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 Fin

CourtCenters For Medicare & Medicaid Services
Citation85 FR 84472
Publication Date28 Dec 2020
Record Number2020-26815
Federal Register, Volume 85 Issue 248 (Monday, December 28, 2020)
[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
                [Rules and Regulations]
                [Pages 84472-85377]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-26815]
                [[Page 84471]]
                Vol. 85
                Monday,
                No. 248
                December 28, 2020
                Part IIDepartment of Health and Human Services-----------------------------------------------------------------------Centers for Medicare & Medicaid Services-----------------------------------------------------------------------42 CFR Parts 400, 410, 414, et al.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; Final Rule
                Federal Register / Vol. 85 , No. 248 / Monday, December 28, 2020 /
                Rules and Regulations
                [[Page 84472]]
                -----------------------------------------------------------------------
                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Centers for Medicare & Medicaid Services
                42 CFR Parts 400, 410, 414, 415, 423, 424, and 425
                [CMS-1734-F, CMS-1734-IFC, CMS-1744-F, CMS-5531-F and CMS-3401-IFC]
                RIN 0938-AU10, 0938-AU31, 0938-AU32, and 0938-AU33
                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
                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.
                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
                [[Page 84473]]
                Schedule: 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 [email protected], 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.
                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
                [[Page 84474]]
                discussions 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
                [[Page 84475]]
                locations 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
                [[Page 84476]]
                these supplemental data through March 1, 2005.
                 In the CY 2007 PFS final rule with comment period (71 FR 69624), we
                revised the methodology for calculating direct PE RVUs from the top-
                down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
                year transition to the new PE RVUs. This transition was completed for
                CY 2010. In the CY 2010 PFS final rule with 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 x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI
                MP)] x 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
                [[Page 84477]]
                that was obtained from the AMA's SMS. The AMA administered a new survey
                in CY 2007 and CY 2008, the Physician Practice Expense Information
                Survey (PPIS). The PPIS is a multispecialty, 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
                [[Page 84478]]
                sought 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
                [[Page 84479]]
                cost of the specialties furnishing the first service with an allocator
                of 10.00 was half of the average indirect cost of the specialties
                furnishing the second service with an indirect allocator of 5.00, the
                indirect portion of the PE RVUs of the first service would be equal to
                that of the second service.
                (3) Facility and Nonfacility Costs
                 For procedures that can be furnished in a physician's office, as
                well as in a facility setting, where Medicare makes a separate payment
                to the facility for its costs in furnishing a service, we establish two
                PE RVUs: Facility and nonfacility. The methodology for calculating PE
                RVUs is the same for both the facility and nonfacility RVUs, but is
                applied independently to yield two separate PE RVUs. In calculating the
                PE RVUs for services furnished in a facility, we do not include
                resources that would generally not be provided by physicians when
                furnishing the service. For this reason, the facility PE RVUs are
                generally lower than the nonfacility PE RVUs.
                (4) Services With Technical Components and Professional Components
                 Diagnostic services are generally comprised of two components: A
                professional component (PC); and a technical component (TC). The PC and
                TC may be furnished independently or by different providers, or they
                may be furnished together as a global service. When services have
                separately billable PC and TC components, the payment for the global
                service equals the sum of the payment for the TC and PC. To achieve
                this, we use a weighted average of the ratio of indirect to direct
                costs across all the specialties that furnish the global service, TCs,
                and PCs; that is, we apply the same weighted average indirect
                percentage factor to allocate indirect expenses to the global service,
                PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum
                to the global.)
                (5) PE RVU Methodology
                 For a more detailed description of the PE RVU methodology, we refer
                readers to the CY 2010 PFS final rule with comment period (74 FR 61745
                through 61746). We also direct readers to the file titled ``Calculation
                of PE RVUs under Methodology for Selected Codes'' which is available on
                our website under downloads for the CY 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
                [[Page 84480]]
                documentation 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.
                [[Page 84481]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.000
                 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.
                [[Page 84482]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.001
                 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) [caret] 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
                [[Page 84483]]
                year 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:
                [GRAPHIC] [TIFF OMITTED] TR28DE20.002
                 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
                [[Page 84484]]
                noted that we believe it likely overstates the maintenance costs for
                other equipment. When we solicited comments regarding sources of data
                containing equipment maintenance rates, commenters were unable to
                identify an auditable, robust data source that could be used by CMS on
                a wide scale. We noted that we did not believe 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.
                [GRAPHIC] [TIFF OMITTED] TR28DE20.003
                 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.
                [[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
                [[Page 84486]]
                prices 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
                [[Page 84487]]
                codes. 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:
                [GRAPHIC] [TIFF OMITTED] TR28DE20.004
                 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,
                [[Page 84488]]
                such 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.
                [[Page 84489]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.005
                 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.
                [[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.
                [GRAPHIC] [TIFF OMITTED] TR28DE20.006
                 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.
                [[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-
                [[Page 84492]]
                up'' 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.
                [GRAPHIC] [TIFF OMITTED] TR28DE20.007
                 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
                [[Page 84493]]
                associated 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:
                [GRAPHIC] [TIFF OMITTED] TR28DE20.008
                 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
                [[Page 84494]]
                what 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
                [email protected].
                 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
                [[Page 84495]]
                procedures. 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:
                [[Page 84496]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.009
                (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
                [email protected].
                (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
                [[Page 84497]]
                market 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 x 15 mm x 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
                [[Page 84498]]
                decrease 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
                [[Page 84499]]
                of their public comments or, if outside the public comment process, via
                email at [email protected].
                 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
                [[Page 84500]]
                facilitate the review and appropriate adjustment of potentially
                misvalued services. This section also authorizes the use of analytic
                contractors to identify and analyze potentially misvalued codes,
                conduct surveys or collect data, and make recommendations on the review
                and appropriate adjustment of potentially misvalued services.
                Additionally, this section provides that the Secretary may coordinate
                the review and adjustment of any RVU with the periodic review described
                in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of
                the Act specifies that the Secretary may make appropriate coding
                revisions (including using existing processes for consideration of
                coding changes) that may include consolidation of individual services
                into bundled codes for payment under the PFS.
                2. Progress in Identifying and Reviewing Potentially Misvalued Codes
                 To fulfill our statutory mandate, we have identified and reviewed
                numerous potentially misvalued codes as specified in section
                1848(c)(2)(K)(ii) of the Act, and we intend to continue our work
                examining potentially misvalued codes in these areas over the upcoming
                years. As part of our current process, we identify potentially
                misvalued codes for review, and request recommendations from the RUC
                and other public commenters on revised work RVUs and direct PE inputs
                for those codes. The RUC, through its own processes, also identifies
                potentially misvalued codes for review. Through our public nomination
                process for potentially misvalued codes established in the CY 2012 PFS
                final rule with comment period, other individuals and stakeholder
                groups submit nominations for review of potentially misvalued codes as
                well. Individuals and stakeholder groups may submit codes for review
                under the potentially misvalued codes initiative to CMS in one of two
                ways. Nominations may be submitted to CMS via email or through postal
                mail. Email submissions should be sent to the CMS emailbox
                [email protected], 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
                [[Page 84501]]
                organizations, such as hospital associations.
                 We evaluate the supporting documentation submitted with the
                nominated codes and assess whether the nominated codes appear to be
                potentially misvalued codes appropriate for review under the annual
                process. In the following year's PFS proposed rule, we publish the list
                of nominated codes and indicate for each nominated code whether we
                agree with its inclusion as a potentially misvalued code. The public
                has the opportunity to comment on these and all other proposed
                potentially misvalued codes. In that year's final rule, we finalize our
                list of potentially misvalued codes.
                a. Public Nominations
                 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
                [[Page 84502]]
                as 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 (Sec. 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
                [[Page 84503]]
                services on the existing Medicare telehealth services list for the
                roles of, and interactions among, the beneficiary, physician (or other
                practitioner) at the distant site and, if necessary, the telepresenter.
                As we stated in the CY 2012 PFS final rule with comment period (76 FR
                73098), we believe that the Category 1 criteria not only streamline our
                review process for publicly requested services that fall into this
                category, but also expedite our ability to identify codes for the
                Medicare telehealth services list that resemble those services already
                on the Medicare telehealth services list. We received several requests
                to 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.
                [[Page 84504]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.010
                [[Page 84505]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.011
                 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.
                [GRAPHIC] [TIFF OMITTED] TR28DE20.012
                 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
                [[Page 84506]]
                with 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
                [[Page 84507]]
                changes 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.
                ---------------------------------------------------------------------------
                 \1\ https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf.
                ---------------------------------------------------------------------------
                 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.
                [[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,
                [[Page 84509]]
                COPD, 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.
                BILLING CODE 4120-01-P
                [[Page 84510]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.013
                [[Page 84511]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.014
                [[Page 84512]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.015
                [[Page 84513]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.016
                [[Page 84514]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.017
                [[Page 84515]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.018
                [[Page 84516]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.019
                BILLING CODE 4120-01-C
                 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
                [[Page 84517]]
                support 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.
                ---------------------------------------------------------------------------
                 \2\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-2Oct2020.aspx.
                ---------------------------------------------------------------------------
                 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-
                [[Page 84518]]
                person 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.
                BILLING CODE 4120-01-P
                [[Page 84519]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.020
                [[Page 84520]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.021
                [[Page 84521]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.022
                [[Page 84522]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.023
                [[Page 84523]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.024
                [[Page 84524]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.025
                [[Page 84525]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.026
                BILLING CODE 4120-01-C
                 The following is a summary of these comments and our responses.
                 Comment: Some commenters requested that we consider adding
                [[Page 84526]]
                initial 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 Sec. 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
                [[Page 84527]]
                may 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
                [[Page 84528]]
                diagnosis-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.
                [[Page 84529]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.027
                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;
                [[Page 84530]]
                initial 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 Sec. 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 Sec. 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 Sec. 410.78 to restrict physicians and
                practitioners from using telehealth to furnish the physician visits
                required under Sec. 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
                [[Page 84531]]
                remove 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 Sec. 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 Sec. 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 Sec. 410.78(a)(3)(i)
                (and reserved Sec. 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 Sec. 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 Sec. 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 Sec. 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
                [[Page 84532]]
                of 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 Sec. 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.
                [[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
                [[Page 84534]]
                care professional who may report evaluation and management services
                provided to an established patient, parent, or guardian not originating
                from a related E/M service provided within the previous 7 days nor
                leading to an E/M service or procedure within the next 24 hours or
                soonest available appointment; 21-30 minutes of medical discussion). 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 Sec. 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
                [[Page 84535]]
                it 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 Sec. 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 Sec. 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
                [[Page 84536]]
                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.
                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,
                [[Page 84537]]
                like 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 Sec. 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
                [[Page 84538]]
                finalizing 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 Sec. 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
                Sec. 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 Sec. Sec. 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 Sec. 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
                [[Page 84539]]
                supervising 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
                [[Page 84540]]
                fraud 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
                [[Page 84541]]
                1834(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 Sec. 410.78(b)(3) on an interim final basis, by adding Sec.
                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
                Sec. 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 Sec. 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 Sec. 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
                [[Page 84542]]
                treating 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 Sec. Sec. 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.
                [GRAPHIC] [TIFF OMITTED] TR28DE20.028
                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
                [[Page 84543]]
                read 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[supreg] 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
                [[Page 84544]]
                clinical staff) ``incident to'' the professional services of the
                billing practitioner. Our regulation at Sec. 410.26(a) defines
                auxiliary personnel and delineates the conditions for payment for
                ``incident to'' services.
                ---------------------------------------------------------------------------
                 \3\ CPT Codebook, p. xiv.
                ---------------------------------------------------------------------------
                 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
                [[Page 84545]]
                current 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.
                [[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
                [[Page 84547]]
                ESRD 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.
                [GRAPHIC] [TIFF OMITTED] TR28DE20.029
                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
                [[Page 84548]]
                of 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\
                ---------------------------------------------------------------------------
                 \4\ 2019 CPT Codebook, Evaluation and Management, pages 6
                through 13.
                ---------------------------------------------------------------------------
                 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.
                [[Page 84549]]
                Generally, 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.
                [GRAPHIC] [TIFF OMITTED] TR28DE20.030
                 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.
                [[Page 84550]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.031
                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.
                [[Page 84551]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.032
                 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
                [[Page 84552]]
                reason 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.
                [[Page 84553]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.033
                 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.
                ---------------------------------------------------------------------------
                 \5\ HHS Launches President Trump's `Advancing American Kidney
                Health' Initiative: https://www.hhs.gov/about/news/2019/07/10/hhs-launches-president-trump-advancing-american-kidney-health-initiative.html.
                ---------------------------------------------------------------------------
                 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
                [[Page 84554]]
                commenter 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.''
                [[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.
                ---------------------------------------------------------------------------
                 \6\ Kilpatrick SJ, Papile L, and Macones GA, eds. AAP Committee
                on Fetus and Newborn and ACOG Committee on Obstetric Practice.
                Guidelines for Perinatal Care. Eighth Edition. 2017. Page 150.
                ---------------------------------------------------------------------------
                 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\
                ---------------------------------------------------------------------------
                 \7\ https://www.hhs.gov/blog/2020/01/29/achieving-better-health-mothers-and-babies.html; https://www.cms.gov/About-CMS/Agency-Information/OMH/equity-initiatives/rural-health/21-Maternal-Health-Forum-Improving-Maternal-Health-for-Our-Communities.pdf; https://innovation.cms.gov/innovation-models/maternal-opioid-misuse-model.
                ---------------------------------------------------------------------------
                 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.
                [[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
                [[Page 84557]]
                the 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.
                BILLING CODE 4120-01-P
                [[Page 84558]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.034
                [[Page 84559]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.035
                [[Page 84560]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.036
                [[Page 84561]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.037
                [[Page 84562]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.038
                BILLING CODE 4120-01-C
                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
                [[Page 84563]]
                the 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),
                [[Page 84564]]
                direct 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.
                BILLING CODE 4120-01-P
                [[Page 84565]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.039
                [[Page 84566]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.040
                [[Page 84567]]
                [GRAPHIC] [TIFF OMITTED] TR28DE20.041
                BILLING CODE 4120-01-C
                 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
                [[Page 84568]]
                primary 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.
                ---------------------------------------------------------------------------
                 \8\ CPT Codebook pp. 656-7.
                ---------------------------------------------------------------------------
                 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
                [[Page 84569]]
                duplication 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
                [[Page 84570]]
                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, 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
                [[Page 84571]]
                descriptor, 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,
                [[Page 84572]]
                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.
                 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
                [[Page 84573]]
                service.'') 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.
                [GRAPHIC] [TIFF OMITTED] TR28DE20.042
                [GRAPHIC] [TIFF OMITTED] TR28DE20.043
                 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,
                [[Page 84574]]
                ``Prolonged office or other outpatient evaluation and management
                service(s) beyond the maximum required time of the primary procedure
                which has been selected using total time on the date of the primary
                service; each additional 15 minutes by the physician or qualified
                healthcare professional, with or without direct patient contact (List
                separately in addition to CPT codes 99205, 99215 for office or other
                outpatient evaluation and management services) ``(Do not report G2212
                on the same date of service as 99354, 99355, 99358, 99359, 99415,
                99416). (Do not report G2212 for any time unit less than 15
                minutes))''.''
                 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.
                ---------------------------------------------------------------------------
                 \9\ Zhang et al. Physician workforce in the United States of
                America: forecasting nationwide shortages. Human Resources for
                Health (2020); 18:8. Published online February 6, 2020 and available
                online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006215/.
                ---------------------------------------------------------------------------
                 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 Sec. Sec. 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
                [[Page 84575]]
                other 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 Sec. 415.172(a)(1), and anesthesia
                services under Sec. 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
                Sec. 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 Sec. 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 Sec. 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.
                [[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 Sec.
                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 Sec. 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: Several commenters supported the policy adopted on an
                interim basis to allow, under the primary care exception described in
                Sec. 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 Sec. 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
                [[Page 84577]]
                that in the case of physicians' services furnished to a patient in a
                hospital with a teaching program, the Secretary shall not provide
                payment for such services unless the physician renders sufficient
                personal and identifiable physicians' services to the patient to
                exercise full, personal control over the management of the portion of
                the case for which payment is sought.
                 Regulations regarding PFS payment for teaching physician services
                and services of moonlighting residents are codified in 42 CFR part 415.
                In general, under Sec. 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 Sec. 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
                Sec. 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 Sec. 415.184, PFS payment is made for psychiatric
                services furnished under an approved graduate medical education (GME)
                program if the requirements of Sec. Sec. 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
                Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. Sec. 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 Sec. 415.184 to eliminate the term ``direct
                supervision'' to conform with the language in sections Sec. Sec.
                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 Sec.
                415.172(a)(1), and anesthesia services under Sec. 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
                [[Page 84578]]
                teaching 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
                Sec. 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 Sec. 415.184 to eliminate the term
                ``direct supervision'' to conform with the language in sections
                Sec. Sec. 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 Sec. 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 Sec. 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 Sec. Sec. 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 Sec. Sec. 415.172,
                [[Page 84579]]
                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 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\
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                 \10\ Supply and Distribution of the Primary Care Workforce in
                Rural America: 2019: https://depts.washington.edu/fammed/rhrc/wp-content/uploads/sites/4/2020/06/RHRC_PB167_Larson.pdf. https://www.hrsa.gov/sites/default/files/hrsa/ruralhealth/reports/HRSA-Rural-Collaboration-Guide.pdf.
                ---------------------------------------------------------------------------
                 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 Sec.
                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.
                ---------------------------------------------------------------------------
                 \11\ CMS Rural Health Strategy: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural-Strategy-2018.pdf.
                 \12\ HHS awards $20 million to 27 organizations to increase the
                rural workforce through the creation of new rural residency
                programs: https://www.hhs.gov/about/news/2019/07/18/hhs-awards-20-million-to-27-organizations-to-increase-rural-workforce.html.
                ---------------------------------------------------------------------------
                 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 Sec. 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.
                ---------------------------------------------------------------------------
                 \13\ Revised Delineations of Metropolitan Statistical Areas,
                Micropolitan Statistical Areas, and Combined Statistical Areas, and
                Guidance on Uses of the Delineations of These Areas: https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf.
                ---------------------------------------------------------------------------
                 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
                [[Page 84580]]
                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 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
                Sec. 415.172(a), to conform with the regulation text we are finalizing
                to describe direct supervision in Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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
                [[Page 84581]]
                particular 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 Sec. 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
                [[Page 84582]]
                is 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 Sec. 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
                [[Page 84583]]
                care exception under Sec. 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.
                ---------------------------------------------------------------------------
                 \14\ A Guide for Rural Health Care Collaboration and
                Coordination: https://www.hrsa.gov/sites/default/files/hrsa/ruralhealth/reports/HRSA-Rural-Collaboration-Guide.pdf.
                 \15\ CMS Rural Health Strategy: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural-Strategy-2018.pdf.
                 \16\ HHS awards $20 million to 27 organizations to increase the
                rural workforce through the creation of new rural residency
                programs: https://www.hhs.gov/about/news/2019/07/18/hhs-awards-20-million-to-27-organizations-to-increase-rural-workforce.html.
                ---------------------------------------------------------------------------
                 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
                Sec. 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 Sec. 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
                [[Page 84584]]
                real-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 Sec.
                415.208, except during the PHE for COVID-19, as defined in the
                regulation at Sec. 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 Sec. Sec. 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 Sec. 415.208(b)(2)(i) through (iii). In addition,
                under Sec. 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 Sec.
                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 Sec. 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
                Sec. 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
                Sec. 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 Sec. 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
                Sec. 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 Sec. 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 Sec. 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
                [[Page 84585]]
                state 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 Sec. 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 Sec. 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 Sec. 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
                [[Page 84586]]
                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, 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 Sec. 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
                [[Page 84587]]
                PHE 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 Sec. 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 Sec. 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
                [[Page 84588]]
                some 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 Sec.
                415.174.
                ---------------------------------------------------------------------------
                 \17\ CMS Rural Health Strategy: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural-Strategy-2018.pdf.
                ---------------------------------------------------------------------------
                 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 Sec. 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 Sec. 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
                [[Page 84589]]
                services 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
                Sec. 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 Sec. 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 Sec. 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
                [[Page 84590]]
                impacts 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 Sec. 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.
                ---------------------------------------------------------------------------
                 \18\ A Guide for Rural Health Care Collaboration and
                Coordination: https://www.hrsa.gov/sites/default/files/hrsa/ruralhealth/reports/HRSA-Rural-Collaboration-Guide.pdf.
                 \19\ CMS Rural Health Strategy. https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural-Strategy-2018.pdf.
                 \20\ HHS awards $20 million to 27 organizations to increase the
                rural workforce through the creation of new rural residency
                programs: https://www.hhs.gov/about/news/2019/07/18/hhs-awards-20-million-to-27-organizations-to-increase-rural-workforce.html.
                ---------------------------------------------------------------------------
                 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 Sec. 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 Sec. 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 Sec. 410.32(a)(2),
                physicians, NPs, CNSs, PAs, certified nurse-midwives (CNMs), clinical
                psychologists (CPs), and clinical social workers (CSWs) who are
                treating
                [[Page 84591]]
                a 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 Sec. 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
                Sec. 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
                Sec. Sec. 410.75 and 410.76, respectively). Similarly, under the
                regulation at Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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
                [[Page 84592]]
                practice 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 Sec. 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 Sec. 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 (Sec.
                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
                Sec. 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
                Sec. 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 perform or report a given
                service using different terms, ``physician or qualified health care
                professional'' (QHP) and ``clinical staff.'' The CPT codebook defines
                these terms as follows, ``A `physician or other qualified health care
                professional' 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 or her scope
                of practice and independently reports that
                [[Page 84593]]
                professional service. These professionals are distinct from `clinical
                staff.' A clinical staff member is a person who works under the
                supervision of physician or other qualified healthcare professional,
                and who is allowed by law, regulation, and facility policy to perform
                or assist in the performance of a professional service, but does not
                individually report that professional service. Other policies may also
                affect who may report specific services.'' \21\ Under the PFS, we
                sometimes use the term ``clinical staff'' to describe specially
                qualified auxiliary personnel who perform services specifically
                comprised of ``clinical staff'' time (such as chronic care management
                services by clinical staff), even though our regulations refers to them
                as ``auxiliary personnel.'' Under the PFS, ``clinical staff'' is a
                subset of ``auxiliary personnel.''
                ---------------------------------------------------------------------------
                 \21\ CPT 2021 Professional Edition, p. xiv.
                ---------------------------------------------------------------------------
                 As commenters noted, pharmacists could be considered QHPs by some
                other payers who provide for their direct payment. We do not consider
                them such because there is no Medicare statutory benefit allowing them
                to enroll, bill and receive direct payment for PFS services. As such,
                pharmacists are not among the physicians and QHPs that can furnish and
                bill for the 2021 office/outpatient E/M visit codes, because levels two
                through five are by definition only performed and directly reported by
                physicians or QHPs.\22\ For example, when time is used to select visit
                level, only the time of the physician or QHP is counted. By definition,
                these codes cannot be furnished and billed as ``incident to'' services;
                therefore, they cannot be used to report services consisting of time
                spent solely by a pharmacist working ``incident to'' the services of a
                billing physician. We also note that services furnished directly by
                pharmacists are listed in a separate section of the CPT Codebook that
                includes codes describing Medication Therapy Management Services.\23\
                ---------------------------------------------------------------------------
                 \22\ CPT 2021 Professional Edition, pp.14-17.
                 \23\ CPT 2021 Professional Edition, p.818.
                ---------------------------------------------------------------------------
                 In summary, we agree with certain stakeholders that under the
                general CPT framework, pharmacists could be considered QHPs or clinical
                staff, depending on their role in a given service. However, under the
                current Medicare law which includes the PFS, we do not have ability to
                pay (or even price) services that are furnished and billed directly by
                pharmacists. Regarding office/outpatient E/M visit levels 2 through 5
                in particular, because CPT does not define these codes as clinical
                staff codes and instead designed them to be directly furnished and
                reported by physicians and other QHPs, they cannot be used to bill the
                PFS for services performed by a pharmacist on an ``incident to'' basis.
                We understand and appreciate the expanding, beneficial roles certain
                pharmacists play, particularly by specially trained pharmacists with
                broadened scopes of practice in certain states, commonly referred to as
                collaborative practice agreements. We note that new coding might be
                useful to specifically identify these particular models of care.
                4. Provision of Maintenance Therapy by Therapy Assistants
                a. Finalization of the Interim Final Rule Related to Provision of
                Maintenance Therapy by Therapy Assistants During the PHE for COVID-19
                 As a means of increasing the availability of needed health care
                services during the PHE for COVID-19, we amended our therapy policy on
                an interim basis in the May 8th COVID-19 IFC (85 FR 27550 through
                27629) to allow physical therapists (PT) and occupational therapists
                (OT) that have established a therapy maintenance program for a patient
                to assign a PTA or OTA to furnish the maintenance therapy services when
                clinically appropriate. We indicated as part of the CY 2021 PFS
                proposed rule that we would respond to comments we received in response
                to our amended policy for the provision of maintenance therapy
                services.
                 Comment: We received several comments, all of which expressed
                support for allowing therapy assistants to furnish maintenance therapy
                when delegated by a therapist, including one commenter that requested
                the CMS make the change permanent.
                 Response: We appreciate the commenters' support for our adopted
                interim policy to allow therapy assistants to furnish maintenance
                therapy services.
                 After considering comments, we are finalizing our interim policy
                from the May 8th COVID-19 IFC to allow physical and occupational
                therapists to delegate maintenance therapy services to therapy
                assistants as clinically appropriate through the end of the PHE for
                COVID-19.
                b. Summary of Proposals and Public Comments Related to Provision of
                Maintenance Therapy by Therapy Assistants
                 In response to our request for feedback on scope of practice (noted
                above), consistent with E.O. 13890 (84 FR 53573 through 53576),
                respondents requested that we allow physical therapy assistants (PTAs)
                and occupational therapy assistants (OTAs) to furnish maintenance
                therapy services associated with a maintenance therapy program.
                Respondents commented that our Part B therapy policy was not consistent
                with policies for these services when provided to patients in skilled
                nursing facilities (SNF) and home health (HH) settings paid under Part
                A. Respondents also wrote that because a therapist is responsible for a
                patient's care over an episode, that this should allow the therapist to
                assign responsibility for maintenance therapy to an assistant when it
                is clinically appropriate. Some respondents stated that permitting PTAs
                and OTAs to furnish maintenance therapy services would give Medicare
                patients greater access to care and give therapists more flexibility in
                allocating therapy resources.
                 After considering respondents' concerns about the incongruity
                between our Part B and Part A maintenance therapy policies and as a
                means of increasing availability of needed health care services during
                the PHE for COVID-19, we amended our policy on an interim final basis
                in the May 8th COVID-19 IFC (85 FR 27550 through 27629) to allow the
                physical therapist (PT) or occupational therapist (OT) who establishes
                a maintenance program to assign a PTA or OTA to furnish maintenance
                therapy services when clinically appropriate.
                 We explained that making this change could free-up the PT or OT to
                furnish other services, particularly services related to the PHE for
                COVID-19 that require a therapist's assessment and intervention skills.
                We stated explicitly that the maintenance therapy services furnished by
                therapist-supervised OTAs and PTAs will be paid in the same manner as
                those we already pay for as rehabilitative therapy services. We
                referred readers to regulatory payment conditions for Part B outpatient
                occupational and physical therapy services (Sec. Sec. 410.59 and
                410.60, respectively) that require, as a basic rule, that the services
                be provided by an individual meeting qualifications in 42 CFR part 484
                for an OT or PT, or an appropriately supervised OTA or PTA.
                 In the CY 2021 PFS proposed rule, we proposed to make permanent our
                Part B policy for maintenance therapy services effective January 1,
                2021 in order to create greater conformity in payment policy for
                maintenance therapy services that are furnished and paid under Part B
                with those in SNF and HH settings under Part A. We noted that if
                finalized, our policy would dovetail with our
                [[Page 84594]]
                amended policy set forth in the May 8th COVID-19 IFC (85 FR 27550
                through 27629) that grants PTs and OTs the discretion to delegate
                maintenance therapy services to the PTAs and OTAs, as clinically
                appropriate, for the duration of the PHE for COVID-19. If the PHE for
                COVID-19 were to end prior to January 1, 2021, the therapist would need
                to personally furnish the maintenance therapy services until the
                finalized policy change took effect. We also noted that we planned to
                address comments from the May 8th COVID-19 IFC in conjunction with the
                comments from the CY 2021 PFS proposed rule in the CY 2021 PFS final
                rule.
                 Our policy for maintenance therapy services is explained in section
                220.2 of chapter 15 of the Medicare Benefit Policy Manual (see https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf). Maintenance programs that can be carried out by a
                patient alone or with the assistance of caregivers are not covered.
                Also, sections 230.1 and 230.2 of chapter 15 of the Medicare Benefit
                Policy Manual specify that a PTA or OTA may not provide skilled
                maintenance program services.
                 In considering this proposal, we reviewed regulatory requirements
                for conditions of payment for outpatient occupational therapy, physical
                therapy, and speech-language pathology services at Sec. Sec. 410.59,
                410.60, and 410.62; the regulation for therapy treatment plans at Sec.
                410.61; and the regulations specifying treatment plan certification and
                recertification requirements at Sec. 424.24 for Part B occupational
                therapy, physical therapy, and speech-language pathology services along
                with the above mentioned manual provisions.
                 Given that we already make payment for rehabilitative services
                requiring improvement in the patient's functional status when they are
                furnished by PTAs and OTAs at the discretion of the supervising
                therapist treating the patient in accordance with the therapist-
                established plan of care, we noted that it would be appropriate for the
                therapist to use that same judgment to decide whether to delegate
                maintenance therapy services under the associated plan of care to a PTA
                or OTA. We stated that there is little difference between the
                rehabilitative therapy services furnished to improve a patient's
                functional status and those for maintenance therapy services other than
                the goals set by the therapist in the therapy plan. We do not believe
                that the therapist-only maintenance therapy requirement is needed in
                the case of outpatient physical or occupational therapy services.
                Instead, we believe that it would be appropriate for an OT or PT to use
                their professional judgment to assign the performance of maintenance
                therapy services to an OTA or PTA when it is clinically appropriate to
                do so.
                 As such, we proposed to allow, on a permanent basis, therapists to
                delegate performance of maintenance therapy services to an OTA or PTA
                for outpatient occupational and physical therapy services in Part B
                settings beginning January 1, 2021. This proposal would better align
                our Part B policy with that in SNFs and HH paid under Part A where
                maintenance therapy services may be performed by a therapist or a
                therapy assistant. Since our regulations at Sec. Sec. 410.59, 410.60,
                410.61, 410.62, and 424.24, do not distinguish between rehabilitative
                and maintenance therapy services, we did not propose to amend them.
                Instead, we proposed to revise sections 220.2, 230.1 and 230.2 of
                chapter 15 of the Medicare Benefit Policy Manual to clarify that PTs
                and OTs no longer need to personally perform maintenance therapy
                services and to specifically remove the prohibitions on PTAs and OTAs
                from furnishing such services. We noted that we believe the proposal to
                allow PTs and OTs to delegate maintenance therapy services to their
                supervised assistants is in keeping with E.O. 13890 and appeals by
                respondents to our request for feedback on scope of practice that
                followed, rather than the alternative option of maintaining the pre-
                COVID-19 policy of requiring PTs and OTs to personally furnish them,
                after the PHE for COVID-19 has ended.
                 We noted also that therapists and therapy providers should consult
                the CQ and CO modifier policies to consider whether these modifiers
                should be applied to claims for services furnished in whole or in part
                by PTAs and OTAs which will, beginning January 1, 2022, be paid at 85
                percent of the amount that would otherwise apply for the service, as
                required by section 1834(v) of the Act, which was added to section
                53107 of the Bipartisan Budget Act of 2018. See the CY 2020 PFS
                rulemaking for policies related to the application of CQ and CO
                modifiers and the associated regulatory requirements (84 FR 40558
                through 40564 (proposed rule) and 84 FR 62702 through 60708 (final
                rule)).
                 We received public comments on the provision of maintenance therapy
                to be furnished by therapy assistants. The following is a summary of
                the comments we received and our responses.
                 Comment: Commenters expressed uniform support for our proposal to
                allow therapy assistants to furnish maintenance therapy services.
                Commenters indicated that having Part B policy align with current Part
                A policy for Home Health and SNF settings will promote consistency as
                well as continuity of care across Medicare programs.
                 Response: We appreciate the commenters' support for our proposal to
                allow therapy assistants to furnish maintenance therapy services. After
                considering comments, we are finalizing our proposal to allow physical
                and occupational therapists to delegate maintenance therapy services to
                therapy assistants on a permanent basis as clinically appropriate.
                5. Medical Record Documentation
                a. Finalization of Interim Final Rule With Comment Period Provisions
                Related to Therapy Student Documentation During the PHE for the COVID-
                19 Pandemic
                 In the May 8th COVID-19 IFC (85 FR 27556 through 27557), to
                increase the availability of clinicians who may furnish healthcare
                services during the PHE, we announced a general policy that there is
                broad flexibility for all members of the medical team to add
                documentation in the medical record which is then reviewed and verified
                (signed) by the appropriate clinician. Specifically, we stated on an
                interim basis during the PHE for COVID-19, any individual who has a
                separately enumerated benefit under Medicare law that authorizes them
                to furnish and bill for their professional services, whether or not
                they are acting in a teaching role, may review and verify (sign and
                date), rather than re-document, notes in the medical record made by
                physicians, residents, nurses, and students (including students in
                therapy or other clinical disciplines), or other members of the medical
                team. We noted that although there are currently no statutory or
                regulatory documentation requirements that would impact payment for
                therapists when documentation is added to the medical record by persons
                other than the therapist, we discussed this issue in response to
                stakeholder concerns about burden and in consideration of the current
                PHE for COVID-19. Specifically, this policy will ensure that
                therapists, as members of the clinical workforce, are able to spend
                more time furnishing therapy services, including pain management
                therapies to patients that may minimize the use of opioids and other
                medications, rather than spending time documenting in the medical
                record. We emphasized that our established principle is focused on the
                [[Page 84595]]
                clinician, as described above who furnishes and bills for their
                professional services rather than the individuals who may enter
                information into the medical record. We emphasized that information
                entered into the medical record should document that the furnished
                services are reasonable and necessary.
                 We received public comments on Therapy Student Documentation. The
                following is a summary of the comments we received and our responses.
                 Comment: One commenter recommended that CMS make the therapy
                student documentation waiver under the PHE for COVID-19 permanent so
                that it aligns with the flexibility extended to physicians and several
                NPPs as promulgated in the CY 2020 PFS final rule.
                 Response: We appreciate the commenter's support of this provision
                for student documentation and making permanent the broad flexibility
                for all members of the medical team to add documentation in the medical
                record which is then reviewed and verified (signed) by the appropriate
                clinician.
                 Comment: One commenter supported these changes which will give more
                flexibility to practitioners and other providing clinically appropriate
                therapy services but asked that CMS clarify who would be considered
                other members of the ``treatment team'' in addition to those enumerated
                (that is, physicians, residents, nurses, and students)--in particular,
                whether this would encompass non-licensed member.
                 Response: We appreciate the commenters request for clarification.
                Any individual who is authorized under Medicare law to furnish and bill
                for their professional services, whether or not they are acting in a
                teaching role, may review and verify (sign and date) the medical record
                for the services they bill, rather than re-document, notes in the
                medical record made by physicians, residents, nurses, and students
                (including students in therapy or other clinical disciplines), or other
                members of the medical team), or other members of the medical team.
                 Comment: One commenter agreed with CMS that these measures should
                be temporary, and should not persist once the PHE for COVID-19 has
                ended. The commenter stated that training-appropriate scope of practice
                standards are important to ensuring quality of care for our members.
                 Response: We appreciate the commenter's feedback. We are discussing
                this issue in response to stakeholder concerns about burden and in
                consideration of the current PHE for COVID-19. Specifically, this
                policy will ensure that therapists, as members of the clinical
                workforce, are able to spend more time furnishing therapy services,
                including pain management therapies to patients that may minimize the
                use of opioids and other medications, rather than spending time
                documenting in the medical record. The provision related to therapy
                student documentation was to increase the availability of clinicians
                who may furnish healthcare services during the PHE for COVID-19 and on
                an interim basis during the PHE for COVID-19.
                 In summary, we reiterate that our clarification about this policy
                as discussed in the May 8th COVID-19 IFC (85 FR 27556 through 27557)
                notes that any individual who has a separately enumerated benefit under
                Medicare law that authorizes them to furnish and bill for their
                professional services, whether or not they are acting in a teaching
                role, may review and verify (sign and date), rather than re-document,
                notes in the medical record made by physicians, residents, nurses, and
                students (including students in therapy or other clinical disciplines),
                or other members of the medical team. We emphasized that our
                established principle is focused on the clinician, as described above
                who furnishes and bills for their professional services rather than the
                individuals who may enter information into the medical record. We
                emphasized that information entered into the medical record should
                document that the furnished services are reasonable and necessary.
                b. Medical Record Documentation Clarification
                 As we established in the CY 2020 PFS final rule (84 FR 62681
                through 62684), and similarly expressed in the May 8th COVID-19 IFC (85
                FR 27556 through 27557), any individual who is authorized under
                Medicare law to furnish and bill for their professional services,
                whether or not they are acting in a teaching role, may review and
                verify (sign and date) the medical record for the services they bill,
                rather than re-document, notes in the medical record made by
                physicians, residents, nurses, and students (including students in
                therapy or other clinical disciplines), or other members of the medical
                team. We noted that although there are currently no documentation
                requirements that would impact payment for PTs, OTs, or SLPs when
                documentation is added to the medical record by persons other than the
                therapist, we are responding in this proposed rule to stakeholder
                requests for clarification. Specifically, we clarified that the broad
                policy principle that allows billing clinicians to review and verify
                documentation added to the medical record for their services by other
                members of the medical team also applies to therapists. We noted that
                this would help ensure that therapists are able to spend more time
                furnishing therapy services, including pain management therapies to
                patients that may minimize the use of opioids and other medications,
                rather than spending time documenting in the medical record. We
                emphasized that, while any member of the medical team may enter
                information into the medical record, only the reporting clinician may
                review and verify notes made in the record by others for the services
                the reporting clinician furnishes and bills. We also emphasized that
                information entered into the medical record should document that the
                furnished services are reasonable and necessary.
                 We received public comments on the medical record documentation
                clarification. The following is a summary of the comments we received
                and our responses.
                 Comment: Many commenters were in support of and commended CMS for
                including therapists in the list of practitioners who may review and
                verify documentation instead of having to re-document notes made by
                students for Medicare Part B patients and stated that this is a
                significant burden reduction that will allow for better use of
                therapists' time.
                 Two commenters appreciated this medical record documentation
                flexibility so long as the provision falls within existing scope of
                practice laws and only reduces the burden of re-documenting. The
                commenter noted that administrative burden is a major reason for
                physician burnout and by alleviating this burden and allowing others to
                share in the administrative process, physicians will spend less time
                documenting and perhaps have a decrease in burnout. Another commenter
                noted in rural areas, there are shortages of therapy and mental health
                professionals and that documentation and paperwork take time away from
                patients who need help.
                 A few commenters noted that this flexibility would better prepare
                clinicians to enter practice by increasing safety and education on how
                to document effectively and appropriately the skilled services they
                provide. One commenter questioned how this flexibility may impact
                documentation requirements pertaining to completion of the progress
                report and Medicare's billing rules in relation to therapy students.
                Another commenter requested licensed audiologists be added to the group
                that can review and verify (sign and date) the documentation entered
                into the medical record by members of
                [[Page 84596]]
                their medical team for their own, appropriately supervised services
                that are paid under the PFS.
                 One commenter requested that CMS issue guidance to clarify that it
                is possible that no additional documentation is required if the
                entirety of the documentation could be included from members of the
                medical team, thus allowing the billing practitioner to ``sign and
                verify'' the entire note.
                 Response: We appreciate commenters' support of this clarification
                to allow therapists to review and verify student documentation instead
                of therapists having to re-document notes made by students. We
                appreciate the insight provided by commenters about how the broad
                flexibility would aide in burden reduction and allow for better use of
                time by therapists.
                 This clarification similarly aligns with what was finalized in the
                CY 2020 PFS final rule which provided broad flexibility to the
                physicians, PAs and APRNs (regardless of whether they are acting in a
                teaching capacity) who document and who are paid under the PFS for
                their professional services. We explained that this principle would
                apply across the spectrum of all Medicare-covered services paid under
                the PFS. We emphasize that, while any member of the medical team may
                enter information into the medical record, only the billing clinician
                may review and verify notes made in the record by others for the
                services the reporting clinician furnishes and bills. As we emphasized
                in our proposal, information entered into the medical record should
                document that the services furnished are reasonable and necessary if
                the billing practitioner has signed and verified complete medical
                record documentation by other members of the medical team.
                 Comment: One commenter supported the CMS policy to provide added
                flexibility for NPPs authorized to deliver part B services including
                nurse practitioners, CNSs and PAs to document teaching physician
                involvement and another commenter noted they believe that the
                additional flexibility will significantly reduce burden for teaching
                physicians.
                 Response: We appreciate the support of this flexibility for NPPs to
                document teaching physician involvement. We would like to reiterate
                that this flexibility does not negate the teaching physician rules, or
                the need to document personal services or split share rules, or other
                aspects of the service provided.
                 Comment: One commenter urged CMS not to expand payment for
                independent NPPs and pressure inappropriate scope-of-practice expansion
                through these proposed rules. The commenter encouraged all advanced
                nurse practitioners and physician assistants to work within their
                respective licensed scope of practice in a team approach to expand
                access and ensure quality of care. Another commenter expressed concern
                that based on the language proposed by CMS, this policy might allow
                therapists to change or modify a physician's documentation, including
                their diagnostic evaluation and treatment plan.
                 Response: We appreciate the commenters concerns and want to
                emphasize that this medical record documentation clarification only
                applies to the clinician who is billing for their professional service.
                The intent of this clarification is to reduce burden and allow the
                billing practitioner to review and verify the documentation in the
                medical record instead of re-documenting information entered by
                students and other members of the medical team. The billing
                practitioner needs to ensure, as we reiterated in our clarification,
                that, while any member of the medical team may enter information into
                the medical record, they review and verify that the information in the
                medical record is accurate and complete for the services the reporting
                clinician furnishes and bills.
                 After considering the comments received, we note that we are
                reiterating what we finalized in the CY 2020 PFS final rule, that any
                individual who is authorized under Medicare law to furnish and bill for
                their professional services, whether or not they are acting in a
                teaching role, may review and verify (sign and date) the medical record
                for the services they bill, rather than re-document, notes in the
                medical record made by physicians, residents, nurses, and students
                (including students in therapy or other clinical disciplines), or other
                members of the medical team. We emphasize that, while any member of the
                medical team may enter information into the medical record, only the
                reporting clinician may review and verify notes made in the record by
                others for the services the reporting clinician furnishes and bills. We
                want to emphasize that information entered into the medical record must
                document that the furnished services are reasonable and necessary.
                H. Valuation of Specific Codes
                1. Background: Process for Valuing New, Revised, and Potentially
                Misvalued Codes
                 Establishing valuations for newly created and revised CPT codes is
                a routine part of maintaining the PFS. Since the inception of the PFS,
                it has also been a priority to revalue services regularly to make sure
                that the payment rates reflect the changing trends in the practice of
                medicine and current prices for inputs used in the PE calculations.
                Initially, this was accomplished primarily through the 5-year review
                process, which resulted in revised work RVUs for CY 1997, CY 2002, CY
                2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY
                2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year
                review process, revisions in RVUs were proposed and finalized via
                rulemaking. In addition to the 5-year reviews, beginning with CY 2009,
                CMS and the RUC identified a number of potentially misvalued codes each
                year using various identification screens, as discussed in section
                II.C. of this proposed rule, Potentially Misvalued Services under the
                PFS. Historically, when we received RUC recommendations, our process
                had been to establish interim final RVUs for the potentially misvalued
                codes, new codes, and any other codes for which there were coding
                changes in the final rule with comment period for a year. Then, during
                the 60-day period following the publication of the final rule with
                comment period, we accepted public comment about those valuations. For
                services furnished during the calendar year following the publication
                of interim final rates, we paid for services based upon the interim
                final values established in the final rule. In the final rule with
                comment period for the subsequent year, we considered and responded to
                public comments received on the interim final values, and typically
                made any appropriate adjustments and finalized those values.
                 In the CY 2015 PFS final rule with comment period (79 FR 67547), we
                finalized a new process for establishing values for new, revised and
                potentially misvalued codes. Under the new process, we include proposed
                values for these services in the proposed rule, rather than
                establishing them as interim final in the final rule with comment
                period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the
                new process was applicable to all codes, except for new codes that
                describe truly new services. For CY 2017, we proposed new values in the
                CY 2017 PFS proposed rule for the vast majority of
                [[Page 84597]]
                new, revised, and potentially misvalued codes for which we received
                complete RUC recommendations by February 10, 2016. To complete the
                transition to this new process, for codes for which we established
                interim final values in the CY 2016 PFS final rule with comment period
                (81 FR 80170), we reviewed the comments received during the 60-day
                public comment period following release of the CY 2016 PFS final rule
                with comment period (80 FR 70886), and re-proposed values for those
                codes in the CY 2017 PFS proposed rule.
                 We considered public comments received during the 60-day public
                comment period for the proposed rule before establishing final values
                in the CY 2017 PFS final rule. As part of our established process, we
                will adopt interim final values only in the case of wholly new services
                for which there are no predecessor codes or values and for which we do
                not receive recommendations in time to propose values.
                 As part of our obligation to establish RVUs for the PFS, we
                thoroughly review and consider available information including
                recommendations and supporting information from the RUC, the Health
                Care Professionals Advisory Committee (HCPAC), public commenters,
                medical literature, Medicare claims data, comparative databases,
                comparison with other codes within the PFS, as well as consultation
                with other physicians and healthcare professionals within CMS and the
                federal government as part of our process for establishing valuations.
                Where we concur that the RUC's recommendations, or recommendations from
                other commenters, are reasonable and appropriate and are consistent
                with the time and intensity paradigm of physician work, we proposed
                those values as recommended. Additionally, we continually engage with
                stakeholders, including the RUC, with regard to our approach for
                accurately valuing codes, and as we prioritize our obligation to value
                new, revised, and potentially misvalued codes. We continue to welcome
                feedback from all interested parties regarding valuation of services
                for consideration through our rulemaking process.
                2. Methodology for Establishing Work RVUs
                 For each code identified in this section, we conduct a review that
                includes the current work RVU (if any), RUC-recommended work RVU,
                intensity, time to furnish the preservice, intraservice, and
                postservice activities, as well as other components of the service that
                contribute to the value. Our reviews of recommended work RVUs and time
                inputs generally include, but have not been limited to, a review of
                information provided by the RUC, the HCPAC, and other public
                commenters, medical literature, and comparative databases, as well as a
                comparison with other codes within the PFS, consultation with other
                physicians and health care professionals within CMS and the federal
                government, as well as Medicare claims data. We also assess the
                methodology and data used to develop the recommendations submitted to
                us by the RUC and other public commenters and the rationale for the
                recommendations. In the CY 2011 PFS final rule with comment period (75
                FR 73328 through 73329), we discussed a variety of methodologies and
                approaches used to develop work RVUs, including survey data, building
                blocks, crosswalks to key reference or similar codes, and magnitude
                estimation (see the CY 2011 PFS final rule with comment period (75 FR
                73328 through 73329) for more information). When referring to a survey,
                unless otherwise noted, we mean the surveys conducted by specialty
                societies as part of the formal RUC process.
                 Components that we use in the building block approach may include
                preservice, intraservice, or postservice time and post-procedure
                visits. When referring to a bundled CPT code, the building block
                components could include the CPT codes that make up the bundled code
                and the inputs associated with those codes. We use the building block
                methodology to construct, or deconstruct, the work RVU for a CPT code
                based on component pieces of the code. Magnitude estimation refers to a
                methodology for valuing work that determines the appropriate work RVU
                for a service by gauging the total amount of work for that service
                relative to the work for a similar service across the PFS without
                explicitly valuing the components of that work. In addition to these
                methodologies, we frequently utilize an incremental methodology in
                which we value a code based upon its incremental difference between
                another code and another family of codes. The statute specifically
                defines the work component as the resources in time and intensity
                required in furnishing the service. Also, the published literature on
                valuing work has recognized the key role of time in overall work. For
                particular codes, we refine the work RVUs in direct proportion to the
                changes in the best information regarding the time resources involved
                in furnishing particular services, either considering the total time or
                the intraservice time.
                 Several years ago, to aid in the development of preservice time
                recommendations for new and revised CPT codes, the RUC created
                standardized preservice time packages. The packages include preservice
                evaluation time, preservice positioning time, and preservice scrub,
                dress and wait time. Currently, there are preservice time packages for
                services typically furnished in the facility setting (for example,
                preservice time packages reflecting the different combinations of
                straightforward or difficult procedure, and straightforward or
                difficult patient). Currently, there are three preservice time packages
                for services typically furnished in the nonfacility setting.
                 We developed several standard building block methodologies to value
                services appropriately when they have common billing patterns. In cases
                where a service is typically furnished to a beneficiary on the same day
                as an E/M service, we believe that there is overlap between the two
                services in some of the activities furnished during the preservice
                evaluation and postservice time. Our longstanding adjustments have
                reflected a broad assumption that at least one-third of the work time
                in both the preservice evaluation and postservice period is duplicative
                of work furnished during the E/M visit.
                 Accordingly, in cases where we believe that the RUC has not
                adequately accounted for the overlapping activities in the recommended
                work RVU and/or times, we adjust the work RVU and/or times to account
                for the overlap. The work RVU for a service is the product of the time
                involved in furnishing the service multiplied by the intensity of the
                work. Preservice evaluation time and postservice time both have a long-
                established intensity of work per unit of time (IWPUT) of 0.0224, which
                means that 1 minute of preservice evaluation or postservice time
                equates to 0.0224 of a work RVU.
                 Therefore, in many cases when we remove 2 minutes of preservice
                time and 2 minutes of postservice time from a procedure to account for
                the overlap with the same day E/M service, we also remove a work RVU of
                0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in
                time had already been accounted for in the work RVU. The RUC has
                recognized this valuation policy and, in many cases, now addresses the
                overlap in time and work when a service is typically furnished on the
                same day as an E/M service.
                 The following paragraphs contain a general discussion of our
                approach to reviewing RUC recommendations and
                [[Page 84598]]
                developing proposed values for specific codes. When they exist we also
                include a summary of stakeholder reactions to our approach. We note
                that many commenters and stakeholders have expressed concerns over the
                years with our ongoing adjustment of work RVUs based on changes in the
                best information we had regarding the time resources involved in
                furnishing individual services. We have been particularly concerned
                with the RUC's and various specialty societies' objections to our
                approach given the significance of their recommendations to our process
                for valuing services and since much of the information we used to make
                the adjustments is derived from their survey process. We are obligated
                under the statute to consider both time and intensity in establishing
                work RVUs for PFS services. As explained in the CY 2016 PFS final rule
                with comment period (80 FR 70933), we recognize that adjusting work
                RVUs for changes in time is not always a straightforward process, so we
                have applied various methodologies to identify several potential work
                values for individual codes.
                 We have observed that for many codes reviewed by the RUC,
                recommended work RVUs have appeared to be incongruous with recommended
                assumptions regarding the resource costs in time. This has been the
                case for a significant portion of codes for which we recently
                established or proposed work RVUs that are based on refinements to the
                RUC-recommended values. When we have adjusted work RVUs to account for
                significant changes in time, we have started by looking at the change
                in the time in the context of the RUC-recommended work RVU. When the
                recommended work RVUs do not appear to account for significant changes
                in time, we have employed the different approaches to identify
                potential values that reconcile the recommended work RVUs with the
                recommended time values. Many of these methodologies, such as survey
                data, building block, crosswalks to key reference or similar codes, and
                magnitude estimation have long been used in developing work RVUs under
                the PFS. In addition to these, we sometimes use the relationship
                between the old time values and the new time values for particular
                services to identify alternative work RVUs based on changes in time
                components.
                 In so doing, rather than ignoring the RUC-recommended value, we
                have used the recommended values as a starting reference and then
                applied one of these several methodologies to account for the
                reductions in time that we believe were not otherwise reflected in the
                RUC-recommended value. If we believe that such changes in time are
                already accounted for in the RUC's recommendation, then we do not make
                such adjustments. Likewise, we do not arbitrarily apply time ratios to
                current work RVUs to calculate proposed work RVUs. We use the ratios to
                identify potential work RVUs and consider these work RVUs as potential
                options relative to the values developed through other options.
                 We do not imply that the decrease in time as reflected in survey
                values should always equate to a one-to-one or linear decrease in newly
                valued work RVUs. Instead, we believe that, since the two components of
                work are time and intensity, absent an obvious or explicitly stated
                rationale for why the relative intensity of a given procedure has
                increased, significant decreases in time should be reflected in
                decreases to work RVUs. If the RUC's recommendation has appeared to
                disregard or dismiss the changes in time, without a persuasive
                explanation of why such a change should not be accounted for in the
                overall work of the service, then we have generally used one of the
                aforementioned methodologies to identify potential work RVUs, including
                the methodologies intended to account for the changes in the resources
                involved in furnishing the procedure.
                 Several stakeholders, including the RUC, have expressed general
                objections to our use of these methodologies and deemed our actions in
                adjusting the recommended work RVUs as inappropriate; other
                stakeholders have also expressed general concerns with CMS refinements
                to RUC-recommended values in general. In the CY 2017 PFS final rule (81
                FR 80272 through 80277), we responded in detail to several comments
                that we received regarding this issue. In the CY 2017 PFS proposed rule
                (81 FR 46162), we requested comments regarding potential alternatives
                to making adjustments that would recognize overall estimates of work in
                the context of changes in the resource of time for particular services;
                however, we did not receive any specific potential alternatives. As
                described earlier in this section, crosswalks to key reference or
                similar codes are one of the many methodological approaches we have
                employed to identify potential values that reconcile the RUC-recommend
                work RVUs with the recommended time values when the RUC-recommended
                work RVUs did not appear to account for significant changes in time.
                 We received several comments regarding our methodologies for work
                valuation in response to the CY 2021 PFS proposed rule and those
                comments are summarized below.
                 Comment: Several commenters disagreed with our reference to older
                work time sources, and stated that their use led to the proposal of
                work RVUs based on flawed assumptions. Commenters stated that codes
                with ``CMS/Other'' or ``Harvard'' work time sources, used in the
                original valuation of certain older services, were not surveyed, and
                therefore, were not resource-based. Commenters also stated that it was
                invalid to draw comparisons between the current work times and work
                RVUs of these services to the newly surveyed work time and work RVUs as
                recommended by the RUC.
                 Response: We agree that it is important to use the recent data
                available regarding work times, and we note that when many years have
                passed between when time is measured, significant discrepancies can
                occur. However, we also believe that our operating assumption regarding
                the validity of the existing values as a point of comparison is
                critical to the integrity of the relative value system as currently
                constructed. The work times currently associated with codes play a very
                important role in PFS ratesetting, both as points of comparison in
                establishing work RVUs and in the allocation of indirect PE RVUs by
                specialty. If we were to operate under the assumption that previously
                recommended work times had routinely been overestimated, this would
                undermine the relativity of the work RVUs on the PFS in general, given
                the process under which codes are often valued by comparisons to codes
                with similar times. It also would undermine the validity of the
                allocation of indirect PE RVUs to physician specialties across the PFS.
                 Instead, we believe that it is crucial that the code valuation
                process take place with the understanding that the existing work times
                used in the PFS ratesetting processes are accurate. We recognize that
                adjusting work RVUs for changes in time is not always a straightforward
                process and that the intensity associated with changes in time is not
                necessarily always linear, which is why we apply various methodologies
                to identify several potential work values for individual codes.
                However, we reiterate that we believe it would be irresponsible to
                ignore changes in time based on the best data available, and that we
                are statutorily obligated to consider both time and intensity in
                establishing work RVUs for PFS services. For additional
                [[Page 84599]]
                information regarding the use of old work time values that were
                established many years ago and have not since been reviewed in our
                methodology, we refer readers to our discussion of the subject in the
                CY 2017 PFS final rule (81 FR 80273 through 80274).
                 Comment: Several commenters disagreed with the use of time ratio
                methodologies for work valuation. Commenters stated that this use of
                time ratios is not a valid methodology for valuation of physician
                services. Commenters stated that treating all components of physician
                time (preservice, intraservice, postservice and post-operative visits)
                as having identical intensity is incorrect, and inconsistently applying
                it to only certain services under review creates inherent payment
                disparities in a payment system, which is based on relative valuation.
                Commenters stated that in many scenarios, CMS selects an arbitrary
                combination of inputs to apply rather than seeking a valid clinically
                relevant relationship that would preserve relativity. Commenters
                suggested that CMS determine the work valuation for each code based not
                only on surveyed work times, but also the intensity and complexity of
                the service and relativity to other similar services, rather than
                basing the work value entirely on time.
                 Response: We disagree and continue to believe that the use of time
                ratios is one of several appropriate methods for identifying potential
                work RVUs for particular PFS services, particularly when the
                alternative values recommended by the RUC and other commenters do not
                account for information provided by surveys that suggests the amount of
                time involved in furnishing the service has changed significantly. We
                reiterate that, consistent with the statute, we are required to value
                the work RVU based on the relative resources involved in furnishing the
                service, which include time and intensity. When our review of
                recommended values reveals that changes in time have been unaccounted
                for in a recommended RVU, then we believe we have the obligation to
                account for that change in establishing work RVUs since the statute
                explicitly identifies time as one of the two elements of the work RVUs.
                 We recognize that it would not be appropriate to develop work RVUs
                solely based on time given that intensity is also an element of work,
                but in applying the time ratios, we are using derived intensity
                measures based on current work RVUs for individual procedures. We
                clarify again that we do not treat all components of physician time as
                having identical intensity. If we were to disregard intensity
                altogether, the work RVUs for all services would be developed based
                solely on time values and that is definitively not the case, as
                indicated by the many services that share the same time values but have
                different work RVUs. For example, among the codes reviewed in this
                current CY 2021 PFS final rule, CPT codes 10006 (Fine needle aspiration
                biopsy, including ultrasound guidance; each additional lesion) and
                57465 (Computer-aided mapping of cervix uteri during colposcopy,
                including optical dynamic spectral imaging and algorithmic
                quantification of the acetowhitening effect), 76513 (Ophthalmic
                ultrasound, diagnostic; anterior segment ultrasound, immersion (water
                bath) B-scan or high resolution biomicroscopy, unilateral or
                bilateral), 93224 (External electrocardiographic recording up to 48
                hours by continuous rhythm recording and storage; includes recording,
                scanning analysis with report, review and interpretation by a physician
                or other qualified health care professional) and 99439 (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 15 minutes) share the identical total work time of 15 minutes.
                However, these codes have very different proposed work RVUs of 1.00 and
                0.81 and 0.53 and 0.39 and 0.61 respectively. In addition, CPT codes
                10010 (Fine needle aspiration biopsy, including CT guidance; each
                additional lesion) and 93662 (Intracardiac echocardiography during
                therapeutic/diagnostic intervention, including imaging supervision and
                interpretation) both share the same intraservice and total work time of
                25 minutes but each code has a different work RVU. These examples
                demonstrate that we do not value services purely based on work time;
                instead, we incorporate time as one of multiple different factors
                employed in our review process. Furthermore, we reiterate that we use
                time ratios to identify potentially appropriate work RVUs, and then use
                other methods (including estimates of work from CMS medical personnel
                and crosswalks to key reference or similar codes) to validate these
                RVUs. For more details on our methodology for developing work RVUs, we
                direct readers to the discussion CY 2017 PFS final rule (81 FR 80272
                through 80277).
                 We also want to clarify for the commenters that our review process
                is not arbitrary in nature. Our reviews of recommended work RVUs and
                time inputs generally include, but have not been limited to, a review
                of information provided by the RUC, the HCPAC, and other public
                commenters, medical literature, and comparative databases, as well as a
                comparison with other codes within the PFS, consultation with other
                physicians and health care professionals within CMS and the federal
                government, as well as Medicare claims data. We also assess the
                methodology and data used to develop the recommendations submitted to
                us by the RUC and other public commenters and the rationale for the
                recommendations. In the CY 2011 PFS final rule with comment period (75
                FR 73328 through 73329), we discussed a variety of methodologies and
                approaches used to develop work RVUs, including survey data, building
                blocks, crosswalks to key reference or similar codes, and magnitude
                estimation (see the CY 2011 PFS final rule with comment period (75 FR
                73328 through 73329) for more information). With regard to the
                invocation of clinically relevant relationships by the commenters, we
                emphasize that we continue to believe that the nature of the PFS
                relative value system is such that all services are appropriately
                subject to comparisons to one another. Although codes that describe
                clinically similar services are sometimes stronger comparator codes, we
                do not agree that codes must share the same site of service, patient
                population, or utilization level to serve as an appropriate crosswalk.
                 Comment: Several commenters discouraged the use of valuation based
                on work RVU increments. Commenters stated that this methodology
                inaccurately treats all components of the physician time as having
                identical intensity and would lead to incorrect work valuations.
                Commenters stated that CMS should carefully consider the clinical
                information justifying the changes in physician work intensity provided
                by the RUC and other stakeholders.
                 Response: We believe the use of an incremental difference between
                codes is a valid methodology for setting values, especially in valuing
                services within a family of revised codes where it is important to
                maintain appropriate intra-family relativity. Historically, we have
                frequently utilized an incremental methodology in which we value a code
                based upon its incremental difference between another code or another
                family of codes. We note that the RUC has also
                [[Page 84600]]
                used the same incremental methodology on occasion when it was unable to
                produce valid survey data for a service. We have no evidence to suggest
                that the use of an incremental difference between codes conflicts with
                the statute's definition of the work component as the resources in time
                and intensity required in furnishing the service. We do consider
                clinical information associated with physician work intensity provided
                by the RUC and other stakeholders as part of our review process,
                although we remind readers again that we do not agree that codes must
                share the same site of service, patient population, or utilization
                level to serve as an appropriate crosswalk.
                 Comment: Several commenters stated that they were concerned about
                CMS' lack of consideration for compelling evidence that services have
                changed. Commenters stated that CMS appeared to dismiss the fact that
                services may change due to technological advances, changes in the
                patient population, shifts in the specialty of physicians providing
                services or changes in the physician work or intensity required to
                perform services. Commenters requested that CMS address the compelling
                evidence that was submitted with the RUC recommendations when the
                agency does not accept the RUC recommendation.
                 Response: The concept of compelling evidence was developed by the
                RUC as part of its review process for individual codes to justify an
                increase in valuation. The RUC's compelling evidence criteria include
                documented changes in physician work, an anomalous relationship between
                the code and multiple key reference services, evidence that technology
                has changed physician work, analysis of other data on time and effort
                measures, and evidence that incorrect assumptions were made in the
                previous valuation of the service. While we appreciate the submission
                of this additional information for review, we emphasize that compelling
                evidence is a concept developed by the RUC for its own review process.
                Compelling evidence is not part of our statutory framework which
                requires that the valuation of codes should be based on time and
                intensity. We do consider changes in technology, patient population,
                etc. insofar as they affect the time and intensity of the service under
                review. However, we do not specifically address the RUC's compelling
                evidence criteria in our rulemaking since it is outside the purview of
                the code valuation process stipulated by statute.
                 In response to comments, in the CY 2019 PFS final rule (83 FR
                59515), we clarified that terms ``reference services'', ``key reference
                services'', and ``crosswalks'' as described by the commenters are part
                of the RUC's process for code valuation. These are not terms that we
                created, and we do not agree that we necessarily must employ them in
                the identical fashion for the purposes of discussing our valuation of
                individual services that come up for review. However, in the interest
                of minimizing confusion and providing clear language to facilitate
                stakeholder feedback, we will seek to limit the use of the term,
                ``crosswalk,'' to those cases where we are making a comparison to a CPT
                code with the identical work RVU. We also occasionally make use of a
                ``bracket'' for code valuation. A ``bracket'' refers to when a work RVU
                falls between the values of two CPT codes, one at a higher work RVU and
                one at a lower work RVU.
                 We look forward to continuing to engage with stakeholders and
                commenters, including the RUC, as we prioritize our obligation to value
                new, revised, and potentially misvalued codes; and will continue to
                welcome feedback from all interested parties regarding valuation of
                services for consideration through our rulemaking process. We refer
                readers to the detailed discussion in this section of the valuation
                considered for specific codes. Table 28 contains a list of codes and
                descriptors for which we proposed work RVUs; this included all codes
                for which we received RUC recommendations by February 10, 2020. As
                noted in the CY 2021 PFS proposed rule, the proposed work RVUs, work
                time and other payment information for all CY 2021 payable codes are
                available on the CMS website under downloads for the CY 2021 PFS final
                rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
                3. Methodology for the Direct PE Inputs To Develop PE RVUs
                a. Background
                 On an annual basis, the RUC provides us with recommendations
                regarding PE inputs for new, revised, and potentially misvalued codes.
                We review the RUC-recommended direct PE inputs on a code by code basis.
                Like our review of recommended work RVUs, our review of recommended
                direct PE inputs generally includes, but is not limited to, a review of
                information provided by the RUC, HCPAC, and other public commenters,
                medical literature, and comparative databases, as well as a comparison
                with other codes within the PFS, and consultation with physicians and
                health care professionals within CMS and the federal government, as
                well as Medicare claims data. We also assess the methodology and data
                used to develop the recommendations submitted to us by the RUC and
                other public commenters and the rationale for the recommendations. When
                we determine that the RUC's recommendations appropriately estimate the
                direct PE inputs (clinical labor, disposable supplies, and medical
                equipment) required for the typical service, are consistent with the
                principles of relativity, and reflect our payment policies, we use
                those direct PE inputs to value a service. If not, we refine the
                recommended PE inputs to better reflect our estimate of the PE
                resources required for the service. We also confirm whether CPT codes
                should have facility and/or nonfacility direct PE inputs and refine the
                inputs accordingly.
                 Our review and refinement of the RUC-recommended direct PE inputs
                includes many refinements that are common across codes, as well as
                refinements that are specific to particular services. Table 29 details
                our refinements of the RUC's direct PE recommendations at the code-
                specific level. In section II.B. of the proposed rule (85 FR 50077),
                Determination of Practice Expense Relative Value Units (PE RVUs), we
                addressed certain refinements that would be common across codes.
                Refinements to particular codes are addressed in the portions of that
                section that are dedicated to particular codes. We noted that for each
                refinement, we indicated the impact on direct costs for that service.
                We noted that, on average, in any case where the impact on the direct
                cost for a particular refinement is $0.35 or less, the refinement has
                no impact on the PE RVUs. This calculation considers both the impact on
                the direct portion of the PE RVU, as well as the impact on the indirect
                allocator for the average service. We also noted that approximately
                half of the refinements listed in Table 29 result in changes under the
                $0.35 threshold and are unlikely to result in a change to the RVUs.
                 We also noted that the direct PE inputs for CY 2021 are displayed
                in the CY 2021 direct PE input files, available on the CMS website
                under the 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. The inputs
                displayed there have been used in developing the CY 2021 PE RVUs as
                displayed in Addendum B.
                [[Page 84601]]
                b. Common Refinements
                (1) Changes in Work Time
                 Some direct PE inputs are directly affected by revisions in work
                time. Specifically, changes in the intraservice portions of the work
                time and changes in the number or level of postoperative visits
                associated with the global periods result in corresponding changes to
                direct PE inputs. The direct PE input recommendations generally
                correspond to the work time values associated with services. We noted
                that we believe that inadvertent discrepancies between work time values
                and direct PE inputs should be refined or adjusted in the establishment
                of proposed direct PE inputs to resolve the discrepancies.
                (2) Equipment Time
                 Prior to CY 2010, the RUC did not generally provide CMS with
                recommendations regarding equipment time inputs. In CY 2010, in the
                interest of ensuring the greatest possible degree of accuracy in
                allocating equipment minutes, we requested that the RUC provide
                equipment times along with the other direct PE recommendations, and we
                provided the RUC with general guidelines regarding appropriate
                equipment time inputs. We appreciate the RUC's willingness to provide
                us with these additional inputs as part of its PE recommendations.
                 In general, the equipment time inputs correspond to the service
                period portion of the clinical labor times. We clarified this principle
                over several years of rulemaking, indicating that we consider equipment
                time as the time within the intraservice period when a clinician is
                using the piece of equipment plus any additional time that the piece of
                equipment is not available for use for another patient due to its use
                during the designated procedure. For those services for which we
                allocate cleaning time to portable equipment items, because the
                portable equipment does not need to be cleaned in the room where the
                service is furnished, we do not include that cleaning time for the
                remaining equipment items, as those items and the room are both
                available for use for other patients during that time. In addition,
                when a piece of equipment is typically used during follow-up
                postoperative visits included in the global period for a service, the
                equipment time would also reflect that use.
                 We believe that certain highly technical pieces of equipment and
                equipment rooms are less likely to be used during all of the preservice
                or postservice tasks performed by clinical labor staff on the day of
                the procedure (the clinical labor service period) and are typically
                available for other patients even when one member of the clinical staff
                may be occupied with a preservice or postservice task related to the
                procedure. We also note that we believe these same assumptions would
                apply to inexpensive equipment items that are used in conjunction with
                and located in a room with non-portable highly technical equipment
                items since any items in the room in question would be available if the
                room is not being occupied by a particular patient. For additional
                information, we refer readers to our discussion of these issues in the
                CY 2012 PFS final rule with comment period (76 FR 73182) and the CY
                2015 PFS final rule with comment period (79 FR 67639).
                (3) Standard Tasks and Minutes for Clinical Labor Tasks
                 In general, the preservice, intraservice, and postservice clinical
                labor minutes associated with clinical labor inputs in the direct PE
                input database reflect the sum of particular tasks described in the
                information that accompanies the RUC-recommended direct PE inputs,
                commonly called the ``PE worksheets.'' For most of these described
                tasks, there is a standardized number of minutes, depending on the type
                of procedure, its typical setting, its global period, and the other
                procedures with which it is typically reported. The RUC sometimes
                recommends a number of minutes either greater than or less than the
                time typically allotted for certain tasks. In those cases, we review
                the deviations from the standards and any rationale provided for the
                deviations. When we do not accept the RUC-recommended exceptions, we
                refine the proposed direct PE inputs to conform to the standard times
                for those tasks. In addition, in cases when a service is typically
                billed with an E/M service, we remove the preservice clinical labor
                tasks to avoid duplicative inputs and to reflect the resource costs of
                furnishing the typical service.
                 We refer readers to section II.B. of the proposed rule (85 FR
                50077), Determination of Practice Expense Relative Value Units (PE
                RVUs), for more information regarding the collaborative work of CMS and
                the RUC in improvements in standardizing clinical labor tasks.
                (4) Recommended Items That Are Not Direct PE Inputs
                 In some cases, the PE worksheets included with the RUC's
                recommendations include items that are not clinical labor, disposable
                supplies, or medical equipment or that cannot be allocated to
                individual services or patients. We addressed these kinds of
                recommendations in previous rulemaking (78 FR 74242), and we do not use
                items included in these recommendations as direct PE inputs in the
                calculation of PE RVUs.
                (5) New Supply and Equipment Items
                 The RUC generally recommends the use of supply and equipment items
                that already exist in the direct PE input database for new, revised,
                and potentially misvalued codes. However, some recommendations include
                supply or equipment items that are not currently in the direct PE input
                database. In these cases, the RUC has historically recommended that a
                new item be created and has facilitated our pricing of that item by
                working with the specialty societies to provide us copies of sales
                invoices. For CY 2021 we received invoices for several new supply and
                equipment items. Tables 31 and 32 detail the invoices received for new
                and existing items in the direct PE database. As discussed in section
                II.B. of the proposed rule (85 FR 50077), Determination of Practice
                Expense Relative Value Units, we encouraged stakeholders to review the
                prices associated with these new and existing items to determine
                whether these prices appear to be accurate. Where prices appear
                inaccurate, we encouraged stakeholders to submit invoices or other
                information to improve the accuracy of pricing for these items in the
                direct PE database by February 10th of the following year for
                consideration in future rulemaking, similar to our process for
                consideration of RUC recommendations.
                 We remind stakeholders that due to the relativity inherent in the
                development of RVUs, reductions in existing prices for any items in the
                direct PE database increase the pool of direct PE RVUs available to all
                other PFS services. Tables 31 and 32 also included the number of
                invoices received and the number of nonfacility allowed services for
                procedures that use these equipment items. We provide the nonfacility
                allowed services so that stakeholders will note the impact the
                particular price might have on PE relativity, as well as to identify
                items that are used frequently, since we believe that stakeholders are
                more likely to have better pricing information for items used more
                frequently. A single invoice may not be reflective of typical costs and
                we encourage stakeholders to provide additional invoices so that we
                might identify and use accurate prices in the development of PE RVUs.
                 In some cases, we did not use the price listed on the invoice that
                [[Page 84602]]
                accompanies the recommendation because we identify publicly available
                alternative prices or information that suggests a different price is
                more accurate. In these cases, we include this in the discussion of
                these codes. In other cases, we cannot adequately price a newly
                recommended item due to inadequate information. Sometimes, no
                supporting information regarding the price of the item has been
                included in the recommendation. In other cases, the supporting
                information does not demonstrate that the item has been purchased at
                the listed price (for example, vendor price quotes instead of paid
                invoices). In cases where the information provided on the item allows
                us to identify clinically appropriate proxy items, we might use
                existing items as proxies for the newly recommended items. In other
                cases, we included the item in the direct PE input database without any
                associated price. Although including the item without an associated
                price means that the item does not contribute to the calculation of the
                final PE RVU for particular services, it facilitates our ability to
                incorporate a price once we obtain information and are able to do so.
                (6) Service Period Clinical Labor Time in the Facility Setting
                 Generally speaking, our direct PE inputs do not include clinical
                labor minutes assigned to the service period because the cost of
                clinical labor during the service period for a procedure in the
                facility setting is not considered a resource cost to the practitioner
                since Medicare makes separate payment to the facility for these costs.
                We addressed code-specific refinements to clinical labor in the
                individual code sections.
                (7) Procedures Subject to the Multiple Procedure Payment Reduction
                (MPPR) and the OPPS Cap
                 We noted that the public use files for the PFS proposed and final
                rules for each year display the services subject to the MPPR for
                diagnostic cardiovascular services, diagnostic imaging services,
                diagnostic ophthalmology services, and therapy services. We also
                include a list of procedures that meet the definition of imaging under
                section 1848(b)(4)(B) of the Act, and therefore, are subject to the
                OPPS cap for the upcoming calendar year. The public use files for CY
                2021 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. For more
                information regarding the history of the MPPR policy, we refer readers
                to the CY 2014 PFS final rule with comment period (78 FR 74261 through
                74263). For more information regarding the history of the OPPS cap, we
                refer readers to the CY 2007 PFS final rule with comment period (71 FR
                69659 through 69662).
                4. Proposed Valuation of Specific Codes for CY 2021
                (1) Fine Needle Aspiration (CPT Codes 10021, 10004, 10005, 10006,
                10007, 10008, 10009, 10010, 10011, and 10012)
                 In June 2017, the CPT Editorial Panel deleted CPT code 10022,
                revised CPT code 10021, and created nine new codes to describe fine
                needle aspiration procedures with and without imaging guidance. These
                ten codes were surveyed and reviewed for the October 2017 and January
                2018 RUC meetings. In the CY 2019 PFS final rule, we finalized the RUC-
                recommended work RVU for seven of the ten codes in the family, while
                finalizing a lower work RVU for CPT codes 10005 (Fine needle aspiration
                biopsy, including ultrasound guidance; first lesion), 10009 (Fine
                needle aspiration biopsy, including CT guidance; first lesion), and
                10021 (Fine needle aspiration biopsy, without imaging guidance; first
                lesion). For a full discussion of this review, we refer readers to the
                CY 2019 PFS final rule (83 FR 59517 through 59521).
                 Following the publication of the CY 2019 PFS final rule, RUC staff
                stated that CMS erroneously double-counted the utilization for new
                codes that had image guidance bundled. We disagreed that this
                constituted a technical error and communicated to the RUC in
                conversations following the publication of the rule that the surveying
                specialties could instead nominate the affected codes from these
                families as being potentially misvalued. At the January 2020 RUC
                meeting, the RUC reaffirmed its CY 2019 recommendations for physician
                work and direct PE for the ten codes in the Fine Needle Aspiration code
                family.
                 In discussing this group of codes, we would like to clarify again
                that we disagree with the RUC and do not believe that utilization was
                erroneously double-counted for this code family. We publish our
                proposed utilization crosswalk each year as a public use file available
                on the CMS website; the current such file is available 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. During the CY 2019 rule cycle, we proposed the
                utilization crosswalk for the Fine Needle Aspiration family as it was
                recommended to CMS by the RUC, and we did not receive any comments on
                this subject until after the valuation of these codes had been
                finalized. We proposed and finalized the utilization crosswalk for this
                code family as recommended by the RUC without receiving any comments
                from the RUC or other stakeholders. If the RUC or other stakeholders
                believed that what CMS had proposed was incorrect or misunderstood what
                the RUC had recommended, there was an opportunity to comment during the
                60 days following the publication of the proposed rule. We disagreed
                that the utilization crosswalk was erroneous, and we did not make a
                technical correction following the publication of the CY 2019 PFS final
                rule for this reason.
                 We also disagreed with the RUC that the utilization crosswalk was
                ``the principle reason CMS rejected the RUC recommendations'' for the
                codes in the Fine Needle Aspiration family, as stated in the RUC's CY
                2021 recommendations for this code family. As we stated in the CY 2019
                PFS proposed rule and restated in the CY 2019 PFS final rule, our
                refinements to the work RVUs of CPT codes 10021, 10005, and 10009 were
                primarily based on changes in surveyed work time and the relationship
                between the codes in the family. For example, this was our rationale
                for refining the work RVU of CPT code 10021 from the RUC-recommended
                value of 1.20 to the finalized value of 1.03: In reviewing CPT code
                10021, we noted that the recommended intraservice time is decreasing
                from 17 minutes to 15 minutes (12 percent reduction), and the
                recommended total time is decreasing from 48 minutes to 33 minutes (32
                percent reduction); however, the RUC-recommended work RVU is only
                decreasing from 1.27 to 1.20, which is a reduction of just over 5
                percent. In the case of CPT code 10021, we believed that it was more
                accurate to propose a work RVU of 1.03 based on a crosswalk to CPT code
                36440 to account for these decreases in the surveyed work time (83 FR
                59518). We noted that this primary rationale for refining the work RVU
                did not mention the utilization crosswalk at all.
                 When we communicated to the RUC following the publication of the CY
                2019 PFS final rule that the codes in the Fine Needle Aspiration family
                could be nominated as potentially misvalued, we indicated that we were
                open to receiving new information about the valuation of these codes.
                In reaffirming its recommendations from CY 2019, however, the RUC has
                not provided any
                [[Page 84603]]
                new information that was not already presented for the previous CMS
                review of these codes. Therefore, we did not propose any changes to the
                codes in the Fine Needle Aspiration family, as the reaffirmed CY 2021
                RUC recommendations are identical to the CY 2019 RUC recommendations
                that already went through notice and comment rulemaking. We welcomed
                the submission of new information regarding these services that was not
                part of the previous CY 2019 review of the code family.
                 We received public comments on the Fine Needle Aspiration code
                family. The following is a summary of the comments we received and our
                responses.
                 Comment: Several commenters maintained that CMS inadvertently
                double counted each bundled image guidance code during their RUC
                recommendation evaluation in CY 2019 due to a misinterpretation of the
                RUC's utilization crosswalk recommendations. Commenters stated that
                after correcting for double counting the utilization for the newly
                created bundled codes, the work pool based on the RUC-recommended
                values would have instead resulted in a decrease by 15 percent using
                the CMS utilizations from the CY 2019 PFS proposed rule. Commenters
                stated that based on the CMS proposed reductions, the work pool for the
                family would decrease by 23 percent based on the utilization data
                available during the CY 2019 rulemaking.
                 Response: As we stated in the CY 2021 PFS proposed rule (85 FR
                50152), we continue to disagree with the RUC and do not believe that
                utilization was erroneously double-counted for this code family. We
                proposed and finalized the utilization crosswalk for this code family
                as recommended by the RUC without receiving any comments from the RUC
                or other stakeholders and we did not make a technical correction
                following the publication of the CY 2019 PFS final rule for this
                reason.
                 Comment: Several commenters stated that they had new information to
                provide based on reviewing actual claim data from CY 2019 to assess the
                accuracy of the RVU pool estimates during the CY 2019 rulemaking
                process. Commenters stated that CMS' projected RVU pool for CY 2019 for
                the updated Fine Needle Aspiration code family was over twice as high
                as what actually occurred in 2019 even though the utilization for the
                newly created codes is largely identical to the source utilization from
                CPT codes 10021 and 10022. Commenters recommended CMS to finalize the
                RUC-recommended work RVUs for CPT codes 10005, 10009, and 10021.
                 Response: We appreciate the additional information provided by the
                commenters in their review of the claims data from CY 2019. However, we
                note that it is not typically part of our methodology to review the
                accuracy of the RUC-recommended utilization crosswalk against the
                claims data when it becomes available 2 years later. Historically,
                there have been many times when the projected crosswalk overestimated
                utilization for a new service. Also, there have been many times when
                the projected crosswalk underestimated utilization. In the absence of a
                systematic process to investigate the accuracy of these projected
                utilization crosswalks across a broad range of services, we do not
                believe that it would serve the interests of relativity to single out
                individual code families and compare them against their projected
                crosswalks. It would distort relativity to conduct this analysis in
                situations where it might be advantageous for valuation while failing
                to conduct the same analysis in situations where it might be
                disadvantageous.
                 More importantly, we continue to disagree with the RUC that the
                utilization crosswalk was ``the principle reason CMS rejected the RUC
                recommendations'' for the codes in the Fine Needle Aspiration family,
                as stated in the RUC's CY 2021 recommendations for this code family. As
                we stated in the CY 2019 PFS proposed rule, restated in the CY 2019 PFS
                final rule, and again restated in the CY 2021 PFS proposed rule, our
                refinements to the work RVUs of CPT codes 10021, 10005, and 10009 were
                primarily based on changes in surveyed work time and the relationship
                between the codes in the family. We noted that this primary rationale
                for refining the work RVU did not mention the utilization crosswalk at
                all. We continue to believe that the changes in surveyed work time and
                the relationship between the codes in the family support the work
                valuations finalized in CY 2019 rulemaking.
                 Comment: Several commenters disagreed with the rationale provided
                by CMS when the work RVUs for these codes were finalized in CY 2019
                rulemaking. Commenters stated that CMS continued to use intraservice
                time ratios to revalue codes and then applied inappropriate crosswalks
                to justify their logic. Commenters stated that the CMS crosswalk codes,
                such as CPT code 36440 (Push transfusion, blood, 2 years or younger),
                are not clinically similar to the reviewed codes including the
                associated risks and required decision-making. Commenters stated that
                the work RVU for CPT code 10005 could be more appropriately crosswalked
                to CPT code 76978 (Ultrasound, targeted dynamic microbubble sonographic
                contrast characterization (non-cardiac); initial lesion) based on the
                identical intraservice work time, intensity, complexity similarities,
                and ultrasound service similarities. Commenters similarly stated that
                the work RVU of CPT code 10021 could be more accurately crosswalked to
                CPT code 95866 (Needle electromyography; hemidiaphragm). Commenters
                again suggested CMS to finalize the RUC's reaffirmed work RVUs for
                these services.
                 Response: We disagree with these valuation suggestions presented by
                the commenters as they reiterate the same arguments that we considered
                and ultimately did not finalize when the codes in the Fine Needle
                Aspiration were previously reviewed. For a full discussion of this
                subject, we direct readers to the CY 2019 PFS final rule (83 FR 59517-
                59521). We continue to believe that the changes in surveyed work time
                and the relationship between the codes in the family support the work
                valuations finalized in CY 2019 rulemaking.
                 Comment: Several commenters stated that for several equipment
                items, including the mayo stand (EF015), the exam table (EF023), and
                the portable ultrasound unit (EQ250), it appeared that there was a
                calculation error in CMS' direct PE refinement table. Commenters
                provided a spreadsheet which clarified the RUC's comments on individual
                refinements of direct PE inputs with suggested equipment times for
                these items.
                 Response: We disagree with the commenters and we continue to
                believe that the equipment times finalized in CY 2019 rulemaking are
                correct. The finalized equipment times for these three equipment items
                conform to the standard established policies for non-highly technical
                equipment. The equipment times recommended by the commenters do not
                conform to these standard equipment time formulas, instead adding
                additional time for the ``Complete post-procedure diagnostic forms, lab
                and x-ray requisitions'' (CA027) and ``Review home care instructions,
                coordinate visits/prescriptions'' (CA035) clinical labor activities. In
                particular, we note that the CA035 clinical labor activity is not part
                of the standard established policies for non-highly technical equipment
                formula; the RUC has mistakenly labeled it as such on some of their
                recommended PE spreadsheets. Since
                [[Page 84604]]
                these clinical labor activities are not part of the standard equipment
                time formula, and we have no reason to believe that they would be
                typical for the services in question; we continue to believe that the
                equipment times finalized in CY 2019 rulemaking are correct.
                 We did not propose any changes to the codes in the Fine Needle
                Aspiration family and although we appreciate the information supplied
                by the commenters, we are not finalizing any changes to these services.
                In the event that there is a new review of these services, as opposed
                to a reaffirmation of the previous review, we would look forward to
                receiving any additional information or new data.
                (2) Tissue Expander Other Than Breast (CPT Code 11960)
                 This service was included in a larger group of similarly related
                codes that were recommended for review for the October 2019 RUC
                meeting. The RUC recommended re-reviewing this code at a more granular
                level for the January 2020 RUC meeting.
                 We disagreed with the RUC-recommended work RVU of 12.40 for CPT
                code 11960 (tissue expander other than breast). We proposed to maintain
                the current work RVU of 11.49 supported by a reference code, CPT code
                45560 (repair of rectocele (separate procedure)), which has a work RVU
                of 11.50. CPT code 45560 shares the same intraservice time of 90
                minutes with CPT code 11960 and has a slightly higher total time of 367
                minutes. The recommended total time for CPT code 11960 decreased from
                444 minutes to 357 minutes, with a slight increase in intraservice time
                of 78 minutes to 90 minutes. We noted that we believe the similar work
                RVU of the reference CPT code 45560, as well as the reduction in total
                time, supports maintaining the current work RVU of 11.49 for CPT code
                11960. We proposed the RUC-recommended direct PE inputs for CPT code
                11960 without refinements.
                 We received public comments on the Tissue Expander Other Than
                Breast.
                 The following is a summary of the comments we received and our
                responses.
                 Comment: Several commenters disagreed with the proposal to maintain
                the current work RVU of 11.49 for CPT code 11960 (Tissue expander other
                than breast) and stated that CMS should finalize the RUC-recommended
                work RVU of 12.40. In particular, commenters stated they believe that
                there is an anomalous relationship between current work RVU and current
                physician time reflected in an inappropriate intensity. The commenters
                also believe that we have not appropriately accounted for the RUC-
                recommended increase in intraservice time.
                 Response: We acknowledge that the RUC recommended an increase in
                intraservice time. However, we believe that when our review of
                recommended values reveals changes in time that have been unaccounted
                for in a recommended RVU, such as in the decrease of total time
                unaccounted for with CPT code 11960, we believe it is appropriate to
                account for that change in establishing work RVUs since the statute
                explicitly identifies time as one of the two elements of the work RVUs.
                To validate further our valuations for work RVUs, we incorporate
                multiple methodologies, which also consider intensity of the service.
                For additional information regarding our use of methodologies for code
                valuation, we refer readers to our discussion of the subject in the
                Methodology for Establishing Work RVUs section of this rule (section
                II.H.2. of this final rule).
                 Comment: Commenters stated that they disagree with our use of the
                chosen reference code, CPT code 45560 (Repair of rectocele (separate
                procedure)). Commenters stated that they believe the chosen reference
                code does not accurately support the proposed work times for this code
                because it is ``low volume'' and it has been too long since the last
                survey to be an accurate comparison for determining an appropriate
                valuation. The commenters also stated that there is no evidence to
                support a clinical comparison between CPT code 11960 and the chosen
                reference code.
                 Response: We consider reference codes as supportive of a code
                valuation rather than as a direct ``cross-walk.'' CPT code 45560 has a
                work RVU of 11.50. It shares the same intraservice time of 90 minutes
                with CPT code 11960 and has a slightly higher total time of 367
                minutes. We do not agree that codes must share the same patient
                population or utilization level to serve as an appropriate reference
                code. We also recognize that it is important to use recent data
                available regarding work times. However, we believe that while some
                reference codes may not have been recently surveyed, they still provide
                support for revision of work RVUs when survey times show a marked
                decrease in time.
                 After consideration of these public comments, we are finalizing the
                work RVU and direct PE inputs for CPT code 11960 as proposed.
                (3) Breast Implant-Expander Placement (CPT Codes 11970, 19325, 19340,
                19342, and 19357)
                 These services were included in a larger group of 22 breast
                reconstruction and similarly related codes that were recommended for
                survey for the October 2019 RUC meeting. At the October 2019 RUC
                meeting, these codes were recommended for a more granular review for
                the January 2020 RUC meeting.
                 We disagreed with the RUC-recommended work RVU of 8.01 for CPT code
                11970 (replacement of tissue expander with permanent implant). We
                proposed a work RVU of 7.49 supported by a reference code CPT code
                35701 (exploration not followed by surgical repair, artery; neck (e.g.,
                carotid, subclavian)), which has a work RVU of 7.50. CPT code 35701
                shares the same intraservice time of 60 minutes with CPT code 11970 and
                has a slightly higher total time of 229 minutes as compared to 216
                minutes. In addition, during our review of CPT code 11970, we noted
                that the recommended intraservice time is decreasing from 78 minutes to
                60 minutes and the recommended total time of 231 minutes is decreasing
                to 216 minutes. We also noted that the proposed work RVU of 7.49 for
                CPT code 11970 is equal to the total time ratio amount, which is the
                current total time compared to the RUC-recommended total time. We
                proposed the RUC-recommended direct PE inputs for CPT code 11970.
                 We disagreed with the RUC-recommended work RVU of 8.64 for CPT code
                19325 (breast augmentation with implant). Although we disagreed with
                the RUC-recommended work RVU, we concurred that the relative difference
                in work between CPT codes 11970 and 19325 is equivalent to the RUC-
                recommended interval of 0.63 RVUs. Therefore, we proposed a work RVU of
                8.12 for CPT code 19325, based on the RUC-recommended interval of 0.63
                additional RVUs above our proposed work RVU of 7.49 for CPT code 11970.
                We noted that we believe the use of an incremental difference between
                these CPT codes is a valid methodology for setting values, especially
                in valuing services within a family of revised codes where it is
                important to maintain appropriate intra-family relativity. We also
                supported the proposed work RVU of 8.12 based on a reference code, CPT
                code 25652 (open treatment of ulnar styloid fracture). CPT code 25652
                shares the same intraservice time of 60 minutes and the same total time
                of 225 minutes with a lower work RVU of 8.06. In addition, during our
                review of CPT code
                [[Page 84605]]
                19325, we noted that the total time has decreased from 244 minutes to
                225 minutes and the intraservice time has decreased from 90 minutes to
                60 minutes. We proposed the RUC-recommended direct PE inputs for CPT
                code 19325.
                 We disagreed with the RUC-recommended work RVU of 11.00 for CPT
                code 19340 (insertion of breast implant on same day of mastectomy (i.e.
                immediate)). Although we disagreed with the RUC-recommended work RVU,
                we concurred that the relative difference in work between CPT codes
                19325 and 19340 is equivalent to the RUC-recommended interval of 2.36
                RVUs. Therefore, we proposed a work RVU of 10.48 for CPT code 19340,
                based on the recommended interval of 2.36 additional RVUs above our
                proposed work RVU of 8.12 for CPT code 19325. We also supported our
                proposed work RVU of 10.48 based on a reference code, CPT code 47562
                (laparoscopy, surgical; cholecystectomy). CPT code 47562 shares the
                same intraservice time of 80 minutes and only a slightly lower total
                time of 251 minutes with a similar work RVU of 10.47. In addition,
                during our review of CPT code 19340, we noted that the total time has
                decreased from 366 minutes to 261 minutes and the intraservice time has
                decreased from 120 minutes to 80 minutes. We proposed the RUC-
                recommended direct PE inputs for CPT code 19340.
                 We disagreed with the RUC-recommended work RVU of 11.00 for CPT
                code 19342 (insertion or replacement of breast implant on different day
                from mastectomy). Although we disagreed with the RUC-recommended work
                RVU, we concurred that the relative difference in work between CPT
                codes 19325 and 19342 is equivalent to the RUC-recommended interval of
                2.36 RVUs. Therefore, we proposed a work RVU of 10.48 for CPT code
                19342, based on the recommended interval of 2.36 additional RVUs above
                our proposed work RVU of 8.12 for CPT code 19325. We also noted that
                the RUC-recommended work RVU of 11.00 is equal to the RUC-recommended
                work RVU for CPT code 19340 because they have stated that both services
                involve an identical amount of physician work and similar times. We
                also supported our proposed work RVU of 10.48 based on a reference
                code, CPT code 47562 (laparoscopy, surgical; cholecystectomy). CPT code
                47562 shares the same intraservice time of 80 minutes and only a
                slightly lower total time of 251 minutes with a similar work RVU of
                10.47. The total time for CPT code 19342 has decreased from 320 minutes
                to 252 minutes and the intraservice time has decreased from 115 minutes
                to 80 minutes. We proposed the RUC-recommended direct PE inputs for CPT
                code 19342.
                 We disagreed with the RUC-recommended work RVU of 15.36 for CPT
                code 19357 (tissue expander placement in breast reconstruction,
                including subsequent expansion). Although we disagreed with the RUC-
                recommended work RVU, we concurred that the relative difference in work
                between CPT codes 11970 and 19357 is equivalent to the RUC-recommended
                interval of 7.35 RVUs. Therefore, we proposed a work RVU of 14.84 for
                CPT code 19357, based on the recommended interval of 7.35 additional
                RVUs above our proposed work RVU of 7.49 for CPT code 11970. We also
                supported our proposed work RVU of 14.84 based on a reference code, CPT
                code 37605 (ligation; internal or common carotid artery). CPT code
                37605 shares the same intraservice time of 90 minutes and only a
                slightly lower total time of 342 minutes with a lower work RVU of
                14.28. In addition, during our review of CPT code 19357, we noted that
                the total time has decreased from 468 minutes to 344 minutes and the
                intraservice time has decreased from 110 minutes to 90 minutes. We
                proposed the RUC-recommended direct PE inputs for CPT code 19357.
                 We received public comments on the Breast Implant-Expander
                Placement code family. The following is a summary of the comments we
                received and our responses.
                 Comment: Commenters disagreed with the proposed work RVU of 7.49
                for CPT code 11970 and stated that CMS should finalize the RUC-
                recommended work RVU of 8.01. Commenters stated that they disagree with
                the use of the total time ratio methodology for the valuation of this
                code. The commenters stated that they believe the total time ratio is
                invalid because it uses 30-year-old total time from the Harvard Study.
                Additionally, commenters stated that they believe CMS did not consider
                intensity of the service while using this methodology, which they
                believe is actually much higher than what CMS has accounted for.
                Commenters stated that they believe CMS substituted an arbitrary
                determination of work values derived from time and a subjective
                estimate of intensity based on an unknown and clinically uniformed
                opinion.
                 Response: We disagree and continue to believe that the use of time
                ratios is an appropriate method for identifying potential work RVUs for
                particular PFS services. In regard to the age of the data from the
                Harvard study, if we were to operate under the assumption that
                previously recommended work times are now arbitrarily invalid, this
                would undermine the relativity of the work RVUs on the PFS in general,
                given that codes are, and have been over many years, often valued by
                comparisons to codes with similar times. For CPT code 11970, survey
                times showed a total time and intraservice time decrease. Therefore, we
                believe the total time ratio, as a comparison of the current work time
                versus the RUC-recommended work times, is an appropriate methodology to
                value the work for this CPT code. For additional information regarding
                our use of time ratios for code valuation, we refer readers to our
                discussion of the subject in the Methodology for Establishing Work RVUs
                section of this rule (section II.H.2. of this final rule).
                 Comment: Commenters disagreed with the proposed work RVU of 8.12
                for CPT code 19325 and stated that CMS should finalize the RUC-
                recommended work RVU of 8.64. Commenters also disagreed with the
                proposed work RVU of 10.48 for CPT code 19340 and CPT code 19342 and
                stated that we should finalize the RUC-recommended work RVU of 11.00
                for both CPT codes. Commenters also stated that they disagreed with the
                proposed work RVU of 14.84 for CPT code 19357 and stated that instead
                we should finalize the RUC-recommended work RVU of 15.36. Commenters
                stated that they do not support the use of an incremental methodology
                as an appropriate method for identifying work RVUs for these PFS
                services. In particular, commenters noted that they believe this
                methodology adds fragility to the relative value system, as an error in
                the foundation code could affect the entire code family.
                 Response: We believe the use of an incremental difference between
                codes is a valid methodology for setting values, especially in valuing
                services within a family of revised codes where it is important to
                maintain appropriate intra-family relativity. We have no evidence to
                suggest that the use of an incremental difference between codes
                conflicts with the statute's definition of the work component as the
                resources in time and intensity required in furnishing the service. We
                do consider clinical information associated with physician work
                intensity provided by the RUC and other stakeholders as part of our
                review process, although we remind readers again that we do not agree
                that codes must share the same site of service, patient population, or
                utilization level to serve as an appropriate crosswalk. For additional
                information regarding
                [[Page 84606]]
                our use of an incremental difference for code valuation, we refer
                readers to our discussion of the subject in the Methodology for
                Establishing Work RVUs section of this rule (section II.H.2. of this
                final rule).
                 Comment: Commenters disagreed with our use of the chosen supporting
                reference codes throughout the code family. For CPT code 11970, CPT
                code 19325, and CPT code19357, commenters stated that they believe the
                chosen reference codes are too ``low-volume'' to accurately support the
                proposed work times for these codes. Additionally, commenters stated
                that for CPT code 19325, CPT code 19340, CPT code 19342, and CPT code
                19357, that the work values for the reference codes chosen by CMS are
                too old to be accurate comparisons for determining appropriate
                valuations. The commenters also stated that several of the reference
                codes are not relevant for purposes of valuation because there is no
                evidence to support clinical comparison.
                 Response: We are statutorily obligated to consider both time and
                intensity in establishing work RVUs for PFS services. Additionally, we
                use other methods to validate work RVUs, such as reference codes. When
                using reference codes to support a proposed work RVU, we do not
                consider them as a direct ``cross-walk'' between the CPT code that is
                being revalued and the chosen reference code. Instead, a reference code
                used as a supportive check in validating work times. We continue to
                believe that the relative value system of the PFS is such that all
                services are appropriately subject to comparisons to one another. We do
                not agree that codes must share the same patient population or
                utilization level to serve as an appropriate reference code. We also
                recognize that it is important to use the most recent data available
                regarding work times. However, we believe that while some reference
                code values may be considered older, they still provide support for
                revision of work RVUs when survey times show a marked increase or
                decrease in total and intraservice time, such as was the case for this
                code family.
                 Comment: Commenters stated that CMS must ensure that any RVU
                reduction of more than 19 percent is phased in over 2 years, under
                1848(c)(7) of the Act. The commenter stated that the magnitude of the
                proposed RVU reductions for CPT codes 19340 and 19357 would trigger the
                phase-in requirements since they would be decreasing by more than 19
                percent.
                 Response: Section 1848(c)(7) of the Act, as added by section 220(e)
                of the PAMA, 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. We proposed to exempt
                all of the CPT codes in the Breast Implant-Expander Placement family
                from the phase-in of significant RVU reductions required by section
                1848(c)(7) of the Act due to the fact that they were designated as
                ``revised'' codes by CPT as a result of significant revisions to their
                code descriptors. Since all of the codes in the family fall under the
                revised designation, the phase-in requirement does not apply to them.
                 Comment: Commenters stated that they are concerned that reducing
                reimbursement for the services in this code family could limit access
                to breast reconstruction following mastectomy. The commenters cited a
                study done by Kamali P et al., titled: Immediate Breast Reconstruction
                among Patients with Medicare and Private Insurance: A Matched Cohort
                Analysis. Commenters also stated that they wanted to bring to our
                attention the Women's Health and Cancer Rights Act of 1998 (WHCRA). The
                commenters stated that this act provides coverage protection for
                patients who choose to have breast reconstruction following a
                mastectomy.
                 Response: We remain committed to supporting the health of all
                Medicare beneficiaries, as well as remaining vigilant in support of all
                services related to minority and women's health. While the WHCRA (Pub.
                L. 105-277, Title IX, Oct. 21, 1998) is an important federal law that
                furthers protections for women's healthcare rights and access to
                services, we note that Medicare does provide coverage for these
                important services.
                 After consideration of these public comments, we are finalizing the
                work RVU and direct PE inputs for the Breast Implant-Expander
                (4) Breast Implant-Expander Removal (CPT Codes 11971, 19328, and 19330)
                 These services were included in a group of codes that were
                recommended for survey for the October 2019 RUC meeting as part of a
                large group of 22 breast reconstruction and similarly related services.
                At its October 2019 meeting, the RUC agreed that a 22-code family was
                too expansive. They recommended these codes be re-reviewed as part of a
                smaller and more granular code family for the January 2020 RUC meeting.
                 We disagreed with the RUC-recommended work RVU of 7.02 for CPT code
                11971 (removal of tissue expander w/out insertion of implant). Although
                we disagreed with the RUC-recommended work RVU, we concurred that the
                relative difference in work between CPT codes 11970 and 11971 is
                equivalent to the RUC recommended interval of 0.99 RVUs. Therefore, we
                proposed a work RVU of 6.50 for CPT code 11971, based on the
                recommended interval of 0.99 RVUs below our proposed work RVU of 7.49
                for CPT code 11970. We noted that as stated previously, we believed the
                use of an incremental difference between these CPT codes is a valid
                methodology for setting values, especially in valuing services within
                families of similarly revised codes. We also supported our proposed
                work RVU of 6.50 based on a reference code, CPT code 25671
                (percutaneous skeletal fixation of distal radioulnar dislocation). CPT
                code 25671 shares the same intraservice time of 45 minutes and a
                slightly less total time of 210 minutes with a very similar work RVU of
                6.46. In addition, during our review of CPT code 11971, we noted that
                the total time has decreased from 303 minutes to 215 minutes and the
                intraservice time has decreased from 90 to 45 minutes. We proposed the
                RUC-recommended direct PE inputs for CPT code 11971.
                 We disagreed with the RUC-recommended work RVU of 7.44 for CPT code
                19328 (removal of intact breast implant). Although we disagreed with
                the RUC-recommended work RVU, we proposed increasing the current work
                RVU from 6.48 to 6.92 to account for the increases in total and
                intraservice time. We also concurred that the relative difference in
                work between CPT codes 11971 and 19328 is equivalent to the RUC-
                recommended interval of 0.42 RVUs. Therefore, we proposed a work RVU of
                6.92 for CPT code 19328, based on the recommended interval of 0.42
                additional RVUs above our proposed work RVU of 6.50 for CPT code 11970.
                We also supported our proposed work RVU of 6.92 based on a reference
                code, CPT code 28289 (Hallux rigidus correction with cheilectomy,
                debridement and capsular release of the first metatarsophalangeal
                joint; without implant). CPT code 28289 shares the same intraservice
                time of 45 minutes and a slightly higher total time of 210 minutes with
                a very similar work RVU of 6.90. The total time for CPT code 19328 has
                increased from 173 minutes to 199 minutes and the intraservice time has
                increased from 38 to 45 minutes. We proposed the RUC-recommended direct
                PE inputs for CPT code 19328.
                 We proposed the RUC-recommended work RVU of 9.00 for CPT code 19330
                [[Page 84607]]
                (removal of ruptured breast implant, including implant contents). The
                survey total time for CPT code 19330 has increased from 218 minutes to
                229 minutes and the intraservice time has increased from 62 minutes to
                75 minutes. We also proposed the RUC-recommended direct PE inputs for
                this code without refinements.
                 We received public comments on the Breast Implant-Expander Removal
                code family. The following is a summary of the comments we received and
                our responses.
                 Comment: Commenters disagreed with the proposed work RVU of 6.50
                for CPT code 11971 and stated that CMS should finalize the RUC-
                recommended work RVU of 7.02. Commenters also disagreed with the
                proposed work RVU of 6.92 for CPT code 19328 and stated that CMS should
                finalize the RUC-recommended work RVU of 7.44. Commenters stated that
                they do not support the proposed work RVU because they do not support
                the use of an incremental methodology as an appropriate tool for
                valuing services in this code family. In particular, commenters noted
                that they believe this methodology is further inappropriate because it
                uses a foundation code that is not within the same code family, which
                adds further fragility to the use of the incremental methodology for
                valuation of this code family.
                 Response: We believe the use of an incremental difference between
                codes is a valid methodology for setting values, especially in valuing
                services within a family of revised codes where it is important to
                maintain appropriate intra-family relativity.
                 Comment: Commenters disagreed with our use of the chosen supporting
                reference codes for CPT code 11971 and CPT code 19328. The commenters
                stated that they believe there is not adequate clinical comparison for
                the work portion of the service. Commenters also stated that they
                believe the reference code values are too old because they are from
                outdated survey results and do not have adequately comparable
                intensities.
                 Response: When using referencing codes to support a proposed work
                RVU, we do not consider them as a direct ``cross-walk'' between the CPT
                code that is being revalued and the chosen reference code. Instead,
                reference codes are used as a supportive check in validating work
                times. We continue to believe that the relative value system of the PFS
                is such that all services are appropriately subject to comparisons to
                one another.
                 After consideration of these public comments, we find the arguments
                for maintaining consistency in methodology and reducing the risk of
                anomalies within the valuation of this code family to be compelling. We
                are finalizing the RUC-recommended work RVU of 7.02 for CPT code 11971
                and the RUC-recommended work RVU of 7.44 for CPT code 19328. We are
                also finalizing the direct PE inputs as proposed.
                (5) Modified Radical Mastectomy (CPT Code 19307)
                 The RUC recommended that CPT code 19307 (Mastectomy, modified
                radical, including axillary lymph nodes, with or without pectoralis
                minor muscle, but excluding pectoralis major muscle) be surveyed for
                the January 2020 RUC meeting for site of service anomaly. The
                Relativity Assessment Workgroup identified services performed less than
                50 percent of the time in the inpatient setting yet included inpatient
                hospital E/M services within the global period and with 2018 Medicare
                utilization over 5,000. The RUC recommended lowering the work RVU to
                17.99 which is the survey's 25th percentile.
                 We proposed the RUC-recommended work RVUs of 17.99 for CPT code
                19307. We also proposed the RUC-recommended direct PE inputs for this
                code.
                 We received public comments on Modified Radical Mastectomy (CPT
                code 19307). The following is a summary of the comments we received and
                our responses.
                 Comment: Commenters were overall in support of CMS proposing the
                RUC recommendations for this code. One commenter noted strong support
                for the process and of the RUC. Additionally, the commenters suggested
                CMS to accept the RUC recommendations to extend the office and
                outpatient E/M work RVU increases to the office and outpatient visits
                included in 10- and 90-day globals.
                 Response: We appreciate the commenters' support for CMS proposing
                the RUC recommendation for Modified Radical Mastectomy (CPT code 19307)
                and note the commenters concern with regard to office and outpatient E/
                M work RVU increases to the office and outpatient visits included in
                10- and 90-day global.
                 After consideration of these public comments, we are finalizing as
                proposed the RUC-recommended work RVU of 17.99 for CPT code 19307. We
                are also finalizing as proposed the RUC-recommended direct PE inputs
                for this code.
                (6) Breast Lift-Reduction (CPT Codes 19316 and 19318)
                 These services were included in a larger code group of similarly
                related services that were recommended for review for the October 2019
                RUC meeting. CPT code 19316 (mastopexy) and CPT code 19318 (Breast
                reduction) were then recommended for a more granular review for the
                January 2020 RUC meeting.
                 We proposed the RUC-recommended work RVU of 11.09 for CPT code
                19316 (mastopexy) and 16.03 for CPT code 19318 (Breast reduction). We
                proposed the RUC-recommended direct PE inputs for this code family
                without refinements.
                 We did not receive public comments on this code family, and are
                finalizing as proposed.
                (7) Secondary Breast Mound Procedure (CPT Codes 19370, 19371, and
                19380)
                 These services were included in a large group of breast
                reconstruction codes that were recommended to be surveyed for the
                October 2019 RUC meeting. At the October 2019 RUC meeting, the RUC
                concurred with the more granular code families but recommended these
                codes be re-surveyed for the January 2020 RUC meeting.
                 We disagreed with the RUC-recommended work RVU of 10.0 for CPT code
                19370 (Revision of peri-implant capsule, breast, including
                capsulorrhaphy, and/or partial capsulectomy). We proposed to maintain
                the current work RVU of 9.17 based on a supporting reference code, CPT
                code 28299 (Correction, hallux valgus (bunionectomy), with
                sesamoidectomy, when performed; with double osteotomy, any method),
                which has a work RVU of 9.29. CPT code 28299 shares a similar
                intraservice time of 75 minutes with CPT code 19370 and has a slightly
                higher total time of 256 minutes. In addition, we noted during our
                review of CPT code 19370 that the recommended total time has increased
                minimally from 253 minutes to 255 minutes, with a slight decrease in
                intraservice time of 82 minutes to 78 minutes. We noted that we believe
                the similar work RVU of the supporting CPT code 28299, as well as the
                minimal changes in physician work time for CPT code 19370, supports
                maintaining the current work RVU of 9.17. We proposed the RUC-
                recommended direct PE inputs for CPT code 19370 without refinements.
                 We disagreed with the RUC-recommended work RVU of 10.81 for CPT
                code 19371 (Peri-implant
                [[Page 84608]]
                capsulectomy, breast, complete, including removal of all intra-capsular
                contents). Although we disagreed with the RUC-recommended work RVU, we
                concur that the relative difference in work between CPT codes 19370 and
                19371 is equivalent to the RUC-recommended interval of 0.81 RVUs.
                Therefore, we proposed a work RVU of 9.98 for CPT code 19371, based on
                the recommended interval of 0.81 additional RVUs above our proposed
                work RVU of 9.17 for CPT code 19370. We noted that as stated
                previously, we believe the use of an incremental difference between
                these CPT codes is a valid methodology for setting values, especially
                in valuing services within a family of revised codes where it is
                important to maintain appropriate intra-family relativity. We also
                supported our proposed work RVU of 9.98 based on a reference code, CPT
                code 25628 (Open treatment of carpal scaphoid (navicular) fracture,
                includes internal fixation, when performed). CPT code 25628 shares the
                same intraservice time of 90 minutes and a slightly higher total time
                of 277 minutes with a work RVU of 9.67. In addition, during our review
                of CPT code 19371, we noted that the total time for CPT code 19371 has
                decreased from 306 minutes to 261 minutes and the intraservice time has
                decreased from 117 to 90 minutes. We proposed the RUC-recommended
                direct PE inputs for CPT code 19371.
                 We disagreed with the RUC-recommended work RVU of 12.00 for CPT
                code 19380 (Revision of reconstructed breast (e.g., significant removal
                of tissue, re-advancement and/or re-inset of flaps in autologous
                reconstruction or significant capsular revision combined with soft
                tissue excision in implant-based reconstruction)). Although we
                disagreed with the RUC-recommended work RVU, we concurred that the
                relative difference in work between CPT codes 19371 and 19380 is
                equivalent to the RUC recommended interval of 1.19 RVUs. Therefore, we
                proposed a work RVU of 11.17 for CPT code 19380, based on the
                recommended interval of 1.19 additional RVUs above our proposed work
                RVU of 9.98 for CPT code 19371. We also supported our proposed work RVU
                of 11.17 based on a reference code, CPT code 64569 (Revision or
                replacement of cranial nerve (e.g., vagus nerve) neurostimulator
                electrode array, including connection to existing pulse generato). CPT
                code 64569 shares the same intraservice time of 120 minutes and only a
                slightly higher total time of 312 minutes with a work RVU of 11.0. The
                total time increased from 277 minutes to 307 minutes and the
                intraservice time has increased from 89 minutes to 120 minutes. We
                proposed the RUC-recommended direct PE inputs for CPT code 19380.
                 We received public comments on the Secondary Breast Mound Procedure
                (CPT codes 19370, 19371, and 19380). The following is a summary of the
                comments we received and our responses.
                 Comment: Several commenters disagreed with the proposal to maintain
                the current work RVU of 9.17 for CPT code 19370 (Revision of peri-
                implant capsule, breast, including capsulorrhaphy, and/or partial
                capsulectomy) and stated that CMS should finalize the RUC- recommended
                work RVU of 10.00. Some of the commenters disagreed with comparing the
                current intraservice time and total time from the Harvard study to the
                RUC-recommended physician time. The commenters also believed that we
                have not appropriately accounted for the CPT Editorial Panel's revised
                additional physician work that is now inclusive in the code descriptor
                and increased intensity.
                 Response: We disagree with the commenter. For CPT code 19370,
                survey times showed only a slight increase in total time and slight
                decrease in intraservice time. Therefore, we continue to believe that
                the survey time does not support increasing the work RVU; in
                particular, there was no significant change in total time.
                 Comment: Commenters disagreed with the proposed work RVU of 9.98
                for CPT code 19371 (Peri-implant capsulectomy, breast, complete,
                including removal of all intra-capsular contents) and stated that CMS
                should finalize the RUC-recommended work RVU of 10.81. Commenters also
                disagreed with the proposed work RVU of 11.17 for CPT code 1980
                (Revision of reconstructed breast (e.g., significant removal of tissue,
                re-advancement and/or re-inset of flaps in autologous reconstruction or
                significant capsular revision combined with soft tissue excision in
                implant-based reconstruction)) and stated that we should finalize the
                RUC-recommended work RVU of 12.00. Commenters stated that they do not
                support the use of an incremental methodology as an appropriate method
                for identifying work RVUs for these PFS services. In particular,
                commenters noted that they believe this methodology adds fragility to
                the relative value system, as an error in the foundation code could
                affect the entire code family.
                 Response: We believe the use of an incremental difference between
                codes is a valid methodology for setting values, especially in valuing
                services within a family of revised codes where it is important to
                maintain appropriate intra-family relativity. We have no evidence to
                suggest that the use of an incremental difference between codes
                conflicts with the statute's definition of the work component as the
                resources in time and intensity required in furnishing the service. We
                do consider clinical information associated with physician work
                intensity provided by the RUC and other stakeholders as part of our
                review process, although we remind readers again that we do not agree
                that codes must share the same site of service, patient population, or
                utilization level to serve as an appropriate crosswalk. For additional
                information regarding our use of an incremental difference for code
                valuation, we refer readers to our discussion of the subject in the
                Methodology for Establishing Work RVUs section of this rule (section
                II.H.2. of this final rule).
                 Comment: For CPT codes 19370, CPT code 19371, and CPT code 19380,
                commenters disagreed with our use of the chosen supporting reference
                codes throughout the code family stating they were not strong reference
                codes, and not relevant for purposes of valuation because there is no
                evidence of clinical comparison. A commenter also stated that the
                reference code used for CPT code 19380 had very low volume.
                 Response: We are statutorily obligated to consider both time and
                intensity in establishing work RVUs for PFS services. Additionally, we
                use other methods to validate work RVUs, such as reference codes. When
                using referencing codes to support a proposed work RVU, we do not
                consider there to be a direct ``cross-walk'' between the CPT code that
                is being revalued and the chosen reference code. Instead, it is meant
                to be supportive in validating work times. We continue to believe that
                the relative value system of the PFS is such that all services are
                appropriately subject to comparisons to one another. We do not agree
                that codes must share the same patient population or utilization level
                to serve as an appropriate reference code. We also recognize that it is
                important to use recent available data regarding work times. However,
                we believe that while some reference code values may be considered
                older, they still provide support for revision of work RVUs when survey
                times show a marked increase or decrease in total and intraservice
                time, such as was the case for this code family.
                 After consideration of public comments, we are finalizing the work
                RVU and direct PE inputs for the
                [[Page 84609]]
                Secondary Breast Mound Procedure code family as proposed.
                (8) Hip-Knee Arthroplasty (CPT Codes 27130 and 27447)
                 CPT codes 27130 (Arthroplasty, acetabular and proximal femoral
                prosthetic replacement (total hip arthroplasty), with or without
                autograft or allograft) and 27447 (Arthroplasty, knee, condyle and
                plateau; medial AND lateral compartments with or without patella
                resurfacing (total knee arthroplasty)) were identified as potentially
                misvalued codes under the CMS high expenditure procedural code screen
                in the CY 2014 PFS final rule with comment period (78 FR 74334). These
                codes were reviewed by the AMA RUC who provided recommendations for
                work RVUs and physician time for these services for CY 2014. We agreed
                with the RUC recommendation to value CPT code 27130 and CPT code 27447
                equally and thus established the same CY 2014 interim final work RVUs
                for these two procedures (78 FR 74334). This change resulted in a 1.12
                work RVU increase for the visits in the global period. We added the
                additional work to the AMA RUC-recommended work RVU of 19.60 for CPT
                codes 27130 and 27447, resulting in an interim final work RVU of 20.72
                for both services.
                 In the CY 2015 PFS final rule with comment period (79 FR 67632), we
                discussed how in the CY 2014 PFS final rule with comment period, we
                sought public comment regarding the appropriate work RVUs for these
                services and the most appropriate reconciliation for the conflicting
                information regarding time values for these services as presented to us
                by the physician community. We did not find the rationales provided for
                modifying the interim final work values established in CY 2014
                compelling, and thus we finalized the CY 2014 interim final values for
                these procedures based upon the best data we had available and to
                preserve appropriate relativity with other codes.
                 In the CY 2019 PFS final rule (83 FR 59500 through 595303), CPT
                code 27130 and CPT code 27447 were added to the list of potentially
                misvalued codes. A stakeholder submitted information requesting that
                CMS nominate these codes as potentially misvalued. The stakeholder
                stated that there were substantial overestimates in pre-service and
                post-service time including follow-up inpatient and outpatient visits
                that do not take place included in the valuation of the service. As a
                result, the codes were resurveyed for the October 2019 RUC meeting.
                 We proposed the RUC-recommended work RVU of 19.60 for CPT code
                27130 and the RUC-recommended work RVU of 19.60 for CPT code 27447. We
                also proposed the RUC-recommended direct PE inputs for both codes.
                Additionally, we solicited comment from the medical community on how to
                consider and/or include pre-optimization time (pre-service work and/or
                activities to improve surgical outcomes) going forward. We also noted
                that we were interested in stakeholders' thoughts on what codes could
                be used to capture these pre-optimization activities that could be
                billed in conjunction with the services discussed previously. Overall,
                we noted interest in continuing our ongoing dialog with stakeholders
                about how CMS might pay more accurately for improved clinical outcomes
                that may result from increased efficiency in furnishing care through
                activities, such as pre-optimization and are appreciative of
                information provided by the medical community. We invited the medical
                community to continue to engage with CMS on this and other topics.
                 We received public comments on Hip-Knee Arthroplasty (CPT codes
                27130 and 27447). The following is a summary of the comments we
                received and our responses.
                 Comment: Many commenters were overall opposed to the proposal to
                reduce the work RVUs associated with CPT codes 27447 and 27130.
                Commenters noted that pre-optimization time is not captured in the
                current RUC survey. Commenters requested that CMS forgo any changes or
                delay adoption of the reduced work RVU for these procedures until an
                accurate assessment of this time can be determined. The commenters
                noted that delaying the adoption of these RVUs would provide time for
                CMS to work with stakeholders to better capture pre-optimization work
                performed by physicians to improve surgical outcomes. One commenter
                recommended the creation of a G code to account for arthroplasty pre-
                optimization work.
                 Two commenters appreciated CMS' interest in capturing these pre-
                optimization activities and seeking comment from the medical community
                on how to consider and/or include pre-optimization time going forward.
                Some stakeholders articulated that CMS may not have fully accounted for
                the preoperative work required to make value-based care cost-effective
                and high-quality. Commenters note, in light of the pandemic, that any
                cuts in payment to health care providers or medically necessary
                services would be harmful, and a reduction in work RVU is not justified
                by a reduction in time spent on patients, but will undercut the
                transition to bundled models.
                 One commenter was in support of CMS accepting the RUC
                recommendation for hip and knee arthroplasty and believes accepting the
                RUC recommendation will address the reimbursement imbalance, increase
                the primary care workforce, and improve the finances in primary care.
                Another commenter opposed the reduction because, if both the CF and RVU
                changes take effect, it would be a 15 percent reduction for physician
                payment. The commenter noted the RUC methodology does not capture the
                patient pre-optimization work related to the APM incentive that
                improves patient outcomes and lowers costs.
                 One commenter noted that patients with a higher BMI are more
                complex and the RVU should go up or a separate category be made for
                complicated joint replacement for those with a Body Mass Index (BMI)
                over 40. Additionally, the commenter noted that implants (for these
                procedures) should be reimbursed to facilities at cost or cost plus 10
                percent, which would save millions of dollars per calendar year; and
                the commenter also believed lowering the RVUs may cause physicians to
                stop taking Medicare and reduce access to care.
                 One commenter noted overwhelming evidence that physicians and/or
                QHPs are spending more time with the typical patient in pre-service
                optimization work and stated that they believe CMS has broad authority
                to remedy the issues presented by the RUC recommendations for
                preservice time. Another commenter stated that there was logical
                outgrowth to add preservice time to the existing code.
                 One commenter noted that there are issues with the existing CPT
                codes in capturing arthroplasty pre-optimization activities or changes
                in practice patterns, and that creation of a new G code would account
                for arthroplasty pre-optimization work. For these procedures, this time
                includes patient screening and education, as well as coordinating with
                other health care providers to help manage the entire episode of care.
                 Response: We appreciate the commenters' feedback about maintaining
                the work RVU and potential resource costs that are not reflected in the
                RUC recommendation. We are also appreciative of the dialog we have had
                with stakeholders. We continue to assess the accuracy of service
                valuations, including global services paid under the PFS, and believe
                it would be prudent before considering
                [[Page 84610]]
                further changes to better understand how existing codes that could be
                billed prior to these procedures do not reflect the pre-optimization
                activities as described by stakeholders.
                 After considering the comments received, we are finalizing the RUC-
                recommended work RVU of 19.60 for CPT code 27130 and the RUC-
                recommended work RVU of 19.60 for CPT code 27447. We are also
                finalizing the RUC-recommended direct PE inputs for both codes. As we
                continue to consider this issue and how to best reflect pre-
                optimization in the valuation for the services, we welcome information
                from stakeholders as to which services may be included or which coding
                selections would be appropriate for various services that are or would
                be provided outside of the global period. We continue to be interested
                in stakeholders' thoughts and would like to discuss and consider the
                potential for more accurate coding, and what kind of coding framework,
                if there is currently none, could be used to capture these pre-
                optimization activities.
                (9) Toe Amputation (CPT Codes 28820 and 28825)
                 These services were identified by the RUC Relativity Assessment
                Workgroup through a site of service anomaly screen based on the review
                of 3 years of data (2015, 2016 and 2017) for services with utilization
                over 10,000 in which a service is typically performed in the inpatient
                hospital setting, yet only a half discharge day management identified
                by CPT code 99238 is included. Prior to conducting the RUC survey, the
                specialty societies recommended that it would be appropriate for these
                services to have their global period changed from 090-day to 000-day so
                the site of service is less of a contributing factor to the codes'
                valuation. These codes were surveyed as a 000-day global service, and
                we proposed them as 000-day global services.
                 We disagreed with the RUC-recommended work RVU of 4.10 for CPT code
                28820 (Amputation, toe; metatarsophalangeal joint). We noted that we
                believe that it would be more accurate to propose a work RVU of 3.51,
                and we are supporting this value with a crosswalk to CPT code 33958
                (Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support
                (ECLS) provided by physician; reposition peripheral (arterial and/or
                venous) cannula(e), percutaneous, 6 years and older (includes
                fluoroscopic guidance, when performed)), which has a work RVU of 3.51,
                to account for the decrease in the surveyed work time. We do not
                believe the RUC-recommended reduction in work RVU from the current
                value of 5.82 is commensurate with the RUC-recommended 102-minute
                reduction in total time. We believe that a further reduction in work
                RVUs is warranted given the significant reduction in RUC-recommended
                physician time.
                 We disagreed with the RUC-recommended work RVU of 4.00 for CPT code
                28825 (Amputation, toe; interphalangeal joint). We proposed a work RVU
                of 3.41 based on the RUC-recommended increment relationship between
                this code and CPT code 28820 (a difference of -0.10), which we apply to
                our proposed value for the latter code. We noted that we do not believe
                the RUC-recommended reduction in work RVU from the current value of
                5.37 is commensurate with the RUC-recommended 97-minute reduction in
                total time. We also noted that we believe that a further reduction in
                work RVUs is warranted given the significance of RUC-recommended
                reduction in physician time.
                 For the direct PE inputs, we proposed to refine the pre-service
                clinical labor times to conform to the 000-day global period standards
                for both codes in the family for CPT codes 28820 and 28825. We also
                proposed to refine the clinical labor times for the ``Provide
                education/obtain consent'' (CA011) and the ``Prepare room, equipment
                and supplies'' (CA013) activities to conform to our established
                standard time of 2 minutes each in the non-facility setting for CPT
                codes 28820 and 28825. We proposed to refine the equipment time to
                conform to these changes in the clinical labor time for both codes.
                 We received public comments on the Toe Amputation (CPT codes 28820
                and 28825).The following is a summary of the comments we received and
                our responses.
                 Comment: Commenters stated that CMS made this proposal without
                demonstrating that the agency also considered the disparity between the
                physician work intensity of the post-operative services that were
                previously bundled in 28820 and the physician work intensity of the
                skin-to-skin time of the service.
                 Response: We disagree with the commenter that we did not consider
                the disparity in intensity between the post-operative services that
                were previously bundled in CPT code 28820 and the skin-to-skin time of
                the service. Consistent with the statute, we are required to value the
                work RVU based on the relative resources involved in furnishing the
                service, which include time and intensity. When our review of
                recommended values reveals that changes in time have been unaccounted
                for in a recommended RVU, then we believe it is appropriate to account
                for that change in establishing work RVUs since the statute explicitly
                identifies time as one of the two elements of the work RVUs. This
                includes changes in the resource of time associated with the post-
                operative services that were previously bundled in CPT code 28820. We
                clarify again that we do not treat all components of physician time as
                having identical intensity. If we were to disregard intensity
                altogether, the work RVUs for all services would be developed based
                solely on time values and that is definitively not the case, as
                indicated by the many services that share the same time values but have
                different work RVUs. In the case of CPT codes 28220 and 28222, we
                believe that in many cases the work time was reduced substantially but
                the work RVU only minimally, which resulted in an implied increase in
                the intensity of work that does not appear to be valid, and ultimately
                creates work intensity anomalies.
                 Comment: Commenters stated that the crosswalk code that CMS used to
                support its proposal to reject the RUC recommendation, CPT code 33958,
                is not an appropriate reference code to use for making valuation
                decisions. The commenter stated that CPT code 33958 is an atypical 000-
                day global code that includes a bundled inpatient hospital visit making
                it inappropriate to use as a direct work value crosswalk for a service
                that does not include bundled visits and it is a low volume service.
                 Response: We continue to believe that the nature of the PFS
                relative value system is such that all services are appropriately
                subject to comparisons to one another. Although codes that describe
                clinically similar services are sometimes stronger comparator codes, we
                do not agree that codes must share the same site of service, patient
                population, or utilization level to serve as an appropriate crosswalk.
                 Comment: One commenter stated that they would also like to remind
                CMS of both the Agency's and the RUC's longstanding position that
                treating all components of physician time (pre-service, intra-service,
                post-service and post-operative visits) as having identical intensity
                is incorrect and that inconsistently applying it to only certain
                services under review creates inherent payment disparities in a payment
                system which is based on relative valuation.
                 Response: We reiterate our previous clarification that we do not
                treat all components of physician time as having
                [[Page 84611]]
                identical intensity. As we have consistently stated, when our review of
                recommended values reveals that changes in time have been unaccounted
                for in a recommended RVU, then we believe it is appropriate to account
                for that change in establishing work RVUs since the statute explicitly
                identifies time as one of the two elements of the work RVUs.
                 Comment: Commenters stated that it does not appear that CMS
                considered the change in the global surgical period from a 90-day
                global to a 000-day global when referencing the decrease in total time
                for the procedure, which would make sense for a change in the global
                period and the associated intensity for the procedure. The intra-
                service time for the procedure did not change.
                 Response: We noted that in reviewing the recommended values for CPT
                codes 28820 and 28825, the change in global periods was taken into
                consideration. However, consistent with the statute, we are required to
                value the work RVU based on the relative resources involved in
                furnishing the service, which include time and intensity. When our
                review of recommended values reveals that changes in time have been
                unaccounted for in a recommended RVU, then we believe it is appropriate
                to account for that change in establishing work RVUs since the statute
                explicitly identifies time as one of the two elements of the work RVUs.
                This includes changes in the resource of time associated with the post-
                operative services that were previously bundled in CPT code 28820.
                 Comment: Several commenters stated that CMS should not impose the
                standard 000-day clinical labor times for CA011 and CA013 with respect
                to CPT codes 28820 and 28825 without regard to the clinically
                significant information that these are major procedures that are
                typically performed in a facility setting.
                 Response: We have reviewed all the information provided by
                commenters and we believe it would be appropriate to maintain 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 provides greater
                consistency among codes that share the same clinical labor tasks and
                could improve relativity of values among codes. Therefore, we maintain
                that these refinements are consistent with the clinical labor times of
                a 000-day global service.
                 After consideration of the comments, we are finalizing the work
                RVUs and direct PE inputs for the Toe Amputation codes as proposed.
                (10) Shoulder Debridement (CPT Codes 29822 and 29823)
                 In September 2019, the CPT Editorial Panel approved revision of CPT
                code 29822 (Arthroscopy, shoulder, surgical; debridement, limited, 1 or
                2 discrete structures (e.g., humeral bone, humeral articular cartilage,
                glenoid bone, glenoid articular cartilage, biceps tendon, biceps anchor
                complex, labrum, articular capsule, articular side of the rotator cuff,
                bursal side of the rotator cuff, subacromial bursa, foreign body[ies]))
                and CPT code 29823 (Arthroscopy, shoulder, surgical; debridement,
                extensive, 3 or more discrete structures (e.g., humeral bone, humeral
                articular cartilage, glenoid bone, glenoid articular cartilage, biceps
                tendon, biceps anchor complex, labrum, articular capsule, articular
                side of the rotator cuff, bursal side of the rotator cuff, subacromial
                bursa, foreign body[ies])) to clarify limited and extensive debridement
                by specifying the number of discrete structures debrided and providing
                examples of the structures.
                 We proposed the RUC-recommended work RVU of 7.03 for CPT code 29822
                and 7.98 for CPT code 29823 without refinement.
                 For the direct PE inputs, we proposed the RUC recommendations CPT
                codes 29822 and 29823 without refinement.
                 We did not receive public comments on this code family, and are
                finalizing as proposed.
                (11) Absorbable Nasal Implant Repair (CPT Codes 30468)
                 In September 2019, the CPT Editorial Panel approved the addition of
                CPT code 30468 (Repair of nasal valve collapse with subcutaneous/
                submucosal lateral wall implant(s)) to report repair of nasal valve
                collapse with subcutaneous/submucosal lateral wall implant(s)).
                 We proposed the RUC-recommended value of 2.80 work RVUs without
                refinement for CPT code 30468.
                 For the direct PE inputs, we also proposed the RUC-recommended
                values without refinement.
                 We received public comments on the Absorbable Nasal Implant Repair
                family (CPT code 30468). The following is a summary of the comments we
                received and our responses.
                 Comment: Several commenters stated their support for our proposal
                to adopt the RUC-recommended values without refinement.
                 Response: We thank commenters for their feedback and support.
                 After consideration of the comments, we are finalizing the work RVU
                and direct PE inputs for CPT code 30468 as proposed.
                (12) Lung Biopsy-CT Guidance Bundle (CPT Code 32408)
                 CPT codes 32405 (Biopsy, lung or mediastinum, percutaneous needle)
                and 77012 (Computed tomography guidance for needle placement (e.g.,
                biopsy, aspiration, injection, localization device), radiological
                supervision and interpretation) were identified by the AMA through a
                screen of code pairs that are reported on the same day, same patient
                and same NPI number at or more than 75 percent of the time. The CPT
                Editorial Panel deleted CPT code 32405 and replaced it with 32408 (Core
                needle biopsy, lung or mediastinum, percutaneous, including imaging
                guidance, when performed).
                 We did not propose the RUC-recommended work RVU of 4.00, which is
                the survey median, because we believe this value somewhat overstates
                the increase in intensity. Although we do not imply that the decrease
                in time, when considering the aggregate time values for CPT codes 32405
                and 77012, as reflected in survey values must equate to a one-to-one or
                linear decrease in the valuation of work RVUs, we believe that since
                the two components of work are time and intensity, significant
                decreases in time should be appropriately reflected in the work RVU.
                Intraservice and total time ratios using the aggregate time values of
                current CPT codes 32405 and 77012 suggest a significantly lower work
                RVU; however, we did not believe a decrease from the current aggregate
                value of 32405 and 77012 was warranted. We noted that we believe there
                is some overlap in physician work and time for the two current
                services, and that the recommended increase to 4.00 does not
                appropriately recognize this overlap. Therefore, we proposed a work RVU
                of 3.18, which is the sum of the work RVUs of the two base codes.
                 We proposed the RUC-recommended direct PE inputs without
                refinement.
                 We received public comments on Lung Biopsy-CT Guidance Bundle (CPT
                code 32408). The following is a summary of the comments we received and
                our responses.
                 Comment: A commenter disagreed with our valuation methodology,
                stating that it inappropriately relies on time-based ratios. The
                commenter stated this methodology is flawed and inaccurately treats all
                components of the physician time as having identical intensity and is
                incorrect. In addition, the commenter suggested it lacks the rigor of
                the survey
                [[Page 84612]]
                process and RUC panel evaluation. The commenter stated that CMS does
                not provide any supporting rationale or clinical information for the
                proposed work RVU of 3.18 other than debating survey times, primarily
                the intraservice time and total time ratios for this service, then
                justifying the proposed work RVU with the work RVU sum of deleted code
                32405 and imaging code 77012.
                 The commenter also states that CMS overlooked the compelling
                evidence rationale for why this service is presently misvalued, and
                that cancer treatment protocols have evolved significantly to require
                more definitive tissue diagnosis including biomolecular marker
                profiles. The new code 32408 has increased the total time and the
                intensity/complexity, warranting the RUC-recommended work RVU of 4.00
                 Response: We disagree and continue to believe that the use of time
                ratios is one of several appropriate methods for identifying potential
                work RVUs for particular PFS services, particularly when the
                alternative values recommended by the RUC and other commenters do not
                account for information provided by surveys that suggests the amount of
                time involved in furnishing the service has changed significantly. We
                reiterate that, consistent with the statute, we are required to value
                the work RVU based on the relative resources involved in furnishing the
                service, which include time and intensity. When our review of
                recommended values reveals that changes in time have been unaccounted
                for in a recommended RVU, then we believe it is appropriate to account
                for that change in establishing work RVUs since the statute explicitly
                identifies time as one of the two elements of the work RVUs. Please see
                above for our discussion of compelling evidence rationale. We do
                consider changes in technology, patient population, etc., insofar as
                they affect the time and intensity of the service under review.
                However, we do not specifically address the RUC's compelling evidence
                criteria in our rulemaking since it is outside the purview of the code
                valuation framework stipulated by statute. In addition, we reiterate
                that our proposal for this code was based on our analysis which
                indicated that there is some overlap in the work described in the two
                base services CPT codes 32405 and 77012. We continue to believe that a
                work RVU that is in excess of the aggregate work RVU of these two codes
                would result in an overestimation of intensity.
                 After consideration of the comments, we are finalizing the work RVU
                and direct PE inputs for CPT code 32408 as proposed.
                (13) Atrial Septostomy (CPT Codes 33741, 33745, 33746)
                 Septostomy procedures are performed on extremely small newborns and
                neonates with severe forms of congenital heart disease and are
                lifesaving/temporizing procedures that do not provide definitive
                therapy to these critically ill patients. These procedures are not
                typical of the Medicare population and are of low volume. CPT code
                92992 (Atrial septectomy or septostomy; transvenous method, balloon
                (e.g., Rashkind type) (includes cardiac catheterization)) and CPT code
                92993 (Atrial septectomy or septostomy; blade method (Park septostomy)
                (includes cardiac catheterization)), are carrier-priced codes. These
                services were not formally designated as potentially misvalued in the
                CY 2019 PFS final rule (83 FR 59500), but we did make mention that the
                RUC had signaled its intention to review these two codes. Both services
                were referred to the CPT Editorial Panel by the specialty societies who
                indicated that CPT code 92992 may not have included related imaging
                guidance, and also commented that CPT code 92993 was antiquated and
                rarely performed. The CPT Editorial Panel deleted both CPT codes and
                proposed to replace them with the following new CPT codes.
                 CPT code 33741 (Transcatheter atrial septostomy (TAS) for
                congenital cardiac anomalies to create effective atrial flow, including
                all imaging guidance by the proceduralist, when performed, any method
                (e.g., Rashkind, Sang-Park, balloon, cutting balloon, blade)), is one
                of three codes intended to replace the two deleted Septostomy codes.
                For CPT code 33741, the RUC recommended an RVU only crosswalk to CPT
                code 33340 (Percutaneous transcatheter closure of the left atrial
                appendage with endocardial implant, including fluoroscopy, transseptal
                puncture, catheter placement(s), left atrial angiography, left atrial
                appendage angiography, when performed, and radiological supervision and
                interpretation), which has a work RVU of 14.00. The RUC recommended 20
                minutes of preservice evaluation time, 15 minutes of preservice
                positioning time, 15 minutes preservice scrub/dress/wait time, 55
                minutes intraservice time and 45 minutes immediate postservice time,
                for 150 minutes total time. We proposed the RUC-recommended work RVU of
                14.00 and physician times without refinement.
                 CPT code 33745 (Transcatheter intracardiac shunt (TIS) creation by
                stent placement for congenital cardiac anomalies to establish effective
                intracardiac flow, all imaging guidance by the proceduralist when
                performed, left and right heart diagnostic cardiac catherization for
                congenital cardiac anomalies, and target zone angioplasty, when
                performed (e.g., atrial septum, Fontan fenestration, right ventricular
                outflow tract, Mustard/Senning/Warden baffles); initial intracardiac
                shunt) is another new procedure code proposed by the CPT Editorial
                Panel. The service is currently performed on neonate infants to
                children with severe forms of congenital heart disease, by having a
                stent implanted inside of an infant's beating heart (and not within a
                blood vessel). This stent replaces the methods described in the deleted
                atrial septostomy codes utilizing the balloon and blade method. The RUC
                recommended 25 minutes preservice evaluation time, 15 minutes
                preservice positioning time, 15 minutes preservice scrub/dress/wait
                time, 92 minutes intraservice time and 60 minutes immediate postservice
                time, for 207 minutes total time. The RUC recommended 20.00 work RVUs
                for CPT code 33745. We proposed to adopt the RUC-recommended work RVUs
                and physician times.
                 CPT code 33746, (Transcatheter intracardiac shunt (TIS) creation by
                stent placement for congenital cardiac anomalies to establish effective
                intracardiac flow, all imaging guidance by the proceduralist when
                performed, left and right heart diagnostic cardiac catherization for
                congenital cardiac anomalies, and target zone angioplasty, when
                performed (e.g., atrial septum, Fontan fenestration, right ventricular
                outflow tract, Mustard/Senning/Warden baffles); each additional
                intracardiac shunt location (List separately in addition to code for
                primary procedure)), is the add-on code to the proposed new procedure
                CPT code 33745, for 60 minutes of physician intraservice time. The RUC
                recommended a work RVU of 10.50 for CPT code 33746. This value for the
                add-on code, in comparison to the recommended work value of 20.00 RVUs
                with 92 minutes/intraservice time and 207 minutes of total time for CPT
                code 33745, appears to be unsupportable given the 60 minutes of
                additional physician intraservice time. We proposed a work RVU of 8.00
                for add-on CPT code 33746, which is the 25th percentile
                value from the survey and of similar valuation from reference CPT code
                93592 (Percutaneous
                [[Page 84613]]
                transcatheter closure of paravalvular leak; each additional occlusion
                device (List separately in addition to code for primary procedure)).
                 This family of CPT codes are facility-only services and have no
                direct PE inputs.
                 We received public comments on the proposed values for the Atrial
                Septostomy CPT codes 33741, 33745, 33746. The following is a summary of
                the comments we received and our responses.
                 Comment: Commenters were supportive of CMS proposing the work RVUs
                as recommended by the AMA RUC for CPT code 33741, at 14.00, and for CPT
                code 33745, at 20.00. Commenters disagreed with CMS proposing 8.00 work
                RVUs for CPT code 33746, that differs from the AMA RUC recommended
                value of 10.50. Commenters did not believe that the work RVU of 8.00
                from CPT reference code 93592 (also an add-on code with the same amount
                of physician time), and from the survey's 25th-percentile
                work RVU value adequately reflected the resources involved in
                furnishing the service and suggested instead the survey's
                50th-percentile median value of 10.50 RVUs due to the
                intensity of the work in CPT code 33746, which involves the typical
                patient who is a small child or infant. The commenters stated that add-
                on code 33746 is not intended as an extension of an initial stent
                procedure described by CPT code 33745 and that CPT code 33746 is the
                placement of a second stent where the work is more intense than the
                primary procedure, CPT code 33745.
                 Response: For the new proposed CPT codes 33741 and 33745, the AMA
                RUC-recommended work RVUs values are considered higher in relationship
                to the physician times to perform the procedures and they note that
                this higher relationship is due to these procedures' higher than
                typical work intensity. The surveyed work RVU for CPT code 33741 at the
                25th-percentile was 10.99 but the AMA RUC-recommended value
                was 14.00, which was lower than the 50th-percentile median
                value of 17.00 RVUs and about midpoint between these upper and low
                quartiles. The surveyed work RVU at the 25th-percentile for
                CPT code 33745 was 20.00 which the AMA RUC recommended.
                 The surveyed work RVU for add-on code CPT code 33746 at the 25th-
                percentile was 8.00 but the AMA RUC recommended the work RVU of 10.50
                from the 50th-percentile median value, based on rationale
                similar to the rationale discussed above. For CPT code 33746, on the
                measure of physician time alone for 60 minutes we see comparable add-on
                codes with the identical amounts of physician time, valued at much less
                than their recommended 10.50 work RVUs, and much less than the CMS'
                referenced CPT code 93592's 8.00 work RVUs. Seeing that AMA RUC
                surveyed work RVU at the 25th percentile yielded a value of
                8.00 and that our comparator CPT code 93592 is also valued at 8.00 for
                60 minutes of physician time, we continue to believe that 8.00 work
                RVUs is the correct value for CPT code 33746.
                 After consideration of the comments, we are finalizing the work RVU
                for CPT code 33741, CPT code 33745, and CPT code 33746, as proposed.
                (14) Percutaneous Ventricular Assist Device Insertion (CPT Codes 33995,
                33990, 33991, 33992, 33997, and 33993)
                 In May 2019, the CPT Editorial Panel approved the revision of four
                codes to clarify the insertion and removal of right and left heart
                percutaneous ventricular assist devices (PVAD), and the addition of two
                codes to report insertion of PVAD venous access and removal of right
                heart PVAD. These codes were surveyed with 000-day global periods and
                reviewed at the October 2019 RUC meeting.
                 We proposed the RUC-recommended work RVUs for all six codes in the
                family. We proposed a work RVU of 6.75 for CPT code 33990 (Insertion of
                ventricular assist device, percutaneous, including radiological
                supervision and interpretation; left heart, arterial access only), a
                work RVU of 6.75 for CPT code 33995 (Insertion of ventricular assist
                device, percutaneous, including radiological supervision and
                interpretation; right heart, venous access only), a work RVU of 8.84
                for CPT code 33991 (Insertion of ventricular assist device,
                percutaneous, including radiological supervision and interpretation;
                left heart, both arterial and venous access, with transseptal
                puncture), a work RVU of 3.55 for CPT code 33992 (Removal of
                percutaneous left heart ventricular assist device, arterial or arterial
                and venous cannula(s), separate and distinct session from insertion), a
                work RVU of 3.00 for CPT code 33997 (Removal of percutaneous right
                heart ventricular assist device, venous cannula, separate and distinct
                session from insertion), and a work RVU of 3.10 for CPT code 33993
                (Repositioning of percutaneous right or left heart ventricular assist
                device, with imaging guidance, at separate and distinct session from
                insertion).
                 Stakeholders contacted CMS regarding the valuation of the codes in
                this family following the arrival of the RUC recommendations. They
                stated that the RUC recommendations did not accurately reflect the work
                time of these procedures, which they stated to be increasing due to the
                adoption of new technology. The stakeholders requested that CMS propose
                to maintain the current work RVUs for the codes in this family and to
                crosswalk the work RVU of the new codes to existing codes.
                 We disagreed with the stakeholders and proposed the RUC-recommended
                work RVUs for each code in this family as noted previously. We noted
                that in this case where the surveyed work times for the existing codes
                are decreasing and the utilization of CPT code 33990 is increasing
                significantly (quadrupling in the last 5 years), we have reason to
                believe that practitioners are becoming more efficient at performing
                the procedure, which, under the resource-based nature of the RVU
                system, lends support for proposing the RUC's recommended work RVUs.
                Although the incorporation of new technology can sometimes make
                services more complex and difficult to perform, it can also have the
                opposite effect by making services less reliant on manual skill and
                technique. We disagreed with the stakeholders that the incorporation of
                this new technology would necessarily be grounds for maintaining the
                current work RVU, as improvements in technology are commonplace across
                many different services and are not specific to this procedure. As
                detailed earlier, we also have reason to believe that the improved
                technology has led to greater efficiencies in the procedure which,
                under the resource-based nature of the RVU system, lends further
                support for proposing a lower work RVU for the existing CPT codes.
                 The RUC did not recommend and we did not propose any direct PE
                inputs for this facility only code family. We proposed a 000-day global
                period for all six codes as surveyed by the RUC.
                 We received public comments on the codes in the Percutaneous
                Ventricular Assist Device Insertion family. The following is a summary
                of the comments we received and our responses.
                 Comment: Several commenters supported the CMS decision to propose
                the RUC-recommended work RVUs for each code in the family and
                recommended that CMS finalize the proposal.
                 Response: We appreciate the commenters' support for our proposals.
                 Comment: A commenter stated that the RUC recommendations included
                in the PFS proposed rule did not accurately reflect the full work
                associated with percutaneous ventricular assist device (PVAD)
                procedures. The commenter stated that
                [[Page 84614]]
                the RUC recommendations do not reflect increases in intra-procedure
                time resulting from the increased usage of SmartAssist technology and
                that if work value reductions continue over multiple years, it will
                impede physician adoption of these new technologies, resulting in a
                negative impact on patient access.
                 Response: We appreciate the information provided by the commenter
                and we share in their concerns regarding the need to maintain patient
                access to these services. However, as we stated in the proposed rule,
                we have reason to believe that practitioners are becoming more
                efficient at performing the procedures, which, under the resource-based
                nature of the RVU system, gives support for proposing the RUC's
                recommended work RVUs. We disagree with the commenter that the
                incorporation of this new technology would necessarily be grounds for
                maintaining the current work RVU, as improvements in technology are
                commonplace across many different services and are not specific to this
                procedure. We continue to believe that the RUC-recommended work RVUs
                are the most accurate valuations for the codes in this family.
                 After consideration of the public comments, we are finalizing our
                proposed work RVUs for the codes in the Percutaneous Ventricular Assist
                Device Insertion family. We did not propose and we are not finalizing
                any direct PE inputs for this facility only code family.
                (15) Esophagogastroduodenoscopy (EGD) With Biopsy (CPT Code 43239)
                 In the CY 2019 PFS final rule (83 FR 59500), CPT code 43239
                (Esophagogastroduodenoscopy, flexible, transoral; with biopsy, single
                or multiple) was publicly nominated for review under the potentially
                misvalued code initiative. As requested, the specialty societies
                conducted a survey for the April 2019 RUC meeting. The RUC survey
                results showed that the current work RVU of 2.39, which is below the
                survey 25th percentile work RVU of 2.50, accurately reflects
                the physician work for CPT code 43239.
                 We proposed to maintain the current work RVU of 2.39 as recommended
                by the RUC. We proposed the RUC-recommended direct PE inputs for CPT
                code 43239 without refinement.
                 We received public comments on Esophagogastroduodenoscopy (EGD)
                with Biopsy (CPT code 43239). The following is a summary of the
                comments we received and our responses.
                 Comment: The commenters all agreed with the CMS proposal to
                maintain the current work RVU of 2.39 as recommended by the RUC. The
                commenters also all agreed with the CMS proposal of the RUC-recommended
                direct PE inputs with without refinement.
                 Response: We appreciate the commenters' support for CMS proposing
                the RUC recommendation for CPT code 43239.
                 After consideration of the public comments, we are finalizing the
                RUC-recommended work RVU of 2.39 for CPT code 43239. We are also
                finalizing the RUC-recommended direct PE inputs for CPT code 43239
                without refinement.
                (16) Colonoscopy (CPT Code 45385)
                 In the CY 2019 PFS final rule (83 FR 59500), CPT code 45385
                (Colonoscopy, flexible; with removal of tumor(s), polyp(s), or other
                lesion(s) by snare technique) was publicly nominated for review under
                the potentially misvalued code initiative. As requested, the specialty
                societies conducted a survey for the April 2019 RUC meeting. The RUC
                survey results showed that the current work RVU of 4.57, which is
                slightly above the survey 25th percentile work RVU of 4.50,
                accurately reflects the physician work for CPT code 45385.
                 We proposed to maintain the current work RVU of 4.57 as recommended
                by the RUC. We proposed the RUC-recommended direct PE inputs for CPT
                code 45385 without refinement.
                 We received public comments on Colonoscopy (CPT code 45385). The
                following is a summary of the comments we received and our responses.
                 Comment: The commenters all agreed with the CMS proposal to
                maintain the current work RVU of 4.57 as recommended by the RUC. The
                commenters also all agreed with the CMS proposal of the RUC-recommended
                direct PE inputs with without refinement.
                 Response: We appreciate the commenters' support for our proposal to
                adopt the RUC recommendation for CPT code 45385.
                 After consideration of the public comments, we are finalizing the
                RUC-recommended work RVU of 4.57 for CPT code 45385. We are also
                finalizing the RUC-recommended direct PE inputs for CPT code 45385
                without refinement.
                (17) Transrectal High Intensity Focused US Prostate Ablation (CPT Codes
                55880)
                 In May 2019, the CPT Editorial Panel established a new code to
                report ablation of malignant prostate tissue with high intensity
                focused ultrasound (HIFU), including ultrasound guidance. For CPT code
                55880, we did not propose the RUC recommendation to use the survey
                median work RVU of 20.00 to value this service because we believe total
                time ratios to the two key reference codes, CPT codes 55840
                (Prostatectomy, retropubic radical, with or without nerve sparing) and
                55873 (Cryosurgical ablation of the prostate (includes ultrasonic
                guidance and monitoring)) indicate that this value is somewhat
                overstated and does not accurately reflect the physician time, and
                because an analysis of all 090-global period codes with similar time
                values indicates that this service is overvalued.
                 We proposed a work RVU of 17.73 based on a crosswalk to CPT code
                69930 (Cochlear device implantation, with or without mastoidectomy)
                which has similar total time and identical intraservice time values and
                is more consistent with other codes of similar time. We proposed the
                RUC-recommended PE inputs without refinement.
                 We received public comments on Transrectal High Intensity Focused
                US Prostate Ablation (CPT code 55880). The following is a summary of
                the comments we received and our responses.
                 Comment: Commenters noted that, for CPT code 55880, the RUC
                recommended the survey 25th percentile work RVU of 20.00, not the
                survey median work RVU, as it is misstated in the proposed rule.
                 Response: We regret the error, and we note that the RUC indeed
                recommended the survey 25th percentile work RVU.
                 Comment: In response to this section, the RUC commented that they
                are increasingly concerned that CMS is eschewing the bedrock principles
                of valuation within the RBRVS (namely, magnitude estimation, survey
                data and clinical expertise) in favor of arbitrary mathematical
                formulas and, in their opinion, making distinctions in the different
                types of physician time, which are ``CMS/Other'' time source,
                ``Harvard'' time source, and ``RUC'' time source (from physician
                surveys). The RUC suggested CMS use valid survey data and review the
                actual relativity for all elements (physician work, time, intensity and
                complexity) when developing work values for services and not foster
                flawed methodologies.
                 Response: As we have discussed in previous rules, we agree that it
                is important to use the most recent data available regarding time, and
                we note that when many years have passed between when physician times
                are measured, significant discrepancies can occur. However, we also
                continue to believe that our operating assumption regarding the
                validity of the existing time values as a point of comparison is
                critical to the integrity of the current relative value system. The
                physician times and intensities currently
                [[Page 84615]]
                associated with codes play important roles in PFS ratesetting in their
                comparativeness to each other, in establishing work RVUs. The PFS is
                grounded in and reliant on the original relativity of the RBRVS, and
                then as services, codes and values evolve over the years, the PFS
                statute contemplates maintaining and building on that base-level of
                relativity. If we were to question the assumption that previously
                recommended work times had routinely been over- or underestimated, this
                would undermine the basis for relativity of the work RVUs on the PFS.
                Given that the process under which codes are often valued by comparison
                to codes with similar times, we acknowledge the distinction between
                ``CMS/Other'' times, ``Harvard'' times, and ``RUC'' physician surveyed
                times, but we do not believe we can apply different validation weights
                to any of these sources of time values while remaining consistent with
                our obligation to consider time and intensity as these are currently
                reflected in the fee schedule. They are all physician time data
                collected over many years. We understand that some time values may not
                have been reviewed or re-surveyed in a number of years, but that alone
                is not an indicator of the current relative accuracy of a time value.
                 We believe that, over the years as more codes are being reviewed
                and examined, the entire collective fee schedule of procedure codes
                should align in a very reliable and accurate relative value system
                reflecting each code's relativity with respect to other codes (in their
                work RVUs, in their procedure times, and in their work intensities). We
                recognize that adjusting work RVUs for changes in physician times is
                not always a straightforward process and that the intensity associated
                with changes in time is not necessarily always linear, which is why we
                always try to apply various methodologies to identify several potential
                work values for individual codes before deciding on the one we find
                most appropriate. Our review of code values under the PFS not only
                examines the relationships between work, time, and intensity, but we
                also look at magnitude and rank order anomalies, particularly in
                families or groups of codes that are closely related but may differ
                slightly in degrees found in their clinical descriptions and possibly
                in the typical beneficiary populations that each code might serve.
                Among these codes, we try to maintain the accurate relative
                relationships in terms of time, work, and intensity measurements. In
                some cases, where there are marked improvements in medical techniques
                and technologies, we may find efficiencies in physician's work for
                certain services that warrant decreases in physician's times, but we
                also recognize that some improvements may introduce greater complexity
                and either an increase in intensity and/or in physician times. We
                reiterate that we believe it would be irresponsible to ignore or
                discount ``CMS/Other'' times or ``Harvard'' times in our data system,
                and that we need to consider all times and all intensities and all
                clinically relevant relatedness (or non-relatedness) of procedure codes
                to each other in establishing more refined work RVUs for PFS services.
                Also note that physician times considered to be ``RUC'' physician times
                as they are listed in the RUC database are not always necessarily AMA
                RUC surveyed times. We may have adjusted AMA RUC surveyed times in our
                annual review of all HCPCS codes; and the same can be said of times
                that the AMA labels as ``Harvard'' or ``CMS/Other'' physician times.
                 Comment: Many commenters stated that the proposed work RVU was too
                low to adequately reflect the work, skill and complexity required for
                this procedure. Commenters were concerned about patient access, stating
                that a significant number of Medicare beneficiaries with prostate
                cancer will not have access to this procedure. Commenters encouraged
                CMS to finalize the RUC-recommended work RVU of 20.00. Commenters
                stated that CMS did not provide any supporting rationale or clinical
                information for the proposed work RVU of 17.73 other than debating
                survey times, primarily the total time ratios between a service that is
                not currently covered to the two key reference codes, then justifying
                our proposed work RVU with a crosswalk to CPT code 69930. Commenters
                stated that this crosswalk is flawed in that it was surveyed 12 years
                ago, and it is clinically a very different procedure. A commenter
                suggested CPT code 42420 (Excision of the parotid tumor or parotid
                gland) with a work RVU of 19.53 as a more appropriate crosswalk as it
                is a more intense procedure than our proposed crosswalk CPT code 69930.
                 Response: Our proposed work RVU of 17.73 is not solely derived from
                time ratios. Our analysis included comparisons to other codes of
                similar time values as well as to codes with similar numbers of the
                total number of post-op visits, as well as a consideration of the RUC-
                recommended key reference services. These factors all indicated a work
                RVU lower than the recommended 20.00. Comparison of relative intensity
                values further indicates this RVU is somewhat overvalued. Our proposed
                value of 17.73 produces an intensity value of 0.066, which is very
                similar to the intensity value for our crosswalk CPT code 69930, which
                is 0.067. We disagree that the patient populations of these two codes
                are too different; the description and vignettes of CPT code 69930 do
                not indicate that this is primarily a pediatric procedure. Further, we
                reiterate that, although codes that describe clinically similar
                services are sometimes stronger comparator codes, we do not agree that
                codes must share the same site of service, patient population, or
                utilization level to serve as an appropriate crosswalk. We continue to
                believe the time values and relative intensity of this procedure
                indicate that a work RVU of 17.73 is a more accurate valuation, and we
                are finalizing this work RVU as proposed.
                 After consideration of the public comments, we are finalizing as
                proposed a work RVU of 17.73, as well as the RUC-recommended direct PE
                inputs without refinement.
                (18) Computer-Aided Mapping of Cervix Uteri (CPT Code 57465)
                 In September 2019, the addition of CPT code 57465 (Computer-aided
                mapping of cervix uteri during colposcopy, including optical dynamic
                spectral imaging and algorithmic quantification of the acetowhitening
                effect (List separately in addition to code for primary procedure)) was
                approved by the CPT Editorial Panel to report computer-aided mapping of
                cervix uteri during colposcopy. The RUC recommended the survey median
                work RVU of 0.81 for this service.
                 We proposed the RUC-recommended value of 0.81 for CPT code 57465.
                We also proposed the RUC-recommended direct PE inputs for this code.
                 We solicited comment on a new medical supply indicated on the PE
                spreadsheet submitted by the RUC. A ``computer aided spectral imaging
                system (colposcopy) disposal speculum'' was noted in the RUC PE meeting
                materials. This name suggests it is digital. However, on the actual
                invoice submitted, the supply item in question was listed as a
                ``disposable medium speculum'' with no mention of a spectral imaging
                system or a digital component. We researched this speculum and could
                not find any evidence that it has a digital component. Therefore, we
                proposed to change the name of this new supply item to ``disposable
                speculum, medium'' (SD337) to reflect the actual product on the invoice
                submitted. We sought clarification as to what aspect of the
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                speculum is digital or if a cheaper, non-digital speculum would
                suffice. We noted for example that the vaginal specula (SD118) supply
                has a CY 2021 price of $1.12 and we were able to find disposable medium
                specula readily available online for a price of roughly $1.00. We
                proposed the new SD337 supply at the $5.80 price as listed on the
                invoice submitted in the RUC materials and sought comment as to why
                other disposable speculums at a lower price would not be typical for
                this procedure.
                 We received public comments on the Computer-Aided Mapping of Cervix
                Uteri code family (CPT code 57465). The following is a summary of the
                comments we received and our responses.
                 Comment: Commenters were overall in support and appreciated CMS
                proposing the RUC-recommended work RVU and the direct PE inputs for
                code 57465. We also received comments with additional information on
                the SD337 supply item in question. Commenters stated that in order for
                the map to be successfully generated, there are stringent technical
                requirements of the vaginal speculum that require it to be attached to
                the optical head of the system. Commenters stated that the specula are
                therefore custom designed to meet performance standards, and are an
                integral part of the imaging system. One commenter noted that the
                speculum referenced is typical. The coating on the plastic that
                enhances the image is necessary, and without its light reflection on
                plastic interferes with the image processing.
                 Response: We appreciate the additional information provided from
                commenters and the commenters' agreement with the proposed name change
                and that the item referenced is typical for the service noted.
                 After consideration of the public comments, we are finalizing the
                RUC-recommended work RVU of 0.81 for CPT code 57465. We are also
                finalizing the proposed RUC-recommended direct PE inputs for this code.
                We are finalizing the new SD337 supply at the $5.80 price as listed on
                the invoice submitted in the RUC materials based on the public comments
                submitted. To clarify the nature of the supply, we are renaming SD337
                to ``digital imaging speculum'' to reflect what the commenters stated
                would be more accurate.
                (19) Colpopexy (CPT Codes 57282 and 57283)
                 The CPT codes 57282 (Colpopexy, vaginal; extra-peritoneal approach
                (sacrospinous, iliococcygeus)) and 57283 (Colpopexy, vaginal; intra-
                peritoneal approach (uterosacral, levator myorrhaphy)) were identified
                by the RUC Relativity Assessment Workgroup as services performed less
                than 50 percent of the time in the inpatient setting yet include
                inpatient hospital E/M services within the global period and the 2018
                Medicare utilization is over 5,000. This code family was surveyed and
                reviewed for the January 2020 RUC meeting. For CY 2021, the RUC
                recommended a work RVU of 13.48 for CPT code 57282, and a work RVU of
                13.51 for CPT code 57283.
                 We disagreed with the RUC-recommended work RVUs for the CPT code
                family of 57282 and 57283. We proposed a work RVU of 11.63 for CPT code
                57282, and also proposed to maintain the current work RVU of 11.66 for
                CPT code 57283. For CPT code 57283, we based our disagreement on the
                total time ratio between the current time of 349 minutes and the
                recommended time established by the survey of 231 minutes. This ratio
                equals 66 percent, and 66 percent of the current work RVU of 11.66 for
                CPT code 57283 equals a work RVU of 7.70. When we reviewed CPT code
                57283, we found that the recommended work RVU was higher than other
                codes with similar time values. This is supported by the reference CPT
                codes we compared to CPT code 57283 with 90 minutes of intraservice
                time; reference CPT code 19350 (Nipple/areola reconstruction) has a
                work RVU of 9.11 with 229 minutes of total time, and reference CPT code
                47563 (Laparoscopy, surgical; cholecystectomy with cholangiography)
                which has a work RVU of 11.47 with 238 minutes of total time. Although
                we did not imply that the decrease in time as reflected in survey
                values must equate to a one-to-one or linear decrease in the valuation
                of work RVUs, we noted that we believe that since the two components of
                work are time and intensity, significant decreases in time should be
                reflected in decreases to work RVUs. The recommendation from the RUC
                acknowledged that the time had decreased for CPT code 57283, and also
                noted that there has been an increase in intensity due to a change in
                technique and knowledge necessary to perform the service. In the case
                of CPT code 57283, we noted that we believe it would be more accurate
                to propose maintaining the current work RVU of 11.66 instead of the
                RUC-recommended work RVU of 13.51 to account for these decreases in the
                surveyed work time while still accounting for the increase in
                intensity. We also noted that the intensity of CPT code 57283 would
                nearly double by maintaining the proposed work RVU of 11.66, due to the
                significant decreases in surveyed work time, which we believe supported
                the RUC's contention that the intensity of this code has increased over
                time.
                 For CPT code 57282, we disagreed with the RUC-recommended RVU of
                13.48. We noted that the significant decrease in total time for code
                57282 suggests an RVU lower than 13.48. Although we disagreed with the
                RUC-recommended work RVU, we concurred that the relative difference in
                work between CPT codes 57282 and 57283 is equivalent to the RUC-
                recommended interval of 0.03 RVUs. We noted that we believe the use of
                an incremental difference between these CPT codes is a valid
                methodology for setting values, especially in valuing services within a
                family of revised codes where it is important to maintain appropriate
                intra-family relativity. Therefore, we proposed a work RVU of 11.63 for
                CPT code 57282, based on the RUC-recommended interval of 0.03 RVUs
                below our proposed work RVU of 11.66 for CPT code 57283.
                 We proposed the RUC-recommended direct PE inputs for the CPT code
                family of 57282 and 57283 without refinement.
                 We received public comments on the Colpopexy code family (CPT codes
                57282 and 57283). The following is a summary of the comments we
                received and our responses.
                 Comment: The commenters disagreed with our proposal to value CPT
                code 57282 using an incremental methodology, and stated that the
                proposal inaccurately treats all components of the physician time as
                having identical intensity. The commenters would prefer that CMS
                finalize the RUC-recommended value rather than values derived by
                increments. Moreover, commenters stated that CMS proposed the RUC work
                RVU increment (0.03) between CPT codes 57282 and 57283 for this code
                family, yet disagreed with the RUC-recommended work RVU.
                 Response: We believe the use of an incremental difference between
                codes is a valid methodology for setting values, especially in valuing
                services within a family of revised codes where it is important to
                maintain appropriate intra-family relativity. Historically, we have
                frequently utilized an incremental methodology in which we value a code
                based upon its incremental difference between another code or another
                family of codes. We noted that the RUC has also used the same
                incremental methodology on occasion when it was unable to produce valid
                survey data for a service.
                [[Page 84617]]
                 Comment: Commenters stated that the RUC recommendation for CPT code
                57282 was based on robust survey results and requested that CMS adopt
                the RUC-recommended work values. The commenters stated that the current
                work value and time for CPT code 57282 were derived from the Harvard
                studies, and therefore, are not resource based. Co