scope equipment code for each category would help provide additional clarity. We sought public comment on the merits of this potential scope organization, as well as any pricing information regarding these five new scope categories.

After considering the comments on the CY 2018 PFS proposed rule, we did not finalize our proposal to create and price a single scope equipment code for each of the five categories previously identified. Instead, we supported the recommendation from the commenters to create scope equipment codes on a per-specialty basis for six categories of scopes as applicable, including the addition of a new sixth category of multi-channeled flexible video scopes. Our goal was to create an administratively simple scheme that would be easier to maintain and help to reduce administrative burden. In 2018, the RUC convened a Scope Equipment Reorganization Workgroup to incorporate feedback from expert stakeholders with the intention of making recommendations to us on scope organization and scope pricing. Since the workgroup was not convened in time to submit recommendations for the CY 2019 PFS rulemaking cycle, we delayed proposals for any further changes to scope equipment until CY 2020 in order to incorporate the feedback from the aforementioned workgroup.

(2) Scope Video System

We proposed in the CY 2017 PFS proposed rule (81 FR 46176 through 46177) to define the scope video system as including: (1) A monitor; (2) a processor; (3) a form of digital capture; (4) a cart; and (5) a printer. We believe that these equipment components represent the typical case for a scope video system. Our model for this system was the “video system, endoscopy (processor, digital capture, monitor, printer, cart)” equipment item (ES031), which we proposed to re-price as part of this separate pricing approach. We obtained current pricing invoices for the endoscopy video system as part of our investigation of these issues involving scopes, which we proposed to use for this re-pricing. In response to comments, we finalized the addition of a digital capture device to the endoscopy video system (ES031) in the CY 2017 PFS final rule (81 FR 80188). We finalized our proposal to price the system at $33,391, based on component prices of $9,000 for the processor, $18,346 for the digital capture device, $2,000 for the monitor, $2,295 for the printer, and $1,750 for the cart. In the CY 2018 PFS final rule (82 FR 52991 through 52993), we outlined, but did not finalize, a proposal to add an LED light source into the cost of the scope video system (ES031), which would remove the need for a separate light source in these procedures. We also described a proposal to increase the price of the scope video system by $1,000 to cover the expense of miscellaneous small equipment associated with the system that falls below the threshold of individual equipment pricing as scope accessories (such as cables, microphones, foot pedals, etc.). With the addition of the LED light (equipment code EQ382 at a price of $1,915), the updated total price of the scope video system would be set at $36,306.

We did not finalize this updated pricing to the scope video system in CY 2018, but we did propose and finalize the updated pricing for CY 2019 to $36,306 along with changing the name of the ES031 equipment item to “scope video system (monitor, processor, digital capture, cart, printer, LED light)” to reflect the fact that the use of the ES031 scope video system is not limited to endoscopy procedures.

(3) Scope Accessories

We understand that there may be other accessories associated with the use of scopes. We finalized a proposal in the CY 2017 PFS final rule (81 FR 80188) to separately price any scope accessories outside the use of the scope video system, and individually evaluate their inclusion or exclusion as direct PE inputs for particular codes as usual under our current policy based on whether they are typically used in furnishing the services described by the particular codes.

(4) Scope Proposals for CY 2020

The Scope Equipment Reorganization Workgroup organized by the RUC submitted detailed recommendations to CMS for consideration in the CY 2020 rule cycle, describing 23 different types of scope equipment, the HCPCS codes associated with each scope type, and a series of invoices for scope pricing. Based on the recommendations from the workgroup, we proposed to establish 23 new scope equipment codes. For the eight new scope equipment items where we received submitted invoices for pricing, we proposed to replace the existing scopes with the new scope equipment at the same amount of equipment time. This scope replacement involved approximately 100 HCPCS codes in total and was detailed in a table published in the CY 2020 PFS proposed rule (84 FR 40495 through 40498). We noted that we did not receive pricing information along with the workgroup recommendations for the other 15 new scope equipment items. Therefore, although we proposed to establish new equipment codes for these scopes, we did not propose to replace existing scope equipment with the new equipment items as we did for the other eight new scope equipment items for CY 2020.

Following the publication of the CY 2020 PFS proposed rule, commenters provided additional information regarding pricing for the new scope equipment and their associated HCPCS Start Printed Page 84487codes. Based on this information provided by the commenters, we finalized a price for eight additional new scope equipment items and finalized the replacement of the existing scopes with the new scope equipment at the same amount of equipment time for approximately two dozen additional HCPCS codes (84 FR 62593 through 62595). Table 5 lists the CY 2020 finalized price for the new scope equipment codes:

We noted that although we updated the scope equipment pricing for CY 2020 such that the ES087 and ES089 scopes shared the same price with the ES088 scope, and the ES090 scope shared the same price with the ES085 scope, we did not mean to suggest that these scopes that shared pricing were identical with one another. We assigned the same price to these scopes because they replaced the same current scope equipment codes, and because we did not have individual pricing information for them. We noted in the CY 2021 PFS proposed rule (85 FR 50087) that we remain open to the submission of additional invoices to establish individual pricing for these scopes, and we welcomed more data to help identify pricing for the remaining seven scope equipment codes that still lack invoices.

(5) Scope Proposals for CY 2021

We did not receive further recommendations from the Scope Equipment Reorganization Workgroup organized by the RUC following the publication of the CY 2020 PFS final rule. However, we did receive invoices associated with the pricing of the scope video system (monitor, processor, digital capture, cart, printer, LED light) (ES031) equipment item as part of the review of the Esophagogastroduodenoscopy (EGD) with Biopsy and the Colonoscopy code families. We previously finalized a price of $36,306 for the ES031 equipment based on the sum of component prices of $9,000 for the processor, $18,346 for the digital capture device, $2,000 for the monitor, $2,295 for the printer, $1,750 for the cart, $1,915 for the LED light, and $1,000 to cover the expense of miscellaneous small equipment associated with the system that falls below the threshold of individual equipment pricing as scope accessories (such as cables, microphones, foot pedals, etc.) We received 37 invoices associated with the components of the ES031 scope video system, which averaged out to prices of $21,988.89 for the processor, $16,175.87 for the digital capture device, $6,987.56 for the monitor, $7,922.80 for the printer, $4,945.45 for the cart, and $12,652.82 for the LED light. Based on the sum of these component prices, we proposed to update the price the ES031 scope video system equipment to $70,673.38. We did not propose to include an additional $1,000 to cover the expense of miscellaneous small equipment as the products listed on the component invoices indicated that cost of cables were already included in this significantly higher equipment pricing. We solicited additional comments from stakeholders regarding the pricing of the full ES031 scope equipment system as well as its components.

As part of our market-based supply and equipment pricing transition, we finalized a policy in CY 2019 to phase in any updated pricing established during the 4-year transition period for very commonly used supplies and equipment that are included in 100 or more codes, even if invoices are provided as part of the formal review of a code family (83 FR 59473 through 59475). Because the ES031 scope equipment system is utilized by more than 250 HCPCS codes, we proposed to transition this pricing increase over the remaining 2 years of the pricing update, Start Printed Page 84488such that the CY 2021 equipment price will be $53,489.69 before moving to its destination price of $70,673.38 in CY 2022. We noted that this transition policy also applies to the price of the suction machine (Gomco) (EQ235) equipment, which, although it is not a scope, is utilized by approximately 360 HCPCS codes, and therefore, is another example of this pricing transition policy. We proposed to transition the EQ235 pricing increase over the remaining 2 years of the pricing update, such that the CY 2021 equipment price would be $1,981.66 before moving to its destination price of $ $3,195.85 in CY 2022. As we stated previously, this policy was intended to minimize any potential disruptive effects during the pricing transition period due to the high number of services that make use of these very common supply and equipment items included in 100 or more HCPCS codes.

We also received invoices for the colonoscopy videoscope (ES033) and gastroscopy videoscopy (ES034) as part of the review of the Esophagogastroduodenoscopy (EGD) with Biopsy and the Colonoscopy code families. We finalized the replacement of both of these scope equipment items in the CY 2020 PFS final rule (84 FR 62588 through 62590), replacing the colonoscopy videoscope (ES033) with the multi-channeled flexible digital scope, colonoscopy (ES086) equipment item and the gastroscopy videoscopy (ES034) with the multi-channeled flexible digital scope, esophagoscopy gastroscopy duodenoscopy (EGD) (ES087) equipment item. In both cases, the submitted invoices were nearly identical to the finalized prices for the ES086 ($38,058.81) and ES087 ($34,585.35) equipment. We believe that these invoices reinforce the prices finalized through rulemaking last year, and therefore, we did not propose to further update the prices of these scopes.

We noted that we remain open to further comments regarding the pricing of the remaining seven scope equipment codes that still lack invoices, as well as additional data regarding the pricing of the scope equipment codes that currently share the same price.

We received public comments on our proposals associated with equipment recommendations for scope systems. The following is a summary of the comments we received and our responses.

Comment: Several commenters thanked CMS for updating the prices of the scope video system (ES031) and Gomco suction machine (EQ235) to reflect the submitted invoices. Commenters stated that they supported the proposed transition in price increase for both pieces of equipment over the remaining 2 years of the pricing update and supported the ES031 price update to correctly account for the cost of the various components included in this scope video system.

Response: We appreciate the support for our proposals from the commenters.

Comment: A commenter stated that although they appreciated CMS's efforts to ensure the accuracy of the inputs for scope equipment, the price inputs for scope video systems do not capture all of the costs needed for near infrared fluorescence visualization with 4K monitors. The commenter stated that the actual cost of these processor, monitor, and digital capture device components are 45 to 97 percent higher than current CMS prices. The commenter encouraged CMS to seek additional price inputs for this newer technology and planned to submit invoices to demonstrate the costs related to the near infrared fluorescence scope video price inputs.

Response: We appreciate the feedback from the commenter regarding the costs associated with new technology being incorporated into scope video systems and we look forward to the submission of invoices or other data sources with additional pricing information. However, in the absence of information demonstrating these additional costs, we will continue to maintain our current scope pricing.

Comment: A commenter submitted invoices associated with three of the eight scope equipment items that still lacked a price: The cystoscopy rigid scope (ES070), the cystoscopy channeled flexible digital scope (ES081), and the hysteroscopy channeled flexible digital scope (ES082). The commenter stated that these invoices were representative of national pricing for these scopes and compiled a list of procedures associated with these scopes. This procedure list submitted by the commenter also included the hysteroscopy rigid scope, channeled (ES071) equipment item which was previously priced in CY 2020.

Response: We appreciate the additional pricing information submitted by the commenter in helping us assign a price to the remaining scope equipment codes. Based on this information, we are finalizing a price of $7,270.00 for the rigid scope, cystoscopy (ES070) equipment, a price of $22,274.36 for the channeled flexible digital scope, cystoscopy (ES081) equipment, and a price of $19,081.82 for the channeled flexible digital scope, hysteroscopy (ES082) equipment. When added to the previously finalized prices for the other scope equipment items from CY 2020, the total list is shown in Table 6.

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With regard to the procedure list submitted by the commenter, we are not finalizing the replacement of any current scope equipment with the new scope equipment codes. We did not propose to make any such replacements in the proposed rule and we had reservations about some of the procedures on the submitted list, which included CPT codes that currently do not contain scopes or any direct PE inputs at all in some cases. We appreciate the submission of this additional information from the commenter and we will consider the procedure list for potential use in future rulemaking.

After consideration of the public comments, we are finalizing our proposal to update the price the ES031 scope video system equipment to $70,673.38 along with our proposed update to the price of the suction machine (Gomco) (EQ235) equipment. We are also finalizing the price for the three new scope equipment items as detailed above.

c. Technical Corrections to Direct PE Input Database and Supporting Files

For CY 2021, we proposed to address the following inconsistencies:

  • Following the publication of the CY 2020 PFS final rule, stakeholders contacted CMS and clarified that CPT code 0466T (Insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator) is always performed on an add-on basis and would never be used as a standalone code. Therefore, we proposed to update the global period for CPT code 0466T to add-on status (ZZZ) to more accurately reflect the way in which this service is performed.

We received public comments on the technical corrections to direct PE input database and supporting files. The following is a summary of the comments we received and our responses.

Comment: A commenter stated that they supported the proposed change to the global period of CPT code 0466T and agreed that this technical correction was appropriate.

Response: We appreciate the support for our proposal from the commenter.

Comment: Several commenters stated that in the direct PE inputs for CPT code 33202 (Insertion of epicardial electrode(s); open incision (e.g., thoracotomy, median sternotomy, subxiphoid approach)), there are two tables listed under the equipment inputs: An exam table (EF023) and a power table (EF031). Commenters stated that spreadsheet information from CPT 2007 listed a power table and an exam light for this service, not an exam table. Commenters stated that it seemed likely that this was an accidental data entry error and requested that the equipment inputs for CPT code 33202 be corrected in the CMS equipment database to include a power table and exam light.

Response: We agree with the commenters that this was likely a data entry error confusing the exam light with the exam table. Based on the information supplied by the commenters, we are finalizing the replacement of the exam table with an exam light (EQ168) at the same equipment time of 36 minutes for CPT code 33202.

Comment: Several commenters stated that in the 2020 CMS direct PE inputs supplies listing, the “unit” type is missing for the skin prep barrier wipes (SM029) supply. Commenters stated that although this omission does not affect pricing, it makes it ambiguous what the units mean and could have an unintended impact if there are multiple different possible unit types, such as a liquid, where it would be unclear if it were ounces, milliliters, or something else. Commenters recommended that each supply item in the CMS database should have a unit type and provided a list of the supply items in the CY 2020 PFS final rule that were missing a unit type, with potential unit type suggestions for each item.Start Printed Page 84490

Response: We agree with the commenters that each supply item in the CMS database should include a unit type in order to avoid potential confusion regarding pricing. We are finalizing the addition of the unit types as listed in Table 7.

All of the supply items in the CMS database should now include a unit type with the additions from this list. We note that we did not add a unit type for the “No Supplies” (SX007) category as the commenter requested since this is not a supply item.

Comment: Several commenters questioned the proposed RVUs associated with several occupational therapy evaluation procedures (CPT codes 97165-97167). Commenters stated that the PE valuation for these codes appeared to be illogical, with the proposed valuation of the codes demonstrating an inverse relationship between PE value and complexity. Commenters stated that 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.

Response: We appreciate the commenters bringing this issue to our attention. However, although we agree with the commenters that the proposed valuation of these services is somewhat illogical, we do not agree that their proposed valuation represents a technical error. Although the three codes in question share the same work RVU and the same direct PE inputs, they do not share the same specialty distribution in the claims data and therefore will not necessarily receive the same allocation of indirect PE. In response to the comments, we are implementing a technical change which should ensure that these three services receive the same allocation of indirect PE.

Following the publication of the proposed rule, we also discovered a technical error in the published RVUs for three HCPCS codes. Code G0102 (Prostate cancer screening; digital rectal examination) was assigned the same value as CPT code 99211, the lowest level E/M service, in the CY 2000 PFS final rule (64 FR 59414). Code G0102 was assigned a work RVU of 0.17 which matched the work RVU of CPT code 99211 at the time. However, when we increased the work RVU for CPT code 99211 to 0.18 in CY 2010 as part of the last E/M revalution, the work RVU for HCPCS code G0102 was not increased to match. We are correcting this technical oversight by finalizing an increase in the work RVU of code G0102 from 0.17 to 0.18 to match the previously finalized crosswalk to CPT code 99211.

We also previously finalized and valued in the CY 1998 PFS final rule (62 FR 59082) the following two G codes for use when a barium enema is being substituted for either a screening sigmoidoscopy or screening colonoscopy: HCPCS codes G0106 (Colorectal cancer screening; alternative to G0104, screening sigmoidoscopy, barium enema) and G0120 (Colorectal cancer screening; alternative to G0105, screening colonoscopy, barium enema). We established the same RVUs for these screening G codes as for the diagnostic barium enema procedure, CPT code 74280 (Radiologic examination, colon, including scout abdominal radiograph(s) and delayed image(s), when performed; double-contrast (e.g., high density barium and air) study, including glucagon, when administered). The work RVU for codes G0106 and G0120 has matched the work RVU for CPT code 74280 for the last two decades; however, we reviewed CPT code 74280 last year and, in the CY 2020 PFS final rule, increased the work RVU for CPT code 74280 to 1.26. Through an oversight, we did not make corresponding changes in the work RVUs for HCPCS codes G0106 and G0120. We are therefore correcting this technical oversight by finalizing an increase in the work RVU for HCPCS codes G0106 and G0120 to match the previously finalized crosswalk to CPT code 74280.

After consideration of the public comments, we are finalizing our proposals along with the additions as detailed above.Start Printed Page 84491

d. 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 2021, we proposed to update the price of one supply and four equipment items in response to the public submission of invoices. As these pricing updates were each part of the formal review for a code family, we proposed that the new pricing take effect for CY 2021 for these items instead of being phased in over 4 years. These supply and equipment items with updated prices associated with the formal review of a code family are listed in the valuation of specific codes section of the preamble under Table 31: CY 2021 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, enacted 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 84492up” 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 8.

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 84493associated with the market research study to update the PFS direct PE inputs for supply and equipment pricing. We continue to believe that implementing the proposed 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 proposed updated supply and equipment pricing, including the submission of additional invoices for consideration.

For CY 2021, we received invoice submissions for approximately a dozen supply and equipment codes from stakeholders as part of the third year of the market-based supply and equipment pricing update. The submitted invoices were used in many cases to supplement the pricing originally proposed for the CY 2019 PFS rule cycle. We reviewed the invoices, as well as prior 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 research, we proposed to update the prices of the supply and equipment items listed in Table 7 of the CY 2021 PFS proposed rule.

We finalized a policy in CY 2019 to phase in the new supply and equipment pricing over 4 years so that supply and equipment values transition smoothly from their current prices to the final updated prices in CY 2022. We finalized our proposal to implement this pricing transition such that one quarter of the difference between the current price and the fully phased in price was 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 8. For CY 2021, one half of the difference between the CY 2020 price and the final price will be implemented as per the previously finalized policy. Table 9 contains the list of proposed CY 2021 market-based supply and equipment pricing updates:

The prices for the supply and equipment items listed in Table 9 were calculated based on averaging together the prices on the submitted invoices. In the case of the vascular sheath (SD136) and RF endovenous occlusion catheter (SD155) supplies, the price was determined by removing the sheath or catheter from the eight submitted kit invoices and then averaging the resulting price together with the single standalone sheath/catheter invoice.

In addition to submitting invoices with information updating the price of the “Vmax 22d and 62j (PFT equip, autobox, computer system)” (EQ041) equipment, stakeholders also clarified that the “Vmax 229 (spirometry testing equip, computer system)” (EQ040) and “Vmax 29s (spirometry testing equip, computer system)” (EQ043) equipment items have become obsolete and are no longer typically used in any HCPCS codes. Based on the information supplied by the stakeholders, we proposed to remove the EQ040 and EQ043 equipment items, replacing them with the EQ041 equipment at the same number of minutes in the six HCPCS codes where they are utilized.

We did not propose to update the price of additional supply and equipment items for which invoices were submitted following the publication of the CY 2020 PFS final rule. We did not propose to update the price for the “pipette, transfer 23ml” (SL109), “slide specimen mailer (1-5 microscope slides)” (SL121), “stain, hematoxylin” (SL135), “stain, eosin” (SL201), and “stain, PAP OG-6” (SL491) supplies. In each case we received a single invoice for these five supplies detailing price increases ranging from 82 percent to 160 percent above the current pricing. These supplies are commonly used in cytopathology procedures and we disagree that the typical price for these supplies has more than doubled since being reviewed by the StrategyGen contractor 2 years ago for CY 2019.

We also did not propose to update the price for the “embedding mold” (SL060) supply or the “microscope, compound” (EP060) equipment based on the same rationale. The submitted invoices represent pricing increases of 339 percent for the compound microscope and 7800 percent for the embedding mold and, based on the recent review of the pricing of these items by our contractor, we do not believe that the submitted invoices reflect typical market-based pricing. The same stakeholder also submitted an invoice to update the price of the surgical mask (SB033) supply by 617 percent over the current price. However, the invoice in question contains the price for a surgical mask with face shield, which is described by the SB034 supply code, not the SB033 supply code. Therefore, we did not propose to update the price of the surgical mask (SB033) supply based on this invoice. Finally, we received an invoice for a ClosureFast Procedure Pack (CFP) but it was unclear Start Printed Page 84494what supply or equipment item this invoice was intended to update. As a result, we noted in the CY 2021 PFS proposed rule that we were unable to use this invoice to make a pricing proposal.

We received public comments on the market-based supply and equipment pricing update. The following is a summary of the comments we received and our responses.

Comment: Several commenters stated that they continued to support the engagement from the agency to work with CMS contractors and stakeholders to incorporate current pricing data based on invoices into the calculation of direct PE cost. Commenters stated that bringing in an outside vendor in addition to accepting invoices from stakeholders was a reasonable approach, and that the incorporation of this new data and the process for determining what is accepted and what is rejected should be done in a transparent manner. Several different commenters urged CMS to be more deliberate and transparent about this decision-making process regarding supply and equipment pricing.

Response: We appreciate the feedback from the commenters and share the desire for transparency in pricing. We continue to believe that it is important to make use of the most current information available for supply and equipment pricing through the use of market-based research, and we agree with the need to explain the rationale behind the adoption or rejection of invoices submitted by stakeholders. We routinely accept public submission of invoices as part of our process for developing payment rates for new, revised, and potentially misvalued codes. We 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 as part of their public comments or, if outside the public comment process, via email at PE_Price_Input_Update@cms.hhs.gov.

Comment: A commenter stated that they supported the proposed pricing for the UroVysion test kit (SA105) supply. The commenter stated that establishing a price that is in line with invoice pricing ensures that reimbursement for the service reflects accurately the cost of resources involved in providing the service.

Response: We appreciate the support for our proposed pricing from the commenter.

Comment: A commenter disagreed with the proposed pricing of the lysing reagent (FACS) (SL089) supply. The commenter submitted six invoices for the supply and requested that CMS use them to update the pricing.

Response: We appreciate the submission of these additional invoices for use in pricing the SL089 supply. Therefore, we are finalizing an update in the price of this supply to $3.645 as indicated on the submitted invoices. As part of our ongoing pricing transition, the CY 2021 price of the supply will be $3.764 before reaching the finalized price of $3.645 in CY 2022.

Comment: One commenter disagreed with the proposed pricing of the radiofrequency introducer kit (SA026). The commenter stated that although some vendors now include this supply in an overall catheter pack, it is still common that many practices purchase this item separately. The commenter submitted two invoices for the supply and requested that CMS use them to update the pricing.

Response: We appreciate the submission of these additional invoices for use in pricing the SA026 supply. Therefore, we are finalizing an update in the price of this supply to $28.575 based on an average of the prices on the two submitted invoices. As part of our ongoing pricing transition, the CY 2021 price of the SA026 supply will be $32.83 before reaching the finalized price of $28.575 in CY 2022.

Comment: Several commenters disagreed with the proposed pricing of the hydrophilic guidewire (SD089) supply. Commenters stated that $27.76 would be a more appropriate reimbursement rate and submitted an invoice in support of their suggested pricing.

Response: We appreciate the submission of these additional invoices for use in pricing the SD089 supply. We noted that the guidewire on the newly submitted invoice was a different size than the guidewire on the invoice that we previously used for pricing the SD089 supply. Since we do not have information currently available as to which of these guidewires would be more typical, we are averaging together the two submitted invoices for a price of $20.555. As part of our ongoing pricing transition, the CY 2021 price of the SD089 supply will be $29.995 before reaching the finalized price of 20.555 in CY 2022.

Comment: A commenter disagreed with the proposed pricing of the endovascular laser treatment kit (SA074). The commenter stated that they were not sure that the proposed pricing was typical for the average clinic due to the economy of scale advantages available for larger providers. The commenter submitted three invoices for the supply and requested that CMS use them to update the pricing.

Response: We appreciate the submission of these additional invoices for use in pricing the SA074 supply. The unit prices on the three submitted invoices were $431.08 (for a pack of five), $438.60 (for a pack of two), and $535.60 for an individual supply. The price for the individual endovascular laser treatment kit was significantly higher than the other invoice prices and we believe that this price would not be typical in light of the other pricing data that we have available. Therefore, we are finalizing an update in the price of this supply to $438.60 based on taking the median of the submitted invoices which we believe to be more representative of typical pricing. As part of our ongoing pricing transition, the CY 2021 price of the SA074 supply will be $429.88 before reaching the finalized price of $438.60 in CY 2022.

Comment: A commenter disagreed with the proposed pricing of the tubing set (Liposorber) (SC083) and plasma separator (Liposorber) (SD188) supplies. The commenter stated that the proposed prices did not accurately reflect the actual average prices paid by their U.S. provider customers. The commenter submitted 45 invoices for the two supplies and requested that CMS use them to update the pricing.

Response: We appreciate the submission of this large quantity of additional invoices for use in pricing the SC083 and SD188 supplies. After reviewing the invoices, we agree with the commenter that the average sales price matches the numbers listed in their comment letter. Therefore, we are finalizing an update in the price of the SC083 supply to $75.71 and an update in the price of the SD188 supply to $131.42 as indicated on the submitted invoices. As part of our ongoing pricing transition, the CY 2021 price of the SC083 supply will be $62.28 and the CY 2021 price of the SD188 supply will be $113.04 before reaching their finalized prices in CY 2022.

Comment: Several commenters disagreed with the proposed pricing for the RF endovenous ablation catheter (SD 155) and the vascular sheath (SD 136) supplies. Commenters stated that the proposed prices did not reflect the reality of their practice's economics and expressed concern that such reductions could encourage office-based physicians to curtail or cease performing these Start Printed Page 84495procedures. Commenters stated that the proposed pricing for RF catheters and sheaths represented the price being paid by high-volume or large multi-location practices and did not reflect the prices paid by smaller providers who are more typical. Due to the greater negotiating power and high volume discounts available to larger practices, commenters stated that the proposed supply pricing did not seem be to what typical providers pay and that the current pricing of $52.80 was more representative for the vascular sheath. One commenter requested a more thorough review of the data CMS used to determine the updated pricing for the SD136 and SD155 supplies as well as the opportunity to provide additional data to validate their pricing. Several commenters submitted a series of invoices for the RF endovenous occlusion catheter (SD155) that they stated were more typical of pricing and urged CMS to update the supply pricing accordingly.

Response: We appreciate the additional information provided by the commenters regarding the pricing of these supplies, especially the invoices with additional pricing data for the SD155 catheter. The commenters are correct that the proposed pricing for the SD155 supply was based in part on a bulk order and that ordering the catheters on an individual basis resulted in higher prices. However, we do not agree that it would be accurate to base the pricing of the SD155 supply solely on the basis of individual orders with no discounts included, as it is clear from the submitted invoices that there exists a variety of discounts available for providers. Therefore, we are averaging together the newly submitted invoices together with our previous invoices for the SD155 supply and finalizing the resulting price of $487.92. As part of our ongoing pricing transition, the CY 2021 price of the supply will be $562.71 before reaching the finalized price of $487.92 in CY 2022.

We did not receive any invoices with updated pricing information for the vascular sheath (SD136) supply. In the absence of additional information, we believe that the proposed price for the vascular sheath accurately reflects the cost of this supply and we are finalizing the proposed price of $24.44. We continue to welcome the submission of invoices with additional information regarding the pricing of these two or any other supply items.

Comment: Several commenters stated that they believe the HDR Afterload System, Nucletron—Oldelft (ER003) and the SRS System, SBRT, Six Systems (ER083) equipment items remain significantly undervalued relative to fair market pricing. The commenters stated that it was imperative for CMS equipment pricing to accurately reflect marketplace pricing given the high cost of these items and their substantial utilization in certain radiation oncology delivery codes. One commenter stated that the pricing for this equipment may represent a less costly electronic brachytherapy system used to treat skin cancer or an equipment upgrade or refurbished equipment. The commenters requested that CMS conduct additional research regarding fair and accurate market pricing for these two equipment items and accept newly submitted invoices during the 60-day comment period. One commenter requested a one-year moratorium on phasing in the StrategyGen revised pricing inputs and maintain all direct PE inputs at 2020 levels.

Response: We share the desire of the commenter for fair and accurate market-based pricing for these two equipment items. However, both of these equipment items were priced based on research conducted by our StrategyGen contractor and then were updated in response to additional information supplied by commenters in the CY 2019 PFS final rule (83 FR 59478-59479). In the absence of additional information, we believe that the current prices accurately reflect the cost of these equipment items. We continue to welcome the submission of invoices with additional information regarding the pricing of these two or any other equipment items. We also note that the ongoing market-based supply and equipment pricing update was previously finalized in CY 2019 rulemaking and we do not agree that a one-year moratorium on the continuing pricing transition would facilitate our goal of ensuring current pricing.

After consideration of the public comments, we are finalizing our proposals associated with the market-based supply and equipment pricing update as detailed above. Table 10 contains the list of finalized CY 2021 market-based supply and equipment pricing updates:

Start Printed Page 84496

(2) Invoice Submission

The full list of updated supply and equipment pricing as it will be 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 2021 PFS final 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 as part of their public comments or, if outside the public comment process, via email at PE_Price_Input_Update@cms.hhs.gov.

(3) Updated Supply Pricing for Venous and Arterial Stenting Services

Following the publication of the CY 2020 PFS final rule, stakeholders contacted CMS and presented additional information regarding supply pricing for certain venous and arterial stenting services. These stakeholders stated that the use of the “stent, vascular, deployment system, Cordis SMART” (SA103) supply was no longer typical in CPT codes 37238 (Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including angioplasty within the same vessel, when performed; initial vein) and 37239 (Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including angioplasty within the same vessel, when performed; each additional vein). The stakeholders stated that a new venous stent system had become the typical standard of care for these services, and they supplied ten invoices for use in pricing this supply.

The stakeholders also requested additional information regarding the nature of the “stent, balloon, implantable” (SD299) supply included in CPT codes 37236 (Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; initial artery) and 37237 (Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; each additional artery). The stakeholders specifically were unclear what the implantable stent balloon represented and sought guidance on whether pricing involved a stent, a balloon, or a combination of both.

In response to the additional information provided by the stakeholders, we proposed to remove the SA103 supply item from CPT codes 37238 and 37239. We proposed to replace it with a newly created “venous stent system” (SD340) supply at the same supply quantity. We proposed a price of $1,750.00 for the venous stent system based on the median price of the ten invoices supplied by the stakeholders. We proposed the use of the median price due to the presence of several invoices that appear to be outliers, which are not reflective of Start Printed Page 84497market pricing for the venous stent system. With regards to the request for additional information regarding the nature of the “stent, balloon, implantable” (SD299) supply, the original invoice used to price this supply during the CY 2015 rule cycle listed an item named “Renal and Biliary Stent System 7.0 mm × 15 mm × 135 cm”. We welcomed additional information from stakeholders regarding the nature and pricing of this supply item.

We received public comments on our proposals associated with updated supply pricing for venous and arterial stenting services. The following is a summary of the comments we received and our responses.

Comment: Several commenters stated that they supported the proposed change to replace the stent for CPT codes 37238 and 37239. One commenter stated that they appreciated the additional information on the two CPT codes and looked forward to researching this issue further.

Response: We appreciate the support for our proposals from the commenters.

After consideration of the public comments, we are finalizing our proposals associated with updated supply pricing for venous and arterial stenting services.

(4) Myocardial PET Equipment Inputs

Following the publication of the CY 2020 PFS final rule, stakeholders contacted CMS and presented additional information regarding the direct PE inputs for several codes associated with Myocardial PET services. The stakeholders stated that the nuclide rod source set (ER044) equipment was inadvertently excluded from the direct PE recommendations for CPT codes 78432 (Myocardial imaging, positron emission tomography (PET), combined perfusion with metabolic evaluation study (including ventricular wall motion[s] and/or ejection fraction[s], when performed), dual radiotracer (eg, myocardial viability)), 78459 (Myocardial imaging, positron emission tomography (PET), metabolic evaluation study (including ventricular wall motion[s] and/or ejection fraction[s], when performed), single study)), 78491 (Myocardial imaging, positron emission tomography (PET), perfusion study (including ventricular wall motion[s] and/or ejection fraction[s], when performed); single study, at rest or stress (exercise or pharmacologic)), and 78492 (Myocardial imaging, positron emission tomography (PET), perfusion study (including ventricular wall motion[s] and/or ejection fraction[s], when performed); multiple studies at rest and stress (exercise or pharmacologic)), and requested that CMS add this equipment to the direct inputs for this group of CPT codes. The stakeholders also stated that the current useful life of 5 years for the ER044 equipment was incorrect as these sources are replaced every 9 months to 1 year. The stakeholders requested that CMS update the useful life of ER044 to 0.75 years. Finally, the stakeholders stated that the costs for the purchase of the Rubidium PET Generator (ER114) equipment are captured elsewhere through the billing of HCPCS supply code A9555, and the stakeholders recommended that we remove equipment item ER114 to avoid incorrect billing duplication.

We noted that we appreciate the additional information submitted by the stakeholders regarding the direct PE inputs for these Myocardial PET services. In response to this new information, we proposed to update the price for the nuclide rod source set (ER044) equipment to $2,081.17 based on averaging together the price of the three submitted invoices after removing the shipping and delivery costs according to our standard pricing methodology. We also proposed to add the ER044 equipment to CPT codes 78432, 78459, 78491, and 78492 as requested, assigning the same equipment time utilized by the “PET Refurbished Imaging Cardiac Configuration” (ER110) equipment in each service. We proposed to update the useful life of the ER044 equipment to one year in accordance with our proposed policy to treat equipment useful life durations of less than 1 year as having a duration of one year. As we stated previously in section II.B, we have concerns that assigning very low useful life durations of less than 1 year would fail to maintain relativity with other equipment on the PFS, and the equipment cost per minute formula was designed under the assumption that each equipment item would remain in use for a period of several years and depreciate over that span of time. We direct readers to the previous discussion regarding equipment cost per minute methodology earlier in section II.B. of this final rule. Finally, we are removing the “PET Generator (Rubidium)” (ER114) equipment from our database as requested by the stakeholders. We noted that since the technical components for CPT codes 78432, 78459, 78491, and 78492 are all contractor-priced, there will be no change to the national pricing of these codes.

We received public comments on our proposals associated with Myocardial PET equipment inputs. The following is a summary of the comments we received and our responses.

Comment: Several commenters stated that they agreed with and supported all four of the CMS proposals associated with Myocardial PET equipment inputs. Commenters also stated that they supported the decision to maintain contractor pricing for the technical components for all the new and revised Myocardial PET codes. Commenters stated that the standard CMS formula and RUC PE inputs do not allow for certain high-cost expenses that are generally part of overhead to be factored into the RVUs and requested that contractor pricing continue to be maintained for these services.

Response: We appreciate the support for our proposals from the commenters.

After consideration of the public comments, we are finalizing our proposals associated with Myocardial PET equipment inputs.

(5) 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 the 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 the therefore the cost inputs for this supply should be used to establish the RVUs for this code as the current MPFS rate is substantially less than the amount it costs to furnish the 3C patch.

We clarify for stakeholders that the valuation of the direct PE inputs increased for HCPCS code G0460 as a result of the ongoing market-based supply and equipment pricing update. However, there was also a minor Start Printed Page 84498decrease in the indirect PE allocation associated with this service, with the net result that the proposed PE RVU coincidentally ended up remaining the same as in the previous year. We also clarify for stakeholders 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.

We understand that the stakeholders originally believed that the new 3C patch system would be reported using new HCPCS coding before CMS issued a clarification that the clinical trials associated with this supply would be reported under HCPCS code G0460. We share the concerns of the stakeholders that patient access to the 3C patch will be materially impacted if CMS maintains reimbursement for HCPCS G0460 at the current rate. However, we note that we did not propose to increase the price of HCPCS code G0460 in the PFS proposed rule, and we have concerns about finalizing a fivefold increase in the pricing of this service without going through notice and comment rulemaking. Therefore, we are finalizing contractor pricing for HCPCS code G0460 for CY 2021 to allow for increased pricing for this service when it includes the 3C patch system without establishing a new national price. We believe that the use of contractor pricing will allow additional time to determine the most accurate pricing for HCPCS code G0460. We are also adding 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.

(6) Adjustment to Allocation of Indirect PE for Some Office-Based Services

In the CY 2018 PFS final rule (82 FR 52999 through 53000), we established criteria for identifying the services most affected by the indirect PE allocation anomaly that does not allow for a site of service differential that accurately reflects the relative indirect costs involved in furnishing services in nonfacility settings. We also finalized a modification in the PE methodology for allocating indirect PE RVUs to better reflect the relative indirect PE resources involved in furnishing these services. The methodology, as described, is based on the difference between the ratio of indirect PE to work RVUs for each of the codes meeting eligibility criteria and the ratio of indirect PE to work RVU for the most commonly reported visit code. We refer readers to the CY 2018 PFS final rule (82 FR 52999 through 53000) for a discussion of our process for selecting services subject to the revised methodology, as well as a description of the methodology, which we began implementing for CY 2018 as the first year of a 4-year transition.

For CY 2021, we proposed to continue with the fourth and final year of the transition of this adjustment to the standard process for allocating indirect PE.

We did not receive public comments on this provision, and therefore, we are finalizing as proposed.

e. Update on Technical Expert Panel Related to Practice Expense

The RAND Corporation is currently studying potential improvements to CMS' PE allocation methodology and the data that underlie it. As we noted earlier in this section, our current system for setting PE RVUs relies in part on data collected in the Physician Practice Information Survey (PPIS), which was administered by the AMA in CY 2007 and 2008.

RAND, in its first phase of research, available at https://www.rand.org/​pubs/​research_​reports/​RR2166.html, found that the PPIS data are outdated and 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. For example, the PPIS preceded the widespread adoption of electronic health records, quality reporting programs, billing codes that promote team-based care, and hospital acquisition of physician practices. Notably, RAND found that practice ownership was strongly associated with indirect PE, with physician-owned practices requiring 190% higher indirect PE compared to facility-owned practices, suggesting a need to potentially update demographic information. Additionally, RAND found that aggregating Medicare provider specialties into broader categories resulted in small specialty-level impacts relative to the current system, suggesting that specialty-specific inputs may not be required to accurately reflect resource costs.

To follow up on these and other issues raised in the first phase of RAND's research, in the CY 2020 PFS, we announced that RAND was convening a technical expert panel (TEP) to obtain input from stakeholders including physicians, practice and health system managers, health care accountants, and health policy experts. The TEP occurred on January 10, 2020 and its report is available at https://www.rand.org/​pubs/​working_​papers/​WR1334.html. Topics discussed included identifying issues with the current system; changes in medicine that have affected PE; how PE inputs could be updated, including through a potential new survey instrument; how best to aggregate PE categories if there were to be new survey instrument; ways to maximize response rates in a potential new survey; and using existing data to inform PFS PE rates. In addition, RAND has issued the results of its subsequent phase of research, available at www.rand.org/​t/​RR3248. This report is also available as a public use file displayed on the CMS website under downloads for the CY 2021 PFS proposed rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

Based on the results of the TEP and RAND's other ongoing research, we are interested in potentially refining the PE methodology and updating the data used to make payments under the PFS. We believe that potential refinements could improve payment accuracy and strengthen Medicare. Our goals are to balance obtaining the data as soon as practicable and in a way that would allow stakeholders and CMS to collectively examine many of the issues the TEP and RAND's research identified. We noted that we were considering several questions, including how to best incorporate market-based information, which could be similar to the market research that we recently conducted to update supply and equipment pricing used to determine direct PE inputs under the PFS payment methodology. For example, stakeholders have expressed an interest in updating the clinical labor data that we use for direct PE inputs based on current salaries and compensation for the health care workforce. We solicited comment regarding how we might update the clinical labor data. We noted that historically we have used data from the Bureau of Labor Statistics and sought comment to determine if this is the best data source or if there is an alternative. We also noted that we are interested in hosting a Town Hall meeting at a date to be determined to provide an open forum for discussion with stakeholders on our ongoing research to potentially update the PE methodology and the underlying inputs. Finally, we welcomed feedback from all interested parties regarding RAND's report and clarified that we were not making any proposals based on this report for this rulemaking cycle We encouraged stakeholders to submit feedback as part Start Printed Page 84499of their public comments or, if outside the public comment process, via email at PE_Price_Input_Update@cms.hhs.gov.

We received public comments on the update on technical expert panel related to PE. The following is a summary of the comments we received and our responses.

Comment: In response to the RAND report, commenters encouraged CMS to work with stakeholders on any new PE data collection effort.

Response: We agree that we would want to engage with stakeholders as part of any new PE data collection effort. Our public notice and comment rulemaking process is the venue we would use for any potential future proposals.

Comment: Commenters were supportive of CMS convening a Town Hall meeting.

Response: We appreciate and are encouraged by commenters' support. We continue to believe that a Town Hall would provide open forum for discussions with stakeholders. We remain interested in hosting this meeting at a date to be determined.

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.H. of this final 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 law. 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 required 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 Start Printed Page 84500facilitate 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 the “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 2021 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 Start Printed Page 84501organizations, 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

We received submissions nominating codes for review under the potentially misvalued code initiative, and several requests for review of PE related inputs prior to our February 10, 2020 deadline. We refer readers to section II.B. of this final rule, Determination of Practice Expense RVUs, for further discussion on the PE-related submissions. The summary of the submissions reviewed under the potentially misvalued code initiative is discussed below.

We received multiple submissions requesting that CMS consider CPT code 22867 (Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level) for nomination as potentially misvalued. In their request, the submitters suggested that the physician work assigned to this code significantly undervalues the procedure relative to the value of 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). The submitters stated that the work performed during the surgical steps to perform a laminectomy for both procedures is generally similar except for the additional intensity and complexity involved in CPT code 22867 to implant the interspinous stabilization device. The submitters also requested that the malpractice RVUs assigned to this code be increased to better align with similar spine procedures, in terms of specialty-level and service-level risk factors, in addition to the intensity and complexity of the procedure. After considering the information provided by the submitter, which suggests that the current valuation for the service may not reflect the level of intensity inherent in furnishing the service relative to other similar services with inputs that exceed those for the nominated service, we proposed to nominate CPT code 22867 as potentially misvalued and welcomed public comment on this code.

We received public comments on the CY 2021 identification and review of potentially misvalued services. The following is a summary of the comments we received and our responses.

Comment: The AMA RUC has indicated that CPT code 22867 will be placed on a list they call the “next Level of Interest for review.”

Response: We acknowledge and thank the AMA RUC's placement of CPT code 22867 on their “next Level of Interest for review” list and look forward to their input, as well as input from the initial submitters of CPT code 22867 and all other parties.

Comment: Some commenters expressed support for the nomination of CPT code 22867 as a potentially misvalued code, but disagreed with the comparison to CPT code 63047. Some commenters stated that CPT code 22867 was misvalued from its last review in 2016, when CMS determined a work RVU of 13.50 over the AMA RUC recommended work RVU of 15.00. Commenters stated that CMS already has the necessary survey data from the specialties who perform this service—which had been surveyed and reviewed twice by the AMA RUC with the same outcome, and that the procedure's technology has not changed since the last survey. One commenter also highlighted differences between CPT code 63047 and CPT code 22867, noting that CPT code 63047 involves more postoperative work (as an inpatient service), spends more time with intense imaging services and device sizing, and that the decompression performed is more extensive than CPT code 22867, all of which supports the relative greater RVU amount for CPT code 63047.

Response: We acknowledge and appreciate comments and feedback from CPT code 22867 stakeholders who have expressed their reasons both for and against the nomination of this code as potentially misvalued.

Comment: Some commenters requested that CMS nominate HCPCS codes G0442 (Annual alcohol misuse screening, 15 minutes) and G0444 (Annual depression screening, 15 minutes) as potentially misvalued due to the possible misinterpretation of their descriptors. These commenters highlighted that the descriptors may appear to convey that the physician providing the service must provide a full 15 minutes of screening to report either of these services. The commenters stated their understanding of the descriptor to mean “up to 15 minutes” to perform the screenings, and suggested that CMS adjust the official descriptors to say G0442 (Annual alcohol misuse screening, up to 15 minutes) and G0444 (Annual depression screening, up to 15 minutes), and for CMS to provide an educational announcement to clarify the proposed change.

Response: We thank the commenters for these suggestions for clarifications on HCPCS codes G0442 and G0444 descriptors and welcome comments and continued engagement with stakeholders on all aspects of coding that improves accuracy and promotes clarity.

Comment: Several commenters nominated CPT code 49436 (Delayed creation of exit site from embedded subcutaneous segment of intraperitoneal cannula or catheter) as being potentially misvalued, due to the PFS presently only making payment for this service in the facility setting and not in the office setting. Commenters requested that CMS review this code, and value the required resources for correct payment in the office setting. They contend that the procedure can be performed in the office, just as safely as it is done in an ASC or outpatient setting, and that it might be a more convenient site of service for the physician and for the patient. CPT code 49436 helps promote home peritoneal dialysis, which falls in line with the President's Executive Order (E.O.) on Advancing American Kidney Health and keeps patients at home during the PHE for COVID-19 rather than having to travel to a dialysis center three times a week.

Response: While CMS had decided not to nominate CPT code 49436 in the proposed rule as being potentially misvalued, commenters resubmitted their nomination during this comment period. We appreciate all of the comments and feedback that we have received for nominating CPT code 49436 as potentially misvalued and further to consider valuing CPT code 49436 in the office setting. We intend to research the information provided and understand more about the potential impact of valuing CPT code 49436 in the office setting and may consider for future rulemaking.

Comment: Commenters referenced codes that were publicly nominated in CY 2019 as misvalued by a national commercial insurer. The commenter expressed disappointment that CMS accepted these public nominations from a private national commercial insurer, as they could potentially represent a possible conflict of interest in their role Start Printed Page 84502as a private commercial medical insurance and Medicare Advantage payer to the providers of physician services. The commenter urged CMS to evaluate how it considers public nominations from parties with possible conflicts in payment determinations.

Response: CMS will accept and review all public nomination of services that may be potentially misvalued, as appropriate. As we had stated in our CY 2019 PFS final rule, we also reiterate that we continue to be open to reviewing additional and supplemental sources of data furnished by stakeholders, and providing such information to CMS is not limited to the public nomination process for potentially misvalued codes. We encourage stakeholders to continue to provide such information for our consideration, as this information may support CMS' review and refinement of work RVUs that are the basis for payment for many services under the PFS.

Comment: One commenter urged CMS to use its authority to adjust CY 2018 Medicare payments for physicians' services to increase the current rate for managing home patients (CPT code 90966 (End-stage renal disease (ESRD) related services for home dialysis per full month, for patients 20 years of age and older) 6.77 RVU) and to the maximum payment amount for managing in-center patients (CPT code 90960 (End-stage renal disease (ESRD) related services monthly, for patients 20 years of age and older; with 4 or more face-to-face visits by a physician or other qualified health care professional per month) 8.07 RVU); however, no supporting documentation was included with this nomination request.

Response: Should there be compelling evidence of substantial change in the nature of CPT codes 90966 and 90960 and their relationship to each other since their 2018 review, the commenter is free to nominate these codes as potentially misvalued and lend support and evidence to that effect for the next proposed rule.

After consideration of the public comments, we are finalizing our proposal to nominate CPT code 22867 as potentially misvalued. We appreciate all of the comments and information we have received from stakeholders about services that they believe to be potentially misvalued and look forward to receiving new and additional information prior to our February 10th deadline for our next round of rulemaking.

D. Telehealth and Other Services Involving Communications Technology, and Interim Final Rule With Comment Period for Coding and Payment of Virtual Check-In Services

1. Payment for Medicare Telehealth Services Under Section 1834(m) of the Act

As discussed in the CY 2021 PFS proposed rule (85 FR 50095) and in prior rulemaking, several conditions must be met for Medicare to make payment for telehealth services under the PFS. For further details, see the full discussion of the scope of Medicare telehealth services in the CY 2018 PFS final rule (82 FR 53006) and in 42 CFR 410.78 and 414.65.

a. Adding Services 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 (§ 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 clinical benefit 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.

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.

For CY 2021, requests to add services to the Medicare telehealth services list must have been submitted and received by February 10, 2020. 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 2021

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 Start Printed Page 84503services 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 add various services as Medicare telehealth services effective for CY 2021. We also conducted an internal review of potential services to add to the Medicare telehealth services list.

In response to the public health emergency (PHE) for Coronavirus Disease 2019 (COVID-19), CMS undertook emergency rulemaking to add a number of services to the Medicare telehealth services list on an interim final basis. In the “Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” interim final rule with comment period (IFC), (which was issued on March 31, 2020 and appeared in the April 6, 2020 Federal Register (85 FR 19230, 19234 through 19241) (hereinafter referred to as the “March 31st COVID-19 IFC”), on an interim final basis for the duration of the PHE for COVID-19, we also finalized the addition of a number of services to the Medicare telehealth services list on a Category 2 basis. The following is a list of those services:

  • Emergency Department (ED) Visits, Levels 1-5 (CPT codes 99281-99285).
  • Initial and Subsequent Observation and Observation Discharge Day Management (CPT codes 99217-99220; CPT codes 99224-99226; CPT codes 99234-99236).
  • Initial Hospital Care and Hospital Discharge Day Management (CPT codes 99221-99223; CPT codes 99238-99239).
  • Initial nursing facility visits, All levels (Low, Moderate, and High Complexity) and nursing facility discharge day management (CPT codes 99304-99306; CPT codes 99315-99316).
  • Critical Care Services (CPT codes 99291-99292).
  • Domiciliary, Rest Home, or Custodial Care services, New and Established patients (CPT codes 99327-99328; CPT codes 99334-99337).
  • Home Visits, New and Established Patient, All levels (CPT codes 99341-99345; CPT codes 99347-99350).
  • Inpatient Neonatal and Pediatric Critical Care, Initial and Subsequent (CPT codes 99468-99472; CPT codes 99475-99476).
  • Initial and Continuing Intensive Care Services (CPT code 99477-994780).
  • Assessment and Care Planning for Patients with Cognitive Impairment (CPT code 99483).
  • Group Psychotherapy (CPT code 90853).
  • End-Stage Renal Disease (ESRD) Services (CPT codes 90952, 90953, 90959, and 90962).
  • Psychological and Neuropsychological Testing (CPT codes 96130-96133; CPT codes 96136-96139).
  • Therapy Services, Physical and Occupational Therapy, All levels (CPT codes 97161-97168; CPT codes 97110, 97112, 97116, 97535, 97750, 97755, 97760, 97761, 92521-92524, 92507).
  • Radiation Treatment Management Services (CPT codes 77427).

When we previously considered adding these services to the Medicare telehealth services list, either through a public request or through our own internal review, we considered whether these services met the Category 1 or Category 2 criteria. In many cases, we reviewed requests to add these services on a Category 1 basis, but did not receive or identify information that allowed us to review the services on a Category 2 basis. While we stated in the March 31st COVID-19 IFC that we did not believe the context of the PHE for COVID-19 would change the assessment of these services as Category 1, we did reassess all of these services on a Category 2 basis in the context of the widespread presence of COVID-19 in the community.

Given the exposure risks for beneficiaries, the health care work force, and the community at large, we stated that in-person interactions between professionals and patients posed an immediate potential risk that would not have been present when we previously reviewed these services. We were concerned that this new risk created a unique circumstance where health care professionals might have to choose between mitigating exposure risk for themselves and for their patients or seeking Medicare payment for the service. For example, certain persons, especially older adults who are particularly vulnerable to complications from this specific viral infection; those considered at risk because of underlying health conditions; and those known to be recently exposed or diagnosed, and therefore, likely to spread the virus to others, were often being directed by local public health officials to self-isolate as much as possible. At the same time, we noted that the risk to medical professionals treating patients is high and we considered it likely that medical professionals would try to treat patients as effectively as possible without exposing themselves or their patients unnecessarily. We explained that, in some cases, the use of telecommunications technology could mitigate the exposure risk; and in such cases, there is a clear clinical benefit of using such technology in furnishing the service. In other words, patients who should not be seen by a professional in-person due to the exposure risk were highly likely to be without access to clinically appropriate treatment or diagnostic options unless they have access to services furnished through interactive communication technology.

Therefore, in the context of the PHE for COVID-19, we believed that all of the services we added met the Category 2 criteria to be added to the Medicare telehealth services list on the basis that there was a patient population that would otherwise not have access to clinically appropriate treatment. We noted that, as with other services on the Medicare telehealth services list, it may not be clinically appropriate or possible to use telecommunications technology to furnish these particular services to every person or in every circumstance. In the context of the PHE for COVID-19, with specific regard to the exposure risks noted above, we recognized the clinical benefit of access to medically reasonable and necessary services furnished using telecommunications technology as opposed to the potential lack of access that could occur to mitigate the risk of disease exposure.

The following presents a discussion of these services and the related proposals.

After reviewing the requests we received and the services we identified for consideration, we identified the services listed in Table 11 as being sufficiently similar to services currently on the Medicare telehealth services list to be added on a Category 1 basis. Therefore, we proposed to add the services in Table 11 to the Medicare telehealth services list on a Category 1 basis for CY 2021.

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We noted that we believe the services described by the HCPCS codes in Table 11 are similar to services currently on the Medicare telehealth services list. The HCPCS codes G2211 and G2212 are add-on codes to the office/outpatient evaluation and management (O/O E/M) services and are, by definition, part of the O/O E/M services with which they are billed; they cannot be billed with any other codes. These codes were previously described by placeholder HCPCS codes GPC1X and 99XXX (for G2211 and G2212, respectively). For further discussion of these codes, please see section II.F.2.c of this rule. The Assessment of and Care Planning for Patients with Cognitive Impairment was defined as a service meant to be billed in specific clinical scenarios in lieu of a level 5 O/O E/M visit. As such, these services fall within the Category 1 criteria, because they are similar to the office visits that are already on the Medicare telehealth services list. As it describes group therapy, CPT code 90853 is similar to the other group therapy services currently on the Medicare telehealth services list.

While the patient's home cannot serve as an originating site (where the patient is located) for purposes of most Medicare telehealth services, the SUPPORT for Patients and Communities Act amended section 1834(m)(4)(C) of the Act and added a new paragraph at section 1834(m)(7) of the Act to remove geographic limitations and authorize the patient's home to serve as a telehealth originating site for purposes of treatment of a substance use disorder (SUD) or a co-occurring mental health disorder, furnished on or after July 1, 2019, to an individual with a SUD diagnosis. These domiciliary/home visits contain the same elements and similar descriptors to the O/O E/M visits, and therefore, we noted that there is sufficient justification to add them to the Medicare telehealth services list on a Category 1 basis. Additionally, we noted that, due to the vulnerability of this particular patient population that are receiving treatment for a diagnosed SUD or co-occurring mental health disorder, we should maximize the availability of telehealth services for the treatment of SUDs and co-occurring mental health disorders. We also noted that, because the home is not generally a permissible telehealth originating site, these services could be billed when furnished as telehealth services only for treatment of a SUD or co-occurring mental health disorder.

Finally, we received a request to add CPT code 96121 (Neurobehavioral status exam (clinical assessment of thinking, reasoning and judgment, [e.g., acquired knowledge, attention, language, memory, planning and problem solving, and visual spatial abilities]), by physician or other qualified health care professional, both face-to-face time with the patient and time interpreting test results and preparing the report; each additional hour (List separately in addition to code for primary procedure)) on the basis that this is an add-on code to CPT code 96116 (Neurobehavioral status exam (clinical assessment of thinking, reasoning and judgment, [e.g., acquired knowledge, attention, language, memory, planning and problem solving, and visual spatial abilities]), by physician or other qualified health care professional, both face-to-face time with the patient and time interpreting test results and preparing the report; first hour), which is currently on the Medicare telehealth services list. In the past, we have added services to the Medicare telehealth services list that are add-on codes that describe a continuation or additional elements of services currently on the Medicare telehealth services list since the services would only be considered telehealth services when billed as an add-on to codes already on the Medicare telehealth services list (82 FR 53008). Therefore, we proposed to add CPT code 96121 to the Medicare telehealth services list.

We also received a request to add services to the Medicare telehealth services list that do not meet our criteria for addition to the Medicare telehealth services list. We did not propose to add the services listed in Table 12 to the Medicare telehealth services list.

We received a request to add Medical Genetics services to the Medicare telehealth services list. We note that CPT code 96040 is considered bundled into O/O E/M visits, which are already on the Medicare telehealth services list. Therefore, we do not believe it is necessary to add CPT code 96040. As we stated in the CY 2012 PFS final rule Start Printed Page 84506with comment period (76 FR 73096 through 73097), physicians and NPPs who may independently bill Medicare for their services and who are counseling individuals would generally report office or other outpatient E/M CPT codes for office visits that involve significant counseling, including genetic counseling, and these office visit CPT codes are already on the Medicare telehealth services list. CPT code 96040 would only be reported by genetic counselors for genetic counseling services. Genetic counselors are not among the practitioners who can bill Medicare directly for their professional services, and they are also not practitioners who can furnish telehealth services as specified in section 1834(m)(4)(E) of the Act. As such, we noted that we do not believe that it would be necessary or appropriate to add CPT code 96040 to the Medicare telehealth services list.

HCPCS code S0265 is a Medication, Supplies, and Services code. There is no separate payment under the PFS for this category of codes. Therefore, we did not propose to add this service to the Medicare telehealth services list.

We received public comments on the requests to add services to the Medicare telehealth services list for CY 2021. The following is a summary of the comments we received and our responses.

Comment: Commenters broadly supported our proposal to add HCPCS codes and CPT codes 90853, 96121, G2212, 99483, 99334, 99335, 99347, and 99348 to the Medicare telehealth list on a Category 1 basis.

Response: We thank the commenters for their support and feedback.

Comment: One commenter opposed the addition of G2211 to the Medicare telehealth list on the basis they do not agree the creation of the code.

Response: We thank the commenter for their feedback and refer them to section II.F.2.c. of this final rule for further discussion of payment policies for HCPCS code G2211. We note that HCPCS codes G2211 and G2212 replace GPC1X and 99XXX respectively, please see section II.F.2.c in this final rule.

Comment: One commenter requested clarification on the addition of CPT codes 99347 and 99348 (Home visit for the evaluation and management of an established patient). Specifically, the commenter requested clarification from CMS on the situations in which a home visit after the end of the PHE for COVID-19 would be allowed via telehealth.

Response: While the patient's home cannot serve as an originating site (where the patient is located) for purposes of most Medicare telehealth services, the SUPPORT for Patients and Communities Act amended section 1834(m)(4)(C) of the Act and added a new paragraph at section 1834(m)(7) of the Act to remove geographic limitations and authorize the patient's home to serve as a telehealth originating site for purposes of treatment of a SUD or a co-occurring mental health disorder, furnished on or after July 1, 2019, to an individual with a SUD diagnosis. These domiciliary/home visits contain the same elements and similar descriptors to the O/O E/M visits, and therefore, we believe there is sufficient justification to add them to the Medicare telehealth services list on a Category 1 basis. We are adding these to the telehealth services list because an office/outpatient visit might not always most accurately or specifically describe the type of visit furnished to treat an individual in their home for an SUD or co-occuring mental health disorder; and that sometimes one of the domiciliary/home visit codes would more accurately describe the service.

Comment: One commenter stated that Assessment and Care Planning for Patients with Cognitive Impairment (CPT Code 99483) should not be added at this time until more study can be done to assess the appropriateness of this service being delivered in the telehealth context given that many cognitive impairments and symptoms may require in-person assessment.

Response: We continue to believe that CPT code 99483 is sufficiently similar to an office visit to warrant addition to the Medicare telehealth list on a permanent basis in that it involves evaluating and managing a patient's cognitive impairment in an office/outpatient setting. When the AMA CPT Editorial Panel created this code, they assumed that the work associated with assessment and care planning for patients with cognitive impairment had been reported with CPT code 99215 (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 comprehensive history; A comprehensive examination; Medical decision making of high 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 presenting problem(s) are of moderate to high severity. Typically, 40 minutes are spent face-to-face with the patient and/or family), which is currently on the Medicare telehealth list.

After considering the public comments received, we are finalizing our proposal and adding HCPCS codes G2211 and CPT codes 90853, 96121, G2212, 99483, 99334, 99335, 99347, and 99348 to the Medicare telehealth list for CY 2021.

Comment: Commenters expressed opposition to CMS' decision not to propose to add Medical Genetics services (CPT code 96040) to the Medicare telehealth services list.

Response: We note that CPT code 96040 is not separately billable under the PFS; it is considered bundled into O/O E/M visits, which are already on the Medicare telehealth services list. Therefore, we believe it is unnecessary, and could potentially be confusing, to add CPT code 96040 to the list. Only codes that are separately billable can be added to the Medicare telehealth list. As we stated in the CY 2012 PFS final rule with comment period (76 FR 73096 through 73097), physicians and NPPs who furnish and bill Medicare for these services would generally report office or other outpatient E/M CPT codes for office visits that involve significant counseling, including genetic counseling; and the office visit CPT codes are already on the Medicare telehealth services list. CPT code 96040 would only be reported by genetic counselors for genetic counseling services. Genetic counselors are not among the practitioners who can bill Medicare directly for their professional services, and they are also not practitioners who can furnish telehealth services as specified in section 1834(m)(4)(E) of the Act. As such, we do not believe that it would be necessary or appropriate to add CPT code 96040 to the Medicare telehealth services list.

c. Proposed Temporary Addition of a Category 3 Basis for Adding to or Deleting Services From the Medicare Telehealth Services List

Legislation enacted to address the PHE for COVID-19 provided the Secretary with new authorities under section 1135(b)(8) of the Act, as added by section 102 of the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (Pub. L. 116-123, March 6, 2020) and subsequently amended by section 6010 of the Families First Coronavirus Response Act (Pub. L. 116-127, March 18, 2020) and section 3703 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136, March 27, 2020)), to waive or modify Medicare telehealth payment requirements during the PHE for COVID-19. We established several flexibilities to accommodate these Start Printed Page 84507changes in the delivery of care. Through waiver authority under section 1135(b)(8) of the Act, in response to the PHE for COVID-19, we removed the geographic and site of service originating site restrictions in section 1834(m)(4)(C) of the Act, as well as the restrictions in section 1834(m)(4)(E) of the Act on the types of practitioners who may furnish telehealth services, for the duration of the PHE for COVID-19.[1] We also used waiver authority to allow certain telehealth services to be furnished via audio-only communication technology. In the March 31st COVID-19 IFC, we added 89 services to the Medicare telehealth services list on an interim basis. Through the “Medicare and Medicaid Programs; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” interim final rule with comment period (IFC), (which was issued on May 1, 2020, and was effective upon publication in the May 8, 2020 Federal Register (85 FR 27550 through 27649)) (hereinafter referred to as the “May 8th COVID-19 IFC”), on an interim basis for the duration of the PHE for COVID-19, we removed the requirement in our regulations that we undertake rulemaking to add or delete services on the Medicare telehealth services list so that we could consider the addition of services on a subregulatory basis as they were recommended by the public or identified internally. On a subregulatory basis, we simultaneously added 46 more services to the Medicare telehealth services list on an interim basis when we issued the May 8th COVID-19 IFC. Finally, on October 14, 2020 we added 11 more services to the Medicare telehealth list on a subregulatory basis. For a full list of Medicare telehealth services please see the CMS website: https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​Telehealth-Codes.

At the conclusion of the PHE for COVID-19, these 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, including in this final rule. We believe that the experiences of clinicians who are furnishing telehealth services during the PHE for COVID-19 will be useful to inform decisions about which of the services we added temporarily to the Medicare telehealth services list might be appropriate to add on a permanent basis. However, we also recognize that the annual PFS rulemaking schedule may not align perfectly with the expiration of the PHE for COVID-19, and that the clinicians providing services via telehealth during the PHE may not have the opportunity to conduct the kinds of review or develop the kind of evidence we usually consider when adding services to the Medicare telehealth services list on a permanent basis. In the event that the PHE for COVID-19 ends prior to the end of CY 2021, stakeholders might not have the opportunity to use our current consideration process for telehealth services to request permanent additions to the Medicare telehealth services list prior to those services being removed from the Medicare telehealth services list. This is especially true for those services that might need to be considered on a Category 2 basis, which involves providing supporting documentation to illustrate the clinical benefit of such services. Recognizing the extent to which practice patterns are shifting as a result of the PHE for COVID-19 from a model of care based on in-person services to one that relies on a combination of in-person services and virtual care, we noted that we believe that it would be disruptive to both clinical practice and beneficiary access to abruptly eliminate Medicare payment for these services when furnished via telehealth as soon as the PHE for COVID-19 ends without first providing an opportunity to use information developed during the PHE to support requests for permanent changes to the Medicare telehealth services list.

As previously noted, in response to the PHE for COVID-19, we added a broad range of services to the Medicare telehealth services list. Before eliminating the full range of these services from the Medicare telehealth services list and potentially jeopardizing beneficiary access to those services that have been clinically beneficial, based primarily on the timing of annual rulemaking, we noted that we believe it would be prudent to collect information from the public regarding which, where, and how various telehealth services have been in use in various communities during the COVID-19 response. Feedback from patients and clinicians is essential to helping CMS understand how the use of telehealth services may have contributed positively to, or negatively affected, the quality of care provided to beneficiaries during the PHE for COVID-19, enabling us to better determine which services should be retained on the Medicare telehealth services list until we can give them full consideration under our established rulemaking process.

Therefore, we proposed to create a third category of criteria for adding services to the Medicare telehealth services list on a temporary basis. This new category would describe services that would be included on the Medicare telehealth services list on a temporary basis. We would include in this category the services that were added during the PHE for COVID-19 for which 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. Recognizing that the services we would add 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 the potential for evidence development that could continue through the Category 3 temporary addition period, we considered each of the services we added on an interim final basis during the PHE for COVID-19.

In developing the proposal 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 when furnished via telehealth outside the circumstances of the PHE for COVID-19 and that we anticipate would be able to demonstrate that clinical benefit in such a way as to meet our Category 2 criteria in full. Any service added under the proposed Category 3 would remain on the Medicare telehealth services list through the calendar year in which the PHE for COVID-19 ends. When assessing whether there was a potential likelihood of clinical benefit for a service such that it should be added to the Medicare telehealth services list on a Category 3 basis, we considered the following factors:

  • Whether, outside of the circumstances of the PHE for COVID-19, there are increased concerns for patient safety if the service is furnished as a telehealth service.
  • Whether, outside of the circumstances of the PHE for COVID-19, there are concerns about whether the provision of the service via telehealth is likely to jeopardize quality of care.Start Printed Page 84508
  • Whether all elements of the service could fully and effectively be performed by a remotely located clinician using two-way, audio/video telecommunications technology.

We recognized that the circumstances of the PHE for COVID-19 have provided clinicians with the opportunity to use telecommunications technology in health care delivery in a scope and manner far surpassing the telehealth services described under section 1834(m) of the Act, particularly as a result of the removal of geographic and site of service restrictions, and the addition of many services to the Medicare telehealth services list. When adding services to the Medicare telehealth services list on an interim basis during the PHE for COVID-19, we reassessed services on a Category 2 basis in the context of the widespread presence of COVID-19 in the community. We recognized that healthcare access issues could arise due to the immediate potential exposure risks to patients and healthcare workers, and that the use of telecommunication technology could mitigate risk and facilitate clinically appropriate treatment. In the context of the PHE for COVID-19. We found that all of the added services met the Category 2 criteria on the basis that there is a patient population who would otherwise not have access to clinically appropriate care (85 FR 19234). While the interim addition of a broad swath of services to the Medicare telehealth services list is responsive to critical needs during the PHE for COVID-19, the impact of adding these services to the Medicare telehealth services list on a permanent basis is currently unknown. Specifically, although it is possible to assess the uptake among health care practitioners of the added telehealth services, the extent to which service delivery via telehealth demonstrates clinical benefit outside the conditions of the PHE for COVID-19 is not known. Adding services to the Medicare telehealth services list on a Category 3 basis will give the public the opportunity to gather data and generate requests to add certain services to the Medicare telehealth services list permanently, which would be adjudicated on a Category 1 or Category 2 basis during future PFS annual rulemaking, while maintaining access to telehealth services with potential likelihood of clinical benefit. We proposed that the Category 3 criteria and the basis for considering additions to the Medicare telehealth services list would be temporary, to expire at the end of the calendar year in which the PHE for COVID-19 expires.

We identified a number of services that we believe, based on our clinical assessment, fit the Category 3 criteria enumerated above in that we did not identify significant concerns over patient safety, quality of care, or the ability of clinicians to provide all elements of the service remotely if these services were to remain on the Medicare telehealth services list for an additional period beyond the PHE for COVID-19. Therefore, we proposed to continue including the services listed in Table 13 on the Medicare telehealth services list through the calendar year in which the PHE for COVID-19 ends. We solicited public comment on the services we identified for temporary addition to the Medicare telehealth services list through the Category 3 criteria, including whether some should not be considered as Category 3 temporary additions to the Medicare telehealth services list, or whether services currently not proposed as Category 3 additions to the Medicare telehealth services list should be considered as such. We noted that while our clinical assessment indicated that the services in Table 13 demonstrate potential likelihood of clinical benefit when furnished as telehealth services and, as such, the potential to meet the Category 1 or Category 2 criteria for permanent addition to the Medicare telehealth services list with the development of additional evidence, we solicited information from the public that would supplement our clinical assessment and assist us in consideration of our proposals regarding the Category 3 addition of services, even though we recognize that formal analyses may not yet be available. The following are examples of the types of information we sought from the public to help inform our decisions about proposed additions under Category 3:

  • By whom and for whom are the services being delivered via telehealth during the PHE;
  • What practical safeguards are being employed to maintain safety and clinical effectiveness of services delivered via telehealth; and how are practices quickly and efficiently transitioning patients from telehealth to in-person care as needed;
  • What specific health outcomes data are being or are capable of being gathered to demonstrate clinical benefit;
  • How is technology being used to facilitate the acquisition of clinical information that would otherwise be obtained by a hands-on physical examination if the service was furnished in person. Certain services on the Medicare telehealth services list prior to the PHE, specifically the O/O E/M code set, involve a physical exam. With the telehealth expansions during the PHE, clinicians may have had valuable experience providing other telehealth services to patients in higher acuity settings of care, such as an emergency department, that involve a hands-on physical examination when furnished in person.
  • Whether patient outcomes are improved by the addition of one or more services to the Medicare telehealth services list, including whether inclusion on the Medicare telehealth services list increases access, safety, patient satisfaction, and overall quality of care;
  • Whether furnishing this service or services via telecommunication technology promotes prudent use of resources;
  • Whether the permanent addition of specific, individual services or categories of services to the Medicare telehealth services list supports quick responses to the spread of infectious disease or other emergent circumstances that may require widespread use of telehealth; and
  • What is the impact on the health care workforce of the inclusion of one or more services or categories of services on the Medicare telehealth services list (for example, whether the health care workforce and its capabilities to provide care are expanded).

In addition, we noted that CMS is committed to the following broad goals, and these weigh heavily in our decision-making around the addition, whether temporary or permanent, of a service or services to the Medicare telehealth services list. We requested that commenters consider these goals in conjunction with their comments on the proposals for the treatment of the telehealth services we added on an interim basis during the PHE for COVID-19:

  • Maintaining the capacity to enable rapid assessment of patterns of care, safety, and outcomes in the Medicare, Medicaid, CHIP, and Marketplace populations;
  • Establishing system safeguards to detect and avert unintended patient harms that result from policy adjustments;
  • Ensuring high quality care is maintained;
  • Demonstrating ongoing quality improvement efforts by Medicare participating providers, while maintaining access to necessary care;
  • Establishing protections for vulnerable beneficiary populations (those with multiple chronic conditions, functional limitations, heart failure, Start Printed Page 84509COPD, diabetes, dementia), and sites of heightened vulnerability (such as nursing homes, rural communities) with high risk of adverse outcomes;
  • Ensuring appropriate resource utilization and supporting cost efficiency;
  • Supporting emergency preparedness and maintaining capacity to surge for potential coronavirus resurgence or other healthcare issues; and
  • Considering timing and pace of policy corrections in light of local and regional variations in systems of care and the impact of the PHE for COVID-19.
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We received public comments on the proposed temporary addition of a category 3 basis for adding to or deleting services from the Medicare telehealth services list. The following is a summary of the comments we received and our responses.

Comment: Many commenters supported our proposal to use a third, temporary category of criteria for adding services to the Medicare telehealth list on a provisional basis. Commenters agreed that keeping certain services added on an interim basis during the PHE for COVID-19 on the Medicare telehealth list on a temporary basis after the end of the PHE will give the medical community time to gather much needed data on services in this category to support Category 2 requests through the regular process for considering additions to the telehealth services list, while maintaining beneficiary access and allowing practitioners to transition back to models of care focused primarily on in-person, rather than virtual, services. The majority of commenters also supported adding the services CMS proposed to add to the Medicare telehealth list on a Category 3 basis.

Response: We appreciate commenters' support for these proposals.

Comment: Most commenters supported the proposed timeframe for services added on a Category 3 basis to remain on the Medicare telehealth list; however, a few commenters stated that adding services to the Medicare telehealth list on a temporary basis would create unnecessary burden for clinicians who are attempting to both treat patients in the midst of a pandemic and develop an evidence base to Start Printed Page 84517support adding these services to the Medicare telehealth list permanently. In addition, by stipulating that certain codes would remain on the list through the year in which the PHE ends, commenters suggested that CMS was creating ambiguity as to when services added to the list on a Category 3 basis would expire. The commenters stated that this would be an impediment to investing in the infrastructure necessary to furnish these services. Some commenters requested that CMS fund the studies necessary to demonstrate whether a given service should be added permanently to the Medicare telehealth list, or at least articulate clear standards CMS would use to assess efficacy.

Response: While we understand commenters' concerns that adding services temporarily to the Medicare telehealth list without a fixed end date would create ambiguity that could serve as a disincentive to providing the services as telehealth services, we would note that the PHE for COVID-19 has now been extended into CY 2021.[2] The extension of the PHE into CY 2021 ensures that clinicians will have at least the entirety of 2021 to collect evidence to support a request to add these services permanently to the Medicare telehealth list.

Comment: Some commenters also expressed concern with the timeframe for which services added on a Category 3 basis will be on the Medicare telehealth list after the conclusion of the PHE. Some commenters suggested alternative timeframes, ranging between 90 days and 2 years after the end of the PHE. Some commenters suggested that CMS should specify a year in which the category 3 additions to the telehealth list will expire, such as 2022.

Response: As stated above, the PHE for COVID-19 has been extended into CY 2021, allowing for services added to the Medicare telehealth list on a Category 3 basis to remain there for at least the entirety of 2021. Any potential extension of this timeframe would be proposed in future rulemaking.

After considering the public comments, we are finalizing the additions in Table 14 to the telehealth list on a Category 3 basis through the later of the end of the year in which the PHE ends or December 31, 2021, as proposed.

d. Comment Solicitation on Medicare Telehealth Services Added on an Interim Basis During the PHE for COVID-19 That CMS Did Not Propose To Retain After the PHE Ends

In the March 31st COVID-19 IFC and the May 8th COVID-19 IFC, we finalized on an interim basis during the PHE for COVID-19 the addition of a number of services to the Medicare telehealth services list. While a number of these services were previously requested by external stakeholders and reviewed for addition as part of our standard process for updating the Medicare telehealth services list, a few were identified through internal review. As discussed above, we conducted a clinical assessment of each of the services added on an interim basis during the PHE for COVID-19 to the Medicare telehealth services list to identify those for which we could foresee a reasonable potential likelihood of clinical benefit when furnished via telehealth outside the circumstances of the PHE for COVID-19. In our clinical review of these services, we did not identify sufficient information to suggest there is a potential likelihood of clinical benefit for the services described below such that they could meet the Category 1 or Category 2 criteria outside the circumstances of the PHE for COVID-19. We specifically considered the potential for these services to be furnished, outside the circumstances of the PHE for COVID-19, without increased concerns for patient safety or jeopardizing quality of care; and furnished fully and effectively, including all elements of the service, by a remotely located clinician via two-way, audio/video telecommunications technology. After assessing these factors, we did not find a potential likelihood that the services could meet Category 2 criteria even with development of additional evidence. As such, we proposed not to extend them on the Medicare telehealth services list beyond the end of the PHE for COVID-19. However, we solicited public comment on whether any service added to the Medicare telehealth services list on an interim basis for the duration of the PHE for COVID-19 should be added to the Medicare telehealth services list on a temporary, Category 3 basis, based on the criteria outlined above. We welcomed additional information from commenters about these services.

We also sought comment on the following considerations associated with particular services. We noted that comments on these specific concerns would inform our final decisions on whether these services should be added to the Medicare telehealth services list on a temporary, Category 3 basis:

  • Initial and final/discharge interactions (CPT codes 99234-99236 and 99238-99239): We noted that we believe that the potential acuity of the patient described by these codes would require an in-person physical exam in order to fulfill the requirements of the service. We expressed concerns that, without an in-person physical examination, the need for the physician or health care provider to fully understand the health status of the person with whom they are establishing a clinical relationship would be compromised. We noted that we believe the need for an in-person interaction would rise beyond any specific diagnosis, and serves as the foundation upon which any and all clinical decisions are based for these services. We noted that, without an in-person interaction, care planning that includes risk-benefit considerations and clinical decision-making will be less well-informed and create risk of patient harm.
  • Higher level emergency department visits (CPT codes 99284-99285): We expressed concern that the full scope of service elements of these codes cannot be met via two-way, audio/video telecommunications technology as higher levels are indicated by patient characteristics, clinical complexity, urgency for care, and require complex decision-making. We also noted that we believe, due to the acuity of the patient described by these codes, that an in-person physical examination is necessary to fulfill the service requirements.
  • Hospital, Intensive Care Unit, Emergency care, Observation stays (CPT codes 99217-99220; 99221-99226; 99484-99485, 99468-99472, 99475-99476, and 99477-99480): These codes describe visits that are furnished to patients who are ill enough to require hospital evaluation and care. We noted that we believe that the codes describe an evaluation for these potentially high acuity patients that is comprehensive and includes an in-person physical examination. Our view that in-person care is necessary to fulfill the requirements of the code is driven by the need for the physician or health provider to fully understand the health status of the person with whom they are establishing a clinical and therapeutic relationship. We also noted that we believe that the need for an in-person interaction would rise above any specific diagnosis, and serves as the foundation upon which any and all clinical decisions are based for these services. We noted that, without an in-Start Printed Page 84518person interaction, care planning that includes risk-benefit considerations and clinical decision-making would be less well-informed and create risk of patient harm. With regard to the physical therapy, occupational therapy, and speech-language pathology services in Table 13, we have received a number of requests that we add therapy services to the Medicare telehealth services list. In the CY 2017 PFS final rule, 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 stated in the CY 2017 PFS final rule (81 FR 80198) 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 to 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.

In the proposed rule, we noted that we continue to believe this is generally the case, and we did not propose to add these services permanently to the Medicare telehealth services list. We solicited comment on whether these services should be added to the Medicare telehealth services list so that, in instances when a practitioner who is eligible to bill for telehealth services furnishes these services via telehealth, they could bill and receive payment for them. We also solicited comment on whether all aspects of these services can be fully and effectively furnished via two-way, audio/video telecommunications technology. We noted that given our clarification regarding telehealth services furnished incident to the professional services of a physician or practitioner (85 FR 27562), if these services were added to the Medicare telehealth services list, they could be furnished by a therapist and billed by a physician or practitioner who can furnish and bill for telehealth services provided that all of the “incident to” requirements are met.

Comment: Commenters expressed concern that we did not propose to add the vast majority of the interim PHE telehealth services to the telehealth list on a Category 3 basis. Commenters stated that, by limiting the availability of these interim PHE telehealth services to the duration of the PHE, CMS would jeopardize access to care for beneficiaries who have come to rely on the provision of these services virtually, and would disrupt practice patterns for those clinicians who were accustomed to furnishing a broader array of telehealth services than included in the proposed permanent and temporary Category 3 additions to the Medicare telehealth list.

Response: We appreciate commenters' concerns. In response, we are finalizing the addition of a broader array of services to the Medicare telehealth list on a Category 3 basis, as described below.

Comment: Many commenters requested that CMS add specific interim PHE telehealth services that we did not propose to the Medicare telehealth list on a Category 3 basis. Most commenters did not provide sufficient (or in some cases, any) evidence to support their requests to be considered under Category 3 criteria. Other commenters did provide additional evidence sufficient to consider certain services on a Category 3 basis. Table 15 includes the complete list of services commenters requested for addition to the CMS Medicare telehealth list on a Category 3 basis.

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The following is a summary of these comments and our responses.

Comment: Some commenters requested that we consider adding Start Printed Page 84526initial nursing facility visits, which are currently interim PHE telehealth services, to the telehealth list on a Category 3 basis. Commenters did provide information regarding how telehealth is used in long-term care facilities; however, they did not provide information indicating how the full scope of service elements of an initial nursing facility visit could be furnished via two-way, audio/telecommunications technology.

Response: We continue to believe that there are components of the initial visit, such as the physical exam, that in the vast majority of circumstances can only be properly performed in person given the vulnerability and frailty of this particular patient population. Commenters did not provide evidence to indicate otherwise. We note that patients in a nursing facility may still receive subsequent visits as telehealth services; however, we are not persuaded that these services, in general, could be furnished via telehealth as described by the CPT codes based upon information provided by commenters.

Comment: Many commenters requested that we add physical therapy, occupational therapy, and speech language pathology services to the Medicare telehealth list on a category 3 basis. Commenters provided extensive information on how they furnish these services via two-way, audio/video telecommunications technology. In response to CMS's longstanding concerns that the practitioners who furnish and bill for the overwhelming majority of these services are, outside of the circumstances of the PHE for COVID-19, not among the statutorily authorized practitioners who may independently bill Medicare for telehealth services, commenters pointed to our proposed clarification that telehealth services could be furnished by a therapist incident to the professional services of a billing clinician in accordance with our regulations at § 410.26.

Response: We appreciate the additional information commenters provided suggesting a possible scenario whereby services furnished by therapists may be provided and billed incident to the professional services of a physician or practitioner who is authorized to furnish and bill for telehealth services. While we continue to have concerns as to whether certain elements of therapy services, particularly when provided to new patients, could be furnished in total via two-way, audio/video telecommunications technology, we recognize that the clarification of billing requirements for these services may allow for additional information to be collected and submitted for consideration by CMS. We are therefore finalizing addition of these services to the Medicare telehealth list on a Category 3 basis.

Comment: Some commenters requested that we add several audiology services to the Medicare telehealth list on a Category 3 basis. These codes are currently interim PHE telehealth services. Commenters explained that including CPT codes for device evaluation and therapeutic services with a device is necessary to support access for patients in needs of these assistive technologies, and that not including them would inhibit the ability of speech language pathologists to perform the evaluation and therapeutic services via telehealth.

Response: We note that, outside of the circumstances of the PHE, speech language pathologists are not eligible to independently bill for Medicare telehealth services, although these services could possibly be furnished by a therapist incident to an eligible billing practitioner. Furthermore, we do not agree that the information provided by commenters demonstrates that, under most circumstances, these services can be furnished, in full, via two-way audio/video communication technology given that these codes describe a new patient interaction which would likely require hands-on, clinical assessment and direct, one-on-one interaction/observation.

Comment: Some commenters requested that we add ESRD MCP services with 1 monthly visit to the Medicare telehealth list on a Category 3 basis. Commenters cited information that they say demonstrates that retaining the ESRD-specific telehealth flexibilities post-pandemic would be valuable to both patients and health care providers and would pose no material detriments to patient safety or quality of care. Commenters further offered that technology exists that would enable physicians and other practitioners to deliver effective ESRD care on a virtual basis beyond the PHE for COVID-19. Additionally, commenters noted that it may take time for medically complex and vulnerable patients to travel for in-person care, and that determining when a patient should return to a physician's office should be left to the patient and the physician.

Response: We did not propose to add these services to the Medicare telehealth list on a Category 3 basis due to concerns regarding the patient receiving an adequate physical examination of the vascular access site and in-person evaluation of the patient's fluid status when a patient is only receiving 1 visit per month. We appreciate the additional information provided by commenters, particularly the information on how ESRD services are furnished using audio/video technology outside of the circumstances of the PHE for COVID-19. Based upon this information, we are finalizing the addition of the ESRD MCP services with a single face-to-face visit per month to the Medicare telehealth list on a Category 3 basis. We would note that, during the PHE for the COVID-19 pandemic, section 3705 of the CARES Act allowed for a waiver of the statutory provision in section 1881(b)(3)(B)(ii) of the Act, which requires that an individual determined to have ESRD receiving home dialysis must receive certain face-to-face clinical assessments without the use of telehealth. Therefore, outside of the PHE for COVID-19, for beneficiaries receiving home dialysis services, a face-to-face ESRD-related clinical assessment must be provided in person (without the use of telehealth) for the first 3 months of home dialysis, and once every 3 months thereafter.

Comment: Some commenters requested that we add hospital observation and discharge day management services to the Medicare telehealth list on a Category 3 basis. Commenters cited information that they believe demonstrates that telehealth services in the emergency setting have proven to be successful and add clinical benefit to patients, and that they should be added on a Category 3 basis, if not permanently. Commenters stated that furnishing these services as telehealth services can be helpful or even essential to enable patients to receive high-quality specialty care in isolated rural communities, communities affected by natural disasters, communities affected by local disease outbreaks, and similar situations. Commenters also requested that we add critical care services and established patient neonatal critical care services to the Medicare telehealth list on a Category 3 basis, stating that there are certain situations where it is appropriate to provide higher level and critical care to patients via telehealth. Commenters further offered that the clinical value of telehealth is particularly clear for patients being treated in rural EDs or at rural hospitals where effective telehealth collaboration for high-level cases could facilitate clinical collaboration and decrease unnecessary transfers. Commenters stated that there is a shortage of rural board-certified emergency physicians, and that, if shortages of these physicians continue, more critical care services Start Printed Page 84527may need to be delivered via telehealth over time to ensure that patients receive timely and necessary care. Finally, we received requests to add level four and five emergency department visits to the Medicare telehealth list on a Category 3 basis.

All of these requests were accompanied by robust supporting evidence including information on teleICU and tele-stroke models of care. Commenters also submitted clinical studies pointing to the efficacy of telehealth in more acute care settings.

Response: We are responding to the comments on these codes together because they are all E/M services that are furnished in a hospital or ED setting. We did not propose to add these services to the Medicare telehealth list on a Category 3 basis due to the presumption that in-person assessment and care, particularly an in-person physical exam, was necessary for patients at this level of acuity. Based upon a review of the information provided by commenters, which included information on how distant site practitioners could collaborate with individuals at the originating site (which, outside of the circumstances of the PHE, must be a medical facility) to obtain an accurate and comprehensive evaluation of the patient, we agree that telehealth in the acute settings described by these codes could offer an excellent opportunity for care to patients if both the distant site and originating site facilities/teams have the appropriate infrastructure, technology, and training to effectively conduct such visits via telehealth. We continue to believe that in most instances, in order to fulfill the full scope of service elements described by codes for new patients, an in-person physical exam is necessary; however, we agree that, for services provided to established patients, such as established patient observation services and established patient neonatal critical care, and for emergency department visits and critical care services (the latter of which is being used extensively during the PHE to support surge capacity), more data are needed to understand how these E/M code families are being used in the field and whether their addition to the telehealth services list ultimately could be supported on a Category 2 basis. Therefore, we are finalizing the addition of established patient observation services and established patient neonatal critical care services to the Medicare telehealth list on a Category 3 basis. We are also finalizing the addition of critical care services to the Medicare telehealth list on a Category 3 basis.

Comment: Some commenters requested that we add electronic device management and treatment services to the Medicare telehealth list on a Category 3 basis, stating that safeguards are being developed to deliver safe and effective remote management of neuromodulation technologies during the PHE and beyond. The commenter suggested rationale for monitoring the provision of these services through use of these codes to ensure improved outcomes.

Response: While we appreciate the additional information as to the safeguards being developed to ensure safe access to these services and the information on improved outcomes, it was not clear whether the capability for clinicians to remotely connect to a patient's hand-held device for the purposes of electronic assessment and analysis is widely available. It is also not within CMS's mandate under the PFS to ensure improved outcomes. Therefore, we remain unconvinced by the evidence provided by the commenter that these services can, in most instances, be conducted in full using two-way, audio/video communication technology. We were also uncertain as to which of these services involve a direct, clinical interaction between the patient and practitioner such that, if the service is furnished as a telehealth service, the interaction would be facilitated by audio/video technology; and those that do not involve such an interaction. To the extent these services do not involve a direct, clinical interaction between the patient and practitioner facilitated by audio/video technology, the services would not be subject to the statutory requirements for telehealth services under section 1834(m) of the Act, and there would be no need to consider adding them to the telehealth services list.

Comment: Most commenters supported CMS not adding CPT code 77427 (Radiation treatment management, 5 treatments) to the Medicare telehealth list on a Category 3 basis. These commenters stated that, given that most radiation oncology practices have been able to secure adequate PPE, it was no longer necessary for radiation treatment management to be available as a telehealth service. A few commenters disagreed, but did not provide supporting information.

Response: We did not propose to add this service to the Medicare telehealth list on a Category 3 basis due to concerns over whether the full service elements described by CPT code 77427 could, in most cases, be furnished in full via two way, audio-video communication technology. We continue to believe this is the case and appreciate the additional information provided by commenters as to the necessity of adding this service to the Medicare telehealth list on a Category 3 basis.

After considering the public comments, we are finalizing the addition of services to the Medicare telehealth list on a Category 3 basis as explained above and detailed in Table 16.

2. Analysis and Response to the Comment Solicitation on Coding and Payment for Tele-ICU

With regard to the critical care services listed in A-D 5 we have received a number of requests in prior years to add these services to the Medicare telehealth services list. In response to one such request, we finalized creation of two HCPCS G codes, G0508 (Telehealth consultation, critical care, initial, physicians typically spend 60 minutes communicating with the patient and providers via telehealth) and G0509 (Telehealth consultation, critical care, subsequent, physicians typically spend 50 minutes communicating with the patient and providers via telehealth), to describe the work associated with furnishing consultation services via Medicare telehealth to critically ill patients in the CY 2017 PFS final rule (81 FR 80196 through 80197). We stated that CPT guidance makes clear that a variety of other services are bundled into the payment rates for critical care, including gastric intubations and vascular access procedures, among others. While we are adding critical care services to the Medicare telehealth list temporarily, on a Category 3 basis, we also solicited comment on whether current coding (either through the CPT codes describing in-person critical care or the HCPCS G codes describing critical care consults furnished via telehealth) does not reflect additional models of critical care delivery, specifically, models of care delivery that utilize a combination of remote monitoring and clinical staff at the location of the beneficiary to allow, when an onsite practitioner is not available, for a practitioner at a distant site to monitor vital signs and direct in-person care as needed.

We sought comment on the definition, potential coding and valuation for this kind of remote service. Specifically, we sought comment on the following concerns:

  • How to distinguish the technical component of the remote monitoring portion of the service from the Start Printed Page 84528diagnosis-related group (DRG) payment already being provided to the hospital.
  • How to provide payment only for monitoring and interventions furnished to Medicare beneficiaries when the remote intensivist is monitoring multiple patients, some of which may not be Medicare beneficiaries.
  • How this service intersects with both the critical care consult G codes and the in-person critical care services.

Comment: One commenter stated that, generally, there are two models of remote critical care services; the first of which is more of a telehealth consultant. Services performed under this scenario may be accurately reported via existing critical care consult G codes. The other model of care includes physicians providing tele-ICU services, which may be enhanced through the use of robotic technology or other methods to complete a remote clinical assessment of the critically ill patient. Commenters stated current critical care consult G-codes may be used for an episodic evaluation and recommendation to the bedside team or may be used for episodic telemedicine consults and do not reflect current models of care. One commenter noted the tele-ICU is involved both before and after the bedside intensivist or physician arrives and leaves the bedside. Several commenters also stated that current CPT and HCPCS coding does not adequately reflect the additional component of monitoring, surveillance, coaching of bedside nurses, physicians who are not intensivists, and active management in real-time and over extended timeframes by tele-ICU Intensivists. Many commenters encouraged CMS to adopt a coding proposal currently under consideration by the CPT editorial panel and the AMA RUC.

Response: We appreciate the feedback regarding the different tele-ICU models. As noted by commenters, the AMA is currently engaged in evaluating coding and valuation for services similar to those identified by commenters. We will keep these comments in mind and look forward to evaluating any new CPT coding and AMA RUC recommendations as part of our future annual rulemaking process.

After considering the public comments, we will consider all of the feedback on the different tele-ICU models of care as well as potential gaps in coding for possible future rulemaking.

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3. Technical Refinement to the Medicare Telehealth Services List To Reflect Current Coding

For CY 2020, the CPT Editorial Panel deleted the six existing Health and Behavior Assessment and Intervention procedure CPT codes and replaced them with nine new CPT codes. The six deleted CPT codes include CPT code 96150 (Health and behavior assessment (e.g., health-focused clinical interview, behavioral observations, psychophysiological monitoring, health oriented questionnaires), each 15 minutes face-to-face with the patient; Start Printed Page 84530initial assessment), CPT code 96151 (Health and behavior assessment (e.g., health-focused clinical interview, behavioral observations, psychophysiological monitoring, health oriented questionnaires), each 15 minutes face-to-face with the patient; reassessment), CPT code 96152 (Health and behavior intervention, each 15 minutes, face-to-face; individual), CPT code 96153 (Health and behavior intervention, each 15 minutes, face-to-face; group (2 or more patients)), CPT code 96154 (Health and behavior intervention, each 15 minutes, face-to-face; family (with the patient present)), and CPT code 96155 (Health and behavior intervention, each 15 minutes, face-to-face; family (without the patient present)). However, we inadvertently neglected to make the corresponding update to reflect these coding changes on the Medicare telehealth services list in CY 2020 PFS rulemaking. Therefore, we proposed to delete CPT codes 96150-96155 from the Medicare telehealth services list and replace them with the following successor codes: CPT code 96156 (Health behavior assessment, including reassessment (i.e., health-focused clinical interview, behavioral observations, clinical decision making)); CPT code 96158 (Health behavior intervention, individual, face-to-face; initial 30 minutes); CPT code 96159 (Health behavior intervention, individual, face-to-face; each additional 15 minutes (list separately in addition to code for primary service)); CPT code 96164 (Health behavior intervention, group (2 or more patients), face-to-face; initial 30 minutes); CPT code 96165 (Health behavior intervention, group (2 or more patients), face-to-face; each additional 15 minutes (list separately in addition to code for primary service)); CPT code 96167 (Health behavior intervention, family (with the patient present), face-to-face; initial 30 minutes); CPT code 96168 (Health behavior intervention, family (with the patient present), face-to-face each additional 15 minutes (list separately in addition to code for primary service)); CPT code 96170 (Health behavior intervention, family (without the patient present), face-to-face; initial 30 minutes); and CPT code 96171 (Health behavior intervention, family (without the patient present), face-to-face; each additional 15 minutes (list separately in addition to code for primary service)).

We also proposed to amend our regulations to stipulate that when new codes are issued to replace codes that describe the same clinical services that are currently on the Medicare telehealth services list, we would consider those new codes to be successor codes to those that are on the Medicare telehealth services list, and would update the Medicare telehealth services list accordingly. At § 410.78(f), we proposed to revise the final sentence of the paragraph to read: CMS maintains on the CMS website the Medicare telehealth services list under this section, including the current HCPCS codes that describe the services.

We received public comments on the technical refinement to the Medicare telehealth services list to reflect current coding. The following is a summary of the comments we received and our responses.

Comment: Commenters supported this proposal.

Response: We are finalizing this technical refinement as proposed.

4. Furnishing Telehealth Visits in Inpatient and Nursing Facility Settings, and Critical Care Consultations

The long term care facility regulations at § 483.30(c) require that residents of SNFs receive an initial visit from a physician, and periodic personal visits subsequently by either a physician or other NPP. In the CY 2010 PFS final rule with comment period (74 FR 61762), we stated that these regulations ensure that at least a minimal degree of personal contact between a physician or a qualified NPP and a resident is maintained, both at the point of admission to the facility and periodically during the course of the resident's stay. In that rule we stated that we believe that these federally-mandated visits should be conducted in-person, and not as Medicare telehealth services. Therefore, we revised § 410.78 to restrict physicians and practitioners from using telehealth to furnish the physician visits required under § 483.30(c).

During the PHE for COVID-19, we waived the requirement in 42 CFR 483.30 for physicians and NPPs to perform in-person required visits for nursing home residents, and allowed visits to be conducted via telehealth (https://www.cms.gov/​files/​document/​summary-covid-19-emergency-declaration-waivers.pdf).

We solicited public comment on whether it would be appropriate to maintain this flexibility on a permanent basis outside of the PHE for COVID-19. We invited public comment on whether the in-person visit requirement is necessary, or whether two-way, audio/video telecommunications technology would be sufficient in instances when, due to continued exposure risk, workforce capacity, or other factors, the clinician determines an in-person visit is not necessary.

We also received requests to revise our frequency limitations for telehealth subsequent inpatient and nursing facility visits. We limit the provision of subsequent inpatient visits via Medicare telehealth to once every 3 days and subsequent nursing facility visits to once every 30 days. We received a request to remove the frequency limitation on the subsequent inpatient services and a separate request to revise the subsequent nursing facility visits to once every 3 days, rather than 30 days.

As we stated in the CY 2019 PFS final rule, we believed the potential acuity of illness of hospital inpatients is greater than that of patients who are likely to receive services that were on the Medicare telehealth services list at that time. We also stated that it would be appropriate to permit some subsequent hospital care services to be furnished through telehealth to ensure that hospitalized patients have sufficiently frequent encounters with their admitting practitioner. In addition, we expressed our belief that the majority of these visits should be furnished in person to facilitate the comprehensive, coordinated, and personal care that medically volatile, acutely ill patients require on an ongoing basis. Because of our concerns regarding the potential acuity of illness of hospital inpatients, we finalized the addition of CPT codes 99231-99233 to the Medicare telehealth services list, but limited the provision of these subsequent hospital care services through telehealth to once every 3 days. We noted that we continue to believe that admitting practitioners should continue to make appropriate in-person visits to all patients who need such care during their hospitalization. Our concerns with, and position on, the provision of subsequent hospital care services via telehealth have not changed (83 FR 59493). Therefore, we did not propose to modify the current policy.

In the CY 2018 PFS final rule, we reiterated that we believed it would be appropriate to permit some subsequent nursing facility (NF) care services to be furnished through telehealth to ensure that complex nursing facility patients have frequent encounters with their admitting practitioner, but because of our concerns regarding the potential acuity and complexity of NF inpatients, we limited the provision of subsequent NF care services furnished through telehealth to once every 30 days. We also stated that we continued to have concerns regarding more routine use of telehealth given the potential acuity and complexity of NF inpatients, and therefore, we were not proposing to Start Printed Page 84531remove the frequency limitation for subsequent NF care services (83 FR 59494). We received comments from stakeholders who stated that the once every 30-day frequency limitation for subsequent NF visits furnished via Medicare telehealth limits access to care for Medicare beneficiaries in the NF setting. Stakeholders stated that the use of Medicare telehealth is crucial to maintaining a continuum of care in this setting and that CMS should leave it up to clinicians to decide how frequently a visit may be furnished as a Medicare telehealth service rather than in person depending on the needs of specific patients. We noted that we were persuaded by the comments from these stakeholders, and therefore, we proposed to revise the frequency limitation from one visit every 30 days to one visit every 3 days. We noted that we believe this interval strikes the right balance between requiring in-person visits and allowing flexibility to furnish services via telehealth when clinically appropriate to do so. We solicited comment on whether frequency limitations broadly are burdensome and limit access to necessary care when services are available only through telehealth, and how best to ensure that patients are receiving necessary in-person care.

We received public comments on furnishing telehealth visits in inpatient and nursing facility settings, and critical care consultations. The following is a summary of the comments we received and our responses.

Comment: Many commenters requested that CMS revise the long term care facility regulations at § 483.30(c), which require that residents of NFs receive an initial visit from a physician, and periodic personal visits subsequently by either a physician or other NPP, to allow the initial visit to be conducted via Medicare telehealth.

Response: As we stated in the CY 2010 PFS final rule with comment period (74 FR 61762), we continue to believe that in-person contact between a physician or a qualified NPP and a resident is needed at the point of admission to the facility to ensure the appropriate level of care.

Comment: Many commenters have stated their support for revising the frequency limitation for subsequent nursing facility visits furnished via telehealth from once every 30 days to once every 3 days, while other commenters encouraged CMS to remove frequency limitations entirely. A few commenters stated that CMS should maintain some frequency limitations so as to not to create a disincentive for in-person care.

Response: We thank all the commenters for their feedback. As discussed in the proposed rule, we have received requests to revise the frequency limitations on subsequent nursing facility visits from one every 30 days to one every 3 days to align with the frequency limitations in the inpatient setting; however, after additional consideration of the issue, we noted that patients in the nursing facility setting tend to have a longer lengths of stay compared to the patients in the inpatient setting. As such, we have further considered whether the frequency limitations for subsequent nursing facility visits furnished via telehealth should be the same as for the inpatient setting. Additionally, we acknowledge commenters' concerns about creating a disincentive for in-person care in the absence of any frequency limitations on services furnished through telehealth, and that a broader view of our frequency limitation policies across the different Part A and B care settings could potentially lead to inadequate in-person care in certain scenarios. While we appreciate that, in some cases, a subsequent nursing facility visit furnished via telehealth may allow flexibility for practitioners to appropriately treat patients, there are also situations where an in-person visit may be more appropriate. In seeking to find the right balance between providing greater access to care through more telehealth visits and ensuring adequate in-person care, especially given the longer length of stays for NF patients, we believe that one telehealth visit every 30 days may be too infrequent and once every 3 days poses a risk of creating a disincentive for in-person care. Therefore, we believe it is appropriate to revise the frequency limitation for subsequent nursing facility visits to permit one Medicare telehealth visit every 14 days. This limitation provides an appropriate balance between increased access to care through telehealth and maintaining appropriate in-person care.

After consideration of the public comments, we are finalizing a policy to allow subsequent nursing visits to be furnished via Medicare telehealth once every 14 days in the NF setting. We are not finalizing any revisions to the frequency limitations on inpatient visits or critical care consultations provided as telehealth services.

5. Proposed Technical Amendment To Remove References to Specific Technology

The final sentence of our regulation at § 410.78(a)(3) prohibits the use of telephones, facsimile machines, and electronic mail systems for purposes of furnishing Medicare telehealth services. In the March 31st COVID-19 IFC, we added a new § 410.78(a)(3)(i) (and reserved § 410.78(a)(3)(ii) for later use) to provide for an exception that removes application of that sentence during the PHE for COVID-19. We added the new section on an interim final basis because we believe that the first sentence of § 410.78(a)(3) adequately describes the technology requirements for an interactive telecommunication system that may be used to furnish a Medicare telehealth service. That sentence defines interactive telecommunication system as “multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication.” We noted that we were also concerned that the reference to “telephones” in the second sentence of the regulation as impermissible technology could cause confusion in instances where otherwise eligible equipment, such as a smart phone, may also be used as a telephone Because these concerns are not situation- or time-limited to the PHE for COVID-19, we proposed to remove the second sentence of the regulation at § 410.78(a)(3) that specified that telephones, facsimile machines, and electronic mail systems do not meet the definition of an interactive telecommunications system. As we proposed to adopt this change on a permanent basis, we also proposed to delete the paragraphs at § 410.78(a)(3)(i) and (ii). We noted that we believe these amendments to our regulations would remove outdated references to specific types of technology and provide a clearer statement of our policy.

We received public comments on proposed technical amendment to remove references to specific technology. The following is a summary of the comments we received and our responses.

Comment: Commenters supported our proposal to amend the regulation. One commenter cited our statement in the March 31st COVID-19 IFC that mobile computing technology colloquially referred to as “phones” are now ubiquitous, and the wording of the regulatory text could be construed to prevent their use for purposes of conducting a telehealth service. According to another commenter, advances in digital communication technology should not be unnecessarily excluded as communication methods for patients and clinicians to utilize for telehealth services. Commenters agreed that the reference in the current regulation creates confusion about use Start Printed Page 84532of equipment such as a smart phone or even an interactive telehealth platform operating within an electronic health information system. Commenters agreed that the reference to “telephones” in the regulation as an impermissible technology in the final sentence of regulation at § 410.78(a)(3) has caused confusion in instances where equipment, such as smartphones, are also used as a telephone. They state that the references in these sections of the CFR are not situation- or time-limited to the PHE for COVID-19 and should be deleted.

Response: We thank commenters for their support and agree with their stated points. .

After consideration of the comments, we are finalizing this proposed technical amendment.

6. Communication Technology-Based Services (CTBS)

In the CY 2019 PFS final rule, we finalized separate payment for a number of services that could be furnished via telecommunications technology, but that are not considered Medicare telehealth services. Specifically, we finalized HCPCS code G2010 (Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, 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), and 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). We finalized maintenance of these codes as part of the set of codes that is only reportable by those practitioners that can furnish E/M services. We stated that we believed this was appropriate since the service describes a check-in directly with the billing practitioner to assess whether an office visit is needed. However, we did note that similar check-ins provided by nurses and other clinical staff can be important aspects of coordinated patient care (83 FR 59486).

In the CY 2020 PFS final rule, we finalized separate payment for HCPCS codes G2061 (Qualified nonphysician healthcare professional online assessment and management, for an established patient, for up to seven days, cumulative time during the 7 days; 5-10 minutes), G2062 (Qualified nonphysician healthcare professional online assessment and management service, for an established patient, for up to seven days, cumulative time during the 7 days; 11-20 minutes), and G2063 (Qualified nonphysician qualified healthcare professional assessment and management service, for an established patient, for up to seven days, cumulative time during the 7 days; 21 or more minutes). In that rule, we stated that these codes may be billed by NPPs consistent with the definition of their respective benefit category, although we did not provide specific examples (84 FR 62796).

We received a number of questions regarding which benefit categories HCPCS codes G2061 through G2063 fall under. In the March 31st COVID-19 IFC (85 FR 19244-19245) we established on an interim basis for the duration of the PHE for COVID-19 that these services could be billed for example, by licensed clinical social workers and clinical psychologists, as well as PTs, OTs, and SLPs who bill Medicare directly for their services when the service furnished falls within the scope of these practitioner's benefit categories. In the CY 2021 PFS proposed rule (85 FR 50112 and 50113), we proposed to adopt that policy on a permanent basis. We noted that this is not an exhaustive list and we solicited comment on other benefit categories into which these services may fall.

We also proposed to allow billing of other CTBS by certain NPPs, consistent with the scope of these practitioners' benefit categories, through the creation of two additional HCPCS G codes that can be billed by practitioners who cannot independently bill for E/M services:

  • G2250 (Remote assessment of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related service provided within the previous 7 days nor leading to a service or procedure within the next 24 hours or soonest available appointment.)
  • G2251 (Brief communication technology-based service, e.g. virtual check-in, by a qualified health care professional who cannot 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 a service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion).

We proposed to value the services identically to HCPCS codes G2010 and G2012, respectively. We acknowledged that it has been agency policy, in general, to differentially value similar services that are performed by practitioners who can and cannot, respectively, bill independently for E/M services, with higher values for the service performed by practitioners who can independently bill E/M services. However, given the relatively low values for HCPCS codes G2010 and G2012, we noted that we did not believe that there was a significant differential in resource costs to warrant different values, but solicited comment on whether we should value these services differentially, including potentially increasing the valuation of HCPCS codes G2010 and G2012.

Further, to facilitate billing of the CTBS by rehabilitative therapists, we proposed to designate HCPCS codes G2250, G2251, G2061, G2062, and G2063 as “sometimes therapy” services. When billed by a private practice PT, OT, or SLP, the codes would need to include the corresponding GO, GP, or GN therapy modifier to signify that the CTB are furnished as therapy services furnished under an OT, PT, or SLP plan of care.

We also noted that we proposed for CY 2021 to replace the eVisit G-codes with corresponding CPT codes, and that this policy would also apply to those codes.

For all of these CTBS, we also clarified that the consent from the patient to receive these services can be documented by auxiliary staff under general supervision, as well as by the billing practitioner. While we continue to believe that beneficiary consent is necessary so that the beneficiary is notified of cost sharing when receiving these services, we noted that we did not believe that the timing or manner in which beneficiary consent is acquired should interfere with the provision of one of these services. We retained the requirement that, in instances when the brief CTBS originates from a related E/M service (including one furnished as a telehealth service) provided within the previous 7 days by the same physician or other qualified health care professional, this service would be considered bundled into that previous E/M service and would not be separately billable.

We received public comments on the CTBS proposals. The following is a summary of the comments we received and our responses.Start Printed Page 84533

Comment: Several commenters supported our proposal to replace the eVisit G codes (G2061-G2063) with corresponding CPT codes 98970-98972 for qualified nonphysician health care professional online digital E/M service.

Response: We thank commenters for their feedback. After consideration of the comments received, we are finalizing our proposal to replace G2061-G2063 with CPT codes 98970-98972.

Comment: Many commenters were supportive of the proposal to allow NPPs, such as licensed clinical social workers, clinical psychologists, PTs, OTs, and SLPs to bill HCPCS codes G2061 through G2063, consistent with the definition of their respective benefit category.

Response: We thank the commenters for their support and feedback. After consideration of the comments received, we are finalizing our proposal to allow NPPs, such as licensed clinical social workers, clinical psychologists, PTs, OTs, and SLPs to bill HCPCS codes G2061 through G2063, consistent with the definition of their respective benefit category.

Comment: Commenters requested that CMS clarify that HCPCS codes G2061 through G2063 fell within the scope of the audiology diagnostic benefit category or the medical nutrition therapist benefit category.

Response: We disagree with the commenter. HCPCS codes G2061-G2063 describe online assessment and management while the audiology benefit is for diagnostic testing. Therefore, we believe these services fall outside the audiologists' benefit category. The benefit for medical nutrition therapists is limited by statute to a few specific services described by certain HCPCS codes, which do not include G2061-G2063.

Comment: Many commenters were supportive of the proposal to allow billing of HCPCS codes G2250 and G2251 by certain NPPs, consistent with the scope of these practitioners' benefit categories.

Response: We thank the commenters for their support and feedback. After consideration of the comments received, we are finalizing our proposal to allow billing of HCPCS codes G2250 and G2251 by certain NPPs, consistent with the scope of these practitioners' benefit categories.

Comment: Many commenters supported the proposal to identically value HCPCS codes G2250 and G2251 to G2010 and G2012, respectively.

Response: We thank commenters for their support and feedback.

Comment: One commenter disagreed with the proposal to identically value HCPCS codes G2250 and G2251 to G2010 and G2012, respectively. The commenter stated that services furnished by NPPs should not be valued the same as those provided by physicians and encouraged CMS to increase the valuation of G2010 and G2012 while not offering recommended value for G2250 and G2251.

Response: As we stated in the proposed rule, given the relatively low values for HCPCS codes G2010 and G2012, we do not believe that there is a significant differential in resource costs to warrant differential values for codes G2250 and G2251, and codes G2010 and G2012.

After consideration of the comments, we are finalizing our proposal to identically value HCPCS codes G2250 and G2251 to G2010 and G2012, respectively.

Comment: Several commenters urged CMS to consider increasing the value of G2010 and G2012.

Response: We thank commenters for their feedback and will consider this matter and propose any potential changes through future rulemaking.

Comment: Many commenters supported the proposal to designate HCPCS codes G2250, G2251, G2061, G2062, and G2063 as “sometimes therapy” services to facilitate billing of these CTBS by therapists. Including when billed by a private practice PT, OT, or SLP, the codes would need to include the corresponding GO, GP, or GN therapy modifier to signify that the CTB are furnished as therapy services furnished under an OT, PT, or SLP plan of care.

Response: We thank the commenters for their support and feedback. After consideration of the comments received, we are finalizing our proposal to designate HCPCS codes G2250, G2251, G2061, G2062, and G2063 as “sometimes therapy” services to facilitate billing of the CTBS by therapists. Additionally, we note that when billed by a private practice PT, OT, or SLP, the codes would need to include the corresponding GO, GP, or GN therapy modifier to signify that the CTB are furnished as therapy services furnished under an OT, PT, or SLP plan of care.

Comment: Many commenters supported and thanked CMS for the clarification that consent from the patient to receive CTBS services can be documented by auxiliary staff under general supervision as well as by the billing practitioner.

Response: We thank commenters for their feedback.

Comment: Several commenters encouraged CMS to permanently allow the use of virtual check-ins and e-visits for new as well as established patients.

Response: In the CY 2019 PFS proposed rule (83 FR 35724), we created HCPCS code G2012 and stated our expectation that these services would be initiated by the patient, especially since many beneficiaries would be financially liable for sharing in the cost of these services. Additionally, MedPAC noted particular concern regarding potential increases in volume that are not related to ongoing, informed patient care. CMS remains concerned about these issues outside of the PHE for COVID-19. As such, we did not propose, and do not anticipate proposing, to permanently allow billing for HCPCS codes G2020 and G2012 when furnished to new patients.

Comment: One commenter suggested it may be helpful for CMS to provide data on specialty-specific uptake of CTBS and e-Visits, both before and after the PHE for COVID-19, in order to determine if there are access challenges in specific specialties.

Response: We thank the commenter for their suggestion and will take this into future consideration after the PHE for COVID-19 ends.

7. Continuation of Payment for Audio-Only Visits

a. Background

In the March 31st COVID-19 IFC, we established separate payment for audio-only telephone E/M services (85 FR 19264 through 19266). The telephone E/M services are 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 Start Printed Page 84534care 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). We noted that, although these services were previously considered non-covered under the PFS, in the context of the PHE for COVID-19 and with the goal of reducing exposure risks associated with COVID-19, especially in the case that two-way, audio and video technology is not available to furnish a Medicare telehealth service, we believed there are circumstances where prolonged, audio-only communication between the practitioner and the patient could be clinically appropriate, yet not fully replace a face-to-face visit. For example, an established patient who was experiencing an exacerbation of their condition could have a 25-minute phone conversation with their physician during which the physician determines that an adjustment to the patient's medication would alleviate their symptoms. The use of CPT code 99443 in this situation prevents a similar in-person service as the evaluation of the patient's symptoms and determination to adjust medication could be conducted without patient and the practitioner being in the same location. We stated our belief that these telephone E/M codes, with their established description and valuation, were the best way to recognize the relative resource costs of these kinds of services and make payment for them under the PFS. For these codes, we initially finalized on an interim basis during the PHE for COVID-19, work RVUs as recommended by the American Medical Association (AMA) Relative Value Scale Update Committee (RUC), as discussed in the CY 2008 PFS final rule with comment period (72 FR 66371), of 0.25 for CPT code 99441, 0.50 for CPT code 99442, and 0.75 for CPT code 99443. We also finalized the RUC-recommended direct PE inputs which consist of 3 minutes of post-service Registered Nurse/Licensed Practical Nurse/Medical Technical Assistant clinical labor time for each code.

In the May 8th COVID-19 IFC, we noted that in the time since we established these payment amounts, stakeholders had informed us that use of audio-only services was more prevalent than we had previously considered, especially because many beneficiaries were not utilizing video-enabled communication technology from their homes. In other words, there were many cases where practitioners would under ordinary circumstances utilize telehealth or in-person visits to evaluate and manage patients' medical concerns, but were instead using audio-only interactions to manage more complex care (85 FR 27589 through 27590). While we had previously acknowledged the likelihood that, under the circumstances of the PHE for COVID-19, more time would be spent interacting with the patient via audio-only technology, we stated that the intensity of furnishing an audio-only visit to a beneficiary during the unique circumstances of the PHE for COVID-19 was not accurately captured by the valuation of these services we established in the March 31st COVID-19 IFC. This would be particularly true to the extent that these audio-only services are actually serving as a substitute for office/outpatient Medicare telehealth visits for beneficiaries not using video-enabled telecommunications technology contrary to the situation we anticipated when establishing payment for them in the March 31st COVID-19 IFC. We stated that, given our understanding that these audio-only services were being furnished primarily as a replacement for care that would otherwise be reported as an in-person or telehealth visit using the O/O E/M codes, we established new RVUs for the telephone E/M services based on crosswalks to the most analogous O/O E/M codes, based on the time requirements for the telephone codes and the times assumed for valuation for purposes of the O/O E/M codes. Specifically, we crosswalked CPT codes 99212, 99213, and 99214 to CPT codes 99441, 99442, and 99443, respectively. We therefore finalized, on an interim basis and for the duration of the PHE for COVID-19, the following work RVUs: 0.48 for CPT code 99441; 0.97 for CPT code 99442; and 1.50 for CPT code 99443. We also finalized the direct PE inputs associated with CPT code 99212 for CPT code 99441, the direct PE inputs associated with CPT code 99213 for CPT code 99442, and the direct PE inputs associated with CPT code 99214 for CPT code 99443. We did not finalize increased payment rates for CPT codes 98966-98968 as these codes describe services furnished by practitioners who cannot independently bill for E/M services and so these telephone assessment and management services, by definition, are not being furnished in lieu of an O/O E/M service. We noted that to the extent that these extended phone services are taking place instead of O/O E/M visits (either in-person or via telehealth), the direct crosswalk of RVUs also better maintains overall budget neutrality and relativity under the PFS. We stated that we believed that the resources required to furnish these services during the PHE for COVID-19 are better captured by the RVUs associated with the level 2-4 established patient O/O E/M visits. Additionally, we stated that, given our understanding that these audio-only services were being furnished as substitutes for O/O E/M services, we recognized that they should be considered as telehealth services, and added them to the Medicare telehealth services list for the duration of the PHE for COVID-19. For these audio-only E/M services, we separately issued a waiver under section 1135(b)(8) of the Act, as amended by section 3703 of the CARES Act, of the requirements under section 1834(m) of the Act and our regulation at § 410.78 that Medicare telehealth services must be furnished using video technology.

b. Summary of Comments Received in Response to Comment Solicitation on Continuation of Payment for Audio-Only Visits

In the CY 2021 PFS proposed rule (85 FR 50113-50114), we did not propose to continue to recognize CPT codes 99441, 99442, and 99443 for payment under the PFS after conclusion of the PHE for COVID-19 because, outside of the circumstances of the PHE, we are not able to waive the requirement that telehealth services be furnished using an interactive telecommunications system that includes two-way, audio/video communication technology. However, we recognized that the need for audio-only interaction could remain as beneficiaries continue to try to avoid sources of potential infection, such as a doctor's office; and in that circumstance, a longer phone conversation may be needed to determine if an in-person visit is necessary rather than what is described by the virtual check-in. We solicited comment on whether CMS should develop coding and payment for a service similar to the virtual check-in but for a longer unit of time and with an accordingly higher value. We sought input from the public on the appropriate duration interval for such services and the resources in both work and PE that would be associated with furnishing them. We also solicited comment on whether separate payment for such telephone-only services should be a provisional policy to remain in effect until a year or some other period after the end of the PHE for COVID-19 or if Start Printed Page 84535it should be PFS payment policy permanently.

We received public comments on the comment solicitation on continuation of payment for audio-only visits. The following is a summary of the comments we received and our responses.

Comment: Commenters broadly supported maintaining the availability of certain audio-only services after the duration of the PHE for COVID-19. Commenters stated that many beneficiaries may not have access to or choose not to use two-way, audio/video communication technology, and therefore, maintaining some form of payment for audio-only services would be crucial for ensuring access to care for this vulnerable population. Some commenters urged CMS to continue payment for audio-only evaluation or assessment and management services beyond the end of the PHE for COVID-19. Other commenters stated that allowing practitioners to furnish certain behavioral health and counseling services via audio-only communication technology has been crucial to ensuring access to these services and that CMS should continue payment for these audio-only services after the conclusion of the PHE for COVID-19. Commenters further suggested, in response to both this proposal and in the context of the proposed revision to the agency's regulation at § 410.78(a)(3), that the statutory text laying out the telehealth services benefit uses the term “telecommunications system” but does not include an explicit definition of that term, except to say that in the case of federal telemedicine demonstrations in Alaska or Hawaii, the term “includes store-and-forward technologies that provide for the asynchronous transmission of health care information in single or multimedia formats.” Therefore, the statute leaves it up to the Department of Health and Human Services (HHS) to determine whether a telehealth telecommunications system must include both audio and video capabilities, and HHS is free to make the modification it proposes under this heading. Based on this assessment, commenters stated that CMS has the authority to redefine our longstanding regulatory interpretation of “interactive telecommunications system” at § 410.78 to include audio-only services.

While the majority of commenters stated that they preferred CMS continuing to recognize the audio evaluation/assessment and management services outside of the PHE for COVID-19, some commenters did state that, in the absence of continuing to recognize those codes, CMS should provide coding and payment for a longer virtual check-in. With regard to the valuation of a longer virtual check in, commenters provided a few recommendations. One commenter suggested that we value this service the same as 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), other commenters suggested a range of times for a new virtual check in, such as 11-22 minutes or 15-20 minutes. Another commenter suggested that CMS could create more than one additional virtual check-in code.

Response: We appreciate these comments. Section 1834(m)(2)(A) of the Act expressly provides payment to the distant site physician or practitioner of an amount equal to the amount that such physician or practitioner would have been paid under this title had such service been furnished without the use of a telecommunications system. This means that we pay an equal amount for a service furnished using a “telecommunications system” as for a service furnished in person (without the use of a telecommunications system). Section 1834(m)(1) of the Act specifies that telehealth services must be furnished via a “telecommunications system,” and it includes an exception to allow “store and forward” technology to be considered a telecommunications system only for purposes of certain federal demonstrations. CMS has in place a longstanding interpretation of “telecommunications system” that includes only technology that enables a visit that is analogous to an in person visit—which aligns closely with our resource-based payment policy under the PFS, given that payment is made for a telehealth service at the same rate as an in-person visit. Our criteria for considering the addition of services to the telehealth services list also rely on an assessment of whether the service furnished via telehealth is analogous to one furnished in person. We continue to believe that our longstanding regulatory definition of “telecommunications system” reflects the intent of statute.

As the audio-only assessment and management or E/M visits are by definition replacements for in-person office visits, they would be subject to the statutory restrictions outlined in section 1834(m) of the Act. Outside of the circumstances of the PHE for COVID-19, we continue to believe that our longstanding regulatory interpretation of “telecommunications system” precludes the use of audio-only technology for purposes of Medicare telehealth services.

Comment: Some commenters stated that if CMS continues payment for the audio-only E/M visits, these should continue to be paid at rates commensurate to the level 2-4 established patient office visits, consistent with how these services have been paid during the PHE for COVID-19. Other commenters disagreed, stating that outside the circumstances of the PHE for COVID-19, these services should not have the same payment rate as in-person services.

Response: After the end of the PHE, there will be no separate payment for the audio-only E/M visit codes. At the conclusion of the PHE, we will assign a status of “bundled” and post the RUC-recommended RVUs for these codes in accordance with our usual practice.

Comment: A few commenters requested that, if CMS continues to recognize the audio-only evaluation/assessment and management services or if CMS creates a longer virtual check-in service, the service should be available to both new and established patients. A few commenters, including MedPAC, suggested that if CMS creates a longer virtual check-in, the policy should be provisional rather than permanent—for example, through the calendar year in which the PHE for COVID-19 ends.

Response: We continue to believe that, outside of the circumstances of the PHE for COVID-19, CTBS services broadly should be billed only for established patients.

c. Interim Final Rule With Comment Period for Coding and Payment of Virtual Check-In Services (HCPCS Code GSADX1)

i. Background

We note that we have historically established coding and payment on an interim final basis for truly new services when it is in the public interest to do so. Outside of the circumstances of the PHE for COVID-19, Medicare does not provide separate payment for a service that would be a substitute for an in-person visit but is furnished using synchronous audio-only technology. However, we recognize that commenters were clear about the continuing need for coding and payment to reflect the Start Printed Page 84536provision of lengthier audio-only services outside of the PHE for COVID-19, if not as substitutes for in-person services, then as a tool to determine whether an in-person visit is needed, particularly as beneficiaries may still be cautious about exposure risks associated with in-person services.

ii. Interim Final Policy

Given the widespread concerns expressed by commenters about the continuing need for audio-only conversations with patients, we believe it would be expedient to establish additional coding and payment for an extended audio-only assessment service on an interim basis for CY 2021. We believe that 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. Therefore, for CY 2021, on an interim basis, we are establishing 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.). We are finalizing 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. This is consistent with our approach to valuing the virtual check-in service (HCPCS code G2012), which used CPT code 99441 as the basis for valuation. In the case of HCPCS code G2252 and CPT code 99442, both codes describe 11-20 minutes of medical discussion when the practitioner may not necessarily be able to visualize the patient, and is used when the acuity of the patient's problem is not necessarily likely to warrant a visit, but when the needs of the particular patient require more assessment time from the practitioner. In the case of HCPCS code G2252, the additional time would be used to determine the necessity of an in person visit result in a work time/intensity that is similar to the crosswalk code. We are finalizing a work RVU of 0.50, direct PE inputs of 3 minutes of clinical labor code L037D, and 1 minute, 15 minutes, and 5 minutes of pre, intra and post service time, respectively. As this service is not a substitute for an in-person visit, but rather an assessment to determine the need for one, the restrictions in section 1834(m) of the Act do not apply and the only technological requirement is that the communication technology must be synchronous. If this service originates from a related E/M service provided within the previous 7 days or leads to an E/M service or procedure within the next 24 hours or soonest available appointment it would be considered bundled into that in-person service. We would consider this service to be a CTBS and refer readers to the CY 2019 PFS final rule for additional discussion as to why these fall outside of the restrictions in 1834(m) of the Act (83 FR 59482 through 59491). We also note that HCPCS code GSADX1 is subject to the same billing requirements as HCPCS code G2012.

iii. Waiver of Proposed Rulemaking for Provisions

Under the Administrative Procedure Act (APA), 5 U.S.C. 553(b), an agency is generally required to publish a notice and solicit comment on a proposed rule in the Federal Register before issuing a final rule. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of a proposed rule in the Federal Register and provide a period of not less than 60 days for public comment. The APA provides for exceptions from the notice and comment requirements see 5 U.S.C. 553(b)(B); in cases in which the APA exceptions apply, section 1871(b)(2)(C) of the Act provides for exceptions from the notice and 60-day comment period requirements of the Act as well. Section 553(b)(B) of Title 5 and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal rulemaking requirements if the agency for good cause finds that the notice and comment process is impracticable, unnecessary, or contrary to the public interest.

We find that there is good cause to waive the notice and comment requirements under sections 553(b)(B) of the APA and section 1871(b)(2)(C) due to widespread concerns expressed by commenters about the continuing need for audio-only conversations with patients. We believe that 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. We find that it would be impracticable and contrary to the public interest to undergo notice and comment procedures before finalizing these payment policies on an interim basis. We also find that delaying implementation of these policies is unnecessary because the impact on other PFS services for 2021 is negligible and the practical alternative for this treatment is no payment under Medicare Part B. In either case, payments for 2022 and beyond would be informed by public comments.

Therefore, we find good cause to waive the notice of proposed rulemaking as provided under section 1871(b)(2)(C) of the Act and section 533(b)(B) of the APA and to issue this interim final rule with an opportunity for public comment. We are providing a 60-day public comment period as specified in the DATES section of this document.

8. Comment Solicitation on Coding and Payment for Virtual Services

The health care community uses the term “telehealth” broadly to refer to medical services furnished via communications technology. Under current PFS payment rules, Medicare routinely pays for many of these kinds of services. This includes some kinds of remote patient monitoring (either as separate services or as parts of bundled services), interpretations of diagnostic tests when furnished remotely and, under conditions specified in section 1834(m) of the Act, services that would otherwise be furnished in person but are instead furnished via real-time, interactive communication technology. Over the past several years, we have also established several PFS policies to make separate payment for non-face-to-face services included as part of ongoing care management. Although all of the kinds of services stated above might be called “telehealth” by patients, payers of health care services, and health care providers, we have generally used the term “Medicare telehealth services” to refer to the subset of services defined in section 1834(m) of the Act. Section 1834(m) of the Act defines Medicare telehealth services and specifies 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.

In the CY 2021 PFS proposed rule, we noted that we believe that the provisions in section 1834(m) of the Act apply particularly to the kinds of professional services explicitly enumerated in the statutory provisions, Start Printed Page 84537like professional consultations, office visits, and office psychiatry services. Generally, the services we have added to the Medicare telehealth services list are similar to these kinds of services. As has long been the case, certain other kinds of services that are furnished remotely using communications technology are not considered “Medicare telehealth services” and are not subject to the restrictions articulated in section 1834(m) of the Act. This is true for services that were routinely paid separately prior to the enactment of the provisions in section 1834(m) of the Act and do not usually include patient interaction (such as remote interpretation of diagnostic imaging tests), and for services that were not discretely defined or separately paid for at the time of enactment and that do include patient interaction (such as chronic care management services).

In recent years, we have begun making separate payment for a number of services that use telecommunications technology but are not considered Medicare telehealth services. These CTB services include, for example, certain kinds of remote patient monitoring (either as separate services or as parts of bundled services), a virtual check-in, and a remote asynchronous service. These services are different than the kinds of services specified in section 1834(m) of the Act, in that they are not the kind of services that are ordinarily furnished in person but are routinely furnished using a telecommunications system.

In the past, we have received requests to add certain services, such as chronic care management or remote physiologic monitoring to the Medicare telehealth services list. However, as these services fall outside the scope of services addressed, and the enumerated list of services included, in section 1834(m) of the Act, they are not considered telehealth services and, therefore, are not subject to the same restrictions. We solicited comment on whether there are additional services that fall outside the scope of telehealth services under section 1834(m) of the Act where it would be helpful for us to clarify that the services are inherently non-face-to-face, so do not need to be on the Medicare telehealth services list in order to be billed and paid when furnished using telecommunications technology rather than in person with the patient present. We also solicited comment on physicians' services that use evolving technologies to improve patient care that may not be fully recognized by current PFS coding and payment, including, for example, additional or more specific coding for care management services. Finally, we solicited comment on any impediments that contribute to healthcare provider burden and that may result in practitioners being reluctant to bill for CTBS. We noted that we appreciate the ongoing engagement and additional information from stakeholders as we work to improve coding and payment for these services that utilize telecommunications technology.

We received public comments on the comment solicitation on coding and payment for virtual services. The following is a summary of the comments we received and our responses.

Comment: Some commenters stated that CMS should provide utilization information for CTBS services before, during, and after the PHE. Others suggested that CMS establish separate coding and payment for additional consultations that may be furnished using communication technology. Other comments suggested that CMS issue clear and consistent guidance on how to code for and appropriately document both telehealth and CTBS. Commenters recommended that CMS collaborate with the AMA to accurately value services furnished using communication technology.

Response: We thank commenters for their input and will consider them for potential future rulemaking or future subregulatory guidance, as appropriate.

9. Clarification of Current PFS Policies for Telehealth Services

In response to the waiver of statutory requirements and the relaxation of regulatory requirements for telehealth during the PHE for COVID-19, we received a number of requests to clarify existing PFS policy for telehealth. For example, we received questions as to whether Medicare allows incident-to billing for telehealth services, particularly for practitioners such as counselors who are supervised by a physician in private practice. We noted that there are no Medicare regulations that explicitly prohibit eligible distant site practitioners from billing for telehealth services provided incident to their services. However, we also noted that our existing definition of direct supervision requires on-site presence of the billing clinician when the service is provided. That requirement could make it difficult for a billing clinician to provide the direct supervision of services provided via telehealth that is required for services furnished incident to their professional services by auxiliary personnel. Under the proposed revision to the definition of direct supervision to permit virtual presence (FR 85 50114 and 50115), we acknowledged that billing practitioners could more easily meet the direct supervision requirements for telehealth services provided incident to their services. Consequently, we noted that we believe services provided incident to the professional services of an eligible distant site physician or practitioner could be reported when they meet direct supervision requirements at both the originating and distant site through the virtual presence of the billing physician or practitioner. Therefore, we proposed to clarify that services that may be billed incident-to may be provided via telehealth incident to a physicians' (or authorized NPP's) service and under the direct supervision of the billing professional. This is consistent with a policy clarification that we made through the May 8th COVID-19 IFC (85 FR 27562).

We also received questions as to whether services should be reported as telehealth services when the individual physician or practitioner furnishing the service is in the same location as the beneficiary; for example, if the physician or practitioner furnishing the service is in the same institutional setting but is utilizing telecommunications technology to furnish the service due to exposure risks. We also clarified, as we did in the May 8th COVID-19 IFC (85 FR 27562), that if audio/video technology is used in furnishing a service when the beneficiary and the practitioner are in the same institutional or office setting, then the practitioner should bill for the service furnished as if it was furnished in person, and the service would not be subject to any of the telehealth requirements under section 1834(m) of the Act or § 410.78 of our regulations.

We received public comments on these proposed clarifications of current policies for telehealth services. The following is a summary of the comments we received and our responses.

Comment: Several commenters supported our proposal to amend the definition of direct supervision to permit supervision through virtual presence because it would allow billing practitioners to more easily meet the direct supervision requirements for telehealth services provided “incident to” their services. Commenters stated that this policy would expand access to needed care in communities that may not have a supervising physician on site, and could make available services that another qualified healthcare professional could provide within their scope of practice if only they had the necessary direct supervision.

Response: We appreciate commenters' support for this clarification. We are Start Printed Page 84538finalizing our proposed clarification that telehealth services may be furnished and billed when provided incident to a distant site physicians' (or authorized NPP's) service under the direct supervision of the billing professional provided through virtual presence in accordance with our regulation at § 410.26.

Comment: One commenter requested that we specify in detail how time should be counted for services furnished and billed incident to the commenter's professional services when the required direct supervision is provided through virtual presence.

Response: As we do not provide specific coding guidance, we suggest that this commenter refer to the AMA CPT guidelines for using time to bill for services furnished and also contact their Medicare Administrative Contractor for further assistance. We further note that time should be counted for telehealth services furnished by auxiliary personnel incident to a billing professional's services in the same way time is counted for other “incident to” services.

Comment: Commenters supported our clarification that, if audio/video technology is used while furnishing a service when the beneficiary and the practitioner are in the same institutional or office setting, then the practitioner should bill for the service furnished as if it was furnished in person. In addition, the service would not be subject to any of the telehealth requirements, such as geographic or site restrictions. Commenters state that this flexibility helps conserve personal protective equipment (PPE) and supports access to care.

Response: We appreciate commenters' support for this clarification.

Comment: One commenter recommended that CMS institute tracking methods to accurately attribute services to the professional who delivered the care when submitting services using Medicare's “incident to” billing provision. They reasoned that, when there is a lack of transparency regarding which clinicians are providing what services, it is difficult, if not impossible, to appropriately measure the type or volume of services or the quality of care delivered by each health professional.

Response: We thank commenters for their feedback and suggestions. We note that CMS has very clear rules about when a physician or practitioner is permitted to bill for services furnished incident to their own. When practitioners bill for their services, they attest to the accuracy of the information they provide; and failure to provide accurate information can result in civil and criminal liability.

10. Direct Supervision by Interactive Telecommunications Technology

Many services for which payment is made under the PFS can be furnished under a level of physician or NPP supervision rather than being performed directly by the billing practitioner. In many cases, the supervision requirements necessitate the presence of the physician or NPP in a particular location, usually in the same location as the beneficiary when the service is provided. For example, as described at § 410.26, services furnished by auxiliary personnel incident to a physician's or NPP's professional service usually require the direct supervision of the physician or NPP. In addition to these “incident to” services, there are a number of diagnostic services under the PFS that also must be furnished under direct supervision. As currently defined in §§ 410.26 and 410.32(b)(3)(ii), direct supervision means that the physician or NPP must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. Direct supervision does not require the physician or NPP to be present in the room when the service or procedure is performed.

For the duration of the PHE for COVID-19, for purposes of limiting exposure to COVID-19, we adopted an interim final policy revising the definition of direct supervision to include virtual presence of the supervising physician or practitioner using interactive audio/video real-time communications technology (85 FR 19245). We recognized that in some cases, the physical proximity of the physician or practitioner might present additional infection exposure risk to the patient and/or practitioner. In the context of the PHE for COVID-19, given the risks of exposure, the immediate risk of foregone medical care, the increased demand for healthcare professionals, and the widespread use of telecommunications technology, we believed that individual practitioners were in the best position to make decisions about how to meet the requirement to provide appropriate direct supervision based on their clinical judgment in particular circumstances.

We proposed to extend the policy until the later of the end of the calendar year in which the PHE for COVID-19 ends or December 31, 2021, to recognize the different and unique circumstances faced by individual communities that may continue after the PHE ends, and provide time to solicit public input on circumstances where the flexibility to use interactive audio/video real-time communications technology to provide virtual direct supervision could still be needed and appropriate. The extension of this flexibility would allow time for clinicians to make adjustments and for us to obtain public input on services and circumstances for which this policy might be appropriate on a permanent basis. We noted that if the proposal were finalized and the PHE for COVID-19 ended before the CY 2021 PFS final rule takes effect, the interim policy adopted during the PHE to allow direct supervision using real-time, interactive audio and video technology would no longer be in effect during the period between expiration of the PHE and the date the final policy takes effect.

Given our continued interaction with practitioners during the PHE for COVID-19 and our growing understanding of how services may be furnished remotely and safely, we noted that we have a better understanding of how, in some cases, depending upon the unique circumstances of individual patients and billing practitioners or physicians, telecommunications technology could safely allow the practitioner or physician's immediate availability to furnish assistance and direction without necessarily requiring the supervising practitioner's or physician's physical presence in the location where the service is being furnished. In such cases, the use of real-time, audio and video telecommunications technology may allow the supervising practitioner or physician to observe the beneficiary and the auxiliary staff performing the service or be engaged (Direct supervision does not require the physician or NPP to be present in the room when the service or procedure is performed) to provide assistance and direction of the service through virtual means, and without the supervising practitioner or physician being physically present.

Consequently, we proposed to revise § 410.32(b)(3)(ii) to allow direct supervision to be provided using real-time, interactive audio and video technology through the later of the end of the calendar year in which the PHE for COVID-19 ends or December 31, 2021. Specifically, we proposed to continue our current rule that “Direct supervision” in the office setting would mean the physician (or other supervising practitioner) must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It would not mean that the physician (or other Start Printed Page 84539supervising practitioner) must be present in the room when the procedure is performed. We proposed to add that, until the later of the end of the calendar year in which the PHE for COVID-19 ends or December 31, 2021, the presence of the physician (or other practitioner) may include virtual presence through audio/video real-time communications technology (excluding audio-only) subject to the clinical judgement of the supervising physician or (other supervising practitioner). In response to questions received since we issued the interim policy for the PHE for COVID-19, we clarified that, to the extent our policy allows direct supervision through virtual presence using audio/video real-time communications technology, the requirement could be met by the supervising physician (or other practitioner) being immediately available to engage via audio/video technology (excluding audio-only), and would not require real-time presence or observation of the service via interactive audio and video technology throughout the performance of the procedure.

While flexibility to provide direct supervision through audio/video real-time communications technology was adopted to be responsive to critical needs during the PHE for COVID-19 to ensure beneficiary access to care, reduce exposure risk and to increase the capacity of practitioners and physicians to respond to COVID-19, we expressed concern that direct supervision through virtual presence may not be sufficient to support PFS payment on a permanent basis, beyond the PHE for COVID-19, due to issues of patient safety. For instance, in complex, high-risk, surgical, interventional, or endoscopic procedures, or anesthesia procedures, a patient's clinical status can quickly change, and we believe it is necessary for such services to be furnished or supervised in person to allow for rapid on-site decision-making in the event of an adverse clinical situation. For example, there could be a case in which a practitioner or physician uses audio/video interactive communications to virtually supervise a nurse performing a post-op evaluation following surgery for hip fracture, and the nurse might note that the patient is uncooperative. In this scenario, had a full exam been performed directly by the practitioner or physician, or under the in-person supervision of a practitioner or physician who was physically or immediately available in the clinic to provide the necessary direction, the physician or practitioner would have recognized that the patient exhibited signs of crystal-mediated acute arthritis, and that the patient's lack of cooperation was likely due to hypoactive delirium. Instead, the supervising practitioner or physician may not have been able to identify this clinical issue as a result of being available only via audio/video interactive communications technology. In this case, the presence of the supervising practitioner or physician through audio/video interactive communications technology would have been insufficient. There also may be certain patient populations that require greater clinical attentiveness and skill than the supervising practitioner or physician could provide via audio/video interactive communications technology. For example, patients with cognitive impairment or dementia, or patients with communication disabilities, may require the experience and skill of a physically present supervising practitioner or physician to recognize needs such as the need for specialized testing. It may not be possible for a supervising practitioner or physician to recognize or meet these clinical needs while being present for the service only through audio/video interactive communications technology. Moreover, the virtual connection between the individual performing the service and the supervising practitioner or physician could be disrupted, making it challenging for the supervising practitioner or physician to remain immediately available to provide assistance and direction to the physically present clinical staff or auxiliary personnel to furnish appropriate care to the patient.

We solicited information from commenters as to whether there should be any additional “guardrails” or limitations to ensure patient safety/clinical appropriateness, beyond typical clinical standards, as well as restrictions to prevent fraud or inappropriate use if we were to finalize a policy to permit direct supervision through audio/video interactive communications technology, with consideration of relevant patient safety, clinical appropriateness criteria or other restrictions, on a temporary basis through the later of the end of the calendar year in which the PHE for COVID-19 ends or December 31, 2021, or consider it beyond the time specified. We solicited information on what risks this policy might introduce to beneficiaries as they receive care from practitioners that would supervise care virtually in this way. Further, we solicited comment on potential concerns around induced utilization and fraud, waste, and abuse and how those concerns might be addressed. We also invited commenters to provide data and information about their implementation experience with direct supervision using virtual presence during the PHE for COVID-19, and are interested in comments on the degree of aging and disability competency training that is required for effective use of audio/video real-time communications technology.

We received public comments on the direct supervision by interactive telecommunications technology. The following is a summary of the comments we received and our responses.

Comment: Commenters supported our proposal to revise the definition of direct supervision to allow virtual presence of the supervising physician or practitioner using real-time, interactive audio-video technology until the later of the end of the calendar year in which the PHE for COVID-19 ends or December 31, 2021, stating that this revision will greatly help reduce barriers to access, and that allowing physicians and auxiliary personnel to provide services from two separate locations will work to support the expansion of telehealth services and protects frontline workers by allowing appropriate social distancing.

Response: We thank the commenters for their support and feedback.

Comment: Many commenters requested that CMS make permanent the current temporary regulatory flexibility allowing physicians to provide direct supervision of clinical staff virtually, using real-time audio/video technology. Others opposed the use of virtual direct supervision following the termination of the PHE due to issues of patient safety, stating it may not be possible for a supervising physician to recognize or meet urgent clinical needs while being present for the service, and potentially other services at the same time, only through audio/video interactive communications technology.

We also received a variety of responses to our stated concerns that direct supervision through virtual presence may not be sufficient to support PFS payment on a permanent basis, beyond the PHE for COVID-19, due to issues of patient safety. Many commenters did not share these concerns, stating that there is no situation whereby clinical staff or auxiliary personnel would conduct complex, high-risk, surgical, interventional, or endoscopic procedures under any circumstance other than in-person. Many other commenters shared our patient-safety concerns, citing increased utilization and spending, and the potential for Start Printed Page 84540fraud and abuse. Many stressed that virtual supervision can be done safely in certain scenarios, but it is not warranted in other scenarios. More specifically, some commenters said remote supervision would not be appropriate for in-person diagnostic or therapeutic procedures since the physician would not be physically available to help the individual being supervised if the need arises. Similarly, commenters suggested that it may not be appropriate when a remote physician is not on-site for an E/M service that requires finesse when performing the physical examination in person. According to some commenters, virtual direct supervision would not be appropriate for data interpretation, such as imaging studies or certain physiologic studies, where the patient is not physically present. A commenter agreed with the agency's assessment that anesthesia services must be furnished or supervised in person to allow for rapid, on-site decision-making in the event of an adverse clinical situation. One commenter recommended that CMS provide clarifying language in the final rule to ensure that the supervising physician is in the United States when using audio-visual technology for purposes of direct supervision.

Commenters offered a range of responses and suggestions in the interest of patient safety and program integrity in response to our request for information as to whether there should be any additional “guardrails” or limitations to ensure patient safety/clinical appropriateness, beyond typical clinical standards, as well as restrictions to prevent fraud or inappropriate use, if we were to finalize a policy to permit direct supervision through audio/video interactive communications technology on a temporary basis. According to some commenters, we should defer entirely to physician judgment to determine clinical appropriateness. Others offered suggestions including that we should closely monitor the use of virtual direct supervision during the interim period to gain information on potential induced utilization or fraud, waste, and abuse concerns. Some commenters stated that virtual direct supervision should be robustly documented to ensure that patients are safely receiving clinically appropriate care from members of the care team. A commenter stated that program integrity concerns could be addressed through provider enrollment rather than through administrative barriers. Other suggestions included: That CMS develop a list of high risk procedures and complex patient populations for whom this policy may not be appropriate; that CMS limit the number of clinicians with whom a supervising physician may simultaneously engage, as well as the number of incident-to relationships in which a supervising physician may be involved at a given time, via audio/video technology; that testing sites that use interactive technologies rely on documentation and training; that we require that a caregiver be present physically with the patient when the services are furnished virtually; and that CMS identify conditions under which the extension of the virtual direct supervision policy may be revoked if evidence suggests such supervision is inadequate.

Response: We appreciate the information and suggestions we received in response to this request for comment. This information will allow us to consider safety and program integrity issues in the context of virtual supervision, and to what degree and on what basis this flexibility could be continued following the PHE. We will consider this and other information as we determine future policy regarding use of communication technology to satisfy direct supervision requirements as well as the best approach for safeguarding patient safety while promoting use of technology to enhance access.

After consideration of the comments, we are finalizing our proposal to allow direct supervision to be provided using real-time, interactive audio and video technology through the later of the end of the calendar year in which the PHE for COVID-19 ends or December 31, 2021.

11. Comment Solicitation on PFS Payment for Specimen Collection for COVID-19 Tests

When physicians and other practitioners collect specimens for clinical diagnostic laboratory tests as part of their professional services, Medicare generally makes payment for the services under the PFS, though often that payment is bundled into the payment rate for other services, including office and outpatient visits. Typically, collection of a specimen via nasal swab or other method during the provision of a service might be reported as part of (bundled with) an O/O E/M visit (CPT codes 99201 through 99205, 99211 through 99215). In visits where a patient has a face-to-face interaction with a billing professional with whom they have an established relationship, these services are generally reported with a level 2 through a level 5 visit (CPT codes 99212 through 99215). In cases where the specimen is collected during a visit where the face-to-face interaction only involves clinical staff of the billing professional with whom the patient has an established relationship, these services are generally reported using CPT code 99211.

In the May 8th COVID-19 IFC (85 FR 27604-27605), we finalized on an interim basis that physicians and NPPs may use CPT code 99211 to bill for services furnished incident to their professional services, for both new and established patients, when clinical staff assess symptoms and collect specimens for purposes of COVID-19 testing, if the billing practitioner does not also furnish a higher level E/M service to the patient on the same day. In the CY 2021 PFS proposed rule, we noted that we considered whether to extend or make permanent the policy to allow physicians and NPPs to use CPT code 99211 to bill for services furnished incident to their professional services, for both new and established patients, when clinical staff assess symptoms and collect specimens for purposes of COVID-19 testing, and solicited public comments on whether we should continue this policy for a period of time, or permanently, after the PHE for COVID-19 ends.

We received public comments in response to our comment solicitation on PFS payment for specimen collection for COVID-19 tests. We appreciate the information and feedback provided. We will consider this information for potential future rulemaking.

12. Finalization of Interim Final Rule Provisions Related to Requirements of the Substance Use Disorder (SUD) Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

a. Expanding Medicare Telehealth Services for the Treatment of Opioid Use Disorder and Other SUDs

In the CY 2019 PFS interim final rule with comment period (83 FR 59452, 59496, Nov. 23, 2018), we implemented on an interim final basis the amendments made by section 2001(a) of the SUPPORT for Patients and Communities Act (Pub. L. 115-271, October 24, 2018) (the SUPPORT Act) to section 1834(m) of the Act. First, section 2001(a) of the SUPPORT Act removed the originating site geographic requirements under section 1834(m)(4)(C)(i) of the Act for telehealth services furnished on or after July 1, 2019 for the purpose of treating individuals diagnosed with a SUD or a co-occurring mental health disorder, as determined by the Secretary, at an originating site described in section Start Printed Page 845411834(m)(4)(C)(ii) of the Act, other than an originating site described in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act. Subclause (IX) of section 1834(m)(4)(C)(ii) of the Act refers to a renal dialysis facility, which is only an allowable originating site for purposes of home dialysis monthly ESRD-related clinical assessments in section 1881(b)(3)(B) of the Act. Section 2001(a) of the SUPPORT Act also added the home of an individual as a permissible originating site for telehealth services for the purpose of treating individuals diagnosed with a SUD or a co-occurring mental health disorder. Section 2001(a) of the SUPPORT Act also amended section 1834(m)(2)(B)(ii) of the Act to require that no originating site facility fee will be paid in instances when the individual's home is the originating site. Section 2001(b) of the SUPPORT Act granted the Secretary specific authority to implement the amendments made by section 2001(a) through an interim final rule, and under that authority, we issued such an interim final rule. In accordance with section 1834(m)(4)(C)(ii)(X) of the Act, as amended by section 2001(a) of the SUPPORT for Patients and Communities Act, we revised § 410.78(b)(3) on an interim final basis, by adding § 410.78(b)(3)(xii), which adds the home of an individual as a permissible originating site for telehealth services furnished on or after July 1, 2019 to individuals with a SUD diagnosis for purposes of treatment of a SUD or a co-occurring mental health disorder. We amended § 414.65(b)(3) on an interim final basis to reflect the requirement in section 1834(m)(2)(B)(ii) of the Act that there is no originating site facility fee paid when the originating site for these services is the individual's home. Additionally, we added § 410.78(b)(4)(iv)(C) on an interim final basis to specify that the geographic requirements in section 1834(m)(4)(C)(i) of the Act do not apply for telehealth services furnished on or after July 1, 2019, to individuals with a SUD diagnosis for purposes of treatment of a SUD or a co-occurring mental health disorder at an originating site other than a renal dialysis facility. We noted that section 2001 of the SUPPORT Act did not amend section 1834(m)(4)(F) of the Act, which limits the scope of telehealth services to those on the Medicare telehealth list. We also noted that practitioners would be responsible for assessing whether individuals have a SUD diagnosis and whether it would be clinically appropriate to furnish telehealth services for the treatment of the individual's SUD or a co-occurring mental health disorder. By billing codes on the Medicare telehealth list with the telehealth place of service code, practitioners would be indicating that the codes billed were used to furnish telehealth services to individuals with a SUD diagnosis for the purpose of treating the SUD or a co-occurring mental health disorder.

Comment: Several commenters expressed support for the changes authorized by section 2001(a) of the SUPPORT Act, noting that these changes that will benefit beneficiaries and advance the use of telehealth as a critical tool to improving access to care. One commenter noted that the changes will mitigate barriers to treatment for this patient population, decreasing stigma associated with seeking mental health and SUD services caused by presenting at a qualified originating site, allow patients to receive services at home, and open access to telehealth services for patients living in urban areas.

Response: We thank the commenters for their comments.

Comment: A few commenters urged CMS to consider expanding this flexibility to beneficiaries without SUDs, particularly those with mental health disorders without a co-occurring SUD.

Response: The interim final changes we adopted to our regulations under § 410.78 described above were based on amendments to the statute made by section 2001(a) of the SUPPORT Act. These amendments were limited to telehealth services furnished to individuals diagnosed with a SUD for purposes of treatment of the SUD or a co-occurring mental health disorder. We do not have the statutory authority at this time to expand these changes to include treatment of mental health disorders that are not co-occurring with a SUD diagnosis.

Comment: A few commenters urged CMS to ensure that the full scope of both SUD treatment services and applicable services for the treatment of co-occurring mental health disorders are included in the Medicare telehealth list in the future, citing examples such as screening, counseling, consultation, psychiatric services, care planning, initiation and continued management of Medication-Assisted Treatment (MAT), and others.

Response: Thank you for your comment. We note that HCPCS codes G2086, G2087, and G2088 were added to the Medicare Telehealth list beginning in CY 2020 (84 FR 62628). These codes describe bundled payments for office-based treatment for opioid use disorder, including development of the treatment plan, care coordination, individual therapy, and group therapy and counseling. We note that for CY 2021, we are finalizing a revision to these code descriptions to include the treatment of any substance use disorder rather than just OUD. See discussion in this final rule describing expansion of these codes to be inclusive of all SUDs beginning in CY 2021. Also, as discussed earlier in this final rule, we are finalizing the addition of CPT codes 99347 and 99348 (Home visit for the evaluation and management of an established patient) to the Medicare Telehealth list for CY 2021, which could be appropriately billed for treatment of an SUD or co-occurring mental health disorder, as well as CPT code 90853 (Group psychotherapy). We welcome recommendations of other codes for addition to the Medicare Telehealth list through our usual process by the February 10th deadline.

Comment: One commenter encouraged CMS to amend section 1834(m)(4)(f) of the Act to include MAT and remote opioid treatment as covered services on the Medicare telehealth list in order to provide the care needed to all patients with SUDs, including Opioid Use Disorder.

Response: We do not have the authority to amend the statute; however, the services associated with the provision of MAT in the office setting, such as E/M visits and psychotherapy, are on the Medicare Telehealth List.

Comment: One commenter cautioned against creating any administrative procedures that would complicate billing for these services when furnished via telehealth, which could create a barrier to implementation and stifle the ability of telehealth to be used effectively to facilitate SUD and co-occurring mental health services, while another commenter stated that CMS should publish clear sub-regulatory guidance on how the current Medicare telehealth services can be billed when treating SUD.

Response: As discussed in the CY 2019 PFS interim final rule with comment period (83 FR 59496), we noted that practitioners are responsible for assessing whether individuals have a SUD diagnosis and whether it would be clinically appropriate to furnish telehealth services for the treatment of the individual's SUD or a co-occurring mental health disorder. By billing codes on the Medicare telehealth list with the telehealth place of service code, practitioners would be indicating that the codes billed were used to furnish telehealth services to individuals with a SUD diagnosis for the purpose of Start Printed Page 84542treating the SUD or a co-occurring mental health disorder.

In summary, after consideration of the comments, we are finalizing the interim revisions to the regulation text at §§ 410.78(b)(3) and 414.65(b)(3) described above.

E. Care Management Services and Remote Physiologic Monitoring Services

1. Background

In recent years, we have updated PFS policies to improve payment for care management and coordination. Working with the CPT Editorial Panel and other clinicians, we have expanded the suite of codes describing these services. New CPT codes were created that describe services that involve direct patient contact (for some services, in-person) or do not involve direct patient contact; represent a single encounter, monthly service, or both; are timed services; address specific conditions; and represent the work of the billing practitioner, auxiliary personnel (specifically, clinical staff), or both (see Table 17). In this final rule for CY 2021, we continue our work to improve payment for care management services through code refinements related to remote physiologic monitoring (RPM), transitional care management (TCM), and psychiatric collaborative care model (CoCM) services.

2. Digitally Stored Data Services/Remote Physiologic Monitoring/Treatment Management Services (RPM)

RPM involves the collection and analysis of patient physiologic data that are used to develop and manage a treatment plan related to a chronic and/or acute health illness or condition. In recent years, we have finalized payment for seven CPT codes in the RPM code family. Five of the seven codes have been the focus of frequent questions from stakeholders.

In response to proposals in the CY 2019 PFS proposed rule (83 FR 35771) and the CY 2020 PFS proposed rule (84 FR 40555 through 40556), stakeholders requested that we clarify how we interpret aspects of the RPM code descriptors for CPT codes 99453, 99454, 99091, and 99457. Commenters asked us, for example, to identify who can furnish RPM services, what kinds of devices can be used to collect data, how data should be collected, and how “interactive communication” is defined. We stated in the CY 2020 PFS final rule (84 FR 62697) that we would provide guidance in the future about the codes. For CY 2021, we are clarifying how we Start Printed Page 84543read CPT code descriptors and instructions associated with CPT codes 99453, 99454, 99091, and 99457 (and the add-on code, CPT code 99458) and their use for remote monitoring of physiologic parameters of a patient's health.

The RPM process begins with two PE only codes, CPT codes 99453 and 99454, finalized in the CY 2019 PFS final rule (83 FR 59574 through 59576). As PE only codes, they are valued to include clinical staff time, supplies, and equipment, including the medical device for the typical case of remote monitoring. CPT code 99453 (Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment) is valued to reflect clinical staff time that includes instructing a patient and/or caregiver about using one or more medical devices. CPT code 99454 (Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days) is valued to include the medical device or devices supplied to the patient and the programming of the medical device for repeated monitoring. We reviewed the PE inputs for CPT code 99454 in the proposed rule and clarified that the medical devices that are supplied to the patient and used to collect physiologic data are considered equipment and, as such, are direct PE inputs for the code.

Review of CPT prefatory language (CPT® 2021 Professional Codebook (hereafter, CPT Codebook), pp. 52-53) provides additional information about the two PE-only codes. For example, the CPT prefatory language indicates that monitoring must occur over at least 16 days of a 30-day period in order for CPT codes 99453 and 99454 to be billed. Additionally, these two codes are not to be reported for a patient more than once during a 30-day period. This language suggests that even when multiple medical devices are provided to a patient, the services associated with all the medical devices can be billed only once per patient per 30-day period and only when at least 16 days of data have been collected. We also noted that CPT code 99453 can be billed only once per episode of care where an episode of care is defined as “beginning when the remote physiologic monitoring service is initiated and ends with attainment of targeted treatment goals” (CPT Codebook, p. 52).

Other stakeholder inquiries about CPT codes 99453 and 99454 focused upon the kinds of medical devices that can be used to collect a patient's physiologic data. Prefatory language in the CPT Codebook states that “the device must be a medical device as defined by the FDA.” CPT simply specifies that the device must meet the FDA's definition of a medical device as described in section 201(h) of the Federal, Food, Drug and Cosmetic Act (FFDCA). As discussed in the CY 2021 PFS proposed rule (85 FR 50118), we found no language in the CPT Codebook indicating that a medical device must be FDA cleared as some stakeholders suggested, although such clearance may be appropriate. We also noted that we did not find information that suggested a medical device must be prescribed by a physician, although this could be possible depending upon the medical device. Beyond acknowledging the CPT specification that the medical device supplied for CPT code 99454 must meet the FDA definition of a medical device, we clarified in the proposed rule that the medical device should digitally (that is, automatically) upload patient physiologic data (that is, data are not patient self-recorded and/or self-reported). We also noted that use of the medical device or devices that digitally collect and transmit a patient's physiologic data must, as usual for most Medicare covered services, be reasonable and necessary for the diagnosis or treatment of the patient's illness or injury or to improve the functioning of a malformed body member. Further, we noted that the device must be used to collect and transmit reliable and valid physiologic data that allow understanding of a patient's health status in order to develop and manage a plan of treatment.

The CPT Codebook lists the RPM codes under the main heading Evaluation and Management (E/M). We clarified in the proposed rule that as E/M codes, CPT codes 99453, 99454, 99091, 99457, and 99458, can be ordered and billed only by physicians or NPPs who are eligible to bill Medicare for E/M services.

Although we initially described RPM services in the CY 2019 PFS final rule (83 FR 59574) as services furnished to patients with chronic conditions, we clarified in the CY 2021 PFS proposed rule (85 FR 50118) that practitioners may furnish these services to remotely collect and analyze physiologic data from patients with acute conditions as well as from patients with chronic conditions.

After the data collection period for CPT codes 99453 and 99454, the physiologic data that are collected and transmitted may be analyzed and interpreted as described by CPT code 99091, a code that includes only professional work (that is, there are no direct PE inputs). We finalized payment for CPT code 99091 (Collection and interpretation of physiologic data (e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/regulation (when applicable) requiring a minimum of 30 minutes of time, each 30 days) in the CY 2018 PFS final rule (82 FR 53013 through 53014). The valuation for CPT code 99091 includes a total time of 40 minutes of physician or NPP work, broken down as follows: 5 minutes of preservice work (for example, chart review); 30 minutes of intra-service work (for example, data analysis and interpretation, report based upon the physiologic data, as well as a possible phone call to the patient); and 5 minutes of post-service work (that is, chart documentation). We noted that stakeholders have expressed confusion about the specification in the code descriptor for CPT code 99091 that the service is furnished by a “physician or other qualified health care professional, qualified by education, training, licensure/regulation.” The phrase “physician or other qualified health care professional” is defined by CPT as “an individual who is qualified by education, training, licensure/regulation (when applicable) and facility privileging (when applicable) who performs a professional service within his/her scope of practice and independently reports that professional service. These professionals are distinct from “clinical staff . . . [which refers to] a person who works under the supervision of a physician or other qualified health care professional and who is allowed by law, regulation, and facility policy to perform or assist in the performance of a specified professional service but does not individually report that professional service.” [3] Accordingly, when referring to a particular service described by a CPT code for Medicare purposes, a physician or other qualified health care professional is an individual whose scope of practice and Medicare benefit category includes the service, and who is authorized to independently bill Medicare for the service. See our previous discussion of this in the CY 2016 PFS final rule at 80 FR 70957. Medicare also covers and makes payment for certain services performed by auxiliary personnel (which includes Start Printed Page 84544clinical staff) “incident to” the professional services of the billing practitioner. Our regulation at § 410.26(a) defines auxiliary personnel and delineates the conditions for payment for “incident to” services.

After analyzing and interpreting a patient's remotely collected physiologic data, we noted that the next step in the process of RPM is the development of a treatment plan that is informed by the analysis and interpretation of the patient's data. It is at this point that the physician or NPP develops a treatment plan with the patient and/or caregiver (that is, develops a patient-centered plan of care) and then manages the plan until the targeted goals of the treatment plan are attained, which signals the end of the episode of care. CPT code 99457 (Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month; first 20 minutes) and its add-on code, CPT code 99458 (Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month; each additional 20 minutes (list separately in addition to code for primary procedure)) describe the treatment and management services associated with RPM. Medicare stakeholders have requested that we clarify aspects of these two codes. The two most frequently asked questions include “Who can furnish the services described by CPT codes 99457 and 99458? ” and “What does it mean to have an `interactive communication' with a patient? ”

We addressed who can furnish CPT codes 99457 and 99458 in the CY 2020 PFS final rule (84 FR 62697 through 62698) when we designated both codes as care management services. We explained that, like other care management services, services described by CPT codes 99457 and 99458 can be furnished by clinical staff under the general supervision of the physician or NPP. We noted that RPM services are not considered to be diagnostic tests; that is, they cannot be furnished and billed by an Independent Diagnostic Testing Facility on the order of a physician or NPP.

The services described by CPT codes 99457 and 99458 are services that are typically furnished remotely using communications technologies that allow “interactive communication,” which we read as real-time interaction, between a patient and the physician, NPP, or clinical staff who provide the services. Stakeholders have requested that we define “interactive communication” as used in the code descriptors for CPT codes 99457 and 99458. We explained in the proposed rule that we saw this remote, non-face-to-face exchange as being similar to the exchange that occurs in providing services described by HCPCS code G2012, Brief Communication Technology-Based Service, which we finalized in the CY 2019 PFS final rule (83 FR 59483 through 59486). We clarified that “interactive communication” for purposes of CPT codes 99457 and 99458 involves, at a minimum, a real-time synchronous, two-way audio interaction that is capable of being enhanced with video or other kinds of data transmission. As indicated in the code descriptor for CPT code 99457, we believed during the writing of the proposed rule that the interactive communication should total at least 20 minutes of time with the patient over the course of a calendar month for CPT code 99457 to be reported. Each additional 20 minutes of interactive communication between the patient and the physician/NPP/clinical staff would be reported using CPT code 99458. We developed our definition of time using the CPT Codebook. The CPT Codebook states that unless there are code- or code-range specific instructions, parenthetical instructions, or code descriptors to the contrary, time is considered to be “face-to-face” time with the patient or patient's caregiver/medical decision-maker. See the CPT Codebook, page xvii for more information about measuring time. Although the services described by CPT codes 99457 and 99458 are not typically in-person services, we interpreted time in the code descriptor to mean the time the practitioner spent in direct, real-time interactive communication with a patient.

Lastly, we proposed to establish as permanent policy two of the changes we made on an interim basis to the requirements for furnishing RPM services in the March 31st and the May 8th COVID-19 IFCs. (See 85 FR 19264 and 85 FR 27605 through 27606 for the interim modifications and clarifications to RPM services in response to the PHE for COVID-19).

Our goals during the PHE for COVID-19 have been to reduce exposure risks to the virus for practitioners and patients while also increasing access to health care services. We eliminated as many obstacles as possible to allow timely delivery of reasonable and necessary health care. We wanted patients to be able to access services quickly and without barriers. With the goals of reducing exposure and increasing access to services, we finalized that RPM services could be furnished to new patients, as well as established patients on an interim basis for the duration of the PHE for COVID-19. We also finalized several policies on an interim basis for the duration of the PHE for COVID-19. These include: (1) Allowing consent to be obtained at the time services are furnished; (2) allowing consent to be obtained by individuals providing RPM services under contract with the billing physician or practitioner; and (3) allowing RPM codes to be billed for a minimum of 2 days of data collection over a 30-day period, rather than the required 16 days of data collection over a 30-day period as provided in the CPT code descriptors.

For CY 2021, we proposed on a permanent basis to allow consent to be obtained at the time that RPM services are furnished. Because the CPT code descriptors do not specify that clinical staff must perform RPM services, we also proposed to allow auxiliary personnel (which includes other individuals who are not clinical staff but are employees or leased or contracted employees) to furnish services described by CPT codes 99453 and 99454 under the general supervision of the billing physician or practitioner.

When the PHE for COVID-19 ends, we again will require that RPM services be furnished only to an established patient. We believe that a physician or practitioner who has an established relationship with a patient would likely have had an opportunity to provide a new patient E/M service. During the new patient E/M service, the physician or practitioner would have collected relevant patient history and conducted a physical exam, as appropriate. As a result, the physician or practitioner would possess information needed to understand the current medical status and needs of the patient prior to ordering RPM services to collect and analyze the patient's physiologic data and to develop a treatment plan. Additionally, and in keeping with the CPT prefatory language for CPT codes 99453 and 99454, when the PHE for COVID-19 ends, we will once again require that 16 days of data be collected within 30 days to meet the requirements to bill CPT codes 99453 and 99454.

In response to the May 19, 2020 E.O. 13924, “Regulatory Relief To Support Economic Recovery,” (85 FR 31353 through 31356), we solicited comment from the medical community and other members of the public on whether Start Printed Page 84545current RPM coding accurately and adequately describes the full range of clinical scenarios where RPM services may be of benefit to patients. We requested information that would help us to understand whether it would be beneficial to consider establishing coding and payment rules that would allow practitioners to bill and be paid for RPM services with shorter monitoring periods. We expressed interest in understanding whether one or more codes that describe a shorter duration, for example, 8 or more days of remote monitoring within 30 days, might be useful. For example, CPT codes 99453 and 99454 currently require use of a medical device as defined by the FDA in section 201(h) of FFDCA that digitally collects and transmits 16 or more days of data every 30 days in order for the codes to be billed; however, some patients may not require remote monitoring for 16 or more days in a 30-day period. For some patients, continuous short-term monitoring might be more appropriate. For example, a post-surgical patient who is recovering at home might benefit from remote monitoring of his or her body temperature as a means of assessing infection and managing medications or dosage. In some clinical situations, monitoring several times throughout a day, over a period of 10 days, may be reasonable and necessary. Sixteen or more days might be unnecessary. We requested information that would help us to understand whether it would be beneficial to consider establishing coding and payment rules that would allow practitioners to bill and be paid for RPM services with shorter monitoring periods. Specifically, we were interested in understanding whether one or more codes that describe a shorter duration, for example, 8 or more days of remote monitoring within 30 days, might be useful. We welcomed comments including any additional information that the medical community and other members of the public believe might provide further clarification on how RPM services are used in clinical practice, and how they might be coded, billed, and valued under the Medicare PFS.

We received public comments on our clarifications and proposals related to digitally stored data services/remote physiologic monitoring/treatment management services. The following is a summary of comments we received and our responses.

Comment: Overall, commenters expressed appreciation and support for the clarifications proposed by CMS regarding RPM CPT codes 99453, 99454, 99091, and 99457 (and the add-on code, CPT code 99458).

Response: We thank commenters for their support, as well as for suggesting additional ways we might interpret the RPM codes. We hope to continue this dialogue as CPT creates more RPM codes.

Comment: A group of commenters disagreed with our clarification that CPT codes 99453, 99454, 99091, 99457, and 99458 can be ordered and billed only by physicians and NPPs who are eligible to bill Medicare for E/M services. Some commenters suggested that we allow the CPT Editorial Panel and the RUC to establish appropriate coding for other practitioners.

Response: We believe that as E/M codes, CPT codes 99453, 99454, 99091, 99457, and 99458, can be ordered and billed only by physicians or NPPs who are eligible to bill Medicare for E/M services. We agree with commenters that additional coding would be necessary, specifically for practitioners who cannot order and bill E/M services.

Comment: Commenters disagreed with our suggestion that CPT codes 99091 and 99457 can be billed together. Commenters reported that these two codes are incompatible and cannot be reported in the same calendar month or in conjunction with one another.

Response: We continue to believe that, if reasonable and necessary, CPT codes 99091 (Collection & interpretation physiologic data) and 99457 (Remote physiologic monitoring treatment management), given their descriptions of services in the CPT Codebook, could be reported for the same patient. We believe the two codes, as currently described, provide different types of services. We agree with commenters that the CPT Codebook states on page 53, “Do not report 99091 in conjunction with 99457.” However, the next section states, “Do not report 99091 for time in a calendar month when used to meet the criteria for 99339, 99340, 99374, 99375, 99377, 99378, 99379, 99380, 99457, and 99491.” We note that these two statements suggest that there may be instances where both codes could be billed for the same patient in the same month as long as the same time was not used to meet the criteria for both CPT codes 99091 and 99457. We remind readers that the valuation for CPT code 99091 includes a total time of 40 minutes of physician or NPP work broken down as follows: 5 minutes of pre-service work (for example, chart review); 30 minutes of intra-service work (for example, data analysis and interpretation, report based upon the physiologic data, as well as a possible phone call to the patient); and 5 minutes of post-service work (that is, chart documentation). We believe that in some instances when complex data are collected, more time devoted exclusively to data analysis and interpretation by a physician or NPP may be necessary such that the criteria could be met to bill for both CPT codes 99091 and 99457 within a 30-day period. The medically necessary services associated with all the medical devices for a single patient can be billed by only one practitioner, only once per patient per 30-day period, and only when at least 16 days of data have been collected.

Comment: Commenters suggested that other devices that do not meet the FDA's definition of medical device, but collect physiologic data, should satisfy the requirements of RPM services.

Response: We disagree with the commenters. The prefatory language and code descriptors developed by the CPT Editorial Panel indicate the device must meet the FDA definition of a medical device as found in section 201(h) of the FFDCA.

Comment: One commenter stated that a coding gap exists between physiologic and non-physiologic remote monitoring and stated that additional coding is required for non-physiologic parameters.

Response: We thank the commenter for this insight. We look forward to engaging with stakeholders on this topic to inform how we might consider a “coding gap” that exists for services related to remote monitoring for non-physiologic measures of health.

Comment: Several commenters suggested that CMS should allow RPM services to be furnished to new patients, as well as to established patients. Other commenters supported our decision to require that patients be known to the practitioner (established patients) prior to the start of RPM services.

Response: We continue to believe that a physician or NPP who has an established relationship with a patient would possess the information needed to understand the current medical status and needs of the patient prior to ordering RPM services to collect and analyze the patient's physiologic data and to develop a treatment plan. We note that during the PHE for COVID-19, RPM services may be furnished and billed for both new and established patients. We refer readers to the March 31st COVID-19 IFC (85 FR 19264) where we adopted the policy on an interim basis for the duration of the PHE for COVID-19 that RPM services could be furnished to new patients as well as established patients.Start Printed Page 84546

After considering public comments, we are not extending this interim policy beyond the end of the PHE for COVID-19. At the conclusion of the PHE, there will need to be an established patient-practitioner relationship in order to bill Medicare for CPT codes 99453, 99454, 99457, and 99458.

Comment: Some commenters suggested that we permit fewer than the required 16 days of monitoring per month that are required to bill CPT codes 99453 and 99454. One commenter indicated that patients and health care personnel are served best by a maximum data collection requirement of 6 days. Another commenter stated that the 8 days we suggested would be best. Another commenter suggested that at least 16 days of data should be required, and when 16 days of data are not collected within the 30-day period, that a modifier should be reported as a means of communicating that the service duration was reduced with an associated reduction in payment.

Response: While we agree that a full 16 days of monitoring may not always be reasonable and necessary, we requested detailed information about meaningful, clinical situations that require fewer days or shorter durations of remote monitoring. We were interested in understanding under what clinical circumstances fewer days of monitoring would be medically reasonable and necessary and allow a practitioner to establish clinically meaningful care. Although we received general support for a reduction in the number of days of data collection required to bill for CPT codes 99453 and 99454, we did not receive specific clinical examples.

After considering public comments, we are not extending the interim policy to permit billing for CPT codes 99453 and 99454 for fewer than 16 days in a 30-day period beyond the end of the PHE for COVID-19. At the conclusion of the PHE for COVID-19, we will require, in accordance with the code descriptors for CPT codes 99453 and 99454, that 16 days of data each 30 days must be collected and transmitted to meet the requirements to bill CPT codes 99453 and 99454.

Comment: A few commenters requested that Independent Diagnostic Testing Facilities (IDTFs) be allowed to bill for RPM services.

Response: As we noted in the proposed rule, RPM services are not considered to be diagnostic tests; therefore, RPM services cannot be furnished and billed by an IDTF on the order of a physician or NPP.

Comment: Commenters agreed with our clarification that practitioners should be allowed to furnish RPM services to patients with acute conditions, as well as patients with chronic conditions.

Response: We thank commenters for their support of our clarification that practitioners may furnish RPM services to patients with acute conditions, as well as patients with chronic conditions.

In the CY 2021 PFS proposed rule, we proposed to make permanent two policies that we adopted in the March 31st COVID-19 IFC (85 FR 19264). We received comments on our proposed policies. The following is a summary of the comments we received and our responses.

Comment: Commenters wrote in favor of our proposal to allow consent to be obtained at the time the services of CPT codes 99453 and 99454 are furnished.

Response: We thank our stakeholders for their comments and support of this proposal.

Comment: Commenters agreed with our proposal to allow auxiliary personnel to furnish the services of CPT codes 99453 and 99454 under the general supervision of the billing physician or practitioner.

Response: We thank commenters for their support of this proposal.

After considering comments related to these two proposals, we are finalizing both as proposed.

3. Transitional Care Management (TCM)

Payment for TCM CPT codes 99495 (Transitional Care Management services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within two business days of discharge; medical decision-making of at least moderate complexity during the service period; face-to-face visit within 14 calendar days of discharge) and 99496 (Transitional Care Management services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within two business days of discharge; medical decision making of at least high complexity during the service period; face-to-face visit within seven calendar days of discharge) was finalized in the CY 2013 PFS final rule (77 FR 68979 through 68993). At that time, we identified a list of 57 HCPCS codes (see 77 FR 68990 for the original guidance) that we stated could not be billed concurrently with TCM services because of potential duplication of services.

For CY 2020, recognizing that use of TCM services was low when compared to the number of Medicare beneficiaries with eligible discharges and that increased utilization of medically necessary TCM services could improve patient outcomes, one of our proposals included modifying our prior rule that prohibited the billing of TCM services with many other services that we had viewed as duplicative (77 FR 68990). In the CY 2020 PFS final rule (84 FR 62685 through 62687), we finalized a policy to allow concurrent billing of TCM services, when reasonable and necessary, with 16 actively priced (that is, not bundled or non-covered) codes during the 30-day period covered by TCM services. We stated at the time that we would continue to refine our billing policies for TCM through future notice and comment rulemaking.

In the CY 2021 PFS proposed rule (85 FR 50120), we proposed to remove 14 additional actively priced (not bundled or non-covered) HCPCS codes from the list of remaining HCPCS codes that cannot be billed concurrently with TCM for CY 2021. We noted that we believe that no overlap exists that would warrant preventing concurrent reporting between TCM and the services of these 14 codes. We also proposed to allow the new Chronic Care Management code HCPCS code G2058 to be billed concurrently with TCM when reasonable and necessary. We stated that the minutes counted for TCM services cannot also be counted towards other services. Table 18 lists the 15 codes that we proposed could be billed concurrently with TCM services when reasonable and necessary. We welcomed comment on our proposal to allow these additional services to billed concurrently with the TCM service.

We received public comments on the TCM proposals. The following is a summary of the comments we received and our responses.

Comment: Commenters wrote in support of our proposal to allow HCPCS code G2058 to be billed concurrently with TCM when reasonable and necessary. Commenters agreed that time should not be double-counted, and that services should not overlap, but should be separately reportable.

Response: We thank the commenters for their support of our proposal to allow HCPCS code G2058 to be billed concurrently with TCM when reasonable and necessary.

Comment: Commenters stated that the services described by the 14 ESRD codes proposed for separate payment do not overlap or duplicate TCM services and should be paid separately when reasonable and necessary.

Response: We appreciate the support of commenters.

Comment: A few commenters disagreed with our proposal to allow the Start Printed Page 84547ESRD codes and the chronic care management code HCPCS code G2058 to be billed concurrently with TCM. These commenters instead urged CMS to allow the RUC process and recommendations determine how these codes should be valued/revalued and reported, rather than having CMS apply a different approach.

Response: We recognize that some commenters would prefer that we follow the AMA RUC recommendations for code valuations and billing policies. We appreciate the work the AMA committees, and in particular the RUC, do to provide recommendations. We will continue to consider those recommendations along with other information when we develop values and payment policies under the PFS. We believe that allowing concurrent billing of TCM services with the proposed ESRD codes and HCPCS code G2058, when reasonable and necessary, can improve patient outcomes.

After considering the public comments, we are finalizing our proposal to remove 14 additional actively priced (not bundled or non-covered) HCPCS codes from the list of remaining HCPCS codes that cannot be billed concurrently with TCM for CY 2021. We also are finalizing our proposal to allow HCPCS code G2058 (which we are finalizing in this rule as new CPT code 99439, see the codes in section II.H. for further information) to be billed concurrently with TCM when reasonable and necessary.

4. Psychiatric Collaborative Care Model (CoCM) Services (HCPCS Code G2214)

In the CY 2017 PFS final rule (81 FR 80230), we established G-codes used to bill for monthly services furnished using the Psychiatric Collaborative Care Model (CoCM), an evidence-based approach to behavioral health integration that enhances “usual” primary care by adding care management support and regular psychiatric inter-specialty consultation. These G-codes were replaced by CPT codes 99492-99494, which we established for payment under the PFS in the CY 2018 PFS final rule (82 FR 53077).

Stakeholders have requested additional coding to capture shorter increments of time spent, for example, when a patient is seen for services, but is then hospitalized or referred for specialized care, and the number of minutes required to bill for services using the current coding is not met. To accurately account for these resources costs, in the CY 2021 PFS proposed rule (85 FR 50121), we proposed to establish a G-code to describe 30 minutes of behavioral health care manager time. Since this code would describe one half of the time described by the existing code that describes subsequent months Start Printed Page 84548of CoCM services, we proposed to price this code based on one half the work and direct PE inputs for CPT code 99493 (Subsequent psychiatric collaborative care management, first 60 minutes in a subsequent month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements):

  • Tracking patient follow-up and progress using the registry, with appropriate documentation; participation in weekly caseload consultation with the psychiatric consultant;
  • Ongoing collaboration with and coordination of the patient's mental health care with the treating physician or other qualified health care professional and any other treating mental health practitioners;
  • Additional review of progress and recommendations for changes in treatment, as indicated, including medications, based on recommendations provided by the psychiatric consultant;
  • Provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies;
  • Monitoring of patient outcomes using validated rating scales; and
  • Relapse prevention planning with patients as they achieve remission of symptoms and/or other treatment goals and are prepared for discharge from active treatment.), which is assigned a work RVU of 1.53.

Therefore, as proposed, the work RVU for the new proposed code is 0.77. We proposed that this code could be used for either the initial month or subsequent months. We noted that the existing CPT time rules for the CoCM services would apply. As proposed, the code would be:

  • GCOL1: Initial or subsequent psychiatric collaborative care management, first 30 minutes in a month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional.

We proposed that the required elements listed for CPT code 99493 would also be required elements for billing HCPCS cod GCOL1. Additionally, we proposed that CPT time rules would apply, consistent with the guidance in the CPT codebook for CPT codes 99492-99494.

In the CY 2017 PFS final rule (81 FR 80235), we finalized that CCM and BHI services could be billed during the same month for the same beneficiary if all the requirements to bill each service are separately met. We also proposed that HCPCS code GCOL1 could be billed during the same month as CCM and TCM services, provided that all requirements to report each service are met and time and effort are not counted more than once. We noted that the patient consent requirement would apply to each service independently.

In the CY 2017 PFS final rule (81 FR 80235), we finalized that the psychiatric CoCM services may be furnished under general supervision because we do not believe it is clinically necessary that the professionals on the team who provide services other than the treating practitioner (namely, the behavioral health care manager and the psychiatric consultant) must have the billing practitioner immediately available to them at all times, as would be required under a higher level of supervision. Therefore, consistent with the other codes in this code family (CPT codes 99492-99494), we proposed to add HCPCS code GCOL1 to the list of designated care management services for which we allow general supervision.

We welcomed comments on the proposal to create this new code, as well as the proposed valuation.

We received public comments on the CoCM services (HCPCS code GCOL1) proposal. The following is a summary of the comments we received and our responses.

Comment: Several commenters supported the creation of a new code to describe a shorter duration of time than is captured by the existing codes describing the psychiatric collaborative care model, noting that this will provide greater flexibility, remove barriers, and encourage further adoption of this model of care. One commenter opposed implementing this code without obtaining further evidence that it is warranted, while another commenter encouraged CMS to work with the CPT Editorial Panel to create a CPT code that would be available for billing by all payers. One commenter urged CMS to eliminate the copayment and deductible for CoCM and other care management services.

Response: We note that we do not have the statutory authority to remove application of the copayment or deductible for these services. After considering the public comments, we are finalizing the creation of HCPCS code GCOL1 as proposed. We note that HCPCS GCOL1 was a placeholder code identifier. The final code is HCPCS code G2214 (Initial or subsequent psychiatric collaborative care management, first 30 minutes in a month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional). We welcome the opportunity to work with the CPT Editorial Panel in the event they are interested in adopting this code into the CPT code set.

F. Refinements to Values for Certain Services To Reflect Revisions to Payment for Office/Outpatient Evaluation and Management (E/M) Visits and Promote Payment Stability During the PHE for COVID-19

1. Background

a. Evaluation and Management (E/M) Visits Overview

Physicians and other practitioners who are paid under the PFS bill for common office visits for E/M visits using a relatively generic set of CPT codes (Level I HCPCS codes) that distinguish visits based on the level of complexity, site of service, and whether the patient is new or established. These CPT codes are broadly referred to as E/M visit codes and historically have included three key components within their code descriptors: History of present illness (history), physical examination (exam), and medical decision-making (MDM).[4]

Currently, there are five levels of O/O E/M visits. There are five codes representing each level for new patients (CPT codes 99201 through 99205), and five codes representing each level for established patients (CPT codes 99211 through 99215). CPT code 99211 (Level 1 established patient) is the only code in the O/O E/M visit code set that describes a visit that may be performed by the billing practitioner or by clinical staff under supervision, and that has no specified history, exam or MDM (see Table 19).

In total, E/M visits billed using these CPT codes comprise approximately 40 percent of allowed charges for PFS services; and O/O E/M visits, in particular, comprise approximately 20 percent of allowed charges for PFS services. Within the E/M visits represented in these percentages, there is wide variation in the volume and level of E/M visits billed by different specialties. According to Medicare claims data, E/M visits are furnished by nearly all specialties, but represent a greater share of total allowed charges for physicians and other practitioners who do not routinely furnish procedural interventions or diagnostic tests. Start Printed Page 84549Generally, these practitioners include primary care practitioners and certain other specialists such as neurologists, endocrinologists and rheumatologists. Certain specialties, such as podiatry, tend to furnish lower level E/M visits more often than higher level E/M visits. Some specialties, such as dermatology, tend to bill more E/M visits on the same day as they bill minor procedures.

b. Overview of Policies Finalized in CY 2020 for CY 2021

In the CY 2020 PFS final rule (84 FR 62844 through 62860), for the O/O E/M visit code set (CPT codes 99201 through 99215), we finalized a policy to generally adopt the new coding, prefatory language, and interpretive guidance framework that has been issued by the AMA's CPT Editorial Panel (see https://www.ama-assn.org/​practice-management/​cpt/​cpt-evaluation-and-management) and will be effective January 1, 2021. Under this new CPT coding framework, history and exam will no longer be used to select the level of code for O/O E/M visits. Instead, an O/O E/M visit will include a medically appropriate history and exam, when performed. The clinically outdated system for number of body systems/areas reviewed and examined under history and exam will no longer apply, and the history and exam components will only be performed when, and to the extent, reasonable and necessary, and clinically appropriate.

The changes will include deletion of CPT code 99201 (Level 1 office/outpatient visit, new patient), which the CPT Editorial Panel decided to eliminate because CPT codes 99201 and 99202 are both straightforward MDM and currently largely differentiated by history and exam elements. Table 19 provides an overview of how the level 1 and level 2 O/O E/M visits are currently structured, demonstrating this current overlap.

For levels 2 through 5 O/O E/M visits, selection of the code level to report will be based on either the level of MDM (as redefined in the new AMA/CPT guidance framework, also available on the AMA website at https://www.ama-assn.org/​practice-management/​cpt/​cpt-evaluation-and-management) or the total time personally spent by the reporting practitioner on the day of the visit (including face-to-face and non-face-to-face time). We continue to believe these policies will further our ongoing effort to reduce administrative burden, improve payment accuracy, and update the O/O E/M visit code set to better reflect the current practice of medicine.

Regarding prolonged visits, we finalized separate payment for a new prolonged visit add-on CPT code (CPT code 99XXX), and discontinued the use of CPT codes 99358 and 99359 (prolonged E/M visit without direct patient contact) to report prolonged time associated with O/O E/M visits. We refer readers to the CY 2020 PFS final rule for a detailed discussion of this policy (84 FR 62849 through 62850). We are not opposed in concept to reporting prolonged office/outpatient visit time on a date other than the visit, but we believe there should be a single prolonged code specific to O/O E/M visits that encompasses all related time.

Also, we finalized separate payment for HCPCS code GPC1X, to provide payment for visit complexity inherent to E/M associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious condition, or a complex condition.

The AMA RUC resurveyed and revalued the revised O/O E/M visit code set, concurrent with the CPT Editorial Panel redefining the services and associated interpretive guidance, and provided us with its recommendations. In the CY 2020 PFS final rule, we also addressed and responded to the AMA RUC recommendations. We finalized new values for CPT codes 99202 through 99215, and assigned RVUs to the new O/O E/M prolonged visit CPT code 99XXX, as well as the new HCPCS code GPC1X. These valuations were finalized with an effective date of January 1, 2021. In Table 20, we provide a summary of the codes and work RVUs finalized in the CY 2020 PFS final rule for CY 2021.

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c. Continuing Stakeholder Feedback

Since issuing the CY 2020 PFS final rule, we have continued to engage with the stakeholder community on the issues addressed in this section of our CY 2021 PFS final rule. These include the time values for levels 2-5 O/O E/M visit codes, revaluation of services that are analogous to O/O E/M visits, the definition and utilization assumptions for the add-on code for office/outpatient visit complexity (GPC1X), and the required time to report prolonged O/O E/M visits. In the CY 2021 PFS proposed rule (85 FR 50121 through 50139), we included proposals on these topics based on continued feedback from stakeholders in the form of public comments, written requests, meetings, and other formal and informal discussions. In this section of our final rule, we summarize and respond to the public comments we received in response to our CY 2021 PFS proposals, and discuss our final polices.

2. Revisions for CY 2021

a. Time Values for Levels 2-5 Office/Outpatient E/M Visit Codes

In the CY 2020 PFS proposed rule (84 FR 40675), we sought comment on the times associated with the O/O E/M visits as recommended by the AMA RUC. When surveying these services for purposes of valuation, the AMA RUC requested that survey respondents consider the total time spent on the day of the visit, as well as any pre- and post-service time occurring within a timeframe of 3 days prior to the visit and 7 days after, respectively. In developing its recommendations to us, the AMA RUC then separately averaged the survey results for pre-service, day of service, and post-service times, and the survey results for total time, with the result that, for some of the codes, the sum of the times associated with the three service periods does not match the RUC-recommended total time. The approach used by the AMA RUC to develop recommendations sometimes resulted in two conflicting sets of times: The component times as surveyed and the total time as surveyed. In the CY 2020 PFS final rule, we finalized adoption of the RUC-recommended times as explained below, but stated that we would continue to consider whether this issue has implications for the PFS broadly. When we establish pre-, intra-, and post-service times for a service under the PFS, these times always sum to the total time. We believe it would be illogical for component times not to sum to the total, and this idea is reflected in our ratesetting system, which requires component times to sum to the total time. Commenters on the CY 2020 PFS proposed rule (84 FR 62849) stated that we should adopt the times as recommended by the RUC, and did not provide any additional details on the times they believed we should use when the total time is not the sum of the component times. Table 21 illustrates the AMA RUC surveyed times for each service period and the surveyed total time. It also shows the actual total time calculated as the sum of the component times.

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Given the lack of clarity provided by commenters on the CY 2020 PFS proposed rule about why the sum of minutes in the components would differ from the total minutes, and our view and systems requirement that total time must equal the mathematical total of component times, we proposed beginning in CY 2021 to adopt the actual total times (defined as the sum of the component times) rather than the total times recommended by the RUC for CPT codes 99202 through 99215. The following is a summary of the comments we received and our responses.

Comment: Some commenters did not support our proposal to adopt the actual total times (defined as the sum of the component times) rather than the total times recommended by the RUC for CPT codes 99202 through 99215. These commenters further stated, if we were to use the sum of the component times instead of the RUC-recommended median total time, that we would not be appropriately capturing the physician time for the office visits, which were based on a robust survey, if we were to use the sum of the component times instead of the RUC recommended median total time.

One commenter suggested that the median survey total time for the office visits should be utilized to retain relativity. The commenter explained that, while total time is usually a sum of the pre-, intra- and immediate post-service time, for purposes of the office visit survey, the pre-service time was described as 3 calendar days prior to the office visit, the intra-service time was described as the calendar day of the office visit and the post-service time was described as within 7 days following the office visit. The commenter stated that the median survey total time will not necessarily equal the sum of the median times for each of the 3 time periods because of different practitioner workflow patterns that result in different proportions of the practitioners' times being spent in different components of the service. However, the total times as recommended by the RUC accurately capture the time associated with furnishing the service, regardless of whether that work was performed on the date of encounter or other dates surrounding the office visit. The commenter also suggested that the median of the component times was mathematically more appropriate than the median of the total times, because the function of a median is to limit the influence of outlier values.

Some commenters supported our proposal, stating that the RUC's survey methodology, which included collection of time before and after the day of the encounter, resulted in an overestimation of time and work, and that the total time in the CMS work time database should reflect the sum of the pre-, intra-, and post-times collected using the RUC survey. This methodology is consistent with the total times for all other codes in the fee schedule.

Response: We continue to believe that it would be illogical for component times not to sum to the total, and we reiterate that our ratesetting programs are constructed in a manner that assumes this. While we recognize the value of robust survey data, for purposes of consistency and relativity, we believe we should use a consistent methodology across the fee schedule. Also it is not clear why the RUC surveyed time before and after the date of service since the new CPT coding guidance instructs practitioners to report this time using CPT codes 99358 and 99359 (although CMS will no longer recognize 99358-99359 for this purpose, for reasons discussed elsewhere in this section). Having considered the public comments received, we are finalizing our proposal to adopt the actual total times (defined as the sum of the component times) rather than the total times recommended by the RUC for CPT codes 99202 through 99215.

b. Revaluing Services That Are Analogous to Office/Outpatient E/M Visits

In our proposed rule, we recognized that there are services other than the global surgical codes for which the values are closely tied to the values of the O/O E/M visit codes. We proposed to increase the valuations for these services commensurate with the valuation increases we previously finalized for the O/O E/M visit codes for 2021. Our proposals took into account input from the public (especially our 2020 comment solicitation on this topic) and our own internal review. We proposed to increase valuations for the following:

  • End-Stage Renal Disease Monthly Capitation Payment (ESRD MCP) services.
  • Transitional care management (TCM) services.
  • Maternity services.
  • Cognitive impairment assessment and care planning.
  • Annual wellness visits (AWV) and initial preventive physical exam (IPPE).
  • Emergency department (ED) visits.
  • Therapy evaluations.
  • Certain behavioral healthcare services.

Many of these services were valued via a building block methodology and have O/O E/M visits explicitly built into their definition or valuation. We noted that, unlike the global surgical codes, some of these services always include an O/O E/M visit(s) furnished by the reporting practitioner as part of the service, and therefore, it may be appropriate to adjust their valuations commensurate with any changes made to the values for O/O E/M visits. Some of these services do not actually include an E/M visit, but we valued them using a direct crosswalk to the RVUs assigned to an O/O E/M visit(s), and for this Start Printed Page 84552reason they are closely tied to values for O/O E/M visits. Overall, we believed that the magnitude of the changes to the values of the O/O E/M visit codes and the associated redefinitions of the codes themselves are significant enough to warrant an assessment of the accuracy of the values of services containing, or closely analogous to, O/O E/M visits.

We received public comments in response to the CY 2020 PFS proposed rule in support of revaluing certain services commensurate with the new O/O E/M visit values. There was particular support from commenters for revaluing the ESRD (MCP) services, TCM services, cognitive impairment assessment and care planning services, and the (ED) visits. Based on input provided after publication of the CY 2020 PFS final rule by the American College of Obstetricians and Gynecologists (ACOG), we also proposed to revalue the maternity surgical packages, which, unlike other global surgery services, were valued using a methodology, described in more detail below, that allowed the valuation of the composite parts of the package to sum to the total value. Additionally, unlike the 10- and 90-day global surgical services codes (referred to in this section as 10- and 90-day globals), we had never expressed concerns as to the accuracy of the values of the maternity packages, and these services were not part of the policy we adopted to transition all 10- and 90- day globals to 0-day globals (79 FR 67591), though that policy was overridden by statutory amendments before it took effect. We also proposed to revalue certain physical therapy evaluations and behavioral healthcare services as closely analogous to the office/outpatient E/M visits. We did not propose to revalue certain ophthalmology services that the public brought to our attention.

In general, some commenters to the CY 2021 PFS proposed rule indicated that they believe CMS used inconsistent methodologies to revise the proposed RVUs to reflect the marginal increase in office/outpatient E/M visits; that other code sets should go through the same consensus process whereby CMS, CPT and the AMA RUC all agree that the services need to be redefined to better describe existing practice and then be revalued; and that CMS should increase all of the global surgical codes if any single global code is increased to reflect changes to the office/outpatient E/M visits. Other commenters agreed with our proposals and methodologies, and a few suggested additional services that should be revalued as analogous to office/outpatient E/M visits. In the following section of our final rule, we discuss the public comments we received in greater detail, respond to the comments and discuss our final policies. By way of overview, we note that we did not rely on any single factor in deciding whether to consider a given code(s) as analogous to office/outpatient E/M visits. Different factors apply to different services, and we took into consideration all of the factors relevant for the code(s) in question, considered together.

(1) End-Stage Renal Disease Monthly Capitation Payment Services

In the CY 2004 PFS final rule with comment period (68 FR 63216), we established new Level II HCPCS G codes for ESRD services and established MCP rates for them as specified under section 1881(b)(3)(A)(ii) of the Act. For ESRD center-based patients, payment for the G codes varied based on the age of the beneficiary and the number of face-to-face visits furnished each month (for example, 1 visit, 2-3 visits and 4 or more visits). We believed that many physicians would provide 4 or more visits to center-based ESRD patients, and a small proportion would provide 2 to 3 visits or only one visit per month. Under the MCP methodology, to receive the highest payment, a physician would have to furnish at least 4 ESRD-related visits per month. In contrast, payment for home dialysis MCP services only varied by the age of beneficiary. Although we did not initially specify a frequency of required visits for home dialysis MCP services, we stated that we expect physicians to provide clinically appropriate care to manage the home dialysis patient.

The CPT Editorial Panel created new CPT codes to replace the G codes for monthly ESRD-related services, and we finalized the new codes for use under the PFS in CY 2009 (73 FR 69898). The codes created were CPT codes 90951 through 90962 for monthly ESRD-related services with a specified number of visits; CPT codes 90963 through 90966 for monthly ESRD-related services for home dialysis patients; and CPT codes 90967 through 90970 for home dialysis patients with less than a full month of services. The latter set of codes is billed per encounter and valued to be 1/30 of the value of CPT codes 90965 and 90966.

In response to our comment solicitation in the CY 2020 PFS final rule and interim final rule regarding whether to adjust the values of the ESRD MCP codes to reflect the increased values of the office/outpatient E/M visit codes, we received a number of supportive comments. These commenters stated that the MCP bundled payments for all ESRD-related care for a month were constructed using a building block methodology and a number of office/outpatient E/M visits were component parts of those bundles; and that the specified number of visits in the code descriptor must be furnished in order to bill for the service. Commenters also noted that although the values of office/outpatient E/M visit codes have been increased once since the creation of the MCP G codes and once after adoption of the MCP CPT codes, the valuation of the ESRD MCP codes was never adjusted to account for increases to the office/outpatient E/M visit codes. In Table 22, we provide a summary of the visits included in the valuation of each ESRD MCP service.

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In the past, we have not updated the valuation of this code set to reflect updates to the valuation of the office/outpatient E/M visit code set, and we do not have information on the number and level of visits actually furnished in connection with these services. So over time, the values of the ESRD MCP codes may have become out of step with valuation of their constituent visits. We believe there is sufficient reason to revalue these services to take into account the changes in valuation for the office/outpatient E/M visits. These services were initially valued using a building block methodology that summed the value of the individual service from its components, and for some of the codes in this code set, a specified number of visits must be furnished in order to bill for the respective ESRD MCP code because they are included in the code descriptor.

Therefore, we noted that we believe that the ESRD MCP codes should be updated to more accurately account for the associated office/outpatient E/M visits. We proposed to increase the work, physician time, and PE inputs in the form of clinical staff time of the ESRD MCP codes based on the marginal difference between the 2020 and 2021 office/outpatient E/M visit work, physician time, and PE inputs built into each code, as summarized in Tables 23 and 24. By improving payment accuracy for the ESRD MCP codes, we would also be supporting broader efforts at advancing kidney health.[5] We noted that we believe the majority of the visits included in the ESRD MCP bundles are being furnished, but sought comment on whether there are instances where the number and/or level of visits being furnished are not consistent with the number and level of visits built into the valuation of the code. The following is a summary of the comments we received and our responses.

Comment: One commenter noted that CMS inadvertently indicated a proposed work RVU of 8.04 for CPT code 90966 in in Table 19 in the CY 2021 PFS proposed rule (85 FR 50129). The commenter urged CMS to finalize a work RVU of 8.04 for this code to help eliminate structural barriers the commenter believes exist to home dialysis, and relieve the disparity in modality choice, as home dialysis receives a low RVU remuneration compared to in-center hemodialysis. Another commenter stated that the work RVU published in Addendum B of the proposed rule, 5.52, is the more accurate value.

Response: We regret the drafting error, and we reiterate that we did indeed propose a work RVU of 5.52 for CPT code 90966 as reflected in Addendum B. While we appreciate the concerns regarding access to care, we agree with comments stating that the proposed work RVU of 5.52 is the more accurate value.

Comment: Some commenters supported our proposal to increase the value of these services in light of previous changes to the E/M visit values. However, some commenters did not support increases to these code values absent a formal review, stating that it would be inconsistent to consider increasing values for some services and not others that are closely tied to the values of the office/outpatient E/M visit codes and/or codes that have E/M visits explicitly built into their definition or valuation, and that these codes should be subject to the same process for other potentially misvalued services. One Start Printed Page 84554commenter disapproved of our proposed increasing the rates for these services, and stated that not all of the ESRD-related service CPT codes 90951-90962 were valued with a building block methodology of discrete E/M services. These commenters stated that CPT code 90951 was valued using magnitude estimation with a crosswalk to CPT code 99295, while CPT code 90954 was valued with a crosswalk to CPT code 99293. The commenters noted that both CPT code 99293 and 99295 have since been deleted. The commenters further stated that for the rest of the ESRD codes, the numbers and levels of visits were not determined based on surveys that led to use of the building block methodology; rather, they were negotiated using magnitude estimation in comparison to the two codes, CPT codes 99295 and 99293.

Response: Commenters are incorrect as to the methodology used to value CPT code 90951 in the proposed rule (as summarized in Table 22). We adopted the RUC recommended value for this service, which included the value of 13 instances of CPT code 99214 in the bundle. It was not valued using a crosswalk. However, we continue to believe it is accurate to consider these services as being among those for which values are closely tied to the values of the office/outpatient E/M visit codes. The ESRD MCP codes have numbers of visits explicitly built into their definitions, the majority of which we believe are taking place. Proportionate increases for these two codes will also maintain the relative relationships among the codes in this family.

We agree with commenters that CPT code 90954, this code was initially valued based on a crosswalk to CPT code 99293. When CPT code 99293 was deleted, it was replaced by CPT code 99471. By crosswalking CPT code 90954 to CPT code 99471, the relationship established between the two services is preserved. The public may nominate any code(s) as potentially misvalued through the usual misvalued code process or request resurvey or valuation through the AMA RUC.

We did not receive responses to our request for comments on whether there are instances where the number and level of visits actually furnished by practitioners reporting the ESRD MCP services differs from the number and level assumed in the valuation.For example, as shown in Table 22, the valuations included specified numbers and levels of office/outpatient E/M visits, but because the descriptors do not require the same level and number of visits to be furnished in order to report the services, the office/outpatient E/M visit resources assumed to be included in the ESRD services might not actually be expended. CPT code 90957 (End-stage renal disease (ESRD) related services monthly, for patients 12-19 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) was valued with 1x 99215, 3x 99214, and 3x 99213. However, CPT code 90957 includes four or more visits of unspecified levels. Similar to the global surgical codes, this might suggest that we should not “transfer” the increase in valuation of the stand-alone office/outpatient E/M visits into these ESRD bundles. Unlike TCM, the number and level of visit included in the ESRD service valuations does not necessarily match the actual services furnished and billed. We continue to be concerned that the number and level of visits built into the valuation of these codes may not accurately reflect the number and level of visits actually being furnished, such that they may be misvalued. We may consider this issue through future rulemaking, as we have for the global surgical codes. However, we still believe the ESRD MCP codes are different from the global surgical codes in that they are valued using building block and involve largely medical care rather than procedural care. The ESRD monthly services include ongoing medical management of a chronic condition, which makes them more similar to the kind of work typically furnished and billed as office/outpatient E/M visits. Therefore, we continue to believe that the ESRD MCP services' valuation should be increased commensurate with the changes made to the values for office/outpatient E/M visits at this time as was proposed, and we are finalizing as proposed.

2. TCM Services (CPT Codes 99495 and 99496)

The goal of TCM services is to improve the health outcomes of patients recently discharged from inpatient and certain outpatient facility stays. We began making separate payment for TCM services in CY 2013. At that time, CPT code 99495 (Transitional Care Management Services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver with 2 business days of discharge; medical decision making of at least moderate complexity during the service period; face-to-face visit within 14 calendar days of discharge) was valued to include one, level 4 established patient office/outpatient visit, while CPT code 99496 (Transitional Care Management Services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver with 2 business days of discharge; medical decision making of high complexity during the service period; face-to-face visit within 7 calendar days of discharge) was valued to include one, level 5 established patient office/outpatient visit (77 FR 68991). In the CY 2020 PFS final rule (84 FR 62687), we finalized the RUC-recommended work and direct PE inputs for the TCM codes which resulted in small RVU increases for both codes.

Because both TCM codes include a required face-to-face E/M visit (either a level 4 or 5 office/outpatient E/M visit), we proposed to increase the work RVUs associated with the TCM codes directly to the new valuations for the level 4 (CPT code 99214) and level 5 (CPT code 99215) office/outpatient E/M visits for established patients. Please see Tables 23 and 24 for long descriptors, as well as current and final work RVUs, physician time, and clinical staff time, for the TCM codes.

Comment: We received several comments specific to TCM, all in support of our proposal to revalue the TCM codes, although they did not provide specific rationale.

Response: We continue to believe that the values for services that explicitly include a single E/M visit of a given setting and level, and that were valued using a direct crosswalk to that visit, should be increased to reflect the new values for the included E/M visit. At this time, we are finalizing our proposed revised values for the two TCM codes shown in Table 23.

3. Maternity Services

In the CY 2002 PFS final rule with comment period (66 FR 55392-55393), we finalized separate global payment for maternity care services. The maternity packages are unique within the PFS in that they are the only global codes that provide a single payment for almost 12 months of services, including visits and other medical care, delivery services (that may include surgical services), and imaging; and were valued using a building-block methodology as opposed to the magnitude estimation method that is commonly used to value the 10- and 90-day global services. Seventeen CPT codes are used to bill for delivery, antepartum, and postpartum maternity care services, and these codes are all designated with a unique global period indicator “MMM.”Start Printed Page 84555

For CY 2021, the AMA RUC made a recommendation to revalue these services, along with their recommendations to revalue the 10- and 90- day global surgical packages, to account for increases in the values of office/outpatient E/M visits. In the CY 2020 PFS final rule, we decided not to make changes to the valuation of 10- and 90- day global surgical packages to reflect changes made to values for the office/outpatient E/M visit codes while we continue to collect and analyze the data on the number and level of office/outpatient E/M visits that are actually being performed as part of these services.

The 10- and 90-day global surgical packages are commonly valued using a methodology known as magnitude estimation. Magnitude estimation refers to a methodology for valuing work that identifies 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. Since its inception, the AMA RUC has worked under the prevailing assumption that magnitude estimation is the standard for valuation of all physicians' services, including those with global surgical packages. Consequently, the work values associated with expected typical E/M visits within a code's global period are not necessarily added to the physician work value for the code to determine the final work RVU. The postoperative visits in the 10- or 90-day global surgical code periods are often valued with reference to RVUs for separately-billed E/M visits, but the bundled post-operative visit RVUs do not directly contribute a certain number of RVUs to the valuation of the procedures.

In contrast, the MMM codes are unique in both the length of the global period and the methodology under which they were valued. When CMS established values for the maternity packages, we based them on RUC recommendations developed by the relevant specialty societies using the building block methodology. When it is used for a CPT code representing a bundle of services, the building block methodology components are the CPT codes that are considered to make up the bundled code and the inputs associated with those codes. Therefore, when the maternity packages were valued, the work (and other inputs) associated with the office/outpatient E/M visits in each package were explicitly included (along with values associated with imaging and other services in the package).

In addition, unlike the global surgical codes, we have reason to believe the visits included in the maternity codes are actually furnished given the evidence-based standards and professional guidelines for obstetrical care. For example, The Guidelines for Perinatal Care state that “a woman with an uncomplicated first pregnancy is examined every 4 weeks for the first 28 weeks of gestation, every 2 weeks until 36 weeks of gestation, and weekly thereafter.”[6] For this reason, we excluded the maternity codes from our recent global surgery data collection.

Given the valuation methodology and expectations for office/outpatient E/M visits in the maternity package codes, and the revaluation recommendation developed by the AMA RUC, we believe that the maternity packages should be updated to more accurately reflect the values of the office/outpatient E/M visits included in the packages. We believe that, due to the use of the building block valuation methodology rather than magnitude estimation, and the likelihood that the bundled visits are actually being furnished, the valuations recommended to us by the AMA RUC more accurately reflect the resource costs associated with furnishing these services. In the past, the work, physician time, and PE for these services have not been revalued to reflect changes to the office/outpatient E/M visits that are included as part of the package and therefore, the valuation of the MMM surgical packages have become misaligned with the valuation of their constituent office visits.

When revaluing the maternity packages, the AMA RUC used a methodology similar to what we used when revaluing the ESRD MCP codes and TCM by adding in the marginal differences in work, physician time, and PE in the form of clinical staff time between the current and 2021 E/M values. We noted that we believe that this method accurately accounts for the increase in valuation relative to the office/outpatient E/M visits. Therefore, we proposed to increase the work RVUs, physician time, and PE inputs in the form of clinical staff time associated with the maternity packages by accepting the revaluation recommendation from the AMA RUC as detailed in Tables 23 and 24.

We also noted that, in addition to appropriately reflecting changes to values of the office and outpatient E/M visits, increases made to the valuation of the maternity package codes would be consistent with our broader focus on improving maternal health and birth outcomes. The proposed changes would account for additional resources involved with additional work that is needed on the part of practitioners to improve care for this patient population, such as risk identification and ensuring appropriate interventions and referrals.[7]

We received public comments on our proposal. The following is a summary of the comments we received and our responses.

Comment: Some commenters supported our proposal regarding the global maternity codes. However, other commenters requested a fair and relative payment for maternity care codes and for all global codes, whether the value of the code is based on magnitude estimation, building block methodology, or a mix of both methodologies, not any subset of them using potentially disparate valuation methodologies. Some commenters stated that it is unfair to apply the RUC-recommended E/M value increases to stand-alone E/M visits, select global codes (for example, monthly end-stage renal disease (ESRD) and bundled maternity care), and select bundled services (for example, monthly psychiatric management), but not to the E/M visits that are included in the global surgical packages, and that this will disrupt the relativity of the MPFS.

Response: We continue to believe that the maternity global surgical packages are distinct from the 10- and 90-day globals for the reasons articulated above. We note that commenters did not provide any information to suggest that the number and level of visits accounted for in the valuation of these codes are not being performed. In addition, unlike the global surgical packages, the maternity packages (and the ESRD monthly services discussed above) are focused on ongoing, comprehensive medical care. This kind of care is similar to the type of care typically furnished and billed as office/outpatient E/M visits and, as such, makes the services analogous. Having considered the public comments we received, we are finalizing our proposal to revalue the maternity bundles as recommended by the AMA RUC.Start Printed Page 84556

4. Assessment and Care Planning for Patients With Cognitive Impairment (CPT Code 99483)

In CY 2017, we established payment for HCPCS code G0505 (Assessment and care planning for patients with cognitive impairment) to provide payment for cognitive assessment and care planning for patients with cognitive impairments, believing that the CPT Editorial Panel was developing new coding for that service. In response to the CY 2017 PFS proposed rule, the AMA RUC submitted recommended values for this code, which we adopted in the CY 2017 PFS final rule. In CY 2018, the CPT Editorial Panel created CPT code 99483 for reporting of this service and in CY 2018, CMS adopted CPT code 99483 (deleting HCPCS code G0505) without changing the service valuation. Based upon input from commenters and the AMA RUC, the valuation of this service reflected the complexity involved in assessment and care planning for patients with cognitive impairment by including resource costs that are greater than the highest valued office/outpatient E/M visit (CPT code 99205, new patient level 5 visit) (81 FR 80352). Specifically, the service includes an evaluation of a patient's cognitive functioning and requires collecting pertinent history and current cognitive status all of which require medical decision making of moderate or high complexity.

With the forthcoming increased valuation for CPT code 99205 in CY 2021, we noted that the current work RVU for CPT code 99483 would have a lower work RVU than a new patient level 5 office/outpatient E/M visit. Given the way CPT code 99483 was valued initially, we noted that this valuation would create a rank order anomaly between the two codes. Since CPT code 99483 was valued in relation to a level 5 office/outpatient E/M new patient visit, we believed that an adjustment to the work, physician time, and PE for this service to reflect the marginal difference between the value of the level 5 new patient office/outpatient E/M visit in CY 2020 and CY 2021 would be appropriate to maintain payment accuracy. Therefore, we proposed to adjust the work, time, and PE in the form of clinical staff time for CPT code 99483 as shown in Tables 23 and 24. We used the ratio between the CY 2020 and CY 2021 values for the level 5 new patient office/outpatient visits and applied that ratio to increase the value of CPT code 99483 commensurate with the increase to CPT code 99205.

We received public comments on the Assessment and Care Planning for Patients with Cognitive Impairment (CPT code 99483). The following is a summary of the comments we received and our responses.

Comment: Commenters generally supported our proposal to increase the valuation of CPT code 99483 in order to maintain the relationship between CPT code 99483 and the level 5 new patient office/outpatient visit, which was an important part of the initial valuation. Commenters stated that accurate payment for this service is essential for maintaining access to care for beneficiaries with cognitive impairment.

However, several commenters disagreed with our proposed revaluation of CPT code 99483. These commenters indicated that our proposed increase to CPT code 99483 would create a rank order anomaly between CPT codes 99205 and 99483. Commenters explained that the work RVU and time for code 99483 were based upon survey data and magnitude estimation. The RUC did not use any code as a crosswalk for valuation of CPT code 99483, and CPT code 99205 is not inherent to this service. Commenters suggested that in order to identify the relative valuation for the services of CPT code 99483, the code should be referred to the RUC for review.

Response: While we appreciate the additional insight into the valuation of these codes, we continue to believe that maintaining the value of CPT code 99483 at its current rate would create a rank order anomaly. This service comprises a stand-alone E/M visit that is always furnished; has most of the same components as CPT code 99205, including identical interpretive guidance for level of medical decision making; and was (and continues to appropriately be) valued in direct relation to CPT code 99205. While the cognitive assessment and care planning code was valued using magnitude estimation, these other factors provide additional support for continuing to reflect its exact relationship with the level 5 new patient office/outpatient visit. Therefore, we believe these services are sufficiently analogous to warrant preserving the same relationship. Members of the public can request that the RUC review certain code sets at any time. After consideration of the public comments, we are finalizing this proposal to revalue CPT code 99483 as proposed.

5. Initial Preventive Physical Examination (IPPE) and Initial and Subsequent Annual Wellness Visits (AWV)

In the CY 2011 PFS final rule with comment period, we finalized separate payment for HCPCS codes G0438 (Annual wellness visit; includes a personalized prevention plan of service (pps), initial visit) and G0439 (Annual wellness visit, includes a personalized prevention plan of service (pps), subsequent visit). These services were valued via a direct crosswalk to the work, time, and direct PE inputs associated with CPT codes 99204 and 99214, respectively. In that same rule, we stated that the HCPCS code G0402 (Initial preventive physical examination; face-to-face visit, services limited to new beneficiary during the first 12 months of Medicare enrollment) was also valued based on a direct crosswalk to the work, time, and direct PE inputs for CPT code 99204 (75 FR 73408 through 73411).

Because these codes are valued using direct crosswalks to office/outpatient E/M visits, we believed that to maintain payment accuracy for the IPPE and the AWV, their values should be adjusted to reflect the changes in value for CPT codes 99204 and 99214. Therefore, we proposed to revise the work, physician time, and direct PE inputs for these codes as shown in Tables 23 and 24. The following is a summary of the comments we received and our responses.

Comment: Several commenters agreed with our proposal to revalue the IPPE and AWV HCPCS codes. These commenters agreed that because these services were valued using direct crosswalks to CPT codes 99204 and 99214, their values should be updated to reflect the increases to those visits finalized for CY 2021.

Response: We thank the commenters for their support.

Comment: Several commenters disagreed with our proposal to revalue the IPPE and AWV HCPCS codes. A commenter indicated that because the AMA RUC has never reviewed these codes, it is unclear that the work associated with the services represents work described by a level 4 office/outpatient E/M visit.

Response: We continue to believe that because the IPPE and AWV were valued using direct crosswalks to CPT codes 99204 and 99214, respectively, changes to the work associated with CPT codes 99204 and 99214 should be applied to the valuation of the IPPE and AWV codes. Regarding the point that these codes have not been reviewed by the RUC, we note that the IPPE and AWV are services that are unique to the Medicare program. These services are reported using Medicare-specific HCPCS G codes that are not applicable for other payers. As such, we do not see a need for these codes to be reviewed by Start Printed Page 84557the RUC. If the RUC did review them, however, we would consider any RUC recommendations through our usual rulemaking process. As discussed above, our decision to consider a given code(s) as analogous to the office/outpatient E/M visits is not based on any single factor, but rather, takes into account various applicable factors. The public may nominate any code(s) as potentially misvalued through the usual misvalued code process, or request that codes reviewed by the AMA RUC.

We received comments primarily in support of our proposal to revalue the IPPE and AWV codes. Our proposed revaluations reflect changes in value to the two office and outpatient E/M codes (that is, CPT codes 99204 and 99214) upon which the IPPE and AWV code values were originally crosswalked. We continue to believe that to maintain payment accuracy, the values for the IPPE and AWV codes should be adjusted accordingly. After considering the comments, we are finalizing as proposed.

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6. Emergency Department Visits

We have revalued the ED visit codes (CPT codes 99281-99285, see Table 25 for long descriptors) under the PFS three times: In 1997, 2007, and most recently in 2020 as part of the misvalued code initiative. In the past, consistent with AMA RUC recommendations, we revalued these services such that the values of levels 1 through 3 of the ED visits were equal to levels 1 through 3 new patient office/outpatient E/M visits, and the levels 4 and 5 ED visits were valued higher than the levels 4 and 5 new patient office/outpatient E/M visits to reflect higher typical intensity. Also in the CY 2018 PFS final rule, we finalized a proposal to nominate all five ED visit codes as potentially misvalued, based on information suggesting that the work RVUs for ED visits may not appropriately reflect the full resources involved in furnishing these services. Specifically, some stakeholders expressed concerns that the work RVUs for these services have been undervalued given the increased acuity of the patient population and the heterogeneity of the sites, such as freestanding and off-campus EDs, where ED visits are furnished (82 FR 53018). Accordingly, the AMA RUC resurveyed and reviewed these five codes for the April 2018 RUC meeting, and provided a recommendation to CMS for consideration in CY 2020 rulemaking. In the CY 2020 PFS final rule (84 FR 62796), we finalized the RUC-recommended increases to the work RVUs of 0.48 for CPT code 99281, a work RVU of 0.93 for CPT code 99282, a work RVU of 1.42 for 99283, a work RVU of 2.60 for 99284, and a work RVU of 3.80 for CPT code 99285. The RUC did not recommend, and we did not finalize, any change in direct PE inputs for the codes in this family. We note that the AMA RUC submitted these recommended values to CMS prior to the submission of the RUC-recommended revaluation of the office/outpatient E/M visit code family.

In response to our proposal to accept the RUC-recommended values for the ED visits, and to our comment solicitation in CY 2020 PFS proposed rule regarding whether we should revalue certain services commensurate with increases to the office/outpatient E/M visits (84 FR 62859 through 62860), a commenter submitted a public comment stating that relativity between the ED visits and office/outpatient E/M visits should be maintained, and submitting a specific recommendation for CPT codes 99283-99285 that was higher than the RUC-recommended values. The commenter stated we should preserve the relationship between the ED and office/outpatient E/M visit code sets that was established in prior years and that they believe would have likely been maintained had the office/outpatient E/M visits been reviewed prior to the ED visits. In order to avoid the rank order anomaly whereby an ED visit would be valued lower than the analogous office/outpatient E/M visit in CY 2021, we proposed in this current rulemaking cycle to adopt the values recommended by this commenter, and as shown in Table 25. The following is a summary of the comments we received and our responses.

Comment: One commenter supported our proposal. This commenter stated that levels 1-3 ED visits should remain the same as the levels 1-3 new patient office visits, and that levels 4-5 ED visits should have a higher value than the corresponding office visits due to the complexity of the patients requiring that level of emergency care.

Response: We are finalizing as proposed, as shown in Table 25, in order to avoid a rank order anomaly. We understand that the AMA workgroup on E/M services is continuing to consider further changes in coding and interpretive guidance for visit level selection for all of the E/M visit code sets other than the office/outpatient E/M visits, in light of the recent changes for office/outpatient visits. We will continue to stay abreast of this important work and continue considering the appropriate valuation of ED and other E/M visit code sets in light of any future changes in this arena by the CPT Editorial Panel and the AMA RUC.

Comment: Several commenters requested that we consider the nursing facility visits (CPT codes 99304-99318), domiciliary visits (CPT codes 99324-99337), and home visits (CPT codes 99341-99350) to be analogous to the office/outpatient E/M visits, noting that they are identical in every way except the setting of care and vulnerability of Start Printed Page 84563the patient population. These commenters indicated that the CPT Editorial Panel and the AMA RUC will be reviewing these code sets in the near future, and their primary concern was to maintain access to care until this review is complete. Accordingly, these commenters recommended that we increase the work RVUs for these services to the extent necessary to maintain the payment rate for these codes at 2020 levels. These commenters provided an estimate of the revised work RVUs necessary to achieve this as a temporary measure, stating that due to relatively low service volume, these changes would not negatively impact the conversion factor.

Response: We did not propose to treat and revalue nursing facility visits, domiciliary visits and home visits as analogous to office/outpatient E/M visits. We do not agree with the commenters' assertions that these visits are identical to the office/outpatient E/M visit codes. The setting of care means that these visits involve different resources. In particular, skilled nursing facility (SNF) visits are reported using the nursing facility visit codes, rendering them substantially different from office/outpatient visits. For these reasons, we do not believe the commenters' requested changes to values for nursing facility visits, domiciliary visits, and home visits would be appropriate at this time. Additionally, we understand that the AMA workgroup on E/M services is continuing to consider further changes in coding and interpretive guidance for visit level selection for all of the E/M visit code sets other than the office/outpatient E/M visits, in light of the forthcoming changes for office/outpatient visits. We will continue to stay abreast of this important work and consider the appropriate valuation of home, domiciliary, nursing facility and other E/M visit code sets in light of any future changes in this arena by the CPT Editorial Panel and the AMA RUC.

7. Therapy Evaluations

There are a number of services paid under the PFS that are similar in many respects to the office/outpatient E/M visit code set, but do not specifically include, were not valued to include, and were not necessarily valued relative to, office/outpatient E/M visits. Some codes inherently include work associated with assessment and work associated with management, similar to the work included in the office/outpatient E/M visits, which involve time spent face-to-face assessing and treating the patient. These services include therapy evaluation services and psychiatric diagnostic evaluation services. The practitioners who furnish these services are prohibited by CMS from billing E/M services due to the limitations of their Medicare benefit categories. As such, the CPT Editorial Panel has created specific coding to describe the services furnished by these practitioners. Although these services are billed using specific, distinct codes relating to therapy evaluations and psychiatric diagnostic evaluations, we believe that a significant portion of the overall work in the codes is for assessment and management of patients, as it is for the office/outpatient E/M visit codes.

Therefore, we proposed to adjust the work RVUs for these services based on a broad-based estimate of the overall change in the work associated with assessment and management to mirror the overall increase in the work of the office/outpatient E/M visits. We calculated this adjustment based on a volume-weighted average of the increases to the office/outpatient E/M visit work RVUs from CY 2020 to CY 2021. Details on this calculation are available as a public use file on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices. We proposed to apply that percentage increase, which we estimated to be approximately 28 percent, to the work RVUs for the therapy evaluation and psychiatric diagnostic evaluation services codes. We noted that we believe that it is important to the relativity of the PFS to revalue these services to reflect the overall increase in value associated with spending time assessing and managing patients, as reflected in the changes to work values for the office/outpatient E/M visits, particularly in recognition of the value of the clinicians' time which is spent treating a growing number of patients with greater needs and multiple medical conditions. We recognized that this is not the methodology typically used to value services under the PFS and solicited comment on potential alternative methodologies or specific values for these services, particularly about whether commenters believe it would be better to develop values using comparator codes from the office/outpatient E/M visit code set, and if so, why.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Some commenters supported our proposal to adjust the work RVUs for outpatient therapy evaluations and to consider alternative approaches submitted by stakeholders in future rulemaking that may better reflect the true values. Many commenters urged us to implement similar increases to the work RVUs of additional therapy services, including CPT codes 97140 (Manual therapy techniques (eg, mobilization/manipulation, manual lymphatic drainage, manual traction), 1 or more regions, each 15 minutes), 97537 (Community/work reintegration training (eg, shopping, transportation, money management, avocational activities and/or work environment/modification analysis, work task analysis, use of assistive technology device/adaptive equipment), direct one-on-one contact, each 15 minutes), 97542 (Wheelchair management (eg, assessment, fitting, training), each 15 minutes), 97760 (Orthotic(s) management and training (including assessment and fitting when not otherwise reported), upper extremity(ies), lower extremity(ies) and/or trunk, initial orthotic(s) encounter, each 15 minutes), 97761 (Prosthetic(s) training, upper and/or lower extremity(ies), initial prosthetic(s) encounter, each 15 minutes), 97763 (Orthotic(s)/prosthetic(s) management and/or training, upper extremity(ies), lower extremity(ies), and/or trunk, subsequent orthotic(s)/prosthetic(s) encounter, each 15 minutes), 97597 (Debridement (eg, high pressure waterjet with/without suction, sharp selective debridement with scissors, scalpel and forceps), open wound, (eg, fibrin, devitalized epidermis and/or dermis, exudate, debris, biofilm), including topical application(s), wound assessment, use of a whirlpool, when performed and instruction(s) for ongoing care, per session, total wound(s) surface area; first 20 sq cm or less), 97598 (Debridement (eg, high pressure waterjet with/without suction, sharp selective debridement with scissors, scalpel and forceps), open wound, (eg, fibrin, devitalized epidermis and/or dermis, exudate, debris, biofilm), including topical application(s), wound assessment, use of a whirlpool, when performed and instruction(s) for ongoing care, per session, total wound(s) surface area; each additional 20 sq cm, or part thereof (List separately in addition to code for primary procedure)), 97750 (Physical performance test or measurement (eg, musculoskeletal, functional capacity), with written report, each 15 minutes), and 97755 (Assistive technology assessment (eg, to restore, augment or compensate for existing function, optimize functional tasks and/or maximize environmental accessibility), Start Printed Page 84564direct one-on-one contact, with written report, each 15 minutes). These commenters stated that these services also involve assessment and management, and thus, are analogous to office/outpatient E/M visit codes.

Response: In the proposed rule, we discussed that these evaluations contained types of work, specifically time spent assessing and managing patients, that is similar to the work described by the office/outpatient E/M visit code set. We stated that the increase in value associated with the office/outpatient E/M visits reflected the changes to work values, particularly in recognition of the value of the clinicians' time spent treating a growing number of patients with greater needs and multiple medical conditions, that could also apply to physical therapy, occupational therapy, and speech language pathology evaluations. The CPT codes identified by commenters involve work that is not similar to that captured by the office/outpatient E/M codes, such as various types of therapeutic treatment. Therefore, we do not believe it would be appropriate to adjust the values of these codes to reflect the changes in valuation for the office/outpatient E/M codes.

Comment: Some commenters did not support our proposal to implement the proposed increases to these therapy codes, stating that it will amplify a previous misvaluation by CMS for codes that do not specifically include, were not valued to include, and were not necessarily valued relative to, office/outpatient E/M visits. According to the commenters, these therapy codes were originally misvalued when CMS finalized a single RVU of 1.20 for all three codes rather than the RUC-recommended work RVUs, which created an overvaluation in aggregate for these services.

Response: In the proposed rule, we discussed our rationale for proposing to increase the values of these services relative to the increased values for the office/outpatient E/M visit code set. If the commenters believe the therapy codes are not appropriately valued, we note the public may nominate any code(s) as potentially misvalued through the usual misvalued code process or request that it be surveyed or valued through the AMA RUC.

After considering the public comments, we are finalizing the changes in values for the therapy codes as proposed.

8. Behavioral Healthcare Services

The psychotherapy code set is divided into psychotherapy that can be furnished as a standalone service and psychotherapy furnished in conjunction with an office/outpatient E/M visit. The standalone psychotherapy services are CPT codes 90832, 90834, and 90837 (See Table 25 for long descriptors). The CPT codes describing psychotherapy furnished in conjunction with an office/outpatient E/M visit are CPT codes 90833 (Psychotherapy, 30 minutes with patient when performed with an evaluation and management service (List separately in addition to the code for primary procedure)), 90836 (Psychotherapy, 45 minutes with patient when performed with an evaluation and management service (List separately in addition to the code for primary procedure)) and 90838 (Psychotherapy, 60 minutes with patient when performed with an evaluation and management service (List separately in addition to the code for primary procedure)). As the values for the office/outpatient E/M visits are increasing, there will necessarily be an increase in the overall value for psychotherapy furnished in conjunction with office/outpatient E/M visits. We believe that it is important, both in terms of supporting access to behavioral health services through appropriate payment and maintaining relativity within this code family, to increase the values for the standalone psychotherapy services to reflect changes to the value of the office/outpatient E/M visits which are most commonly furnished with the add-on psychotherapy services with equivalent times. For example, under the finalized revaluation of the office/outpatient E/M visits, the proportional work value of the standalone psychotherapy CPT code 90834 (Psytx w pt 45 minutes) would decrease relative to the combined work RVUs for CPT code 99214 (Level 4 Office/outpatient visit est) when billed with CPT code 90836 (Psytx w pt w e/m 45 min). The current combined work RVU for CPT code 99214 when reported with CPT code 90836 is 3.40 (1.90 + 1.50) and the current work RVU for CPT code 90834 is 2.0. With the revaluation of the office/outpatient E/M visits beginning for CY 2021, the combined work RVU for CPT codes 99214 and 90836 would be 3.82 (1.90 + 1.92), while the current work RVU for 90834 would remain at 2.0, resulting in a change to relativity between these services.

To maintain the current relativity, which we believe to be appropriate based on the proportionate difference between these services, we are proposing to increase the work RVU for CPT code 90834 from 2.00 to 2.25 based on the marginal increase in work value for CPT code 99214 from CY 2020 to CY 2021. Similarly, for CPT code 90832, which describes 30 minutes of psychotherapy, we proposed to increase its work RVU based on the increase to CPT code 99213, which is most commonly billed with the 30 minutes of psychotherapy add-on, CPT code 90833. For CPT code 90837, which describes 60 minutes of psychotherapy, we propose to increase the work RVU based on the proportional increase to CPT codes 99214 and 90838, which is the office/outpatient E/M visit code most frequently billed with the 60 minutes of psychotherapy add-on. Table 25 provides a summary of the current and final RVUs for these services.

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We received public comments on the Behavioral Healthcare services. The following is a summary of the comments we received and our responses.

Comment: A few commenters did not support this proposal, stating it relies on a flawed methodology; specifically, the stand-alone codes, which were established for NPPs to report psychotherapy services, were not valued based on a comparison to the psychotherapy codes delivered in conjunction with an E/M (codes 90833, 90836 and 90838). These commenters noted that these are two distinct codes sets: one for NPPs and one for physicians/QHPs representing different levels of similar work. CMS should compare psychotherapy to psychotherapy, not psychotherapy to psychotherapy plus E/M. Accordingly, these commenters did not support CMS's proposal to increase the values of 90832, 90834, and 90837 to reflect changes to the value of the office/outpatient E/M visits which are most commonly furnished with the add-on psychotherapy services with equivalent times.

Other commenters were concerned that the increases to some of the psychotherapy services will skew the relativity not only to the psychotherapy services provided along with an E/M service but to other services within the psychiatry section.

Some commenters supported increases for these services, but stated that commensurate relativity adjustments are needed for all Psychotherapy, Psychological and Neuropsychological Testing, and HBAI codes. Specifically, these commenters recommended proportionate increases to CPT codes 90791 (Psychiatric diagnostic evaluation), 90839 (Psychotherapy for crisis; first 60 minutes), 90845 (Psychoanalysis), 90847 (Family psychotherapy (conjoint psychotherapy) (with patient present), 50 minutes), and 90853 (Group psychotherapy (other than of a multiple-family group)), as well as to the HBAI code set (CPT codes 96156 (Health behavior assessment, or re-assessment (ie, health-focused clinical interview, behavioral observations, clinical decision making)), 96158 (Health behavior intervention, individual, face-to-face; initial 30 minutes), 96159 (Health behavior intervention, individual, face-to-face; each additional 15 minutes (List separately in addition to code for primary service)), and 97170 (Athletic training evaluation, moderate complexity, requiring these components: A medical history and physical activity profile with 1-2 comorbidities that affect physical activity; An examination of affected body area and other symptomatic or related systems addressing a total of 3 or more elements from any of the following: body structures, physical activity, and/or participation deficiencies; and Clinical decision making of moderate complexity using standardized patient assessment instrument and/or measurable assessment of functional outcome. Typically, 30 minutes are spent face-to-face with the patient and/or family.); and to the Psychological and Neuropsychological Testing code set (CPT codes 96116 (Neurobehavioral status exam (clinical assessment of thinking, reasoning and judgment, [eg, acquired knowledge, attention, language, memory, planning and problem solving, and visual spatial abilities]), by physician or other qualified health care professional, both face-to-face time with the patient and time interpreting test results and preparing the report; first hour), 96121 (Neurobehavioral status exam (clinical assessment of thinking, reasoning and judgment, [eg, acquired knowledge, attention, language, memory, planning and problem solving, and visual spatial abilities]), by physician or other qualified health care professional, both face-to-face time with the patient and time interpreting test results and preparing the report; each additional hour (List separately in addition to code for primary procedure)), 96130 (Psychological testing evaluation services by physician or other qualified health care professional, including integration of patient data, interpretation of standardized test results and clinical data, clinical decision making, treatment planning and report, and interactive feedback to the patient, family member(s) or caregiver(s), when performed; first hour), 96131 (Neuropsychological testing evaluation services by physician or other qualified health care professional, including integration of patient data, interpretation of standardized test results and clinical data, clinical decision making, treatment planning and report, and interactive feedback to the patient, family member(s) or caregiver(s), when performed; first hour), 96132 (Neuropsychological testing evaluation services by physician or other qualified health care professional, including integration of patient data, interpretation of standardized test results and clinical data, clinical decision making, treatment planning and report, and interactive feedback to the patient, family member(s) or caregiver(s), when performed; first hour), 96133 (Neuropsychological testing evaluation services by physician or other qualified health care professional, including integration of patient data, interpretation of standardized test results and clinical data, clinical decision making, treatment planning and report, and interactive feedback to the patient, family member(s) or caregiver(s), when performed; each additional hour (List separately in addition to code for Start Printed Page 84568primary procedure)), 96136 (Psychological or neuropsychological test administration and scoring by physician or other qualified health care professional, two or more tests, any method; first 30 minutes), 96137 (Psychological or neuropsychological test administration and scoring by physician or other qualified health care professional, two or more tests, any method; each additional 30 minutes (List separately in addition to code for primary procedure)), 96138 (Psychological or neuropsychological test administration and scoring by technician, two or more tests, any method; first 30 minutes), 96139 (Psychological or neuropsychological test administration and scoring by technician, two or more tests, any method; each additional 30 minutes (List separately in addition to code for primary procedure)), and 96146 (Psychological or neuropsychological test administration, with single automated, standardized instrument via electronic platform, with automated result only)), all of which were valued relative to the family of psychotherapy services through the AMA RUC process.

Response: We identified standalone psychotherapy services for adjustment to preserve the relative value of these services to psychotherapy services performed in conjunction with an office/outpatient E/M. We disagree with commenters who stated that, as the standalone psychotherapy codes were purposefully and appropriately valued without reference to the values of E/M services, we should not consider updating these values to retain relativity between standalone psychotherapy and psychotherapy billed in conjunction with an office/outpatient E/M. With regard to requests from commenters to adjust values of additional services, we continue to believe that our rationale for proposing proportionate adjustments to the stand-alone psychotherapy services does not apply to the wider psychotherapy code set. We believe that the value of stand-alone psychotherapy is analogous to the values of the office/outpatient E/M visit codes due to the nature of the work performed. These services describe E/M-type services furnished in some circumstances by practitioners who would not bill E/M services. Health and Behavior Assessment and Intervention and Psychological and Neuropsychological Testing are fundamentally different in that they describe testing services.

Having considered the public comments we received, we are finalizing our proposed increases to the values of CPT codes 90832, 90834, and 90837.

9. Ophthalmological Services

Prior to the CY 2021 PFS proposed rule, we had received a request to revalue the following ophthalmological services that we did not propose to revalue:

  • CPT code 92002: Ophthalmological services: Medical examination and evaluation with initiation of diagnostic and treatment program; intermediate, new patient.

CPT code 92004: Ophthalmological services: Medical examination and evaluation with initiation of diagnostic and treatment program; comprehensive, new patient, 1 or more visits.

CPT code 92012: Ophthalmological services: Medical examination and evaluation, with initiation or continuation of diagnostic and treatment program; intermediate, established patient.

CPT code 92014: Ophthalmological services: Medical examination and evaluation, with initiation or continuation of diagnostic and treatment program; comprehensive, established patient, 1 or more visits.

We did not propose to revalue these services because they are not sufficiently analogous to the office/outpatient E/M visit codes. While these ophthalmological services have historically been valued relative to office/outpatient E/M visits, the AMA RUC has not reviewed them since 2007. Two of these ophthalmological services can include more than one visit, and the number of visits included in the package is uncertain and therefore not so closely tied to office and outpatient E/M services, which describe a single visit. In addition, starting in 2021, the office/outpatient E/M visit codes will be substantially redefined to allow time or medical decision-making for code level selection—concepts that do not apply to the ophthalmological visits which rely on criteria specific to evaluation, examination, specified technical procedures, and treatment of ocular conditions for purposes of level selection.[8] The number of levels is different within the two code sets, and the number of levels has changed for office/outpatient E/M visits. Given the revised code set and framework for level selection for office/outpatient E/M visits, the level of office/outpatient E/M visits to which the ophthalmological visits might be analogous is unclear. We also noted that we are aware that ophthalmologists report office/outpatient E/M visits as well these ophthalmologic-specific evaluation codes. The relationship between the two separate code sets and the reason for maintaining and using both of them is unclear.

In the proposed rule, we also noted that the four ophthalmological evaluation codes are frequently reported with modifier -25 (significant, separately identifiable E/M service by the same physician on the same day of the procedure or other service), as are ED visits. For the ophthalmological evaluations and ED visits, approximately one-third of the time, the same-day E/M service is a zero-day global surgical code, whereas for the office/outpatient E/M visits, approximately one-fifth of the same-day claims are for zero-day global services. We noted that we believe that visit/evaluation codes furnished the same day as a minor procedure are not closely analogous to stand-alone office/outpatient E/M visits. As we discussed in prior rulemaking, we continue to believe that separately identifiable visits occurring on the same day as minor procedures (such as zero-day global procedures) have resources that are sufficiently distinct from the costs associated with furnishing office/outpatient E/M visits to warrant different payment (see, for example, the CY 2019 PFS final rule, 83 FR 59639). As we were still in process of analyzing these data, we solicited public comment on whether visits/evaluations that are furnished frequently with same-day procedures should be revalued commensurate with increases to the office/outpatient E/M visits, or whether they are substantially different enough to warrant independent valuation. We noted further that the stand-alone psychotherapy services would be revalued to maintain relativity with the psychotherapy services that can be performed in conjunction with an E/M visit. Stand-alone psychotherapy services cannot be billed with office/outpatient E/M visits while ophthalmological visits can, as well as with a separate procedure.

We received public comments on our decision not to propose new valuations for these ophthalmological services. The following is a summary of the comments we received and our responses.

Comment: One commenter stated that concurrent billing with same-day, zero-day global procedures should not be factor in whether or not we increase the ophthalmology evaluation codes commensurate with office/outpatient E/M visits. The commenter stated that the intravitreal injection code accounting for much of the volume of these zero-day global procedures (CPT code 67028) does not include an office examination. The commenter also stated that resource Start Printed Page 84569duplication between the same-day services is accounted for in the RUC valuation that reduces the pre- and post-times for the procedure if it is furnished more than 50 percent of the time with an E/M visit or eye evaluation. Another commenter noted that the AWV can be reported the same day as an office/outpatient E/M visit, and urged CMS not to treat primary care and surgical specialties differentially.

Response: We continue to believe that separately identifiable visits occurring on the same day as minor procedures (such as zero-day global procedures) have resources that are sufficiently distinct from the costs associated with furnishing stand-alone office/outpatient E/M visits to warrant different payment. However, we understand that such a policy would apply to ophthalmology evaluations, ED visits and other services. We believe the better way to account for duplicative resources across the fee schedule would be a payment reduction along the lines of a multiple procedure payment reduction for services reported using modifier −25.We will continue to consider implementing a policy to address this issue. We note that the policy that we proposed and declined to finalize for CY 2019 would have applied a multiple “procedure” payment adjustment to two visits reported the same day, as well as a visit with a minor procedure. We are also considering whether the office/outpatient visit complexity HCPCS add-on code GPC1X should be reported when the visit is reported with modifier −25 (see section II.F.2.c. of this final rule).

Comment: One commenter stated that while the ophthalmological evaluations have not been recently revalued by the AMA RUC, the AWV has never been reviewed by the RUC.

Response: We discuss above our rationale for considering the AWV as an analogous service to the office/outpatient E/M services. Regarding consideration of the AWV by the RUC, we note that the AWV is a service described by a code that is unique to Medicare and not applicable for other payers. As such, we do not see a need for the RUC to review this service, but if it did, we would consider its recommendations through our usual rulemaking process. As discussed above, our decision to consider a given code(s) as analogous to the office/outpatient E/M visits is not based on any single factor, but rather takes into account various applicable factors. The public may nominate any code(s) as potentially misvalued through the usual misvalued code process or request that it be surveyed or valued through the AMA RUC.

Comment: The same commenter stated that all four of the ophthalmology codes are valued based on a single visit on the date of encounter, and the level of that visit is directly compared to levels of office E/M codes. The commenter also stated that while the ophthalmological codes do not rely on time to select visit level, both code sets will be able to use MDM to select visit level, and that MDM was a basis for prior comparison to office/outpatient E/M visit codes.

Response: We continue to note that two of these ophthalmological services can include more than one visit, and therefore, the resource costs are not as closely tied to office and outpatient E/M visits (that describe a single visit) as the AWV/IPPE, TCM, cognitive impairment and other codes we are considering to be analogous to office/outpatient E/M visits. We disagree that reliance on time and differences in MDM interpretive guidance are not substantial differences between the 2021 office/outpatient E/M visit codes and the ophthalmology evaluation codes. Also, we continue to believe that the corresponding visit levels for the two code sets are not clear, such that the level of office/outpatient E/M visits to which the ophthalmological visits might be analogous is not apparent. We continue to note that ophthalmologists report office/outpatient E/M visits as well these ophthalmologic-specific evaluation codes. The relationship between the two separate code sets and the reason for maintaining and using both of them remains unclear. Having considered the public comments we received, we are finalizing our decision not to revalue the ophthalmological evaluations commensurate with the changes to the office/outpatient EM visit valuations for 2021. Stakeholders may still request review of these services by the RUC or through our misvalued code initiative.

c. Comment Solicitation on the Definition of HCPCS Add-On Code G2211

Although we believe that the RUC-recommended values for the revised office/outpatient E/M visit codes will more accurately reflect the resources involved in furnishing a typical office/outpatient E/M visit, we continue to believe that the typical visit described by the revised and revalued office/outpatient E/M visit code set still does not adequately describe or reflect the resources associated with primary care and certain types of specialty visits. Therefore, in the CY 2020 PFS final rule (84 FR 62856), we finalized the HCPCS add-on code G2211 (which replaces temporary HCPCS add-on code GPC1X) and which describes the “visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious, or complex condition.” We stated that we were not restricting billing based on specialty, but that we did assume that certain specialties furnished these types of visits more than others.

Since the publication of the CY 2020 PFS final rule, some specialty societies have stated that our definition of this service, as articulated in the code descriptor and the associated preamble discussion, is unclear. For example, some stakeholders have suggested that HCPCS add-on code G2211, as currently described, could be applicable for every office/outpatient E/M visit. They have also expressed concerns regarding our utilization assumptions, since we assumed that specialties that predominantly furnish the kind of care described by the code would bill it with every visit. Therefore, we solicited public comments providing additional, more specific information regarding what aspects of the definition of HCPCS add-on code G2211 are unclear, how we might address those concerns, and how we might refine our utilization assumptions for the code.

We continue to believe that the time, intensity, and PE involved in furnishing services to patients on an ongoing basis that result in a comprehensive, longitudinal, and continuous relationship with the patient and involves delivery of team-based care that is accessible, coordinated with other practitioners and providers, and integrated with the broader health care landscape, are not adequately described by the revised office/outpatient E/M visit code set. We believe the inclusion of HCPCS add-on code G2211 appropriately recognizes the resources involved when practitioners furnish services that are best-suited to patients' ongoing care needs and potentially evolving illness. We also believe the work reflected in HCPCS add-on code G2211 is inherently distinct from existing coding that describes preventive and care management services. For example, the AWV describes and pays for a static annual health assessment rather than the time, intensity, and PE involved in furnishing services to patients on an ongoing basis. Similarly, TCM service codes are focused on care management for 30 days Start Printed Page 84570following a discharge rather than the time, intensity, and PE involved in furnishing services to patients on an ongoing basis. Chronic care management and principal care management service codes are limited to patients with chronic condition(s). Under chronic care management codes, patients have two or more chronic conditions that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, whereas principal care management services are for patients who have a single high-risk disease of sufficient severity to place the patient at risk of hospitalization or have been the cause of recent hospitalization. In contrast, we believe HCPCS add-on code G2211 reflects the time, intensity, and PE when practitioners furnish services that enable them to build longitudinal relationships with all patients (that is, not only those patients who have a chronic condition or single-high risk disease) and to address the majority of patients' health care needs with consistency and continuity over longer periods of time. For example, in the context of primary care, HCPCS add-on code G2211 could recognize the resources inherent in holistic, patient-centered care that integrates the treatment of illness or injury, management of acute and chronic health conditions, and coordination of specialty care in a collaborative relationship with the clinical care team. In the context of specialty care, HCPCS add-on code G2211 could recognize the resources inherent in engaging the patient in a continuous and active collaborative plan of care related to an identified health condition the management of which requires the direction of a clinician with specialized clinical knowledge, skill and experience. Such collaborative care includes patient education, expectations and responsibilities, shared decision-making around therapeutic goals, and shared commitments to achieve those goals. In both examples, HCPCS add-on code G2211 reflects the time, intensity, and PE associated with providing services that result in care that is personalized to the patient. Finally, we believe that the HCPCS add-on code G2211 could bolster the efforts of practitioners in rural communities, including NPPs, to deliver the comprehensive and longitudinal care that HCPCS add-on code G2211 describes.

We received public comments on our comment solicitation related to HCPCS add-on code G2211. The following is a summary of the comments we received and our responses.

Comment: Many commenters who rely upon office/outpatient E/M visits to report the majority of their services continued to be supportive of HCPCS add-on code G2211. These commenters agreed with CMS that the revised office/outpatient E/M visit codes do not adequately describe or reflect the resources associated with primary care and certain types of specialty visits and agreed that the code descriptor fits its intended purpose, is well-defined, and did not allude to specific specialties. Other commenters disagreed, maintaining that the definition of HCPCS add-on code G2211 is unclear. Some commenters stated that it appeared that HCPCS add-on code G2211 could be reported with most office/outpatient E/M visits and questioned whether widespread use accurately captured genuine longitudinal care relationships. These commenters requested that CMS provide clinical examples for appropriate reporting. Other commenters provided CMS with suggested clinical examples for when HCPCS add-on code G2211 could be reported. For example, some commenters stated that HCPCS add-on code G2211 would capture additional work by the reporting practitioner to treat patients with disease processes that require active monitoring outside of office/outpatient E/M visits and are not captured in current coding. This work could include oversight of medication refills; evaluating appropriateness of current and new medications, including those initially prescribed by other practitioners; and conducting medication-related monitoring and safety activities when these activities are not part of a visit. It could also include review of lab and imaging reports, including those requested by another practitioner, that fall outside the timeframe of an office/outpatient E/M visit, and do not necessitate a new visit. Finally, some commenters suggested that CMS describe circumstances when HCPCS add-on code G2211 would not be reported with an office/outpatient E/M visit.

Response: We appreciate all of the feedback from the commenters. We believe that HCPCS add-on code G2211 captures the work by the reporting practitioner for many office/outpatient E/M visits that is not accounted for in the valuation of the primary office/outpatient E/M visit code. In the context of primary care, a clinical example for the use of HCPCS add-on code G2211 could be: a 68 year-old woman with progressive congestive heart failure (CHF), diabetes, and gout, on multiple medications, who presents to her physician for an established patient visit. The clinician discusses the patient's current health issues, which includes confirmation that her CHF symptoms have remained stable over the past 3 months. She also denies symptoms to suggest hyper- or hypoglycemia, but does note ongoing pain in her right wrist and knee. The clinician adjusts the dosage of some of the patient's medications, instructs the patient to take acetaminophen for her joint pain, and orders laboratory tests to assess glycemic control, metabolic status, and kidney function. The practitioner also discusses age appropriate prevention with the patient and orders a pneumonia vaccination and screening colonoscopy. In this clinical example, the practitioner is serving as a focal point for the patient's care, addressing the broad scope of the patient's health care needs, by furnishing care for some or all of the patient's conditions across a spectrum of diagnoses and organ systems with consistency and continuity over time.

Moreover, we believe that similar visits might be furnished by other specialists when management of a particular disease condition(s) is ongoing or serves as a focal point of care for a patient's overall health needs over a period of time. In other words, when care by specialists for a particular disease condition(s) is consistent and continuous over long periods of time, the work associated with those visits is similar to the kind of work described above.

In contrast, there are many visits with new or established patients where HCPCS add-on code G2211 would not be appropriately reported, such as when the care furnished during the office/outpatient E/M visit is provided by a professional whose relationship with the patient is of a discrete, routine, or time-limited nature, such as a mole removal or referral to a physician for removal of a mole; for treatment of a simple virus; for counseling related to seasonal allergies, initial onset gastroesophageal reflux disease; treatment for a fracture; and where comorbidities are either not present or not addressed, and/or and when the billing practitioner has not taken responsibility for ongoing medical care for that particular patient with consistency and continuity over time, or does not plan to take responsibility for subsequent, ongoing medical care for that particular patient with consistency and continuity over time. Reporting the add-on code with these types of visits would be inconsistent with the code Start Printed Page 84571descriptor, which describes care that is a continuing focal point and/or part of ongoing care. We also would not expect that HCPCS add-on code G2211 would be reported when the office/outpatient E/M is reported with a payment modifier, such as the modifier -25 described in the ophthalmological services section above. It seems likely that visits reported with payment modifiers have resources that are sufficiently distinct from stand-alone office/outpatient E/M visits. We will be considering this issue to inform potential future rulemaking.

Comment: Some commenters suggested that a lack of clarity in the definition of HCPCS add-on code G2211 poses program integrity challenges for CMS. They pointed out that CMS has offered no information about how appropriate use will be determined or what documentation will be expected. Some commenters requested guidance on what documentation would need to be included when HCPCS add-on code G2211 is reported.

Response: We appreciate the concerns raised by the commenters. Since HCPCS add-on code G2211 is a new service paid under the PFS, we plan to monitor utilization for appropriate use of the add-on code, which could inform additional efforts to refine the code descriptor, or provide further guidance, as appropriate. With respect to documentation, we are considering an approach to minimize burden similar to what we finalized in the CY 2019 PFS final rule (83 FR 59560) for HCPCS add-on codes GPC1X and GCG0X. In that rule, we discussed that we would expect that information included in the medical record or in the claims history for a patient/practitioner combination, such as diagnoses, the practitioner's assessment and plan for the visit, and/or other service codes billed could serve as supporting documentation. We believe Medicare claims data could be a useful gauge of appropriate use of the code. For example, when billing practitioners are separately reporting care management services for particular beneficiaries, the G2211 add-on service would be appropriately reported with their visits, as claims for these care management services could indicate an ongoing, continuous relationship with the patient. Likewise, patients returning to the same practitioner for routine preventive services would indicate that the practitioner has taken responsibility for ongoing medical needs for that patient with consistency and continuity over time. In contrast, an annual visit for ophthalmologic care, or a single episode of dermatologic care—even when several services are billed over a few months—would not suggest ongoing care provided with consistency and continuity over time and would suggest an inappropriate use of the code, were it to be billed with such visits. Additionally, to provide evidence of the ongoing relationship between the patient and practitioner, it is possible that use of patient relationship codes that were established under MACRA and finalized in the CY 2018 PFS (82 FR 53234) could be further example of evidence in the claims record to support the use of HCPCS add-on code G2211. These codes are Level II HCPCS modifiers that help define and distinguish the relationship and responsibility of a clinician with a patient at the time of furnishing an item or service, facilitate the attribution of patients and episodes to one or more clinicians, and to allow clinicians to self-identify their patient relationships.

Comment: Some commenters recommended that HCPCS add-on code G2211 should be available for both new and established patients. A few other commenters noted that the code descriptor for HCPCS add-on code G2211 had one version of the long descriptor in this section of the proposed rule and another version of the long descriptor in section II.D. Another commenter recommended an edit to the code descriptor to eliminate the comma between “single” and “serious.”

Response: We are confirming that HCPCS add-on code G2211 can be reported for both new and established patients. With respect to the version of the long descriptor, the version used in section II.D of the proposed rule was a drafting error. We regret the error and have corrected the description in section II.D of this final rule. While we appreciate the suggested edit to the code descriptor, we did not believe it offered additional clarification. To improve the clarity of the code descriptor, we are finalizing a refinement for the code description to clarify that the code applies to a single condition that is serious, rather than any single condition. We are inserting the word “condition” after “single, serious”. The revised descriptor reads as follows, “Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious condition or a complex condition. (Add-on code, list separately in addition to office/outpatient evaluation and management visit, new or established).”

Comment: A few commenters recommended that CMS allow HCPCS add-on code G2211 to be reported with E/M services furnished in domiciliary care settings.

Response: We reiterate that we are implementing HCPCS add-on code G2211 because we believe the that the typical visit described by the revised and revalued office/outpatient E/M visit code set still does not adequately describe or reflect the resources associated with primary care and certain types of specialty visits and as such, does not include other types of E/M visits. As the CPT Editorial Panel, the AMA RUC and CMS consider future changes to other E/M visit code sets, we will consider this issue in that context.

Comment: Other commenters expressed continued concern regarding the necessity of HCPCS add-on code G2211 entirely and recommended that CMS withdraw the code. A few stated that HCPCS add-on code G2211 is not a separately identifiable service given the changes to the office/outpatient E/M visit code set and that it may be duplicative to care management services, such as TCM or CCM.

Response: As we stated in the proposed rule, we continue to believe that the time, intensity, and PE involved in furnishing services to patients on an ongoing basis that result in a comprehensive, longitudinal, and continuous relationship with the patient and involves delivery of team-based care that is accessible, coordinated with other practitioners and providers, and integrated with the broader health care landscape, are not adequately described by the revised office/outpatient E/M visit code set. We also reiterate what we stated in the proposed rule that HCPCS add-on code G2211 is inherently distinct from coding that describes care management services. For example, TCM service codes are focused on care management for 30 days following a discharge rather than the time, intensity, and PE involved in furnishing services to patients on an ongoing basis. Chronic care management and principal care management service codes are limited to patients with chronic condition(s). Under chronic care management codes, patients have two or more chronic conditions that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, whereas principal care management services are for patients who have a single high-risk disease of sufficient severity to place the patient at risk of hospitalization or have been the cause of recent hospitalization. In contrast, we believe HCPCS add-on code G2211 reflects the time, intensity, Start Printed Page 84572and PE when practitioners furnish services that enable them to build longitudinal relationships with all patients (that is, not only those patients who have a chronic condition or single-high risk disease) and to address the majority of patients' health care needs with consistency and continuity over longer periods of time.

Comment: Many commenters expressed concerns about the utilization assumptions for HCPCS add-on code G2211. Commenters stated that, in the CY 2020 PFS rulemaking cycle, CMS appeared to assume that HCPCS add-on code G2211 would be reported with 50 percent of all office/outpatient E/M visits; and in the CY 2021 PFS proposed rule, CMS appeared to assume that HCPCS add-on code G2211 would be reported with 75 percent of all office/outpatient E/M visits. Commenters noted that this additional utilization further contributed to the redistributive effect of the budget neutrality adjustment related to revaluing the office/outpatient visit codes. The AMA RUC requested that CMS publish the methodology used for the utilization assumptions in the CY 2021 PFS proposed rule prior to HCPCS add-on code G2211's implementation.

Response: In the CY 2020 PFS rulemaking cycle, we proposed and finalized that HCPCS add-on code G2211 would be billed with every level of an office/outpatient E/M visit. We assumed that specialties that rely on office/outpatient E/M visit coding to report the majority of their services would be most likely to report HCPCS add-on code G2211 with every office/outpatient E/M visit they reported and we did not restrict billing to any particular specialty or group of specialties. We published the utilization estimates for HCPCS add-on code G2211 in the CY 2020 PFS final rule in this public use file: https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​Downloads/​CY2020-PFS-FR-EM-Add-on-Code.zip.

In the CY 2021 PFS proposed rule, we continued to assume that the specialties listed in the aforementioned public use file would report HCPCS add-on code G2211 with all of their office/outpatient E/M visits. As part of updating our data sources from CY 2018 to CY 2019 claims data for setting rates for the CY 2021 PFS proposed rule, we included modifier −25 utilization, meaning that we assumed that HCPCS add-on code G2211 would also be reported with office/outpatient E/M visits that were reported with a modifier −25. While this additional utilization was included in the budget neutrality calculations, we note that other proposals for CY 2021 also factor into the budget neutrality adjustment.

As we noted above, while we would not expect that HCPCS add-on code G2211 would be reported when the office/outpatient E/M visits is reported with a payment modifier, such as a modifier −25, we are not establishing any policies that prohibit reporting the add-on code under those circumstances. Thus, we will continue to include office/outpatient visits reported with a modifier −25 in our utilization assumptions for HCPCS code G2211 as part of calculating the budget neutrality adjustment for the policies we are finalizing in this rule. As we noted above, we would not expect HCPCS add-on code G2211 to be reported when the visit is reported with a modifier 2−5, and will consider whether to establish an explicit prohibition in future rulemaking. We continue to believe that separately identifiable visits occurring on the same day as minor procedures (such as zero-day global procedures) have resources that are sufficiently distinct from the costs associated with furnishing stand-alone office/outpatient E/M visits to warrant different payment. We are also analyzing our data to determine if separately identifiable visits occurring on the same day as another visit have resources that are sufficiently distinct from the costs associated with furnishing stand-alone office/outpatient E/M visits to warrant different payment. We will consider these analyses to inform potential future rulemaking.

Comment: Many commenters recommended that CMS reexamine and lower utilization assumptions for HCPCS add-on code G2211. These commenters stated that utilization tends to be lower than expected in the first year of implementation and cited the initial low utilization of the TCM and CCM codes These commenters also stated that they expected adoption to be slow given the necessity for medical societies to educate their members about appropriate use, ongoing implementation of the revisions to the office/outpatient E/M visit code set, electronic health records integration, and the persistence of the COVID-19 pandemic in many parts of the country. They recommended that utilization in the initial year could be as low as 10 percent of reported office/outpatient E/M visits and could range as high as 25 percent of reported office/outpatient E/M visits. Other commenters recommended that CMS delay the implementation of HCPCS add-on code G2211, citing the expected budget neutrality offset.

Response: We acknowledge commenters' concerns that, given the necessity of medical societies to educate their members about appropriate use, ongoing implementation of the revisions to the office/outpatient E/M visit code set, electronic health records integration, and the persistence of the COVID-19 pandemic, practitioners that rely on office/outpatient E/M visits to report the majority of their services are not likely to report HCPCS add-on code G2211 with every office visit. However, we disagree the utilization will be as low as the 10 percent to 25 percent range as recommended by these commenters. We have not implemented any additional policies that restrict the billing of this code, and so we are assuming that utilization will be 90 percent of office/outpatient E/M visits instead of the 100 percent that we assumed in the proposed rule.

d. Prolonged Office/Outpatient E/M Visits (CPT Code 99417/HCPSC Code G2212)

We reviewed our final policy for 2021 regarding the reporting of prolonged office/outpatient E/M visits finalized in the CY 2020 PFS final rule (84 FR 62848 through 62850). To report these visits beginning in 2021, we finalized CPT code 99417 (Prolonged office or other outpatient evaluation and management service(s) (beyond the total time of the primary procedure which has been selected using total time), requiring total time with or without direct patient contact beyond the usual service, on the date of the primary service; each additional 15 minutes (List separately in addition to CPT codes 99205, 99215 for office or other outpatient evaluation and management services)), which was referred to in our previous rules as temporary CPT code 99XXX. Under CPT prefatory language, CPT code 99417 should only be reported when time is used to select the visit level, and only time of the physician or qualified healthcare professional is counted. In the CY 2020 PFS final rule, we stated that our interpretation of revised CPT prefatory language and reporting instructions would mean that CPT code 99417 could be reported when the physician's (or NPP's) time is used for code level selection and the time for a level 5 office/outpatient E/M visit (the floor of the level 5 time range) is exceeded by 15 minutes or more on the date of service (84 FR 62848 through 62849). The intent of the CPT Editorial Panel was unclear because of the use of the terms “total time” and “usual service” in the CPT code descriptor (“requiring total time with or without direct patient contact beyond the usual Start Printed Page 84573service.”) The term “total time” is unclear because office/outpatient E/M visits now represent a range of time, and “total” time could be interpreted as including prolonged time. Further, the term, “usual service” is undefined. There is no longer a typical time in the code descriptor that could be used as point of reference for when the “usual time” is exceeded for all practitioners, and there would be variation (as well as potential double counting of time) if applied at the individual practitioner level.

Having reviewed the policy we finalized last year, we believe that allowing reporting of CPT code 99417 after the minimum time for the level 5 visit is exceeded by at least 15 minutes would result in double counting time. As a specific example, the time range for CPT code 99215 is 40-54 minutes. If the reporting practitioner spent 55 minutes of time, 14 of those minutes are included in the services described by CPT code 99215. Therefore, only 1 minute should be counted towards the additional 15 minutes needed to report CPT code 99417 and prolonged services should not be reportable as we finalized last year (see Table 33 of the CY 2020 PFS final rule (84 FR 62849)). Therefore, we proposed that when the time of the reporting physician or NPP is used to select office/outpatient E/M visit level, CPT code 99417 could be reported when the maximum time for the level 5 office/outpatient E/M visit is exceeded by at least 15 minutes on the date of service. In Tables 26 and 27, we provided examples.

We received public comments on our proposal for use of CPT code 99417. The following is a summary of the comments we received and our responses.

Comment: Several commenters agreed with our concerns about the lack of clarity in the code descriptor and the potential for double-counting time. Several other commenters disagreed with our proposal and recommended that CMS adopt the CPT code descriptors. These commenters stated that a change in policy by CMS could be confusing to practitioners and disruptive to the ongoing work of medical societies to educate practitioners about the use of these codes. Some commenters also stated the CPT Editorial Panel intended to apply the general CPT rule where practitioners can report a timed code once the midpoint is reached.

Response: In the CPT 2021 Professional Edition, CPT code 99417 is described as, “Prolonged office or other outpatient evaluation and management service(s) beyond the minimum required time of the primary procedure which has been selected using total time, requiring total time with or without direct patient contact beyond the usual service, on the date of the primary service; each additional 15 minutes (List separately in addition to CPT codes 99205, 99215 for office or other outpatient evaluation and management services)).” The terms “total time” and “usual service” continue to be unclear.

While we prefer to align with CPT coding to reduce potential confusion to practitioners, we continue to believe that CPT code 99417 as written is unclear and that allowing reporting of CPT code 99417 when the minimum required time for the level 5 visit is exceeded by at least 15 minutes would result in double counting time. It has not been our understanding that CPT intended for the midpoint time to suffice for reporting this code, and regardless, we did not previously finalize or intend to apply such a policy.

We continue to believe it is important for CMS and other stakeholders to know with certainty how much time practitioners spend furnishing office/outpatient E/M visits, in order to assess whether resources are accurately accounted for in their valuation. This is especially true once time can be used to select visit level, with new times established for this code set. To resolve the lack of clarity, we are finalizing our proposal regarding the time that may be counted for prolonged office/outpatient E/M visits; and to resolve the potential inconsistency of our policy with CPT code 99417, we are creating a new HCPCS code G2212 to be used when billing Medicare for this service instead of CPT code 99417, starting in 2021. HCPCS code G2212 is as follows, Start Printed Page 84574Prolonged 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))”.”

We believe 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 we frequently receive about the required times and what time may be counted toward the required time to report prolonged office/outpatient E/M visits. We also note that we are not opposed in concept to reporting prolonged office/outpatient visit time on a date other than the visit. However, we continue to believe there should be a single prolonged code specific to office/outpatient E/M visits that encompasses all related time (see the CY 2020 PFS final rule for a more detailed discussion of this issue, (84 FR 62849 through 62850)). We will continue to stay abreast of any changes in CPT coding. The valuation for HCPCS code G2212 will be the same as for CPT code 99417.

G. Scope of Practice and Related Issues

We proposed several policies consistent with the President's E.O. 13890 on “Protecting and Improving Medicare for Our Nation's Seniors” to modify supervision and other requirements of the Medicare program that limit healthcare professionals from practicing at the top of their license (84 FR 53573, October 8, 2019, E.O. 13890). In December 2019, we requested feedback in response to part of this E.O. seeking the public's help in identifying additional Medicare regulations which contain more restrictive supervision requirements than existing state scope of practice laws, or which limit health professionals from practicing at the top of their license (the request for feedback is available at https://www.cms.gov/​files/​document/​request-information-reducing-scope-practice-burden.pdf). Through review of the feedback we received, we identified the proposed policies in section II.G. of the CY 2021 PFS proposed rule (85 FR 50139). We noted that we believe that physicians, NPPs, and other professionals should be able to furnish services to Medicare beneficiaries in accordance with their scope of practice and state licensure, including education and training, to the extent permitted under the Medicare statute, as long as it is not likely to result in fraud, waste or abuse or create potential risks to beneficiary safety. The proposed policies may also help ensure an adequate number of clinicians, in addition to physicians, are able to furnish critical services including primary care services in areas where there is a shortage of physicians.[9] We noted that some of the proposals may also help alleviate the opioid crisis.

We solicited information about the number and names of states that have licensure or scope of practice laws in place, as well as any facility-specific policies, that would impact the ability of clinicians to exercise the flexibilities we proposed, to help us assess the potential impact of, or challenges for, the proposed changes. We noted that information about specific services (service-level information) would be especially helpful. We solicited public comment on whether applicable state laws, scope of practice, and facility policies would permit practitioners to exercise the proposed flexibilities if we were to adopt the proposed policies, and to what extent practitioners would be permitted to exercise the proposed flexibilities, such as for all diagnostic tests or only a subset.

We solicited information on these topics because the responses to our request for feedback issued in 2019 did not indicate the number of states that have more flexible scope of practice rules than our federal regulations, or whether facilities (such as hospitals or nursing facilities) have relevant policies that limit the ability of the impacted professionals to perform certain services. For example, if Medicare payment policy provided for payment of diagnostic tests supervised by NPPs, there may still be facility- or state-specific policies in place that limit NPPs' ability to supervise some or all diagnostic tests, and those limitations would inform the potential impact of changing our policy. While our proposed flexibility may increase the capacity and availability of practitioners who can supervise diagnostic tests, which would alleviate some of the demand on physicians as the only source to perform this particular function, we noted that we have not located information indicating the degree to which NPP scope of practice includes supervision of auxiliary staff, especially for the subset of services that are diagnostic tests. There is a wide range of diagnostic tests, from a simple strep throat swab to more sophisticated and/or invasive tests such as x-rays and cardiology procedures. We would need to understand the scope of practice for many types of auxiliary staff (some of whom are not licensed) who could potentially provide these tests under the supervision of an NPP, including RNs, LPNs, medical assistants, radiologic technicians, and many others. To the extent practice patterns change, there could be induced utilization that would increase costs, but this might be offset by reduced payment rates because direct payment to NPPs is at a lower rate than payment to physicians.

1. Teaching Physician and Resident Moonlighting Policies

a. Background

In the March 31st COVID-19 IFC (85 FR 19258 through 19261) and the May 8th COVID-19 IFC (85 FR 27587 through 27589), we implemented several policies on an interim final basis related to PFS payment for the services of teaching physicians involving residents and resident moonlighting during the PHE for COVID-19. In the proposed rule, we noted that we planned to address comments received on the IFCs for those policies that we made proposals or solicited comment on in the proposed rule when we published the PFS final rule.

b. Finalization of Interim Final Rule With Comment Period Provisions Related to Application of Teaching Physician and Moonlighting Regulations During the PHE for the COVID-19 Pandemic

We received public comments on the policies that we adopted on an interim basis in the Interim Final Rule with Comment Period provisions related to the Application of Teaching Physician and Moonlighting Regulations During the PHE for the COVID-19 Pandemic (85 FR 19258 through 19261). The following is a summary of the comments we received and our responses.

i. Virtual Presence of a Teaching Physician Using Audio/Video Real-Time Communications Technology

Comment: Commenters were generally supportive of the virtual presence policies in §§ 415.172, 415.174, 415.180, and 415.184 that we implemented on an interim basis during the PHE for COVID-19. Several commenters supported extending the flexibilities permanently, while several Start Printed Page 84575other commenters recommended continuing the policy temporarily through the end of the PHE for COVID-19, or for a period of time following the end of the PHE for COVID-19.

Response: We appreciate commenters' support for the virtual presence policies adopted on an interim basis during the PHE for COVID-19. After considering the comments, we are finalizing these policies for the duration of the PHE for COVID-19.

Comment: One commenter, in support of the virtual presence policies adopted on an interim basis during the PHE for COVID-19, recommended that CMS encourage residency programs, residency review committees, and ACGME to increase monitoring of clinical and educational work hour standards, acknowledge the impact of the changes to the teaching physician presence requirements on the residents and their optimal learning environment, and share additional information regarding how to best meet the need for reporting of information related to workload and growing service demands, patient safety, medical error, continuity of care, resident well-being and burnout, development of professionalism, resident learning outcomes, and preparation for independent practice as they relate to the use of teaching physician presence through real-time interactive audio and video technology.

Response: We do not believe it is CMS' role to regulate or monitor training outcomes or advocate on behalf of the residents themselves. Organizations representing the interests of residents and overseeing the actual operation of residency programs are in a better position to establish rules regarding the impact of virtual presence and involvement of teaching physicians on residency training outcomes.

Comment: One commenter noted that the GME community has learned many lessons during the pandemic, related to resident education and supervision. Consequently, the commenter believed that the GME community should be provided the flexibility to test new and better modalities of treatment and learning.

Response: We appreciate the commenter's support of our policies. As described previously, we are finalizing these policies for the duration of the PHE for COVID-19.

Comment: One commenter requested clarification of the definition of “telecommunications,” and asked whether supervision, in the context of a teaching institution, can be performed by telephone as opposed to a tablet or smartphone.

Response: The policy to allow a teaching physician to use audio/video real-time communications technology for purposes of furnishing care with a resident, and in the case of the primary care exception, directing, managing, and reviewing the care furnished by the resident, generally requires real-time direct observation (not mere availability) by the teaching physician through interactive, real-time audio and video technology, and does not include audio-only technology (for example, telephone without video).

Comment: Several commenters expressed support for the exclusion of surgical, high risk, interventional, endoscopic, or other complex procedures identified under § 415.172(a)(1), and anesthesia services under § 415.178 from the policy to allow the teaching physician to be present using audio/video real-time communications technology. One commenter recommended that the teaching physician virtual presence policy be permitted for CPT codes 31231 (Nasal endoscopy, diagnostic, unilateral or bilateral (separate procedure)), 31575 (Laryngoscopy, flexible; diagnostic), and 31579 (Laryngoscopy, flexible or rigid telescopic, with stroboscopy) performed through an endoscope.

Response: We continue to believe the requirement for the physical, in-person presence of the teaching physician during all key or critical portions of the procedure and immediately availability to furnish services during the entire service or procedure is necessary for patient safety given the risks associated with these services. In complex, high-risk procedures, including the endoscopic procedures associated with CPT codes 31231, 31575 and 31579, a patient's clinical status can quickly change. To permit payment under the PFS for such teaching physician services, we believe the services must be furnished with a certain level of personal oversight and involvement of the teaching physician who has the experience and judgment that is necessary for rapid on-site decision-making during these procedures. With respect to the procedures associated with CPT codes 31231, 31575 and 31579, we do not believe that virtual presence by a teaching physician would provide sufficient personal involvement and control over the service to warrant billing of the services under the PFS or allow for the rapid on-site decision-making that could be necessary during the procedures, which could pose an increased risk to patients.

ii. Virtual Presence of a Teaching Physician During Medicare Telehealth Services

Comment: Commenters were generally supportive of the policy adopted on an interim basis to allow payment under the PFS when residents furnish telehealth services to beneficiaries with the teaching physician present using audio/video real-time communications technology. In addition, several commenters supported extending the flexibility permanently.

Response: We appreciate commenters' support for the policy, adopted on an interim basis during the PHE for COVID-19, to allow payment under the PFS when residents furnish telehealth services to beneficiaries with the teaching physician present using interactive, audio/video real-time communications technology (excluding audio-only). After considering the comments, we are finalizing this policy for the duration of the PHE for COVID-19.

iii. Resident Moonlighting in the Inpatient Setting

Comment: Commenters were generally supportive of the policy under § 415.208 that we adopted on an interim basis during the PHE for COVID-19 to allow PFS payment for services provided by fully licensed residents that are not related to their approved GME program in the inpatient setting of a hospital in which they are training, provided that the conditions specified in § 415.208(b)(2)(i) through (iii) are met. Several commenters recommended that this policy be implemented permanently, and some other commenters recommended that the policy be implemented for the duration of the PHE only.

Response: We appreciate commenters' support for the moonlighting policy we adopted on an interim basis during the PHE for COVID-19. After considering the comments, we are finalizing this policy for the duration of the PHE for COVID-19.

iv. Primary Care Exception Policies

Comment: Commenters were generally supportive of the policy adopted on an interim basis under § 415.174 to expand the primary care exception to include all levels of office and outpatient E/M codes. Some commenters recommended that this policy be implemented permanently, and some other commenters recommended that the policy be implemented for the duration of the PHE for COVID-19 only.Start Printed Page 84576

Response: We appreciate commenters' support of the expansion of the primary care exception policy adopted on an interim basis during the PHE for COVID-19. After considering the comments, we are finalizing this policy for the duration of the PHE for COVID-19.

Comment: One commenter interpreted the policy described in § 415.174 to mean that the “immediately available supervision” requirement described in this section could be met by the teaching physician being “immediately available” via real-time audio/video technology.

Response: Subsequent to the publication of the March 31st COVID-19 IFC, the May 8th COVID-19 IFC amended § 415.174 to add a new paragraph (c) to allow that, on an interim basis for the duration of the PHE for COVID-19, the teaching physician may not only direct the care furnished by residents, but also review the services provided with the resident, during or immediately after the visit, remotely through virtual means via interactive, audio/video real-time communications technology (excluding audio-only).

v. Payment Under the PFS for Teaching Physician Services When Resident Under Quarantine

Comment: A commenter supported the interim policy for the duration of the PHE for COVID-19 to permit PFS payment for teaching physician services that do not require face-to-face patient care when the resident is furnishing such services while in quarantine when the teaching physician is present through audio/video real-time communications technology.

Response: We thank the commenter for their support. After considering the comments, we are finalizing this policy for the duration of the PHE for COVID-19.

c. Finalization of Interim Final Rule Provisions Related to Additional Flexibility Under the Teaching Physician Regulations

We received public comments on the policies that we adopted on an interim basis in the Interim Final Rule provisions related to Additional Flexibility Under the Teaching Physician Regulations (85 FR 27587 through 27589). The following is a summary of the comments we received and our responses.

i. Primary Care Exception Policies

Comment: S everal commenters supported the policy adopted on an interim basis to allow, under the primary care exception described in § 415.174(c), the teaching physician to direct the care furnished by the resident, and to review the services furnished by the resident during or immediately after the visit, remotely using audio/video real-time communications technology. Several commenters supported a temporary extension of the policy through the end of the PHE for COVID-19 or through 2021, while other commenters suggested a permanent extension of this flexibility.

Response: We appreciate the commenters' support of this policy during the PHE for COVID-19. After considering the comments and for the reasons discussed above, we are finalizing this policy for the duration of the PHE for COVID-19.

Comment: Some commenters requested clarification of the phrase “interactive audio/visual real-time communication technology” because CMS has used various terms when expressing technology requirements for remote supervision and in the context of teaching physician services, and because the presence of the slash mark in the phrase makes it unclear whether both audio and visual communication must be utilized to meet the requirement, or if one or the other is sufficient. One commenter also recommended that the phrase be revised to explicitly state that a real-time audio-only communication is sufficient in order to meet the regulations set forth in § 415.174(a)(3) for use of the primary care exception.

Response: While we believe our statements have been clear on this point, we clarify here that this virtual presence policy requires real-time observation (not mere availability) by the teaching physician through a contemporaneous, interactive combination of both audio and video communications technology, and does not include audio-only technology (for example, telephone without video). We note that we have used the “audio/video” formulation in our regulations, and that the “slash” should be read consistently to mean a synchronous, interactive, real-time combination of both audio and video technology, which would not include audio-only communications for any portion of the time of the furnished service.

Comment: Commenters were generally supportive of the policy adopted on an interim basis to allow Medicare to make payment to the teaching physician for additional services under the primary care exception, including all levels of office and outpatient E/M codes, audio-only telephone E/M services, transitional care management, and communication technology-based services. Several commenters supported a temporary extension of the policy through the end of the PHE for COVID-19 or through 2021, while other commenters suggested a permanent expansion of the services that residents could furnish under the primary care exception.

Response: We appreciate commenters' support of this policy during the PHE for COVID-19. After considering the comments, we are finalizing the policy for the duration of the PHE for COVID-19.

Comment: Several commenters thanked CMS for the clarification that Medicare may make payment under the PFS for teaching physician services when a resident furnishes services permitted under the primary care exception, including via telehealth, and the teaching physician can provide the necessary direction, management and review of the resident's services using interactive audio/video real-time communications technology.

Response: We appreciate the commenters' support for this policy during the PHE.

Comment: Several commenters supported the interim policy during the PHE for COVID-19 that the office/outpatient E/M level selection for services under the primary care exception when furnished via telehealth can be based on medical decision-making or time.

Response: We thank the commenters for their support of this policy during the PHE. This policy is similar to the policy that will apply to all office/outpatient E/M services beginning in 2021 under policies finalized in the CY 2020 PFS final rule and thus, we are not finalizing it.

d. Summary of Proposed Rule Provisions and Public Comments

i. Background

In the proposed rule, we considered whether the policies implemented on an interim basis in the March 31st COVID-19 IFC or the May 8th COVID-19 IFC should be extended on a temporary basis (that is, if the PHE for COVID-19 ends in 2021, these policies could be extended to December 31, 2021, to allow for a transition period before reverting to status quo policy) or be made permanent, and solicited public comment. We noted that the public comments would assist us in identifying appropriate policies that we would consider in drafting the CY 2021 PFS final rule.

For teaching physicians, section 1842(b)(7)(A)(i)(I) of the Act specifies Start Printed Page 84577that 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 and services of moonlighting residents 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 who 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. Under § 415.172, if a resident participates in a service furnished in a teaching setting, PFS payment is made only if the teaching physician is present during the key portion of any service or procedure for which payment is sought. The regulation at § 415.180 states that, for the interpretation of diagnostic radiology and other diagnostic tests, PFS payment is made if the interpretation is performed or reviewed by a physician other than a resident. Under § 415.184, PFS payment is made for psychiatric services furnished under an approved graduate medical education (GME) program if the requirements of §§ 415.170 and 415.172 are met, except that the requirement for the presence of the teaching physician during psychiatric services in which a resident is involved may be met by observation of the service by use of a one-way mirror, video equipment, or similar device.

ii. Supervision of Residents in Teaching Settings Through Audio/Video Real-Time Communications Technology

In both the March 31st COVID-19 IFC (85 FR 19258 through 19261) and the May 8th COVID-19 IFC (85 FR 27587 through 27589), we adopted a policy on an interim basis during the PHE for COVID-19 that, under § 415.172, the requirement for the presence of a teaching physician during the key portion of the service furnished with the involvement of a resident can be met using audio/video real-time communications technology. In other words, the teaching physician must be present, either in person or virtually through audio/video real-time communications technology, during the key portion of the service. This policy generally requires real-time observation (not mere availability) by the teaching physician through audio and video technology, and does not include audio-only technology (for example, telephone without video). For the primary care exception under § 415.174(c), we adopted a policy on an interim final basis for the duration of the PHE for COVID-19 to allow the teaching physician to direct the care furnished by the resident, and to review the services furnished by the resident during or immediately after the visit, remotely using audio/video real-time communications technology.

Under § 415.180, we adopted a policy on an interim basis for the duration of the PHE for COVID-19 to allow PFS payment for the interpretation of diagnostic radiology and other diagnostic tests if the interpretation is performed by a resident when the teaching physician is present through audio/video real-time communications technology. A physician other than the resident must still review the resident's interpretation. Under § 415.184, we adopted a policy on an interim basis during the PHE for COVID-19 that the requirement for the presence of the teaching physician during the psychiatric service in which a resident is involved may be met by the teaching physician's direct supervision using audio/video real-time communications technology. We considered whether the flexibilities described above that we implemented on an interim basis during the PHE for COVID-19 under §§ 415.172, 415.174, 415.180, and 415.184 should be extended on a temporary basis (that is, if the PHE ends in 2021, these policies could be extended to December 31, 2021, to allow for a transition period before reverting to status quo policy) or be made permanent, and solicited public comments on whether these policies should continue once the PHE for COVID-19 ends. We noted that the public comments would assist us in identifying appropriate policy continuation decisions that we would consider finalizing in the CY 2021 PFS final rule. In addition, we proposed to make a technical edit to the regulation text at § 415.184 to eliminate the term “direct supervision” to conform with the language in sections §§ 415.172, 415.174, and 415.180 regarding the presence of the teaching physician via audio/video real-time communications technology.

While we believe it was appropriate to permit teaching physicians to be involved in services furnished with residents through audio/video real-time communications technology to respond to critical needs during the PHE to reduce exposure risk and to increase the capacity of teaching settings to respond to COVID-19, we expressed concern that continuing to permit teaching physicians to be involved through their virtual presence may not be sufficient to warrant PFS payment to the teaching physician on a temporary or permanent basis. Absent the circumstances of the PHE for COVID-19, the physical, in-person presence of the teaching physician may be necessary to provide oversight to ensure that care furnished to Medicare beneficiaries is medically reasonable and necessary, and to ensure that the teaching physician renders sufficient personal services to exercise full, personal control of the key portion of the case.

We also noted concerns about patient safety when the teaching physician is only virtually present. For example, in the March 31st COVID-19 IFC, we excluded the surgical, high risk, interventional, endoscopic, or other complex procedures identified under § 415.172(a)(1), and anesthesia services under § 415.178 from the policy to allow the teaching physician to be present using audio-video real-time communications technology because we believed the requirement for the physical, in-person presence of the teaching physician for either the entire procedure or the key portion of the service with immediate availability throughout the procedure, as applicable, is necessary for patient safety given the risks associated with these services. In complex, high-risk, surgical, interventional, or endoscopic procedures, or anesthesia procedures, a patient's clinical status can quickly change. To permit payment under the PFS for these teaching physician services, we believed the services must be furnished with a certain level of personal oversight and involvement of the teaching physician who has the experience and judgment that is necessary for rapid on-site decision-making during these procedures.

We also noted that there may be circumstances in which virtual presence of the teaching physician, considered in light of the potential risks to patient safety and absent exposure risk concerns due to COVID-19, does not demonstrate sufficient personal involvement in the service to the patient to warrant payment to the teaching physician under the PFS. For example, a resident could evaluate a patient for change in mental status following surgery for hip fracture, perform a physical exam and report it as unrevealing, and note that the patient is uncooperative with a full exam. If a full exam had been performed by the Start Printed Page 84578teaching physician or with the physical presence of the teaching physician (or with the teaching physician immediately available in the clinic to provide the necessary direction, under the primary care exception) to render personal and identifiable physicians' services to the patient, the exam would likely have revealed crystal-mediated acute arthritis, and that the patient's lack of cooperation was due to hypoactive delirium. However, the teaching physician may not have been able to identify this concern through the use of audio/video interactive communications technology. In this case, the presence of the teaching physician through audio/video interactive communications technology might have been insufficient to allow the teaching physician to render personal and identifiable physicians' services to exercise full, personal control over the key portion of the encounter.

We stated that there also may be certain patient populations that require greater clinical attentiveness and skill than the teaching physician could provide via audio/video interactive communications technology. For example, patients with cognitive impairment or dementia may require the experience and skill to recognize a need for specialized testing, and patients with communication disabilities may require more experience and skill to recognize specialized needs. It may not be possible for the teaching physician to meet these clinical needs and exercise full, personal control while being present for the key portion of the service through audio/video interactive communications technology. Moreover, the virtual connection between the teaching physician and the resident who is with the patient could be disrupted (as with any virtual supervision scenario), rendering it impossible for the teaching physician to provide necessary direction for the resident to furnish appropriate care to the patient, thus foreclosing the ability of the teaching physician to exercise full, personal control over the key portion of the services, and potentially putting the patient's safety at risk.

While we expressed significant concerns about extending our interim policy to permit virtual presence of the teaching physician, whether on a temporary or permanent basis, we noted that we believe public comments would be helpful as we further consider the status of this policy. For example, because COVID-19 may continue to persist in some communities after the expiration of the PHE for COVID-19, we considered extending our policy to permit the teaching physician to be present through audio/video interactive communications technology on a temporary basis until the end of the calendar year in which the PHE for COVID-19 ends. The presence of COVID-19 may result in a need for some teaching settings to continue to limit exposure risks, especially for high risk patients isolated for their own protection or in cases where the teaching physician has been exposed to the virus and must be under quarantine. If the teaching physician is under quarantine, termination of the policy to permit virtual presence of the teaching physician could unintentionally limit the number of licensed practitioners available to furnish services to Medicare patients in some communities, and could have the unintended consequence of limiting access to services for Medicare patients. Some communities may experience a resurgence of COVID-19, and extending our policy until the end of the calendar year in which the PHE for COVID-19 ends to permit PFS payment when the teaching physician is present through audio/video real-time communications technology could temporarily help teaching settings remain prepared with surge capacity.

Based on the clinical experience gained during the PHE for COVID-19, we noted that we might identify circumstances or procedures for which the teaching physician can routinely render sufficient personal and identifiable services to the patient to exercise full, personal control over the management of the key portion of the case when the services are furnished by a resident with the teaching physician present through audio/video real-time communications technology. For example, under ordinary circumstances for the primary care exception at § 415.174, we permit PFS payment to the teaching physician when a resident furnishes office/outpatient evaluation and management (E/M) visit codes of lower and mid-level complexity and annual wellness visits without the presence of a teaching physician (these codes are discussed in section II.F. of this final rule (85 FR XXXXX)). Additionally, the teaching physician may be able to provide sufficient involvement for simple procedures such as CPT code 36410 (Venipuncture, age 3 years or older, necessitating the skill of a physician or other qualified health care professional (separate procedure), for diagnostic or therapeutic purposes (not to be used for routine venipuncture) or CPT code 51701 (Insertion of non-indwelling bladder catheter (e.g., straight catheterization for residual urine)). For such circumstances and procedures, we stated that it may be appropriate to continue the virtual presence policy on a temporary or permanent basis.

We noted that having the virtual presence policy in place temporarily or permanently would not preclude teaching physicians from providing a greater degree of involvement in services furnished with residents, and teaching physicians would still have discretion to determine whether, and if so, when it is appropriate to be present virtually rather than in person depending on the services being furnished and the experience of the particular residents involved. We solicited comments to help us understand how the option to provide for teaching physician presence using audio/video real-time communications technology would support patient safety for all patients and particularly for at-risk patients (for example, patients who are aged and/or who have a disability); ensure burden reduction without creating risks to patient care or increasing fraud; avoid duplicative payment between the PFS and the IPPS for GME programs; and support emergency preparedness. We also solicited comments to provide data and other information on experiences implementing this policy during the PHE for COVID-19.

We received public comments on our proposal to make a technical edit to the regulation text at § 415.184 to eliminate the term “direct supervision” to conform with the language in sections §§ 415.172, 415.174, and 415.180 regarding the presence of the teaching physician via audio/video real-time communications technology. The following is a summary of the comments we received and our responses.

Comment: Multiple commenters supported striking the term “direct supervision” from § 415.184 to conform to related sections describing the requirements for supervision of residents in teaching settings.

Response: We appreciate the commenters' support and are finalizing the technical edit to the regulation text at § 415.184 as proposed.

We also received public comments in response to the CY 2021 PFS proposed rule on whether the policies we adopted on an interim basis during the PHE for COVID-19 under §§ 415.172, 415.174, 415.180, and 415.184 should continue once the PHE ends. The following is a summary of the comments we received and our responses.

Comment: Commenters were generally supportive of the virtual presence policies in §§ 415.172, Start Printed Page 84579415.174, 415.180, and 415.184 that we implemented on an interim basis during the PHE for COVID-19. Several commenters supported extending the flexibilities permanently and asserted that a permanent expansion would promote patient access to physicians' services, particularly in rural areas, as well as continuity, convenience, flexibility, choice, and a decrease in the spread of COVID-19. Another commenter stated that in rural settings, it was not always possible for the teaching physician to accompany a resident while also being present with other residents. This commenter stated that the ability for the resident to be physically with a patient while the teaching physician is virtually present has increased patient access to physicians' services in rural areas. Similarly, other commenters stated that the permanent ability for teaching physicians to be virtually present when not physically present could open up additional training opportunities to care for underserved populations or increase specialty training opportunities for rural training programs.

Commenters broadly supported the exclusion of surgical, high risk, interventional, endoscopic, or other complex procedures, including anesthesia, from the virtual presence policy. While supportive of the flexibilities that we implemented on an interim basis, some commenters recommended temporarily extending the policies through the end of the PHE for COVID-19 to provide flexibility for communities that may experience resurgences in COVID-19 infections. These commenters cited a need to gather data regarding patient safety and potential impacts on resident training outside the context of the PHE before considering permanent implementation of the policies. For example, one commenter noted that CMS could use data from procedures furnished by residents during the PHE under virtual presence of the teaching physician to determine which procedures may be appropriate for virtual supervision on an ongoing basis.

Response: We appreciate commenters' support of the virtual presence policies that we implemented on an interim basis during the PHE for COVID-19. We remain concerned that, absent the circumstances of the PHE, virtual presence may not allow the teaching physician to render 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 the payment is sought, in accordance with section 1842(b)(7)(A)(i)(I) of the Act in most settings. For rural areas, however, we found compelling the commenters' statements that our virtual presence policy has increased access to Medicare-covered services. Accordingly, we believe that permitting the teaching physician to meet the requirements to bill under the PFS for their services through virtual presence when furnishing services involving residents in rural training settings could increase access to Medicare-covered services by preventing the beneficiary from potentially having to travel long distances to obtain care, particularly as rural areas have stretched and diminishing clinical workforces.[10]

Increasing beneficiary access to care in rural areas is also consistent with our longstanding interest in increasing beneficiary access to Medicare-covered services in rural areas.[11] Further, permitting the virtual presence of the teaching physician could facilitate expanded training opportunities for residents in rural settings, which have historically been in limited supply.[12] As such, the need to improve rural access to care for patients and training for residents overshadows our concerns about the ability for the teaching physician to render sufficient personal and identifiable physicians' services through virtual presence. Accordingly, we believe it would be appropriate to continue our policy to permit teaching physicians to meet the requirements to bill under the PFS for their services through virtual presence when furnishing services involving residents in rural settings after the conclusion of the PHE for COVID-19. This policy not only furthers our goals to increase beneficiary access to Medicare-covered services, it also facilitates needed training opportunities in a similar way to the longstanding primary care exception under § 415.174. The primary care exception permits the teaching physician to bill for certain types of physicians' services furnished by residents in certain settings even when the teaching physician is not present with the resident. Like the policy we are finalizing in this rule, the primary care exception facilitates access to Medicare-covered services and expanded residency training opportunities in primary care settings.

Therefore, we are finalizing a permanent policy to permit teaching physicians to meet the requirements to bill for their services involving residents through virtual presence, but only for services furnished in residency training sites that are located outside of an OMB-defined metropolitan statistical area (MSA).[13] In order to ensure that the teaching 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 the payment is sought in accordance with section 1842(b)(7)(A)(i)(I) of the Act, we are clarifying our existing documentation requirements to specify that, when a teaching physician, through virtual presence, furnishes services involving residents in a residency training site located outside of a MSA, the patient's medical record must clearly reflect how and when the teaching physician was present for the service in accordance with our regulations. For example, in the medical record, the teaching physician could document their physical or virtual presence at the training site during the key portion of a service, along with a notation describing the specific portion(s) of the service for which the teaching physician was virtually present, and/or that the teaching physician reviewed the service with the resident during or immediately after the service in accordance with the primary care exception under § 415.174. We also expect that, if the teaching physician is virtually present and bills for services during which there is a disruption to the virtual connection between the teaching physician and the resident who is with the patient, the encounter would be paused until the connection resumes, or the appointment would be rescheduled.

For all other settings, we are not permanently finalizing our teaching physician virtual presence policies; however, they will remain in place for the duration of the PHE to provide flexibility for communities that may experience resurgences in COVID-19 infections. While we do not anticipate any program integrity concerns to arise from this expanded flexibility in rural areas, we agree with commenters that it is necessary for use to consider Start Printed Page 84580additional data prior to proposing additional policies in this area, which could range from expanding this flexibility to include non-rural settings to terminating this flexibility in all settings. Specifically, we anticipate considering to what degree the permanent establishment of the policy to permit teaching physician virtual presence in residency training sites that are located outside of a MSA increased patient access to Medicare-covered services and provided additional training opportunities for residents while enabling the teaching physician to render sufficient personal and identifiable physicians' services. We may use such information, obtained through, for example, a commissioned study, analysis of Medicare claims data or another assessment mechanism, to further study the impacts of this limited permanent expansion of the virtual presence policy to inform potential future rulemaking, and in an effort to prevent possible fraud, waste and abuse.

We are amending our regulations to reflect this final policy. In § 415.172(a), to conform with the regulation text we are finalizing to describe direct supervision in § 410.32(b)(3)(ii), we are adding language to state that, as a general rule, the required presence of a teaching physician in order to bill under the PFS for their services at a residency training site that is located outside of a MSA can be met through interactive, audio/video real-time communications technology, which, as noted above, means synchronous, interactive, audio and video communications technology, and does not include audio-only communications. We are also adding language to provide that, for the duration of the PHE for COVID-19, in all teaching settings, the required presence of a teaching physician can be met through interactive, audio/video real-time communications technology (excluding audio-only).

In § 415.172(a)(2), we are adding language to note the exceptions under which virtual presence is permitted in the case of E/M services.

In § 415.172(b), which discusses existing documentation requirements, we are adding language to clarify that, for residency training sites that are located outside of a MSA, the medical record must clearly reflect whether the teaching physician was physically or virtually present at the training site during the key portion of the service. We are also adding language to clarify that, for all teaching settings and for the duration of the PHE for COVID-19, the patient's medical record must clearly reflect whether the teaching physician was physically or virtually present during the key portion of the service. Finally, we are adding language to clarify that the medical records must contain a notation describing the specific portion(s) of the service for which the teaching physician was present through interactive, audio/video real-time communications technology (excluding audio-only).

In § 415.174(c), we are adding language to state that, for all teaching settings and for the duration of the PHE for COVID-19, the teaching physician may not only direct the care furnished by residents, but also review the services provided with the resident, during or immediately after the visit, remotely through interactive, audio/video real-time communications technology (excluding audio-only).

In § 415.174(d), we are adding language to state that, for residency training sites that are located outside of a MSA, the teaching physician may not only direct the care furnished by residents, but also review the services provided with the resident, during or immediately after the visit, remotely through interactive, audio/video real-time communications technology (excluding audio-only).

In § 415.180(a), we are adding language to state that, for residency training sites that are located outside of an MSA, PFS payment may be made for the interpretation of diagnostic radiology and other diagnostic tests when the interpretation is performed by a resident and when the teaching physician is present through interactive, audio/video real-time communications technology (excluding audio-only). We are also adding language to state that, for all teaching settings and for the duration of the PHE for COVID-19, PFS payment may be made for the interpretation of diagnostic radiology and other diagnostic tests when the interpretation is performed by a resident and when the teaching physician is present through interactive, audio/video real-time communications technology (excluding audio-only). Finally, we are adding language to clarify that the medical records must document the extent of the teaching physician's participation in the interpretation or review of the diagnostic radiology or diagnostic test.

In § 415.184, we are adding language to state that, for residency training sites that are located outside of a MSA, the requirement for the presence of the teaching physician during the psychiatric service in which a resident is involved may be met using interactive, audio/video real-time communications technology (excluding audio-only). We are also adding language to state that, for all teaching settings and for the duration of the PHE for COVID-19, the requirement for the presence of the teaching physician during the psychiatric service in which a resident is involved may be met using interactive, audio/video real-time communications technology (excluding audio-only). Finally, we are adding language to clarify that the medical records must document the extent of the teaching physician's participation in the service.

While difficult to quantify, we believe that permanently extending the policy to permit virtual presence of teaching physicians in residency training sites that are located outside of an MSA will improve patient access to Medicare-covered physicians' services in rural areas. In addition, the ability of a teaching physician to meet the requirements to bill for services furnished involving residents through their virtual presence in these settings will improve teaching capabilities and potentially allow for additional resident education opportunities in rural areas. Settings that have traditionally been inaccessible as training sites for residents due to the limited ability of teaching physicians to be physically present will be more readily available, thereby affording increased access to physicians' services to patients in these areas. However, in order to ensure that this limited extension of the virtual presence policy is also consistent with section 1842(b)(7)(A)(i)(I) of the Act, we are clarifying our existing documentation requirements to specify that the medical record must clearly reflect how and when the teaching physician was present for the service. We believe this documentation clarification will ensure that the teaching 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 the payment is sought. Further, in order to minimize potential risks to patients, we remind physicians and other practitioners that the adoption of these virtual presence policies in residency training sites that are located outside a MSA does not preclude teaching physicians from being physically present when providing services furnished with residents. We therefore urge teaching physicians to continue to use their professional judgment to determine the circumstances under which it is appropriate to be present virtually rather than in person depending on the services being furnished and the experience of the Start Printed Page 84581particular resident(s) and/or teaching physician involved.

Comment: In response to our comment solicitation for information regarding how the virtual presence of a teaching physician would support patient safety, several commenters stated that guardrails exist through the Accreditation Council for Graduate Medical Education (ACGME) and other accrediting organizations that have standards and systems to ensure patient safety and oversight of residents when virtual supervision of residents occurs.

Response: We appreciate commenters' suggestions that the policies of the ACGME and other accrediting organizations could serve as guardrails in the context of virtual supervision; however, the commenters provided no specific description of any such policies or any other evidence to further identify those guardrails. Without further information, CMS cannot opine on the sufficiency of ACGME or other accrediting organization policies. Therefore, we continue to rely on the clinical judgment of teaching physicians and the residents they involve in their care to ensure appropriate patient safety.

iii. Virtual Teaching Physician Presence During Medicare Telehealth Services

In the March 31st COVID-19 IFC (85 FR 19230), we adopted a policy on an interim basis to allow Medicare to make payment under the PFS for teaching physician services when a resident furnishes Medicare telehealth services to beneficiaries while a teaching physician is present using audio/video real-time communications technology. We also noted that we were considering whether this policy should be extended on a temporary basis (that is, if the PHE for COVID-19 ends in 2021, this policy could be extended to December 31, 2021, to allow for a transition period before reverting to status quo policy) or be made permanent, and solicited public comments on whether this policy should continue once the PHE for COVID-19 ends. We noted that the public comments would assist us in identifying appropriate policy continuation decisions that we would consider finalizing in the CY 2021 PFS final rule. Outside the circumstances of the PHE for COVID-19, under the requirements at section 1834(m) of the Act that discuss payment for telehealth services, the patient would be located at a telehealth originating site, and the teaching physician would be furnishing the service as the distant site practitioner with the involvement of the resident.

While teaching physician presence through audio/video real-time communications technology when a resident furnishes Medicare telehealth services was responsive to critical needs during the PHE for COVID-19 to reduce exposure risk and to increase the capacity of teaching settings to respond to COVID-19, we expressed concern that the policy to permit virtual presence of the teaching physician may not allow for sufficient personal and identifiable physicians' services to exercise full, personal control over the services such that PFS payment to the teaching physician would be appropriate outside the circumstances of the PHE for COVID-19 on a temporary or permanent basis. We also noted concern that if the resident was furnishing the service at the distant site and the teaching physician was at a third site and present with the resident through audio/video real-time communications technology, the teaching physician may not be able to render sufficient personal and identifiable physicians' services to the patient to exercise full, personal control over the service to warrant separate payment on the PFS.

Absent the need to reduce exposure risk to COVID-19 during the PHE, we also expressed some concerns about patient safety when the teaching physician is present only virtually during a telehealth service furnished by a resident. For example, the virtual connection between the teaching physician and the resident who is with the patient could be disrupted (as with any virtual supervision scenario), rendering it impossible for the teaching physician to provide necessary direction for the resident to furnish appropriate care to the patient, thus foreclosing the ability of the teaching physician to exercise full, personal control over the key portion of the service, and potentially putting the patient's safety at risk.

However, because COVID-19 may continue to persist in some communities and some communities may experience a resurgence of COVID-19 after the expiration of the PHE for COVID-19, we solicited comments about whether it would be appropriate to extend this policy on a temporary basis until the end of the calendar year in which the PHE for COVID-19 ends. The presence of COVID-19 may result in a need to continue to limit exposure risks. In cases where the teaching physician has been exposed to the virus and is under quarantine, termination of the policy to permit virtual presence of the teaching physician could unintentionally limit the number of licensed practitioners available to furnish services to Medicare patients in some communities, and could have the unintended consequence of limiting access for Medicare patients. Finally, based on experience gained during the PHE for COVID-19, we noted that we might identify circumstances for which the teaching physician can routinely render sufficient personal and identifiable services to the patient to exercise full, personal control over the management of the key portion of the case while providing virtual presence during Medicare telehealth services furnished by a resident on a permanent basis. For example, under ordinary circumstances for the primary care exception at § 415.174, we permit PFS payment to the teaching physician when a resident furnishes office/outpatient E/M visit codes of lower and mid-level complexity and annual wellness visits without the presence of a teaching physician (these codes were discussed in section II.F. of the proposed rule (85 FR 50121)). For such services, we noted that it may be appropriate to continue the virtual presence policy on a temporary or permanent basis. We solicited comments to help us understand how the option to allow teaching physician presence using audio/video real-time communications technology could support patient safety for all patients and particularly for at-risk patients (for example, patients who are aged and/or who have a disability), ensure burden reduction without creating risks to patient care or increasing fraud, avoid duplicative payment between the PFS and the IPPS for GME programs, and support emergency preparedness. We also solicited comments to provide data and other information on experiences implementing this policy during the PHE for COVID-19.

We received public comments on whether the policy we adopted on an interim final basis during the PHE for COVID-19 to allow Medicare to make payment under the PFS to the teaching physician when a resident furnishes Medicare telehealth services to beneficiaries while a teaching physician is present using audio/video real-time communications technology should continue once the PHE for COVID-19 ends. The following is a summary of the comments we received and our responses.

Comment: Commenters were generally supportive of our interim policy to allow Medicare to make payment under the PFS to the teaching physician when a resident furnishes Medicare telehealth services to beneficiaries while a teaching physician Start Printed Page 84582is present using audio/video real-time communications technology. Several commenters supported extending the flexibility permanently, while others recommended temporarily extending the policy through the end of the PHE for COVID-19, and cited a need to gather data regarding patient safety and potential impacts on resident training outside the context of the PHE for COVID-19. One commenter stated that in rural settings, it was not always possible for the teaching physician to accompany a resident while also being present to other residents. This commenter stated that the ability for the teaching physician is virtually present has increased patient access to physicians' services in rural areas. Similarly, other commenters stated that the permanent ability for teaching physicians to be virtually present when not physically present could increase training opportunities for rural training programs, and better prepare residents for the nuances and differences of providing care over video instead of in person.

Response: We appreciate commenters' support of our interim policy to allow Medicare to make payment under the PFS for teaching physician services when a resident furnishes Medicare telehealth services to beneficiaries while a teaching physician is present using interactive, audio/video real-time communications technology (excluding audio-only). We remain concerned that, absent the circumstances of the PHE, a teaching physician's presence via interactive, audio/video real-time communications technology (excluding audio-only) when a resident is furnishing Medicare telehealth services may not allow the teaching physician to render 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, in accordance with section 1842(b)(7)(A)(i)(I) of the Act, in most settings. For rural areas, however, we found compelling the commenters' statements that our virtual presence policy has increased access to Medicare-covered services. Accordingly, we believe that a policy to permit Medicare to make PFS payment for teaching physician services when a resident located within a rural training setting furnishes Medicare telehealth services to beneficiaries while a teaching physician is present through interactive, audio/video real-time communications technology (excluding audio-only) could increase access to Medicare-covered services in rural areas by preventing the beneficiary from potentially having to travel long distances to obtain care, particularly as rural areas have stretched and diminishing clinical workforces.[14] Increasing beneficiary access to care in rural areas is also consistent with our longstanding interest in increasing beneficiary access to Medicare-covered services in rural areas; therefore, in order to allow for more widespread access to care for beneficiaries in rural areas, we believe it would be appropriate for a resident located within a rural training setting to furnish telehealth services to a beneficiary who is in a separate location within the same rural area as the resident or within a different rural area, while a teaching physician is present, through interactive, audio/video real-time communications technology (excluding audio-only), in a third location, either within the same rural training setting as the resident or outside of that rural training setting.[15] Further, allowing Medicare to make PFS payment for teaching services when a resident furnishes Medicare telehealth services to a beneficiary while a teaching physician is present through interactive, audio/video real-time communications technology (excluding audio-only) could facilitate additional training opportunities for residents in rural settings, which have historically been in limited supply.[16] As such, the need to improve rural access to care for patients and training for residents overshadows our concerns about the ability for the teaching physician to render 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. Accordingly, in rural areas, we believe it would be appropriate to continue our policy to permit teaching physicians to meet the requirements to bill under the PFS for their services when a resident furnishes Medicare telehealth services to beneficiaries while a teaching physician is present through interactive, audio/video real-time communications technology (excluding audio-only) after the conclusion of the PHE for COVID-19. This policy not only furthers our goals to increase beneficiary access to Medicare-covered services, it also facilitates needed training opportunities in a similar way to the longstanding primary care exception under § 415.174. The primary care exception permits the teaching physician to bill for certain types of physicians' services furnished by residents in certain settings even when the teaching physician is not present with the resident. Like the policy we are finalizing in this rule, the primary care exception facilitates access to Medicare-covered services and expanded residency training opportunities in primary care settings. Therefore, we are permanently finalizing our policy that Medicare may make payment under the PFS for teaching physician services when a resident furnishes Medicare telehealth services in a residency training site located outside of a MSA to a beneficiary who is in a separate location outside the same MSA (that is, in the same rural area) as the residency training site or is within a rural area outside of a different MSA, while a teaching physician is present, through interactive, audio/video real-time communications technology (excluding audio-only), in a third location, either within the same rural training site as the resident or outside of that rural training site. In order to ensure that the teaching 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 the payment is sought, in accordance with section 1842(b)(7)(A)(i)(I) of the Act, we are clarifying our existing documentation requirements to specify that, when a resident furnishes Medicare telehealth services in a residency training site located outside of a MSA and the teaching physician is present using interactive, audio/video real-time communications technology (excluding audio-only), the patient's medical record must clearly reflect how and when the teaching physician was present during the key portion of the service, in accordance with our regulations. For example, in the medical record, the teaching physician could document their physical or virtual presence at the training site during the key portion of the service, along with a notation describing the specific portion(s) of the service for which the teaching physician was virtually present, and/or that the teaching physician reviewed the service with the resident during or immediately after the service in accordance with the primary Start Printed Page 84583care exception under § 415.174. We also expect that, if the teaching physician is virtually present and bills for services during which there is a disruption to the virtual connection between the teaching physician and the resident who is with the patient, the encounter would be paused until the connection resumes, or the appointment would be rescheduled.

For all other settings, we are not permanently finalizing this policy; however, the policy will remain in place for the duration of the PHE for COVID-19 to provide flexibility for communities that may experience resurgences in COVID-19 infections. While we do not anticipate any program integrity concerns from this expanded flexibility, we agree with commenters that it is necessary for us to consider additional data prior to proposing additional policies in this area, which could range from expanding this flexibility to include non-rural settings to terminating this flexibility in all settings. Specifically, we anticipate considering to what degree the permanent implementation of the policy to allow PFS payment for teaching services when a teaching physician is virtually present while a resident furnishes Medicare telehealth services in a residency training site located outside of an MSA increased patient access to Medicare-covered services and provided more training opportunities for residents while enabling the teaching physician to render sufficient personal and identifiable physicians' services. We may use such information, obtained through, for example, a commissioned study, analysis of Medicare claims data or another assessment mechanism, to further study the impacts of this limited permanent expansion of the policy to allow PFS payment for teaching services when a teaching physician is virtually present while a resident furnishes Medicare telehealth services to inform potential future rulemaking, and in an effort to prevent possible fraud, waste and abuse.

We are amending our regulations to reflect this final policy. In § 415.172(a), we are adding language to state that, in a residency training site located outside of an MSA, a teaching physician may bill under the PFS for services furnished when they are present with the resident during the key portion of the service through interactive, audio/video real-time communications technology (excluding audio-only), including when the resident provides Medicare telehealth services. We are also adding language to state that, for all teaching settings and for the duration of the PHE for COVID-19, payment under the PFS is permitted if a teaching physician is present during the key portion of the service, including Medicare telehealth services, through interactive, audio/video real-time communications technology (excluding audio-only). In § 415.172(b), which discusses existing documentation requirements, we are adding language to clarify that, for residency training sites that are located outside of a MSA, the patient's medical record must clearly reflect whether the teaching physician was physically or virtually present at the training site during the key portion of the service, including for Medicare telehealth services. We are also adding language to clarify that, for all teaching settings and for the duration of the PHE for COVID-19, the patient's medical record must clearly reflect whether the teaching physician was physically or virtually present during the key portion of the service, including for Medicare telehealth services. Finally, we are adding language to clarify that the medical records must contain a notation describing the specific portion(s) of the service, including Medicare telehealth services, for which the teaching physician was present through interactive, audio/video real-time communications technology (excluding audio-only).

While difficult to quantify, we believe that permanently extending our policy to allow payment under the PFS for teaching physician services when a resident furnishes Medicare telehealth services in a residency training site located outside of an MSA and the teaching physician is present through interactive audio/video real-time communications technology (excluding audio-only) will promote enhanced patient access to Medicare-covered physicians' services in rural areas. In addition, allowing PFS payment for teaching physician services when a resident furnishes Medicare telehealth services in a residency training site located outside of an MSA and the teaching physician is present through interactive audio/video real-time communications technology (excluding audio-only) will improve teaching capabilities and potentially allow for additional resident education opportunities in rural areas. Settings that have traditionally been inaccessible as training sites for residents due to the limited ability of teaching physicians to be physically present will be more readily available, thereby affording increased access to physicians' services to patients in these areas. However, in order to ensure that the limited extension of this policy is also consistent with section 1842(b)(7)(A)(i)(I) of the Act, we are clarifying the existint documentation requirements to specify that the medical record must clearly reflect how and when the teaching physician was present for the Medicare telehealth service. We believe this documentation clarification will ensure that the teaching 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. Further, in order to minimize potential risks to patients, we remind physicians and other practitioners that the adoption of this policy in residency training sites that are located outside of an MSA does not preclude teaching physicians from being physically present when a resident is furnishing Medicare telehealth services. We therefore urge teaching physicians to continue to use their professional judgment to determine the circumstances under which it is appropriate to be present virtually rather than in person, depending on the Medicare telehealth services being furnished and the experience of the particular residents involved.

Comment: One commenter, who favored a permanent policy to allow PFS payment for teaching physician services when a resident furnishes Medicare telehealth services in a residency training site located outside of a MSA and the teaching physician is present using interactive audio/video real-time communications technology, advocated for the permanent extension of the policy by noting that ACGME recognizes and endorses an expansion of telemedicine as well as the use of audio/visual communications devices by residents and their teaching physicians. Further, the commenter stated that, as long as the virtual presence of teaching physicians during Medicare telehealth services continues to adhere to ACGME standards, an optimal learning environment, with appropriate education and supervision, would be maintained.

Response: We appreciate the commenter's feedback regarding ACGME standards in the context of the expansion of telemedicine and the use of audio/visual communication devices by residents and teaching physicians; however, the commenter provided no specific description of ACGME's standards or any evidence to support a permanent implementation of the policy to allow PFS payment for teaching services when a resident furnishes Medicare telehealth services in all settings when a teaching physician is present through interactive, audio/video Start Printed Page 84584real-time communications technology (excluding audio-only). Without further information, CMS cannot opine on whether or not ACGME's standards would support a wider permanent implementation of this policy. Therefore, we continue to rely on the clinical judgment of teaching physicians and the residents they involve in their care to ensure appropriate patient safety.

iv. Resident Moonlighting in the Inpatient Setting

Under certain conditions, the services of a licensed resident physician who is “moonlighting” are considered to be furnished by the individual in their capacity as a physician, rather than as a resident in an approved GME program. As specified in the regulation at § 415.208, except during the PHE for COVID-19, as defined in the regulation at § 400.200, the services of residents to inpatients of hospitals in which the residents have their approved GME program are not considered separately billable as physicians' services and instead are payable under §§ 413.75 through 413.83 regarding direct GME payments, whether or not the services are related to the approved GME training program. When a resident furnishes services that are not related to their approved GME programs in an outpatient department or emergency department of a hospital in which they have their training program, those services can be billed separately as physicians' services and payable under the PFS if they meet the criteria described in our regulation at § 415.208(b)(2)(i) through (iii). In addition, under § 415.208(c), services of a licensed resident furnished outside the scope of an approved GME program when moonlighting in a hospital or other setting that does not participate in the approved GME program are payable under the PFS when the resident is fully licensed to practice in the state where the services are furnished, and the resident's time spent in patient care activities in that setting is not counted for the purpose of Medicare direct GME payments.

In the March 31st COVID-19 IFC, we amended our regulation at § 415.208 to state that, during the PHE for COVID-19, the services of residents that are not related to their approved GME programs and are furnished to inpatients of a hospital in which they have their training program are separately billable physicians' services for which payment can be made under the PFS provided that the services are identifiable physicians' services and meet the conditions for payment of physicians' services to beneficiaries by providers in § 415.102(a), the resident is fully licensed to practice medicine, osteopathy, dentistry, or podiatry by the state in which the services are performed, and the services can be separately identified from those services that are required as part of the approved GME program. We considered whether this flexibility that we implemented on an interim basis should be extended on a temporary basis (that is, if the PHE for COVID-19 ends in 2021, these policies could be extended to December 31, 2021, to allow for a transition period before reverting to status quo policy) or be made permanent, and solicited public comments on whether this policy should continue once the PHE ends. We expressed concerns that there may be risks to program integrity in allowing residents to furnish separately billable physicians' services to inpatients in the teaching hospitals where they are training when the services are outside the scope of their approved GME program. For example, there could be a risk of duplicate Medicare payment for the resident's services under the IPPS for GME and the PFS if the physicians' services furnished by residents were not adequately separately identified from those services that are required as part of the GME program. However, because COVID-19 may continue to persist in some communities or some communities may experience a resurgence of COVID-19 after the expiration of the PHE, we noted that it may be appropriate for us to extend this policy on a temporary basis to meet the needs of teaching hospitals to ensure that there are as many qualified practitioners available as possible. We noted that the public comments would assist us in identifying appropriate policy continuation decisions that we would consider finalizing in this CY 2021 PFS final rule. We also solicited comments to provide data and other information on experiences implementing this policy during the PHE for COVID-19.

We received public comments from our comment solicitation in the proposed rule regarding whether our resident moonlighting policy under § 415.208 that we implemented on an interim basis for the PHE for COVID-19 should continue once the PHE ends. The following is a summary of the comments we received and our responses.

Comment: Commenters were generally supportive of the policy under § 415.208 that we adopted on an interim basis during the PHE for COVID-19. Several commenters supported extending the flexibility permanently, while others recommended temporarily extending the policy through the end of the PHE for COVID-19, and cited a need to maintain surge capacity and to allow more data to be gathered regarding patient safety and potential impacts on resident training outside the context of the PHE. A few commenters suggested that to prevent duplicate billing, CMS should educate practitioners about the need for sufficient documentation to demonstrate that services furnished while residents are moonlighting are separate from those services that are required as part of approved GME programs.

Response: We appreciate commenters' support for our interim policy. After considering the comments, we are finalizing our interim policy for the services of moonlighting residents on a permanent basis. Consequently, we are amending our regulation at § 415.208(b)(2) to state that the services of residents that are not related to their approved GME programs and are performed in the outpatient department, emergency department, or inpatient setting of a hospital in which they have their training program are separately billable physicians' services for which payment can be made under the PFS provided that the services are identifiable physicians' services and meet the conditions of payment for physicians' services to beneficiaries in providers in § 415.102(a), the resident is fully licensed to practice medicine, osteopathy, dentistry, or podiatry by the State in which the services are performed, and the services are not performed as part of the approved GME program.

We agree with commenters about the need for sufficient documentation to allay concerns about potential duplication of payment with the IPPS for GME. Thus, we are also amending § 415.208(b)(2) to clarify that, regardless of whether the resident's services are performed in the outpatient department, emergency department or inpatient setting of a hospital in which they have their training program, the patient's medical record must clearly reflect that the resident furnished identifiable physician services that meet the conditions of payment of physician services to beneficiaries in providers in § 415.102(a), that the resident is fully licensed to practice medicine, osteopathy, dentistry, or podiatry by the State in which the services are performed, and that the services are not performed as part of the approved GME program. For example, in the medical record, the resident could state that they are licensed to practice medicine, osteopathy, dentistry or podiatry by the Start Printed Page 84585state in which the service was performed, document that the service was performed outside of their approved GME program, and include a notation describing the specific physician service that was furnished,

v. Primary Care Exception Policies

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 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. 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.

As provided in the regulation at § 415.174(a), the codes of lower and mid-level complexity that can be furnished under the primary care exception are specified in section 100 of chapter 12 of the Medicare Claims Processing Manual (https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Manuals/​Downloads/​clm104c12.pdf). They are the following:

  • CPT code 99201 (Office or other outpatient visit for the evaluation and management of a new patient, which requires 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);
  • CPT code 99202 (Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: An expanded problem focused history; An expanded 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 of low to moderate severity. Typically, 20 minutes are spent face-to-face with the patient and/or family);
  • CPT code 99203 (Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: A detailed history; A detailed examination; Medical decision making 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 presenting problem(s) are of moderate severity. Typically, 30 minutes are spent face-to-face with the patient and/or family);
  • CPT code 99211 (Office or other outpatient visit for the evaluation and management of an established patient, that may not require the presence of a physician or other qualified health care professional. Usually, the presenting problem(s) are minimal. Typically, 5 minutes are spent performing or supervising these services);
  • 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);
  • 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);
  • HCPCS code G0402 (Initial preventive physical examination; face-to-face visit, services limited to new beneficiary during the first 12 months of Medicare enrollment);
  • HCPCS code G0438 (Annual wellness visit; includes a personalized prevention plan of service (PPS), initial visit); and
  • HCPCS code G0439 (Annual wellness visit, includes a personalized prevention plan of service (PPS), subsequent visit).

In the March 31st COVID-19 IFC, we amended § 415.174 of our regulations to allow, during the PHE for COVID-19, all levels of office/outpatient E/M visits to be furnished by the resident and billed by the teaching physician under the primary care exception. In the May 8th COVID-19 IFC), we further expanded the list of services included in the primary care exception during the PHE for COVID-19. We also allowed PFS payment to the teaching physician for services furnished by residents via telehealth under the primary care exception if the services were also on the list of Medicare telehealth services.

We noted that we were considering whether these policies should be extended on a temporary basis (that is, if the PHE for COVID-19 ends in 2021, these policies could be extended to December 31, 2021, to allow for a transition period before reverting to status quo policy) or be made permanent, and solicited public comments on whether these policies should continue once the PHE for COVID-19 ends. We also noted that the public comments would assist us in identifying appropriate policy continuation decisions that we would consider finalizing in the CY 2021 PFS final rule. We also considered whether specific services added under the primary care exception should be extended temporarily or made permanent and solicited public comments on whether these services should continue as part of the primary care exception once the PHE for COVID-19 ends. These services are the following:

  • CPT code 99204 (Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; Medical decision making of moderate complexity. Counseling and/or Start Printed Page 84586coordination 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 moderate to high severity. Typically, 45 minutes are spent face-to-face with the patient and/or family);
  • CPT code 99205 (Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; Medical decision making of high 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 presenting problem(s) are of moderate to high severity. Typically, 60 minutes are spent face-to-face with the patient and/or family);
  • CPT code 99214 (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 detailed history; A detailed 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 presenting problem(s) are of moderate to high severity. Typically, 25 minutes are spent face-to-face with the patient and/or family);
  • CPT code 99215 (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 comprehensive history; A comprehensive examination; Medical decision making of high 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 presenting problem(s) are of moderate to high severity. Typically, 40 minutes are spent face-to-face with the patient and/or family);
  • CPT code 99495 (Transitional Care Management services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within two business days of discharge; medical decision making of at least moderate complexity during the service period; face-to-face visit within 14 calendar days of discharge);
  • CPT code 99496 (Transitional Care Management services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within two business days of discharge; medical decision making of at least high complexity during the service period; face-to-face visit within 7 calendar days of discharge);
  • CPT code 99421 (Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 5-10 minutes);
  • CPT code 99422 (Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 11-20 minutes);
  • CPT code 99423 (Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 21 or more minutes);
  • CPT code 99452 (Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or qualified health care professional, 30 minutes);
  • 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); and
  • HCPCS code G2010 (Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, 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).

We noted that expanding the array of services for which Medicare may make PFS payment to the teaching physician when furnished by a resident under the primary care exception was responsive to critical needs during the PHE for COVID-19 for patients who may be quarantined at home or who may need to be isolated for purposes of minimizing exposure risk based on presumed or confirmed COVID-19 infection. Because COVID-19 may continue to persist in some communities or some communities may experience a resurgence of COVID-19 after the expiration of the PHE for COVID-19, we also noted that it may be appropriate for us to extend all of these services on a temporary basis (that is, until the end of the calendar year in which the PHE for COVID-19 ends).

However, we expressed concern that it may be inappropriate to extend all of these services on a temporary basis or add them to the primary care exception permanently. 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. While CPT code 99421 and HCPCS code G2012 may be simple services, others such as levels 4 and 5 office/outpatient E/M visits (CPT codes 99204 through 99205 and CPT codes 99214 through 99215) and transitional care management codes (CPT codes 99495 through 99496) require medical decision-making that is of at least moderate complexity. We also noted 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. Thus, we considered whether, upon expiration of the PHE for COVID-19, we should extend on a temporary basis some or all of the services we added to the primary care exception list during the PHE and solicited public comments on whether these services should continue as part of the primary care exception after the PHE ends. We also solicited comments to provide data and other information on experiences implementing this policy during the PHE for COVID-19.

We also considered whether our interim policy that PFS payment could be made to the teaching physician when residents furnish telehealth services under the primary care exception should be extended on a temporary basis or be made permanent, and solicited public comments on whether this policy should continue once the Start Printed Page 84587PHE for COVID-19 ends. In these cases, outside the circumstances of the PHE for COVID-19, the patient would be at the originating site and the resident furnishing the care, along with the teaching physician billing for it, would be located at the primary care center as the distant site practitioner. If we were to temporarily extend or add permanently to the primary care exception services such as e-visits or communication technology-based services, we noted that it may also make sense to permit PFS payment to the teaching physician when the resident furnishes an office/outpatient E/M visit via telehealth, on the basis that the patient is not physically in the clinic and that these services all involve the use of virtual technology (for example, patient portals for e-visits, telecommunications technology for the office/outpatient E/M visit) to facilitate care delivery. Further, we noted that, if we were to remove the services that we added to the primary care exception on an interim basis, we could separately consider continuing to permit PFS payment to the teaching physician when the resident furnishes an office/outpatient E/M visit via telehealth because the teaching physician would be immediately available in the distant site clinic with the resident to direct and manage the care.

We received public comments on the primary care exception policies. The following is a summary of the comments we received and our responses.

Comment: Commenters were generally supportive of the policy adopted on an interim basis under § 415.174 to allow Medicare to make payment to the teaching physician for additional services under the primary care exception, including all levels of office and outpatient E/M, audio-only telephone E/M services, transitional care management, and communication technology-based services. Commenters were also generally supportive of our interim policy to allow Medicare to make payment under the PFS to the teaching physician for services furnished by residents via telehealth under the primary care exception if the services are on the list of Medicare telehealth services. These commenters stated that in general, the expansion of the primary care exception increases beneficiary access to Medicare-covered services and provides additional training opportunities for residents, particularly in rural areas.

Several commenters supported making permanent all the services that we implemented on an interim basis during the PHE for COVID-19. Several other commenters supported making certain services permanent, stating that services such as communication technology-based services (for example, CPT codes 99421-99423 and HCPCS codes G2010 and G2012) were simple, require low to moderate complexity medical decision-making, and do not involve a diagnostic complexity that is beyond a resident's skill. In addition, some commenters supported the permanent inclusion of CPT code 99452 and stated that in some models of care, these inter-professional consults are typically initiated by a primary care practitioner to a specialist for a low acuity, condition-specific question that can be answered without an in-person visit.

Some commenters supported the permanent inclusion of CPT codes 99204 and 99214, while other commenters did not. Commenters in support of including these codes stated that office/outpatient level 4 visits are typical visit for the Medicare population and that these visits do not involve a level of diagnostic complexity that is beyond a resident's skill. Other commenters stated that office/outpatient level 4 visits should be furnished with the teaching physician present, either physically or through interactive audio/video real-time communications technology. These commenters were concerned that allowing office/outpatient level 4 visits to be furnished without the presence of the teaching physician could pose risks to patient safety and potential for abuse.

Some commenters did not support the permanent inclusion of high-complexity services, including office/outpatient level 5 visits (CPT codes 99205 and 99215) and transitional care management (CPT code 99496), due to the high level of medical complexity, patient safety concerns, and potential for abuse.

Several commenters recommended temporarily extending the primary care exception policies through the end of the PHE for COVID-19 and cited a need to gather data regarding patient safety and potential impacts on resident training outside the context of the PHE. Other commenters stated that the expansion of the primary care exception has allowed residents to be trained based on “real life,” which will leave them better prepared to furnish additional services upon completion of their residency programs.

Response: We appreciate commenters' support of our interim policy to allow Medicare to make payment to the teaching physician when the resident furnishes an expanded array of services under the primary care exception. We remain concerned that permanently adding all of the proposed services to the primary care exception may be inappropriate because some of the services require at least a moderate level of medical decision-making, whereas 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 for 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. We also remain concerned 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. However, we found the comments regarding the advantages of an expansion of services under the primary care exception in rural areas particularly compelling. Specifically, allowing PFS payment for additional primary care services furnished by residents without the physical presence of a teaching physician in rural areas could increase the availability of Medicare-covered services, which is consistent with our longstanding interest in increasing beneficiary access to Medicare-covered services in rural areas[17] . For example, permitting PFS payment to the teaching physician when the resident furnishes communication-technology based services, an inter-professional consultation, or an office/outpatient visit via telehealth without a teaching physician present could prevent the beneficiary from potentially having to travel long distances to obtain care. Accordingly, we believe that permitting Medicare to make PFS payment to the teaching physician when the resident furnishes an expanded array of services under the primary care exception in rural settings could increase access to Medicare-covered services. Further, this policy could also provide the benefit of additional training opportunities for residents in rural settings, which have historically been in limited supply. As such, the need to improve rural access to care for patients and training for resident overshadows our concerns 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 Start Printed Page 84588some or all of the residents might be furnishing services that are more than lower and mid-level complexity. Accordingly, we are finalizing, for residency training sites that are located outside of a MSA, a policy to allow Medicare to make payment to the teaching physician when the resident furnishes an expanded array of services under the primary care exception. However, in accordance with the original intent of the primary care exception to limit the scope of services to those of lower and mid-level complexity, we are limiting the permanent expanded array of services under the primary care exception to include communication-technology based services and inter-professional consults. These services are described by CPT codes 99421-99423, and 99452, and HCPCS codes G2010 and G2012. We are also adding to the primary care exception, for residency training sites that are located outside of an MSA, Medicare telehealth services that furnished by residents. Based on the descriptors, these codes all represent E/M services of a low-to-mid-level complexity, which is consistent with our regulations in § 415.174.

As noted above, some commenters supported adding office/outpatient E/M level 4 visits (CPT codes 99204 and 99214) to the primary care exception. While we included these services in the exception during the PHE to meet the needs of all teaching settings to ensure that there are as many qualified practitioners available as possible, we agree with the commenters who stated that it is inappropriate to allow these services to be billed by the teaching physician when furnished by residents without the presence of a teaching physician on a permanent basis because these services involve medical decision-making of at least a moderate level of complexity, so the ability for the teaching physician to be immediately available to other residents could be compromised. Thus, we agree with the commenters who stated that adding office/outpatient E/M level 4 visits to the primary care exception could pose risks to patient safety. We also believe that, because the transitional care management codes require medical decision-making of at least moderate complexity, the ability for the teaching physician to be immediately available to other residents could be compromised.

This policy to limit the expanded array of services permitted to be furnished under the primary exception only to those services furnished in residency training sites that are located outside of a MSA is consistent with other teaching physician payment policies regarding virtual presence and telehealth that we are finalizing as described earlier in this final rule, and which were also similarly limited to residency training sites that are located outside of a MSA. However, practitioners are reminded that the permanent extension of the expanded primary care exception in residency training sites that are located outside of a MSA does not preclude teaching physicians from being physically present when a resident is furnishing these primary care services. We therefore urge teaching physicians to continue to use their professional judgment to determine the circumstances under which it is appropriate for residents to perform these services without the presence of the teaching physician, depending on the Medicare service being furnished and the experience of the particular resident involved.

For all other settings, we are not finalizing a policy to allow Medicare to make payment to the teaching physician when the resident furnishes an expanded array of services under the primary care exception, including when those services are furnished under Medicare telehealth; however, the interim policy to include an expanded set of services under the primary care exception will remain in place for the duration of the PHE for COVID-19 to provide flexibility for communities that may experience resurgences in COVID-19 infections. Accordingly, at the end of the PHE, we will be terminating the inclusion of CPT codes 99204, 99214, 99205, 99215, 99495 and 99496 from the primary care exception for all settings.

While we do not anticipate any program integrity concerns to arise from the final policy to expand the services that may be furnished under the primary care exception in rural settings, we also agree with commenters that it is necessary for us to consider additional data prior to proposing additional policies in this area, which could range from expanding this flexibility to include non-rural settings to terminating this flexibility in all settings. Specifically, anticipate considering to what degree the permanent establishment of the policy to allow PFS payment to teaching physicians when the resident furnishes an expanded array of services under the primary care exception in residency training sites that are located outside of an MSA increased patient access to care and provided more training opportunities for residents while enabling the teaching physician to remain immediately available. We may use such information, obtained through, for example, a commissioned study, analysis of Medicare claims data or another assessment mechanism, to further study the impacts of this limited permanent expansion of the policy to allow PFS payment to teaching physicians when the resident furnishes an expanded array of services under the primary care exception in residency training sites of a teaching setting that are outside of an MSA to inform potential future rulemaking, and in an effort to prevent possible fraud, waste and abuse.

Comment: One commenter requested clarification that when teaching physicians meet all of the requirements of the primary care exception, they are also able to provide direction and immediate availability thru virtual presence for moderate to high complexity encounters, such CPT codes 99204, 99205, 99214, and 99215.

Response: Through the end of the PHE for COVID-19, a teaching physician that meets the requirements of the primary care exception described in § 415.174(c) to direct the care and then to review the services furnished by each resident during or immediately after each visit may be met through interactive, audio/video real-time communications technology (excluding audio-only). This policy applies for moderate to high complexity encounters, including all levels of office/outpatient services. Once the PHE for COVID-19 ends, in accordance with the final policy to allow PFS payment to teaching physicians when the resident furnishes an expanded array of services under the primary care exception in residency training sites that are located outside of an MSA, a teaching physician may meet the requirements of the primary care exception described in § 415.174 to direct the care and then to review the services furnished by each resident during or immediately after each visit through interactive, audio/video real-time communications technology (excluding audio-only) when residents furnish services that we are including under the primary care exception, as described above. We believe that establishing this policy for residency training sites that are located outside of an MSA is consistent with the expansion of services that are permitted under the primary care exception in residency training sites that are located outside of an MSA, and that similarly, this policy will also increase beneficiary access to Medicare-covered primary care services and provide additional training opportunities for residents in settings to which there has previously been limited access. However, as noted above, the Start Printed Page 84589services we are permanently including under the primary care exception in residency training sites that are located outside of an MSA do not include codes 99204, 99214, 99205, 99215, 99495 and 99496 because these services are of moderate to high complexity, and we believe it is inappropriate to allow these services to be furnished by residents without the presence of a teaching physician.

We are amending our regulations to reflect this final policy. In § 415.174, we are adding a new paragraph (d) to state that, in residency training sites that are located outside of an MSA, a teaching physician that meets the requirements of the primary care exception described in § 415.174 may meet the requirement to direct the care and then to review the services furnished by each resident during or immediately after each visit through interactive, audio/video real-time communications technology (excluding audio-only) when residents furnish services that are included under the primary care exception associated with these sites.

Comment: One commenter requested clarification that office/outpatient E/M services furnished by residents under the primary care exception described in § 415.174 may be billed on the basis of time, and also requested confirmation that, under the primary care exception, the teaching physician need not be present with the resident for the period of time billed.

Response: In the May 8th COVID-19 IFC, we stated that, consistent with policy that we established in the March 31st COVID-19 IFC for selecting the level of office/outpatient E/M visits when furnished as Medicare telehealth services, (85 FR 19268 through 19269), the office/outpatient E/M level selection for services under the primary care exception when furnished via telehealth can be based on medical decision-making or time, with time defined as all of the time associated with the E/M on the day of the encounter; and the requirements regarding documentation of history and/or physical exam in the medical record do not apply. As described in section II.Z. of the May 8th COVID-19 IFC, the typical times for purposes of level selection for an office/outpatient E/M are the times listed in the CPT code descriptor.

vi. Conclusion

In summary, we reminded stakeholders that during the PHE for COVID-19 we implemented these policies on an interim basis to support our goals of ensuring beneficiary access to necessary services and maintenance of sufficient workforce capacity by offering flexibility to practitioners. While we anticipated reverting to our previous teaching physician policy that was in place prior to the PHE for COVID-19 for the reasons discussed above, we considered whether the teaching physician and resident moonlighting policies that we implemented on an interim basis during the PHE for COVID-19 should be extended on a temporary basis (that is, if the PHE ends in 2021, these policies could be extended to December 31, 2021, to allow for a transition period before reverting to status quo policy) or be made permanent policy for CY 2021. As discussed above, we noted 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 or mid-level complexity. We also noted concern that when the teaching physician is directing the care of a patient that requires moderate or higher medical decision-making, their ability to be immediately available to other residents could be compromised, which can potentially put patients at risk. We noted that we would consider under which scenarios our policies for moonlighting or virtual presence as discussed above, should apply, if any. As discussed for our moonlighting policy, we expressed concern that there may be risks to program integrity in allowing residents to furnish separately billable physicians' services to inpatients in the teaching hospitals where they are training when the services are outside the scope of their approved GME program. For example, there could be a risk of duplicate Medicare payment for the resident's services under the IPPS for GME and the PFS if the physicians' services furnished by residents were not adequately separately identified from those services that are required as part of the GME program. Under our discussion of virtual presence, we highlighted concerns about how continuing to permit teaching physicians to be involved through their virtual presence may not be sufficient to warrant PFS payment to the teaching physician on a temporary or permanent basis. Absent the circumstances of the PHE for COVID-19, the physical, in-person presence of the teaching physician may be necessary to provide oversight to ensure that care furnished to Medicare beneficiaries is medically reasonable and necessary, and to ensure that the teaching physician renders sufficient personal services to exercise full, personal control of the key portion of the case. We also discussed concerns about patient safety when the teaching physician is only virtually present.

We noted that public comments, especially those that focused on the variables we identified regarding the specific services included on the primary care exception list, and clinical scenarios under which residents could moonlight or furnish certain types of services under the supervision of a teaching physician via virtual presence, would assist us in identifying the appropriate policy continuation decisions after the end of the PHE for COVID-19, which we would consider while drafting this CY 2021 PFS final rule. As part of our review of public comments, we would weigh and make decisions based on the potential benefits and risks associated with the potential temporary or permanent continuation, in whole or in part, of these policies. We noted that the benefits of continuation may include limiting COVID-19 exposure risk for practitioners and patients, increasing workforce capacity of teaching settings to respond to continuing effects following the PHE for COVID-19 as practitioners may be asked to assist with the response, and increasing access so that we do not unintentionally limit the number of licensed practitioners available to furnish services to Medicare beneficiaries. We noted that the risks may include the potential for duplicative payment with Medicare Part A reimbursement for GME training programs, the potential for increases to cost-sharing for Medicare beneficiaries that could result from additional Part B claims for services furnished by the teaching physician with the involvement of residents, and potential threats to patient safety.

Comment: Commenters were generally supportive of the teaching physician and resident moonlighting policies that we implemented on an interim basis during the PHE for COVID-19. Several commenters recommended that we finalize our policies and asserted that making these policies permanent would promote patient access to physicians' services, particularly in rural and underserved areas and could provide additional training opportunities for rural training programs. Other commenters recommended that we extend the policies on a temporary basis, to provide flexibility for communities that may experience resurgences in COVID-19 infections. In addition, these commenters cited a need to gather data regarding patient safety and potential Start Printed Page 84590impacts on resident training outside the context of the PHE before considering permanent implementation of the polices.

Response: We appreciate commenters' support of the teaching physician and resident moonlighting policies that we implemented on an interim basis during the PHE for COVID-19. As we reviewed these comments, we considered the benefits and risks of finalizing the proposals. After considering the comments, we are finalizing our virtual presence and primary care exception policies for residency training sites that are located outside of an MSA. We are finalizing our resident moonlighting policies for all inpatient teaching settings.

We found compelling the comments regarding the benefits of the virtual presence and primary care exception policies in rural settings. Accordingly, we believe that permitting the teaching physician to meet the requirements to bill under the PFS for their services through virtual presence when furnishing services involving residents in rural training settings, and allowing PFS payment for additional primary care services furnished by residents without the physical presence of a teaching physician in rural areas could increase access to Medicare-covered services by preventing the beneficiary from potentially having to travel long distances to obtain care, particularly as rural areas have stretched and diminishing clinical workforces.[18] Increasing beneficiary access to care in rural areas is also consistent with our longstanding interest in increasing beneficiary access to Medicare-covered services in rural areas.[19] Further, these policies could provide the benefit of additional training opportunities for residents in rural settings, which have historically been in limited supply.[20] As such, the need to improve rural access to care for patients and training for residents overshadows our aforementioned concerns about the teaching physician's ability to render sufficient personal and identifiable physicians' services through virtual presence, or 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. Accordingly, we believe it would be appropriate to continue these policies in rural settings after the conclusion of the PHE for COVID-19. These policies not only further our goal to increase beneficiary access to Medicare-covered services, they also facilitate needed training opportunities is similar to the rationale for the existing primary care exception under § 415.174. The primary care exception permits the teaching physician to bill for certain types of physicians' services furnished by residents in certain settings even when the teaching physician is not present with the resident. Like the policies we are finalizing in this rule, the primary care exception facilitates access to Medicare-covered services and expanded residency training opportunities in primary care settings. Therefore, we are finalizing our virtual presence and primary care exception policies for residency training sites that are located outside of an OMB-defined MSA. In addition, in order to ensure that the teaching 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 the payment is sought in accordance with section 1842(b)(7)(A)(i)(I) of the Act, we are clarifying existing documentation requirements to specify that the patient's medical record must clearly reflect how and when the teaching physician was present during the key portion of the service, in accordance with our regulations.

For our resident moonlighting policies, we believe that complete documentation in the medical record would guard against the risk of potential duplicative payment with the IPPS. Consequently, we are clarifying that, regardless of whether the resident's services are performed in the outpatient department, emergency department or inpatient setting of a hospital in which they have their training program, the patient's medical record must clearly reflect that the resident furnished identifiable physician services that meet the conditions of payment of physician services to beneficiaries in providers in § 415.102(a), that the resident is fully licensed to practice medicine, osteopathy, dentistry, or podiatry by the State in which the services are performed, and that the services are not performed as part of the approved GME program.

For the virtual presence, primary care exception and resident moonlighting policies, while we do not anticipate any program integrity concerns, we agree with commenters that it is necessary for us to consider additional data prior to proposing additional policies in this area, which could range from expanding these flexibilities to include non-rural settings to terminating these flexibilities in all settings. Specifically, we anticipate considering to what degree the permanent establishment of these policies increased patient access to Medicare-covered services and provided additional training opportunities for residents while enabling the teaching physician to render sufficient personal and identifiable physicians' services. We may use such information, obtained through, for example, a commissioned study, analysis of Medicare claims data, or another assessment mechanism, to further study the impacts of these policies to inform potential future rulemaking, and in an effort to prevent possible fraud, waste and abuse.

2. Supervision of Diagnostic Tests by Certain NPPs

In response to E.O. 13890 discussed above, we sought assistance from stakeholders in identifying Medicare regulations that contain more restrictive supervision requirements than existing state scope of practice laws, or that limit health professionals from practicing at the top of their license. In response to our request for feedback discussed above, physician assistants (PAs) and nurse practitioners (NPs) recommended regulatory changes that would allow them to supervise the performance of diagnostic tests because they are currently authorized to do so under their state scope of practice rules in many states. In the May 8th COVID-19 IFC (85 FR 27550 through 27629), we established on an interim basis during the PHE for COVID-19, a policy to permit these and certain other NPPs to supervise diagnostic tests. In the CY 2021 PFS proposed rule, we proposed to make those changes permanent by making modifications to the regulations at § 410.32. We noted that we planned to address comments we received on the proposals from the CY 2021 PFS proposed rule and comments received on the May 8th COVID-19 IFC (85 FR 27550 through 27629) simultaneously in this final rule.

Prior to the PHE for COVID-19, under § 410.32(a)(2), physicians, NPs, CNSs, PAs, certified nurse-midwives (CNMs), clinical psychologists (CPs), and clinical social workers (CSWs) who are treating Start Printed Page 84591a beneficiary for a specific medical problem may order diagnostic tests when they use the results of the tests in the management of the beneficiary's specific medical problem. However, generally only physicians were permitted to supervise diagnostic tests. The regulation at § 410.32(b)(1) provided as a basic general rule that all diagnostic tests paid under the PFS must be furnished under an appropriate level of supervision by a physician as defined in section 1861(r) of the Act. Section 410.32(b)(2) then provided for certain exceptions to which this basic rule did not apply. For instance, under § 410.32(b)(2)(v), the requirement that diagnostic tests must be furnished under the appropriate level of supervision by a physician did not apply for tests performed by an NP or CNS authorized under applicable state law to furnish the test. (We noted that, as for all services furnished by a NP or CNS, they would have to be furnished working in collaboration with a physician as provided in regulations at §§ 410.75 and 410.76, respectively). Similarly, under the regulation at § 410.32(b)(2)(vii), the requirement that diagnostic tests must be furnished under the appropriate level of supervision by a physician did not apply for tests performed by a CNM authorized under applicable state law to furnish the test. This exception is in place because the Medicare statute does not include any physician supervision requirement for CNM services. Thus, while NPs, CNSs, PAs, and CNMs were permitted to furnish diagnostic tests to the extent they were authorized under state law and their scope of practice to do so, the regulations at § 410.32 did not address whether these practitioners could supervise others who furnished diagnostic tests.

In light of stakeholder feedback to CMS on identifying additional Medicare regulations that contain more restrictive supervision requirements than existing state scope of practice laws, or that limit health professionals from practicing at the top of their license, effective January 1, 2021, we proposed to amend the basic rule under the regulation at § 410.32(b)(1) to allow NPs, CNSs, PAs or CNMs to supervise diagnostic tests on a permanent basis as allowed by state law and scope of practice. These NPPs have separately enumerated benefit categories under Medicare law that permit them to furnish services that would be physician's services if furnished by a physician, and are authorized to receive payment under Medicare Part B for the professional services they furnish either directly or “incident to” their own professional services, to the extent authorized under state law and scope of practice.

We proposed to amend the regulation at § 410.32(b)(2)(iii)(B) on a permanent basis to specify that supervision of diagnostic psychological and neuropsychological testing services can be done by NPs, CNS's, PAs or CNMs to the extent that they are authorized to perform the tests under applicable State law and scope of practice, in addition to physicians and CPs who are currently authorized to supervise these tests. We also proposed to amend on a permanent basis, the regulation at § 410.32 to add paragraph (b)(2)(ix) to specify that diagnostic tests performed by a PA in accordance with their scope of practice and State law do not require the specified level of supervision assigned to individual tests, because the relationship of PAs with physicians as defined under § 410.74 would continue to apply. We also proposed to make permanent the removal of the parenthetical, previously made as part of the May 8th COVID-19 IFC (85 FR 27550 through 27629), at § 410.32(b)(3) that required a general level of physician supervision for diagnostic tests performed by a PA.

We received public comments on whether the policies we adopted on an interim basis during the PHE for COVID-19 under § 410.32 should continue once the PHE ends. The following is a summary of the comments we received and our responses.

Comment: We received many comments expressing appreciation for the flexibilities that we put in place for purposes of the PHE for COVID-19, allowing NPPs to supervise the performance of diagnostic tests and treat patients at the top of their scope of practice. Additionally, they encouraged CMS to make this flexibility permanent, beyond the COVID-19 pandemic.

Response: We appreciate the feedback from these commenters and plan to finalize these provisions as proposed, with modifications described below.

Comment: We received a comment that certified registered nurse anesthetists (CRNAs) should be listed among the delineated NPPs, explaining the value of their services within the health care system. The commenter noted that in the CY 2013 PFS final rule (77 FR 69006), CMS indicated Medicare coverage of CRNA services within their state scope of practice. The commenter stated that CRNAs have continuously practiced autonomously, and provide every aspect of anesthesia delivery as well as acute and chronic pain management services.

Response: We appreciate the information provided and are adding CRNAs to the previously enumerated list of NPPs.

Comment: Some commenters opposed our proposed change to allow NPPs to supervise the performance of psychological and neuropsychological tests. These commenters provided information indicating that these tests are not within the scope of practice of the proposed NPPs, and require special training only available to psychologists and physicians.

Response: We appreciate the information provided by these commenters stating that the specified NPPs are not qualified or authorized by their scope of practice and State law to supervise the performance of this specific category of diagnostic tests. As directed under the E.O. to allow NPPs to practice at the top of their license, our intent regarding this supervision flexibility is to allow NPPs with separate benefit categories under Medicare law to supervise the performance of diagnostic tests, regardless of the specific category of diagnostic tests, only to the extent their scope of practice and State laws authorize them to do so. Accordingly, we believe that the scope of practice and State laws for the State in which the specified NPPs furnish diagnostic psychological and neuropsychological tests will determine whether these NPPs are qualified to supervise the performance of diagnostic psychological and neuropsychological tests in addition to physicians and clinical psychologists who are already authorized to supervise such tests.

Comment: Some commenters expressed concern about the ability of NPPs to supervise diagnostic tests beyond the PHE for COVID-19. They opined that such supervision should not extend beyond the PHE for COVID-19. These commenters expressed that while NPPs are critical team members, it is vital to maintain physician-led teams for quality and cost of care. They cited information indicating that NPPs order more tests and prescribe opioids more than physicians, that patients prefer physicians, and that increasing the supply of NPPs does not increase access to care.

Response: We appreciate the commenters' feedback; however, we did not find sufficient evidence to support altering our proposal. Accordingly, we are finalizing our policy as proposed on a permanent basis and amending regulations text at § 410.32(b) to include CRNAs in the group of specified NPPs with a separately enumerated Medicare benefit category to who are allowed to supervise the performance of diagnostic tests, as permitted within their scope of Start Printed Page 84592practice and State law for the State in which the test is furnished.

3. Pharmacists Providing Services Incident to Physicians' Services

Stakeholders have asked us to clarify that pharmacists can provide services incident to the professional services of a physician or other NPP just as other clinical staff may do. These stakeholders have asked us, in particular, about pharmacists who provide medication management services. Medication management is covered under both Medicare Part B and Part D. We are reiterating the clarification we provided in the May 8th COVID-19 IFC (85 FR 27550 through 27629), that pharmacists fall within the regulatory definition of auxiliary personnel under our regulations at § 410.26. As such, pharmacists may provide services incident to the services, and under the appropriate level of supervision, of the billing physician or NPP, if payment for the services is not made under the Medicare Part D benefit. This includes providing the services incident to the services of the billing physician or NPP and in accordance with the pharmacist's state scope of practice and applicable state law.

We noted that when a pharmacist provides services that are paid under the Part D benefit, the services are not also reportable or paid for under Part B. In addition to circumstances where medication management is offered as part of the Part D benefit, Part B payment is also not available for services included in the Medicare Part D dispensing fees, such as a pharmacist's time in checking the computer for information about an individual's coverage, measurement or mixing of the covered Part D drug, filling the container, physically providing or delivering the completed prescription to the Part D enrollee. Similarly, performing required quality assurance activities consistent with § 423.153(c)(2), such as screening for potential drug therapy problems due to therapeutic duplication, age/gender-related contraindications, potential over-utilization and under-utilization, drug-drug interactions, incorrect drug dosage or duration of drug therapy, drug-allergy contraindications, and clinical abuse/misuse are considered part of dispensing fees under Part D and are not separately reportable services under Part B. Additionally, services and supplies paid under the incident to benefit must be an integral, though incidental, part of the service of a physician (or other practitioner) in the course of diagnosis or treatment of an injury or illness (§ 410.26). We also noted that our manual provisions specify that “incident to” services must be of a type that are medically appropriate to provide in the office setting; and that where a physician supervises auxiliary personnel to assist him or her in rendering services to patients and includes the charges for their services in his or her own bills, the services of such personnel are considered incident to the physicians' service if there is a physicians' service rendered to which the services of such personnel are an incidental part and there is direct supervision by the physician (section 60.1 of chapter 15 of the Medicare Benefit Policy Manual (Pub. 100-02) available on the CMS website at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Manuals/​Downloads/​bp102c15.pdf).

Although it is fully consistent with current CMS policy for pharmacists to provide services incident to the services of the billing physician or NPP, we believe this clarification may encourage pharmacists to work with physicians and NPPs in new ways where pharmacists are working at the top of their training, licensure and scope of practice. It may free up the time of physicians and NPPs for other work and increase access to medication management services, for individuals with chronic conditions and other conditions. As an example, we found that this clarification was helpful in recently addressing in the May 8th COVID-19 IFC (85 FR 27550 through 27629), the ability of pharmacies to enroll as laboratories and work with physicians in the assessment of clinical information, specimen collection and reporting results of COVID-19 clinical diagnostic laboratory tests.

We received a few public comments on this clarification made in our IFC and proposed rule. The following is a summary of the comments we received and our responses.

Comment: We received several comments asking us to allow pharmacists to directly bill office/outpatient E/M visit codes (CPT codes 99202-99215), or if this is not possible, allow physicians to bill these codes for time spent by pharmacists providing services incident to a physician's service. One commenter questioned why we referred to pharmacists as auxiliary staff or auxiliary personnel, and whether the AMA CPT Editorial Panel would agree with this classification.

Response: As mentioned above, the Medicare Part B benefit category of services furnished “incident to” the professional services of a physician, describe services furnished by the staff (or contracted staff) of a physician under his or her supervision. Specifically, section 1861(s)(2)(A) of the Act describes, services and supplies (including drugs and biologicals which are not usually self-administered by the patient) furnished as an incident to a physician's professional service, of kinds which are commonly furnished in physicians' offices and are commonly either rendered without charge or included in the physicians' bills.” Our regulation that implements section 1861(s)(2)(A) of the Act similarly describes these services in § 410.26(b) where we specify, among other things, that “incident to” services and supplies must be an integral, though incidental, part of the service of a physician (or other practitioner) in the course of diagnosis or treatment of an injury or illness. In the regulation at § 410.26(a), we have long used the term “auxiliary personnel” to describe the individuals who may provide services incident to the professional services of a physician or practitioner who is authorized by law to bill Medicare for their services. The regulation defines the term as any individual who is acting under the supervision of a physician (or other practitioner), regardless of whether the individual is an employee, leased employee, or independent contractor of the physician (or other practitioner) or of the same entity that employs or contracts with the physician (or other practitioner) and meets other stated rules, including licensure rules imposed by the State in which the services are being furnished. This Medicare Part B framework applies to any individual working with the billing physician or other practitioner to provide services on an “incident to” basis, for example, a physician assistant, medical assistant, nurse, pharmacist, administrative assistant or others, whether they have a clinical role or not. The Medicare term “auxiliary personnel” could include staff that have clinical roles and staff that do not.

The CPT codebook that delineates a common system of codes for use by all payers, describes individuals who perfo