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Rule2021-23831

Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination

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Published

November 5, 2021

Effective

November 5, 2021

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

This interim final rule with comment period revises the requirements that most Medicare- and Medicaid-certified providers and suppliers must meet to participate in the Medicare and Medicaid programs. These changes are necessary to help protect the health and safety of residents, clients, patients, PACE participants, and staff, and reflect lessons learned to date as a result of the COVID-19 public health emergency. The revisions to the requirements establish COVID-19 vaccination requirements for staff at the included Medicare- and Medicaid-certified providers and suppliers.

Full Text

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<title>Federal Register, Volume 86 Issue 212 (Friday, November 5, 2021)</title>
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[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Rules and Regulations]
[Pages 61555-61627]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23831]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 416, 418, 441, 460, 482, 483, 484, 485, 486, 491 and
494

[CMS-3415-IFC]
RIN 0938-AU75

Medicare and Medicaid Programs; Omnibus COVID-19 Health Care
Staff Vaccination

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 revises the
requirements that most Medicare- and Medicaid-certified providers and
suppliers must meet to participate in the Medicare and Medicaid
programs. These changes are necessary to help protect the health and
safety of residents, clients, patients, PACE participants, and staff,
and reflect lessons learned to date as a result of the COVID-19 public
health emergency. The revisions to the requirements establish COVID-19
vaccination requirements for staff at the included Medicare- and
Medicaid-certified providers and suppliers.

DATES:
Effective date: These regulations are effective on November 5,
2021.
Implementation dates: The regulations included in Phase 1 [42 CFR
416.51(c) through (c)(3)(i) and (c)(3)(iii) through (x), 418.60(d)
through (d)(3)(i) and (d)(3)(iii) through (x), 441.151(c) through
(c)(3)(i) and (c)(3)(iii) through (x), 460.74(d) through (d)(3)(i) and
(d)(3)(iii) through (x), 482.42(g) through (g)(3)(i) and (g)(3)(iii)
through (x), 483.80(d)(3)(v) and 483.80(i) through (i)(3)(i) and
(i)(3)(iii) through (x), 483.430(f) through (f)(3)(i) and (f)(3)(iii)
through (x), 483.460(a)(4)(v), 484.70(d) through (d)(3)(i) and
(d)(3)(iii) through (x), 485.58(d)(4), 485.70(n) through (n)(3)(i) and
(n)(3)(iii) through (x), 485.640(f) through (f)(3)(i) and (f)(3)(iii)
through (x), 485.725(f) through (f)(3)(i) through (f)(3)(iii) through
(x), 485.904(c) through (c)(3)(i) and (c)(3)(iii) through (x),
486.525(c) through (c)(3)(i) and (c)(3)(iii) through (x), 491.8(d)
through (d)(3)(i) and (d)(3)(iii) through (x), 494.30(b) through
(b)((3)(i) and (b)(3)(iii) through (x) must be implemented by December
6, 2021.
The regulations included in Phase 2 [42 CFR 416.51(c)(3)(ii),
418.60(d)(3)(ii), 441.151(c)(3)(ii), 460.74(d)(3)(ii),
482.42(g)(3)(ii), 483.80(i)(3)(ii), 483.430(f)(3)(ii),
484.70(d)(3)(ii), 485.70(n)(3)(ii), 485.640(f)(3)(ii),
485.725(f)(3)(ii), 485.904(c)(3)(ii), 486.525(c)(3)(ii),
491.8(d)(3)(ii), 494.30(b)(3)(ii)] must be implemented by January 4,
2022. Staff who have completed a primary vaccination series by this
date are considered to have met these requirements, even if they have
not yet completed the 14-day waiting period required for full
vaccination.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on January 4, 2022.

ADDRESSES: In commenting, please refer to file code CMS-3415-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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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-3415-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.

[[Page 61556]]

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-3415-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:
For press inquiries: CMS Office of Communications, Department of
Health and Human Services; email <a href="/cdn-cgi/l/email-protection#ee9e9c8b9d9dae8d839dc086869dc0898198">[email&#160;protected]</a>.
For technical inquiries: Contact CMS Center for Clinical Standards
and Quality, Department of Health and Human Services, (410) 786-6633.

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: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments. CMS will not post on <a href="http://Regulations.gov">Regulations.gov</a> public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.

I. Background

The Centers for Medicare & Medicaid Services (CMS) establishes
health and safety standards, known as the Conditions of Participation,
Conditions for Coverage, or Requirements for Participation for 21 types
of providers and suppliers, ranging from hospitals to hospices and
rural health clinics to long term care facilities (including skilled
nursing facilities and nursing facilities, collectively known as
nursing homes). Most of these providers and suppliers are regulated by
this interim final rule with comment period (IFC). Specifically, this
IFC directly regulates the following providers and suppliers, listed in
the numerical order of the relevant CFR sections being revised in this
rule:

<bullet> Ambulatory Surgical Centers (ASCs) (Sec. 416.51)
<bullet> Hospices (Sec. 418.60)
<bullet> Psychiatric residential treatment facilities (PRTFs) (Sec.
441.151)
<bullet> Programs of All-Inclusive Care for the Elderly (PACE) (Sec.
460.74)
<bullet> Hospitals (acute care hospitals, psychiatric hospitals,
hospital swing beds, long term care hospitals, children's hospitals,
transplant centers, cancer hospitals, and rehabilitation hospitals/
inpatient rehabilitation facilities) (Sec. 482.42)
<bullet> Long Term Care (LTC) Facilities, including Skilled Nursing
Facilities (SNFs) and Nursing Facilities (NFs), generally referred to
as nursing homes (Sec. 483.80)
<bullet> Intermediate Care Facilities for Individuals with Intellectual
Disabilities (ICFs-IID) (Sec. 483.430)
<bullet> Home Health Agencies (HHAs) (Sec. 484.70)
<bullet> Comprehensive Outpatient Rehabilitation Facilities (CORFs)
(Sec. Sec. 485.58 and 485.70)
<bullet> Critical Access Hospitals (CAHs) (Sec. 485.640)
<bullet> Clinics, rehabilitation agencies, and public health agencies
as providers of outpatient physical therapy and speech-language
pathology services (Sec. 485.725)
<bullet> Community Mental Health Centers (CMHCs) (Sec. 485.904)
<bullet> Home Infusion Therapy (HIT) suppliers (Sec. 486.525)
<bullet> Rural Health Clinics (RHCs)/Federally Qualified Health Centers
(FQHCs) (Sec. 491.8)
<bullet> End-Stage Renal Disease (ESRD) Facilities (Sec. 494.30)

This IFC directly applies only to the Medicare- and Medicaid-
certified providers and suppliers listed above. It does not directly
apply to other health care entities, such as physician offices, that
are not regulated by CMS. Most states have separate licensing
requirements for health care staff and health care providers that would
be applicable to physician office staff and other staff in small health
care entities that are not subject to vaccination requirements under
this IFC. We have not included requirements for Organ Procurement
Organizations or Portable X-Ray suppliers, as these only provide
services under contract to other health care entities and would thus be
indirectly subject to the vaccination requirements of this rule, as
discussed in section II.A.1. of this rule. We note that entities not
covered by this rule may still be subject to other State or Federal
COVID-19 vaccination requirements, such as those issued by Occupational
Safety and Health Administration (OSHA) for certain employers.
Currently, the United States (U.S.) is responding to a public
health emergency (PHE) of respiratory disease caused by a novel
coronavirus that has now been detected in more than 190 countries
internationally, all 50 States, the District of Columbia, and all 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 Secretary of the Department of Health and Human Services
(Secretary) determined that a PHE exists for the U.S. (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, the President
of the United States declared the COVID-19 pandemic a national
emergency. The January 31, 2020 determination that a PHE for COVID-19
exists and has existed since January 27, 2020, lasted for 90 days, and
was renewed on April 21, 2020; July 23, 2020; October 2, 2020; January
7, 2021; April 15, 2021; July 19, 2021; and October 18, 2021. Pursuant
to section 319 of the PHSA, the determination that a PHE continues to
exist may be renewed at the end of each 90-day period.\1\
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\1\ <a href="https://www.phe.gov/emergency/events/COVID19/Pages/2019-Public-Health-and-Medical-Emergency-Declarations-and-Waivers.aspx">https://www.phe.gov/emergency/events/COVID19/Pages/2019-Public-Health-and-Medical-Emergency-Declarations-and-Waivers.aspx</a>.
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COVID-19 has had significant negative health effects--on
individuals, communities, and the nation as a whole. Consequences for
individuals who have COVID-19 include morbidity, hospitalization,
mortality, and post-COVID conditions (also known as long COVID). As of
mid-October 2021, over 44 million COVID-19 cases, 3 million new COVID-
19 related hospitalizations, and 720,000 COVID-19 deaths have been
reported in the U.S.\2\ Indeed, COVID-19 has overtaken the 1918
influenza pandemic as the deadliest disease in American history.\3\
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\2\ <a href="https://covid.cdc.gov/covid-data-tracker#datatracker-home">https://covid.cdc.gov/covid-data-tracker#datatracker-home</a>.
\3\ <a href="https://www.statnews.com/2021/09/20/covid-19-set-to-overtake-1918-spanish-flu-as-deadliest-disease-in-american-history">https://www.statnews.com/2021/09/20/covid-19-set-to-overtake-1918-spanish-flu-as-deadliest-disease-in-american-history</a>.

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[[Page 61557]]

Given recent estimates of undiagnosed infections and under-reported
deaths, these figures likely underestimate the full impact.\4\ In
addition, these figures fail to capture the significant, detrimental
effects of post-acute illness, including nervous system and
neurocognitive disorders, cardiovascular disorders, gastrointestinal
disorders, and signs and symptoms related to poor general well-being,
including malaise, fatigue, musculoskeletal pain, and reduced quality
of life. Recent estimates suggest more than half of COVID-19 survivors
experienced post-acute sequelae of COVID-19 6 months after recovery.\5\
The individual and public health ramifications of COVID-19 also extend
beyond the direct effects of COVID-19 infections. Several studies have
demonstrated significant mortality increases in 2020, beyond those
attributable to COVID-19 deaths. In some percentage, this could be a
problem of misattribution (for example, the cause of death was
indicated as ``heart disease'' but in fact the true cause was
undiagnosed COVID-19), but some proportion are also believed to reflect
increases in other causes of death that are sensitive to decreased
access to care and/or increased mental/emotional strain. One paper
quantifies the net impact (direct and indirect effects) of the pandemic
on the U.S. population during 2020 using three metrics: excess deaths,
life expectancy, and total years of life lost. The findings indicate
there were 375,235 excess deaths, with 83 percent attributable to
direct, and 17 percent attributable to indirect effects of COVID-19.
The decrease in life expectancy was 1.67 years, translating to a
reversion of 14 years in historical life expectancy gains. Total years
of life lost in 2020 was 7,362,555 across the U.S. (73 percent directly
attributable, 27 percent indirectly attributable to COVID-19), with
considerable heterogeneity at the individual State level.\6\
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\4\ <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8354557/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8354557/</a>.
\5\ <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784918">https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784918</a>.
\6\ <a href="https://pubmed.ncbi.nlm.nih.gov/34469474/">https://pubmed.ncbi.nlm.nih.gov/34469474/</a>.
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One analysis published in February 2021 found that Black and Latino
Americans have experienced a disproportionate burden of COVID-19
morbidity and mortality, reflecting persistent structural inequalities
that increase risk of exposure to COVID-19 and mortality risk for those
infected. The authors projected that COVID-19 would reduce U.S. life
expectancy in 2020 by 1.13 years. Furthermore, the estimated reduction
for Black and Latino populations is 3-4 times the estimate for the
White population, reversing over 10 years of progress in reducing the
gaps in life expectancy between Black and White populations and
reducing the Latino mortality advantage by over 70 percent. The study
further expects that reductions in life expectancy may persist because
of continued COVID-19 mortality and term health, social, and economic
impacts of the pandemic.\7\ Because SARS-CoV-2, the virus that causes
COVID-19 disease, is highly transmissible,\8\ Centers for Disease
Control and Prevention (CDC) has recommended, and CMS reiterated, that
health care providers and suppliers implement robust infection
prevention and control practices, including source control measures,
physical distancing, universal use of personal protective equipment
(PPE), SARS-CoV-2 testing, environmental controls, and patient
isolation or quarantine.9 10 11 12 Available evidence
suggests these infection prevention and control practices have been
highly effective when implemented correctly and consistently.\13\ \14\
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\7\ Andrasfay, T., & Goldman, N. (2021). Reductions in 2020 US
life expectancy due to COVID-19 and the disproportionate impact on
the Black and Latino populations. Proceedings of the National
Academy of Sciences of the United States of America, 118(5),
e2014746118. <a href="https://doi.org/10.1073/pnas.2014746118">https://doi.org/10.1073/pnas.2014746118</a> Accessed 10/17/
2021.
\8\ <a href="https://www.npr.org/sections/goatsandsoda/2021/08/11/1026190062/covid-delta-variant-transmission-cdc-chickenpox">https://www.npr.org/sections/goatsandsoda/2021/08/11/1026190062/covid-delta-variant-transmission-cdc-chickenpox</a>.
\9\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html">https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html</a>.
\10\ <a href="https://www.cms.gov/files/document/qso-21-08-nltc.pdf">https://www.cms.gov/files/document/qso-21-08-nltc.pdf</a>.
\11\ <a href="https://www.cms.gov/files/document/qso-21-07-psych-hospital-prtf-icf-iid.pdf">https://www.cms.gov/files/document/qso-21-07-psych-hospital-prtf-icf-iid.pdf</a>.
\12\ <a href="https://www.cms.gov/files/document/qso-20-38-nh-revised.pdf">https://www.cms.gov/files/document/qso-20-38-nh-revised.pdf</a>.
\13\ <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2770287">https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2770287</a>.
\14\ <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2777317">https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2777317</a>.
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Studies have also shown, however, that consistent adherence to
recommended infection prevention and control practices can prove
challenging--and those lapses can place patients in
jeopardy.15 16 17 18 A retrospective analysis from England
found up to 1 in 6 SARS-CoV-2 infections among hospitalized patients
with COVID-19 in England during the first 6 months of the pandemic
could be attributed to healthcare-associated transmission.\19\ In
outbreaks reported from acute care settings in the U.S. following
implementation of universal masking, unmasked exposures to other health
care workers were frequently implicated.\20\ A retrospective cohort
study of health care staff behaviors, exposures, and cases between June
and December 2020 in a large health system found more employees were
exposed via coworkers than patients--and secondary cases among
employees typically followed unmasked interactions with infected
colleagues (for example, convening in breakrooms without proper source
control).\21\ The same study found that cases of health care worker
infection associated with patient exposures could often be attributed
to failure to adhere to PPE requirements (for example, eye protection).
Past experience with influenza, and available evidence, suggest that
vaccination of health care staff offers a critical layer of protection
against healthcare-associated COVID-19 (HA-COVID-19). For example,
evidence has shown that influenza vaccination of health care staff is
associated with declines in nosocomial influenza in hospitalized
patients,22 23 24 and among nursing home
residents.25 26 27 28 29 30 31

[[Page 61558]]

As a result, CDC, the Society for Healthcare Epidemiology of America,
and others recommend--and a number of states require-- annual influenza
vaccination for health care staff.32 33 34
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\15\ <a href="https://www.pnas.org/content/pnas/118/1/e2015455118.full.pdf">https://www.pnas.org/content/pnas/118/1/e2015455118.full.pdf</a>.
\16\ <a href="https://jamanetwork.com/journals/jamanetworkopen/article-abstract/2782430">https://jamanetwork.com/journals/jamanetworkopen/article-abstract/2782430</a>.
\17\ <a href="https://www.medrxiv.org/content/10.1101/2021.09.08.21263057v1">https://www.medrxiv.org/content/10.1101/2021.09.08.21263057v1</a>.
\18\ <a href="https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003816">https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003816</a>.
\19\ <a href="https://www.medrxiv.org/content/10.1101/2021.02.16.21251625v1">https://www.medrxiv.org/content/10.1101/2021.02.16.21251625v1</a>.
\20\ <a href="https://jamanetwork.com/journals/jama/fullarticle/2773128">https://jamanetwork.com/journals/jama/fullarticle/2773128</a>.
\21\ <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8349432/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8349432/</a>.
\22\ Weinstock DM, Eagan J, Malak SA, et al. Control of
influenza A on a bone marrow transplant unit. Infect Control Hosp
Epidemiol. 2000; 21:730-732.
\23\ Salgado CD, Giannetta ET, Hayden FG, Farr BM. Preventing
nosocomial influenza by improving the vaccine acceptance rate of
clinicians. Infect Control Hosp Epidemiol 2004; 25:923-928.
\24\ <a href="https://pubmed.ncbi.nlm.nih.gov/31384750/">https://pubmed.ncbi.nlm.nih.gov/31384750/</a>.
\25\ Hayward AC, Harling R, Wetten S, et al. Effectiveness of an
influenza vaccine programme for care home staff to prevent death,
morbidity, and health service use among residents: cluster
randomised controlled trial. BMJ 2006; 333: 1241-1246.
\26\ Potter J, Stott DJ, Roberts MA, et al. Influenza
vaccination of healthcare workers in long-term-care hospitals
reduces the mortality of elderly patients. J Infect Dis. 1997;
175:1-6.
\27\ Thomas RE, Jefferson TO, Demicheli V, et al. Influenza
vaccination for health-care workers who work with elderly people in
institutions: a systematic review. Lancet Infect Dis. 2006; 6:273-
279.
\28\ Van den Dool C, Bonten MJM, Hak E, Heijne JCM, Wallinga J.
The effects of influenza vaccination of health care workers in
nursing homes: insights from a mathematical model. PLoS Medicine.
2008; 5:1453-1460.
Lemaitre M, Meret T, Rothan-Tondeur M, et al. Effect of
influenza vaccination of nursing home staff on mortality of
residents: a cluster-randomized trial. J Am Geriatr Soc. 2009;
57:1580-1586.
\29\ Lemaitre M, Meret T, Rothan-Tondeur M, et al. Effect of
influenza vaccination of nursing home staff on mortality of
residents: a cluster-randomized trial. J Am Geriatr Soc. 2009;
57:1580-1586.
Van den Dool C, Bonten MJM, Hak E, Heijne JCM, Wallinga J. The
effects of influenza vaccination of health care workers in nursing
homes: insights from a mathematical model. PLoS Medicine. 2008;
5:1453-1460.
\30\ Oshitani H, Saito R, Seiki N, et al. Influenza vaccination
levels and influenza-like illness in long-term-care facilities for
elderly people in Niigata, Japan, during an influenza A (H3N2)
epidemic. Infect Control Hosp Epidemiol. 2000; 21:728-730.
\31\ <a href="https://pubmed.ncbi.nlm.nih.gov/31384750/">https://pubmed.ncbi.nlm.nih.gov/31384750/</a>.
\32\ <a href="https://www.cdc.gov/flu/professionals/infectioncontrol/healthcaresettings.htm">https://www.cdc.gov/flu/professionals/infectioncontrol/healthcaresettings.htm</a>.
\33\ <a href="https://www.cambridge.org/core/journals/infection-control-and-hospital-epidemiology/article/revised-shea-position-paper-influenza-vaccination-of-healthcare-personnel/E83D4D87FBBBD80C66A2A4926D00F4B8">https://www.cambridge.org/core/journals/infection-control-and-hospital-epidemiology/article/revised-shea-position-paper-influenza-vaccination-of-healthcare-personnel/E83D4D87FBBBD80C66A2A4926D00F4B8</a>.
\34\ <a href="https://www.cdc.gov/phlp/publications/topic/vaccinationlaws.html">https://www.cdc.gov/phlp/publications/topic/vaccinationlaws.html</a>.
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In addition to preventing morbidity and mortality associated with
COVID-19, currently approved or authorized vaccines also demonstrate
effectiveness against asymptomatic SARS-CoV-2 infection. A recent study
of health care workers in 8 states found that, between December 14,
2020 through August 14, 2021, full vaccination with COVID-19 vaccines
was 80 percent effective in preventing RT-PCR-confirmed SARS-CoV-2
infection among frontline workers.\35\ Emerging evidence also suggests
that vaccinated people who become infected with the SARS-CoV-2 Delta
variant have potential to be less infectious than infected unvaccinated
people, thus decreasing transmission risk.\36\ For example, in a study
of breakthrough infections among health care workers in the
Netherlands, SARS-CoV-2 infectious virus shedding was lower among
vaccinated individuals with breakthrough infections than among
unvaccinated individuals with primary infections.\37\ Fewer infected
staff and lower transmissibility equates to fewer opportunities for
transmission to patients, and emerging evidence indicates this is the
case. The best data come from long term care facilities, as early
implementation of national reporting requirements have resulted in a
comprehensive, longitudinal, high quality data set. Data from CDC's
National Healthcare Safety Network (NHSN) have shown that case rates
among LTC facility residents are higher in facilities with lower
vaccination coverage among staff; specifically, residents of LTC
facilities in which vaccination coverage of staff is 75 percent or
lower experience higher rates of preventable COVID-19.\38\ Several
articles published in CDC's Morbidity and Mortality Weekly Reports
(MMWRs) regarding nursing home outbreaks have also linked the spread of
COVID-19 infection to unvaccinated health care workers and stressed
that maintaining a high vaccination rate is important for reducing
transmission.39 40 41
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\35\ <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm?s_cid=mm7034e4_w">https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm?s_cid=mm7034e4_w</a>.
\36\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html#ref43">https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html#ref43</a>.
\37\ <a href="https://www.medrxiv.org/content/10.1101/2021.08.20.21262158v1.full.pdf">https://www.medrxiv.org/content/10.1101/2021.08.20.21262158v1.full.pdf</a>.
\38\ <a href="https://emergency.cdc.gov/han/2021/han00447.asp">https://emergency.cdc.gov/han/2021/han00447.asp</a>.
\39\ COVID-19 Outbreak Associated with a SARS-CoV-2 R.1 Lineage
Variant in a Skilled Nursing Facility After Vaccination Program --
Kentucky, March 2021.'' April 21, 2021. Available at <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e2.htm">https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e2.htm</a>.
\40\ Postvaccination SARS-CoV-2 Infections Among Skilled Nursing
Facility Residents and Staff Members -- Chicago, Illinois, December
2020-March 2021.'' April 30, 2021. Available at <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e1.htm">https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e1.htm</a>.
\41\ Effectiveness of the Pfizer-BioNTech COVID-19 Vaccine Among
Residents of Two Skilled Nursing Facilities Experiencing COVID-19
Outbreaks -- Connecticut, December 2020-February 2021.'' March 19,
2021. Available at: <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7011e3.htm">https://www.cdc.gov/mmwr/volumes/70/wr/mm7011e3.htm</a>.
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There is also some published evidence from other settings that
suggest similar dynamics can be expected in other health care delivery
settings. For example, a recent analysis from Yale New Haven Hospital
(YNHH) found health care units with at least 1 inpatient case of HA-
COVID-19 had lower staff vaccination rates.\42\ Similarly, a small
study in Israel demonstrated that transmission of COVID-19 was linked
to unvaccinated persons. In 37 cases, patients for whom data were
available regarding the source of infection, the suspected source was
an unvaccinated person; in 21 patients (57 percent), this person was a
household member; in 11 cases (30 percent), the suspected source was an
unvaccinated fellow health care worker or patient.\43\ While similarly
comprehensive data are not available for all Medicare- and Medicaid-
certified provider types, the available evidence for ongoing
healthcare-associated COVID-19 transmission risk is sufficiently
alarming in and of itself to compel CMS to take action.
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\42\ Roberts, S., Aniskiewicz, M., Choi, S., Pettker, C., &
Martinello, R. (2021). Correlation of healthcare worker vaccination
on inpatient healthcare-associated COVID-19. Infection Control &
Hospital Epidemiology, 1-6. Doi:10.1017/ice.2021.414.
\43\ Moriah Bergwerk, M.B., B.S., Tal Gonen, B.A., Yaniv Lustig,
Ph.D., Sharon Amit, M.D., Marc Lipsitch, Ph.D., Carmit Cohen, Ph.D.,
Michal Mandelboim, Ph.D., Einav Gal Levin, M.D., Carmit Rubin, N.D.,
Victoria Indenbaum, Ph.D., Ilana Tal, R.N., Ph.D., Malka Zavitan,
R.N., M.A., et al. Covid-19 Breakthrough Infections in Vaccinated
Health Care Workers. N Engl J Med 2021; 385:1474-1484. DOI: 10.1056/
NEJMoa2109072. <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2109072">https://www.nejm.org/doi/full/10.1056/NEJMoa2109072</a>.
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The threats that unvaccinated staff pose to patients are not,
however, limited to SARS-CoV-2 transmission. Unvaccinated staff
jeopardize patient access to recommended medical care and services, and
these additional risks to patient health and safety further warrant CMS
action.
Fear of exposure to and infection with COVID-19 from unvaccinated
health care staff can lead patients to themselves forgo seeking
medically necessary care. In a small but informative qualitative study
of 33 home health care workers in New York City, one of the key themes
to emerge from interviews with those workers was a keen recognition
that ``providing care to patients placed them in a unique position with
respect to COVID-19 transmission. They worried . . . about transmitting
the virus to [their clients].'' They also noted that care for home
bound clients might involve other health care staff, and they worried
about ``transmitting COVID-19 . . . to one another.'' \44\
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\44\ <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2769096">https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2769096</a>).
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Anecdotal evidence suggests health care consumers have drawn
similar conclusions--and this, too, has implications for overall health
and welfare in health care settings. For example, CMS has received
anecdotal reports suggesting individuals in care are refusing care from
unvaccinated staff, limiting the extent to which providers and
suppliers can effectively meet the health care needs of their patients
and residents. Further, nationwide there are reports of individuals
avoiding or forgoing health care due to fears of contracting COVID-19
from health care workers.45 46 47 While avoidance of
necessary care appears to have abated somewhat since the first months
of the COVID-19 pandemic, it remains an area of concern for many
individuals.48 49 Because

[[Page 61559]]

unvaccinated staff are at greater risk for infection, they also present
a threat to health care operations--absenteeism due to COVID-19-related
exposures or illness can create staffing shortages that disrupt patient
access to recommended care. Data suggest the current surge in COVID-19
cases associated with emergence of the Delta variant has exacerbated
health care staffing shortages. For example, 1 in 5 hospitals report
that they are currently experiencing a critical staffing shortage.\50\
Through the week ending September 19, 2021, approximately 23 percent of
LTC facilities reported a shortage in nursing aides; 21 percent
reported a shortage of nurses; and 10 to 12 percent reported shortages
in other clinical and non-clinical staff categories.\51\ And while some
studies suggest overall staffing levels (as defined by nurse hours per
resident day) have been relatively stable, this appears to be
associated with concurrent decreases in patient demand (for example,
resident census in nursing homes)--decreases that have ramifications
for patient access to recommended and medically appropriate
services.52 53 Over half (58 percent) of nursing homes
participating in a recent survey conducted by the American Health Care
Association and National Center for Assisted Living (AHCA/NCAL)
indicated that they are limiting new admissions due to staffing
shortages.\54\ Similarly, hospital administrators responding to an OIG
pulse survey conducted during February 22-26, 2021, reported difficulty
discharging COVID-19 patients to post-acute facilities (for example,
nursing homes, rehabilitation hospitals, and hospice facilities)
following the acute stage of the patient's illness. These delays in
discharge affected available bed space throughout the hospital (for
example, creating bottlenecks in ICUs and EDs) and delayed patient
access to specialized post-acute care (such as rehabilitation).\55\ The
drivers of this staffing crisis are multi-factorial. They include:
Longstanding shortages in certain fields and professions; prolonged
physical, mental, and emotional stress and trauma associated with
responding to the ongoing PHE; and competing personal or professional
obligations (such as child care) or opportunities (for example, new
careers). But illnesses and deaths associated with COVID-19 are
exacerbating staffing shortages across the health care system. Over
half a million COVID-19 cases and 1,900 deaths among health care staff
have been reported to CDC since the start of the PHE.\56\ When
submitting case-level COVID-19 reports, State and territorial
jurisdictions may identify whether individuals are or are not health
care workers. Since health care worker status has only been reported
for a minority of cases (approximately 18 percent), these numbers are
likely gross underestimates of true burden in this population. COVID-19
case rates among staff have also grown in tandem with broader national
incidence trends since the emergence of the Delta variant. For example,
as of mid-September 2021, COVID-19 cases among LTC facility and ESRD
facility staff have increased by over 1400 percent and 850 percent,
respectively, since their lows in June 2021.\57\ Similarly, the number
of cases among staff for whom case-level data were reported by State
and territorial jurisdictions to CDC increased by nearly 600 percent
between June and August 2021.\58\ Vaccination is thus a powerful tool
for protecting health and safety of patients, and, with the emergence
and spread of the highly transmissible Delta variant, it has been an
increasingly critical one to address the extraordinary strain the
COVID-19 pandemic continues to place on the U.S. health system. While
COVID-19 cases, hospitalizations, and deaths declined over the first 6
months of 2021, the emergence of the Delta variant reversed these
trends.\59\ Between late June 2021 and September 2021, daily cases of
COVID-19 increased over 1200 percent; new hospital admissions, over 600
percent; and daily deaths, by nearly 800 percent.\60\ Available data
also continue to suggest that the majority of COVID-19 cases and
hospitalizations are occurring among individuals who are not fully
vaccinated. In a recent study of reported COVID-19 cases,
hospitalizations, and deaths in 13 U.S. jurisdictions that routinely
link case surveillance and immunization registry data, CDC found that
unvaccinated individuals accounted for over 85 percent of all
hospitalizations in the period between June and July 2021, when Delta
became the predominant circulating variant.\61\
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\45\ J Anxiety Disord. 2020 Oct; 75: 102289. Published online
2020 Aug 19. Doi: 10.1016/j.janxdis.2020.102289
\46\ <a href="https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6936a4-H.pdf">https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6936a4-H.pdf</a>.
\47\ <a href="https://www.nahc.org/wp-content/uploads/2020/03/NATIONAL-SURVEY-SHOWS-HOME-HEALTH-CARE-ON-THE-FRONTLINES-OF-COVID-19-AND-CONTINUES-TO-BE-IN-A-FRAGILE-FINANCIAL-STATE.pdf">https://www.nahc.org/wp-content/uploads/2020/03/NATIONAL-SURVEY-SHOWS-HOME-HEALTH-CARE-ON-THE-FRONTLINES-OF-COVID-19-AND-CONTINUES-TO-BE-IN-A-FRAGILE-FINANCIAL-STATE.pdf</a>.
\48\ <a href="https://www.urban.org/sites/default/files/publication/103651/delayed-and-forgone-health-care-for-nonelderly-adults-during-the-covid-19-pandemic_1.pdf">https://www.urban.org/sites/default/files/publication/103651/delayed-and-forgone-health-care-for-nonelderly-adults-during-the-covid-19-pandemic_1.pdf</a>.
\49\ Gale R, Eberlein S, Fuller G, Khalil C, Almario CV, Spiegel
BM. Public Perspectives on Decisions About Emergency Care Seeking
for Care Unrelated to COVID-19 During the COVID-19 Pandemic. JAMA
Netw Open. 2021;4(8):e2120940. Doi:10.1001/
jamanetworkopen.2021.20940.
\50\ Analysis of data submitted by hospitals through HHS
Protect; accessed September 20, 2021.
\51\ Data reported through CDC's NHSN.
\52\ <a href="https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.02351">https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.02351</a>.
\53\ <a href="https://www.npr.org/sections/health-shots/2021/10/14/1043414558/with-hospitals-crowded-from-covid-1-in-5-american-families-delays-health-care">https://www.npr.org/sections/health-shots/2021/10/14/1043414558/with-hospitals-crowded-from-covid-1-in-5-american-families-delays-health-care</a>.
\54\ <a href="https://www.ahcancal.org/News-and-Communications/Fact-Sheets/FactSheets/Workforce-Survey-September2021.pdf">https://www.ahcancal.org/News-and-Communications/Fact-Sheets/FactSheets/Workforce-Survey-September2021.pdf</a>.
\55\ See HHS OIG reports OEI-09-21-00140 and OEI-06-20-00300,
both accessed September 26, 2021.
\56\ <a href="https://covid.cdc.gov/covid-data-tracker/#health-care-personnel">https://covid.cdc.gov/covid-data-tracker/#health-care-personnel</a>; accessed September 24, 2021.
\57\ Analysis of dialysis facility and nursing home data
reported through NHSN.
\58\ Ibid. 8footnote 56.
\59\ <a href="https://emergency.cdc.gov/han/2021/han00447.asp">https://emergency.cdc.gov/han/2021/han00447.asp</a>.
\60\ Internal estimates based on data published at: <a href="https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html">https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html</a>;
accessed September 24, 2021.
\61\ <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm?s_cid=mm7037e1_w">https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm?s_cid=mm7037e1_w</a>.
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Unfortunately, health care staff vaccination rates remain too low
in too many health care facilities and regions. For example, national
COVID-19 vaccination rates for LTC facility, hospital, and ESRD
facility staff are 67 percent, 64 percent, and 60 percent,
respectively. Moreover, these averages obscure sizable regional
differences. LTC facility staff vaccination rates range from lows of 56
percent to highs of over 90 percent, depending upon the State. Similar
patterns hold for ESRD facility and hospital staff.62 63 64
Given slow but steady increases in vaccination rates among staff
working in these settings over time,\65\ widespread availability of
vaccines, and targeted efforts to facilitate vaccine access like the
Federal Retail Pharmacy program,\66\ vaccine hesitancy,\67\ rather than
other factors (for example, staff turnover) is likely to account for
suboptimal staff vaccination rates.
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\62\ LTC facility rates derived from data reported through CDC's
NHSN and posted online at the Nursing Home COVID-19 Vaccination Data
Dashboard: <a href="https://www.cdc.gov/nhsn/covid19/ltc-vaccination-dashboard.html">https://www.cdc.gov/nhsn/covid19/ltc-vaccination-dashboard.html</a>; accessed September 15, 2021.
\63\ Dialysis facility rates derived from data reported through
CDC's NHSN and posted online at the Dialysis COVID-19 Vaccination
Data Dashboard: <a href="https://www.cdc.gov/nhsn/covid19/dial-vaccination-dashboard.html">https://www.cdc.gov/nhsn/covid19/dial-vaccination-dashboard.html</a>; accessed September 15, 2021.
\64\ Hospital data come from unpublished analyses of data
reported to HHS and posted on HHS Protect.
\65\ Ibid. footnotes 62-64.
\66\ <a href="https://www.cdc.gov/vaccines/covid-19/retail-pharmacy-program/index.html">https://www.cdc.gov/vaccines/covid-19/retail-pharmacy-program/index.html</a>.
\67\ <a href="https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive.html">https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive.html</a>.
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While a significant number of health care staff have been infected
with SARS-CoV-2,\68\ evidence indicates their infection-induced
immunity, also called ``natural immunity,'' is not equivalent to
receiving the COVID-19 vaccine. Available evidence indicates that
COVID-19 vaccines offer better protection than infection-induced
immunity alone and that vaccines, even after prior infection, help
prevent

[[Page 61560]]

reinfections.\69\ Consequently, CDC recommends that all people be
vaccinated, regardless of their history of symptomatic or asymptomatic
SARS-CoV-2 infection.\70\
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\68\ <a href="https://covid.cdc.gov/covid-data-tracker/#health-care-personnel">https://covid.cdc.gov/covid-data-tracker/#health-care-personnel</a>.
\69\ <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7032e1.htm?s_cid=mm7032e1_w">https://www.cdc.gov/mmwr/volumes/70/wr/mm7032e1.htm?s_cid=mm7032e1_w</a>.
\70\ <a href="https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#CoV-19-vaccination">https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#CoV-19-vaccination</a>.
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Further, the risks of unvaccinated health care staff may
disproportionately impact communities who experience social risk
factors and populations described under Executive Order 13985,
Advancing Racial Equity and Support for Underserved Communities Through
the Federal Government, including members of racial and ethnic
communities; individuals with disabilities; individuals with limited
English proficiency; Lesbian, Gay, Bisexual, Transgender, and Queer
(LGBTQ+) individuals; individuals living in rural areas; and others
adversely affected by persistent poverty or inequality. CDC data show
that across the U.S., physicians and advanced practice providers have
significantly higher vaccination rates than aides.71 72
Among aides, lower vaccination coverage was observed in those
facilities located in zip codes where communities experience greater
social risk factors. The finding that vaccination coverage among aides
was lower among those working at LTC facilities located in zip code
areas with higher social vulnerability is consistent with an earlier
analysis of overall county-level vaccination coverage by indices of
social vulnerability.\73\ CDC notes that together, these data suggest
that vaccination disparities among job categories are likely to mirror
social disparities as well as disparities in surrounding communities.
In addition, nurses and aides who may have the most patient contact
have the lowest rates of vaccination coverage among health care staff.
COVID-19 outbreaks have occurred in LTC facilities in which residents
were highly vaccinated, but transmission occurred through unvaccinated
staff members.\74\ These findings have implications regarding
occupational safety and health outcome equity--national data indicates
that aides in nursing homes are disproportionately women and members of
racial and ethnic communities with lower hourly wages than physicians
and advance practice clinicians,\75\ and are also more likely to have
underlying conditions that put them at risk for adverse outcomes from
COVID-19.\76\ Ensuring full vaccination coverage across health care
settings is critical to addressing these disparities among health care
workers, particularly those from communities who experience social
risk, and to equitably protecting individuals CMS serves from
unnecessary and significant harm associated with COVID-19 cases and the
ongoing pandemic.
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\71\ <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7030a2.htm">https://www.cdc.gov/mmwr/volumes/70/wr/mm7030a2.htm</a>.
\72\ <a href="https://doi.org/10.7326/M21-3150">https://doi.org/10.7326/M21-3150</a>.
\73\ Hughes MM, Wang A, Grossman MK, et al. County-level COVID-
19 vaccination coverage and social vulnerability--United States,
December 14, 2020-March 1, 2021. MMWR Morb Mortal Wkly Rep
2021;70:431-6. <a href="https://doi.org/10.15585/mmwr.mm7012e1external">https://doi.org/10.15585/mmwr.mm7012e1external</a> icon
PMID:33764963external icon.
\74\ Cavanaugh AM, Fortier S, Lewis P, et al. COVID-19 outbreak
associated with a SARS-CoV-2 R.1 lineage variant in a skilled
nursing facility after vaccination program--Kentucky, March 2021.
MMWR Morb Mortal Wkly Rep 2021;70:639-43. <a href="https://doi.org/10.15585/mmwr.mm7017e2external">https://doi.org/10.15585/mmwr.mm7017e2external</a><ls-thn-eq> icon PMID:33914720external icon.
\75\ Bureau of Labor Statistics. May 2020 national occupational
employment and wage estimates. Washington, DC: US Department of
Labor, Bureau of Labor Statistics; 2021. Accessed May 1, 2021.
<a href="https://www.bls.gov/oes/current/oes_nat.htm#00-0000externalicon">https://www.bls.gov/oes/current/oes_nat.htm#00-0000externalicon</a>.
\76\ Silver SR, Li J, Boal WL, Shockey TL, Groenewold MR.
Prevalence of underlying medical conditions among selected essential
critical infrastructure workers--behavioral risk factor surveillance
system, 31 states, 2017-2018. MMWR Morb Mortal Wkly Rep
2020;69:1244-9. <a href="https://doi.org/10.15585/mmwr.mm6936a3external">https://doi.org/10.15585/mmwr.mm6936a3external</a> icon
PMID:32914769external icon.
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It is essential to reduce the transmission and spread of COVID-19,
and vaccination is central to any multi-pronged approach for reducing
health system burden, safeguarding health care workers and the people
they serve, and ending the COVID-19 pandemic. Currently FDA-approved
and FDA-authorized vaccines in use in the U.S. are both safe and highly
effective at protecting vaccinated people against symptomatic and
severe COVID-19.\77\ Higher rates of vaccination, especially in health
care settings, will contribute to a reduction in the transmission of
SARS-CoV-2 and associated morbidity and mortality across providers and
communities, contributing to maintaining and increasing the amount of
healthy and productive health care staff, and reducing risks to
patients, resident, clients, and PACE program participants.
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\77\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html">https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html</a>. Accessed 10/14/2021.
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In light of our responsibility to protect the health and safety of
individuals providing and receiving care and services from for
Medicare- and Medicaid-certified providers and suppliers, and CMS's
broad statutory authority to establish health and safety regulations,
we are compelled to require staff vaccinations for COVID-19 in these
settings. For these reasons, we are issuing this IFC based on these
authorities and in accordance with established rule making processes.
Specifically, sections 1102 and 1871 of the Social Security Act (the
Act) grant the Secretary of Health and Human Services authority to make
and publish such rules and regulations, not inconsistent with the Act,
as may be necessary to the efficient administration of the functions
with which the Secretary is charged under this Act and as may be
necessary to carry out the administration of the insurance programs
under the Act. The discussions of the provider- and supplier-specific
provisions in section II. of this IFC set out the specific authorities
for each provider or supplier type. Provider and supplier compliance
with the Federal rules issued under these statutory authorities are
mandatory for participation in the Medicare and Medicaid programs.
To the extent a court may enjoin any part of the rule, the
Department intends that other provisions or parts of provisions should
remain in effect. Any provision of this section held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give maximum
effect to the provision permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this section and shall not affect the
remainder thereof or the application of the provision to persons not
similarly situated or to dissimilar circumstances.

A. Regulatory Responses to the PHE

1. Waivers
CMS and other Federal agencies have taken many actions and
exercised extensive regulatory flexibilities to help health care
providers contain the spread of SARS-CoV-2. When the President declares
a national emergency under the National Emergencies Act or an emergency
or disaster under the Stafford Act, CMS is empowered to take proactive
steps by waiving certain CMS regulations, as authorized under section
1135 of the Act (``1135 waivers''). CMS may also grant certain
flexibilities to skilled nursing facilities (SNFs) under Medicare, as
authorized separately under section 1812(f) of the Act (``1812(f)
flexibilities''). The 1135 waivers and 1812(f) flexibilities allowed us
to rapidly expand efforts to help control the spread of SARS-CoV-2. We
have issued PHE waivers for most Medicare- and Medicaid-certified

[[Page 61561]]

providers and suppliers, with the goal of supporting each facility's
operational flexibility while preserving health and safety and core
health care functions.
2. Rulemaking
Since the onset of the PHE, we have issued five IFCs to help
contain the spread of SARS-CoV-2. On April 6, 2020, we issued an IFC
(Medicare and Medicaid Programs; Policy and Regulatory Revisions in
Response to the COVID-19 Public Health Emergency (85 FR 19230 through
19292), which established that certain requirements for face-to-face/
in-person encounters will not apply during the PHE for COVID-19
effective for claims with dates of service on or after March 1, 2020,
and for the duration of the PHE for COVID-19. On May 8, 2020, we issued
a second IFC (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
(85 FR 27550 through 27629)) (``May 8, 2020 COVID-19 IFC''). This
second IFC contained additional information on changes Medicare made to
existing regulations to provide flexibilities for Medicare
beneficiaries and providers to respond effectively to the PHE for
COVID-19. On September 2, 2020, we issued a third IFC (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 (85 FR 54820 through 54874)) (``September 2, 2020 COVID-19
IFC''), that included new requirements for hospitals and CAHs to report
data in accordance with a frequency and in a standardized format as
specified by the Secretary during the PHE for COVID-19. On November 6,
2020, we issued a fourth IFC (Additional Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency (85 FR
71142 through 71205)). This IFC discussed CMS's implementation of
section 3713 of the Coronavirus Aid, Relief, and Economic Security Act
(CARES Act), which established Medicare Part B coverage and payment for
Coronavirus Disease 2019 (COVID-19) vaccine and its administration.
This IFC implemented requirements in the CARES Act that providers of
COVID-19 diagnostic tests make public their cash prices for those tests
and established an enforcement scheme to enforce those requirements.
This IFC also established an add-on payment for cases involving the use
of new COVID-19 treatments under the Medicare Inpatient Prospective
Payment System (IPPS). Most recently, on May 13, 2021, we issued the
fifth IFC (Medicare and Medicaid Programs; COVID-19 Vaccine
Requirements for Long-Term Care (LTC) Facilities and Intermediate Care
Facilities for Individuals with Intellectual Disabilities (ICFs-IID)
Residents, Clients, and Staff (86 FR 26306)) (``May 13, 2021 COVID-19
IFC''), that revised the infection control requirements that LTC
facilities and ICFs-IID must meet to participate in the Medicare and
Medicaid programs.
OSHA has also engaged in rulemaking in response to the PHE for
COVID-19. On June 21, 2021, OSHA issued the COVID-19 Healthcare
Emergency Temporary Standard (ETS) at 29 CFR 1910 subpart U (86 FR
32376) to protect health care and health care support service workers
from occupational exposure to COVID-19.\78\ Health care employers
covered by the ETS must develop and implement a COVID-19 plan for each
workplace to identify and control COVID-19 hazards in the workplace and
implement requirements to reduce transmission of SARS-CoV-2 in their
workplaces related to the following: (1) Patient screening and
management, (2) standard and transmission-based precautions, (3)
personal protective equipment (including facemasks, and respirators),
(4) controls for aerosol-generating procedures performed on persons
with suspected or confirmed COVID-19, (5) physical distancing, (6)
physical barriers, (7) cleaning and disinfection, (8) ventilation, (9)
health screening and medical management, (10) training, (11) anti-
retaliation, (12) recordkeeping, and, (13) reporting. In addition, the
ETS requires covered employers to support COVID-19 vaccination for each
employee by providing reasonable time and paid leave for employees to
receive vaccines and recover from side effects.
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\78\ <a href="https://www.osha.gov/coronavirus/ets">https://www.osha.gov/coronavirus/ets</a>. Accessed 10/6/2021.
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The ETS generally applies to all workplace settings where any
employee provides health care services or health care support services;
however, because the ETS targets settings where care is provided for
individuals with known or suspected COVID-19, the rule contains several
exceptions. The ETS does not apply to: (1) Provision of first aid by
any employee who is not a licensed health care provider, (2) dispensing
of prescriptions by pharmacists in retail settings, (3) non-hospital
ambulatory care settings where all non-employees are screened prior to
entry, and people with suspected or confirmed COVID-19 are not
permitted to enter, (4) well-defined hospital ambulatory care settings
where all employees are fully vaccinated, all non-employees are
screened prior to entry, and people with suspected or confirmed COVID-
19 are not permitted to enter, (5) home health care settings where all
employees are fully vaccinated, all non-employees are screened prior to
entry, and people with suspected or confirmed COVID-19 are not present,
(6) health care support services not performed in a health care setting
(for example, offsite laundry, off-site medical billing), and (7)
telehealth services performed outside of a setting where direct patient
care occurs. Furthermore, in well-defined areas where there is no
reasonable expectation that any person with suspected or confirmed
COVID-19 will be present, the ETS exempts fully vaccinated workers from
masking, distancing, and barrier requirements.
Moreover, the ETS requires employers to immediately remove
employees from the workplace if they (1) have tested positive for
COVID-19, (2) have been diagnosed with COVID-19 by a licensed health
care provider, (3) have been advised by a licensed health care provider
that they are suspected to have COVID-19, or (4) are experiencing
certain symptoms (defined as either loss of taste and/or smell with no
other explanation, or fever of at least 100.4 degrees Fahrenheit and
new unexplained cough associated with shortness of breath). Employers
must also immediately remove an employee who was not wearing a
respirator and any other required PPE and had been in close contact
with a COVID-19 positive person in the workplace. However, removal from
the workplace due to instances of close contact exposure in the
workplace is not required for asymptomatic employees who either had
COVID-19 and recovered with the last 3 months, or have been fully
vaccinated (that is, 2 or more weeks have passed since the final dose).
Complementary to the OSHA ETS, this interim final rule requires
certain providers and suppliers participating in Medicare and Medicaid
programs to ensure staff are fully vaccinated for COVID-19, unless
exempt, because vaccination of staff is necessary for the health and
safety of individuals to whom care and services are furnished. Health
care staff are at high risk for SARS-CoV-2 exposure, the virus that
causes COVID-19, due to interactions with patients and individuals in
the

[[Page 61562]]

community.\79\ Receiving a complete primary vaccination series reduces
the risk of COVID-19 by 90 percent or more thereby inhibiting the
spread of disease to others.\80\ Furthermore, a COVID-19 vaccination
requirement reduces the likelihood of medical removal of health care
staff from the workplace, as required by the OSHA COVID-19 Healthcare
ETS. This is yet another way in which this interim final rule protects
the individuals who receive services from the providers and suppliers
to whom the rule applies by minimizing unpredictable disruptions to
operations and care.
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\79\ <a href="https://www.cdc.gov/mmwr/volumes/69/wr/mm6938a3.htm?s_cid=mm6938a3_w">https://www.cdc.gov/mmwr/volumes/69/wr/mm6938a3.htm?s_cid=mm6938a3_w</a>. Accessed10/16/2021.
\80\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/work.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/work.html</a>. Accessed 10/16/2021.
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OSHA is the Federal agency responsible for setting and enforcing
standards to ensure safe and healthy working conditions for workers.
The COVID-19 Healthcare ETS addresses protections for health care and
health care support service workers from the grave danger of COVID-19
exposure in certain workplaces. CMS is the Federal agency responsible
for establishing health and safety regulations for Medicare- and
Medicaid-certified providers and suppliers. Hence, we are establishing
a final rule requiring COVID-19 vaccination of staff to safeguard the
health and safety of patients, residents, clients, and PACE program
participants who receive care and services from those providers and
suppliers. Providers and suppliers may be covered by both the OSHA ETS
and our interim final rule. Although the requirements and purpose of
each regulation text are different, they are complementary.

B. COVID-19 Vaccine Development and Approval

FDA analysis has shown that all of the currently approved or
authorized vaccines are safe and CDC reports that over 408 million
doses of the vaccine have been given through October 18, 2021.\81\
Bringing a new vaccine to the public involves many steps, including
vaccine development, clinical trials, and U.S. Food and Drug
Administration (FDA) authorization or approval. While COVID-19 vaccines
were developed rapidly, all steps have been taken to ensure their
safety and effectiveness. Scientists have been working for many years
to develop vaccines against coronaviruses, such as those that cause
severe acute respiratory syndrome (SARS) and Middle East respiratory
syndrome (MERS). SARS-CoV-2, the virus that causes COVID-19, is related
to these other coronaviruses and the knowledge that was gained through
past research on coronavirus vaccines helped speed up the initial
development of the current COVID-19 vaccines. After initial
development, vaccines go through three phases of clinical trials to
make sure they are safe and effective. For other vaccines routinely
used in the U.S., the three phases of clinical trials are performed one
at a time. During the development of COVID-19 vaccines, these phases
overlapped to speed up the process so the vaccines could be used as
quickly as possible to control the pandemic. No trial phases were
skipped.\82\
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\81\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/
safety-of-
vaccines.html#:~:text=Millions%20of%20people%20in%20the,monitoring%20
in%20US%20history.
\82\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/distributing/steps-ensure-safety.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/distributing/steps-ensure-safety.html</a>.
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All COVID-19 vaccines currently licensed (approved) \83\ or
authorized for use in the U.S. were tested in clinical trials involving
tens of thousands of people. FDA evaluated all of the information
submitted to it in requests for Emergency Use Authorization (EUA) for
the authorized COVID-19 vaccines and, for the Comirnaty COVID-19
Vaccine, in a Biologics License Application (the conventional path to
FDA approval of a vaccine). FDA determined that these vaccines meet
FDA's standards for safety, effectiveness, and manufacturing quality
needed to support emergency use authorization and licensure, as
applicable. The clinical trials included participants of different
races, ethnicities, and ages, including adults over the age of 65.\84\
Because COVID-19 continues to be widespread, researchers have been able
to conduct vaccine clinical trials more quickly than if the disease
were less common. Side effects following vaccination are dependent on
the specific vaccine that an individual receives, and the most common
include pain, redness, and swelling at the injection site, tiredness,
headache, muscle pain, nausea, vomiting, fever, and chills.\85\ After a
review of all available information, the Advisory Committee on
Immunization Practices (ACIP) and CDC have concluded the lifesaving
benefits of COVID-19 vaccination outweigh the risks or possible side
effects.\86\
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\83\ ``Licensed'' is the statutory term under section 351 of the
Public Health Service Act for what is commonly referred to as
approval of a biological product. For purposes of this rulemaking,
the terms `approved' or `licensed' and `approval' or `licensure' are
being used interchangeably with respect to COVID-19 vaccines.
\84\ <a href="https://www.kff.org/racial-equity-and-health-policy/issue-brief/racial-diversity-within-covid-19-vaccine-clinical-trials-key-questions-and-answers/">https://www.kff.org/racial-equity-and-health-policy/issue-brief/racial-diversity-within-covid-19-vaccine-clinical-trials-key-questions-and-answers/</a>.
\85\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html</a>.
\86\ See Centers for Disease Control and Prevention. Benefits of
Getting a COVID-19 Vaccine. <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html</a>. Updated January 5, 2021.
Accessed January 14, 2021.
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The COVID-19 vaccines currently licensed or authorized for use in
the U.S. are generally administered as either a single dose or a two-
dose series given at least 21 or 28 days apart. Following completion of
that primary series, a subsequent dose or doses may be recommended for
one of two purposes. In the first instance, an additional dose of
vaccine is administered when the immune response following a primary
vaccine series is likely to be insufficient. In other words, the
additional dose augments the original primary series. Currently, the
EUA for the Moderna mRNA COVID-19 vaccine has been amended to include
the use of a third primary series dose (that is, ``additional dose'')
in certain immunocompromised individuals 18 years of age or older.
Similarly, the EUA for the Pfizer BioNTech mRNA COVID-19 vaccine has
been amended to include the use of an additional, or third primary
series, dose in certain immunocompromised individuals 12 years of age
and older.
In the second instance, a booster dose of vaccine is administered
when the initial immune response to a primary vaccine series is likely
to have waned over time. In other words, although an adequate immune
response occurred after the primary vaccine series, over time, immunity
decreases.87 88 89 On September 22, 2021, the FDA amended
the EUA for the Pfizer BioNTech mRNA COVID-19 vaccine to allow for use
of a single booster dose in certain individuals, to be administered at
least 6 months after completion of the primary series. Specifically,
this booster dose is authorized for individuals 65 years of age and
older, individuals 18 through 64 years of age at high risk of severe
COVID-19, and individuals 18 through 64 years of age whose frequent
institutional or occupational exposure to SARS-CoV-2 puts them at high
risk of serious complications of COVID-19 including severe COVID-
19.\90\

[[Page 61563]]

Throughout this rule, we will use the terms ``additional dose'' and
``booster'' to differentiate between the two use cases outlined above.
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\87\ Summaries of evidence presented to CDC's Advisory Council
on Immunization Practices available at <a href="https://www.cdc.gov/vaccines/acip/meetings/slides-2021-09-22-23.html">https://www.cdc.gov/vaccines/acip/meetings/slides-2021-09-22-23.html</a>.
\88\ <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2114583">https://www.nejm.org/doi/full/10.1056/NEJMoa2114583</a>.
\89\ <a href="https://www.medrxiv.org/content/10.1101/2020.10.26.20219725v1">https://www.medrxiv.org/content/10.1101/2020.10.26.20219725v1</a>.
\90\ <a href="https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine">https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine</a>.
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Every person who receives a COVID-19 vaccine receives a vaccination
record card noting which vaccine and the dose that was received.
Vaccine materials specific to each vaccine are located on CDC \91\ and
FDA \92\ websites. CDC has posted a collection of informational
toolkits for specific communities and settings at <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/toolkits.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/toolkits.html</a>. These toolkits provide
staff, facility administrators, clinical leadership, caregivers, and
health care consumers with information and resources.
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\91\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html</a>.
\92\ <a href="https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines">https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines</a>.
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While we are not requiring participation, we encourage staff who
use smartphones to use CDC's smartphone-based tool called ``v-safe
After Vaccination Health Checker'' (v-safe) \93\ to self-report on
one's health after receiving a COVID-19 vaccine. V-safe is a program
that differs from the Vaccine Adverse Event Reporting System (VAERS),
which we discuss in section I.C. of this rule. Individuals may report
adverse reactions to a COVID-19 vaccine to either program. Enrollment
in v-safe allows any participating vaccine recipient to directly and
efficiently report to CDC how they are feeling after receiving a
specific vaccine, including any problems or adverse reactions. When an
individual receives the vaccine, they should also receive a v-safe
information sheet telling them how to enroll in v-safe or they can
register at <a href="http://www.vsafe.cdc.gov">http://www.vsafe.cdc.gov</a>. Individuals who enroll will
receive regular text messages providing links to surveys where they can
report any problems or adverse reactions after receiving a COVID-19
vaccine, as well as receive ``check-ins,'' and reminders for a second
dose if applicable.\94\ We note again that participation in v-safe is
not mandatory, and further that staff participation and any health
information provided is not traced to or shared with employers.
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\93\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html</a>.
\94\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html</a>.
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Based on current CDC guidance,\95\ individuals are considered fully
vaccinated for COVID-19 14 days after receipt of either a single-dose
vaccine (Janssen/Johnson & Johnson) or the second dose of a two-dose
primary vaccination series (Pfizer-BioNTech/Comirnaty or Moderna). This
guidance can also be applied to COVID-19 vaccines listed for emergency
use by the World Health Organization (WHO) and some vaccines used in
COVID-19 clinical trials conducted in the U.S. These circumstances are
addressed in more detail in section I.C. of this IFC. To improve immune
response for those individuals with moderately to severely compromised
immune systems who receive the Pfizer-BioNTech Vaccine, Comirnaty, or
Moderna Vaccine, the CDC advises an additional (third) dose of an mRNA
COVID-19 vaccine after completing the primary vaccination series.\96\
In addition, certain individuals who received the Pfizer-BioNTech
COVID-19 Vaccine may receive a booster dose at least 6 months after
completing the primary vaccination series.\97\
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\95\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html</a>. Accessed 10/16/2021.
\96\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html</a>. Accessed 10/14/2021.
\97\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html</a>. Accessed 10/16/2021.
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This IFC requires Medicare- and Medicaid-certified providers and
suppliers to ensure that staff are fully vaccinated for COVID-19,
unless the individual is exempted. Consistent with CDC guidance, we
consider staff fully vaccinated if it has been 2 or more weeks since
they completed a primary vaccination series for COVID-19. We define
completion of a primary vaccination series as having received a single-
dose vaccine or all doses of a multi-dose vaccine. Currently, CDC
guidance does not include either the additional (third) dose of an mRNA
COVID-19 vaccine for individuals with moderately or severely
immunosuppression or the booster dose for certain individuals who
received the Pfizer-BioNTech Vaccine in their definition of fully
vaccinated.\98\ Therefore, for purposes of this IFC, neither additional
(third) doses nor booster doses are required. The OSHA Emergency
Temporary Standard for Healthcare discussed in section I.A.2. of this
IFC also defines fully vaccinated in accordance with CDC guidance.
Hence, definitions of fully vaccinated are consistent among the
requirements in these regulations.
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\98\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html</a>. Accessed 10/16/2021.
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C. Administration of Vaccines Outside the U.S., Listed for Emergency
Use by the WHO, Heterologous Primary Series, and Clinical Trials

We expect the majority of staff will likely receive a COVID-19
vaccine authorized for emergency use by the FDA or licensed by the FDA.
Currently, this would include the authorized Pfizer-BioNTech
(interchangeable with the licensed Comirnaty vaccine made by Pfizer for
BioNTech), Moderna, and Janssen (Johnson & Johnson) COVID-19 vaccines.
We also expect COVID-19 vaccine administration will likely occur within
the U.S. for the majority of staff. However, some staff may receive FDA
approved or authorized COVID-19 vaccines outside of the U.S., vaccines
administered outside of the U.S. that are listed by the WHO for
emergency use that are not approved or authorized by the FDA, or
vaccines during their participation in a clinical trial at a site in
the U.S. For these staff, we defer to CDC guidance for COVID-19
vaccination briefly discussed here. For more information, providers and
suppliers should consult the CDC website at <a href="https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#">https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#</a>.
Repeat vaccine doses are not recommended by CDC for individuals who
previously completed the primary series of a vaccine approved or
authorized by the FDA, even if administration of the vaccine occurred
outside of the U.S. Individuals who receive a COVID-19 vaccine for
which two doses are required to complete the primary vaccination series
should adhere as closely as possible to the recommended intervals.
Following completion of their second dose, certain individuals who had
received the Pfizer-BioNTech COVID-19 vaccine may receive a booster
dose at least 6 months after completion of the primary vaccination
series. Moderately to severely immunocompromised individuals who have
received 2 doses of an mRNA vaccine may receive a third dose at least
28 days after the second dose. Vaccine administration may occur inside
or outside of the U.S.
Furthermore, the WHO maintains a list of COVID-19 vaccines for
emergency use.\99\ The CDC advises that doses of an FDA approved or
authorized COVID-19 vaccine are not recommended for individuals who
have previously completed the primary series of a vaccine listed for
emergency use by

[[Page 61564]]

the WHO. For those who have not completed the primary series of a
vaccine listed for emergency use by the WHO, they may receive an FDA
approved or authorized COVID-19 vaccination series. In addition,
individuals who have received a COVID-19 vaccine that is neither
approved nor authorized by the FDA, nor listed on the WHO emergency use
list, may receive an FDA approved or authorized vaccination series. The
CDC guidelines recommend at least 28 days between administration of an
FDA licensed or authorized vaccine, a non-FDA approved or authorized
vaccine, and a vaccine listed by WHO for emergency use.
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\99\ <a href="https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines">https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines</a>. Accessed September 14, 2021.
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For the completion of the primary series of COVID-19 vaccination,
individuals should generally avoid using heterologous vaccines--meaning
receiving doses of different vaccines--to complete a primary COVID-19
vaccination series. Nevertheless, CDC does recognize that, in certain
situations (for example, when the vaccine product given for the first
dose cannot be determined or is no longer available), a different
vaccine may be used to complete the primary COVID-19 vaccination
series. Accordingly, staff may be considered compliant with the
requirements within this regulation if they have received any
combination of two doses of a vaccine licensed or authorized by the FDA
or listed on the WHO emergency use list as part of a two-dose series.
Of note, the recommended interval between the first and second doses of
a vaccine licensed or authorized by FDA, or listed on the WHO emergency
use list, varies by vaccine type. For interpretation of vaccination
records and compliance with this rule, people who received a
heterologous primary series (with any combination of FDA-authorized,
FDA-approved, or WHO EUL-listed products) can be considered fully
vaccinated if the second dose in a two dose heterologous series must
have been received no earlier than 17 days (21 days with a 4 day grace
period) after the first dose.\100\ Because the science and clinical
recommendations are evolving rapidly, we refer individuals to CDC's
Interim Public Health Recommendations for Fully Vaccinated People for
additional details.
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\100\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html</a>.
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Some staff may receive COVID-19 vaccines due to their participation
in a clinical trial at a site in the U.S. Repeat vaccine doses are not
recommended by CDC for participants in a clinical trial who previously
completed the primary series of a vaccine approved or authorized by
FDA, or listed for emergency use by the WHO. Likewise, for individuals
who participated in a clinical trial at a site in the U.S. and received
the full series of an ``active'' vaccine candidate (not placebo) and
``vaccine efficacy has been independently confirmed (for example, by a
data and safety monitoring board),'' CDC does not recommend repeat
doses.\101\
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\101\ <a href="https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#">https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#</a> Accessed 9/14/2021.
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D. FDA Emergency Use Authorization (EUA) and Licensure of COVID-19
Vaccines

The FDA provides scientific and regulatory advice to vaccine
developers and undertakes a rigorous evaluation of the scientific
information it receives from all phases of clinical trials; such
evaluation continues after a vaccine has been licensed by FDA or
authorized for emergency use. On August 23, 2021, FDA licensed the
first COVID-19 vaccine. The vaccine had been known as the Pfizer-
BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty, for
the prevention of COVID-19 in individuals 16 years of age and
older.\102\ The vaccine continues to be available in the U.S. under
EUA, including for individuals 12 through 15 years of age. This EUA has
been amended to allow for the use of a third dose for certain
immunocompromised individuals 12 years of age and older. This EUA has
also been amended to allow for use of a single booster dose in certain
individuals. FDA has issued EUAs for two additional vaccines for the
prevention of COVID-19, one for the Moderna COVID-19 vaccine (December
18, 2020) (indicated for use in individuals 18 years of age and older),
and the other for Janssen (Johnson & Johnson) COVID-19 Vaccine
(February 27, 2021) (indicated for use in individuals 18 years of age
and older). The EUA for the Moderna COVID-19 vaccine has been amended
to allow for the use of a third dose in certain immunocompromised
individuals. Package inserts and fact sheets for health care providers
administering COVID-19 vaccines are available for each licensed and
authorized vaccine from the FDA.103 104 105
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\102\ <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine">https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine</a> Accessed 10/14/2021.
\103\ Pfizer Fact Sheet--<a href="https://www.fda.gov/media/144413/download">https://www.fda.gov/media/144413/download</a>.
\104\ Moderna Fact Sheet--<a href="https://www.fda.gov/media/144637/download">https://www.fda.gov/media/144637/download</a>.
\105\ Janssen Fact Sheet--<a href="https://www.fda.gov/media/146304/download">https://www.fda.gov/media/146304/download</a>.
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Section 564 of the Federal Food, Drug, and Cosmetic Act authorizes
FDA to issue EUAs. An EUA is a mechanism to facilitate the availability
and use of medical countermeasures, including vaccines, during public
health emergencies, such as the current COVID-19 pandemic. FDA may
authorize certain unapproved medical products or unapproved uses of
approved medical products to be used in an emergency to diagnose,
treat, or prevent serious or life-threatening diseases or conditions
caused by threat agents when certain criteria are met, including there
are no adequate, approved, and available alternatives.\106\
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\106\ <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization</a>.
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The safety of the approved and authorized COVID-19 vaccines is
closely monitored. VAERS is a safety and monitoring system that can be
used by anyone to report adverse events after vaccines. For COVID-19
vaccines, vaccination providers and licensed and authorized vaccine
manufacturers, must report select adverse events to VAERS following
receipt of COVID-19 vaccines (including serious adverse events, cases
of multisystem inflammatory syndrome (MIS), and COVID-19 cases that
result in hospitalization or death).\107\ Providers also must adhere to
any revised safety reporting requirements. FDA's website includes
letters of authorization and fact sheets and these documents should be
checked for any updates that may occur. Other adverse events following
vaccination may also be reported to VAERS. Additionally, adverse events
are also monitored through electronic health record- and claims-based
systems (through CDC's Vaccine Safety Datalink and FDA's Biologics
Effectiveness and Safety System (BEST)).
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\107\ Department of Health and Human Services. VAERS--Vaccine
Adverse Event Reporting System. Accessed at <a href="https://vaers.hhs.gov/">https://vaers.hhs.gov/</a>.
Accessed on January 26, 2021.
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FDA is closely monitoring the safety of the COVID-19 vaccines both
authorized for emergency use and licensed use. Vaccination providers
are responsible for mandatory reporting to VAERS of certain adverse
events as listed on the Health Care Provider Fact Sheets for the
authorized COVID-19 vaccines and for Comirnaty.
Vaccine safety is critically important for all vaccination
programs. Side effects following vaccinations often include swelling,
redness, and pain at the injection site; flu-like symptoms; headache;
and nausea; all typically of

[[Page 61565]]

short duration.\108\ Serious adverse reactions also have been reported
following COVID-19 vaccines; however, they are rare.109 110
For example, it is estimated that anaphylaxis following the mRNA COVID-
19 vaccines occurs in 2-5 individuals per million vaccinated (<a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html</a>).
For these individuals, another shot of an mRNA COVID-19 vaccine is not
recommended,\111\ and they should discuss receiving a different type of
COVID-19 vaccine with their health care practitioner.\112\ Other rare
serious adverse reactions that have been reported to occur following
COVID-19 vaccines include thrombosis with thrombocytopenia syndrome
(TTS) following the Janssen COVID-19 vaccine and myocarditis and/or
pericarditis following the mRNA COVID-19 vaccines (<a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html</a>). In the face
of the COVID-19 pandemic, global researchers were able to build upon
decades of vaccine development, research, and use to produce safe
vaccines that have been highly effective in protecting individuals from
COVID-19. From December 14, 2020, through October 12, 2021, over 403
million doses of COVID-19 vaccine have been administered in the U.S.
<a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html</a>. ``CDC recommends everyone 12 years and older get
vaccinated as soon as possible to help protect against COVID-19 and the
related, potentially severe complications that can occur.'' \113\ They
state that the ``potential benefits of COVID-19 vaccination outweigh
the known and potential risks, including the possible risk of
myocarditis or pericarditis.'' \114\
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\108\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html</a>. Accessed 10/17/2021.
\109\ Ibid.
\110\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html</a>. Access 10/17/2021.
\111\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/allergic-reaction.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/allergic-reaction.html</a>. Accessed 10/17/2021.
\112\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/specific-groups/allergies.html#anchor_1624541541034">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/specific-groups/allergies.html#anchor_1624541541034</a>.
Accessed 10/17/2021.
\113\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html</a>. Accessed 10/17/2021.
\114\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html</a>. Accessed 10/17/2021.
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E. COVID-19 Vaccine Effectiveness

COVID-19 vaccines currently approved or authorized by FDA are
highly effective in preventing serious outcomes of COVID-19, including
severe disease, hospitalization, and death.\115\ Moreover, available
evidence suggests that these vaccines offer protection against known
variants, including the Delta variant (B.1.617.2), particularly against
hospitalization and death.116 117 Furthermore, a recent
study found that, between December 14, 2020, and August 14, 2021, full
vaccination with COVID-19 vaccines was 80 percent effective in
preventing RT-PCR-confirmed SARS-CoV-2 infection among frontline
workers, further affirming the highly protective benefit of full
vaccination up to and through the 2021 summer COVID-19 pandemic waves
in the U.S.\118\ While vaccine effectiveness point estimates did
decline over the course of the study as the Delta variant became
predominant, the protection afforded by vaccination remained
significant, underscoring the continued importance and benefits of
COVID-19 vaccination.\119\
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\115\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/work.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/work.html</a>.
\116\ <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e2.htm?s_cid=mm7034e2_w">https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e2.htm?s_cid=mm7034e2_w</a>.
\117\ <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e1.htm?s_cid=mm7034e1_w">https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e1.htm?s_cid=mm7034e1_w</a>.
\118\ <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm#contribAff">https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm#contribAff</a>.
\119\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html?s_cid=11504:cdc%20delta%20variant%20vaccine%20effectiveness:sem.ga:p:RG:GM:gen:PTN:FY21">https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html?s_cid=11504:cdc%20delta%20variant%20vaccine%20effectiveness:sem.ga:p:RG:GM:gen:PTN:FY21</a>.
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Like most vaccines, COVID-19 vaccines are not 100 percent effective
in preventing COVID-19. Consequently, some ``breakthrough'' cases are
expected and, as the number of people who have completed a primary
vaccination series and are considered fully vaccinated for COVID-19
increases, breakthrough COVID-19 cases will also increase
commensurately. However, the risk of developing COVID-19, including
severe illness, remains much higher for unvaccinated than vaccinated
people. Vaccinated people with a breakthrough COVID-19 case are less
likely to develop serious disease, be hospitalized, and die than those
who are unvaccinated and get COVID-19.\120\ The combined protections
offered by vaccination and ongoing implementation of other infection
control measures, especially source control (masking),\121\ remain
critical to safeguarding patients, residents, clients, PACE program
participants, and staff.
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\120\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/why-measure-effectiveness/breakthrough-cases.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/why-measure-effectiveness/breakthrough-cases.html</a>.
\121\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html">https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html</a>. Accessed 10/15/2021.
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F. Stakeholder Response to Vaccines

There has been growing national interest in COVID-19 vaccination
requirements among health care workers, including requests from various
national health care stakeholders. In a joint statement released on
July 26, 2021, more than 50 health care professional societies and
organizations called for all health care employers and facilities to
require that all their staff be vaccinated against COVID-19. Included
as signatories to this statement were organizations representing
millions of workers throughout the U.S. health care industry, including
those representing doctors, nurses, pharmacists, physician assistants,
public health workers, and epidemiologists as well as long term care,
home care, and hospice workers.\122\
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\122\ <a href="https://www.hematology.org/newsroom/press-releases/2021/joint-statement-in-support-of-covid-19-vaccine-mandates-for-all-workers-in-health">https://www.hematology.org/newsroom/press-releases/2021/joint-statement-in-support-of-covid-19-vaccine-mandates-for-all-workers-in-health</a>.
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In addition, a large nonprofit, nonpartisan organization focused on
empowering Americans over the age of 50 recently called on all LTC
facilities to require vaccinations for staff and residents.\123\ A non-
profit organization dedicated to advancing dignity in aging issued a
statement in support of COVID-19 vaccine mandates for staff and
residents of long-term care facilities.\124\ In a policy statement
dated July 21, 2021, a large long term care association, ``strongly
urges all residents and staff in long-term care to get vaccinated'' and
``supports requiring vaccines for current and new staff in long-term
care and other healthcare settings. COVID-19 vaccination should be a
condition of employment for all healthcare workers, including
employees, contract staff and others, with appropriate exemptions for
those with medical reasons or as specified by federal or state law.''
\125\ The statement further notes that ``COVID-19 vaccines are safe . .
. effective for preventing infection, and especially severe illness and
death [and] reduce the risk of spreading the virus.'' \126\ Moreover,
the

[[Page 61566]]

statement observes that ``the COVID crisis exacerbated long-standing
workforce challenges, and some in the sector fear that a vaccine
mandate could lead to worker resignations. But providers that have
required staff vaccination have reported high vaccine accepted by
previously hesitant care professionals, and many providers report that
when staff vaccination rates are high, they become providers of choice
in their communities.'' \127\ A non-profit federation of affiliated
State health organizations, representing more than 14,000 non-profit
and for-profit nursing homes, assisted living communities, and
facilities for individuals with disabilities expressed support for all
health care ``strongly urges the vaccination of all health care
personnel'' to ``protect all residents, staff and others in our
communities from the known and substantial risks of COVID-19.'' They
also assert that ``COVID-19 vaccines protect health care personnel when
working both in health care facilities and in the community,'' and
``provide strong protection against workers unintentionally carrying
the disease to work and spreading it to patients and peers.'' \128\
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\123\ <a href="https://press.aarp.org/2021-8-12-New-AARP-Analysis-Shows-Nursing-Homes-Vaccination-Rates-Still-Well-Short-of-Benchmark-as-COVID-Cases-Trend-Upwards">https://press.aarp.org/2021-8-12-New-AARP-Analysis-Shows-Nursing-Homes-Vaccination-Rates-Still-Well-Short-of-Benchmark-as-COVID-Cases-Trend-Upwards</a>.
\124\ <a href="https://justiceinaging.org/justice-in-aging-supports-mandatory-covid-vaccinations-in-long-term-care-facilities/">https://justiceinaging.org/justice-in-aging-supports-mandatory-covid-vaccinations-in-long-term-care-facilities/</a>, accessed
10/6/21, 1:02 p.m. EDT.
\125\ <a href="https://leadingage.org/sites/default/files/LeadingAge%20Statement%20on%20Vaccine%20Mandates%20for%20Healthcare%20Workers.pdf">https://leadingage.org/sites/default/files/LeadingAge%20Statement%20on%20Vaccine%20Mandates%20for%20Healthcare%20Workers.pdf</a>.
\126\ Ibid.
\127\ Ibid.
\128\ <a href="https://www.ahcancal.org/News-and-Communications/Press-Releases/Pages/AHCANCAL-Issues-Policy-Statement-Regarding-COVID-19-Vaccinations-of-Long-Term-Care-Personnel.aspx">https://www.ahcancal.org/News-and-Communications/Press-Releases/Pages/AHCANCAL-Issues-Policy-Statement-Regarding-COVID-19-Vaccinations-of-Long-Term-Care-Personnel.aspx</a>. Accessed 10/16/2021.
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Numerous health systems and individual health care employers across
the country have implemented vaccine mandates independent of this rule.
For example, a health care system that is the largest private employer
in Delaware with more than 14,000 employees, a health care system and
academic medical center with over 26,000 employees in Texas, and an
integrated health system in North Carolina with more than 35,000
employees, to name a few, have all preceded this rule with their own
vaccination requirements, achieving rates of at least 97 percent
vaccination among their staff.129 130 131 132 These
organizations are already realizing the effectiveness of strong
vaccination policies. Despite the successes of these organizations in
increasing levels of staff vaccination, there remains an inconsistent
patchwork of requirements and laws that is only effective at local
levels and has not successfully raised staff vaccination rates
nationwide. Patients, residents, clients, PACE program participants,
and staff alike are not adequately protected from COVID-19.
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\129\ <a href="https://news.christianacare.org/2021/09/safe-care-safe-workplace-we-are-vaccinated/">https://news.christianacare.org/2021/09/safe-care-safe-workplace-we-are-vaccinated/</a>. Accessed 10/15/2021.
\130\ <a href="https://www.delawareonline.com/story/news/health/2021/09/27/christianacare-fires-employees-not-complying-vaccine-mandate/5887784001/">https://www.delawareonline.com/story/news/health/2021/09/27/christianacare-fires-employees-not-complying-vaccine-mandate/5887784001/</a>. Accessed 10/15/2021.
\131\ <a href="https://www.houstonmethodist.org/leading-medicine-blog/articles/2021/jun/houston-methodist-requires-covid-19-vaccine-for-credentialed-doctors/">https://www.houstonmethodist.org/leading-medicine-blog/articles/2021/jun/houston-methodist-requires-covid-19-vaccine-for-credentialed-doctors/</a>. Accessed 10/15/202021.
\132\ <a href="https://www.novanthealth.org/home/about-us/newsroom/press-releases/newsid33987/2576/novant-health-update-on-mandatory-covid-19-vaccination-program-for-employees.aspx">https://www.novanthealth.org/home/about-us/newsroom/press-releases/newsid33987/2576/novant-health-update-on-mandatory-covid-19-vaccination-program-for-employees.aspx</a>. Accessed 10/15/2021.
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In September 2021, Jeffrey Zients, the White House Coronavirus
Response Coordinator, noted that ``vaccination requirements work . . .
and are the best path out of the pandemic.'' He further noted that
vaccination requirements are not only key to the nation's path out of
the pandemic, but also accelerate our economic recovery, keeping
workplaces safer, and helping to curb the spread of the virus in
communities, and boost job growth, the labor market, and the nation's
overall economy.

G. Populations at Higher Risk for Severe COVID-19 Outcomes

COVID-19 can affect anyone, with symptoms ranging from mild
(infections not requiring hospitalization) to very severe (requiring
intensive care in a hospital). Nonetheless, studies have shown that
COVID-19 does not affect all population groups equally.\133\ Age
remains a strong risk factor for severe COVID-19 outcomes.
Approximately 54.1 million people aged 65 years or older reside in the
U.S.; this age group accounts for more than 80 percent of U.S. COVID-19
related deaths. Residents of LTC facilities make up less than 1 percent
of the U.S. population but accounted for more than 35 percent of all
COVID-19 deaths in the first 12 months of the pandemic.\134\
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\133\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html">https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html</a>.
\134\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html">https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html</a>.
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Additionally, adults of any age with certain underlying medical
conditions are at increased risk for severe illness from COVID-19.
These include, but are not limited to, cancer, cerebrovascular disease,
diabetes (Type 1 and Type 2), chronic kidney disease, COPD, heart
conditions, Down Syndrome, obesity, substance use, smoking status, and
pregnancy.\135\ The risk of severe COVID-19 also increases as the
number of underlying medical conditions increases in a particular
individual.
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\135\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/underlying-evidence-table.html">https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/underlying-evidence-table.html</a>.
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A confluence of structural and epidemiological factors has also
contributed to disparate risk for COVID-19 infection, severe illness,
and death in certain populations. For example, evidence clearly
indicates that racial and ethnic minority groups, including Black and
Hispanic or Latino, have disproportionately higher hospitalization
rates among every age group, including children aged younger than 18
years.\136\ These same groups are disproportionately affected by long-
standing inequities in social determinants of health, such as poverty
and health care access, that increase risk of severe illness and death
from COVID-19.\137\ People with intellectual disabilities are more
likely to have chronic health conditions, live in congregate settings,
and face more barriers to health care; some studies suggest they are
also more likely to get COVID-19 and have worse outcomes.\138\ Finally,
rural communities often have a higher proportion of residents who live
with comorbidities or disabilities and are aged >=65 years; these risk
factors, combined with more limited access to health care facilities
with intensive care capabilities, place rural dwellers at increased
risk for COVID-19-associated morbidity and mortality.\139\
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\136\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/disparities-hospitalization.html">https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/disparities-hospitalization.html</a>.
\137\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/disparities-illness.html">https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/disparities-illness.html</a>.
\138\ <a href="https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0051">https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0051</a>.
\139\ <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7020e3.htm">https://www.cdc.gov/mmwr/volumes/70/wr/mm7020e3.htm</a>.
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In addition, CDC data indicate that vaccination rates are
disproportionately low among nurses and health care aides in long term
care settings, particularly in communities that experience social risk
factors. Further, CDC data indicate that nurses and aides in these
settings are more likely to be members of racial and ethnic minority
communities.\140\ This disparity in vaccination coverage may be
exacerbating existing and emerging disparities related to COVID-19
cases and impact, placing members of communities who experience social
risk factors--those in rural areas with geographic and transportation
barriers to care, those in low income areas who experience persistent
poverty and inequality, and others--at further increased risk for
COVID-19-associated morbidity and mortality.\141\ This disparity may
be, in part, reduced by the potential positive health equity impacts of
requiring staff vaccination among provider and supplier types subject
to rulemaking.
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\140\ <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7030a2.htm">https://www.cdc.gov/mmwr/volumes/70/wr/mm7030a2.htm</a>.
\141\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/vaccine-equity.html">https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/vaccine-equity.html</a>.

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[[Page 61567]]

CMS believes that the developing data about staff vaccination rates
and rates of COVID-19 cases, and the urgent need to address COVID-
related staffing shortages that are disrupting patient access to care,
provides strong justification as to the need to issue this IFC
requiring staff vaccination for most provider and supplier types over
which we have authority.

H. CMS Authority To Require Staff Vaccinations

CMS has broad statutory authority to establish health and safety
regulations, which includes authority to establish vaccination
requirements. Section 1102 of the Act grants the Secretary of Health
and Human Services authority to make and publish such rules and
regulations, not inconsistent with the Act, as may be necessary to the
efficient administration of the functions with which the Secretary is
charged under the Act. Section 1871 of the Act grants the Secretary of
Health and Human Services authority to prescribe regulations as may be
necessary to carry out the administration of the Medicare program. The
statutory authorities to establish health and safety requirements for
COVID-19 vaccination for each provider and supplier included in this
IFC are listed in Table 1 and discussed in sections II.C. through II.F.
of this IFC.
[GRAPHIC] [TIFF OMITTED] TR05NO21.022

Section 1863 of the Act provides that ``[i]n carrying out his
functions, relating to determination of conditions of participation by
providers . . . the Secretary shall consult with appropriate State
agencies and recognized national listing or accrediting bodies[.]'' For
the reasons discussed in greater detail throughout sections I. through
III. this IFC, the COVID-19 pandemic presents a serious and continuing
threat to the health and to the lives of staff of health care
facilities and of consumers of these providers' and suppliers'
services. This threat has grown to be particularly severe since the
emergence of the Delta variant. Any delay in the implementation of this
rule would result in additional deaths and serious illnesses among
health care staff and consumers, further exacerbating the newly-
arising, and ongoing, strain on the capacity of health care facilities
to serve the public. For these reasons, in carrying out the agency's
functions relating to determination of conditions of participation,
conditions for coverage, and requirements, we intend to engage in
consultations with appropriate State agencies and listing or
accrediting bodies following the issuance of this rule, and toward that
end we invite these entities to submit comments on this IFC. Given the
urgent need to issue this rule, however, we do not believe that there
exists an entity with which it would be appropriate to engage in these
consultations in advance of issuing this IFC, nor do we understand the
statute to impose a temporal requirement to do so in advance of the
issuance of this rule.
We have not previously required any vaccinations, but we recognize
that many health care workers already comply with employer or State
government vaccination requirements (for example, influenza, and
hepatitis B virus (HBV)) and invasive employer or State government-
required screening procedures (such as tuberculosis screening).
Further, most of these

[[Page 61568]]

individuals met State and local vaccination requirements in order to
attend school to complete the necessary education to qualify for health
care positions. In addition to these longstanding vaccination
requirements, many now require vaccination for COVID-19 as well.
However, studies on annual seasonal influenza vaccine uptake
consistently show that half of health care workers may resist seasonal
influenza vaccination nationwide.\142\
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\142\ Field R.I. (2009). Mandatory vaccination of health care
workers: whose rights should come first? P & T: a peer-reviewed
journal for formulary management, 34(11), 615-618.
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Other ongoing CMS staff vaccination programs include hospital
quality improvement contractors that provide educational resources to
help hospitals and staff overcome vaccine hesitancy, coordinate with
State health departments to support vaccine uptake (for COVID-19 and
flu), and monitor staff vaccination rates for additional action. ESRD
networks also provide education on patient influenza and pneumococcal
vaccinations as a part of their work and also recently (in 2020) added
a goal of 85 percent of patients vaccinated for flu while also
encouraging vaccinations for staff within ESRD facilities. While we
have not, until now, required any health care staff vaccinations, we
have established, maintained, and regularly updated extensive health
and safety requirements (CfCs, CoPs, requirements, etc.) for Medicare-
and Medicaid-certified providers and suppliers. These requirements
focus a great deal on infection prevention and control standards, often
incorporating guidelines as recommended by CDC and other expert groups,
as CMS's highest duty is to protect the health and safety of patients,
clients, residents, and PACE program participants in all applicable
settings.
The Medicare statute's various provisions authorizing the Secretary
to impose requirements necessary in the interest of the health and
safety of beneficiaries encompass authority to require that staff
working in and for Medicare-certified providers and suppliers be
vaccinated against specific diseases. In addition, parallel Medicaid
statutes provide authority to establish requirements to protect
beneficiary health and safety, as reflected in Table 1. We acknowledge
that we have not previously imposed such requirements, but, as
discussed throughout section I. of this rule, this is a unique pandemic
scenario with unique access to effective vaccines. In addition, for
many infectious diseases, it is not necessary for CMS to impose such
requirements because other entities, including employers, states, and
licensing organizations, already impose sufficient standards for those
specific diseases. We believe that, given the fast-moving nature of the
COVID-19 pandemic and its ongoing threat to the health and safety of
individuals receiving health care services in Medicare- and Medicaid-
certified providers and suppliers, our intervention is warranted. We
understand that some states and localities have established laws that
would seem to prevent Medicare- and Medicaid-certified providers and
suppliers from complying with the requirements of this IFC. We intend,
consistent with the Supremacy Clause of the United States Constitution,
that this nationwide regulation preempts inconsistent State and local
laws as applied to Medicare- and Medicaid-certified providers and
suppliers. CDC estimates that 45.4 percent of U.S. adults are at
increased risk for complications from coronavirus disease because of
cardiovascular disease, diabetes, respiratory disease, hypertension, or
cancer. Rates increased by age, from 19.8 percent for persons 18-29
years of age to 80.7 percent for persons >80 years of age, and varied
by State, race/ethnicity, health insurance status, and employment.\143\
We expect that individuals seeking health care services are more likely
to fall into the high-risk category. While we do not have provider- or
supplier-specific estimates, we would anticipate the percentage of
high-risk individuals in health care settings is much higher than the
general population. Health care consumers seeking services from the
provider and suppliers included in this rule are often at significantly
higher risk of severe disease and death than their paid care
givers.\144\ As discussed in section I.F. of this IFC, COVID-19 has
disproportionally affected minority and underserved populations, who
will receive safer care and better outcomes through this
requirement.\145\ Families, unpaid caregivers, and communities will
also experience overall benefit.146 147 Staff will directly
benefit from the protective effects of COVID-19 vaccination, but the
primary reason that we are issuing this IFC requiring health care
workers be vaccinated against COVID-19 is for the protection of
residents, clients, patients, and PACE program participants.
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\143\ <a href="https://wwwnc.cdc.gov/eid/article/26/8/20-0679_article">https://wwwnc.cdc.gov/eid/article/26/8/20-0679_article</a>.
\144\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html">https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html</a>.
\145\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/disparities-impact.html">https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/disparities-impact.html</a>.
\146\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html">https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html</a>.
\147\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html?s_cid=11509:cdc%20guidance%20delta%20variant:sem.ga:p:RG:GM:gen:PTN:FY21">https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html?s_cid=11509:cdc%20guidance%20delta%20variant:sem.ga:p:RG:GM:gen:PTN:FY21</a>.
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I. Vaccination Requirements and Employee Protections

This IFC requires most Medicare- and Medicaid-certified providers
and suppliers to ensure that their staff are fully vaccinated for
COVID-19. The U.S. Equal Employment Opportunity Commission (EEOC)
enforces workplace anti-discrimination laws and has established that
employers can mandate COVID-19 vaccination for all employees that
physically enter their facility.\148\ We are expanding upon that to
include all of the staff described in section II.A.1. of this IFC, for
the providers and suppliers addressed by this IFC, not just those staff
who perform their duties within a health care facility, as many health
care staff routinely care for patients and clients outside of such
facilities, such as home health, home infusion therapy, hospice, and
therapy staff. In addition, there may be other times that staff
encounter fellow employees, such as in an administrative office or at
an off-site staff meeting, who will themselves enter a health care
facility or site of care for their job responsibilities. Thus, we
believe it is necessary to require vaccination for all staff that
interact with other staff, patients, residents, clients, or PACE
program participants in any location, beyond those that physically
enter facilities or other sites of patient care.
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\148\ What You Should Know About COVID-19 and the ADA, the
Rehabilitation Act, and Other EEO Laws. U.S. Equal Opportunity
Commission. Accessed at <a href="https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws">https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws</a>.
Accessed on October 16, 2021, 2:20 p.m. EDT. Updated October 13,
2021. Section K. Vaccinations.
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In implementing the COVID-19 vaccination policies and procedures
required by this IFC, however, employers must comply with applicable
Federal anti-discrimination laws and civil rights protections.
Applicable laws include: (1) The Americans with Disabilities Act (ADA);
(2) Section 504 of the Rehabilitation Act (RA); (3) Title VII of the
Civil Rights Act of 1964; (4) the Pregnancy Discrimination Act; and (5)
the Genetic Information Nondiscrimination Act.\149\ In addition, other
Federal laws may provide employees with additional protections.
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\149\ Genetic Information Nondiscrimination Act of 2008. Public
Law 110-233.
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These Federal laws continue to apply during the PHE and, in some
instances, require employers to offer

[[Page 61569]]

accommodations for some individual staff members in some circumstances.
These laws do not interfere with or prevent employers from following
the guidelines and suggestions made by CDC or public health authorities
about steps employers should take to promote public health and safety
in light of COVID-19, to the extent such guidelines and suggestions are
consistent with the requirements set forth in this regulation. In other
words, employers following CDC guidelines and the new requirements in
this IFC may also be required to provide appropriate accommodations, to
the extent required by Federal law, for employees who request and
receive exemption from vaccination because of a disability, medical
condition, or sincerely held religious belief, practice, or observance.
Vaccination against COVID-19 is a critical protective action for
all individuals, especially health care workers, because the SARS-Cov-2
virus poses direct threats to patients, clients, residents, PACE
program participants, and staff. COVID-19 disease at this time is
resulting in much higher morbidity and mortality than seasonal
flu.150 151 152 These individual vaccinations provide
protections to the health care system as a whole, protecting capacity
and operations during disease outbreaks.
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\150\ Comparison of the characteristics, morbidity, and
mortality of COVID-19 and seasonal influenza: a nationwide,
population-based retrospective cohort study, The Lancet, Published
Online December 17, 2020 <a href="https://doi.org/10.1016/">https://doi.org/10.1016/</a> S2213-
2600(20)30527-0.
\151\ Comparative evaluation of clinical manifestations and risk
of death in patients admitted to hospital with covid-19 and seasonal
influenza: cohort study, BMJ 2020;371:m4677.
\152\ Klompas, M, Pearson, M, and Morris, C. The Case for
Mandating COVID-19 Vaccines for Health Care Workers. Annuals of
Internal Medicine. <a href="http://Annals.org">Annals.org</a>. Accessed at <a href="https://www.acpjournals.org/doi/10.7326/M21-2366">https://www.acpjournals.org/doi/10.7326/M21-2366</a>. Accessed on August 30,
2021. Published on July 13, 2021.
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We also recognize ethical reasons to issue these vaccination
requirements. All health care workers have a general ethical duty to
protect those they encounter in their professional capacity.\153\
Patient safety is a central tenet of the ethical codes and practice
standards published by health care professional associations, licensure
and certification bodies, and specialized industry groups. Health care
workers also have a special ethical and professional responsibility to
protect and prioritize the health and well-being of those they are
caring for, as well as not exposing them to threats that can be
avoided. This holds true not only for health care professionals, but
also for all who provide health care services or choose to work in
those settings. The ethical duty of receiving vaccinations is not new,
as staff have long been required by employers to be vaccinated against
certain diseases, such as influenza, hepatitis B, and other infectious
diseases.
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\153\ Emanuel, E and Skorton, D. Mandating COVID-19 Vaccination
for Health Care Workers. Annuals of Internal Medicine. <a href="http://Annals.org">Annals.org</a>.
Accessed at <a href="https://www.acpjournals.org/doi/10.7326/M21-3150">https://www.acpjournals.org/doi/10.7326/M21-3150</a>.
Accessed on August 30, 2021. Article includes the ``Joint Statement
in Support of COVID-19 Vaccine Mandates for All Workers in Health
and Long-Term Care'' that is signed by 80 organizations.
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We are aware of concerns about health care workers choosing to
leave their jobs rather than be vaccinated. While we understand that
there might be a certain number of health care workers who choose to do
so, there is insufficient evidence to quantify and compare adverse
impacts on patient and resident care associated with temporary staffing
losses due to mandates and absences due to quarantine for known COVID-
19 exposures and illness. We encourage providers and suppliers, where
possible, to consider on-site vaccination programs, which can
significantly reduce barriers that health care staff may face in
getting vaccinated, including transportation barriers, need to take
time off of work, and scheduling. However, vaccine declination may
continue to occur, albeit at lower rates, due to hesitancy among
particular communities, and the Assistant Secretary for Planning and
Evaluation (ASPE) indicates that vaccination promotion and outreach
efforts focused on groups and communities who experience social risk
factors could help address inequities.\154\
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\154\ Kolbe A. Disparities in COVID-19 vaccination rates across
racial and ethnic minority groups in the United States. Washington,
DC: US Department of Health and Human Services, Office of the
Assistant Secretary for Planning and Evaluation; 2021. <a href="https://aspe.hhs.gov/system/files/pdf/265511/vaccination-disparities-brief.pdf">https://aspe.hhs.gov/system/files/pdf/265511/vaccination-disparities-brief.pdf</a>.
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Despite these hesitations, many COVID-19 vaccination mandates have
already been successfully initiated in a variety of health care
settings, systems, and states. In general, workers across the economy
are responding to mandates by getting vaccinated.\155\ A large hospital
system in Texas instituted a vaccine mandate and 99.5 percent of its
staff received the vaccine. Further, only a few of their staff resigned
rather than receive the vaccine.\156\ A Detroit-based health system
also instituted a vaccine mandate, and reported that 98 percent of the
system's 33,000 workers were fully or partially vaccinated or in the
process of obtaining a religious or medical exemption when the
requirement went into effect, with exemptions comprising less than 1
percent of staffers.\157\ In addition, a LTC parent corporation
established a COVID-19 vaccine mandate for its more than 250 LTC
facilities, leading to more than 95 percent of their workers being
vaccinated. Again, they noted that very few workers quit their jobs
rather than be vaccinated.\158\ New York enacted a State-wide health
care worker COVID-19 vaccine mandate and recorded a jump in vaccine
compliance in the final days before the requirements took effect on
October 1, 2021.\159\
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\155\ <a href="https://theconversation.com/half-of-unvaccinated-workers-say-theyd-rather-quit-than-get-a-shot-but-real-world-data-suggest-few-are-following-through-168447">https://theconversation.com/half-of-unvaccinated-workers-say-theyd-rather-quit-than-get-a-shot-but-real-world-data-suggest-few-are-following-through-168447</a>.
\156\ Emanuel, E and Skorton, D. Mandating COVID-19 Vaccination
for Health Care Workers. Annuals of Internal Medicine. <a href="http://Annuals.org">Annuals.org</a>.
Accessed <a href="https://www.acpjournals.org/doi/10.7326/M21-3150">https://www.acpjournals.org/doi/10.7326/M21-3150</a>. Accessed
on August 30, 2021. Article includes the ``Joint Statement in
Support of COVID-19 Vaccine Mandates for All Workers in Health and
Long-Term Care'' that is signed by 88 organizations.
\157\ <a href="https://www.bridgemi.com/michigan-health-watch/despite-protests-98-henry-ford-hospital-workers-get-covid-vaccinations">https://www.bridgemi.com/michigan-health-watch/despite-protests-98-henry-ford-hospital-workers-get-covid-vaccinations</a>
accessed 09/15/2021 at 2:24 p.m. EDT.
\158\ Emanuel, E and Skorton, D. Mandating COVID-19 Vaccination
for Health Care Workers. Annuals of Internal Medicine. <a href="http://Annals.org">Annals.org</a>.
Accessed at <a href="https://www.acpjournals.org/doi/10.7326/M21-3150">https://www.acpjournals.org/doi/10.7326/M21-3150</a>.
Accessed on August 30, 2021. Article includes the ``Joint Statement
in Support of COVID-19 Vaccine Mandates for All Workers in Health
and Long-Term Care'' that is signed by 88 organizations.
\159\ <a href="https://www.nytimes.com/2021/09/28/nyregion/vaccine-health-care-workers-mandate.html">https://www.nytimes.com/2021/09/28/nyregion/vaccine-health-care-workers-mandate.html</a>.
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We believe that the COVID-19 vaccine requirements in this IFC will
result in nearly all health care workers being vaccinated, thereby
benefiting all individuals in health care settings. This will greatly
contribute to a reduction in the spread of and resulting morbidity and
mortality from the disease, positive steps towards health equity, and
an improvement in the numbers of health care staff who are healthy and
able to perform their professional responsibilities. For individual
staff members that have legally permitted justifications for exemption,
the providers and suppliers covered by this IFC can address those
individually.

II. Provisions of the Interim Final Rule With Comment Period

Through this IFC, we are requiring that the following Medicare- and
Medicaid-certified providers and suppliers, listed here in order of
their appearance in 42 CFR, ensure that all applicable staff are
vaccinated for COVID-19:

<bullet> Ambulatory Surgical Centers (ASCs)
<bullet> Hospices
<bullet> Psychiatric residential treatment facilities (PRTFs)
<bullet> Programs of All-Inclusive Care for the Elderly (PACE)

[[Page 61570]]

<bullet> Hospitals (acute care hospitals, psychiatric hospitals, long
term care hospitals, children's hospitals, hospital swing beds,
transplant centers, cancer hospitals, and rehabilitation hospitals)
<bullet> Long Term Care (LTC) Facilities, including SNFs and NFs,
generally referred to as nursing homes
<bullet> Intermediate Care Facilities for Individuals with Intellectual
Disabilities (ICFs-IID)
<bullet> Home Health Agencies (HHAs)
<bullet> Comprehensive Outpatient Rehabilitation Facilities (CORFs)
<bullet> Critical Access Hospitals (CAHs)
<bullet> Clinics, rehabilitation agencies, and public health agencies
as providers of outpatient physical therapy and speech-language
pathology services
<bullet> Community Mental Health Centers (CMHCs)
<bullet> Home Infusion Therapy (HIT) suppliers
<bullet> Rural Health Clinics (RHCs)/Federally Qualified Health Centers
(FQHCs)
<bullet> End-Stage Renal Disease (ESRD) Facilities

For discussion purposes, we have grouped these providers and
suppliers into four categories below: (1) Residential congregate care
facilities; (2) acute care settings; (3) outpatient clinical care and
services; and (4) home-based care. We note that the appropriate term
for the individual receiving care and/or services differs depending
upon the provider or supplier. For example, for hospitals and CAHs, the
appropriate term is patient, but for ICFs-IID, it is client. Further,
LTC facilities have residents and PACE Programs have participants. The
appropriate term is used when discussing each individual provider or
supplier, but when we are discussing all or multiple providers and
suppliers we will use the general term ``patient.'' Similarly, despite
the different terms used for specific provider and supplier entities
(such as campus, center, clinic, facility, organization, or program),
when we are discussing all or multiple providers and suppliers, we will
use the general term ``facility.''

A. Provisions of the Interim Final Rule With Comment Period

In this IFC, we are issuing a common set of provisions for each
applicable provider and supplier. As there are no substantive
regulatory differences across settings, we discuss the provisions
broadly in this section of the rule, along with their rationales. In
subsequent sections of the rule we discuss any unique considerations
for each setting.
1. Staff Subject to COVID-19 Vaccination Requirements
The provisions of this IFC require applicable providers and
suppliers to develop and implement policies and procedures under which
all staff are vaccinated for COVID-19. Each facility's COVID-19
vaccination policies and procedures must apply to the following
facility staff, regardless of clinical responsibility or patient
contact and including all current staff as well as any new staff, who
provide any care, treatment, or other services for the facility and/or
its patients: Facility employees; licensed practitioners; students,
trainees, and volunteers; and individuals who provide care, treatment,
or other services for the facility and/or its patients, under contract
or other arrangement. These requirements are not limited to those staff
who perform their duties within a formal clinical setting, as many
health care staff routinely care for patients and clients outside of
such facilities, such as home health, home infusion therapy, hospice,
PACE programs, and therapy staff. Further, there may be staff that
primarily provide services remotely via telework that occasionally
encounter fellow staff, such as in an administrative office or at an
off-site staff meeting, who will themselves enter a health care
facility or site of care for their job responsibilities. Thus, we
believe it is necessary to require vaccination for all staff that
interact with other staff, patients, residents, clients, or PACE
program participants in any location, beyond those that physically
enter facilities, clinics, homes, or other sites of care. Individuals
who provide services 100 percent remotely, such as fully remote
telehealth or payroll services, are not subject to the vaccination
requirements of this IFC.
In the May 13, 2021 COVID-19 IFC, we included an extensive
discussion on the subject of ``staff'' in relation to the LTC facility
staff and to whom the testing, reporting, and education and offering of
COVID-19 vaccine requirements of that rule might apply. In that
discussion, we considered LTC facility staff to be those individuals
who work in the facility on a regular (that is, at least once a week)
basis. We note that this includes those individuals who may not be
physically in the LTC facility for a period of time due to illness,
disability, or scheduled time off, but who are expected to return to
work. We also note that this description of staff differs from that in
Sec. 483.80(h), established for the LTC facility COVID-19 testing
requirements in the September 2, 2020 COVID-19 IFC. As in the May 13,
2021 COVID-19 IFC, we considered applying the Sec. 483.80(h)
definition to the staff vaccination requirements in this rule, but
previous public feedback and our own experience tells us the definition
in Sec. 483.80(h) was overbroad for these purposes.
Stakeholders across settings have reported that there are many
individuals providing occasional health care services under
arrangement, and that the requirements may be excessively burdensome
for facilities to apply the definition at Sec. 483.80(h) because it
includes many individuals who have very limited, infrequent, or even no
contact with facility staff and residents. Stakeholders also report
that applying the staff vaccination requirements to these individuals
who may only make unscheduled visits to the facility would be extremely
burdensome. That said, the description in this rule still includes many
of the individuals included in Sec. 483.80(h). In addition to
facility-employed staff, many facilities have services provided
directly, on a regular basis, by individuals under contract or
arrangement, including hospice and dialysis staff, physical therapists,
occupational therapists, mental health professionals, social workers,
and portable x-ray suppliers. Any of these individuals who provide such
health care services at a facility would be included in ``staff'' for
whom COVID-19 vaccination is now required as a condition for continued
provision of those services for the facility and/or its patients.
In order to best protect patients, families, caregivers, and staff,
we are not limiting the vaccination requirements of this IFC to
individuals who are present in the facility or at the physical site of
patient care based upon frequency. Regardless of frequency of patient
contact, the policies and procedures must apply to all staff, including
those providing services in home or community settings, who directly
provide any care, treatment, or other services for the facility and/or
its patients, including employees; licensed practitioners; students,
trainees, and volunteers; and individuals who provide care, treatment,
or other services for the facility and/or its patients, under contract
or other arrangement. This includes administrative staff, facility
leadership, volunteer or other fiduciary board members, housekeeping
and food services, and others. We considered excluding individual staff
members who are present at the site of care less frequently than once
per week from these vaccination requirements, but were concerned that
this might lead to

[[Page 61571]]

confusion or fragmented care. Therefore, any individual that performs
their duties at any site of care, or has the potential to have contact
with anyone at the site of care, including staff or patients, must be
fully vaccinated to reduce the risks of transmission of SARS-CoV-2 and
spread of COVID-19.
Facilities that employ or contract for services by staff who
telework full-time (that is, 100 percent of their time is remote from
sites of patient care, and remote from staff who do work at sites of
care) should identify and monitor these individuals as a part of
implementing the policies and procedures of this IFC, documenting and
tracking overall vaccination status, but those individuals need not be
subject to the vaccination requirements of this IFC. Note, however,
that these individuals may be subject to other Federal requirements for
COVID-19 vaccination.
We recognize that many infrequent services and tasks performed in
or for a health care facility are conducted by ``one off'' vendors,
volunteers, and professionals. Providers and suppliers are not required
to ensure the vaccination of individuals who infrequently provide ad
hoc non-health care services (such as annual elevator inspection), or
services that are performed exclusively off-site, not at or adjacent to
any site of patient care (such as accounting services), but they may
choose to extend COVID-19 vaccination requirements to them if feasible.
Other individuals who may infrequently enter a facility or site of care
for specific limited purposes and for a limited amount of time, but do
not provide services by contract or under arrangement, may include
delivery and repair personnel.
We believe it would be overly burdensome to mandate that each
provider and supplier ensure COVID-19 vaccination for all individuals
who enter the facility. However, while facilities are not required to
ensure vaccination of every individual, they may choose to extend
COVID-19 vaccination requirements beyond those persons that we consider
to be staff as defined in this rulemaking. We do not intend to prohibit
such extensions and encourage facilities to require COVID-19
vaccination for these individuals as reasonably feasible.
When determining whether to require COVID-19 vaccination of an
individual who does not fall into the categories established by this
IFC, facilities should consider frequency of presence, services
provided, and proximity to patients and staff. For example, a plumber
who makes an emergency repair in an empty restroom or service area and
correctly wears a mask for the entirety of the visit may not be an
appropriate candidate for mandatory vaccination. On the other hand, a
crew working on a construction project whose members use shared
facilities (restrooms, cafeteria, break rooms) during their breaks
would be subject to these requirements due to the fact that they are
using the same common areas used by staff, patients, and visitors.
Again, we strongly encourage facilities, when the opportunity exists
and resources allow, to facilitate the vaccination of all individuals
who provide services infrequently and are not otherwise subject to the
requirements of this IFC.
2. Determining When Staff Are Considered ``Fully Vaccinated''
In consideration of the different vaccines available for COVID-19,
we require that providers and suppliers ensure that staff are fully
vaccinated for COVID-19, which, for purposes of these requirements, is
defined as being 2 weeks or more since completion of a primary
vaccination series. This definition of ``fully vaccinated'' is
consistent with the CDC definition. Additionally, the completion of a
primary vaccination series for COVID-19 is defined in the requirements
as the administration of a single-dose vaccine, or the administration
of all required doses of a multi-dose vaccine.
We note that the concept of a ``primary series'' is commonly
understood with respect to vaccinations, particularly among health care
professionals as well as the providers and suppliers regulated by this
rule. For purposes of this IFC, and if permitted or recommended by CDC,
COVID-19 vaccine doses from different manufacturers may be combined to
meet the requirements for a primary vaccination series.
We further note that recommendations for booster doses currently
vary by vaccine and population, and expect that they will continue to
vary for the foreseeable future. We also require that providers and
suppliers must have a process for tracking and securely documenting the
COVID-19 vaccination status of any staff who have obtained any booster
doses as recommended by the CDC. Additionally, some staff members may
have been vaccinated during participation in a clinical trial, or in
countries other than the U.S. We discuss the applicability of these
less common vaccination pathways in section I.B. of this IFC.
Currently, for two of the three vaccines licensed or authorized for
use in the U.S., the primary vaccination series consists of a defined
number of doses administered a certain number of weeks apart;
therefore, we have made this particular requirement effective in two
different phases. We discuss these implementation phases further in
section II.B. of this IFC, but note here that Phase 1, effective 30
days after publication of this IFC, includes the requirement that staff
receive the first dose, or only dose as applicable, of a COVID-19
vaccine, or have requested or been granted an exemption to the
vaccination requirements of this IFC. Phase 2, effective 60 days after
publication of this IFC, requires that the primary vaccination series
has been completed and that staff are fully vaccinated, except for
those staff have been granted exemptions, or those staff for whom
COVID-19 vaccination must be temporarily delayed, as recommended by
CDC, due to clinical precautions and considerations. As discussed in
section II.B. of this IFC, staff who have completed the primary series
for the vaccine received by the Phase 2 implementation date are
considered to have met these requirements, even if they have not yet
completed the 14-day waiting period required for full vaccination.
3. Infection Prevention and Control
We require through this IFC that all applicable providers and
suppliers have a process for ensuring the implementation of additional
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19. While
every health care facility should be following recommended infection
control and prevention measures as recommended by CDC as part of their
provision of safe health care services, not all of the providers and
suppliers subject to the requirements of this IFC have specific
infection control and prevention regulations in place. Specifically,
there are no infection prevention and control requirements for PRTFs,
RHCs/FQHCs, and HIT suppliers. Therefore, for PRTFs, RHCs/FQHCs, and
HIT suppliers, we require that they have a process for ensuring that
they follow nationally recognized infection prevention and control
guidelines intended to mitigate the transmission and spread of COVID-
19. This process must include the implementation of additional
precautions for all staff who are not fully vaccinated for COVID-19.
For the providers and suppliers included in this IFC that are already
subject to meeting specific infection prevention and control
requirements on

[[Page 61572]]

an ongoing basis, we require that they have a process for ensuring the
implementation of additional precautions, intended to mitigate the
transmission and spread of COVID-19, for all staff who are not fully
vaccinated for COVID-19.
4. Documentation of Staff Vaccinations
In order to ensure that providers and suppliers are complying with
the vaccination requirements of this IFC, we are requiring that they
track and securely document the vaccination status of each staff
member, including those for whom there is a temporary delay in
vaccination, such as recent receipt of monoclonal antibodies or
convalescent plasma. Vaccine exemption requests and outcomes must also
be documented, discussed further in section II.A.5. of this IFC. This
documentation will be an ongoing process as new staff are onboarded.
While provider and supplier staff may not have personal medical
records on file with their employer, all staff COVID-19 vaccines must
be appropriately documented by the provider or supplier. Examples of
appropriate places for vaccine documentation include a facilities
immunization record, health information files, or other relevant
documents. All medical records, including vaccine documentation, must
be kept confidential and stored separately from an employer's personnel
files, pursuant to ADA and the Rehabilitation Act.
Examples of acceptable forms of proof of vaccination include:
<bullet> CDC COVID-19 vaccination record card (or a legible photo
of the card),
<bullet> Documentation of vaccination from a health care provider
or electronic health record, or
<bullet> State immunization information system record.
If vaccinated outside of the U.S., a reasonable equivalent of any
of the previous examples would suffice.
Providers and suppliers have the flexibility to use the appropriate
tracking tools of their choice. For those who would like to use it, CDC
provides a staff vaccination tracking tool that is available on the
NHSN website (<a href="https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html">https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html</a>). This is a generic Excel-based tool available for free to
anyone, not just NHSN participants, that facilities can use to track
COVID-19 vaccinations for staff members.
5. Vaccine Exemptions
While nothing in this IFC precludes an employer from requiring
employees to be fully vaccinated, we recognize that there are some
individuals who might be eligible for exemptions from the COVID-19
vaccination requirements in this IFC under existing Federal law.
Accordingly, we require that providers and suppliers included in this
IFC establish and implement a process by which staff may request an
exemption from COVID-19 vaccination requirements based on an applicable
Federal law. Certain allergies, recognized medical conditions, or
religious beliefs, observances, or practices, may provide grounds for
exemption. With regard to recognized clinical contraindications to
receiving a COVID-19 vaccine, facilities should refer to the CDC
informational document, Summary Document for Interim Clinical
Considerations for Use of COVID-19 Vaccines Currently Authorized in the
United States, accessed at <a href="https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinical-considerations.pdf">https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinical-considerations.pdf</a>.
As described in section I.I. of this IFC, there are Federal laws,
including the ADA, section 504 of the Rehabilitation Act, section 1557
of the ACA, and Title VII of the Civil Rights Act, that prohibit
discrimination based on race, color, national origin, religion,
disability and/or sex, including pregnancy. We recognize that, in some
circumstances, employers may be required by law to offer accommodations
for some individual staff members. Accommodations can be addressed in
the provider or supplier's policies and procedures.
Applicable staff of the providers and suppliers included in this
IFC must be able to request an exemption from these COVID-19
vaccination requirements based on an applicable Federal law, such as
the Americans with Disabilities Act (ADA) and Title VII of the Civil
Rights Act of 1964. Providers and suppliers must have a process for
collecting and evaluating such requests, including the tracking and
secure documentation of information provided by those staff who have
requested exemption, the facility's decision on the request, and any
accommodations that are provided.
Requests for exemptions based on an applicable Federal law must be
documented and evaluated in accordance with applicable Federal law and
each facility's policies and procedures. As is relevant here, this IFC
preempts the applicability of any State or local law providing for
exemptions to the extent such law provides broader exemptions than
provided for by Federal law and are inconsistent with this IFC.
For staff members who request a medical exemption from vaccination,
all documentation confirming recognized clinical contraindications to
COVID-19 vaccines, and which supports the staff member's request, must
be signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable State and local laws. Such documentation must contain all
information specifying which of the authorized COVID-19 vaccines are
clinically contraindicated for the staff member to receive and the
recognized clinical reasons for the contraindications; and a statement
by the authenticating practitioner recommending that the staff member
be exempted from the facility's COVID-19 vaccination requirements based
on the recognized clinical contraindications.
Under Federal law, including the ADA and Title VII of the Civil
Rights Act of 1964 as noted previously, workers who cannot be
vaccinated or tested because of an ADA disability, medical condition,
or sincerely held religious beliefs, practice, or observance may in
some circumstances be granted an exemption from their employer. In
granting such exemptions or accommodations, employers must ensure that
they minimize the risk of transmission of COVID-19 to at-risk
individuals, in keeping with their obligation to protect the health and
safety of patients. Employers must also follow Federal laws protecting
employees from retaliation for requesting an exemption on account of
religious belief or disability status. For more information about these
situations, employers can consult the Equal Employment Opportunity
Commission's website at <a href="https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws">https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws</a>.
We also direct providers and suppliers to the Equal Employment
Opportunity Commission (EEOC) Compliance Manual on Religious
Discrimination \160\ for information on evaluating and responding to
such requests. While employers have the flexibility to establish their
own processes and procedures, including forms, we point to The Safer
Federal Workforce Task Force's ``request for a religious exception to
the COVID-19 vaccination requirement'' template as an example. This
template can be viewed at https://

[[Page 61573]]

www.saferfederalworkforce.gov/downloads/RELIGIOUS%20REQUEST%20FORM%20-
%2020211004%20-%20MH508.pdf.
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\160\ <a href="https://www.eeoc.gov/laws/guidance/section-12-religious-discrimination">https://www.eeoc.gov/laws/guidance/section-12-religious-discrimination</a>.
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6. Planning
Despite the near-universal applicability of the requirements
described in sections II.A.1. through 5 of this IFC, we recognize that
the course of the COVID-19 pandemic remains unpredictable. Due to
likely unforeseen circumstances, we require that providers and
suppliers make contingency plans in consideration of staff that are not
fully vaccinated to ensure that they will soon be vaccinated and will
not provide care, treatment, or other services for the provider or its
patients until such time as such staff have completed the primary
vaccination series for COVID-19 and are considered fully vaccinated,
or, at a minimum, have received a single-dose COVID-19 vaccine, or the
first dose of the primary vaccination series for a multi-dose COVID-19
vaccine. This planning should also address the safe provision of
services by individuals who have requested an exemption from
vaccination while their request is being considered and by those staff
for whom COVID-19 vaccination must be temporarily delayed, as
recommended by the CDC, due to clinical precautions and considerations.
While the nature of this rulemaking suggests the potential that
virtually all health care staff in the U.S. will be vaccinated for
COVD-19 within a matter of months, local outbreaks, new viral
variations, changes in disease manifestation, or other factors
necessitate contingency planning. Contingency planning may extend
beyond the specific requirements of this rule to address topics such as
staffing agencies that can supply vaccinated staff if some of the
facility's staff are unable to work. Contingency plans might also
address special precautions to be taken when, for example, there is a
regional or local emergency declaration, such as for a hurricane or
flooding, which necessitates the temporary utilization of unvaccinated
staff, in order to assure the safety of patients. For example,
expedient evacuation of a flooding LTC facility may require assistance
from local community members of unknown vaccination status. Facilities
may already have contingency plans that meet the requirements of this
IFC in their existing Emergency Preparedness policies and procedures.

B. Implementation Dates

Due to the urgent nature of the vaccination requirements
established in this IFC, we have not issued a proposed rule, as
discussed in section III. of this IFC. While some IFCs are effective
immediately upon publication, we understand that instantaneous
compliance, or compliance within days, with these regulations is not
possible. Vaccination requires time, especially those vaccines
delivered in a series, and facilities may wish to coordinate scheduling
of staff vaccination appointments in a staggered manner so that
appropriate coverage is maintained. The policies and procedures
required by the IFC will also take time for facilities to develop.
However, in order to provide protection to residents, patients,
clients, and PACE program participants (as applicable), we believe it
is necessary to begin staff vaccinations as quickly as reasonably
possible.
In order to provide protection as soon as possible, we are
establishing two implementation phases for this IFC. Phase 1, effective
30 days after publication, includes nearly all provisions of this IFC,
including the requirements that all staff have received, at a minimum,
the first dose of the primary series or a single dose COVID-19 vaccine,
or requested and/or been granted a lawful exemption, prior to staff
providing any care, treatment, or other services for the facility and/
or its patients. Phase 1 also includes the requirements for facilities
to have appropriate policies and procedures developed and implemented,
and the requirement that all staff must have received a single dose
COVID-19 vaccine or the initial dose of a primary series by December 6,
2021.
Phase 2, effective 60 days after publication, consists of the
requirement that all applicable staff are fully vaccinated for COVID-
19, except for those staff who have been granted exemptions from COVID-
19 vaccination or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations). Although an individual is not
considered fully vaccinated until 14 days (2 weeks) after the final
dose, staff who have received the final dose of a primary vaccination
series by the Phase 2 effective date are considered to have meet the
individual vaccination requirements, even if they have not yet
completed the 14-day waiting period. For example, an individual may
receive the first dose of the Moderna mRNA COVID-19 Vaccine 2 or 3 days
prior to the Phase 1 deadline, but must wait at least 28 days before
receiving the second dose. This second dose could (and must, for
purposes of this IFC) be administered prior to the Phase 2 effective
date, but the individual would still be subject to meeting additional
precautions as described in section II.A.3. of this IFC until 14 days
had passed. This timing flexibility applies only to the initial
implementation of this IFC and has no bearing on ongoing compliance.
This information is also presented in Table 2.

[[Page 61574]]

[GRAPHIC] [TIFF OMITTED] TR05NO21.023

We note that although this IFC is being issued in response to the
PHE for COVID-19, we expect it to remain relevant for some time beyond
the end of the formal PHE. Depending on the future nature of the COVID-
19 pandemic, we may retain these provisions as a permanent requirement
for facilities, regardless of whether the Secretary continues the
ongoing PHE declarations. Therefore, this rulemaking's effectiveness is
not associated with or tied to the PHE declarations, nor is there a
sunset clause. Pursuant to section 1871(a)(3) of the Act, Medicare
interim final rules expire 3 years after issuance unless finalized. We
expect to make a determination based on public comments, incidence,
disease outcomes, and other factors regarding whether it will be
necessary to conduct final rulemaking and make this rule permanent.

C. Enforcement

As we do with all new or revised requirements, CMS will issue
interpretive guidelines, which include survey procedures, following
publication of this IFC. We will advise and train State surveyors on
how to assess compliance with the new requirements among providers and
suppliers. For example, the guidelines will instruct surveyors on how
to determine if a provider or supplier is compliant with the
requirements by reviewing the entity's records of staff vaccinations,
such as a list of all staff and their individual vaccination status or
qualifying exemption. The guidelines will also instruct surveyors to
conduct interviews staff to verify their vaccination status.
Furthermore, the entity's policy and procedures will be reviewed to
ensure each component of the requirement has been addressed. We will
also provide guidance on how surveyors should cite providers and
suppliers when noncompliance is identified. Lastly, providers and
suppliers that are cited for noncompliance may be subject to
enforcement remedies imposed by CMS depending on the level of
noncompliance and the remedies available under Federal law (for
example, civil money penalties, denial of payment for new admissions,
or termination of the Medicare/Medicaid provider agreement). CMS will
closely monitor the status of staff vaccination rates, provider
compliance, and any other potential risks to patient, resident, client,
and PACE program participant health and safety.

[[Page 61575]]

D. Residential Congregate Care Facilities

Individuals residing in congregate care settings such as LTC
facilities, intermediate care facilities for individuals with
intellectual disabilities (ICFs-IID), and psychiatric residential
treatment facilities for individuals under 21 years of age (PRTFs),
regardless of health or medical conditions, are at greater risk of
acquiring infections. This higher risk applies to most bacterial and
viral infections, including SARS-CoV-2. Staff working in these
facilities often work across facility types (that is, LTC facilities,
group homes, assisted living facilities, in home and community-based
services settings, and even different congregate settings within the
employer's purview), and for different providers, which may contribute
to virus transmission. Other factors impacting virus transmission in
these settings might include: Clients or residents who are employed
outside the congregate living setting; clients or residents who require
close contact with staff or direct service providers; clients or
residents who have difficulty understanding information or practicing
preventive measures; and clients or residents in close contact with
each other in shared living or working spaces.
1. Long Term Care Facilities (Skilled Nursing Facilities and Nursing
Facilities)
Long term care (LTC) facilities, a category that includes Medicare
skilled nursing facilities (SNFs) and Medicaid nursing facilities
(NFs), also collectively called nursing homes, must meet the
consolidated Medicare and Medicaid requirements for participation
(requirements) for LTC facilities (42 CFR part 483, subpart B) that
were first published in the Federal Register on February 2, 1989 (54 FR
5316). These regulations have been revised and added to since that
time, principally as a result of legislation or a need to address
specific issues. The requirements were comprehensively revised and
updated in October 2016 (81 FR 68688), including a comprehensive update
to the requirements for infection prevention and control.
CMS establishes requirements for acceptable quality in the
operation of health care entities. LTC facilities are required to
comply with the requirements in 42 CFR part 483, subpart B, to receive
payment under the Medicare or Medicaid programs. In addition to several
discrete requirements set out under sections 1819 and 1919 of the Act,
Medicare- and Medicaid-participating LTC facilities ``must meet such
other requirements relating to the health, safety, and well-being of
residents or relating to the physical facilities thereof as the
Secretary may find necessary.'' \161\ More specifically, the infection
control requirements for LTC facilities are based on sections
1819(d)(3)(A) (for skilled nursing facilities) and 1919(d)(3)(A) (for
nursing facilities) of the Act, which both require that a facility
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.
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\161\ Section 1819(d)(4)(B) of the Act. Section 1919(d)(4)(B) is
nearly identical, but omitting ``well-being''.
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Since the onset of the PHE, we have revised the requirements for
LTC facilities through three IFCs focused on COVID-19 testing, data
reporting and vaccine requirements for residents and staff.
Specifically, we have published the following IFCs:
<bullet> The first IFC, ``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'' (FR27550) was published on May 8, 2020. The
May 8, 2020 COVID-19 IFC established requirements for LTC facilities to
report information related to COVID-19 cases among facility residents
and staff, we received 299 public comments. About 161, or over one-half
of those comments, addressed the requirement for COVID-19 reporting for
LTC facilities set forth at Sec. 483.80(g).
<bullet> The second IFC, ``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'' (FR54873) was
published on September 2, 2020. The September 2, 2020 COVID-19 IFC
strengthened CMS' ability to enforce compliance with LTC facility
reporting requirements and established a new requirement for LTC
facilities to test facility residents and staff for COVID-19. We
received 171 public comments in response to the September 2, 2020
COVID-19 IFC, of which 113 addressed the requirement for COVID-19
testing of LTC facility residents and staff set forth at Sec.
483.80(h).
<bullet> The third IFC, ``Medicare and Medicaid Programs; COVID-19
Vaccine Requirements for Long-Term Care (LTC) Facilities and
Intermediate Care Facilities for Individuals with Intellectual
Disabilities (ICFs-IID) Residents, Clients, and Staff'' (86FR26306) was
published on May 13, 2021. We received 71 public comments in response
to the May 13, 2021 COVID-19 IFC, of which most addressed the
requirements for COVID-19 educating, offering, and reporting of the
uptake of COVID-19 vaccine for LTC facility residents and staff set
forth at Sec. Sec. 483.80(d)(3) and 483.80(g)(1). In that rule, we
also required the educating, offering, and recommended voluntary
reporting of COVID-19 vaccine uptake in ICFs-IID facility clients and
staff set forth at Sec. Sec. 483.430, Facility Staffing requirements,
and 483.460, Health Care Services for Clients.
Under Sec. 483.80(d)(3), as established in the May 13, 2021 IFC,
we require LTC facilities to educate residents and staff on the COVID-
19 vaccines and also to offer the vaccine, when available, to all
residents and staff. The May 13, 2021 IFC also required LTC facilities
to report both resident and staff vaccine uptake and status to CDC's
National Healthcare Safety Network (NHSN) (Sec. 483.80(d)(3)(vii));
this has been a requirement since May 21, 2021. The CDC data collected
under this requirement show that vaccination rates for LTC facility
staff have stalled, with a 64 percent national average of vaccinated
staff according to CDC data as of August 28, 2021, while the number of
new LTC facility resident COVID-19 cases reported per week has risen by
just over 1455 percent from recorded lows in June 2021 (323 cases in
the week ending June 27, 2021; 4701 in the week ending August 22,
2021). There is wide variation among states in staff vaccination rates.
With this IFC, we are amending the requirements at Sec. 483.80,
Infection Control, by revising paragraph (d)(3)(v) by deleting the
words, ``or a staff member,'' and adding the word, ``or'' before
``resident representative,'' so that the provision now reads, ``the
resident, or resident representative, has the opportunity to accept or
refuse a COVID-19 vaccine, and change their decision.'' Retaining the
language permitting staff to refuse vaccination would be inconsistent
with the goals of this IFC. We are further amending the requirements at
Sec. 483.80 to add a new paragraph (i), titled ``COVID-19 Vaccination
of facility staff,'' to specify that facilities must now develop and
implement policies and procedures to ensure that all staff are fully

[[Page 61576]]

vaccinated--that is, staff for whom it has been 2 weeks or more since
they completed a primary vaccination series for COVID-19, with the
completion of a primary vaccination series for COVID-19 defined as the
administration of a single-dose vaccine, or the administration of all
required doses of a multi-dose vaccine.
For this rule, we have also added a new paragraph at Sec.
483.80(i)(2), which specifies which staff for whom the requirements for
staff COVID-19 vaccination will not apply: (1) Staff who exclusively
provide telehealth or telemedicine services outside of the facility
setting and who do not have any direct contact with residents and other
staff (for whom the requirements do apply) and (2) staff who provide
support services for the facility that are performed exclusively
outside of the facility setting and who do not have any direct contact
with residents and other staff (for whom the requirements do apply).
Additionally, under the requirements of this IFC, we are adding
Sec. 483.80(i)(3) to now require that a facility's policies and
procedures for COVID-19 vaccination of staff must include, at a
minimum, the components specified in section II.A. of this IFC. New
Sec. Sec. 483.80(i)(3)(i) through (x) specify these required minimum
components of the facility's policies and procedures.
2. Intermediate Care Facilities for Individuals With Intellectual
Disabilities (ICFs-IID)
ICFs-IID are residential facilities that provide services for
people with intellectual disabilities. ICF-IID clients with certain
underlying medical or psychiatric conditions may be at increased risk
of serious illness from COVID-19.\162\ On March 2, 2021, CDC issued
Interim Considerations for Phased Implementation of COVID-19
Vaccination and Sub Prioritization Among Recommended Populations, which
notes that increased rates of transmission have been observed in these
settings, and that jurisdictions may choose to prioritize vaccination
of persons living in congregate settings based on local, State, tribal,
or territorial epidemiology. CDC further notes that congregate living
facilities may choose to vaccinate residents and clients at the same
time as staff, due to numerous factors, such as convenience or shared
increased risk of disease.
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\162\ <a href="https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html">https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html</a>.
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Sections 1905(c) and (d) of the Act gave the Secretary authority to
prescribe regulations for intermediate care facility services in
facilities for individuals with intellectual disabilities or persons
with related conditions. The ICFs-IID Conditions of Participation were
issued on June 3, 1988 (53 FR 20496) and were last updated on May 13,
2021 (86 FR 20448). There are currently 5,768 Medicare- and/or
Medicaid-certified ICFs-IID. As of April 2021, 4,661 of the 5,770 are
small (1 to 8 beds) in size, but there are 1,107 that are larger (14 or
more beds) facilities. These facilities serve over 64,812 individuals
with intellectual disabilities and other related conditions. All must
qualify for Medicaid coverage. While national data about ICFs-IID
clients is limited, we take an example from Florida where almost one
quarter of clients (23 percent) require 24-hour nursing services and a
medical care plan in addition to their services plans.\163\ Data from a
single State are not nationally representative and thus we are unable
to generalize, but it is illustrative.
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\163\ <a href="http://www.floridaarf.org/assets/Files/ICF-IID%20Info%20Center/ICFHandoutonWebsite2-14.pdf">http://www.floridaarf.org/assets/Files/ICF-IID%20Info%20Center/ICFHandoutonWebsite2-14.pdf</a>.
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Currently, the Conditions of Participation: ``Health Care
Services'' at Sec. 483.460(a)(4)(i) require that ICFs-IID offer
clients and staff vaccination against COVID-19 when vaccine supplies
are available (86 FR 26306). Based on anecdotal reports, this new
requirement has not significantly increased vaccination among ICFs-IID
staff. We conclude that additional regulatory action is necessary to
achieve widespread vaccination among ICFs-IID staff to protect ICFs-IID
clients.
For these reasons and the reasons set forth in section II.A. of
this IFC, we are adding a new regulatory requirement at Sec.
483.430(g) related to establishing and implementing policies and
procedures for COVID-19 vaccination of all staff (includes employees;
licensed practitioner; students, trainees, and volunteers; and other
individuals) who provide care, treatment, or other services for the
provider or its patients.
3. Psychiatric Residential Treatment Facilities (PRTFs)
PRTFs are non-hospital facilities that provide inpatient
psychiatric services to Medicaid-eligible individuals under the age of
21 (also called the ``psych under 21 benefit''). There are 357 PRTFs in
the U.S. The facilities must meet accreditation standards, the
requirements in Sec. Sec. 441.151 through 441.182, and the Condition
of Participation on the use of restraint and seclusion at Sec. 483.350
through Sec. 483.376.
Among the requirements for the psych under 21 benefit are
certification of need for inpatient care and a plan of care for active
treatment developed by an interdisciplinary team. The psych under 21
benefit is significant as a means for Medicaid to cover the cost of
inpatient behavioral health services. The Federal Medicaid program does
not reimburse states for the cost of covered services provided to
beneficiaries in institutions for mental diseases (IMDs) except in
specific, statutorily-authorized exceptions, including for young people
who receive this service, and individuals age 65 or older served in an
IMD. A PRTF provides comprehensive behavioral health treatment to
children and adolescents (youth) who, due to mental illness, substance
use disorders, or severe emotional disturbance, need treatment that can
most effectively be provided in a residential treatment facility. PRTF
programs are designed to offer a short term, intense, focused
behavioral health treatment program to promote a successful return of
the youth to the community.
As a congregate living setting, PRTFs are subject to many of the
same elevated transmission risk factors as LTC facilities and ICFs-IID
as set forth in section I. of this IFC. Section 1905(h) of the Act
defines inpatient psychiatric hospital services for individuals under
21 as any inpatient facility that the Secretary has prescribed in
regulations that in the case of any individual involve active treatment
which meets such standards as may be prescribed in regulations by the
Secretary. Implementing essential infection control practices,
including vaccination, is a basic infection control treatment standard.
For these reasons and the reasons set forth in section II.A. of
this IFC, we are adding a new regulatory requirement at Sec.
441.151(c) related to establishing and implementing policies and
procedures for COVID-19 vaccination of all staff (includes employees;
licensed practitioner; students, trainees, and volunteers; and other
individuals) who provide care, treatment, or other services for the
provider or its clients.

E. Acute Care Settings

Acute care settings are those providers who generally provide
active care for short-term medical needs. For our discussion purposes
acute care settings include: Hospitals, critical access hospitals
(CAHs), and ambulatory surgical centers (ASCs).
1. Hospitals
Hospitals are large health care providers that treat patients with
acute

[[Page 61577]]

care needs including emergency medicine, surgery, labor and delivery,
cardiac care, oncology, and a wide variety of other services. Hospitals
also administer general and specialty care that cannot safely be
provided in other settings, under the supervision of physicians and
licensed practitioners. They may operate as independent institutions or
as part of a larger health care system or learning institution.
Section 1861(e) of the Act provides that hospitals participating in
Medicare and Medicaid must meet certain specified requirements, and the
Secretary may impose additional requirements if they are found
necessary in the interest of the health and safety of the individuals
who are furnished services in hospitals. Medicare-participating
hospitals, which include nearly all hospitals in the U.S., must meet
the Conditions of Participation (CoPs) at 42 CFR part 482, originally
issued June 17, 1986. In addition to smaller updates over the years,
these CoPs were reformed in 2012 (77 FR 29034). Hospital CoPs identify
infection control and prevention as a basic hospital function and lay
out specific requirements at 42 CFR 482.42. Infection control within a
hospital campus is especially important, because hospitals treat
individuals with infectious diseases (such as COVID-19) and healthy yet
higher-risk individuals (for example, pregnant and post-partum
individuals, infants, transplant recipients, etc.) within the same
facility. Hospitals that provide emergency care must do so in
accordance with the requirements of the Emergency Medical Treatment and
Labor Act (EMTALA) of 1986.
Hospitals have borne the brunt of caring for patients with acute
COVID-19 during the PHE. Individuals experiencing respiratory problems,
cardiac events, kidney failure, and other serious effects of COVID-19
illness have required in-hospital care in large numbers, to the point
of occupying or even exceeding most or all critical care or ICU
capacity in a facility, city, or region. Despite emergency expansion of
critical care units, these waves of severely ill patients have
overwhelmed hospitals, health care systems, and the professionals and
other staff who work in them. This has had the disastrous effect of
limiting access and increasing risk to both routine and emergency
hospital care across the U.S.164 165 166 167
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\164\ <a href="https://www.nytimes.com/live/2021/09/23/world/covid-delta-variant-vaccine#covid-alaska-hospital">https://www.nytimes.com/live/2021/09/23/world/covid-delta-variant-vaccine#covid-alaska-hospital</a>, accessed 10/18/2021.
\165\ <a href="https://www.healthline.com/health-news/how-surging-delta-variant-is-leading-to-rationed-care-at-hospitals">https://www.healthline.com/health-news/how-surging-delta-variant-is-leading-to-rationed-care-at-hospitals</a>, accessed 10/18/
2021.
\166\ <a href="https://www.aamc.org/news-insights/worst-surge-we-ve-seen-some-hospitals-delta-hot-spots-close-breaking-point">https://www.aamc.org/news-insights/worst-surge-we-ve-seen-some-hospitals-delta-hot-spots-close-breaking-point</a>, accessed 10/18/
2021.
\167\ <a href="https://www.washingtonpost.com/health/2021/08/18/covid-hospitals-delta/">https://www.washingtonpost.com/health/2021/08/18/covid-hospitals-delta/</a>, accessed 10/18/2021.
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Transplant centers, psychiatric hospitals, and swing beds are
governed by the infection control CoPs for hospitals, and are thus
subject to the staff vaccination requirements issued in this IFC. We
are particularly concerned about transplant center patients, who are
among the most severely immunocompromised individuals due to anti-
rejection medications that ensure the function of transplanted organs.
An additional member of the transplant ecosystem, Organ Procurement
Organizations (OPOs) coordinate and support donation, recovery, and
placement of organs. As OPO staff do not provide patient care, and
typically work in locations removed from health care facilities, we are
not issuing vaccination requirements for OPOs in this IFC. That said,
we note that the vaccination policies required in this IFC apply to all
individuals who provide care, treatment, or other services for the
hospital and/or its patients, under contract or other arrangement.
Accordingly, OPO staff members that provide organ transplantation
services directly to hospital and transplant center patients and
families must meet the vaccination requirements of this IFC.
For these reasons and the reasons set forth in section II.A. of
this IFC, we are adding a new regulatory requirement at Sec. 482.42(g)
related to establishing and implementing policies and procedures for
COVID-19 vaccination of all staff (including employees; licensed
practitioner; students, trainees, and volunteers; and other
individuals) who provide care, treatment, or other services for the
provider or its patients.
2. Critical Access Hospitals (CAHs)
CAHs are rural hospitals that have been designated as critical
access hospitals by the State, in a State that has established a State
Medicare Rural Hospital Flexibility Program. These hospitals have 25 or
fewer acute care inpatient beds (except as permitted for CAHs having
distinct part units under Sec. 485.647, where the beds in the distinct
part are excluded from the 25 inpatient-bed count limit specified in
Sec. 485.620(a)), must be more than 35 miles away from another
hospital, and provide emergency care services 24 hours a day, 7 days a
week. On average, acute patients stay in CAHs for less than 96 hours.
CAHs may be granted approval to provide post-hospital skilled nursing
care, may offer hospice care under the Medicare hospice benefit, and
may operate a psychiatric and/or rehabilitation distinct part unit of
up to 10 beds each. CAHs also administer general and specialty care
that cannot safely be provided in other settings, under the supervision
of physicians and licensed practitioners. They may operate as
independent institutions or as part of a larger health care system.
Generally, they serve to help ensure access to health-care services in
rural communities.
Section 1820 of the Act sets forth the conditions for certifying a
facility as a CAH to include meeting such other criteria as the
Secretary may require. Medicare-certified CAHs must meet the Conditions
of Participation (CoPs) at 42 CFR part 485 subpart F, originally issued
May 26, 1993 (58 FR 30630). These CoPs contain specific requirements
for infection control and prevention at Sec. 485.640. Much like a
standard hospital, infection control within a CAH is especially
important, because CAHs treat individuals with infectious diseases
(such as COVID-19) and healthy yet higher-risk individuals (for
example, pregnant and post-partum individuals, infants, transplant
recipients, etc.) within the same facility.
While organ transplants are not performed in CAHs, we note that
organ donors may be CAH patients, and organ donation and recovery may
occur in CAHs. We note that the vaccination policies required in this
IFC apply to all individuals who provide care, treatment, or other
services for the hospital and/or its patients, under contract or other
arrangement. Accordingly, OPO staff members that provide organ donation
and transplantation services directly to CAH patients and families must
meet the vaccination requirements of this IFC in the same manner as
they meet such requirements for hospitals.
For these reasons and the reasons set forth in section II.A. of
this IFC, we are adding a new regulatory requirement at Sec.
485.640(f) related to establishing and implementing policies and
procedures for COVID-19 vaccination of all staff (including employees;
licensed practitioner; students, trainees, and volunteers; and other
individuals) who provide care, treatment, or other services for the
provider or its patients.
3. Ambulatory Surgical Centers (ASCs)
ASCs are distinct entities that operate exclusively for the purpose
of providing surgical services to patients not requiring
hospitalization, and in which the expected duration of services would
not exceed 24 hours following an

[[Page 61578]]

admission. The surgical services performed in ASCs generally are
scheduled, non-life-threatening procedures that can be safely performed
in either a hospital setting (inpatient or outpatient) or in an ASC.
Currently, there are 6,071 Medicare-certified ASCs in the U.S.
Section 1833(i)(1)(A) of the Act authorizes the Secretary to
specify those surgical procedures that can be performed safely in an
ASC. Section 1832(a)(2)(F)(i) of the Act defines an ASC as a facility
``which meets health, safety, and other standards specified by the
Secretary in regulations . . .''.
The ASC Conditions for Coverage (CfCs) at 42 CFR part 416, subpart
C, are the minimum health and safety standards a center must meet to
obtain Medicare certification. The ASC CfCs were issued on August 5,
1982 (47 FR 34082), and the Conditions related to infection control
were last updated on November 18, 2008 (73 FR 68502, 68813). Section
416.51, Infection control, requires ASCs to maintain an infection
control program that seeks to minimize infections and communicable
diseases. In this IFC we are adding new Sec. 416.51(c) which requires
ASCs to meet the same COVID-19 vaccination of staff requirements as
those we are issuing for the other providers and suppliers identified
in this rule.
During the COVID-19 pandemic and PHE, hospitals moved many non-
elective surgical procedures to ASCs and other outpatient settings.
Such movement conserves hospital resources for treating severe COVID-
19, performing more urgent procedures, and caring for patients with
more critical health needs. Moreover, referring patients in need of
suitable procedures to ASCs limits the overall number of individuals
visiting the hospital setting, thereby inhibiting spread of infection.
ASCs also offer an alternative setting for outpatient surgery for
individuals reluctant to enter a hospital due to fears of COVID-19
exposure. Based on these and other factors, the demand for ASC services
has increased.\168\
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\168\ <a href="https://www.beckersasc.com/asc-news/5-ways-covid-19-affected-ascs-in-2020.html">https://www.beckersasc.com/asc-news/5-ways-covid-19-affected-ascs-in-2020.html</a>. Accessed 10/17/2021.
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In response to the COVID-19 pandemic, ASCs assumed new roles. CMS's
Hospital Without Walls initiative permitted hospitals to provide
inpatient care in ASCs and other temporary sites. ASCs have assisted
with COVID-19 testing. They provided staff to work in COVID-19 hot
spots. These efforts illustrate that staff and patients of ASCs
regularly interact with staff and patients of other health care
organizations and facilities.
For these reasons and the reasons set forth in section II.A. of
this IFC, we are adding a new regulatory requirement at Sec. 416.51(c)
related to establishing and implementing policies and procedures for
COVID-19 vaccination of all staff (includes employees; licensed
practitioner; students, trainees, and volunteers; and other
individuals) who provide care, treatment, or other services for the
provider or its patients.

F. Outpatient Clinical Care & Services

These clinical settings provide necessary, ongoing care for
individuals who need ongoing therapeutic, and in some cases life-
sustaining, care. While many of these settings have been able to
provide some services safely and effectively via telehealth during the
PHE, many of the services they provide require patients and clients to
see staff in person.
1. End-Stage Renal Disease (ESRD) Facilities
ESRD facilities provide a set of life-sustaining services to
individuals without kidney function, including dialysis, medication,
routine evaluations and monitoring, nutritional counselling, social
support, and organ transplantation evaluation and referral. Section
1881(b)(1)(A) of the Act authorizes the Secretary to pay only those
dialysis facilities ``which meet such requirements as the Secretary
shall by regulation prescribe for institutional dialysis services and
supplies . . .'' also known as CfCs. The ESRD facility CfCs at 42 CFR
part 494 are the minimum health and safety rules that all Medicare- and
Medicaid-certified dialysis facilities must meet in order to
participate in the programs. The ESRD CfCs were initially issued in
1976 and were comprehensively revised in 2008 (73 FR 20370). There are
currently 7,893 Medicare-certified ESRD facilities in the U.S., serving
over 500,000 patients.
Routine dialysis treatments, typically delivered 3 times per week,
remove toxins from a patient's blood and are necessary to sustain life.
Dialysis treatments are most often delivered in the ESRD facility but
can be performed by the patients themselves at home, or in the
patient's nursing facility with assistance. ESRD facilities serve
patients whether they are diagnosed with COVID-19 or not, and people
receiving dialysis cannot always be adequately distanced from one
another during treatment. In-center dialysis precludes social
distancing because it involves being in close proximity (<6 feet) to
caregivers and fellow patients for extended periods of time (12-15
hours per week). Because dialysis patients are not able to defer
dialysis sessions, in-center dialysis patients are at increased risk
for developing COVID-19 due in part to difficulty maintaining physical
distancing.\169\ Many ESRD patients are also residents of LTC
facilities or other congregate living settings, which is also a risk
factor for COVID-19.\170\ Further, individuals with kidney failure on
dialysis may have a higher risk of worse outcomes.\171\
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\169\ Am J Kidney Dis. 2020 Nov;76(5):690-695.e1. doi: 10.1053/
j.ajkd.2020.07.001. Epub 2020 Jul 15.
\170\ <a href="https://www.jhunewsletter.com/article/2020/09/hopkins-finds-dialysis-patients-at-greater-risk-of-covid-19">https://www.jhunewsletter.com/article/2020/09/hopkins-finds-dialysis-patients-at-greater-risk-of-covid-19</a>.
\171\ CJASN March 2021, 16 (3) 452-455; DOI: <a href="https://doi.org/10.2215/CJN.12360720">https://doi.org/10.2215/CJN.12360720</a>.
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Dialysis health care personnel are considered a priority population
for vaccination by the Advisory Committee on Immunization Practices
(ACIP), yet ESRD facilities are currently reporting low COVID-19
vaccination coverage among ESRD facility health care personnel, at less
than 63 percent as of September 26, 2021.\172\ Ensuring health care
personnel have access to COVID-19 vaccination is critical to protect
both them and their medically fragile patients.\173\
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\172\ <a href="http://www.synas.plus/nhsn/covid19/dial-vaccination-dashboard.html#anchor_1594393306">http://www.synas.plus/nhsn/covid19/dial-vaccination-dashboard.html#anchor_1594393306</a>.
\173\ <a href="https://www.cdc.gov/vaccines/covid-19/planning/vaccinate-dialysis-patients-hcp.html">https://www.cdc.gov/vaccines/covid-19/planning/vaccinate-dialysis-patients-hcp.html</a>, accessed 09/08/2021 22:00 EDT.
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For these reasons and the reasons set forth in section II.A. of
this IFC, we are adding a new regulatory requirement at Sec. 494.30(b)
related to establishing and implementing policies and procedures for
COVID-19 vaccination of all staff (includes employees; licensed
practitioner; students, trainees, and volunteers; and other
individuals) who provide care, treatment, or other services for the
provider or its patients.
2. Community Mental Health Centers (CMHCs)
CMHCs are entities that meet applicable enrollment requirements,
and applicable licensing or certification requirements in the State in
which they are located. CMHCs provide the set of mental health care
services specified in section 1913(c)(1) of the PHS Act (or, in limited
circumstances, provides for such service by contract with an approved
organization or entity). Section 4162 of the Omnibus Budget
Reconciliation Act of 1990 (Pub. L. 101-508, enacted November 5, 1990)
(OBRA 1990), which added sections 1861(ff) and 1832(a)(2)(J) to the
Act, includes CMHCs as entities that are authorized to provide partial
hospitalization services under Part B of the Medicare program,

[[Page 61579]]

effective for services provided on or after October 1, 1991. Section
1861(ff)(3)(B)(iv)(I) of the Act specifically requires CMHCs providing
partial hospitalization services under Medicare to meet such additional
conditions as the Secretary specifies to ensure the health and safety
of individuals being furnished such services. Section 1866(e)(2) of the
Act and 42 CFR 489.2(c)(2) recognize CMHCs as providers of services for
purposes of provider agreement requirements but only with respect to
providing partial hospitalization services. Pursuant to 42 CFR 410.2
and 410.110, a CMHC may receive Medicare payment for partial
hospitalization services only if it demonstrates that it provides the
core services identified in the requirements. To qualify for Medicare
reimbursement, CMHCs must comply with requirements for coverage of
partial hospitalization services at Sec. 410.110 and conditions for
Medicare payment of partial hospitalization services at 42 CFR
424.24(e).
Currently there are 129 Medicare-certified CMHCs in the U.S. The
Secretary has established in regulations, at 42 CFR part 485, subpart
J, the minimum health and safety standards a CMHC must meet to obtain
Medicare certification. CMHC CoPs were issued on October 29, 2013 (78
FR 64604). Section 485.904, Personnel qualifications, establishes
requirements for CMHC personnel. In this IFC we are adding new Sec.
485.904(c) which requires the CMHC to meet the same COVID-19
vaccination of staff requirements as those we are issuing for the other
providers and suppliers affected by this rule.
CMHCs provide mental health services to treat patients under the
Medicare partial hospitalization program and other patients for various
mental health conditions. Partial hospitalization programs provide
structured, outpatient mental health services that are more intense
than office visits with physicians or therapists. Patients in partial
hospitalization programs receive treatment for several hours during the
day, multiple days a week. In response to the PHE, CMHCs continued to
treat patients by using telecommunications, and some centers paused
their partial hospitalization programs or reduced the frequency and
duration of treatment. However, many centers have begun to see and
treat patients in person again and have resumed their customary partial
hospitalization programming schedules. With increased in-person
services being offered in the CMHC, it is essential to ensure all staff
are vaccinated against COVID-19 not only to protect themselves but to
prevent the spread of COVID-19 to CMHC patients.
For these reasons and the reasons set forth in section II.A. of
this IFC, we are adding a new regulatory requirement at Sec.
485.904(c) related to establishing and implementing policies and
procedures for COVID-19 vaccination of all staff (includes employees;
licensed practitioner; students, trainees, and volunteers; and other
individuals) who provide care, treatment, or other services for the
provider or its patients.
3. Comprehensive Outpatient Rehabilitation Facilities (CORFs)
CORFs are non-residential facilities that are established and
operated exclusively for the purpose of providing diagnostic,
therapeutic, and restorative services to outpatients for the
rehabilitation of injured persons, sick persons, and persons with
disabilities, at a single fixed location, by or under the supervision
of a physician. In response to the PHE, outpatient rehabilitation
facilities suspended operations, reduced their patient care capacity,
and transitioned from in-person to telecommunications as able. However,
certain rehabilitation services require physical contact with patients,
such as fitting or adjusting a prosthesis or assistive device and
assessing strength with manual resistance. During the pandemic, some
patients in need of rehabilitation chose to delay care and others
encountered delays in accessing care. These delays likely contributed
to increased disability or illness.\174\ Moreover, patients admitted to
the hospital have been discharged as soon as possible to provide beds
for individuals with more critical conditions, including COVID-19. For
those patients recovering from severe COVID-19 illness with long-term
symptoms, prompt comprehensive outpatient rehabilitation services upon
their discharge from inpatient care is necessary to restore physical
and mental health.\175\ All of these factors stress the importance of
rehabilitation facilities who are treating patients with increased
morbidity and complex needs. CORFs have resumed operations and are
providing services to an increasing number of patients; therefore,
COVID-19 vaccination of staff is pivotal for inhibiting spread of
infection and ensuring health and safety of patients.
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\174\ <a href="https://gh.bmj.com/content/bmjgh/5/5/e002670.full.pdf">https://gh.bmj.com/content/bmjgh/5/5/e002670.full.pdf</a>.
Accessed 9/23/2021.
\175\ <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7027a2.htm?s_cid=mm7027a2_w">https://www.cdc.gov/mmwr/volumes/70/wr/mm7027a2.htm?s_cid=mm7027a2_w</a> Accessed 9/23/2021.
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Currently, there are 159 Medicare-certified CORFs in the U.S.
Section 1861(cc)(2)(J) of the Act states that the CORF must ``meet such
conditions of participation as the Secretary may find necessary in the
interest of the health and safety of individuals who are furnished
s

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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.