Federal Register, Volume 85 Issue 171 (Wednesday, September 2, 2020)

[Federal Register Volume 85, Number 171 (Wednesday, September 2, 2020)]
[Rules and Regulations]
[Pages 54820-54874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19150]

[[Page 54819]]

Vol. 85

Wednesday,

No. 171

September 2, 2020

Part IV

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Parts 410, 413, 414, et al.

Medicare and Medicaid Programs, Clinical Laboratory Improvement
Amendments (CLIA), and Patient Protection and Affordable Care Act;
Additional Policy and Regulatory Revisions in Response to the COVID-19
Public Health Emergency; Final Rule

Federal Register / Vol. 85 , No. 171 / Wednesday, September 2, 2020 /
Rules and Regulations

[[Page 54820]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 410, 413, 414, 422, 423, 482, 483, 485, 488 and 493

[CMS-3401-IFC]
RIN 0938-AU33

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) revises
regulations to strengthen CMS' ability to enforce compliance with
Medicare and Medicaid long-term care (LTC) facility requirements for
reporting information related to coronavirus disease 2019 (COVID-19),
establishes a new requirement for LTC facilities for COVID-19 testing
of facility residents and staff, establishes new requirements in the
hospital and critical access hospital (CAH) Conditions of Participation
(CoPs) for tracking the incidence and impact of COVID-19 to assist
public health officials in detecting outbreaks and saving lives, and
establishes requirements for all CLIA laboratories to report COVID-19
test results to the Secretary of Health and Human Services (Secretary)
in such form and manner, and at such timing and frequency, as the
Secretary may prescribe during the Public Health Emergency (PHE).

DATES: Effective date: These regulations are effective on September 2,
2020.
Applicability date: These regulations are applicable for the
duration of the PHE for COVID-19. Section 488.447 is applicable 1 year
beyond the expiration of the PHE for COVID-19. The amendment to Sec.
414.1305 and the expansion of telehealth codes used in beneficiary
assignment for the CMS Web Interface and CAHPS for MIPS survey (found
in section II.I. of the preamble) are applicable beginning January 1,
2020.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on November 2, 2020.

ADDRESSES: In commenting, please refer to file code CMS-3401-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-3401-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-3401-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:
Debra Lyons, (410) 786-6780, for information on the LTC enforcement
regulation at 42 CFR part 488.
CAPT Scott Cooper, USPHS, (410) 786-9465, for the hospital and CAH
COVID-19 reporting requirements.
Sarah Bennett, (410) 786-3354, for laboratory reporting
information.
Julia Venanzi, (410) 786-1471, for provisions related to the
Hospital Value-Based Purchasing Program.
Erin Patton, (410) 786-2437, for provisions related to the Hospital
Readmissions Reduction Program.
Lang Le, (410) 786-5693, for provisions related to the Skilled-
Nursing Facility Value-Based Purchasing Program and the Hospital-
Acquired Condition Reduction Program.
Delia Houseal, (410) 786-2724, for provisions related to the End-
Stage Renal Disease Quality Incentive Program.
Kimberly Long, (410) 786-5702, or
NCDsPublicHealthEmergency@cms.hhs.gov, for provisions related to NCD
Procedural Volumes for Facilities and Practitioners to Maintain
Medicare Coverage.
Jennifer Dupee, (410) 786-6537, for provisions related to order
requirements for COVID-19 and related testing.
Jaya Ghildiyal, (301) 492-5149, for PPACA risk adjustment
requirements.
Christina Whitefield, (301) 492-4172, for PPACA medical loss ratio
requirements.
Elizabeth Goldstein, (410) 786-6665, or
PartCandDStarRatings@cms.hhs.gov, for the modifications to the
calculation of the 2022 Part C and D Star Ratings.
Molly MacHarris, (410) 786-4461, for issues related to the Merit-
based Incentive Payment System (MIPS).
Kianna Banks, (410) 786-3498, for the LTC resident and staff COVID-
19 testing requirements.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following website as soon as possible after they have been
received: http://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. New Enforcement Requirement for LTC Facilities
B. Condition of Participation (CoP) Requirements for Hospitals
and CAHs to Report COVID-19 Data As Specified by the Secretary
During the PHE for COVID-19
C. Requirements for Laboratories to Report SARS-CoV-2 Test
Results During the PHE for COVID-19
D. Quality Reporting: Updates to the Extraordinary Circumstances
Exceptions (ECE) Granted for Four Value-Based Purchasing Programs in
Response to the PHE for COVID-19, and Update to the Performance
Period for the FY 2022 SNF VBP Program
E. NCD Procedural Volumes for Facilities and Practitioners to
Maintain Medicare Coverage
F. Limits on COVID-19 and Related Testing without an Order and
Expansion of Testing Order Authority
G. Recognizing Temporary Premium Credits as Premium Reductions
H. Addressing the Impact of COVID-19 on Part C and Part D
Quality Rating Systems
I. Merit-Based Incentive Payment System (MIPS) Updates
J. Requirement for Long-Term Care (LTC) Facilities to Test
Facility Residents and Staff for COVID-19
III. Waiver of Proposed Rulemaking
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Analysis
Regulations Text

Executive Summary

This interim final rule with comment period (IFC) revises
regulations to strengthen CMS' ability to enforce compliance with
Medicare and

[[Page 54821]]

Medicaid long-term care (LTC) facility requirements for reporting
information related to coronavirus disease 2019 (COVID-19), establishes
a new requirement for LTC facilities for COVID-19 testing of facility
residents and staff, establishes new requirements in the hospital and
critical access hospital (CAH) Conditions of Participation (CoPs) for
tracking the incidence and impact of COVID-19 to assist public health
officials in detecting outbreaks and saving lives, and establishes
requirements for all CLIA laboratories to report COVID-19 test results
to the Secretary of Health and Human Services (Secretary) in such form
and manner, and at such timing and frequency, as the Secretary may
prescribe during the Public Health Emergency (PHE). This IFC updates
the extraordinary circumstances exceptions granted for the ESRD Quality
Incentive Program (QIP), Hospital Acquired Condition (HAC) Reduction
Program, Hospital Readmissions Reduction Program (HRRP), and Hospital
VBP Program for the PHE for COVID-19, and revises the FY 2022
performance period under the Skilled Nursing Facility (SNF) VBP as a
result of the PHE for COVID-19. This IFC also announces that with
respect to the Hospital VBP Program, HRRP, HAC Reduction Program, SNF
VBP Program and the ESRD QIP, if, as a result of a decision to grant a
new nationwide ECE without request or a decision to grant a substantial
number of individual ECE requests, we do not have enough data to
reliably compare national performance on measures, we may propose to
not score facilities, hospitals, or SNFs based on such limited data or
make the associated payment adjustments for the affected program year.
In addition, this IFC announces that CMS will not enforce certain
procedural volume requirements for four national coverage
determinations, revises the previous policy outlined in the May 8th
COVID-19 IFC by establishing that one single COVID-19 diagnostic test
and one of each other applicable related tests without an order from a
treating physician or other practitioner is reasonable and necessary,
establishes a policy whereby the orders of pharmacists and other
practitioners that are allowed to order laboratory tests in accordance
with state scope of practice and other pertinent laws can fulfill the
requirements related to orders for covered COVID-19 and related tests
for Medicare patients, specifies how temporary premium credits for
individual and small group health insurance coverage are treated for
purposes of the risk adjustment and medical loss ratio programs,
modifies the application of the extreme and uncontrollable
circumstances policy for calculation of the 2022 Part C and D Star
Ratings to address the effects of the PHE for COVID-19, includes in the
Merit-Based Incentive Payment System (MIPS) beneficiary assignment
methodology for the CMS Web Interface and Consumer Assessment of
Healthcare Providers and Systems (CAHPS) for MIPS survey for
performance year 2020 and any subsequent performance year that starts
during the PHE for COVID-19 certain Current Procedural Terminology
(CPT) and Healthcare Common Procedure Coding System (HCPCS) code
additions, and modifies IA_ERP_3.

I. Background

The United States is responding to an outbreak of respiratory
disease caused by coronavirus disease that was first detected in China
and which has now been detected in more than 190 countries
internationally, and all 50 States, the District of Columbia, and the
U.S. territories. 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, pursuant to section 319 of the Public Health Service Act (PHSA)
(42 U.S.C. 247d), the Health and Human Services Secretary (the
Secretary) 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 COVID-19).
On March 11, 2020, the WHO publicly declared COVID-19 a pandemic. On
March 13, 2020, President Donald J. Trump (the President) declared the
COVID-19 pandemic a national emergency. Effective July 25, 2020, the
Secretary renewed the January 31, 2020 determination that was
previously renewed on April 21, 2020, that a PHE for COVID-19 exists
and has existed since January 27, 2020.
The Centers for Disease Control and Prevention (CDC) has reported
that some people are at higher risk of severe illness from COVID-19.\1\
These higher-risk categories include:
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\1\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6915e3.htm.
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Older adults, with risk increasing by age.
People of any age who have certain underlying medical
conditions such as:
++ Cancer.
++ Chronic kidney disease.
++ Obesity.
++ Serious heart conditions (for example, heart failure, coronary
artery disease, or cardiomyopathies).
++ Sickle cell disease.
++ Diabetes mellitus.
++ Hypertension.
++ Chronic obstructive pulmonary disease (COPD).
++ Neurologic/Neurodevelopmental disability.\2\
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\2\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6924e2.htm?s_cid=mm6924e2_w.
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++ Immunocompromised state from solid organ transplant.
Residents of LTC facilities, including nursing homes,
Intermediate Care Facilities for Individuals with Intellectual and
Developmental Disabilities (ICF/IIDs), inpatient psychiatric and
substance abuse treatment facilities including institutions for mental
disorders (IMD) and Psychiatric Residential Treatment Facilities
(PRTF), assisted living facilities, group homes for individuals with
developmental disabilities and board-and-care facilities.
The CDC has developed guidance to help in the risk assessment and
management of people with potential exposures to COVID-19, including
recommending that healthcare professionals make every effort to
interview a person under investigation for infection by telephone, text
monitoring system, or video conference.\3\
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\3\ https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html.
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As the healthcare community establishes and implements recommended
infection prevention and control practices, regulatory agencies
operating under appropriate waiver authority granted by the PHE for
COVID-19 are also working to revise and implement regulations that
support these healthcare community infection prevention and treatment
practices. Based on the current and projected increases in the COVID-19
incidence rates in the US, observed fatalities in the older adult
population, and the impact on health workers who are at increased risk
due to treating special populations, it is CMS' belief that certain
regulations should be reviewed and revised as appropriate to offer
additional flexibilities in furnishing and providing services to combat
the PHE for COVID-19 and to address and minimize the

[[Page 54822]]

unique impact of the PHE for COVID-19 on other regulatory provisions.
We addressed some of these regulations in two previous interim final
rules with comment period (IFCs). The ``Medicare and Medicaid Programs;
Policy and Regulatory Revisions in Response to the COVID-19 Public
Health Emergency'' IFC appeared in the April 6, 2020 Federal Register
(85 FR 19230) with an effective date of March 31, 2020 (hereafter
referred to as the ``March 31st COVID-19 IFC''), and the ``Medicare and
Medicaid Programs, Basic Health Program, and Exchanges; Additional
Policy and Regulatory Revisions in Response to the COVID-19 Public
Health Emergency and Delay of Certain Reporting Requirements for the
Skilled Nursing Facility Quality Reporting Program'' IFC appeared in
the May 8, 2020 Federal Register (85 FR 27550) with an effective date
of May 8, 2020 (hereafter referred to as the ``May 8th COVID-19 IFC'').
In this IFC, we are revising regulations to strengthen CMS' ability
to enforce new LTC requirements added to 42 CFR part 483 published in
the May 8th COVID-19 IFC to report facility data related to COVID-19
and infection control at least weekly. Specifically, we are adding a
regulation to specify the civil money penalty (CMP) amounts that may be
imposed for the failure to electronically report COVID-19 data each
week, which includes, among other things, suspected and confirmed
COVID-19 infections among residents and staff, including residents
previously treated for COVID-19, total deaths of COVID-19 deaths among
residents and staff, and personal protective equipment and hand hygiene
supplies in the facility.
We are also requiring hospitals and CAHs to report information in
accordance with a frequency, and in a standardized format, as specified
by the Secretary during the PHE for COVID-19. We believe that universal
reporting by all hospitals and CAHs is and will be an important tool
for supporting surveillance of COVID-19 and for future planning to
prevent the spread of the virus, especially to those most vulnerable
and at risk to its effects.
In this IFC, we also address condition-level noncompliance related
to SARS-CoV-2 laboratory reporting and strengthen CMS' ability to
enforce new requirements to electronically report SARS-CoV-2 test
results in such form and manner, and at such timing and frequency, as
the Secretary may prescribe during the PHE for COVID-19.
On October 31, 1988, Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578) (codified as
amended at 42 U.S.C. 263a), requiring any laboratory that examines
human specimens for the purpose of providing information for the
diagnosis, prevention, or treatment of any disease or impairment of, or
the assessment of health, of human beings to be certified by the
Secretary for the categories of examinations or procedures performed by
the laboratory. The implementing regulations at 42 CFR part 493 specify
the conditions and standards that must be met to achieve and maintain
CLIA certification. These conditions and standards strengthen federal
oversight of clinical laboratories and help ensure the accuracy and
reliability of patient test results.
On March 27, 2020, the President signed the Coronavirus Aid,
Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136) into
law. The CARES Act includes section 18115, which requires every
laboratory that performs or analyzes a test that is intended to detect
SARS-CoV-2 or to diagnose a possible case of COVID-19 to report the
results for such test to the Secretary until the conclusion of the PHE
for COVID-19.
Subsequently, on June 4, 2020, the Department of Health and Human
Services (HHS) published the COVID-19 Pandemic Response, Laboratory
Data Reporting: CARES Act Section 18115 Guidance,\4\ implementing the
requirement under section 18115 of the CARES Act for laboratories to
report COVID-related information to the Secretary.
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\4\ https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf.
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With regard to laboratory oversight, HHS endeavors to improve
consistency in application of laboratory standards, to improve
coordination, collaboration, and communication in both routine and
emergent situations, and thereby further improve the level of
laboratory oversight and ultimately patient care. In order for CMS to
ensure laboratories are properly reporting SARS-CoV-2 test results, CMS
has determined that modifications to the CLIA regulations must be made.
We are requiring all laboratories performing testing related to SARS-
CoV-2, to report SARS-CoV-2 test results in such form and manner, and
at such timing and frequency, as the Secretary may prescribe during the
PHE for COVID-19.
In addition, this IFC clarifies the data reporting requirements for
issuers of risk adjustment covered plans \5\ to specify that, for the
purposes of 2020 benefit year risk adjustment data submissions, issuers
of risk adjustment covered plans that provide temporary premium credits
must report to their distributed data environments (EDGE servers) the
adjusted plan premiums that reflect actual premiums billed to
enrollees, taking the premium credits into account as a reduction in
premiums. In addition, we clarify that, consistent with the reporting
of the actual premium amounts billed to enrollees for 2020 benefit year
risk adjustment data submissions, HHS's calculation of risk adjustment
payment and charges for the 2020 benefit year under the state payment
transfer formula will be calculated using the statewide average premium
that reflects actual premiums billed, taking into account any temporary
premium credits provided as a reduction in premium for the applicable
months of 2020 coverage. In this IFC, we similarly clarify the Medical
Loss Ratio (MLR) reporting and rebate calculation requirements in 45
CFR part 158 for issuers that elect to provide temporary premium
credits in 2020 such that these issuers must report as earned premium
the actual premium paid, taking into account any temporary premium
credits provided for the applicable months of 2020 coverage.
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\5\ See 45 CFR 153.20 for a definition of ``risk adjustment
covered plan''.
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This IFC also announces that we will not enforce certain procedural
volume requirements in order for facilities and practitioners to
maintain Medicare coverage under specific national coverage
determinations (NCDs). This applies to facilities and practitioners
that, prior to the PHE for COVID-19, met the volume requirements for
these NCDs.
In this IFC, we are also revising the previous policy outlined in
the May 8th COVID-19 IFC, which allowed for broad COVID-19 testing for
a single beneficiary without a physician or other practitioner order,
by establishing that one single COVID-19 diagnostic test and one of
each other related tests (as listed in the May 8th COVID-19 IFC)
without a treating physician or other practitioner order is reasonable
and necessary. We are also establishing a policy whereby the orders of
pharmacists and other practitioners that are allowed to order
laboratory tests in accordance with state scope of practice and other
pertinent laws can fulfill the requirements related to orders for
covered COVID-19 tests for Medicare patients. In addition, this IFC
updates the extraordinary circumstances exceptions (ECEs) we granted on
March 22, 2020, for the ESRD Quality Incentive Program (QIP), Hospital
Acquired Condition (HAC) Reduction Program, HRRP, and Hospital Value-
Based

[[Page 54823]]

Purchasing (VBP) Program in response to the PHE for COVID-19, revises
the FY 2022 performance period under the SNF VBP as a result of the PHE
for COVID-19, implements a COVID-19 reporting requirement for hospitals
and critical access hospitals (CAHs), and modifies the application of
the extreme and uncontrollable circumstances policy for calculation of
the 2022 Part C and D Star Ratings to address the effects of the PHE
for COVID-19.
This IFC also announces that with respect to the Hospital VBP
Program, HRRP, HAC Reduction Program, SNF VBP Program and the ESRD QIP,
if, as a result of a decision to grant a new nationwide ECE without
request or a decision to grant a substantial number of individual ECEs,
we do not have enough data to reliably compare national performance on
measures, we may propose to not score facilities based on such limited
data or make the associated payment adjustments for the affected
program year.
In this IFC, for the 2020 performance year and any subsequent
performance year that starts during the PHE for COVID-19, we are
including in the MIPS beneficiary assignment methodology for the CMS
Web Interface and Consumer Assessment of Healthcare Providers and
Systems (CAHPS) for MIPS survey the following additions due to the PHE
for COVID-19: (1) CPT codes: 99421, 99422, and 99423 (codes for online
digital evaluation and management (E/M) service (e-visit)), and 99441,
99442, and 99443 (codes for telephone E/M services); and (2) HCPCS
codes: G2010 (code for remote evaluation of patient video/images) and
G2012 (code for virtual check-in). In addition, we are: (1) Expanding
the improvement activity IA_ERP_3 titled ``COVID-19 Clinical Trial'' to
also allow credit for clinicians who participate in the care of
patients diagnosed with COVID-19 and simultaneously submit relevant
clinical data to a clinical data registry for ongoing or future COVID-
19 research; (2) updating the title; and (3) extending it through the
CY 2021 performance period.
In an effort to support national efforts to control the spread of
COVID-19, we are also revising the LTC facility infection control
regulations at Sec. 483.80 to establish a new requirement for LTC
facilities to test their facility residents and staff, including
individuals providing services under arrangement and volunteers. We are
requiring that resident and staff testing in LTC facilities for COVID-
19 be conducted based on parameters set forth by the Secretary. We
believe these requirements will positively and substantially impact
efforts to control the spread of COVID-19 in LTC facilities.
All provisions included in this IFC are effective only for the
duration of the PHE for COVID-19, unless otherwise indicated. The
provision at Sec. 488.447 is intended to be in effect beyond the
expiration of the PHE for COVID-19.

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 under section 319 of the PHSA on
January 31, 2020, and renewed effective July 25, 2020,\6\ as a result
of confirmed cases of COVID-19.
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\6\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
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A. New Enforcement Requirement for LTC Facilities

Under sections 1866 and 1902 of the Social Security Act (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. 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 nursing facilities (NFs) for Medicaid.
The federal participation requirements for these facilities are
specified in sections 1819 and 1919 of the Act and in implementing
regulations at 42 CFR part 483, subpart B.
Under sections 1819(f)(1) and 1919(f)(1) of the Act, the Secretary
must assure that the enforcement of compliance with the participation
requirements are adequate to protect the health, safety, welfare, and
rights of residents and to promote the effective use of public moneys.
The federal requirements related to enforcement of the requirements for
SNFs, NFs, or dually-certified facilities, are set forth in sections
1819(h) and 1919(h) of the Act and codified in the regulations at 42
CFR part 488, subpart F. Among the remedies available to be imposed for
noncompliance with the requirements is a civil money penalty (CMP), as
authorized in sections 1819(h)(2)(B)(ii) and 1919(h)(3)(C)(ii) of the
Act, and Sec. Sec. 488.430 through 488.444.
We are using our authority under this IFC to immediately implement
a new enforcement regulation identified below in order to effectively
enhance enforcement of the new infection prevention and control
reporting requirements at Sec. 483.80(g)(1) and (2) that became
effective on May 8, 2020 as discussed in the May 8th COVID-19 IFC.
Prior to the PHE for COVID-19, regulations at Sec.
483.80(a)(2)(ii) required facilities to have written standards,
policies and procedures regarding infection control, which must include
when and to whom possible incidents of communicable disease or
infections should be reported. This includes reporting to local/state
health authorities.
In an effort to support ongoing surveillance of COVID-19 cases, we
added to the infection control requirements provisions to establish
weekly facility reporting of suspected and/or confirmed COVID-19 cases,
among other information, at new Sec. 483.80(g) in the May 8th COVID-19
IFC (85 FR 27550, 27601 through 27602). This new regulation requires
nursing homes to report COVID-19 related facility data to the CDC
National Healthcare Safety Network (NHSN). These new CMS reporting
requirements do not preclude a facility from following all state and
local public health reporting laws and regulations.
Specifically, we revised our requirements by adding new provisions
at Sec. Sec. 483.80(g)(1) and (2), to require facilities to
electronically report information about COVID-19 in a standardized
format and at a frequency specified by the Secretary, but not less than
weekly to the CDC NHSN. This critical information will provide real-
time information on COVID-19 in nursing homes, and will be used to
monitor trends in infection rates, and inform public health policies.
To coincide with this new reporting requirement, we developed an
automated process within the existing ASPEN (Automated Survey Process
Environment) survey software application, which uses information
received weekly from the CDC to determine whether a provider reported
the data as required. We will determine if noncompliance exists through
a retrospective review each week to identify the facilities that failed
to take the necessary and timely actions to report to CDC.
Noncompliance with this requirement for each weekly reporting cycle
will be cited at a scope of widespread, and a severity of no actual
harm with potential for more than minimal harm that is not immediate
jeopardy, which constitutes a level ``F'' deficiency. This is
consistent with guidance that was issued in QSO 20-

[[Page 54824]]

29-NH \7\ which also included enforcement policies for the imposition
of a CMP for the failure to report to the CDC NHSN.
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\7\ ``Interim Final Rule Updating Requirements for Notification
of Confirmed and Suspected COVID-19 Cases Among Residents and Staff
in Nursing Homes.'' QSO-20-29-NH (May 6, 2020) https://www.cms.gov/files/document/qso-20-29-nh.pdf.
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With this IFC, we are furthering enforcement efforts of the
recently issued requirements at Sec. 483.80(g)(1) and (2) that
facilities report COVID-19 related information to the CDC's NHSN by
making revisions to part 488. These revisions codify enforcement
policies that are specifically tailored to reviewing compliance with
and imposing CMPs for the failure to report. We are enforcing the new
reporting requirements through the imposition of CMPs for each time a
facility fails to report the required data to the CDC NHSN system. We
believe that CMPs are an appropriate enforcement remedy that will
facilitate a swift return to compliance with the new reporting
requirement. Sections 1819(h)(2)(B)(ii)(I) and 1919(h)(3)(C)(ii)(I) of
the Act limit the amount of a CMP to $10,000 \8\ for each day of
noncompliance. We have determined that a minimum $1,000 initial CMP,
with a $500 incremental increase, is within the authorized CMP range
and an appropriate amount to deter noncompliance with this requirement.
Specifically, we are noting that a minimum $1,000 CMP will be imposed
for the first occurrence of noncompliance, that is, the first time the
facility fails to submit a timely report as required under Sec.
483.80(g)(1) and (2). For each subsequent time the facility fails to
report the requisite COVID-19 related data, the amount of the CMP
imposed will be increased by $500, which is consistent with sections
1819(h)(2)(B) and 1919(h)(3)(C) of the Act providing for the imposition
of incrementally more severe fines for repeated deficiencies. For
example, if a facility fails to report in 1 week, a minimum $1,000 CMP
will be imposed for that occurrence of noncompliance. If it fails to
report again in the subsequent week that new noncompliance
determination will lead to the imposition of another CMP but in the
increased amount of $1,500 for that failure to report. In this example,
if the facility complies with the reporting requirements by submitting
the required report in a 3rd week, but then subsequently fails to
report again in a following week, a CMP in the amount of $2,000 for
failing to report a third time will be imposed for that missed weekly
report (which is $500 more than the last imposed amount). After each
CMP is imposed, CMS will place the facility back into compliance,
without requiring a Plan of Correction (POC) in accordance with Sec.
488.408(f). A facility may still submit a POC if it chooses to do so;
however, because compliance will be imposed each week and facilities
will be assessed an increased CMP amount for each subsequent failure to
report, a POC will not be necessary. Facilities are offered an
opportunity for Independent Informal Dispute Resolution under Sec.
488.431. This may be requested for reasons, such as technical
difficulties that should be adequately documented, that may have
prevented the facility from submitting its report in a timely manner.
---------------------------------------------------------------------------

\8\ This amount is adjusted annually under the Federal Civil
Penalties Inflation Adjustment Act Improvements Act of 2015, and
listed in 42 CFR 102.3. The 2020 adjusted amount is $22,320 (85 FR
2870, January 17, 2020): https://www.federalregister.gov/documents/2020/01/17/2020-00738/annual-civil-monetary-penalties-inflation-adjustment.
---------------------------------------------------------------------------

Currently, under Sec. 488.408(d), Category 2 CMP remedies for
noncompliance that is not immediate jeopardy, but is widespread
deficient practice that does not constitute actual harm with a
potential for more than minimal harm, or that constitutes actual harm,
are imposed at a daily amount not to exceed $6,695.\9\ Similarly,
because noncompliance with Sec. 483.80(g)(1) and (2) will be cited at
an scope and severity of an ``F'', which would trigger a Category 2
remedy, we will not continue incrementally increasing the CMPamount
after 12 occurrences of noncompliance, so that the maximum CMP amount
imposed would not exceed $6,500 for each subsequent occurrence of
noncompliance. This specific maximum amount imposed for the failure to
report was established to be consistent with the existing CMPs within
Category 2 noncompliance. We believe imposing CMPs in this manner is a
fair and effective penalty for the failure to report, as assessed each
week.
---------------------------------------------------------------------------

\9\ Reflects the 2020 annual inflation adjusted amount under the
Federal Civil Penalties Inflation Adjustment Act Improvements Act of
2015, listed in 42 CFR 102.3 (85 FR 2870, January 17, 2020): https://www.federalregister.gov/documents/2020/01/17/2020-00738/annual-civil-monetary-penalties-inflation-adjustment.
---------------------------------------------------------------------------

To support and further codify these enhanced enforcement efforts,
we are adding Sec. 488.447 to impose a minimum CMP amount of $1,000
for the first occurrence of noncompliance with the reporting
requirements at Sec. 483.80(g)(1) and (2), and will increase the CMP
by $500 for each subsequent time the facility fails to report COVID-19
related data as required. Compliance with the requirements at Sec.
483.80(g)(1) and (2) will be assessed weekly. Facilities found out of
compliance with Sec. 483.80(g)(1) and (2) are not required to submit a
plan of correction as indicated in Sec. 488.408(f)(1). These CMP
amounts are subject to annual adjustments for inflation at 45 CFR
102.3. Under this rule, we will increase the CMP amounts for up to 12
subsequent noncompliance occurrences to the amount specified in Sec.
488.408(d)(1)(iii), which would be $6,500 per occurrence of
noncompliance. CMPs imposed in accordance with this rule are subject to
the same procedures as all other CMPs imposed under sections 1819(h)
and 1919(h) of the Act, including notice, escrow, independent informal
dispute resolution, and collections. Also, facilities may appeal the
determination leading to a CMP imposed under this rule in accordance
with 42 CFR part 498.
As discussed in section III. of this IFC, ``Waiver of Proposed
Rulemaking,'' we believe the urgency of this PHE for COVID-19
constitutes good cause to waive the normal notice-and-comment process
under Administrative Procedure Act (APA), 5 U.S.C. 533, and section
1871(b)(2)(C) of the Act. Waiving notice and comment is in the public
interest because the heightened threat to resident health and safety
for, widespread infection control noncompliance necessitates the
expedited imposition of enforcement remedies. Additionally, because it
is imperative to track the incidence and impact of COVID-19 in nursing
homes, it is crucial that a financial penalty be imposed for failure to
report. The CMP amounts we codify in this IFC will help deter
noncompliance and encourage facilities to establish procedures that
result in prompt weekly COVID-19 related data reports for the duration
of the PHE for COVID-19. Proper enforcement mechanisms designed to
deter noncompliant behavior and prompt corrective actions will help to
ensure that residents, staff, and the public are safe, and will help
provide critical COVID-19 related data to assist CMS and public health
authorities in detecting and expeditiously responding to outbreaks.
Furthermore, requiring prior notice and comment is impracticable
because the PHE for COVID-19 that the CMP amounts are tailored to
address may expire or be nearly over before a proposed rule can be
finalized. Finally, we think prior notice and comment is unnecessary
because we have broad discretion under the statute and existing CMP
regulations to establish a CMP amount, but we are

[[Page 54825]]

choosing to make our policies more transparent. We believe that a
completely transparent CMP structure will help deter noncompliance,
encourage timely reporting, and eliminate possible gaps in reporting
that could hinder the government's response to the PHE for COVID-19 in
specific geographic areas. For example, depending on the circumstances,
the failure of one facility to report COVID-19 cases on a timely basis
could delay our ability to detect and respond to an emerging COVID-19
hot spot.
For similar reasons, we are also waiving the 30-day delay in
effective date for these provisions. The effective date for Sec.
488.447 is the date of the publication of this rule (that is, the
effective date as noted in the DATES section of this IFC). Furthermore,
while we would generally expect that the new Sec. 488.447 would no
longer be in effect as of the end of the PHE for COVID-19 as defined in
Sec. 400.200, enhanced enforcement to ensure facilities continue to
comply with infection control reporting requirements to avoid possible
spread of COVID-19 will need to temporarily be in effect for a longer
period of time. In conjunction with the PHE for COVID-19, these
enforcement policies will continue to be in effect for up to one year
beyond the end of the PHE.

B. Condition of Participation (CoP) Requirements for Hospitals and CAHs
To Report COVID-19 Data As Specified by the Secretary During the PHE
for 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. Hospitals (all hospitals to which the
requirements of 42 CFR part 482 apply, including short-term acute care
hospitals, LTC hospitals, rehabilitation hospitals, psychiatric
hospitals, cancer hospitals, and children's hospitals) and CAHs seeking
to be Medicare and Medicaid providers of services must be certified as
meeting federal participation requirements. Our conditions of
participation (CoPs), conditions for coverage (CfCs), and requirements
set out the patient health and safety protections established by the
Secretary for various types of providers and suppliers. The specific
statutory authority for hospital CoPs is set forth in section 1861(e)
of the Act; section 1820(e) of the Act provides similar authority for
CAHs. The hospital provision authorizes the Secretary to issue any
regulations he or she deems necessary to protect the health and safety
of patients receiving services in those facilities; the CAH provision
authorizes the Secretary to issue such other criteria as he or she may
require. The CoPs are codified in the implementing regulations at part
482 for hospitals, and at 42 CFR part 485, subpart F, for CAHs.
Our CoPs at Sec. 482.42 for hospitals and Sec. 485.640 for CAHs,
require that hospitals and CAHs, respectively, have active facility-
wide programs, for the surveillance, prevention, and control of
healthcare-associated infections (HAIs) and other infectious diseases
and for the optimization of antibiotic use through stewardship.
Additionally, the programs must demonstrate adherence to nationally
recognized infection prevention and control guidelines, as well as to
best practices for improving antibiotic use where applicable, and for
reducing the development and transmission of HAIs and antibiotic-
resistant organisms. Infection prevention and control problems and
antibiotic use issues identified in the required hospital and CAH
programs must also be addressed in coordination with facility-wide
quality assessment and performance improvement (QAPI) programs.
Infection prevention and control is a primary goal of hospitals and
CAHs in their normal day-to-day operations, and these programs have
been at the center of initiatives taking place in hospitals and CAHs
during the PHE for COVID-19. Our regulations at Sec. Sec. 482.42(a)(3)
and 485.640(a)(3) require infection prevention and control program
policies to address any infection control issues identified by public
health authorities. On March 4, 2020, we issued guidance \10\ stating
that hospitals should inform infection prevention and control services,
local and state public health authorities, and other healthcare
facility staff as appropriate about the presence of a person under
investigation for COVID-19.
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\10\ https://www.cms.gov/files/document/qso-20-13-hospitalspdf.pdf-2.
---------------------------------------------------------------------------

In this IFC, we are now requiring hospitals and CAHs to report
information in accordance with a frequency, and in a standardized
format, as specified by the Secretary during the PHE for COVID-19.
Examples of data elements that may be required to be reported include
things such as the number of staffed beds in a hospital and the number
of those that are occupied, information about its supplies, and a count
of patients currently hospitalized who have laboratory-confirmed COVID-
19. This list is not exhaustive of those data items that we may require
hospitals and CAHs to submit, as specified by the Secretary (see
https://www.hhs.gov/sites/default/files/covid-19-faqs-hospitals-hospital-laboratory-acute-care-facility-data-reporting.pdf for the
current list of data items specified.).
We believe that universal reporting by all hospitals and CAHs is
and will be an important tool for supporting surveillance of COVID-19
and for future planning to prevent the spread of the virus, especially
to those most vulnerable and at risk to its effects, and we thank the
thousands of hospitals and CAHs that have voluntarily reported this
data in support of our efforts. However, while we recognize the
important and immeasurable role that the timely and continued delivery
of COVID-19 information plays in protecting both individual patients,
as well as the overall health of the general public, we also recognize
the crucial need for data reporting options that will help eliminate
the duplicative and sometimes competing reporting requests that
continue to place a significant burden on hospitals and CAHs whose
resources are already stressed during this PHE for COVID-19.
We expect that the new reporting requirements that will be
specified by the Secretary, would include reporting channel options to
make submission of data as user-friendly as possible to reduce the
strain and burden hospitals and CAHs are currently experiencing as they
face data requests from a multitude of federal, state, local, and
private entities. The new standards will require hospitals and CAHs to
report information on COVID-19 in a standardized format specified by
the Secretary. Also, the information must be reported at a frequency
and manner specified by the Secretary.
We believe that a streamlined approach to reporting data will
greatly assist the White House Coronavirus Task Force (COVID-19 Task
Force) in tracking the movement of the virus and identifying potential
problems in the healthcare delivery system. The completeness, accuracy,
and timeliness of the data will inform the COVID-19 Task Force
decisions on capacity and resource needs to ensure a fully coordinated
effort across the nation. Furthermore, we believe that consistent
processes and streamlined methods for the reporting of COVID-19
information will possibly reduce future, and urgent, requests for such
data.
We note here that the new reporting requirements at Sec. Sec.
482.42(e) and 485.640(d) do not relieve a hospital or a CAH,
respectively, of its obligation to continue to comply with Sec. Sec.
482.42(a)(3)

[[Page 54826]]

or 485.640(a)(3), each of which requires a facility to address any
infection prevention and control issues identified by public health
authorities. We believe that the requirements, as specified in this
rule, to collect and transmit these data, will also encourage greater
awareness and promotion of best practices in infection prevention and
control within these facilities.
This reporting requirement supports our responsibility to protect
and ensure the health and safety of hospital and CAH patients by, among
other things, ensuring that these facilities follow infection
prevention and control protocols based on recognized standards of
practice. We believe that these reporting requirements are necessary
for CMS to monitor whether individual hospitals and CAHs are
appropriately tracking, responding to, and mitigating the spread and
impact of COVID-19 on patients, the staff who care for them, and the
general public. We believe that this action reaffirms our commitment to
protecting the health and safety of all patients who receive care at
the approximately 6,200 Medicare- and Medicaid-participating hospitals
and CAHs nationwide.
As discussed in section III. of this IFC, ``Waiver of Proposed
Rulemaking,'' we believe the urgency of this PHE for COVID-19
constitutes good cause to waive the normal notice-and-comment process
under the APA 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
tracking the incidence and impact of COVID-19 in hospitals and CAHs;
such information will assist public health officials in detecting
outbreaks and saving lives.
The applicability date for Sec. 482.42(e) for hospitals and Sec.
485.640(d) for CAHs is the date of the publication of this rule as
noted in the DATES section of this IFC.
2. Enforcement of Requirements for Hospitals and Critical Access
Hospitals (CAHs) To Report COVID-19 Data
We believe reporting by hospitals and CAHs is an important tool for
supporting surveillance of COVID-19 and we will enforce violations of
reporting requirements to the extent authorized by the Secretary.
Should a hospital or CAH fail to consistently report test results
throughout the duration of the PHE for COVID-19, it will be non-
compliant with the hospital and the CAH CoPs set forth at Sec. Sec.
482.42(e) and 485.640(d), respectively, and subject to termination as
defined at 42 CFR 489.53(a)(3). We have taken a position on the
importance of COVID-19 test results reporting in other provider areas,
including use of CMPs for nursing homes that fail to report, and find
it prudent to enact penalties for hospitals and CAHs that similarly
fail to report COVID-19 test results. CMS currently lacks the statutory
authority to impose CMPs against hospitals and CAHs; however,
intermediate penalties such as CMPs have been an extremely useful tool
in the enforcement of reporting requirements for nursing homes, helping
to achieve 98 percent compliance. Therefore, we will continue to
utilize all enforcement and payment authorities available to
incentivize and promote compliance with all health and safety
requirements, as allowed by statute and regulation.

C. Requirements for Laboratories To Report SARS-CoV-2 Test Results
During the PHE for COVID-19

Assuring a rapid and thorough public health response to the COVID-
19 pandemic relies on having complete and comprehensive laboratory
testing data, including standardized test results, relevant demographic
details, and additional information that can improve both the response
to SARS-CoV-2 and treatment of COVID-19. These data can contribute to
understanding disease incidence and trends: Initiating epidemiologic
case investigations, assisting with contact tracing, assessing
availability and use of testing resources, and identifying supply chain
issues for reagents and other material. Laboratory testing data, in
conjunction with case reports and other data, also provide vital
guidance for mitigation and control activities.
Section 18115(a) of the CARES Act requires every laboratory that
performs or analyzes a test that is intended to detect SARS-CoV-2 or to
diagnose a possible case of COVID-19 (hereinafter referred to as a
``SARS-CoV-2 test'' or ``COVID-19 diagnostic test'') to report the
results from each such test to the Secretary until the end of the PHE
for COVID-19. In addition, the statute authorizes the Secretary to
prescribe the form and manner, and timing and frequency, of such
reporting. As indicated in HHS guidance issued on June 4, 2020,\11\ in
an effort to receive these data in the most efficient and effective
manner, the Secretary has required that all data be reported through
existing public health data reporting methods. The June 4, 2020
guidance states that ``as a guiding principle, data should be sent to
state or local public health departments using existing reporting
channels (in accordance with state law or policies) to ensure rapid
initiation of case investigations by those departments, concurrent to
laboratory results being shared with an ordering provider, or patient
as applicable.'' \12\
---------------------------------------------------------------------------

\11\ COVID-19 Pandemic Response, Laboratory Data Reporting:
Section 18115 of the CARES Act, https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf.
\12\ https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf.
---------------------------------------------------------------------------

The June 4, 2020 guidance further explains that ``all
laboratories--including laboratories, testing locations operating as
temporary overflow or remote locations for a laboratory, and other
facilities or locations performing testing at point of care or with at-
home specimen collection related to SARS-CoV-2--shall report data for
all testing completed, for each individual tested, within 24 hours of
results being known or determined, on a daily basis to the appropriate
state or local public health department based on the individual's
residence.''
On October 31, 1988, Congress enacted the CLIA (Pub. L. 100-578)
(codified as amended at 42 U.S.C. 263a) requiring any laboratory that
examines human specimens for the purpose of providing information for
the diagnosis, prevention, or treatment of any disease or impairment
of, or the assessment of health, of human beings to be certified by the
Secretary for the categories of examinations or procedures performed by
the laboratory. The implementing regulations at 42 CFR part 493 specify
the conditions and standards that must be met to achieve and maintain
CLIA certification. These conditions and standards strengthen federal
oversight of clinical laboratories and help ensure the accuracy and
reliability of patient test results.
Currently, the CLIA program only collects non-waived testing
specialty and subspecialty information from laboratories issued a
Certificate of Compliance (CoC), Certificate of Accreditation (CoA), or
Certificate of Registration (CoR). Such information is collected for
certain specialties, subspecialties, and analytes for proficiency
testing purposes and during surveys to ensure that the laboratory is
meeting CLIA requirements for the level and specialty/subspecialty of
testing performed. CMS does not know the complete universe of
laboratories performing SARS-CoV-2 testing, or which tests are being
performed as information related to specific test systems is not
captured in our database.
While we collect this information when laboratories initially apply
for all certificate types, subsequently it is only

[[Page 54827]]

collected for CoC and CoA laboratories during an initial,
recertification, validation, or complaint survey, as described above.
This data is collected to ensure that such labs are meeting the
applicable CLIA test complexity testing quality requirements.
Certificate of Waiver (CoW) and Certificate for Provider-Performed
Microscopy (PPM) laboratories are not required to submit information
related to updating their test menu as long as the new testing falls
under their current certificate. During this PHE for COVID-19, the Food
and Drug Administration (FDA) is issuing Emergency Use Authorizations
for in vitro diagnostics that are categorized to be run by certain
CLIA-certified laboratories (which may include laboratories with a CoW
or Certificate for PPM), depending on the scope and FDA's
categorization of the authorized test. SARS-CoV-2 testing includes
molecular, antibody, and antigen methods. Molecular (RT-PCR) tests
detect the virus's genetic material and antigen tests detect specific
proteins on the surface of the virus. Both types of tests are used to
detect active or acute infection with SARS-CoV-2. Serology (antibody)
testing is used to look for the presence of antibodies which are
proteins produced by the body in response to infections. Due to the
variety of COVID-19 testing available, our current informational
limitations present a gap in understanding the universe of laboratories
performing SARS-CoV-2 testing.
We believe that, by collecting testing information, the CLIA
program will be able to identify quality and accuracy issues with
laboratories performing SARS-CoV-2 testing during this PHE for COVID-
19. Currently we do not have a specific reporting requirement that
allows for collection of SARS-CoV-2 testing information. Once we have
accurate information on which laboratories are performing SARS-CoV-2
testing, our oversight authority will allow us to survey these
laboratories to determine if they are performing testing within their
appropriate CLIA certificate and that they are meeting applicable CLIA
requirements to perform accurate and reliable testing. For CMS to
ensure laboratories are reporting SARS-CoV-2 test results, the CLIA
regulations need to be modified to require SARS-CoV-2 test result
reporting. In the interest of ensuring quality laboratory testing
during the PHE for COVID-19, we are finalizing the requirement for
submission of SARS-CoV-2 test results to the Secretary. Specifically,
we are finalizing that during the PHE for COVID-19, as defined in Sec.
400.200, each laboratory that performs a SARS-CoV-2 test must report
SARS-CoV-2 test results in such form and manner, and at such timing and
frequency, as the Secretary may prescribe. We are also finalizing that
failure to submit SARS-CoV-2 test results to the Secretary will be
considered a violation of the new CLIA reporting requirements,
resulting in condition level deficiencies for which CMPs or other
penalties may apply.
These regulatory amendments at Sec. Sec. 493.41 and 493.1100(a)
will require all laboratories, including, those holding a CoW, to
report SARS-CoV-2 test results to the Secretary for the duration of the
PHE for COVID-19, and specify that failure to do so will result in a
condition level violation of the CLIA regulations. Should a laboratory
not report required SARS-CoV-2 test results, we will impose a CMP under
Sec. Sec. 493.1804 and 493.1834.
We are adding or amending the following regulations:
At Sec. 493.2, Definitions, we are amending the
definition of ``Condition level requirements'' to include the
requirements in Sec. 493.41. This change is necessary to allow for the
imposition of CMPs on CoW laboratories that fail to comply with Sec.
493.41 during the Secretary's PHE declaration for COVID-19 or any
extension of such declaration.
At Sec. 493.41, we are adding a that, for the duration of
the PHE for COVID-19, CoW laboratories report SARS-CoV-2 test results
to the Secretary.
At Sec. 493.555, we are amending the provision by adding
paragraph (c)(6) requiring that, for the duration of the PHE for COVID-
19, CMS-deemed Accreditation Organizations (AO) and State Licensure
Programs, Exempt States (ES), notify CMS within 10 days after
identifying a laboratory that fails to report SARS-CoV-2 test results
as required at Sec. Sec. 493.41 and 493.1100(a).
At Sec. 493.1100, we are adding paragraph (a) which
requires that, for the duration of the PHE for COVID-19, all
laboratories performing non-waived SARS-CoV-2 testing report SARS-CoV-2
test results to the Secretary.
At Sec. 493.1804, we are revising paragraph (c)(1) to
allow us to impose alternative sanctions (including CMPs) on CoW
laboratories for failure to comply with Sec. Sec. 493.41 and
493.1100(a) during the PHE for COVID-19.
At Sec. 493.1834, we are amending the provision by adding
paragraph (d)(2)(iii) to define the per day CMP amounts that may be
imposed as a result of SARS-CoV-2 reporting violations. Such CMPs will
be $1000 for the first day of noncompliance with the new reporting
requirements, and $500 for each subsequent day the laboratory fails to
report SARS-CoV-2 test results. The statute allows for the imposition
of CMPs in an amount not to exceed $10,000 for each violation (for
example, per sample not reported) or for each day of substantial
noncompliance. We believe imposing CMPs based on a per day basis is a
fairer and more effective penalty for failure to report than a per
violation basis. The latter could lead to large CMPs for brief lapses
in reporting.
The CLIA regulations at Sec. 493.551(a)(1) require both the AOs
and ESs to have requirements that are equal to, or more stringent than,
the CLIA condition-level requirements, so we would expect the AOs and
ESs to have equivalent reporting requirements to CMS. AOs do not impose
CMPs; however, ESs do have the ability to impose CMPs, so we would
expect ESs to have an equivalent penalty structure to CMS. The ESs are
generally approved by CMS to operate their own oversight programs so we
would expect that the two ESs would report these laboratories to CMS,
but would then impose the penalties based on their updated CMS-approved
standards. In the case of the accredited laboratories, the laboratories
identified as not reporting SARS-CoV-2 results as required would result
in CMS taking a subsequent enforcement action as described in this
section.

D. Quality Reporting: Updates to the Extraordinary Circumstances
Exceptions (ECE) Granted for Four Value-Based Purchasing Programs in
Response to the PHE for COVID-19, and Update to the Performance Period
for the FY 2022 SNF VBP Program

As part of our response to the COVID-19 pandemic, on March 22,
2020, we granted ECEs to ESRD facilities, hospitals, and SNFs to reduce
the data collection and reporting burden on these facilities and
providers so they could direct their full resources to patient care
during the early months of the pandemic. Each of these ECEs relieved
these providers and facilities of their obligation to report data for
the fourth quarter calendar year (CY) 2019, first quarter CY 2020 and
second quarter CY 2020, but we stated that we would score such data if
optionally reported.
We continue to believe that the data we have excepted from
mandatory reporting under these ECEs serves multiple purposes,
including allowing us to understand the impact of the PHE for COVID-19
on quality of care. However, we are concerned about the national
comparability of these data due to the geographic differences of COVID-
19 incidence rates and hospitalizations, along with different impacts
resulting from different state and local laws and

[[Page 54828]]

policy changes implemented in response to COVID-19.
As a result, we believe it is necessary in this IFC to update the
ECEs that we have granted for the following value-based purchasing
programs:
The End-Stage Renal Disease Quality Incentive Program
(ESRD QIP);
The Hospital-Acquired Condition (HAC) Reduction Program;
The Hospital Readmissions Reduction Program (HRRP); and
The Hospital Value-Based Purchasing (HVBP) Program.
Under these updated ECEs, we will only score data that was
optionally reported for fourth quarter CY 2019. We will also exclude
all data that was optionally reported for the first or second quarter
of CY 2020 from our calculation of performance. We note that all of the
ECEs that have been granted for the time periods discussed above have
now ended.
In this IFC, we are also updating the performance period for the FY
2022 SNF VBP Program because we are concerned that using qualifying
claims from the two quarters that are not excepted under the ECE for
COVID-19 (October 1, 2019 through December 31, 2019 (Q4 2019), and July
1, 2020 through September 30, 2020 (Q3 2020)) for all SNFs nationwide
to calculate the SNF Readmission Measure (SNFRM) for the FY 2022
Program will not yield measure scores that reliably reflect SNF quality
of care as determined by hospital readmission rates. As explained more
fully below, the new performance period will be April 1, 2019 through
December 31, 2019 and July 1, 2020 through September 30, 2020.
1. Updates to ESRD QIP: Utilization of Fourth Quarter CY 2019 ESRD QIP
Data and the Removal of the Option for Facilities to Opt-Out of the
Extraordinary Circumstances Exception (ECE) Granted With Respect to
First and Second Quarter (CY) 2020 ESRD QIP Data
a. Background of the ESRD QIP ECE Policy
The ESRD QIP is authorized under section 1881(h) of the Act, and it
aims to promote high-quality care in dialysis facilities by linking a
portion of their payment under the ESRD prospective payment system
(PPS) directly to their performance on quality of care measures. The
ESRD QIP assesses facility performance on clinical and reporting
measures adopted through the rulemaking process and scores dialysis
facilities based on that performance. A facility that does not meet or
exceed the minimum total performance score (TPS) set by CMS for the
applicable payment year receives up to a 2 percent reduction to its
ESRD PPS payment for that year.
In the CY 2015 ESRD PPS final rule (79 FR 66189 through 66190), we
adopted an ECE policy for the ESRD QIP, which recognized that there are
times when facilities are unable to submit required quality data due to
extraordinary circumstances that are not within their control, and that
facilities should not be penalized for such circumstances or have their
burden unduly increase during these times. This policy was implemented
under the authority of section 1881(h)(3)(A)(i) of the Act, which
requires the Secretary to develop a methodology for assessing the total
performance of each provider of services and renal dialysis facility
based on performance standards for the measures selected under section
1881(h)(2) of the Act for a performance period established under
section 1881(h)(4)(D) of the Act. We interpreted section
1881(h)(3)(A)(i) of the Act to enable us to configure the methodology
for assessing facilities' total performance such that we would not
require a facility to submit, nor penalize a facility for failing to
submit, data on any ESRD QIP quality measure data from any month in
which a facility is granted an ECE.
In the CY 2018 ESRD PPS final rule (82 FR 50761 through 50763), we
modified the requirements for the ESRD QIP's ECE policy to further
align that policy with the ECE policy adopted by other quality
reporting and VBP programs. In the CY 2020 ESRD PPS final rule (84 FR
60714), we codified requirements for the ECE policy at 42 CFR
413.178(d)(3) through (7), including a new option for facilities to
reject an ECE granted by CMS under certain circumstances. We stated
that this option would provide facilities with flexibility under the
ECE policy. We also adopted this provision to provide further guidance
to the public on the scope of our ECE policy.
b. Background of the ESRD QIP ECE Granted in Response to the PHE for
COVID-19
On March 22, 2020, in response to COVID-19, we announced relief for
clinicians, providers, hospitals and facilities participating in
Medicare quality reporting programs (QRPs) and VBP programs.\13\ On
March 27, 2020, we published a supplemental guidance memorandum that
described in more detail the scope and duration of the ECE we were
granting under each Medicare QRP and VBP program.\14\
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\13\ CMS press release available at https://www.cms.gov/newsroom/press-releases/cms-announces-relief-clinicians-providers-hospitals-and-facilities-participating-quality-reporting.
\14\ CMS memorandum available at https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
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Under the ECE for the PHE for COVID-19 that we granted to all
facilities participating in the ESRD QIP, such facilities are currently
excepted from the following reporting requirements and submission
deadlines:
For the National Healthcare Safety Network (NHSN) blood
stream infection (BSI) clinical measure and NHSN Dialysis Event
reporting measure:
++ March 31, 2020, June 30, 2020, September 30, 2020 reporting
deadlines for encounters during the following periods:
--October 1, 2019 to December 31, 2019 (Q4 2019)--We noted that
data from the 4th quarter 2019 would be utilized if submitted.
--January 1, 2020 to March 30, 2020 (Q1 2020).
--April 1, 2020 to June 30, 2020 (Q2 2020).
For ESRD QIP CROWNWeb reporting deadlines and applicable
clinical months:
++ March 31, 2020 (January 2020 clinical month).
++ April 30, 2020 (February 2020 clinical month).
++ June 1, 2020 (March 2020 clinical month).
++ June 30, 2020 (April 2020 clinical month).
++ August 3, 2020 (May 2020 clinical month).
++ August 31, 2020 (June 2020 clinical month).
For the Consumer Assessment of Healthcare Providers and
Systems In-Center Hemodialysis (ICH-CAHPS) Survey:
++ The data collected to fulfill the July 2020 data submission
deadline for the Spring 2020 Survey.
++ Data collected May 1, 2020-July 10, 2020.
For ESRD QIP claims-based measures, claims data during the
following times would be excluded from measure calculations:
++ March 1, 2020-June 30, 2020.
With respect to the requirement that facilities selected for
validation under one or both ESRD QIP data validation studies (CROWNWeb
and NHSN) submit medical records within 60 days of the date identified
on the written request letter, we excepted facilities from that
requirement as follows:
NHSN and CROWNWeb record requests for discharge periods:
++ January 1, 2019-March 31, 2019 (Q1 2019).

[[Page 54829]]

++ April 1, 2019-June 30, 2019 (Q2 2019).
In the March 27, 2020 guidance, we also advised that facilities
should be aware of the potential subsequent impact to a facility's TPS
when data are excluded from score calculations, and noted that
facilities impacted by COVID-19 could elect to opt out of this ECE by
emailing their request to the ESRD QIP at esrdqip@cms.hhs.gov by June
19, 2020.
c. Update to the ESRD QIP ECE Policy for the PHE for COVID-19
We continue to believe that the ESRD QIP data we have excepted
serves multiple purposes, including allowing us to understand the
impact of the PHE for COVID-19 on the quality of ESRD care provided to
Medicare beneficiaries and supporting the continued analysis and
evaluation of ESRD quality data submitted to CROWNWeb. However, we are
concerned about the national comparability of these data due to the
geographic differences of COVID-19 incidence rates and
hospitalizations, along with different impacts resulting from different
state and local law and policy changes implemented in response to
COVID-19. For these reasons, we are adopting in this IFC two updates to
our current ECE policy for the ESRD QIP. First, we are updating our
regulations at 42 CFR 413.178(d)(7) to state that a facility has opted
out of the ECE for COVID-19 with respect to the reporting of fourth
quarter 2019 NHSN data if the facility actually reported the data by
the March 31, 2020 deadline but did not notify CMS that it would do so.
Additionally, we are removing the ability of facilities to opt-out of
the ECE we granted with respect to Q1 and Q2 2020 ESRD QIP data.
i. CY 2019 Fourth Quarter NHSN ESRD QIP Measure Data
As described previously, we excepted facilities from the
requirement to report fourth quarter CY 2019 data for the NHSN BSI
clinical measure and NHSN Dialysis Event reporting measure to alleviate
the reporting burden on facilities responding to the PHE for COVID-19
that would otherwise be required to report these data by the March 31,
2020 submission deadline. However, in both the March 22nd and March
27th guidance we also stated that we would utilize these data if
submitted. At the time we announced the ECE for COVID-19, there were
approximately 9 days (time period between March 22, 2020 to March 31,
2020) remaining for facilities to submit their fourth quarter 2019 NHSN
data, and nearly all facilities (97.6 percent) timely reported fourth
quarter 2019 ESRD QIP data on these measures. These data also assess
facility performance prior to the start of the PHE for COVID-19. Unlike
the first and second quarter 2020 data, we do not have concerns about
the national comparability or representativeness of the fourth quarter
2019 NHSN data because those data reflect facility performance prior to
the start of the PHE for COVID-19. In addition, nearly all facilities
reported these data prior to the announcement of the ECE with the
expectation that they would be used for scoring. Accordingly, we are
updating our regulations at Sec. 413.178(d)(7) to state that a
facility has opted out of the ECE for COVID-19 with respect to the
reporting of fourth quarter 2019 NHSN data if the facility actually
reported the data by the March 31, 2020 submission deadline but did not
notify CMS that it would do so, and we will include these data when we
calculate facility TPSs for PY 2021 and performance standards for PY
2023. This change will enable us to use the data which, as we explain
above, are reflective of facility performance and were reported with
the expectation that they would be used for scoring. This change is
also consistent with our statement in the ECE announcement that we
would score these data if they were submitted. A facility that did not
timely report its fourth quarter 2019 NHSN BSI clinical measure and
NHSN Dialysis Event reporting measure data will not be eligible to
receive scores on those measures for PY 2021.
ii. CY 2020 First and Second Quarter ESRD QIP Data
Under our current policy, facilities may opt out of the ECE we
proactively granted in response to the PHE for COVID-19, and continue
to report ESRD QIP data. We implemented this policy to give facilities
flexibility to continue to report, in particular where a facility does
not believe it has been impacted by the extraordinary circumstance(s).
We do not believe that is the case here, as the PHE for COVID-19 is a
nationwide PHE and an overwhelming majority of facilities continue to
be impacted by COVID-19. For example, regardless of protocols in place
at facilities, dialysis patients concerned about being exposed to
COVID-19 at a facility may decide to skip their treatment sessions.\15\
This could be reflected in quality metrics captured for the facility
when the patients return to treatment. Furthermore, due to the national
nature of this PHE for COVID-19, we believe performance scores for
certain measures could be biased and not reflective of nationally
comparable performance. Similarly, we are concerned that there may be
indirect and unintended consequences of calculating scores using
potentially biased data that may not reflect the facility's overall
quality. Due to facilities having the option to submit or not submit
data for this period, the data may not provide a nationally comparable
assessment of performance. Thus, reporting bias is possible due to the
voluntary submission of data; that is, a bias could be potentially
introduced because only high performers and/or facilities not impacted
or better resourced would choose to submit data, while impacted
facilities and/or facilities with fewer resources would choose not to
submit data. This would affect comparisons between facilities with
different circumstances, and would not be in keeping with the program
goal of national comparison. Therefore, we believe that it would be
inappropriate to include data submitted regarding care provided during
first and second quarter CY 2020 in our calculation of a facility's
TPS, which is used to determine each facility's payment adjustment.
Therefore, we are revising the opt out policy currently codified at
Sec. 413.178(d)(7) to provide that the opt out policy does not apply
to data excepted due to the PHE for COVID-19 with--that is, the first
quarter and second quarters of CY 2020 ESRD QIP data.
---------------------------------------------------------------------------

\15\ See https://www.kidney.org/coronavirus/dialysis-covid-19.
---------------------------------------------------------------------------

Finally, although the ECE we granted for the ESRD QIP has ended,
with data collection and reporting requirements having resumed July 1,
2020, we understand that geographic differences in COVID-19 incidence
continue to change during the PHE for COVID-19. To maintain flexibility
for addressing the impact of COVID-19 on the ESRD QIP and determine how
best to implement the program equitably, we are announcing in this IFC
that if, as a result of an extension of the ECE for the whole country
that we grant without a request or the submission of individual ECE
requests, we do not have enough data to reliably measure national
performance under the ESRD QIP, we may propose to not score facilities
based on such limited data or make the associated payment adjustments
to facilities under the ESRD PPS for the affected program year. For
example, if we granted an ECE that excepted facilities from the
requirement to report data for 11 of the 12 months of a given
performance period, we would consider

[[Page 54830]]

not scoring or applying payment adjustments for the associated ESRD QIP
payment year because data from the one non-excepted month may not be
large enough to calculate reliable measure results for scoring
purposes. Although the data themselves may be accurate, the measure(s)
might not meet the reliability standards because of the small sample of
the remaining non-excepted part of the performance period.\16\ In
addition, in the scenario we describe above, it is plausible that only
larger facilities would be able to meet the required case minimums to
be scored in the non-excepted part of the performance period. We may
conclude that only scoring remaining facilities would not produce an
accurate national comparison of dialysis facilities. Alternatively, if
we do not extend the ECE to cover Q3 and Q4 2020, it is possible that a
majority of facilities might still submit individual ECE requests for
those quarters and it is possible that so many facilities will submit
individual ECE requests that we will not be able to produce a reliable
national comparison. In both cases, we are concerned about using the
measures calculated based on these data to score facilities under the
ESRD QIP and base payment adjustments on those scores. If circumstances
warrant, we may propose to suspend prospective application of program
penalties or payment adjustments through the annual ESRD PPS proposed
rule. However, in the interest of time and transparency, we may provide
subregulatory advance notice of our intentions to suspend such
penalties and adjustments through routine communication channels to
facilities, vendors, and Quality Improvement Organizations (QIOs). The
communications could include memos, emails, and notices on the public
QualityNet website (https://www.qualitynet.org/). We welcome public
comments on the update to our regulations at Sec. 413.178(d)(7) to
consider a facility as having opted out of the ECE with respect to NHSN
data reported for Q4 2019 if the facility actually reported the data by
the submission deadline, without notifying CMS, and we will include
these data when we calculate facility TPSs for PY 2021 and performance
standards for PY 2023. We also welcome public comments on the exception
we are finalizing to the ECE opt out policy for the ESRD QIP, and we
will exclude any ESRD QIP data that facilities optionally reported
during Q1 and Q2 2020 from our calculation of Payment Year 2022 TPSs
and from the baseline for PY 2023.
---------------------------------------------------------------------------

\16\ See http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=86453 and choose the
``Evaluation Guidance'' link.
---------------------------------------------------------------------------

2. Updates to the Application of the HAC Reduction Program ECE Policy
in Response to the PHE for COVID-19
a. Background of the HAC Reduction Program ECE Policy
The Hospital-Acquired Condition Reduction Program (``HAC Reduction
Program'') is authorized under section 1886(p) of the Act and it aims
to heighten awareness of HACs and reduce the number of incidences that
occur through implementing the payment adjustments authorized under
such statute. The HAC Reduction Program began affecting hospitals'
Medicare payments with FY 2015 discharges (that is, October 1, 2014).
In the FY 2016 Inpatient Prospective Payment System (IPPS)/Long-term
Care Hospitals (LTCH) PPS final rule (80 FR 49579 through 49581), we
adopted an ECE policy for the HAC Reduction Program, which recognized
that there may be periods of time during which a hospital is affected
by an extraordinary circumstance beyond its control. We noted that we
considered the feasibility and implications of excluding data for
certain measures for a limited period of time from the calculations of
the hospital's measure results or Total HAC Score for the applicable
performance period. We expressed our aim to minimize data excluded from
the program to allow affected hospitals to continue to participate in
the HAC Reduction Program for a given year if these hospitals continue
to meet applicable measure minimum threshold requirements. We further
observed that section 1886(p)(4) of the Act permits the Secretary to
determine the applicable period for HAC data collection, and we
interpreted the statute to allow us to determine that the period not
include times when hospitals may encounter extraordinary circumstances.
This policy was similar to the ECE policy for the Hospital Inpatient
QRP, as initially adopted in the FY 2012 IPPS/LTCH PPS final rule (76
FR 51651), and modified in the FY 2014 IPPS/LTCH PPS final rule (78 FR
50836) and the FY 2015 IPPS/LTCH PPS final rule (79 FR 50277).
In the FY 2016 IPPS/LTCH PPS final rule (80 FR 49580 through
49581), we also stated that this policy would not preclude CMS from
granting ECEs to hospitals that do not request them if we determine at
our discretion that a disaster or other extraordinary circumstance has
affected an entire region or locale. We noted that if CMS makes such a
determination to grant an ECE to hospitals in an affected region or
locale, we will convey this decision through routine communication
channels to hospitals, vendors, and QIOs, including, but not limited
to, issuing memos, emails, and notices on the QualityNet website. When
time permits we will also communicate such decisions through the annual
IPPS/LTCH PPS proposed rule.
In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38276 through
38277), we modified the requirements for the HAC Reduction Program ECE
policy to further align with the process used by other QRP and VBP
programs for requesting an exception from program reporting due to an
extraordinary circumstance not within a provider's control.
b. Background of the HAC Reduction Program ECE Granted for the PHE for
COVID-19
On March 22, 2020, in response to COVID-19, we announced relief for
clinicians, providers, hospitals, and facilities participating in
Medicare QRPs and VBP programs.\17\ On March 27, 2020, we published a
supplemental guidance memorandum that described in more detail the
scope and duration of the ECEs we were granting under each Medicare QRP
and VBP program.\18\
---------------------------------------------------------------------------

\17\ CMS press release available at https://www.cms.gov/newsroom/press-releases/cms-announces-relief-clinicians-providers-hospitals-and-facilities-participating-quality-reporting.
\18\ CMS memorandum available at https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
---------------------------------------------------------------------------

Under the ECE granted to all eligible hospitals under the HAC
Reduction Program, we stated that qualifying claims would be excluded
from the measure calculations for the CMS Patient Safety Indicators
(PSI) 90 during the periods January 1, 2020-March 31, 2020 (Q1 2020)
and April 1, 2020-June 30, 2020 (Q2 2020). We also provided an
exception to reporting for all chart-abstracted HAC Reduction Program
measures for the May, August, and November 2020 submission deadlines
(for reporting Q4 2019, Q1 2020, and Q2 2020 data, respectively). This
exception includes the following NHSN HAI Measures:
++ NHSN Catheter-Associated Urinary Tract Infection (CAUTI) Outcome
Measure, National Quality Forum (NQF) #0138.
++ NHSN Central Line-Associated Blood Stream Infection (CLABSI)
Outcome Measure, NQF #0139.
++ NHSN Facility-wide Inpatient Hospital-onset Clostridium
difficile

[[Page 54831]]

Infection (CDI) Outcome Measure, NQF #1717.
++ NHSN Facility-wide Inpatient Hospital-onset Methicillin-
Resistant Staphylococcus aureus (MRSA) Bacteremia Outcome Measure, NQF
#1716.
++ American College of Surgeons--Centers for Disease Control and
Prevention Harmonized Procedure Specific Surgical Site Infection (SSI)
Outcome Measure, NQF #0753.
We also advised that hospitals should be aware of the potential
subsequent impact to the HAC Reduction Program minimum case threshold
counts for inclusion in these programs.
c. Update to the HAC Reduction Program ECE Granted in Response to the
PHE for COVID-19
We continue to believe that the HAC Reduction Program data we have
excepted serves multiple purposes, including allowing us to understand
the impact of the PHE for COVID-19 on quality of care. Furthermore, the
chart-abstracted measures in the HAC Reduction Program are calculated
based on data submitted to the CDC's NHSN. We recognize that because
the CDC uses the same data for epidemiological surveillance, hospitals
may have reporting requirements which are not affected by our ECE (for
example, state requirements). We are also concerned with the national
comparability of these data due to the geographic differences of COVID-
19 incidence rates and hospitalizations along with different impacts
resulting from different state and local law and policy changes
implemented in response to COVID-19.
For data which hospitals optionally report, we believe that the
exception granted for those programs with data submission deadlines in
April and May 2020 (that is, data from the fourth quarter of CY 2019)
is distinct from the exceptions granted because data collected may be
greatly impacted by the response to COVID-19 (that is, data from the
first and second quarters of CY 2020).
i. CY 2019 Fourth Quarter Data
As described previously, we excepted hospitals from the requirement
to report fourth quarter CY 2019 data for the HAC Reduction Program to
alleviate the reporting burden on hospitals that were responding to the
PHE for COVID-19 during the May 18, 2020 data submission deadline.
However, nearly all hospitals (95.3 percent) reported these data by the
submission deadline, which reflects care provided prior to January 27,
2020, which is the start of the PHE for COVID-19 under the Secretary's
declaration of a PHE under section 319 of the PHSA. Therefore, we
determined that it would be appropriate to include data that were
optionally reported by hospitals for the fourth quarter of CY 2019 in
calculating hospitals' Total HAC Scores, which are used to determine
the worst-performing 25 percent of hospitals on HAC performance for
assessing the 1 percent HAC Reduction Program penalty. This
determination is consistent with the policy stated in the March 27,
2020 guidance memo.\19\
---------------------------------------------------------------------------

\19\ CMS memorandum available at https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
---------------------------------------------------------------------------

ii. CY 2020 First and Second Quarter Data
In our application of the ECE policy for the PHE for COVID-19, we
excepted hospitals from the requirement to report first and second
quarter of CY 2020 HAC Reduction Program chart-abstracted measures and
stated we would exclude qualifying claims both because we hoped to
alleviate the reporting burden on hospitals that were responding to the
PHE for COVID-19 and because of our concern that the representativeness
of the data collected during this period may be greatly impacted by the
response to COVID-19.
We also noted that if hospitals optionally chose to report data, we
would use that data for program calculations. While we continue to
encourage optional submission of data, we also aim to have the most
representative comparison of hospital performance as possible and do
not wish to unfairly penalize hospitals that were responding to COVID-
19. We believe that using CY 2020 optionally reported data may not
provide a nationally comparable assessment of hospital performance for
multiple reasons. First, allowing hospitals the option to voluntarily
submit for this period may introduce reporting bias; that is, a bias
introduced because, for example, only high performers and/or hospitals
not impacted or better resourced would choose to submit data, which
would render comparisons between hospitals with different circumstances
not in keeping with the program goal of national comparison. In
addition, a number of other factors could also contribute to our
ability to accurately calculate a national comparison. For example,
geographic differences in COVID-19 incidence rates and COVID-19 related
hospitalizations and differences resulting from changes in referral and
hospitalization patterns could both impact the national comparability
of optionally submitted data. Because the HAC Reduction Program relies
on a relative scoring methodology, we believe that it would be
inappropriate and could disparately impact hospitals to include data
from quarters excepted under CMS guidance for the PHE for COVID-19 in
our calculation of hospitals' performance for the program.
Finally, although the ECE we granted for the HAC Reduction Program
has ended, with data collection and reporting requirements resuming
July 1, 2020, we understand that geographic differences in COVID-19
incidence continue to change during the PHE for COVID-19. To maintain
flexibility for addressing the impact of COVID-19 on the HAC Reduction
Program and determine how best to implement the program equitably, we
are announcing that if, as a result of the extension of the ECE for the
whole country that we grant without a request or the submission of
individual ECE requests, we do not have enough HAC Reduction Program
data to reliably measure national performance, we may propose to not
score hospitals based on such limited data or make the associated
payment adjustments to hospitals under the IPPS for the affected
program year. If we grant another ECE in the future, we would not
require that hospitals report the excepted data for the duration of the
ECE. Although a hospital may voluntarily report data during the ECE, we
may determine that such data will not be used for scoring purposes. We
would still require that hospitals report the non-excepted data.
However, we may determine that it would be inappropriate to score such
data or base payment adjustments on it because of reliability concerns.
For illustrative purposes only, if a PHE excepted enough quarters from
the HAC Reduction Program's 24-month performance period to lead to
unreliable measure calculations, we might consider not scoring for the
fiscal year because the sample may not be large enough to calculate
reliable measure results for scoring purposes. Although the data itself
may be accurate, the measure(s) may not meet the reliability standards
because of the small sample of the remaining non-excepted part of the
performance period. In addition, in the scenario we describe above, it
is likely that only larger hospitals would be able to meet the required
case minimums to be scored in the non-excepted part of the performance
period. We may conclude that only scoring those remaining large
hospitals will not produce an accurate national

[[Page 54832]]

comparison of hospitals. Alternatively, if we do not extend the ECE to
cover Q3 and Q4 2020, it is possible that a majority of providers may
still submit individual ECE requests for those quarters and it is
possible that so many hospitals will submit individual ECE requests
that we will not be able to produce a reliable national comparison. In
both cases, we are concerned about using the measure calculated based
on these data to score hospitals under the HAC Reduction Program and
base payment adjustments on those scores. If circumstances warrant, we
may propose to suspend prospective application of program penalties or
payment adjustments through the annual IPPS/LTCH PPS proposed rule.
However, in the interest of time and transparency, we may provide
subregulatory advance notice of our intentions to suspend such
penalties and adjustments through routine communication channels to
hospitals, vendors, and Quality Improvement Organizations (QIOs). The
communications could include memos, emails, and notices on the public
QualityNet website (https://www.qualitynet.org/). We welcome public
comments on our policy to exclude any data submitted regarding care
provided during the first and second quarter of CY 2020 from our
calculation of performance for the FY 2022 and FY 2023 program years.
3. Update to the HRRP ECE Granted in Response to the PHE for COVID-19
a. Background of the Hospital Readmissions Reduction Program ECE Policy
In the FY 2016 IPPS/LTCH PPS final rule (80 FR 49542 through
49543), we adopted an ECE policy for the Hospital Readmissions
Reduction Program, which recognized that there may be periods of time
during which a hospital is not able to submit all claims (from which
readmission measures data are derived) in an accurate or timely fashion
due to an extraordinary circumstance beyond its control. We noted that
we considered the feasibility and implications of excluding data for
certain measures for a limited period of time from the calculations for
a hospital's excess readmissions ratios for the applicable performance
period. We expressed that we hoped to minimize data excluded from the
program to allow affected hospitals to continue to participate in the
HRRP for a given year if these hospitals otherwise continue to meet
applicable measure minimum threshold requirements. We further observed
that section 1886(q)(5)(D) of the Act permits the Secretary to
determine the applicable period for readmissions data collection, and
we interpreted the statute to allow us to determine that the period not
include times when hospitals may encounter extraordinary circumstances.
This policy was similar to the ECE policy for the Hospital Inpatient
Quality Reporting (IQR) Program, as initially adopted in the FY 2012
IPPS/LTCH PPS final rule (76 FR 51651), and modified in the FY 2014
IPPS/LTCH PPS final rule (78 FR 50836) and the FY 2015 IPPS/LTCH PPS
final rule (79 FR 50277).
In the FY 2016 IPPS/LTCH PPS final rule (80 FR 49542), we also
stated that this policy would not preclude CMS from granting ECEs to
hospitals that do not request them if we determined at our discretion
that a disaster or other extraordinary circumstance has affected an
entire region or locale. We noted that if CMS made such a determination
to grant an ECE to hospitals in an affected region or locale, we would
convey this decision through routine communication channels to
hospitals, vendors, and QIOs, including, but not limited to, issuing
memos, emails, and notices on the QualityNet website.
In the 2018 IPPS/LTCH PPS final rule (82 FR 38239), we modified the
requirements for the HRRP ECE policy to further align with the
processes used by other QRP and VBP programs for requesting an
exception from program reporting due to an extraordinary circumstance
not within a provider's control.
b. Background of the HRRP ECE Granted for the PHE for COVID-19
On March 22, 2020, in response to COVID-19, CMS announced relief
for clinicians, providers, hospitals and facilities participating in
Medicare QRPs and VBP programs.\20\ Specifically, we announced that we
were granting ECEs for certain data reporting requirements and
submission deadlines for the first and second quarters of CY 2020. On
March 27, 2020, we published a supplemental guidance memorandum that
described the scope and duration of the ECEs we were granting under
each Medicare QRP and VBP program.\21\
---------------------------------------------------------------------------

\20\ CMS press release available at https://www.cms.gov/newsroom/press-releases/cms-announces-relief-clinicians-providers-hospitals-and-facilities-participating-quality-reporting.
\21\ CMS memorandum available at https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
---------------------------------------------------------------------------

Under the ECE for the PHE for COVID-19 that we granted to all
hospitals subject to the HRRP, qualifying claims from January 1, 2020
through March 31, 2020 (Q1 2020) and April 1, 2020 through June 30,
2020 (Q2 2020) will be excluded from the measure calculations for the
readmission measures used in the program. We also advised that
hospitals should be aware of the potential subsequent impact to the
HRRP minimum case threshold counts for inclusion in this program.
c. Update to the HRRP ECE Granted in Response to the PHE for COVID-19
We continue to believe that the readmissions claims data we have
excepted serve multiple purposes, including allowing us to understand
the impact of the PHE for COVID-19 on the quality of care provided to
Medicare beneficiaries. However, we are concerned that excess
readmission ratios calculated using excepted claims data could affect
the national comparability of these data due to the geographic
differences of COVID-19 incidence rates and hospitalizations along with
different impacts resulting from different state and local law and
policy changes implemented in response to COVID-19. Thus, the excess
readmission ratios and payment adjustments calculated from excepted
data during the PHE for COVID-19 may not provide a nationally
comparable assessment of performance in keeping with the program goal
of national comparison.
i. CY 2019 Fourth Quarter Data
Data were not excepted from the fourth quarter of CY 2019 from the
HRRP. The readmissions measures used to evaluate performance are
claims-based measures and do not require hospitals to report data to
CMS. Additionally, we believe that the quality measure data regarding
care provided prior to the PHE would not be affected by the PHE for
COVID-19.
ii. CY 2020 First and Second Quarter Data
In our application of the ECE policy for the PHE for COVID-19, we
excepted the use of claims data from the first and second quarters of
CY 2020 from the HRRP because of our concern that the data collected
during this period may be greatly impacted by the response to COVID-19,
and therefore, may not be reflective of a hospital's performance during
this time due to concerns with national comparability, as described
above. Therefore, we believe that it would be inappropriate to include
claims data submitted regarding care provided during first and second
quarter CY 2020 in our calculation of a hospital's performance that
assesses their performance as compared to other

[[Page 54833]]

hospitals in the nation to determine penalties for excess readmissions.
Finally, although the ECE we granted for HRRP has ended, with data
collection and reporting requirements having resumed July 1, 2020, we
understand that geographic differences in COVID-19 incidence continue
to change during the PHE for COVID-19. To maintain flexibility for
addressing the impact of COVID-19 on HRRP and determine how best to
implement the program equitably, we are announcing in this IFC that if,
as a result of the extension of the ECE for the whole country that we
grant without a request or the submission of individual ECE requests,
we do not have enough data to reliably measure national performance, we
may propose to not score hospitals based on such limited data or make
the associated payment adjustments to hospitals under the IPPS for the
affected program year. If we grant another ECE in the future, we would
not require that hospitals report the excepted data for the duration of
the ECE. Although a hospital may report data during the ECE, we may
determine that such data will not be used for scoring purposes. We
would still require that hospitals report the non-excepted data.
However, we may determine that it would be inappropriate to score such
data or base payment adjustments on it because of reliability concerns.
For illustrative purposes only, if a PHE excepted enough quarters from
the HRRP 36-month performance period to lead to unreliable measure
calculations, we might consider not scoring for the entire year because
the sample may not be large enough to calculate reliable measure
results for scoring purposes. Although the data itself may be accurate,
the measure(s) may not meet the reliability standards because of the
small sample of the remaining non-excepted part of the performance
period. In addition, in the scenario we describe above, it is likely
that only larger hospitals would be able to meet the required case
minimums to be scored in the non-excepted part of the performance
period. We may conclude that only scoring those remaining large
hospitals will produce an accurate national comparison of hospitals.
Alternatively, if we do not extend the ECE to cover Q3 and Q4 2020, it
is possible that a majority of providers may still submit individual
ECE requests for those quarters and it is possible that so many
hospitals will submit individual ECE requests that we will not be able
to produce a reliable national comparison. In both cases, we are
concerned about using the measures calculated based on these data to
score hospitals under the HRRP and base payment adjustments on those
scores. If circumstances warrant, we may propose to suspend prospective
application of program penalties or payment adjustments through the
annual IPPS/LTCH PPS proposed rule. However, in the interest of time
and transparency, we may provide subregulatory advance notice of our
intentions to suspend such penalties and adjustments through routine
communication channels to facilities, vendors, and QIOs). The
communications could include memos, emails, and notices on the public
QualityNet website (https://www.qualitynet.org/).
We welcome public comments on our policy to exclude any data
submitted regarding care provided during first and second quarter of CY
2020 from our calculation of performance for FY 2022, FY 2023, and FY
2024.
4. Update to the Hospital VBP Program ECE Granted in Response to the
PHE for COVID-19
a. Background of the Hospital VBP ECE Policy
In the FY 2014 IPPS/LTCH final rule (78 FR 50704 through 50707), we
finalized a disaster/ECE policy for the Hospital VBP Program. We stated
that, 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, 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.
In the May 8th COVID-19 IFC (85 FR 27550), we modified 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 (85 FR 27597 through 27598). We
stated that 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 also stated that 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 diagnosis-
related group (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. We referred 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 in order to receive a TPS for a program year under
the Hospital VBP Program.
b. Background of the Hospital VBP Program ECE Granted in Response to
the PHE for COVID-19
On March 22, 2020, in response to COVID-19, CMS announced relief
for clinicians, providers, hospitals, and facilities participating in
Medicare QRPs and VBP programs.\22\ On March 27, 2020, CMS published a
supplemental guidance memorandum that described in more detail the
scope and duration of the ECEs we were granting under each Medicare QRP
and VBP program.\23\
---------------------------------------------------------------------------

\22\ CMS press release available at https://www.cms.gov/newsroom/press-releases/cms-announces-relief-clinicians-providers-hospitals-and-facilities-participating-quality-reporting.
\23\ CMS memorandum available at https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
---------------------------------------------------------------------------

Specifically, we granted an ECE for the PHE for COVID-19 to all
hospitals participating in the Hospital VBP Program for the following
reporting requirements:
Hospitals will not be required to report data for the NHSN
HAI measures and Hospital Consumer Assessment of Healthcare Providers
and Systems (HCAHPS) survey for the following quarters: October 1, 2019
through December 31, 2019 (Q4 2019), January 1, 2020 through March 31,
2020 (Q1 2020), and April 1, 2020 through June 30, 2020 (Q2 2020).
However, hospitals can optionally submit part or all of these data by
the posted submission deadlines on the Hospital VBP Program QualityNet
site (available at https://www.qualitynet.org/inpatient/iqr/participation). This includes the following specific measures:
++ HCAHPS, NQF #0166.

[[Page 54834]]

++ NHSN Catheter-Associated Urinary Tract Infection (CAUTI) Outcome
Measure, NQF #0138.
++ NHSN CLABSI Outcome Measure, NQF #0139.
++ NHSN Facility-wide Inpatient Hospital-onset CDI Outcome Measure,
NQF #1717.
++ NHSN Facility-wide Inpatient Hospital-onset MRSA Bacteremia
Outcome Measure, NQF #1716.
++ American College of Surgeons--Centers for Disease Control and
Prevention Harmonized Procedure SSI Outcome Measure, NQF #0753.
In the March 27, 2020 guidance, we also advised that hospitals
should be aware of the potential subsequent impact to its Hospital VBP
Program minimum case threshold counts for inclusion in that program,
and that data from the impacted quarters for the HCAHPS survey and HAI
measures would be used if submitted voluntarily.
The ECE also stated that we would exclude qualifying
claims data from measure calculations for the following quarters:
January 1, 2020 through March 31, 2020 (Q1 2020) and April 1, 2020
through June 30, 2020 (Q2 2020). This exception applies to the
following measures:
++ Medicare Spending Per Beneficiary (MSPB)-Hospital, NQF #2158.
++ Hospital 30-Day, All Cause, Risk-Standardized Mortality Rate
Following Acute Myocardial Infarction (AMI) 30-Day Mortality Rate, NQF
#0230.
++ Hospital 30-Day, All Cause, Risk-Standardized Mortality Rate
Following Heart Failure (HF) 30-Day Mortality Rate, NQF #0229.
++ Hospital 30-Day, All Cause, Risk-Standardized Mortality Rate
Following Pneumonia (PN) 30-Day Mortality Rate, NQF #0468.
++ Hospital-Level Risk-Standardized Complication Rate Following
Total Hip Arthroplasty (THA)/Total Knee Arthroplasty Complication Rate
(TKA), NQF #1550.
++ Hospital 30-Day, All Cause, Risk-Standardized Mortality Rate
Following Chronic Obstructive Pulmonary Disease (COPD) 30-Day Mortality
Rate, NQF #1893.
++ Hospital 30-Day, All Cause, Risk-Standardized Mortality Rate
Following Coronary Artery Bypass Grafting (CABG) 30-Day Mortality Rate,
NQF #2558.
c. Update to the Hospital VBP ECE Granted in Response to the PHE for
COVID-19
We continue to believe that the Hospital VBP Program data we have
excepted serves multiple purposes, including allowing us to understand
the impact of COVID-19 on quality of care. Furthermore, the HAI
measures in the Hospital VBP Program are not abstracted from claims and
are calculated based on data submitted to the CDC through the NHSN. We
recognize that the CDC separately collects the same data for
epidemiological surveillance and that hospitals may have other
reporting requirements which are not affected by our ECE (for example,
state requirements). We are concerned with the national comparability
of these data due to the geographic differences of COVID-19 incidence
rates and hospitalizations along with different impacts resulting from
different state and local law and policy changes implemented in
response to COVID-19. For these reasons, and as discussed more fully
below, we are revising the current ECE we granted for the Hospital VBP
Program with respect to first and second quarter CY 2020 excepted data.
Under the revised ECE, we will not use any first or second quarter CY
2020 excepted Hospital VBP data that hospitals optionally reported to
calculate total performance scores for the FY 2022 through FY 2025
program years or baseline scores for the FY 2024 through FY 2030
program years. We will still use optionally reported fourth quarter CY
2019 Hospital VBP Program data to calculate TPSs for those hospitals
for the FY 2021 through FY 2024 program years and baseline scores for
the FY 2026 through FY 2029 program years because, as explained below,
we believe that the exception granted for those programs with data
submission deadlines in April and May 2020 (that is, data from the
fourth quarter of CY 2019) is distinct from the exceptions granted
because data collected may be greatly impacted by the response to
COVID-19 (that is, data from the first and second quarters of CY 2020).
i. CY 2019 Fourth Quarter Hospital VBP Program HAI and HCAHPS Data
We excepted hospitals from the requirement to report fourth quarter
CY 2019 HAI and HCAHPS data for the HVBP Program to alleviate the
reporting burden on hospitals that were responding to the PHE for
COVID-19 that would otherwise be required to report these data by the
May 18, 2020 and April 1, 2020 submission deadlines, respectively.
However, we believe that the quality measure data regarding care
provided prior to the PHE for COVID-19 would not be affected.
Additionally, as of April 2020, 92.6 percent of hospitals submitted
fourth quarter CY 2019 HAI data. Therefore, we are not making changes
to the Hospital VBP Program ECE that we granted with respect to these
data for the PHE for COVID-19 and will include all voluntarily reported
measure data for the HCAHPS survey and the five NHSN HAI measures when
we calculate hospital TPSs for the FY 2021 program year, as well as
when we calculate baseline data for the FY 2023 program year. Because
we did not except fourth quarter CY 2019 claims-based data for the
Hospital VBP Program, we will also include those data when we calculate
hospital TPSs for the FY 2021 through FY 2024 program years and
baseline data for the FY 2026 through FY 2029 program years.
ii. CY 2020 First and Second Quarter Hospital VBP Program Data
We excepted hospitals from the requirement to report all first and
second quarter CY 2020 Hospital VBP Program data to alleviate the
reporting burden on hospitals that were responding to the PHE for
COVID-19 and because we were concerned that the data collected during
this period could be greatly impacted by the response to COVID-19.
Although we permitted hospitals to voluntarily report these data, we
aim to have the most representative comparison of hospital performance
as possible and do not wish to unfairly penalize hospitals that were
responding to COVID-19. We believe that using first and second quarter
CY 2020 optionally reported data may not provide an accurate national
assessment of hospital performance for multiple reasons. First, if only
the optionally submitted data is used, it may not provide an accurate
national comparison as it is possible that there may be reporting bias
introduced by voluntary submission. Reporting bias could be introduced
if, for example, only high performers and/or hospitals not impacted or
better resourced would choose to submit data, hindering comparisons
between hospitals with different circumstances and preventing the
program from keeping with its goal of national comparison. A number of
other factors could also contribute to CMS' ability to generate an
accurate national comparison. For example, geographic differences in
COVID-19 incidence rates and COVID-19 related hospitalizations and
differences resulting from changes in referral and hospitalization
patterns could both impact the national comparability of optionally
submitted data. We believe that it would be inappropriate to include
optionally submitted data regarding care provided

[[Page 54835]]

during first and second quarter CY 2020 in our calculation of a
hospital's TPS.
Accordingly, for these reasons, we will not use any first or second
quarter CY 2020 excepted Hospital VBP data to calculate total
performance scores for the FY 2022 through FY 2025 program years or
baseline scores for the FY 2024 through FY 2030 program years to avoid
unfairly penalizing hospitals.
Finally, although the ECE we granted for the Hospital VBP Program
has ended, with data collection and reporting requirements having
resumed July 1, 2020, we understand that geographic differences in
COVID-19 incidence continue to change during the PHE for COVID-19. To
maintain flexibility for addressing the impact of COVID-19 on the
Hospital VBP Program and determine how best to implement the program
equitably, we are announcing in this IFC that if, as a result of the
extension of the ECE for the whole country that we grant without a
request or the submission of individual ECE requests, we do not have
enough data to reliably measure national performance, we may propose to
not score hospitals based on such limited data or make the associated
payment adjustments to facilities under the Hospital VBP Program for
the affected program year. If we grant another ECE in the future, we
would not require that hospitals report the excepted data for the
duration of the ECE. Although a hospital may voluntarily report data
during the ECE, we may determine that it would be inappropriate to use
such data for scoring purposes. We would still require that hospitals
report the non-excepted data. However, we may determine that it would
be inappropriate to score such data or base payment adjustments on it
because of reliability concerns. For example, if we granted an ECE that
excepted hospitals from the requirement to report data for 11 of the 12
months of a given performance period, we would consider not scoring or
applying payment adjustments for the associated program year because
data from the one non-excepted month may not be large enough to
calculate reliable measure results. Although the data itself may be
accurate, the measure(s) may not meet the reliability standards because
of the small sample of the remaining non-excepted part of the
performance period. In addition, in the scenario we describe above, it
is plausible that only larger hospitals would be able to meet the
required case minimums to be scored in the non-excepted part of the
performance period. We may conclude that only scoring those remaining
large hospitals will produce an accurate national comparison of
hospitals. Alternatively, if we do not extend the ECE to cover Q3 and
Q4 2020, it is possible that a majority of hospitals may still submit
individual ECE requests for those quarters and it is possible that so
many hospitals will submit individual ECE requests that we will not be
able to produce a reliable national comparison. In both cases, we are
concerned about using the measures calculated based on these data to
score facilities under the Hospital VBP Program and base payment
adjustments on those scores. At this time, we are not applying this
updated ECE policy to the Hospital VBP Program. If circumstances
warrant, we may propose to suspend prospective application of program
penalties or payment adjustments through the annual IPPS/LTCH PPS
proposed rule. However, in the interest of time and transparency, we
may provide subregulatory advance notice of our intentions to suspend
such penalties and adjustments through routine communication channels
to facilities, vendors, and QIOs. The communications could include
memos, emails, and notices on the public QualityNet website (https://www.qualitynet.org/). We welcome public comments on our updated
Hospital VBP Program ECE policy to exclude any data submitted regarding
care provided during the first and second quarter of CY 2020 from our
calculation of performance.
5. Revised Performance Period for the FY 2022 SNF VBP Program as a
Result of the ECE Granted for the PHE for COVID-19
In this IFC, we are revising the performance period for the FY 2022
SNF VBP Program because, as explained more fully below, we are
concerned that using qualifying claims from the two quarters that are
not excepted under the ECE for COVID-19 (October 1, 2019 through
December 31, 2019 (Q4 2019), and July 1, 2020 through September 30,
2020 (Q3 2020)) for all SNFs nationwide to calculate the SNFRM for the
FY 2022 Program will not yield measure scores that reliably reflect
quality of care as determined by hospital readmission rates. We are
also announcing that we may propose to update the SNF VBP ECE policy
for future ECEs that may be granted during the PHE for COVID-19.
a. Background of the SNF VBP ECE Policy
In the FY 2019 SNF PPS final rule (83 FR 39280 through 39281), we
finalized an ECE policy for the SNF VBP Program. We stated that a SNF
requesting an ECE would indicate the dates and duration of the
extraordinary circumstance in its request, along with any available
evidence of the extraordinary circumstance, and if approved, we would
exclude the corresponding calendar months from that SNF's measure rate
for the applicable measurement period and by extension, its SNF
performance score for applicable fiscal years. We noted that this
policy does not preclude us from granting exceptions to SNFs that have
not requested them when we determine that an extraordinary
circumstance, such as an act of nature or PHE, affects an entire region
or locale.
We also finalized under the SNF VBP Program ECE policy that we
would score any SNFs receiving ECEs on achievement and improvement for
any remaining months during the performance period, provided the SNF
had at least 25 eligible stays during both of those periods. As an
example, we stated that if a SNF received an approved ECE for 6 months
of the performance period, we would score the SNF on its achievement
during the remaining 6 months on the Program's measure as long as the
SNF met the 25 eligible stay threshold during the performance period.
We also stated that under this example, we would score the SNF on
improvement as long as it met the proposed 25 eligible stay threshold
during the applicable baseline period.
b. Background of the SNF VBP Program ECE Granted for the PHE for COVID-
19
On March 22, 2020, in response to the PHE for COVID-19,\24\ we
announced relief for clinicians, providers, hospitals and facilities
participating in Medicare QRPs and VBP programs. On March 27, 2020, we
published a supplemental guidance memorandum that described in more
detail the scope and duration of the ECEs we were granting under each
Medicare QRP and VBP program.\25\
---------------------------------------------------------------------------

\24\ CMS press release available at https://www.cms.gov/newsroom/press-releases/cms-announces-relief-clinicians-providers-hospitals-and-facilities-participating-quality-reporting.
\25\ CMS memorandum available at https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
---------------------------------------------------------------------------

Under the ECE, SNFs qualifying claims are excepted from the
calculation of the SNF 30-Day All-Cause Readmission Measure (SNFRM; NQF
#2510) for the following periods:
January 1, 2020-March 31, 2020 (Q1 2020).
April 1, 2020-June 30, 2020 (Q2 2020).
We refer readers to the March 22 and March 27, 2020 guidance memos
for additional information regarding

[[Page 54836]]

exceptions related to the PHE for COVID-19.
We continue to believe that the claims data we have excepted serves
multiple purposes, including allowing us to understand the impact of
the PHE for COVID-19 on the quality of care provided to Medicare
beneficiaries. However, we excepted claims data from the first and
second quarters of CY 2020 from the SNF VBP Program because of our
concern that the data reliability during this period may be greatly
impacted by the response to COVID-19. We are also concerned with the
national comparability of these data due to the geographic differences
of COVID-19 incidence rates and hospitalizations along with different
impacts resulting from different state and local law and policy changes
implemented in response to COVID-19. Therefore, we believe that it
would be inappropriate to include data submitted regarding care
provided during first and second quarter CY 2020 in our calculation of
a SNF's performance score. However, by excluding 6 months of qualifying
claims in CY 2020 (January 1, 2020 through June 30, 2020) for all SNFs
nationally, this policy will impact the performance period (October 1,
2019 through September 30, 2020) for the FY 2022 SNF VBP Program Year
by reducing the total amount of data available to evaluate SNF
performance. Accordingly, as discussed below, we are finalizing in this
IFC a new performance period for the FY 2022 SNF VBP that we believe
will more reliably reflect SNF performance and quality of care provided
to Medicare beneficiaries.
In addition, although the ECE we granted for the SNF VBP Program
has ended, and data collection resumed July 1, 2020, we understand that
geographic differences in COVID-19 incidence continue to change during
the PHE for COVID-19. To maintain flexibility for addressing the impact
of COVID-19 on the SNF VBP Program and determine how best to implement
the program equitably, we are announcing in this IFC that if, as a
result a ECE that we grant for the whole country without a request or
the submission of individual ECE requests, we do not have enough SNF
VBP Program data to reliably measure national performance, we may
propose to not score facilities based on such limited data or make the
associated payment adjustments to facilities under the SNF PPS for the
affected program year. If we grant another ECE in the future, we would
not use claims data submitted to CMS during the ECE for scoring
purposes under the SNF VBP program. We may determine that it would be
inappropriate to score remaining non-excepted data or base payment
adjustments on it because of reliability concerns. For example, if we
granted an ECE that excepted, for all facilities nationwide, the use of
claims data for 11 of the 12 months of a given performance period, we
would consider not scoring or applying payment adjustments for the
associated program year because data from the one non-excepted month
may not be large enough to calculate reliable measure results for
scoring purposes. Although the data itself may be accurate, the
measure(s) may not meet the reliability standards because of the small
sample of the remaining non-excepted part of the performance period. In
addition, in the scenario we describe above, it is likely that only
larger facilities would be able to meet the required minimum number of
eligible SNF stays to be scored in the non-excepted part of the
performance period. We may conclude that only scoring those remaining
large facilities will not produce an accurate national comparison of
SNFs. Alternatively, if we do not extend the ECE to cover Q3 and Q4
2020, it is possible that a majority of SNFs may still submit
individual ECE requests for those quarters and it is possible that so
many SNFs will submit individual ECE requests that we will not be able
to produce a reliable national comparison. In both cases, we are
concerned about using the measures calculated based on these data to
score facilities under the SNF VBP Program and base payment adjustments
on those scores. At this time, we are not applying this updated ECE
policy to the SNF VBP Program. Rather, as described in detail in the
next section, we are revising the performance period of the FY 2022 SNF
VBP Program to include data from: April 1, 2019 through December 31,
2019 and July 1, 2020 through September 30, 2020. However, if at a
future date if circumstances warrant, we may propose to suspend
prospective application of program penalties or payment adjustments
through the annual SNF PPS proposed rule. However, in the interest of
time and transparency, we may provide subregulatory advance notice of
our intentions to suspend such penalties and adjustments through
routine communication channels to facilities, vendors, and QIOs. The
communications could include memos, emails, and notices on the public
CMS website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/SNF-VBP/SNF-VBP-Page) or,
if time allows, through the annual SNF PPS proposed rule.
d. Revised Performance Period for the FY 2022 SNF VBP Program
The performance period for the FY 2022 SNF VBP Program is FY 2020
(84 FR 38822). The ECE for the PHE for COVID-19 excepts 6 months of
claims data from the calculation of the SNFRM during the performance
period of the FY 2022 SNF VBP Program.
We are concerned that using qualifying claims during only the
remaining 6 months of FY 2020 (October 1, 2019 through December 31,
2019 (Q4 2019), and July 1, 2020 through September 30, 2020 (Q3 2020))
for all SNFs nationwide to calculate the SNFRM for the FY 2022 Program
will not yield measure scores that reliably reflect quality of care as
determined by hospital readmission rates because the reliability of the
SNFRM rate is related to sample size. We distinguish between ECEs that
grant exceptions for a limited number of SNFs on a case-by-case basis
(that is, if a SNF submits an ECE form with appropriate supporting
evidence), which would yield an acceptable reflection of those SNFs'
performance, and blanket ECEs that grant exceptions for all SNFs
nationwide, which may decrease the likelihood that measure performance
would reflect the quality of care across a large number of SNFs.
Furthermore, the NQF endorsed the SNFRM as a one-year measure.\26\ In
line with NQF endorsement, the performance period and baseline period
SNFRM rate for a program year has been calculated based on one year of
data since the Program's inception. Our internal analysis indicates
that calculating the SNFRM based on 6 months data for all SNFs
nationwide would decrease the SNFRM's reliability by approximately one-
third compared to calculating the SNFRM based on one year of data,
resulting in unacceptably low measure reliability. This situation
differs from, for example, calculating the SNFRM based on 6-months of
data for only several SNFs, which would not meaningfully impact the
SNFRM's reliability and would not impact the vast majority of SNFs
whose SNFRM rate would still be calculated based on one year of data.
We do not believe it is appropriate to calculate the SNFRM in such a
way that does not align with NQF endorsement and may decrease the
likelihood that the SNFRM reliably reflects the quality of care
provided by those SNFs. Therefore, we are revising the performance
period for the FY 2022 SNF VBP Program. The revised

[[Page 54837]]

performance period for the FY 2022 SNF VBP program will include data
from: April 1, 2019 through December 31, 2019 and July 1, 2020 through
September 30, 2020. We note that this 12-month period includes 6 months
of FY 2019 data and 6 months FY 2020 data, but does not include the 6
months of data that we excepted for the SNF VBP Program under the ECE
for the PHE for COVID-19. Eligible SNF stays with admissions during
this revised 12-month period, April 1, 2019 through December 31, 2019
and July 1, 2020 through September 30, 2020, will be included in
performance period SNFRM calculations for the FY 2022 SNF VBP Program.
We believe using data from these two periods, which combines 9 months
of data prior to the start of the PHE for COVID-19 and 3 months of data
after the end of the ECE we granted for this program, will provide
sufficiently reliable data for evaluating SNF performance that can be
used for FY 2022 scoring. We selected this performance period data as
it was the most operationally feasible, did not use data from FY 2018
(the baseline period for the SNF VBP FY 2022 program year), and
provided the least overlap with performance periods for other program
years.
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\26\ From https://www.qualityforum.org/Measures_Reports_Tools.aspx, click ``NQF-Endorsed Measures (QPS)''
under ``Find Measures'' then search ``2510'' to view the SNFRM.
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We are aware that the revised performance period for the FY 2022
Program overlaps with the performance period of the FY 2021 Program (FY
2019) by 6 months. However, in order to ensure that 12 months of claims
data are used to calculate the SNFRM, we believe that this is the most
feasible option. We also note that although April 1, 2019 through
September 30, 2019 data would be used for two different program years
(FY 2021 and FY 2022), October 1, 2019 through December 31, 2019 and
July 1, 2020 through September 30, 2020 data would only be used for the
FY 2022 program year. Beginning with the FY 2023 program year, the
performance period will be FY 2021, consistent with our previously
finalized policy. Furthermore, we note that historically there has been
an instance of overlapping data during performance periods of the SNF
VBP Program; when the SNF VBP Program transitioned from using CY to FY
data for calculating the performance period, the performance period of
the FY 2019 SNF VBP Program (CY 2017) overlapped with the performance
period of the FY 2020 SNF VBP Program (FY 2018) by 3 months (October 1,
2017 through December 31, 2017). We refer readers to the FY 2018 SNF
PPS final rule (82 FR 36613 through 36614) for additional information
on those performance periods.
The baseline period of the FY 2022 Program has not been impacted by
the PHE for COVID-19 and will remain as FY 2018 (October 1, 2017
through September 30, 2018), and the FY 2022 Program performance
standards included in the FY 2020 final rule (84 FR 38822 through
38823) will remain as finalized.
We welcome public comments regarding our policy to revise the FY
2022 SNF VBP Program performance period to April 1, 2019 through
December 31, 2019 and July 1, 2020 through September 30, 2020.

E. NCD Procedural Volumes for Facilities and Practitioners To Maintain
Medicare Coverage

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 of the Act. Some NCDs include
procedural volume requirements that facilities and/or practitioners
must meet as conditions of coverage for specific items and services. If
those volume requirements are not satisfied, Medicare payment would not
be permitted. On March 18, 2020, CMS encouraged hospitals and
practitioners to delay certain non-essential procedures due to the
COVID-19 pandemic.\27\ On June 9, 2020, as coronavirus disease-related
healthcare demand decreased, CMS found it was important to safely
resume care to treat ongoing health needs that had been postponed and
issued guidance that hospitals could resume providing these
services.\28\ Even so, as a result of the PHE for COVID-19, hospitals
and practitioners have performed fewer non-essential procedures for
several months and as a result may not be able to meet certain
procedural volume requirements that are set forth in these NCDs.
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\27\ https://www.cms.gov/newsroom/press-releases/cms-releases-recommendations-adult-elective-surgeries-non-essential-medical-surgical-and-dental.
\28\ https://www.cms.gov/files/document/covid-recommendations-reopening-facilities-provide-non-emergent-care.pdf.
---------------------------------------------------------------------------

Four NCDs set forth such procedural volume requirements. These NCDs
are:
NCD 20.34 Percutaneous Left Atrial Appendage Closure
(LAAC).
NCD 20.32 Transcatheter Aortic Valve Replacement (TAVR).
NCD 20.33 Transcatheter Mitral Valve Repair (TMVR).
NCD 20.9.1 Ventricular Assist Devices (VADs).
Because of the disruption in the healthcare delivery system,
including the delay in non-essential procedures as noted above, we are
not enforcing the procedural volume requirements contained in the four
NCDs noted above for facilities and practitioners that, prior to the
PHE for COVID-19, met the volume requirements. This enforcement
discretion applies only during the period of the PHE for COVID-19 and
ensures that beneficiaries will continue to have access to the services
that are covered under the NCD.
Please note that all other coverage requirements under these NCDs
remain in effect.

F. Limits on COVID-19 and Related Testing Without an Order and
Expansion of Testing Order Authority

In this IFC, we are establishing that one COVID-19 diagnostic test
and one of each other related test (as listed in the May 8th COVID-19
IFC) without an order from a physician or other practitioner is
reasonable and necessary for Medicare payment purposes. For the COVID-
19 and other related diagnostic tests for which an order is required,
we are also establishing a policy whereby tests can be covered when
ordered by a pharmacist or other healthcare professional who is
authorized to order diagnostic laboratory tests in accordance with
state scope of practice and other pertinent laws.
In the May 8th COVID-19 IFC, CMS stated that, given the critical
importance of expanding COVID-19 testing to combat the pandemic and the
heightened risk that the disease presents to Medicare beneficiaries
during the PHE for COVID-19, Medicare would not require an order from a
physician or other applicable practitioner for COVID-19 testing. We
amended our regulation at 42 CFR 410.32(a) to remove the requirement
that otherwise covered COVID-19 diagnostic laboratory tests are covered
only based on the order of a treating physician or other
practitioner.\29\ In addition, we removed the ordering requirement for
coverage of a diagnostic laboratory test for influenza virus and
respiratory syncytial virus, a type of common respiratory virus, but
only when these tests 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. We also noted that
FDA-authorized COVID-19 serology tests are included as covered tests
during the PHE for COVID-19, as they are

[[Page 54838]]

reasonable and necessary under section 1862(a)(1)(A) of the Act for
beneficiaries with a known current or known prior COVID-19 infection or
a suspected current or suspected prior COVID-19 infection.
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\29\ The list of COVID-19, Influenza, and RSV clinical
diagnostic laboratory tests is available at https://www.cms.gov/files/document/covid-ifc-2-flu-rsv-codes.pdf.
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In this IFC, we are revising the previous policy adopted in the May
8th COVID-19 IFC, which allowed for broad coverage of multiple
instances of COVID-19 testing for a single beneficiary without a
physician or other practitioner order, by establishing that one single
COVID-19 diagnostic test and one of each other related test (as listed
in the May 8th COVID-19 IFC) without an order from a physician or other
practitioner is reasonable and necessary. This limitation on tests
without a physician/other practitioner order will apply beginning on
the effective date of this rule, and any tests furnished prior to the
effective date will not be considered for purposes of this limit on
tests without a physician or other practitioner order. In other words,
if a beneficiary received a test or multiple tests without an order
before the effective date of this rule, these tests would not count
toward the limit of one test without a physician or other practitioner
order under this rule. We believe that this approach will provide
sufficient notice for laboratories to set up the systems and processes
necessary to require an order beyond one test. For the COVID-19 and
other related diagnostic tests for which an order is required, we are
also establishing a policy whereby the tests can be covered when
ordered by a pharmacist or other healthcare professional who is
authorized to order diagnostic laboratory tests in accordance with
state scope of practice and other pertinent laws.
Just as the previous policy was developed based on what was known
about COVID-19 at the time, as additional information has become
available, policies require modification. This approach is consistent
with the CDC's introductory statement in its July 2, 2020 testing
guidance that ``recommendations for SARS-CoV-2 testing have been
developed based on what is currently known about COVID-19 and are
subject to change as additional information becomes available.'' \30\
Whereas we are committed to reducing impediments to access to COVID-19
testing and the other related tests identified in the May 8th COVID-19
IFC, we believe that it is contrary to the public interest to allow
open-ended coverage of COVID-19 testing without an order from a
physician, practitioner, or other healthcare professional. Our
determination to revise the May 8th IFC policy is due both to the
significant potential for fraud, waste, and abuse, as well as public
health and safety issues that would arise from beneficiaries being
subjected to repeated testing without proper medical attention or
oversight, including public health issues with the ongoing spread of
COVID-19, as outlined by CDC guidance on specific patient categories
\31\ that has been published in the May 8th COVID-19 IFC.
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\30\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html.
\31\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html.
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First, laboratory testing has been a significant source of fraud
and abuse in the Medicare program. In one recent example from September
2019, CMS, along with our law enforcement partners, undertook a
landmark investigation and prosecution of fraudulent genetic cancer
testing, resulting in charges against 35 defendants associated with
dozens of telemedicine companies and cancer genetic testing
laboratories for their alleged participation in one of the largest
healthcare fraud schemes ever charged. According to the charges, the
defendants fraudulently billed Medicare for genetic testing, using
telemarketers to make phone calls and other unsolicited contacts with
Medicare beneficiaries to fraudulently bill more than $2.1 billion to
the Medicare program.\32\
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\32\ https://oig.hhs.gov/newsroom/media-materials/2019/geneticscam/index.asp.
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We have already found that similar schemes are occurring whereby
fraudulent laboratories and telemarketing companies are directly
contacting beneficiaries, oftentimes using stolen identifying
information, to solicit items and services payable by Medicare under
the guise of COVID-19 treatment or prevention. An HHS Office of
Inspector General (HHS-OIG) fraud alert \33\ describes situations in
which scammers are offering unapproved and illegitimate COVID-19 tests
and other services to Medicare beneficiaries in exchange for personal
details, including Medicare information. However, the services are
unapproved and illegitimate. Fraudsters are targeting beneficiaries in
a number of ways, including telemarketing calls, text messages, social
media platforms, and door-to-door visits. The personal information
collected can be used to fraudulently bill federal healthcare programs
and commit medical identity theft. In addition, if Medicare denies the
claim for an unapproved test, the beneficiary could be responsible for
the cost. The availability of broad COVID-19 and related testing
without an order significantly increases the risk and scope of these
fraud schemes, leading not only to considerable risk to taxpayer
dollars, but also potential physical and financial harm to Medicare
beneficiaries.
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\33\ https://oig.hhs.gov/coronavirus/fraud-alert-covid19.asp.
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In addition to our concerns about previous laboratory schemes being
applied to COVID-19 testing itself, the risk is exacerbated by the
ability of the laboratory to perform add-on tests, such as to confirm
or rule-out diagnoses other than COVID-19. The HHS-OIG has recognized
that ``[r]elaxation of the [ordering] rules could allow unscrupulous
actors more leeway for fraudulent billing of unnecessary add-on
testing,'' and announced in June 2020 that it was undertaking a trend
analysis for potential fraud and abuse with COVID-19 add-on
testing.\34\
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\34\ https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000489.asp.
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In addition to our concerns about potential fraud, we believe that
broad COVID-19 testing without the order of any healthcare
professional--including testing for the related conditions identified
in the May 8th COVID-19 IFC--may result in a beneficiary not receiving
the medical attention and oversight required to ensure that diagnosis
and treatment is applied consistent with CDC guidelines and other
medical standards. Allowing testing to occur without proper medical
attention or oversight can lead to direct or indirect harm to
beneficiaries, their families and their contacts, from a variety of
perspectives, including the fact that the beneficiary may not receive
complete and accurate information on how the test results should be
interpreted and acted upon (for example, contact tracing and public
health precautions) and how the beneficiary should be monitored in the
case of a positive test.
Of the nearly 1.9 million beneficiaries who have been tested,
approximately 83 percent have had only one test performed. However,
claims data from the past 8 months have shown that the number of
beneficiaries receiving more than one COVID-19 test has been
increasing. While we do not have data to examine whether these tests
are being performed without a physician or other practitioner order, we
expect the proportion of beneficiaries who are tested more than once to
increase over time until a vaccine or other containment strategy is
available to

[[Page 54839]]

meaningfully reduce the risk of COVID-19. We believe that allowing
Medicare payment for one test without an order will allow beneficiaries
access to urgent testing, as we outlined in the May 8th COVID-19 IFC,
yet also provide sufficient opportunity for beneficiaries to seek out
the medical care needed to ensure that the test results are interpreted
and acted upon appropriately, both from the perspective of the
individual beneficiary and also in the context of the area of the
country in which the beneficiary is located.
While some areas of the country continue to have minimal impact
from the disease or are seeing the COVID-19 infection curve flattening,
other areas are seeing a resurgence. Executing an effective, regional
response to COVID-19 disease requires coordinated effort and guidance
by qualified medical professionals who know how to interpret and react
to testing results. Recent experience with this disease has also
demonstrated that substantial COVID-19 transmission occurs from
infectious individuals both with and without symptoms, and that
isolation of infected persons has been identified as a key strategy for
preventing further spread of COVID-19. Testing without healthcare
oversight can lead to a bypassing of risk-stratified protocols for
management of negative COVID-19 test results. A negative test does not
rule out the disease; if a physician or other appropriate healthcare
professional suspects a patient may have COVID-19 based on symptoms or
other factors, infection control measures should be implemented
regardless of test results. For example, isolation of persons infected
with SARS-CoV-2, the virus that causes COVID-19, is a key strategy for
preventing further spread of COVID-19. In fact, when infected
individuals are separated from others while awaiting their test
results, transmission is reduced much more than when individuals are
not separated. By having patients isolated one to two days earlier,
spread of COVID-19 can be reduced significantly.\35\ When a physician
or other health care provider is able to counsel patients who are being
tested for COVID-19, beneficiaries may be more likely to isolate or
quarantine themselves more quickly, which may reduce transmission in
the community. Self-quarantine for those who may be infectious is also
a key element to ensuring that health care providers and suppliers are
able to continue to safely provide COVID-19-related and non-COVID-19
essential care, patients can resume elective procedures, and that the
nation can continue steps to reopen the economy.
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\35\ https://www.cms.gov/files/document/se20011.pdf.
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We remain committed to ensuring beneficiaries have access to needed
testing services, and to the medical oversight required to address this
complex pandemic. First, we note that our numerous provisions enhancing
access to and use of telehealth and other communications technology-
based services (CTBS) have enabled beneficiaries to overcome some of
the obstacles associated with seeking care in physician offices and
other medical facilities during the PHE for COVID-19. The telehealth
and CTBS flexibilities have provided a modernized framework for care
delivery, including the ability for clinicians to remotely assess the
medical condition of patients and determine the need for COVID-19
testing and perform related clinical oversight, which takes advantage
of modern technology while addressing the health needs of the Medicare
beneficiary population.
In addition, in our March 31st COVID-19 IFC, we established payment
policies to provide specimen collection fees for independent
laboratories collecting specimens from beneficiaries who are homebound
or non-hospital inpatients for COVID-19 testing during the PHE for
COVID-19. In our May 8th COVID-19 IFC, we also established payment
mechanisms for specimen collection for COVID-19 testing under the
Physician Fee Schedule (PFS) and OPPS during the PHE for COVID-19. To
help ensure that laboratories located in the United States wishing to
perform COVID-19 testing that are applying for a CLIA certificate are
able to begin testing as quickly as possible during the PHE for COVID-
19, we have also reviewed our regulations (42 CFR part 493) and our
procedures to expedite review of applications for a CLIA certificate.
We are committed to taking critical steps to ensure Medicare
beneficiaries are able to access safe and reliable COVID-19 and related
testing.
CMS and CDC are also taking steps to ensure that physicians and
other practitioners who counsel patients on COVID-19 testing are paid
for these services. On July 30, 2020, CMS and CDC announced that
payment is available to practitioners and suppliers to counsel
patients, at the time of COVID-19 testing, about the importance of
self-isolation after they are tested and prior to the onset of
symptoms.\36\ Through counseling, health care providers can discuss
with patients: (1) The signs and symptoms of COVID-19; (2) the
immediate need to separate from others by isolation, particularly while
awaiting test results; (3) the importance of informing close contacts
of the person being tested (for example, family members) to separate
from the patient awaiting test results; (4) the fact that if the
patient tests positive, the patient will be contacted by the public
health department to learn the names of the patient's close contacts;
and (5) the services that may be available to assist the patient in
successfully isolating at home.
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\36\ https://www.cms.gov/newsroom/press-releases/cms-and-cdc-announce-provider-reimbursement-available-counseling-patients-self-isolate-time-covid-19.
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We also believe that pharmacists and other healthcare professionals
play an important role in the response to the PHE for COVID-19, and we
explicitly clarified in the May 8th COVID-19 IFC that pharmacists fall
within the regulatory definition of auxiliary personnel under our
regulation at Sec. 410.26. As such, pharmacists may provide services
incident-to the professional services, and under the appropriate level
of supervision, of the billing physician or practitioner, 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 practitioner and in accordance with the pharmacist's state
scope of practice and applicable state law. We believe this
clarification may encourage pharmacists to work with physicians and
other applicable practitioners in new ways that expand the availability
of health care services during the PHE for COVID-19. One service that
may be rendered in accordance with these authorities is an assessment
and specimen collection for COVID-19 testing. Specifically, we stated
in the May 8th COVID-19 IFC that CPT code 99211 can be billed for both
new and established patients for the duration of the PHE for COVID-19,
when the services described by that code for a level 1 E/M visit are
furnished for the purpose of a COVID-19 assessment and specimen
collection. These services can be billed as services provided by
auxiliary clinical staff, including pharmacists, if those staff meet
all of the requirements to furnish services as ``incident to,'' as
described in Sec. 410.26 of our regulations and in our frequently
asked questions document discussing virtual supervision.\37\
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\37\ https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf.
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To further ensure that beneficiaries continue to have access to
appropriate COVID-19 testing even when some

[[Page 54840]]

professional care is not separately billable under Medicare, we are
establishing a policy whereby otherwise covered COVID-19 and specified
related tests ordered by pharmacists and other healthcare professionals
who are authorized to order diagnostic laboratory tests in accordance
with state scope of practice and other pertinent laws are covered for
the duration of the PHE for COVID-19. Under this policy, an otherwise
covered COVID-19 test (and other related tests, as specified on the CMS
website) is considered reasonable and necessary during the PHE for
COVID-19 if ordered by a pharmacist or other healthcare professional
who is practicing in accordance with applicable state scope of practice
laws. Because pharmacists and certain other healthcare professionals
are not considered to be physicians or practitioners under the Medicare
statute, they cannot be paid directly under the Medicare program;
therefore, pharmacists and other auxiliary personnel still need to be
functioning in an incident-to arrangement with a physician or non-
physician practitioner for the services they provide to be paid by
Medicare under Part B for the front-end assessment and specimen
collection associated with the order, as described above. However, we
believe this interim ordering policy is appropriate during the duration
of the PHE for COVID-19 to ensure adequate access to testing as
permitted under state scope of practice and other applicable laws.
With this IFC, we are amending our regulation at Sec. 410.32(a)(3)
to state that, starting with the effective date of the revision and
carrying forward for the remaining duration of the PHE for COVID-19,
the order of a physician or other practitioner is not required for one
otherwise covered diagnostic laboratory test for COVID-19 and for one
otherwise covered diagnostic laboratory test each for influenza virus
or similar respiratory condition needed to obtain a final COVID-19
diagnosis, when performed in conjunction with a COVID-19 diagnostic
laboratory test in order to discount influenza virus or related
diagnosis.\38\ This includes 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 prior COVID-19 infection.
We are also amending the regulation so the orders of pharmacists and
other practitioners that are allowed to order laboratory tests in
accordance with state scope of practice and other pertinent laws can
fulfill the requirements related to orders for covered COVID-19 tests
for Medicare patients. We note that Medicare continues to cover other
medically necessary clinical diagnostic laboratory tests when a
treating physician or other practitioner orders them, and that other
Medicare conditions of coverage and payment continue to apply,
including any applicable local coverage determinations.
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\38\ The list of COVID-19, Influenza, and RSV clinical
diagnostic laboratory tests is available at https://www.cms.gov/files/document/covid-ifc-2-flu-rsv-codes.pdf.
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The policies described in this section apply to the Medicare
program only. Coverage policies for COVID-19 testing for group health
plans and health insurance issuers offering group and individual health
insurance coverage are generally governed by other rules of other
federal agencies and/or HHS and states. States administer the Medicaid
program and the Children's Health Insurance Program (CHIP) subject to
federal requirements, and therefore, have significant responsibility
for establishing coverage and payment policies for those programs,
within federal parameters.

G. Recognizing Temporary Premium Credits as Premium Reductions

1. Background
Title I of the Health Insurance Portability and Accountability Act
of 1996 (HIPAA) (Pub. L. 104-191, enacted on August 21, 1996) added a
new title XXVII to the PHSA to establish various reforms to the group
and individual health insurance markets. These provisions of the PHSA
have also been augmented by later laws, including the Patient
Protection and Affordable Care Act (PPACA).\39\ Subtitles A and C of
title I of the PPACA reorganized, amended, and added to the provisions
of part A of title XXVII of the PHSA relating to group health plans and
health insurance issuers in the group and individual markets.
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\39\ 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'' or ``PPACA''.
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Section 1321(a) of the PPACA provides broad authority for the
Secretary to establish standards and regulations to implement the
statutory requirements related to Exchanges,\40\ qualified health plans
(QHPs), and other components of title I of the PPACA. Section
1321(a)(1) of the PPACA directs the Secretary to issue regulations that
set standards for meeting the requirements of title I of the PPACA for,
among other things, the establishment and operation of Exchanges.
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\40\ American Health Benefit Exchanges, or ``Exchanges,'' are
entities established under the PPACA through which qualified
individuals and qualified employers can purchase health insurance
coverage in qualified health plans (QHPs).
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Section 1321(d) of the PPACA provides that nothing in title I of
the PPACA must be construed to preempt any state law that does not
prevent the application of title I of the PPACA. Section 1311(k) of the
PPACA specifies that Exchanges may not establish rules that conflict
with or prevent the application of regulations issued by the Secretary.
Section 1343 of the PPACA establishes an annual permanent risk
adjustment program to provide payments to health insurance issuers that
attract higher-than-average risk populations, such as those with
chronic conditions, funded by payments from those that attract lower-
than-average risk populations, thereby reducing incentives for issuers
to avoid higher-risk enrollees. Consistent with section 1321(c)(1) of
the PPACA, the Secretary is responsible for operating the risk
adjustment program on behalf of any state that does not elect to do so.
We established the framework for the risk adjustment program in a final
rule, published in the March 23, 2012 Federal Register (77 FR 17219)
(Premium Stabilization Rule), and first established the federally-
certified risk adjustment methodologies and other parameters related to
the risk adjustment program applicable to the 2014 benefit year in the
2014 Payment Notice final rule in the March 11, 2013 Federal Register
(78 FR 15409). In the October 30, 2013 Federal Register (78 FR 65046),
we finalized the proposed modification to the HHS methodology related
to community rating states. We published a correcting amendment to the
2014 Payment Notice final rule in the November 6, 2013 (78 FR 66653) to
address how an enrollee's age for the risk score calculation would be
determined under the HHS methodology. We have generally published the
parameters and methodology for the applicable risk adjustment benefit
year in each subsequent HHS annual notice of benefit and payment
parameters.\41\ In

[[Page 54841]]

the July 30, 2018 Federal Register (83 FR 36456), we published a final
rule that adopted the 2017 benefit year risk adjustment methodology as
established in the final rules published in the March 23, 2012 (77 FR
17220 through 17252) and in the March 8, 2016 editions of the Federal
Register (81 FR 12204 through 12352). The final rule sets forth
additional explanation of the rationale supporting the use of the
statewide average premium in the HHS-operated risk adjustment state
payment transfer formula for the 2017 benefit year, including the
reasons why the program is operated in a budget-neutral manner. The
final rule permitted HHS to resume 2017 benefit year risk adjustment
payments and charges. HHS also provided guidance as to the operation of
the HHS-operated risk adjustment program for the 2017 benefit year in
light of publication of this IFC.\42\
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\41\ See the 2015 Payment Notice final rule published in the
March 11, 2014 Federal Register (79 FR 13743); the 2016 Payment
Notice final rule published in the February 27, 2015 Federal
Register (80 FR 10749); the 2017 Payment Notice final rule published
in the March 8, 2016 Federal Register (81 FR 12203); the 2018
Payment Notice final rule published in the December 22, 2016 Federal
Register (81 FR 94058); the 2019 Payment Notice final rule published
in the April 17, 2018 Federal Register (83 FR 16930); and the 2019
Payment Notice final rule correction published in the May 11, 2018
Federal Register (83 FR 21925).
\42\ ``Update on the HHS-operated Risk Adjustment Program for
the 2017 Benefit Year.'' July 27, 2018. Available at https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/2017-RA-Final-Rule-Resumption-RAOps.pdf.
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In the August 10, 2018 Federal Register (83 FR 39644), we published
a proposed rule seeking comment on adopting the 2018 benefit year risk
adjustment methodology in the final rules published in the March 23,
2012 (77 FR 17219) and in the December 22, 2016 editions of the Federal
Register (81 FR 94058). The proposed rule set forth additional
explanation of the rationale supporting use of statewide average
premium in the HHS-operated risk adjustment state payment transfer
formula for the 2018 benefit year, including the reasons why the
program is operated in a budget-neutral manner. In the December 10,
2018 Federal Register (83 FR 63419), we issued a final rule adopting
the 2018 benefit year HHS-operated risk adjustment methodology as
established in the final rules published in the March 23, 2012 (77 FR
17219) and the December 22, 2016 (81 FR 94058) editions of the Federal
Register. That final rule sets forth additional explanation of the
rationale supporting use of statewide average premium in the HHS-
operated risk adjustment state payment transfer formula for the 2018
benefit year, including the reasons why the program is operated in a
budget-neutral manner. We adopted the risk adjustment methodology and
parameters for the 2020 benefit year in the 2020 Payment Notice final
rule in the April 25, 2019, Federal Register (84 FR 17454). On May 14,
2020, we adopted the risk adjustment methodology and parameters for the
2021 benefit year in the 2021 Payment Notice final rule in the Federal
Register (85 FR 29164).
Section 2718 of the PHSA, as added by the PPACA, generally requires
health insurance issuers to submit an annual report to the Secretary
that details the percentage of premium revenue (after certain
adjustments) expended on reimbursement for clinical services provided
to enrollees under health insurance coverage and on activities that
improve healthcare quality. The ratio of premium revenue spent on
clinical services and quality improvement activities is called the
medical loss ratio (MLR). Section 2718(b) of the PHSA requires an
issuer to provide rebates to enrollees if its MLR falls below specified
MLR standards (generally 80 percent for the individual and small group
markets, and 85 percent for the large group market). We published an
interim final rule in the December 1, 2010 Federal Register (75 FR
74863). A final rule was published in the December 7, 2011 Federal
Register (76 FR 76573). The MLR program requirements were amended in
final rules published in the December 7, 2011 Federal Register (76 FR
76595), the May 16, 2012 Federal Register (77 FR 28790), the March 11,
2014 Federal Register (79 FR 13743), the May 27, 2014 Federal Register
(79 FR 30339), the February 27, 2015 Federal Register (80 FR 10749),
the March 8, 2016 Federal Register (81 FR 12203), the December 22, 2016
Federal Register (81 FR 94183), the April 17, 2018 Federal Register (83
FR 16930), and the April 25, 2019 Federal Register (84 FR 17454).
Due to the urgent need to help facilitate the nation's response to
the COVID-19 pandemic, CMS announced the adoption of certain temporary
policies of relaxed enforcement for all issuers offering health
insurance coverage in the individual and small group markets to support
continuity of coverage for individuals, families, and small employers
who may struggle to pay premiums because of illness or loss of incomes
or revenue resulting from the PHE for COVID-19. On August 4, 2020, CMS
issued a memo, ``Temporary Policy on 2020 Premium Credits Associated
with the COVID-19 Public Health Emergency,'' wherein CMS adopted
certain temporary policies of relaxed enforcement for the premium rules
set forth at 45 CFR 147.102, 155.200(f)(4), 155.400(e) and (g),
155.706(b)(6)(1)(A), 156.80(d), 156.210(a), and 156.286(a)(2) through
(4) to allow issuers in the individual and small group markets the
flexibility, when consistent with state law, to temporarily offer
premium credits for 2020 coverage.\43\ The memo also advised of our
intention to pursue future rulemaking to address risk adjustment data
submissions and MLR reporting requirements for issuers that elect to
provide these credits to ensure that issuers accurately report premium
amounts actually billed for months in 2020 for which issuers are
providing these credits.
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\43\ See https://www.cms.hhs.ov/CCIIO/Programs-and-Initiative/Health-Insurance-Marketplaces/Downloads/Premium-Credit-Guidance.pdf.
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This IFC clarifies the data reporting requirements for issuers of
risk adjustment covered plans \44\ to specify that, for the purposes of
2020 benefit year risk adjustment data submissions, issuers of risk
adjustment-covered plans that provide temporary premium credits must
report to their dedicated distributed data environment (EDGE server)
adjusted plan premiums that reflect actual premiums billed to
enrollees, taking the premium credits into account as a reduction in
premiums. In addition, this IFC clarifies, consistent with the
reporting of the actual premium amounts billed to enrollees for 2020
benefit year risk adjustment data submissions, HHS's calculation of
risk adjustment payment and charges for the 2020 benefit year under the
state payment transfer formula \45\ will be calculated using the
statewide average premium that reflects actual premiums billed, taking
into account any temporary premium credits provided as a reduction in
premium for the applicable months of 2020 coverage.
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\44\ See 45 CFR 153.20 for a definition of ``risk adjustment
covered plan''.
\45\ The state payment transfer formula refers to the part of
the HHS risk adjustment methodology established consistent with 45
CFR 153.320 that calculates payments and charges at the state market
risk pool level. See, for example, the 2020 Payment Notice final
rule, 84 FR at 17485. The state payment transfer calculations are
performed prior to the calculation of the high-cost risk pool
payment and charge terms.
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This IFC similarly clarifies the MLR reporting and rebate
requirements in 45 CFR part 158 for issuers that elect to provide
temporary premium credits such that these issuers must report as earned
premium the actual premium paid, taking into account any temporary
premium credits as a reduction in premium for the applicable months of
2020 coverage.
These interim final provisions are effective as of the date of
finalization of this IFC and apply to temporary

[[Page 54842]]

premium credits provided for 2020 coverage.
2. Standards Related to Reinsurance, Risk Corridors, and Risk
Adjustment (45 CFR Part 153)
This IFC addresses changes necessary to align the 2020 benefit year
data submission requirements and state payment transfer formula
calculations under the HHS-operated risk adjustment program with
guidance published by CMS allowing temporary premium credits due to the
PHE for COVID-19.
a. Provisions and Parameters for the Risk Adjustment Program
In subparts A, B, D, G, and H of part 153, we established standards
for the administration of the PPACA risk adjustment program. The risk
adjustment program is a permanent program created by section 1343 of
the PPACA that transfers funds from lower-than-average risk, risk
adjustment covered plans to higher-than-average risk, risk adjustment
covered plans in the individual and small group markets (including
merged markets), inside and outside the Exchanges. HHS is responsible
for operating risk adjustment in any state that does not elect to do
so.\46\ HHS did not receive any requests from states seeking to operate
their own risk adjustment program for the 2020 benefit year.\47\
Therefore, HHS is responsible for operating the risk adjustment program
established under section 1343 of the PPACA in all 50 states and the
District of Columbia for the 2020 benefit year.\48\
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\46\ See section 1321(c)(1) of the PPACA. Also see 45 CFR
153.310(a).
\47\ See the 2020 Payment Notice final rule, 84 FR at 17463
(April 25, 2019).
\48\ Ibid.
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i. Calculation of Plan Average Premium and State Average Premium Under
the Federally-Certified Risk Adjustment Methodology (Sec. 153.320)
The HHS risk adjustment methodology applicable to the 2020 benefit
year includes the state payment transfer formula and the high-cost risk
pool parameters.\49\ The state payment transfer formula includes a set
of cost adjustment terms that require transfers to be calculated at the
geographic rating area level for each plan (that is, we calculate
separate transfer amounts for each rating area in which a risk
adjustment covered plan operates). It also includes a 14 percent
administrative cost reduction to the statewide average premium. The
state payment transfer formula generally calculates the difference
between the revenues required by a plan, based on the health risk of
the plan's enrollees, and the revenues that the plan can generate for
those enrollees. These differences are then compared across plans in
the state market risk pool \50\ and converted to a dollar amount based
on the statewide average premium. The difference between the two
premium estimates determines whether a plan pays a risk adjustment
charge or receives a risk adjustment payment.\51\
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\49\ See the 2020 Payment Notice final rule, 84 FR at 17466
through 17468 and 17480 through 17486.
\50\ Risk adjustment transfer under the state payment transfer
formula are calculated at the risk pool level, and catastrophic
plans are treated as a separate risk pool for purpose of these
calculations.
\51\ The value of the plan average risk score by itself does not
determine whether a plan would be assessed a charge or receive a
payment--even if the risk score is greater than 1.0, it is possible
that the plan would be assessed a charge if the premium compensation
that the plan may receive through its rating (as measured through
the allowable rating factor) exceeds the plan's predicated liability
associated with risk selection.
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HHS chose to use statewide average premium and normalize the risk
adjustment state payment transfer formula to reflect state average
factors so that each plan's enrollment characteristics are compared to
the state average and the calculated payment amounts equal calculated
charges in each state market risk pool.\52\ Thus, the state payment
transfer formula provides a per member per month (PMPM) transfer amount
for a plan within a rating area. This resulting PMPM plan payment or
charge is multiplied by the number of billable member months to
determine the plan payment or charge based on plan liability risk
scores for a plan's geographic rating area for the applicable state
market risk pool. The payment or charge under the state payment
transfer formula is thus calculated to balance the state market risk
pool in question.
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\52\ See the 2020 Payment Notice final rule for further details
on other reasons why statewide average premium is the cost-scaling
factor in the state payment transfer formula. See 84 FR at 17480
through 17484.
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In prior rulemaking,\53\ CMS finalized the calculation of plan
average premium as equal to the actual premiums charged to plan
enrollees, weighted by the number of months enrolled, and finalized the
calculation of the state average premium as equal to the average of
individual plan average premiums, weighted by each plan's share of
statewide enrollment in the risk pool market, based on billable member
months.
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\53\ See, for example, the 2014 Payment Notice final rule, 78 FR
15409, available at https://www.govinfo.gov/content/pkg/FR-2013-03-11/pdf/2013-04902.pdf (March 11, 2013). Also see the 2020 Payment
Notice final rule, 84 FR 17454, available at https://www.govinfo.gov/content/pkg/FR-2019-04-25/pdf/2019-08017.pdf.
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This IFC sets forth how HHS will treat temporary premium credits
provided for purposes of applying the state payment transfer formula
for the 2020 benefit year.\54\ For states where issuers of risk
adjustment covered plans have provided temporary premium credits, the
plan average premium and statewide average premium used in the state
payment transfer formula will be calculated using issuers' adjusted
premium amounts--that is, the actual premiums billed to plan enrollees
will be the amounts used in the calculations under the state payment
transfer formula. We clarify that HHS will use adjusted plan premiums
for all enrollees whom the issuer has actually provided premium credits
as a reduction to 2020 benefit year premiums, even if the credits were
not provided in a manner consistent with the August 4, 2020 memo, when
calculating transfers under the state payment transfer formula for the
2020 benefit year. As detailed further below, issuers providing these
temporary premium credits must report the lower, actual premium amounts
billed to plan enrollees to their respective EDGE servers. We believe
that the applicable definitions of plan average premium and state
average premium retain the meaning previously finalized by reflecting
the actual monthly premium billed to enrollees. In addition, the
recognition of temporary premium credits for 2020 coverage as a
reduction in premium for purposes of the risk adjustment program is a
necessary and appropriate step to align risk adjustment charges and
payments under the state payment transfer formula with the
flexibilities provided to issuers and states elsewhere in this
rulemaking to respond to the PHE for COVID-19. This approach also
provides necessary clarity to issuers as they evaluate whether and in
what amount to offer premium relief to enrollees to assist those
adversely affected financially by the PHE for COVID-19 to maintain
continuous health insurance coverage. This IFC does not change any
other aspect of the state payment transfer formula or the method for
calculating payments and charges under the HHS risk adjustment
methodology (inclusive of the state payment transfer formula and high-
cost risk pool parameters).\55\
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\54\ CMS intends to consider adopting a similar approach for the
2021 benefit year, as may be appropriate (for example, if similar
temporary premium credits are permitted for 2021 coverage).
\55\ See the 2020 Payment Notice final rule, 84 FR at 17466
through 17468 and 17480 through 17486.
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In the 2019 Payment Notice, we provided states the flexibility to
request

[[Page 54843]]

a reduction to the otherwise applicable risk adjustment transfers
calculated under the HHS-operated risk adjustment methodology's state
payment transfer formula, which is calibrated on a national dataset,
for the state's individual, small group, or merged markets, by up to 50
percent to more precisely account for differences in actuarial risk in
the applicable state's market(s).\56\ For the 2020 benefit year, HHS
approved a request from Alabama state insurance regulators to reduce
risk adjustment transfers for the Alabama small group market by 50
percent.\57\ Consistent with this IFC, the state payment transfer
formula will incorporate calculations using issuers' adjusted premium
amounts--that is, the lower actual premiums billed to plan enrollees
will be the amounts used in the calculations under the state payment
transfer formula to reflect these temporary premium credits. As such,
if an issuer in the Alabama small group market chooses to provide
temporary premium credits, the state average premium will decrease, and
HHS will apply the 50 percent transfer reduction to the lower PMPM
payment or charge transfer amount calculated under the state payment
transfer formula for the Alabama small group market.
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\56\ See the 2019 Payment Notice final rule, 83 FR at 6955 to
16960. Also see 45 CFR 153.320(d).
\57\ See the 2020 Payment Notice final rule, 84 FR at 17484
through 17485. HHS approved a similar request to reduce 2021 benefit
year Alabama small group market transfers by 50 percent. See the
2021 Payment Notice final rule, 85 FR at 29193 through 29194.
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ii. Data Requirements for Risk Adjustment Covered Issuers (Sec.
153.610 and Sec. 153.710)
Section 153.610 requires an issuer of a risk adjustment covered
plan to submit or make accessible risk adjustment data for all risk
adjustment covered plans in accordance with the risk adjustment data
collection approach established by a state, or HHS on behalf of a
state. The HHS-operated risk adjustment program uses a distributed data
collection approach, and issuers of risk adjustment covered plans must
provide HHS with access to plan enrollment data, enrollee claims data,
and enrollee encounter data through their respective EDGE server,
pursuant to the requirements of Sec. 153.710 and applicable technical
guidance.\58\ Issuers are required to report to their EDGE server
subscriber-level premium information that is used by HHS to calculate
each plan's total premium revenue for the state payment transfer
formula. We clarify in this IFC that, for purposes of 2020 benefit year
data submissions,\59\ the subscriber-level premium information that
issuers upload to their EDGE servers must reflect the adjusted (that
is, lower) monthly premium reflecting the amounts actually billed to
their enrollees, inclusive of any premium credits provided. We clarify
in this IFC that CMS will require issuers to submit adjusted plan
premiums to their EDGE servers for all enrollees whom the issuer has
actually provided premium credits as a reduction to 2020 benefit year
premiums, even if these premium credits were not provided in a manner
consistent with the August 4, 2020 memo. Issuers should continue to
submit the full, unadjusted premium amounts for any coverage for which
they did not provide temporary premium credits. This IFC does not
change any other aspect of the 2020 benefit year data submission
requirements for the HHS-operated risk adjustment program. As such, any
temporary premium credits that are reported as a reduction in premium
for risk adjustment purposes are subject to the applicable regulations
at part 153, the EDGE server business rules, and applicable CMS
guidance.
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\58\ See EDGE Server Business Rules (ESBR) v16.0 Section 5.8
Premium Amounts, at https://www.regtap.info/uploads/library/DDC_ESBR_V16.0_052920_5CR_052920.pdf.
\59\ As noted above, CMS intends to consider adopting a similar
approach for the 2021 benefit year, as may be appropriate.
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3. Issuer Use of Premium Revenue: Reporting Requirements (45 CFR Part
158)
In this IFC, we also address changes necessary to align the
reporting and data submission requirements under the PPACA MLR program
with the temporary premium credits that issuers may provide to
enrollees in 2020.\60\
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\60\ The MLR reporting year means a calendar year during which
group or individual health insurance coverage is provided by an
issuer. See 45 CFR 158.103. The 2020 MLR reporting year refers to
the MLR reports that issuers must submit for the 2020 benefit year
by July 31, 2021. See 45 CFR 158.110(b).
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a. Premium Revenue (Sec. 158.130)
Section 2718(a) of the PHSA requires health insurance issuers to
report to the Secretary the percentage of premium revenue (after
certain adjustments) expended on reimbursement for clinical services
provided to enrollees under health insurance coverage and on activities
that improve healthcare quality. Section 158.130 specifies the
reporting requirements with regard to earned premium, which must
include all monies paid by a policyholder or subscriber as a condition
of receiving coverage from the issuer, with certain adjustments.
This IFC sets forth how CMS will treat temporary premium credits
for purposes of MLR reporting and rebate requirements of these amounts
for 2020 coverage.\61\ During 2020, a number of issuers are expected to
provide premium relief to enrollees, which will result in policyholders
and subscribers paying a reduced amount of premium for coverage in 2020
in the months for which the credits are provided. The recognition of
temporary premium credits as a reduction in premium for purposes of the
MLR program is a necessary and appropriate step to align MLR
calculations with the flexibilities provided to issuers and states
elsewhere in this rulemaking to respond to the PHE for COVID-19. This
approach also provides necessary clarity to issuers as they evaluate
whether and in what amount to offer temporary premium credits to assist
enrollees in maintaining continuous health insurance coverage during
the PHE for COVID-19.
---------------------------------------------------------------------------

\61\ CMS intends to consider adopting a similar approach if
temporary premium credits are permitted for 2021 coverage, if
appropriate.
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To ensure that an issuer's MLR accurately reflects the amounts
actually paid by their enrollees as the issuer's premium revenue, we
clarify that for purposes of Sec. 158.130, issuers must account for
temporary premium credits as reductions in earned premium in the
individual and small group (or merged) markets,\62\ consistent with any
technical guidance set forth in the applicable MLR Annual Reporting
Form Instructions.\63\ Specifically, we clarify that the amount of
temporary premium credits \64\ constitutes neither collected premium
nor due and unpaid premium described in the MLR Annual Reporting Form
Instructions for purposes of reporting written premium (which is a
component of earned premium). As a result of this flexibility, issuers
who offer temporary premium credits should

[[Page 54844]]

report as earned premium for MLR and rebate calculation purposes the
actual, reduced premium paid. We clarify that issuers must report the
actual, reduced premium amount for all enrollees whom the issuer has
actually provided premium credits for 2020 coverage, even if these
premium credits were not provided in a manner consistent with the
August 4, 2020 memo. This IFC does not change any other aspect of the
MLR reporting or rebate calculation requirements.
---------------------------------------------------------------------------

\62\ While this IFC and the August 4, 2020 memo focus on the
individual and small group markets, to remove the barriers in
support of issuers offering these premium credits to enrollees
impacted by PHE for COVID-19, we note that issuers in the large
group market may also, when consistent with state law, offer premium
credits and should similarly report the lower, adjusted amount that
accounts for the premium credits for MLR purposes.
\63\ Available from https://www.cms.gov/cciio/Resources/Forms-Reports-and-Other-Resources/index#Medical_Loss_Ratio.
\64\ MLR rebates provided in the form of premium credits are
different than the temporary premium credits such as those outlined
in the August 4, 2020 guidance issued by CMS. When MLR rebates are
provided in the form of premium credits, issuers must continue to
report the full amount of earned premium and may not reduce it by
the amount of MLR rebates provided in form of premium credits, as
required by Sec. 158.130(b)(3).
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H. Addressing the Impact of COVID-19 on Part C and Part D Quality
Rating Systems

1. Background
CMS develops and publicly posts a 5-star rating system for Medicare
Advantage (MA) and Part D plans based on its authority to disseminate
comparative information, including about quality, to beneficiaries
under sections 1851(d) and 1860D-1(c) of the Act and authority to
collect various types of quality data under section 1852(e) of the Act.
The Star Rating system for MA and Part D plans is also the basis for
determining quality bonus payment (QBP) status for MA plans under
section 1853(o) of the Act and the amount of beneficiary rebates under
section 1854(b) of the Act. As background, approximately $12 billion
for 2020 will be paid as part of QBPs in the form of higher benchmarks
for both Individual and Employer Group Waiver Plans, which represent
about 4.35 percent of the total MA benchmarks. Cost plans under section
1876 of the Act are also included in the MA and Part D Star Rating
system, as codified at 42 CFR 417.472(k).
The Star Ratings are generally based on measures of performance
during a period that is 2 calendar years before the year for which the
Star Ratings are issued; for example, 2022 Star Ratings will generally
be based on performance during 2020. We use a variety of data sources
to measure quality and performance of contracts, such as CMS
administrative data, surveys of enrollees, information from health and
drug plans, and data collected by CMS contractors. Various regulations
require plans to report on quality improvement and quality assurance
and to provide data which we can use to help beneficiaries compare
plans (for example, Sec. Sec. 417.472(j) and (k), 422.152(b),
423.153(c), and 423.156). In addition, we can require plans to report
statistics and other information in specific categories (Sec. Sec.
422.516 and 423.514). Data from these sources and other sources are
used to calculate measures of plan sponsor performance each year, as
provided in Sec. Sec. 422.162 and 423.182. The Star Ratings are
central in providing comparative information to enrollees and are also
used to determine whether an MA plan is eligible for a QBP and the
amount of beneficiary rebates.
Sections 1853(o) and 1854(b)(1)(c) of the Act provide for quality
ratings, based on a 5-star rating system and the information collected
under section 1852(e) of the Act, to be used in calculating payment to
MA organizations beginning in 2012. Specifically, these provisions
provide, respectively, for an increase in the benchmark against which
MA organizations bid and in the portion of the savings between the bid
and the benchmark available to the MA organization to use as a rebate.
In addition, CMS assigns both low and high performing icons, which are
displayed on https://www.medicare.gov/plan-compare/, to help Medicare
beneficiaries make plan decisions, based on either consistently low
performance (2.5 or fewer stars at the summary rating level) for 3 or
more years or receipt of 5 stars for the highest rating in any given
year.
There are other regulations, regarding marketing authority, special
enrollment periods, and contract terminations, that are tied to the
Star Ratings, demonstrating how the Star Ratings are important to the
MA and Part D programs as a whole. Because the Star Ratings serve a
variety of purposes for CMS, cost plans, and MA and Part D plans, we
assume plans engage in multiple activities during the measurement
period to improve their Star Ratings. Therefore, it is necessary to
adopt rules for, and provide information about how performance in
2020--during the PHE for COVID-19--will be used in the Star Ratings
program as quickly as possible. Without adopting these rules
immediately, plans will believe that, based on current rules, CMS will
be unable to assign Star Ratings for Contract Year 2022 and be unable
to pay QBPs for Contract Year 2023. Given the significant impact of
QBPs on overall plan payments, described above, without immediate
action, plans would not have a clear incentive to focus on providing
high quality care for enrollees impacted by COVID-19, and instead
either spend time and effort trying to ensure that future Star Ratings
and QBP ratings are not impacted by the PHE for COVID-19, or shift
focus from providing quality care to cost containment. Delaying these
changes would limit (or eliminate) the time left in the 2020
measurement period for plans to manage their performance based on these
changes.
In the March 31st COVID-19 IFC, we adopted a series of changes to
the 2021 and 2022 Star Ratings to accommodate the disruption to data
collection and impact on performance posed by the PHE for COVID-19. The
Star Ratings changes adopted in that rule addressed the need of health
and drug plans and their providers to curtail certain data collections
and to adapt their current practices in light of the PHE for COVID-19
and the need to care for the most vulnerable patients, such as the
elderly and those with chronic health conditions. As explained in the
March 31st COVID-19 IFC, we believe that there will be changes in
measure-level scores because of increased healthcare utilization due to
COVID-19, reduced or delayed non-COVID-19 care due to advice to
patients to delay routine and/or elective care, and changes in non-
COVID-19 inpatient utilization. We realize that this will impact the
data collected during the 2020 measurement year which will impact the
2022 Part C and D Star Ratings. Thus, as part of the March 31st COVID-
19 IFC, we made some adjustments to account for the potential decreases
in measure-level scores so health and drug plans can have some degree
of certainty knowing that the Star Ratings will be adjusted and can
continue their focus on patients who are most in need right now.
Specifically, the March 31st COVID-19 IFC:
Eliminates the requirement to collect and submit
Healthcare Effectiveness Data and Information Set (HEDIS) and Medicare
CAHPS data otherwise collected in 2020, and replaces the 2021 Star
Ratings measures calculated based on those HEDIS and CAHPS data
collections with earlier values from the 2020 Star Ratings (which are
not affected by the public health threats posed by COVID-19);
Establishes how we will calculate or assign the 2021 Star
Ratings in the event that CMS' functions become focused on only
continued performance of essential agency operations and the agency
and/or its contractors do not have the ability to calculate the 2021
Star Ratings;
Modifies the current rules for the 2021 Star Ratings to
replace any measure that has a systemic data quality issue for all
plans due to the COVID-19 outbreak with the measure-level Star Ratings
and scores from the 2020 Star Ratings;
Replaces the measures calculated based on Health Outcomes
Survey (HOS) data collections with earlier values that are not affected
by the public

[[Page 54845]]

health threats posed by COVID-19 for the 2022 Star Ratings in the event
that we are unable to complete HOS data collection in 2020 (for the
2022 Star Ratings) due to the PHE for COVID-19;
Removes guardrails for the 2022 Star Ratings by delaying
their application to the 2023 Star Ratings;
Expands the existing hold harmless provision for the Part
C and D Improvement measures to include all contracts for the 2022 Star
Ratings; and
Revises the definition of ``new MA plan'' so that, for
purposes of 2022 QBPs based on 2021 Star Ratings only, new MA plan
means an MA contract offered by a parent organization that has not had
another MA contract in the previous 4 years, in order to address how
the 2021 Star Ratings will be based in part on data for the 2018
performance period.
Please see the March 31st COVID-19 IFC for further information on
these changes for the 2021 and 2022 Star Ratings.
2. Impact of COVID-19 on the Extreme and Uncontrollable Circumstance
Policy for the 2022 Star Ratings
The March 31st COVID-19 IFC amended, as necessary, certain
calculations for the 2021 and 2022 Part C and D Star Ratings to
incorporate changes to address the expected impact of the PHE for
COVID-19 on data collection and performance in 2020 that were
immediately apparent. As the PHE for COVID-19 has progressed and
various federal and state agencies have taken steps to address the PHE,
we have become aware that application of the current Star Ratings
disaster policy for extreme and uncontrollable circumstances
(Sec. Sec. 422.166(i) and 423.186(i)) will cause unintended and
unworkable consequences for the 2022 Star Ratings, which will be based
on the 2020 measurement period for cost, MA, and Part D plans. The Star
Ratings disaster policy for extreme and uncontrollable circumstances
was developed with natural disasters such as hurricanes and wildfires
in mind. Those types of emergencies typically impact well-defined
geographic areas. The policy uses declarations by the Federal Emergency
Management Agency (FEMA) of counties or county-equivalents as
Individual Assistance areas that make up all or part of a contract's
service area, as well as whether the contract's service area is within
an ``emergency area'' during an ``emergency period'' as defined in
section 1135(g) of the Act, as a condition for applying an adjustment
to how the Star Ratings are calculated for the contract. Contracts with
a certain minimum percentage of enrollees residing in an area declared
as an Individual Assistance area are eligible for Star Ratings
adjustments for extreme and uncontrollable circumstances. The disaster
policy was not designed to address global pandemics. In the past
several years that we have used the extreme and uncontrollable
circumstance adjustment for the Part C and D Star Ratings, the FEMA
declarations have only been to county/county-equivalents and the
declarations have only resulted in adjustments for a limited number of
contracts.
At the time of writing the March 31st COVID-19 IFC to adopt a
series of changes for the 2021 and 2022 Star Ratings as a result of the
PHE for COVID-19, no counties or county-equivalents had been declared
Individual Assistance areas as a result of COVID-19. As of July 28,
2020, 51 out of 55 states/territories \65\ covering all counties or
county-equivalents within these states and territories have been
designated as Individual Assistance areas due to COVID-19 with an
incident period starting in 2020 (thus affecting the 2020 measurement
year), and this number could continue to grow throughout 2020 as the
PHE for COVID-19 evolves. This means that the PHE for COVID-19 now
meets the Star Ratings criteria for an extreme and uncontrollable
circumstance in nearly all states/territories (and service areas), and
most contracts would be eligible for the extreme and uncontrollable
circumstance adjustments to their 2022 Star Ratings as a result of the
PHE for COVID-19.
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\65\ This includes the 50 states, Washington, DC, Guam, Northern
Mariana Islands, Puerto Rico and Virgin Islands.
---------------------------------------------------------------------------

Under the current disaster policy, for all non-CAHPS measures, the
numeric scores for contracts with 60 percent or more of their enrollees
living in a FEMA-designated Individual Assistance area at the time of
the extreme and uncontrollable circumstance are excluded from: (1) The
measure-level cut point calculations for non-CAHPS measures; and (2)
the performance summary and variance thresholds for the Reward Factor
as described at Sec. Sec. 422.166(i)(9)(i) and (i)(10)(i), and
423.186(i)(7)(i) and (i)(8)(i). When only a small number of counties
are designated as Individual Assistance areas, application of these
exclusions means that the performance from other contracts serving
larger or other service areas are used to establish the necessary
thresholds for Star Ratings. Up until now, disasters have been
localized, and the 60 percent rule has removed only a small fraction of
contracts (that is, less than 5 percent of contracts on average).
The unprecedented impact of COVID-19 creates a new methodological
issue where, without a revision to our current disaster policy rules
for calculating the measure-level cut points for the 2022 Star Ratings,
we will not have enough contracts to reliably calculate the non-CAHPS
measure-level cut points. Consequently, CMS will not be able to assign
Star Ratings for all non-CAHPS measures. Similarly, we will not have
enough contracts to reliably calculate the performance summary and
variance thresholds for the Reward Factor. Applying the 60 percent rule
for extreme and uncontrollable circumstances to the 2022 Star Ratings
would result in removal of a large proportion of contracts (close to 98
percent) from threshold calculations, resulting in too few contracts to
reliably calculate cut points using the clustering methodology for the
non-CAHPS measures and too few contracts to reliably calculate the
weighted means and variance used to calculate the Reward Factor. Due to
the unprecedented way the PHE for COVID-19 has affected all contracts
in 2020, and the fact that a majority of the country has been
designated as Individual Assistance areas, we are creating special
rules for the 2022 Star Ratings to remove the 60 percent rule to avoid
having to exclude the vast majority of contracts from the methodology
used to assign Star Ratings which would result in unreliable ratings or
missing data for all contracts in the 2022 Star Ratings.
Under our current regulation, the 60 percent rule would remove
nearly all values from the calculation of cut points and the Reward
Factor for the 2022 Star Ratings and, if we are unable to calculate
non-CAHPS measure-level cut points for the 2022 Star Ratings (such as
because of the application of the 60 percent rule), all contracts will
have missing measure-level Star Ratings for all non-CAHPS measures. In
that circumstance, we will not have enough measures with Star Ratings
to calculate either the 2022 overall or summary Star Ratings or 2023
QBPs. In addition to the 60 percent rule, for contracts that have 25
percent or more of their enrollees living in FEMA-designated Individual
Assistance areas, our current regulations at Sec. Sec. 422.166(i) and
423.186(i) apply various rules including permitting use of the previous
year's measure-level rating and corresponding measure score if it is
higher on most Star Rating measures. However, Sec. Sec. 422.166(i)(8)
and 423.186(i)(6) state that if the measure-level rating is missing for
most measures

[[Page 54846]]

in the current or prior year and a comparison cannot be done, the
contract gets the current year's measure-level rating. Therefore, under
our current regulations, without a change to the 60 percent rule to
ensure that contracts receive measure-level ratings for the 2022 Star
Ratings, we would not be able to apply the 25 percent rule to compare
the 2022 measure-level Star Ratings to the 2021 measure-level Star
Ratings, and nearly all contracts would have missing 2022 overall and
summary Star Ratings and 2023 QBPs.
The change adopted by this IFC will remove application of the 60
percent rule and avoid the exclusion of contracts with 60 percent or
more of their enrollees living in FEMA-designated Individual Assistance
areas from calculation of the non-CAHPS measure-level cut points and
calculation of the Reward Factor for the 2022 Star Ratings. By removing
application of this particular exclusion, the performance of contracts
in 2020 in these service areas will be used to calculate the cut points
for all non-CAHPS measures and to calculate the Reward Factor; subject
to these changes, all other Star Ratings rules (as revised in the March
31st COVID-19 IFC) will apply. This change will ensure that CMS can:
calculate measure-level cut points for the 2022 Star Ratings; calculate
measure-level ratings for the 2022 Star Ratings; apply the ``higher
of'' policy for non-CAHPS measures, as described at Sec. Sec.
422.166(i)(3)(iv), 422.166(i)(4)(v) and 423.186(i)(4)(i); calculate the
Reward Factor; and ultimately calculate overall and summary ratings for
2022 Star Ratings and 2023 QBPs. It is critical to adopt the change in
this IFC to avoid an unworkable result from the current policy in these
extraordinary circumstances and so that CMS can measure actual
performance for the 2020 measurement period so plans have an
opportunity to demonstrate how they are tailoring care in innovative
ways to meet the needs of their enrollees during the PHE for COVID-19.
Given the unprecedented impacts of the PHE for COVID-19, it is
important to be able to calculate the 2022 Star Ratings to help to
continue to drive quality improvement for plans and providers.
3. Provisions of IFC
In this IFC, we are adopting a change to tailor the existing
disaster policy described at Sec. Sec. 422.166(i) and 423.186(i) to
address the impact of the PHE for COVID-19 and in calculating the 2022
Part C and D Star Ratings. As the current rules are written, we will
not be able to calculate the 2022 overall or summary Star Ratings or
2023 QBP ratings, and the change adopted in this IFC will avoid that
outcome and preserve the ability to calculate and issue 2022 Star
Ratings.
Furthermore, plans need to know this change so they have certainty
about how their ratings will be calculated which will allow them to
focus on providing the best care possible to beneficiaries during the
remainder of the 2020 measurement period. Without knowing the changes
made by this IFC to the methodology for calculating the 2022 Star
Ratings, plans could have conflicting priorities between continued
focus on caring for enrollees impacted by COVID-19 and keeping Medicare
beneficiaries safe, while at the same time wanting to ensure that
future Star Ratings and QBP ratings are not impacted by the PHE for
COVID-19 which could negatively impact future benefits offered by MA
organizations. The changes to the calculations for 2022 Star Ratings
are designed to avoid inadvertently creating incentives for plans to
place cost considerations above efforts to address the care of patients
during the PHE for COVID-19, which they may do if they believe that
quality performance in 2020 would not factor into their 2022 Star
Rating or potential 2023 QBP.
This IFC modifies the calculation of the 2022 Part C and D Star
Ratings to address the application of the extreme and uncontrollable
circumstances policy for the PHE for COVID-19. Specifically, for the
2022 Star Ratings, CMS will not exclude the numeric values (that is,
the performance data) for affected contracts with 60 percent or more of
their enrollees in FEMA-designated Individual Assistance areas during
the 2020 performance and measurement period: (1) From the clustering
algorithms; or (2) from the determination of the performance summary
and variance thresholds for the Reward Factor. This means that CMS will
use the performance scores for contracts for the 2020 performance and
measurement period to establish cut points for non-CAHPS measures and
the Reward Factor for the 2022 Star Ratings, subject to the other rules
in the Star Ratings methodology, including the specific rules adopted
in the March 31st COVID-19 IFC. We are not modifying the 25 percent
rules, even though it is clear that the 25 percent rules will result in
nearly all contracts being ``affected contracts'' and eligible for
adjustment to their measure-level ratings for the 2022 Star Ratings
because the PHE for COVID-19 was an extreme and uncontrollable
circumstance that may have negatively impacted contracts' performance
on Star Ratings measures. Under the 25 percent rules at Sec. Sec.
422.166(i)(2) through (6) and 423.186(i)(2) through (5), contracts with
at least 25 percent of their service area in a FEMA-designated
Individual Assistance area in 2020 will receive the higher of their
measure-level rating from the current and prior Star Ratings years for
purposes of calculating the 2022 Star Ratings (thus, for 2022 Star
Ratings, contracts will receive the higher of their measure-level
rating from 2021 or 2022).
For the 2022 Star Ratings, we expect data collection and submission
of HEDIS and CAHPS data to continue as usual; those data will be
collected during spring and summer 2021. The majority of measures for
the 2022 Star Ratings are based on the 2020 measurement year, during
which the PHE for COVID-19 continues. The March 31st COVID-19 IFC made
some changes to the methodology for the 2022 Star Ratings so as not to
inappropriately incentivize actions by plans and healthcare providers
that are not directly related to the PHE for COVID-19 and to provide
assurances to Medicare health and drug plans about how performance
changes driven or caused by the PHE for COVID-19 will be addressed in
the 2022 Star Ratings. The significant number of declarations of
Individual Assistance areas makes it impossible to calculate the cut
points of non-CAHPS measures for the 2022 Star Ratings since almost all
contracts will be excluded from the calculations as a result of the 60
percent exclusion rule. In this IFC, at Sec. Sec. 422.166(i)(11) and
423.186(i)(9), we are revising, for 2022 Star Ratings only, the current
disaster policy codified at Sec. Sec. 422.166(i) and 423.186(i) to:
(1) Remove the 60 percent exclusion rule for cut point calculations for
non-CAHPS measures; and (2) remove the 60 percent exclusion rule for
the determination of the performance summary and variance thresholds
for the Reward Factor. The new regulation for MA Star Ratings
specifically provides that CMS will not apply the provisions Sec. Sec.
422.166(i)(9) or (i)(10) in calculating the 2022 Star Ratings, and the
new regulation for the Part D Star Ratings provides that CMS will not
apply the provisions of Sec. Sec. 423.186(i)(7) or (i)(8) in
calculating the 2022 Star Ratings. This change will ensure that CMS
can: (1) Calculate measure-level cut points for the 2022 Star Ratings;
(2) calculate measure-level Star Ratings for the 2022 Star Ratings; (3)
apply the ``higher of'' policy for non-CAHPS measures, as described at
Sec. Sec. 422.166(i)(3)(iv), 422.166(i)(4)(v), and 423.186(i)(4)(i)
for all contracts with 25 percent or more of their enrollees living

[[Page 54847]]

in FEMA-designated Individual Assistance areas which will include
almost all Part C and D contracts for the 2020 measurement period; and
(4) ultimately calculate overall and summary ratings for 2022 Star
Ratings and 2023 QBPs.

I. Merit-Based Incentive Payment System (MIPS) Updates

1. Quality Performance Category: Expansion of Telehealth Codes Used in
Beneficiary Assignment for the CMS Web Interface and CAHPS for MIPS
Survey
a. Background
On March 17, 2020, we announced (https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet) 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 (Pub. L. 116-123, enacted March
6, 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 COVID-19, we recognize that physicians and other
healthcare professionals are faced with new challenges regarding
potential exposure risks, including for Medicare beneficiaries, for
healthcare providers, and for members of the community at large. For
example, the CDC has urged healthcare professionals to make every
effort to interview persons under investigation for infection by
telephone, text messaging system, or video conference instead of in-
person (85 FR 27582). In the March 31st COVID-19 IFC, to facilitate the
use of telecommunications technology as a safe substitute for in-person
services, CMS added on an interim basis many services to the list of
eligible Medicare telehealth services, eliminating frequency
limitations and other requirements associated with particular services
furnished via telehealth, and clarifying 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, these specified Medicare telehealth services are reported using
the same codes used for the ``face-to-face'' services, but are
furnished using audio/video, real-time, interactive communications
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 for purposes of the PHE for COVID-
19 are already included in the definition of primary care services for
purposes of the MIPS beneficiary assignment methodology for the CMS Web
Interface and CAHPS for MIPS survey (81 FR 77168 through 77169; and 82
FR 53646 through 53647).
In the March 31st COVID-19 IFC, we also established flexibilities
and separate payment for certain services that are furnished virtually
using communication technologies, but that are not considered Medicare
telehealth services such as virtual check-ins and e-visits.
Additionally, we established separate payment for telephone E/M and
other services codes during the PHE for COVID-19. The communications
technology-based services (CTBS) and the telephone E/M services are not
currently included in the definition of primary care services that is
used for purposes of the MIPS beneficiary assignment methodology for
the CMS Web Interface and CAHPS for MIPS survey.
We believe it is critical to include the codes for CTBS and
telephone E/M services, as identified and discussed later in this
section, 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. Including these codes will ensure that the assignment
methodology appropriately reflects the expanded use of technology that
is helping people who need routine care during the PHE for COVID-19 and
allowing vulnerable beneficiaries and beneficiaries with mild symptoms
to remain in their homes, while maintaining access to the care they
need. By including services provided virtually, either through
telehealth or other uses of communications technology, we ensure that
this care is appropriately reflected in our consideration of where
beneficiaries receive the plurality of their primary care, for purposes
of assigning beneficiaries to groups and virtual groups.
b. Use of Codes for Virtual Check-ins, Remote Evaluations, E-Visits,
and Telephone E/M Services in MIPS Beneficiary Assignment for the CMS
Web Interface and CAHPS for MIPS Survey
We have added new services to the separately billable CTBS under
the PFS over the past several years and as a result of the PHE for
COVID-19, we expect that the utilization of CTBS will substantially
increase during the PHE for COVID-19 and thereafter. We believe that
clinicians are increasingly using such services as a key component of
their ongoing primary care. At Sec. 414.1305, we are codifying the
definition of primary care services for purposes of MIPS beneficiary
assignment methodology for the CMS Web Interface and CAHPS for MIPS
survey. The included codes consist of previously finalized codes that
are already considered primary care services and additional codes that
CMS will be treating as primary care services for the duration of the
PHE for COVID-19. The previously finalized codes are as follows:
CPT codes: 99201 through 99215 (codes for office or other
outpatient visit for the E/M of a patient); 99304 through 99318 (codes
for professional services furnished in a nursing facility, excluding
professional services furnished in a SNF for claims identified by place
of service (POS) modifier 31) (81 FR 77168); 99319 through 99340 (codes
for patient domiciliary, rest home, or custodial care visit); 99341
through 99350 (codes for E/M services furnished in a patients' home for
claims identified by POS modifier 12); 99487, 99489, and 99490 (codes
for chronic care management); and 99495 and 99496 (codes for
transitional care management services); and
HCPCS codes: G0402 (code for the Welcome to Medicare
visit); and G0438 and G0439 (codes for the annual wellness visits).
The additional codes we are adding through this IFC are as follows:
(1) CPT codes: 99421, 99422, and 99423 (codes for online digital E/M
service (e-visit)), and 99441, 99442, and 99443 (codes for telephone E/
M services); and (2) HCPCS codes: G2010 (code for remote evaluation of
patient video/images) and G2012 (code for virtual check-in).
We note that including these codes in the MIPS beneficiary
assignment methodology for the CMS Web Interface and CAHPS for MIPS
survey aligns with the revision that was made in the May 8th COVID-19
IFC (85 FR 27583) to the definition of primary care services used for
purposes of beneficiary assignment

[[Page 54848]]

under the Medicare Shared Savings Program to include the same codes in
determining beneficiary assignment for performance year 2020 and any
subsequent performance year that starts during the PHE for COVID-19.
The services listed above are an important component of primary
care and as a result, we believe it is appropriate to include these
codes in the definition of primary care services used for assignment
for the CMS Web Interface and CAHPS for MIPS survey because the
services represented by these codes are being used during the PHE for
COVID-19 in place of similar E/M services, the codes for which are
already included in the list of codes used for assignment. It should be
noted that the remote evaluation of patient video/images and virtual
check-in codes, and the online digital E/M service (e-visit) codes are
not separately billable by a clinician if they are related to a visit
within the past 7 days or lead to a visit within the following 24 hours
or next available appointment. The only codes that are newly billable
during the PHE for COVID-19 pertain to the telephone E/M services.
We are including these codes in the definition of primary care
services for the 2020 MIPS performance year and any subsequent
performance year that starts during the PHE for COVID-19. We recognize
that the application of this policy for the 2020 MIPS performance
period is retroactive. Section 1871(e)(1)(A)(ii) of the Act provides
for retroactive application of a substantive change to an existing
policy when the Secretary determines that failure to apply the policy
change retroactively would be contrary to the public interest. Without
the inclusion of these codes in the MIPS beneficiary assignment
methodology for the CMS Web Interface and CAHPS for MIPS survey for the
2020 MIPS performance year during the PHE for COVID-19, we would not be
able to adequately account for the ways in which beneficiaries are
receiving primary care services during the PHE for COVID-19 and as a
result, the process to derive assignment and sampling of beneficiaries
for the CMS Web Interface and CAHPS for MIPS survey would not be able
to comprehensively capture how primary care services are being
furnished to beneficiaries, which may cause many groups and virtual
groups to have insufficient sample sizes to be able to administer the
2020 CAHPS for MIPS survey or report data for the quality performance
category using the CMS Web Interface measures.
In regard to the CMS Web Interface, such groups and virtual groups
may not have sufficient time to select an alternate collection type and
prepare their systems to report on measures from a different collection
type before the submission period begins for the 2020 MIPS performance
period and as a result, they would not be able to meet the quality
performance category reporting requirements, which could negatively
impact their MIPS final score and MIPS payment adjustment. We believe
it is important to include these codes in our assignment methodology
because we determine assignment based upon where beneficiaries receive
the plurality of their primary care services and whether beneficiaries
have designated a MIPS eligible clinician as their primary clinician,
responsible for their overall care, and hold groups and virtual groups
accountable for the resulting assigned beneficiary population.
Including these codes in the definition of primary care services used
in MIPS beneficiary assignment during the PHE for COVID-19 will result
in a more accurate identification of where beneficiaries have received
the plurality of their primary care services.
2. Improvement Activities Performance Category: Improvement Activities
Inventory Update
a. Background
The CY 2018 Quality Payment Program final rule (82 FR 53660)
finalized that we would add new improvement activities or make
modifications to existing improvement activities in the Improvement
Activities Inventory through notice-and-comment rulemaking. An
improvement activity means an activity that relevant MIPS eligible
clinician, organizations and other relevant stakeholders identify as
improving clinical practice or care delivery and that the Secretary
determines, when effectively executed, is likely to result in improved
outcomes. We refer readers to Table H in the Appendix of the CY 2017
Quality Payment Program final rule (81 FR 77177 through 77199), Tables
F and G in the Appendix of the CY 2018 Quality Payment Program final
rule (82 FR 54175 through 54229), Tables A and B in the Appendix 2 of
the CY 2019 PFS final rule (83 FR 60286 through 60303), and Tables A,
B, and C in the Appendix 2 of the CY 2020 PFS final rule (84 FR 63514
through 63538) for our previously finalized Improvement Activities
Inventory. We also refer readers to the Quality Payment Program website
at https://qpp.cms.gov/ for a complete list of the most current list of
improvement activities.
The COVID-19 pandemic has been deemed a PHE \66\ by the Secretary
of the Department of HHS. In response, in the March 31st IFC for COVID-
19 (85 FR 19276 through 19277), we added one new improvement activity
to the Improvement Activities Inventory for the CY 2020 performance
period in response to the PHE titled ``COVID-19 Clinical Trials.'' As
described in the March 31st IFC for COVID-19, this improvement activity
promotes clinician participation in a COVID-19 clinical trial utilizing
a drug or biological product to treat a patient with a COVID-19
infection.\67\ We stated that to receive credit for this improvement
activity, a clinician must attest to participation in a COVID-19
clinical trial utilizing a drug or biological product to treat a
patient with a COVID-19 infection and report their findings through a
clinical data repository or clinical data registry (85 FR 19276). In
that IFC, we also stated that we believe that participation in this
activity would likely result in improved outcomes by improving the
collection of data clinicians use for the care of their patients as
they monitor and manage COVID-19 and drive care improvements (85 FR
19277). We stated that we believe that encouraging clinicians to
utilize an open source clinical data repository or clinical data
registry for data reporting will bring the results of their research to
the forefront of healthcare far quicker than if it goes through the
cycle of peer review and publishing (85 FR 19277). In addition, we
stated that we believe that centralized data could improve clinical
practice and care delivery (85 FR 19277).
---------------------------------------------------------------------------

\66\ Information regarding the PHE for COVID-19 is available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
\67\ For more information on the COVID-19 clinical trials, we
refer readers to the U.S. National Library of Medicine website at
https://clinicaltrials.gov/ct2/results?cond=COVID-19.
---------------------------------------------------------------------------

b. Modification
Following the publication of the March 31st IFC for COVID-19, we
received several inquiries through meetings, email correspondence, and
Quality Payment Program help desk requesting further information on
whether a clinician working with COVID-19 patients who provides their
data to a clinical data registry, without participating in a clinical
trial, may get credit for this activity. The Quality Payment Program
help desk tracks, documents, and resolves inquiries submitted by MIPS
eligible clinicians and groups. Stakeholders may submit inquiries to
the help desk via 1-866-288-8292 (Monday-Friday 8 a.m.-8

[[Page 54849]]

p.m. ET) or email QPP@cms.hhs.govmailto: d687868696b5bba5f8bebea5f8b1b9a0. Some
stakeholders believed that clinicians providing care to patients with
COVID-19 outside of a clinical trial that report that data through a
clinical data registry should receive credit for this activity. It has
come to our attention that clinical data registries not only collect
data as part of clinical trials, but also collect data from clinicians
not participating in clinical trials. The improvement activity as
written was causing confusion for clinicians and groups attempting to
meet the needs of patients and address gaps in research. Since IA_ERP_3
titled ``COVID-19 Clinical Trials'' was established, this improvement
activity has been the subject of approximately 30 percent of the
inquiries to the Quality Payment Program help desk, demonstrating the
desire for clinicians to improve clinical care and overall outcomes for
patients diagnosed with COVID-19 by conducting this improvement
activity, but also indicating the need for further clarity in its
activity description.
As a result, we are expanding the improvement activity to include
clinicians participating in the care of a patient diagnosed with COVID-
19 who simultaneously submit their clinical patient data to a clinical
data registry for research. Thus, in order to receive credit for this
improvement activity, a MIPS eligible clinician or group must: (1)
Participate in a COVID-19 clinical trial utilizing a drug or biological
product to treat a patient with a COVID-19 infection and report their
findings through a clinical data repository or clinical data registry
for the duration of their study; or (2) participate in the care of
patients diagnosed with COVID-19 and simultaneously submit relevant
clinical data \68\ to a clinical data registry for ongoing or future
COVID-19 research.\69\ Data would be submitted to the extent permitted
by applicable privacy and security laws. We are also modifying the
improvement activity title to reflect this change.
---------------------------------------------------------------------------

\68\ We refer readers to the U.S. National Library of Medicine
website at https://clinicaltrials.gov/ct2/results?cond=COVID-19 for
more information on the COVID-19 clinical trials.
\69\ We also refer readers to the National Institute of Health
website at https://search.nih.gov/search?utf8=%E2%9C%93&affiliate=nih&query=COVID-19+registries&commit=Search for more information on COVID-19
clinical data registries.
---------------------------------------------------------------------------

For purposes of this improvement activity, clinical data registries
must meet the following requirements: (1) The receiving entity must
declare that they are ready to accept data as a clinical registry; and
(2) be using the data to improve population health outcomes. Most
public health agencies and clinical data registries declare readiness
to accept data from clinicians via a public online posting. Clinical
data registries should make publicly available specific information on
what data the registry gathers, technical requirements or
specifications for how the registry can receive the data, and how the
registry may use, re-use, or disclose individually identifiable data it
receives. For purposes of credit toward this improvement activity, any
data should be sent to the clinical data registry in a structured
format, which the registry is capable of receiving. A MIPS-eligible
clinician may submit the data using any standard or format that is
supported by the clinician's health IT systems, including but not
limited to, certified functions within those systems. Such methods may
include, but are not limited to, a secure upload function on a web
portal, or submission via an intermediary, such as a health information
exchange. To ensure interoperability and versatility of the data
submitted, any electronic data should be submitted to the clinical data
registry using appropriate vocabulary standards for the specific data
elements, such as those identified in the United States Core Data for
Interoperability (USCDI) standard adopted in 45 CFR 170.213.
As stated in the March 31st COVID-19 IFC, we continue to believe
that participation in this activity is likely to result in improved
outcomes by improving the collection of data clinicians use for the
care of their patients. We believe that all clinical data gathered in
the treatment of patients diagnosed with COVID-19 may be helpful in
finding a solution to end this pandemic. We believe encouraging
clinicians collectively to utilize a clinical data registry for data
reporting could facilitate sharing of data for use in additional
clinical studies with larger sample sizes. These additional and larger
clinical studies are likely to identify efficacy of certain treatments,
which in turn could result in wider improvements in health outcomes,
including reduced severity and mortality due to COVID-19 across the
nation. This could benefit patients nationwide as well as improve
clinical practice and care delivery for the patients of the clinician
attesting to this improvement activity. We would like to encourage all
clinicians to provide data through an open source clinical data
repository or clinical data registry, meaning that the results of
research are made public, including via publications and scientific
data sources, which enables reuse, increases transparency, and
facilitates reproducibility of research results. Furthermore, a
clinical data registry may allow such data to be publicly available
which may be used for research.
We believe that this improvement activity would incentivize
clinicians to submit COVID-19 data to clinical data registries, which
is imperative to help combat the PHE for COVID-19 because the data
could be used to inform research and treatment options and potentially
save lives. We recognize that under the Promoting Interoperability
performance category there is the required Public Health and Clinical
Data Exchange Objective that includes the reporting of data to two
different public health agencies or clinical data registries.
We note that under the Promoting Interoperability performance
category there are five specific types of public health agencies and
clinical data registries that clinicians may submit data to, including
an immunization registry or public health registry. The submission
requirements for the Promoting Interoperability performance category
would not be changed by this improvement activity. Thus a clinician
could report COVID-19 data to a public health agency or clinical data
registry as part of fulfilling one of the required Public Health and
Clinical Data Exchange Objective reporting options under the Promoting
Interoperability performance category and include it in their Promoting
Interoperability performance category data submission. They could also
receive credit for this improvement activity if they fulfill the
requirements of the improvement activity and include it in their
improvement activity performance category data submission.
We refer readers to section IV.H.3.h.(4)(d)(i)(C) of CY 2019 PFS
final rule (83 FR 59776 through 59777) where we discussed that high-
weighting should be used for activities that directly address areas
with the greatest impact on beneficiary care, safety, health, and well-
being and/or is of high intensity, requiring significant investment of
time and resources. We believe this modified improvement activity
should still be high-weighted because it directly addresses an area
with the greatest impact on beneficiary care, safety, health, and well-
being particularly under this PHE for COVID-19 and participation in a
clinical trial and/or collection and submission of patient data to a
clinical data registry or repository requires a significant investment
of time and resources.

[[Page 54850]]

In the CY 2019 PFS final rule (83 FR 59778 through 59782), we
provided details regarding the Annual Call for Activities and how
stakeholders submit potential improvement activities. In general, to
nominate a new activity or request a modification to an existing
improvement activity, a stakeholder must submit a nomination form
available at www.qpp.cms.gov during the Annual Call for Activities. For
this improvement activity, we made a one-time exception from our
established Annual Call for Activities timeframe and processes due to
the PHE for COVID-19 (85 FR 19277). In this IFC, we are again making an
exception from our established Annual Call for Activities timeframe and
processes due to the ongoing PHE for COVID-19. We believe the
modifications to the improvement activity should be established as soon
as possible because the PHE for COVID-19 continues to require
considerable effort by clinicians and researchers. As discussed above,
we want to allow clinicians treating patients with COVID-19 and
providing that data to a clinical data registry receive credit for this
improvement activity.
c. Continuation Through CY 2021 Performance Period
As stated above, we previously added the improvement activity to
the Inventory for the CY 2020 performance period only in response to
the PHE for COVID-19. In this IFC, we are extending the newly modified
COVID-19 Clinical Data Reporting with or without Clinical Trial
improvement activity through the CY 2021 performance period due to the
increased rate of COVID-19 infection we are experiencing nationwide. We
anticipate the need for COVID-19 clinical trials and data collection/
sharing through registries to continue through CY 2021 at which time we
will reassess whether there remains a need for additional data sharing
or if preventive measures and clinical treatments have advanced to the
point where these type of data are not needed. We would like eligible
clinicians to be able to attest to this improvement activity if it is
still pertinent. We believe that participation in this improvement
activity is likely to result in improved outcomes by improving the
collection of data clinicians use for the care of their patients as
they monitor and manage COVID-19.
Table 1 displays a full description of the modified improvement
activity.

Table 1--Continuation With Modification of Improvement Activity for the
MIPS CY 2020-2021 Performance Periods
------------------------------------------------------------------------

------------------------------------------------------------------------
Improvement Activity
------------------------------------------------------------------------
Current Activity ID:.............. IA_ERP_3.
Current Subcategory:.............. Emergency Response and Preparedness.
Current Activity Title:........... COVID-19 Clinical Trials.
Current Activity Description:..... To receive credit for this activity,
a MIPS-eligible clinician must
participate in a COVID-19 clinical
trial utilizing a drug or
biological product to treat a
patient with a COVID-19 infection
and report their findings through a
clinical data repository or
clinical data registry for the
duration of their study. For more
information on the COVID-19
clinical trials, we refer readers
to the U.S. National Library of
Medicine website at https://clinicaltrials.gov/ct2/results?cond=COVID-19.
Current Weighting:................ High.
Change and Rationale:............. This improvement activity addresses
the COVID-19 pandemic, which has
been deemed a public health
emergency (PHE) by the Secretary of
the Department of Health and Human
Services.* While this improvement
activity was finalized in the
interim final rule in response to
the PHE for the CY 2020 performance
period only (85 FR 19230), we
believe it should be continued for
the CY 2021 performance period
because the COVID-19 pandemic may
extend into CY 2021, and we would
like eligible clinicians to be able
to attest to this improvement
activity if it is still pertinent.
We believe that clinicians who treat
patients diagnosed with COVID-19
and simultaneously submit relevant
data regarding that patient to a
clinical data registry for COVID-19
research should also receive
credit. We believe that all
clinical data gathered in the
treatment of patients diagnosed
with COVID-19 may be helpful in
finding a solution to end this
pandemic. Encouraging clinicians
collectively to utilize a clinical
data registry for data reporting
could facilitate sharing of data
for use in additional clinical
studies with larger sample sizes.
These additional and larger
clinical studies are likely to
identify efficacy of certain
treatments, which in turn could
result in wider improvements in
health outcomes, including reduced
severity and mortality due to COVID-
19 across the nation. This could
benefit patients nationwide as well
as improve clinical practice and
care delivery for the patients of
the clinician attesting to this
improvement activity.
We refer readers to section
IV.H.3.h.(4)(d)(i)(C) of CY 2019
PFS final rule (83 FR 59776 through
59777) where we discussed that high-
weighting should be used for
activities that directly address
areas with the greatest impact on
beneficiary care, safety, health,
and well-being and/or is of high
intensity, requiring significant
investment of time and resources.
We believe this modified
improvement activity should still
be high-weighted because it
directly addresses an area with the
greatest impact on beneficiary
care, safety, health, and well-
being particularly under this PHE
and participation in a clinical
trial and/or clinical data registry
requires a significant investment
of time and resources.
New Activity Title:............... COVID-19 Clinical Data Reporting
with or without Clinical Trial.

[[Page 54851]]

New Activity Description:......... In order to receive credit for this
improvement activity, a MIPS
eligible clinician or group must:
(1) Participate in a COVID-19
clinical trial utilizing a drug or
biological product to treat a
patient with a COVID-19 infection
and report their findings through a
clinical data repository or
clinical data registry for the
duration of their study; or (2)
participate in the care of patients
diagnosed with COVID-19 and
simultaneously submit relevant
clinical data to a clinical data
registry for ongoing or future
COVID-19 research. Data would be
submitted to the extent permitted
by applicable privacy and security
laws. Examples of COVID-19 clinical
trials may be found on the U.S.
National Library of Medicine
website at https://clinicaltrials.gov/ct2/results?cond=COVID-19. In addition,
examples of COVID-19 clinical data
registries may be found on the
National Institute of Health
website at https://search.nih.gov/search?utf8=%E2%9C%93&affiliate=nih&query=COVID-19+registries&commit=Search.
For purposes of this improvement
activity, clinical data registries
must meet the following
requirements: (1) The receiving
entity must declare that they are
ready to accept data as a clinical
registry; and (2) be using the data
to improve population health
outcomes. Most public health
agencies and clinical data
registries declare readiness to
accept data from clinicians via a
public online posting. Clinical
data registries should make
publically available specific
information on what data the
registry gathers, technical
requirements or specifications for
how the registry can receive the
data, and how the registry may use,
re-use, or disclose individually
identifiable data it receives. For
purposes of credit toward this
improvement activity, any data
should be sent to the clinical data
registry in a structured format,
which the registry is capable of
receiving. A MIPS-eligible
clinician may submit the data using
any standard or format that is
supported by the clinician's health
IT systems, including but not
limited to, certified functions
within those systems. Such methods
may include, but are not limited
to, a secure upload function on a
web portal, or submission via an
intermediary, such as a health
information exchange. To ensure
interoperability and versatility of
the data submitted, any electronic
data should be submitted to the
clinical data registry using
appropriate vocabulary standards
for the specific data elements,
such as those identified in the
United States Core Data for
Interoperability (USCDI) standard
adopted in 45 CFR 170.213.
New Weighting:.................... High.
------------------------------------------------------------------------
* For more information, see https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.

J. Requirement for Long-Term Care (LTC) Facilities To Test Facility
Residents and Staff for 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. LTC facilities seeking to be Medicare and
Medicaid providers of services must be certified as meeting federal
participation requirements. LTC facilities include skilled nursing
facilities (SNFs) for Medicare and nursing facilities (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)(4)(B) and 1919(d)(4)(B) of the Act explicitly
authorize the Secretary to issue any regulations deemed necessary to
protect the health and safety of residents. Sections 1819(d)(3) and
1919(d)(3) of the Act authorize the Secretary to establish criteria for
assessing a facility's compliance with such regulations with respect to
infection control. Under the explicit instructions of Congress,
existing regulations at Sec. 483.80 require facilities to establish
and maintain an infection control program designed to provide a safe,
sanitary, and comfortable environment in which residents reside and to
help prevent the development and transmission of disease and infection.
After several months facing the effects of COVID-19, we believe
there exists a need to strengthen the requirements for LTC facilities
to better protect residents, members of a high-risk population. As
demonstrated by the PHE for COVID-19, a strong infection control
program is critical to protect the health and safety of both residents
and healthcare personnel of LTC facilities. The CDC has developed
guidance identifying those who are ``. . . more likely than others to
become severely ill . . .'' if they become infected with COVID-19
titled, People Who Are at Increased Risk for Severe Illness (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-at-increased-risk.html).\70\ Based on this guidance, given the congregate
nature of LTC facilities and the high-risk nature of the population
served, LTC facilities are at greater risk of COVID-19 outbreaks as
well as higher rates of incidence, morbidity, and mortality. To support
national efforts to control the spread of COVID-19, we are revising the
LTC facility infection control regulations at Sec. 483.80 to establish
a new requirement for LTC facilities to test their facility residents
and staff, including individuals providing services under arrangement
and volunteers. We believe these requirements will positively and
substantially impact efforts to control the spread of COVID-19 in LTC
facilities.
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\70\ The Centers for Disease Control and Prevention, (2020).
People Who Are at Increased Risk for Severe Illness. Retrieved from:
https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-at-increased-risk.html.
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1. LTC Facility Resident and Staff Testing
The CDC published guidelines titled, Testing Guidelines for Nursing
Homes, which note that, ``Nursing home residents are at high risk for
infection, serious illness, and death from COVID-19. Testing for
[COVID-19] . . . can detect current infections . . . among residents in
nursing homes. Testing is an important addition to other infection
prevention and control recommendations aimed at preventing [COVID-19]
from entering nursing homes, detecting cases quickly, and stopping
transmission.'' \71\ CMS recognizes the need for facilities to protect
LTC facility staff while preventing the spread of COVID-19 within the
facility. As a result, we are amending the current infection control
requirements for LTC facilities at Sec. 483.80 by adding a paragraph
(h) that requires a facility to test all of its residents and facility
staff for COVID-19. Under this requirement, ``staff'' are considered
any individuals employed

[[Page 54852]]

by the facility, any individuals that have arrangements to provide
services for the facility, and any individuals volunteering at the
facility. An example of individuals providing services under
arrangement include a hospice that may have an agreement in accordance
with the requirements for the use of outside resources under Sec.
483.70(g) and (o) to provide hospice care for residents in the
facility. We expect that only those individuals that are physically
working on-site at the facility be required to be tested for COVID-19.
The facility may have staff, including individuals providing services
under arrangement and volunteers, who provide services for the facility
from an off-site location that is not physically located within the
facility, and such staff would not be required to be tested for COVID-
19.
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\71\ The Centers for Disease Control and Prevention, (2020).
Testing Guidelines for Nursing Homes. Retrieved from: https://www.cdc.gov/coronavirus/2019-ncov/hcp/nursing-homes-testing.html.
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Other individuals may require access to the facility, such as state
surveyors and ombudsmen. Sections 1819(c)(3)(A) and 1919(c)(3)(A) of
the Act, and implementing regulations at Sec. 483.10(f)(4)(i)(C),
require that LTC facilities provide representatives of the State LTC
Ombudsman with immediate access to any resident. In accordance with the
guidance published in a CMS Quality, Safety, and Oversight Memorandum
on April 24, 2020 (and revised on July 9, 2020), during the PHE for
COVID-19, in-person access to residents may be restricted. If in-person
access is not advisable due to infection control concerns and
transmission of COVID-19, facilities must facilitate resident
communication (for example, by phone or through use of other
technology) with the ombudsman (QSO-20-28-NH, https://www.cms.gov/files/document/qso-20-28-nh-revised.pdf). Regarding state surveyors,
facilities have a statutory obligation to allow facility access to the
surveyors. In accordance with the requirements at 42 CFR part 488,
state agencies are responsible for ensuring that surveyors are
following CDC guidance for infection prevention and refraining or
returning to work.
At Sec. 483.80(h)(1), we are requiring that resident and staff
testing for COVID-19 be conducted based on parameters set forth by the
Secretary. These parameters may include, but are not limited to:
Testing frequency;
The identification of any facility resident or staff
diagnosed with COVID-19 in the facility;
The identification of any facility resident or staff with
symptoms consistent with COVID-19 or with known or suspected exposure
to COVID-19;
The criteria for conducting testing of asymptomatic
individuals specified in this paragraph, such as the positivity rate of
COVID-19 in a county;
The response time for test results; and
Other factors specified by the Secretary that help
identify and prevent the transmission of COVID-19.
We recognize that there may be additional factors that may be
useful in developing parameters for COVID-19 testing. As a result, we
are soliciting comments on other factors the Secretary should consider
for LTC facility resident and staff testing for COVID-19. The testing
guidelines that have been specified by the Secretary will be made
available to LTC facilities via CMS memoranda, and CMS and CDC
websites.
We are requiring at Sec. 483.80(h)(2) that all resident and staff
testing be conducted in a manner that is consistent with current
professional standards of practice for conducting COVID-19 tests.
Current ``professional standards of practice'' refers to those
professional standards that apply at the time that the care or service
is delivered. Given that COVID-19 is caused by a newly discovered
coronavirus, the standards of practice for testing for the virus may
continue to change or evolve as more is learned about the virus and as
technological advances are developed. Testing residents and staff for
COVID-19 in a manner that is consistent with current professional
standards of practice is important to ensure accurate and effective
testing. A key factor in the effectiveness of testing is the turnaround
time for results of the tests that are being used. There are many
different tests available and facilities have the flexibility and
discretion to select the test that best suits their needs so long as
the tests are conducted in accordance with nationally recognized
standards and meet the response time for test results as specified by
the Secretary. The CDC provides detailed recommendations for testing
both residents and healthcare personnel for COVID-19 at https://www.cdc.gov/coronavirus/2019-ncov/hcp/nursing-homes-testing.html. These
recommendations provide information about the use of specific testing
methods and focus on how testing can be added to other infection
prevention and control practices to keep COVID-19 out of facilities,
detect cases quickly, and stop its transmission.
We are requiring at Sec. 483.80(h)(3)(i) that for each instance of
resident or staff COVID-19 testing, which includes testing of
individuals providing services under arrangement and volunteers, the
facility document that testing was completed and the results of each
staff test. We expect that this documentation would be located in the
staff personnel record for all staff. In the case of individuals who
are providing services under arrangement at the facility, we expect
that this documentation be located in the record or file that the
facility maintains for the individual. In the event that no such record
or file is maintained, we expect that the agreement for the services
that are being provided under arrangement include a process for
documenting these results. Consistent with the documentation
requirements we are adding for LTC facility staff, we are requiring at
Sec. 483.80(h)(3)(ii) that the facility document in the resident's
medical record that testing was offered, completed (as appropriate to
the resident's testing status), and the results of each test.
According the CDC, ``The virus that causes COVID-19 is spreading
very easily and sustainably between people. Information from the
ongoing COVID-19 pandemic suggests that this virus is spreading more
efficiently than influenza. . . . In general, the more closely a person
interacts with others and the longer that interaction, the higher the
risk of COVID-19 spread.'' \72\ The nature of LTC facilities make
outbreaks of COVID-19 difficult to control. To address the
transmissibility of COVID-19 in LTC facilities, we are requiring at
Sec. 483.80(h)(4) that the facility take actions to prevent the
transmission of COVID-19 when a resident or staff member, including
individuals providing services under arrangement and volunteers,
present with symptoms consistent with COVID-19 or who test positive for
COVID-19.
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\72\ The Centers for Disease Control and Prevention (2020). How
COVID-19 Spreads. Retreived from: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html.
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In accordance with the current regulatory requirements for LTC
facilities at Sec. 483.80(g), facilities are required to
electronically report information about COVID-19 in a standardized
format specified by the Secretary, which includes reporting suspected
and confirmed COVID-19 infections among residents and staff.
For facility staff, we expect facilities to restrict the access to
the facility for any staff member, including individuals providing
services under arrangement and volunteers, who presents with symptoms
consistent with COVID-19 or who tests positive for COVID-19 until he or
she is deemed to be safe to return to work. The testing guidelines
specified

[[Page 54853]]

by the Secretary include specified return to work criteria. Following
the return to work criteria established by the Secretary will ensure
that staff, including individuals providing services under arrangement
and volunteers, who are still capable of spreading the virus do not
have access to the facility, thus increasing resident safety by
removing any potential threats of exposure. These proactive efforts
support a facility's ability to prevent outbreaks, create opportunities
for early intervention, and mitigate the transmission of the virus
between healthcare personnel and facility residents.
For facility residents who present with symptoms consistent with
COVID-19 or who test positive for COVID-19, we expect the facility to
take measures to mitigate the transmission of the virus within the
facility that may include resident cohorting, consistent with CDC's
guidance, Responding to Coronavirus (COVID-19) in Nursing Homes.\73\
Cohorting involves preventing the spread of COVID-19 in the facility by
confining residents who are known or suspected to have COVID-19 to a
specified area to prevent contact with other residents who do not have
(or suspected to have) COVID-19. The CDC's current recommendations
include avoiding the sharing of staff between residents that are COVID-
19 positive and residents that have not tested positive.
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\73\ The Centers for Disease Control and Prevention, (2020).
Responding to Coronavirus (COVID-19) in Nursing Homes. Retrieved
from: https://www.cdc.gov/coronavirus/2019-ncov/hcp/nursing-homes-responding.html.
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We acknowledge that not all residents and staff will consent to
COVID-19 testing. In accordance with the requirements at Sec.
483.10(c)(6), residents have the right to refuse and/or discontinue
treatment. In addition, staff retain the right to refuse COVID-19
testing. There may also be instances in which facility residents or
staff are not able to be tested, such as the presence of anatomical or
other medical contraindications. At Sec. 483.80(h)(5), we are
requiring that the facility have procedures for addressing residents
and staff, including individuals providing services under arrangement
and volunteers, who refuse or are unable to be tested. In these
instance, we also expect facilities to take steps to maintain the
health and safety of its staff and residents who have not been
diagnosed with COVID-19 that may include limiting the staff's access to
the facility and cohorting residents.
We are requiring at Sec. 483.80(h)(6) that the LTC facility must
coordinate with state and local health departments on the availability
of testing supplies, obtaining testing supplies, and processing test
results when necessary. As appropriate, facilities should also
coordintate with their tribal representatives and authorities for these
resources as well. Facilities may also coordinate with their local
certified laboratories covered under Clinical Laboratory Improvement
Amendments (CLIA) on the availability of testing supplies, obtaining
testing suppliers, and processing test results. Considerations such as
access to adequate testing supplies and arrangements for acquiring
testing supplies must be addressed by a facility's infection prevention
and control plan. Additionally, the testing plan must include any
arrangements that may be necessary to conduct, process, and receive
test results prior to the administration of the required tests.
LTC facilities are currently required to have policies and
procedures in place to address the use of volunteers in an emergency
under the emergency preparedness requirements at Sec. 483.73(b)(6).
During this pandemic, the use of volunteers and other emergency
staffing strategies, including the use of state and federal healthcare
professionals, is important in addressing staff shortages. Facilities
are expected to assess their ability to replace workers who can no
longer work, either on a short term basis or permanently, with
personnel trained for the vacant positions. The LTC facility should
maintain an appropriate staffing level at all times to provide a safe
work environment for healthcare personnel (HCP) and safe resident care.
As the COVID-19 pandemic continues, staffing shortages will likely
occur due to HCP exposures and illness. Due to the unique challenges in
managing the mitigation of COVID-19, facilities should assess their
staffing needs and the minimum number of staff needed to provide a safe
work environment and care for residents. In addition, facilities should
be prepared to make various adjustments such as using volunteers, and
adjusting work and time-off schedules. Facilities should also be
prepared to contact ``The Emergency System for Advance Registration of
Volunteer Health Professionals'' (https://www.phe.gov/esarvhp), their
local healthcare coalition, federal, state and local healthcare
partners for assistance with staffing shortages. Further resources and
guidelines, such as those provided by the CDC at https://www.cdc.gov/coronavirus/2019-ncov/hcp/mitigating-staff-shortages.html, can provide
additional suggestions for managing staff shortages.
We believe that these new regulatory actions strengthen CMS'
response to the PHE for COVID-19, and reaffirms our commitment to
transparency and protecting the health and safety of LTC residents. As
discussed in section III. of this IFC, ``Waiver of Proposed
Rulemaking'', we believe the urgency of this PHE for COVID-19
constitutes good cause to waive the normal notice-and-comment process
under the APA 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
controlling the spread of COVID-19, and universal resident and staff
testing will assist public health officials in detecting outbreaks and
saving lives.

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 are finalized, either as proposed or as
amended in response to public comments, and take effect, in accordance
with the Administrative Procedure Act (APA) (Pub. L. 79-404), 5 U.S.C.
553, and, where applicable, section 1871 of the Act. Specifically, 5
U.S.C. 553 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. Further, 5 U.S.C. 553 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 for rulemaking carrying out the
administration of the insurance programs under title XVIII of the Act.
Section 1871(b)(2)(C) of the Act and 5 U.S.C. 553 authorize the agency
to waive these procedures, however, if the agency for good cause finds
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(b)(B) of title 5 of the U.S. Code 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

[[Page 54854]]

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) (Pub. L. 104-121, Title II) 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
a ``Public Health Emergency of international concern''. On January 31,
2020, pursuant to section 319 of the PHSA, the Secretary determined
that a PHE exists for the United States to aid the nation's healthcare
community in responding to COVID-19. On March 11, 2020, the WHO
publicly declared COVID-19 a pandemic. On March 13, 2020, the President
declared the COVID-19 pandemic a national emergency. Effective July 25,
2020, the Secretary renewed the January 31, 2020 determination that was
previously renewed on April 21, 2020, that a PHE exists and has existed
since January 27, 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.\74\
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\74\ https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
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Ensuring the health and safety of all Americans, including Medicare
beneficiaries, Medicaid recipients, and healthcare workers is of
primary importance. This IFC directly supports that goal by requiring
COVID-19 reporting by hospitals, CAHs, and CLIA laboratories; by
requiring testing of nursing home staff and residents; and by
strengthening enforcement of important nursing home infection
prevention and control requirements related to COVID-19 reporting. It
is critically important that we implement the policies in this IFC as
quickly as possible. As we are in the midst of the PHE for COVID-19, 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. 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 establish these policies in this IFC applicable as of the
date this rule is published.
In this IFC, we are revising the previous policy outlined in the
May 8th COVID-19 IFC, which allowed for broad COVID-19 testing for a
single beneficiary without a physician order, by establishing that only
a single COVID-19 test and one of each other related test (as listed in
the May 8th COVID-19 IFC) without a treating physician or NPP order is
reasonable and necessary. We are also establishing a policy whereby the
orders of pharmacists and other practitioners that are allowed to order
laboratory tests in accordance with state scope of practice and other
pertinent laws can fulfill the requirements related to orders for
covered COVID-19 tests for Medicare patients.
Just as the previous policy was developed based on what was known
about COVID-19 at the time, as additional information has become
available, policies require modification. Whereas we are committed to
reducing impediments to access to COVID-19 testing and the other
related tests identified in the May 8th COVID-19 IFC, we believe that
it is contrary to the public interest to allow open-ended coverage of
COVID-19 testing without an order from a physician, practitioner, or
other healthcare professional. Our determination to revise the May 8th
IFC policy is due both to the significant potential for fraud, waste,
and abuse, as well as public health and safety issues that would arise
from beneficiaries being subjected to repeated testing without proper
medical attention or oversight, including public health issues with the
ongoing spread of COVID-19.
Laboratory testing has been a significant source of fraud and abuse
in the Medicare program. We have already found that schemes are
occurring whereby fraudulent laboratories and telemarketing companies
are directly contacting beneficiaries, oftentimes using stolen
identifying information, to solicit items and services payable by
Medicare under the guise of COVID-19 treatment or prevention. In fact,
an HHS Office of Inspector General (HHS-OIG) fraud alert \75\ describes
situations in which scammers are offering unapproved and illegitimate
COVID-19 tests and other services to Medicare beneficiaries in exchange
for personal details, including Medicare information. The financial
impact of this fraud risk is exacerbated by the ability of the
laboratory to perform expensive add-on tests, such as to confirm or
rule-out diagnoses other than COVID-19, that are not medically
necessary.
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\75\ https://oig.hhs.gov/coronavirus/fraud-alert-covid19.asp.
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We also believe that allowing Medicare payment for one test without
an order will allow beneficiaries access to urgent testing, as we
outlined in the May 8th COVID-19 IFC, yet also provide sufficient
opportunity for beneficiaries to seek out the medical care needed to
ensure that the test results are interpreted and acted upon
appropriately, both from the perspective of the individual beneficiary
and also in the context of the area of the country in which the
beneficiary is located. Executing an effective, regional response to
COVID-19 disease requires coordinated effort and guidance by qualified
medical professionals who know how to interpret and react to testing
results. When a physician or other healthcare provider is able to
counsel patients who are being tested for COVID-19, beneficiaries may
be more likely to isolate themselves more quickly, which may reduce
transmission in the community. Consistent with this information, CMS
and CDC recently announced that they are taking steps to ensure that
physicians and other practitioners who counsel patients on COVID-19
testing are paid for these services.\76\
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\76\ https://www.cms.gov/newsroom/press-releases/cms-and-cdc-announce-provider-reimbursement-available-counseling-patients-self-isolate-time-covid-19.
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We also believe that pharmacists and other healthcare professionals
play an important role in the response to the PHE for COVID-19, and to
further ensure that beneficiaries continue to have access to
appropriate COVID-19 testing even when some professional care is not
separately billable under

[[Page 54855]]

Medicare, we are establishing a policy whereby otherwise covered COVID-
19 and specified related tests ordered by pharmacists and other
healthcare professionals who are authorized to order diagnostic
laboratory tests in accordance with state scope of practice and other
pertinent laws are covered for the duration of the PHE for COVID-19.
In this IFC, we are updating the extraordinary circumstances
exceptions (ECEs) we granted on March 22, 2020, for the ESRD QIP, HAC
Reduction Program, HRRP, and Hospital VBP Program in response to the
PHE for COVID-19. We are also revising the FY 2022 performance period
under the SNF VBP Program.
We believe that these policy updates are immediately necessary to
provide clarification to hospitals, dialysis facilities, and SNFs on
which reporting requirements under the ESRD QIP, HAC Reduction Program,
HRRP, Hospital VBP Program, and SNF VBP Program are excepted and how
the exceptions will impact program scoring. These updates will also
clarify how optionally submitted data for excepted reporting periods
will be used. Since existing Q1 and Q2 2020 deadlines are upcoming in
August, October and November 2020, providing this clarification now
will allow hospitals, facilities and SNFs to have the information they
need and the flexibility to determine how best to direct their
resources during the PHE for COVID-19. Therefore, we believe that it
would be impracticable and contrary to the public interest to undertake
full notice and comment rulemaking to implement these policies.
The IFC also modifies the calculation of the 2022 Part C and D Star
Ratings to address the application of the extreme and uncontrollable
circumstances policy for the PHE for COVID-19. Applying the 60 percent
rule to 2022 Star Ratings would result in removal of a large fraction
of contracts from threshold calculations, resulting in too few
contracts to reliably calculate cut points for non-CAHPS measures using
the clustering methodology and too few contracts to reliably calculate
and apply Reward Factors for 2022 Star Ratings; failure to adopt the
change would result in CMS' inability to calculate 2022 Star Ratings.
This change to the calculation methodology for the 2022 Star Ratings is
urgently necessary to ensure that MA organizations, cost plans, and
Part D plan sponsors are aware during the 2020 measurement period how
their performance in the 2020 measurement period will be used in
calculating the Star Ratings.
We believe that the clarifications are immediately necessary to
address both program integrity and clinical issues that have arisen
since the publication of the May 8th COVID-19 IFC. We believe that it
is contrary to the public interest to allow open-ended coverage of
COVID-19 testing without an order due to the significant potential for
fraud, waste, and abuse, as well as public health and safety issues
that would arise from beneficiaries being subjected to testing without
proper medical necessity or oversight.
In this IFC, we clarify the data reporting requirements for issuers
of risk adjustment covered plans to specify that, for the purposes of
2020 benefit year risk adjustment data submissions, issuers of risk
adjustment-covered plans that provide temporary premium credits must
report to their EDGE server the adjusted plan premiums that reflect
actual premiums billed to enrollees, taking the premium credits into
account as a reduction in premiums. In addition, we clarify that,
consistent with the reporting of the actual premium amounts billed to
enrollees for 2020 benefit year risk adjustment data submissions, HHS's
calculation of risk adjustment payment and charges for the 2020 benefit
year under the state payment transfer formula \77\ will be calculated
using the statewide average premium that reflects actual premiums
billed, taking into account any temporary premium credits provided as a
reduction in premium for the applicable months of 2020 coverage,
including premium credits that were not provided in a manner consistent
with the August 4, 2020 memo. We believe that, in light of the
temporary premium credits authorized in CMS guidance during the PHE for
COVID-19, immediate clarification on risk adjustment reporting
requirements are necessary in order to maintain confidence in the risk
adjustment program and stability in the individual and small group (or
merged) insurance markets, as issuers have already begun to prepare for
2020 benefit year risk adjustment data submission. These clarifications
are also immediately necessary to enable issuers to move quickly to
evaluate the impact of these policies and, for those that elect to do
so, to begin providing this premium relief to support continuity of
coverage for those enrollees adversely affected financially by the PHE
for COVID-19. We believe that it is contrary to the public interest to
require full notice and comment because delayed clarification may
prevent some issuers from offering temporary premium credits and may
lead some enrollees who have been adversely affected financially by
COVID-19 to lose health insurance coverage.
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\77\ The state payment transfer formula refers to the part of
the HHS risk adjustment methodology established consistent with 45
CFR 153.320 that calculates payments and charges at the state market
risk pool level. See, for example, the 2020 Payment Notice final
rule, 84 FR at 17485. The state payment transfer calculations are
performed prior to the calculation of the high-cost risk pool
payment and charge terms.
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In this IFC, we similarly clarify the MLR reporting and rebate
requirements in 45 CFR part 158 for issuers that elect to provide
temporary premium credits in 2020 such that these issuers must report
as earned premium the actual premium billed to enrollees, taking into
account any temporary premium credits as a reduction in premium for the
applicable months of 2020 coverage. These changes are necessary to
align MLR calculations with the flexibilities provided to issuers and
states elsewhere in this rulemaking to respond to the PHE for COVID-19.
HHS believes that these clarifications are immediately necessary to
enable issuers to quickly and accurately evaluate the financial impact
of offering temporary premium credits to enrollees to support
continuity of coverage during the PHE for COVID-19. We believe that it
is contrary to the public interest to require full notice and comment
because delayed clarification may prevent some issuers from offering
temporary premium credits and may lead some enrollees who have been
adversely affected financially by COVID-19 to lose health insurance
coverage.
In this IFC, we are including CPT and HCPCS codes for CTBS and
telephone E/M services to the definition of primary care services that
is used for purposes of the MIPS beneficiary assignment methodology for
the CMS Web Interface and the CAHPS for MIPS survey in order to ensure
these services are included in determining where beneficiaries receive
the plurality of their primary care for purposes of beneficiary
assignment. Without the inclusion of these codes in the MIPS
beneficiary assignment methodology for the CMS Web Interface and CAHPS
for MIPS survey for the 2020 MIPS performance year and any subsequent
performance year that starts during the PHE for COVID-19, we would not
be able to adequately account for the ways in which beneficiaries are
receiving primary care services during the PHE for COVID-19 and as a
result, the process to derive assignment and sampling of beneficiaries
for the CMS Web Interface and CAHPS for MIPS survey would not be able
to comprehensively capture how primary care services are being
furnished to beneficiaries, which may

[[Page 54856]]

cause many groups and virtual groups to have insufficient sample sizes
to be able to administer the 2020 CAHPS for MIPS survey or report data
for the quality performance category using the CMS Web Interface
measures. Therefore, these codes are necessary to ensure a
comprehensive assessment of MIPS quality performance and avoid imposing
undue burden on clinicians during the PHE for COVID-19.
Lastly, under the MIPS Program in this IFC, we are also: (1)
Expanding IA_ERP_3 to include clinicians participating in the care of a
patient diagnosed with COVID-19 who simultaneously submit their
clinical patient data to a clinical data registry for research; (2)
updating the title; and (3) extending the activity through the CY 2021
performance period. For this improvement activity, we are making a one-
time exception from our established Annual Call for Activities
timeframe and processes due to the ongoing PHE for COVID-19. The
modifications to the improvement activity should be established as soon
as possible because the PHE for COVID-19 continues to require
considerable effort by clinicians and researchers and this modified
improvement activity would allow clinicians who treat patients with
COVID-19 and provide data to a clinical data registry to receive credit
under MIPS. We believe that this improvement activity as modified would
incentive clinicians to submit COVID-19 data to clinical data
registries, which is imperative to help combat the PHE for COVID-19 as
the data could be used to inform research and treatment options and
potentially save lives. We believe that all clinical data gathered in
the treatment of patients diagnosed with COVID-19 may be helpful in
finding a solution to end this pandemic, and the earlier the data is
collected and shared, the sooner clinical treatment can evolve and a
solution may be found. In this IFC, we are also extending the newly
modified COVID-19 Clinical Data Reporting with or without Clinical
Trial improvement activity through the CY 2021 performance period due
to the increased rate of COVID-19 infection we are experiencing
nationwide. We believe that the continued and increasing need for a
solution to the PHE for COVID-19 indicates that we should encourage
both participation in clinical trials, as well as data collection and
sharing through clinical data registries as soon as practicable and at
least through CY 2021.
For this IFC, 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 the CRA, 5 U.S.C. 808(2), we find it is
impracticable and contrary to the public interest not to waive the
delay in effective date of this IFC under the CRA, 5 U.S.C. 801(a)(3).
Therefore, we find there is good cause to waive the CRA's delay in
effective date pursuant to the CRA, 5 U.S.C. 808(2).

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.
Collection of Information for Clinical Laboratories
We are soliciting public comment on each of the section
3506(c)(2)(A)-required issues for the following information collection
requirements (ICRs). The requirements and burden related to laboratory
test result reporting is covered under OMB Control Number 0920-1299.
CDC will be collecting the test results and other information related
to SARS-CoV-2 testing. CDC will then provide the information to CMS to
ensure that CLIA-certified laboratories are reporting as required under
the CLIA regulations.

A. Laboratory Costs To Develop a Mechanism to Track SARS-CoV-2 Test
Results

As discussed in section II. of this IFC, we are adding Sec. Sec.
493.41 and 493.1100(a) to require that, during the PHE for COVID-19,
each CLIA-certified laboratory that performs a test that is intended to
detect SARS-CoV-2 or to diagnose a possible case of COVID-19 must
report SARS-CoV-2 test results in such form and manner, and at such
timing and frequency, as the Secretary may prescribe. We estimate that
approximately 30 percent (n (number) =77,024) of the total CLIA-
certified laboratories \78\ could potentially be performing SARS-CoV-2
testing. We are soliciting public comments related to the number of
laboratories performing SARS-CoV-2 testing. Each of these laboratories
would incur a one-time cost for the time needed to develop a mechanism
to track and collect SARS-CoV-2 test results to be in compliance with
this new requirement. We estimate it would take each laboratory 5 to 7
hours to develop such a mechanism. The burden hours range from 385,120
to 539,168 (77,024 laboratories x 5 or 7 hours). A management level
employee (11-9111) would perform this task at an hourly wage of $55.37
per hour as published by the Bureau of Labor Statistics (BLS) in
2019).\79\ The wage rate would be doubled to $110.74 to include
overhead and fringe benefits. In addition, a database administrator/
architect (15-1245) would be needed to perform this task at an hourly
wage of $46.21 per hour as published by the BLS in 2019.\80\ The wage
rate would be doubled to $92.42 to include overhead and fringe
benefits. The total hourly wage would be $203.16 ($110.74+ $92.42). The
total cost would range from $78,240,979 to $109,537,371 (385,120 to
539,168 x $203.16).
---------------------------------------------------------------------------

\78\ Includes Certificate of Waiver (CoW), Certificate of
Provider-Performed Microscopy (PPM), Certificate of Compliance (CoC)
and Certificate of Accreditation (CoA). Based on the CLIA web page
the total number of laboratories as of March 2020 are as follows:
CoW, n=193,474; PPM n=30,120; CoC n=17,432; CoA n=15,721; total
=256,747.
\79\ https://www.bls.gov/oes/current/oes_nat.htm. (11-9111).
\80\ https://www.bls.gov/oes/current/oes_nat.htm. (15-1245).
---------------------------------------------------------------------------

B. Laboratory Costs To Collect SARS-CoV-2 Test Results for Reporting

[[Page 54857]]

test volumes to approximate a range from low volume laboratory to a
laboratory using high throughput technology. We estimate that a low
volume laboratory may report out 20 test results in a 24-hour period
and a high throughput laboratory may report out 500 test results during
the same period. We estimate it would take each laboratory
approximately 0.5 hours for low volume laboratories and approximately 3
hours per day for a high throughput laboratory to collect this
information to be in compliance with this new requirement. The burden
hours range from 38,512 to 231,072 (77,024 laboratories x 0.5 or 3
hours). A clinical laboratory technician would perform this task at an
hourly wage of $26.34 per hour as published by the BLS in 2019.\81\ The
wage rate would be doubled to $52.68 to include overhead and fringe
benefits. The total cost would range from $2,028,812 to $12,172,873
(38,512 to 231,072 x $52.68) per day to collect the required
information. Collection of test results would be an ongoing burden for
each laboratory performing this type of testing.
---------------------------------------------------------------------------

\81\ https://www.bls.gov/oes/current/oes_nat.htm. (29-2010).
---------------------------------------------------------------------------

C. Laboratory Costs To Report SARS-CoV-2 Test Results

As discussed in section II. of this IFC, we are adding Sec. Sec.
493.41 and 493.1100(a) to require that, during the PHE for COVID-19,
each laboratory that performs a SARS-CoV-2 test must report SARS-CoV-2
test results in such form and manner, and at such timing and frequency,
as the Secretary may prescribe. We estimated the number of laboratories
as outlined in section IV.A. of this IFC. We estimate that the
approximately 30 percent (n=77,024) of the total CLIA-certified
laboratories could potentially be performing SARS-CoV-2 and need to
report test results in accordance with Sec. Sec. 493.41 and
493.1100(a).
For purposes of this IFC, we are estimating a wide range of test
volumes to approximate a range from low volume laboratory to a
laboratory using high throughput technology. We estimate that a low
volume laboratory may report out 20 test results in a 24-hour period
and a high throughput laboratory may report out 500 test results during
the same period. We estimate it would take each laboratory
approximately 0.5 hours for low volume laboratories and approximately 3
hours for a high throughput laboratory to report this information to be
in compliance with this new requirement. The burden hours range from
38,512 to 231,072 (77,024 laboratories x 0.5 or 3 hours). A healthcare
support worker (31-9099) would perform this task at an hourly wage of
$19.24 per hour as published by the BLS in 2019.\82\ The wage rate
would be doubled to $38.48 to include overhead and fringe benefits. The
total cost would range from $1,481,942 to $8,891,651 (38,512 to 231,072
x $38.48) per day to collect the required information. Reporting of
test results would be an ongoing burden for each laboratory performing
this type of testing.
---------------------------------------------------------------------------

\82\ https://www.bls.gov/oes/current/oes_nat.htm. (31-9099).
---------------------------------------------------------------------------

D. Laboratory Costs to Update Policies and Procedures

We expect that the approximately 77,024 laboratories performing
SARS-CoV-2 testing would incur costs for the time needed to review the
revised reporting regulations and update their policies and procedures
to be in compliance. We estimate the total one-time burden per
laboratory to review and update affected policies and procedures is 5
hours. The burden hours are 385,120 (77,024 laboratories x 5 hours). A
management level employee would perform this task at an hourly wage of
$55.37 per hour as published by the BLS in 2019.\83\ The wage rate
would be $110.74 to include overhead and fringe benefits. The total
estimated cost would be $42,648,189 (385,120 hours x $110.74).
---------------------------------------------------------------------------

\83\ https://www.bls.gov/oes/current/oes_nat.htm. (11-9111).
---------------------------------------------------------------------------

E. Accreditation Organization (AO) and Exempt State (ES) Costs To
Update Standards for Reporting SARS-CoV-2 Test Results

We would expect the seven approved AOs and two ESs would have to
review their standards, provide updates and submit the changes to CMS
related to SARS-CoV-2 test reporting for approval (9 organizations/
exempt states x 25 or 30 hours). The CLIA regulations require both the
AOs and ESs to have requirements that are equal to, or more stringent
than the CLIA condition-level requirements, and the laboratory would
meet the condition-level requirements if it were inspected against
these requirements.\84\ We assume a one-time cost of 25 to 30 hours to
identify the applicable legal obligations and to develop the updated
standards needed to reflect the new requirements for SARS-CoV-2
testing. The burden hours range from 225 to 270 (9 AO/ESs x 25 or 30
hours). A management level employee (11-9111) would perform this task
at an hourly wage of $55.37 per hour as published by the BLS in
2019.\85\ The wage rate would be doubled to $110.74 to include overhead
and fringe benefits. The total cost would range from would range from
$24,917 to $29,900 (225 to 270 hours x $110.74).
---------------------------------------------------------------------------

\84\ CLIA Requirements at 42 CFR 493.551 (https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5%23se42.5.493_1551).
\85\ https://www.bls.gov/oes/current/oes_nat.htm. (11-9111).
---------------------------------------------------------------------------

F. Accreditation Organization (AO) and Exempt State (ES) Costs To
Update Policies and Procedures Related to Reporting Laboratories
Performing SARS-CoV-2 Testing That Do Not Report Results as Required

We would expect the seven approved AOs and two ESs would have to
develop policies and procedures related to identifying laboratories
that do not report SARS-CoV-2 test results in order to report these
laboratories to CMS. In the case of the accredited laboratories, the
laboratories identified as not reporting SARS-CoV-2 results as required
would result in CMS taking an enforcement action as described in
section II. of this IFC. As stated in section IV.G. of this IFC, the
CLIA regulations require both the AOs and ESs to have requirements that
are equal to, or more stringent, the CLIA condition-level requirements,
so we would expect the AOs and ESs to have equivalent reporting
requirements to CMS. AOs do not impose CMPs; however, ESs do have the
ability to impose CMPs so we would expect ESs to have an equivalent
penalty structure to CMS. The ES are generally approved by CMS to
operate their own oversight programs so we would expect that the two
ESs would report these laboratories to CMS, but would then impose the
penalties based on their CMS-approved updated standards. We are
requiring the AOs/ESs to report this information to CMS no later than
10 days from identifying a laboratory that has failed to report SARS-
CoV-2 test results as required. We assume a one-time cost of 10 to 15
hours to develop the policy and procedures needed to reflect the new
requirements for reporting of SARS-CoV-2 test results. The burden hours
range from 90 to 135 (9 AO/ESs x 10 or 15 hours). A management level
employee (11-9111) would perform this task at an hourly wage of $55.37
per hour as published by the BLS in 2019. The wage rate would be
doubled to $110.74 to include overhead and fringe benefits. The total
cost would range from $9,967 to $14,950 (90 to 135 hours x $110.74). In
addition, the AOs and ESs would be required to report to CMS

[[Page 54858]]

every 10 days those laboratories that have not reported test results as
required. The annual total number of times each AO and ES is required
to report to CMS is 36.5. We assume a weekly cost of 2 to 4 hours to
identify the laboratories and submit the information to CMS. The total
burden hours range from 18 to 36 (9 AO/ESs x 2 or 4 hours). A computer
network support specialist (15-1231) would perform this task at an
hourly wage of $33.10 per hour as published by the BLS in 2019.\86\ The
wage rate would be doubled to $66.20 to include overhead and fringe
benefits. The total cost would range from would range from $1,192 to
$2,383 (18 to 36 hours x $66.20) per 10 days for an annual total of
$43,508 to $86,980 ($1,192 to $2,383 x 36.5).
---------------------------------------------------------------------------

\86\ https://www.bls.gov/oes/current/oes_nat.htm. (15-1231).
---------------------------------------------------------------------------

G. Condition of Participation (CoP) Requirements for Hospitals and
Critical Access Hospitals (CAHs) To Report COVID-19 Data as Specified
by the Secretary During the PHE for COVID-19

We are revising the regulations by adding provisions to the CoPs
(Sec. 482.42 for hospitals and Sec. 485.640 for CAHs), requiring
hospitals and CAHs to electronically report information related to
confirmed or suspected COVID-19 cases in a standardized format, and at
a frequency, specified by the Secretary. Our preliminary estimates for
these reporting activities can be found in Tables 2 and 3.

Table 2--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Hospitals and CAHs............ HHS Teletracking 5500 365 1.5 3,011,250
COVID-19 Portal.
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 3,011,250
----------------------------------------------------------------------------------------------------------------

Table 3--Estimated Annualized Respondent Burden Costs
----------------------------------------------------------------------------------------------------------------
Total burden Total respondent
Type of respondent hours Hourly wage rate costs
----------------------------------------------------------------------------------------------------------------
Hospital Staff--Registered Nurses...................... 3,011,250 * $70.48 $212,232,900
--------------------------------------------------------
Total.............................................. ................. ................. 212,232,900
----------------------------------------------------------------------------------------------------------------
* The wage rate includes overhead and fringe benefits.

The burden associated with these reporting activities will be
submitted under OMB Control Number 0990-NEW.

H. Requirements for Long-Term Care (LTC) Facilities To Test Facility
Residents and Staff for COVID-19

As discussed in section II.J. of this IFC, we are revising the
regulations at Sec. 483.80(h) to require LTC facilities to test
residents and facility staff, including individuals providing services
under arrangement and volunteers, for COVID-19. We are also requiring
at Sec. 483.80(h)(3)(i) that for each instance of resident and staff
COVID-19 testing (which includes testing of individuals providing
services under arrangement and volunteers), the facility document that
testing was completed and the results of each test. We expect that this
documentation would be located in the staff personnel record for all
staff. In the case of individuals who are providing services under
arrangement at the facility, we expect that this documentation be
located in the record or file that the facility maintains for such
individuals. In the event that no such record or file is maintained, we
expect that the agreement for the services that are being provided
under arrangement include a process for documenting these results.
Consistent with the documentation requirements we are adding for LTC
facility staff, we are requiring at Sec. 483.80(h)(3)(ii) that the
facility document in the resident's medical record that testing was
offered, completed (as appropriate to the resident's testing status),
and the results of each test.
Based on data from the Kaiser Family Foundation's report on
coronavirus statistics (https://www.kff.org/report-section/covid-19-and-workers-at-risk-examining-the-long-term-care-workforce-tables), we
estimate that 1.8 million LTC facility staff would be tested for COVID-
19 initially for each facility. We also estimate that 1.3 million
residents would be tested. We have estimated that it will take
approximately 2 minutes to locate a staff's file and document the
result of a COVID-19 test. Furthermore, we estimate that, based on the
guidelines given regarding testing frequency, the criteria for
conducting a test, and the response time for test result, not all staff
will be tested on the same frequency. For example, a third of the staff
population could be tested weekly and two thirds of the staff
population could receive a test every ten days or monthly. However,
with variables that are not knowable at this time, we have provided an
estimate based on an average schedule of all staff receiving a test
every 14 days and residents to be tested monthly during the PHE for
COVID-19. We estimate that it would take 2 minutes to provide
documentation in 1.8 million records of staff members for 30 weeks
(from September 2020 to March 2021) to record the test was administered
and to record the test results. We also estimate that it would take 2
minutes to provide the same documentation in 1.3 million medical
records of residents for the same period of time. The annual and
ongoing cost to comply with this requirement can be further assessed
based on guidelines established by the Secretary. The ongoing burden
associated with these reporting activities will, if necessary, be

[[Page 54859]]

submitted under OMB Control Number 0938-New.
For the purpose of this analysis, we estimate that it would take 2
minutes to document the initial test and that a healthcare support
worker (31-9099) would perform this task at an hourly wage of $19.24
per hour as published by the BLS in 2019.\87\ The wage rate would be
doubled to $38.48 to include overhead and fringe benefits. Based on our
assumptions, we estimate that the total cost to document the testing
results for staff and LTC residents over the estimated course of the
PHE for COVID-19 would be $48,158,193. See Table 4.
---------------------------------------------------------------------------

\87\ https://www.bls.gov/oes/current/oes_nat.htm. (31-9099).
\88\ https://www.kff.org/report-section/covid-19-and-workers-at-risk-examining-the-long-term-care-workforce-tables/.

Table 4--Total Cost To Document the Testing Results for Staff and LTC Residents Over the Estimated Course of the PHE for COVID-19
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wage for
Time to document Staff Resident Testing Testing health staff Total
frequency duration worker
--------------------------------------------------------------------------------------------------------------------------------------------------------
Staff............................. 2 minutes........... \88\ 1,899,000 .............. 14 days 30 weeks * $38.48 $36,344,360
Resident.......................... 2 minutes........... .............. 1,315,757 30 days 7 months $38.48 11,813,833
.................... .............. .............. .............. .............. .............. 48,158,193
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The wage rate includes overhead and fringe benefits.

I. Quality Reporting: Updates to the Extraordinary Circumstances
Exceptions (ECE) Granted for Four Value-Based Purchasing Programs in
Response to the PHE for COVID-19, and Update to the Performance Period
for the FY 2022 SNF VBP Program

1. Updates to ESRD QIP: Utilization of Fourth Quarter CY 2019 ESRD QIP
Data and the Removal of the Option for Facilities To Opt-Out of the
Extraordinary Circumstances Exception (ECE) Granted With Respect to
First and Second Quarter (CY) 2020 ESRD QIP Data
In section II.D.1. of this IFC, we are updating our regulations at
Sec. 413.178(d)(7) to state that a facility has opted out of the ECE
for COVID-19 with respect to the reporting of fourth quarter 2019 NHSN
data if the facility actually reported the data by the March 31, 2020
deadline but did not notify CMS that it would do so. Additionally, we
are removing the ability of facilities to opt-out of the ECE we granted
with respect to Q1 and Q2 2020 ESRD QIP data. These updates do does not
require facilities to complete any forms or submit any additional
information to receive an ECE, and therefore, the program does not
anticipate any change in burden associated with this IFC.
2. Updates to the Application of the HAC Reduction Program ECE Policy
in Response to the PHE for COVID-19
In section II.D.2. of this IFC, we are updating the ECE granted for
the HAC Reduction Program to not use Q1 and Q2 2020 data that were made
optional under the Guidance memo for scoring in the HAC Reduction
Program for scoring calculations in future program years (that is, the
FY 2022 and FY 2023 program years). This policy does not require
hospitals to complete any forms or submit any additional information to
receive an ECE, and therefore, the program does not anticipate any
change in burden associated with this IFC.
3. Update to the HRRP ECE Granted in Response to the PHE for COVID-19
In section II.D.3. of this IFC, we excepted the use of claims data
from the first and second quarters of CY 2020 from the HRRP because of
our concern that the data collected during this period may be greatly
impacted by the response to COVID-19, and therefore, may not be
reflective of a hospital's performance during this time due to concerns
with national comparability of the data. This update does not require
hospitals to complete any forms or submit any additional information,
and therefore, the program does not anticipate any change in burden
associated with this IFC.
4. Update to the Hospital VBP Program ECE Granted in Response to the
PHE for COVID-19
In section II.D.4. of this IFC, we are updating the ECE granted for
the Hospital VBP Program to not use Q1 and Q2 2020 data that was made
optional under the Guidance memo for scoring in the Hospital VBP
Program for the FY 2022 payment year. This change to the ECE policy
does not require hospitals to complete any forms or submit any
additional information, and therefore, the program does not anticipate
any change in burden associated with this IFC.
5. Revised Performance Period for the FY 2022 SNF VBP Program as a
Result of the ECE Granted for the PHE for COVID-19
As described in section II.D.5. of this IFC, we granted an ECE for
the PHE for COVID-19 to exclude qualifying claims from the claims-based
SNF 30-Day All-Cause Readmission Measure (SNFRM; NQF #2510) calculation
for the following periods: January 1, 2020 through March 31, 2020 (Q1
2020); and April 1, 2020 through June 30, 2020 (Q2 2020).
Because we are excluding qualifying claims from January 1, 2020
through June 30, 2020, we are adopting a revised performance period for
the FY 2022 SNF VBP Program Year in section II.D.5. of this IFC. The
revised performance period for the FY 2022 SNF VBP program will be
from: April 1, 2019 through December 31, 2019, and July 1, 2020 through
September 30, 2020.
Changing the performance period for a SNF VBP Program Year does not
require SNFs to complete any forms or submit any additional
information. Accordingly, the SNF VBP Program does not anticipate any
change in burden associated with this IFC.

J. Submission of Adjusted Premium Amounts for PPACA Risk Adjustment

Sections 153.610 and 153.710 provide that issuers of a risk
adjustment covered plan must provide HHS with access to risk adjustment
data through a dedicated distributed data environment, in a manner and
timeframe specified by HHS. In section II.G.2. of this IFC, we clarify
that, for purposes of 2020 benefit year risk adjustment data
submissions, issuers that choose to provide temporary premium credits
must submit the adjusted (that is, lower) plan premiums for those
months, instead of the

[[Page 54860]]

unadjusted plan premiums. We also clarify that CMS will require issuers
to submit adjusted plan premiums to their EDGE servers for all
enrollees whom the issuer has actually provided premium credits as a
reduction to 2020 benefit year premiums, even if these premium credits
were not provided in a manner consistent with the August 4, 2020 memo.
This IFC does not change any other aspect of the 2020 benefit year data
submission requirements for the HHS-operated risk adjustment program.
We do not believe that issuers who elect to provide these temporary
premium credits will incur additional operational burden associated
with EDGE server data submissions as a result of these requirements
because we expect issuers' premium reporting systems will already be
configured to enable issuers to upload the billable premiums actually
charged to enrollees for the applicable benefit year to the EDGE
server. Additionally, the current EDGE server operational guidance for
the risk adjustment program allows issuers to submit billable premium
changes so there will be no changes to the data submission rules.\89\
Therefore, the burden related to this information collection is
currently approved under OMB control number 0938-1155 (Standards
Related to Reinsurance, Risk Corridors, Risk Adjustment, and Payment
Appeals). The information collection request expires on February 23,
2021.
---------------------------------------------------------------------------

\89\ See EDGE Server Business Rules (ESBR) v16.0 Section 5.8
Premium Amounts, at https://www.regtap.info/uploads/library/DDC_ESBR_V16.0_052920_5CR_052920.pdf.
---------------------------------------------------------------------------

K. Medical Loss Ratio Premium Reporting Requirements

In section II.G.3. of this IFC, we are clarifying that issuers that
elect to provide temporary premium credits to consumers in 2020 must
account for these credits as reductions to premium for the applicable
months during 2020 when reporting earned premium for the applicable MLR
reporting year.\90\ We do not anticipate that this clarification will
require changes to the MLR Annual Reporting Form or change the
associated burden for issuers. As noted above, we expect issuers'
premium reporting systems will already be configured to enable issuers
to track the premiums actually charged to enrollees for the applicable
benefit year, enabling issuers that offer temporary premium credits to
accurately report the adjusted (that is, lower) amounts actually billed
to their enrollees on their respective MLR Annual Reporting Forms. The
burden related to this information collection is currently approved
under OMB control number 0938-1164 (Medical Loss Ratio Annual Reports,
MLR Notices, and Recordkeeping Requirements (CMS-10418)). The
information collection request expires on October 31, 2020.
---------------------------------------------------------------------------

\90\ Because the MLR and rebate calculations are based on 3
years of data, reporting earned premium for the 2020 benefit year
will impact the MLR and rebate calculations for the 2020 through
2022 reporting years. See section 2718(b)(1)(B)(ii) of the PHSA.
Also see 45 CFR 158.220(b).
---------------------------------------------------------------------------

L. Merit-Based Incentive Payment System (MIPS) Updates

In section II.I. of this IFC, for the 2020 performance year, we are
proposing to include in the MIPS assignment methodology for the CMS Web
Interface and CAHPS for MIPS survey the following additions due to the
PHE for COVID-19: (1) CPT codes: 99421, 99422, and 99423 (codes for
online digital E/M service (e-visit)), and 99441, 99442, and 99443
(codes for telephone E/M services); and (2) HCPCS codes: G2010 (code
for remote evaluation of patient video/images) and G2012 (code for
virtual check-in). We do not believe this proposal will impact the
number of beneficiaries selected for sampling, which will be used to
complete quality reporting via the CMS Web Interface or administer the
CAHPS for MIPS survey; however, this proposal could impact the number
of beneficiaries eligible to be sampled. Therefore, we do not
anticipate any change in burden or impact on clinicians.
In addition, we are: (1) Expanding the improvement activity
IA_ERP_3 titled ``COVID-19 Clinical Trial'' to also allow credit for
clinicians who participate in the care of patients diagnosed with
COVID-19 and simultaneously submit relevant clinical data to a clinical
data registry for ongoing or future COVID-19 research; (2) updating the
title; and (3) extending it through the CY 2021 performance period.
Because MIPS eligible clinicians are still required to submit the same
number of activities and the per response time for each activity is
uniform, we do not expect this proposal to affect our currently
approved information collection burden estimates in terms of neither
the number of estimated respondents nor the burden per response.

M. Summary of Burden in This IFC

Table 5 shows the burden and associated costs for sections IV.A.
through F. in this IFC.

Table 5--Burden and Associated Costs for the Provisions Included in This IFC
----------------------------------------------------------------------------------------------------------------
Burden hours
Information collection requests increase/ Cost (+/-) *
decrease (+/-) *
----------------------------------------------------------------------------------------------------------------
A. Laboratory Costs to Develop Mechanism to Track Results (one time cost). +539,168 +109,537,371
B. Laboratory Costs to Collect Results for Reporting (per day cost *)..... +231,072 +12,172,873
C. Laboratory Costs to Report Results (per day cost *).................... +231,072 +8,891,651
D. Laboratory Costs to Update Policies/Procedures (one time cost)......... +385,120 +42,648,189
E. AO/ES Costs to Update Standards (one time cost)........................ +270 +29,900
F. (a) AO/ES Costs to Update Policies/Procedures (one time cost).......... +135 +15,971
F. (b) AO/ES Costs to Report Laboratories to CMS for not Reporting Results +36 +86,980
-------------------------------------
Total................................................................. +1,386,873 +173,382,935
----------------------------------------------------------------------------------------------------------------
* Note that these are per day costs. For annual costs, see Table 9.

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

[[Page 54861]]

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 healthcare providers and health
insurance issuers maximum flexibility to minimize the spread of COVID-
19 among Medicare and Medicaid beneficiaries, consumers of health
insurance coverage in the individual and small group insurance markets,
healthcare 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
and consumers of health insurance coverage in the individual and small
group insurance markets suffering from COVID-19 will likely test the
capacity of the healthcare 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, and clinical
laboratories. Additionally, the policies and regulatory updates
implemented in this IFC will increase the affordability and support
continuity of health insurance coverage for consumers in the individual
and small group (or merged) market during the PHE for COVID-19.

B. Overall Impact

We have examined the potential 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 Social
Security 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, 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. For CLIA purposes, no
regulatory alternatives were considered as the CARES Act requires all
laboratories to reports SARS-CoV-2 test results. Only CLIA regulations
requiring laboratories to report SARS-CoV-2 test results were added/
revised.
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). As described in section IV. of this IFC (Collection of
Information Requirements) and this section, this IFC would be
economically significant within the meaning of section 3(f)(1) of the
Executive Order. We are adding Sec. Sec. 493.41 and 493.1100(a) to
require that, during the PHE for COVID-19, as defined in Sec. 400.200,
each laboratory that performs a test that is intended to detect SARS-
CoV-2 or to diagnose a possible case of COVID-19 must report SARS-CoV-2
test results in such form and manner, and at such timing and frequency,
as the Secretary may prescribe. These anticipated costs would result
from laboratories needing to develop a mechanism to collect and report
SARS-CoV-2 test results, update policies and procedures, update
software, and train personnel. In addition, AOs and Exempt States (ESs)
will also need to update their laboratory standards and policies and
procedures to comply with the new federal regulatory changes. We have
provided an assessment of the impact of estimated costs of these
changes in Tables 6 and 7.
Executive Order 13771, titled Reducing Regulation and Controlling
Regulatory Costs, was issued on January 30, 2017 and requires that the
costs associated with significant new regulations ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations.'' 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. For purposes of the RFA, we estimate that the
great majority of laboratories are small entities, either by being
nonprofit organizations or by meeting the Small Business Administration
definition of a small business (having revenues of less than $8.0
million to $41.5 million in any 1 year). For purposes of the RFA,
approximately 75 percent of laboratories performing SARS-CoV-2 testing
qualify as small entities. For purposes of this IFC, we expect that
approximately 30 percent (n=77,024) of the total CLIA certified
laboratories (n=256,747) could potentially be performing SARS-CoV-2
tests. Further, based on data from the CLIA website, we are estimating
that 75 percent of the laboratories have a CoW (n=57,768) and 25
percent have a Certificate of PPM, CoC, CoA, or CoR (n=19,256). Each
individual EUA test system authorized by the FDA specifies the settings
in which the tests are authorized to be used during the PHE for COVID-
19. Generally, COW and PPM laboratories include, but are not limited
to, the following types of facilities: Physician office laboratories;
pharmacies; skilled nursing/nursing facilities; and other types of
point-of-care facilities. Generally, we would consider these types of
laboratories to be small entities. Individuals and states are not
included in the definition of a small entity. All laboratories
performing SARS-CoV-2 testing are affected by this IFC, and the impact
is economically significant. Therefore, the Secretary has determined
that this IFC will have a significant economic impact on a substantial
number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a

[[Page 54862]]

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. There are
approximately 905 small rural hospitals in the U.S. Of the 905 small
rural hospitals, approximately 500 are subsection (d) hospitals paid
under IPPS and are subject to the HAC Reduction Program and HRRP. In
section II.D. of IFC, we are updating the ECE policy for the two
programs to allow the exclusion of data submitted for quarters impacted
by the PHE for COVID-19. We estimate that the impact of the exclusion
of data on scoring for small rural hospitals for the programs will be
dependent upon hospitals' individual performance and experience, but
that the exclusion of data will make small hospitals less likely to
receive measure scores or meet minimum eligible discharge requirements
for participation in the HAC Reduction Program and HRRP. All small
rural hospitals, that is, both subsection (d) and critical access
hospitals, often provide very limited laboratory services or may refer
all their testing to larger facilities. We are unable to estimate the
number of laboratories that support small rural hospitals, but do
expect that the rule will have a significant impact on small rural
hospitals. Therefore, the Secretary has determined that this rule will
have a significant impact on the operations of a substantial number of
small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any proposed rule, or any final rule preceded by a proposed
rule whose mandates require spending in any 1 year of $100 million in
1995 dollars, updated annually for inflation. In 2020, that threshold
is approximately $156 million. This IFC was is not preceded by a
general notice of proposed rulemaking, and thus the requirements of
UMRA do not apply.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a rule that imposes substantial
direct requirement costs on state and local governments, preempts state
law, or otherwise has federalism implications. Two states have exempt
status, which means we have determined that the state has enacted laws
relating to the laboratory requirements that are equal to or more
stringent than CLIA requirements and the state licensure program has
been approved by us. These two states, New York and Washington, would
need to update their standards, policies and procedures to maintain
their exempt status to require reporting to CMS those accredited/exempt
laboratories that have not reported SARS-CoV-2 test results as
required. In addition, these two states would need to develop a CMP
structure to impose CMPs that is equivalent to CMS and is based on
their updated standards. In order to determine compliance with the
reporting requirements, the State Agencies would be required to perform
additional surveys on 5 percent of CoW and 5 percent of PPM
laboratories. As previously stated, these two type of laboratories are
not routinely surveyed. The total number of CoW laboratories as of
March 2020 is 193,474. Five percent of 193,474 is 9,674 so for the
duration of the IFC (3 years), a total of 3,225 CoW surveys would need
to be performed annually across all State Agencies. The total number of
PPM laboratories as of March 2020 is 30,120. Five percent of 30,120 is
1,506 so for the 3 years that this IFC would be in place, a total of
502 PPM surveys would need to be performed annually across all State
Agencies. The combined number of these surveys that will need to be
performed annually over the 3 years of the timeframe of the IFC is
3,727 across all State Agencies. Over the 3 years that this IFC is in
place, one-third of the total number CoW and PPM laboratories would be
surveyed each year. This would ensure that a total of 5 percent of each
of these types of laboratories are surveyed during the duration of the
PHE for COVID-19 to determine if SARS-CoV-2 requirements are met.
Currently, there are no resources available to the State Agencies to
perform these additional surveys. Therefore, this IFC would have a
substantial direct effect on state or local governments. This IFC would
also have a direct effect on preempting state laboratory requirements
as they must change their current laboratory standards to remain equal
to or more stringent than Federal laws when finalized.

C. Detailed Economic Analysis of the Provisions of the IFC

1. Revised Enforcement Requirements for LTC Facilities
Section II.A. of this IFC which implements a policy for specifying
the CMP amounts tailored to noncompliance related to Sec. 483.80(g)(1)
and (2) (electronic reporting COVID-19 related data) will not result in
any additional financial burden for LTC providers if they remain
compliant in reporting. Following the May 8th effective date of this
reporting requirement, we began assessing the compliance for all 15,674
(data from Quality, Certification and Oversight Reports (QCOR) as of
August 11, 2020) Medicare and Medicaid certified nursing homes each
week and have found compliance has consistently increased week after
week. Based on data provided to CMS by the CDC, compliance with this
requirement has been greater than 98 percent since the reporting week
ending June 28, 2020. Although there has been unprecedented compliance
with the requirement to report, CMS has issued 2,507 citations for
noncompliance as of August 10, 2020, with corresponding CMPs imposed.
Financial impact will occur for facilities who are not compliant with
the new reporting requirement. We do not expect these requirements to
have a substantial economic impact or pose a financial burden to
nursing homes beyond that which has already been established by CMS's
existing enforcement regulations. This rule does not add new
requirements, but clarifies our process to impose penalties for a
failure to report for which compliance is assessed on a weekly basis,
which is different from how all other LTC requirements are reviewed.
CMS' enforcement authority remains unchanged under this IFC. Instead,
it clarifies the specific CMP penalty range for noncompliance with the
new COVID-19 related reporting requirements at Sec. 483.80(g)(1) and
(2). Furthermore, the penalty amounts are consistent with the lower
level penalty range available at Sec. 488.438(a)(1)(ii) in order to
encourage compliance and to discourage similar conduct in the future
without causing undue hardship that could impair a facility's ability
to minimize COVID-19 infections among its residents and staff. In
addition, the penalty is not aggregated but is increased only if future
compliance assessments reveal repeated violations. In the event that a
facility is unable to meet reporting requirements and/or experiences
financial hardship, a facility may utilize the Independent Informal
Dispute Resolution process under Sec. 488.431 to dispute the findings
and may submit a financial hardship request to CMS.

[[Page 54863]]

2. CoP Requirements for Hospitals and CAHs, and Requirements for LTC
Facilities
a. CoP Requirements for Hospitals and CAHs To Report COVID-19 Data as
Specified by the Secretary During the PHE for COVID-19
Section II.B. of this IFC revises the infection prevention and
control requirements for hospitals and CAHs 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 specified by the Secretary.
Many hospitals are already reporting data in a standardized format
voluntarily. As detailed in section IV.G. of this IFC, we currently
estimate the cost of these reporting requirements to total
$212,232,900. This estimate is likely an overestimate of the costs
associated with reporting because it assumes that all hospitals will
report manually. Efforts are underway to automate hospital and CAH
reporting that have the potential to significantly decrease reporting
burden and improve reliability. We anticipate that the need for
reporting will be temporary in direct relationship to the duration of
the PHE. Existing guidance on reporting, which may be revised in the
future, can be found at https://www.hhs.gov/sites/default/files/covid-19-faqs-hospitals-hospital-laboratory-acute-care-facility-data-reporting.pdf, and these guidance documents will be in CMS' 13891
portal. Data reported to the Secretary is used by Federal agencies and
states, to provide data for the unified hospital picture, as well as
guidance on the distribution of resources.
b. Requirement for Long-Term Care Facilities To Test Facility Staff and
Residents for COVID-19
Section II.J. of this IFC revises the infection control
requirements for LTC facilities at Sec. 483.80 to require facilities
to test their staff and residents for COVID-19 based on parameters set
forth by the Secretary. Based on data from CDC and states where similar
policies have already been implemented, we anticipate that this will
result in widespread testing and significant resource use, but catch
many cases that might otherwise go undetected. For example,
implementing universal testing in 11 LTC facilities in Maryland
increased the total number of detected cases in those facilities from
153 to 507.\91\ Costs incurred by facilities have potential to vary
drastically depending on the extent of outbreaks in their respective
communities, whether the facility has point-of-care testing, and the
size of each facility; however, for some of these facilities the cost
of testing may be less than the costs associated with lost productivity
and revenue due to unmitigated outbreaks. We solicit comments on our
cost estimates, as well as any additional costs associated with
acquiring reagents, test kits, or anything else we may not have
considered.
---------------------------------------------------------------------------

\91\ Bigelow BF, Tang O, Barshick B, et al. Outcomes of
Universal COVID-19 Testing Following Detection of Incident Cases in
11 Long-term Care Facilities. JAMA Intern Med. Published online July
14, 2020. doi:10.1001/jamainternmed.2020.3738.
---------------------------------------------------------------------------

Best practices for catching and eliminating these outbreaks, as
well as availability of the tools necessary to do so, is a quickly
changing landscape. As of late July, over 600 point-of-care antigen
testing devices had already been shipped to LTC facilities nationwide,
with plans to provide every facility with their own instrument(s) and
tests within 14 weeks.\92\ This method of testing effectively reduces
the cost-per-test from approximately $100 to only $20. These efforts to
provide every facility with these devices continue, but for the
purposes of our estimates below, we assume a cost of $60 per test; this
accounts for the potential cost of replacing the antigen testing
device, as well as the possibility that some facilities will choose to
verify negative results with lab testing. The cost of these testing
activities will ultimately depend on the extent of future outbreaks,
and how the best practices, and thus our parameters for universal
testing, evolve. We recognize that testing alone is not enough to
control, treat, and eliminate outbreaks of COVID-19. Providing safe
care is the inherent duty of all long term care facilities.
Implementing highly effective infection prevention and control
procedures, such as proper hand washing techniques and techniques for
donning and removing PPE, are expected to be part of everyday facility
procedures and do not impose an additional burden upon facilities. CDC
provides, and continually updates, their infection control guidance for
LTC facilities.\93\ This guidance recommends, among other things,
expanded viral testing of all residents if there is an outbreak in a
facility; cohorting residents in a COVID-19 care unit; assigning
dedicated staff to the aforementioned care unit; and additional
cleaning procedures. Although we do not have data to support exactly
how many facilities are fully prepared for intervention at this scale,
we assume that most facilities have made basic preparations in line
with current best practices. Acknowledging this uncertainty, we are
assuming the average facility requires intervention costing between 5
and 40 hours of the hourly wage of a registered nurse for each
additional round of testing, doubled to account for the cost of
overhead and fringe benefits. For facilities that are less prepared, a
different mix of staffing could provide additional support for a
similar cost.
---------------------------------------------------------------------------

\92\ https://www.cms.gov/files/document/covid-faqs-snf-testing.pdf.
\93\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html.
---------------------------------------------------------------------------

In Tables 6 and 7, we provide sensitivity analyses showing the
potential costs of universal testing in LTC facilities given these
unknown variables described above. All costs below are assumed to be in
addition to the current baseline testing activities; facilities that
are already performing tests that would be in compliance with these
testing requirements, or different parameters to trigger the testing
requirements, would impact the number of facilities affected as
detailed below. In the context of the Table 6, ``rounds of testing''
refers to the number of times each facility tests their entire staff
and resident population on an annual basis. In light of uncertainty,
this can be interpreted as the number of times the parameters set forth
by the Secretary are triggered; additional tests that may be necessary
to facilitate cohorting and identify new transmission events; or
additional tests to verify negative results. We note that if baseline
testing is not accounted for, benefits of this provision would be
overstated in addition to (this category of) costs.
---------------------------------------------------------------------------

\94\ For these estimates we assume the number of staff and
residents are evenly distributed across facilities. This $10 million
estimate is equal to: (approximately 3.2 million staff and residents
* 5 percent of facilities * $60 per test * 1 round of testing) +
(($37.24 cost for RN * 2 for fringe benefits and overhead) * 5 hours
* 1 round of testing).

[[Page 54864]]

Table 6--Sensitivity Analysis of Potential Costs of LTC Testing; Low Costs of Intervention
[In millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Facilities affected
-----------------------------------------------------------------------------------------------
Rounds of testing 5% 10% 25% 50% 75% 100%
-----------------------------------------------------------------------------------------------
775 1,550 3,874 7,748 11,621 15,495
--------------------------------------------------------------------------------------------------------------------------------------------------------
1....................................................... \94\ $10 $20 $50 $99 $149 $198
2....................................................... 20 40 99 198 297 396
3....................................................... 30 59 149 297 446 594
4....................................................... 40 79 198 396 594 792
5....................................................... 50 99 248 495 743 990
6....................................................... 59 119 297 594 891 1,188
7....................................................... 69 139 347 693 1,040 1,386
8....................................................... 79 158 396 792 1,188 1,584
9....................................................... 89 178 446 891 1,337 1,783
10...................................................... 99 198 495 990 1,485 1,981
11...................................................... 109 218 545 1,089 1,634 2,179
12...................................................... 119 238 594 1,188 1,783 2,377
13...................................................... 129 257 644 1,287 1,931 2,575
14...................................................... 139 277 693 1,386 2,080 2,773
15...................................................... 149 297 743 1,485 2,228 2,971
16...................................................... 158 317 792 1,584 2,377 3,169
17...................................................... 168 337 842 1,683 2,525 3,367
18...................................................... 178 357 891 1,783 2,674 3,565
19...................................................... 188 376 941 1,882 2,822 3,763
20...................................................... 198 396 990 1,981 2,971 3,961
--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 7--Sensitivity Analysis of Potential Costs of LTC Testing; High Costs of Intervention
[In millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Facilities affected
-----------------------------------------------------------------------------------------------
Rounds of testing 5% 10% 25% 50% 75% 100%
-----------------------------------------------------------------------------------------------
775 1,550 3,874 7,748 11,621 15,495
--------------------------------------------------------------------------------------------------------------------------------------------------------
1....................................................... * $12 $24 $60 $119 $179 $238
2....................................................... 24 48 119 238 358 477
3....................................................... 36 72 179 358 537 715
4....................................................... 48 95 238 477 715 954
5....................................................... 60 119 298 596 894 1,192
6....................................................... 72 143 358 715 1,073 1,431
7....................................................... 83 167 417 835 1,252 1,669
8....................................................... 95 191 477 954 1,431 1,908
9....................................................... 107 215 537 1,073 1,610 2,146
10...................................................... 119 238 596 1,192 1,788 2,384
11...................................................... 131 262 656 1,311 1,967 2,623
12...................................................... 143 286 715 1,431 2,146 2,861
13...................................................... 155 310 775 1,550 2,325 3,100
14...................................................... 167 334 835 1,669 2,504 3,338
15...................................................... 179 358 894 1,788 2,683 3,577
16...................................................... 191 382 954 1,908 2,861 3,815
17...................................................... 203 405 1,013 2,027 3,040 4,054
18...................................................... 215 429 1,073 2,146 3,219 4,292
19...................................................... 227 453 1,133 2,265 3,398 4,531
20...................................................... 238 477 1,192 2,385 3,577 4,769
--------------------------------------------------------------------------------------------------------------------------------------------------------
* For these estimates we assume the number of staff and residents are evenly distributed across facilities. This $12 million estimate is equal to:
(Approximately 3.2 million staff and residents * 5 percent of facilities * $60 per test * 1 round of testing) + (($37.24 cost for RN * 2 for fringe
benefits and overhead) * 40 hours * 1 round of testing). This upper-bound scenario accounts for the possibility that each round of testing and
intervention costs approximately $2,607 more per facility than the lower-bound scenario.

While we currently have no reason to believe testing will be
required anywhere near the extent demonstrated at the high end of this
range, we are presenting our cost estimates in this format to
underscore the unpredictable nature of this pandemic. Other potential
administrative costs associated with this provision are detailed in
section IV.G.2. of this IFC. We note that almost half of the potential
costs detailed above would be attributable to the testing of residents,
the vast majority of which are enrolled in Medicare, Medicaid, or both,
but Medicaid is the primary payer for approximately 62% of residents.
The Families First Coronavirus Response Act requires state Medicaid and
CHIP programs to cover any COVID-19-related testing and diagnostic
services; cost-sharing is not permitted for COVID-19 testing and
testing-related services. For residents in a Medicare covered Part A
skilled nursing facility

[[Page 54865]]

stay, testing is covered by the global PPS per diem rate that the long
term care facility receives. In addition, HHS recently announced
approximately $5 billion in Provider Relief Fund distributions under
the CARES Act for nursing homes. However, we would like to note that
LTC facilities are responsible for the costs of testing in order to
comply with the infection control requirements of this rule, regardless
of whether specific reimbursement is available from Medicare, Medicaid,
the Provider Relief Fund, or any other sources. Of this amount,
approximately $2.5 billion provides upfront funding to support
increased testing, staffing, and Personal Protective Equipment (PPE),
according to facilities' needs.\95\
---------------------------------------------------------------------------

\95\ https://www.hhs.gov/about/news/2020/08/07/hhs-announces-allocations-of-cares-act-provider-relief-fund-for-nursing-homes.html.
---------------------------------------------------------------------------

There is also potential for substantial benefits by catching and
eliminating COVID-19 outbreaks early in these facilities. HHS'
``Guidelines for Regulatory Impact Analysis'' explain in some detail
the concept of Quality Adjusted Life Years (QALYs).\96\ QALYs, when
multiplied by a monetary estimate such as the Value of a Statistical
Life Year (VSLY), are estimates of the value that people are willing to
pay for life-prolonging and life-improving health care interventions of
any kind (see sections 3.2 and 3.3 of the HHS Guidelines for a detailed
explanation). The QALY and VSLY amounts used in any estimate of overall
benefits is not meant to be precise, but instead are rough statistical
measures that allow an overall estimate of benefits expressed in
dollars.\97\
---------------------------------------------------------------------------

\96\ https://aspe.hhs.gov/pdf-report/guidelines-regulatory-impact-analysis.
\97\ We note that using such a measure to make coverage or
reimbursement determinations is prohibited by Section 1182(e) of the
Act. That prohibition does not apply to the situation addressed in
this IFC, where the purpose is not to determine medical coverage for
individual patients, but to measure overall success in life-saving
efforts to avert disease.
---------------------------------------------------------------------------

Research surrounding changes in health-related quality of life due
to the novel coronavirus, as well as the overall case fatality rate, is
still ongoing. Due to these substantial uncertainties, as well as the
unknown extent of future outbreaks, we have presented a threshold
analysis of life-saving benefits below. The following estimates assume
a the Value of a Statistical Life (VSL) of approximately $10.1 million
in 2020 as described in the aforementioned HHS Guidelines, inflated to
2019 dollars using the Implicit Price Deflators for Gross Domestic
Product. We note, as detailed in the HHS Guidelines, that there is
substantial uncertainty regarding how VSL varies with age,\98\ making
estimates of the VSL, which are typically developed using wage data for
working-age populations, potentially overstated in contexts such as
this for a novel coronavirus that disproportionately affects the
elderly; overstatement of the VSL would in turn lead to underestimation
of the fatal illnesses that would need to be avoided in order for the
regulatory provision to break even.
---------------------------------------------------------------------------

\98\ There is somewhat more clarity about willingness-to-pay
being positively correlated with length of life extension achieved
by a rule or other policy intervention--an outcome that is related
to age, but only somewhat loosely.
---------------------------------------------------------------------------

Consistent with the HHS Guidelines, we assume that the average
individual in these underlying VSL studies is approximately 40 years of
age, allowing us to calculate a VSLY of approximately $469,000 to
$818,000 at 3 and 7 percent discount rates respectively. Table 8, when
viewed alongside Table 7, demonstrates the number of years of life
extension needed to break-even with the corresponding costs of testing
and intervention. We reiterate, as discussed in our cost estimates,
that the break-even points below are subject to any flaws in our
assumptions of costs. Due to this uncertainty, these estimates are
based on our high estimate of the costs of intervention.

Table 8--Threshold Analysis of Avoided Fatal Illnesses, Due to LTC Testing and Associated Protective Actions, Required for the Regulatory Provision To
Break Even
[In life years]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Facilities affected
-----------------------------------------------------------------------------------------------
Rounds of testing 5% 10% 25% 50% 75% 100%
-----------------------------------------------------------------------------------------------
775 1,550 3,874 7,748 11,621 15,495
--------------------------------------------------------------------------------------------------------------------------------------------------------
1....................................................... 15-26 29-51 73-128 145-254 219-382 291-507
2....................................................... 29-51 59-102 145-254 291-507 438-763 583-1017
3....................................................... 44-77 88-153 219-382 438-763 657-1145 874-1524
4....................................................... 59-102 116-203 291-507 583-1017 874-1524 1166-2034
5....................................................... 73-128 145-254 364-635 729-1271 1093-1906 1457-2541
6....................................................... 88-153 175-305 438-763 874-1524 1312-2287 1749-3051
7....................................................... 101-177 204-356 510-889 1021-1780 1531-2669 2040-3558
8....................................................... 116-203 234-407 583-1017 1166-2034 1749-3051 2333-4068
9....................................................... 131-228 263-458 657-1145 1312-2287 1968-3432 2624-4575
10...................................................... 145-254 291-507 729-1271 1457-2541 2186-3812 2915-5082
11...................................................... 160-279 320-559 802-1398 1603-2795 2405-4193 3207-5592
12...................................................... 175-305 350-610 874-1524 1749-3051 2624-4575 3498-6099
13...................................................... 189-330 379-661 947-1652 1895-3304 2842-4957 3790-6609
14...................................................... 204-356 408-712 1021-1780 2040-3558 3061-5338 4081-7116
15...................................................... 219-382 438-763 1093-1906 2186-3812 3280-5720 4373-7626
16...................................................... 234-407 467-814 1166-2034 2333-4068 3498-6099 4664-8133
17...................................................... 248-433 495-863 1238-2160 2478-4321 3717-6481 4956-8643
18...................................................... 263-458 524-915 1312-2287 2624-4575 3935-6862 5247-9150
19...................................................... 278-484 554-966 1385-2415 2769-4829 4154-7244 5539-9659
20...................................................... 291-507 583-1017 1457-2541 2916-5084 4373-7626 5830-10167
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 54866]]

As described above, it is difficult to predict how many lives might
be saved as a result of these testing requirements, but the benefits of
catching, treating, and eliminating COVID-19 transmission and outbreaks
among the over 3.2 million employees and residents of LTC facilities
has potential to far exceed the costs. These benefits may be compounded
by the possibility of LTC staff unknowingly infecting their families
and respective communities, giving these testing requirements the
potential for far-reaching benefits beyond the walls of LTC facilities.
3. Clinical Laboratories
As discussed in section II.C of this IFC, these provisions could
impact all of the 256,747 CLIA-certified laboratories \99\ to some
extent. However, for purposes of this IFC, we estimate that
approximately 30 percent (n=77,024) of the total CLIA-certified
laboratories could potentially be performing SARS-CoV-2 testing.
Although complete data are not available to calculate all estimated
costs and benefits that would result from the changes in this IFC, we
are providing an analysis of the potential impact based on available
information and certain assumptions. Assuring a rapid and thorough
public health response to the COVID-19 pandemic relies on having
complete and comprehensive laboratory testing data, including
standardized test results, relevant demographic details, and additional
information that can improve both the public health response to SARS-
CoV-2 and treatment of COVID-19. These data can contribute to
understanding disease incidence and trends: Initiating epidemiologic
case investigations, assisting with contact tracing, assessing
availability and use of testing resources, and identifying supply chain
issues for reagents and other material. Laboratory testing data, in
conjunction with case reports and other data, also provide vital
guidance for mitigation and control activities. Implementation of the
requirements of this IFC will result in changes that are anticipated to
have both quantifiable and non-quantifiable impacts on laboratories. In
estimating the quantifiable impacts, we include costs to all
laboratories that could result from the need to meet the new CLIA
provisions.
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\99\ https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/cert_type.pdf.
---------------------------------------------------------------------------

a. Laboratory Costs To Develop a Mechanism To Track SARS-CoV-2 Test
Results
As discussed in section II.C. of this IFC, we are adding Sec. Sec.
493.41 and 493.1100(a) to require that, during the PHE for COVID-19, as
defined in Sec. 400.200, each laboratory that performs a test that is
intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-
19 must report SARS-CoV-2 test results in such form and manner, and at
such timing and frequency, as the Secretary may prescribe. We estimate
that approximately 30 percent (n=77,024) of the total CLIA-certified
laboratories \100\ could potentially be performing SARS-CoV-2 testing.
Each of these laboratories would incur a one-time cost for the time
needed to develop a mechanism to track and report SARS-CoV-2 test
results to be in compliance with this new requirement. As described in
Table 10, we estimate the one-time costs for all laboratories to
implement this requirement to be $78,240,979 to $109,537,371. (See
section IV.A. of this IFC.)
---------------------------------------------------------------------------

\100\ Includes Certificate of Waiver (CoW), Certificate of
Provider-Performed Microscopy (PPM), Certificate of Compliance (CoC)
and Certificate of Accreditation (CoA). Based on the CLIA web page
(https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/cert_type.pdf), the total number of laboratories as of
March 2020 are as follows: CoW, n=193,474; PPM n=30,120; CoC
n=17,432; CoA n=15,721; total =256,747.
---------------------------------------------------------------------------

b. Laboratory Costs To Collect Test Results for Reporting SARS-CoV-2
Test Results
As discussed in section II.C. of this IFC, we are adding Sec. Sec.
493.41 and 493.1100(a) to require that, during the PHE for COVID-19, as
defined in Sec. 400.200, each laboratory that performs a test that is
intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-
19 must report SARS-CoV-2 test results in such form and manner, and at
such timing and frequency, as the Secretary may prescribe. We estimate
that approximately 30 percent (n=77,024) of the total CLIA-certified
laboratories could potentially be performing SARS-CoV-2, and by this
rule would need to collect those test results to report them in
accordance with Sec. Sec. 493.41 and 493.1100(a). We estimate the
total cost would range from $2,028,812 to $12,172,873 per day to
collect and report the SARS-CoV-2 test results. Collection of test
results, as well as reporting would be an ongoing burden (including,
for example, the daily requirement to report, testing, volume, and
personnel) for each laboratory performing this type of testing. See
sections IV.B. and IV.D. of this IFC.
c. Laboratory Costs To Report SARS-CoV-2 Test Results
As discussed in section II.C. of this IFC, we are adding Sec. Sec.
493.41 and 493.1100(a) to require that, during the PHE for COVID-19, as
defined in Sec. 400.200, each laboratory that performs a test that is
intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-
19 must report SARS-CoV-2 test results in such form and manner, and at
such timing and frequency, as the Secretary may prescribe. We expect
that approximately 30 percent (n=77,024) of the total CLIA-certified
laboratories could potentially be performing SARS-CoV-2 and need to
report test results as required by the Secretary. Each of these
laboratories would incur a per day cost that would range from
$1,481,942 to $8,891,651. Reporting of test results would be an ongoing
burden for each laboratory performing this type of testing. (See to
section IV.C. of this IFC.)
d. Laboratory Costs To Update Policies and Procedures
We expect that the approximately 77,024 laboratories performing
SARS-CoV-2 testing would incur costs for the time needed to review the
revised reporting regulations and update their policies and procedures
to be in compliance. The total one-time burden per laboratory to review
and update affected policies and procedures is $42,648,189. (See
section IV.D. of this IFC.).
e. Accreditation Organization (AO) and Exempt State (ES) Costs To
Update Standards for Reporting SARS-CoV-2 Test Results
We would expect the seven approved AOs and two ESs would have to
review their standards, provide updates and submit the changes to CMS
related to SARS-CoV-2 test reporting for approval (9 organizations/
exempt states x 25 or 30 hours). We assume a one-time cost of from
$24,917 to $29,900 to identify the applicable legal obligations and to
develop the updated standards needed to reflect the new requirements
for SARS-CoV-2 testing. (See section IV E. of this IFC.)
f. Accreditation Organization (AO) and Exempt State (ES) Costs To
Update Policies and Procedures Related to Reporting Laboratories
Performing SARS-CoV-2 Testing That Do Not Report Results as Required
We would expect the seven approved AOs and two ESs would have to
develop policies and procedures related

[[Page 54867]]

to identifying laboratories that do not report SARS-CoV-2 test results
in order to report these laboratories to CMS. We are requiring the AOs/
ESs to report this information no later than 10 days after determining
a laboratory is not reporting results, as required under Sec. Sec.
493.41 and 493.1100(a). We assume a one-time cost would range from
$9,967 to $14,950. In addition, the AOs and ESs would be required to
report to CMS every 10 days those laboratories that have not reported
test results as required. The annual total number of times each AO and
ES is required to report to CMS is 36.5 (365 days/10 days). We estimate
a cost of $1,192 to 2,383 per 10 days which translates to an annual
total cost range of $43,508 to $86,980 to identify the laboratories and
submit the information to CMS. (See section IV.F. of this IFC.)
g. Enforcement, Imposition of Civil Money Penalties (CMPs)
CLIA/AO/ES surveyors typically perform approximately 16,577 surveys
annually.\101\ In addition, the new requirements would also require
3,727 COW and PPM laboratories to be surveyed annually for reporting
requirements. This is a total of 20,304 laboratories that would be
required to be surveyed annually and that may be impacted by the
imposition of CMPs for failing to report SARS-CoV-2 as required. We
estimate the fiscal impact of imposing CMPs on the estimated 20,304
laboratories performing this testing to be 20 percent of laboratories
performing SARS-CoV-2 testing. That is, 4,061 laboratories may have a
CMP imposed during the PHE for COVID-19 for not complying with the new
CLIA reporting requirements. While we believe initially the number of
laboratories having a CMP imposed would be significantly higher, we
postulate that the number of laboratories that will require the
imposition of a CMP for not reporting SARS-CoV-2 test results will
decrease during the PHE for COVID-19. We believe this decrease will be
a result of laboratories implementing the new requirements included in
this IFC.
---------------------------------------------------------------------------

\101\ As of March 2020, there were 17,432 Certificate of
Compliance and 15,721 Certificate of Accreditation laboratories.
CLIA surveys are performed biennially, so each year approximately
half of the laboratories would be surveyed (33,154 x 0.50 = 16,577).
---------------------------------------------------------------------------

We have no data indicating how imposition of the alternative
sanction of CMP would affect all laboratories. Prior to the changes
included in this IFC, CMPs were not imposed on CoW laboratories. In
2016, CMS imposed 30 CMPs for an average of $35,436 per laboratory; in
2017, 25 CMPs were imposed for an average of $72,237 per laboratory;
and in 2018, 24 CMPs were imposed for an average of $44,230 per
laboratory. The average total CMP imposed per fined laboratory over the
3-year period was $52,634. Based on our CMP requirements specific to
SARS-CoV-2 at 493.1834(d)(2)(iii), we anticipate that would be a range
of $1,000 per violation and $500 for each additional day of
noncompliance that test results are not reported. For example, we are
providing estimates for a minimum period of 3 days and a maximum period
of 30 days. We estimate that the total cost of CMPs imposed across all
laboratories collectively would range from $8,122,000 to $62,945,500
(4,061 laboratories x $2000 (3 days) or 4,061 laboratories x $15,500
(30 days)) for laboratories performing SARS-CoV-2 testing. (see Table
9).
h. Infrastructure
Several issues related to infrastructure have been identified (that
is, reporting test results, personnel) that will have an increased
burden on all laboratories. As stated above, for purposes of this IFC,
we expect that the approximately 30 percent (n=77,024) of the total
CLIA-certified laboratories could potentially be performing SARS-CoV-2
testing. Furthermore, based on data from the CLIA website \102\ we are
estimating that 75 percent of the 77,024 laboratories have a CoW
(n=57,768), and 25 percent have a Certificate of PPM, CoC, CoA, or CoR
(n=19,256). Generally, the types of facilities that have a CoW include,
but are not limited to: Physician office laboratories (45%); pharmacies
(5%); skilled nursing/nursing facility (6%); and other types of point-
of-care facilities.\103\ The facilities with PPM generally are
physician office laboratories (POL) or other types of point-of-care
(POC) facilities.\104\ We would also estimate that 45 percent of the
CoC, CoA, and CoR laboratories would be POLs. For these POL and POC
laboratories (n=66,433; 57,768 (CoWs) + 8,665 (other certificate
types)), we believe there would be infrastructure issues related to
implementing the new CLIA requirement that test results must be
reported as required by the Secretary. While reporting of SARS-CoV-2
test results affects all laboratories performing this testing, we
believe that meeting the new reporting requirements will be more
challenging for POL and POC laboratories given that this requirement
creates the need for systemic changes to the ability to report results.
If a laboratory does not currently have this capability to report in
the form and manner specified by the Secretary, they would need to
expeditiously ensure that the laboratory was able to submit the SARS-
CoV-2 test results in such form and manner, and at such timing and
frequency, as the Secretary may prescribe. Personnel would need to be
trained to implement the new CLIA reporting requirements related to
reporting of test results as prescribed by the Secretary. Further,
given that CoW laboratories are not required to meet any personnel
requirements, including laboratory director and testing personnel, this
could contribute a significant challenge for these laboratories. In
some cases, laboratory directors and testing personnel are not medical
professionals. CoW laboratories may not have individuals in place that
can train laboratory personnel to perform this task and may need to
outsource this training.
---------------------------------------------------------------------------

\102\ https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/cert_type.pdf.
\103\ https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/factype.pdf.
\104\ https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/factype.pdf.
---------------------------------------------------------------------------

While we do not have any data to be able estimate the fiscal burden
that it would cost to update a laboratory's current software to ensure
that the laboratory is able to report test results as required by the
Secretary, we can estimate the time it would take each laboratory to
implement the requirement. We are soliciting public comments related to
cost and time it would take laboratories to update their software to
ensure reporting of SARS-CoV-2 test results. It would take
approximately 3 hours to implement or update to the form and manner
prescribed by the Secretary and approximately 1 hour to train employees
to be in compliance with this new requirement. We estimate the burden
hours for updating and implementing the form would be 231,072 (77,024
laboratories x 3 hours). We estimate a database administrator/architect
(15-1245) would be needed to implement or update the software to report
the test results at an hourly wage of $46.21 per hour as published by
the BLS in 2019.\105\ The wage rate would be doubled to $92.42 to
include overhead and fringe benefits. The total estimated cost to
implement this requirement per laboratory would be $21,355,674 (77,024
laboratories x 3 hours x $92.42). We estimate a healthcare support
worker (31-9099) would train employees to collect the additional
required information at an hourly wage of $19.24 per hour as published
by the

[[Page 54868]]

BLS in 2019.\106\ We estimate that at least one new or existing
employee per laboratory (n=77,024) would need to be trained for the
purpose of collecting this information. The wage rate would be doubled
to $38.48 to include overhead and fringe benefits. The total estimated
cost would be $2,963,884 (77,024 laboratories x 1 hour x $38.48) per
day to collect the required information. Reporting of test results
would be an ongoing burden for each laboratory performing this type of
testing since laboratories would need to train employees to perform
this task as employees left and needed to be replaced. (See Table 9.)
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\105\ https://www.bls.gov/oes/current/oes_nat.htm.
\106\ https://www.bls.gov/oes/current/oes_nat.htm. 31-9099.

Table 9--Estimated Costs, Including Daily Costs, to Laboratories, Accreditation Organizations (AO) and Exempt States (ES) to Implement Reporting
Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hours Range of cost estimate for
Total number ------------------ implementing new CLIA
Regulatory change Affected group of affected Hourly cost Occupation requirements
entities Low High ---------------------------------
Low estimate High estimate
--------------------------------------------------------------------------------------------------------------------------------------------------------
Collect Laboratory Results \1\..... All Laboratories 77,024 $52.68 29-2010 0.5 3 $405,762,400 $2,434,574,600
Performing SARS-CoV-
2 Testing.
Reporting Costs \1\................ All Laboratories 77,024 38.48 31-9099 0.5 3 296,388,400 1,778,330,200
Performing SARS-CoV-
2 Testing.
AO/ES Reporting to CMS \2\......... AO/ES................ 9 66.20 15-1231 2 4 43,508 86,980
Imposition of CMPs................. All Laboratories 4,061 n/a n/a n/a n/a 8,122,000 62,945,500
Performing SARS-CoV-
2 Testing.
---------------------------------
Total Increased Cost........... ..................... .............. ........... ........... ....... ....... 710,316,308 4,275,937,280
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Please note that ``Collect Laboratory Results'' and ``Reporting Costs'' per day estimates are $2,028,812 to $12,172,873, and $1,481,942 to
$8,891,651, respectively. For purposes of the annual cost, we estimated 200 days/year for testing/reporting (365 days/year-104 weekend days-10 federal
holidays-approximately 50 days to account for laboratories who do not test 7 days/week.)
\2\ Reporting requirement of once every 10 days. Calculation factor is 36.5 (365 days per year/10 days). The total cost would range from $1,192 to
$2,383 (9 x 2 or 4 hours x $66.20) per 10 days for an annual total cost of $43,508 to $86,980 ($1,192 or $2,383 x 36.5).

Table 10--Estimated One-Time Costs to Laboratories, Accreditation Organizations (AO) and Exempt States (ES) to Implement Reporting Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hours Range of cost estimate for
------------------ implementing new CLIA
Total number requirements \1\ and Section
Regulatory change Affected group of affected Hourly cost Occupation 3202(b) of the CARES Act
entities Low High ---------------------------------
Low estimate High estimate
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tracking Mechanism................. All Laboratories 77,024 $203.16 11-9111, 15- 5 7 $78,240,979 $109,537,371
Performing SARS-CoV- [sup1] 1245
2 Testing.
Update Policies and Procedures..... All Laboratories 77,024 110.74 11-9111 5 n/a 42,648,189 42,648,189
Performing SARS-CoV-
2 Testing.
AO/ES Updating Standards........... AO/ES................ 9 110.74 11-9111 25 30 24,917 29,900
AO/ES Update Policies and AO/ES................ 9 110.74 11-9111 10 15 9,967 14,950
Procedures.
Infrastructure, Implementation of All Laboratories 77,024 92.42 15-1245 3 n/a 21,355,674 21,355,674
Test Reporting. Performing SARS-CoV-
2 Testing.
Infrastructure, Personnel.......... All Laboratories 77,024 38.48 31-9099 1 n/a 2,963,884 2,963,884
Performing SARS-CoV-
2 Testing.
---------------------------------

[[Page 54869]]

Total Increased Cost........... ..................... .............. ........... ........... ....... ....... 145,243,610 176,529,968
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ $101.58 hourly rate includes $55.37 (Management Level Employee) + $46.21 (Database Administrative/Architect). The wage rate would be double to
$203.16 to include overhead and fringe benefits.

4. Quality Reporting: Updates to the Extraordinary Circumstances
Exceptions (ECE) Granted for Four Value-Based Purchasing Programs in
Response to the PHE for COVID-19, and Update to the Performance Period
for the FY 2022 SNF VBP Program
a. Updates to ESRD QIP: Utilization of Fourth Quarter CY 2019 ESRD QIP
Data and the Removal of the Option for Facilities To Opt-Out of the
Extraordinary Circumstances Exception (ECE) Granted With Respect to
First and Second Quarter (CY) 2020 ESRD QIP Data a
In section II.D.1. of this IFC, we are updating our regulations at
42 CFR 413.178(d)(7) to state that a facility has opted out of the ECE
for COVID-19 with respect to the reporting of fourth quarter 2019 NHSN
data if the facility actually reported the data by the March 31, 2020
deadline but did not notify CMS that it would do so., Additionally, we
are removing the ability of facilities to opt-out of the ECE we granted
with respect to Q1 and Q2 2020 ESRD QIP data. These updates do not
require facilities to complete any forms or submit any additional
information to receive an ECE, and therefore, the program does not
anticipate any change in burden associated with this IFC.
The existing individual ECE request form policy is accounted for in
the currently approved Hospital Inpatient Reporting PRA package, OMB
control #0938-1022 (expiration date December 31, 2022). There are no
changes to the individual ECE request form policy and therefore no
changes to the burden associated with the ESRD QIP.
b. Updates to the Application of the HAC Reduction Program ECE Policy
in Response to the PHE for COVID-19
In section II.D.2. of this IFC, we are updating the ECE policy for
the HAC Reduction Program to not use Q1 and Q2 2020 data that were made
optional under the Guidance memo for scoring in the HAC Reduction
Program for scoring calculations in future program years (that is, the
FY 2022 and FY 2023 program years). The existing individual ECE request
form policy is accounted for in the currently approved Hospital
Inpatient Reporting PRA package, OMB control #0938-1022 (expiration
date December 31, 2022). There are no changes to the individual ECE
request form policy.
This update does not require hospitals to complete any forms or
submit any additional information to receive an ECE, and therefore, the
program does not anticipate any change in burden associated with this
IFC.
c. Update to the HRRP ECE Granted in Response to the PHE for COVID-19
In section II.D.3. of this IFC, we excepted the use of claims data
from the first and second quarters of CY 2020 from the Hospital
Readmissions Reduction Program because of our concern that the data
collected during this period may be greatly impacted by the response to
COVID-19, and therefore, may not be reflective of a hospital's
performance during this time. The existing individual ECE request form
policy is accounted for in the currently approved Hospital Inpatient
Reporting PRA package, OMB control #0938-1022 (expiration date December
31, 2022). There are no changes to the individual ECE request form
policy.
This update does not require hospitals to complete any forms or
submit any additional information, and therefore, the program does not
anticipate any change in burden associated with this IFC.
d. Update to the Hospital VBP Program ECE Granted in Response to the
PHE for COVID-19
Section II.D.4. of this IFC updates the Hospital VBP Program ECE
policy to allow CMS to exclude any data submitted regarding care
provided during the first and second quarter of CY 2020 from our
calculation of performance. This change does not require hospitals to
complete any forms or submit any additional information, and therefore,
the program does not anticipate any change in burden associated with
this IFC.
The existing individual ECE request form policy is accounted for in
the currently approved Hospital Inpatient Reporting PRA package, OMB
control #0938-1022 (expiration date December 31, 2022). There are no
changes to the individual ECE request form policy, and therefore, no
changes to the burden associated with the Hospital VBP Program.
e. Revised Performance Period for the FY 2022 SNF VBP Program as a
Result of the ECE Granted for the PHE for COVID-19
In section II.D.5. of this IFC, we are revising the performance
period for the FY 2022 SNF VBP Program Year.
In the FY 2021 SNF PPS final rule,\107\ we set out estimated
impacts of the FY 2021 SNF VBP Program. At this time, those estimates
represent our best approximation of the financial impact of the FY 2022
SNF VBP Program. We anticipate that the revised performance period
would not have a substantial impact on the estimated payback
percentage, Medicare savings, and amount of value-based incentive
payments redistributed to SNFs for the FY 2022 SNF VBP Program.
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\107\ The FY 2021 SNF PPS Final Rule can be accessed at https://www.federalregister.gov/documents/2020/08/05/2020-16900/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities.
---------------------------------------------------------------------------

5. NCD Procedural Volumes for Facilities and Practitioners to Maintain
Medicare Coverage
As discussed in section II.E. of this IFC, these provisions result
in no impact to the Medicare program because they will enable
facilities and practitioners to continue to be eligible for coverage
under the impacted NCDs during the PHE for COVID-19 that would have
been eligible for coverage if the COVID-

[[Page 54870]]

19 pandemic had not occurred. Without the pandemic, facilities and
practitioners would likely have continued to perform procedures
necessary to meet the procedural volume requirements specified in the
NCDs.
6. Limits on COVID-19 and Related Testing Without an Order
As discussed in section II.F. of this IFC, we are revising the
previous policy outlined in the May 8th COVID-19 IFC, which allowed for
broad COVID-19 testing for a single beneficiary without a physician or
other practitioner order by establishing that only a single COVID-19
diagnostic test and one of each other related test (as listed in the
May 8th COVID-19 IFC) without a treating physician or other
practitioner order is reasonable and necessary for Medicare payment.
This limitation on tests without a treating physician/practitioner
order will apply beginning on the effective date of this rule, and any
tests furnished prior to the effective date would not be considered for
purposes of the limit on tests without a physician or eligible ordering
practitioner order. We are also establishing a policy whereby the
orders of pharmacists and other practitioners that are allowed to order
laboratory tests in accordance with state scope of practice and other
pertinent laws can fulfill the requirements related to orders for
covered COVID-19 tests for Medicare patients. We do not anticipate that
these changes will affect overall Medicare expenditures over time
because they will better align the requirements for COVID-19 and
related testing with other Medicare laboratory tests, which require the
order of a physician or other practitioner based on the clinical needs
of the beneficiary.
6. Premium Reductions
a. PPACA Risk Adjustment
In this IFC, we clarify that issuers that choose to provide
temporary premium credits to consumers \108\ must report the adjusted
plan premium amount, taking into account the credits provided to
consumers as a reduction to premiums for the applicable months during
2020, for risk adjustment data submissions for the 2020 benefit year.
As stated in section IV. of this IFC, the Collection of Information
section, we do not believe that the clarifications regarding risk
adjustment reporting in this IFC would impose additional administrative
burden on health insurance issuers beyond the effort already required
to submit data to HHS for the purposes of operating risk adjustment.
Although we do not know how many states will permit issuers to provide
temporary credits to reduce 2020 premiums or how many issuers will
elect to do so, for purposes of this analysis, we estimate that
approximately 40 percent of risk adjustment covered plans in each state
market risk pool will provide these temporary premium credits to reduce
the premiums charged to enrollees to support continuity of coverage
during the PHE for COVID-19. We anticipate that reporting of the
adjusted, lower subscriber level premiums for 2020 benefit year risk
adjustment data submissions will lower the statewide average premium
used to determine risk adjustment transfer amounts under the state
payment transfer formula for the 2020 benefit year, thereby lowering
aggregate risk adjustment payments, aggregate risk adjustment charges,
and the overall magnitude of risk adjustment transfers, proportional to
the amount of temporary premium credits provided by issuers of risk
adjustment covered plans for the 2020 benefit year. Consistent with the
assumptions used for the MLR program, as described below, we estimate
that the aggregate impact of premium credits will result in an 8
percent reduction in annual premium, and a commensurate 8 percent
reduction in transfers for the 2020 benefit year.\109\ In the 2020
Payment Notice, HHS finalized the risk adjustment state payment
transfer formula under the HHS risk adjustment methodology for the 2020
benefit year, and reaffirmed that HHS will continue to operate the risk
adjustment program in a budget neutral manner. Therefore, there is no
net aggregate financial impact on health insurance issuers or the
federal government as a result of the risk adjustment provisions in
this IFC. However, while risk adjustment transfers are net neutral in
aggregate, we recognize that individual issuers may be financially
impacted by reduced transfers (either lower risk adjustment payments or
lower risk adjustment charges) if any issuer in the issuer's state
market risk pool provides premium credits to enrollees. The extent of
this impact will vary based on the number of issuers in a state market
risk pool that elect to provide the temporary premium credits, the
amount of these premium credits provided, as well as the market share
of the issuers that provide these premium credits. For example, issuers
with larger market share that offer large premium credits will affect
the statewide average premium more significantly. Although we recognize
the potential for financial impacts for individual issuers as a result
of the clarifications in this IFC, we believe that if HHS permitted
issuers that provided premium credits to submit unadjusted premiums for
the purposes of calculating risk adjustment, distortions could occur
which could also financially impact individual issuers. For example,
absent the requirement that issuers that offer premium credits report
the adjusted, lower premium amount for risk adjustment purposes, an
issuer with a large market share with higher-than-average risk
enrollees that provides temporary premium credits would inflate the
statewide average premium by submitting the higher, unadjusted premium
amount, thereby increasing its risk adjustment payment. In such a
scenario, a smaller issuer in the same state market risk pool that owes
a risk adjustment charge, and also provides premium credits to
enrollees, would pay a risk adjustment charge that is relatively higher
than it would have been if it were calculated based on a statewide
average that reflected the actual, reduced premium charged to enrollees
by issuers in the state market risk pool. Therefore, we believe that
requiring issuers that offer temporary premium credits for 2020
coverage to accurately report to the EDGE server the adjusted, lower
premium amounts actually charged to enrollees is most consistent with
existing risk adjustment program requirements and mitigates the
distortions that would occur if issuers that offer these temporary
premium credits did not report the actual amounts charged to enrollees,
while not imposing additional financial burden on issuers, as compared
to an approach that would permit issuers to report unadjusted premium
amounts.
---------------------------------------------------------------------------

\108\ See the CMS Memo ``Temporary Policy on 2020 Premium
Credits Associated with the COVID-19 Public Health Emergency,''
(August 4, 2020), available at https://www.cms.gov/CCIIO/Programs-and-Initiatives/Health-Insurance-Marketplaces/Downloads/Premium-Credit-Guidance.pdf.
\109\ The effects of the risk adjustment program, including
estimated outlays and receipts for the 2020 benefit year are
provided in the 2020 Payment Notice final rule, published in the
April 25, 2019, Federal Register (84 FR 17454 at 17551). We relied
on those estimates for purposes of estimating the impacts of the
temporary premium credit policies in this IFC.
---------------------------------------------------------------------------

b. Medical Loss Ratio
In this IFC, we clarify that issuers that choose to provide
temporary premium credits to consumers in 2020 must account for these
credits as reductions to premium for the applicable months during 2020
when reporting earned premium for the applicable MLR reporting
year.\110\ Although we do not

[[Page 54871]]

know how many states will permit issuers to provide temporary credits
to reduce premiums or how many issuers will elect to do so, for
purposes of this analysis, we estimate that approximately 40 percent of
issuers offering individual, small group or merged market health
insurance coverage will provide these temporary premium credits to
reduce the 2020 premiums charged to enrollees to support continuity of
coverage during the PHE for COVID-19. If an issuer provides temporary
premium credits and consequently reports a lower premium amount for MLR
purposes, the lower reported premium will have the effect of increasing
MLRs and reducing rebates. Although we do not know the number of
issuers that will provide these credits or the amount of premium
credits that issuers may elect to provide, for purposes of this
estimate we assume that such premium credits would on average
constitute approximately 8 percent of total annual premium (equivalent
to one month of premium). Based on data for the 2018 MLR reporting
year, we estimate that rebates for the 2020 MLR reporting year that
will be paid in 2021 to enrollees by issuers that choose to provide
temporary premium credits could decline by up to $500 million, as a
result of enrollees receiving a total of up to $2 billion in premium
relief up front in 2020. Because the MLR calculation uses three
consecutive years of data, there may be additional rebate decreases in
subsequent years, although the impact on rebates may be smaller as
issuers would likely account for the premium relief provided to
enrollees through these temporary premiums credits at the time they
develop premium rates for the 2021 and 2022 benefit years.
---------------------------------------------------------------------------

\110\ Because the MLR and rebate calculations are based on three
years of data, reporting earned premium for the 2020 benefit year
will impact the MLR and rebate calculations for the 2020 through
2022 reporting years. See section 2718(b)(1)(B)(ii) of the PHSA.
Also see 45 CFR 158.220(b).
---------------------------------------------------------------------------

7. Merit-Based Incentive Payment System (MIPS) Updates
In section II.I. of this IFC, for the 2020 MIPS performance period,
we are proposing to include in the MIPS assignment methodology for the
CMS Web Interface and CAHPS for MIPS survey the following additions due
to the PHE for COVID-19: (1) CPT codes: 99421, 99422, and 99423 (codes
for online digital E/M service (e-visit)), and 99441, 99442, and 99443
(codes for telephone E/M services); and (2) HCPCS codes: G2010 (code
for remote evaluation of patient video/images) and G2012 (code for
virtual check-in). We do not believe this proposal will impact the
number of beneficiaries selected for sampling, which will be used to
complete quality reporting via the CMS Web Interface or administer the
CAHPS for MIPS survey; however, this proposal could impact the number
of beneficiaries eligible to be sampled. Therefore, we do not
anticipate any change in burden or impact on clinicians. In addition,
we are modifying the improvement activity IA_ERP_3 previously titled
``COVID-19 Clinical Trial'' and continuing it through CY 2021. Because
MIPS eligible clinicians are still required to submit the same number
of activities and the per response time for each activity is uniform,
we do not expect this modification to affect our impact estimates in
terms of the number of estimated respondents or the burden of
compliance.
8. Addressing the Impact of COVID-19 on Part C and Part D Quality
Rating Systems
As discussed in section II.H. of this IFC, this policy allows us to
calculate the 2022 Star Ratings. We do not anticipate changes in the
distribution of ratings from prior years. Therefore, these provisions
result in no impact to the Medicare program since ratings will be
similar to prior years.

List of Subjects

42 CFR Part 410

Diseases, Health facilities, Health professions, Laboratories,
Medicare, Reporting and recordkeeping requirements, Rural areas, X-
rays.

42 CFR Part 413

Diseases, Health facilities, Medicare, Puerto Rico, Reporting and
recordkeeping requirements.

42 CFR Part 414

Administrative practice and procedure, Biologics, Drugs, Health
facilities, Health professions, Diseases, Medicare, Reporting and
recordkeeping requirements.

42 CFR Part 422

Administrative practice and procedure, Health facilities, Health
maintenance organizations (HMO), Medicare, Penalties, Privacy,
Reporting and recordkeeping requirements.

42 CFR Part 423

Administrative practice and procedure, Emergency medical services,
Health facilities, Health maintenance organizations (HMO), Health
professionals, Medicare, Penalties, Privacy, Reporting and
recordkeeping requirements.

42 CFR Part 482

Grant program-health, Hospitals, Medicaid, Medicare, Reporting and
recordkeeping requirements.

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 485

Grant programs-health, Health facilities, Medicaid, Reporting and
recordkeeping requirements.

42 CFR Part 488

Administrative practice and procedure, Health facilities, Health
professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 493

Administrative practice and procedure, Grant programs-health,
Health facilities, Laboratories, Medicaid, Medicare, Penalties,
Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
1. The authority citation for part 410 continues to read as follows:

Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.

0
2. Section 410.32 is amended by revising paragraph (a)(3) to read as
follows:

Sec. 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and
other diagnostic tests: Conditions.

(a) * * *
(3) Public Health Emergency exceptions. During the Public Health
Emergency for COVID-19, as defined in Sec. 400.200 of this chapter,
the order of a physician or other applicable practitioner is not
required for one otherwise covered diagnostic laboratory test for
COVID-19 and for one otherwise covered diagnostic laboratory test each
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 rule-out influenza virus or
related diagnosis. Subsequent otherwise covered COVID-19 and related
tests described in the previous sentence are reasonable and necessary
when ordered by a physician

[[Page 54872]]

or nonphysician practitioner in accordance with this paragraph (a), or
when ordered by a pharmacist or other healthcare professional who is
authorized under applicable state law to order diagnostic laboratory
tests. FDA-authorized COVID-19 serology tests are included as covered
tests subject to the same order requirements during the Public Health
Emergency for COVID-19, as defined in Sec. 400.20 of this chapter, 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.
* * * * *

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
3. 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
4. Section 413.178 is amended by revising paragraph (d)(7) to read as
follows:

Sec. 413.178 ESRD quality incentive program.

* * * * *
(d) * * *
(7) With the exception of first and second quarter 2020 ESRD QIP
data for which CMS granted an exception under paragraph (d)(6) of this
section, a facility that has been granted an exception to the data
submission requirements under paragraph (d)(6) of this section may
notify CMS that it will continue to submit data under paragraph (d)(1)
of this section by sending an email signed by the CEO or another
designated contact to the ESRD QIP mailbox at [email protected] Upon
receipt of an email under this clause, CMS will notify the facility in
writing that CMS is withdrawing the exception it previously granted to
the facility. With respect to fourth quarter 2019 ESRD QIP data for
which CMS granted an exception under paragraph (d)(6) of this section,
a facility is deemed to have met the requirements of this paragraph if
the facility actually submitted the data by the March 31, 2020
submission deadline but did not notify CMS that it would do so.
* * * * *

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
5. The authority citation for part 414 continues to read as follows:

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).

0
6. Section 414.1305 is amended by adding the definition of ``Primary
care services'' in alphabetical order to read as follows:

Sec. 414.1305 Definitions.

* * * * *
Primary care services for purposes of CMS Web Interface and the
CAHPS for MIPS survey beneficiary assignment means the set of services
identified by any of the following:
(1) CPT codes:
(i) 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 nursing facility,
excluding professional services furnished in a SNF for claims
identified by place of service (POS) modifier 31); 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 POS modifier
12); 99490 (code for chronic care management); and 99495 and 99496
(codes for transitional care management services);
(ii) Beginning with the 2020 MIPS payment year, 99487 and 99489
(codes for chronic care management); and
(iii) For the CY 2020 MIPS performance period and any subsequent
performance period that starts during the Public Health Emergency, as
defined in Sec. 400.200, 99421, 99422, and 99423 (codes for online
digital evaluation and management services (e-visit)); and 99441,
99442, and 99443 (codes for telephone evaluation and management
services).
(2) HCPCS codes:
(i) G0402 (code for the Welcome to Medicare visit); and G0438 and
G0439 (codes for the annual wellness visits); and
(ii) For the CY 2020 MIPS performance period and any subsequent
performance period that starts during the Public Health Emergency, as
defined in Sec. 400.200, G2010 (code for remote evaluation of patient
video/images); and G2012 (code for virtual check-in).
* * * * *

PART 422--MEDICARE ADVANTAGE PROGRAM

0
7. The authority citation for part 422 continues to read as follows:

Authority: 42 U.S.C. 1302 and 1395hh.

0
8. Section 422.166 is amended by adding paragraph (i)(11) to read as
follows:

Sec. 422.166 Calculation of Star Ratings.

* * * * *
(i) * * *
(11) Special rules for the 2022 Star Ratings only. For the 2022
Star Ratings only, CMS will not apply the provisions in paragraph
(i)(9) or (10) of this section and CMS will not exclude the numeric
values for affected contracts with 60 percent or more of their
enrollees in the FEMA-designated Individual Assistance area at the time
of the extreme and uncontrollable circumstance from the clustering
algorithms or from the determination of the performance summary and
variance thresholds for the Reward Factor.
* * * * *

PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

0
9. The authority citation for part 423 continues to read as follows:

Authority: 42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152,
and 1395hh.

0
10. Section 423.186 is amended by adding paragraph (i)(9) to read as
follows:

Sec. 423.186 Calculation of Star Ratings.

* * * * *
(i) * * *
(9) Special rules for the 2022 Star Ratings only. For the 2022 Star
Ratings only, CMS will not apply the provisions in paragraphs (i)(7) or
(8) of this section and CMS will not exclude the numeric values for
affected contracts with 60 percent or more of their enrollees in the
FEMA-designated Individual Assistance area at the time of the extreme
and uncontrollable circumstance from the clustering algorithms or from
the determination of the performance summary and variance thresholds
for the Reward Factor.
* * * * *

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

0
11. The authority citation for part 482 continues to read as follows:

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise
noted.

0
12. Section 482.42 is amended by adding paragraph (e) to read as
follows:

[[Page 54873]]

Sec. 482.42 Condition of participation: Infection prevention and
control and antibiotic stewardship programs.

* * * * *
(e) COVID-19 Reporting. During the Public Health Emergency, as
defined in Sec. 400.200 of this chapter, the hospital must report
information in accordance with a frequency as specified by the
Secretary on COVID-19 in a standardized format specified by the
Secretary.

PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES

0
13. The authority citation continues to read as follows:

Authority: 42 U.S.C. 1302, 1320, 1320a-7, 1395i, 1395hh and
1396r.

0
14. Section 483.80 is amended by adding paragraph (h) to read as
follows:

Sec. 483.80 Infection control.

* * * * *
(h) COVID-19 Testing. The LTC facility must test residents and
facility staff, including individuals providing services under
arrangement and volunteers, for COVID-19. At a minimum, for all
residents and facility staff, including individuals providing services
under arrangement and volunteers, the LTC facility must:
(1) Conduct testing based on parameters set forth by the Secretary,
including but not limited to:
(i) Testing frequency;
(ii) The identification of any individual specified in this
paragraph diagnosed with COVID-19 in the facility;
(iii) The identification of any individual specified in this
paragraph with symptoms consistent with COVID-19 or with known or
suspected exposure to COVID-19;
(iv) The criteria for conducting testing of asymptomatic
individuals specified in this paragraph, such as the positivity rate of
COVID-19 in a county;
(v) The response time for test results; and
(vi) Other factors specified by the Secretary that help identify
and prevent the transmission of COVID-19.
(2) Conduct testing in a manner that is consistent with current
standards of practice for conducting COVID-19 tests;
(3) For each instance of testing:
(i) Document that testing was completed and the results of each
staff test; and
(ii) Document in the resident records that testing was offered,
completed (as appropriate to the resident's testing status), and the
results of each test.
(4) Upon the identification of an individual specified in this
paragraph with symptoms consistent with COVID-19, or who tests positive
for COVID-19, take actions to prevent the transmission of COVID-19.
(5) Have procedures for addressing residents and staff, including
individuals providing services under arrangement and volunteers, who
refuse testing or are unable to be tested.
(6) When necessary, such as in emergencies due to testing supply
shortages, contact state and local health departments to assist in
testing efforts, such as obtaining testing supplies or processing test
results.
* * * * *

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

0
15. The authority citation for part 485 continues to read as follows:

Authority: 42 U.S.C. 1302 and 1395hh.

0
16. Section 485.640 is amended by adding paragraph (d) to read as
follows:

Sec. 485.640 Condition of participation: Infection prevention and
control and antibiotic stewardship programs.

* * * * *
(d) COVID-19 Reporting. During the Public Health Emergency, as
defined in Sec. 400.200 of this chapter, the CAH must report
information in accordance with a frequency as specified by the
Secretary on COVID-19 in a standardized format specified by the
Secretary.

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

0
17. The authority citation for part 488 continues to read as follows:

Authority: 42 U.S.C. 1302 and 1395hh.

0
18. Section 488.447 is added to read as follows:

Sec. 488.447 Civil Money Penalties imposed for failure to comply with
42 CFR 483.80(g)(1) and (2).

(a) CMS may impose a civil money penalty for noncompliance with the
requirements at Sec. 483.80(g)(1) and (2) of this chapter as follows:
(1) Minimum. A minimum of $1,000 for the first occurrence.
(2) Increased amount. An amount equal to $500 added to the
previously imposed civil money penalty amount for each subsequent
occurrence, not to exceed the maximum amount set forth in Sec.
488.408(d)(1)(iii).
(b) The penalty amounts in this section will be adjusted annually
under 45 CFR part 102.
(c) Compliance with the requirements at Sec. 483.80(g)(1) and (2)
of this chapter will be assessed weekly. Facilities found out of
compliance with Sec. 483.80(g)(1) and (2) of this chapter are not
required to submit a plan of correction as indicated in Sec.
488.408(f)(1).
(d) This section is in effect during and the Public Health
Emergency (PHE), as defined in Sec. 400.200 of this chapter, and will
continue for up to one year after the end of the PHE.

PART 493--LABORATORY REQUIREMENTS

0
19. The authority citation for part 493 is revised to read as follows:

Authority: 42 U.S.C. 263a, 1302, 1395x(e), the sentence
following 1395x(s)(11) through 1395x(s)(16)).

0
20. Section 493.2 is amended by revising the definition of ``Condition
level requirements'' to read as follows:

Sec. 493.2 Definitions.

* * * * *
Condition level requirements means any of the requirements
identified as ``conditions'' in Sec. 493.41 and subparts G through Q
of this part.
* * * * *

0
21. Section 493.41 is added to subpart B to read as follows:

Sec. 493.41 Condition: Reporting of SARS-CoV-2 test results.

During the Public Health Emergency, as defined in Sec. 400.200 of
this chapter, each laboratory that performs a test that is intended to
detect SARS-CoV-2 or to diagnose a possible case of COVID-19
(hereinafter referred to as a ``SARS-CoV-2 test'') must report SARS-
CoV-2 test results to the Secretary in such form and manner, and at
such timing and frequency, as the Secretary may prescribe.

0
22. Section 493.555 is amended by adding paragraph (c)(6) to read as
follows:

Sec. 493.555 Federal review of laboratory requirements.

* * * * *
(c) * * *
(6) Notify CMS within 10 days of any conditional level deficiency
under Sec. Sec. 493.41 or 493.1100(a).

0
23. Section 493.1100 is amended by adding paragraph (a) and reserving
paragraph (b) to read as follows:

Sec. 493.1100 Condition: Facility administration.

* * * * *
(a) Reporting of SARS-CoV-2 test results. During the Public Health
Emergency, as defined in Sec. 400.200 of this chapter, each laboratory
that performs a test that is intended to detect SARS-CoV-2 or to
diagnose a possible

[[Page 54874]]

case of COVID-19 (hereinafter referred to as a ``SARS-CoV-2 test'')
must report SARS-CoV-2 test results to the Secretary in such form and
manner, and at such timing and frequency, as the Secretary may
prescribe.
(b) [Reserved]

0
24. Section 493.1804 is amended by revising paragraph (c)(1) to read as
follows:

Sec. 493.1804 General considerations.

* * * * *
(c) * * *
(1) CMS may impose alternative sanctions in lieu of, or in addition
to principal sanctions. (Except for a condition level deficiency under
Sec. Sec. 493.41 or 493.1100(a), CMS does not impose alternative
sanctions on laboratories that have certificates of waiver because
those laboratories are not routinely inspected for compliance with
condition-level requirements.)
* * * * *

0
25. Section 493.1834 is amended by adding paragraph (d)(2)(iii) to read
as follows:

Sec. 493.1834 Civil money penalty.

* * * * *
(d) * * *
(2) * * *
(iii) For a condition level deficiency under Sec. Sec. 493.41 or
493.1100(a), the penalty amount is $1,000 for the first day of
noncompliance and $500 for each additional day of noncompliance.
* * * * *

Dated: August 14, 2020.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: August 21, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-19150 Filed 8-27-20; 4:15 pm]
BILLING CODE 4120-01-P