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

 
CONTENT
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.
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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.
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 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.
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 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.
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 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.
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 \22\ www.cms.gov.
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 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.
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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.
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 \24\ www.cms.gov.
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 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.
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 \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.
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 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.
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 \26\ https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf.
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 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.
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[[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.
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 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.
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 \39\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6913e2.htm;
https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html.
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 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.
---------------------------------------------------------------------------
 \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''.
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 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).
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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).
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 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.
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 \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.
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 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\
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 \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
.
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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.
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 \48\ Available at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/580/2020%20Self-Nomination%20Toolkit%20for%20QCDRs%20%26%20Qualified%20Registries.zip
.
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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.
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 \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.
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 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:
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 \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.
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 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\
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 \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.
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 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.
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 \55\ https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html.
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 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.
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 \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.
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 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.
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 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