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

CourtCenters For Medicare & Medicaid Services
Citation85 FR 27550
Publication Date08 May 2020
Record Number2020-09608
Federal Register, Volume 85 Issue 90 (Friday, May 8, 2020)
[Federal Register Volume 85, Number 90 (Friday, May 8, 2020)]
                [Rules and Regulations]
                [Pages 27550-27629]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-09608]
                [[Page 27549]]
                Vol. 85
                Friday,
                No. 90
                May 8, 2020
                Part II
                 Department of Health and Human Services
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                Centers for Medicare & Medicaid Services
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                42 CFR Parts 409, 410, 412, et al.
                45 CFR Part 156
                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; Interim Final
                Rule
                Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and
                Regulations
                [[Page 27550]]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Centers for Medicare & Medicaid Services
                42 CFR Parts 409, 410, 412, 413, 414, 415, 424, 425, 440, 483, 484,
                and 600
                Office of the Secretary
                45 CFR Part 156
                [CMS-5531-IFC]
                RIN 0938-AU32
                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
                AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
                ACTION: Interim final rule with comment period.
                -----------------------------------------------------------------------
                SUMMARY: This interim final rule with comment period (IFC) gives
                individuals and entities that provide services to Medicare, Medicaid,
                Basic Health Program, and Exchange beneficiaries needed flexibilities
                to respond effectively to the serious public health threats posed by
                the spread of the coronavirus disease 2019 (COVID-19). Recognizing the
                critical importance of expanding COVID-19 testing, we are amending
                several Medicare policies on an interim basis to cover FDA-authorized
                COVID-19 serology tests, to allow any healthcare professional
                authorized to do so under State law to order COVID-19 diagnostic
                laboratory tests (including serological and antibody tests), and to
                provide for new specimen collection fees for COVID-19 testing under the
                Physician Fee Schedule and Outpatient Prospective Payment System,
                during the public health emergency (PHE) for the COVID-19 pandemic.
                Recognizing the urgency of this situation, and understanding that some
                pre-existing CMS rules may inhibit innovative uses of technology and
                capacity that might otherwise be effective in the efforts to mitigate
                the impact of the pandemic on beneficiaries and the American public, we
                are amending several CMS policies and regulations in response to the
                COVID-19 PHE and recent legislation, as outlined in this IFC. These
                changes apply to physicians and other practitioners, hospice providers,
                federally qualified health centers, rural health clinics, hospitals,
                critical access hospitals (CAHs), community mental health centers
                (CMHCs), clinical laboratories, teaching hospitals, providers of the
                laboratory testing benefit in Medicaid, Opioid treatment programs, and
                quality reporting programs (QRPs) for inpatient rehabilitation
                facilities (IRFs), long-term care hospitals (LTCHs), skilled nursing
                facilities (SNFs), home health agencies (HHAs) and durable medical
                equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers.
                DATES:
                 Effective date: These regulations are effective on May 8, 2020.
                 Applicability date: The policies in this IFC are applicable
                beginning on March 1, 2020, or January 27, 2020, except as further
                described in the table in SUPPLEMENTARY INFORMATION.
                 Comment date: To be assured consideration, comments must be
                received at one of the addresses provided below, no later than 5 p.m.
                on July 7, 2020.
                ADDRESSES: In commenting, please refer to file code CMS-5531-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-5531-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-5531-IFC, Mail
                Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
                 For information on viewing public comments, see the beginning of
                the SUPPLEMENTARY INFORMATION section.
                FOR FURTHER INFORMATION CONTACT: Rebecca Cole, (410) 786-1589, for
                general information, or contact one of the following:
                 [email protected], for issues related to the HHVBP Model.
                 [email protected], for issues related to scope of practice
                issues; additional flexibilities for hospital outpatient departments
                and CMHCs to furnish outpatient services at temporary expansion sites,
                including the beneficiary's home and expanded CMHCs; expansion of the
                extraordinary circumstances relocation exception policy for on-campus
                and excepted off-campus provider-based departments (PBDs) that relocate
                in response to the COVID-19 PHE; teaching physician policies, including
                time spent by residents at another hospital and the medical education
                methodology of counting teaching hospital beds; counting beds for
                provider-based rural health clinic payment level; services furnished by
                opioid treatment programs; modified requirements for ordering COVID-19
                diagnostic laboratory tests; payment to hospitals and physician's
                offices for specimen collection; counting time for telehealth
                evaluation and management visits; method for updating the telehealth
                list during the PHE; paying for remote monitoring services; and
                increased payment for telephone evaluation and management visits (Note
                this email address has an underscore``_'' between ``HAPG'' and ``COVID-
                19''.)
                 [email protected], for issues related to the Medicare IRF
                benefits.
                 [email protected], for issues related to section 3712 of the CARES
                Act.
                 Hillary Loeffler, (410) 786-0456, [email protected], or
                [email protected], for issues related to the Medicare home
                health and hospice benefits.
                 [email protected], for issues related to the Partial
                Hospitalization Program (PHP) and CMHC issues.
                 [email protected], for issues pertaining to the
                Medicaid home health benefit related to section 3708 of the CARES Act.
                 Kari Vandegrift, (410) 786-4008, and Elizabeth November, (410) 786-
                4518 or [email protected], for issues related to the
                Medicare Shared Savings Program.
                 Leigha Basini, (301) 492-4380, for issues related to the separate
                billing requirement.
                 Sheri Gaskins, (410) 786-9274, for issues related to Medicaid
                laboratory flexibilities.
                 Cassandra Lagorio, (410) 786-4554, for issues related to the BHP.
                 Molly MacHarris, (410) 786-4461, or [email protected], for issues
                related to the Merit-based Incentive Payment System (MIPS).
                 [email protected], for issues related to
                national coverage determination and local coverage determination
                requirements.
                [[Page 27551]]
                 Joan Proctor, (410) 786-0949, or [email protected], for
                issues related to the following Post-Acute Care QRPs: HH QRP, IRF QRP,
                LTCH QRP, and SNF QRP.
                 Julia Venanzi, (410) 786-1471, for issues related to the Hospital
                VBP Program.
                 Adam Rubin, (410-786-1919), for issues related to Certification of
                Home Health Services.
                SUPPLEMENTARY INFORMATION: The policies in this IFC are applicable
                beginning on March 1, 2020, or January 27, 2020, except as further
                described in the following table:
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                 Provision Applicability date
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                Medicare Shared Savings We are revising Sec. 425.400 to expand
                 Program--Expansion of Codes the definition of primary care services
                 used in Beneficiary used in the Shared Savings Program
                 Assignment. beneficiary assignment methodology for
                 the performance year starting on January
                 1, 2020, and for any subsequent
                 performance year that starts during the
                 PHE for the COVID-19 pandemic, as
                 defined in Sec. 400.200, which
                 includes any subsequent renewals.
                Modification to Medicare We are revising Sec. Sec. 409.41
                 Rules and Medicaid through 409.48; 424.22; 424.507(b)(1);
                 Concerning Certification and Sec. 440.70(a)(2) and (3), and (b)(1),
                 Provision of Home Health (2) and (4); and several sections of 42
                 Services. CFR part 484 to include physician
                 assistants, nurse practitioners, and
                 clinical nurse specialists as
                 individuals who can certify the need for
                 home health services and order services.
                 These changes are permanent, and
                 applicable to services provided on or
                 after March 1, 2020.
                Flexibility for Medicaid We are revising Sec. 440.30 to provide
                 Laboratory Services. states with flexibility to provide
                 Medicaid coverage for certain laboratory
                 tests and X-ray services that may not
                 meet certain requirements in Sec.
                 440.30(a) or (b) (such as the
                 requirement that tests be furnished in
                 an office or similar facility). This
                 flexibility is retroactive to March 1,
                 2020, during the period of the COVID-19
                 PHE and for any subsequent periods of
                 active surveillance. The flexibility
                 also applies to future PHEs resulting
                 from outbreaks of communicable disease
                 and subsequent periods of active
                 surveillance.
                Requirement for Facilities to We are revising Sec. 483.80 to
                 Report Nursing Home establish explicit reporting
                 Residents and Staff requirements for long-term care (LTC)
                 Infections, Potential facilities to report information related
                 Infections, and Deaths to COVID-19 cases among facility
                 Related to COVID-19. residents and staff. These reporting
                 requirements are applicable on the
                 effective date of this IFC.
                Separate Billing and We are delaying by 60 days the date when
                 Segregation of Funds for individual market qualified health plan
                 Abortion Services. (QHP) issuers must be in compliance with
                 the separate billing policy for non-Hyde
                 abortion services. Under this 60-day
                 delay, individual market QHP issuers
                 must comply with the separate billing
                 policy beginning on or before the QHP
                 issuer's first billing cycle following
                 August 26, 2020.
                DME Interim Pricing in the We are revising Sec. 414.210 to provide
                 CARES Act. increased fee schedule amounts in
                 certain areas starting on March 6, 2020,
                 and for the duration of the PHE for the
                 COVID-19 pandemic.
                Merit-based Incentive Payment For the reasons discussed in section
                 System (MIPS) Qualified II.R. of this IFC, we are delaying the
                 Clinical Data Registry implementation of the completion of QCDR
                 (QCDR) Measure Approval measure testing policy by 1 year.
                 Criteria: Specifically, we are amending Sec.
                 --Completion of QCDR Measure 414.1400(b)(3)(v)(C) to state that
                 Testing. beginning with the 2022 performance
                 --Collection of Data on QCDR period, all QCDR measures must be fully
                 Measures. developed and tested, with complete
                 testing results at the clinician level,
                 prior to submitting the QCDR measure at
                 the time of self-nomination. This change
                 is applicable on the effective date of
                 this IFC.
                 For the reasons discussed in section
                 II.R. of this IFC, we are delaying the
                 implementation of the collection of data
                 on QCDR measures policy by one year.
                 Specifically, we are amending Sec.
                 414.1400(b)(3)(v)(D) to state that
                 beginning with the 2022 performance
                 period, QCDRs are required to collect
                 data on a QCDR measure, appropriate to
                 the measure type, prior to submitting
                 the QCDR measure for CMS consideration
                 during the self-nomination period. This
                 change is applicable on the effective
                 date of this IFC.
                Hospital VBP Program......... We are revising the extraordinary
                 circumstances exception policy to allow
                 CMS to grant an exception to hospitals
                 located in an entire region or locale
                 without a request and we are codifying
                 the updated policy at Sec. 412.165(c).
                 This change is permanent, and is
                 applicable beginning on the effective
                 date of this IFC.
                IRF QRP...................... We are revising the compliance date for
                 the IRF QRP to October 1st of the year
                 that is at least one full fiscal year
                 after the end of the PHE. This change is
                 applicable on the effective date of this
                 IFC.
                LTCH QRP..................... We are revising the compliance date for
                 the LTCH QRP to October 1st of the year
                 that is at least one full fiscal year
                 after the end of the PHE. This change is
                 applicable on the effective date of this
                 IFC.
                HH QRP....................... We are revising the compliance date for
                 the HH QRP to January 1st of the year
                 that is at least one full calendar year
                 after the end of the PHE. This change is
                 applicable on the effective date of this
                 IFC.
                SNF QRP...................... We are revising the compliance date for
                 the SNF QRP to October 1st of the year
                 that is at least two full fiscal years
                 after the end of the PHE. This change is
                 applicable on the effective date of this
                 IFC.
                ------------------------------------------------------------------------
                 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://regulations.gov. Follow the search instructions on that website to view
                public comments.
                Table of Contents
                I. Background
                II. Provisions of the Interim Final Rule With Comment Period (IFC)
                 A. Reporting Under the Home Health Value-Based Purchasing Model
                for CY 2020 During the COVID-19 Public Health Emergency
                [[Page 27552]]
                 B. Scope of Practice
                 C. Modified Requirements for Ordering COVID-19 Diagnostic
                Laboratory Tests
                 D. Opioid Treatment Programs (OTPs)--Furnishing Periodic
                Assessments via Communication Technology
                 E. Treatment of Certain Relocating Provider-Based Departments
                During the COVID-19 PHE
                 F. Furnishing Hospital Outpatient Services in Temporary
                Expansion Locations of a Hospital or a Community Mental Health
                Center (Including the Patient's Home)
                 G. Medical Education
                 H. Rural Health Clinics (RHCs)
                 I. Durable Medical Equipment (DME) Interim Pricing in the CARES
                Act
                 J. Care Planning for Medicare Home Health Services
                 K. CARES Act Waiver of the ``3-Hour Rule'' and Modification of
                IRF Coverage and Classification Requirements for Freestanding IRF
                Hospitals for the PHE During the COVID-19 Pandemic
                 L. Medicare Shared Savings Program
                 M. Additional Flexibility Under the Teaching Physician
                Regulations
                 N. Payment for Audio-Only Telephone Evaluation and Management
                Services
                 O. Flexibility for Medicaid Laboratory Services
                 P. Improving Care Planning for Medicaid Home Health Services
                 Q. Basic Health Program Blueprint Revisions
                 R. Merit-Based Incentive Payment System (MIPS) Qualified
                Clinical Data Registry (QCDR) Measure Approval Criteria
                 S. Application of Certain National Coverage Determination and
                Local Coverage Determination Requirements During the PHE for the
                COVID-19 Pandemic
                 T. Delay in the Compliance Date of Certain Reporting
                Requirements Adopted for IRFs, LTCHs, HHAs and SNFs
                 U. Update to the Hospital Value-Based Purchasing (VBP) Program
                Extraordinary Circumstance Exception (ECE) Policy
                 V. COVID-19 Serology Testing
                 W. Modification to Medicare Provider Enrollment Provision
                Concerning Certification of Home Health Services
                 X. Health Insurance Issuer Standards Under the Affordable Care
                Act, Including Standards Related to Exchanges: Separate Billing and
                Segregation of Funds for Abortion Services
                 Y. Requirement for Facilities To Report Nursing Home Residents
                and Staff Infections, Potential Infections, and Deaths Related to
                COVID-19
                 Z. Time Used for Level Selection for Office/Outpatient
                Evaluation and Management Services Furnished Via Medicare Telehealth
                 AA. Updating the Medicare Telehealth List
                 BB. Payment for COVID-19 Specimen Collection to Physicians,
                Nonphysician Practitioners and Hospitals
                 CC. Payment for Remote Physiologic Monitoring (RPM) Services
                Furnished During the COVID-19 Public Health Emergency
                III. Waiver of Proposed Rulemaking
                IV. Collection of Information Requirements
                V. Response to Comments
                VI. Regulatory Impact Analysis
                Regulations Text
                CPT (Current Procedural Terminology) Copyright Notice
                 Throughout this IFC, 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. Background
                 The United States is responding to an outbreak of respiratory
                disease caused by a novel (new) coronavirus that was first detected in
                China and which has now been detected in more than 190 countries
                internationally, and all 50 States and the District of Columbia. The
                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 30, 2020, the International Health Regulations Emergency
                Committee of the World Health Organization (WHO) declared the outbreak
                a ``Public Health Emergency of international concern''. On January 31,
                2020, Health and Human Services Secretary, Alex M. Azar II, determined
                that a Public Health Emergency (PHE) exists for the United States to
                aid the nation's healthcare community in responding to COVID-19
                (hereafter referred to as the PHE for the COVID-19 pandemic) and on
                April 21, 2020, Secretary Azar renewed, effective April 26, 2020, the
                determination that a PHE exists. On March 11, 2020, the WHO publicly
                declared COVID-19 a pandemic. On March 13, 2020, the President of the
                United States declared the COVID-19 pandemic a national emergency.
                 Coronaviruses are a large family of viruses that are common in
                people and many different species of animals, including camels, cattle,
                cats, and bats. Rarely, animal coronaviruses can infect people and then
                spread between people such as with MERS-CoV, SARS-CoV, and now with
                this new virus (SARS-CoV-2).
                 The complete clinical picture with regard to COVID-19 is not fully
                known. Reported illnesses have ranged from very mild (including some
                with no reported symptoms) to severe, including illness resulting in
                death. While information so far suggests that much COVID-19 illness is
                mild, the Centers for Disease Control and Prevention (CDC) reports find
                that in the United States, between March 1 and 28, 2020, the overall
                laboratory-confirmed COVID-19-associated hospitalization rate was 4.6
                per 100,000 population.\1\ A pandemic is a global outbreak of disease.
                Pandemics happen when a new virus emerges to infect people and can
                spread sustainably, from person-to-person. The virus, SARS-CoV-2, that
                causes COVID-19 is infecting people and spreading easily worldwide from
                person-to-person because there is little to no pre-existing immunity.
                This is the first pandemic known to be caused by the emergence of a new
                coronavirus.\2\
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                 \1\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6915e3.htm.
                 \2\ https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html.
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                 People in places where ongoing community spread of the virus that
                causes COVID-19 has been reported are at elevated risk of exposure,
                with the level of risk dependent on the location. Healthcare workers
                caring for patients with COVID-19 are at elevated risk of exposure.
                Close contacts of persons with COVID-19 also are at elevated risk of
                exposure.
                 The CDC has reported that some people are at higher risk of getting
                very sick from this illness.\3\ This includes:
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                 \3\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6915e3.htm.
                 Older adults, with risk increasing by age.
                 People who have serious chronic medical conditions like:
                ++ Obesity
                ++ Cardiovascular disease
                ++ Diabetes mellitus
                ++ Hypertension
                ++ Chronic lung disease.
                The CDC has developed guidance to help in the risk assessment and
                management of people with potential exposures to COVID-19, including
                recommending that health care professionals make every effort to
                interview a person under investigation for infection by telephone, text
                monitoring system, or video conference.\4\
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                 \4\ https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html.
                 As the healthcare community establishes and implements recommended
                infection prevention and control practices, regulatory agencies under
                appropriate waiver authority granted by the PHE for the COVID-19
                pandemic declaration are also working to revise and implement
                regulations that work in concert with healthcare community infection
                prevention and
                [[Page 27553]]
                treatment practices. Based on the current and projected increase in the
                rate of incidence of the COVID-19 disease in the US population, and
                observed fatalities in the elderly population, who are particularly
                vulnerable due to age and co-morbidities, and additionally, the impact
                on health workers who are at increased risk due to treating the
                population, we believe that certain regulations should be reviewed and
                revised as appropriate to offer providers and suppliers additional
                flexibilities in furnishing services to combat the COVID-19 pandemic.
                We are addressing some of these regulations in a previous IFC which
                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''). In this interim final rule with comment period
                (IFC), we are revising additional regulations to ensure that sufficient
                health care items and services are available to meet the needs of
                individuals enrolled in the programs under Title XVIII (Medicare) and
                Title XIX (Medicaid) of the Social Security Act (the Act), or in the
                identified programs authorized under the Affordable Care Act. In
                addition, we are implementing regulations in response to recent
                legislation including the Coronavirus Preparedness and Response
                Supplemental Appropriations Act, 2020 (Pub. L. 116-123, March 6, 2020),
                the Families First Coronavirus Response Act (Pub. L. 116-127, March 18,
                2020), and the Coronavirus Aid, Relief, and Economic Security Act
                (CARES Act) (Pub. L. 116-136, March 27, 2020).
                 In this extraordinary circumstance, we recognize that the COVID-19
                pandemic greatly increases the overall risk to public health. We
                believe that this increased risk results in an immediate change, not
                only in the circumstances under which services can safely occur, but
                also in to the business relationships among providers, suppliers, and
                practitioners. By increasing access to hospital and community mental
                health services furnished in temporary expansion locations of the
                hospital including the patient's home, increasing access to laboratory
                and diagnostic testing in a patient's home or other settings that could
                help to minimize transmission of communicable disease, and improving
                infection control, this IFC will provide the necessary flexibility for
                Medicare and Medicaid beneficiaries to be able to receive medically
                necessary services without jeopardizing their health or the health of
                those who are providing those services, while also minimizing the
                overall risk to public health. Notably, all final provisions included
                in this IFC are only for the duration of the PHE for the COVID-19
                pandemic, unless otherwise indicated.
                 We also acknowledge that the COVID-19 PHE has created a lack of
                predictability for many ACOs regarding the impact of expenditure and
                utilization changes on historical benchmarks and financial performance,
                created uncertainty around future program participation, and disrupted
                population health activities as clinicians, care coordinators, and
                financial and other resources are diverted to address immediate acute
                care needs. We are amending the Shared Savings Program regulations in
                order to address the impact of the COVID-19 pandemic and encourage
                continued participation by ACOs. In addition, this IFC also provides
                flexibility to states operating a BHP to seek certification for
                temporary significant changes to its BHP Blueprint that are directly
                tied to the PHE for the COVID-19 pandemic, including the ability to
                apply the changes retroactively to the start of the PHE. Finally, in
                light of these extraordinary circumstances and the immediate need for
                QHP issuers to divert resources to responding to the COVID-19 PHE, we
                are delaying by 60 days the date when individual market issuers must be
                in compliance with the separate billing policy. Under this 60-day
                delay, QHP issuers must comply with the separate billing policy
                beginning on or before the QHP issuer's first billing cycle following
                August 26, 2020.
                 As QHP issuers and Exchanges work to respond to the COVID-19 PHE
                and implement and establish policies to ensure access to COVID-19-
                related care for enrollees, HHS is working to assess and extend
                regulatory flexibility to QHP issuers, Exchanges, and other health
                industry stakeholders where doing so may enable these stakeholders to
                divert existing resources to aiding the COVID-19 PHE response. We
                believe extending the deadline 60 days for QHP issuers and Exchanges to
                comply with the separate billing policy is appropriate so that they may
                adequately respond to and divert resources to address the COVID-19 PHE.
                 Also, consistent with section 3708 of the CARES Act, we are
                expanding 42 CFR parts 409, 424.22, 424.507(b), 440.70 and part 484 to
                permit nurse practitioners (NPs), clinical nurse specialists (CNSs),
                and physician assistants (PAs) to certify the need for home health
                services and to order services in the Medicare and Medicaid programs.
                II. Provisions of the Interim Final Rule With Comment Period (IFC)
                 In this IFC, we use the term, ``Public Health Emergency (PHE),'' as
                defined at 42 CFR 400.200. The definition identifies the PHE determined
                to exist nationwide by the Secretary of Health and Human Services (the
                Secretary) under section 319 of the Public Health Service Act on
                January 31, 2020, and renewed effective April 26, 2020, as a result of
                confirmed cases of COVID-19.
                A. Reporting Under the Home Health Value-Based Purchasing Model for CY
                2020 During the COVID-19 PHE
                 Through this IFC, we are implementing a policy to align the Home
                Health Value-Based Purchasing (HHVBP) Model data submission
                requirements with any exceptions or extensions granted for purposes of
                the Home Health Quality Reporting Program (HH QRP) during the PHE for
                COVID-19. We are also implementing a policy for granting exceptions to
                the New Measures data reporting requirements under the HHVBP Model
                during the PHE for COVID-19. Specifically, during the PHE for COVID-19,
                to the extent that the data that participating HHAs in the nine HHVBP
                Model states are required to report are the same data that those HHAs
                are also required to report for the HH QRP, HHAs are required to report
                those data for the HHVBP Model in the same time, form and manner that
                HHAs are required to report those data for the HH QRP. As such, if CMS
                grants an exception or extension that either excepts HHAs from
                reporting certain quality data altogether, or otherwise extends the
                deadlines by which HHAs must report those data, the same exceptions
                and/or extensions apply to the submission of those same data for the
                HHVBP Model. In addition, in this IFC, we are adopting a policy to
                allow exceptions or extensions to New Measure reporting for HHAs
                participating in the HHVBP Model during the PHE for COVID-19.
                 As authorized by section 1115A of the Act and finalized in the CY
                2016 HH PPS final rule (80 FR 68624), the HHVBP Model has an overall
                purpose of improving the quality and delivery of home health care
                services to Medicare beneficiaries. The specific goals of the Model are
                to: (1) Provide incentives for better quality care with greater
                efficiency; (2) study new potential quality and efficiency measures for
                appropriateness in the home health setting; and (3) enhance the current
                public reporting process. All Medicare certified HHAs providing
                services in Arizona, Florida, Iowa, Nebraska, North
                [[Page 27554]]
                Carolina, Tennessee, Maryland, Massachusetts, and Washington are
                required to compete in the Model. The HHVBP Model uses the waiver
                authority under section 1115A(d)(1) of the Act to adjust Medicare
                payment rates under section 1895(b) of the Act based on the competing
                HHAs' performance on applicable measures. The maximum payment
                adjustment percentage increases incrementally over the course of the
                HHVBP Model in the following manner, upward or downward: (1) 3 percent
                in CY 2018; (2) 5 percent in CY 2019; (3) 6 percent in CY 2020; (4) 7
                percent in CY 2021; and (5) 8 percent in CY 2022. Payment adjustments
                are based on each HHA's Total Performance Score (TPS) in a given
                performance year (PY), which is comprised of performance on: (1) A set
                of measures already reported via the Outcome and Assessment Information
                Set (OASIS),\5\ completed Home Health Consumer Assessment of Healthcare
                Providers and Systems (HHCAHPS) surveys, and select claims data
                elements; and (2) three New Measures for which points are achieved for
                reporting data.
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                 \5\ OASIS is the instrument/data collection tool used to collect
                and report performance data by HHAs.
                ---------------------------------------------------------------------------
                 The HHVBP Model utilizes some of the same quality measure data that
                are reported by HHAs for the HH QRP, including HHCAHPS survey data. The
                other HHVBP measures are calculated using OASIS data, which are still
                required to be reported during the PHE; however, we have given
                providers additional time to submit OASIS data (https://www.cms.gov/files/document/covid-home-health-agencies.pdf); claims-based data
                extracted from Medicare fee-for-service (FFS) claims; and New Measure
                data. To assist HHAs while they direct their resources toward caring
                for their patients and ensuring the health and safety of patients and
                staff, we are adopting a policy for the HHVBP Model to align the HHVBP
                data submission requirements with any exceptions or extensions granted
                for purposes of the HH QRP during the PHE for COVID-19. For the same
                reason, we are also establishing a policy for granting exceptions to
                New Measure reporting requirements for HHAs participating in the HHVBP
                Model during the PHE for COVID-19.
                 Under this policy, to the extent CMS has granted an exception to
                the HH QRP (for 2019 Q4 and 2020 Qs 1-2 as noted below in this
                section), or may grant any future exceptions or extensions under this
                same program for other CY 2020 reporting periods, HHAs in the nine
                HHVBP Model states do not need to separately report these measures for
                purposes of the HHVBP Model, and those same exceptions apply to the
                submission of those same data for the HHVBP Model. In accordance with
                this policy, if CMS grants an exception or extension under the HH QRP
                that either excepts HHAs from reporting certain quality data
                altogether, or otherwise extends the deadlines by which HHAs must
                report those data, the same exceptions and/or extensions apply to the
                submission of those same data for the HHVBP Model.
                 In response to the PHE for COVID-19, on March 27, 2020, we issued
                supplemental public guidance (https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf) excepting HHAs from the requirement to
                report any HH QRP data for the following quarters:
                 October 1, 2019-December 31, 2019 (Q4 2019).
                 January 1, 2020-March 31, 2020 (Q1 2020).
                 April 1, 2020-June 30, 2020 (Q2 2020).
                 Under our policy to align HHVBP data submission requirements with
                any exceptions or extensions granted for purposes of the HH QRP during
                the PHE for COVID-19, HHAs in the nine HHVBP Model states are not
                required to separately report measure data for these quarters for
                purposes of the HHVBP Model. We note that with regard to the exception
                from the requirement to report Q4 2019 HH QRP data, we do not
                anticipate any issues in calculating the TPSs based on CY 2019 data
                under the HHVBP Model because HHAs had the opportunity to submit these
                Q4 2019 data on a rolling basis.
                 In addition, to ensure that HHAs are able to focus on patient care
                in lieu of data submission during the PHE for COVID-19, in this IFC, we
                are establishing a policy to allow us to grant exceptions to New
                Measure reporting for HHAs participating in the HHVBP Model during the
                PHE for COVID-19. We are codifying these changes at Sec. 484.315(b).
                In accordance with this policy, we are granting an exception to all
                HHAs participating in the HHVBP Model for the following New Measure
                reporting requirements:
                 April 2020 New Measures submission period (data collection
                period October 1, 2019-March 31, 2020).
                 July 2020 New Measures submission period (data collection
                period April 1, 2020-June 30, 2020).
                 We note that although the data collection period for the April 2020
                New Measures submission period began in 2019, the data collected during
                this period are used for the calculation of the TPSs for CY 2020
                performance, not CY 2019 data. We further note that HHAs may optionally
                submit part or all of these data by the applicable submission
                deadlines. If we make the determination to grant an exception to New
                Measure data reporting for periods beyond the April and July 2020
                submission periods, for example if the PHE for COVID-19 extends beyond
                the New Measure submission periods we have listed in this IFC, we will
                communicate this decision through routine communication channels to the
                HHAs participating in the HHVBP Model, including but not limited to
                issuing memos, emails and posting on the HHVBP Connect website (https://app.innovation.cms.gov/HHVBPConnect).
                 We acknowledge that the exceptions to the HH QRP reporting
                requirements, as well as the modified submission deadlines for OASIS
                data and our exceptions for the New Measures reporting requirements,
                may impact the calculation of performance under the HHVBP Model for the
                performance year (PY) 2020. We also note that while we are able to
                extract the claims-based data from submitted Medicare FFS claims, we
                may need to assess the appropriateness of using the claims data
                submitted for the period of the PHE for COVID-19 for purposes of
                performance calculations under the HHVBP Model. We are evaluating
                possible changes to our payment methodologies for CY 2022 in light of
                this more limited data, such as whether we would be able to calculate
                payment adjustments for participating HHAs for CY 2022, including those
                that continue to report data during CY 2020, if the overall data is not
                sufficient, as well as whether we may consider a different weighting
                methodology given that we may have sufficient data for some measures
                and not others. We are also evaluating possible changes to our public
                reporting of CY 2020 performance year data. We intend to address any
                such changes to our payment methodologies for CY 2022 or public
                reporting of data in future rulemaking.
                B. Scope of Practice
                 In December 2019, CMS issued a request for feedback in response to
                part of the President's Executive Order (E.O.) 13890 on ``Protecting
                and Improving Medicare for Our Nation's Seniors,'' seeking the public's
                help in identifying additional Medicare regulations which contain more
                restrictive supervision requirements than existing state scope
                [[Page 27555]]
                of practice laws, or which limit health professionals from practicing
                at the top of their license (for a link to this request for feedback
                see https://www.cms.gov/files/document/request-information-reducing-scope-practice-burden.pdf). In response to this request, we received
                several recommendations from nonphysician practitioners (NPPs) that
                inform CMS policymaking to ensure an adequate number of clinicians are
                able to furnish critical services and tests during the COVID-19 PHE.
                According to the American Association of Nurse Practitioners,
                currently, twenty-two states and DC are considered Full Practice
                Authority (FPA) states because their licensure laws allow full and
                direct patient access to NPs. We are finalizing provisions that address
                several of those recommendations in this section of the IFC, on an
                interim basis for the duration of the PHE. We note that the responses
                to our request for information on these topics did not indicate the
                number of states having more flexible scope of practice rules than our
                federal regulations. In this rule, we are also seeking public feedback
                indicating the number of states to help us understand the scope of
                impact of these changes.
                1. Supervision of Diagnostic Tests by Certain Nonphysician
                Practitioners
                 Rapid expansion of COVID-19-related diagnostic testing capacity
                (such as lab tests and respiratory imaging) is a top priority in the
                strategy to combat the pandemic. In response to the request for
                feedback discussed above, PAs and NPs recommended regulatory changes
                that would allow them to supervise diagnostic tests because they stated
                that they are currently authorized to do so under their State scope of
                practice rules. We also received feedback from radiologists who did not
                support making any changes to our regulations that would result in any
                inappropriate expansion of the role of NPPs. Currently, under 42 CFR
                410.32(a)(3) of our regulations, physicians and NPPs who are treating 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. Specifically, NPPs who furnish
                services that would be physicians' services if furnished by a physician
                (that is, NPs, PAs, CNSs, clinical psychologists (CPs), clinical social
                workers (CSWs), and certified nurse-midwives (CNMs)), and who are
                operating within the scope of their authority under State law and
                within the scope of their Medicare statutory benefit may order
                diagnostic tests when they use the results of the tests in the
                management of the beneficiary's specific medical problem. However,
                under our current regulation at Sec. 410.32(b), only physicians are
                generally permitted to supervise diagnostic tests. The regulation at
                Sec. 410.32(b)(1) provides as a basic rule that all diagnostic tests
                paid under the Physician Fee Schedule (PFS) must be furnished under an
                appropriate specified minimum level of supervision by a physician as
                defined in section 1861(r) of the Act. Section 410.32(b)(2) then
                provides for certain exceptions to which the general basic rule does
                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 does not apply for tests performed by an NP
                or CNS authorized under applicable state law to furnish the test. (We
                note that, as for all services they furnish, the NP or CNS necessarily
                would be working in collaboration with a physician under Sec. Sec.
                410.75 and 410.76, respectively). Similarly, at Sec.
                410.32(b)(2)(vii), the requirement that diagnostic tests must be
                furnished under the appropriate level of supervision by a physician
                does not apply for tests performed by a CNM authorized under applicable
                state law to furnish the test. There are not currently any exceptions
                under Sec. 410.32(b)(2) for services furnished by PAs. As such, any
                diagnostic tests furnished by PAs would need to be under the
                appropriate level of supervision by a physician in accordance with
                Sec. 410.32(b)(1). We note further that our regulation at Sec.
                410.32(b)(3) specifies that only a general level of physician
                supervision is required for diagnostic tests performed by a PA that the
                PA is legally authorized to perform under state law. Of course, all
                services furnished by PAs must meet the physician supervision
                requirements under Sec. 410.74, which generally defers to state law
                requirements that address the requisite practice relationship between
                PAs and physicians, or requires certain documentation of the working
                relationship between the PA and physicians to supervise PA services if
                the issue is not addressed in state law. Thus, while NPs, CNSs, PAs,
                and CNMs are permitted to furnish diagnostic tests to the extent they
                are otherwise authorized under state law to do so, the regulations at
                Sec. 410.32 does not address whether NPs, CNSs, PAs and CNMs may
                supervise others when furnishing diagnostic tests.
                 In light of the need to reinforce and increase COVID-19-related
                diagnostic testing capacity throughout the duration of the PHE, and to
                increase the flexibility and availability of health care professionals
                to provide needed care, we are finalizing on an interim basis changes
                to our regulation at Sec. 410.32(b) to add flexibility for NPs, CNSs,
                PAs, and CNMs, which are types of practitioners that have separately
                enumerated benefit categories under Medicare law that permit them to
                furnish services that would be physicians' services if furnished by a
                physician and be paid under Medicare Part B for the professional
                services they furnish directly and ``incident to'' their own
                professional services, to the extent authorized under their State scope
                of practice. The interim changes will ensure that these practitioners
                may order, furnish directly, and supervise the performance of
                diagnostic tests, subject to applicable state law, during the PHE. As
                we observe how rapidly the COVID-19 virus is transmitted in the
                population, we believe this policy will help to ensure that an adequate
                number of health care professionals are available to support critical
                COVID-19-related and other diagnostic testing needs, and provide needed
                medical care. This policy will support the rapid expansion of COVID-19-
                related diagnostic testing capacity to quickly identify affected
                individuals and protect against transmission of the virus to vulnerable
                populations, and help to address potential clinical workforce shortages
                that may impact access to services and other diagnostic tests that
                still need to be furnished during the PHE.
                 Specifically, we are amending the regulation at Sec. 410.32(b)(1)
                to specify in the basic rule that diagnostic tests covered under
                section 1861(s)(3) of the Act and payable under the PFS must be
                furnished under the appropriate level of supervision by a physician as
                defined under section 1861(r) of the Act or, during the PHE, by a NP,
                CNS, PA, and CNM, as described above. Additionally, we are amending the
                regulation at Sec. 410.32(b)(2)(iii)(B) which addresses supervision of
                COVID-19-related diagnostic psychological and neuropsychological
                testing services to allow these services to be supervised by a NP, CNS,
                PA and CNM as described above, during the PHE, in addition to
                physicians and CPs who are currently authorized to supervise these
                tests. We are also amending the regulation at Sec. 410.32 by adding a
                new paragraph (b)(2)(viii) to allow diagnostic tests to be performed by
                a PA without physician supervision (although as noted above, the
                regulation at Sec. 410.74 continues to apply) when authorized to
                perform the tests under applicable state law. Furthermore, we are
                amending the
                [[Page 27556]]
                regulation at Sec. 410.32(b)(3) regarding the levels of supervision,
                to also authorize NPs, CNSs, PAs, and CNMs, as described above, during
                the PHE to provide the appropriate level of supervision assigned to
                diagnostic tests. Since we are adding PAs under Sec.
                410.32(b)(2)(viii) to the list of exceptions to the general basic rule
                for supervision during the PHE, and given that the physician
                supervision requirement in the regulation at Sec. 410.74 continues to
                apply, we are removing the parenthetical regarding general physician
                supervision for diagnostic tests furnished by PAs from Sec.
                410.32(b)(3). We are also correcting the typographical error under
                Sec. 410.32(d)(2)(i) regarding documentation and recordkeeping
                requirements to state that when ordering diagnostic tests, the
                physician (or qualified NPP, as defined in paragraph (a)(2) of this
                section), who orders the service must maintain documentation of medical
                necessity in the beneficiary's medical record.
                2. Therapy--Therapy Assistants Furnishing Maintenance Therapy (PFS)
                 We currently make payment under Medicare Part B for outpatient
                occupational and physical therapy (Sec. Sec. 410.59(a) and 410.60(a),
                respectively) when they are furnished by an individual meeting
                qualifications in part 484 for an occupational therapist (OT) or
                physical therapist (PT), or an appropriately supervised occupational
                therapy assistant (OTA) or physical therapy assistant (PTA). This
                includes our policy for rehabilitative services for which improvement
                of the beneficiary's functional status is expected. However, in cases
                where it is medically necessary to maintain, prevent or slow the
                deterioration of a patient's condition, a separate policy requires the
                skills of a physical or OT, not a PTA or OTA, to carry out a therapist-
                established maintenance program, which is generally known as
                ``maintenance therapy.'' For services furnished by PTAs and OTAs,
                claims from therapists and providers are required to use the ``CO'' and
                ``CQ'' modifiers for their respective OTA and PTA therapy services, to
                indicate that a supervised therapy assistant performed the
                rehabilitative or maintenance therapy services.
                 In response to the request for feedback discussed above, therapists
                and therapy providers pointed out that our Part B policy specifying
                that maintenance therapy requires the skills of a therapist is not
                consistent with the policy for services furnished in SNF and Home
                Health Part A settings where PTAs and OTAs are permitted to furnish
                these services. They recommended that we revise our policy to permit
                the treating therapist who established or is responsible for the
                maintenance program plan to determine when it is clinically appropriate
                to delegate the performance of maintenance therapy services to PTAs and
                OTAs, as they are charged with overseeing a patient's course of
                treatment and assigning responsibilities to assistants. They suggested
                that permitting PTAs and OTAs to furnish maintenance therapy services
                would give Medicare patients greater access to care and permit
                therapists and therapy providers more flexibility for resource
                utilization.
                 To increase availability of needed health care services during the
                COVID-19 PHE, we believe it is appropriate to synchronize our Part B
                payment policies as suggested by the stakeholders, and to permit the PT
                or OT who established the maintenance program to delegate the
                performance of maintenance therapy services to a PTA or OTA when
                clinically appropriate. We believe that, by allowing PTAs and OTAs to
                perform maintenance therapy services, PTs and OTs will be freed up to
                furnish other services, including such services as non-medication pain
                management therapies that may reduce reliance on opioids or other
                medications, as well as those services related to the COVID-19 PHE that
                require a therapist's assessment and evaluation skills, including
                communication technology-based services (CTBS) that were made available
                for PTs, OTs and speech-language pathologists (SLPs) during the PHE in
                the March 31st COVID-19 IFC (85 FR 19245 and 19265 through 19266).
                3. Therapy--Student Documentation (PFS)
                 In the CY 2020 PFS final rule,\6\ we simplified medical record
                documentation requirements and finalized a general principle to allow
                the physician, PA, or the advanced practice registered nurses (APRNs),
                specifically, NPs, CNSs, CNMs, and certified registered nurse
                anesthetist (CRNAs) who furnish and bill for their professional
                services to review and verify, rather than re-document, information
                included in the medical record by physicians, residents, nurses,
                students or other members of the medical team. We explained that this
                principle would apply across the spectrum of all Medicare-covered
                services paid under the PFS. We noted that the policy was intended to
                apply broadly, and accordingly amended regulations for teaching
                physicians, other physicians, PAs, and APRNs to expressly provide for
                this flexibility for medical record documentation requirements for
                professional services furnished by physicians, PAs and APRNs in all
                settings.
                ---------------------------------------------------------------------------
                 \6\ Medicare Program; CY 2020 Revisions to 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; Establishment of an Ambulance Data Collection System;
                Updates to the Quality Payment Program; Medicare Enrollment of
                Opioid Treatment Programs and Enhancements to Provider Enrollment
                Regulations Concerning Improper Prescribing and Patient Harm; and
                Amendments to Physician Self-Referral Law Advisory Opinion
                Regulations Final Rule; and Coding and Payment for Evaluation and
                Management, Observation and Provision of Self-Administered
                Esketamine Interim Final Rule (84 FR 62568-63563).
                ---------------------------------------------------------------------------
                 To increase the availability of clinicians who may furnish
                healthcare services during the PHE, we are announcing 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, on an
                interim basis during the PHE for the COVID-19 pandemic, 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 note 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 are discussing this
                issue in response to stakeholder concerns about burden and in
                consideration of the current COVID-19 PHE. 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 emphasize 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 want to emphasize that
                [[Page 27557]]
                information entered into the medical record should document that the
                furnished services are reasonable and necessary.
                4. Pharmacists Providing Services Incident to a Physicians' Service
                 In response to the request for feedback discussed above, numerous
                stakeholders asked us to clarify that pharmacists are permitted to
                provide services to Medicare beneficiaries incident to the professional
                services of a physician, like other clinical staff or certain other
                clinicians. 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
                clarifying explicitly 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. This clarification does not alter current payment policy for
                pharmacist services furnished incident to the professional services of
                a physician or NPP.
                 Although fully consistent with current CMS policy, we believe this
                clarification may encourage pharmacists to work with physicians and
                NPPs in new ways that expand the availability of health care services
                during the COVID-19 PHE, and increase access to medication management
                of individuals with substance/opioid use disorder. We emphasize that
                consistent with the Controlled Substances Act (Pub. L. 91-513, enacted
                October 27, 1970), methadone should continue to be dispensed from
                certified and accredited Opioid Treatment Programs (OTPs) under the
                supervision of clinicians who have received appropriate training and
                fully understand the risks of that medication as is required by
                statute.
                C. Modified Requirements for Ordering COVID-19 Diagnostic Laboratory
                Tests
                 The rapid expansion of COVID-19 diagnostic laboratory testing
                capacity is a top priority in our strategy to combat the pandemic. To
                that end, several large clinical diagnostic laboratory and pharmacy
                businesses are operating community testing sites across the country in
                cooperation with state and federal authorities.\7\ In combination with
                the availability of point of care tests that provide rapid results,
                these sites are a key component in the expansion of COVID-19 testing
                capacity.
                ---------------------------------------------------------------------------
                 \7\ Guidance for Licensed Pharmacists, COVID-19 Test, and
                Immunity Under the PREP Act, HHS, April 8, 2020, https://www.hhs.gov/sites/default/files/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf.
                ---------------------------------------------------------------------------
                 Under Medicare Part B, clinical diagnostic laboratory tests,
                including COVID-19 diagnostic tests, are paid for under the Clinical
                Laboratory Fee Schedule (CLFS), without any beneficiary cost-sharing
                requirements (coinsurance or Part B deductible). See generally sections
                1861(s)(3), 1833(a)(1)(D)(i)(II), (b)(3)(A), (h)(5)(C) and (D), and
                1834A of the Act, and 42 CFR part 414, subpart G.
                 Under our current regulation at Sec. 410.32(a), diagnostic
                laboratory tests such as the COVID-19 tests are covered only when they
                are ordered by a physician or other practitioner who is treating the
                beneficiary, and who uses the results of the test in managing the
                patient's specific medical condition. If a patient arrives at a
                community testing site without an order for the test from his or her
                physician or practitioner, Medicare would not currently cover the test.
                 We have taken substantial steps to broaden access to safely-
                delivered care via telehealth and other communication technology-based
                services during the COVID-19 PHE in an attempt to ensure that a COVID-
                19 test could be ordered by a physician or other practitioner treating
                the beneficiary. Notwithstanding these flexibilities, not all
                beneficiaries have access to a doctor to obtain a COVID-19 diagnostic
                laboratory test. The most recently available results from the Medicare
                Current Beneficiary Survey indicated that only 70 percent of Medicare
                beneficiaries view a doctor's office as their source of care. In the
                same survey, 23 percent of beneficiaries indicated that a medical
                clinic, urgent care center, or hospital outpatient department (HOPD)
                was their source of care. HOPDs and urgent care clinics may not be able
                to furnish community patient visits because they are treating an excess
                number of patients already testing positive for the virus. The survey
                also indicated that 7 percent of beneficiaries reported no source of
                care.\8\ We anticipate needing to test many Medicare beneficiaries
                quickly as part of the rapid expansion of COVID-19 testing capacity to
                combat the pandemic. Therefore, the need for a patient to first have a
                visit with a physician or practitioner to obtain an order for COVID-19
                testing to meet Medicare ordering requirements could still present a
                significant barrier to patients who might otherwise seek a test.
                ---------------------------------------------------------------------------
                 \8\ Centers for Medicare & Medicaid Services. Medicare Current
                Beneficiary Survey Chart Book 2016. https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/MCBS/Data-Tables-Items/2016Chartbook.
                ---------------------------------------------------------------------------
                 Prior to the Guidance for Licensed Pharmacists, COVID-19 Test, and
                Immunity Under the PREP Act, which HHS issued on April 8, 2020 (April
                Guidance),\9\ state governments had sought to increase access to
                testing by removing prior authorization of COVID-19 tests in the
                commercial health insurance market.\10\ States and State Boards of
                Pharmacy had also sought to increase physician capacity by permitting
                pharmacists to test for and treat influenza and streptococcus
                infections under protocols.\11\ State Boards of Pharmacy have in turn
                sought to increase pharmacist capacity by relaxing pharmacist to
                pharmacy technician supervision ratios.\12\ With growing supplies of
                tests and in light of the April Guidance we anticipate that States will
                look increasingly to pharmacists and other qualified healthcare
                professionals to order and furnish COVID-19 tests.
                ---------------------------------------------------------------------------
                 \9\ HHS Statements on Authorizing Licensed Pharmacists to Order
                and Administer COVID-19 Tests, HHS, April 8, 2020, https://www.hhs.gov/about/news/2020/04/08/hhs-statements-on-authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.html.
                 \10\ Karen Pollitz, ``Private Health Coverage of COVID-19: Key
                Facts and Issues,'' Kaiser Family Foundation, March 18, 2020,
                https://www.kff.org/private-insurance/issue-brief/private-health-coverage-of-covid-19-key-facts-and-issues/.
                 \11\ National Alliance of State Pharmacy Associations (NASPA),
                Pharmacist Prescribing: ``Test and Treat,'' February 8, 2019,
                available at https://naspa.us/resource/pharmacist-prescribing-for-strep-and-flu-test-and-treat/
                 \12\ NASPA. ``COVID-19: Information from the States,'' April 14,
                2020, available at https://naspa.us/resource/covid-19-information-from-the-states/.
                ---------------------------------------------------------------------------
                 Information provided by the CDC shows that the likelihood of severe
                outcomes of COVID-19 illness is highest in adults aged 65 and older and
                people with underlying health conditions, which suggests that the
                Medicare beneficiary population is at particularly high risk from the
                disease.\13\ Additionally, as noted by the CDC in guidance on how to
                protect against COVID-19 infection, some studies have
                [[Page 27558]]
                suggested that COVID-19 may be spread by people who are not showing
                symptoms.\14\ We believe it is vital for Medicare beneficiaries to have
                broad access to COVID-19 testing so that they can properly monitor
                their symptoms, make prompt decisions about seeking further care, and
                take appropriate precautions to prevent further spread of the disease.
                ---------------------------------------------------------------------------
                 \13\ Preliminary Estimates of the Prevalence of Selected
                Underlying Health Conditions Among Patients with Coronavirus Disease
                2019--United States, February 12-March 28, 2020. MMWR Morb Mortal
                Wkly Rep 2020;69:382-386. DOI: http://dx.doi.org/10.15585/mmwr.mm6913e2.
                 \14\ Coronavirus Disease 2019 (COVID-19): How to Protect
                Yourself & Others, CDC, https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html.
                ---------------------------------------------------------------------------
                 Given the critical importance of expanding COVID-19 testing to
                combat the pandemic and the heightened risk that the disease presents
                to Medicare beneficiaries, we are amending our regulation at Sec.
                410.32(a) to remove the requirement that certain diagnostic tests are
                covered only based on the order of a treating physician or NPP. Under
                this interim policy, during the COVID-19 PHE, COVID-19 tests may be
                covered when ordered by any healthcare professional authorized to do so
                under state law. Additionally, because the symptoms for influenza and
                COVID-19 might present in the same way, during the COVID-19 PHE, we are
                also removing the same ordering requirements for a diagnostic
                laboratory test for influenza virus and respiratory syncytial virus, a
                type of common respiratory virus. CMS will make a list of diagnostic
                laboratory tests for which we are removing the ordering requirements
                publicly available. We are removing the treating physician or NPP
                ordering requirement for these additional diagnostic laboratory tests
                only when they are furnished in conjunction with a COVID-19 diagnostic
                laboratory test as medically necessary in the course of establishing or
                ruling out a COVID-19 diagnosis or of identifying patients with an
                adaptive immune response to SARS-CoV-2 indicating recent or prior
                infection. We would not expect there to be any medical necessary reason
                to use the specimen for unrelated or repeat testing. When COVID-19
                diagnostic laboratory testing becomes sufficiently prevalent,
                sensitive, and specific such that laboratory tests for influenza or
                related respiratory conditions are no longer needed to establish a
                definitive COVID-19 diagnosis, we expect that additional testing for
                influenza or related respiratory viral illness would no longer be
                medically necessary. We are also making conforming amendments to our
                regulations at Sec. 410.32(d)(2) and (3) to remove certain
                documentation and recordkeeping requirements associated with orders for
                COVID-19 tests during the COVID-19 PHE, as these requirements would not
                be relevant in the absence of a treating physician's or NPP's order.
                While no order is required under Medicare, we do expect the entity
                submitting the claim to include the ordering or referring NPI
                information on the claim form when an order is written for the test,
                consistent with current billing instructions.
                 When COVID-19 tests are furnished without a physician's or NPP's
                order as set forth in this regulation during the COVID-19 PHE, the
                laboratory conducting the tests is required to directly notify the
                patient of the results consistent with other applicable laws, as well
                as meet other applicable test result reporting requirements.
                Comprehensive and timely reporting of all testing results to local
                officials is critical to public health management of the pandemic, and
                we would expect any clinician or laboratory receiving results to report
                those results promptly, consistent with state and local public health
                requirements, typically within 24 hours.
                D. Opioid Treatment Programs (OTPs)--Furnishing Periodic Assessments
                via Communication Technology
                 In the CY 2020 PFS final rule (84 FR 62634), we finalized an add-on
                code describing periodic assessments furnished by OTPs. The finalized
                add-on code is Healthcare Common Procedure Coding System (HCPCS) code
                G2077 (Periodic assessment; assessing periodically by qualified
                personnel to determine the most appropriate combination of services and
                treatment). The medical services described by this add-on code can be
                furnished by a program physician, a primary care physician or an
                authorized healthcare professional under the supervision of a program
                physician or qualified personnel such as NPs and PAs. The other
                assessments, including psychosocial assessments can be furnished by
                practitioners who are eligible to do so under their state law and scope
                of licensure. We note that to bill for the add-on code, the services
                need to be medically reasonable and necessary and that OTPs should
                document the rationale for billing the add-on code in the patient's
                medical record (84 FR 62647).
                 In light of the PHE for the COVID-19 pandemic, during which the
                public has been instructed to practice self-isolation or social
                distancing, in the March 31st COVID-19 IFC, we revised Sec.
                410.67(b)(3) and (4) to allow the therapy and counseling portions of
                the weekly bundles of services furnished by OTPs, as well as the add-on
                code for additional counseling or therapy, to be furnished using audio-
                only telephone calls rather than via two-way interactive audio-video
                communication technology during the PHE for the COVID-19 pandemic if
                beneficiaries do not have access to two-way audio/video communications
                technology, provided all other applicable requirements are met (85 FR
                19258).
                 In addition to the flexibilities described above, we have
                determined that it is also necessary to revise Sec. 410.67(b)(7) on an
                interim final basis to allow periodic assessments to be furnished
                during the PHE for the COVID-19 pandemic via two-way interactive audio-
                video communication technology. In addition, in cases where
                beneficiaries do not have access to two-way audio-video communications
                technology, the periodic assessments may be furnished using audio-only
                telephone calls rather than via two-way interactive audio-video
                communication technology, provided all other applicable requirements
                are met. We believe this change is necessary to ensure that
                beneficiaries with opioid use disorders are able to continue to receive
                these important services during the PHE for the COVID-19 pandemic.
                While we will allow this flexibility during the PHE for the COVID-19
                pandemic, we expect that OTPs will use clinical judgment to determine
                whether they can adequately perform the periodic assessment over audio-
                only phone calls, and if not, then they should perform the assessment
                using two-way interactive audio-video communication technology or in
                person as clinically appropriate. Regardless of the format that is
                used, the OTP should document in the medical record the reason for the
                assessment and the substance of the assessment.
                 Additionally, we note that SAMHSA has offered flexibilities to
                states to ensure that individuals being treated with medication for
                opioid use disorders can continue to receive their medication during
                the PHE for the COVID-19 pandemic. SAMHSA provides specific guidance
                for OTPs on its website at SAMHSA.gov/coronavirus. The following is a
                list of resources posted on the SAMHSA website as of the time of
                publication of this rule:
                 Opioid Treatment Program (OTP) Guidance (March 16, 2020)
                available at https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf.
                 OTP Guidance for Patients Quarantined at Home with the
                Coronavirus available at https://www.samhsa.gov/sites/default/files/otp-covid-implementation-guidance.pdf.
                [[Page 27559]]
                 FAQs: Provision of Methadone and Buprenorphine for the
                Treatment of Opioid Use Disorder in the COVID-19 Emergency available at
                https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
                 COVID-19 Public Health Emergency Response and 42 CFR part
                2 Guidance available at https://www.samhsa.gov/sites/default/files/covid-19-42-cfr-part-2-guidance-03192020.pdf.
                 Considerations for the Care and Treatment of Mental and
                Substance Use Disorders in the COVID-19 Epidemic: March 20, 2020
                available at https://www.samhsa.gov/sites/default/files/considerations-care-treatment-mental-substance-use-disorders-covid19.pdf.
                E. Treatment of Certain Relocating Provider-Based Departments During
                the COVID-19 PHE
                1. Background
                 In 2015, the Congress addressed payments for services furnished by
                certain off-campus provider-based departments (PBDs) through section
                603 of the Bipartisan Budget Act of 2015 (BBA 2015) (Pub. L. 114-74,
                enacted November 2, 2015). In the CY 2017 Outpatient Prospective
                Payment System (OPPS) and Ambulatory Surgical Center Payment System
                (ASC) proposed rule, we discussed the provisions of section 603 of the
                BBA 2015, which amended section 1833(t) of the Act (81 FR 45681). For
                the full discussion of our initial implementation of this provision, we
                refer readers to the CY 2017 OPPS/ASC final rule with comment period
                (81 FR 79699 through 79719) and interim final rule with comment period
                (81 FR 79720 through 79729).
                 Section 603 of the BBA 2015 amended section 1833(t) of the Act by
                amending paragraph (1)(B) and adding a new paragraph (21). As a general
                matter, under sections 1833(t)(1)(B)(v) and (t)(21) of the Act,
                applicable items and services furnished by certain off-campus
                outpatient departments (OPD) of a provider on or after January 1, 2017
                are not considered covered OPD services as defined under section
                1833(t)(1)(B) of the Act for purposes of payment under the OPPS and are
                instead paid ``under the applicable payment system'' under Medicare
                Part B if the requirements for payment are otherwise met.
                 In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79699
                through 79719) and the interim final rule with comment period (81 FR
                79720 through 79729), we established a number of policies to implement
                section 603 of the BBA 2015. Broadly, we finalized policies that define
                whether certain items and services furnished by a given off-campus PBD
                may be considered excepted, and thus, continue to be paid under the
                OPPS; established the requirements for the off-campus PBDs to maintain
                excepted status (both for the excepted off-campus PBDs and for the
                items and services furnished by excepted off-campus PBDs); and
                described the applicable payment system for non-excepted items and
                services (generally, the PFS).
                 We created the ``PO'' modifier in the CY 2015 Outpatient
                Prospective Payment System Final Rule (79 FR 66910-66914), which is
                reported with every HCPCS code for all outpatient hospital items and
                services furnished in an excepted off-campus PBD of a hospital. In the
                CY 2017 OPPS/ASC final rule with comment period (81 FR 79699 through
                79719) and the interim final rule with comment period (81 FR 79720
                through 79729), we created the ``PN'' modifier to collect data for
                purposes of implementing section 603 of the BBA 2015 and also to
                trigger payment under the newly adopted PFS-equivalent rates (50
                percent of the OPPS for CY 2017) for non-excepted items and services.
                In the CY 2018 PFS final rule (82 FR 53023 through 53030), the PFS
                Relativity Adjuster was revised to be 40 percent of the OPPS rate
                beginning in CY 2018.
                2. Definition of Off-Campus Outpatient Department (OPD)
                 Under section 603 of the BBA 2015, certain ``off-campus departments
                of a provider'' are considered ``non-excepted'' and paid under the
                ``applicable payment system'' instead of the OPPS. In defining the term
                ``off-campus outpatient department of a provider,'' section
                1833(t)(21)(B)(i) of the Act specifies that the term means a department
                of a provider (as defined at 42 CFR 413.65(a)(2) as that regulation was
                in effect on November 2, 2015, the date of enactment of the BBA 2015)
                that is not located on the campus (as defined in Sec. 413.65(a)(2)),
                of the provider or within the distance (described in the definition of
                campus) from a remote location of a hospital facility (as defined in
                Sec. 413.65(a)(2)). The definition of ``campus'' in Sec. 413.65(a)(2)
                includes the physical area immediately adjacent to the provider's main
                buildings, other areas and structures that are not strictly contiguous
                to the main buildings but are located within 250 yards of the main
                buildings, and any other areas determined on an individual case basis,
                by the CMS regional office (RO), to be part of the provider's campus.
                 We note that on March 30, 2020, the Secretary issued several
                waivers \15\ under section 1135(b) of the Act in response to the PHE
                for the COVID-19 pandemic, including a waiver of Medicare's provider-
                based rules in Sec. 413.65. Importantly, the waiver does not determine
                whether a PBD is excepted or non-excepted for purposes of section 603
                of the BBA 2015, and the definitions in Sec. 413.65 that section 603
                cross-references, including the definition of campus at Sec.
                413.65(a)(2), remain relevant to that determination.
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                 \15\ https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf.
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                 We note that the definition of ``applicable items and services''
                specifically excludes items and services furnished by a dedicated
                emergency department as defined at 42 CFR 489.24(b). Section
                1833(t)(21)(B)(ii) of the Act also excepts from the definition of
                ``off-campus outpatient department of a provider,'' for purposes of
                paragraphs (1)(B)(v) and (21)(B) of the section, an off-campus PBD that
                was billing under section 1833(t) of the Act with respect to covered
                OPD services furnished prior to November 2, 2015, the date of enactment
                of the BBA 2015. As a result, the definition of ``off-campus outpatient
                department of a provider'' does not include:
                 Off-campus PBDs that were billing under the OPPS for
                covered OPD services furnished prior to November 2, 2015;
                 PBDs located on the campus of a hospital;
                 Those PBDs within the distance (described in the
                definition of campus at Sec. 413.65(a)(2), as of November 2, 2015) of
                a remote location of a hospital facility; or
                 Those PBDs determined by the CMS Regional Office to be
                part of the provider's campus.
                 The items and services furnished by these excepted off-campus PBDs
                on or after January 1, 2017 continue to be paid under the OPPS.
                3. Extraordinary Circumstances Policy
                 In implementing section 603 of the BBA 2015, we recognized the need
                to determine the status of PBDs that had been excepted but subsequently
                relocated. In 42 CFR 419.48(a)(2), we established a policy that
                excepted off-campus PBDs that have not impermissibly relocated can
                remain excepted. Generally speaking, this means that excepted PBDs that
                relocate will typically lose their excepted status and be paid under
                the applicable payment system (generally the PFS) instead. In the CY
                2017 OPPS/ASC final
                [[Page 27560]]
                rule (81 FR 79705), we also explained that on-campus PBDs, which are
                considered excepted due to their on-campus status, that relocate off-
                campus would be considered non-excepted following their relocation. In
                other words, excepted on-campus and off-campus PBDs that relocate to an
                off-campus location are then typically paid the PFS-equivalent rate for
                items and services.
                 In the CY 2017 OPPS/ASC proposed rule (81 FR 45684), we sought
                comment on potential extraordinary circumstances outside of a
                hospital's control that may lead a hospital to relocate an off-campus
                PBD. In the CY 2017 OPPS/ASC final rule (81 FR 79704 through 79706), we
                finalized a policy to allow excepted off-campus PBDs to relocate,
                temporarily or permanently, without loss of excepted status, for
                extraordinary circumstances outside of the hospital's control, such as
                natural disasters, significant seismic building code requirements, or
                significant public health and public safety issues. We also finalized
                that CMS Regional Offices would evaluate and approve or deny these
                relocation requests. In 2017, we provided additional subregulatory
                guidance on the process to request an extraordinary circumstances
                relocation exception, including the requested minimum information
                hospitals should submit to support such a request.\16\
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                 \16\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/Subregulatory-Guidance-Section-603-Bipartisan-Budget-Act-Relocation.pdf.
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                4. Extraordinary Circumstances for Relocating PBDs During the PHE for
                the COVID-19 Pandemic
                 We continue to believe that our current extraordinary circumstances
                policy is appropriate under normal circumstances. However, we wish to
                give hospitals that provide services to Medicare beneficiaries the
                flexibility to respond effectively to the serious public health threats
                posed by the COVID-19 PHE. We are aware that many hospitals are
                repurposing existing clinical and non-clinical space for use as
                temporary expansion sites to furnish inpatient and outpatient care
                during the PHE for the COVID-19 pandemic. In addition, we recognize
                that many hospitals are financially constrained due to the reduction in
                volume caused by the PHE for the COVID-19 pandemic.\17\ We believe
                these constraints may have led, in certain cases, to hospitals
                furloughing or otherwise laying off clinical staff. Congress recognized
                these financial constraints in the passage of the CARES Act and the
                $100 billion appropriation \18\ for Medicare and Medicaid providers and
                suppliers for, among other things, health care-related expenses or lost
                revenues that are attributable to coronavirus. Nonetheless, we remain
                concerned that if an excepted PBD that was previously paid the OPPS
                rate relocates off-campus due to the COVID-19 PHE, some hospitals would
                have difficulty sustaining operations for necessary services during the
                COVID-19 PHE at the PBD if they were paid a reduced rate for services
                that would have otherwise been paid the OPPS rate but for the fact that
                the COVID-19 PHE necessitated the temporary relocation of the excepted
                off-campus or on-campus department. Recognizing the urgency of this
                situation and understanding that hospitals may need additional
                flexibilities and financial stability to quickly expand capacity to
                mitigate the impact of the pandemic on Medicare beneficiaries and the
                American public, we are adopting a temporary relocation exception
                policy specific to the PHE for the COVID-19 pandemic so that hospitals
                can maintain treatment capacity and deliver needed care for patients.
                ---------------------------------------------------------------------------
                 \17\ For example, analysis of Medicare claims in the Integrated
                Data Repository paid through mid-April 2020 for hospital inpatient
                services furnished in the final week of March 2020 shows significant
                decreases (more than 50%), relative to claims paid through mid-April
                2019 for hospital services furnished in the final week of March
                2019, for certain high-volume elective procedures, like total knee
                arthroplasty and total hip arthroplasty. We note that any analysis
                of 2020 claims data is preliminary since providers have up to a year
                after a service is rendered to submit a claim.
                 \18\ This appropriation is included in Title VIII of the CARES
                Act as part of the Public Health and Social Services Emergency Fund.
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                 For purposes of enabling greater hospital flexibility, and, in
                particular, enabling hospitals to rapidly develop temporary expansion
                sites for patient care, we are temporarily adopting an expanded version
                of the extraordinary circumstances relocation policy during the COVID-
                19 PHE to include on-campus PBDs that relocate off-campus during the
                COVID-19 PHE for the purposes of addressing the COVID-19 pandemic. Our
                policy has historically applied only to excepted off-campus departments
                that relocate to a different off-campus location for extraordinary
                circumstances outside of the hospital's control, that submit an
                extraordinary relocation exception request to their CMS Regional
                Office, and for which the CMS Regional Office evaluates and approves
                the request. However, on-campus departments that relocate on or after
                March 1, 2020 through the remainder of the PHE for the purposes of
                addressing the COVID-19 pandemic may also seek an extraordinary
                circumstances relocation exception so that they may bill at the OPPS
                rate, as long as their relocation is not inconsistent with the state's
                emergency preparedness or pandemic plan. We believe it is important for
                hospitals to align their PBD relocations with the state's emergency
                preparedness or pandemic plans to ensure continuity with state efforts,
                as well as efforts by other health care providers in their community,
                to mitigate the effects of the PHE for the COVID-19 pandemic.
                 We note that this temporary extraordinary circumstances policy is
                time-limited to the PHE for COVID-19 to enable short-term hospital
                relocation of excepted off-campus and on-campus departments to improve
                access to care for patients during this time. The temporary
                extraordinary circumstances relocation policy established here will end
                following the end of the PHE for the COVID-19 pandemic, and we
                anticipate that most, if not all, PBDs that relocate during the COVID-
                19 PHE will relocate back to their original location prior to, or soon
                after, the COVID-19 PHE concludes. Hospitals that choose to permanently
                relocate these PBDs off-campus would be considered new off-campus PBDs
                billing after November 2, 2015, and therefore, would be required to
                bill using the PN modifier for hospital outpatient services furnished
                from that PBD location and would be paid the PFS-equivalent rate
                following the end of the COVID-19 PHE.
                 Following the COVID-19 PHE, hospitals may seek an extraordinary
                circumstances relocation exception for excepted off-campus locations
                that have permanently relocated, but these hospitals would need to
                follow the standard extraordinary circumstances application process we
                adopted in CY 2017 \19\ and file an updated CMS-855A enrollment form to
                reflect the new address(es) of the PBD(s). We note that our standard
                relocation exception policy only applies to excepted off-campus PBDs
                that relocate; on-campus PBDs that wish to permanently relocate off-
                campus will not be able to receive an extraordinary circumstances
                relocation exception under the standard extraordinary circumstances
                relocation request process after the conclusion of the COVID-19 PHE. We
                also note that hospitals should not rely on having relocated the off-
                campus PBD during the COVID-19 PHE as the reason the off-campus PBD
                should be permanently excepted following the end of the
                [[Page 27561]]
                COVID-19 PHE. In other words, the fact that the off-campus PBD
                relocated in response to the pandemic will not, by itself, be
                considered an ``extraordinary circumstance'' for purposes of a
                permanent relocation exception, although CMS Regional Offices will
                continue to have discretion to approve or deny relocation requests for
                hospitals that apply after the COVID-19 PHE, depending on if the
                relocation request meets the requirements for the normal extraordinary
                circumstances exception. Following the COVID-19 PHE, if temporarily
                relocated off-campus PBDs do not go back to their original location,
                they will be considered to be non-excepted PBDs and paid the PFS-
                equivalent rate.
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                 \19\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/Subregulatory-Guidance-Section-603-Bipartisan-Budget-Act-Relocation.pdf.
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                5. New Exception Process for Extraordinary Circumstances Relocation of
                Existing On-Campus and Excepted Off-Campus PBDs
                 We are also taking steps to streamline the process for the
                extraordinary circumstances relocation exceptions for purposes of
                addressing the COVID-19 pandemic during the PHE. Specifically, using
                the process outlined below, both excepted off-campus and on-campus PBDs
                may relocate to off-campus locations during the COVID-19 PHE and begin
                furnishing and billing for services under the OPPS in the new location
                prior to submitting documentation to the RO to support the
                extraordinary circumstances relocation request.
                 Importantly, if the relocation is denied by the RO under the
                extraordinary circumstances policy, and the hospital did not bill for
                them using the ``PN'' modifier, any claims billed under the OPPS in the
                new location would need to be reprocessed as having been billed by a
                non-excepted PBD and will instead be paid the PFS-equivalent rate. Non-
                excepted off-campus departments will continue to be non-excepted during
                the COVID-19 PHE, even if they relocate, and thus, will continue to be
                paid the PFS-equivalent rate. They do not need to follow the process
                outlined below for relocation approval since they are already, and will
                continue to be, non-excepted.
                 Hospitals with on-campus and excepted off-campus PBDs that
                relocate due to the COVID-19 PHE in a manner that is not inconsistent
                with their state's emergency preparedness or pandemic plan should
                append modifier ``PO'' to OPPS claims for services furnished at the
                relocated PBDs. This modifier indicates a service that is provided at
                an excepted off-campus PBD and is paid the OPPS payment rate.
                 In place of the process adopted in the CY 2017 OPPS/ASC
                final rule with comment period (81 FR 79704 through 79705) and included
                in the existing subregulatory guidance under which off-campus PBDs can
                apply for an extraordinary circumstance relocation exception,\20\ all
                hospitals that relocate excepted on- or off-campus PBDs to off-campus
                locations in response to the COVID-19 PHE should notify their CMS
                Regional Office by email of their hospital's CCN; the address of the
                current PBD; the address(es) of the relocated PBD(s); the date which
                they began furnishing services at the new PBD(s); a brief justification
                for the relocation and the role of the relocation in the hospital's
                response to COVID-19; and an attestation that the relocation is not
                inconsistent with their state's emergency preparedness or pandemic
                plan. We expect hospitals to include in their justification for the
                relocation why the new PBD location (including instances where the
                relocation is to the patient's home) is appropriate for furnishing
                covered outpatient items and services.
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                 \20\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/Subregulatory-Guidance-Section-603-Bipartisan-Budget-Act-Relocation.pdf.
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                 To the extent that a hospital may relocate to an off-campus PBD
                that otherwise is the patient's home, only one relocation request
                during the COVID-19 PHE is necessary. In other words, the hospital
                would not have to submit a unique request each time it registers a
                hospital outpatient for a PBD that is otherwise the patient's home; a
                single submission per location is sufficient. Hospitals must send this
                email to their CMS Regional Office within 120 days of beginning to
                furnish and bill for services at the relocated on- or off-campus PBD.
                 To provide additional flexibility, for purposes of
                addressing the PHE for the COVID-19 pandemic, hospitals may divide
                their PBD into multiple locations during a relocation. That is, if a
                single excepted PBD location relocates to multiple off-campus PBD
                locations in response to the COVID-19 PHE and in a manner that is not
                inconsistent with the state's emergency preparedness or pandemic plan,
                it will be permissible for all of the off-campus PBDs to which the
                excepted PBD relocated to continue to bill under the OPPS under the
                temporary extraordinary circumstances policy that is in place during
                the COVID-19 PHE. In addition, for purposes of the COVID-19 PHE,
                hospitals may relocate part of their excepted PBD to a new off-campus
                location while maintaining the original PBD location. Said differently,
                if a hospital relocates part of an excepted PBD to one or more off-
                campus PBD locations, it would be permissible for the original excepted
                PBD location, as well as the relocated off-campus PBD location(s) of
                that excepted PBD, to continue to bill under the OPPS under the revised
                extraordinary circumstances policy that is in place during the COVID-19
                PHE so long as the extraordinary circumstances policy in effect during
                the COVID-19 PHE (described earlier in this section) is followed. We
                believe these flexibilities are needed for hospitals to respond
                effectively to the COVID-19 PHE. For example, one PBD may need to
                utilize two locations to maintain separation between COVID-positive and
                COVID-negative patients. Further, the relocation or partial relocation
                of an excepted PBD for the extraordinary circumstance of the COVID-19
                PHE could involve a single excepted PBD that relocates (or partially
                relocates) to a patient's home (for purposes of furnishing a covered
                OPD service), which under the Hospitals without Walls initiative, can
                be provider-based to the hospital during the COVID-19 PHE. We note
                that, during the COVID-19 PHE, a patient's home would be considered a
                PBD of the hospital when the patient is registered as a hospital
                outpatient (as discussed in section II.F. of this IFC) and is receiving
                covered OPD services from the hospital.
                 However, in most cases we do not anticipate that excepted PBDs
                would need to relocate or partially relocate into many different new
                locations. Rather, we anticipate most multi-relocations or partial
                relocations would be to a limited number of locations as needed to
                respond to the COVID-19 PHE in a manner not inconsistent with the
                state's preparedness and pandemic plan, with the exception being
                multiple relocations to accommodate care in patient's homes. We also
                expect hospitals exercising this flexibility to be able to support that
                the excepted PBD is still the same PBD, just split into more than one
                location. For example, if the excepted PBD was an oncology clinic, we
                would expect that the relocated PBD(s) during the COVID-19 PHE would
                still be providing oncologic services, including in the patient's home
                to the extent such location is made provider based to the hospital.
                 If Medicare-certified hospitals will be rendering services
                in relocated excepted PBDs, but intend to bill Medicare for the
                services under the main hospital, no additional provider enrollment
                actions are required (for example, hospitals do not need to submit an
                updated CMS-855A enrollment form) for the off-campus
                [[Page 27562]]
                relocated site during the COVID-19 PHE. Following the COVID-19 PHE, as
                noted in section II.E.4. of this IFC, hospitals that wish to
                permanently relocate their excepted PBD must file an updated CMS-855A
                enrollment form to reflect the new address(es) of the PBD(s).
                 In summary, and as discussed in more detailed above, we are
                adopting a temporary extraordinary circumstances relocation exception
                policy for excepted off-campus PBDs that relocate off-campus during the
                COVID-19 PHE. We are extending that temporary policy to on-campus PBDs
                that relocate off-campus during the COVID-19 PHE, and permitting the
                relocating PBDs to continue to be paid under the OPPS. Finally, we are
                streamlining the process for relocating PBDs to obtain the temporary
                extraordinary circumstances policy exception.
                F. Furnishing Outpatient Services in Temporary Expansion Locations of a
                Hospital or a Community Mental Health Center (Including the Patient's
                Home)
                 Infection control is one of the primary goals of many initiatives
                CMS has undertaken during the COVID-19 PHE. Through all of the
                flexibilities offered, we have concentrated on increasing providers'
                ability to furnish services at temporary expansion locations, including
                the patient's home, to limit the need for patients to receive care in
                the hospital itself, which could unnecessarily expose the patients or
                providers to the pandemic contagion. Among the types of services that
                beneficiaries would benefit from receiving at temporary expansion
                locations are those critical outpatient services that hospitals, CMHCs,
                and CAHs furnish in their service areas. HOPDs, in particular, furnish
                a wide array of services, from clinic visits and counseling services,
                to complex surgical procedures and emergency care.
                 We have taken several actions to create regulatory flexibilities in
                response to the COVID-19 PHE, including publishing the March 31st
                COVID-19 IFC, issuing numerous blanket waivers of requirements for
                health care providers under section 1135 of the Act, and exercising the
                authority granted under section 1812(f) of the Act. Since that time, we
                have received many questions about how hospital outpatient services can
                be furnished when the patient is in a temporary expansion location,
                including his or her home, particularly for those hospital outpatient
                services that typically do not co-occur with a physician or NPP
                furnishing a professional service. Those services are billed only under
                the hospital OPPS when furnished by the hospital and there is no
                professional service that is separately billable under the PFS.
                 In addition, we have received questions about how the hospital
                should bill during the COVID-19 PHE when the practitioners typically
                furnishing services in HOPDs are now instead furnishing professional
                services as Medicare telehealth services under section 1834(m) of the
                Act under the flexibilities provided by both the waiver of requirements
                under section 1135(b)(8) of the Act and the March 31st COVID-19 IFC.
                Because we continue to believe that it is important for beneficiaries
                to be able to receive care in temporary expansion locations to maintain
                infection control, we explain in this section the flexibilities that
                are available to hospitals to enable them to furnish outpatient
                services to beneficiaries in their homes (or other temporary expansion
                locations), when such a location is considered to be a PBD of the
                hospital, as permitted under the waivers in effect during the COVID-19
                PHE.
                 Under ordinary circumstances, Medicare would not pay for hospital
                outpatient therapeutic services that are furnished to a beneficiary in
                the beneficiary's home or any other location that could not ordinarily
                be provider-based to the hospital. Our regulations at Sec.
                410.27(a)(1)(iii) explicitly include a requirement that therapeutic
                outpatient hospital services must be furnished in the hospital or CAH
                or in a department of the hospital or CAH.
                 However, as noted above, we have issued numerous blanket section
                1135 waivers to give health care providers needed flexibility to
                address the COVID-19 PHE.\21\ As part of this initiative, we have
                waived the requirements associated with becoming a PBD of a hospital at
                Sec. 413.65, as well as certain requirements under the Medicare
                conditions of participation in Sec. Sec. 482.41 and 485.623, to
                facilitate the availability of temporary expansion locations. Because
                of these waivers, during the COVID-19 PHE, temporary expansion
                locations, including beneficiaries' homes, can become PBDs of hospitals
                and therapeutic outpatient hospital services furnished to beneficiaries
                in these provider-based locations can meet the requirement that these
                services be furnished in the hospital so long as all other requirements
                are met, including the hospital conditions of participation, to the
                extent not waived, during the COVID-19 PHE. That is, while certain
                locations would not normally be permitted to be considered part of a
                hospital, during the COVID-19 PHE, the section 1135 waivers of the
                provider-based rules allow temporary expansion locations to become
                provider-based to the hospital to bill for medically necessary hospital
                outpatient therapeutic services furnished at those locations, assuming
                all other applicable requirements are met (including, to the extent not
                waived, the hospital conditions of participation).
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                 \21\ https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf.
                ---------------------------------------------------------------------------
                 For purposes of clarifying regulatory flexibilities for hospital
                outpatient therapeutic services furnished to beneficiaries in their
                homes or other temporary expansion locations for the duration of the
                COVID-19 PHE, we considered hospital outpatient therapeutic services in
                three categories: (1) Hospital outpatient therapy, education, and
                training services, including partial hospitalization program services,
                that can be furnished other than in-person, and are furnished in a
                temporary expansion location (which may be the patient's home) that is
                a PBD of the hospital or an expanded CMHC; (2) hospital outpatient
                clinical staff services furnished in-person to the beneficiary in a
                temporary expansion location; and (3) hospital services associated with
                a professional service delivered by telehealth. We address each of
                these three categories in more detail below.
                1. Hospital Outpatient and CMHC Therapy, Education, and Training
                Services
                 In many cases, hospitals provide hospital outpatient therapy
                (including behavioral health), education, and training services that
                are furnished by hospital-employed counselors or other licensed
                professionals. Examples of these services include psychoanalysis,
                psychotherapy, diabetes self-management training, and medical nutrition
                therapy. With few exceptions, the Medicare statute does not have a
                benefit category that would allow these types of professionals (for
                example, counselors, nurses, and registered dieticians) to bill
                Medicare directly for their services. These services can, in many
                cases, be billed by providers such as hospitals under the OPPS or by
                physicians and other practitioners as services incident to their
                professional services under the PFS.
                 Potentially the most prominent of these services are partial
                hospitalization program (PHP) services, which comprise an intensive
                outpatient program of psychiatric services provided as an alternative
                to inpatient psychiatric care
                [[Page 27563]]
                for individuals who have an acute mental illness. We discuss treatment
                of PHP services separately within this section of this IFC.
                 Outpatient therapy, education, and training services require
                communication and interaction. Facility staff can effectively furnish
                these services using telecommunication technology and, unlike many
                hospital services, the clinical staff and patient are not required to
                be in the same location to furnish them. We have already stated that
                section 1135 blanket waivers in effect during the COVID-19 PHE allow
                the hospital to consider the beneficiary's home, and any other
                temporary expansion location operated by the hospital during the COVID-
                19 PHE, to be a PBD of the hospital, so long as the hospital can ensure
                the locations meet all of the conditions of participation, to the
                extent not waived. In light of the need for infection control and a
                desire for continuity of behavioral health care and treatment services,
                we recognize the ability of the hospital's clinical staff to continue
                to deliver these services even when they are not physically located in
                the hospital. Provided a hospital's clinical staff is furnishing
                hospital outpatient therapy, education, and training services to a
                patient in the hospital (which can include the patient's home so long
                as it is provider based to the hospital), and the patient is registered
                as an outpatient of the hospital, we will consider the requirements of
                the regulations at Sec. 410.27(a)(1) to be met. We remind readers that
                the physician supervision level for the vast majority of hospital
                outpatient therapeutic services is currently general supervision under
                Sec. 410.27. This means a service must be furnished under the
                physician's overall direction and control, but the physician's presence
                is not required during the performance of the service.
                 To facilitate public understanding of the types of services we
                believe can be furnished by the hospital to a patient in the hospital
                (including the patient's home if it is a PBD of the hospital) using
                telecommunications technology, we have provided on our website \22\ a
                list of the outpatient therapy, counseling, and educational services
                that hospital clinical staff can furnish incident to a physician's or
                qualified NPP's service during the COVID-19 PHE to a beneficiary in
                their home or other temporary expansion location that functions as a
                PBD of the hospital when the beneficiary is registered as an outpatient
                of the hospital. We note that this list may not include every service
                that falls into this category and we intend to update the list
                periodically, to the extent that would be helpful for public awareness.
                ---------------------------------------------------------------------------
                 \22\ www.cms.gov.
                ---------------------------------------------------------------------------
                 All services furnished by the hospital still require an order by a
                physician or qualified NPP and must be supervised by a physician or
                other NPP appropriate for supervising the service given their hospital
                admitting privileges, state licensing, and scope of practice,
                consistent with the requirements in Sec. 410.27. We note that
                hospitals may bill for these services as if they were furnished in the
                hospital and consistent with any specific requirements for billing
                Medicare in general, including any relevant modifications in effect
                during the COVID-19 PHE.\23\ We note that when these services are
                provided by clinical staff of the physician or other practitioner and
                furnished incident to their professional services, and are not provided
                by staff of the hospital, the hospital would not bill for the services.
                The physician or other practitioner should bill for such services
                incident to their own services and would be paid under the PFS. As
                always, documentation in the medical record of the reason and necessity
                of the visit is required.
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                 \23\ https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page.
                ---------------------------------------------------------------------------
                a. Partial Hospitalization Program (PHP)
                 A PHP is an intensive outpatient program of psychiatric services
                provided as an alternative to inpatient psychiatric care for
                individuals who have an acute mental illness, which includes, but is
                not limited to, conditions such as depression and schizophrenia.
                Section 1861(ff)(1) of the Act defines partial hospitalization services
                as the items and services described in paragraph (2) prescribed by a
                physician and provided under a program described in paragraph (3) under
                the supervision of a physician pursuant to an individualized, written
                plan of treatment established and periodically reviewed by a physician
                (in consultation with appropriate staff participating in such program),
                which sets forth the physician's diagnosis, the type, amount,
                frequency, and duration of the items and services provided under the
                plan, and the goals for treatment under the plan. Section 1861(ff)(2)
                of the Act describes the items and services included in partial
                hospitalization services. Section 1861(ff)(3)(A) of the Act specifies
                that a PHP is a program furnished by a hospital to its outpatients or
                by a CMHC, as a distinct and organized intensive ambulatory treatment
                service, offering less than 24-hour-daily care, in a location other
                than an individual's home or inpatient or residential setting. Section
                1861(ff)(3)(B) of the Act defines a CMHC for purposes of this benefit.
                 In CY 2018, which is the most recent period for which we have
                complete PHP claims data, there were a total of 482,973 paid PHP days,
                including 394,311 paid PHP days for hospital-based providers and 88,662
                paid PHP days for CMHCs. In comparison, inpatient psychiatric
                facilities (IPFs) billed 4,291,461 utilization days in FY 2019, the
                most recent period for which we have complete IPF claims data. Based on
                this comparison, we estimate that IPF services are utilized between 8
                and 9 times more frequently than PHP services.
                 Previously in this section, we identified that infection control is
                a primary goal of CMS initiatives undertaken during the COVID-19 PHE.
                We also believe continuity of behavioral health services is critical
                for those participating in a PHP, particularly at a time of heightened
                anxiety and uncertainty. As noted above, we have issued numerous
                blanket waivers under section 1135 of the Act, including for hospitals
                and CMHCs providing PHP services, to give health care providers needed
                flexibility to address the COVID-19 PHE and support the goal of
                infection control while maintaining access to partial hospitalization
                services and ensuring continuity of care for patients. Effective as of
                March 1, 2020 and for the duration of the COVID-19 PHE, a temporary
                expansion location where the beneficiary may be located, including a
                beneficiary's home, may be a PBD of the hospital, or may be a temporary
                extension of the CMHC (discussed in more detail below).
                 Consistent with the goals of infection control and maintaining
                access, for the duration of the COVID-19 PHE only, providers can
                furnish certain partial hospitalization services remotely to patients
                in a temporary expansion location of the hospital or CMHC, which may
                include the patient's home to the extent it is made provider-based to
                the hospital or an extension of the CMHC. PHP services consist of
                unique combinations of services designated at section 1861(ff)(2) of
                the Act, including individual psychotherapy, patient education, and
                group psychotherapy. Certain PHP services such as these require
                communication and interaction, but do not require the clinical staff or
                patient to be in the same location, nor do clinical staff need to be in
                the hospital or CMHC when furnishing these PHP services. Therefore, the
                [[Page 27564]]
                following types of services--to the extent they were already billable
                as PHP services in accordance with existing coding requirements prior
                to the COVID-19 PHE--can now be furnished to beneficiaries by facility
                staff using telecommunications technology during the COVID-19 PHE: (1)
                Individual psychotherapy; (2) patient education; and (3) group
                psychotherapy. Because of the intensive nature of PHP, we expect PHP
                services to be furnished using telecommunications technology involving
                both audio and video. However, we recognize that in some cases
                beneficiaries might not have access to video communication technology.
                In order to maintain beneficiary access to PHP services, only in the
                case that both audio and video are not possible can the service be
                furnished exclusively with audio. To be clear, services that require
                drug administration cannot be furnished using telecommunications
                technology. To facilitate public understanding of the types of PHP
                services that can be furnished using telecommunications technology by
                the hospital to a patient in the hospital (including the patient's home
                if it is a PBD of the hospital) or by the CMHC to a patient in an
                expanded CMHC location, we have provided on our website \24\ a list of
                the individual psychotherapy, patient education, and group
                psychotherapy services that hospital or CMHC staff can furnish during
                the COVID-19 PHE to a beneficiary in their home or other temporary
                expansion location that functions as a PBD of the hospital or expanded
                CMHC when the beneficiary is registered as an outpatient. We note that
                this list may not include every service that falls into this category
                and we intend to update the list periodically, to the extent that would
                be helpful for public awareness.
                ---------------------------------------------------------------------------
                 \24\ www.cms.gov.
                ---------------------------------------------------------------------------
                 Although these services can be furnished remotely, all other PHP
                requirements are unchanged and still in effect, including that all
                services furnished under the PHP still require an order by a physician,
                must be supervised by a physician, must be certified by a physician,
                and must be furnished in accordance with coding requirements by a
                clinical staff member working within his or her scope of practice. In
                accordance with the longstanding requirements that are detailed in the
                Medicare Benefit Policy Manual, Pub 100-02, chapter 6, section 70.3,
                documentation in the medical record of the reason for the visit and the
                substance of the visit is required. As noted above, when these services
                are provided by clinical staff of the physician or other practitioner
                and furnished incident to their professional services, and are not
                provided by staff of the hospital or CMHC, the hospital or CMHC would
                not bill for the services. The physician or other practitioner should
                bill for such services incident to their own services and would be paid
                under the PFS.
                (i.) Hospital-Based PHP Providers
                 As detailed above, in CY 2018, hospital-based providers furnished
                394,311 paid PHP days to Medicare beneficiaries, approximately 81.6
                percent of Medicare-paid PHP days in that year. As part of the
                initiative to promote infection control and maintain access to PHP
                services, we have waived the requirements for being a PBD of the
                hospital in Sec. 413.65, as well as certain requirements under the
                Medicare conditions of participation in Sec. Sec. 482.41 and 485.623,
                to facilitate the availability of temporary expansion locations. As
                noted above, for purposes of the COVID-19 PHE and effective as of March
                1, 2020, a temporary expansion location where the beneficiary may be
                located, including a beneficiary's home, may be a PBD of the hospital
                where the location meets the non-waived conditions of participation.
                Together, these waivers allow hospitals to consider a temporary
                expansion location where the beneficiary may be located, including
                their homes, an HOPD only in the context of the COVID-19 PHE. Thus, for
                the duration of the COVID-19 PHE, we will consider the PHP services
                furnished by hospital clinical staff, when the beneficiary is
                registered as an outpatient of the hospital and in accordance with the
                supervising practitioner's scope of practice, to the beneficiary in a
                temporary expansion location where the beneficiary may be located,
                including a beneficiary's home, to have been furnished in the hospital
                so long as the temporary expansion location is made provider-based to
                the hospital. The hospital should bill for these services as if they
                were furnished in the hospital and consistent with any specific
                requirements for billing Medicare during the COVID-19 PHE.
                (ii.) Community Mental Health Centers
                 A CMHC is a provider of PHP services defined under section
                1861(ff)(3)(B) of the Act. As detailed above, in CY 2018, CMHCs
                furnished 88,662 paid PHP days to Medicare beneficiaries, approximately
                18.4 percent of Medicare-paid PHP days in that year. For the duration
                of the COVID-19 PHE, we are waiving the restriction at Sec.
                485.918(b)(1)(iii) for the purpose of providing PHP services to CMHC
                patients in their homes, which will be considered a temporary expansion
                location of a CMHC. A temporary expansion location where the
                beneficiary may be located, including the beneficiary's home, can be
                considered part of a CMHC, and certain therapeutic services furnished
                to beneficiaries, when the beneficiary is registered as an outpatient
                of the CMHC, in these temporary expansion locations can meet the
                requirement that these services be furnished in the CMHC. Specifically,
                for the purposes of the COVID-19 PHE and effective as of March 1, 2020,
                we will consider temporary expansion locations where the beneficiary
                may be located, including a beneficiary's home, to be a part of the
                CMHC once a patient is registered as an outpatient of the CMHC, while
                PHP services are being furnished at that location by CMHC staff in
                accordance with the supervising practitioner's scope of practice.
                Therefore, we will consider services furnished in that location to have
                been furnished in the CMHC. The CMHC should bill for these services as
                if they were furnished in the CMHC and consistent with any specific
                requirements for billing Medicare during the COVID-19 PHE.
                2. Hospital In-Person Clinical Staff Services in a Temporary Expansion
                Location (Which May the Home)
                 Hospitals also provide services that are furnished by clinical
                staff under a physician's or qualified NPP's order that do not require
                professional work by the physician or qualified NPP, and thus, are
                billed only under the OPPS when furnished by the hospital and are not
                separately billable under the PFS. Wound care, chemotherapy
                administration, and other drug administration are examples \25\ of
                these types of services. We note that while surgical services also fall
                under this category, we would not anticipate that they would be
                furnished in a home that becomes provider-based to the hospital, due to
                infection control and operating room requirements. In addition, there
                are several other hospital outpatient therapeutic services that require
                the hospital's clinical staff's presence to furnish the service. The
                current section 1135 blanket waivers in place during the COVID-19 PHE
                allow the patient's home to be considered an outpatient
                [[Page 27565]]
                PBD of the hospital. With a primary goal of infection control and
                understanding that hospitals must meet the conditions of participation,
                to the extent not waived during the COVID-19 PHE, we are making the
                public aware of the flexibilities that exist during the COVID-19 PHE
                that enable hospitals to furnish these clinical staff services in the
                patient's home as an outpatient PBD and to bill and be paid for these
                services as HOPD services when the patient is registered as a hospital
                outpatient. Because these services have to be provided in person by
                clinical staff, these services cannot be furnished by telecommunication
                technology by the hospital. In these instances, hospital clinical staff
                must be physically present in the patient's home or other temporary
                expansion location that is provider based to the hospital to furnish
                the hospital outpatient therapeutic service. The physician supervision
                level must be met for these services, and we note that for the vast
                majority of therapeutic hospital outpatient services, the required
                supervision level is currently general supervision under Sec. 410.27.
                This means a service is furnished under the physician's overall
                direction and control, but the physician's presence is not required
                during the performance of the service. This includes non-surgical
                extended duration therapeutic services (NSEDTSs), which are services
                that can last a significant period of time, have a substantial
                monitoring component that is typically performed by auxiliary
                personnel, have a low risk of requiring the physician's or appropriate
                NPP's immediate availability after the initiation of the service, and
                are not primarily surgical in nature. Direct supervision is generally
                required for the initiation of these NSEDTs, followed by a general
                supervision requirement for the duration of the service. In the March
                31st COVID-19 IFC, we changed the supervision requirement for NSEDTs to
                instead require a general level of supervision throughout the service,
                including at service initiation, for the duration of the COVID-19 PHE.
                ---------------------------------------------------------------------------
                 \25\ With regard to observation services, we note that to bill
                for observation services all existing requirements must be met.
                These requirements are identified in Chapter 4, Section 290 of the
                Medicare Claims Processing Manual.
                ---------------------------------------------------------------------------
                 Importantly, during the time period that the patient is receiving
                services from the hospital clinical staff as a registered outpatient,
                the patient's place of residence cannot be considered a home for
                purposes of HHA services. This is because HHAs cannot bill for services
                furnished in PBDs of hospitals, and a patient's home has provider-based
                status when the patient is a registered hospital outpatient and HOPD
                services are being furnished. Because the home is not a traditional
                PBD, and because there are interactions with other types of providers
                or suppliers who may furnish services in the home, but not in the
                ``hospital,'' we note that hospitals should only consider the patient
                home to be provider-based to the hospital when the patient is
                registered as a hospital outpatient. When the patient is not receiving
                outpatient services by the hospital, the patient's home can be
                considered a home for purposes of the home health benefit and the HHA
                can furnish and bill for home health services. The hospital should be
                aware if the patient is under a home health plan of care, and it must
                not furnish services to the patient that could be furnished by the HHA
                while the plan of care is active. That is, to the extent that there is
                some overlap between the types of services a HHA and a HOPD can
                provide, and the patient has a current home health plan of care, the
                hospital should only furnish services that cannot be furnished by the
                HHA.
                 The fact that these services can be furnished in a patient's home
                or another temporary expansion location that is temporarily provider
                based to the hospital does not change the requirements that all
                services furnished by the hospital require an order by a physician or
                qualified NPP and must be supervised by a physician or other NPP
                appropriate for supervising the service given their hospital admitting
                privileges, state licensing, and scope of practice consistent with the
                requirements in Sec. 410.27. Hospitals should bill for these services
                as they ordinarily bill for services along with any specific billing
                requirements for relocating PBDs specific to billing during a COVID-19
                PHE as discussed in section II.D. of this IFC (that is, appending the
                PO modifier for excepted items and services and the PN modifier for
                nonexcepted services). Information regarding the application of section
                603 of the BBA 2015 to relocating PBDs is available in section II.F.4.
                of this IFC, as well as section II.E. of this IFC.
                3. Hospital Services Accompanying a Professional Service Furnished Via
                Telehealth
                 The majority of hospital services are furnished in conjunction with
                professional services of physicians and other practitioners. In these
                instances, practitioners furnish and bill separately for their
                professional services indicating the place of service as a HOPD, and
                the hospital bills separately to be paid for the clinical labor,
                equipment, overhead, and capital to support the delivery of that
                professional service. In the March 31st COVID-19 IFC, we instructed
                physicians and other practitioners furnishing telehealth services to
                beneficiaries in their homes as permitted during the COVID-19 PHE to
                bill for those services in the same way they would if they were
                furnishing the services in person (85 FR 19233). For many
                professionals, the HOPD is the usual location where they furnish
                services. For the duration of the COVID-19 PHE and effective March 1,
                2020, when a practitioner who ordinarily practices in a HOPD furnishes
                a telehealth service to a patient who is located at home (or otherwise
                not in a telehealth originating site), they would submit a professional
                claim with the place of service code indicating the service was
                furnished in the HOPD and using the Current Procedural Terminology
                (CPT) telehealth modifier, modifier 95. Medicare would pay the
                practitioner under the PFS at the ``facility'' rate as if the service
                was furnished in the HOPD. We adopted the aforementioned interim rule
                because we believed that, but for the COVID-19 PHE, the physician or
                practitioner would likely have furnished the service in person at their
                usual practice location; and that the service was instead furnished via
                telehealth for purposes of infection control. The March 31st COVID-19
                IFC did not provide for the hospital to submit any claim for the
                service under the aforementioned scenario.
                 We acknowledge that when a physician or practitioner who ordinarily
                practices in the HOPD furnishes a telehealth service to a patient who
                is located at home, the hospital would often still provide some
                administrative and clinical support for that service. When a registered
                outpatient of the hospital is receiving a telehealth service, the
                hospital may bill the originating site facility fee to support such
                telehealth services furnished by a physician or practitioner who
                ordinarily practices there. This includes patients who are at home,
                when the home is made provider-based to the hospital (which means that
                all applicable conditions of participation, to the extent not waived,
                are met), under the current waivers in effect for the COVID-19 PHE.
                 More specifically, when a telehealth service is furnished by a
                practitioner located at a distant site to a patient who is located in
                the HOPD, the hospital is presumed to provide administrative and
                clinical support resources. In such circumstances, section
                1834(m)(2)(B) of the Act allows for an originating site facility fee to
                be paid to the hospital. Section 1834(m)(2)(B)(ii) of the Act further
                provides that no facility fee shall be paid to an originating site
                described in paragraph (4)(C)(ii)(X) (that is, the home). However, as
                described
                [[Page 27566]]
                throughout this section, the patient's home may be considered a PBD of
                the hospital during the COVID-19 PHE if other applicable requirements
                (including the non-waived conditions of participation) are met. As
                noted above, because the home is not a traditional PBD, and because
                there are interactions with other types of providers or suppliers who
                may furnish services in the home, but not in the ``hospital,'' we note
                that hospitals should only furnish hospital outpatient services to a
                patient (who is registered as a hospital outpatient) after the
                patient's home has been made provider-based to the hospital for the
                provision of such services. In that event, the home would be serving as
                a PBD of the hospital, and as the originating site for the telehealth
                service furnished by a physician or practitioner located at a distant
                site.
                 The originating site facility fee is the statutory payment that is
                made to the facility for providing the site where the patient is
                located, and any other administrative or clinical support, for a
                telehealth service. Therefore, during the COVID-19 PHE, when telehealth
                services are furnished by a physician or practitioner who ordinarily
                practices in the HOPD to a patient who is located at home or other
                applicable temporary expansion location that has been made provider
                based to the hospital, we believe it would be appropriate to permit the
                hospital to bill and be paid the originating site facility fee amount
                for those telehealth services, just as they would have ordinarily done
                outside of the COVID-19 PHE in this circumstance.
                 As such, for the duration of the COVID-19 PHE, we are making the
                public aware that under the flexibilities already in effect, when a
                patient is receiving a professional service via telehealth in a
                temporary expansion location that is a PBD of the hospital, and the
                patient is a registered outpatient of the hospital, the hospital in
                which the patient is registered may bill the originating site facility
                fee for the service. As always, documentation in the medical record of
                the reason for the visit and the necessity of the visit is required.
                4. Intersection With Payment Policy for Hospital Outpatient PBDs
                 As discussed previously, we have waived \26\ the requirements for
                being a PBD of the hospital in Sec. 413.65, as well as certain
                requirements under the Medicare conditions of participation in
                Sec. Sec. 482.41 and 485.623, to facilitate the availability of
                temporary expansion sites. Importantly, these waivers do not determine
                whether a PBD is excepted or non-excepted for purposes of section 603
                of the BBA 2015, and the definitions in Sec. 413.65 that section 603
                cross-references, including the definition of campus at Sec.
                413.65(a)(2), remain relevant to that determination. However, in
                section II.E. of this IFC, we discuss a temporary extraordinary
                circumstances relocation policy for on-campus and excepted off-campus
                hospital outpatient PBDs that relocate due to the COVID-19 PHE, under
                which these PBDs that relocate in accordance with that policy can
                continue to bill and be paid as an on-campus or excepted off-campus PBD
                at the full OPPS payment rate. The hospital's relocation must not be
                inconsistent with their state's emergency preparedness or pandemic
                plan. For purposes of the COVID-19 PHE, on-campus or excepted off-
                campus PBDs can be considered to have relocated (or partially
                relocated) to a beneficiary's home, or other temporary expansion
                location of the hospital, when the beneficiary is registered as an
                outpatient of the hospital during service delivery. Under this policy,
                the PBD is still considered either an on-campus or excepted off-campus
                PBD that is not subject to section 603 of the BBA 2015 and would bill
                with the ``PO'' modifier for services furnished to beneficiaries in
                their homes as a relocated (or partially relocated) PBD and will
                receive the full OPPS rate. However, we note that if the hospital does
                not relocate (or partially relocate) an existing on-campus or excepted
                off-campus PBD to the patient's home and does not seek an exception
                under the temporary extraordinary circumstances relocation exception
                policy discussed in section II.E. of this IFC, the patient's home would
                be considered a new non-excepted off-campus PBD and the hospital would
                bill with the ``PN'' modifier and receive the PFS-equivalent rate.
                ---------------------------------------------------------------------------
                 \26\ https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf.
                ---------------------------------------------------------------------------
                 Under section II.F.1. of this IFC, we have identified certain
                outpatient therapy, counseling, and educational services that hospital
                clinical staff can furnish (using telecommunications technology)
                incident to a physician's service during the COVID-19 PHE to a
                beneficiary who is registered as an outpatient when those services are
                furnished in the beneficiary's home, which functions as a PBD of the
                hospital. For example, hospital clinical staff can now remotely furnish
                psychotherapy (for example, HCPCS code 90832) to the beneficiary in
                their home, as long as the beneficiary is a registered outpatient of
                the hospital and the patient's home is made provider-based to the
                hospital. In this circumstance, if the hospital considers the
                beneficiary's home a relocated (or partially relocated) PBD, and
                follows the temporary extraordinary circumstances exception policy
                discussed in section II.E. of this IFC, the hospital would bill the
                applicable HCPCS code (for example, HCPCS code 90832) along with
                modifier ``PO'' to receive the full OPPS payment amount. The hospital
                will be paid under the PFS for services furnished to a beneficiary in
                their home if the hospital does not seek an extraordinary circumstances
                relocation exception for their PBD and, if applicable, include the
                patient's home address as one of the locations to which the PBD
                relocated and bill the claim for the services furnished in the
                patient's home using the PO modifier.
                5. Summary
                 As discussed above, we clarified that hospital and CMHC staff can
                furnish certain outpatient therapy, counseling, and educational
                services (including PHP services) incident to a physician's service
                during the COVID-19 PHE to a beneficiary in their home or other
                temporary expansion location using telecommunications technology. In
                these circumstances, the hospital can furnish services to a beneficiary
                in a temporary expansion location (including the beneficiary's home) if
                that beneficiary is registered as an outpatient; and the CMHC can
                furnish services in an expanded CMHC (including the beneficiary's home)
                to a beneficiary who is registered as an outpatient. We also clarified
                that hospitals can furnish clinical staff services (for example, drug
                administration) in the patient's home, which is considered provider-
                based to the hospital during the COVID-19 PHE, and to bill and be paid
                for these services when the patient is registered as a hospital
                outpatient. Further, we clarified that when a patient is receiving a
                professional service via telehealth in a location that is considered a
                hospital PBD, and the patient is a registered outpatient of the
                hospital, the hospital in which the patient is registered may bill the
                originating site facility fee for the service. Finally, we clarified
                the applicability of section 603 of the BBA 2015 to hospitals
                furnishing care in the beneficiaries' homes (or other temporary
                expansion locations), and whether those locations are considered
                relocated, partially relocated, or new PBDs.
                [[Page 27567]]
                G. Medical Education
                1. Indirect Medical Education
                a. Overview of Indirect Medical Education
                 Section 1886(d)(5)(B) of the Act provides for a payment adjustment
                known as the indirect medical education (IME) adjustment under the
                inpatient prospective payment system (IPPS) for hospitals that have
                residents in an approved Graduate Medical Education (GME) program, to
                account for the higher indirect patient care costs of teaching
                hospitals relative to non-teaching hospitals. The statute describes the
                calculation of the IME payment adjustment, which is applied to the
                (Medicare Severity-Diagnosis Related Group) MS-DRG payments based on
                the ratio of the hospital's number of full-time equivalent (FTE)
                residents training in the portion of the hospital subject to the IPPS
                or in such hospital's outpatient departments (OPDs), as well as
                qualifying non-provider sites to the number of inpatient hospital beds.
                The regulation regarding the calculation of this additional payment is
                located at 42 CFR 412.105.
                 The calculation of IME payments is affected by a hospital's
                resident-to-bed ratio, which is the ratio of the number of FTE
                residents that a hospital is allowed to count to the number of
                available beds at the hospital. Generally, the greater the number of
                allowable FTE residents a hospital counts, the greater the amount of
                Medicare IME payments the hospital will receive. Conversely, the
                greater number of beds at the hospital for the same number of
                residents, the lower the amount of the IME payments the hospital will
                receive.
                 Similar payment adjustments to reflect the higher costs of
                facilities that train medical interns and residents are applied in the
                inpatient rehabilitation facility (IRF) and IPF contexts (referred to
                as ``teaching status adjustments''). For IRFs, section 1886(j)(3)(A)(v)
                of the Act confers broad authority upon the Secretary to adjust the per
                unit payment rate by such factors as the Secretary determines are
                necessary to properly reflect variations in necessary costs of
                treatment. For example, we adjust the federal IRF prospective payment
                amount to account for facility-level characteristics such as an IRF's
                low-income percentage, teaching status, and location in a rural area,
                if applicable, as described in Sec. 412.624(e). Under Sec.
                412.624(e)(4), for discharges on or after October 1, 2005, we adjust
                the Federal prospective payment on a facility basis by a factor as
                specified by CMS for facilities that are teaching institutions or units
                of teaching institutions. This adjustment is made on a claim basis as
                an interim payment and the final payment in full for the claim is made
                during the final settlement of the cost report.
                 Under the regulatory authority set out at Sec. 412.624(e)(4), the
                IRF teaching adjustment is based on the ratio of the number of FTE
                residents training in the IRF divided by the facility's average daily
                census (ADC), subject to a cap. Specifically, the amount of the
                adjustment is calculated by adding 1 to the ratio of interns and
                residents to the ADC, and then raising that sum to the 1.0163 power, as
                described in Chapter 3, Section 140.2.5.4 of the Medicare Claims
                Processing Manual (Pub. 100-04) at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs.
                 For IPFs, section 1886(s) of the Act authorizes the Secretary to
                develop a per diem PPS for inpatient hospital services furnished in
                psychiatric hospitals and psychiatric units (IPFs) in accordance with
                section 124 of the Balanced Budget Refinement Act of 1999 (BBRA) (Pub.
                L. 106-113, November 29, 1999); section 124(a)(1) of the BBRA, in turn
                requires the Secretary to develop an adequate patient classification
                system that reflects the differences in patient resource use and costs
                among IPFs. Under this authority, we adjust the IPF federal per diem
                base rate to account for facility-level characteristics such as being
                located in a rural area, teaching status, and the cost of living for
                IPFs located in Alaska and Hawaii, if applicable, as described in Sec.
                412.424(d). For cost reporting periods beginning on or after January 1,
                2005 under Sec. 412.424(d)(1)(iii), we adjust the Federal per diem
                base rate by a factor to account for indirect teaching costs. This
                adjustment is made on a claim basis as an interim payment and the final
                payment in full for the claim is made during the final settlement of
                the cost report.
                 In accordance with Sec. 412.424(d)(1)(iii), an IPF's teaching
                adjustment is based on the ratio of the number of FTE residents
                training in the IPF divided by the facility's ADC, subject to a cap.
                Specifically, the amount of the adjustment is calculated by adding 1 to
                the ratio of interns and residents to the ADC, and then raising that
                sum to the 0.5150 power, as described in Chapter 3, Section 190.6.3 of
                the Medicare Claims Processing Manual (Pub. 100-04) at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c03.pdf.
                 We continue to believe that our current policies for calculating
                IME payments and the IRF and IPF teaching status adjustments are
                consistent with the statute and appropriate under normal circumstances.
                However, we wish to give hospitals, IRFs, and IPFs that provide
                services to Medicare beneficiaries the flexibility to respond
                effectively to the serious public health threats posed by COVID-19.
                Recognizing the urgency of this situation, and understanding that
                hospitals may need additional flexibilities to expand capacity in the
                efforts to mitigate the impact of the pandemic on Medicare
                beneficiaries and the American public, we are changing our policies
                during the PHE for the COVID-19 pandemic so that hospitals, IRFs, and
                IPFs do not experience undue reductions in IME or teaching status
                adjustment payment amounts.
                b. Holding Hospitals Harmless From Reductions in IME Payments Due to
                Increases in Bed Counts Due to COVID-19
                 We have been asked by multiple teaching hospitals if CMS can hold
                hospitals harmless from a reduction in IME payments resulting from the
                temporary increase in the number of available hospital beds due to the
                influx of COVID-19 patients. The IME payment formula (under section
                1886(d)(5)(B) of the Act and Sec. 412.105) is determined in part using
                each teaching hospital's ratio of allowable FTE residents in the
                numerator and available beds in the denominator. To accommodate the
                increase in COVID-19-related patients, many hospitals are increasing
                their number of inpatient beds. Using our exceptions and adjustments
                authority under section 1886(d)(5)(I)(i) of the Act, and to mitigate
                IME payment changes from pre-COVID levels, for the duration of the
                COVID-19 PHE, for purposes of determining a hospital's IME payment
                amount, the hospital's available bed count is considered to be the same
                as it was on the day before the COVID-19 PHE was declared. We are
                revising Sec. 412.105(d)(1), to state that beds temporarily added
                during the timeframe of the COVID-19 PHE, as defined in Sec. 400.200,
                is in effect, are excluded from the calculations to determine IME
                payment amounts.
                c. Holding IRFs and IPFs Harmless From Reductions to Teaching Status
                Adjustment Payments Due to COVID-19
                 We have been asked by IRFs and IPFs if CMS can hold facilities
                harmless from a reduction in teaching status adjustment payments
                resulting from the
                [[Page 27568]]
                temporary increase in facilities' ADC due to the influx of COVID-19
                patients. We are concerned that, if a teaching IRF or IPF accepts
                patients from the inpatient acute care hospital to alleviate bed
                capacity during the PHE for the COVID-19 pandemic, the IRF's or IPF's
                ADC would increase, which would artificially decrease the IRF's or
                IPF's ratio of number of interns and residents to ADC and thereby
                decrease the facility's teaching status adjustment. To ensure that
                teaching IRFs or teaching IPFs can alleviate bed capacity issues by
                taking patients from the inpatient acute care hospitals without being
                penalized by lower teaching status adjustments, we believe it is
                appropriate to freeze the IRFs' or IPFs' teaching status adjustment
                payments at their values prior to the COVID-19 PHE. Therefore, for the
                duration of the COVID-19 PHE, an IRF's or an IPF's teaching status
                adjustment payment amount will be the same as it was on the day before
                the COVID-19 PHE was declared.
                2. Time Spent by Residents at Another Hospital During the COVID-19 PHE
                a. Overview of Graduate Medical Education
                 Section 1886(h) of the Act, as added by section 9202 of the
                Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA) (Pub. L.
                99-272, enacted April 7, 1986), establishes a methodology for
                determining Medicare payments to hospitals for the direct costs of
                approved GME programs. Section 1886(h)(2) of the Act sets forth a
                methodology for the determination of a hospital-specific base-period
                per resident amount that is calculated by dividing a hospital's
                allowable direct costs of GME in a base period by its number of FTE
                residents in the base period. The base period is, for most hospitals,
                the hospital's cost reporting period beginning in FY 1984 (that is,
                October 1, 1983 through September 30, 1984). The base year per resident
                amount is updated annually for inflation. In general, Medicare direct
                GME (DGME) payments are calculated by multiplying the hospital's
                updated per resident amount by the weighted number of FTE residents
                working in all areas of the hospital complex (and at non-provider
                sites, when applicable), and the hospital's Medicare share of total
                inpatient days. The provisions of section 1886(h) of the Act are
                implemented in regulations at Sec. Sec. 413.75 through 413.83.
                 As noted earlier, section 1886(d)(5)(B) of the Act provides for a
                payment adjustment known as the IME adjustment under the IPPS for
                hospitals that have residents in an approved GME program, to account
                for the higher indirect patient care costs of teaching hospitals
                relative to non-teaching hospitals. The regulation regarding the
                calculation of this additional payment is located at Sec. 412.105. The
                hospital's IME adjustment applied to the MS-DRG payments is calculated
                based on the ratio of the hospital's number of FTE residents training
                in the portion of the hospital subject to the IPPS or the OPDs of such
                hospital, as well as qualifying nonprovider sites to the number of
                inpatient hospital beds.
                 The calculation of both DGME and IME payments is affected by the
                number of FTE residents that a hospital is allowed to count. Generally,
                the greater the number of FTE residents a hospital counts, the greater
                the amount of Medicare DGME and IME payments the hospital will receive.
                Congress, through the Balanced Budget Act of 1997 (Pub. L. 105-33,
                enacted August 5, 1997), established a limit (that is, a cap) on the
                number of allopathic and osteopathic residents that a hospital may
                include in its FTE resident count for DGME and IME payment purposes.
                Under section 1886(h)(4)(F) of the Act, for cost reporting periods
                beginning on or after October 1, 1997, a hospital's unweighted FTE
                count of allopathic and osteopathic residents for purposes of DGME may
                not exceed the hospital's unweighted FTE count for DGME in its most
                recent cost reporting period ending on or before December 31, 1996.
                Under section 1886(d)(5)(B)(v) of the Act, a similar limit based on the
                allopathic and osteopathic FTE count for IME during that cost reporting
                period is applied effective for discharges occurring on or after
                October 1, 1997. Dental and podiatric residents are not included in
                this statutorily mandated cap.
                 We continue to believe that our current policies for calculating
                DGME and IME payments are consistent with the statute and are
                appropriate under normal circumstances. However, we wish to give
                hospitals that provide services to Medicare beneficiaries the
                flexibility to respond effectively to the serious public health threats
                posed by COVID-19. Recognizing the urgency of this situation, and
                understanding that our current policies may inhibit use of residents or
                capacity that might otherwise be effective in the efforts to mitigate
                the impact of the COVID-19 pandemic on Medicare beneficiaries and the
                American public, we are changing our policies during the PHE for the
                COVID-19 pandemic so that hospitals do not experience undue reductions
                in DGME or IME payment amounts.
                b. Time Spent by Residents at Another Hospital During the COVID-19 PHE
                 We have been asked about the Medicare GME payment consequences of
                teaching hospitals sending residents assigned to them to other
                hospitals to meet COVID-19-related surges in patient volume.
                 Under our current regulations, a hospital cannot claim the time
                spent by residents training at another hospital for purposes of GME
                payments (Sec. Sec. 412.105(f)(1)(iii)(A) for IME and 413.78(b) for
                DGME).
                 In the unprecedented context of the nationwide COVID-19 PHE, when
                teaching hospitals need flexibility to determine resident training on
                an emergency basis to respond to the COVID-19 pandemic and hospitals
                are facing significant workforce challenges, we believe that teaching
                hospitals should be able to send residents, on an emergency basis,
                without regard to GME financial considerations, to hospitals where they
                are most needed to treat COVID-19 or non-COVID-19 patients. Therefore,
                we are revising Sec. Sec. 412.105(f)(1)(iii)(A) for IME and 413.78 for
                DGME to allow teaching hospitals during the COVID-19 PHE to claim for
                purposes of IME and DGME payments the time spent by residents training
                at other hospitals. We recognize this is a significant departure from
                existing policy and this action is being taken only during this PHE due
                to the unprecedented nature of the COVID-19 PHE. If the teaching
                hospital to which a resident is assigned sends the resident to another
                hospital and claims the resident's time, no other hospital, teaching or
                non-teaching, would be able to claim that time. During the COVID-19
                PHE, the presence of residents in non-teaching hospitals will not
                trigger establishment of per resident amounts or FTE resident caps at
                those non-teaching hospitals.
                 Specifically, for the timeframe that the PHE associated with COVID-
                19 is in effect, we are using our authority under section 1886(h)(4)(A)
                and (B) of the Act to suspend the requirement that a hospital cannot
                claim the time spent by residents training at another hospital so that
                a hospital which sends residents to another hospital can claim those
                FTE residents on its Medicare cost report while they are training at
                another hospital in its FTE count, if all of the following conditions
                and all other applicable requirements are met:
                 The sending hospital sends the resident to another
                hospital in response to the COVID-19 pandemic. This criterion would be
                met if either the sending hospital or the other hospital
                [[Page 27569]]
                are treating COVID-19 patients. We would not require that the resident
                be involved in patient care activities for patients with COVID-19 for
                the sending hospital to demonstrate that it sent the resident to the
                other hospital in response to the COVID-19 pandemic.
                 Time spent by the resident at the other hospital would be
                considered to be time spent in approved training if the activities
                performed by the resident at the other hospital are consistent with any
                guidance in effect during the COVID-19 PHE for the approved medical
                residency program at the sending hospital.
                 The time that the resident spent training immediately
                prior to and/or subsequent to the timeframe that the PHE associated
                with COVID-19 was in effect was included in the sending hospital's FTE
                resident count.
                 We believe that this policy will allow hospitals to react quickly
                and in ``real time'' to send residents to facilities where they are
                most needed during the PHE associated with COVID-19.
                 We are revising Sec. 413.78(b), adding new Sec. 413.78(i), and
                revising Sec. 412.105(f)(1)(iii)(A) to state the conditions under
                which a hospital may claim, in its FTE resident count, residents that
                it sends to another hospital during the PHE associated with COVID-19.
                 For the duration of the PHE related to COVID-19, CMS has waived
                certain requirements under the Medicare conditions of participation at
                Sec. Sec. 482.41 and 485.623, and the PBD requirements at Sec.
                413.65, to the extent necessary, in order to allow hospitals to
                establish and operate as part of the hospital any location meeting
                those non-waived conditions of participation for hospitals that
                continue to apply during the PHE. (See https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf). Time
                spent by residents at these locations is not treated any differently
                from time spent by residents at locations established and operated by
                the hospital prior to the COVID-19 PHE.
                 Also, for the duration of the PHE related to COVID-19, CMS has
                adopted a policy that if routine services are provided under
                arrangements outside the hospital to its inpatients, these services are
                deemed to have been provided by the hospital (85 FR 19280). Similarly,
                time spent by residents at these locations is not treated any
                differently from time spent by residents at locations established and
                operated by the hospital prior to the COVID-19 PHE.
                H. Rural Health Clinics (RHCs)
                1. Revision of Bed Count Methodology for Determining Provider-Based
                RHCs Exemption to the RHC Payment Limit
                 RHCs furnish services in rural areas that have been determined to
                be medically underserved areas or health professional shortage areas.
                RHCs are paid an all-inclusive rate (AIR) for medically-necessary,
                face-to-face visits with an RHC practitioner. Section 1833(f) of the
                Act established an RHC payment limit, which is adjusted annually based
                on the Medicare Economic Index (MEI). Under section 1833(f) of the Act,
                an RHC that is provider-based to a hospital with fewer than 50 beds is
                exempt from the national per-visit payment limit.
                 To determine which provider-based RHCs are exempt from the payment
                limit, we use the same methodology that is used to calculate hospital
                bed count for the Indirect Medical Education adjustment at Sec.
                412.105(b). Specifically, a provider-based RHC (as authorized by Sec.
                413.65(a)(1)(ii)(L)) that is an integral and subordinate part of a
                hospital (including a CAH) is excepted from the per-visit payment limit
                if the hospital has fewer than 50 beds. We have used the methodology
                set out at Sec. 412.105(b) to make this calculation.
                 Due to the COVID-19 pandemic, health care providers such as
                hospitals have been or are planning to increase inpatient bed capacity
                to address the surge in need for inpatient care. Given this, we do not
                believe that RHCs that are currently exempt from the national per-visit
                payment limit should now be subject to the per-visit payment limit due
                to the COVID-19 PHE, and we do not want to discourage them from
                increasing bed capacity if needed. Allowing for these provider-based
                RHCs to continue to receive the payment amounts they would otherwise
                receive in the absence of the PHE will help maintain their ability to
                provide necessary health care services to underserved communities. We
                are implementing, on an interim basis, a change to the period of time
                used to determine the number of beds in a hospital at Sec. 412.105(b)
                for purposes of determining which provider-based RHCs are subject to
                the payment limit. For the duration of the PHE, we will use the number
                of beds from the cost reporting period prior to the start of the PHE as
                the official hospital bed count for application of this policy. As
                such, RHCs with provider-based status that were exempt from the
                national per-visit payment limit in the period prior to the effective
                date of the PHE (January 27, 2020) would continue to be exempt for the
                duration of the PHE for the COVID-19 pandemic, as defined at Sec.
                400.200.
                I. Durable Medical Equipment (DME) Interim Pricing in the CARES Act
                1. Background
                a. Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
                Competitive Bidding Program
                 Section 1847(a) of the Act, as amended by section 302(b)(1) of the
                Medicare Prescription Drug, Improvement, and Modernization Act of 2003
                (Pub. L. 108-173, enacted on December 8, 2003), mandates the Medicare
                Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
                (DMEPOS) Competitive Bidding Program (CBP) for contract award purposes
                to furnish certain competitively priced DMEPOS items and services
                subject to the CBP:
                 Off-the-shelf (OTS) orthotics, for which payment would
                otherwise be made under section 1834(h) of the Act;
                 Enteral nutrients, equipment, and supplies described in
                section 1842(s)(2)(D) of the Act; and
                 Certain DME and medical supplies, which are covered items
                (as defined in section 1834(a)(13) of the Act) for which payment would
                otherwise be made under section 1834(a) of the Act.
                 For a list of product categories included in the DMEPOS CBP, please
                refer to https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSCompetitiveBid/Round-2021/PCs.
                 Areas in which the CBP are not implemented are known as non-
                competitive bidding areas (non-CBAs). Currently, there are no CBAs due
                to the 2-year gap period in the DMEPOS CBP, allowing any Medicare-
                enrolled DMEPOS suppliers to furnish DMEPOS items.\27\ However, we use
                the term ``former CBAs'' to refer to areas that were CBAs prior to the
                2-year gap, to distinguish those areas from non-CBAs in which the CBP
                has not previously been implemented.
                ---------------------------------------------------------------------------
                 \27\ All DMEPOS CBP contracts expired on December 31, 2018.
                There is currently a temporary gap in the DMEPOS CBP. Round 2021 of
                the CBP is scheduled to begin again in January 2021 and extend
                through December 31, 2023.
                ---------------------------------------------------------------------------
                b. Fee Schedule Adjustment Methodology for Non-CBAs
                 Section 1834(a)(1)(F)(ii) of the Act requires the Secretary to use
                information on the payment determined under the Medicare DMEPOS CBP to
                adjust the fee schedule amounts for DME items and services furnished in
                all non-CBAs on or after January 1, 2016. Section 1834(a)(1)(F)(iii) of
                the Act
                [[Page 27570]]
                requires the Secretary to continue to make these adjustments as
                additional covered items are phased in under the CBP or information is
                updated as new CBP contracts are awarded. Similarly, sections
                1842(s)(3)(B) and 1834(h)(1)(H)(ii) of the Act authorize the Secretary
                to use payment information from the DMEPOS CBP to adjust the fee
                schedule amounts for enteral nutrition and OTS orthotics, respectively,
                furnished in all non-CBAs. Section 1834(a)(1)(G) of the Act requires
                the Secretary to specify the methodology to be used in making these fee
                schedule adjustments by regulation, and to consider, among other
                factors, the costs of items and services in non-CBAs (where the
                adjustments would be applied) compared to the single payment amounts
                for such items and services in the CBAs.
                 In accordance with the requirements of section 1834(a)(1)(G) of the
                Act, we conducted notice and comment rulemaking in 2014 to specify
                methodologies for adjusting the fee schedule amounts for DME, enteral
                nutrition, and OTS orthotics in non-CBAs in Sec. 414.210(g). We refer
                readers to the proposed rule entitled ``Medicare Program; End-Stage
                Renal Disease Prospective Payment System, Quality Incentive Program,
                and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies,''
                published on July 11, 2014 (79 FR 40208), (hereinafter CY 2015 ESRD PPS
                DMEPOS proposed rule), and the final rule entitled ``Medicare Program;
                End-Stage Renal Disease Prospective Payment System, Quality Incentive
                Program, and Durable Medical Equipment, Prosthetics, Orthotics, and
                Supplies,'' published on November 6, 2014 (79 FR 66120), (hereinafter
                CY 2015 ESRD PPS DMEPOS final rule) for additional details.
                 The methodologies set forth in Sec. 414.210(g) account for
                regional variations in prices, including for rural and non-contiguous
                areas of the United States. In accordance with Sec. 414.210(g)(1), we
                determine regional adjustments to fee schedule amounts for each state
                in the contiguous United States and the District of Columbia, based on
                the definition of region in Sec. 414.202, which refers to geographic
                areas defined by the Bureau of Economic Analysis (BEA) in the
                Department of Commerce for economic analysis purposes (79 FR 66226).
                Under Sec. 414.210(g)(1)(i) through (iv), adjusted fee schedule
                amounts for areas within the contiguous United States are determined
                based on regional prices limited by a national ceiling of 110 percent
                of the regional average price and a floor of 90 percent of the regional
                average price (79 FR 66225). Under Sec. 414.210(g)(1)(v), adjusted fee
                schedule amounts for rural areas are based on 110 percent of the
                national average of regional prices. Under Sec. 414.210(g)(2), fee
                schedule amounts for non-contiguous areas are adjusted based on the
                higher of the average of the single payment amounts for CBAs in non-
                contiguous areas in the United States, or the national ceiling amount.
                 We use ZIP codes for rural, non-rural, and non-contiguous areas to
                establish geographic areas that are then used to define non-CBAs for
                the purposes of the DMEPOS fee schedule adjustments. A rural area is
                defined in Sec. 414.202 as a geographic area represented by a postal
                ZIP code, if at least 50 percent of the total geographic area of the
                area included in the ZIP code is estimated to be outside any
                Metropolitan Statistical Area (79 FR 66228). A rural area also includes
                a geographic area represented by a postal ZIP code that is a low
                population density area excluded from a CBA in accordance with section
                1847(a)(3)(A) of the Act at the time the rules in Sec. 414.210(g) are
                applied. Non-contiguous areas refer to areas outside the contiguous
                United States--that is, areas such as Alaska, Guam, and Hawaii (81 FR
                77936).
                 In the final rule entitled ``Medicare Program; End-Stage Renal
                Disease Prospective Payment System, Payment for Renal Dialysis Services
                Furnished to Individuals With Acute Kidney Injury, End-Stage Renal
                Disease Quality Incentive Program, Durable Medical Equipment,
                Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding
                Program (CBP) and Fee Schedule Amounts, and Technical Amendments To
                Correct Existing Regulations Related to the CBP for Certain DMEPOS,''
                published in the November 14, 2018 Federal Register (83 FR 56922), we
                established fee schedule adjustment methodologies for items and
                services furnished from January 1, 2019 through December 31, 2020.
                 For the fee schedule amounts for items and services furnished from
                January 1, 2019 through December 31, 2020, in all rural and non-
                contiguous non-CBAs, the fee schedule amounts are based on a blend of
                50 percent of the unadjusted fee schedule amounts and 50 percent of the
                fee schedule amounts adjusted in accordance with the current
                methodologies under Sec. 414.210(g)(1) through (8) (83 FR 57029). For
                items and services furnished from January 1, 2019 through December 31,
                2020 in all non-CBAs other than rural or non-contiguous areas, the fee
                schedule amounts are based on 100 percent of the fee schedule amounts
                adjusted in accordance with the current methodologies under Sec.
                414.210(g)(1) through (8) (83 FR 57029). These rules are located at
                Sec. 414.210(g)(9) and, again, apply to items and services furnished
                from January 1, 2019 through December 31, 2020 (83 FR 57039; 83 FR
                57070 through 57071).
                2. Current Issues
                 Section 3712 of the CARES Act revises the fee schedule amounts for
                certain DME and enteral nutrients, supplies, and equipment furnished in
                non-CBAs other than former CBAs through the duration of the emergency
                period described in section 1135(g)(1)(B) of the Act.
                 Section 3712(a) of the CARES Act directs the Secretary to implement
                Sec. 414.210(g)(9)(iii) (or any successor regulation), to apply the
                transition rule described in such section to all applicable items and
                services as planned through December 31, 2020, and through the duration
                of the emergency period described in section 1135(g)(1)(B) of the Act,
                if longer. Therefore, section 3712(a) of the CARES Act continues our
                current policy at Sec. 414.210(g)(9)(iii) of paying for DMEPOS items
                and services furnished in rural and non-contiguous non-CBAs based on a
                50/50 blend of adjusted and unadjusted fee schedule amounts through
                December 31, 2020, or through the duration of the emergency period,
                whichever is longer. This fee schedule adjustment in rural and non-
                contiguous areas results in fee schedule amounts that are approximately
                66 percent higher than the fully adjusted fee schedule amounts that we
                currently pay for DMEPOS items and services furnished in non-rural
                areas in the contiguous United States.
                 Section 3712(b) of the CARES Act states, for items and services
                furnished on or after the date that is 30 days after the date of the
                enactment of this legislation, the Secretary shall apply Sec.
                414.210(g)(9)(iv) (or any successor regulation), as if the reference to
                ``dates of service from June 1, 2018 through December 31, 2020, based
                on the fee schedule amount for the area is equal to 100 percent of the
                adjusted payment amount established under this section'' were instead a
                reference to ``dates of service from March 6, 2020, through the
                remainder of the duration of the emergency period described in section
                1135(g)(1)(B) of the Act (42 U.S.C. 1320b-5(g)(1)(B)), based on the fee
                schedule amount for the area is equal to 75 percent of the adjusted
                payment amount established under this section and 25 percent of the
                unadjusted fee schedule amount.'' Therefore, section
                [[Page 27571]]
                3712(b) of the CARES Act directs the Secretary to increase the fee
                schedule amounts for DMEPOS items and services furnished in non-CBAs
                other than rural and non-contiguous non-CBAs through the duration of
                the PHE period described in section 1135(g)(1)(B) of the Act. In
                accordance with Sec. 414.210(g)(9)(iv), the fee schedule amounts in
                these non-CBA areas are currently based on 100 percent of the adjusted
                fee schedule amount, but section 3712(b) of the CARES Act requires CMS
                to pay for these DMEPOS items and services based on 75 percent of the
                adjusted fee schedule amount and 25 percent of the historic, unadjusted
                fee schedule amount until the end of the emergency period. This
                increases payments so that they are approximately 33 percent higher
                than the payments at the fully adjusted fee schedule amounts.
                 Section 3712 of the CARES Act does not affect the current adjusted
                fee schedule amounts in former CBAs. In accordance with Sec.
                414.210(g)(10), the fee schedule amounts in the former CBAs will
                continue to be based on the single payment amounts from 2018 increased
                by update factors for subsequent calendar years until new competitive
                bidding contracts are in place.
                 Section 3712(b) of the CARES Act references two dates on which CMS
                should implement the payment amount increases for items and services
                furnished in non-rural and contiguous non-CBAs: April 26, 2020 (April
                26th is 30 days after March 27th, the date of the enactment of the
                CARES Act); and March 6, 2020. We believe that the law was written in a
                way that is ambiguous and essentially mandates two different and
                conflicting effective dates for the increase in the fee schedule
                amounts in non-rural and contiguous non-CBAs. Due to this ambiguity, we
                believe that we could implement the higher fee schedule amounts in non-
                rural and contiguous non-CBAs on either March 6, 2020 or April 26,
                2020. Because we believe the purpose of the law is to aid suppliers in
                furnishing items under very challenging situations during the COVID-19
                PHE, we believe it is in the public's interest to implement the higher
                fee schedule amounts starting with the earlier date of March 6, 2020.
                Therefore, we are revising the regulations to implement the higher fee
                schedule amounts required under the CARES Act as of March 6, 2020.
                 Additionally, section 3712(b) of the CARES Act requires CMS to pay
                the higher fee schedule amounts for the duration of the emergency
                period described in section 1135(g)(1)(B) of the Act (42 U.S.C. 1320b-
                5(g)(1)(B)), but it does not specify the fee schedule amounts that
                should be in effect if the emergency period ends before December 31,
                2020. If not for section 3712(b) of the CARES Act, CMS would be paying
                the fully adjusted fee schedule amounts for DME items and services
                furnished in non-rural and contiguous non-CBAs until December 31, 2020.
                As such, we are specifying in Sec. 414.210(g)(9)(v) that the fee
                schedule amounts in non-rural and contiguous non-CBAs will again be
                based on 100 percent of the fee schedule amounts adjusted in accordance
                with Sec. 414.210(g)(9)(1) through (8) if the emergency period
                described in section 1135(g)(1)(B) of the Act (42 U.S.C. 1320b-
                5(g)(1)(B)) ends before December 31, 2020.
                 In summary, we are making conforming changes to Sec.
                414.210(g)(9), consistent with section 3712(a) and (b) of the CARES
                Act, but we are omitting the language in section 3712(b) of the CARES
                Act that references an effective date that is 30 days after the date of
                enactment of the law. We are revising Sec. 414.210(g)(9)(iii), which
                describes the 50/50fee schedule adjustment blend for items and services
                furnished in rural and noncontiguous areas, to address dates of service
                from June 1, 2018 through December 31, 2020 or through the duration of
                the emergency period described in section 1135(g)(1)(B) of the Act (42
                U.S.C. 1320b-5(g)(1)(B)), whichever is later. We are also adding Sec.
                414.210(g)(9)(v) which will state that, for items and services
                furnished in areas other than rural or noncontiguous areas with dates
                of service from March 6, 2020, through the remainder of the duration of
                the emergency period described in section 1135(g)(1)(B) of the Act (42
                U.S.C. 1320b-5(g)(1)(B)), based on the fee schedule amount for the area
                is equal to 75 percent of the adjusted payment amount established under
                ``this section'' (by which we mean Sec. 414.210(g)(1) through (8)),
                and 25 percent of the unadjusted fee schedule amount. For items and
                services furnished in areas other than rural or noncontiguous areas
                with dates of service from the expiration date of the emergency period
                described in section 1135(g)(1)(B) of the Act (42 U.S.C. 1320b-
                5(g)(1)(B)) through December 31, 2020, based on the fee schedule amount
                for the area is equal to 100 percent of the adjusted payment amount
                established under Sec. 414.210(g)(1) through (8) (referred to as
                ``this section'' in the regulation text). In addition, we are revising
                Sec. 414.210(g)(9)(iv) to specify for items and services furnished in
                areas other than rural and noncontiguous areas with dates of service
                from June 1, 2018 through March 5, 2020, based on the fee schedule
                amount for the area is equal to 100 percent of the adjusted payment
                amount established under Sec. 414.210(g)(1) through (8) (``this
                section'' in the regulation text).
                J. Care Planning for Medicare Home Health Services
                 Historically, sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act
                have stated that for Medicare to make payment for home health services,
                a physician, who does not have a direct or indirect employment
                relationship with the HHA, must certify that home health services are
                required because the individual is confined to his or her home and is
                in need of skilled nursing care on an intermittent basis, physical or
                speech therapy, or a continued need for occupational therapy as defined
                at section 1861(m) of the Act. The certifying physician must establish
                and periodically review a plan for furnishing such services to such
                individual while the individual is under the care of a physician. The
                physician must document that the physician himself or herself or a NP
                or CNS (as those terms are defined in section 1861(aa)(5) of the Act),
                who is working in collaboration with the physician in accordance with
                State law, or a CNM (as defined in section 1861(gg) of the Act) as
                authorized by State law, or a PA (as defined in section 1861(aa)(5) of
                the Act) under the supervision of the physician, has had a face-to-face
                encounter related to the reason the home health services are needed.
                 Section 3708 of the CARES Act amended sections 1814(a) and 1835(a)
                of the Act to allow NPs, CNSs, and PAs (as those terms are defined in
                section 1861(aa) of the Act), to order and certify patients for
                eligibility under the Medicare home health benefit. Additionally,
                section 3708 of the CARES Act amended sections 1814(a)(2)(C), 1835
                (a)(2)(A)(ii), and 1861(m) of the Act to allow the home health plan of
                care to be established and periodically reviewed by a physician, NP,
                CNS, or PA where such services are or were furnished while the
                individual was under the care of a physician, NP, CNS, or PA. The CARES
                Act also amended sections 1861(o)(2) and 1861(kk) of the Act to allow
                (CNMs, NPs, CNSs, or PAs to perform the role originally reserved for a
                physician in establishing HHA policies that govern the services (and
                supervision of such services) provided to patients under the Medicare
                home health benefit, as well as certify that an individual has suffered
                a bone fracture related to post-menopausal osteoporosis and that the
                [[Page 27572]]
                individual is unable to learn the skills needed to self-administer the
                osteoporosis drug or is otherwise mentally or physically incapable of
                self-administering such drug. Finally, section 3708 of the CARES Act
                amended section 1895(c) of the Act to allow payment for the furnishing
                of items and services under the home health prospective payment system
                (HH PPS) when these items and services are prescribed by an NP, CNS, or
                PA.
                 In accordance with section 3708 of the CARES Act, these changes are
                required to take effect within 6 months of enactment of the law and the
                Secretary shall issue an IFC, if necessary to comply with the required
                effective date. Per the explicit statutory instructions at section
                3708(f) of the CARES Act, we are addressing changes in the regulations
                in this IFC to ensure these requirements are issued within the
                timeframe required by statute. These regulations are effective on May
                8, 2020, and will be retroactively applicable to March 1, 2020.We
                believe that enacting these provisions at this time will afford maximum
                flexibility for providers seeking to order home health care services
                during the PHE for the COVID-19 pandemic. That is, NPs, CNSs, and PAs
                would be able to practice to the top of their state licensure to
                certify eligibility for home health services, as well as establish and
                periodically review the home health plan of care. This is imperative
                during the PHE for the COVID-19 pandemic as more beneficiaries may be
                considered ``homebound'', either because a practitioner has determined
                that it is medically contraindicated for a beneficiary to leave the
                home because he or she has a confirmed or suspected diagnosis of COVID-
                19, or because a practitioner has determined that it is medically
                contraindicated for a beneficiary to leave the home because the patient
                has a condition that may make the patient more susceptible to
                contracting COVID-19.
                 In accordance with section 1861(aa)(5) of the Act, NPs, CNSs, and
                PAs are required to practice in accordance with state law in the state
                in which the individual performs such services. Individual states have
                varying requirements for conditions of practice, which determine
                whether a practitioner may work independently without a written
                collaborative agreement or supervision from a physician, or whether
                general or direct supervision and collaboration is required. HHAs or
                other practitioners should check with the relevant state licensing
                authority websites to ensure that practitioners are working within
                their scope of practice and prescriptive authority. A review of these
                websites reveals that the majority of states require physician
                collaboration for these NPPs. We note that even in states that allow
                independent practice authority, many of these practitioners continue to
                work in a practice environment (inpatient facility or outpatient or
                physician's office) that includes a physician.
                 Section 1861(aa)(5) of the Act allows the Secretary regulatory
                discretion regarding the requirements for NPs, CNSs, and PAs. As such,
                the regulations at Sec. Sec. 410.74 through 410.76 set out in detail
                the qualifications needed and services provided by these practitioners
                under the Medicare program. We believe that we should align, for
                Medicare home health purposes, the definitions for such practitioners
                with the existing definitions in regulation at Sec. Sec. 410.74
                through 410.76 for consistency across the Medicare program and to
                ensure that Medicare home health beneficiaries are afforded the same
                standard of care. Therefore, we are amending the regulations at parts
                409, 424, and 484 to define a NP, a CNS, and a PA (as such
                qualifications are defined at Sec. Sec. 410.74 through 410.76) as an
                ``allowed practitioner''. This means that in addition to a physician,
                as defined at section 1861(r) of the Act, an ``allowed practitioner''
                may certify, establish and periodically review the plan of care, as
                well as supervise the provision of items and services for beneficiaries
                under the Medicare home health benefit. Additionally, we are amending
                the regulations to reflect that we would expect the allowed
                practitioner to also perform the face-to-face encounter for the patient
                for whom they are certifying eligibility; however, if a face-to-face
                encounter is performed by an allowed NPP, as set out at 42 CFR
                424.22(a)(1)(v)(A), in an acute or post-acute facility, from which the
                patient was directly admitted to home health, the certifying
                practitioner may be different from the provider performing the face-to-
                face encounter. These regulation changes will become permanent and are
                not time limited to the period of the PHE for COVID-19. We will review
                and respond to any comments received on this IFC in the CY 2021 HH PPS
                final rule.
                K. CARES Act Waiver of the ``3-Hour Rule'' and Modification of IRF
                Coverage and Classification Requirements for Freestanding IRF Hospitals
                for the PHE During the COVID-19 Pandemic
                a. CARES Act Waiver of the ``3-Hour Rule''
                 In the March 31st COVID-19 IFC (85 FR 19252, 19287), we provided a
                clarification regarding Sec. 412.622(a)(3)(ii) (commonly referred to
                as the ``3-hour rule''). On March 27, 2020, the CARES Act was enacted
                and further addressed Sec. 412.622(a)(3)(ii). Specifically, section
                3711(a) of the CARES Act requires the Secretary to waive Sec.
                412.622(a)(3)(ii) during the emergency period described in section
                1135(g)(1)(B) of the Act. This waiver was issued on April 15 2020, and
                is available at https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf. We note that the clarification
                provided in the March 31st COVID-19 IFC does not address section
                3711(a) of the CARES Act as it was developed prior to the enactment of
                the CARES Act. Because Sec. 412.622(a)(3)(ii) is more directly and
                comprehensively addressed by section 3711(a) of the CARES Act, the
                clarification provided in the March 31st COVID-19 IFC is moot and
                hereby rescinded.
                 We note that the waiver required by section 3711(a) of the CARES
                Act is not limited to particular IRFs or patients, and therefore, is
                available during the emergency period described in section
                1135(g)(1)(B) of the Act regardless of whether a patient was admitted
                for standard IRF care or to relieve acute care hospital capacity. In
                this IFC, we are waiving Sec. 412.622(a)(3)(ii) to reflect the waiver
                required by section 3711(a) of the CARES Act.
                b. Modification of IRF Coverage and Classification Requirements for
                Freestanding IRF Hospitals for the PHE During the COVID-19 Pandemic
                 IRF care is only considered by Medicare to be reasonable and
                necessary under section 1862(a)(1) of the Act if the patient meets all
                of the IRF coverage requirements outlined in Sec. 412.622(a)(3), (4),
                and (5). Failure to meet the IRF coverage criteria in a particular case
                results in denial of the IRF claim. We note that the March 31st COVID-
                19 IFC removes the requirement at Sec. 412.622(a)(4)(ii) to complete a
                post-admission physician evaluation during the COVID-19 PHE, as defined
                in Sec. 400.200.
                 While we generally believe that all IRFs should have to comply with
                the requirements at Sec. 412.29(d), (e), (h), and (i) and Sec.
                412.622(a)(3), (4), and (5), we
                [[Page 27573]]
                recognize that there are certain institutional differences between
                freestanding IRF hospitals and IRF distinct part units of hospitals
                that may impose barriers on freestanding IRF hospitals seeking to admit
                patients to relieve acute care hospital capacity during the COVID-19
                PHE. Specifically, freestanding IRF hospitals do not have the same
                close affiliations with acute care hospitals that IRF distinct part
                units of hospitals have, and are not as able to establish billing
                procedures under the IPPS as have IRF distinct part units by virtue of
                the fact that the distinct part units have access to (or at least
                affiliations with) their parent hospitals' billing departments.
                Therefore, we are amending the requirements at Sec. Sec. 412.29(d),
                (e), (h), and (i) and 412.622(a)(3), (4), and (5) to add an exception
                for care furnished to patients admitted to freestanding IRF hospitals
                (identified as those facilities with the last 4 digits of their
                Medicare provider numbers between 3025 through 3099) solely to relieve
                acute care hospital capacity during the COVID-19 PHE.
                 We believe that freestanding IRF hospitals need the flexibility
                during this COVID-19 PHE to determine the best care for each patient
                who is admitted solely to relieve acute care hospital capacity.
                Consistent with the Guidelines for Opening Up America Again at https://www.whitehouse.gov/openingamerica/, for the purposes of exercising
                these IRF flexibilities that are intended to provide broad flexibility
                for freestanding IRF hospitals to provide surge capacity in support of
                acute care hospitals in their state or community, CMS considers surge
                to be alleviated with regard to exercising these flexibilities when the
                state (or region, as applicable) in which the freestanding IRF is
                located is in phase 2 or phase 3. In other words, the flexibilities in
                this IFC are available for freestanding IRF hospitals admitting
                patients in support of acute care hospitals when the state is in phase
                1 or prior to entering phase 1, but are no longer available to the
                freestanding IRF hospital when the state is in phase 2 or phase 3 of
                these Guidelines. These flexibilities apply to specific patients who
                must be discharged from the acute care hospitals to the freestanding
                IRFs to provide surge capacity for the acute care hospitals, and
                therefore apply only when those specific patients are admitted to the
                freestanding IRF hospitals and continue for the duration of that
                patient's care. We believe this will allow for continuity of care and
                care planning consistency at admission and throughout a patient's stay
                if the same flexibilities apply for the duration of a patient's IRF
                stay. These limitations only apply to the provisions in this IFC and
                not to any blanket waivers issued, which have their own conditions.
                Freestanding IRF hospitals must document the particular phase for the
                state when admitting the patient and electing to exercise these
                flexibilities.
                 For billing purposes, we are requiring freestanding IRF hospitals
                to append the ``DS'' modifier to the end of the IRF's unique patient
                identifier number (used to identify the patient's medical record in the
                IRF) to identify patients who are being treated in a freestanding IRF
                hospital solely to alleviate inpatient bed capacity in a state that is
                experiencing a surge during the PHE for the COVID-19 pandemic. The
                modifier will be used to identify those patients for whom the
                requirements in Sec. 412.622(a)(3)(i), (iii), (iv), (4) and (5) do not
                apply. Freestanding IRF hospitals will be paid at the IRF PPS rates for
                patients with the ``DS'' modifier.
                 We anticipate that freestanding IRF hospitals will take advantage
                of these flexibilities for those beneficiaries (who are surge patients
                from inpatient hospitals), while continuing to provide standard IRF-
                level care for those beneficiaries who would benefit from IRF-level
                care and would otherwise receive such care in the absence of the COVID-
                19 PHE. This will provide crucial flexibility to allow freestanding IRF
                hospitals to aid in the response to the COVID-19 pandemic in several
                ways. First, we expect that some of the patients that freestanding IRF
                hospitals care for during the COVID-19 PHE in a state that is
                experiencing a surge would need high-acuity clinical care but may not
                need or be able to tolerate the intensive rehabilitation therapy
                typically provided in an IRF, such as at least two types of therapy.
                Second, waiving the documentation requirements in Sec. 412.622(a)(4)
                and (5) for patients alleviating inpatient hospital bed capacity allows
                freestanding IRF hospitals to concentrate on providing care for surge
                patients from the acute care hospitals in a state that is experiencing
                a surge, instead of completing documentation that may not be applicable
                to these acute patients during the PHE. Third, this flexibility allows
                freestanding IRF hospitals to maximize their available beds to take
                advantage of space where COVID-19 patients or surge patients could be
                safely managed. We believe this policy will allow freestanding IRF
                hospitals to make a clinical determination about what level of care
                each individual patient needs during the PHE for the COVID-19 pandemic.
                 To effectuate these changes, we are amending Sec.
                412.622(a)(3)(i), (ii), (iii), and (iv) to state that these IRF
                coverage criteria continue to be required, except for care furnished to
                patients in a freestanding IRF hospital solely to relieve acute care
                hospital capacity in a state (or region, as applicable) that is
                experiencing a surge during the PHE, as defined in Sec. 400.200.
                Similarly, in Sec. 412.622(a)(4), we are amending this paragraph to
                state that the IRF documentation requirements must be present in the
                IRF medical record, except for care furnished to patients in a
                freestanding IRF hospital solely to relieve acute care hospital
                capacity in a state (or region, as applicable) that is experiencing a
                surge during the PHE, as defined in Sec. 400.200. In Sec.
                412.622(a)(5), we are amending this paragraph to state that an
                interdisciplinary team approach to care is required, except for care
                furnished to patients in a freestanding IRF hospital solely to relieve
                acute care hospital capacity in a state (or region, as applicable) that
                is experiencing a surge during the PHE, as defined in Sec. 400.200. We
                are also amending Sec. 412.29(d), (e), (h), and (i) to align the
                provisions we have waived in Sec. 412.622 with the classification
                criteria for payment to freestanding IRF hospitals under the IRF
                prospective payment system. Finally, we are amending Sec. 412.622(c)
                to add a definition of state (or region, as applicable) that are
                experiencing a surge and Sec. 412.29 to cross-reference that
                definition where applicable.
                L. Medicare Shared Savings Program
                 As of January 1, 2020, there are 517 Medicare Shared Savings
                Program (Shared Savings Program) Accountable Care Organizations (ACOs)
                serving approximately 11.2 million Medicare FFS beneficiaries across
                the country: 37 percent of ACOs (192 of 517) are participating under
                two-sided shared savings and shared losses models; and 160 ACOs have
                agreements ending December 31, 2020, and must renew under the BASIC
                track or ENHANCED track to continue in the Shared Savings Program,
                including 20 ACOs participating in the Medicare ACO Track 1+ Model
                (Track 1+ Model).
                 The COVID-19 pandemic, and the resulting PHE as defined in Sec.
                400.200, have created a lack of predictability for many ACOs regarding
                the impact of expenditure and utilization changes on historical
                benchmarks and performance year expenditures, and for those under
                performance-based risk, the potential liability for shared losses, as
                well as disrupting population health activities,
                [[Page 27574]]
                as clinicians, care coordinators and financial and other resources are
                diverted to address immediate acute care needs. ACOs and other program
                stakeholders have advocated for CMS to modify Shared Savings Program
                policies to address the impact of the COVID-19 pandemic including to:
                 Adjust the methodology for determining shared savings and
                shared losses, such as by: Reducing or eliminating liability for ACOs
                under performance-based risk for shared losses for PY 2020; not sharing
                savings or losses with ACOs for PY 2020; or adjusting program
                calculations to address the impact of COVID-19 on benchmark and PY
                expenditures, particularly for calendar year 2020.
                 Eliminate or extend the deadline for ACOs to voluntarily
                terminate from the program without being financially reconciled for PY
                2020, which under Sec. 425.221(b)(2)(ii)(A) is June 30, 2020, with
                notification 30 days prior (no later than June 1).
                 Maintain or ``freeze'' ACOs in their current participation
                options so that ACOs required to renew their participation for a new
                agreement period starting on January 1, 2021, are not burdened with
                meeting application deadlines and forgo the requirement that ACOs
                participating in the BASIC track's glide path advance to the next level
                for PY 2021.
                 Account for changes in billing and care patterns in
                determining beneficiary assignment.
                 ACOs and other program stakeholders have indicated that there is an
                urgent need to address these concerns because ACOs need to make
                participation decisions for PY 2020 and PY 2021 soon and may choose to
                terminate their participation in the Shared Savings Program on or
                before June 30th, rather than face the potential of pro-rated losses
                for PY 2020 if the COVID-19 PHE does not extend for the entire year or
                the program's policies do not adequately mitigate liability for shared
                losses.
                 We believe it is vital to the stability of the Shared Savings
                Program to encourage continued participation by ACOs by adjusting
                program policies as necessary to address the impact of the COVID-19
                pandemic, including by offering certain flexibilities in program
                participation options to currently participating ACOs and addressing
                potential distortions in expenditures resulting from the pandemic to
                ensure that ACOs are treated equitably regardless of the degree to
                which their assigned beneficiary populations are affected by the
                pandemic. The changes we are making in this IFC will help to ensure a
                more equitable comparison between ACOs' expenditures for PY 2020 and
                ACOs' updated historical benchmarks and that ACOs are not rewarded or
                penalized for having higher/lower COVID-19 spread in their patient
                populations which, in turn, will help to protect ACOs from owing
                excessive shared losses and the Medicare Trust Funds from paying out
                windfall shared savings. As described in this section of this IFC, we
                are modifying Shared Savings Program policies to: (1) Allow ACOs whose
                current agreement periods expire on December 31, 2020, the option to
                extend their existing agreement period by 1-year, and allow ACOs in the
                BASIC track's glide path the option to elect to maintain their current
                level of participation for PY 2021; (2) clarify the applicability of
                the program's extreme and uncontrollable circumstances policy to
                mitigate shared losses for the period of the COVID-19 PHE; (3) adjust
                program calculations to mitigate the impact of COVID-19 on ACOs; and
                (4) expand the definition of primary care services for purposes of
                determining beneficiary assignment to include telehealth codes for
                virtual check-ins, e-visits, and telephonic communication. We also
                address how these adjustments to program policies will apply to ACOs
                participating in the Track 1+ Model.
                1. Application Cycle for January 1, 2021 Start Date and Extension of
                Agreement Periods Expiring on December 31, 2020
                 A renewing ACO is defined as an ACO that continues its
                participation in the program for a consecutive agreement period,
                without a break in participation, because it is an ACO whose
                participation agreement expired and that immediately enters a new
                agreement period to continue its participation in the program, or an
                ACO that terminated its current participation agreement under Sec.
                425.220 and immediately enters a new agreement period to continue its
                participation in the program (see Sec. 425.20). Section 425.224
                specifies application procedures for a renewing ACO applying to enter a
                new participation agreement with CMS for participation in the Shared
                Savings Program. We are seeking to reduce operational burden for ACOs
                and their health care providers while they respond to the serious
                health threats posed by the spread of the COVID-19. We have received
                feedback from ACO stakeholders requesting that CMS delay the Shared
                Savings Program application cycle for a January 1, 2021 start date
                (occurring in CY 2020), since they have reassigned staff and care
                coordinators to respond to the current pandemic. Due to COVID-19,
                stakeholders have expressed concern about focusing resources on
                applying to the Shared Savings Program rather than on patient care.
                Additionally, stakeholders have expressed uncertainty over their
                continued participation in the Shared Savings Program in 2021 given the
                lack of predictability of the impact of COVID-19 on expenditures used
                to establish an ACO's historical benchmark.
                 In response to stakeholder feedback, we are forgoing the
                application cycle for a January 1, 2021 start date (herein referred to
                as the 2021 application cycle). We believe it is appropriate to forgo
                the 2021 application cycle as the COVID-19 PHE continues because this
                will allow ACOs and their ACO providers/suppliers currently
                participating in the Shared Savings Program to continue focusing on
                treating patients during the pandemic. There are 160 ACO Shared Savings
                Program participation agreements that will end on December 31, 2020,
                including 20 ACOs participating in the Track 1+ Model. These ACOs are
                eligible to apply to renew their participation agreement for the Shared
                Savings Program effective January 1, 2021. To reduce burden and allow
                these ACOs to continue participating in the program without a 2021
                application cycle, ACOs that entered a first or second agreement period
                with a start date of January 1, 2018, may elect to extend their
                agreement period for an optional fourth performance year. The fourth
                performance year would span 12 months from January 1, 2021, to December
                31, 2021. This election to extend the agreement period is voluntary and
                an ACO could choose not to make this election, and therefore, conclude
                its participation in the program with the expiration of its current
                agreement period on December 31, 2020. Under this approach, eligible
                ACOs will be able to remain under their existing historical benchmark
                for an additional year, which will increase stability and
                predictability given the potential impact of the pandemic on
                beneficiary expenditures under FFS Medicare and help provide greater
                certainty for ACOs making determinations regarding their future
                participation in the Shared Savings Program.
                 Additionally, by forgoing the 2021 application cycle for new
                applicants, CY 2020 will not serve as benchmark year 3 for a cohort of
                ACOs that would otherwise be January 1, 2021 starters. An ACO's
                historical benchmark is determined based on the 3 most recent years
                prior to the start of its agreement period. For ACOs in a first
                agreement
                [[Page 27575]]
                period, benchmark year 3 is given the highest weight of the 3 benchmark
                years and, because CY 2020 is an anomalous year, we believe it could be
                disadvantageous to include CY 2020 expenditures as the third benchmark
                year for this cohort of ACOs. Cancelling the 2021 application cycle
                would provide us with additional time to consider and develop
                approaches to further mitigate the role of 2020 as a benchmark year
                given the unusual expenditure and utilization trends likely to result
                from the pandemic.
                 The ACO's voluntary election to extend its agreement period must be
                made in the form and manner and by a deadline established by CMS, and
                an ACO executive who has the authority to legally bind the ACO must
                certify the election. We note that this optional 12-month agreement
                period extension is a one-time exception for all ACOs with agreements
                expiring on December 31, 2020; it will not be available to other ACOs
                or to future program entrants. We anticipate that eligible ACOs will be
                able to elect to extend their agreement starting June 18, 2020, and the
                anticipated final date to make the election will be September 22, 2020.
                We will provide additional guidance regarding the form and manner, and
                the timeframe (including any changes to the above dates), for making
                the election.
                 Under the existing provision at Sec. [thinsp]425.210(a), the ACO
                must provide a copy of its participation agreement with CMS to all ACO
                participants, ACO providers/suppliers, and other individuals and
                entities involved in ACO governance. In the case of an ACO that elects
                to extend its agreement period pursuant to this IFC, we will consider
                the ACO to be in compliance with Sec. 425.210(a) if it notifies these
                parties that it will continue to participate in the program for an
                additional year. Further, under Sec. 425.210(b), all contracts or
                arrangements between or among the ACO, ACO participants, ACO providers/
                suppliers, and other individuals or entities performing functions or
                services related to ACO activities must require compliance with the
                requirements and conditions of the program's regulations, including,
                but not limited to, those specified in the participation agreement with
                CMS (see also Sec. Sec. 425.116(a)(3) (as to agreements with ACO
                participants) and 425.116(b)(3) (as to agreements with ACO providers/
                suppliers)). Thus, an ACO that elects to extend its participation
                agreement pursuant to this IFC must require its ACO participants, ACO
                providers/suppliers, and other individuals or entities performing
                functions or services related to ACO activities during PY 2021 to
                comply with the program's requirements through December 31, 2021. We
                note that to remain in compliance with Sec. 425.116, an ACO may need
                to extend the duration of its agreements with ACO participants and ACO
                providers/suppliers.
                 We believe there is good cause to address the extension of expiring
                participation agreements in this IFC. It would be impracticable and
                contrary to the public interest to undertake traditional notice and
                comment rulemaking for this policy because we previously announced on
                our website that the 2021 application cycle would begin on April 20,
                2020 (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/for-acos/application-types-and-timeline). If we
                delayed finalizing this policy until after the public has had an
                opportunity to comment on it, ACOs might begin applying (or make
                preparations to apply) to the Shared Savings Program for an agreement
                period beginning January 1, 2021, rather than devote their scarce
                resources to care delivery and coordination activities.
                 We are revising Sec. 425.200(b)(3)(ii) to allow ACOs that entered
                a first or second agreement period with a start date of January 1,
                2018, to elect to extend their agreement period for an optional fourth
                performance year. Lastly, while we will forgo the application cycle for
                ACOs to apply to enter an agreement period beginning on January 1,
                2021, we note that eligible, currently participating ACOs will be able
                to apply for a SNF 3-day rule waiver (Sec. 425.612(a)(1)(i)), apply to
                establish a beneficiary incentive program (Sec. 425.304(c)(2)), modify
                ACO participant (Sec. 425.118(b)) and/or SNF affiliate lists (Sec.
                425.612(a)(1)(i)(B)), and elect to change their assignment methodology
                (Sec. 425.226(a)(1)) for PY 2021. Also, an ACO participating under the
                BASIC track's glide path may still elect to transition to a higher
                level of risk and potential reward within the BASIC track's glide path
                other than the level of risk and potential reward that the ACO would be
                automatically transitioned to for PY 2021, absent the ACO's election to
                maintain its current participation level for one year as described in
                section II.L.2. of this IFC. For example, an ACO participating in BASIC
                track Level B in PY 2020 can still elect to transition to BASIC track
                level D or E in PY 2021.
                 We seek comment on the approach we are establishing with this IFC
                to address the extension of participation agreements that are scheduled
                to expire on December 31, 2020.
                2. Allow BASIC Track ACOs To Elect To Maintain Their Participation
                Level for One Year
                 We finalized a redesign of Shared Savings Program's participation
                options in the final rule entitled ``Medicare Program; Medicare Shared
                Savings Program; Accountable Care Organizations--Pathways to Success
                and Extreme and Uncontrollable Circumstances Policies for Performance
                Year 2017'', which appeared in the Federal Register on December 31,
                2018 (83 FR 67816). We finalized the BASIC track, added as a new
                provision at Sec. [thinsp]425.605, which includes an option for
                eligible ACOs to begin participation under a one-sided model and
                incrementally phase-in risk (calculated based on ACO participant
                revenue and capped at a percentage of the ACO's updated benchmark) and
                potential reward over the course of a single agreement period, an
                approach referred to as the glide path (83 FR 67841). The glide path
                includes five levels: A one-sided model available only for the first 2
                consecutive performance years of a 5-year agreement period, each year
                of which is identified as a separate level (Levels A and B); and three
                levels of progressively higher risk and potential reward in performance
                years 3 through 5 of the agreement period (Levels C, D, and E). ACOs
                are automatically advanced along the progression of risk/reward levels
                at the start of each participation year, over the course of a 5-year
                agreement period, unless the ACO elects to advance more quickly, until
                ACOs reach the BASIC track's maximum level of risk/reward (Level E) (83
                FR 67844). For ACOs that entered the BASIC track's glide path for an
                agreement period beginning on July 1, 2019, the progression through the
                levels of risk and potential reward spans 6 performance years,
                including the ACO's first performance year from July 1, 2019, through
                December 31, 2019; these ACOs were not automatically advanced to the
                next risk/reward level at the start of PY 2020 (42 CFR
                425.200(b)(4)(ii), (c)(3); Sec. 425.600(a)(4)(i)(B)(2)(i)).
                 Stakeholders have expressed concern that due to the unpredictable
                impact of COVID-19 during PY 2020 and the uncertainty as to their
                ability to secure a repayment mechanism for PY 2021, ACOs are uncertain
                they will continue participating in the program if they are
                automatically transitioned to downside risk or a higher level of
                downside risk in PY 2021. Specifically, stakeholders have requested we
                ``freeze,'' or forgo the automatic advancement of, BASIC track
                [[Page 27576]]
                ACOs at their current level of participation for PY 2021. Additionally,
                per Sec. 425.204(f)(3)(iii), an ACO entering an agreement period in
                Level A or Level B of the BASIC track must demonstrate the adequacy of
                its repayment mechanism prior to the start of any performance year in
                which it either elects to participate in, or is automatically
                transitioned to a two-sided model of the BASIC track, including Level
                C, Level D, or Level E. We have concerns whether some ACOs,
                particularly those that would automatically transition to Level C of
                the BASIC track, will have the ability to establish a repayment
                mechanism prior to the start of PY 2021 because the source of capital
                to cover potential losses may be uncertain for some ACOs given the
                resource intensity of responding to the pandemic. Currently, the Shared
                Savings Program has 136 ACOs participating under Level B of the BASIC
                track that are scheduled to automatically advance to Level C on January
                1, 2021. Some stakeholders have indicated that they may be unable to
                secure a letter of credit at this time, while other stakeholders have
                indicated that their discretionary funds are currently fully committed
                to responding to the COVID-19 PHE.
                 We are also concerned that some of the care coordination processes
                ACOs have been developing may be interrupted by the pandemic. For
                example, ACOs may have reallocated funding and staff resources to
                respond to the COVID-19 PHE, thereby temporarily disrupting their
                ability to implement redesigned care processes that would support their
                transition to risk. We agree that most ACOs do not know the impact that
                COVID-19 will have on their expenditures or beneficiary population and
                the potential for losses under risk arrangements. Therefore, through
                this IFC, we are permitting ACOs participating in the BASIC track glide
                path to elect to maintain their current level under the BASIC track for
                PY 2021. Prior to the automatic advancement for PY 2021, an applicable
                ACO may elect to remain in the same level of the BASIC track's glide
                path that it entered for PY 2020. For PY 2022, an ACO that elects this
                advancement deferral option will be automatically advanced to the level
                of the BASIC track's glide path in which it would have participated
                during PY 2022 if it had advanced automatically to the next level for
                PY 2021 (unless the ACO elects to advance more quickly before the start
                of PY 2022). For example, if an ACO participating in the BASIC track,
                Level B, in PY 2020 elects to maintain its current level of
                participation for PY 2021, it will participate under Level B for PY
                2021 and then will automatically advance to Level D for PY 2022, since
                the ACO would have moved automatically to Level C for PY 2021 under
                current program rules, absent this change. The ACO could also elect to
                advance more quickly by opting to move to Level E instead of Level D
                for PY 2022, in which case the ACO would participate under Level E for
                the remainder of its agreement period.
                 The ACO's voluntary election to maintain its participation level
                must be made in the form and manner and by a deadline established by
                CMS, and an ACO executive who has the authority to legally bind the ACO
                must certify the election. We anticipate that eligible ACOs will be
                able to elect to maintain their participation level for PY 2021
                starting June 18, 2020, and the anticipated final date to make the
                election will be September 22, 2020. We will provide additional
                guidance regarding the form and manner, and the timeframe (including
                any changes to the above dates), for making the election; an ACO that
                does not elect to maintain its current participation level for PY 2021
                by the final date specified by CMS in this guidance will be
                automatically advanced to the next level of the glide path for that
                performance year (unless it elects to advance more quickly). This
                option is a one-time exception for ACOs currently participating in the
                Shared Savings Program under the BASIC track' glide path and will not
                be available to other ACOs that are currently participating in the
                program or to future program entrants.
                 We believe there is good cause to address the automatic advancement
                of BASIC track ACOs along the glide path in this IFC. We believe we
                need to provide ACOs adequate time in 2020 to determine their
                participation options for PY 2021. It would be infeasible to finalize
                the necessary amendments to the program regulations with sufficient
                time for ACOs to be aware of the advancement deferral option, make
                related program participation decisions, and provide their election to
                CMS, if we did not implement this policy through this IFC.
                Additionally, this policy will provide further relief to ACOs that may
                not currently have the ability to establish a repayment mechanism prior
                to PY 2021 and that otherwise would be struggling during this period to
                establish one, or perhaps seeking to terminate their participation
                agreements early, rather than devoting scarce resources to care
                delivery and coordination and continuing in the program. Therefore, we
                are redesignating Sec. 425.600(a)(4)(i)(B)(2)(iii) as Sec.
                425.600(a)(4)(i)(B)(2)(iv) and adding a new Sec.
                425.600(a)(4)(i)(B)(2)(iii) to allow ACOs currently participating in
                the BASIC track's glide path to elect to maintain their current
                participation level for PY 2021.
                 We seek comment on the advancement deferral option we are
                establishing with this IFC.
                3. Applicability of Extreme and Uncontrollable Circumstances Policies
                to the COVID-19 Pandemic
                 In December 2017, we issued an interim final rule with comment
                period entitled ``Medicare Program; Medicare Shared Savings Program:
                Extreme and Uncontrollable Circumstances Policies for Performance Year
                2017'' (hereinafter referred to as the ``December 2017 IFC''), which
                appeared in the Federal Register on December 26, 2017 (82 FR 60912
                through 60919). The December 2017 IFC established a policy for
                mitigating shared losses for Shared Savings Program ACOs participating
                in a performance-based risk track, when the ACO's assigned
                beneficiaries were located in geographic areas that were impacted by
                extreme and uncontrollable circumstances, such as hurricanes,
                wildfires, or other triggering events, during PY 2017. In the final
                rule entitled ``Medicare Program; Revisions to Payment Policies Under
                the Physician Fee Schedule and Other Revisions to Part B for CY 2019;
                Medicare Shared Savings Program Requirements; Quality Payment Program;
                Medicaid Promoting Interoperability Program; Quality Payment Program-
                Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS
                Payment Year; Provisions From the Medicare Shared Savings Program-
                Accountable Care Organizations-Pathways to Success; and Expanding the
                Use of Telehealth Services for the Treatment of Opioid Use Disorder
                Under the Substance Use-Disorder Prevention That Promotes Opioid
                Recovery and Treatment (SUPPORT) for Patients and Communities Act''
                (hereinafter referred to as the ``CY 2019 PFS final rule'') (83 FR
                59452), we extended the extreme and uncontrollable circumstances policy
                finalized for PY 2017 to PY 2018 and subsequent performance years.
                Under the policy adopted in that final rule, for a given performance
                year, as set forth in Sec. Sec. 425.605(f) (applicable to ACOs in two-
                sided models of the BASIC track), 425.606(i) (applicable to ACOs in
                Track 2) and 425.610(i) (applicable to ACOs in the ENHANCED track), CMS
                reduces the amount of the ACO's shared losses by an amount determined
                by
                [[Page 27577]]
                multiplying the shared losses by the percentage of the total months in
                the performance year affected by an extreme and uncontrollable
                circumstance, and the percentage of the ACO's assigned beneficiaries
                who reside in an area affected by an extreme and uncontrollable
                circumstance. Further, as specified in the Track 1+ Model participation
                agreement available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/track-1plus-model-par-agreement.pdf, CMS adjusts the amount of shared losses for Track 1+
                Model ACOs for extreme and uncontrollable circumstances in the manner
                described in Sec. 425.610(i).
                 As specified in the Shared Savings Program regulations at
                Sec. Sec. 425.605(f), 425.606(i) and 425.610(i), CMS applies
                determinations made under the Quality Payment Program with respect to
                whether an extreme and uncontrollable circumstance has occurred and the
                affected areas. Further, CMS has sole discretion to determine the time
                period during which an extreme and uncontrollable circumstance occurred
                and the percentage of the ACO's assigned beneficiaries residing in the
                affected areas. In November 2017, we issued an interim final rule with
                comment period for the Quality Payment Program entitled ``Medicare
                Program; CY 2018 Updates to the Quality Payment Program; and Quality
                Payment Program: Extreme and Uncontrollable Circumstance Policy for the
                Transition Year'' IFC (hereinafter referred to the ``Quality Payment
                Program IFC'') (82 FR 53568), which appeared in the Federal Register on
                November 16, 2017. In the Quality Payment Program IFC (82 FR 53897), we
                explained that we anticipated that the types of events that could
                trigger the extreme and uncontrollable circumstances policies would be
                events designated a FEMA major disaster or a PHE declared by the
                Secretary, although we indicated that we would review each situation on
                a case-by-case basis.
                 In the CY 2019 PFS final rule (83 FR 59969), we explained our
                belief that the extreme and uncontrollable circumstance policies under
                the Shared Savings Program address stakeholders' concerns that ACOs
                participating under a performance-based risk track could be held
                responsible for sharing losses with the Medicare program resulting from
                catastrophic events outside the ACO's control given the increase in
                utilization, difficulty of coordinating care for patient populations
                leaving the impacted areas, and the use of natural disaster payment
                modifiers making it difficult to identify whether a claim would
                otherwise have been denied under normal Medicare FFS rules. Absent this
                relief, we explained that ACOs participating in performance-based risk
                tracks might reconsider whether they are able to continue their
                participation in the Shared Savings Program under a performance-based
                risk track.
                 In the March 31st COVID-19 IFC (85 FR 19230), we briefly addressed
                considerations related to applying the Shared Savings Program's extreme
                and uncontrollable circumstances policies for mitigating shared losses
                for ACOs in PY 2020 because of the COVID-19 pandemic. We explained that
                for purposes of PY 2020 financial reconciliation, we will reduce the
                amount of an ACO's shared losses by an amount determined by multiplying
                the shared losses by the percentage of the total months in the
                performance year affected by an extreme and uncontrollable
                circumstance, and the percentage of the ACO's assigned beneficiaries
                who reside in an area affected by an extreme and uncontrollable
                circumstance (85 FR 19268). We explained that the PHE for the COVID-19
                pandemic applies to all counties in the country; therefore, 100 percent
                of assigned beneficiaries for all Shared Savings Program ACOs reside in
                an affected area. However, in describing the timeframe during which the
                extreme and uncontrollable circumstances policy would apply for
                mitigating shared losses because of the COVID-19 pandemic, we
                inadvertently stated that it would begin in March 2020 and continue
                through the end of the COVID-19 PHE, as defined in Sec. 400.200. This
                statement was inconsistent with the beginning of the COVID-19 PHE as
                defined in Sec. 400.200 (January 2020). Therefore, we are clarifying
                in this IFC that, for purposes of the Shared Savings Program, the
                months affected by an extreme and uncontrollable circumstance will
                begin with January 2020, consistent with the COVID-19 PHE determined to
                exist nationwide as of January 27, 2020, by the Secretary on January
                31, 2020, and will continue through the end of the PHE, as defined in
                Sec. 400.200, which includes any subsequent renewals.
                 Catastrophic events outside the ACO's control can also increase the
                difficulty of coordinating care for patient populations, and due to the
                unpredictability of changes in utilization and cost of services
                furnished to beneficiaries, may have a significant impact on
                expenditures for the applicable performance year and the ACO's
                benchmark in the subsequent agreement period (as further discussed in
                section II.L.4. of this IFC). These factors could jeopardize the ACO's
                ability to succeed in the Shared Savings Program, and ACOs, especially
                those in performance-based risk tracks, may reconsider whether they are
                able to continue their participation in the program.
                 Therefore, we believe it is important to make clear that, under the
                existing extreme and uncontrollable circumstances policies for the
                Shared Savings Program, the timeframe for the extreme and
                uncontrollable circumstance of the COVID-19 pandemic for purposes of
                mitigating shared losses will extend for the duration of the COVID-19
                PHE as specified in Sec. 400.200, which begins in January 2020. If the
                COVID-19 PHE extends through all of CY 2020, all shared losses for PY
                2020 will be mitigated for all ACOs participating in a performance-
                based risk track: Including Track 2, the ENHANCED track, Levels C, D
                and E of the BASIC track, and the Track 1+ Model (as discussed in
                section II.L.6. of this IFC). At this time, the COVID-19 PHE has
                already covered 4 months (January through April 2020) meaning any
                shared losses an ACO incurs for PY 2020 will be reduced by at least
                one-third. Further, if the COVID-19 PHE extends for a large portion, if
                not all of the year, the existing extreme and uncontrollable
                circumstances policy under the Shared Savings Program would mitigate a
                significant portion of, if not all, shared losses an ACO may owe for PY
                2020. For example, if the COVID-19 PHE covers 6 months (January through
                June 2020) any shared losses an ACO incurs for PY 2020 would be reduced
                by one-half; if the COVID-19 PHE covers 9 months (January through
                September 2020) any shared losses an ACO incurs for PY 2020 would be
                reduced by three-fourths; and if the COVID-19 PHE covers the full year
                (January through December 2020) any shared losses an ACO incurs for PY
                2020 would be reduced completely, and the ACO would not owe any shared
                losses.
                4. Adjustments to Shared Savings Program Calculations To Address the
                COVID-19 Pandemic
                a. Background
                 Section 1899(d)(1)(B)(ii) of the Act addresses how ACO benchmarks
                are to be established and updated under the Shared Savings Program.
                This provision specifies that the Secretary shall estimate a benchmark
                for each agreement period for each ACO using the most recent available
                3 years of per
                [[Page 27578]]
                beneficiary expenditures for Parts A and B services for Medicare FFS
                beneficiaries assigned to the ACO. Such benchmark shall be adjusted for
                beneficiary characteristics and such other factors as the Secretary
                determines appropriate, and updated by the projected absolute amount of
                growth in national per capita expenditures for Parts A and B services.
                Section 1899(d)(1)(B)(i) of the Act specifies that, in each year of the
                agreement period, an ACO is eligible to receive payment for shared
                savings only if the estimated average per capita Medicare expenditures
                under the ACO for Medicare FFS beneficiaries for Parts A and B
                services, adjusted for beneficiary characteristics, is at least the
                percent specified by the Secretary below the applicable benchmark under
                section 1899(d)(1)(B)(ii) of the Act.
                 Section 1899(i)(3) of the Act grants the Secretary the authority to
                use other payment models if the Secretary determines that doing so
                would improve the quality and efficiency of items and services
                furnished under Title XVIII and the alternative methodology would
                result in program expenditures equal to or lower than those that would
                result under the statutory payment model. The authority under section
                1899(i)(3) of the Act to use other payment models includes authority to
                adopt alternatives to the benchmarking methodology set forth in section
                1899(d)(1)(B)(ii) of the Act, and alternatives to the methodology for
                determining expenditures for each performance year as set forth in
                section 1899(d)(1)(B)(i) of the Act. As discussed in earlier
                rulemaking, we have used our authority under section 1899(i)(3) of the
                Act to adopt alternative policies to the provisions of section
                1899(d)(1)(B) of the Act for updating the historical benchmark,\28\ and
                calculating performance year expenditures.\29\ We have also used our
                authority under section 1899(i)(3) of the Act to establish the Shared
                Savings Program's two-sided payment models,\30\ and to mitigate shared
                losses owed by ACOs affected by extreme and uncontrollable
                circumstances during PY 2017 and subsequent performance years.\31\
                ---------------------------------------------------------------------------
                 \28\ Such as using only assignable beneficiaries instead of all
                Medicare FFS beneficiaries in calculating the benchmark update based
                on national FFS expenditures (81 FR 37986-37989), calculating the
                benchmark update using factors based on regional FFS expenditures
                (81 FR 37977-37981), and calculating the benchmark update using a
                blend of national and regional expenditure growth rates (83 FR
                68027-68030).
                 \29\ Such as excluding indirect medical education and
                disproportionate share hospital payments from ACO performance year
                expenditures (76 FR 67921-67922), and determining shared savings and
                shared losses for the 6-month performance years (or performance
                period) in 2019 using expenditures for the entire CY 2019 and then
                pro-rating these amounts to reflect the shorter performance year or
                performance period (83 FR 59949-59951, 83 FR 67950-67956).
                 \30\ See earlier rulemaking establishing two-sided models: Track
                2 (76 FR 67904-67909), Track 3 (subsequently renamed the ENHANCED
                track) (80 FR 32771-32772), and the BASIC track (83 FR 67834-67841).
                 \31\ See earlier rulemaking establishing policies for mitigating
                shared losses owed by ACOs affected by extreme and uncontrollable
                circumstances (82 FR 60916-60917, 83 FR 59974-59977).
                ---------------------------------------------------------------------------
                 Under the Shared Savings Program, providers and suppliers continue
                to bill for services furnished to Medicare beneficiaries and receive
                FFS payments under traditional Medicare. CMS uses payment amounts for
                Parts A and B FFS claims for a variety of Shared Savings Program
                operations, which include: Calculations under the benchmarking
                methodology; determining an ACO's eligibility for shared savings and
                liability for shared losses for each performance year under the
                program's financial models as specified in the regulations in subpart
                G; determining an ACO's eligibility for certain participation options
                as set forth in Sec. 425.600(d); and calculating the amount of the
                repayment mechanism required for ACOs participating in a two-sided
                model according to Sec. 425.204(f)(4). These operations typically
                require the determination of expenditures for Parts A and B services
                under the original Medicare FFS program for a specified population of
                Medicare FFS beneficiaries or the Medicare Parts A and B FFS revenue of
                ACO participants. We note that the Medicare FFS beneficiary population
                for which expenditures are determined may differ depending on the
                specific program operation being performed and may reflect expenditures
                for the ACO's assigned beneficiaries, assignable beneficiaries as
                defined in Sec. 425.20, or all Medicare FFS beneficiaries. The
                applicable Medicare FFS beneficiary population is specified in the
                regulations governing each program operation.
                b. Removing Payment Amounts for Episodes of Care for Treatment of
                COVID-19 From Shared Savings Program Expenditure and Revenue
                Calculations
                 Section 3710 of the CARES Act amended section 1886(d)(4)(C) of the
                Act to specify that for discharges occurring during the emergency
                period described in section 1135(g)(1)(B) of the Act, in the case of a
                discharge of an individual diagnosed with COVID-19, the Secretary shall
                increase the weighting factor that would otherwise apply to the
                diagnosis-related group (DRG) to which the discharge is assigned by 20
                percent. Further, the Secretary shall identify a discharge of such an
                individual through the use of diagnosis codes, condition codes, or
                other such means as may be necessary. In this section of this IFC, we
                refer to this increase in the weighting factor for DRGs as the ``DRG
                adjustment.''
                 We anticipate that the localized nature of infections (for example,
                rapid outbreaks in individual nursing facilities (NFs)) and the
                unanticipated increase in expenditures, along with the increased
                flexibilities that have been implemented to allow health care providers
                to identify and treat COVID-19 patients will affect the level of
                Medicare Parts A and B expenditures during 2020, both for the Medicare
                FFS beneficiaries assigned to ACOs and for the other populations of
                Medicare FFS beneficiaries whose expenditures are considered in
                performing calculations under the Shared Savings Program. The localized
                nature of outbreaks and the increased utilization of acute care
                occurring in PY 2020 and the associated higher costs are not reflected
                in ACOs' historical benchmarks, which are determined under Sec. Sec.
                425.601(b), 425.602(b), or 425.603(d), as applicable, based on Parts A
                and B expenditures for the beneficiaries who would have been assigned
                to that ACO during the three benchmark years. For some ACOs, the higher
                costs associated with COVID-19 may not be fully accounted for (or in
                other cases may be over-represented) by the retrospective application
                of the update factor to the benchmark at the time of financial
                reconciliation. In addition, the prospective CMS-HCC risk scores, which
                are used to adjust the historical benchmark each performance year for
                changes in severity and case mix (refer to Sec. Sec. 425.601(a)(10),
                425.602(a)(9) and 425.603(c)(10); and Sec. Sec. 425.604(a)(1),
                425.605(a)(1), 425.606(a)(1), 425.610(a)(1), (2)), would not be
                expected to meaningfully adjust for such variability because they are
                prospective, and therefore, use diagnoses from 2019 to predict costs in
                2020.
                 Furthermore, including the increased expenditures related to
                treatment of COVID-19 in calculations of ACO benchmarks for which CY
                2020 is a benchmark year could lead to higher than anticipated future
                historical benchmarks unnecessarily advantaging some ACOs once the
                prevalence of COVID-19 in the population begins to decrease, and the
                corresponding reduction in expenditures is reflected in performance
                year expenditures. In
                [[Page 27579]]
                contrast, we anticipate that the methodology used to update benchmarks
                will appropriately reflect any reduction in expenditures due to a
                cumulative yearlong decline in elective services and the deferral of
                other services as a result of regionally-uniform responses by
                beneficiaries and providers/suppliers to directives issued at federal,
                state, and local levels. Therefore, the retrospective application of
                the historical benchmark update (which for PY 2020 is either an update
                factor based on national growth rates, regional growth rates, or a
                blend of national and regional growth rates, depending on the start
                date of the ACO's agreement period) is expected to reasonably account
                for lower utilization of services by non-COVID-19 patients and prevent
                windfall shared savings payments to ACOs for PY 2020.
                 Including payment amounts for treatment of acute care for COVID-19
                in calculations for which calendar year 2020 is used as a reference
                year could also distort repayment mechanism estimates and the
                identification of high and low revenue ACOs and influence ACO
                participation options. For example, ACOs could potentially be
                misclassified as either high revenue or low revenue, due to changes in
                expenditures arising from the COVID-19 pandemic, and either moved more
                quickly to higher levels of risk and reward if they are identified as
                high revenue ACOs or allowed additional time under a one-sided model
                (if eligible) or in relatively lower levels of performance-based risk
                if they are identified as low revenue ACOs.
                 ACOs currently participating in a performance-based risk track have
                an urgent need to understand how we will address any distortions in
                expenditures resulting from the COVID-19 pandemic. Under the Shared
                Savings Program's regulations at Sec. 425.221(b)(2)(ii)(A), an ACO
                under a two-sided model that voluntarily terminates its participation
                agreement with an effective date of termination after June 30th of the
                applicable performance year is liable for a pro-rated share of any
                shared losses determined for that performance year. Under Sec.
                425.220(a) of the regulations, ACOs are required to provide CMS at
                least 30 days' advance notice of their decision to voluntarily
                terminate from the program. As a result, ACOs that are participating
                under a two-sided model would need to provide notice to CMS no later
                than June 1, 2020, to avoid liability for a pro-rated share of any
                shared losses that may be determined for PY 2020. ACOs and other
                program stakeholders have expressed concern that ACOs need to make
                participation decisions in advance of this June 1, 2020 deadline, and
                may choose to terminate their participation in the Shared Savings
                Program on or before June 30th, rather than risk owing pro-rated shared
                losses for PY 2020. We note that as we explain in section II.L.3. of
                this IFC, the Shared Savings Program's extreme and uncontrollable
                circumstances policy will mitigate shared losses for these ACOs.
                However, given the uncertainty surrounding whether the COVID-19 PHE
                will cover the entire year and absent information regarding the steps
                that CMS intends to take to address the high costs associated with
                COVID-19 patients, many risk-based ACOs may choose to leave the program
                by June 30, 2020, to avoid the risk of owing shared losses.
                 We believe it is necessary to revise the policies governing Shared
                Savings Program financial calculations, as well as certain other
                program operations, to mitigate the impact of unanticipated increased
                expenditures related to the treatment of COVID-19. Given that ACOs in
                two-sided models have very limited time (less than 2 months at the time
                of development of this IFC) to decide whether to continue their
                participation in the program or voluntarily terminate without being
                liable for shared losses, we believe there is an urgent need to
                establish policies that address the impact of COVID-19 on Shared
                Savings Program financial calculations. More generally, ACOs engage in
                care coordination and population-based activities for Medicare FFS
                beneficiaries, as they work towards achieving the Shared Savings
                Program's goals of lowering growth in Medicare FFS expenditures and
                improving the quality of care furnished to Medicare beneficiaries. We
                believe there is an urgency in taking steps to avoid adversely
                impacting ACOs, many of which have rapidly adapted to current
                circumstances in order to continue to coordinate care and deliver
                value-based care to Medicare FFS beneficiaries and meet program goals.
                In the absence of policies that adjust certain program calculations to
                remove payment amounts for episodes of care for treatment of COVID-19,
                ACOs may choose to leave the Shared Savings Program, setting back
                progress made in transitioning the health care system from volume-based
                to value-based payment. For these reasons, we find good cause to waive
                prior notice and comment rulemaking to establish policies to mitigate
                the impact of the COVID-19 pandemic on Shared Savings Program financial
                calculations.
                 We are revising our policies under the Shared Savings Program to
                exclude from Shared Savings Program calculations all Parts A and B FFS
                payment amounts for an episode of care for treatment of COVID-19,
                triggered by an inpatient service, and as specified on Parts A and B
                claims with dates of service during the episode. We are relying on our
                authority under section 1899(d)(1)(B)(ii) of the Act to adjust
                benchmark expenditures for other factors in order to remove COVID-19-
                related expenditures from the determination of benchmark expenditures.
                As discussed elsewhere in this section, we are also exercising our
                authority under section 1899(i)(3) of the Act to apply this adjustment
                to certain other program calculations, including the determination of
                performance year expenditures.
                 We believe an approach that makes the triggering event for this
                adjustment the beneficiary's receipt of inpatient care for COVID-19,
                will identify the most acutely ill patients and, as a result, those
                patients with the highest-costs associated with acute care treatment.
                In contrast, we believe that treatment for COVID-19 that does not
                result in an inpatient admission does not raise the same level of
                concern in terms of generating unexpected performance year expenditures
                that are not appropriately reflected in the benchmark calculations. As
                William Bleser and colleagues have described,\32\ citing a recent
                actuarial estimate of COVID-19 costs,\33\ outpatient care was
                approximately 10 percent of the cost of hospital care, indicating that
                hospital costs are the dominant source of overall costs for treatment
                of COVID-19. We believe these findings support an approach that bases
                the exclusion of expenditures on the triggering event of an inpatient
                admission for treatment of COVID-19. Furthermore, we believe that some
                outpatient care will occur close-in-time to an eventual inpatient
                admission and following discharge. Under the approach we are
                establishing, where an episode of care includes the month of admission
                and the month following discharge, outpatient care occurring within the
                timeframe for an episode of care would also be excluded from financial
                calculations.
                ---------------------------------------------------------------------------
                 \32\ Bleser WK, et al. Maintaining Progress Toward Accountable
                Care And Payment Reform During A Pandemic, Part 1: Utilization And
                Financial Impact. Health Affairs. April 14, 2020. Available at
                https://www.healthaffairs.org/do/10.1377/hblog20200410.281882/full/.
                 \33\ COVERED California. The Potential National Health Cost
                Impacts to Consumers, Employers and Insurers Due to the Coronavirus
                (COVID-19). Policy/Actuarial Brief (March 22, 2020). Available at
                https://hbex.coveredca.com/data-research/library/COVID-19-NationalCost-Impacts03-21-20.pdf.
                ---------------------------------------------------------------------------
                [[Page 27580]]
                 Accordingly, under the approach we are adopting in this IFC, we
                will identify an episode of care triggered by an inpatient service for
                treatment of COVID-19, based on either: (1) Discharges for inpatient
                services eligible for the 20 percent DRG adjustment under section
                1886(d)(4)(C) of the Act; or (2) discharges for acute care inpatient
                services for treatment of COVID-19 from facilities that are not paid
                under the IPPS, such as CAHs, when the date of admission occurs within
                the COVID-19 PHE as defined in Sec. 400.200.
                 For example, we will identify discharges of an individual diagnosed
                with COVID-19 using the following ICD-10-CM codes:
                 B97.29 (Other coronavirus as the cause of diseases
                classified elsewhere) for discharges occurring on or after January 27,
                2020, and on or before March 31, 2020.
                 U07.1 (COVID-19) for discharges occurring on or after
                April 1, 2020, through the duration of the COVID-19 PHE period, as
                defined in Sec. 400.200.\34\
                ---------------------------------------------------------------------------
                 \34\ See for example, MLN Matters, ``New Waivers for Inpatient
                Prospective Payment System (IPPS) Hospitals, Long-Term Care
                Hospitals (LTCHs), and Inpatient Rehabilitation Facilities (IRFs)
                due to Provisions of the CARES Act'' (April 15, 2020), available at
                https://www.cms.gov/files/document/se20015.pdf.
                ---------------------------------------------------------------------------
                 Episodes of care for treatment of COVID-19 may be triggered by an
                inpatient admission for acute care either at an acute care hospital or
                other healthcare facility, which may include temporary expansion sites,
                Medicare-enrolled ASCs providing hospital services to help address the
                urgent need to increase hospital capacity to treat COVID-19 patients,
                CAHs, and potentially other types of providers.\35\
                ---------------------------------------------------------------------------
                 \35\ See CMS fact sheet, ``Hospitals: CMS Flexibilities to Fight
                COVID-19'', dated March 30, 2020, available at https://www.cms.gov/files/document/covid-hospitals.pdf, describing flexibilities CMS
                specified for hospitals for the provision of inpatient care to fight
                COVID-19.
                ---------------------------------------------------------------------------
                 We will define the episode of care as starting in the month in
                which the inpatient stay begins as identified by the admission date,
                all months during the inpatient stay, and the month following the end
                of the inpatient stay as indicated by the discharge date. This approach
                to measuring the length of the episode of care in units of months
                aligns with the Shared Savings Program's existing methodology for
                calculating benchmark year and performance year expenditures by
                performing separate calculations for each of four Medicare enrollment
                types (ESRD, disabled, aged/dual eligible for Medicare and Medicaid,
                and aged/non-dual eligible for Medicare and Medicaid). As described in
                the final rule entitled ``Medicare Program; Medicare Shared Savings
                Program; Accountable Care Organizations--Revised Benchmark Rebasing
                Methodology, Facilitating Transition to Performance-Based Risk, and
                Administrative Finality of Financial Calculations'', which appeared in
                the Federal Register on June 10, 2016 (81 FR 37950), we account for
                circumstances where a beneficiary is enrolled in a Medicare enrollment
                type for only a fraction of a year (see 81 FR 37981). Specifically, we
                determine the number of months that an assigned beneficiary is enrolled
                in each specific Medicare enrollment type and divide by 12. Summing
                these fractions across all assigned beneficiaries in each Medicare
                enrollment type results in total person years for the beneficiaries
                assigned to the ACO. Benchmark and performance year expenditures for
                each enrollment type are calculated on a per capita basis. The
                numerator of the per capita expenditure calculation for a particular
                enrollment type reflects the total Parts A and B expenditures incurred
                by all assigned beneficiaries in that enrollment type during the year,
                with adjustments made to exclude indirect medical education and
                disproportionate share hospital payments, to include individually
                beneficiary identifiable final payments made under a demonstration,
                pilot or time limited program, and to truncate beneficiary expenditures
                to minimize variation from catastrophically large claims. The
                denominator reflects total person years for the enrollment type.
                 In addition to excluding Parts A and B payment amounts with dates
                of service in the months associated with an episode of care for
                treatment of COVID-19, we will also exclude the affected months from
                total person years used in per capita expenditure calculations. For
                example, if a beneficiary had an episode of care for COVID-19 that
                lasted for 2 months, but was otherwise enrolled as an aged/non-dual
                eligible beneficiary for the full calendar PY, we will exclude their
                Parts A and B expenditures for those two months and compute their
                fraction of the year enrolled in the aged/non-dual eligible population
                as 10/12. Adjusting both expenditures and person years will ensure that
                both the numerator and denominator used to calculate per capita
                expenditures are based on the same number of months of beneficiary
                experience and allow ACOs to be treated equitably regardless of the
                degree to which their assigned beneficiary population is affected by
                the pandemic.
                 We believe that the approach described in this section will provide
                for a more equitable comparison between an ACO's performance year
                expenditures and its historical benchmark and will help to ensure that
                ACOs are not rewarded or penalized for having higher/lower COVID-19
                spread in their assigned beneficiary populations which, in turn, will
                help to protect CMS against paying out windfall shared savings and ACOs
                in two-sided models from owing excessive shared losses. Further, as
                described previously in this section of this IFC, we believe that the
                retrospective application of the historical benchmark update, which
                will be calculated based on factors that reflect actual expenditure and
                utilization changes nationally and regionally, other than expenditures
                for episodes of care for treatment of COVID-19, will also help to
                mitigate the potential for windfall savings due to potentially lower
                utilization of services not related to treatment for COVID-19.
                 We will adjust the following Shared Savings Program calculations to
                exclude all Parts A and B FFS payment amounts for a beneficiary's
                episode of care for treatment of COVID-19:
                 Calculation of Medicare Parts A and B FFS expenditures for
                an ACO's assigned beneficiaries for all purposes, including the
                following: Establishing, adjusting, updating, and resetting the ACO's
                historical benchmark and determining performance year expenditures.
                 Calculation of FFS expenditures for assignable
                beneficiaries as used in determining county-level FFS expenditures and
                national Medicare FFS expenditures, including the following
                calculations:
                 ++ Determining average county FFS expenditures based on
                expenditures for the assignable population of beneficiaries in each
                county in the ACO's regional service area according to Sec. Sec.
                425.601(c) and 425.603(e) for purposes of calculating the ACO's
                regional FFS expenditures. For example, for ACOs in agreement periods
                beginning on July 1, 2019, and in subsequent years, we will use county
                FFS expenditures from which we exclude all Parts A and B FFS payment
                amounts for a beneficiary's episode of care for treatment of COVID-19
                in determining the regional component of the blended national and
                regional growth rates used to (1) trend forward benchmark year 1 and
                benchmark year 2 expenditures to benchmark year 3 according to Sec.
                425.601(a)(5)(iii), and (2) to update the benchmark according to Sec.
                425.601(b)(3). Further, we will use county expenditures from which we
                exclude all Parts A and B FFS payment amounts for a beneficiary's
                episode of care for treatment of COVID-19 to
                [[Page 27581]]
                update the ACO's rebased historical benchmark, according to Sec.
                425.603(d) for ACOs in a second agreement period beginning on or before
                January 1, 2019, based on regional growth rates in Medicare FFS
                expenditures.
                 ++ Determining the 99th percentile of national Medicare FFS
                expenditures for assignable beneficiaries for purposes of the
                following: (1) Truncating assigned beneficiary expenditures used in
                calculating benchmark expenditures (Sec. Sec. 425.601(a)(4),
                425.602(a)(4), 425.603(c)(4)), and performance year expenditures
                (Sec. Sec. 425.604(a)(4), 425.605(a)(3), 425.606(a)(4),
                425.610(a)(4)); and (2) truncating expenditures for assignable
                beneficiaries in each county for purposes of determining county FFS
                expenditures according to Sec. Sec. 425.601(c)(3) and 425.603(e)(3).
                 ++ Determining 5 percent of national per capita expenditures for
                Parts A and B services under the original Medicare FFS program for
                assignable beneficiaries for purposes of capping the regional
                adjustment to the ACO's historical benchmark according to Sec.
                425.601(a)(8)(ii)(C).
                 ++ Determining the flat dollar equivalent of the projected absolute
                amount of growth in national per capita expenditures for Parts A and B
                services under the original Medicare FFS program for assignable
                beneficiaries, for purposes of updating the ACO's historical benchmark
                according to Sec. 425.602(b)(2).
                 ++ Determining national growth rates that are used as part of the
                blended growth rates used to trend forward benchmark year 1 and
                benchmark year 2 expenditures to benchmark year 3 according to Sec.
                425.601(a)(5)(ii) and as part of the blended growth rates used to
                update the benchmark according to Sec. 425.601(b)(2).
                 Calculation of Medicare Parts A and B FFS revenue of ACO
                participants for purposes of calculating the ACO's loss recoupment
                limit under the BASIC track as specified in Sec. 425.605(d).
                 Calculation of total Medicare Parts A and B FFS revenue of
                ACO participants and total Medicare Parts A and B FFS expenditures for
                the ACO's assigned beneficiaries for purposes of identifying whether an
                ACO is a high revenue ACO or low revenue ACO, as defined under Sec.
                425.20, and determining an ACO's eligibility for participation options
                according to Sec. 425.600(d).
                 Calculation or recalculation of the amount of the ACO's
                repayment mechanism arrangement according to Sec. 425.204(f)(4).
                 We note that there are certain payments related to the COVID-19 PHE
                that fall outside of Medicare FFS Parts A and B claims, and by virtue
                of this fact, these payments would not be utilized under the Shared
                Savings Program methodology for determining beneficiary expenditures.
                For example, we would not account for recoupment of accelerated or
                advance payments,\36\ which occurs outside of the FFS claims processing
                system. This is because the underlying Parts A and B claims used in
                Shared Savings Program expenditure calculations would continue to
                reflect the amount the providers/suppliers are eligible to be paid,
                although that payment may be subject to offset for repayment of
                accelerated or advance payments. Further, Shared Savings Program
                expenditure calculations would also not account for lump sum payments
                made to hospitals and other healthcare providers through the CARES Act
                Provider Relief Fund,\37\ that occur outside of Parts A and B claims.
                We will continue to capture Medicare FFS Parts A and B payments to
                providers/suppliers in Shared Savings Program calculations from
                hospitals and other healthcare providers receiving these funds.
                ---------------------------------------------------------------------------
                 \36\ See CMS, ``Fact Sheet: Expansion of the Accelerated and
                Advance Payments Program for Providers and Suppliers During COVID-19
                Emergency,'' available at https://www.cms.gov/files/document/accelerated-and-advanced-payments-fact-sheet.pdf.
                 \37\ See HHS website, CARES Act Provider Relief Fund, at https://www.hhs.gov/provider-relief/index.html.
                ---------------------------------------------------------------------------
                 It is necessary to use our authority under section 1899(i)(3) of
                the Act to remove payment amounts for episodes of care for treatment of
                COVID-19 from the following calculations: (1) Performance year
                expenditures; (2) updates to the historical benchmark; and (3) ACO
                participants' Medicare FFS revenue used to determine the loss sharing
                limit in the two-sided models of the BASIC track. To use our authority
                under section 1899(i)(3) of the Act to adopt an alternative payment
                methodology to remove payment amounts for episodes of care for
                treatment of COVID-19 from these calculations, we must determine that
                the alternative payment methodology will improve the quality and
                efficiency of items and services furnished to Medicare beneficiaries,
                without resulting in additional program expenditures. We believe that
                these adjustments, which will remove payment amounts for episodes of
                care for treatment of COVID-19 from the specified Shared Savings
                Program calculations, will capture and remove from program calculations
                expenditures that are outside of an ACO's control, but that could
                significantly affect the ACO's performance under the program. In
                particular, we believe that failing to remove this spending would
                likely create highly variable savings and loss results for individual
                ACOs that happen to have over-representation or under-representation of
                COVID-19 hospitalizations in their assigned beneficiary populations.
                 As described in the Regulatory Impact Analysis (section VI. of this
                IFC), we do not believe excluding payment amounts for episodes of care
                for treatment of COVID-19 from the specified calculations will result
                in an increase in spending beyond the expenditures that would otherwise
                occur under the statutory payment methodology in section 1899(d) of the
                Act. Further, we believe that these adjustments to our payment
                calculations to remove expenditures associated with treatment of COVID-
                19, in combination with the optional 1-year extension for ACOs whose
                current agreement periods expire on December 31, 2020 (as discussed in
                section II.L.1. of this IFC), and the option for ACOs in the BASIC
                track's glide path to elect to maintain their current level of risk and
                reward for PY 2021 (as discussed in section II.L.2. of this IFC) will
                provide greater certainty for currently participating ACOs. As a
                result, we expect these policies will support ACOs' continued
                participation in the Shared Savings Program in the face of significant
                uncertainty arising from the disruptions due to the COVID-19 pandemic
                and the resulting PHE. This, in turn, means that these organizations
                would continue working towards meeting the Shared Savings Program's
                goals of lowering growth in Medicare FFS expenditures and improving the
                quality of care furnished to Medicare beneficiaries.
                 Based on these considerations, and as specified in the Regulatory
                Impact Analysis (section VI. of this IFC), we believe adjusting certain
                Shared Savings Program calculations to remove payment amounts for
                episodes of care for treatment of COVID-19 from the calculation of
                performance year expenditures, updates to the historical benchmark, and
                ACO participants' Medicare FFS revenue used to determine the loss
                sharing limit in the two-sided models of the BASIC track, meets the
                requirements for use of our authority under section 1899(i)(3) of the
                Act.
                 We also acknowledge that some trends and longer lasting effects of
                the COVID-19 pandemic are challenging to anticipate at the time of
                development of
                [[Page 27582]]
                this IFC, and we will continue to evaluate the ongoing impact of the
                COVID-19 pandemic to determine whether additional rulemaking is
                necessary to further adjust Shared Savings Program policies. For
                example, it is unclear whether the COVID-19 pandemic may have longer-
                term effects into 2021, such as through rebounding elective procedure
                costs in 2021 following potentially sustained reductions in 2020 or to
                what extent the reduction in these procedures may persist. Further, we
                anticipate learning more about the potential longer-term implications
                of the COVID-19 pandemic on Medicare beneficiaries' health and the
                health care system.
                 We are adding a new provision at Sec. 425.611 to describe the
                adjustments CMS will make to Shared Savings Program calculations to
                address the impact of the COVID-19 pandemic.
                 We seek comment on the approach to adjusting program calculations
                to mitigate the financial impact of the COVID-19 pandemic on ACOs that
                we are establishing with this IFC.
                5. Expansion of Codes Used in Beneficiary Assignment
                a. Background
                 Section 1899(c)(1) of the Act, as amended by the 21st Century Cures
                Act (Pub. L. 114-255, enacted December 13, 2016) and the Bipartisan
                Budget Act of 2018 (BBA 2018) (Pub. L. 115-123, enacted February 9,
                2018), provides that for performance years beginning on or after
                January 1, 2019, the Secretary shall assign beneficiaries to an ACO
                based on their utilization of primary care services provided by
                physicians participating in the ACO and all services furnished by RHCs
                and Federally Qualified Health Centers (FQHCs) that are ACO
                participants. However, the statute does not specify which kinds of
                services may be considered primary care services for purposes of
                beneficiary assignment.
                 For performance years beginning on January 1, 2019, and subsequent
                performance years, we defined primary care services in Sec.
                [thinsp]425.400(c)(1)(iv) for purposes of assigning beneficiaries to
                ACOs under Sec. [thinsp]425.402 as the set of services identified by
                the following HCPCS/CPT codes:
                 CPT codes:
                 99201 through 99215 (codes for office or other outpatient
                visit for the evaluation and management of a patient).
                 99304 through 99318 (codes for professional services
                furnished in a NF; services identified by these codes furnished in a
                SNF are excluded).
                 99319 through 99340 (codes for patient domiciliary, rest
                home, or custodial care visit).
                 99341 through 99350 (codes for evaluation and management
                services furnished in a patient's home for claims identified by place
                of service modifier 12).
                 99487, 99489 and 99490 (codes for chronic care
                management).
                 99495 and 99496 (codes for transitional care management
                services).
                 99497 and 99498 (codes for advance care planning).
                 96160 and 96161 (codes for administration of health risk
                assessment).
                 99354 and 99355 (add-on codes, for prolonged evaluation
                and management or psychotherapy services beyond the typical service
                time of the primary procedure; when the base code is also a primary
                care service code).
                 99484, 99492, 99493 and 99494 (codes for behavioral health
                integration services).
                 HCPCS codes:
                 G0402 (code for the Welcome to Medicare visit).
                 G0438 and G0439 (codes for the annual wellness visits).
                 G0463 (code for services furnished in ETA hospitals).
                 G0506 (code for chronic care management).
                 G0444 (code for annual depression screening service).
                 G0442 (code for alcohol misuse screening service).
                 G0443 (code for alcohol misuse counseling service).
                 On March 17, 2020, we announced the expansion of payment for
                telehealth services on a temporary and emergency basis pursuant to
                waiver authority added under section 1135(b)(8) of the Act by the
                Coronavirus Preparedness and Response Supplemental Appropriations Act,
                2020 such that Medicare can pay for telehealth services, including
                office, hospital, and other visits furnished by physicians and other
                practitioners to patients located anywhere in the country, including in
                a patient's place of residence, starting March 6, 2020. In the context
                of the PHE for the COVID-19 pandemic, we recognize that physicians and
                other health care professionals are faced with new challenges regarding
                potential exposure risks, including for Medicare beneficiaries, for
                health care providers, and for members of the community at large. For
                example, the CDC has urged health care professionals to make every
                effort to interview persons under investigation for COVID-19 infection
                by telephone, text messaging system, or video conference instead of in-
                person. In the March 31st COVID-19 IFC, to facilitate the use of
                telecommunications technology as a safe substitute for in-person
                services, we added, on an interim basis, many services to the list of
                eligible Medicare telehealth services, eliminated frequency limitations
                and other requirements associated with particular services furnished
                via telehealth, and clarified several payment rules that apply to other
                services that are furnished using telecommunications technologies that
                can reduce exposure risks (85 FR 19232).
                 Section 1834(m) of the Act 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. When furnished under the telehealth
                rules, many of these specified Medicare telehealth services are still
                reported using codes that describe ``face-to-face'' services but are
                furnished using audio/video, real-time communication technology instead
                of in-person. As such, the majority of the codes for primary care
                services included in the additional telehealth services added in the
                March 31st COVID-19 IFC on an interim basis for the duration of the PHE
                for COVID-19 are already included in the definition of primary care
                services for purposes of the Shared Savings Program assignment
                methodology in Sec. [thinsp]425.400(c)(1)(iv).
                 The March 31st COVID-19 IFC also established flexibilities and
                separate payment for certain services that are furnished virtually
                using technologies but that are not considered Medicare telehealth
                services such as virtual check-ins, e-visits, and telephone E/M
                services, for which payment has been authorized during the COVID-19
                PHE. The codes for these virtual services are not currently included in
                the definition of primary care services for purposes of the Shared
                Savings Program assignment methodology. We believe it is critical to
                include these additional codes in the definition of primary care
                services to ensure these services are included in our determination of
                where beneficiaries receive the plurality of their primary care for
                purposes of beneficiary assignment, so that the assignment methodology
                appropriately reflects the expanded use of technology that is helping
                people who need routine care during the PHE for the COVID-19 pandemic
                and allowing vulnerable beneficiaries and beneficiaries with mild
                symptoms to remain in their homes, while maintaining access to the
                [[Page 27583]]
                care they need. By including services provided virtually, either
                through telehealth, virtual check-ins, e-visits or telephone, in the
                definition of primary care services, we ensure that physicians and
                other practitioners can offer options to beneficiaries whom they treat,
                while also allowing this care to be included in our consideration of
                where beneficiaries receive the plurality of their primary care, for
                purposes of assigning beneficiaries to ACOs. As a result, revising the
                definition of primary care services used in assignment to include these
                services will further allow for continuity and coordination of care. We
                also reiterate our policy defined at Sec. 425.404(b) that, for
                performance years starting on January 1, 2019, and subsequent
                performance years, under the assignment methodology in Sec. 425.402,
                CMS treats a service reported on an FQHC/RHC claim as a primary care
                service performed by a primary care physician.
                b. Use of Codes for Virtual Check-Ins, Remote Evaluation E-Visits,
                Telephone Evaluation and Management Services, and Telehealth in
                Beneficiary Assignment
                 Based on feedback from ACOs and the expansion of payment, on an
                interim basis, for the virtual services discussed above, we are
                revising the definition of primary care services used in the Shared
                Savings Program assignment methodology for the performance year
                starting on January 1, 2020, and for any subsequent performance year
                that starts during the PHE for the COVID-19 pandemic, as defined in
                Sec. 400.200, to include the following additions: (1) HCPCS code G2010
                (remote evaluation of patient video/images) and HCPCS code G2012
                (virtual check-in); (2) CPT codes 99421, 99422 and 99423 (online
                digital evaluation and management service (e-visit)); and (3) CPT codes
                99441, 99442, and 99443 (telephone evaluation and management services).
                 Because the services listed above and described in detail in the
                preamble discussion below are similar to and may replace an E/M service
                for a beneficiary, we believe it is appropriate to include these CPT
                and HCPCS codes in the definition of primary care services used for
                assignment because the services represented by these codes are being
                used in place of similar E/M services, the codes for which are already
                included in the list of codes used for assignment. We believe it is
                important to include these services in our assignment methodology
                because we determine assignment to ACOs based upon where beneficiaries
                receive the plurality of their primary care services or whether they
                have designated an ACO professional as their primary clinician,
                responsible for their overall care, and hold ACOs accountable for the
                resulting assigned beneficiary population. Including these codes in the
                definition of primary care services used in assignment for performance
                years during the PHE for the COVID-19 pandemic will result in a more
                accurate identification of where beneficiaries have received the
                plurality of their primary care services.
                 In preamble discussion below, we are also clarifying that CPT codes
                99304, 99305 and 99306, 99315 and 99316, 99327 and 99328, 99334 through
                99337, 99341 through 99345, and 99347 through 99350 will be included in
                the assignment methodology when these services are furnished using
                telehealth, consistent with additions to the Medicare telehealth list
                for the duration of the PHE for the COVID-19 pandemic as discussed in
                the March 31st COVID-19 IFC (85 FR 19235 through 19237). We use the
                assignment methodology described in Sec. Sec. 425.402 and 425.404 for
                purposes of assigning beneficiaries to ACOs for a performance year or
                benchmark year based on preliminary prospective assignment with
                retrospective reconciliation (including quarterly updates) or
                prospective assignment.
                 With the emergence of the virus that causes COVID-19, there is an
                urgency to expand the use of technology to allow people who need
                routine care, vulnerable beneficiaries, and beneficiaries with mild
                symptoms to remain in their homes, while maintaining access to the care
                they need. Limiting community spread of the virus, as well as limiting
                beneficiaries' exposure to other patients and health care staff
                members, will slow viral spread. We anticipate that the patterns and
                types of care provided during the COVID-19 PHE will be different and,
                in an effort to capture these changes in the methodology used to assign
                beneficiaries to ACOs as soon as possible, so that ACOs, particularly
                those that have elected preliminary prospective assignment with
                retrospective reconciliation for PY 2020, can understand the
                beneficiary population for which they will be responsible during PY
                2020, we have determined that there is good cause to waive prior notice
                and comment rulemaking in order to implement these changes to the
                definition of primary care services in Sec. 425.400(c) immediately.
                 As discussed in the March 31st COVID-19 IFC (85 FR 19244), 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 Medicare telehealth services. Specifically, beginning with
                CY 2019, we finalized separate payment for remote evaluation of video
                and/or images, 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 virtual check-in, 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 E/M 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).
                 These codes were finalized as part of the set of codes that is only
                reportable by the physicians and practitioners who can furnish E/M
                services. Per the March 31st COVID-19 IFC, on an interim basis for the
                PHE for the COVID-19 pandemic, we will allow these codes to be used for
                new patients. In the March 31st COVID-19 IFC (85 FR 19244), we
                explained that, in the context of the PHE for the COVID-19 pandemic,
                when brief communications with practitioners and other non-face-to-face
                services might mitigate the need for an in-person visit that could
                represent an exposure risk for vulnerable patients, we believe that
                these services should be available to as large a population of Medicare
                beneficiaries as possible. In some cases, use of telecommunication
                technology could mitigate the exposure risk, and in such cases, the
                clinical benefit of using technology to furnish the service is self-
                apparent. This would be especially true should a significant increase
                in the number of people or health care professionals needing treatment
                or isolation occur in a way that would limit access to brief
                communications with established providers. Therefore, on an interim
                basis, during the PHE for the COVID-19 pandemic, we finalized that
                these services, which may only be reported if they do not result in a
                visit, including a telehealth visit, can be furnished to both new and
                established patients
                 As discussed in the March 31st COVID-19 IFC (85 FR 19254), in the
                CY 2019 PFS final rule (83 FR 59452), we
                [[Page 27584]]
                finalized payment for new online digital assessment services, also
                referred to as ``E-Visits,'' beginning with CY 2020 for practitioners
                billing under the PFS. These are non-face-to-face, patient-initiated
                communications using online patient portals. These digital assessment
                services are for established patients who require a clinical decision
                that otherwise typically would have been provided in the office. Per
                the March 31st COVID-19 IFC (85 FR 19244), while the code descriptors
                for these e-visit codes refer to an ``established patient'', during the
                PHE for the COVID-19 pandemic, we are exercising enforcement discretion
                on an interim basis to relax enforcement of this aspect of the code
                descriptors. Practitioners who may independently bill Medicare for E/M
                visits (for instance, physicians and NPs) can bill the following codes:
                 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.)
                 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.)
                 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.)
                 We also considered adding additional e-visit HCPCS codes which are
                used by clinicians who may not independently bill for E/M visits and
                who are not included in the definition of ACO professional in Sec.
                425.20 (for example, PTs, OTs, SLPs, CPs). However, because these
                services are not furnished by ACO professionals, we determined it was
                not necessary to include the following codes in our definition of
                primary care services for use in assignment:
                 G2061 (Qualified nonphysician healthcare professional
                online assessment and management service, 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.)
                 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.)
                 As discussed in the March 31st COVID-19 IFC (85 FR 19264 through
                19265) and as discussed previously in this IFC, CMS finalized, on an
                interim basis for the duration of the PHE for the COVID-19 pandemic,
                separate payment for CPT codes 99441 through 99443 and 98966 through
                98968, which describe E/M and assessment and management services
                furnished via telephone. While the code descriptors for these services
                refer to an ``established patient'' during the COVID-19 PHE we are
                exercising enforcement discretion on an interim basis to relax
                enforcement of this aspect of the code descriptors. Practitioners who
                may independently bill Medicare for E/M visits (for instance,
                physicians and NPs) can bill the following 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.)
                 99443 (Telephone evaluation and management service by a
                physician or other qualified health care professional who may report
                evaluation and management services provided to an established patient,
                parent, or guardian not originating from a related E/M service provided
                within the previous 7 days nor leading to an E/M service or procedure
                within the next 24 hours or soonest available appointment; 21-30
                minutes of medical discussion.)
                 We also considered adding the additional telephone assessment and
                management CPT codes which are used by clinicians who may not
                independently bill for E/M visits and who are not included in the
                definition of ACO professional in Sec. 425.20 (for example, PTs, OTs,
                SLPs, CPs). However, because these services are not furnished by ACO
                professionals, we determined it was not necessary to include these
                codes in our definition of primary care services for use in assignment:
                 98966 (Telephone assessment and management service
                provided by a qualified nonphysician health care professional to an
                established patient, parent, or guardian not originating from a related
                assessment and management service provided within the previous 7 days
                nor leading to an assessment and management service or procedure within
                the next 24 hours or soonest available appointment; 5-10 minutes of
                medical discussion.)
                 98967 (Telephone assessment and management service
                provided by a qualified nonphysician health care professional to an
                established patient, parent, or guardian not originating from a related
                assessment and management service provided within the previous 7 days
                nor leading to an assessment and management service or procedure within
                the next 24 hours or soonest available appointment; 11-20 minutes of
                medical discussion.)
                 98968 (Telephone assessment and management service
                provided by a qualified nonphysician health care professional to an
                established patient, parent, or guardian not originating from a related
                assessment and management service provided within the previous 7 days
                nor leading to an assessment and management service or procedure within
                the next 24 hours or soonest available appointment; 21-30 minutes of
                medical discussion.)
                 Several codes, detailed below, that are included on the ``Covered
                Telehealth Services for PHE for the COVID-19 pandemic, effective March
                1, 2020'' list available at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes, are already included
                in the definition of primary care services used in the Shared Savings
                Program assignment methodology:
                 99304 (Initial nursing facility care, per day, for the
                evaluation and management of a patient, which requires these 3 key
                components: A detailed or comprehensive history; A detailed or
                comprehensive examination; and Medical decision making that is
                straightforward or of low complexity. Counseling and/or coordination of
                care with other physicians, other qualified health care professionals,
                or agencies are provided consistent with the nature of the problem(s)
                and the patient's and/or family's needs. Usually, the problem(s)
                requiring admission are of low severity. Typically, 25 minutes are
                spent at the bedside and on the patient's facility floor or unit.)
                 99305 (Initial nursing facility care, per day, for the
                evaluation and management of a patient, which requires these 3 key
                components: A comprehensive history; A comprehensive examination; and
                [[Page 27585]]
                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
                problem(s) requiring admission are of moderate severity. Typically, 35
                minutes are spent at the bedside and on the patient's facility floor or
                unit.)
                 99306 (Initial nursing facility care, per day, for the
                evaluation and management of a patient, which requires these 3 key
                components: A comprehensive history; A comprehensive examination; and
                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
                problem(s) requiring admission are of high severity. Typically, 45
                minutes are spent at the bedside and on the patient's facility floor or
                unit.)
                 99315 (Nursing facility discharge day
                management; 30 minutes or less.)
                 99316 (Nursing facility discharge day
                management; more than 30 minutes.)
                 99327 (Domiciliary or rest home visit for the
                evaluation and management of a new patient, which requires these 3 key
                components: A comprehensive history; A comprehensive examination; and
                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 high severity. Typically, 60 minutes are
                spent with the patient and/or family or caregiver.)
                 99328 (Domiciliary or rest home visit for the
                evaluation and management of a new patient, which requires these 3 key
                components: A comprehensive history; A comprehensive examination; and
                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
                patient is unstable or has developed a significant new problem
                requiring immediate physician attention. Typically, 75 minutes are
                spent with the patient and/or family or caregiver.)
                 99334 (Domiciliary or rest home visit for the
                evaluation and management of an established patient, which requires at
                least 2 of these 3 key components: A problem focused interval 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, 15 minutes are spent with the patient and/or family
                or caregiver.)
                 99335 (Domiciliary or rest home visit for the
                evaluation and management of an established patient, which requires at
                least 2 of these 3 key components: An expanded problem focused interval
                history; An expanded problem focused examination; Medical decision
                making of 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 low to moderate severity. Typically, 25 minutes are spent with
                the patient and/or family or caregiver.)
                 99336 (Domiciliary or rest home visit for the
                evaluation and management of an established patient, which requires at
                least 2 of these 3 key components: A detailed interval 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, 40 minutes are spent with the patient and/or
                family or caregiver.)
                 99337 (Domiciliary or rest home visit for the
                evaluation and management of an established patient, which requires at
                least 2 of these 3 key components: A comprehensive interval history; A
                comprehensive examination; Medical decision making of moderate to 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. The patient may be unstable or may have
                developed a significant new problem requiring immediate physician
                attention. Typically, 60 minutes are spent with the patient and/or
                family or caregiver.)
                 99341 (Home visit for the evaluation and management of a
                new patient, which requires these 3 key components: A problem focused
                history; A problem focused examination; and 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
                severity. Typically, 20 minutes are spent face-to-face with the patient
                and/or family.)
                 99342 (Home 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; and 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.)
                 99343 (Home visit for the evaluation and management of a
                new patient, which requires these 3 key components: A detailed history;
                A detailed examination; and 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, 45 minutes are spent face-to-face
                with the patient and/or family.)
                 99344 (Home visit for the evaluation and management of a
                new patient, which requires these 3 key components: A comprehensive
                history; A comprehensive examination; and 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 high
                severity.
                [[Page 27586]]
                Typically, 60 minutes are spent face-to-face with the patient and/or
                family.)
                 99345 (Home visit for the evaluation and management of a
                new patient, which requires these 3 key components: A comprehensive
                history; A comprehensive examination; and 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 patient is unstable or has
                developed a significant new problem requiring immediate physician
                attention. Typically, 75 minutes are spent face-to-face with the
                patient and/or family.)
                 99347 (Home visit for the evaluation and management of an
                established patient, which requires at least 2 of these 3 key
                components: A problem focused interval 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, 15 minutes
                are spent face-to-face with the patient and/or family.)
                 99348 (Home visit for the evaluation and management of an
                established patient, which requires at least 2 of these 3 key
                components: An expanded problem focused interval history; An expanded
                problem focused examination; Medical decision making of 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 low to
                moderate severity. Typically, 25 minutes are spent face-to-face with
                the patient and/or family.)
                 99349 (Home visit for the evaluation and management of an
                established patient, which requires at least 2 of these 3 key
                components: A detailed interval 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 moderate to high severity. Typically, 40
                minutes are spent face-to-face with the patient and/or family.)
                 99350 (Home visit for the evaluation and management of an
                established patient, which requires at least 2 of these 3 key
                components: A comprehensive interval history; A comprehensive
                examination; Medical decision making of moderate to 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. The patient may be unstable or may have developed a
                significant new problem requiring immediate physician attention.
                Typically, 60 minutes are spent face-to-face with the patient and/or
                family.)
                 Because these CPT codes are already included in the definition of
                primary care services used in the Shared Savings Program assignment
                methodology, we are clarifying that these CPT codes will continue to be
                included in the definition of primary care services used for
                assignment, including when they are furnished via telehealth during the
                PHE for the COVID-19 pandemic, beginning March 1, 2020. We believe it
                is important to include these services in our assignment methodology,
                regardless of whether they are furnished in-person or via telehealth,
                because we determine assignment based upon where beneficiaries receive
                the plurality of their primary care services or whether they have
                designated an ACO professional as their primary clinician, responsible
                for their overall care, and hold ACOs accountable for the resulting
                assigned beneficiary population. Include these codes in the definition
                of primary care services used in assignment during the PHE for the
                COVID-19 pandemic, even when services are furnished via telehealth,
                will result in a more accurate identification of where beneficiaries
                have received the plurality of their primary care services.
                 Accordingly, we are adding a paragraph (c)(2) to our regulation at
                Sec. 425.400, in which we specify additional primary care service
                codes that will be considered for purposes of beneficiary assignment
                for the performance year starting on January 1, 2020, and for any
                subsequent performance year that starts during the PHE for the COVID-19
                pandemic, as defined in Sec. 400.200. Under this provision the
                existing CPT codes and HCPCS codes included in the definition of
                primary care services at Sec. 425.400(c)(1) will continue to apply for
                purposes of determining beneficiary assignment under Sec.
                [thinsp]425.402.
                 We seek comment on the revisions to the definition of primary care
                services that we are adopting in this IFC including the alternatives
                considered with regard to adding codes used by non-ACO professionals.
                6. Applicability of Policies to Track 1+ Model ACOs
                 The Track 1+ Model was established under the Innovation Center's
                authority at section 1115A of the Act, to test innovative payment and
                service delivery models to reduce program expenditures while preserving
                or enhancing the quality of care for Medicare, Medicaid, and Children's
                Health Insurance Program beneficiaries. The Track 1+ Model, which is a
                time-limited model that began on January 1, 2018, is based on Shared
                Savings Program Track 1, but tests a payment design that incorporates
                more limited downside risk, as compared to Track 2 and the ENHANCED
                track. We discontinued all future application cycles for the Track 1+
                Model, as explained in earlier rulemaking (83 FR 68032 and 68033). As
                of January 1, 2020, there are 20 Track 1+ Model ACOs participating in
                performance year 3 of a 3-year agreement under the model.
                 ACOs approved to participate in the Track 1+ Model are required to
                agree to the terms and conditions of the model by executing a Track 1+
                Model Participation Agreement. See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/track-1plus-model-par-agreement.pdf. Track 1+ Model ACOs are also required to
                have been approved to participate in the Shared Savings Program (Track
                1) and to have executed a Shared Savings Program Participation
                Agreement. As indicated in the Track 1+ Model Participation Agreement,
                in accordance with our authority under section 1115A(d)(1) of the Act,
                we have waived certain requirements of the Shared Savings Program that
                otherwise would be applicable to ACOs participating in Track 1 of the
                Shared Savings Program, as necessary for purposes of testing the Track
                1+ Model, and established alternative requirements for the ACOs
                participating in the Track 1+ Model. Unless stated otherwise in the
                Track 1+ Model Participation Agreement, the requirements of the Shared
                Savings Program under part 425 continue to apply. Consistent with Sec.
                425.212, Track 1+ Model ACOs generally are subject to all applicable
                regulatory changes,
                [[Page 27587]]
                including but not limited to, changes to the regulatory provisions
                referenced within the Track 1+ Model Participation Agreement that
                become effective during the term of the ACO's Shared Savings Program
                Participation Agreement and Track 1+ Model Participation Agreement,
                unless otherwise specified through rulemaking or amendment to the Track
                1+ Model Participation Agreement. We note that the terms of the Track
                1+ Model Participation Agreement also permit the parties (CMS and the
                ACO) to amend the agreement at any time by mutual written agreement.
                 Therefore, unless specified otherwise, the changes to the Shared
                Savings Program regulations established in this IFC that are applicable
                to ACOs within a current agreement period will apply to ACOs in the
                Track 1+ Model in the same way that they apply to ACOs in Track 1, so
                long as the applicable regulation has not been waived under the Track
                1+ Model. Similarly, to the extent that certain requirements of the
                regulations that apply to ACOs under Track 2 or the ENHANCED track have
                been incorporated for ACOs in the Track 1+ Model under the terms of the
                Track 1+ Model Participation Agreement, changes to those regulations as
                adopted in this IFC will also apply to ACOs in the Track 1+ Model in
                the same way that they apply to ACOs in Track 2 or the ENHANCED track.
                For example, the following policies apply to Track 1+ Model ACOs:
                 Revisions to the definition of primary care services used
                in beneficiary assignment (section II.L.5. of this IFC), to include
                telehealth codes for virtual check-ins, e-visits, and telephonic
                communication. These codes are applicable beginning with beneficiary
                assignment for the performance year starting on January 1, 2020, and
                for any subsequent performance year that starts during the PHE for the
                COVID-19 pandemic, as defined in Sec. 400.200.
                 Clarification that the total months affected by an extreme
                and uncontrollable circumstance for the COVID-19 pandemic will begin
                with January 2020 and continue through the end of the COVID-19 PHE, for
                purposes of mitigating shared losses for PY 2020 (section II.L.3. of
                this IFC).
                 Adjustments to expenditure calculations to remove
                expenditures for episodes of care for treatment of COVID-19 (section
                II.L.4. of this IFC).
                 We will also apply the following policies established in this IFC
                to Track 1+ Model ACOs through an amendment to the Track 1+ Model
                Participation Agreement executed by CMS and the ACO:
                 Adjustments to revenue calculations to remove expenditures
                for episodes of care for treatment of COVID-19 (section II.L.4. of this
                IFC).
                M. Additional Flexibility Under the Teaching Physician Regulations
                 In the March 31st COVID-19 IFC (85 FR 19258 through 19261), we
                introduced flexibilities in our regulations governing PFS payment for
                teaching physicians and residents. Since we published the March 31st
                COVID-19 IFC, stakeholders have asked us to relax additional
                requirements related to the provision of services furnished by a
                resident without the presence of a teaching physician under the so-
                called primary care exception specified in our regulation at 42 CFR
                415.174.
                 For teaching physicians, section 1842(b) of the Act specifies that
                in the case of physicians' services furnished to a patient in a
                hospital with a teaching program, the Secretary shall not provide
                payment for such services unless the physician renders sufficient
                personal and identifiable physicians' services to the patient to
                exercise full, personal control over the management of the portion of
                the case for which payment is sought. Regulations regarding PFS payment
                for teaching physician services are codified in part 415. Under Sec.
                415.174, Medicare makes PFS payment in primary care settings for
                certain services of lower and mid-level complexity furnished by a
                resident without the physical presence of a teaching physician,
                referred to as the primary care exception. Our regulation at Sec.
                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, ensure that
                the services furnished are appropriate, and review with each resident
                during or immediately after each visit the beneficiary's medical
                history, physical examination, diagnosis, and record of tests and
                therapies.
                 As provided in the regulation at Sec. 415.174(a), the E/M 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
                [[Page 27588]]
                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 context of the PHE for the COVID-19 pandemic, teaching
                hospitals have expressed a need to increase their capacity to respond
                to the increased demand for physicians to meet patient needs.
                Additionally, there are often circumstances where the teaching
                physician may be under quarantine or otherwise at home, or the physical
                proximity of the teaching physician might present additional exposure
                risks. In section II.E. the March 31st COVID-19 IFC (85 FR 19245
                through 19246), we stated that as a general rule under Sec. 415.172,
                the requirement for the presence of a teaching physician can be met, at
                a minimum, through direct supervision by audio/video real-time
                communications technology. We also revised the scope of E/M codes that
                can be furnished under the primary care exception and amended Sec.
                415.174 of our regulations to allow all levels of office/outpatient E/M
                services furnished in primary care centers under the primary care
                exception to be furnished under direct supervision of the teaching
                physician by interactive telecommunications technology. We are making
                clarifying technical edits to the regulation text at Sec. Sec.
                415.172, 415.174, 415.180, and 415.184 to reflect the audio/video real-
                time requirement for communications technology.
                 Since we published the March 31st COVID-19 IFC, stakeholders have
                requested that we also revise our regulations to allow the teaching
                physician to meet the requirement to review the service with the
                resident, during or immediately after the visit, through virtual or
                remote means via interactive audio/video real-time communications
                technology. Given the circumstances of the COVID-19 PHE, the teaching
                physician may be under quarantine or otherwise not physically available
                to review the service with the resident. We note that in the March 31st
                COVID-19 IFC, we inadvertently deleted the former Sec. 415.174(b)
                which stated that, nothing in paragraph (a) of the section may be
                construed as providing a basis for the coverage of services not
                determined to be covered under Medicare, such as routine physical
                check-ups. We are reinstating the former paragraph (b) and adding a new
                paragraph (c) to allow that, on an interim basis for the duration of
                the PHE for the COVID-19 pandemic, 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 audio/video real time communications
                technology.
                 We believe that permitting the teaching physician to interact with
                the resident remotely through virtual means would still allow the
                teaching physician to direct, manage, and review the care furnished by
                residents as specified in Sec. 415.174(a). For example, this means
                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. The remainder of the policies at Sec.
                415.174(a)(3) continue to apply in that the teaching physician must
                have no other responsibilities at the time, assume management
                responsibility for the beneficiaries seen by the residents, ensure that
                the services furnished are appropriate, and review with each resident
                during or immediately after each visit the beneficiary's medical
                history, physical examination, diagnosis, and record of tests and
                therapies.
                 Since we published the March 31st COVID-19 IFC, stakeholders have
                requested that additional services be added to the primary care
                exception, such as the telephone E/M services we added for separate
                payment in the March 31st COVID-19 IFC, as well as transitional care
                management, and communication technology-based services. Adding
                services to the primary care exception would permit the resident to
                provide a more expansive array of services to 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. Consequently, on an interim basis for the duration of the
                COVID-19 PHE, Medicare may make PFS payment to the teaching physician
                for the following additional services when furnished by a resident
                under the primary care exception:
                 CPT code 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);
                 CPT code 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);
                 CPT code 99443 (Telephone evaluation and management
                service by a physician or other qualified health care professional who
                may report evaluation and management services provided to an
                established patient, parent, or guardian not originating from a related
                E/M service provided within the previous 7 days nor leading to an E/M
                service or procedure within the next 24 hours or soonest available
                appointment; 21-30 minutes of medical discussion);
                [[Page 27589]]
                 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).
                 Finally, 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), we are clarifying that the office/outpatient E/M level
                selection for services under the primary care exception when furnished
                via telehealth can be based on MDM 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 this
                IFC, the typical times for purposes of level selection for an office/
                outpatient E/M are the times listed in the CPT code descriptor. 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. Taken together, these policies mean that,
                on an interim basis for the duration of the PHE for the COVID-19
                pandemic, Medicare may make PFS payment for teaching physician services
                when a resident furnishes a service included in this expanded list of
                services in primary care centers, including via telehealth, and the
                teaching physician can provide the necessary direction, management and
                review for the resident's services using audio/video real-time
                communications technology. We believe that these policies will increase
                the capacity of teaching settings to respond to the PHE for the COVID-
                19 pandemic as more practitioners are being asked to assist with the
                response.
                N. Payment for Audio-Only Telephone Evaluation and Management Services
                 In the March 31st COVID-19 IFC, we established separate payment for
                audio-only telephone evaluation and management services. The telephone
                evaluation and management (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 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 PHE and with the goal of
                reducing exposure risks associated with the COVID-19 pandemic,
                especially in the case that two-way, audio and video technology
                required to furnish a Medicare telehealth service might not be
                available, 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. We
                stated we believed 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 finalized on an interim basis during the PHE
                for the COVID-19 pandemic, work relative value units (RVUs) as
                recommended by the American Medical Association (AMA) Relative Value
                Scale Update Committee (RUC) as discussed in the CY 2008 PFS final rule
                (72 CFR 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
                practice expense (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 time since we established these payment amounts,
                stakeholders have informed us that use of audio-only services is more
                prevalent than we had previously considered, especially because many
                beneficiaries are not
                [[Page 27590]]
                utilizing video-enabled communication technology from their homes. In
                other words, there are many cases where practitioners would under
                ordinary circumstances utilize telehealth or in-person visits to
                evaluate and manage patients' medical concerns, but are instead using
                audio-only interactions to manage more complex care. While we
                previously acknowledged the likelihood that, under the circumstances of
                the PHE, more time would be spent interacting with the patient via
                audio-only technology, we are now recognizing that the intensity of
                furnishing an audio-only visit to a beneficiary during the unique
                circumstances of the COVID-19 pandemic is not accurately captured by
                the valuation of these services we established in the March 31st COVID-
                19 IFC. This is 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.
                Given our new understanding that these audio-only services are being
                furnished primarily as a replacement for care that would otherwise be
                reported as an in-person or telehealth visit using the office/
                outpatient E/M codes, we are establishing new RVUs for the telephone E/
                M services based on crosswalks to the most analogous office/outpatient
                E/M codes, based on the time requirements for the telephone codes and
                the times assumed for valuation for purposes of the office/outpatient
                E/M codes. Specifically, we are crosswalking CPT codes 99212, 99213,
                and 99214 to 99441, 99442, and 99443 respectively. We are finalizing,
                on an interim basis and for the duration of the COVID-19 PHE the
                following work RVUs: 0.48 for CPT code 99441; 0.97 for CPT code 99442;
                and 1.50 for CPT code 99443. We are also finalizing 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
                are not finalizing increased payment rates for CPT codes 98966-98968 as
                these codes describe services furnished by practitioners who cannot
                independently bill for E/Ms and so these telephone assessment and
                management services, by definition, are not furnished in lieu of an
                office/outpatient E/M service.
                 We note that to the extent that these extended phone services are
                taking place instead of office/outpatient 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 believe that
                the resources required to furnish these services during the PHE for the
                COVID-19 pandemic are better captured by the RVUS associated with the
                level 2-4 established patient office/outpatient E/M visits.
                Additionally, given our understanding that these audio-only services
                are being furnished as substitutes for office/outpatient E/M services,
                we recognize that they should be considered as telehealth services, and
                are adding them to the list of Medicare telehealth services for the
                duration of the PHE. We also note that, for these audio-only E/M
                services, we will be separately issuing 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. The full list of Medicare telehealth services,
                including those added during the PHE, is available here https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes. We note that these codes describe medical discussion,
                and should not be used for administrative or other non-medical
                discussion with the patient. Although practitioners have been provided
                flexibility around cost-sharing for the duration of the PHE,
                beneficiaries are still liable for cost-sharing for these services in
                instances where the practitioner does not waive cost-sharing.
                Practitioners should educate beneficiaries on any applicable cost-
                sharing. We are seeking comment on how best to minimize unexpected cost
                sharing for beneficiaries. We plan to monitor utilization of these
                services and will consider making refinements to billing rules,
                documentation requirements or claims edits through future rulemaking.
                O. Flexibility for Medicaid Laboratory Services
                 Section 6004(a) of the Families First Coronavirus Response Act
                added a new mandatory benefit in the Medicaid statute at section
                1905(a)(3)(B) of the Act, and this provision was amended by section
                3717 of the CARES Act. Section 1905(a)(3)(B) of the Act provides that,
                for any portion of the COVID-19 emergency period defined in section
                1135(g)(1)(B) of the Act that begins on or after March 18, 2020,
                Medicaid coverage must include in vitro diagnostic products (as defined
                in Food and Drug Administration (FDA) regulations at 21 CFR 809.3(a))
                for the detection of SARS-CoV-2 or diagnosis of the virus that causes
                COVID-19, and the administration of such in vitro diagnostic products.
                As discussed in CMS guidance issued on April 13, 2020,\38\ FDA has
                advised that serological tests for COVID-19 meet the definition in 21
                CFR 809.3(a) of an in vitro diagnostic product for the detection of
                SARS-CoV-2 or the diagnosis of COVID-19. Therefore, coverage under
                section 1905(a)(3)(B) of the Act must include those serological tests.
                Section 1905(a)(3)(B) was an addition to the existing mandatory benefit
                for laboratory and X-ray services that was formerly at section
                1905(a)(3) of the Act, and that is now at section 1905(a)(3)(A) of the
                Act.
                ---------------------------------------------------------------------------
                 \38\ Families First Coronavirus Response Act, Public Law 116-
                127; Coronavirus Aid, Relief, and Economic Security (CARES) Act,
                Public Law 116-136; Frequently Asked Questions (FAQs) (April 13,
                2020) 5-6, at https://www.medicaid.gov/state-resource-center/downloads/covid-19-section-6008-CARES-faqs.pdf.
                ---------------------------------------------------------------------------
                 The regulation currently implementing section 1905(a)(3) of the
                Act, at 42 CFR 440.30, includes certain limitations and conditions on
                Medicaid coverage of laboratory tests and X-rays, and describes who may
                provide laboratory tests and where laboratory tests may be
                administered. Specifically, Sec. 440.30(a) requires that Medicaid-
                covered laboratory and X-ray services be ordered and provided by or
                under the direction of a physician or other licensed practitioner of
                the healing arts within the scope of his or her practice as defined by
                state law or ordered by a physician but provided by a referral
                laboratory. Section 440.30(b) specifies that Medicaid will cover
                laboratory and X-ray services only if provided in an office or similar
                facility other than a HOPD or clinic, and Sec. 440.30(c) specifies
                that Medicaid will cover these services only if they are furnished by a
                laboratory that meets the requirements of 42 CFR part 493.
                 As the CDC noted when issuing advice on how to protect against
                COVID-19 infection, some recent studies have suggested that COVID-19
                may be spread by people who are not showing symptoms.\39\ We believe it
                is vital for Medicaid beneficiaries to have broad access to tests to
                detect the SARS-CoV-2 virus, antibodies to the SARS-CoV-2 virus, or
                COVID-19, so that they can properly monitor their symptoms, make
                decisions about seeking further care, and take appropriate precautions
                [[Page 27591]]
                to prevent further spread of disease. The requirements at Sec.
                440.30(a) and (b) could present an obstacle to Medicaid coverage for
                administering and processing COVID-19 laboratory and diagnostic tests
                in certain non-office settings, such as parking lots or other temporary
                outdoor locations, where the setting is intended to maximize physical
                distancing and thereby minimize transmission of COVID-19. Given the
                nature and scope of the COVID-19 pandemic, the critical importance of
                expanding COVID-19 testing to combat the pandemic, and the heightened
                risk the disease presents to Medicaid beneficiaries, we also would like
                to accommodate evolving COVID-19 diagnostic mechanisms, such as FDA-
                authorized tests that allow for patients to self-collect a specimen in
                alternative locations (such as at home) to send to a laboratory, to
                detect the SARS-CoV-2 virus, antibodies to the SARS-CoV-2 virus, or
                COVID-19 (sometimes referred to as ``self-collection''). Self-
                collection of tests at home is likely to minimize transmission of
                COVID-19, and the need for a Medicaid beneficiary to obtain an order
                for coverage of a self-collected COVID-19 test could present a
                significant barrier to beneficiaries who might otherwise seek a test
                that FDA authorizes as not requiring a prescription. We are using the
                term self-collection to encompass evolving mechanisms for testing that
                would be processed by a laboratory that can receive Medicaid payment.
                ---------------------------------------------------------------------------
                 \39\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6913e2.htm;
                https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html.
                ---------------------------------------------------------------------------
                 Accordingly, we are amending Sec. 440.30 to permit flexibility for
                coverage of COVID-19 tests, including coverage for tests administered
                in non-office settings, and coverage for laboratory processing of self-
                collected COVID-19 tests that are FDA-authorized for self-collection.
                The flexibility would apply not only during the current COVID-19 PHE,
                but also during any subsequent periods of active surveillance, to allow
                for continued surveillance as part of strategies to detect recurrence
                of the virus in individuals and populations to prevent further spread
                of the disease. State officials may continue to need the flexibility
                offered under this amendment during such periods of active surveillance
                after the COVID-19 PHE ends. We define a period of active surveillance
                as an outbreak of communicable disease during which no approved
                treatment or vaccine is widely available. A period of active
                surveillance ends on the date the Secretary terminates it, or the date
                that is two incubation periods after the last known case of the
                communicable disease, whichever is sooner. We seek comments on this
                definition of the period of active surveillance.
                 To allow similar flexibilities in future emergencies with similar
                circumstances, these amendments would not be limited to the COVID-19
                PHE and any subsequent period of active surveillance (as defined
                above), but would also apply to future PHEs resulting from outbreaks of
                communicable disease (and subsequent periods of active surveillance, as
                defined above), during which measures are necessary to avoid
                transmission of the communicable disease, and when such measures might
                result in difficulty meeting the requirements of Sec. 440.30(a) or
                (b). The flexibilities available under this amendment would be
                applicable as described below for the COVID-19 PHE, and with respect to
                future PHEs, would be applicable only upon formal declaration of a PHE
                that CMS determines meets these criteria, and would last for the
                duration of that future PHE and any subsequent period of active
                surveillance.
                 We are therefore adding a new Sec. 440.30(d) that specifies that,
                during the COVID-19 PHE or any future PHE resulting from an outbreak of
                communicable disease, and during any subsequent period of active
                surveillance (as defined above), Medicaid coverage is available for
                laboratory tests and X-ray services that do not meet conditions
                specified in Sec. 440.30(a) or (b) so long as the purpose of the
                laboratory or X-ray service is to diagnose or detect SARS-CoV-2,
                antibodies to SARS-CoV-2, COVID-19, or the communicable disease named
                in the PHE or its causes, and so long as the deviation from the
                conditions specified in Sec. 440.30(a) or (b) is intended to avoid
                transmission of the communicable disease. We further specify that under
                these same circumstances and subject to these same conditions, Medicaid
                coverage is available for laboratory processing of self-collected
                laboratory test systems that the FDA has authorized for home use, if
                available to diagnose or detect SARS-CoV-2, antibodies to SARS-CoV-2,
                COVID-19, or the communicable disease named in the PHE or its causes,
                even if those self-collected tests would not otherwise meet the
                requirements in Sec. 440.30(a) or (b). Among other flexibilities,
                these amendments would permit states to cover laboratory processing of
                self-collected test systems that the FDA has authorized for home use,
                without the order of a treating physician or other licensed non-
                physician practitioner (NPP). Laboratories that process such test
                systems without an order, as permitted under this new Sec. 440.30(d),
                must notify the patient and the patient's physician or NPP, if known by
                the laboratory, of the results. Again, in order to protect the public,
                the flexibilities that would permit self-collection of testing will
                apply only for test systems authorized by the FDA for home use. We are
                soliciting comment on the implications of applying this provision to
                future public health emergencies, and the specifications that should be
                included in doing so.
                 These changes to Sec. 440.30 apply not only to the benefit
                described at section 1905(a)(3)(B) of the Act, but also apply to the
                longstanding laboratory and X-ray services benefit that was formerly at
                section 1905(a)(3) of the Act, and is now at section 1905(a)(3)(A) of
                the Act. In light of the urgent need to provide these flexibilities
                during the COVID-19 PHE, and because this provision will ease
                restrictions under existing law and make Medicaid coverage of testing
                more available, new paragraph (d) in Sec. 440.30 will be effective
                retroactive to March 1, 2020.
                 Lastly, while Sec. 440.30(d) does not provide flexibility
                regarding Sec. 440.30(c), which provides that services under Sec.
                440.30 must be furnished by a laboratory that meets the requirements of
                part 493, we are soliciting comment on whether continuing to apply the
                requirements of Sec. 440.30(c) would present any obstacle to providing
                Medicaid coverage for COVID-19 testing.
                P. Improving Care Planning for Medicaid Home Health Services
                1. Background
                a. General Information
                 Title XIX of the Act requires that to receive federal Medicaid
                matching funds, a state must offer certain services to the
                categorically needy populations specified in the statute. Home health
                services for Medicaid-eligible individuals who are entitled to NF
                services is one of these mandatory services. Individuals entitled to NF
                services include the basic categorically needy populations that receive
                the standard Medicaid benefit package, and can include medically needy
                populations if NF services are offered to the medically needy within a
                state. Home health services include part-time or intermittent nursing,
                home health aide services, medical supplies, equipment, and appliances,
                and may include therapy services (physical therapy, occupational
                therapy, speech pathology and audiology services). Prior to 1997,
                Medicaid regulations required an individual's physician to order home
                [[Page 27592]]
                health services as part of a written plan of care, and review the plan
                of care every 60 days. In 1997, Medicaid regulations (62 FR 47902),
                were amended to allow the plan of care for medical supplies, equipment
                and appliances to be reviewed by a physician annually.
                 Title XIX was amended in 2010, when section 6407 of the Patient
                Protection and Affordable Care Act of 2010 \40\ added the requirement
                that physicians document the occurrence of a face-to-face encounter
                (including through the use of telehealth) with the Medicaid beneficiary
                within reasonable timeframes when ordering home health services.
                Section 504 of the Medicare Access and CHIP Reauthorization Act of 2015
                (MACRA) (Pub. L. 114-10, enacted on April 16, 2015) amended Medicare
                requirements at section 1834(a)(11)(B)(ii) of the Act to allow certain
                authorized NPPs to document the face-to-face encounter and applied such
                changes to the Medicaid program. CMS finalized the implementing
                provisions on February 2, 2016, in the Medicaid Program; Face-to-Face
                Requirements for Home Health Services; Policy Changes and Clarification
                Related to Home Health final rule (81 FR 5529) became effective July 1,
                2016.
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                 \40\ The Patient Protection and Affordable Care Act (Pub. L.
                111-148) was enacted on March 23, 2010. The Health Care and
                Education Reconciliation Act of 2010 (Pub. L. 111-152), which
                amended and revised several provisions of the Patient Protection and
                Affordable Care Act, was enacted on March 30, 2010. In this IFC, we
                refer to the two statutes collectively as the ``Patient Protection
                and Affordable Care Act''.
                ---------------------------------------------------------------------------
                 In the March 31st COVID-19 IFC, we amended the Medicaid home health
                regulations to allow other licensed practitioners to order all
                components of home health services in accordance with state scope of
                practice laws, for the period of this COVID-19 PHE.
                b. Changes To Modernize Requirements for Ordering Medicaid Home Health
                Nursing, Aide and Therapy Services; and Modernize Face-to-Face
                Encounter Requirements
                 When the Medicaid program was signed into law in 1965, most skilled
                medical professional services in the United States were provided by
                physicians, with the assistance of nurses. Over the decades, the
                medical professional field has diversified and allowed for a wider
                range of certifications and specialties, including the establishment of
                mid-level practitioners such as NPs and PAs that are also known as
                NPPs. Both Medicare and Medicaid policies and regulations have been
                updated over recent years to make changes to allow NPPs to provide
                certain services within the extent of their scope of practice as
                defined by state law.
                 The recognition of the advanced training and qualifications of
                these practitioners continues with the enactment of the CARES Act.
                Section 3708 of the CARES Act amended Medicare requirements at sections
                1814(a) and 1835(a) of the Act to expand the list of practitioners who
                can order home health services. Specifically, sections 1814(a)(2)(C) of
                the Act under Part A and section 1835(a)(2)(A) of the Act under Part B
                of the Medicare program were amended to allow an NP, CNS or PA to order
                home health services in addition to physicians so long as these NPPs
                are permitted to provide such services under the scope of practice laws
                in the state. Section 3708(e) of the CARES Act also provides that the
                requirements for ordering home health services shall apply under title
                XIX in the same manner and to the same extent as such requirements
                apply under title XVIII of such Act. In accordance with this language
                on applying these requirements ``in the same manner'' as Medicare is,
                in light of the urgent need to provide these flexibilities during the
                COVID-19 PHE, and because this provision will increase flexibility in
                the delivery of benefits and make Medicaid coverage of home health
                services more available, the Medicaid regulations discussed in this
                section will take effect on the same date as the Medicare regulations
                implementing section 3708 discussed in section II.J. of this IFC,
                ``Care Planning for Medicare Home Health Services.'' Further, the
                language in section 3708 of the CARES Act is not time limited to the
                period of the COVID-19 PHE; the revisions to the Medicaid home health
                program will be permanently in effect.
                 The purpose of this regulation is to implement this statutory
                directive in the CARES Act within the Medicaid program. In implementing
                the CARES Act home health provisions, it is important to note the
                structural differences between the Medicare home health benefit and the
                Medicaid home health benefit that require some adaptation for the
                requirement to apply the new Medicare rules in section 3708 of the
                CARES Act to Medicaid ``in the same manner and to the same extent as
                such requirements apply'' under Medicare. Under the Medicare program,
                the home health benefit includes skilled part-time or intermittent
                nursing, home health aide service, therapies and medical social
                services. DME is a separate benefit under Medicare, and could already
                be ordered, prior to the enactment of section 3708 of the CARES Act, by
                a more extensive list of NPPs than the practitioners identified in
                section 3708 of the CARES Act for Medicare home health services.
                Comparatively, as noted previously in this section of the IFC, the
                Medicaid home health benefit includes part-time or intermittent
                nursing, home health aide services, and medical supplies, equipment and
                appliances, also known as DME. Therapy services can be included at the
                state's option.
                 Based on the statutory directive to apply section 3708 of the CARES
                Act changes to Medicaid in the same manner as Medicare, we had to
                determine whether to interpret this directive as applying the rules for
                who can order services under the more limited Medicare home health
                services benefit only to the subset of Medicaid home health services
                that align with Medicare, or to apply the Medicare rules on who can
                order services to the full range of Medicaid home health services. As
                discussed earlier in this section, Medicare allows a more extensive
                list of NPPs to order DME, than the practitioners identified for
                Medicaid or the practitioners identified in the CARES Act. Because DME
                (``medical supplies, equipment and appliances'') is covered under the
                Medicaid home health benefit, this would mean applying the current
                Medicare rules on who can order DME under that Medicare benefit to that
                component of the Medicaid home health benefit. We believe that aligning
                the Medicaid program with Medicare regarding who can order medical
                supplies, equipment and appliances promotes access to services for
                Medicaid beneficiaries, including those who are dually eligible, and
                will eliminate burden to states and providers on dealing with
                inconsistencies between the Medicare and Medicaid programs.
                Specifically, we are amending the home health regulation at Sec.
                440.70(a)(3) to allow other licensed practitioners, to order medical
                equipment, supplies and appliances in addition to physicians, when
                practicing in accordance with state laws.
                 For other services covered under the Medicaid home health benefit,
                we are applying the new list of practitioners set forth in section 3708
                of the CARES Act to who can order those services, specifically, part-
                time or intermittent nursing services, home health aide services, and
                if included in the state's home health benefit, therapy services.
                Specifically, Sec. 440.70(a)(2) is amended to allow a NP, CNS and PA
                to order home health services described in Sec. 440.70(b)(1), (2) and
                (4).
                [[Page 27593]]
                 Through this IFC, we are also amending the current regulation to
                remove the requirement that the NPPs described in Sec. 440.70(a)(2)
                have to communicate the clinical finding of the face-to-face encounter
                to the ordering physician. With expanding authority to order home
                health services, the CARES Act also provides that such practitioners
                are now capable of independently performing the face-to-face encounter
                for the patient for whom they are the ordering practitioner, in
                accordance with state law. If state law does not allow such
                flexibility, the NPP is required to work in collaboration with a
                physician.
                 Finally, we note that the flexibility allowed in this IFC to NPs,
                CNSs and PAs to order home health services must be done in accordance
                with state law. Individual states have varying requirements for
                conditions of practice, which determine whether a practitioner may work
                independently, without a written collaborative agreement or supervision
                from a physician, or whether general or direct supervision and
                collaboration is required. State Medicaid Agencies can consult the
                specific practitioner association or relevant state agency website to
                ensure that practitioners are working within their scope of practice
                and prescriptive authority.
                Q. Basic Health Program Blueprint Revisions
                1. Background
                 Section 1331 of the Patient Protection and Affordable Care Act \41\
                provides states with a coverage option, the Basic Health Program (BHP),
                for specified individuals who do not qualify for Medicaid but whose
                income does not exceed 200 percent of the federal poverty level (FPL).
                More information about the BHP is available in the ``Basic Health
                Program'' final rule \42\ which was published in the March 12, 2014
                Federal Register (79 FR 14112). The BHP regulations are codified at
                part 600. As of April 2020, Minnesota and New York are the only states
                operating a BHP.
                ---------------------------------------------------------------------------
                 \41\ The Patient Protection and Affordable Care Act (Pub. L.
                111-148) was enacted on March 23, 2010. The Health Care and
                Education Reconciliation Act of 2010 (Pub. L. 111-152), which
                amended and revised several provisions of the Patient Protection and
                Affordable Care Act, was enacted on March 30, 2010. In this IFC, we
                refer to the two statutes collectively as the ``Patient Protection
                and Affordable Care Act''.
                 \42\ Basic Health Program: State Administration of Basic Health
                Programs; Eligibility and Enrollment in Standard Health Plans;
                Essential Health Benefits in Standard Health Plans; Performance
                Standards for Basic Health Programs; Premium and Cost Sharing for
                Basic Health Programs; Federal Funding Process; Trust Fund and
                Financial Integrity; Final Rule (79 FR 14111 through 14151, March
                12, 2014).
                ---------------------------------------------------------------------------
                2. Changes to Requirements for Revisions of a Certified Blueprint
                 As we explain in Sec. 600.110, the BHP Blueprint is a
                comprehensive written document submitted by the State to the Secretary
                for certification of a BHP. Section 600.110(a) specifies what content
                needs to be included in the BHP Blueprint that must be certified by
                HHS. Section 600.125(a) currently requires that a state that seeks to
                make significant changes to its BHP must submit a revised BHP Blueprint
                to the Secretary for review and certification.\43\ We previously
                explained in the September 25, 2013 BHP proposed rule \44\ (78 FR
                59125) that, while not an exhaustive list, the types of changes that
                would be considered ``significant'' for purposes of this provision
                include changes that have a direct impact on the enrollee experience in
                BHP or the program financing. Section 600.125(b) currently requires
                that a state is responsible for continuing to operate under the terms
                of the existing Blueprint until and unless a revised Blueprint is
                certified. Taken together, these regulations require that states
                wishing to make significant changes to a certified Blueprint must do so
                on a prospective basis and such changes cannot be implemented until a
                revised Blueprint is certified by HHS.
                ---------------------------------------------------------------------------
                 \43\ This provision states that ``in the event that a State
                seeks to make significant change(s) that alter program operations
                the BHP benefit package, enrollment, disenrollment and verification
                policies described in the certified BHP Blueprint, the State must
                submit a revised Blueprint to the Secretary for review and
                certification.''
                 \44\ Basic Health Program: State Administration of Basic Health
                Programs; Eligibility and Enrollment in Standard Health Plans;
                Essential Health Benefits in Standard Health Plans; Performance
                Standards for Basic Health Programs; Premium and Cost Sharing for
                Basic Health Programs; Federal Funding Process; Trust Fund and
                Financial Integrity; Proposed Rule, 78 FR 59121 at 59125 (September
                25, 2013).
                ---------------------------------------------------------------------------
                 We believe that during the PHE for the COVID-19 pandemic, it is not
                feasible for a state to receive certification by HHS prior to
                implementing certain necessary significant changes to their BHP.
                Specifically, during the PHE for the COVID-19 pandemic, states may need
                to immediately revise certain provisions of or add certain provisions
                to their BHP Blueprints that would be considered significant changes to
                ensure BHP enrollees can access necessary services without delay or
                access these services without cost sharing. For example, based on our
                experience with the PHE for the COVID-19 pandemic, we recognize that
                states operating a BHP may need to temporarily waive limitations on
                certain benefits covered under its BHP or temporarily waive enrollee
                premiums and cost sharing.
                 Therefore, at Sec. 600.125, we are revising paragraph (b) and
                adding a new paragraph (c) to allow a state to submit to the Secretary
                for review and certification a revised Blueprint that makes temporary
                significant changes to respond to the PHE for the COVID-19 pandemic
                with the option for the states to make such changes effective
                retroactive to the start of the PHE for the COVID-19 pandemic as
                defined in Sec. 400.200. While we would generally expect that
                revisions submitted under Sec. 600.125(c) would no longer be in effect
                as of the end of the PHE for the COVID-19 pandemic as defined in Sec.
                400.200, there may be instances in which policies will need to
                temporarily be in effect for a longer period of time. For example,
                following the end of the PHE for the COVID-19 pandemic, a state may
                need additional time to process all of the renewals or changes in
                circumstance that were not completed during the PHE. A state may need
                an additional, temporary period of time (for example, 90 days), before
                resuming its usual processing standards. We will work with states to
                determine a reasonable amount of time after the PHE for returning to
                normal course of business.
                 Specifically, the flexibility in the new Sec. 600.125(c) only
                applies to Blueprint revisions that make temporary significant changes
                that are directly tied to the PHE for the COVID-19 pandemic and would
                increase enrollee access to coverage.\45\ States may not submit under
                Sec. 600.125(c), and we will not certify, retroactive Blueprint
                revisions under this provision that are not directly tied to the PHE
                for the COVID-19 pandemic. In addition, states may not submit under
                Sec. 600.125(c), and we will not certify, retroactive Blueprint
                revisions under this provision that are restrictive in nature, such as
                Blueprint revisions that increase enrollee cost sharing, reduce BHP
                benefits, or limit or reduce eligibility for BHP coverage. Revised
                Blueprints submitted under Sec. 600.125(c) can only implement
                temporary revisions to increase access to coverage that would remain in
                effect only through the
                [[Page 27594]]
                duration of the PHE for the COVID-19 pandemic, or a reasonable
                additional amount of time as discussed above. To submit and receive
                certification for a revised Blueprint under Sec. 600.125(c), a state
                will need to submit a cover letter to CMS that lists each change for
                which it is seeking certification alongside an explanation for how each
                change is directly related to the PHE for the COVID-19 pandemic and how
                each change is not restrictive in nature. The state should also specify
                the requested duration of each of the changes. If the state is seeking
                certification to implement temporary changes beyond the end of the
                COVID-19 pandemic, the state should specify why the later end date is
                needed. The state should also submit a revised Blueprint that
                incorporates the temporary changes. In addition, as noted above, the
                process outlined in the new section Sec. 600.125(c) does not apply to
                Blueprint revisions that do not make significant changes.
                ---------------------------------------------------------------------------
                 \45\ These flexibilities are similar to those that are currently
                available in the Medicaid State Plan Amendment (SPA) template and
                instructions that CMS created in March 2020 to assist states in
                responding to the PHE for the COVID-19 pandemic and CHIP SPAs that
                allow for temporary adjustments to enrollment and redetermination
                policies during disaster events. More information about these
                Medicaid and CHIP flexibilities is available at https://www.medicaid.gov/resources-for-states/disaster-response-toolkit/state-plan-flexibilities/index.html.
                ---------------------------------------------------------------------------
                 Revised Blueprints submitted under Sec. 600.125(c) will not be
                subject to the public comment requirements under Sec. 600.115(c), as
                we have determined that the existence of unforeseen circumstances
                resulting from the PHE for the COVID-19 pandemic warrants an exception
                to the normal public notice procedures to expedite the certification of
                a revised Blueprint that implements temporary changes to expand access
                to coverage. We have determined that it would not be practical to
                solicit public comment during the PHE for the COVID-19 pandemic, and we
                recognize that there is a need to ensure consumers have access to the
                care they need as expeditiously as possible. Nonetheless, we encourage
                states to seek public input, when appropriate, consistent with
                applicable state requirements.
                 If a state seeks to make a permanent, significant change to its
                BHP, such as permanently altering verification, enrollment, or
                disenrollment policies, the state must follow the usual process for
                submission of a revised Blueprint with a prospective effective date in
                accordance with Sec. 600.125(a). In addition, when seeking to make
                permanent, significant changes to its BHP, the state must continue to
                operate under the terms of the existing certified Blueprint until HHS
                certifies the revision.
                R. Merit-Based Incentive Payment System (MIPS) Qualified Clinical Data
                Registry (QCDR) Measure Approval Criteria
                 We have heard from third party intermediaries, specifically QCDRs,
                that due to the COVID-19 pandemic they anticipate being unable to
                complete QCDR measure testing or collect data on QCDR measures for the
                2021 MIPS performance period as specified at Sec. 414.1400(b)(3)(v)(C)
                and (D). Both QCDR measure approval criteria necessitate QCDRs
                collecting data from clinicians in order to assess the measure. Over 50
                percent of the QCDRs approved for the 2020 performance period are
                supported by specialty societies that represent and support clinicians
                on the front lines of the COVID-19 pandemic, or are hospitals that are
                directly impacted by the pandemic. We also anticipate that there will
                be a lack of available data for some QCDR measures because clinicians
                who work in specialties that are not primarily caring for COVID-19
                patients may have their cases or elective procedures canceled or
                delayed so that resources can be redistributed. As a result, we
                anticipate that QCDRs may be unable to collect, and clinicians unable
                to submit, data on QCDR measures due to prioritizing the care of COVID-
                19 patients.
                 We believe that clinicians who are on the frontlines taking care of
                COVID-19 cases should not be burdened with having to submit data to a
                QCDR for purposes of QCDR measure assessment (testing and data
                collection). In consideration of clinicians' limited resources and in
                an effort to reduce burden on clinicians and health care organizations
                that are responding to the COVID-19 pandemic, we are amending the QCDR
                measure approval criteria previously finalized in the CY 2020 PFS final
                rule (84 FR 63065 through 63068), specifically: (1) Completion of QCDR
                measure testing at Sec. 414.1400(b)(3)(v)(C) as discussed in section
                II.R.1. of this IFC; and (2) collection of data on QCDR measures at
                Sec. 414.1400(b)(3)(v)(D) as discussed in section II.R.2. of this IFC.
                1. Completion of QCDR Measure Testing
                 In the CY 2020 PFS final rule (84 FR 63065 through 63067), we
                finalized at Sec. 414.1400(b)(3)(v)(C) that beginning with the 2021
                performance period, all QCDR measures must be fully developed and
                tested, with complete testing results at the clinician level, prior to
                submitting the QCDR measure at the time of self-nomination. For the
                reasons discussed in section II.R. of this IFC, we are delaying the
                implementation of this policy by 1 year. Specifically, we are amending
                Sec. 414.1400(b)(3)(v)(C) to state that beginning with the 2022
                performance period, all QCDR measures must be fully developed and
                tested, with complete testing results at the clinician level, prior to
                submitting the QCDR measure at the time of self-nomination.
                 During this 1 year delay, we will continue to review QDCR measures
                as in past years to ensure they are valid, reliable, and align with the
                goals of the Meaningful Measure initiative.\46\ This process includes
                review by quality measure experts; QCDR policy subject matter experts;
                clinicians, including physicians, nurses, and PTs/OTs, who work on our
                support contractor team; and CMS Medical Officers. We will continue to
                review QCDR measures for potential risk of patient harm (for example,
                QCDR measures that promote clinical practices related to overuse). We
                also will continue to review QCDR measures for feasibility and accuracy
                and reliability of results. For more information, we refer readers to
                the 2020 QCDR Measure Development Handbook.\47\
                ---------------------------------------------------------------------------
                 \46\ See https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.
                 \47\ Available at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/580/2020%20Self-Nomination%20Toolkit%20for%20QCDRs%20%26%20Qualified%20Registries.zip
                .
                ---------------------------------------------------------------------------
                2. Collection of Data on QCDR Measures
                 In the CY 2020 PFS final rule (84 FR 63067 through 63068), we
                finalized at Sec. 414.1400(b)(3)(v)(D) that beginning with the 2021
                performance period, QCDRs are required to collect data on a QCDR
                measure, appropriate to the measure type, prior to submitting the QCDR
                measure for CMS consideration during the self-nomination period. For
                the reasons discussed in section II.R. of this IFC, we are delaying the
                implementation of this policy by 1 year. Specifically, we are amending
                Sec. 414.1400(b)(3)(v)(D) to state that beginning with the 2022
                performance period, QCDRs are required to collect data on a QCDR
                measure, appropriate to the measure type, prior to submitting the QCDR
                measure for CMS consideration during the self-nomination period.
                 During this 1-year delay, we will continue to review QDCR measures
                as in past years to ensure they are valid and identify performance gaps
                in the area of measurement. As described in the 2020 QCDR Measure
                Development Handbook,\48\ this process includes vetting the measures to
                ensure they are implementable and collectible, which includes an
                evaluation of the measure and coding constructs (for example, whether
                the measure is constructed as a ratio, proportional, or inverse
                measure). Additionally, we will review the
                [[Page 27595]]
                evidence provided by the QCDR (for example, clinical studies and/or
                scientific journals) that would support the need for measurement in
                lieu of insufficient data collection to demonstrate that there is a
                measurement gap.
                ---------------------------------------------------------------------------
                 \48\ Available at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/580/2020%20Self-Nomination%20Toolkit%20for%20QCDRs%20%26%20Qualified%20Registries.zip
                .
                ---------------------------------------------------------------------------
                S. Application of Certain National Coverage Determination and Local
                Coverage Determination Requirements During the PHE for the COVID-19
                Pandemic
                 National Coverage Determinations (NCDs) are determinations by the
                Secretary with respect to whether or not a particular item or service
                is covered nationally under Title XVIII. Local Coverage Determinations
                (LCDs) are determinations by a Medicare Administrative Contractor (MAC)
                with respect to whether or not a particular item or service is covered
                under section 1862(a)(1)(A) of the Act in the particular MAC's
                geographical areas. Articles are often published alongside LCDs and
                contain coding or other guidelines that complement an LCD. NCDs and
                LCDs contain clinical conditions a patient must meet to qualify for
                coverage of the item or service.
                 In section II.U. of the March 31st COVID-19 IFC, we finalized on an
                interim basis that to the extent an NCD or LCD (including articles)
                would otherwise require a face-to-face or in-person encounter or other
                implied face-to-face services, those requirements would not apply
                during the PHE for the COVID-19 pandemic. Additionally, we finalized on
                an interim basis that we will not enforce the clinical indications for
                coverage across respiratory, home anticoagulation management and
                infusion pump NCDs and LCDs (including articles) allowing for
                flexibility for practitioners to care for their patients. This section
                provides clarification and expands upon section II.U. of the March 31st
                COVID-19 IFC.
                1. Applicability of Reasonable and Necessary Requirement for Covered
                Items and Services
                 Some external stakeholders appear to be misinterpreting statements
                that CMS made in the March 31st COVID-19 IFC as waiving medical
                necessity requirements; there are now questions as to whether items and
                services can be furnished or ordered without reason during the PHE for
                the COVID-19 pandemic. We note there is nothing in guidance or the
                March 31st COVID-19 IFC, that could be interpreted to permanently or
                temporarily waive the reasonable and necessary statutory requirement,
                which is expressed in section 1862(a)(1)(A) of the Act and cannot be
                waived under the section 1135 PHE waiver authority. Except as expressly
                permitted by statute, we remind physicians, practitioners and suppliers
                that most items and services must be reasonable and necessary for the
                diagnosis or treatment of an illness or injury or to improve the
                functioning of a malformed body member to be paid under Part A or Part
                B of Title XVIII. Physicians, practitioners, and suppliers are required
                to continue documenting the medical necessity for all services.
                Accordingly, the medical record must be sufficient to support payment
                for the services billed (that is, the services were actually provided,
                were provided at the level billed, and were medically necessary).
                2. Enforcement Discretion of Clinical Indications for Additional LCDs
                 In the March 31st COVID-19 IFC, we finalized on an interim basis
                that we will not enforce the clinical indications for coverage across
                respiratory, home anticoagulation management and infusion pump NCDs and
                LCDs (including articles) allowing for more flexibility for
                practitioners to care for their patients. This enforcement discretion
                will only apply during the PHE for the COVID-19 pandemic.
                 In this IFC, we are finalizing on an interim basis that we will not
                enforce the clinical indications for therapeutic continuous glucose
                monitors in LCDs. For example, we will not enforce the current clinical
                indications restricting the type of diabetes that a beneficiary must
                have or relating to the demonstrated need for frequent blood glucose
                testing in order to permit COVID-19 infected patients with diabetes to
                receive a Medicare covered therapeutic continuous glucose monitor. This
                discretion is intended to permit COVID-19 patients to more closely
                monitor their glucose levels given that they are at risk for
                unpredictable impacts of the infection on their glucose levels and
                health. The use of therapeutic continuous glucose monitors may allow
                patients to proactively treat their diabetes and prevent the need for
                hospital-based diabetic care. Practitioners will also have greater
                flexibility to allow more of their diabetic patients to better monitor
                their glucose and adjust insulin doses from home by using a therapeutic
                continuous glucose monitor. This enforcement discretion will only apply
                during the PHE for the COVID-19 pandemic.
                T. Delay in the Compliance Date of Certain Reporting Requirements
                Adopted for IRFs, LTCHs, HHAs and SNFs
                1. Delay of the Compliance Date of the Transfer of Health (TOH)
                Information Quality Measures and Certain Standardized Patient
                Assessment Data Elements (SPADEs) Adopted for the IRF QRP, LTCH QRP,
                and HH QRP
                 In the FY 2020 IRF PPS final rule (84 FR 39100 through 39161), we
                adopted the TOH Information to Provider-Post-Acute Care and TOH
                Information to Patient-Post-Acute Care quality measures (collectively,
                the TOH Information Measures) beginning with the FY 2022 IRF QRP and
                finalized that IRFs would be required to collect data on both measures
                beginning with patients discharged on or after October 1, 2020. We also
                adopted standardized patient assessment data elements (SPADEs) for six
                categories that IRFs must report for patients beginning with the FY
                2022 IRF QRP, with data collection beginning with admissions and
                discharges (except for the hearing, vision, race and ethnicity SPADEs,
                which would be collected for admissions only) on October 1, 2020 (84 FR
                39114 through 84 FR 39149). In the FY 2020 Inpatient Prospective
                Payment System (IPPS)/Long-Term Care Hospital (LTCH) PPS final rule (84
                FR 42526 through 84 FR 84534), we adopted the same two measures and
                SPADEs for reporting by LTCHs beginning with FY 2022 LTCH QRP with data
                collection beginning with patients discharged on October 1, 2020 and
                data collection on the SPADEs beginning with admissions and discharges
                (except for the hearing, vision, race, and ethnicity SPADEs, which
                would be collected for admissions only) on October 1, 2020.
                 In the CY 2020 HH PPS final rule (84 FR 60557 through 60610), we
                also adopted these measures for reporting by HHAs in the CY 2022 HH QRP
                beginning with patients discharged or transferred January 1, 2021 and
                data collection on the SPADEs beginning with the start of care,
                resumption of care, and discharges (except for the hearing, vision,
                race, and ethnicity SPADEs, which would be collected at the start of
                care only) on January 1, 2021.
                 The current assessment instruments that IRFs, LTCHs, and HHAs use
                to submit data to meet the requirements of their respective QRPs do not
                include the data elements that these providers need to report the TOH
                Information Measures or the SPADEs that we previously finalized for
                data collection beginning either October 1, 2020 for IRFs and
                [[Page 27596]]
                LTCHs or January 1, 2021 for HHAs. We have developed updated assessment
                instruments that include these new data elements, and under our current
                implementation timeline, we would be in the process of training
                providers on how to operationalize them. Each of these providers would
                also be in the process of training their staffs on how to use the
                updated versions, as well as working with their vendors to make
                programming changes necessary to implement them timely. However, we
                want to provide maximum flexibilities for these providers to respond to
                the public health threats posed by the COVID-19 PHE, and to reduce the
                burden in administrative efforts associated with attending training,
                training their staffs and working with their vendors to incorporate the
                updated assessment instruments into their operations. Accordingly, we
                are delaying the release of updated versions of the IRF Patient
                Assessment Instrument (IRF-PAI), LTCH Continuity Assessment Record and
                Evaluation Data Set (LTCH CARE Data Set), and HHA's Outcome and
                Assessment Information Set (OASIS) Instrument to reduce the burden that
                these providers would otherwise incur as a result of being required to
                incorporate the updated versions into their operations before October
                1, 2020 (for IRFs and LTCHs) or January 1, 2021 (for HHAs). This delay
                will enable these providers to continue using the current versions of
                their assessment instruments, with which they are already familiar. The
                current version of the IRF-PAI has been in use since October 1, 2019
                (IRF-PAI v. 3.0). The current version of the LTCH CARE Data Set has
                also been in use since October 1, 2019 (LTCH CARE Data Set v. 4.00).
                The current version of the OASIS Instrument has been in use since
                January 1, 2019 (OASIS-D).
                 This delay of the updated assessment instruments will impact the
                ability of IRFs, LTCHs and HHAs to collect and report data on the two
                TOH Information Measures and SPADEs under their respective QRPs.
                Accordingly, in this IFC, we are delaying the compliance dates for the
                collection and reporting of these TOH Information Measures and SPADEs.
                Specifically, we will require IRFs to use IRF-PAI V4.0 and LTCHs to use
                LTCH CARE Data Set V5.0 to begin collecting data on the two TOH
                Information Measures beginning with discharges on October 1st of the
                year that is at least 1 full fiscal year after the end of the COVID-19
                PHE. For example, if the COVID-19 PHE ends on September 20, 2020, IRFs
                and LTCHs will be required to begin collecting data on these measures
                beginning with patients discharged on October 1, 2021. We will also
                require IRFs and LTCHs to begin collecting data on the SPADEs for
                admissions and discharges (except for the hearing, vision, race, and
                ethnicity SPADEs, which would be collected for admissions only) on
                October 1st of the year that is at least 1 full fiscal year after the
                end of the COVID-19 PHE. HHAs will be required to use OASIS-E to begin
                collecting data on the two TOH Information Measures beginning with
                discharges and transfers on January 1st of the year that is at least 1
                full calendar year after the end of the COVID-19 PHE. For example, if
                the COVID-19 PHE ends on September 20, 2020, HHAs will be required to
                begin collecting data on those measures beginning with patients
                discharged or transferred on January 1, 2022. We will also require HHAs
                to begin collecting data on the SPADEs beginning with the start of
                care, resumption of care, and discharges (except for the hearing,
                vision, race, and ethnicity SPADEs, which would be collected at the
                start of care only) on January 1st of the year that is at least 1 full
                calendar year after the end of the COVID-19 PHE.
                 We believe that these delays will give IRFs, LTCHs, and HHAs enough
                time to operationalize the updated versions of their respective
                assessment instruments, including taking any necessary training and
                ensuring that their vendors can make appropriate programming updates.
                We plan to release the drafts of the new instruments again for these
                programs shortly after the COVID-19 PHE ends to provide ample time for
                training and any vendor programming.
                2. Delay in the Compliance Date of the Transfer of Health Information
                Measures and Certain SPADEs Adopted for the SNF QRP
                 In the FY 2020 SNF PPS final rule (84 FR 38755 through 84 FR
                38764), we adopted the TOH quality measures beginning with the FY 2022
                SNF QRP and finalized that SNFs would be required to collect data on
                both measures beginning with patients discharged on October 1, 2020. We
                also adopted SPADEs for six categories that SNFs must report for
                patients beginning with the FY 2022 SNF QRP, with data collection for
                patients discharged October 1, 2020 for admissions and discharges
                (except for the hearing, vision, race, and ethnicity SPADEs, which
                would be collected for admissions only).
                 The current version of the Minimum Data Set (MDS), MDS 3.0 v1.17.1,
                that SNFs use to submit data in order to meet the requirements of the
                SNF QRP does not include the data elements that are needed to report
                the TOH Information Measures and the SPADEs that we previously
                finalized for data collection beginning October 1, 2020. We previously
                released a draft version of the updated MDS 3.0 v1.18.1 that includes
                these new data elements, and under our current implementation timeline,
                we would be in the process of training providers on how to
                operationalize them. Each of these providers would also be in the
                process of training their staffs on how to use the updated versions, as
                well as working with their vendors to make programming changes
                necessary to timely implement them. However, as we previously noted in
                a March 19, 2020 notice posted on our website \49\ stakeholders have
                expressed concerns that the length of our planned implementation period
                is too short for SNFs to properly educate their staffs on how to
                operationalize the updated MDS given that the updated version did not
                adequately address the needs of states that use the instrument for
                payment and to report data. For these reasons, we stated that we were
                delaying the release of the updated version of the MDS. This delay will
                enable SNFs to continue using the current version of the MDS, with
                which they are already familiar.
                ---------------------------------------------------------------------------
                 \49\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Skilled-Nursing-Facility-Quality-Reporting-Program/SNF-Quality-Reporting-Program-Spotlights-and-Announcements.
                ---------------------------------------------------------------------------
                 Our delay of the release of the updated version of the MDS 3.0
                v1.18.1 will impact the ability of SNFs to collect and report data on
                the two TOH Information Measures and SPADEs. Accordingly, in this IFC,
                we are delaying the compliance dates for the collection and reporting
                of these measures and SPADEs. Although we did not originally delay the
                release of the updated version of the MDS because of the COVID-19 PHE,
                we believe that this PHE is appropriate to take into consideration when
                determining when it will be feasible to release the updated version,
                and when it will likewise be feasible to require SNFs to begin to
                report the new quality measure and SPADEs data.
                 Therefore, we will require SNFs to begin collecting data on the two
                TOH Information Measures beginning with discharges on October 1st of
                the year that is at least 2 full fiscal years after the end of the
                COVID-19 PHE. For example, if the COVID-19 PHE ends on September, 20,
                2020, SNFs will be required to begin collecting data on these measures
                beginning with patients discharged on October 1, 2022. We will
                [[Page 27597]]
                also require SNFs to begin collecting data on the SPADEs beginning with
                admissions and discharges (except for the hearing, vision, race, and
                ethnicity SPADEs, which would be collected for admissions only) on
                October 1st of the year that is at least 2 full fiscal years after the
                end of the COVID-19 PHE. Although this delay is longer than the delay
                we are adopting for IRFs, LTCHs and HHAs, we believe that the
                additional delay for SNFs is appropriate because it will give us enough
                time to work with stakeholders to ensure that their concerns are
                addressed while also allowing SNFs a reasonable amount of time to
                complete required training, train their staffs, and work with their
                vendors to make necessary programming updates. Shortly after the COVID-
                19 PHE ends, we plan to work with stakeholders to develop a mutually
                agreeable timeline for releasing the updated MDS 3.0 v1.18.1 that
                provides sufficient time for SNFs to incorporate the updated version
                into their operations.
                U. Update to the Hospital Value-Based Purchasing (VBP) Program
                Extraordinary Circumstance Exception (ECE) Policy
                 In the FY 2014 IPPS/LTCH final rule (78 FR 50704 through 50707), we
                finalized a disaster/extraordinary circumstance exception (ECE) policy
                for the Hospital VBP Program. The intent of the Hospital VBP ECE policy
                is to mitigate any adverse impact on quality performance as a direct
                result of unforeseen extraordinary circumstances outside of the
                hospital's control and the resulting impact on their value-based
                incentive payment amounts.
                 Under the current policy and upon a hospital's request, we will
                consider providing an exception from the Hospital VBP Program
                requirements to hospitals affected by natural disasters or other
                extraordinary circumstances (78 FR 50704 through 50706). Specifically,
                in the FY 2014 IPPS/LTCH final rule, we stated that we interpreted the
                minimum number of cases and measures requirement in sections
                1886(o)(1)(C)(ii)(III) and (IV) of the Act to not include any measures
                or cases for which a hospital has submitted data during a performance
                period for which the hospital has been granted a Hospital VBP Program
                ECE. We also stated that, if after the applicable quality measure data
                from a performance period has been excepted due to the granting of an
                ECE, the hospital still reports the minimum number of cases and
                measures required for the program year, the hospital will still receive
                a Total Performance Score (TPS) that has been calculated without use of
                the excepted quality data.
                 Based on our previously finalized policy, a hospital must submit
                the Hospital VBP Program ECE request form (OMB control #0938-1022),
                including any available evidence of the impact of the extraordinary
                circumstances on the hospital's quality measure performance, within 90
                calendar days of the date on which the natural disaster or other
                extraordinary circumstance occurred (78 FR 50706).
                 We continue to recognize that unforeseen extraordinary
                circumstances, such as the current PHE for COVID-19, could
                substantially affect the ability of hospitals to perform under the
                Hospital VBP Program at the same level at which they might otherwise
                have performed if the natural disaster or extraordinary circumstance
                had not occurred. We also continue to acknowledge that using quality
                measure data from these periods to generate the Hospital VBP Program
                TPS might substantially impact the value-based incentive payment amount
                that the hospital would otherwise receive. Further, we believe that
                during an extraordinary circumstance that affects an entire geographic
                region or locale, which could include the entire United States (such as
                the COVID-19 PHE), the requirement for hospitals to submit individual
                ECE request forms along with supporting evidence to CMS within 90 days
                of the date the extraordinary circumstance occurred could be overly
                burdensome for hospitals by requiring additional administrative actions
                from hospital personnel, who may need to focus on care delivery and
                related priorities during and subsequent to the extraordinary
                circumstance.
                 Therefore, we believe it is necessary to update the Hospital VBP
                Program's ECE policy to include the ability for us to grant exceptions
                to hospitals located in entire regions or locales, which could include
                the entire United States, without a request where we determine that the
                extraordinary circumstance has affected the entire region or locale.
                Accordingly, in this IFC, we are modifying the Hospital VBP Program's
                ECE policy to allow us to grant ECE exceptions to hospitals which have
                not requested them when we determine that an extraordinary circumstance
                that is out of their control, such as an act of nature (for example, a
                hurricane) or PHE (for example, the COVID-19 pandemic), affects an
                entire region or locale, in addition to retaining the individual ECE
                request policy. We are codifying this updated ECE policy at Sec.
                412.165(c) of our regulations. When we make the determination to grant
                an exception to all hospitals in a region or locale, we will
                communicate this decision through routine communication channels to
                hospitals, vendors, and Quality Improvement Organizations (QIOs),
                including but not limited to issuing memos, emails, and notices on the
                public QualityNet website (see https://www.qualitynet.org). This policy
                will more closely align the Hospital VBP Program ECE policy with the
                ECE policy adopted for other quality reporting and VBP programs,
                including the Hospital Inpatient Quality Reporting, Hospital Outpatient
                Quality Reporting, Inpatient Psychiatric Facility Quality Reporting,
                Ambulatory Surgical Center Quality Reporting, PPS-Exempt Cancer
                Hospital Quality Reporting, Hospital-Acquired Condition Reduction, and
                Hospital Readmissions Reduction Programs. If we grant an ECE to
                hospitals located in an entire region or locale under this revised
                policy and, as a result of granting that ECE, one or more hospitals
                located in that region or locale does not report the minimum number of
                cases and measures required to enable us to calculate a TPS for that
                hospital for the applicable program year, the hospital will be excluded
                from the Hospital VBP Program for the applicable program year. We refer
                readers to the FY 2020 IPPS/LTCH PPS final rule (84 FR 42399 through
                42400) for the minimum number of measures and cases that we currently
                require hospitals to report to receive a TPS for a program year under
                the Hospital VBP Program.
                 A hospital that does not report the minimum number of cases or
                measures for a program year will not receive a 2 percent reduction to
                its base operating DRG payment amount for each discharge in the
                applicable program year, and will also not be eligible to receive any
                value-based incentive payments for the applicable program year.
                 In accordance with this updated policy and consistent with the ECE
                guidance we issued on March 22, 2020 and March 27, 2020,\50\ we are
                granting an ECE with respect to the COVID-19 PHE to all hospitals
                participating in the Hospital VBP Program for the following reporting
                requirements:
                ---------------------------------------------------------------------------
                 \50\ https://www.cms.gov/newsroom/press-releases/cms-announces-relief-clinicians-providers-hospitals-and-facilities-participating-quality-reporting, and https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf%20.
                ---------------------------------------------------------------------------
                 Hospitals will not be required to report National
                Healthcare Safety Network (NHSN) HAI measures and HCAHPS survey data
                for the following quarters: October 1, 2019-December 31,
                [[Page 27598]]
                2019 (Q4 2019), January 1, 2020-March 31, 2020 (Q1 2020), and April 1,
                2020-June 30, 2020 (Q2 2020). However, hospitals can optionally submit
                part or all of these data by the posted submission deadlines on the
                HVBP QualityNet site (available at https://www.qualitynet.org/inpatient/iqr/participation). We refer readers to the March 27 guidance
                memo for more information on the HAI and HCAHPS measures in that are
                included in the Hospital-Acquired Condition Reduction Program.
                 We will exclude qualifying claims data from the mortality,
                complications, and Medicare Spending per Beneficiary measures for the
                following quarters: January 1, 2020-March 31, 2020 (Q1 2020) and April
                1, 2020--June 30, 2020 (Q2 2020).
                 We are granting these exceptions to assist hospitals while they
                direct their resources during the PHE related to COVID-19 toward caring
                for their patients and ensuring the health and safety of patients and
                staff. We believe it is appropriate to except hospitals from the
                requirement to report HAI measure data, HCAHPS survey data, and claims-
                based data for Q1 and Q2 2020 discharges because the data collected
                during that period may be greatly impacted by the hospital's response
                to COVID-19. While hospitals will continue to submit claims for
                reimbursement, we will not use discharge data from these quarters for
                measure calculations because we are concerned that these claims data
                may not be fully reflective of their quality or cost of care. For the
                Q4 2019 HAI and HCAHPS data, the exception is being granted because the
                April and May 2020 data submission deadlines for those data fall during
                the COVID-19 PHE, and we believe it is important to reduce the data
                collection and reporting burden so that hospitals can direct their
                resources toward responding to the COVID-19 PHE. We continue to closely
                monitor and analyze the impact that the COVID-19 PHE has on the HVBP
                program, and if necessary, will communicate any other exceptions and/or
                extensions that we believe are appropriate for the Hospital VBP Program
                through routine communication channels to hospitals, vendors, and QIOs,
                including but not limited to issuing memos, emails, and notices on the
                public QualityNet website (see https://www.qualitynet.org).
                V. COVID-19 Serology Testing
                 A blood-based serology test can be used to detect whether a patient
                may have previously been infected with the virus that causes COVID-19
                by identifying whether the patient has antibodies specific to the SARS-
                CoV-2 virus. Patients who have these antibodies may have developed an
                immune response to SARS-CoV-2 indicating recent or prior infection, and
                therefore, potentially may not be at immediate risk for re-infection.
                It is expected that patients have been infected with COVID-19 who
                either had characteristic symptoms and were not tested or had minor or
                non-specific symptoms and did not seek testing. An FDA-authorized
                serology test that detects antibodies to SARS-CoV-2, the virus that
                causes COVID-19, may potentially aid in identifying patients who have
                had an immune response to current or prior SARS-CoV-2 infection.
                 Based on this information, we are finalizing on an interim basis
                that these FDA-authorized COVID-19 serology tests fall under the
                Medicare benefit category of diagnostic laboratory test (section
                1861(s)(3) of the Act). Therefore, these tests are coverable by the
                Medicare program because they fall under at least one Medicare benefit
                category. This may not be an exhaustive list of benefit categories as
                CMS did not evaluate information about the test to identify additional
                benefit categories.
                 Having COVID-19 serology test results is useful to individual
                patients, their practitioners, and their communities because it could
                change the decisions Medicare beneficiaries make for themselves and
                influences practitioner management of the beneficiaries' medical
                treatment.
                 If it can be determined that they are immune, these patients would
                possibly not be at risk for contracting COVID-19 and not be risking the
                health of their communities if they travel outside of their home as
                they would not spread COVID-19. Among the biggest risks to the
                community are patients with COVID-19 infection who have not developed
                symptoms or had minor non-specific symptoms, yet are infectious.\51\
                ---------------------------------------------------------------------------
                 \51\ Wei WE, Li Z, Chiew CJ, Yong SE, Toh MP, Lee VJ.
                Presymptomatic Transmission of SARS-CoV-2--Singapore, January 23-
                March 16, 2020. MMWR Morb Mortal Wkly Rep 2020;69:411-415. DOI:
                http://dx.doi.org/10.15585/mmwr.mm6914e1.
                ---------------------------------------------------------------------------
                 Beneficiaries who are negative for COVID-19 antibodies through
                serology testing may need to take more preventive measures to reduce
                their personal risk of infection as some persons, based on age and
                other factors, are at higher risk of serious illness or death from the
                disease. Further, a practitioner should discuss the results of the
                serology test with the beneficiary to ensure that the beneficiary
                understands the results of the test and the results are considered in
                the overall management of the patient.
                 In circumstances outside of the COVID-19 PHE, we would ordinarily
                use the NCD process to establish a benefit category and establish that
                an item or service is reasonable and necessary under section
                1862(a)(1)(A) of the Act. The NCD process is established in section
                1862(l) of the Act and requires the Secretary to make a proposed
                decision available to the public for 30 days of public comment followed
                by issuing a final decision not later than 60 days after the close of
                the comment period. Given the need to establish timely and uniform
                national coverage that is relevant during the PHE for the COVID-19
                pandemic, we have determined that coverage for FDA-authorized COVID-19
                serology tests should be established in an interim final manner through
                this IFC. Since we are not aware of any professional society
                recommendations for confirmatory or repeat testing on the same sample,
                CMS would expect to be billed once per sample. Further, we would not
                expect such tests to be performed and billed unless clinically
                indicated.
                 We are finalizing on an interim basis, that during the PHE for the
                COVID-19 pandemic, Medicare will cover FDA-authorized COVID-19 serology
                tests as they are reasonable and necessary under section 1862(a)(1)(A)
                of the Act for beneficiaries with known current or known prior COVID-19
                infection or suspected current or suspected past COVID-19 infection. We
                are amending Sec. 410.32 to reflect this determination of coverage.
                W. Modification to Medicare Provider Enrollment Provision Concerning
                Certification of Home Health Services
                1. Background--Provider Enrollment
                 Section 1866(j)(1)(A) of the Act requires the Secretary to
                establish a process for the enrollment of providers and suppliers in
                the Medicare program. The overarching purpose of the enrollment process
                is to help ensure that providers and suppliers that seek to bill the
                Medicare program for services or items furnished to Medicare
                beneficiaries are qualified to do so under federal and state laws.
                 The applicable provider enrollment regulations are largely, though
                not exclusively, contained in part 424, subpart P (currently Sec. Sec.
                424.500 through 424.570). Several of our previous provider enrollment
                rulemaking efforts have focused on strengthening existing enrollment
                procedures and eliminating existing vulnerabilities; in other words,
                the objectives have been to enhance our
                [[Page 27599]]
                ability to: (1) Conduct strict screening activities; (2) take prompt
                action against problematic providers and suppliers; and (3) implement
                important safeguards against improper Medicare payments. Yet we believe
                that the current COVID-19 PHE requires us to undertake provider
                enrollment rulemaking for a different reason; specifically, the need to
                help providers and suppliers concentrate their resources on treating
                those beneficiaries affected by COVID-19. Therefore, as discussed in
                section III. of this IFC, ``Waiver of Proposed Rulemaking,'' we believe
                the urgency of this COVID-19 PHE constitutes good cause to waive the
                normal notice-and-comment process under the Administrative Procedure
                Act and statute. Accordingly, this IFC contains an important revision
                to part 424, subpart P that will give providers and suppliers certain
                flexibilities in their activities during the existing COVID-19 PHE.
                2. Certification of Home Health Services--Revision to Sec. 424.507
                 Currently, Sec. 424.507(b)(1) contains certain payment
                requirements for covered Part A or Part B home health services.
                Specifically, and consistent with section 6405(b) of the Patient
                Protection and Affordable Care Act (which amended sections 1814(a)(2)
                and 1835(a)(2) of the Act), to receive payment for such services, the
                provider's claim must meet all of the following requirements:
                 The ordering/certifying physician must be identified by
                his or her legal name and National Provider Identifier (NPI) on the
                claim.
                 The ordering/certifying physician must be enrolled in
                Medicare in an approved status or have validly opted-out of the
                Medicare program.
                 However, and as previously mentioned in this IFC, section 3708 of
                the CARES Act made several important amendments to sections 1814(a)(2)
                and 1835(a)(2) of the Act (as well as other related sections of the
                statute). One amendment was that NPs, CNSs, and PAs (as those terms are
                defined in section 1861(aa)(5) of the Act) working in accordance with
                state law may also certify the need for home health services. Section
                3708(f) of the CARES Act authorizes us to promulgate an interim final
                rule, if necessary, to implement the provisions in section 3708 by the
                statutory deadline. Further, given the need for flexibility in the
                provision of health care services in the COVID-19 PHE, we believe it is
                appropriate to implement these statutory changes in this IFC, rather
                than through notice-and-comment rulemaking. Consequently, we are
                revising Sec. 424.507(b)(1) to include ordering/certifying physicians,
                PAs, NPs, and CNSs as individuals who can certify the need for home
                health services. We note that, for reasons similar to those related to
                our other modifications to Medicare rules concerning the certification
                and provision of home health services, this change to Sec. 424.507 is
                final and applicable to services provided on or after March 1, 2020. We
                will review and respond to any comments thereon in the CY 2021 HH PPS
                final rule or in another future rule.
                X. Health Insurance Issuer Standards Under the Affordable Care Act,
                Including Standards Related to Exchanges: Separate Billing and
                Segregation of Funds for Abortion Services
                 In light of these extraordinary circumstances and the immediate
                need for qualified health plan (QHP) issuers to devote resources to
                respond to the COVID-19 PHE, we are revising 45 CFR 156.280(e)(2)(ii)
                to delay implementation of the separate billing policy for 60 days from
                the effective date we finalized in the ``Patient Protection and
                Affordable Care Act; Exchange Program Integrity'' final rule (84 FR
                71674) (``2019 Program Integrity Rule'').\52\ Under this 60-day
                extension, QHP issuers must comply with the separate billing policy
                finalized at Sec. 156.280(e)(2)(ii) beginning on or before the QHP
                issuer's first billing cycle following August 26, 2020.
                ---------------------------------------------------------------------------
                 \52\ A typographical error in the date in the regulation text
                promulgated in the 2019 Program Integrity Rule was corrected on
                January 17, 2020. 85 FR 2888.
                ---------------------------------------------------------------------------
                 To better align QHP issuer billing for coverage of non-Hyde
                abortion services with the separate payment requirement in section 1303
                of the Patient Protection and Affordable Care Act,\53\ we finalized a
                policy in the 2019 Program Integrity Rule requiring issuers of
                individual market QHPs offering coverage of non-Hyde abortion services
                to separately bill policy holders for the portion of their premium
                attributable to coverage of non-Hyde abortion services. We explained in
                the 2019 Program Integrity Rule that separately billing policy holders
                in this manner for coverage of non-Hyde abortion services is a
                necessary change to better align issuer billing with the statutory
                requirements specified in section 1303 of the Patient Protection and
                Affordable Care Act, which requires non-Hyde abortion services be
                treated differently from other covered services. Specifically,
                requiring separate billing for coverage of non-Hyde abortion services
                better aligns with Congress's intent for QHP issuers to collect two
                distinct premium payments for coverage of these services, one for the
                coverage of non-Hyde abortion services, and one for coverage of all
                other services covered under a QHP.
                ---------------------------------------------------------------------------
                 \53\ The Patient Protection and Affordable Care Act (Pub. L.
                111-148) was enacted on March 23, 2010. The Health Care and
                Education Reconciliation Act of 2010 (Pub. L. 111-152), which
                amended and revised several provisions of the Patient Protection and
                Affordable Care Act, was enacted on March 30, 2010. In this IFC, we
                refer to the two statutes collectively as the ``Patient Protection
                and Affordable Care Act''.
                ---------------------------------------------------------------------------
                 Under the separate billing policy finalized in the 2019 Program
                Integrity Rule at Sec. 156.280(e)(2)(ii), issuers of individual market
                QHPs are required to begin separately billing policy holders for the
                portion of the policy holder's premium attributable to non-Hyde
                abortion services, as specified by the regulation, on or before the QHP
                issuer's first billing cycle following June 27, 2020.
                 To address the risk of coverage terminations related to failure on
                the part of policy holders to pay the separately billed amount for
                coverage of non-Hyde abortion services, we determined that HHS would
                exercise enforcement discretion in two scenarios related to policy
                holder nonpayment of the separate bill for coverage of non-Hyde
                abortion services. Under the first scenario, we explained that HHS will
                not take enforcement action against a QHP issuer that adopts and
                implements a policy, applied uniformly to all its QHP enrollees, under
                which an issuer does not place an enrollee into a grace period and does
                not terminate QHP coverage based solely on the policy holder's failure
                to pay the separate payment for coverage of non-Hyde abortion services.
                We further explained that the QHP issuer would: (1) Be prohibited from
                using any federal funds for coverage of non-Hyde abortion services; (2)
                be required to collect the premium for the non-Hyde abortion coverage;
                and (3) not be able to relieve the policy holder of the duty to pay the
                amount of premium attributable to coverage for non-Hyde abortion
                services. We explained that this enforcement posture would take effect
                upon the effective date of the separate billing requirements on June
                27, 2020.
                 Under the second scenario, we explained that HHS will not take
                enforcement action against QHP issuers that, on or after the effective
                date of the final rule (February 25, 2020), modify the benefits of a
                plan either at the time of enrollment or during a plan year to
                effectively allow enrollees to opt out of
                [[Page 27600]]
                coverage of non-Hyde abortion services by not paying the separate bill
                for such services, resulting in an enrollee effectively having a
                modified plan that does not cover non-Hyde abortion services.
                 We also stated in the 2019 Program Integrity rule that, for those
                State Exchanges and QHP issuers that may face uncommon or unexpected
                impediments to timely compliance, HHS would consider extending
                enforcement discretion to an Exchange or QHP issuer that fails to
                timely comply with the separate billing policy as required under the
                final rule, if we find that the Exchange or QHP issuer attempted in
                good faith to timely meet the requirements. However, we noted that HHS
                would be unlikely to exercise such discretion for an Exchange or QHP
                issuer that fails to meet the separate billing requirements after more
                than 1 year following publication of the 2019 Program Integrity Rule.
                 We have received a number of requests from QHP issuers requesting
                that HHS exercise its enforcement discretion for delayed implementation
                in light of the heightened burden QHP issuers are experiencing related
                to addressing the COVID-19 PHE. QHP issuers explained in their requests
                to HHS that the dedication of numerous cross-functional resources in
                response to the COVID-19 PHE has led to an overall reduction in
                resources available for other initiatives, such as preparatory
                arrangements to timely implement the separate billing policy. QHP
                issuers further explained how the already existing challenges to timely
                compliance with the separate billing policy pose an even greater
                obstacle when considered in conjunction with the mounting demands on
                QHP issuers in responding to the COVID-19 PHE. We are also aware that
                for many QHP issuers, some, if not all, of their daily work is being
                accomplished while staff is working remotely, adding yet another
                barrier to timely compliance.
                 We believe that despite timely QHP initiation of planning for
                compliance with the separate billing policy, there are circumstances
                outside of the control of QHP issuers, due to the COVID-19 PHE, that
                make timely compliance with the separate billing policy impractical by
                the deadline, on or before the first billing cycle following June 27,
                2020. Moreover, we believe it is imprudent to require QHP issuers to
                devote resources to timely compliance with the separate billing policy
                when these resources can instead be directed towards addressing the
                immediate needs associated with the COVID-19 PHE. Therefore, in light
                of these extraordinary circumstances and the immediate need for QHP
                issuers to divert resources to responding to the COVID-19 PHE, we are
                revising Sec. 156.280(e)(2)(ii) to delay implementation of the
                separate billing policy for 60 days. Under this 60-day delay, QHP
                issuers must comply with the separate billing policy finalized at Sec.
                156.280(e)(2)(ii) beginning on or before the QHP issuer's first billing
                cycle following August 26, 2020.
                 We acknowledge that a particular QHP issuer's or Exchange's ability
                to comply with the separate billing policy by the extended deadline of
                August 26, 2020, may depend on the particular impact the COVID-19 PHE
                has on the resources, systems, and operations of that QHP issuer or
                Exchange. We also acknowledge that the timeline for how long the COVID-
                19 PHE continues to impact QHP issuers and Exchanges is uncertain, and
                therefore, QHP issuers and Exchanges may be confronted with additional
                unexpected impediments to timely compliance past the 60-day delay we
                are finalizing in this IFC. HHS will still consider exercising its
                enforcement discretion in connection with an Exchange or QHP issuer
                that fails to timely comply with the separate billing policy on or
                before the first billing cycle following August 26, 2020, if HHS finds
                that the Exchange or QHP issuer attempted in good faith to timely meet
                the requirements. We do not anticipate that HHS would exercise such
                discretion for an Exchange or QHP issuer that fails to meet the
                separate billing requirements after more than 1 year following
                publication of the 2019 Program Integrity Rule or more than 6 months
                after the end of the COVID-19 PHE, whichever comes later. However, we
                emphasize that QHP issuers and Exchanges should make good faith efforts
                to fully comply by the extended deadline of the first billing cycle
                following August 26, 2020. We believe the 60-day delay will
                sufficiently alleviate burden on resources in the short-term, as well
                as provide sufficient time for QHP issuers and Exchanges, such that
                responding to the COVID-19 PHE and timely compliance with the separate
                billing policy are both practical. As a consequence, we do not
                anticipate formally extending the compliance deadline again.
                 As QHP issuers and Exchanges work to respond to the COVID-19 PHE,
                and implement and establish policies to ensure access to COVID-19-
                related care for enrollees, HHS is working to assess and extend
                regulatory flexibility to QHP issuers, Exchanges, and other health
                industry stakeholders, where doing so may enable these stakeholders to
                divert existing resources to the COVID-19 PHE response. We believe
                extending the deadline 60 days for QHP issuers and Exchanges to comply
                with the separate billing policy is appropriate, so that they may
                adequately respond to the COVID-19 PHE and divert resources to address
                the COVID-19 PHE that may otherwise have been used for timely
                compliance with the separate billing policy.
                 Although the 2019 Program Integrity Rule provides an existing
                framework for HHS to exercise its enforcement discretion in connection
                with QHP issuers and Exchanges unable to timely comply with the
                separate billing policy based on the circumstances of the particular
                Exchange or QHP issuer, based on reports from a number of QHP issuers
                and Exchanges, we have concluded that handling requests for additional
                time to come into compliance on a case-by-case basis is not an
                efficient mechanism to address these requests and does not adequately
                acknowledge the shared burden that the COVID-19 PHE is placing on QHP
                issuers and Exchanges. We believe that the COVID-19 PHE is an
                unexpected impediment to timely compliance with the separate billing
                policy for all QHP issuers and Exchanges alike. As a consequence, we
                have determined that it is appropriate to extend the deadline for
                compliance 60 days through this IFC, and to codify this change in the
                Federal Register.\54\
                ---------------------------------------------------------------------------
                 \54\ In light of the ongoing litigation challenging the separate
                billing policy and the delayed briefing schedule for this
                litigation, delaying implementation of the separate billing policy
                by 60 days would also be justified, as the 60-day delay provides the
                court additional time to resolve the issues before compliance with
                the separate billing provision is required and offers regulated
                parties more certainty before dedicating limited resources to the
                necessary changes during this PHE. This extension is also consistent
                with the representations made by the federal government to the
                federal court in lawsuits challenging the separate billing policy in
                response to requests that HHS delay implementation of the separate
                billing policy in light of COVID-19.
                ---------------------------------------------------------------------------
                 As previously noted, we finalized in the 2019 Program Integrity
                Rule that HHS would exercise enforcement discretion in two scenarios
                related to policy holder nonpayment of the separate bill. We note that
                the extension for compliance we are finalizing here only impacts the
                first of those scenarios, by delaying when this enforcement posture
                becomes available by 60 days. As previously stated, HHS will not take
                enforcement action against a QHP issuer that adopts and implements a
                policy, applied uniformly to all its QHP enrollees, under which an
                issuer does not place an enrollee into a grace period and does not
                terminate QHP coverage based solely on the policy holder's
                [[Page 27601]]
                failure to pay the separate payment for coverage of non-Hyde abortion
                services. This enforcement posture will now take effect on the earliest
                date on which QHP issuers will need to begin complying with the
                separate billing requirements, August 26, 2020. We are not making any
                additional revisions to the separate billing provisions finalized in
                the 2019 Program Integrity Rule other than extending the date for
                compliance with the separate billing policy by 60 days.
                 When explaining our rationale for the implementation deadline of
                the first billing cycle following June 27, 2020 in the 2019 Program
                Integrity Rule, we expressed the importance of QHP issuers implementing
                the separate billing policy changes at the earliest date feasible to
                better align QHP issuer billing of non-Hyde abortion services with the
                separate payment requirement in section 1303 of the Patient Protection
                and Affordable Care Act. Although expeditious implementation of this
                policy continues to be important, we believe the impact of the COVID-19
                PHE on QHP issuer and Exchange operations has shifted the date by which
                it is operationally and administratively feasible to require QHP
                issuers to timely comply with the separate billing policy. We
                acknowledge that extending the date for compliance by 60 days also
                delays the added transparency the separate billing policy would provide
                for policy holders related to whether QHPs cover non-Hyde abortion
                services. However, we believe the delay in increasing transparency and
                better aligning QHP issuer billing with the separate payment
                requirement in section 1303 of the Patient Protection and Affordable
                Care Act is outweighed by the immediate need for QHP issuers and
                Exchanges to divert resources to respond to the current COVID-19 PHE.
                Y. Requirement for Facilities To Report Nursing Home Residents and
                Staff Infections, Potential Infections, and Deaths Related to COVID-19
                 Under sections 1866 and 1902 of the Act, providers of services
                seeking to participate in the Medicare or Medicaid program, or both,
                must enter into an agreement with the Secretary or the state Medicaid
                agency, as appropriate. Long-term care (LTC) facilities seeking to be
                Medicare and Medicaid providers of services must be certified as
                meeting federal participation requirements. LTC facilities include SNFs
                for Medicare and NFs for Medicaid. The federal participation
                requirements for SNFs, NFs, and dually certified facilities, are set
                forth in sections 1819 and 1919 of the Act and codified in the
                implementing regulations at 42 CFR part 483, subpart B.
                 Sections 1819(d)(3) and 1919(d)(3) of the Act explicitly require
                that LTC facilities develop and maintain an infection control program
                that is designed, constructed, equipped, and maintained in a manner to
                protect the health and safety of residents, personnel, and the general
                public. In addition, sections 1819(d)(4)(B) and 1919(d)(4)(B) of the
                Act explicitly authorize the Secretary to issue any regulations he
                deems necessary to protect the health and safety of residents.
                Infection prevention and control is a primary goal of initiatives
                taking place in LTC facilities during the COVID-19 PHE. Under the
                explicit instructions of Congress, existing regulations at Sec. 483.80
                require facilities to, among other things, establish and maintain an
                infection prevention and control program (IPCP) designed to provide a
                safe, sanitary, and comfortable environment and to help prevent the
                development and transmission of communicable diseases and infections.
                Furthermore, current Sec. 483.80(a)(2) requires facilities to have
                written standards, policies, and procedures for the program, which
                among other things, must include a system of surveillance designed to
                identify possible communicable diseases or infections before they can
                spread to other persons in the facility and when and to whom possible
                incidents of communicable disease or infections should be reported. In
                an effort to support surveillance of COVID-19 cases, we are revising
                the requirements to establish explicit reporting requirements for
                confirmed or suspected cases. Specifically, we are revising our
                requirements by adding a new provision at Sec. 483.80(g)(1), to
                require facilities to electronically report information about COVID-19
                in a standardized format specified by the Secretary. The report
                includes, but is not limited to, information on: Suspected and
                confirmed COVID-19 infections among residents and staff, including
                residents previously treated for COVID-19; total deaths and COVID-19
                deaths among residents and staff; personal protective equipment and
                hand hygiene supplies in the facility; ventilator capacity and supplies
                available in the facility; resident beds and census; access to COVID-19
                testing while the resident is in the facility; staffing shortages; and
                other information specified by the Secretary. This information will be
                used to monitor trends in infection rates, and inform public health
                policies.
                 In addition, at Sec. 483.80(g)(2), facilities are required to
                provide the information specified above at a frequency specified by the
                Secretary, but no less than weekly to the Center for Disease Control
                and Prevention's (CDC) National Healthcare Safety Network (NHSN) (OMB
                Control Number 0920-1290). Furthermore, we note that the information
                reported will be shared with CMS and we will retain and publicly report
                this information to support protecting the health and safety of
                residents, personnel, and the general public, in accordance with
                sections 1819(d)(3)(B) and 1919(d)(3) of the Act. The Freedom of
                Information Act (FOIA) (found in Title 5 of the United States Code,
                section 552) provides that, upon request from any person, a Federal
                agency must release any agency record unless that record falls within
                one of the nine statutory exemptions and three exclusions (see https://www.foia.gov/faq.html for detailed information). Further, FOIA requires
                that agencies make available for public inspection copies of records,
                that because of the nature of their subject matter, the agency
                determines the records have become or are likely to become the subject
                of subsequent requests for substantially the same information. We have
                received, and expect to continue to receive, COVID-19 related FOIA
                requests. These requirements will support our efforts to proactively
                inform interested parties and ensure that the most complete information
                on COVID-19 cases is available. The new reporting requirements at Sec.
                483.80(g)(1) and (2) do not relieve LTC facilities of the obligation to
                continue to comply with Sec. 483.80(a)(2)(ii), which requires
                facilities to report possible incidents of communicable disease and
                infections. This includes complying with state and local reporting
                requirements for COVID-19.
                 At Sec. 483.80(g)(3), we are adding a new provision to require
                facilities to inform residents, their representatives, and families of
                those residing in facilities of confirmed or suspected COVID-19 cases
                in the facility among residents and staff. This reporting requirement
                supports the overall health and safety of residents by ensuring they
                are informed participants in the care that they receive as well as
                providing assurances of the mitigating steps the facility is taking to
                prevent and control the spread of COVID-19. Facilities must inform
                residents, their representatives, and families by 5 p.m. the next
                calendar day following the occurrence of either: A single confirmed
                infection of COVID-19; or three or more residents or staff with new-
                onset of respiratory symptoms that occur within 72 hours of each other.
                Also, cumulative
                [[Page 27602]]
                updates to residents, their representatives, and families must be
                provided at least weekly by 5 p.m. the next calendar day following the
                subsequent occurrence of either: Each time a confirmed infection of
                COVID-19 is identified; or whenever three or more residents or staff
                with new onset of respiratory symptoms occur within 72 hours of each
                other. This information must be reported in accordance with existing
                privacy regulations and statute, and must not include Personally
                Identifiable Information (PII). Facilities must include information on
                mitigating actions implemented to prevent or reduce the risk of
                transmission, including if normal operations in the nursing home will
                be altered such as restrictions or limitations to visitation or group
                activities. For purposes of this reporting requirement, facilities are
                not expected to make individual telephone calls. Instead, facilities
                can utilize communication mechanisms that make this information easily
                available to all residents, their representatives, and families, such
                as paper notification, listservs, website postings, and/or recorded
                telephone messages.
                 These reporting requirements along with public reporting of the
                data support our responsibility to protect and ensure the health and
                safety of residents by enforcing the standards required to help each
                resident attain or maintain their highest level of well-being. As
                noted, sections 1819(d)(3)(B) and 1919(d)(3) of the Act requires that a
                facility must establish an infection control program that is designed,
                constructed, equipped, and maintained in a manner to protect the health
                and safety of residents, personnel, and the general public. We believe
                that these reporting requirements are necessary for CMS to monitor
                whether individual nursing homes are appropriately tracking,
                responding, and mitigating the spread and impact of COVID-19 on our
                most vulnerable citizens, personnel who care for them, and the general
                public. The information provided may be used to inform residents,
                families, and communities of the status of COVID-19 infections in their
                area. We believe that this action strengthens CMS' response to the PHE
                for the COVID-19 pandemic, and reaffirms our commitment to transparency
                and protecting the health and safety of nursing home residents.
                 As discussed in section III. of this IFC, ``Waiver of Proposed
                Rulemaking'', we believe the urgency of this COVID-19 PHE constitutes
                good cause to waive the normal notice-and-comment process under the
                Administrative Procedure Act and section 1871(b)(2)(C) of the Act.
                Waiving notice and comment is in the public interest, because time is
                of the essence in informing residents, their families, and the general
                public of the incidence of COVID-19; such information will assist
                public health officials in detecting outbreaks and saving lives.
                 The applicability date for Sec. 483.80(g)(1) through (3)(iii) is
                the date of the publication of this rule (that is, the effective date
                as noted in the DATES section of this notice).
                Z. Time Used for Level Selection for Office/Outpatient Evaluation and
                Management Services Furnished Via Medicare Telehealth
                 In the March 31st COVID-19 IFC (85 FR 19268 through 19269), for the
                duration of the PHE for the COVID-19 pandemic, we revised our policy to
                specify that the office/outpatient E/M level selection for office/
                outpatient E/M services when furnished via telehealth can be based on
                MDM or time, with time defined as all of the time associated with the
                E/M on the day of the encounter. We stated that currently there are
                typical times associated with the office/outpatient E/M visits, and
                that those times are what should be met for purposes of level
                selection. We stated that typical times associated with the office/
                outpatient E/M visits were available as a public use file at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1715-F.
                 Members of the physician community have brought to our attention
                that the policy announced in the March 31st COVID-19 IFC relies on
                typical times listed in our public use file even when those times do
                not align with the typical times included in the office/outpatient E/M
                code descriptors. We agree that discrepancies between times can be
                confusing. We believe that, because the times are being used for the
                purpose of choosing which level of office/outpatient E/M CPT code to
                bill, the times listed in the codes themselves would be most
                appropriate for the purpose. Therefore, we are finalizing on an interim
                basis, for the duration of the PHE for the COVID-19 pandemic, that the
                typical times for purposes of level selection for an office/outpatient
                E/M are the times listed in the CPT code descriptor.
                AA. Updating the Medicare Telehealth List
                 In the CY 2002 PFS final rule with comment period (64 FR 80041) we
                amended regulations at Sec. 410.78(f) to state that PFS annual
                rulemaking would serve as the process for adding and deleting services
                from the telehealth list as is required under section 1834(m)(4)(F)(ii)
                of the Act.
                 In the March 31st COVID-19 IFC (85 FR 19232-19253), we added a
                number of services to the Medicare telehealth list on an interim final
                basis for the duration of the PHE for the COVID-19 pandemic. While we
                believe that we have already added the vast majority of services that
                it would appropriate to add to the Medicare telehealth list for
                purposes of the PHE for the COVID-19 pandemic, it is possible that we
                might identify other services that would be appropriate additions to
                the telehealth list, taking into consideration infection control,
                patient safety, and other public health concerns resulting from the
                COVID-19 PHE. Due to the urgency of minimizing unnecessary contact
                between beneficiaries and practitioners, we believe that, for purposes
                of the PHE for the COVID-19 pandemic, we should modify the process we
                established for adding or deleting services from the Medicare
                telehealth services list under our regulation at Sec. 410.78(f) to
                allow for an expedited process during the PHE that does not involve
                notice and comment rulemaking. Therefore, for the duration of the PHE
                for the COVID-19 pandemic, we are revising our regulation at Sec.
                410.78(f) to specify that, during a PHE, as defined in Sec. 400.200 of
                this chapter, we will use a subregulatory process to modify the
                services included on the Medicare telehealth list.
                 While we are not codifying a specific process to be in effect
                during the PHE for the COVID-19 pandemic, we note that we could add
                services to the Medicare telehealth list on a subregulatory basis by
                posting new services to the web listing of telehealth services when the
                agency receives a request to add (or identifies through internal
                review) a service that can be furnished in full, as described by the
                relevant code, by a distant site practitioner to a beneficiary in a
                manner that is similar to the in-person service. We also note that any
                additional services added using the revised process would remain on the
                list only during the PHE for the COVID-19 pandemic.
                BB. Payment for COVID-19 Specimen Collection to Physicians,
                Nonphysician Practitioners and Hospitals
                 In the March 31st COVID-19 IFC (85 FR 19256 through 19258), we
                changed Medicare payment policies for independent laboratories for
                specimen collection related to COVID-19 testing under certain
                circumstances. Specifically, under sections 1833(h)(3) and 1834A(b)(5)
                of the Act, we established a policy for the duration of
                [[Page 27603]]
                the PHE for the COVID-19 pandemic to pay a nominal specimen collection
                fee and associated travel allowance to independent laboratories for
                collection of specimens for COVID-19 clinical diagnostic laboratory
                testing from beneficiaries who are homebound or inpatients not in a
                hospital. In that IFC, we stated that Medicare-enrolled independent
                laboratories can bill Medicare for the specimen collection fee using
                one of the two new HCPCS codes effective March 1, 2020, HCPCS code
                G2023 (specimen collection for severe acute respiratory syndrome
                coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), any
                specimen source) and HCPCS code G2024 (specimen collection for severe
                acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus
                disease [COVID-19]), from an individual in a SNF or by a laboratory on
                behalf of a HHA, any specimen source).
                 To establish a payment amount for HCPCS code G2023 for the Clinical
                Laboratory Fee Schedule (CLFS) policy, we looked to similar services in
                other settings of care as a potential benchmark. In looking at other
                Medicare payment systems, we concluded that the PFS was the best source
                for assigning a payment amount since physicians and other practitioners
                often bill for services that involve specimen collection by trained,
                non-institutional staff. Additionally, we stated that under the PFS, a
                Level 1 established patient office visit (CPT code 99211) typically
                does not require the presence of a physician or other qualified health
                care professional and the usual presenting problem(s) are minimal and
                is typically reported by physician practices when the patient only sees
                clinical office staff for services like acquiring a routine specimen
                sample. We also explained that we considered establishing a higher
                payment amount that considered the Level 1 E/M visit plus the payment
                amount for CPT code 89220, Sputum obtaining specimen aerosol induced
                technique. However, as noted in the March 31st COVID-19 IFC (85 FR
                19257), we believe there are likely overlapping costs in staff time for
                these two services and the Level 1 office visit payment rate is
                adequate for HCPCS code G2023. The difference in payment for HCPCS code
                G2024 in comparison to HCPCS code G2023 represents the statutory
                payment increase under section 1834A(b)(5) of the Act for specimen
                collection when a sample is collected from an individual in a SNF or by
                a laboratory on behalf of an HHA. Under current CLFS policies, when an
                independent laboratory sends skilled laboratory staff to collect
                specimens from homebound individuals or non-hospital inpatients, the
                laboratory can bill Medicare for mileage in addition to specimen
                collection. The travel codes allow for payment either on a per mileage
                basis (P9603) or on a flat rate per trip basis (P9604). Payment of the
                travel allowance is made only if a specimen collection fee is also
                payable. The travel allowance is intended to cover the estimated travel
                costs of collecting a specimen including the laboratory technician's
                salary and travel expenses.
                 Unchecked spread of the coronavirus COVID-19 threatens to overwhelm
                healthcare resources in many areas of the country. The coronavirus is
                very contagious, spreading easily between people through communities
                largely through droplet transmission. The CDC considers it more
                contagious than influenza.\55\ Widespread diagnostic testing for COVID-
                19 is a critical component of a public pandemic response to support
                infection control and proper treatment. Testing ensures individuals
                with positive diagnoses can be aware of their own condition and
                treatment they may need, and can isolate themselves to contain
                spreading. Testing on the scale that will be required to contain COVID-
                19 entails a tremendous commitment of labor, equipment, and capital
                resources. Assessment and specimen collection to support widespread
                COVID-19 testing will require extraordinary and resource-intensive
                measures for infection control, such as providing masks and protective
                equipment to staff and, setting up significant physical space to avoid
                additional spread when specimens are collected, among many other unique
                requirements. Recognizing the critical importance of expanding COVID-19
                testing, in this IFC, we are providing additional payment for
                assessment and COVID-19 specimen collection to support testing by
                HOPDs, and physicians and other practitioners, to recognize the
                significant resources involved in safely collecting specimens from many
                beneficiaries during a pandemic. The majority of ambulatory care in any
                community is furnished by physicians and other practitioners in offices
                and HOPDs, and these are natural locations for COVID-19 testing in
                addition to laboratories.
                ---------------------------------------------------------------------------
                 \55\ https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html.
                ---------------------------------------------------------------------------
                 When physicians and other practitioners collect specimens 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 office/outpatient E/M visit (CPT codes 99201-99205,
                99211-99215). In visits where a patient has 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 99212-99215). 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. As noted previously, we referred to the
                PFS payment rate for CPT code 99211 in establishing a payment amount
                under section 1833(h)(3) of the Act for specimen collection for the
                COVID-19 tests described by G2023 (specimen collection for severe acute
                respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease
                [COVID-19]), any specimen source)).
                 During this PHE, we understand that some professional practices are
                collecting specimens for COVID-19 tests. In many cases, we expect that
                these services are appropriately paid as part of the visit codes
                described above. Given the critical need for widespread testing as part
                of the pandemic response, we also expect that COVID-19 specimen
                collection may occur in circumstances other than the typical
                interaction between the patients and the professionals or staff of
                these practices. In our review of available HCPCS codes, we did not
                identify a code that would specifically describe the services that
                would be furnished in the context of large-scale dedicated testing
                operations involving a physician or NPP, specifically, assessment of
                COVID-19 symptoms and exposure, and specimen collection for new
                patients. In circumstances outside of the PHE, such a code would not be
                needed. We would ordinarily expect physicians and NPPs to establish a
                relationship with a patient before their clinical staff could
                effectively assist in managing care incident to their services.
                However, in the context of the widespread testing that is necessary
                during this COVID-19 PHE, we believe it is important to recognize such
                a service for new patients in addition to established patients. In
                considering possible codes for this purpose, we believe that CPT
                [[Page 27604]]
                code 99211 for a level 1 E/M visit, appropriately describes the
                required clinical staff and patient interaction. However, billing for
                CPT code 99211is currently limited to patients with whom the billing
                practitioner has an established relationship. As discussed above, CPT
                code 99211 typically does not involve interaction with physician or
                other qualified health care professional and the usual presenting
                problem(s) are minimal. Thus, this CPT code typically is reported by a
                physician or practitioner when the patient only sees clinical office
                staff for services like acquiring a routine specimen sample.
                Additionally, as previously noted, we based our valuation of HCPCS code
                G2023 for specimen collection by independent laboratories on CPT code
                99211. Therefore, for the duration of the PHE, we will recognize
                physician and NPP use of CPT code 99211 for all patients, not just
                patients with whom they have an established relationship, to bill for a
                COVID-19 symptom and exposure assessment and specimen collection
                provided by clinical staff incident to their services.
                 For the duration of the COVID-19 PHE, we are therefore finalizing
                on an interim basis that when the services described by CPT code 99211
                for a level 1 E/M visit are furnished for the purpose of a COVID-19
                assessment and specimen collection, the code can be billed for both new
                and established patients. We believe this policy will support expanded
                access to COVID-19 testing, and provide appropriate payment for COVID-
                19 testing-related services furnished by physician and other
                practitioners. This policy will allow physicians and practitioners to
                bill for services provided by clinical staff to assess symptoms and
                take specimens for COVID-19 laboratory testing for all patients, not
                just established patients. We note that a physician or practitioner
                cannot bill for services provided by auxiliary clinical staff unless
                those staff meet all the requirements to furnish services ``incident
                to'' services, as described in 42 CFR 410.26 and further described in
                section 60 of Chapter 15 Covered Medical and other Health Services in
                the Medicare Benefit Policy Manual 100-02. We further note that we
                adopted an interim final policy to permit the direct supervision
                requirement to be met through virtual presence of the supervising
                physician or practitioner using interactive audio and video technology
                for the duration of the PHE (85 FR 19245).
                 During this COVID-19 PHE, we understand HOPDs also are engaging in
                significant additional specimen collection and testing for COVID-19
                both at temporary expansion locations, as well as original locations of
                the hospital. As with the physician office clinical staff, hospital
                clinical staff are reviewing symptoms for patients relative to CDC
                guidelines and obtaining specimen samples for laboratory testing. As
                noted above, in our review of available HCPCS and CPT codes, we did not
                identify a code that explicitly describes the exact services that
                widespread testing efforts would require, assessment of symptoms and
                specimen collection. Such a uniquely auxiliary service would not
                normally be needed. Typically, clinical staff services such as specimen
                collection are included in a clinic or emergency room visit or in other
                primary services furnished in the HOPD, such as observation services or
                critical are services. However, during this COVID-19 PHE, facilitating
                widespread testing requires recognizing such a service for the
                standalone work hospitals are undertaking to assess symptoms and
                collect specimens form a significant number of patients. In light of
                the tremendous need for testing created by this PHE and the resource
                needs to provide extensive symptom assessment for specimen collection,
                we are creating a new E/M code solely to support COVID-19 testing for
                the PHE, HCPCS code C9803 (Hospital outpatient clinic visit specimen
                collection for severe acute respiratory syndrome coronavirus 2 (sars-
                cov-2) (coronavirus disease [covid-19]), any specimen source). We
                believe this code is necessary to address the resource requirements
                hospitals face in establishing broad community diagnostic testing for
                COVID-19, including the significant specimen collection necessary to
                conduct that testing.
                 We will assign HCPCS code C9803 to APC 5731 Level 1 Minor
                Procedures. In assigning a service to an APC grouping, section
                1833(t)(2)(B) of the Act requires that the groupings within the OPPS be
                comparable clinically and with respect to the use of resources. APC
                5731 Level 1 Minor Procedures already contains many similar services to
                new HCPCS code C9803, including HCPCS code Q0091 (Obtaining screening
                pap smear) and G0117 (Glaucoma Screening for high risk patients
                furnished by an optometrist or an ophthalmologist). Earlier in this
                section, we established that clinical staff symptoms review and
                specimen collection is similar to the services described by, a Level 1
                established patient office visit (CPT code 99211), which typically does
                not require the presence of a physician or other qualified health care
                professional, for which the usual presenting problem(s) are minimal and
                which is typically reported by physician practices when the patient
                only sees clinical office staff. We further established the payment for
                HCPCS code G2023 for specimen collection based on the resources
                required for CPT code 99211. Currently the PFS pays a national
                unadjusted rate of $23.46 for CPT code 99211. APC 5731 Level 1 Minor
                Procedures pays a national unadjusted rate of $22.98. Because these
                payment amounts for APC 5731 Level 1 Minor Procedures approximates our
                best estimate of the resource cost for this service, and because HCPCS
                code C9803 for a clinic visit dedicated to specimen collection is
                similar to other services in APC 5731, we will assign HCPCS code C9803
                to APC 5731 for the duration of the PHE. We established HCPCS code
                C9803 only to meet the need of the PHE, and we expect to retire this
                code once the PHE concludes.
                 Under the OPPS, we pay for HOPD services through separate payment
                or through packaged payment when the service is integral, ancillary,
                supportive, dependent, or adjunctive to the primary service or services
                provided in the hospital outpatient setting during the same outpatient
                encounter and billed on the same claim to the OPPS. The clinical staff
                services described by HCPCS code C9803 are services that are integral
                and ancillary to other primary services, such as emergency room or
                clinic visits, or even observation or critical care services. We would
                not expect to make separate payment for a clinic visit dedicated to
                specimen collection (HCPCS code C9803) when the hospital furnished
                other more significant services in the same encounter. We are assigning
                a status indicator of ``Q1'' to HCPCS code C9803 indicating that this
                services will be conditionally packaged under the OPPS when billed with
                a separately payable primary service in the same encounter. The OPPS
                will only make separate payment to a hospital when HCPCS code C9803 is
                billed without another primary covered hospital outpatient service. The
                OPPS also will make separate payment for CPT code C9803 when it is
                billed with a clinical diagnostic laboratory test with a status
                indicator of ``A'' on Addendum B of the OPPS.
                 Finally, section 6002(a) of the Families First Coronavirus Response
                Act (Pub. L. 116-127) amended section 1833 of the Act by adding a new
                paragraph (DD) to section (a)(1) and a new paragraph (11) to section
                (b) to provide, respectively, that the payment
                [[Page 27605]]
                amount for a specified COVID-19 testing-related service for which
                payment may be made under certain outpatient payment provisions will be
                100 percent of the payment amount otherwise recognized and that the
                deductible for such a service will not apply. These amendments mean
                that there is no beneficiary cost-sharing (coinsurance and deductible
                amounts) for COVID-19 testing-related services, which is defined in new
                section 1833(cc) of the Act as, among other requirements, are medical
                visits in any of several categories of HCPCS E/M service codes,
                including office and other outpatient services, that results in an
                order for or administration of a COVID-19 clinical diagnostic
                laboratory test described in section 1852(a)(1)(B)(iv)(IV) of the Act
                and relates to the furnishing or administration of such test or to the
                evaluation of such individual for purposes of determining the need of
                such individual for such test. Because physicians and other
                practitioners will be using the level 1 E/M code for established
                patients, CPT code 99211, to conduct testing related visits, there will
                not be beneficiary cost sharing when the practitioner's office bills
                for this service, provided it results in an order for or administration
                of a COVID-19 test. Similarly, because HOPDs will use HCPCS code C9803
                to bill for a clinic visit for specimen collection, which we consider
                an E/M code in the office and other outpatient services category of
                HCPCS codes, beneficiary cost sharing will not apply for this service,
                provided it results in an order for or administration of a COVID-19
                test and meets other requirements of the law. We anticipate that a
                COVID-19 test will always be ordered or administered with HCPCS code
                C9803 because the descriptor for this code includes specimen collection
                for COVID-19.
                 In summary, in the March 31st COVID-19 IFC, which created
                regulatory flexibilities to address the COVID-19 PHE, we finalized two
                codes to recognize the unique resource costs of specimen collection in
                a way that retains the integrity of infection control during a
                pandemic: CPT codes G2023 and G2024 for specimen collection for COVID-
                19 laboratory tests (85 FR 19257). In this IFC, to further support
                widespread community testing for COVID-19, we are finalizing 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. Cost-sharing
                for this service will be waived when all other requirements under
                section 6002(a) of the Families First Coronavirus Response Act are met.
                We are further creating a new code, CPT code C9803 under the OPPS for
                HOPDs to bill for a clinic visit dedicated to specimen collection and
                adopting a policy to conditionally package payment for this code. The
                OPPS will make separate payment for HCPCS code C9803 under the OPPS
                when no other primary service is furnished in the same encounter. Cost-
                sharing for this service will be waived when all other requirements
                under section 6002(a) of the Families First Coronavirus Response Act
                are met.
                CC. Payment for Remote Physiologic Monitoring (RPM) Services Furnished
                During the COVID-19 Public Health Emergency
                 In the March 31st COVID-19 IFC, we changed several policies related
                to payment for Remote Physiologic Monitoring services under the PFS
                during the COVID-19 PHE. We had previously finalized payment in the CY
                2018 PFS final rule for CPT code 99091 (Collection and interpretation
                of physiologic data 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
                requiring a minimum of 30 minutes of time). In the CY 2019 PFS final
                rule the following year, we finalized payment for CPT codes 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), 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), and
                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). Most recently,
                in the CY 2020 PFS final rule (84 FR 62645 and 62646), we finalized a
                treatment management 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) and two self-measured blood
                pressure monitoring codes, CPT code 99473 (Self-measured blood pressure
                using a device validated for clinical accuracy; patient education/
                training and device calibration) and CPT code 99474 (Separate self-
                measurements of two readings one minute apart, twice daily over a 30-
                day period (minimum of 12 readings), collection of data reported by the
                patient and/or caregiver to the physician or other qualified health
                care professional, with report of average systolic and diastolic
                pressures and subsequent communication of a treatment plan to the
                patient).
                 As we stated in the March 31st COVID-19 IFC, we believe that RPM
                services support the CDC's goal of reducing human exposure to the novel
                coronavirus while also increasing access to care and improving patient
                outcomes. RPM services could allow a patient with an acute respiratory
                virus to monitor pulse and oxygen saturation levels using pulse
                oximetry. Nurses or other auxiliary personnel, working with physicians,
                can check-in with the patient and then using patient data, determine
                whether home treatment is safe, all the while reducing exposure risk
                and eliminating potentially unnecessary emergency department and
                hospital visits. Based on these considerations, we established interim
                policies to eliminate as many unnecessary obstacles as possible to
                delivering these services as part of the response to the pandemic. To
                that end, a combination of our permanent and interim policies for the
                duration of the COVID-19 PHE allow RPM services to be furnished to new
                patients in addition to established patients; with beneficiary consent
                to be obtained at the time services are furnished and by auxiliary
                personnel for physiologic monitoring of patients with acute and/or
                chronic conditions; and under general supervision.
                 In recent weeks, we have been notified by stakeholders that CPT
                coding guidance states that the RPM service described by CPT code 99454
                cannot be reported for monitoring of fewer than 16 days during a 30-day
                period. In reviewing other RPM codes, we also observed that CPT codes
                99091, 99453, 99457, and 99458, also have 30-day reporting periods.
                Stakeholders have alerted CMS that while it is possible that remote
                physiologic monitoring would be used to monitor a patient with COVID-19
                for 16 or more days, many patients with COVID-19 who need monitoring do
                not need to be monitored for as many as 16 days.
                [[Page 27606]]
                Consequently, and for all of the same reasons we articulated for
                establishing the other policies supporting use of RPM services as part
                of the pandemic response, for purposes of treating suspected COVID-19
                infections, we are establishing a policy on an interim final basis for
                the duration of the COVID-19 PHE to allow RPM monitoring services to be
                reported to Medicare for periods of time that are fewer than 16 days of
                30 days, but no less than 2 days, as long as the other requirements for
                billing the code are met. We are not proposing to alter the payment for
                CPT codes 99454, 99453, 99091, 99457, and 99458 because the overall
                resource costs for long-term monitoring for chronic conditions assumed
                under the current valuation would appropriately reflect those for
                short-term monitoring for acute conditions in the context of COVID-19
                disease and exposure risks. Payment for CPT codes 99454, 99453, 99091,
                99457, and 99458 when monitoring lasts for fewer than 16 days of 30
                days, but no less than 2 days, is limited to patients who have a
                suspected or confirmed diagnosis of COVID-19.
                III. Waiver of Proposed Rulemaking
                 We ordinarily publish a notice of proposed rulemaking in the
                Federal Register and invite public comment on the proposed rule before
                the provisions of the rule take effect, in accordance with the
                Administrative Procedure Act (APA), 5 U.S.C. 553, and section 1871 of
                the Act. Specifically, section 553(b) of the APA requires the agency to
                publish a notice of the proposed rule in the Federal Register that
                includes a reference to the legal authority under which the rule is
                proposed, and the terms and substance of the proposed rule or a
                description of the subjects and issues involved. Section 553(c) further
                requires the agency to give interested parties the opportunity to
                participate in the rulemaking through public comment before the
                provisions of the rule take effect. Similarly, section 1871(b)(1) of
                the Act requires the Secretary to provide for notice of the proposed
                rule in the Federal Register and a period of not less than 60 days for
                public comment. Section 553(b)(B) and section 1871(b)(2)(C) of the Act
                authorize the agency to waive these procedures, however, if the agency
                finds good cause that notice and comment procedures are impracticable,
                unnecessary, or contrary to the public interest and incorporates a
                statement of the finding and its reasons in the rule issued.
                 Section 553(d) ordinarily requires a 30-day delay in the effective
                date of a final rule from the date of its publication in the Federal
                Register. This 30-day delay in effective date can be waived, however,
                if an agency finds good cause to support an earlier effective date.
                Section 1871(e)(1)(B)(i) of the Act also prohibits a substantive rule
                from taking effect before the end of the 30-day period beginning on the
                date the rule is issued or published. However, section
                1871(e)(1)(B)(ii) of the Act permits a substantive rule to take effect
                before 30 days if the Secretary finds that a waiver of the 30-day
                period is necessary to comply with statutory requirements or that the
                30-day delay would be contrary to the public interest. Furthermore,
                section 1871(e)(1)(A)(ii) of the Act permits a substantive change in
                regulations, manual instructions, interpretive rules, statements of
                policy, or guidelines of general applicability under Title XVIII of the
                Act to be applied retroactively to items and services furnished before
                the effective date of the change if the failure to apply the change
                retroactively would be contrary to the public interest. Finally, the
                Congressional Review Act (CRA) requires a delay in the effective date
                for major rules unless an agency finds good cause that notice and
                public procedure are impracticable, unnecessary, or contrary to the
                public interest, in which case the rule shall take effect at such time
                as the agency determines. 5 U.S.C. 801(a)(3), 808(2).
                 On January 30, 2020, the International Health Regulations Emergency
                Committee of the World Health Organization (WHO) declared the outbreak
                of the 2019 Novel Coronavirus (2019-nCoV) to be a Public Health
                Emergency of International Concern.\56\ On January 31, 2020, Health and
                Human Services Secretary Alex M. Azar II determined that a PHE exists
                retroactive to January 27, 2020 \57\ under section 319 of the Public
                Health Service Act (42 U.S.C. 247d), in response to COVID-19), and on
                April 21, 2020, Secretary Azar renewed, effective April 26, 2020, the
                determination that a PHE exists.\58\ On March 11, 2020, the WHO
                publicly declared COVID-19 to be a pandemic.\59\ On March 13, 2020, the
                President declared that the COVID-19 pandemic in the United States
                constitutes a national emergency,\60\ beginning March 1, 2020. This
                declaration, along with the Secretary's January 30, 2020 declaration of
                a PHE, conferred on the Secretary certain waiver authorities under
                section 1135 of the Act. On March 13, 2020, the Secretary authorized
                waivers under section 1135 of the Act, effective March 1, 2020.\61\
                Ensuring the health and safety of Medicare beneficiaries, Medicaid
                recipients, BHP enrollees, CHIP enrollees, and healthcare workers is of
                primary importance. As this IFC directly supports that goal by offering
                healthcare professionals flexibilities in furnishing services while
                combatting the COVID-19 pandemic and ensuring that sufficient health
                care items and services are available to meet the needs of individuals
                enrolled in the Medicare, Medicaid, CHIP and BHP programs, it is
                critically important that we implement this IFC as quickly as possible
                and for certain provisions, retroactive to either the start of the
                national emergency for the COVID-19 pandemic, beginning on March 1,
                2020, or the start of the PHE for the COVID-19 pandemic on January 27,
                2020. Not applying these revisions retroactive to either the start of
                the national emergency for the COVID-19 pandemic, beginning on March 1,
                2020, or the start of the PHE for the COVID-19 pandemic on January 27,
                2020 would be contrary to the public interest of supporting necessary
                flexibilities during the entire PHE. As we are in the midst of a PHE,
                we find good cause to waive notice and comment rulemaking as we believe
                it would be impracticable and contrary to the public interest for us to
                undertake normal notice and comment rulemaking procedures, as that
                would delay giving healthcare providers the flexibilities to provide
                critical care. For the same reasons, because we cannot afford any delay
                in effectuating this IFC, we find good cause to waive the 30-day delay
                in the effective date and, moreover, to make certain policies in this
                IFC applicable as of March 1, 2020--the date the President of the
                United States declared to be the beginning of the national emergency
                concerning the COVID-19 pandemic, or, if applicable, January 27, 2020,
                the date on which the PHE for the COVID-19 pandemic started.
                ---------------------------------------------------------------------------
                 \56\ https://www.who.int/news-room/detail/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-
                (2005)-emergency-committee-regarding-the-outbreak-of-novel-
                coronavirus-(2019-ncov).
                 \57\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
                 \58\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-21apr2020.aspx.
                 \59\ https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19-11-march-2020.
                 \60\ https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
                 \61\ https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
                ---------------------------------------------------------------------------
                 In support of the imperative to contain and combat the virus in the
                United States, this IFC will give health care workers and hospitals
                additional
                [[Page 27607]]
                flexibility to respond to the virus and continue caring for patients
                while minimizing exposure to COVID-19. CDC guidelines are clear that
                public exposure greatly increases the overall risk to public health and
                they stress the importance of containment and mitigation strategies to
                minimize public exposure and the spread of COVID-19. As of April 26th
                2020, the CDC reports 957,875 cases of COVID-19 in the United States
                and 53,922 deaths.\62\ Individuals such as healthcare workers who come
                in close contact with those infected with COVID-19 are at an elevated
                risk of contracting the disease. To minimize these risks, the CDC has
                urged healthcare professionals to make every effort to distance
                themselves from those who are potentially sick with COVID-19 by using
                modalities such as telephonic interviews, text monitoring systems, or
                video conference.\63\ As the healthcare community works to establish
                and implement infection prevention and control practices, we are also
                working to revise and implement regulations that function in concert
                with those healthcare community infection prevention and treatment
                practices.
                ---------------------------------------------------------------------------
                 \62\ https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html.
                 \63\ https://www.cdc.gov/coronavirus/2019-ncov/php/guidance-evaluating-pui.html.
                ---------------------------------------------------------------------------
                 This IFC offers flexibilities in certain Medicare, Medicaid, and
                BHP regulations that support measures to combat the COVID-19 pandemic
                and safeguard all interests by protecting healthcare providers and
                vulnerable beneficiaries. The provisions of this IFC better enable and
                facilitate physicians and other clinicians, to focus on caring for
                these beneficiaries during this PHE for the COVID-19 pandemic and
                minimize their own risks to COVID-19 exposure.
                 Furthermore, we are also adopting an extraordinary circumstances
                relocation exception policy for on-campus and excepted off-campus PBDs
                of hospitals that relocate in response to the PHE, as well as
                describing the hospital outpatient services and CMHC that can to be
                furnished in temporary expansion locations of a hospital (including the
                patient's home).
                 We are also establishing a national coverage policy under Medicare
                Part B for COVID-19 antibody diagnostic tests in order to ensure
                patients and practitioners have clinically relevant information to
                allow for ongoing health monitoring and isolation, as appropriate.
                 We are allowing Opioid Treatment Programs (OTPs) to furnish
                periodic assessments via communication technology.
                 In addition, we are allowing states that operate a BHP to seek
                certification of temporary BHP Blueprint revisions to make significant
                changes directly tied to the PHE for the COVID-19 pandemic and that
                increase access to necessary services without delay or other barriers
                (such as cost sharing) during the duration of the PHE for the COVID-19
                pandemic.
                 We are modifying the methodology to determine IME payments teaching
                hospitals so that temporary increases in available beds or bed capacity
                during the PHE for the COVID-19 pandemic will not lower teaching
                hospitals' IME payments or impact provider-based RHC payments for those
                RHCs who are not currently subject to the national payment limit. We
                are also implementing temporary policies to allow teaching hospitals to
                claim, in their resident FTE counts, residents that teaching hospitals
                send to other hospitals to respond to the PHE associated with COVID,
                which will allow teaching hospitals to maintain GME payments and will
                not trigger establishment of FTE counts or PRA caps at non-teaching
                receiving hospitals. Likewise, we are adopting a policy to hold, for
                the duration of the COVID-19 PHE, IRF and IPF average daily census
                numbers at their values prior to the COVID-19 PHE, so that IRF and IPF
                teaching status adjustment payments do not decrease during the
                pandemic. We are implementing various flexibilities for IRFs in this
                IFC so that IRFs may utilize their excess bed capacity to care for
                patients to alleviate capacity issues in acute care hospitals during
                the COVID-19 pandemic. Specifically, IRFs will still be required to
                meet requirements for IRF payment for patients who receive regular IRF
                care. However, for those patients who are cared for in an IRF solely to
                alleviate acute care hospital bed capacity, IRFs will not have to
                comply with some regulations governing documentation, therapy
                requirements, and other policies to maximize time spent on patient care
                during this pandemic.
                 We are also making changes to the Medicare regulations to revise
                payment rates for certain DME and enteral nutrients, supplies, and
                equipment as part of implementation of section 3712 of the CARES Act.
                We are also increasing flexibilities for hospitals participating in the
                Hospital VBP Program by expanding the Extraordinary Circumstances
                Exceptions (ECE) policy so that we can grant an ECE to hospitals within
                an entire region or locale, including the entire United States, that
                have been affected by an extraordinary circumstance, including the
                COVID-19 PHE, without requiring that each affected hospital
                individually submit an ECE request form.
                 Additionally, immediate implementation of section 3712 of the CARES
                Act is necessary to provide prompt relief, as intended by the CARES
                Act, in the form of higher Medicare payments to suppliers of DME in
                certain areas to ensure beneficiary access to necessary medical
                equipment and supplies during the PHE.
                 The COVID-19 pandemic PHE has created a lack of predictability for
                many ACOs participating in the Shared Savings Program regarding the
                impact of expenditure and utilization changes on financial benchmarks
                and performance year expenditures, and for those under performance-
                based risk, the potential liability for shared losses, as well as
                disrupting population health activities as clinicians, care
                coordinators and financial and other resources are diverted to address
                immediate acute care needs. ACOs and other program stakeholders have
                advocated that there is an urgent need to address these concerns
                because ACOs need to make participation decisions for PY 2020 and PY
                2021 soon and may choose to terminate their participation in the Shared
                Savings Program on or before the June 30, 2020 deadline, rather than
                face the potential of pro-rated shared losses for PY 2020 if the PHE
                does not extend for the entire year and if the existing policies under
                the Shared Savings Program do not adequately mitigate liability for
                shared losses. We believe it is vital to the stability of the Shared
                Savings Program to encourage continued participation by ACOs by
                adjusting program policies as necessary to address the impact of the
                COVID-19 pandemic, including by offering certain flexibilities in
                program participation options to currently participating ACOs and
                addressing potential distortions in expenditures resulting from the
                COVID-19 pandemic. The changes included in this IFC will help to ensure
                a more equitable comparison between ACOs' expenditures for PY 2020 and
                their updated historical benchmarks and that ACOs are not rewarded or
                penalized for having higher/lower COVID-19 spread in their assigned
                beneficiary populations which, in turn, will help to protect ACOs from
                owing excessive shared losses and the Medicare Trust Funds from paying
                out windfall shared savings. For these reasons and the reasons set
                forth in section II.L. of this IFC, we find good cause to waive notice
                and comment procedures for the
                [[Page 27608]]
                regulatory changes being made to the Shared Savings Program in this
                IFC.
                 Furthermore, changes effectuated in this rule to broaden the scope
                of practitioners who may order home health services and expand the
                availability of Medicaid coverage for certain laboratory testing during
                a PHE and subsequent periods of active surveillance are being made to
                maximize beneficiary access to needed services and minimize the
                transmission of the disease, which is of critical importance in the
                current PHE. Additionally, during the PHE for the COVID-19 pandemic, we
                are adding flexibility for teaching physicians, NPPs, PTs, OTs, SLPs,
                and others in supervision, documentation, and other requirements of the
                Medicare program that could impact the availability and efficiency of
                care to ensure an adequate number of clinicians are able to furnish
                critical services and tests.
                 Section 3708 of the CARES Act is applicable to Medicare and
                Medicaid and allows a home health patient to be under the care of a NP
                or CNS or a PA and allows such practitioner to: (1) Order home health
                services; (2) establish and periodically review a plan of care for home
                health services; and (3) certify and re-certify that the patient is
                eligible for home health services. Currently, these functions can only
                be paid for by Medicare when performed by physicians. However, these
                changes are not effective until CMS implements the changes in
                regulation, and pursuant to section 3708(f) of the CARES Act, may be
                implemented by an IFC. Implementing all of the conforming regulations
                changes in this IFC are needed to implement section 3708 of the CARES
                Act, and will allow us to meet the statutorily-required 6-month
                timeframe for implementation, but also allows us to act as expediently
                as possible to implement this new flexibility during the current PHE
                for the COVID-19 pandemic.
                 We are also permitting flexibility with respect to the
                administration of COVID-19 tests for purposes of Medicaid coverage,
                both during the COVID-19 PHE and any subsequent periods of active
                surveillance, to allow for continued surveillance as part of strategies
                to detect recurrence of the virus in individuals and populations to
                prevent further spread of the disease. These flexibilities related to
                Medicaid laboratory coverage, which are urgently needed during the
                COVID-19 PHE, will also apply during future PHEs resulting from
                outbreaks of communicable disease and any subsequent period of active
                surveillance. We are amending Medicare regulations to remove the
                Medicare requirement for a physician or other practitioner's order for
                COVID-19 testing and certain related testing, as well as allowing
                increased flexibilities regarding documentation requirements for such
                tests, during the COVID-19 PHE.
                 We are also allowing flexibilities to HHAs in the HHVBP Model by
                aligning HHVBP Model data submission requirements with any exceptions
                or extensions granted for purposes of the HH QRP during the PHE for the
                COVID-19 pandemic, as well as a policy for granting exceptions to the
                New Measures data reporting requirements under the HHVBP Model during
                the PHE for the COVID-19 pandemic.
                 In addition, we are delaying the compliance dates for collecting
                and reporting the TOH Information to Provider-Post-Acute Care and TOH
                Information to Patient-Post-Acute Care quality measures and certain
                standardized patient assessment data with respect to six categories by
                IRFs, LTCHs, and HHAs under, respectively, the IRF QRP, LTCH QRP, and
                HH QRP.
                 Additionally, in regard to the Quality Payment Program, due to the
                PHE, we are amending Sec. 414.1400(b)(3)(v)(C) and (D) to delay the
                implementation of these policies by 1 year. Both QCDR measure approval
                criteria necessitate QCDRs collecting data from clinicians in order to
                assess the measure, and we anticipate that QCDRs may be unable to
                collect, and clinicians unable to submit, data on QCDR measures due to
                prioritizing the care of COVID-19 patients.
                 We are also revising Sec. 156.280(e)(2)(ii) to delay
                implementation of the separate billing policy for 60 days from the date
                finalized in the 2019 Program Integrity Rule (84 FR 71674). Under this
                60-day extension, QHP issuers must comply with the separate billing
                policy finalized at Sec. 156.280(e)(2)(ii) beginning on or before the
                QHP issuer's first billing cycle following August 26, 2020. We believe
                extending the deadline 60 days for QHP issuers and Exchanges to comply
                with the separate billing policy is appropriate so that they may
                adequately respond to the current national PHE and divert resources to
                address COVID-19 that may otherwise have been used for timely
                compliance with the separate billing policy. Therefore, the 60-day
                delayed implementation for QHP issuers subject to the separate billing
                policy is effective immediately, such that QHP issuers are required to
                begin complying with the separate billing policy finalized at Sec.
                156.280(e)(2)(ii) beginning on or before the first billing cycle
                following August 26, 2020.
                 Finally, we are adding a new paragraph (g) to Sec. 483.80, to
                require facilities to report information on COVID-19 incidence among
                residents and staff in LTC facilities to the CDC, without a previous
                opportunity for public comment. We believe we have good cause to waive
                the normal notice-and-comment process under the Administrative
                Procedure Act and section 1871(b)(2)(C) of the Act, because acting
                immediately to provide information to the CDC and the public can help
                control the spread of the virus. Waiving notice and comment is in the
                public interest, because time is of the essence in informing residents,
                their families, and the general public of the incidence of COVID-19 in
                the LTC facility population; such information will assist public health
                officials in detecting outbreaks and saving lives.
                 As noted in this IFC, it is critical in emergencies and disaster
                situations to respond as efficiently and effectively as possible to
                address immediate public health needs; as such, we may extend
                flexibilities in this IFC for future national emergencies, public
                health emergencies, or disasters. We welcome comments on whether some
                of these flexibilities should be extended to future situations.
                 We believe it would be impracticable and contrary to the public
                interest for us to undertake normal notice and comment procedures and
                to thereby delay the effective date of this IFC. We find good cause to
                waive notice of proposed rulemaking under the APA, 5 U.S.C. 553(b)(B),
                and section 1871(b)(2)(C) of the Act. For those same reasons, as
                authorized by section 808(2) of the CRA, we find it is impracticable
                and contrary to the public interest not to waive the delay in effective
                date of this IFC under section 801 of the CRA. We therefore find there
                is good cause to waive the CRA's delay in effective date pursuant to
                section 808(2) of the CRA. Furthermore, as noted above, the President
                declared that the COVID-19 outbreak in the United States constituted a
                national emergency beginning March 1, 2020. In addition, the
                Secretary's declaration of a PHE for the COVID-19 pandemic took effect
                on January 27, 2020. To ensure the availability of the measures we are
                taking to address the COVID-19 pandemic, we believe it is vital that
                many of the Medicare policies in this IFC apply starting either with
                the first day of the national emergency or the start of the PHE for the
                COVID-19 pandemic, as applicable. It is also important to ensure that
                health care providers that acted expeditiously to implement appropriate
                physical and
                [[Page 27609]]
                operational changes to their practices to adapt to emergency
                conditions, even in the absence of changes in our policies to address
                them, are not disadvantaged relative to other health care providers,
                and will not be discouraged from taking similar appropriate actions in
                the future. Specifically, in this IFC we have concentrated on
                increasing providers' ability to furnish services at temporary
                expansion locations, including the patient's home, that is a PBD of the
                hospital or an expanded CMHC to limit the need for patients to receive
                care in the hospital itself, which could unnecessarily expose the
                patients or providers to the pandemic contagion. For example, hospital
                staff can now remotely furnish psychotherapy to the beneficiary in
                their home, as long as the beneficiary is a registered outpatient of
                the hospital and the patient's home is made provider-based to the
                hospital. It is critical this provision be retroactive to the first day
                of the national emergency in order to ensure providers' have the
                necessary flexibilities to provide services at temporary expansion
                locations and to ensure beneficiaries continue to receive critical
                services, while limiting their exposure to the pandemic contagion. Both
                March 1, 2020, and January 27, 2020, precede the date of publication of
                this IFC in the Federal Register, which means that certain Medicare
                provisions of this rule have a retroactive effect. However, section
                1871(e)(1)(A)(ii) of the Act permits the Secretary to issue a rule for
                the Medicare program with retroactive effect if the failure to do so
                would be contrary to the public interest. As we have explained above,
                we believe it would be contrary to the public interest not to implement
                certain Medicare provisions of this IFC as soon as we are authorized to
                do so under the authority of section 1871(e)(1)(A)(ii) of the Act, that
                is, retroactively to either the start of the national emergency or the
                PHE for the COVID-19 pandemic, as applicable. Accordingly, the
                provisions in this IFC have retroactive applicability to March 1, 2020,
                or January 27, 2020, unless otherwise noted.
                 Separately, in light of the urgent need to provide the
                flexibilities under new paragraph (d) in Sec. 440.30 during the COVID-
                19 PHE, and because this provision will ease restrictions under
                existing law and make Medicaid coverage of testing more available, this
                provision will also be effective on March 1, 2020. Similarly, in light
                of the urgent need to provide the flexibilities in the amendments to
                Sec. 440.70 during the COVID-19 PHE, and because they will increase
                flexibility in the delivery of benefits and make Medicaid coverage of
                home health services more available, the amendments to Sec. 440.70
                will take effect on the same date as the Medicare regulations
                implementing section 3708 of the CARES Act, March 1, 2020. We are
                providing a 60-day public comment period for this IFC as specified in
                the DATES section of this document.
                 In this IFC, we are also delaying the date by which SNFs must start
                collecting and reporting data on the TOH Information to Provider-Post-
                Acute Care and TOH Information to Patient-Post-Acute Care quality
                measures and standardized patient assessment data elements (SPADEs)
                with respect to six categories for the SNF QRP. We are delaying these
                requirements because in response to stakeholder concerns, we have
                delayed the release of an updated version of the Minimum Data Set (MDS)
                that would have included the data elements that SNFs need to report
                these two quality measures and SPADEs. In the absence of a vehicle to
                report these data, SNFs cannot report them beginning with October 1,
                2020 admissions and discharges. We have taken the COVID-19 PHE into
                consideration in selecting a new compliance date, which will be on
                October 1st of the year that is at least two fiscal years after the PHE
                ends.
                 We find the notice-and-comment procedure impracticable because SNFs
                cannot comply with the reporting requirements for the two quality
                measures and SPADEs until CMS releases the updated MDS and SNFs have
                had an opportunity to become familiar with the updated version. Also,
                this IFC does not impose any additional requirements, but rather delays
                the compliance date for collecting and reporting the two quality
                measures and SPADEs. Therefore, we find good cause to waive notice-and-
                comment procedures and to issue this IFC without a delay of effective
                date.
                IV. Collection of Information Requirements
                 Under the Paperwork Reduction Act of 1995, we are required to
                provide 30-day notice in the Federal Register and solicit public
                comment before a collection of information requirement is submitted to
                the Office of Management and Budget (OMB) for review and approval. In
                order to fairly evaluate whether an information collection should be
                approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
                of 1995 (PRA) requires that we solicit comment on the following issues:
                 The need for the information collection and its usefulness
                in carrying out the proper functions of our agency.
                 The accuracy of our estimate of the information collection
                burden.
                 The quality, utility, and clarity of the information to be
                collected.
                 Recommendations to minimize the information collection
                burden on the affected public, including automated collection
                techniques.
                 We are soliciting public comment for the following sections of this
                document that contain information collection requirements (ICRs):
                A. ICRs Regarding Rules Relating to Separate Billing and Segregation of
                Funds for Abortion Services (Sec. 156.280)
                 This IFC does not impose any additional information collection
                burden under the PRA, and does not contain any information collection
                activities beyond the information collection currently awaiting
                approval by OMB under the control number: 0938-1358 (Billing and
                Collection of the Separate Payment for Certain Abortion Services (CMS-
                10681)).
                 Based on 2020 QHP certification data in the Federally-facilitated
                Exchanges (FFEs) and State-based Exchanges on the Federal Platform
                (SBE-FPs), in the 2019 Program Integrity Rule (84 FR 71674), we
                estimated that 23 QHP issuers will offer a total of 338 plans with
                coverage of non-Hyde abortion services in 9 FFE and SBE-FP states. We
                also estimated that in the 12 State Exchanges that will operate their
                own technology platforms in 2020, 71 QHP issuers will offer a total of
                approximately 1,129 plans that include coverage for non-Hyde abortions
                services. Three of those State Exchanges perform premium billing and
                payment processing, while the other 9 have their issuers perform
                premium billing and payment processing. In total, we estimated that
                there will be 94 QHP issuers offering a total of 1,467 plans
                (representing approximately 32 percent of individual market, on-
                Exchange plans) covering non-Hyde abortion services across 21 states in
                plan year 2020. With the 60-day delay, we continue to believe the one-
                time burden QHP issuers will incur to complete the necessary technical
                build to implement the changes for the separate billing policy will be
                incurred primarily in 2020. Therefore, we are unable to quantify any
                additional cost or savings related to the one-time technical build that
                would be attributable to this rule.
                 In the 2019 Program Integrity Rule, we estimated that each issuer
                and State Exchange performing premium billing and payment processing
                will incur
                [[Page 27610]]
                ongoing annual costs, such as those related to identifying impacted
                enrollees, ensuring billing accuracy, reconciliation, quality
                assurance, printing, recordkeeping, and document retention. The total
                burden for each issuer and State Exchange performing premium billing
                and payment processing was estimated to be 24,120 hours with an
                equivalent cost of $1.07 million. Delaying the implementation of the
                deadline for the separate billing policies by 60 days will result in a
                reduction in this burden. We estimate that the burden for each issuer
                and State Exchange performing premium billing and payment processing
                will be reduced by 4,020 hours with an equivalent cost reduction of
                approximately $177,629 in 2020. For all 97 issuers and State Exchanges
                performing premium billing and payment processing, the total reduction
                in burden in 2020 will be 389,940 hours with an equivalent cost
                reduction of approximately $17.4 million.
                 In addition, we estimated that issuers and State Exchanges
                performing premium billing and payment processing will need to print
                and send approximately 1.82 million separate paper bills per month in
                2020, incurring monthly costs of approximately $91,200. Delaying the
                implementation of the deadline for the separate billing policies by 60
                days will reduce the cost of printing separate bills in 2020 by
                approximately $182,400.
                 The revised burden estimates will be included in the next
                submission of the information collection to OMB.
                B. ICRs Regarding Temporary Extraordinary Circumstances Policy for
                Relocating Excepted Provider-Based Departments During the COVID-19 PHE
                 In section II.E. of this IFC, for purposes of enabling greater
                hospital flexibility, and, in particular, enabling hospitals to rapidly
                develop temporary expansion sites for patient care, we are temporarily
                adopting an expanded version of the extraordinary circumstances
                relocation policy during the COVID-19 PHE to include on-campus PBDs
                that relocate off-campus during the COVID-19 PHE for the purposes of
                addressing the COVID-19 pandemic. We note that this temporary
                extraordinary circumstances policy is time-limited to the PHE for
                COVID-19 to enable short-term hospital relocation of excepted off-
                campus and on-campus departments to improve access to care for patients
                during this time. The temporary extraordinary circumstances relocation
                policy established here will end following the end of the PHE for the
                COVID-19 pandemic, and we anticipate that most, if not all, PBDs that
                relocate during the COVID-19 PHE will relocate back to their original
                location prior to, or soon after, the COVID-19 PHE concludes.
                 In place of the process adopted in the CY 2017 OPPS/ASC final rule
                with comment period (81 FR 79704 through 79705) and included in the
                existing subregulatory guidance under which off-campus PBDs can apply
                for an extraordinary circumstance relocation exception, all hospitals
                that relocate excepted on- or off-campus PBDs to off-campus locations
                in response to the COVID-19 PHE should notify their CMS Regional Office
                by email of their hospital's CCN; the address of the current PBD; the
                address(es) of the relocated PBD(s); the date which they began
                furnishing services at the new PBD(s); a brief justification for the
                relocation and the role of the relocation in the hospital's response to
                COVID-19; and an attestation that the relocation is not inconsistent
                with their state's emergency preparedness or pandemic plan. We expect
                hospitals to include in their justification for the relocation why the
                new PBD location (including instances where the relocation is to the
                patient's home) is appropriate for furnishing covered outpatient items
                and services. To the extent that a hospital may relocate to an off-
                campus PBD that otherwise is the patient's home, only one relocation
                request during the COVID-19 PHE is necessary.
                 We estimate that 450 hospitals will request the temporary
                extraordinary circumstances exception for one or more excepted PBDs
                during the PHE. There are roughly 500 hospitals as identified by a
                unique CMS Certification Number (CCN) in the states of New York, New
                Jersey, Michigan, Washington, Massachusetts, and Louisiana. These
                states have some of the counties with the highest per-capita incidence
                of COVID-19, and we estimate that roughly 50 percent of the hospitals
                in those states will apply for an exception (roughly 250 hospitals) due
                to their need to relocate an on-campus or excepted off-campus PBD in
                response to the PHE. In the remaining states, we believe a smaller
                percent of hospitals in each state may also apply for the exception--
                resulting in a total of 450 hospitals.
                 We estimate that it will take each hospital 15 minutes to complete
                and submit the request to the CMS Regional Office. We believe that all
                hospitals will submit a maximum of one relocation request email (even
                though the request may include more than one location) and this request
                can include some of the same information (for example, the same CCN,
                original PBD address, and justification) for multiple sites as deemed
                appropriate by the hospital. We believe a Medical and Health Services
                Manager will develop and submit the relocation request to the CMS
                Regional Office. These employees have an average hourly wage rate of
                $55.35 based on the May 2019 Bureau of Labor and Statistics' Occupation
                Employment Statistics. (Citation: BLS code 11-9111, website for May
                2019 data here: >https://www.bls.gov/oes/current/oes119111.htm 5,000 currently unenrolled or non-opted out NPs, CNSs, and
                PAs will elect to enroll in or opt-out of Medicare solely for the
                purpose of certifying home health services. We believe they will do so
                in the first year following the effective date of this IFC.
                 1,000 new NPs, CNSs, and PAs each year will enroll in or
                opt-out of Medicare for the same purpose.
                 Physicians and practitioners complete the Form CMS-855O (Medicare
                Enrollment Application--Registration for Eligible Ordering and
                Referring Physicians and Non-Physician Practitioners) if they are
                enrolling in Medicare not to obtain Medicare billing privileges but
                strictly to order, refer, or certify certain Medicare items and
                services. The information collection for Form CMS-855O is currently
                approved under OMB control number 0938-1135 with an expiration date of
                December 31, 2021.
                 According to the most recent wage data provided by the Bureau of
                Labor
                [[Page 27611]]
                Statistics (BLS) for May 2019 (see http://www.bls.gov/oes/current/oes_nat.htm#43-0000), the mean hourly wage for the general category of
                ``Health Diagnosing and Treating Practitioners, All Others'' is $49.26.
                With fringe benefits and overhead, the per hour rate are $98.52. We
                also project that, on average, it takes individuals approximately .5
                hours to complete and submit the Form CMS-855O or an opt-out affidavit.
                 Given the foregoing, we estimate a first-year burden of 3,000 hours
                (0.5 hr x (5,000 + 1,000)) at a cost of $295,560. The annual burden in
                Year 2 and in Year 3 is 500 hours (0.5 hr x 1,000) at a cost of
                $49,260. This results in a total burden of 4,000 hours (3,000 hr + 500
                hr + 500 hr) at a cost of $394,080. When averaged over the typical 3-
                year OMB approval period, we estimate an annual burden of 1,333 hours
                (4,000 hr/3) at a cost of $131,360 ($394,080/3).
                 The information collection requirements in this section associated
                with Sec. 424.507 have been submitted to OMB for emergency review and
                approval in accordance with the implementing regulations of the PRA at
                5 CFR 1320.13.
                D. ICRs for Merit-Based Incentive Payment System (MIPS) Qualified
                Clinical Data Registry (QCDR) Measure Approval Criteria Sec. 414.1400
                 In section II.R. of this IFC, we are amending Sec.
                414.1400(b)(3)(v)(C) and (D) to delay the implementation of these
                policies by 1 year. Both QCDR measure approval criteria necessitate
                QCDRs collecting data from clinicians in order to assess the measure,
                and we anticipate that QCDRs may be unable to collect, and clinicians
                unable to submit, data on QCDR measures due to prioritizing the care of
                COVID-19 patients. Because these policies are not modifying the
                approval criteria for QCDR measures but are instead amending the
                timeline for implementation of previously finalized policies, we are
                not making any changes to our previously approved burden estimates.
                E. ICRs for the Hospital Value-Based Purchasing (VBP) Program
                 In section II.U. of this IFC, we are updating the Extraordinary
                Circumstance Exception (ECE) policy for the Hospital VBP Program to
                allow us to grant exceptions to hospitals which have not requested them
                when we determine that an extraordinary circumstance, such as PHE,
                including the current PHE for COVID-19, affects an entire region or
                locale. In a situation where we are granting such an exception for an
                entire region or locale, hospitals are not required to complete any
                forms or submit any additional information, therefore the program does
                not anticipate any change in burden associated with this IFC.
                F. ICRs for COVID-19 Reporting in Nursing Homes
                 We are revising the regulations by adding a provision at Sec.
                483.80(g) to require LTC facilities to electronically report
                information related to confirmed or suspected COVID-19 cases in a
                standardized format and frequency specified by the Secretary, but no
                less frequent than weekly. This information will be reported to the
                CDC's National Healthcare Safety Network (NHSN). As of April 14, 2020,
                there are approximately 15,446 LTC facilities listed in the CMS Nursing
                Home Compare database. As CMS will require these facilities to
                participate in data collection and reporting, we estimate that 95% of
                these facilities will report COVID-19 case data.
                 We have estimated that the COVID-19 LTC facility forms will take an
                average of 55 minutes to complete weekly, knowing that the reporting
                burden includes surveillance and data entry. We further estimate that
                LTC facility users will report these data on a weekly basis. The Module
                allows retrospective data collected from previous dates to be entered.
                Because OMB PRA approval is requested for 180 days, the total number of
                responses per respondent is 26. This burden will be submitted under the
                ICR titled National Healthcare Safety Network (NHSN) Patient Impact
                Module for Coronavirus (COVID-19) Surveillance in Healthcare Facilities
                (OMB Control Number 0920-1290). Details of this burden can be found in
                Table 1.
                 Table 1--Burden and Responses
                --------------------------------------------------------------------------------------------------------------------------------------------------------
                 Number Average burden Total
                 Type of respondent Form name Number of responses per per response Total burden Hourly wage respondent
                 respondents respondent (in hrs.) (in hrs.) rate costs
                --------------------------------------------------------------------------------------------------------------------------------------------------------
                LTCF personnel................. COVID-19 Module, Long- 9,782 26 15/60 63,583 $50.91 $3,237,011
                 Term Care Facility:
                 Staff and Personnel
                 Impact form.
                Business and financial COVID-19 Module, Long- 2,446 26 15/60 15,899 37.56 597,166
                 operations occupations. Term Care Facility:
                 Staff and Personnel
                 Impact form.
                State and local health COVID-19 Module, Long- 2,446 26 15/60 15,899 40.21 639,299
                 department occupations. Term Care Facility:
                 Staff and Personnel
                 Impact form.
                LTCF personnel................. COVID-19 Module, Long- 9,782 26 20/60 84,777 50.91 4,315,997
                 Term Care Facility:
                 Resident Impact and
                 Facility Capacity form.
                Business and financial COVID-19 Module, Long- 2,446 26 20/60 21,199 37.56 796,234
                 operations occupations. Term Care Facility:
                 Resident Impact and
                 Facility Capacity form.
                State and local health COVID-19 Module, Long- 2,446 26 20/60 21,199 40.21 852,412
                 department occupations. Term Care Facility:
                 Resident Impact and
                 Facility Capacity form.
                LTCF personnel................. COVID-19 Module, Long- 9,782 26 5/60 21,194 50.91 1,078,987
                 Term Care Facility:
                 Ventilator Capacity &
                 Supplies form.
                Business and financial COVID-19 Module, Long- 2,446 26 5/60 5,300 37.56 199,068
                 operations occupations. Term Care Facility:
                 Ventilator Capacity &
                 Supplies form.
                State and local health COVID-19 Module, Long- 2,446 26 5/60 5,300 40.21 213,113
                 department occupations. Term Care Facility:
                 Ventilator Capacity &
                 Supplies form.
                [[Page 27612]]
                
                LTCF personnel................. COVID-19 Module, Long- 9,782 26 15/60 63,583 50.91 3,237,011
                 Term Care Facility:
                 Supplies & Personal
                 Protective Equipment
                 form.
                Business and financial COVID-19 Module, Long- 2,446 26 15/60 15,899 37.56 597,166
                 operations occupations. Term Care Facility:
                 Supplies & Personal
                 Protective Equipment
                 form.
                State and local health COVID-19 Module, Long- 2,446 26 15/60 15,899 40.21 639,299
                 department occupations. Term Care Facility:
                 Supplies & Personal
                 Protective Equipment
                 form.
                 -----------------------------------------------------------------------------------------------
                 Total...................... ....................... .............. .............. .............. 349,731 .............. 16,402,763
                --------------------------------------------------------------------------------------------------------------------------------------------------------
                V. Response to Comments
                 Because of the large number of public comments we normally receive
                on Federal Register documents, we are not able to acknowledge or
                respond to them individually. We will consider all comments we receive
                by the date and time specified in the DATES section of this preamble,
                and, when we proceed with a subsequent document, we will respond to the
                comments in the preamble to that document.
                VI. Regulatory Impact Analysis
                A. Statement of Need
                 Throughout this IFC, we discuss several changes to payment and
                coverage policies intended to allow health care providers maximum
                flexibility to minimize the spread of COVID-19 among Medicare and
                Medicaid beneficiaries, health care personnel, and the community at
                large, and increase capacity to address the needs of their patients.
                The flexibilities and changes contained within this IFC are responsive
                to this developing pandemic emergency and to recent legislation that
                gives us additional authority. Given the potentially catastrophic
                impact to public health, it is difficult to estimate the economic
                impact of the spread of COVID-19 under current payment rules compared
                to the rules issued in this IFC.
                 We believe that the needs of Medicare and Medicaid beneficiaries
                suffering from COVID-19 will likely test the capacity of the health
                care system over the coming months. Our policies implemented in this
                IFC will provide flexibilities, during the PHE for COVID-19, to
                physicians and other practitioners, home health and hospice providers,
                FQHCs, RHCs, hospitals, critical access hospitals, CMHCs, IRFs, IPFs
                LTCHs, skilled clinical laboratories, providers of the laboratory
                testing benefit in Medicaid, Opioid Treatment Programs (OTPs), Shared
                Savings Program ACOs, and DMEPOS suppliers. These policies will likely
                minimize exposure risks to patients, clinicians and the general public.
                 The flexibilities available to hospitals and CMHCs to furnish
                certain outpatient services remotely will allow more of these services
                to be furnished in a manner that reduces the exposure risk to patients,
                hospital staff, and physicians. To the extent that hospitals use these
                flexibilities to care for patients who would have otherwise received
                care in more traditional hospital settings, they likely would not
                result in any significant change in aggregate Medicare payments for
                hospital services.
                 The policy to exclude temporarily added surge capacity beds when
                determining a teaching hospital's IME payments, may increase costs
                relative to those that would otherwise been incurred under current
                policies during the PHE for COVID-19; however, we estimate that there
                will not be a significant change in aggregate Medicare IME payments
                relative to current policies absent the PHE for COVID-19. A similar
                policy will also allow RHCs that are provider-based to a hospital to
                maintain their payment amounts levels if the hospital temporarily adds
                additional beds, which would otherwise disqualify them. Likewise, we
                are adopting a policy to maintain IRF and IPF average daily census
                numbers so that IRF and IPF teaching status adjustment payments do not
                decrease during the pandemic.
                 The changes to Medicare and Medicaid regulations to expand the
                scope of the practitioners who may order home health services are
                anticipated to eliminate some burdens on practitioners and
                beneficiaries. Similarly, the changes to Medicaid's regulations to
                expand the circumstances under which certain laboratory tests can be
                covered during a PHE and subsequent periods of active surveillance are
                anticipated to eliminate some burdens on providers and beneficiaries.
                The changes to the BHP regulations to allow states to submit a revised
                Blueprint retroactive to the start of the PHE for the COVID-19 pandemic
                will eliminate some burdens on states and will help ensure enrollees'
                increased access to coverage during the PHE for the COVID-19 pandemic.
                 The temporary increase to certain DME payment rates, as required by
                section 3712 of the CARES Act, will increase Medicare expenditures as
                well as beneficiary cost-sharing. Moreover, it is possible that the
                other flexibilities and changes contained within this IFC would
                increase aggregate Medicare or Medicaid services. Improvements in both
                provider and/or patient health are intended benefits of this IFC. For
                example, if the protections against exposure risk, such as teaching
                physicians remotely reviewing visits furnished by residents, are
                effective, providers may maintain their own health and thus be
                available to furnish more services overall.
                B. Overall Impact
                 We have examined the impacts of this rule as required by Executive
                Order 12866 on Regulatory Planning and Review (September 30, 1993),
                Executive Order 13563 on Improving Regulation and Regulatory Review
                (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
                1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the
                Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4),
                Executive Order 13132 on Federalism (August 4, 1999), the Congressional
                Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing
                Regulation and Controlling Regulatory Costs (January 30, 2017).
                 Executive Orders 12866 and 13563 direct agencies to assess all
                costs and benefits of available regulatory alternatives and, if
                regulation is necessary, to select regulatory approaches that maximize
                net benefits (including potential economic,
                [[Page 27613]]
                environmental, public health and safety effects, distributive impacts,
                and equity). Section 3(f) of Executive Order 12866 defines a
                ``significant regulatory action'' as an action that is likely to result
                in a rule: (1) Having an annual effect on the economy of $100 million
                or more in any 1 year, or adversely and materially affecting a sector
                of the economy, productivity, competition, jobs, the environment,
                public health or safety, or state, local or tribal governments or
                communities (also referred to as ``economically significant''); (2)
                creating a serious inconsistency or otherwise interfering with an
                action taken or planned by another agency; (3) materially altering the
                budgetary impacts of entitlement grants, user fees, or loan programs or
                the rights and obligations of recipients thereof; or (4) raising novel
                legal or policy issues arising out of legal mandates, the President's
                priorities, or the principles set forth in the Executive Order.
                 Executive Order 12866 and other laws and Executive Orders require
                economic analysis of the effects of proposed and final (including
                interim final) rules.\64\ The Office of Management and Budget has
                designated this rulemaking as ``economically significant'' under E.O.
                12866 and also major under the Congressional Review Act.
                ---------------------------------------------------------------------------
                 \64\ Section 202 of the Unfunded Mandates Reform Act of 1995
                (UMRA) (Pub. L. 104-04, enacted on March 22, 1995) also requires
                that agencies assess anticipated costs and benefits before issuing
                any rule whose mandates require spending in any 1 year of $100
                million in 1995 dollars, updated annually for inflation. In 2020,
                that amount is approximately $156 million. This IFC does not
                mandate, on an unfunded basis, any requirements for State, local, or
                tribal governments, or for the private sector.
                ---------------------------------------------------------------------------
                 This IFC's designation under Executive Order 13771, titled Reducing
                Regulation and Controlling Regulatory Costs (82 FR 9339), which was
                issued on January 30, 2017, will be informed by public comments
                received.
                 The RFA requires agencies to analyze options for regulatory relief
                of small entities, if a rule has a significant impact on a substantial
                number of small entities. The great majority of hospitals and most
                other health care providers and suppliers are small entities, either by
                being nonprofit organizations or by meeting the SBA definition of a
                small business (having revenues of less than $8.0 million to $41.5
                million in any 1 year). Individuals and states are not included in the
                definition of a small entity. As its measure of significant economic
                impact on a substantial number of small entities, HHS uses an adverse
                change in revenue of more than 3 to 5 percent. We do not believe that
                this threshold will be reached by the provisions in this IFC.
                 In addition, section 1102(b) of the Act requires us to prepare a
                regulatory impact analysis if a rule may have a significant impact on
                the operations of a substantial number of small rural hospitals. This
                analysis must conform to the provisions of section 604 of the RFA. For
                purposes of section 1102(b) of the Act, we define a small rural
                hospital as a hospital that is located outside of a metropolitan
                statistical area and has fewer than 100 beds. This IFC will not have a
                significant impact on the operations of a substantial number of small
                rural hospitals.
                 Executive Order 13132 establishes certain requirements that an
                agency must meet when it issues a proposed rule that imposes
                substantial direct requirement costs on state and local governments,
                preempts state law, or otherwise has Federalism implications. This IFC
                does not have a substantial direct cost impact on state or local
                governments, preempt state law, or otherwise have federalism
                implications.
                C. Detailed Economic Analysis of the Provisions of the IFC
                1. Reporting Under the Home Health Value-Based Purchasing Model for CY
                2020 During the COVID-19 Public Health Emergency
                 Section II.A. of this IFC implements a policy to align HHVBP Model
                data submission requirements with any exceptions or extensions granted
                for purposes of the HH QRP during the PHE for the COVID-19 pandemic, as
                well as a policy for granting exceptions to the New Measures data
                reporting requirements under the HHVBP Model during the PHE for the
                COVID-19 pandemic. We do not anticipate a change to Medicare
                expenditures as a result of this policy. However, we expect reduced
                burden on providers.
                2. Scope of Practice
                 Section II.B. of this IFC implements several policies to
                temporarily add flexibility for certain nonphysician healthcare
                professionals in supervision, documentation and other requirements of
                the Medicare program that could impact the availability and efficiency
                of care. As discussed in section II.B. of this IFC, several states have
                sought to increase pharmacist capacity by relaxing supervision
                requirements during the PHE for COVID-19. We expect that, especially
                when coupled with policies adopted by states, the temporary flexibility
                and clarification we provide in this IFC will increase capacity for
                pharmacists and other healthcare practitioners. We anticipate that
                these changes could possibly result in higher Medicare expenditures
                because, although the changes primarily modify supervision
                requirements, without a corresponding change in payment rate, the added
                flexibility could result in a higher volume of services. We anticipate
                that the changes will allow the same services that were occurring
                before the PHE to continue during the PHE; however, expenditures could
                increase if additional services are furnished. To the extent that
                expenditures increased due to increases in service volume, this would
                represent a cost to the Federal Government.
                3. Modified Requirements for Ordering COVID-19 Diagnostic Laboratory
                Tests
                 Section II.C. of this IFC implements a policy to allow Medicare
                beneficiaries to get COVID-19 and other related testing during the
                COVID-19 PHE without requiring the order of the treating physician or
                practitioner, and instead allowing the testing to be ordered by any
                healthcare professional who is authorized to do so under applicable
                state law. We do not anticipate that this change will affect overall
                Medicare expenditures over time because we expect that the change would
                accelerate the timing of COVID-19 testing that would otherwise have
                occurred over a longer timeframe.
                4. Opioid Treatment Programs--Furnishing Periodic Assessments via
                Communication Technology
                 Section II.D. of this IFC implements a change to allow periodic
                assessments furnished by OTPs to be furnished via two-way interactive
                audio-video communication technology, and in cases where beneficiaries
                do not have access to two-way audio/video communications technology, to
                allow periodic assessments to be furnished using audio-only telephone
                calls rather than via two-way interactive audio-video communication
                technology, provided all other applicable requirements are met. This
                change will not result in an increase in Medicare expenditures because
                the add-on payment for these services was available prior to the PHE
                for COVID-19 and because this change only provides OTPs additional
                flexibilities regarding the manner in which they furnish these services
                during the pandemic.
                5. Treatment of Certain Relocating Provider-Based Departments During
                the PHE
                 Section II.E. of this IFC adopts a temporary extraordinary
                circumstances relocation exception policy for on-
                [[Page 27614]]
                campus and excepted off-campus PBDs that relocate off-campus in
                response to the PHE that permits the PBDs that relocate to continue to
                be paid under the OPPS. This policy could drive slightly higher
                spending during the PHE than would otherwise occur, but generally it
                would maintain current payment rates to on-campus and excepted off-
                campus PBDs in the event of a temporary relocation due to the PHE for
                COVID-19. These policies would be time limited and we do not believe
                they would result in higher use of services; rather they would allow
                services furnished by these relocated departments to continue to be
                paid at the higher rate under the OPPS, rather than at the lower PFS-
                equivalent rate if these excepted PBDs relocated off-campus outside of
                the PHE and were not granted an extraordinary circumstances relocation
                exception.
                 Overall there would be minimal change in the types of patients
                treated under these policies compared to the absence of these policy
                changes. To the extent that Medicare expenditures increased, it would
                represent a transfer from the Federal Government to hospitals paid
                under the OPPS.
                6. Furnishing Hospital Outpatient Services Remotely
                 Section II.F. of this IFC discusses flexibilities under which
                certain outpatient services, including PHP services furnished by a
                hospital or CMHC in the beneficiary's home, can be furnished remotely
                during the PHE for COVID-19. These changes will not result in higher
                costs because they only provide flexibility for providers to continue
                to furnish these services during the pandemic.
                7. Medical Education
                 Section II.G. of this IFC implements a policy that excludes
                temporarily added surge capacity beds when determining a teaching
                hospital's IME payments. This policy could increase costs relative to
                the baseline IME payments that would be established under current
                payment rules if teaching hospitals temporarily add beds given the
                COVID-19 PHE, but will mitigate changes in IME payments relative to
                their levels before the COVID-19 PHE. To the extent that IME payments
                do change, the changes in payments would represent a transfer between
                teaching hospitals and the Federal Government (that is, an increase in
                payments would be a transfer from the Federal Government to teaching
                hospitals, and vice versa).
                 This section also implements a policy to hold, for the duration of
                the COVID-19 PHE, IRF and IPF teaching status adjustment payments at
                their values prior to the COVID-19 PHE. This will mitigate changes in
                teaching adjustment payments relative to their levels before the COVID-
                19 PHE. To the extent that teaching adjustment payments did change, the
                changes would represent a transfer between IPFs or IRFs and the Federal
                Government (with an increase in payments being a transfer from the
                Federal Government to IPFs or IRFs, and vice versa).
                 This section also implements a policy to allow, for the duration of
                the COVID-19 PHE, teaching hospitals to claim, towards their resident
                FTE counts, residents that teaching hospitals send to other hospitals
                to respond to the PHE associated with COVID. To the extent that
                hospitals are not sending or accepting residents because of our current
                regulations, and those residents continue to train at the home teaching
                hospitals, allowing the residents to train elsewhere is budget neutral.
                The hospitals would continue to get paid the same GME payments that
                they would have received if the residents had continued to train at the
                home hospitals. No other hospitals would receive additional GME
                payments for that resident training.
                8. Rural Health Clinics
                 Section II.H. of this IFC implements a policy that excludes
                temporarily added surge capacity beds from a hospital's bed count for
                the purposes of determining whether a RHC that is provider-based to
                that hospital is subject to a per-visit national payment limit. We do
                not anticipate that this policy would increase the number of RHCs that
                would not be subject to the payment limit; rather, it would ensure
                those RHCs who were not subject to the limit prior to the PHE maintain
                that status. This policy could increase costs relative to the baseline
                of current payment rules and the PHE, but will mitigate changes in
                costs relative to their levels before the COVID-19 PHE. To the extent
                payments to RHCs increased, it would represent a transfer from the
                Federal Government to RHCs.
                9. DME Interim Pricing in the CARES Act
                 Section II.I. of this IFC implements the temporary increase to
                certain DME payment rates, as required by section 3712 of the CARES
                Act. Section 3712 of the CARES Act increases Medicare expenditures, as
                well as beneficiary cost-sharing by increasing Medicare payment rates
                for certain DMEPOS items furnished in non-rural and contiguous non-
                competitively bid areas.
                 The increase is a result of paying a blend of 75 percent of the
                fully adjusted payment rates and 25 percent of the unadjusted payment
                rates and is estimated to increase affected rates on average 33%.
                However, the estimated Medicare gross benefit cost against the FY 2021
                President's Budget baseline is $140 million dollars. It would represent
                a transfer from the Federal Government to DMEPOS suppliers and a
                transfer from beneficiaries to the Federal Government. This change may
                also affect the federal financial participation limit for DMEPOS items
                and services furnished to Medicaid beneficiaries, but we are unable to
                quantify the effect.
                10. Care Planning for Medicare Home Health Services
                 Section II.J. of this IFC implements conforming regulations text
                changes required by section 3708 of the CARES Act. We believe that
                section 3708 of the CARES Act will have a negligible impact on Medicare
                expenditures. NPPs generally work in collaboration with or under the
                supervision of a physician; therefore, utilization is unlikely to
                change substantially as a result of the CARES Act. In areas where NPPs
                are able to act independently under their state scopes of practice and
                where physicians are scarce, there may be a slight increase in
                utilization; however, we are unable to quantify the impact. Although
                the majority of states require physician collaboration for these NPPs,
                we note that even in states that allow independent practice authority,
                many of these practitioners continue to work in a practice environment
                (inpatient facility or outpatient or physician's office) that includes
                a physician.
                11. CARES Act Waiver of the ``3-Hour Rule'' and Modification of IRF
                Coverage and Classification Requirements for Freestanding IRF Hospitals
                for the PHE During the COVID-19 Pandemic
                 Section II.K. of this IFC amends section Sec. 412.622(a)(3)(ii)
                (commonly referred to as the ``3-hour rule'') to address the waiver
                required by section 3711(a) of the CARES Act during the emergency
                period described in section 1135(g)(1)(B) of the Act and amends Sec.
                412.29(d), (e), (h), and (i) and Sec. 412.622(a)(3), (4), and (5) to
                add an exception for patients admitted solely for care furnished to
                patients in an IRF solely to relieve acute care hospital capacity in a
                state (or region, as applicable) that is experiencing a surge during
                the PHE. We expect that the waiver required by the CARES Act will
                increase Medicare expenditures because it will increase the volume of
                patients admitted to IRFs and paid for under the
                [[Page 27615]]
                IRF PPS. However, we do not expect that the other changes to Sec.
                412.29(d), (e), (h), and (i) and Sec. 412.622(a)(3), (4), and (5) for
                freestanding IRF hospitals will increase the IRF volume of cases beyond
                the increases that will already be expected to occur as a result of the
                CARES Act. Moreover, these changes are likely to minimize exposure
                risks to patients, clinicians, and the general public. To the extent
                that Medicare expenditures increase, it would represent a transfer from
                the Federal Government to IRFs.
                12. Shared Savings Program
                 Changes to the Shared Savings Program as described in section II.L.
                of this IFC are estimated to reduce program spending relative to a
                status quo baseline by preventing COVID-19-related treatment costs from
                causing highly variable and uncertain distortions in the calculation of
                shared savings and shared losses for individual ACOs and by offering
                flexibilities that are expected to help retain ACO participation in the
                face of broader uncertainties from the historic disruption caused by
                the COVID-19 pandemic. In modeling the impacts of these changes, we
                used ACO performance data from performance year 2018 to simulate 2020
                performance, and included assumptions for variation in COVID-19
                spending and a decline in elective services and the deferral of other
                services. In modeling the impact of these changes, we considered the
                following:
                 Based on a typical year, we assumed up to a 20 percent
                reduction in expenditures for 2020 because of a decline in elective
                services and the deferral of other services, and we assumed increases
                in expenditures due to COVID-19 inpatient treatment and related
                spending. We estimate that this variation in COVID-19 related spending
                would roughly double the standard deviation in gross measured savings
                and losses (expressed as a percentage of benchmark) that would have
                been determined across all ACOs participating in PY 2020.
                 Absent flexibilities to encourage continued participation
                (by allowing a voluntary 1-year extension for ACOs whose agreement
                periods expire on December 31, 2020, and allowing ACOs to maintain
                participation at the same level of the BASIC track's glide path for
                performance year 2021) and an adjustment to certain program
                calculations to remove payment amounts for episodes of care for
                treatment of COVID-19, we project that up to 30 percent of all ACOs
                would elect to discontinue their participation. This would represent a
                significant increase in the program's attrition rate, which was 16
                percent in 2019 and has been 11 percent on average.\65\ Further, based
                on a recent National Association of ACOs (NAACOS) survey, 56 percent of
                risk-based ACOs may leave the program due to concerns about having to
                pay shared losses in 2020 because of costs incurred in treating COVID-
                19.\66\
                ---------------------------------------------------------------------------
                 \65\ Verma S. Number of ACOs Taking Downside Risk Doubles Under
                `Pathways To Success'. Health Affairs. January 10, 2020. Available
                at https://www.healthaffairs.org/do/10.1377/hblog20200110.9101/full/
                .
                 \66\ NAACOS, Survey Shows ACOs' Concerns About the Effect of
                COVID-19. Available at https://www.naacos.com/assets/docs/pdf/2020/SurveyReportACO-EffectsCOVID19-04132020.pdf.
                ---------------------------------------------------------------------------
                 A key new flexibility is the allowance for ACOs in the last
                performance year of their current agreement period (mainly Track 1 ACOs
                and Track 1+ Model ACOs) to elect to extend their agreement period by
                an additional performance year in 2021. The anticipated resulting
                increase in retention of existing ACOs that would have otherwise been
                unlikely to renew in the face of pandemic uncertainty is estimated to
                lower net program spending (that is, increase federal savings) by $100
                million (ranging from $90 to $120 million) despite potential increases
                in shared savings payments to certain ACOs that will benefit from the
                additional year under their existing agreement period for which the
                ACO's historical benchmark is established, adjusted, updated, and reset
                (as applicable) according to the methodologies specified in Sec. Sec.
                425.602 and 425.603.
                 Another important new flexibility allows certain ACOs to
                temporarily freeze their position along the BASIC track's glide path,
                which will allow some ACOs to avoid transitioning to a higher level of
                performance-based risk for performance year 2021. This flexibility is
                also estimated to decrease program spending (increase federal savings)
                mainly by reducing the chance that risk-averse ACOs would drop out of
                the Shared Savings Program rather than transition to a higher level of
                performance-based risk for performance year 2021. For example, ACOs
                opting to remain in Level B instead of transitioning to Level C or
                higher risk and reward (such as Level E, which qualifies as an Advanced
                APM) for performance year 2021 would in effect accept a lower savings
                sharing rate (and their participating ACO providers/suppliers would
                forgo potential incentive payments from qualifying as participating in
                an Advanced APM) in exchange for elimination of performance-based risk
                in the face of elevated uncertainty. The net effect of offering this
                flexibility is estimated to be a $60 million reduction in federal
                spending, with the reduction ranging from $0 to $170 million.
                 In modeling the impact of forgoing the application cycle for a
                January 1, 2021 agreement start date, we considered a combination of
                factors. Not offering an application cycle for a 2021 start date helps
                to mitigate any complexity arising from the use of 2020 as a benchmark
                year, when expenditures for 2020 could be extremely unusual given the
                COVID-19 pandemic and the related disruption to normal health care
                utilization. In particular, forgoing a January 1, 2021 agreement start
                date prevents 2020 serving as benchmark year 3, which is most heavily
                weighted in the case of ACOs entering a first agreement period (Sec.
                425.601(a)(7)).
                 In addition, maintaining an application cycle for a January 1, 2021
                start date could result in a scenario where only a small number of
                organizations are able to devote resources to applying to participate
                (or renew their participation) in the Shared Savings Program given the
                impact of the COVID-19 pandemic on their operations and the challenges
                facing providers and suppliers. There is a particular risk that the
                unusual circumstances surrounding the COVID-19 pandemic could result in
                selective participation by only those ACOs that find their historical
                benchmark, for whatever reason, would provide for large windfall shared
                savings payments over a 5-year agreement period. Therefore, forgoing
                the application cycle for a January 1, 2021 start date is estimated to
                mitigate such selective participation and therefore reduce program
                spending by $150 million (with the reduction estimate ranging from $0
                to $410 million).
                 The most significant impact is estimated to result from the new
                policy to adjust certain Shared Savings Program calculations to remove
                Parts A and B expenditures for episodes of care for treatment of COVID-
                19. Failing to remove this spending would likely create highly variable
                shared savings and shared losses results for individual ACOs that
                happen to have over-representation or under-representation of COVID-19-
                related hospitalizations in their assigned beneficiary population. At
                baseline, such variability would likely produce windfall payments to
                certain ACOs while causing other ACOs with significant exposure to
                COVID-19 in their assigned beneficiary populations to potentially leave
                the Shared Savings Program. Excluding
                [[Page 27616]]
                expenditures for these episodes of care for treatment of COVID-19 from
                the specified financial calculations under the Shared Savings Program
                is anticipated to reduce program spending by $1,110 million (reduction
                estimate ranging from $560 to $1,710 million) mainly by preventing
                windfall payments of shared savings to ACOs favored by such extreme
                variation.
                 By reducing program spending (even at the low-magnitude end of the
                range of uncertainty), this change to exclude payment amounts for
                episodes of care for treatment of COVID-19 necessarily satisfies the
                requirement under section 1899(i)(3)(B) of the Act that program
                spending not exceed spending that would have occurred under a
                hypothetical version of the program that would not have utilized
                flexibilities allowed under section 1899(i)(3) of the Act. The
                adjustments to expenditure and revenue calculations to mitigate the
                impact of COVID-19 that require the use of our authority under section
                1899(i)(3) of the Act will only lower anticipated program spending
                further below the hypothetical baseline compared to what we have
                determined in previous rulemaking to meet the requirements of section
                1899(i)(3)(B) of the Act.\67\ Therefore, we believe that the
                adjustments to remove payment amounts for episodes of care for
                treatment of COVID-19 from the calculation of performance year
                expenditures, updates to the historical benchmark, and ACO
                participants' Medicare FFS revenue used to determine the loss sharing
                limit in the two-sided models of the BASIC track, meet the requirements
                for use of our authority under section 1899(i)(3) of the Act.
                ---------------------------------------------------------------------------
                 \67\ See for example, 81 FR 38011 and 38012, and 83 FR 68060.
                ---------------------------------------------------------------------------
                 In total, the changes to the Shared Savings Program described in
                this IFC are estimated to reduce program spending by $1.43 billion over
                the 2020 to 2025 period (ranging from a reduction of $790 million to
                $2.12 billion), with most of the reduction ($1.11 billion) attributable
                to performance year 2020.
                 Table 2 provides our best estimate, net of shared savings payments
                to ACOs, of the change in resource use and transfers between the
                Federal Government and ACOs and ACO providers/suppliers as a result of
                the changes to the Shared Savings Program included in this IFC. The
                change in expenditures is classified as a net change in expenditures
                because it is a mix of transfers between the Federal Government and
                ACOs and other Medicare-enrolled providers, suppliers, and
                practitioners as well as real changes in resource use. At this time, we
                are unable to separately estimate transfers and real changes in
                resource use.
                 As shown Table 2, the net change in expenditures to the Federal
                Government associated with the Shared Savings Program policies in this
                IFC is estimated at -$1.1 billion for performance year 2020, -$0.13
                billion for performance year 2021, -$0.05 billion for performance years
                2022 and 2023, and -$0.04 billion for performance years 2024 and 2025.
                We present the estimates as undiscounted streams over 6 performance
                years rather than annualized streams because we estimate that more than
                75 percent of the total change will accrue to performance year 2020.
                 Table 2--Estimated Net Savings to Medicare Program From Shared Savings
                 Program Policies
                ------------------------------------------------------------------------
                 Performance year Net change in expenditures
                ------------------------------------------------------------------------
                2020...................................... -$1.11 billion.
                2021...................................... -$0.13 billion.
                2022...................................... -$0.05 billion.
                2023...................................... -$0.05 billion.
                2024...................................... -$0.04 billion.
                2025...................................... -$0.04 billion.
                ------------------------------------------------------------------------
                Note: Performance years co-occur with calendar years. Negative values
                 reflect a reduction in federal net cost. Net change in expenditures
                 includes both changes in real resource use and transfers between the
                 Federal Government and ACOs and Medicare-enrolled suppliers,
                 providers, and practitioners.
                13. Additional Flexibility Under the Teaching Physician Regulations
                 Section II.M. of this IFC discusses changes to allow teaching
                physicians to review the services furnished by residents, as required
                under the primary care exception rules, remotely through virtual means
                via interactive telecommunications technology during the PHE for COVID-
                19. This change will give teaching physicians additional flexibilities
                to direct the care furnished by residents remotely to minimize exposure
                risks to patients, clinicians, and the general public; and there would
                be no change in Medicare payment rates or change in the types of
                patients treated under this policy compared to the absence of this
                policy change. Aggregate Medicare expenditures could increase if the
                changes allow residents to furnish more services with remote
                supervision from teaching physicians. To the extent that Medicare
                expenditures increase because residents furnish more services, this
                change will represent a cost to the Federal Government.
                14. Payment for Audio-Only Telephone Evaluation and Management Services
                 Section II.N. of this IFC increases payment rates, for the duration
                of the PHE for COVID-19, for telephone E/M visits to match payment
                rates under the PFS for office/outpatient visits with established
                patients. We expect that these increases in payment rates will not
                result in higher aggregate Medicare expenditures as long as these
                telephone E/M visits fully substitute during the pandemic for in-person
                or telehealth E/M visits that otherwise would have occurred. Absent the
                increase in payment rates, it is unlikely that telephone E/M visits
                would have served as an alternative for in-person or telehealth E/M
                visits to the same extent as could occur with the increase in payment
                rates. However, it is also possible that this provision would increase
                aggregate Medicare payments. For example, if the protections against
                exposure risk are effective, physicians may maintain their own health
                and thus be available to furnish more services overall. Improvements in
                the health of patients and physicians are intended benefits of this
                provision. If additional services are furnished, Medicare expenditures
                will increase, resulting in a cost to the Federal Government.
                15. Flexibility for Medicaid Laboratory Services
                 Section II.O. of this IFC implements revisions to the Medicaid
                laboratory benefit at Sec. 440.30 to provide states with flexibility
                to provide Medicaid coverage for laboratory tests and X-ray services
                that may not meet certain requirements in Sec. 440.30(a) or (b) (such
                as the requirement that tests be furnished in an office or similar
                facility) during periods of a PHE resulting from an outbreak of
                communicable disease and during any subsequent periods of active
                surveillance. The purpose of such laboratory and X-ray services must be
                to diagnose or detect SARS-CoV-2, antibodies to SARS-CoV-2, COVID-19,
                or the communicable disease named in the PHE or its causes, and the
                deviation from the requirements in Sec. 440.30 (a) or (b) must be
                intended to avoid transmission of the communicable disease. This change
                is not estimated to have a significant impact on federal expenditures
                for the Medicaid program.
                16. Improving Care Planning for Medicaid Home Health Services
                 Section II.P. of this IFC implements revisions to the Medicaid home
                health benefit at Sec. 440.70 to expand the scope of practitioners who
                may order home health services. This change is not
                [[Page 27617]]
                estimated to have a significant impact on federal expenditures for the
                Medicaid program.
                17. Basic Health Program (BHP) Blueprint Revisions
                 Section II.Q. of this IFC provides flexibility to states that
                operate a BHP to seek certification of temporary revisions that make
                significant changes to their respective Blueprint that are directly
                tied to the PHE for the COVID-19 pandemic and increase access to
                coverage. A state operating a BHP can seek to apply these revisions
                retroactively to the start of the PHE for the COVID-19 pandemic. Such
                revisions would expire at the end of the PHE, or a reasonable later
                date as certified by HHS. This change is not estimated to have a
                significant impact on federal expenditures for the BHP.
                18. Merit-Based Incentive Payment System (MIPS) Qualified Clinical Data
                Registry (QCDR) Measure Approval Criteria
                 Section II.R. of this IFC amends Sec. 414.1400(b)(3)(v)(C) and (D)
                to delay the implementation of these policies by 1 year. Both QCDR
                measure approval criteria necessitate QCDRs collecting data from
                clinicians in order to assess the measure, and we anticipate that QCDRs
                may be unable to collect, and clinicians unable to submit, data on QCDR
                measures due to prioritizing the care of COVID-19 patients. This delay
                will not affect reporting burden for QDCRs or clinicians; therefore,
                there is no expected impact.
                19. Application of Certain National Coverage Determination and Local
                Coverage Determination Requirements During the PHE for the COVID-19
                Pandemic
                 Section II.S.2. of this IFC exercises enforcement discretion for
                LCDs related to clinical indications for therapeutic continuous glucose
                monitors. This policy may temporarily allow additional beneficiaries to
                be covered by Medicare for home use of therapeutic continuous glucose
                monitors during the PHE for the COVID-19 pandemic including diabetic
                patients with COVID-19 infections. While this should be a small and
                temporary increase in the use of therapeutic continuous glucose
                monitors it is possible that this increase will be offset by a
                reduction in hospitalizations. Additionally, patients using therapeutic
                continuous glucose monitors may be able to reduce their use of other
                diabetic testing supplies which could also contribute to offsetting
                costs.
                20. Delay in the Compliance Date of Policies Adopted for the IRF QRP,
                LTCH QRP, HH QRP and SNF QRP
                 Section II.T. of this IFC delays certain reporting requirements for
                policies adopted for the IRF QRP, LTCH QRP, HH QRP, and SNF QRP. We do
                not anticipate any economic impact as a result of the delay.
                21. Update to the Hospital Value-Based Purchasing (VBP) Program
                Extraordinary Circumstance Exception Policy
                 Section II.U. of this IFC updates the Hospital VBP Program's ECE
                policy to more closely align that policy with the ECE policies of CMS'
                other hospital QRP and VBP program, and to also provide more
                flexibility to hospitals confronted with unforeseen extraordinary
                circumstances beyond their control. Under the current policy, a
                hospital must submit the Hospital VBP Program ECE request form,
                including any available evidence of the impact of the extraordinary
                circumstances on the hospital's quality measure performance, within 90
                calendar days of the date on which the natural disaster or other
                extraordinary circumstance occurred (78 FR 50706). We are retaining
                this policy as well as introducing a new policy that allows us to grant
                an ECE to hospitals affected by an extraordinary circumstance, such as
                the COVID-19 PHE, within an entire region or locale without requiring
                that each affected hospital individually submit an ECE request form.
                 The existing individual ECE request form policy is accounted for in
                the currently approved Hospital Inpatient Reporting PRA package, OMB
                control #0938-1022. There are no changes to the individual ECE request
                form policy and therefore no changes to the burden associated with the
                HVBP program.
                 The updated policy that allows CMS to grant exceptions for entire
                regions, including the entire United States, during an extraordinary
                circumstance, does not require hospitals to submit any documentation:
                Therefore, we do not anticipate any change in burden or costs for the
                Hospital VBP Program based on the changes to the ECE policy set forth
                in this IFC.
                22. COVID-19 Serology Testing
                 Section II.V. of this IFC provides for national coverage of COVID-
                19 FDA-authorized serology tests for certain Medicare beneficiaries
                during the PHE for the COVID-19 pandemic. It is unclear to what extent
                this test will increase Medicare expenditures. The cost to Medicare
                will be primarily dependent on the availability of testing, the price
                of the test and the length of the PHE. While the tests are new and have
                not previously been covered by Medicare it is possible that some of the
                cost of furnishing the test will be offset. As a result of serology
                testing there may be patients identified as not having had an immune
                response to COVID-19. If these patients take preventive measures to
                reduce their risk of infection as a result of this information then
                they may avoid COVID-19 infections, related hospitalizations and
                additional costs to Medicare.
                23. Certification of Home Health Services--Revision to Sec. 424.507
                 In section II.W. of this IFC, we discuss the provision to allow
                certain NPPs the ability to certify a patient's need for home health
                services. Previously only physicians were eligible to certify the need
                for home health under Medicare. The majority of NPPs are likely already
                enrolled in the Medicare program and will not need to take any
                additional enrollment actions. However, we estimate that approximately
                5,000 currently unenrolled or non-opted out NPs, CNSs, and PAs will
                elect to enroll in or opt-out of Medicare solely for the purpose of
                certifying home health services. We believe they will do so in the
                first year following the effective date of this IFC; moreover, 1,000
                new NPs, CNSs, and PAs each year will enroll in or opt-out of Medicare
                for the same purpose.
                24. Separate Billing and Segregation of Funds for Abortion Services
                 In light of the immediate need for QHP issuers and Exchanges to
                divert resources to responding to COVID-19, we are delaying
                implementation of the separate billing policy for 60 days as discussed
                in section II.X. of this IFC. Under this 60-day extension, QHP issuers
                must comply with the separate billing policies finalized at Sec.
                156.280(e)(2)(ii) beginning on or before their first billing cycle
                following August 26, 2020. We estimate that delaying the implementation
                deadline for the separate billing policies by 60 days will not result
                in substantial changes to the one-time implementation costs as
                estimated in the 2019 Program Integrity final rule. Some issuers and
                State Exchanges may have already sent notices to enrollees informing
                them of the separate billing and payment requirements and may now have
                to send additional notices to inform them of the change. In such cases,
                the reduction in ongoing costs will be lower. We request comment that
                would allow for refinement of the upfront and ongoing
                [[Page 27618]]
                cost savings estimates. Reduction in costs directly related to printing
                and sending of separate bills for issuers and State Exchanges that
                perform premium billing and payment processing have been discussed
                previously in the ``Collection of Requirements'' section of this IFC.
                 In the 2019 Program Integrity final rule, we estimated that issuers
                and State Exchanges that perform premium billing and payment processing
                will each incur ongoing annual costs of approximately $1 million
                associated with activities such as processing and reconciling separate
                payments, support for enrollees who enter grace period for non-
                payments, customer service, outreach and compliance. Delaying the
                implementation by 60 days will reduce these ongoing costs by
                approximately $16.2 million for all 94 issuers and 3 State Exchanges
                that perform premium billing and payment processing. We also estimated
                that each of the 12 State Exchanges will incur ongoing annual costs
                associated with increased customer service, outreach, and compliance,
                estimated to be approximately $200,000 for the 6 months in 2020. The
                60-day delay in implementation will reduce these ongoing costs in 2020
                by approximately $0.8 million for all 12 Exchanges. In addition, we
                estimated that the FFEs will incur ongoing costs of approximately
                $400,000 for the 6 months in 2020. The delay in implementation will
                reduce the ongoing costs in 2020 by approximately $133,333.
                 Consumers will also experience a reduction in burden. In the 2019
                Program Integrity final rule, we estimated that issuers and State
                Exchanges performing premium billing and payment processing will be
                required to send a separate bill to approximately 2 million policy
                holders and that consumers will incur a burden of 5 minutes per month
                after the initial month to read and understand the separate bill.
                Delaying the implementation by 60 days will result in a burden
                reduction of 10 minutes (at a cost of $12.37 per hour) in 2020 for each
                consumer. For approximately 2 million policyholders, the total
                reduction in burden in 2020 will be approximately 337,793 hours with an
                equivalent cost savings of approximately $4.2 million.
                25. Requirement for Facilities To Report Nursing Home Residents and
                Staff Infections, Potential Infections, and Deaths Related to COVID-19
                 Section II.Y. of this IFC revises the infection prevention and
                control requirements for LTC facilities to more effectively respond to
                the specific challenges posed by the COVID-19 pandemic. Specifically,
                we are adding provisions to require facilities to electronically report
                information related to confirmed or suspected COVID-19 cases in a
                standardized format and frequency specified by the Secretary and
                requiring facilities to inform residents and their representatives of
                confirmed or suspected COVID-19 cases in the facility among residents
                and staff. As discussed in the Collection of Information section, we
                expect a burden increase of $16,402,763 attributed to the CDC's NHSN
                collection (OMB Control #0920-1290).
                26. Time Used for Level Selection for Office/Outpatient Evaluation and
                Management Services Furnished Via Medicare Telehealth
                 Section II.Z. of this IFC implements a policy that for the duration
                of the PHE for the COVID-19 pandemic, the typical times for purposes of
                level selection for an office/outpatient E/M service furnished via
                telehealth are the times listed in the CPT code descriptor. We do not
                anticipate a change to Medicare expenditures as a result of this
                policy.
                27. Updating the Medicare Telehealth List
                 Section II.AA. of this IFC revises the process during the PHE for
                COVID-19 by which CMS could add services to the Medicare telehealth
                list and that services added through the process would remain on the
                Medicare telehealth list during the PHE for COVID-19. This section does
                not add any services to the Medicare telehealth list. Therefore, we do
                not anticipate a change to Medicare expenditures.
                28. Payment for COVID-19 Specimen Collection to Physicians,
                Nonphysician Practitioners and Hospitals
                 Section II.BB. of this IFC describes a policy to make assessment
                and specimen collection for COVID-19 testing payable under the Medicare
                PFS and conditionally packaged under the OPPS for the duration of the
                PHE for COVID-19. Because these services were not previously payable
                under the Medicare PFS or conditionally packaged under the OPPS,
                Medicare expenditures will increase, representing a cost to the Federal
                Government. However, on net we estimate that greater testing combined
                with proper public health practices of physical distancing and
                isolation for exposed or infected individuals would result in fewer
                COVID-19 infections and consequently, this policy would reduce
                expenditures for the treatment of Medicare beneficiaries with COVID-19,
                which would be a benefit to the Federal Government.
                29. Payment for Remote Physiologic Monitoring (RPM) Services Furnished
                During the COVID-19 PHE
                 Section II.CC. of this IFC describes a policy, for the duration of
                the PHE for COVID-19, to allow the RPM monitoring service to be
                reported to Medicare for periods of time that are fewer than 16 days of
                30 days, as long as the other requirements for billing the code are
                met. To the extent that this increases volume of the RPM monitoring
                service, this policy would increase Medicare expenditures, resulting in
                a cost to the Federal Government.
                D. Accounting Statement
                1. Medicare Program
                 As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in the following Table 3, we have prepared an accounting
                statement showing the classification of the expenditures associated
                with the provisions of this IFC as they relate to the Medicare program.
                 Table 3--Accounting Statement: Classification of Estimated Transfers
                ----------------------------------------------------------------------------------------------------------------
                 Units
                 -----------------------------------------------------
                 Category Estimates Discount rate Period covered
                 Year dollar (%) (CY)
                ----------------------------------------------------------------------------------------------------------------
                Transfers:
                 Annualized Monetized ($million/year) -269.6 2019 7 2020-2025
                 -250.8 2019 3 2020-2025
                 -----------------------------------------------------------------------
                [[Page 27619]]
                
                 From Whom to Whom................... Reduced transfer from Federal Government to ACOs and Medicare-enrolled
                 suppliers, providers, and practitioners.
                ----------------------------------------------------------------------------------------------------------------
                List of Subjects
                42 CFR Part 409
                 Health facilities, Medicare.
                42 CFR Part 410
                 Diseases, Health facilities, Health professions, Laboratories,
                Medicare, Reporting and recordkeeping requirements, Rural areas, X-
                rays.
                42 CFR Part 412
                 Administrative practice and procedure, Health facilities, Medicare,
                Puerto Rico, Reporting and recordkeeping requirements.
                42 CFR Part 413
                 Diseases, Health facilities, Medicare, Puerto Rico, Reporting and
                recordkeeping requirements.
                42 CFR Part 414
                 Administrative practice and procedure, Biologics, Diseases, Drugs,
                Health facilities, Health professions, Medicare, Reporting and
                recordkeeping requirements.
                42 CFR Part 415
                 Health facilities, Health professions, Medicare, Reporting and
                recordkeeping requirements.
                42 CFR Part 424
                 Emergency medical services, Health facilities, Health professions,
                Medicare.
                42 CFR Part 425
                 Administrative practice and procedure, Health facilities, Health
                professions, Medicare, Reporting and recordkeeping requirements.
                42 CFR Part 440
                 Grant programs--health, Medicaid.
                42 CFR Part 483
                 Grant programs--health, Health facilities, Health professions,
                Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting
                and recordkeeping requirements, Safety.
                42 CFR Part 484
                 Health facilities, Health professions, Medicare, Reporting and
                recordkeeping requirements.
                42 CFR Part 600
                 Administration practice and procedure, Health care, Health
                insurance, Intergovernmental relations, Penalties, Reporting and
                recordkeeping requirements.
                45 CFR Part 156
                 Administrative practice and procedure, Advertising, Advisory
                committees, Brokers, Conflict of interests, Consumer protection, Grant
                programs--health, Grants administration, Health care, Health insurance,
                Health maintenance organization (HMO), Health records, Hospitals,
                Indians, Individuals with disabilities, Intergovernmental relations,
                Loan programs--health, Medicaid, Organization and functions (Government
                agencies), Prescription drugs, Public assistance programs, Reporting
                and recordkeeping requirements, Sunshine Act, Technical assistance,
                Women, Youth.
                 For the reasons set forth in the preamble, the Centers for Medicare
                & Medicaid Services amends 42 CFR chapter IV, and the Department of
                Health and Human Services amends 45 CFR part 156, as set forth below:
                Title 42
                PART 409--HOSPITAL INSURANCE BENEFITS
                0
                1. The authority citation for part 409 continues to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                Sec. 409.41 [Amended]
                0
                2. Section 409.41 is amended in paragraph (b) by removing the phrase
                ``The physician certification'' and adding in its place the phrase
                ``The certification''.
                Sec. 409.42 [Amended]
                0
                3. Section 409.42 is amended--
                0
                a. In the paragraph (b), subject heading and text, and in paragraph (c)
                introductory text by removing the phrase ``a physician'' and adding in
                its place the phrase ``a physician or allowed practitioner, as defined
                at Sec. 484.2 of this chapter''.
                0
                b. In paragraph (c) introductory text by removing the phrase ``the
                physician certification'' and adding in its place the phrase ``the
                certification''.
                0
                4. Section 409.43 is amended--
                0
                a. By revising paragraphs (a) introductory text and (a)(1);
                0
                b. In paragraph (b), by removing the phrases ``physician's orders'' and
                ``physician order'' and adding in its place the phrases ``physician or
                allowed practitioner's orders'' and ``physician or allowed practitioner
                order'', respectively;
                0
                c. In the paragraph (c) subject heading by removing the word
                ``Physician'' and in paragraph (c)(1) introductory text by removing the
                term ``physician'' and adding in its place the phrase ``Physician or
                allowed practitioner'' and ``physician or allowed practitioner'',
                respectively;
                0
                d. In paragraph (c)(1)(i) introductory text by removing the phrase
                ``physician's verbal order'' and adding in its place the phrase
                ``physician or allowed practitioner's orders''; and
                0
                e. In paragraphs (d), (e)(1) introductory text, (e)(2), and (f) by
                removing the term ``physician'' and adding in its place the phrase
                ``physician or allowed practitioner''.
                 The revisions read as follows:
                Sec. 409.43 Plan of care requirements.
                 (a) Contents. An individualized plan of care must be established
                and periodically reviewed by the certifying physician or allowed
                practitioner, as defined at Sec. 484.2 of this chapter.
                 (1) The HHA must be acting upon a plan of care that meets the
                requirements of this section for HHA services to be covered.
                * * * * *
                0
                5. Section 409.44 is amended--
                0
                a. By revising paragraph (c)(1) introductory text;
                0
                b. In paragraphs (c)(1)(i), (c)(2)(i)(D)(1), and (c)(2)(i)(F)(3) by
                removing the term ``physician'' and adding in its place the term
                ``physician or allowed practitioner'';
                0
                c. In paragraphs (c)(2)(iii)(A), by removing the term ``physician's''
                and adding in its place the term ``physician's or allowed
                practitioner's''; and
                0
                d. In paragraph (c)(2)(iv) introductory text by removing the term
                ``physician'' and adding in its place the term ``physician or allowed
                practitioner''.
                [[Page 27620]]
                 The revision reads as follows:
                Sec. 409.44 Skilled services requirements.
                * * * * *
                 (c) * * *
                 (1) Speech-language pathology services and physical or occupational
                therapy services must relate directly and specifically to a treatment
                regimen (established by the physician or allowed practitioner) after
                any needed consultation with the qualified therapist, that is designed
                to treat the beneficiary's illness or injury. Services related to
                activities for the general physical welfare of beneficiaries (for
                example, exercises to promote overall fitness) do not constitute
                physical therapy, occupational therapy, or speech-language pathology
                services for Medicare purposes. To be covered by Medicare, all of the
                requirements apply as follows:
                * * * * *
                Sec. 409.45 [Amended]
                0
                6. Section 409.45 is amended--
                0
                a. In paragraph (a) by removing the term ``physician'' and adding in
                its place the phrase ``physician or allowed practitioner''.
                0
                b. In paragraph (b)(1) introductory text by removing the phrase
                ``physician's order'' and adding in its place the phrases ``physician
                or allowed practitioner's orders''; and
                0
                c. In paragraphs (b)(2)(i), (c)(1), and (g) by removing the term
                ``physician'' and add in its place the phrase ``physician or allowed
                practitioner''.
                Sec. 409.46 [Amended]
                0
                7. Section 409.46 is amended in paragraph (a) by removing the term
                ``physician'' and adding in its place the phrase ``physician or allowed
                practitioner''.
                Sec. 409.48 [Amended]
                0
                8. Section 409.48 is amended in paragraph (c)(1) by removing the term
                ``physician'' and adding in its place the phrase ``physician or allowed
                practitioner''.
                PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
                0
                9. The authority citation for part 410 continues to read as follows:
                 Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.
                0
                10. Section 410.32 is amended--
                0
                a. In paragraph (a) introductory text by removing the phrase ``All
                diagnostic x-ray tests, diagnostic laboratory tests'' and adding in its
                place the phrase ``Except as otherwise provided in this section, all
                diagnostic x-ray tests, diagnostic laboratory tests'';
                0
                b. By adding paragraph (a)(3);
                0
                c. By revising paragraphs (b)(1) and (b)(2)(iii)(B);
                0
                d. By adding paragraph (b)(2)(viii);
                0
                e. By revising paragraph (b)(3) introductory text;
                0
                f. By revising paragraph (d)(2)(i) and paragraph(d)(2)(ii) introductory
                text; and
                0
                g. By revising paragraph (d)(3)(i) introductory text.
                 The revisions and additions read as follows:
                Sec. 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and
                other diagnostic tests: Conditions.
                 (a) * * *
                 (3) Public Health Emergency exception. During the Public Health
                Emergency, as defined in Sec. 400.200 of this chapter, for the COVID-
                19 pandemic, the order of a physician or NPP is not required for
                otherwise covered diagnostic laboratory tests for COVID-19 and for
                otherwise covered diagnostic laboratory tests for influenza virus or
                similar respiratory condition needed to obtain a final COVID-19
                diagnosis when performed in conjunction with COVID-19 diagnostic
                laboratory test in order to discount influenza virus or related
                diagnosis. FDA-authorized COVID-19 serology tests are included as
                covered tests during the Public Health Emergency, as defined in Sec.
                400.20 of this chapter, for the COVID-19 pandemic, as they are
                reasonable and necessary under section 1862(a)(1)(A) of the Act for
                beneficiaries with known current or known prior COVID-19 infection or
                suspected current or suspected prior COVID-19 infection.
                 (b) * * *
                 (1) Basic rule. Except as indicated in paragraph (b)(2) of this
                section, all diagnostic x-ray and other diagnostic tests covered under
                section 1861(s)(3) of the Act and payable under the physician fee
                schedule must be furnished under the appropriate level of supervision
                by a physician as defined in section 1861(r) of the Act or, during the
                Public Health Emergency as defined in Sec. 400.200 of this chapter,
                for the COVID-19 pandemic, by a nurse practitioner, clinical nurse
                specialist, physician assistant or a certified nurse-midwife to the
                extent that they are authorized to do so under applicable state law.
                Services furnished without the required level of supervision are not
                reasonable and necessary (see Sec. 411.15(k)(1) of this chapter).
                 (2) * * *
                 (iii) * * *
                 (B) Furnished under the general supervision of a physician,
                clinical psychologist, or during the Public Health Emergency, as
                defined in Sec. 400.200 of this chapter, for the COVID-19 pandemic, by
                a nurse practitioner, clinical nurse specialist, physician assistant or
                a certified nurse-midwife, to the extent that they are authorized to
                perform the tests under applicable State law.
                * * * * *
                 (viii) During the COVID-19 Public Health Emergency as defined in
                Sec. 400.200 of this chapter, diagnostic tests performed by a
                physician assistant authorized to perform the tests under applicable
                State law.
                * * * * *
                 (3) Levels of supervision. Except where otherwise indicated, all
                diagnostic x-ray and other diagnostic tests subject to this provision
                and payable under the physician fee schedule must be furnished under at
                least a general level of supervision as defined in paragraph (b)(3)(i)
                of this section. In addition, some of these tests also require either
                direct or personal supervision as defined in paragraph (b)(3)(ii) or
                (iii) of this section, respectively. When direct or personal
                supervision is required, supervision at the specified level is required
                throughout the performance of the test.
                * * * * *
                 (d) * * *
                 (2) * * *
                 (i) Ordering the service. Except for tests described in paragraph
                (a)(3) of this section, the physician (or qualified nonphysician
                practitioner, as defined in paragraph (a)(2) of this section), who
                orders the service must maintain documentation of medical necessity in
                the beneficiary's medical record.
                 (ii) Submitting the claim. Except for tests described in paragraph
                (a)(3) of this section, the entity submitting the claim must maintain
                the following documentation:
                * * * * *
                 (3) * * *
                 (i) Documentation requirements. Except for tests described in
                paragraph (a)(3) introductory text, upon request by CMS, the entity
                submitting the claim must provide the following information:
                * * * * *
                0
                11. Section 410.67 is amended in paragraph (b)(7) by adding two
                sentences at the end to read as follows:
                Sec. 410.67 Medicare coverage and payment of Opioid use disorder
                treatment services furnished by Opioid treatment programs.
                * * * * *
                 (b) * * *
                [[Page 27621]]
                 (7) * * * During the Public Health Emergency for the COVID-19
                pandemic, as defined in Sec. 400.200 of this chapter, these periodic
                assessments can be furnished via two-way interactive audio-video
                communication technology, as clinically appropriate, and in compliance
                with all other applicable requirements. In cases where a beneficiary
                does not have access to two-way audio-video communications technology,
                periodic assessments can be furnished using audio-only telephone calls
                rather than via two-way interactive audio-video communication
                technology if all other applicable requirements are met.
                * * * * *
                0
                12. Section 410.78 is amended by revising paragraph (f) to read as
                follows:
                Sec. 410.78 Telehealth services.
                * * * * *
                 (f) Process for adding or deleting services. Except as otherwise
                provided in this paragraph, changes to the list of Medicare telehealth
                services are made through the annual physician fee schedule rulemaking
                process. During the Public Health Emergency for the COVID-19 pandemic,
                as defined in Sec. 400.200 of this chapter, we will use a
                subregulatory process to modify the services included on the Medicare
                telehealth list during the Public Health Emergency taking into
                consideration infection control, patient safety, and other public
                health concerns resulting from the emergency. A list of the services
                covered as telehealth services under this section is available on the
                CMS website.
                PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL
                SERVICES
                0
                13. The authority citation for part 412 continues to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                0
                14. Section 412.29 is amended by revising paragraphs (d), (e), (h), and
                (i) to read as follows:
                Sec. 412.29 Classification criteria for payment under the inpatient
                rehabilitation facility prospective payment system.
                * * * * *
                 (d) Except for care furnished to patients in a freestanding IRF
                hospital solely to relieve acute care hospital capacity in a state (or
                region, as applicable) that is experiencing a surge, as defined in
                Sec. 412.622 of this chapter, during the Public Health Emergency, as
                defined in Sec. 400.200 of this chapter, have in effect a preadmission
                screening procedure under which each prospective patient's condition
                and medical history are reviewed to determine whether the patient is
                likely to benefit significantly from an intensive inpatient hospital
                program. This procedure must ensure that the preadmission screening for
                each Medicare Part A fee-for-Service patient is reviewed and approved
                by a rehabilitation physician prior to the patient's admission to the
                IRF.
                 (e) Except for care furnished to patients in a freestanding IRF
                hospital solely to relieve acute care hospital capacity in a state (or
                region, as applicable) that is experiencing a surge, as defined in
                Sec. 412.622 of this chapter, during the Public Health Emergency, as
                defined in Sec. 400.200 of this chapter, have in effect a procedure to
                ensure that patients receive close medical supervision, as evidenced by
                at least 3 face-to-face visits per week by a licensed physician with
                specialized training and experience in inpatient rehabilitation to
                assess the patient both medically and functionally, as well as to
                modify the course of treatment as needed to maximize the patient's
                capacity to benefit from the rehabilitation process except that during
                the Public Health Emergency, as defined in Sec. 400.200 of this
                chapter, for the COVID-19 pandemic such visits may be conducted using
                telehealth services (as defined in section 1834(m)(4)(F) of the Act).
                * * * * *
                 (h) Except for care furnished to patients in a freestanding IRF
                hospital solely to relieve acute care hospital capacity in a state (or
                region, as applicable) that is experiencing a surge, as defined in
                Sec. 412.622 of this chapter, during the Public Health Emergency, as
                defined in Sec. 400.200 of this chapter, have a plan of treatment for
                each inpatient that is established, reviewed, and revised as needed by
                a physician in consultation with other professional personnel who
                provide services to the patient.
                 (i) Except for care furnished to patients in a freestanding IRF
                hospital solely to relieve acute care hospital capacity in a state (or
                region, as applicable) that is experiencing a surge, as defined in
                Sec. 412.622 of this chapter, during the Public Health Emergency, as
                defined in Sec. 400.200 of this chapter, use a coordinated
                interdisciplinary team approach in the rehabilitation of each
                inpatient, as documented by the periodic clinical entries made in the
                patient's medical record to note the patient's status in relationship
                to goal attainment and discharge plans, and that team conferences are
                held at least once per week to determine the appropriateness of
                treatment.
                * * * * *
                0
                15. Section 412.105 is amended by revising paragraphs (d)(1) and
                (f)(1)(iii)(A) to read as follows:
                Sec. 412.105 Special treatment: Hospitals that incur indirect costs
                for graduate medical education programs.
                * * * * *
                 (d) * * *
                 (1) Step one. A factor representing the sum of 1.00 plus the
                hospital's ratio of full-time equivalent residents to beds, as
                determined under paragraph (a)(1) of this section, excluding beds
                temporarily added during the time frame that the Public Health
                Emergency as defined in Sec. 400.200 of this chapter is in effect, is
                raised to an exponential power equal to the factor set forth in
                paragraph (c) of this section.
                * * * * *
                 (f) * * *
                 (1) * * *
                 (iii)(A) Full-time equivalent status is based on the total time
                necessary to fill a residency slot. No individual may be counted as
                more than one full-time equivalent. If a resident is assigned to more
                than one hospital, the resident counts as a partial full-time
                equivalent based on the proportion of time worked in any areas of the
                hospital listed in paragraph (f)(1)(ii) of this section to the total
                time worked by the resident. A hospital cannot claim the time spent by
                residents training at another hospital, unless the exception provided
                at Sec. 413.78(i) of this chapter applies. A part-time resident or one
                working in an area of the hospital other than those listed under
                paragraph (f)(1)(ii) of this section (such as a freestanding family
                practice center or an excluded hospital unit) would be counted as a
                partial full-time equivalent based on the proportion of time assigned
                to an area of the hospital listed in paragraph (f)(1)(ii) of this
                section, compared to the total time necessary to fill a full-time
                residency slot.
                * * * * *
                0
                16. Section 412.165 is amended by adding paragraph (c) to read as
                follows:
                Sec. 412.165 Performance scoring under the Hospital Value-Based
                Purchasing (VBP) Program.
                * * * * *
                 (c) Extraordinary circumstances exception. (1) A hospital may
                request and CMS may grant exceptions to the Hospital VBP Program's
                requirements under this section when there are certain extraordinary
                circumstances beyond the control of the hospital.
                [[Page 27622]]
                 (2) A hospital may request an exception within 90 calendar days of
                the date that the extraordinary circumstances occurred by submitting a
                completed Extraordinary Circumstances Request Form (available on the
                Hospital Value-Based Purchasing (HVBP) Program section of the
                QualityNet website (QualityNet.org)), and any available evidence of the
                impact of the extraordinary circumstances on the hospital's quality
                measure performance. The form must be sent via secure file transfer via
                the QualityNet Secure portal, secure fax, email, or conventional mail.
                 (3) Following receipt of the request form, CMS will provide a
                written acknowledgement using the contact information provided in the
                request, to the CEO and any additional designated personnel, notifying
                them that the hospital's request has been received, and provide a
                written response to the CEO and any additional designated personnel
                using the contact information provided in the request.
                 (4) CMS may grant an exception to one or more hospitals that have
                not requested an exception if CMS determines that an extraordinary
                circumstance has affected an entire region or locale, which may include
                the entire United States. CMS will notify hospitals that it has granted
                an exception under this paragraph via multiple methods, which may
                include memos, emails, and notices posted on the public QualityNet
                website (see https://www.qualitynet.org).
                0
                17. Section 412.622 is amended--
                0
                a. By revising paragraphs (a)(3)(i) through (iv), (a)(4) introductory
                text, and (a)(5) introductory text; and
                0
                b. In paragraph (c) by adding a definition for ``State (or region, as
                applicable) that is experiencing a surge'' in alphabetical order.
                 The revisions and addition read as follows:
                Sec. 412.622 Basis of payment.
                 (a) * * *
                 (3) * * *
                 (i) Except for care furnished to patients in a freestanding IRF
                hospital solely to relieve acute care hospital capacity in a state (or
                region, as applicable) that is experiencing a surge during the Public
                Health Emergency, as defined in Sec. 400.200 of this chapter, requires
                the active and ongoing therapeutic intervention of multiple therapy
                disciplines (physical therapy, occupational therapy, speech-language
                pathology, or prosthetics/orthotics therapy), one of which must be
                physical or occupational therapy.
                 (ii) Except during the emergency period described in section
                1135(g)(1)(B) of the Act, generally requires and can reasonably be
                expected to actively participate in, and benefit from, an intensive
                rehabilitation therapy program. Under current industry standards, this
                intensive rehabilitation therapy program generally consists of at least
                3 hours of therapy (physical therapy, occupational therapy, speech-
                language pathology, or prosthetics/orthotics therapy) per day at least
                5 days per week. In certain well-documented cases, this intensive
                rehabilitation therapy program might instead consist of at least 15
                hours of intensive rehabilitation therapy within a 7-consecutive-day
                period, beginning with the date of admission to the IRF. Benefit from
                this intensive rehabilitation therapy program is demonstrated by
                measurable improvement that will be of practical value to the patient
                in improving the patient patient's functional capacity or adaptation to
                impairments. The required therapy treatments must begin within 36 hours
                from midnight of the day of admission to the IRF.
                 (iii) Except for care furnished to patients in a freestanding IRF
                hospital solely to relieve acute care hospital capacity in a state (or
                region, as applicable) that is experiencing a surge during the Public
                Health Emergency, as defined in Sec. 400.200 of this chapter, is
                sufficiently stable at the time of admission to the IRF to be able to
                actively participate in the intensive rehabilitation therapy program
                that is described in paragraph (a)(3)(ii) of this section.
                 (iv) Except for care furnished to patients in a freestanding IRF
                hospital solely to relieve acute care hospital capacity in a state (or
                region, as applicable) that is experiencing a surge during the Public
                Health Emergency, as defined in Sec. 400.200 of this chapter, requires
                physician supervision by a rehabilitation physician. The requirement
                for medical supervision means that the rehabilitation physician must
                conduct face-to-face visits with the patient at least 3 days per week
                throughout the patient 's stay in the IRF to assess the patient both
                medically and functionally, as well as to modify the course of
                treatment as needed to maximize the patient's capacity to benefit from
                the rehabilitation process except that during the Public Health
                Emergency, as defined in Sec. 400.200 of this chapter, for the COVID-
                19 pandemic such visits may be conducted using telehealth services (as
                defined in section 1834(m)(4)(F) of the Act).The post-admission
                physician evaluation described in paragraph (a)(4)(ii) of this section
                may count as one of the face-to-face visits.
                 (4) Documentation. Except for care furnished to patients in a
                freestanding IRF hospital solely to relieve acute care hospital
                capacity in a state (or region, as applicable) that is experiencing a
                surge during the Public Health Emergency, as defined in Sec. 400.200
                of this chapter, to document that each patient for whom the IRF seeks
                payment is reasonably expected to meet all of the requirements in
                paragraph (a)(3) of this section at the time of admission, the
                patient's medical record at the IRF must contain the following
                documentation--
                * * * * *
                 (5) Interdisciplinary team approach to care. Except for care
                furnished to patients in a freestanding IRF hospital solely to relieve
                acute care hospital capacity in a state (or region, as applicable) that
                is experiencing a surge during the Public Health Emergency, as defined
                in Sec. 400.200 of this chapter, in order for an IRF claim to be
                considered reasonable and necessary under section 1862(a)(1) of the
                Act, the patient must require an interdisciplinary team approach to
                care, as evidenced by documentation in the patients' medical record of
                weekly interdisciplinary team meetings that meet all of the following
                requirements--
                * * * * *
                 (c) * * *
                 State (or region, as applicable) that is experiencing a surge means
                a state (or region, as applicable) that is in phase 1 of the
                President's Guidelines for Opening Up America Again (https://www.whitehouse.gov/openingamerica/), specifically, a state (or region,
                as applicable) that satisfies all of the following, as determined by
                applicable state and local officials:
                 (i) All vulnerable individuals continue to shelter in place.
                 (ii) Individuals continue social distancing.
                 (iii) Individuals avoid socializing in groups of more than 10.
                 (iv) Non-essential travel is minimized.
                 (v) Visits to senior living facilities and hospitals are
                prohibited.
                 (vi) Schools and organized youth activities remain closed.
                [[Page 27623]]
                PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR
                END-STAGE RENAL DISEASE SERVICES; PROSPECTIVELY DETERMINED PAYMENT
                RATES FOR SKILLED NURSING FACILITIES; PAYMENT FOR ACUTE KIDNEY
                INJURY DIALYSIS
                0
                18. The authority citation for part 413 continues to read as follows:
                 Authority: 42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a),
                (i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww.
                0
                19. Section 413.78 is amended by revising paragraph (b) and adding
                paragraph (i) to read as follows:
                Sec. 413.78 Direct GME payments: Determination of the total number of
                FTE residents.
                * * * * *
                 (b) No individual may be counted as more than one FTE. A hospital
                cannot claim the time spent by residents training at another hospital,
                except as provided in paragraph (i) of this section. Except as provided
                in paragraphs (c), (d), and (e) of this section, if a resident spends
                time in more than one hospital or in a nonprovider setting, the
                resident counts as partial FTE based on the proportion of time worked
                at the hospital to the total time worked. A part-time resident counts
                as a partial FTE based on the proportion of allowable time worked
                compared to the total time necessary to fill a full-time internship or
                residency slot.
                * * * * *
                 (i) For the time frame that the Public Health Emergency (as defined
                in Sec. 400.200 of this chapter) associated with COVID-19 was in
                effect, a sending hospital can include FTE residents training at
                another hospital in its FTE count if all of the following conditions
                are met.
                 (1) The sending hospital sends the resident to the other hospital
                in response to the COVID-19 pandemic.
                 (2) The time spent by the resident training at the other hospital
                is in lieu of time that would have been spent in approved training at
                the sending hospital.
                 (3) The time that the resident spent training immediately prior to
                and/or subsequent to the time frame that the Public Health Emergency
                (as defined in Sec. 400.200 of this chapter) associated with COVID-19
                was in effect is included in the FTE count for the sending hospital.
                PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
                0
                20. The authority citation for part 414 continues to read as follows:
                 Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).
                0
                21. Section 414.210 is amended by revising paragraph (g)(9)(iii) and
                (iv) and adding paragraph (g)(9)(v) to read as follows:
                Sec. 414.210 General payment rules.
                * * * * *
                 (g) * * *
                 (9) * * *
                 (iii) For items and services furnished in rural areas and non-
                contiguous areas (Alaska, Hawaii, and U.S. territories) with dates of
                service from June 1, 2018 through December 31, 2020 or through the
                duration of the emergency period described in section 1135(g)(1)(B) of
                the Act (42 U.S.C. 1320b-5(g)(1)(B)), whichever is later, based on the
                fee schedule amount for the area is equal to 50 percent of the adjusted
                payment amount established under this section and 50 percent of the
                unadjusted fee schedule amount.
                 (iv) For items and services furnished in areas other than rural or
                noncontiguous areas with dates of service from June 1, 2018 through
                March 5, 2020, based on the fee schedule amount for the area is equal
                to 100 percent of the adjusted payment amount established under this
                section.
                 (v) For items and services furnished in areas other than rural or
                noncontiguous areas with dates of service from March 6, 2020, through
                the remainder of the duration of the emergency period described in
                section 1135(g)(1)(B) of the Act (42 U.S.C. 1320b-5(g)(1)(B)), based on
                the fee schedule amount for the area is equal to 75 percent of the
                adjusted payment amount established under this section and 25 percent
                of the unadjusted fee schedule amount. For items and services furnished
                in areas other than rural or noncontiguous areas with dates of service
                from the expiration date of the emergency period described in section
                1135(g)(1)(B) of the Act (42 U.S.C. 1320b-5(g)(1)(B)), through December
                31, 2020, based on the fee schedule amount for the area is equal to 100
                percent of the adjusted payment amount established under this section.
                * * * * *
                Sec. 414.1400 [Amended]
                0
                22. Section 414.1400 is amended in paragraphs (b)(3)(v)(C) and (D) by
                removing the phrase ``Beginning with the 2021 performance period'' and
                adding in its place the phrase ``Beginning with the 2022 performance
                period''.
                PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS,
                SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN
                CERTAIN SETTINGS
                0
                23. The authority citation for part 415 continues to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                0
                24. Section 415.172 is amended by revising paragraphs (a) introductory
                text, (a)(2), and (b) to read as follows:
                Sec. 415.172 Physician fee schedule payment for services of teaching
                physicians.
                 (a) General rule. If a resident participates in a service furnished
                in a teaching setting, physician fee schedule payment is made only if a
                teaching physician is present during the key portion of any service or
                procedure for which payment is sought. During the Public Health
                Emergency, as defined in Sec. 400.200 of this chapter, for the COVID-
                19 pandemic, if a resident participates in a service furnished in a
                teaching setting, physician fee schedule payment is made if a teaching
                physician is present during the key portion of the service using audio/
                video real-time communications technology for any service or procedure
                for which payment is sought.
                * * * * *
                 (2) In the case of evaluation and management services, the teaching
                physician must be present during the portion of the service that
                determines the level of service billed. (However, in the case of
                evaluation and management services furnished in hospital outpatient
                departments and certain other ambulatory settings, the requirements of
                Sec. 415.174 apply.) During the Public Health Emergency, as defined in
                Sec. 400.200 of this chapter, for the COVID-19 pandemic, the teaching
                physician may be present during the portion of the service that
                determines the level of service billed using audio/video real-time
                communications technology. (However, in the case of evaluation and
                management services furnished in hospital outpatient departments and
                certain other ambulatory settings, the requirements of Sec. 415.174
                apply.)
                 (b) Documentation. Except for services furnished as set forth in
                Sec. Sec. 415.174 (concerning an exception for services furnished in
                hospital outpatient and certain other ambulatory settings), 415.176
                (concerning renal dialysis
                [[Page 27624]]
                services), and 415.184 (concerning psychiatric services), the medical
                records must document the teaching physician was present at the time
                the service is furnished. The presence of the teaching physician during
                procedures and evaluation and management services may be demonstrated
                by the notes in the medical records made by the physician or as
                provided in Sec. 410.20(e) of this chapter. During the Public Health
                Emergency, as defined in Sec. 400.200 of this chapter, for the COVID-
                19 pandemic, except for services furnished as set forth in Sec. Sec.
                415.174 (concerning an exception for services furnished in hospital
                outpatient and certain other ambulatory settings), 415.176 (concerning
                renal dialysis services), and 415.184 (concerning psychiatric
                services), the medical records must document if the teaching physician
                was physically present or if the teaching physician was present through
                audio/video real-time communications technology at the time the service
                is furnished. The presence of the teaching physician during procedures
                and evaluation and management services may be demonstrated by the notes
                in the medical records made by the physician or as provided in Sec.
                410.20(e) of this chapter.
                * * * * *
                0
                25. Section 415.174 is amended by revising paragraph (b) and adding
                paragraph (c) to read as follows:
                Sec. 415.174 Exception: Evaluation and management services furnished
                in certain centers.
                * * * * *
                 (b) Nothing in paragraph (a) of this section may be construed as
                providing a basis for the coverage of services not determined to be
                covered under Medicare, such as routine physical check-ups.
                 (c) During the Public Health Emergency, as defined in Sec. 400.200
                of this chapter, for the COVID-19 pandemic, the requirements in
                paragraph (a)(3) of this section for a teaching physician to direct the
                care and then to review the services furnished by each resident during
                or immediately after each visit may be met using audio/video real-time
                communications technology.
                0
                26. Section 415.180 is revised to read as follows:
                Sec. 415.180 Teaching setting requirements for the interpretation of
                diagnostic radiology and other diagnostic tests.
                 (a) General rule. Physician fee schedule payment is made for the
                interpretation of diagnostic radiology and other diagnostic tests if
                the interpretation is performed or reviewed by a physician other than a
                resident. During the Public Health Emergency, as defined in Sec.
                400.200 of this chapter, for the COVID-19 pandemic, physician fee
                schedule payment may also be made 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.
                 (b) [Reserved]
                0
                27. Section 415.184 is revised to read as follows:
                Sec. 415.184 Psychiatric services.
                 To qualify for physician fee schedule payment for psychiatric
                services furnished under an approved GME program, the physician must
                meet the requirements of Sec. Sec. 415.170 and 415.172, including
                documentation, except that the requirement for the presence of the
                teaching physician during the service 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. During the Public Health Emergency,
                as defined in Sec. 400.200 of this chapter, for the COVID-19 pandemic,
                the requirement for the presence of the teaching physician during the
                service in which a resident is involved may be met by direct
                supervision by audio/video real-time communications technology.
                PART 424--CONDITIONS FOR MEDICARE PAYMENT
                0
                28. The authority citation for part 424 continues to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                0
                29. Section 424.22 is amended--
                0
                a. By revising the introductory text;
                0
                b. In paragraphs (a)(1) introductory text and (a)(1)(i), by removing
                the term ``physician'' each time it appears and adding in its place the
                phrase ``physician or allowed practitioner'';
                0
                c. In paragraph (a)(1)(i) by removing the phrase ``physician's
                signature'' each time it appears and adding in its place the phrase
                ``physician or allowed practitioner's signature'';
                0
                d. By revising paragraph (a)(1)(iii) and (iv), (a)(1)(v) introductory
                text, and (a)(1)(v)(A);
                0
                e. By adding paragraph (a)(1)(v)(C);
                0
                f. In paragraphs (a)(2), (b)(1) introductory text, (b)(2) introductory
                text, and (b)(2)(ii) introductory text, by removing the term
                ``physician'' and adding in its place the phrase ``physician or allowed
                practitioner'';
                0
                g. In paragraph (b)(2)(ii)(A) by removing the phrase ``physician's
                signature'' and adding in its place the phrase ``physician or allowed
                practitioner's signature'';
                0
                h. By revising paragraph (b)(2)(ii)(B);
                0
                i. In paragraphs (c)(1) introductory text by removing the phrase
                ``physician's medical records'' and adding in its place the phrase
                ``physician or allowed practitioner's medical record'';
                0
                j. In paragraph (c)(1)(i) by removing the phrase ``physician's medical
                record'' and adding in its place the phrase ``physician or allowed
                practitioner's medical record'';
                0
                k. In paragraph (c)(1)(ii)(A) by removing the term ``physician'' and
                adding in its place the phrase ``physician or allowed practitioner'';
                0
                l. In the paragraph (d) subject heading by removing the term
                ``physician'' and adding in its place the phrase ``physician or allowed
                practitioner's'';
                0
                m. In paragraph (d) introductory text by removing the term
                ``physician'' and adding in its place the phrase ``physician or allowed
                practitioner''; and by removing the term ``physician's'' adding in its
                place the phrase ``physician or allowed practitioner's''; and
                0
                n. In paragraph (d)(1) by removing the term ``physician'' each time it
                appears and adding in its place the phrase ``physician or allowed
                practitioner''.
                 The revisions and addition read as follows:
                Sec. 424.22 Requirements for home health services.
                 Medicare Part A or Part B pays for home health services only if a
                physician or allowed practitioner as defined at Sec. 484.2 of this
                chapter certifies and recertifies the content specified in paragraphs
                (a)(1) and (b)(2) of this section, as appropriate.
                 (a) * * *
                 (1) * * *
                 (iii) A plan for furnishing the services has been established and
                will be or was periodically reviewed by a physician or allowed
                practitioner and who is not precluded from performing this function
                under paragraph (d) of this section.
                 (iv) The services will be or were furnished while the individual
                was under the care of a physician or allowed practitioner.
                 (v) A face-to-face patient encounter, which is related to the
                primary reason the patient requires home health services, occurred no
                more than 90 days prior to the home health start of care date or within
                30 days of the start of the home health care and was performed by
                physician or non-physician practitioner defined in paragraph
                (a)(1)(v)(A) of this section. The certifying physician or
                [[Page 27625]]
                certifying allowed practitioner must also document the date of the
                encounter as part of the certification.
                 (A) The face-to-face encounter must be performed by one of the
                following:
                 (1) The certifying physician (as defined at Sec. 484.2 of this
                chapter) or a physician, with privileges, who cared for the patient in
                an acute or post-acute care facility from which the patient was
                directly admitted to home health.
                 (2) The certifying nurse practitioner (as defined at Sec. 484.2 of
                this chapter), certifying clinical nurse specialist (as defined at
                Sec. 484.2 of this chapter), or a nurse practitioner or a clinical
                nurse specialist who is working in accordance with State law and in
                collaboration with a physician or in collaboration with an acute or
                post-acute care physician with privileges who cared for the patient in
                the acute or post-acute care facility from which the patient was
                directly admitted to home health.
                 (3) A certified nurse midwife (as defined in section 1861(gg) of
                the Act) as authorized by State law, under the supervision of a
                physician or under the supervision of an acute or post-acute care
                physician with privileges who cared for the patient in the acute or
                post-acute care facility from which the patient was directly admitted
                to home health.
                 (4) A certifying physician assistant (as defined at Sec. 484.2 of
                this chapter) or a physician assistant under the supervision of a
                physician or under the supervision of an acute or post-acute care
                physician with privileges who cared for the patient in the acute or
                post-acute care facility from which the patient was directly admitted
                to home health.
                * * * * *
                 (C) The face-to-face patient encounter must be performed by the
                certifying physician or allowed practitioner unless the encounter is
                performed by:
                 (1) A certified nurse midwife as described in paragraph
                (a)(1)(v)(A)(4) of this section.
                 (2) A physician, physician assistant, nurse practitioner, or
                clinical nurse specialist with privileges who cared for the patient in
                the acute or post-acute facility from which the patient was directly
                admitted to home health and who is different from the certifying
                practitioner.
                * * * * *
                 (b) * * *
                 (2) * * *
                 (ii) * * *
                 (B) Exists as an addendum to the recertification form, in addition
                to the physician or allowed practitioner's signature on the
                recertification form, the physician or allowed practitioner must sign
                immediately following the narrative in the addendum.
                * * * * *
                0
                30. Section 424.507 is amended by revising paragraph (b)(1)
                introductory text to read as follows:
                Sec. 424.507 Ordering covered items and services for Medicare
                beneficiaries.
                * * * * *
                 (b) * * *
                 (1) The ordering/certifying physician, or the ordering/certifying
                physician assistant, nurse practitioner, or clinical nurse specialist
                working in accordance with State law, must meet all of the following
                requirements:
                * * * * *
                PART 425--MEDICARE SHARED SAVINGS PROGRAM
                0
                31. The authority citation for part 425 continues to read as follows:
                 Authority: 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.
                0
                32. Section 425.200 is amended by revising paragraph (b)(3)(ii) to read
                as follows:
                Sec. 425.200 Participation agreement with CMS.
                * * * * *
                 (b) * * *
                 (3) * * *
                 (ii) The term of the participation agreement is 3 years, except as
                follows:
                 (A) For an ACO whose first agreement period in Track 1 began in
                2014 or 2015, in which case the term of the ACO's initial agreement
                period under Track 1 (as described under Sec. 425.604) may be
                extended, at the ACO's option, for an additional year for a total of 4
                performance years if the conditions specified in paragraph (e) of this
                section are met.
                 (B) For an ACO whose agreement period started on January 1, 2018,
                the term of the participation agreement is extended by 12 months if
                both of the following conditions are met:
                 (1) The ACO elects to extend the participation agreement for a
                fourth performance year until December 31, 2021.
                 (2) The ACO's election to extend its agreement period is made in
                the form and manner and by a deadline established by CMS.
                * * * * *
                0
                33. Section 425.400 is amended by adding paragraph (c)(2) to read as
                follows:
                Sec. 425.400 General.
                * * * * *
                 (c) * * *
                 (2) For the performance year starting on January 1, 2020, and for
                any subsequent performance year that starts during the COVID-19 Public
                Health Emergency defined in Sec. 400.200, in determining beneficiary
                assignment, we use the primary care service codes identified in
                paragraph (c)(1) of this section, and additional primary care service
                codes as follows:
                 (i) CPT codes:
                 (A) 99421, 99422, and 99423 (codes for online digital evaluation
                and management services).
                 (B) 99441, 99442, and 99443 (codes for telephone evaluation and
                management services).
                 (ii) HCPCS codes:
                 (A) G2010 (code for remote evaluation of patient video/images).
                 (B) G2012 (code for virtual check-in).
                0
                34. Section 425.600 is amended by redesignating paragraph
                (a)(4)(i)(B)(2)(iii) as paragraph (a)(4)(i)(B)(2)(iv) and adding new
                paragraph (a)(4)(i)(B)(2)(iii) to read as follows:
                Sec. 425.600 Selection of risk model.
                 (a) * * *
                 (4) * * *
                 (i) * * *
                 (B) * * *
                 (2) * * *
                 (iii) Exception for ACOs participating in the BASIC track's glide
                path that elect to maintain their participation level for performance
                year 2021. Prior to the automatic advancement for performance year
                2021, an ACO that is participating in the BASIC track's glide path for
                performance year 2020 may elect to remain in the same level of the
                BASIC track's glide path that it entered for the 2020 performance year,
                for performance year 2021. For performance year 2022, the ACO is
                automatically advanced to the level of the BASIC track's glide path to
                which the ACO would have automatically advanced absent the election to
                maintain its participation level for performance year 2021, unless the
                ACO elects to transition to a higher level of risk and potential reward
                within the BASIC track's glide path as provided in Sec.
                425.226(a)(2)(i). A voluntary election by an ACO under this paragraph
                must be made in the form and manner and by a deadline established by
                CMS.
                * * * * *
                0
                35. Section 425.611 is added to read as follows:
                Sec. 425.611 Adjustments to Shared Savings Program calculations to
                address the COVID-19 pandemic.
                 (a) General. This section describes adjustments CMS makes to Shared
                [[Page 27626]]
                Savings Program calculations to address the impact of the COVID-19
                pandemic.
                 (b) Episodes of care for treatment of COVID-19. (1) CMS identifies
                an episode of care for treatment of COVID-19 based on either of the
                following:
                 (i) Discharges for inpatient services eligible for the 20 percent
                adjustment under section 1886(d)(4)(C) of the Act.
                 (ii) Discharges for acute care inpatient services for treatment of
                COVID-19 from facilities that are not paid under the inpatient
                prospective payment system, such as CAHs, when the date of admission
                occurs within the Public Health Emergency as defined in Sec. 400.200
                of this chapter.
                 (2) CMS defines the episode of care as starting in the month in
                which the inpatient stay begins as identified by the admission date,
                all months during the inpatient stay, and the month following the end
                of the inpatient stay as indicated by the discharge date.
                 (c) Applicability of adjustments. Notwithstanding any other
                provision in this part, CMS adjusts the following Shared Savings
                Program calculations to exclude all Parts A and B fee-for-service
                payment amounts for a beneficiary's episode of care for treatment of
                COVID-19 as described in paragraph (b) of this section:
                 (1) Calculation of Medicare Parts A and B fee-for-service
                expenditures for an ACO's assigned beneficiaries for all purposes
                including the following: Establishing, adjusting, updating, and
                resetting the ACO's historical benchmark and determining performance
                year expenditures.
                 (2) Calculation of fee-for-service expenditures for assignable
                beneficiaries as used in determining county-level fee-for-service
                expenditures and national Medicare fee-for-service expenditures,
                including the following calculations:
                 (i) Determining average county fee-for-service expenditures based
                on expenditures for the assignable population of beneficiaries in each
                county in the ACO's regional service area according to Sec. Sec.
                425.601(c) and 425.603(e) for purposes of calculating the ACO's
                regional fee-for-service expenditures.
                 (ii) Determining the 99th percentile of national Medicare fee-for-
                service expenditures for assignable beneficiaries for purposes of the
                following:
                 (A) Truncating assigned beneficiary expenditures used in
                calculating benchmark expenditures under Sec. Sec. 425.601(a)(4),
                425.602(a)(4), and 425.603(c)(4), and performance year expenditures
                under Sec. Sec. 425.604(a)(4), 425.605(a)(3), 425.606(a)(4), and
                425.610(a)(4).
                 (B) Truncating expenditures for assignable beneficiaries in each
                county for purposes of determining county fee-for-service expenditures
                according to Sec. Sec. 425.601(c)(3) and 425.603(e)(3).
                 (iii) Determining 5 percent of national per capita expenditures for
                Parts A and B services under the original Medicare fee-for-service
                program for assignable beneficiaries for purposes of capping the
                regional adjustment to the ACO's historical benchmark according to
                Sec. 425.601(a)(8)(ii)(C).
                 (iv) Determining the flat dollar equivalent of the projected
                absolute amount of growth in national per capita expenditures for Parts
                A and B services under the original Medicare fee-for-service program
                for assignable beneficiaries, for purposes of updating the ACO's
                historical benchmark according to Sec. 425.602(b)(2).
                 (v) Determining national growth rates that are used as part of the
                blended growth rates used to trend forward BY1 and BY2 expenditures to
                BY3 according to Sec. 425.601(a)(5)(ii) and as part of the blended
                growth rates used to trend the benchmark and update the benchmark
                according to Sec. 425.601(b)(2).
                 (3) Calculation of Medicare Parts A and B fee-for-service revenue
                of ACO participants for purposes of calculating the ACO's loss
                recoupment limit under the BASIC track as specified in Sec.
                425.605(d).
                 (4) Calculation of total Medicare Parts A and B fee-for-service
                revenue of ACO participants and total Medicare Parts A and B fee-for-
                service expenditures for the ACO's assigned beneficiaries for purposes
                of identifying whether an ACO is a high revenue ACO or low revenue ACO,
                as defined under Sec. 425.20, and determining an ACO's eligibility for
                participation options according to Sec. 425.600(d).
                 (5) Calculation or recalculation of the amount of the ACO's
                repayment mechanism arrangement according to Sec. 425.204(f)(4).
                PART 440--SERVICES: GENERAL PROVISIONS
                0
                36. The authority citation for part 440 continues to read as follows:
                 Authority: 42 U.S.C. 1302.
                0
                37. Section 440.30 is amended by adding paragraph (d) to read as
                follows:
                Sec. 440.30 Other laboratory and X-ray services.
                * * * * *
                 (d) During the Public Health Emergency defined in 42 CFR 400.200 or
                any future Public Health Emergency resulting from an outbreak of
                communicable disease, and during any subsequent period of active
                surveillance (as defined in this paragraph), Medicaid coverage is
                available for laboratory tests and X-ray services that do not meet
                conditions specified in paragraph (a) or (b) of this section, if the
                purpose of such laboratory and X-ray services is to diagnose or detect
                SARS-CoV-2, antibodies to SARS-CoV-2, COVID-19, or the communicable
                disease named in the Public Health Emergency or its causes, and if the
                deviation from the conditions specified in paragraph (a) or (b) of this
                section is intended to avoid transmission of the communicable disease.
                For purposes of this paragraph, a period of active surveillance is
                defined as an outbreak of communicable disease during which no approved
                treatment or vaccine is widely available, and it ends on the date the
                Secretary terminates it, or the date that is two incubation periods
                after the last known case of the communicable disease, whichever is
                sooner. Additionally, during the Public Health Emergency defined in 42
                CFR 400.200 or any future Public Health Emergency resulting from an
                outbreak of communicable disease, and during any subsequent period of
                active surveillance (as defined in this paragraph), Medicaid coverage
                is available for laboratory processing of self-collected laboratory
                test systems that are authorized by the FDA for home use, if available
                to diagnose or detect SARS-CoV-2, antibodies to SARS-CoV-2, COVID-19,
                or the communicable disease named in the Public Health Emergency or its
                causes, even if those self-collected tests would not otherwise meet the
                requirements of paragraph (a) or (b) of this section, provided that the
                self-collection of the test is intended to avoid transmission of the
                communicable disease. If, pursuant to this paragraph, a laboratory
                processes a self-collected test system that is authorized by the FDA
                for home use, and the test system does not meet the conditions in
                paragraph (a) of this section, the laboratory must notify the patient
                and the patient's physician or other licensed non-physician
                practitioner (if known by the laboratory), of the results.
                0
                38. Section 440.70 is amended--
                0
                a. By revising paragraph (a)(2);
                0
                b. By adding paragraph (a)(3);
                0
                c. By revising paragraph (b)(1)(ii);
                0
                d. In paragraph (b)(3)(iii), by removing the phrase ``for the period of
                the Public Health Emergency,'';
                0
                e. In paragraph (b)(3)(iv), by removing the phrase ``for the period of
                the Public Health Emergency,'';
                0
                f. By revising paragraphs (f) introductory text and (f)(3)(i);
                0
                g. In paragraph (f)(3)(ii) by removing the phrase ``working in
                collaboration
                [[Page 27627]]
                with the physician referenced in paragraph (a) of this section'' and
                adding in its place the phrase ``in accordance with State law'';
                0
                h. In paragraph (f)(3)(iv) by removing the phrase ``under the
                supervision of the physician referenced in paragraph (a) of this
                section'' and adding in its place the phrase ``in accordance with State
                law'';
                0
                i. By adding paragraph (f)(3)(vi);
                0
                j. By revising paragraphs (f)(4);
                0
                k. In paragraph (f)(5) introductory text, by removing the phrase ``the
                physician responsible'' and adding in its place the phrase ``the
                practitioner responsible''; and
                0
                l. By revising paragraph (g)(1).
                 The revisions and addition read as follows:
                Sec. 440.70 Home health services.
                * * * * *
                 (a) * * *
                 (2) On orders written by a physician, nurse practitioner, clinical
                nurse specialist or physician assistant, working in accordance with
                State law, as part of a written plan of care that the ordering
                practitioner reviews every 60 days for services described in (b)(1),
                (2), and (4) of this section; and
                 (3) On his or her physician's orders or orders written by a
                licensed practitioner of the healing arts acting within the scope of
                practice authorized under State law, as part of a written plan of care
                for services described in paragraph (b)(3) of this section. The plan of
                care must be reviewed by the ordering practitioner as specified in
                paragraph (b)(3)(iii) of this section.
                 (b) * * *
                 (1) * * *
                 (ii) Receives written orders from the patient's practitioner as
                defined in (a)(2) of this section;
                * * * * *
                 (f) No payment may be made for services referenced in paragraphs
                (b)(1) through (4) of this section, unless a practitioner referenced in
                paragraph (a)(2) of this section or for medical equipment, a
                practitioner described in paragraph (a)(3) of this section documents
                that there was a face-to-face encounter with the beneficiary that meets
                the following requirements.
                * * * * *
                 (3) * * *
                 (i) A physician;
                * * * * *
                 (vi) For medical equipment, supplies, or appliances, a licensed
                practitioner of the healing arts acting within the scope of practice
                authorized under state law.
                 (4) If State law does not allow the non-physician practitioner, as
                described in paragraphs (f)(3)(ii) through (vi) of this section, to
                perform the face-to-face encounter independently, the non-physician
                practitioner must communicate the clinical findings of that face-to-
                face encounter to the ordering physician. Those clinical findings must
                be incorporated into a written or electronic document included in the
                beneficiary's medical record.
                * * * * *
                 (g)(1) No payment may be made for medical equipment, supplies, or
                appliances referenced in paragraph (b)(3) of this section to the extent
                that a face-to-face encounter requirement would apply as durable
                medical equipment (DME) under the Medicare program, unless a
                practitioner referenced in paragraph (a)(3) of this section documents a
                face-to-face encounter with the beneficiary consistent with the
                requirements of paragraph (f) of this section except as indicated in
                paragraph (g)(2) of this section.
                * * * * *
                PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
                0
                39. The authority citation continues to read as follows:
                 Authority: 42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r.
                0
                40. Section 483.80 is amended by adding paragraph (g) to read as
                follows:
                Sec. 483.80 Infection control.
                * * * * *
                 (g) COVID-19 reporting. The facility must--
                 (1) Electronically report information about COVID-19 in a
                standardized format specified by the Secretary. This report must
                include but is not limited to--
                 (i) Suspected and confirmed COVID-19 infections among residents and
                staff, including residents previously treated for COVID-19;
                 (ii) Total deaths and COVID-19 deaths among residents and staff;
                 (iii) Personal protective equipment and hand hygiene supplies in
                the facility;
                 (iv) Ventilator capacity and supplies in the facility;
                 (v) Resident beds and census;
                 (vi) Access to COVID-19 testing while the resident is in the
                facility;
                 (vii) Staffing shortages; and
                 (viii) Other information specified by the Secretary.
                 (2) Provide the information specified in paragraph (g)(1) of this
                section at a frequency specified by the Secretary, but no less than
                weekly to the Centers for Disease Control and Prevention's National
                Healthcare Safety Network. This information will be posted publicly by
                CMS to support protecting the health and safety of residents,
                personnel, and the general public.
                 (3) Inform residents, their representatives, and families of those
                residing in facilities by 5 p.m. the next calendar day following the
                occurrence of either a single confirmed infection of COVID-19, or three
                or more residents or staff with new-onset of respiratory symptoms
                occurring within 72 hours of each other. This information must--
                 (i) Not include personally identifiable information;
                 (ii) Include information on mitigating actions implemented to
                prevent or reduce the risk of transmission, including if normal
                operations of the facility will be altered; and
                 (iii) Include any cumulative updates for residents, their
                representatives, and families at least weekly or by 5 p.m. the next
                calendar day following the subsequent occurrence of either: Each time a
                confirmed infection of COVID-19 is identified, or whenever three or
                more residents or staff with new onset of respiratory symptoms occur
                within 72 hours of each other.
                PART 484--HOME HEALTH SERVICES
                0
                41. The authority citation for part 484 is revised to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                0
                42. Section 484.2 is amended by--
                0
                a. Adding definitions for ``Allowed practitioner'', ``Clinical nurse
                specialist'', ``Nurse practitioner'', ``Physician'', and ``Physician
                assistant'' in alphabetical order; and
                0
                b. Revising the definitions of ``Summary report'' and ``Verbal order''.
                 The additions and revisions read as follows:
                Sec. 484.2 Definitions.
                * * * * *
                 Allowed practitioner means a physician assistant, nurse
                practitioner, or clinical nurse specialist as defined at this part.
                * * * * *
                 Clinical nurse specialist means an individual as defined at Sec.
                410.76(a) and (b) of this chapter, and who is working in collaboration
                with the physician as defined at Sec. 410.76(c)(3) of this chapter.
                * * * * *
                 Nurse practitioner means an individual as defined at Sec.
                410.75(a) and (b) of this chapter, and who is working in collaboration
                with the physician as defined at Sec. 410.75(c)(3) of this chapter.
                * * * * *
                [[Page 27628]]
                 Physician is a doctor of medicine, osteopathy, or podiatric
                medicine, and who is not precluded from performing this function under
                paragraph (d) of this section. (A doctor of podiatric medicine may
                perform only plan of treatment functions that are consistent with the
                functions he or she is authorized to perform under State law.)
                 Physician assistant means an individual as defined at Sec.
                410.74(a) and (c) of this chapter.
                * * * * *
                 Summary report means the compilation of the pertinent factors of a
                patient's clinical notes that is submitted to the patient's physician,
                physician assistant, nurse practitioner, or clinical nurse specialist.
                * * * * *
                 Verbal order means a physician, physician assistant, nurse
                practitioner, or clinical nurse specialist order that is spoken to
                appropriate personnel and later put in writing for the purposes of
                documenting as well as establishing or revising the patient's plan of
                care.
                Sec. 484.50 [Amended]
                0
                43. Section 484.50 is amended in paragraphs (d)(1) and (3) by removing
                the term ``physician'' and adding in its place the phrase ``physician
                or allowed practitioner''.
                Sec. 484.55 [Amended]
                0
                44. Section 484.55 is amended in paragraphs (a)(1), (b)(3) and (d)(2)
                by removing the term ``physician'' and add in its place the phrase
                ``physician or allowed practitioner''.
                0
                45. Section 484.60 is amended--
                0
                a. By revising paragraphs (a)(1), (a)(2)(xvi), (b), and (c)(1); and
                0
                b. In paragraphs (c)(3)(i) and (ii) and (d)(1) and (2) by removing the
                term ``physicians'' and adding in its place the phrase ``physicians or
                allowed practitioners''.
                 The revisions read as follows:
                Sec. 484.60 Condition of participation: Care planning, coordination
                of services, and quality of care.
                * * * * *
                 (a) * * *
                 (1) Each patient must receive the home health services that are
                written in an individualized plan of care that identifies patient-
                specific measurable outcomes and goals, and which is established,
                periodically reviewed, and signed by a doctor of medicine, osteopathy,
                or podiatry or allowed practitioner acting within the scope of his or
                her state license, certification, or registration. If a physician or
                allowed practitioner refers a patient under a plan of care that cannot
                be completed until after an evaluation visit, the physician or allowed
                practitioner is consulted to approve additions or modifications to the
                original plan.
                 (2) * * *
                 (xvi) Any additional items the HHA or physician or allowed
                practitioner may choose to include.
                 (b) Standard: Conformance with physician or allowed practitioner
                orders. (1) Drugs, services, and treatments are administered only as
                ordered by a physician or allowed practitioner.
                 (2) Influenza and pneumococcal vaccines may be administered per
                agency policy developed in consultation with a physician, physician
                assistant, nurse practitioner, or clinical nurse specialist, and after
                an assessment of the patient to determine for contraindications.
                 (3) Verbal orders must be accepted only by personnel authorized to
                do so by applicable state laws and regulations and by the HHA's
                internal policies.
                 (4) When services are provided on the basis of a physician or
                allowed practitioner's verbal orders, a nurse acting in accordance with
                state licensure requirements, or other qualified practitioner
                responsible for furnishing or supervising the ordered services, in
                accordance with state law and the HHA's policies, must document the
                orders in the patient's clinical record, and sign, date, and time the
                orders. Verbal orders must be authenticated and dated by the physician
                or allowed practitioner in accordance with applicable state laws and
                regulations, as well as the HHA's internal policies.
                 (c) * * *
                 (1) The individualized plan of care must be reviewed and revised by
                the physician or allowed practitioner who is responsible for the home
                health plan of care and the HHA as frequently as the patient's
                condition or needs require, but no less frequently than once every 60
                days, beginning with the start of care date. The HHA must promptly
                alert the relevant physician(s) or allowed practitioner(s) to any
                changes in the patient's condition or needs that suggest that outcomes
                are not being achieved and/or that the plan of care should be altered.
                * * * * *
                Sec. 484.75 [Amended]
                0
                46. Section 484.75 is amended in the introductory text and paragraph
                (b)(3) by removing the term ``physician'' and adding in its place the
                phrase ``physician or allowed practitioner''.
                Sec. 484.80 [Amended]
                0
                47. Section 484.80 is amended in paragraph (g)(2)(i) by removing the
                term ``physician;'' and adding in its place the phrase ``physician or
                allowed practitioner;''.
                Sec. 484.205 [Amended]
                0
                48. Section 484.205 is amended--
                0
                a. In paragraphs (h)(1)(ii) by removing the term ``physician's'' and
                adding in its place the phrase ``physician or allowed practitioner's'';
                0
                b. In paragraphs (h)(1)(iii) and (h)(2) introductory text by removing
                the term ``physician'' and adding in its place the phrase ``physician
                or allowed practitioner''; and
                0
                c. In paragraphs (i)(2)(i) and (j)(2)(i) by removing the term
                ``physician's'' and adding in its place the phrase ``physician or
                allowed practitioner's''.
                Sec. 484.235 [Amended]
                0
                49. Section 484.235 is amended--
                0
                a. In paragraphs (a)(1) and (3) by removing the term ``physician'' and
                adding in its place the phrase ``physician or allowed practitioner'';
                0
                b. In paragraph (b)(1) by removing the phrase ``assessment and
                physician certification'' and adding in its place the phrase
                ``assessment and certification''; and
                0
                c. In paragraph (b)(3) by removing the term ``physician'' and adding in
                its place the phrase ``physician or allowed practitioner''.
                0
                50. Section 484.315 is amended by revising paragraph (b) to read as
                follows:
                Sec. 484.315 Data reporting for measures and evaluation and the
                public reporting of model data under the Home Health Value-Based
                Purchasing (HHVBP) Model
                * * * * *
                 (b) Competing home health agencies in selected states will be
                required to report information on New Measures, as determined
                appropriate by the Secretary, to CMS in the form, manner, and at a time
                specified by the Secretary, and subject to any exceptions or extensions
                CMS may grant to home health agencies for the Public Health Emergency
                as defined in Sec. 400.200 of this chapter.
                * * * * *
                PART 600--ADMINISTRATION, ELIGIBILITY, ESSENTIAL HEALTH BENEFITS,
                PERFORMANCE STANDARDS, SERVICE DELIVERY REQUIREMENTS, PREMIUM AND
                COST SHARING, ALLOTMENTS, AND RECONCILIATION
                0
                51. The authority citation for part 600 continues to read as follows:
                [[Page 27629]]
                 Authority: Section 1331 of the Patient Protection and Affordable
                Care Act of 2010 (Pub. L. 111-148, 124 Stat. 119), as amended by the
                Health Care and Education Reconciliation Act of 2010 (Pub. L. 111--
                152, 124 State. 1029).
                0
                52. Section 600.125 is amended by revising paragraph (b) and adding
                paragraph (c) to read as follows:
                Sec. 600.125 Revisions to a certified BHP Blueprint.
                * * * * *
                 (b) Continued operations. The state is responsible for continuing
                to operate under the terms of the existing certified Blueprint until
                and unless a revised Blueprint that seeks to make significant change(s)
                is certified, except as specified in paragraph (c) of this section.
                 (c) Public health emergency. For the Public Health Emergency, as
                defined in Sec. 400.200 of this chapter, the State may submit to the
                Secretary for review and certification a revised Blueprint, in the form
                and manner specified by HHS, that makes temporary significant changes
                to its BHP that are directly related to the Public Health Emergency and
                would increase enrollee access to coverage. Such revised Blueprints may
                have an effective date retroactive to the first day of the Public
                Health Emergency and through the last day of the Public Health
                Emergency, or a later date if requested by the state and certified by
                HHS. Such revised Blueprints are not subject to the public comment
                requirements under Sec. 600.115(c).
                Title 45
                PART 156--HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE
                CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES
                0
                53. The authority citation for part 156 continues to read as follows:
                 Authority: 42 U.S.C. 18021-18024, 18031-18032, 18041-18042,
                18044, 18054, 18061, 18063, 18071, 18082, 26 U.S.C. 36B, and 31
                U.S.C. 9701.
                0
                54. Section 156.280 is amended by revising paragraph (e)(2)(ii)
                introductory text to read as follows:
                Sec. 156.280 Separate billing and segregation of funds for abortion
                services.
                * * * * *
                 (e) * * *
                 (2) * * *
                 (ii) Beginning on or before the first billing cycle following
                August 26, 2020, to satisfy the obligation in paragraph (e)(2)(i) of
                this section--
                * * * * *
                 Dated: April 24, 2020.
                Seema Verma,
                Administrator, Centers for Medicare & Medicaid Services.
                 Dated: April 28, 2020.
                Alex M. Azar II,
                Secretary, Department of Health and Human Services.
                [FR Doc. 2020-09608 Filed 5-1-20; 4:15 pm]
                 BILLING CODE 4120-01-P