[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 [www.gpo.gov]
[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 http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-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 [email protected].
    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: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments. CMS will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the individual will take actions to harm the individual. CMS 
continues to encourage individuals not to submit duplicative comments. 
We will post acceptable comments from multiple unique commenters even 
if the content is identical or nearly identical to other comments.

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:

 Ambulatory Surgical Centers (ASCs) (Sec.  416.51)
 Hospices (Sec.  418.60)
 Psychiatric residential treatment facilities (PRTFs) (Sec.  
441.151)
 Programs of All-Inclusive Care for the Elderly (PACE) (Sec.  
460.74)
 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)
 Long Term Care (LTC) Facilities, including Skilled Nursing 
Facilities (SNFs) and Nursing Facilities (NFs), generally referred to 
as nursing homes (Sec.  483.80)
 Intermediate Care Facilities for Individuals with Intellectual 
Disabilities (ICFs-IID) (Sec.  483.430)
 Home Health Agencies (HHAs) (Sec.  484.70)
 Comprehensive Outpatient Rehabilitation Facilities (CORFs) 
(Sec. Sec.  485.58 and 485.70)
 Critical Access Hospitals (CAHs) (Sec.  485.640)
 Clinics, rehabilitation agencies, and public health agencies 
as providers of outpatient physical therapy and speech-language 
pathology services (Sec.  485.725)
 Community Mental Health Centers (CMHCs) (Sec.  485.904)
 Home Infusion Therapy (HIT) suppliers (Sec.  486.525)
 Rural Health Clinics (RHCs)/Federally Qualified Health Centers 
(FQHCs) (Sec.  491.8)
 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\ https://www.phe.gov/emergency/events/COVID19/Pages/2019-Public-Health-and-Medical-Emergency-Declarations-and-Waivers.aspx.
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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\ https://covid.cdc.gov/covid-data-tracker#datatracker-home.
    \3\ https://www.statnews.com/2021/09/20/covid-19-set-to-overtake-1918-spanish-flu-as-deadliest-disease-in-american-history.

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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\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8354557/.
    \5\ https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784918.
    \6\ https://pubmed.ncbi.nlm.nih.gov/34469474/.
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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. https://doi.org/10.1073/pnas.2014746118 Accessed 10/17/
2021.
    \8\ https://www.npr.org/sections/goatsandsoda/2021/08/11/1026190062/covid-delta-variant-transmission-cdc-chickenpox.
    \9\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html.
    \10\ https://www.cms.gov/files/document/qso-21-08-nltc.pdf.
    \11\ https://www.cms.gov/files/document/qso-21-07-psych-hospital-prtf-icf-iid.pdf.
    \12\ https://www.cms.gov/files/document/qso-20-38-nh-revised.pdf.
    \13\ https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2770287.
    \14\ https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2777317.
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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\ https://www.pnas.org/content/pnas/118/1/e2015455118.full.pdf.
    \16\ https://jamanetwork.com/journals/jamanetworkopen/article-abstract/2782430.
    \17\ https://www.medrxiv.org/content/10.1101/2021.09.08.21263057v1.
    \18\ https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003816.
    \19\ https://www.medrxiv.org/content/10.1101/2021.02.16.21251625v1.
    \20\ https://jamanetwork.com/journals/jama/fullarticle/2773128.
    \21\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8349432/.
    \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\ https://pubmed.ncbi.nlm.nih.gov/31384750/.
    \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\ https://pubmed.ncbi.nlm.nih.gov/31384750/.
    \32\ https://www.cdc.gov/flu/professionals/infectioncontrol/healthcaresettings.htm.
    \33\ https://www.cambridge.org/core/journals/infection-control-and-hospital-epidemiology/article/revised-shea-position-paper-influenza-vaccination-of-healthcare-personnel/E83D4D87FBBBD80C66A2A4926D00F4B8.
    \34\ https://www.cdc.gov/phlp/publications/topic/vaccinationlaws.html.
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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\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm?s_cid=mm7034e4_w.
    \36\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html#ref43.
    \37\ https://www.medrxiv.org/content/10.1101/2021.08.20.21262158v1.full.pdf.
    \38\ https://emergency.cdc.gov/han/2021/han00447.asp.
    \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 https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e2.htm.
    \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 https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e1.htm.
    \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: https://www.cdc.gov/mmwr/volumes/70/wr/mm7011e3.htm.
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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. https://www.nejm.org/doi/full/10.1056/NEJMoa2109072.
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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\ https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2769096).
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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\ https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6936a4-H.pdf.
    \47\ 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.
    \48\ https://www.urban.org/sites/default/files/publication/103651/delayed-and-forgone-health-care-for-nonelderly-adults-during-the-covid-19-pandemic_1.pdf.
    \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\ https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.02351.
    \53\ https://www.npr.org/sections/health-shots/2021/10/14/1043414558/with-hospitals-crowded-from-covid-1-in-5-american-families-delays-health-care.
    \54\ https://www.ahcancal.org/News-and-Communications/Fact-Sheets/FactSheets/Workforce-Survey-September2021.pdf.
    \55\ See HHS OIG reports OEI-09-21-00140 and OEI-06-20-00300, 
both accessed September 26, 2021.
    \56\ https://covid.cdc.gov/covid-data-tracker/#health-care-personnel; accessed September 24, 2021.
    \57\ Analysis of dialysis facility and nursing home data 
reported through NHSN.
    \58\ Ibid. 8footnote 56.
    \59\ https://emergency.cdc.gov/han/2021/han00447.asp.
    \60\ Internal estimates based on data published at: https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html; 
accessed September 24, 2021.
    \61\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm?s_cid=mm7037e1_w.
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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: https://www.cdc.gov/nhsn/covid19/ltc-vaccination-dashboard.html; 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: https://www.cdc.gov/nhsn/covid19/dial-vaccination-dashboard.html; 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\ https://www.cdc.gov/vaccines/covid-19/retail-pharmacy-program/index.html.
    \67\ https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive.html.
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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\ https://covid.cdc.gov/covid-data-tracker/#health-care-personnel.
    \69\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7032e1.htm?s_cid=mm7032e1_w.
    \70\ https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#CoV-19-vaccination.
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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\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7030a2.htm.
    \72\ https://doi.org/10.7326/M21-3150.
    \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. https://doi.org/10.15585/mmwr.mm7012e1external 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. https://doi.org/10.15585/mmwr.mm7017e2external 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. 
https://www.bls.gov/oes/current/oes_nat.htm#00-0000externalicon.
    \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. https://doi.org/10.15585/mmwr.mm6936a3external 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\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html. 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\ https://www.osha.gov/coronavirus/ets. 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\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6938a3.htm?s_cid=mm6938a3_w. Accessed10/16/2021.
    \80\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/work.html. 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\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/distributing/steps-ensure-safety.html.
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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\ https://www.kff.org/racial-equity-and-health-policy/issue-brief/racial-diversity-within-covid-19-vaccine-clinical-trials-key-questions-and-answers/.
    \85\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html.
    \86\ See Centers for Disease Control and Prevention. Benefits of 
Getting a COVID-19 Vaccine. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html. 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 https://www.cdc.gov/vaccines/acip/meetings/slides-2021-09-22-23.html.
    \88\ https://www.nejm.org/doi/full/10.1056/NEJMoa2114583.
    \89\ https://www.medrxiv.org/content/10.1101/2020.10.26.20219725v1.
    \90\ https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine.
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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 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/toolkits.html. These toolkits provide 
staff, facility administrators, clinical leadership, caregivers, and 
health care consumers with information and resources.
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    \91\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html.
    \92\ https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines.
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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 http://www.vsafe.cdc.gov. 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.
---------------------------------------------------------------------------

    \93\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html.
    \94\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html.
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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\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html. Accessed 10/16/2021.
    \96\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html. Accessed 10/14/2021.
    \97\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html. 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\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html. 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 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#.
    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\ https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines. 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\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html.
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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\ https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html# 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\ https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine Accessed 10/14/2021.
    \103\ Pfizer Fact Sheet--https://www.fda.gov/media/144413/download.
    \104\ Moderna Fact Sheet--https://www.fda.gov/media/144637/download.
    \105\ Janssen Fact Sheet--https://www.fda.gov/media/146304/download.
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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\ https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
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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)).
---------------------------------------------------------------------------

    \107\ Department of Health and Human Services. VAERS--Vaccine 
Adverse Event Reporting System. Accessed at https://vaers.hhs.gov/. 
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 (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html). 
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 (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html). 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. 
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html. ``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\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html. Accessed 10/17/2021.
    \109\ Ibid.
    \110\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html. Access 10/17/2021.
    \111\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/allergic-reaction.html. Accessed 10/17/2021.
    \112\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/specific-groups/allergies.html#anchor_1624541541034. 
Accessed 10/17/2021.
    \113\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html. Accessed 10/17/2021.
    \114\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html. 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\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/work.html.
    \116\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e2.htm?s_cid=mm7034e2_w.
    \117\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e1.htm?s_cid=mm7034e1_w.
    \118\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm#contribAff.
    \119\ 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.
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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\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/why-measure-effectiveness/breakthrough-cases.html.
    \121\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. 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\ https://www.hematology.org/newsroom/press-releases/2021/joint-statement-in-support-of-covid-19-vaccine-mandates-for-all-workers-in-health.
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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\
---------------------------------------------------------------------------

    \123\ 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.
    \124\ https://justiceinaging.org/justice-in-aging-supports-mandatory-covid-vaccinations-in-long-term-care-facilities/, accessed 
10/6/21, 1:02 p.m. EDT.
    \125\ https://leadingage.org/sites/default/files/LeadingAge%20Statement%20on%20Vaccine%20Mandates%20for%20Healthcare%20Workers.pdf.
    \126\ Ibid.
    \127\ Ibid.
    \128\ https://www.ahcancal.org/News-and-Communications/Press-Releases/Pages/AHCANCAL-Issues-Policy-Statement-Regarding-COVID-19-Vaccinations-of-Long-Term-Care-Personnel.aspx. 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\ https://news.christianacare.org/2021/09/safe-care-safe-workplace-we-are-vaccinated/. Accessed 10/15/2021.
    \130\ https://www.delawareonline.com/story/news/health/2021/09/27/christianacare-fires-employees-not-complying-vaccine-mandate/5887784001/. Accessed 10/15/2021.
    \131\ https://www.houstonmethodist.org/leading-medicine-blog/articles/2021/jun/houston-methodist-requires-covid-19-vaccine-for-credentialed-doctors/. Accessed 10/15/202021.
    \132\ https://www.novanthealth.org/home/about-us/newsroom/press-releases/newsid33987/2576/novant-health-update-on-mandatory-covid-19-vaccination-program-for-employees.aspx. 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\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html.
    \134\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html.
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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.
---------------------------------------------------------------------------

    \135\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/underlying-evidence-table.html.
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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\ https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/disparities-hospitalization.html.
    \137\ https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/disparities-illness.html.
    \138\ https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0051.
    \139\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7020e3.htm.
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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\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7030a2.htm.
    \141\ https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/vaccine-equity.html.

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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\ https://wwwnc.cdc.gov/eid/article/26/8/20-0679_article.
    \144\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html.
    \145\ https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/disparities-impact.html.
    \146\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
    \147\ 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.
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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 https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws. 
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 https://doi.org/10.1016/ 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. Annals.org. Accessed at https://www.acpjournals.org/doi/10.7326/M21-2366. 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. Annals.org. 
Accessed at https://www.acpjournals.org/doi/10.7326/M21-3150. 
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. https://aspe.hhs.gov/system/files/pdf/265511/vaccination-disparities-brief.pdf.
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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\ 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.
    \156\ Emanuel, E and Skorton, D. Mandating COVID-19 Vaccination 
for Health Care Workers. Annuals of Internal Medicine. Annuals.org. 
Accessed https://www.acpjournals.org/doi/10.7326/M21-3150. 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\ https://www.bridgemi.com/michigan-health-watch/despite-protests-98-henry-ford-hospital-workers-get-covid-vaccinations 
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. Annals.org. 
Accessed at https://www.acpjournals.org/doi/10.7326/M21-3150. 
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\ https://www.nytimes.com/2021/09/28/nyregion/vaccine-health-care-workers-mandate.html.
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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:

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

[[Page 61570]]

 Hospitals (acute care hospitals, psychiatric hospitals, long 
term care hospitals, children's hospitals, hospital swing beds, 
transplant centers, cancer hospitals, and rehabilitation hospitals)
 Long Term Care (LTC) Facilities, including SNFs and NFs, 
generally referred to as nursing homes
 Intermediate Care Facilities for Individuals with Intellectual 
Disabilities (ICFs-IID)
 Home Health Agencies (HHAs)
 Comprehensive Outpatient Rehabilitation Facilities (CORFs)
 Critical Access Hospitals (CAHs)
 Clinics, rehabilitation agencies, and public health agencies 
as providers of outpatient physical therapy and speech-language 
pathology services
 Community Mental Health Centers (CMHCs)
 Home Infusion Therapy (HIT) suppliers
 Rural Health Clinics (RHCs)/Federally Qualified Health Centers 
(FQHCs)
 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:
     CDC COVID-19 vaccination record card (or a legible photo 
of the card),
     Documentation of vaccination from a health care provider 
or electronic health record, or
     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 (https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html). 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 https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinical-considerations.pdf.
    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 https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
    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\ https://www.eeoc.gov/laws/guidance/section-12-religious-discrimination.
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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.
---------------------------------------------------------------------------

    \161\ Section 1819(d)(4)(B) of the Act. Section 1919(d)(4)(B) is 
nearly identical, but omitting ``well-being''.
---------------------------------------------------------------------------

    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:
     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).
     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).
     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\ https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \163\ http://www.floridaarf.org/assets/Files/ICF-IID%20Info%20Center/ICFHandoutonWebsite2-14.pdf.
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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\ https://www.nytimes.com/live/2021/09/23/world/covid-delta-variant-vaccine#covid-alaska-hospital, accessed 10/18/2021.
    \165\ https://www.healthline.com/health-news/how-surging-delta-variant-is-leading-to-rationed-care-at-hospitals, accessed 10/18/
2021.
    \166\ https://www.aamc.org/news-insights/worst-surge-we-ve-seen-some-hospitals-delta-hot-spots-close-breaking-point, accessed 10/18/
2021.
    \167\ https://www.washingtonpost.com/health/2021/08/18/covid-hospitals-delta/, accessed 10/18/2021.
---------------------------------------------------------------------------

    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\ https://www.beckersasc.com/asc-news/5-ways-covid-19-affected-ascs-in-2020.html. 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\ https://www.jhunewsletter.com/article/2020/09/hopkins-finds-dialysis-patients-at-greater-risk-of-covid-19.
    \171\ CJASN March 2021, 16 (3) 452-455; DOI: https://doi.org/10.2215/CJN.12360720.
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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\ http://www.synas.plus/nhsn/covid19/dial-vaccination-dashboard.html#anchor_1594393306.
    \173\ https://www.cdc.gov/vaccines/covid-19/planning/vaccinate-dialysis-patients-hcp.html, 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\ https://gh.bmj.com/content/bmjgh/5/5/e002670.full.pdf. 
Accessed 9/23/2021.
    \175\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7027a2.htm?s_cid=mm7027a2_w 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 
services by such facility, including conditions concerning 
qualifications of personnel in these facilities.'' Under this 
authority, the Secretary has established in regulations, at 42 CFR part 
485, subpart B, the minimum health and safety standards a CORF must 
meet to obtain Medicare certification. The CORF Conditions of 
Participation were issued on December 15, 1982 (47 FR 56282). Section 
485.70, Personnel qualifications, sets forth the qualifications that 
various personnel must meet, as a condition of participation. We are 
adding a new paragraph (n) at Sec.  485.70 which requires the CORF 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.
    Our rules at Sec.  485.58(d)(4), state that personnel that do not 
meet the qualifications specified in Sec.  485.70 may be used by the 
facility in assisting qualified staff. We recognize this sentence is 
inconsistent with newly added Sec.  485.70(n) which requires 
vaccination of all facility staff. We also recognize that assisting 
personnel are used by CORFs. We established our requirements at Sec.  
485.70 (a) through (m) to provide a role for personnel that might not 
meet our education and experience qualifications. We do not believe 
that this exception for employees that do not meet our professional 
requirements should prohibit us from issuing staff qualifications 
referencing infection prevention, which we intend to apply to all 
personnel. Hence, we are revising Sec.  485.58(d)(4) to state that 
personnel that do not meet the qualifications specified in Sec.  
485.70(a) through (m) may be used by the facility in assisting 
qualified staff. However, such assisting staff will not be exempt from 
the newly added requirements in paragraph (n).
    As with other parallel regulations for our facilities, we are 
revising Sec.  485.58(d)(4) as previously discussed. For these reasons 
and the reasons set forth in section II.A. of this IFC, we are adding a 
new regulatory requirement at Sec.  485.70(n) 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.

[[Page 61580]]

4. Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs)
    Section 1861(aa) and 1905(l)(2)(B) of the Act sets forth the RHC 
and FQHC services covered by the Medicare program; section 1905(l) 
cross-references the Medicare provision for Medicaid program purposes. 
The Act requires that RHCs be located in an area that is both rural and 
underserved, are not rehabilitation agencies or facilities primarily 
for the care and treatment of mental diseases, and meet such other 
requirements as the Secretary may find necessary in the interest of the 
health and safety of the individuals who are furnished services by the 
clinic. Likewise, 42 CFR 491.2 defines a FQHC as an entity as defined 
in Sec.  405.2401(b). The definition at Sec.  405.2401 includes an 
entity that has entered into an agreement with CMS to meet Medicare 
Program requirements under Sec.  405.2434. And at 42 CFR 405.2434, the 
content and terms of the agreement require FQHCs to maintain compliance 
with requirements set forth in part 491, except the provisions of Sec.  
491.3 Certification procedures. Conditions for certification for RHCs 
and Conditions of Coverage for FQHCs are found at 42 CFR part 491, 
subpart A.
    RHCs and FQHCs, as essential contributors to the health care 
infrastructure in the U.S., provide care and services to medically 
underserved areas and populations. They play a critical role in helping 
to alleviate access to care barriers and health equity gaps in these 
communities. RHCs and FQHCs provide primary care, diagnostic 
laboratory, and immunization services, and they have incorporated 
COVID-19 screening, triage, testing, diagnosis, treatment, and 
vaccination into these services. However, the medically underserved 
communities in the U.S. have been disproportionately affected by COVID-
19. Hence, the Health Resources and Services Administration (HRSA) has 
established new programs to help RHCs and FQHCs meet the needs of their 
communities and ensure continuity of health care services during the 
PHE.176 177 178 For example: (1) The Rural Health Clinic 
COVID-19 Testing and Mitigation Program which helps RHCs with COVID-19 
testing and mitigation strategies to prevent the spread of infection; 
(2) the Rural Health Clinic Vaccine Distribution Program which 
strengthens COVID-19 vaccine allocations for RHCs; (3) the Rural Health 
Clinic Vaccine Confidence Program that helps RHCs with outreach efforts 
to improve vaccination rates in rural areas with nearly 2,000 RHCs 
across the nation participating; (4) the Health Center COVID-19 Vaccine 
Program whereby FQHCs receive direct allocations of vaccines; (5) the 
Department of Defense (DoD) and HHS partnered to provide point-of-care 
rapid COVID-19 testing supplies to FQHCs through the Health Center 
COVID-19 Testing Supply Distribution Program; and (6) delivery of 5.1 
million adult and 7.4 million child masks between April and August 2021 
to FQHCs at no cost for subsequent distribution to patients, staff, and 
community members. To implement these programs and to provide services 
and care, RHC/FQHC staff must interact with patients and members of the 
community at large. Hence, a requirement for these staff to receive 
COVID-19 vaccination is necessary to assure health and safety for the 
individuals residing in their respective service areas and their 
patients.
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    \176\ https://www.hrsa.gov/coronavirus/rural-health-clinics. 
Accessed 9/24/2021.
    \177\ https://bphc.hrsa.gov/emergency-response/coronavirus-frequently-asked-questions. Accessed 9/24/2021.
    \178\ https://www.hrsa.gov/coronavirus/health-center-program. 
Accessed 10/6/2021.
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    Currently, there are 4,933 Medicare-and Medicaid-certified RHCs and 
10,384 FQHCs that participate in the Medicare and Medicaid programs in 
the U.S. The Conditions at 42 CFR part 491, subpart A are the minimum 
health and safety standards a center or clinic must meet to participate 
in the Medicare and Medicaid programs. The conditions were issued on 
June 12, 1992 (57 FR 27106), and the conditions related to staffing and 
staff responsibilities were last updated on May 12, 2014 (79 FR 27106). 
Section 491.8, Staffing and staff responsibilities, establishes 
requirements for RHC and FQHC staffing and staff responsibilities. We 
are adding new Sec.  491.8(d) which requires the clinic or center 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.
    For these reasons and the reasons set forth in section II.A. of 
this IFC, we are adding a new regulatory requirement at Sec.  491.8(d) 
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.
5. Clinics, Rehabilitation Agencies, and Public Health Agencies as 
Providers of Outpatient Physical Therapy and Speech-Language Pathology 
Services
    Under the authority of section 1861(p) of the Act, the Secretary 
has established CoPs that clinics, rehabilitation agencies, and public 
health agencies (collectively, ``organizations'') must meet when they 
provide outpatient physical therapy (OPT) and speech-language pathology 
(SLP) services. Under section 1861(p) of the Act, the Secretary is 
responsible for ensuring that the CoPs and their enforcement are 
adequate to protect the health and safety of individuals receiving OPT 
and SLP services from these entities. The CoPs are set forth at 42 CFR 
part 485, subpart H. Section 1861(p) of the Act describes outpatient 
physical therapy services to mean physical therapy services furnished 
by a provider of services, a clinic, rehabilitation agency, or a public 
health agency, or by others under an arrangement with, and under the 
supervision of, such provider, clinic, rehabilitation agency, or public 
health agency to an individual as an outpatient. The patient must be 
under the care of a physician. The term ``outpatient physical therapy 
services'' also includes physical therapy services furnished to an 
individual by a physical therapist (in the physical therapist's office 
or the patient's home) who meets licensing and other standards 
prescribed by the Secretary in regulations, other than under 
arrangement with and under the supervision of a provider of services, 
clinic, rehabilitation agency, or public health agency. Pursuant to the 
statutory requirement set out at section 1861(p)(4)(A) and (B) of the 
Act, the furnishing of such services by a clinic, rehabilitation 
agency, or public health agency must meet such conditions relating to 
health and safety as the Secretary may find necessary. The term also 
includes SLP services furnished by a provider of services, a clinic, 
rehabilitation agency, or by a public health agency, or by others under 
an arrangement.
    Currently, there are 2,078 clinics, rehabilitation agencies, and 
public health agencies that provide outpatient physical therapy and 
speech-language services. In the remainder of this rule and throughout 
the requirements, we use the term ``organizations'' instead of 
``clinics, rehabilitation agencies, and public health agencies as 
providers of outpatient physical therapy and speech-language pathology 
services'' for consistency with current regulatory language. Patients 
receive services from organizations due to loss of functional

[[Page 61581]]

ability associated with injury or illness. Hence, these patients 
experience episodic issues and seek care to restore their level of 
functioning and wellness to baseline. In response to the PHE, 
organizations experienced a reduction in patients. They supplemented 
in-person care with telecommunications. However, just over 50 percent 
of physical therapists report in-person care results in better outcomes 
than care provided virtually and the majority of patients are less 
satisfied with care received by telecommunications.\179\ Although the 
data is limited, we believe these findings are consistent with other 
therapeutic services including occupational therapy and speech 
pathology. Comprehensive assessment of balance, strength, range-of-
motion, and proper exercise technique is supported by physical touch, 
and three-dimensional visualization of the patient. Organizations have 
begun seeing more patients, and those patients are presenting with more 
severe functional issues. Organizations care for patients recovering 
from COVID-19 and those who delayed receiving non-COVID-19 related care 
due to fears of exposure to illness after the onset of the pandemic. 
These factors underscore the need to ensure safety and health of 
individuals who receive care from organizations with a requirement for 
COVID-19 vaccination of staff.
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    \179\ American Physical Therapy Association. May 2021. Impact of 
COVID-19 on the Physical Therapy Profession Over One Year.
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    The CoPs for organizations at 42 CFR part 485, subpart H are the 
minimum health and safety standards an organization must meet to obtain 
Medicare certification. The CoPs were first issued May 21, 1976 (41 FR 
20863), and the Conditions related to infection control were last 
updated on September 29, 1995 (60 FR 50446). Section 485.725, Infection 
control, requires organizations to establish an infection-control 
committee with responsibility for overall infection control. We are 
adding new paragraph (f) to Sec.  485.725, which requires the 
organizations 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.
    For these reasons and the reasons set forth in section II.A. of 
this IFC, we are adding a new regulatory requirement at Sec.  
485.725(f) 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.

G. Home-Based Care

    Home-based care providers provide necessary care and services for 
individuals who need ongoing therapeutic, and in some cases life-
sustaining, care. These settings require that health care staff enter 
the patient's personal home (regardless of location in a private home, 
assisted living facility, or another setting) to provide services and 
care in person, thus exposing patients and other members of their 
household, to the staff. Home-based provider staff also often serve 
multiple patients in different homes in the same day, week, or month, 
which presents opportunities for transmission of infectious diseases 
across households. Because home-based providers work outside of a 
regulated health care facility, there is also the potential for staff 
to either not use the appropriate PPE or use it improperly because on-
site oversight mechanisms are not in place, that could increase the 
risk of transmission of COVID-19 or other infectious diseases across 
households. We also believe these patients are especially vulnerable to 
COVID-19 due to receiving care in their homes. Many patients have 
serious illnesses that increases the risk of morbidity and mortality 
from COVID-19. For hospice patients that are receiving non-curative but 
supportive care, we are concerned that contracting COVID-19 could 
increase their discomfort, decrease their quality of life, or perhaps 
even hasten their death. In addition, the patients' homes may have poor 
ventilation or members of the household may not be complying with 
recommended safety precautions. Thus, COVID-19 vaccination mandates 
will provide patients and their household members with safety 
assurances that will facilitate acceptance of home care services, and 
will protect the patients, staff, and the other members of the 
patients' households.
1. Home Health Agencies (HHAs)
    Under the authority of sections 1861(m), 1861(o), and 1891 of the 
Act, the Secretary has established in regulations the requirements that 
a home health agency (HHA) must meet to participate in the Medicare 
program, our regulations at 42 CFR 440.70(d) require that Medicaid-
participating home health agencies meet Medicare conditions of 
participation. Section 1861(o)(6) of the Act requires that home health 
agencies ``meet the conditions of participation specified in section 
1891(a) and such other conditions of participation as the Secretary may 
find necessary in the interest of the health and safety of individuals 
who are furnished services by such agency or organization.'' The CoPs 
for home health services are found in Title 42, Part 484, subparts A 
through C, Sec. Sec.  484.40 through 484.115. HHAs provide care and 
services for qualifying older adults and people with disabilities who 
are beneficiaries under the Hospital Insurance (Part A) and 
Supplemental Medical Insurance (Part B) benefits of the Medicare 
program. These services include skilled nursing care, physical, 
occupational, and speech therapy, medical social work and home health 
aide services which must be furnished by, or under arrangement with, an 
HHA that participates in the Medicare program and must be provided in 
the beneficiary's home. As of September 1, 2021, there were 11,649 HHAs 
participating in the Medicare program. The majority of HHAs are for-
profit, privately owned agencies. The effective delivery of quality 
home health services is essential to the care of the HHA's patients to 
provide necessary care and services and prevent hospitalizations. Since 
patients and other members of their households will be exposed to HHA 
staff, it is essential that staff be vaccinated against COVID-19 for 
the safety of the patients, members of their households, and the staff 
themselves.
    With so many patients depending on the services of HHAs nationwide, 
it is imperative that HHAs have processes in place to address the 
safety of patients and staff and the continued provision of services. 
Because these patients are at home, essential care must be provided, 
regardless of COVID-19 vaccination or infection status. In addition, by 
going into patients' homes, HHA employees are exposed to numerous 
individuals who might not be vaccinated or perhaps are asymptomatic but 
infected. Therefore, it is imperative that HHAs have appropriate 
procedures to ensure the continued provision of care and services for 
their patients. Section 484.70 Condition of participation: Infection 
prevention and control (a) requires that the ``HHA must follow accepted 
standards of practice, including the use of standard precautions, to 
prevent the transmission of infections and communicable diseases.''
    For these reasons and the reasons set forth in section II.A. of 
this IFC, we are adding a new regulatory requirement at Sec.  484.70(d) 
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

[[Page 61582]]

provide care, treatment, or other services for the provider or its 
patients.
2. Hospice
    Section 122 of the Tax Equity and Fiscal Responsibility Act of 1982 
(Pub. L. 97-248, enacted September 3. 1982) (TEFRA), added section 
1861(dd) to the Act to provide coverage for hospice care to terminally 
ill Medicare beneficiaries who elect to receive care from a Medicare-
participating hospice. Under the authority of section 1861(dd) of the 
Act, the Secretary has established the CoPs that a hospice must meet in 
order to participate in Medicare and Medicaid. Under section 
1861(dd)(2)(G) of the Act, the Secretary may impose ``such requirements 
as the Secretary may find necessary in the interest of the health and 
safety of the individuals who are provided care and services by such 
agency or organization.'' The CoPs found at part 418, subparts C and D 
apply to a hospice, as well as to the services furnished to each 
patient under hospice care. These requirements are set forth in 
Sec. Sec.  418.52 through 418.116.
    Hospice care provides palliative care rather than curative 
treatment to terminally ill patients. Palliative care improves the 
quality of life of patients and their families and caregivers facing 
the challenges associated with terminal illness through the prevention 
and relief of suffering by means of early identification, assessment, 
and treatment of pain and other issues. Hospice care allows the patient 
to remain at home by providing support to the patient and family and 
caregiver and by keeping the patient as comfortable as possible while 
maintaining his or her dignity and quality of life. Hospices use an 
interdisciplinary approach to deliver medical, social, physical, 
emotional, and spiritual services through the use of a broad spectrum 
of support.
    Hospices are unique health care providers because they serve 
patients, families, and caregivers in a wide variety of settings. 
Hospice patients may be served in their place of residence, whether 
that residence is a private home, an LTC facility, an assisted living 
facility, or even a recreational vehicle, as long as such locations are 
determined to be the patient's place of residence. Hospice patients may 
also be served in inpatient facilities, including those operated by the 
hospice itself.
    With so many patients depending on the services of hospice services 
nationwide, it is imperative that hospices have processes in place to 
address the safety of patients and staff and the continued provision of 
services. The goal of hospice care is to provide non-curative, but 
supportive care of an individual during the final days, weeks, or 
months of a terminal illness. Contracting any infectious disease, 
especially COVID-19, could result in additional pain or perhaps even 
accelerate a patient's death. Thus, it is critical that hospices 
protect patients and staff from contracting or transmitting COVID-19. 
As of September 1, 2021, there were 5,556 hospices. Section 418.60(a), 
Condition of participation: Infection Control, requires that the 
``hospice must follow accepted standards of practice to prevent the 
transmission of infections and communicable disease, including the use 
of standard precautions.''
    The effective delivery of hospice services is essential to the care 
of the hospice's patients and their families and caregivers. Since 
patients and other members of their households will be exposed to 
hospice staff, it is essential that staff be vaccinated against COVID-
19 for the safety of the patients, members of their households, and the 
staff themselves.
    For these reasons and the reasons set forth in section II.A. of 
this IFC, we are adding a new regulatory requirement at Sec.  418.60(d) 
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. Home Infusion Therapy Suppliers (HIT) Suppliers
    Section 5012 of the 21st Century Cures Act (Pub. L. 114-255, 
enacted December 13, 2016) (Cures Act) created a separate Medicare Part 
B benefit category under 1861(s)(2)(GG) of the Act for coverage of home 
infusion therapy-associated professional services for certain drugs and 
biologicals administered intravenously or subcutaneously for periods of 
15 minutes or more in the patient's home through a pump that is an item 
of durable medical equipment. Section 1861(iii)(3)(D)(i)(IV) of the Act 
requires qualified home infusion therapy (HIT) suppliers to meet, in 
addition to specified qualifications, ``such other requirements as the 
Secretary determines appropriate.'' The regulatory requirements for 
home therapy infusion (HIT) suppliers are located at 42 CFR part 486, 
subpart I, Sec. Sec.  486.500 through 486.525.
    The nature of the home setting presents different challenges than 
in-center services as well as the administration of the particular 
medications. The items and equipment needed to perform home infusion 
include the drug (for example, immune globulin), equipment (a pump), 
and supplies (for example, tubing and catheters) which are covered 
under the Durable Medical Equipment benefit. Skilled professional 
visits, such as those from nurses, often play a critical role in the 
provision of home infusion and are covered under the home infusion 
therapy benefit. For example, nurses typically train the patient or 
caregiver to self-administer the drug, educate on side effects and 
goals of therapy, and visit periodically to provide catheter and site 
care. Depending on patient acuity or the complexity of the drug 
administration, certain skilled professional visits may require more 
time. The HIT infusion process typically requires coordination among 
multiple entities, including patients, the responsible physicians and 
practitioners, hospital discharge planners, pharmacies, and, if 
applicable, home health agencies.
    The current requirements for HIT suppliers do not contain specific 
infection prevention and control requirements. However, Sec.  486.525, 
Required services, does state that these providers must ``provide home 
infusion therapy services in accordance with nationally recognized 
standards of practice, and in accordance with all applicable state and 
federal laws and regulations.'' We believe that ``nationally recognized 
standards of practice'' include appropriate policies and procedures for 
infection prevention and control.
    For these reasons and the reasons set forth in section II.A. of 
this IFC, we are adding a new regulatory requirement at Sec.  
486.525(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.
4. Programs of All-Inclusive Care for the Elderly (PACE) Organizations
    The Programs of All-Inclusive Care for the Elderly (PACE) program 
provides a model of managed care service delivery for frail older 
adults, most of whom are dually eligible for Medicare and Medicaid 
benefits, and all of whom are assessed as being eligible for LTC 
facility placement according to the Medicaid standards established by 
their respective states. PACE organizations furnish comprehensive 
medical, health, and social services that integrate acute and long-term 
care, and these services must be furnished in at least the PACE

[[Page 61583]]

center, the home, and inpatient facilities. The PACE model involves a 
multidisciplinary team of providers known as the interdisciplinary team 
(IDT) that comprehensively assesses and meets the needs of each PACE 
participant by planning and coordinating all participant care. PACE 
organizations must provide all Medicare-covered items and services, all 
Medicaid-covered items and services, and any other services determined 
necessary by the IDT to improve and maintain the participant's overall 
health status, either directly or under contract with third party 
service providers.
    The statutory authorities that permit Medicare payments and 
coverage of benefits under the PACE program, as well as the 
establishment of PACE organizations as a State option under Medicaid to 
provide for Medicaid payments and coverage of benefits under the PACE 
program, are under sections 1894 and 1934 of the Act. These statutory 
authorities are implemented at 42 CFR part 460, where CMS has set out 
the minimum requirements an entity must meet to operate a PACE program 
under Medicare and Medicaid.
    There are 141 PACE organizations nationally. These organizations 
serve approximately 52,000 participants, all in need of the 
comprehensive services provided by PACE organizations. Due to their 
health status, PACE participants are at high risk of severe COVID-19 
and as such have been among the populations prioritized for vaccination 
since the vaccines were authorized. Participants' regular interactions 
with PACE organization staff and contractors indicate that those staff 
and contractors should also be vaccinated against COVID-19.
    For these reasons and the reasons set forth in section II.A. of 
this IFC, we are adding new regulatory requirements at Sec.  460.74(d) 
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 on behalf 
of a PACE organization.

III. Waiver of Proposed Rulemaking

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule before 
the provisions of the rule take effect, in accordance with the 
Administrative Procedure Act (APA), 5 U.S.C. 553, and section 1871 of 
the Act. Specifically, section 553(b) of the APA requires the agency to 
publish a notice of the proposed rule in the Federal Register that 
includes a reference to the legal authority under which the rule is 
proposed, and the terms and substance of the proposed rule or a 
description of the subjects and issues involved. Section 553(c) further 
requires the agency to give interested parties the opportunity to 
participate in the rulemaking through public comment before the 
provisions of the rule take effect. Similarly, section 1871(b)(1) of 
the Act requires the Secretary to provide for notice of the proposed 
rule in the Federal Register and a period of not less than 60 days for 
public comment. Section 553(b)(B) of the APA and section 1871(b)(2)(C) 
of the Act authorize the agency to waive these procedures, however, if 
the agency finds good cause that notice and comment procedures are 
impracticable, unnecessary, or contrary to the public interest and 
incorporates a statement of the finding and its reasons in the rule 
issued.
    The 2021 outbreaks associated with the SARS-Cov-2 Delta variant 
have shown that current levels of COVID-19 vaccination coverage up 
until now have been inadequate to protect health care consumers and 
staff. The data showing the vital importance of vaccination indicate to 
us that we cannot delay taking this action in order to protect the 
health and safety of millions of people receiving critical health care 
services, the workers providing care, and our fellow citizens living 
and working in communities across the nation.
    Although section 564 of the FDCA does not prohibit public or 
private entities from imposing vaccination requirements, even when the 
only vaccines available are those authorized under EUAs (https://www.justice.gov/olc/file/1415446/download), CMS initially chose, among 
other actions, to encourage rather than mandate vaccination, believing 
that a combination of other Federal actions, a variety of public 
education campaigns, and State and employer-based efforts would be 
adequate. However, despite all of these efforts, including CMS's 
mandate for vaccination education and offering of vaccines to LTC 
facility and ICF-IID staff, residents, and clients (86 FR 26306), 
OSHA's June 21, 2021 ETS to protect health care and health care support 
service workers from occupational exposure to COVID-19 (86 FR 3276), 
and ongoing CDC information and encouragement, vaccine uptake among 
health care staff has not been as robust as hoped for and have been 
insufficient to protect the health and safety of individuals receiving 
health care services from Medicare- and Medicaid-certified providers 
and suppliers, particularly given the advent of the Delta variant and 
the potential for new variants.
    As discussed throughout the preamble of this IFC, the PHE continues 
to strain the U.S. health care system. Over the first 6 months of 2021, 
COVID-19 cases, hospitalizations and deaths declined. The emergence of 
the Delta variant reversed these trends.\180\ 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.\181\ Available data also continue to suggest 
that the majority of COVID-19 cases and hospitalizations are occurring 
among individuals who are not fully vaccinated. From January through 
May 2021, of the more than 32,000 laboratory-confirmed COVID-19-
associated hospitalizations in adults over 18 years of age for whom 
vaccination status is known, less than 3 percent of hospitalizations 
occurred in fully vaccinated persons.\182\ More recently published data 
continue to suggest that fully vaccinated persons account for a 
minority (~10 percent) of COVID-19 related hospitalizations.\183\ For 
all adults aged 18 years and older, the cumulative COVID-19-associated 
hospitalization rate was about 12-times higher in unvaccinated 
persons.\184\ Consequently, some hospitals and health care systems are 
currently experiencing tremendous strain due to high case volume 
coupled with persistent staffing shortages due, at least in part, to 
COVID-19 infection or quarantine following exposure.
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    \180\ https://emergency.cdc.gov/han/2021/han00447.asp.
    \181\ Internal estimates based on data published at https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html; 
accessed September 24, 2021.
    \182\ 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, 
accessed October 18, 2021.
    \183\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm?s_cid=mm7037e1_w, accessed October 18, 2021.
    \184\ https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination, accessed October 18, 2021.
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    We recognize that newly reported COVID-19 cases, hospitalizations, 
and deaths have begun to trend downward at a national level; 
nonetheless, they remain substantially elevated relative to numbers 
seen in May and June 2021, when the Delta variant became the 
predominant strain circulating in the U.S.\185\ And while cases are 
trending

[[Page 61584]]

downward in some states, there are emerging indications of potential 
increases in others--particularly northern states where the weather has 
begun to turn colder. This is not surprising: Respiratory virus 
infections typically circulate more frequently during the winter 
months, with peaks in pneumonia and influenza deaths typically during 
winter months.\186\ Similarly, the U.S. experienced a large COVID-19 
wave in the winter of 2020. Approximately 1 in 3 people 12 years of age 
and older in the U.S. remain unvaccinated--and they could pose a threat 
to the country's progress on the COVID-19 pandemic, potentially 
incurring a fifth wave of COVID-19 infections.\187\
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    \185\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
    \186\ https://www.cdc.gov/flu/professionals/acip/background-epidemiology.htm.
    \187\ Ibid.
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    The onset of the 2021-2022 influenza season presents an additional 
threat to patient health and safety. Although influenza activity during 
the 2020-2021 season was low throughout the U.S.,\188\ the intensity of 
the upcoming 2021-2022 influenza season cannot be predicted. Several 
factors could make this flu season more severe; these include return to 
school by children with no prior exposure to flu (and therefor lower 
immunity), waning protection over time from previous seasonal influenza 
vaccination, and the fact that adult immunity (especially among those 
who were not vaccinated last season) will now partly depend on exposure 
to viruses two or more seasons earlier.189 190 COVID-19 
vaccination thus remains an important tool for decreasing stress on the 
U.S. health care system during ongoing circulation of influenza. As 
previously noted, health system strain can adversely impact patient 
access to care and care quality.
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    \188\ CDC. FluView. Weekly influenza surveillance report. 
Atlanta, GA: U.S. Department of Health and Human Services, CDC. 
Accessed February 11, 2021. https://www.cdc.gov/flu/weekly/index.htm.
    \189\ https://www.medrxiv.org/content/10.1101/2021.08.29.21262803v1.
    \190\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7029a1.htm.
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    Furthermore, data on the health consequences of coinfection with 
influenza and SARS-CoV-2 are limited. Preliminary evidence suggests 
that a combination of infections with influenza and SARS-CoV-2 would 
result in more severe health outcomes for patients than either 
infection alone.191 192 193 However, COVID-19 is more 
infectious and has greater rates of mortality, hospitalizations, and 
severe illness than influenza. Accordingly, it is imperative that the 
risk for healthcare-associated COVID-19 transmission be minimized 
during the influenza season. Influenza is most common during the fall 
and winter with the highest incidence of cases reported between 
December through March.\194\ COVID-19 vaccines require time after 
administration for the body to build an immune response. Hence, given 
that the influenza season is imminent, a staff COVID-19 vaccination 
requirement for the providers and suppliers identified in this rule 
cannot be further delayed. The impact of unvaccinated populations on 
the health-care system and the inconsistent web of State, local, and 
employer COVID-19 vaccination requirements have established a pressing 
need for a consistent Federal policy mandating staff vaccination in 
health care settings that receive Medicare and Medicaid funds. The 
current patchwork of regulations undermines the efficacy of COVID-19 
vaccine mandates by encouraging unvaccinated workers to seek employment 
at providers that do not have such patient protections, exacerbating 
staffing shortages, and creating disparities in care across 
populations. This includes workers moving between various types of 
providers, such as from LTC facilities to HHAs and others, creating 
imbalances. As discussed in section I. of this IFC, we have received 
numerous requests from diverse stakeholders for Federal intervention to 
implement a health-care staff vaccine mandate.\195\ Of particular note, 
several representatives of the long-term care community (not limited to 
Medicare- and Medicaid-certified LTC facilities) expressed concerns 
about inequities that would result from imposition of a mandate on only 
one type of provider and strongly recommended a broad approach.\196\ 
While there is opposition to the vaccine mandate, a combination of 
factors now have persuaded us that a vaccine mandate for health care 
workers is an essential component of the nation's COVID-19 response, 
the delay of which would contribute to additional negative health 
outcomes for patients including loss of life. These include, but are 
not limited to, the following: Failure to achieve sufficiently high 
levels of vaccination based on voluntary efforts and patchwork 
requirements; ongoing risk of new COVID-19 variants; potential harmful 
impact of unvaccinated healthcare workers on patients; continuing 
strain on the health care system, particularly from Delta-variant-
driven surging case counts beginning in summer 2021; demonstrated 
efficacy, safety and real-world effectiveness of available vaccines; 
FDA's full licensure of the Pfizer-BioNTech's Comirnaty vaccine; our 
observations of the efficacy of COVID-19 vaccine mandates in other 
settings; and the calls from numerous stakeholders for Federal 
intervention. Moreover, a further delay in imposing a vaccine mandate 
would endanger the health and safety of additional patients and be 
contrary to the public interest.
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    \191\ https://academic.oup.com/cid/article/72/12/e993/6024509?login=true.
    \192\ https://onlinelibrary.wiley.com/doi/epdf/10.1002/jmv.26163.
    \193\ https://www.cdc.gov/flu/about/season/flu-season.htm.
    \194\ Ibid.
    \195\ https://www.aamc.org/news-insights/press-releases/major-health-care-professional-organizations-call-covid-19-vaccine-mandates-all-health-workers. Accessed 10/06/2021.
    \196\ https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-september-2021/. Accessed 10/06/2021.
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    We note that health care workers were among the first groups 
provided access to vaccinations, which were initially authorized for 
emergency use. EUA status may have been a factor in some individual 
decisions to delay or refuse vaccination. The Pfizer-BioNTech COVID-19 
vaccine was first authorized for emergency use on December 11, 2020. 
The vaccine continues to be available in the U.S. under EUA, and the 
EUA was subsequently amended to include use in individuals 12 through 
15 years of age, to allow for the use of an additional dose in the 
primary series for certain immunocompromised individuals, and to allow 
for use of a single booster dose to be administered at least 6 months 
after completion of the primary series in certain individuals. FDA has 
issued EUAs for two additional vaccines for the prevention of COVID-19, 
one to Moderna (December 18, 2020) (indicated for use by individuals 18 
years of age and older), and the other to Janssen (Johnson & Johnson) 
(February 27, 2021) (indicated for use by individuals 18 years of age 
and older). Fact sheets for health care providers administering vaccine 
are available for each vaccine product from FDA. However, on August 23, 
2021, FDA licensed Pfizer-BioNTech's Comirnaty Vaccine. Health care 
workers whose hesitancy was related to EUA status now have a fully 
licensed COVID-19 vaccine option. Despite this, as noted earlier, 
health care staff vaccination rates remain sub-optimal 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 sizeable regional differences.

[[Page 61585]]

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.197 198 199
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    \197\ LTC facility rates derived from data reported through 
CDC's NHSN and posted online at the Nursing Home COVID-19 
Vaccination Data Dashboard: https://www.cdc.gov/nhsn/covid19/ltc-vaccination-dashboard.html; accessed September 15, 2021.
    \198\ Dialysis facility rates derived from data reported through 
CDC's NHSN and posted online at the Dialysis COVID-19 Vaccination 
Data Dashboard: https://www.cdc.gov/nhsn/covid19/dial-vaccination-dashboard.html; accessed September 15, 2021.
    \199\ Hospital data come from unpublished analyses of data 
reported to HHS and posted on HHS Protect.
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    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.\200\ 
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 Delta variant's emergence. 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.\201\ 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.\202\ Because they are at greater risk for 
developing COVID-19 infection and severe disease,203 204 205 
unvaccinated staff present a risk of exacerbating ongoing staffing 
shortages--particularly during periods of community surges in SARS-CoV-
2 infection, when demand for health care services is most acute. Health 
care staff who remain unvaccinated may also pose a direct threat to 
patient, resident, workplace, family, and community safety and 
population health. 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 crude rates of 
preventable SARS-CoV-2 infection.\206\ Similarly, 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.207 208 209 And multiple studies have 
demonstrated SARS-CoV-2 transmissions between health-care workers and 
patients in hospitals, despite universal masking and other 
protocols.210 211 212 213 Acute and LTC facilities engage 
many, if not all, of the same health care professionals and support 
services of other provider and supplier types. As a result, while 
similarly comprehensive data are not available for all Medicare- and 
Medicaid-certified provider and supplier types, we believe the LTC 
facilities experience may generally be extrapolated to other settings.
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    \200\ https://covid.cdc.gov/covid-data-tracker/#health-care-personnel; accessed September 24, 2021.
    \201\ Analysis of dialysis facility and nursing home data 
reported through NHSN.
    \202\ Ibid. 110.
    \203\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
    \204\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm?s_cid=mm7037e1_w.
    \205\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm?s_cid=mm7034e4_w.
    \206\ https://emergency.cdc.gov/han/2021/han00447.asp.
    \207\ 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 https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e2.htm.
    \208\ Postvaccination SARS-CoV-2 Infections Among Skilled 
Nursing Facility Residents and Staff Members--Chicago, Illinois, 
December 2020-March 2021.'' April 30, 2021. Available at https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e1.htm.
    \209\ 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 https://www.cdc.gov/mmwr/volumes/70/wr/mm7011e3.htm.
    \210\ Klompas M, Baker MA, Griesbach D, et al. Transmission of 
SARS-CoV-2 from asymptomatic and presymptomatic individuals in 
healthcare settings despite medical masks and eye protection. Clin 
Infect Dis. 2021. [PMID: 33704451] doi:10.1093/cid/ciab218.
    \211\ https://www.medrxiv.org/content/10.1101/2021.02.16.21251625v1.
    \212\ https://jamanetwork.com/journals/jama/fullarticle/2773128.
    \213\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8349432/.
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    The efficacy of COVID-19 vaccinations has been demonstrated.\214\ 
An ASPE report published on October 5, 2021, found that COVID-19 
vaccines are a key component in controlling the COVID-19 pandemic. 
Clinical data show vaccines are highly effective in preventing COVID-19 
cases and severe outcomes including hospitalization and death. The ASPE 
analysis of individual-level health data and county-level vaccination 
rates found that higher county vaccination rates were associated with 
significant reductions in the odds of COVID-19 infection, 
hospitalization, and death among Medicare fee-for-service (FFS) 
beneficiaries between January and May 2021. Further, comparing the 
rates of these outcomes to what ASPE modeling predicted would have 
happened without any vaccinations, we estimate COVID-19 vaccinations 
were linked to estimated reductions of approximately 107,000 
infections, 43,000 hospitalizations, and 16,000 deaths in our study 
sample of 25.3 million beneficiaries. The report also noted that the 
difference in vaccination rates for those age 65 and older between the 
lowest (34 percent) and highest (85 percent) counties and states by the 
end of May highlights the continued opportunity to leverage COVID-19 
vaccinations to prevent COVID-19 hospitalizations and deaths.\215\ 
Vaccines continue to be effective  in preventing COVID-19 associated 
with the  now-dominant Delta variant.216 217
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    \214\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
    \215\ https://aspe.hhs.gov/sites/default/files/documents/c5d0dde224c224dd726694367846b609/aspe-covid-medicare-vaccine-analysis.pdf. Accessed 10/06/2021.
    \216\ https://www.nejm.org/doi/full/10.1056/nejmoa2108891.
    \217\ https://www.mayoclinic.org/coronavirus-covid-19/covid-variant-vaccine.
    \218\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm?s_cid=mm7034e4_w.
    \219\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html#ref43.
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    In addition to preventing morbidity and mortality associated with 
COVID-19, the vaccines also appear to be effective 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.\218\ Emerging evidence also suggests that vaccinated people 
who become infected with Delta have potential to be less infectious 
than infected unvaccinated people, thus decreasing transmission 
risk.\219\ 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

[[Page 61586]]

among unvaccinated individuals with primary infections.\220\
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    \220\ https://www.medrxiv.org/content/10.1101/2021.08.20.21262158v1.full.pdf.
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    As noted earlier in this section, a combination of factors, 
including but not limited to failure to achieve sufficiently high 
levels of vaccination based on voluntary efforts and patchwork 
requirements, potential harm to patients from unvaccinated health-care 
workers, and continuing strain on the health care system and known 
efficacy and safety of available vaccines, have persuaded us that a 
vaccine mandate for health care workers is an essential component of 
the nation's COVID-19 response. Further, it would endanger the health 
and safety of patients, and be contrary to the public interest to delay 
imposing it. Therefore, we believe it would be impracticable and 
contrary to the public interest for us to undertake normal notice and 
comment procedures and to thereby delay the effective date of this IFC. 
We find good cause to waive notice of proposed rulemaking under the 
APA, 5 U.S.C. 553(b)(B), and section 1871(b)(2)(C) of the Act. For 
those same reasons, as authorized by the Small Business Regulatory 
Enforcement Fairness Act of 1996 (the Congressional Review Act or CRA), 
5 U.S.C. 808(2), we find it is impracticable and contrary to the public 
interest not to waive the delay in effective date of this IFC under 
section 801 of the CRA. Therefore, we find there is good cause to waive 
the CRA's delay in effective date pursuant to section 808(2) of the 
CRA.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA), we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment before a collection of information requirement (ICR) is 
submitted to the Office of Management and Budget (OMB) for review and 
approval. The ICRs in this section will be included in an emergency 
revision of the information collection request currently approved under 
the appropriate OMB Control number. All PRA-related comments received 
in response to this IFC will be reviewed and addressed in a subsequent, 
non-emergency, submission of the information collection request. The 
emergency approval is only valid for 6 months. Within that 6-month 
approval period, CMS will seek a regular, non-emergency, approval and 
as required by the PRA, this action will be announced in the requisite 
60-day and 30-day Federal Register notices.
    In order to fairly evaluate whether an information collection 
should be approved by OMB, section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 requires that we solicit comment on the following 
issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are soliciting public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs):
    For the estimated costs contained in the analysis below, we used 
data from the U.S. Bureau of Labor Statistics (BLS) to determine the 
mean hourly wage for the positions used in this analysis.\221\ For the 
total hourly cost, we doubled the mean hourly wage for a 100 percent 
increase to cover overhead and fringe benefits, according to standard 
HHS estimating procedures. If the total cost after doubling resulted in 
0.50 or more, the cost was rounded up to the next dollar. If it was 
0.49 or below, the total cost was rounded down to the next dollar. The 
total costs used in this analysis are indicated in Table 3.
---------------------------------------------------------------------------

    \221\ BLS. May 2020 National Occupational Employment and Wage 
Estimates United States. United States Department of Labor. Accessed 
at https://www.bls.gov/oes/current/oes_nat.htm. Accessed on August 
25, 2021.
---------------------------------------------------------------------------

BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C
    In this analysis, we used specific resources to estimate the burden 
for the providers and suppliers in this rule. Based upon our 
experience, there are minimal fluctuations in the numbers of providers 
and suppliers monthly. Thus, unless otherwise indicated, all of the 
numbers for the providers and suppliers in this analysis were located 
on September 1, 2021 on the Quality, Certification & Oversight Reports 
(QCOR) website at https://qcor.cms.gov/main.jsp. For the number of 
employees for each provider and supplier, those numbers were obtained 
from Table 5: Estimates of Number of Staff by Type of Provider 
(thousands) located in section VI.B. of this IFC.
    This analysis is also based upon certain assumptions. We believe 
that many of the providers and suppliers covered in this rule have 
already either encouraged their employees to get

[[Page 61589]]

vaccinated for COVID-19 or have mandates for the vaccine. Mandates for 
employees to be vaccinated for COVID-19 can result from State, county, 
or local actions or result from a decision by the facility. These 
facilities would likely have already developed policies and procedures, 
as well as documentation requirements, related to their employees being 
vaccinated for COVID-19. However, we have no reliable method to 
estimate the number or percentage of these facilities. In addition, it 
is likely that those facilities would not comply with all of the 
requirements in this rule. For example, many facilities might not 
define ``employees'' as set forth in this rule. Each facility would 
have to review its policies, procedures, and documentation requirements 
to ensure that they comply with the requirements in this rule. Hence, 
based upon these assumptions, this analysis will assess the burden for 
all facilities and employees for each provider and supplier type.
    We also made some assumption regarding analysis of the burden for 
the documentation requirements. If an employee receives the appropriate 
vaccinations, reviewing and documenting that the employee has been 
vaccinated would likely only require 1 to 3 minutes, depending upon how 
the facility is documenting the vaccination, which is likely to vary 
substantially between facilities. However, for employees that request 
exemptions or have to be contacted repeatedly for the appropriate 
documentation, it would likely take more time to comply with this 
requirement. At a minimum, both the initial request for the exemption 
and the final determination would have to be documented. In cases where 
the exemption was denied and the employee receives the appropriate 
vaccinations, those vaccine doses would also have to be documented. 
There might also be additional documentation that would need to be 
copied or scanned for their records. While the documentation for 
employees requesting an exemption would require more burden, we believe 
that there would only be a small percentage of employees that would 
request an exemption. Since we have no reliable method for estimating a 
number or percentage of employees who would be in each category, we 
will analyze the burden for the documentation requirements using 5 
minutes or 0.0833 hours for each employee.
    The position of the individual who would perform the activities 
related to the documentation requirement would also vary depending upon 
the type of provider or supplier and whether the employee requested an 
exemption. If the employee has been vaccinated in compliance with this 
rule, an administrative support person might review their vaccination 
card and document that the employee has been vaccinated. However, if an 
administrative support person performs these activities, we believe an 
administrator or another member of the health care staff would be 
responsible for overseeing these activities. For other providers and 
suppliers, a nurse would likely be assigned to verify and document 
vaccination status. If an employee requests an exemption, we believe 
that a nurse, another health care professional, or an administrator 
would likely review the request and document it. Some other providers 
or suppliers might have an administrator or another member of the 
health care staff perform these activities. Thus, for this analysis, if 
a provider is required to have at least one infection preventionist 
(IP), such as hospitals, we believe the IP would be responsible for 
documenting the vaccination status for all employees. For other 
providers and suppliers, we assessed the burden using a registered 
nurse (RN), another member of the health care staff, such as a physical 
therapist, or an administrator.
    The estimates that follow are largely based on our experience with 
these various providers. However, given the uncertainty and rapidly 
changing nature of the current pandemic, we acknowledge that there will 
likely need to be revisions to these requirements over time. We welcome 
comments that might improve these estimates.

A. ICRs Regarding the of Development of Policies and Procedures for 
ASCs Sec.  416.51(c), ``COVID-19 Vaccination of Staff''

1. Policies and Procedures
    At Sec.  416.51(c), we require ASCs to develop and implement 
policies and procedures to ensure their staff are vaccinated for COVID-
19 and track and maintain documentation of their vaccination status. 
Each ASC must also have a contingency plan for any staff that are not 
fully vaccinated according to this rule.
    The ICRs for this section would require each ASC to develop the 
policies and procedures needed to satisfy all of the requirements in 
this section. Based upon our experience with ASCs, we believe some 
centers have already developed policies and procedures requiring COVID-
19 vaccination for staff. However, each ASC will need to review their 
current policies and procedures and modify them, if necessary, to 
ensure compliance with the requirements in this IFC, especially that 
their policies and procedures cover all of the center staff as 
identified in this IFC. Hence, we will base our estimate for this ICR 
on all 6,071 ASCs. We believe activities associated with this IFC would 
be performed by the RN functioning as the designated and qualified 
infection control professional (ICP) and ASC administrator as analyzed 
below.
    The ICP would conduct research and then either modify or develop 
the policies and procedures needed to comply with this section's 
requirements. The ICP would work with the ASC administrator in 
developing these policies and procedures. For the ICP, we estimate this 
would require 8 hours initially to perform research and revise or 
develop the policies and procedures to meet these requirements. 
According to Table 3, the ICP's total hourly cost is $77. Thus, for 
each ASC, the burden for the ICP would be 8 hours at a cost of $616 (8 
x $77). For the ICPs in all 6,071 ASCs, the burden would be 48,568 
hours (8 x 6,071) at an estimated cost of $3,739,736 ($616 x 6,071).
    As discussed above, the revision and approval of these initial 
policies and procedures would also require activities by the ASC 
administrator. The administrator would need to have meetings with the 
ICP to discuss the revisions and approve the final policies and 
procedures. We estimate this would require 2 hours for the 
administrator. According to Table 3, the total hourly cost for the 
administrator is $98. The burden for the administrator in each ASC 
would be 2 hours at an estimated cost of $196 (2 x $98). For the 
administrators in all 6,071 ASCs, the burden would be 12,142 hours (2 x 
6,071) at an estimated cost of $1,189,916 ($196 x 6,071).
    Therefore, for all 6,071 ASCs, the estimated burden associated with 
the requirement for policies and procedures would be 67,010 hours 
(48,568 + 12,142) at a cost of $4,929,652 ($3,739,736 + $1,189,916).
2. Documentation and Storage
    Section 416.51(c) also requires ASCs to track and securely maintain 
the required documentation of staff COVID-19 vaccination status. Any 
burden for modifying the center's policies and procedures for these 
activities is already accounted for above. We believe that this would 
require an RN 5 minutes or 0.0833 hours to perform the required 
documentation an adjusted hourly wage of $77 for each employee. 
According to Table 3, ASCs have 200,000 employees.

[[Page 61590]]

Hence, the burden for these documentation requirements for all 6,071 
ASCs would be 16,660 (0.0833 x 200,000) hours at an estimated cost of 
$1,282,820 (16,660 x $77).
    The total burden for all 6,071 ASCs for this IFC would be 83,670 
(67,010 + 16,660) hours at an estimated cost of $6,212,472 ($4,929,652 
+ $1,282,820).
    The requirements and burden will be submitted to OMB under OMB 
control number 0938-0266 (expiration date July 31, 2024).

B. ICRs Regarding the Development of Policies and Procedures for 
Hospices Sec.  418.60(d), ``COVID-19 Vaccination of Facility Staff''

1. Policies and Procedures
    At Sec.  418.60(d), we require hospices to develop and implement 
policies and procedures to ensure their staff are vaccinated for COVID-
19 and that appropriate documentation of those vaccinations are tracked 
and maintained. The hospice must also have a contingency plan for all 
staff not fully vaccinated according to this rule.
    The ICRs for this section would require each hospice to develop the 
policies and procedures needed to satisfy all of the requirements in 
this section. Current regulations are set forth at Sec.  418.60 
Condition of participation: Infection control, and require each hospice 
to maintain and document an infection control program to prevent and 
control infections and communicable diseases. The hospice must also 
follow accepted standards of practice, including the use of standard 
precautions to prevent the transmission of infections and communicable 
diseases. Thus, all hospices should already have infection prevention 
and control policies and procedures, but they likely do not comply with 
all of the requirements in this IFC.
    All hospices would need to review their current policies and 
procedures and modify them to comply with all of the requirements in 
Sec.  418.60(d) as set forth in this IFC. While we believe that many 
hospices have already addressed COVID-19 vaccination with their staff, 
we have no reliable means to estimate that number. Therefore, we will 
assess the burden for these requirements for all 5,556 hospices. We 
believe these activities would be performed by the RN and an 
administrator. According to Table 3, an RN in these settings has a 
total hourly cost of $79. Since there are not any current requirements 
that address COVID-19 vaccination, we estimate it would require 8 hours 
for the RN to research, draft, and work with an administrator to 
finalize the policies and procedures. Thus, for each hospice, the 
burden for the RN would be 8 hours at a cost of $632 (8 hours x $79). 
For all 5,556 hospices, the burden would be 44,448 hours (8 hours x 
5,556) at an estimated cost of $3,511,392 ($632 x 5,556).
    As discussed above, the revision and approval of these policies and 
procedures would also require activities by an administrator. The 
administrator would need to work with the RN to develop the policies 
and procedures, and then review and approve the changes. We estimate 
this would require 2 hours. According to Table 3, the total hourly cost 
for the administrator in this setting is $122. Hence, for each hospice, 
the burden would be 2 hours at an estimated cost of $244 (2 x $122). 
For all 5,556 hospices, the total burden would be 11,112 hours (2 x 
5,556) at an estimated cost of $1,355,664 (5,556 x $244).
    Thus, the total burden for hospices to comply with the requirements 
for policies and procedures in this IFC is 55,560 hours (44,448 + 
11,112) at an estimated cost of $4,867,056 ($3,511,392 + $1,355,664).
2. Documentation and Storage
    Section 418.60(d) also requires hospices to track and securely 
maintain the required documentation of staff COVID-19 vaccination 
status. Any burden for modifying the hospice's policies and procedures 
for these activities is already accounted for above. We believe that 
this would require an RN 5 minutes or 0.0833 hours to perform the 
required documentation an adjusted hourly wage of $79 for each 
employee. According to Table 3, hospices have 340,000 employees. Hence, 
the burden for these documentation requirements for all 5,556 hospices 
would be 28,322 (0.0833 x 340,000) hours at an estimated cost of 
$2,237,438 (28,322 x 79).
    Therefore, the total burden for all 5,556 hospices for this rule 
would be 83,882 (55,560 + 28,322) hours at an estimated cost of 
$7,104,494 (4,867,056 + 2,237,438).
    The requirements and burden will be submitted to OMB under OMB 
control number 0938-1067 (expiration date March 31, 2024).

C. ICRs Regarding the Development of Policies and Procedures for PACE 
Organizations Sec.  460.74(d), ``COVID-19 Vaccination of PACE 
Organization Staff''

1. Policies and Procedures
    Section 460.74(d) requires that programs for all-inclusive care for 
the elderly (PACE) organizations to develop and implement policies and 
procedures to ensure their staff are vaccinated for COVID-19 and that 
appropriate documentation of those vaccinations are tracked and 
maintained. Each PACE organization must also have a contingency plan 
for all staff not fully vaccinated according to this rule.
    The ICRs for this section would require each PACE organization to 
develop the policies and procedures needed to satisfy all of the 
requirements in this section. Current regulations at Sec.  460.74 
already require that each PACE organization follow accepted policies 
and standard procedures with respect to infection control in place. 
Thus, all PACE organizations should have policies and procedures 
regarding infection prevention and control. We also believe that many 
have already addressed COVID-19 vaccination policies for their staff. 
However, since we do not have a reliable method to estimate how many 
have, we will assess the burden for all 141 PACE organizations.
    All PACE organizations would need to review their current infection 
prevention and control policies and procedures and develop or modify 
them to satisfy the requirements in this section. We believe these 
activities would require an RN and an administrator. According to Table 
3, an RN's total hourly cost is $74. Since there are not any current 
requirements that address COVID-19 vaccination, we estimate it would 
require 8 hours for the RN to research, draft, and work with an 
administrator to finalize the policies and procedures. Thus, for each 
PACE organization, the burden for the RN would be 8 hours at a cost of 
$592 (8 hours x $74). For all 141 PACE organizations, the burden would 
be 1,128 hours (8 hours x 141) at an estimated cost of $83,472 (592 x 
141).
    As discussed above, the revision and approval of these policies and 
procedures would also require activities by an administrator. The 
administrator would need to work with the RN to develop the policies 
and procedures, and then review and approve the changes. We estimate 
this would require 2 hours. According to Table 3, the total hourly cost 
for the administrator is $122. Hence, for each PACE organization, the 
burden would be 2 hours at an estimated cost of $244 (2 x 122). For all 
141 PACE organizations, the total burden would be 282 hours (2 x 141) 
at an estimated cost of $34,404 (141 x $244).
    Thus, the total burden for all 141 PACE organizations to comply 
with the requirements for the policies and

[[Page 61591]]

procedures is 1,410 hours (1,128 + 282) at an estimated cost of 
$117,876 (83,472 + 34,404).
2. Documentation and Storage
    Section 460.74(d) also requires PACE organizations to track and 
securely maintain the required documentation of staff COVID-19 
vaccination status. Any burden for modifying the PACE organization's 
policies and procedures for these activities is already accounted for 
above. We believe that this would require an RN 5 minutes or 0.0833 
hours to perform the required documentation an adjusted hourly wage of 
$74 for each employee. According to Table 3, PACE organizations have 
10,000 employees. Hence, the burden for these documentation 
requirements for all 141 PACE organizations would be 833 (0.0833 x 
10,000) hours at an estimated cost of $61,642 (833 x 74).
    Therefore, the total burden for all 141 PACE organizations for this 
rule would be 2,243 (1,410 + 833) hours at an estimated cost of 
$179,518 (117,876 + 61,642).
    The requirements and burden will be submitted to OMB under OMB 
control number 0938-1326 (expiration date April 20, 2023).

D. ICRs Regarding the Development of Policies and Procedures for 
Hospitals Sec.  482.42(g), ``COVID-19 Vaccination of Hospital Staff''

1. Policies and Procedures
    At Sec.  482.42(g), we require hospitals to develop and implement 
policies and procedures to ensure their staff are vaccinated for COVID-
19 and that appropriate documentation of those vaccinations are tracked 
and maintained. The hospital must also have a contingency plan for all 
staff not fully vaccinated according to this rule.
    The ICRs for this section would require each hospital to develop 
the policies and procedures needed to satisfy all of the requirements 
in this section. Current regulations at Sec.  482.42 Condition of 
participation: Infection prevention and control and antibiotic 
stewardship programs already require hospitals to have an infection 
prevention and control program (IPCP) and an infection preventionist 
(IP). The IPCP must have methods to prevent and control the 
transmission of infection within the hospital and between the hospital 
and other settings. Thus, all 5,194 hospitals should already have 
infection prevention and control policies and procedures. However, each 
hospital would need to review their current policies and procedures and 
modify them, if necessary, to ensure compliance with all of the 
requirements in this IFC, especially that their policies and procedures 
cover all of the eligible facility staff identified in this IFC. Based 
upon our experience with hospitals, we believe many hospitals have 
already developed policies and procedures requiring COVID-19 
vaccination for staff. Since we have no reliable means to estimate the 
number of hospitals that may have already addressed COVID-19 
vaccination of their staff, we will base our estimate for these 
requirements on all 5,194 hospitals.
    We believe these activities would be performed by the IP, the 
director of nursing (DON), and an administrator. The IP would need to 
research COVID-19 vaccines, modify the policies and procedures, as 
necessary, and work with the DON and administrator to develop the 
policies and procedures and obtain appropriate approval. For the IP, we 
estimate these activities would require 8 hours. According to Table 3, 
the IP's total hourly cost is $79. Thus, for each hospital, the burden 
for the IP would be 8 hours at a cost of $632 (8 hours x 79). For the 
IPs in all 5,194 hospitals, the burden would be 41,552 hours (8 hours x 
5,194) at an estimated cost of $3,282,608 (632 x 5,194).
    As discussed above, the revision and approval of these policies and 
procedures would also require activities by the DON and an 
administrator. We believe these activities would require 2 hours each 
for the DON and an administrator. According to Table 3, the total 
adjusted hourly wage for both the DON and an administrator is $122. 
Hence, for each hospital, the burden would be 4 hours (2 x 2) at an 
estimated cost of $488 (4 x $122). The total burden for all 5,194 
hospitals would be 20,776 hours (4 x 5,194) at an estimated cost of 
$2,534,672 (5,194 x 488).
    Therefore, for all 5,194 hospitals, the total burden for the 
requirements for policies and procedures is 62,328 hours (41,552 + 
20,776) at an estimated cost of $5,817,280 (3,282,608 + 2,534,672).
2. Documentation and Storage
    Section 482.42(g) also requires hospitals to track and securely 
maintain the required documentation of staff COVID-19 vaccination 
status. Any burden for modifying the hospital's policies and procedures 
for these activities is already accounted for above. We believe that 
this would require an RN 5 minutes or 0.0833 hours to perform the 
required documentation an adjusted hourly wage of $79 for each 
employee. According to Table 3, hospitals have 6,070,000 employees. We 
could not locate a reliable number for critical access hospital (CAH) 
employees so they are included here with the hospital employees. Hence, 
the burden for these documentation requirements for all 5,194 hospital 
and 1,358 CAHs would be 505,631 (0.0833 x 6,070,000) hours at an 
estimated cost of $39,944,849 (505,631 x 79).
    Therefore, the total burden for this rule for all 5,194 hospitals 
and 1,358 CAHs (documentation burden only) would be 567,959 (62,328 + 
505,631) hours at an estimated cost of $45,762,129 (5,817,280 + 
39,944,849).
    The requirements and burden will be submitted to OMB as an 
emergency reinstatement of an existing OMB control number 0938-0328.

E. ICRs Regarding the Development of Policies and Procedures for LTC 
Facilities Sec.  483.80(i), ``COVID-19 Vaccination of Facility Staff''

1. Policies and Procedures
    At Sec.  483.80(i), we require LTC facilities to develop and 
implement policies and procedures to ensure their staff are vaccinated 
for COVID-19 and that appropriate documentation of those vaccinations 
are tracked and maintained. The LTC facility must also have a 
contingency plan for all staff not fully vaccinated according to this 
rule.
    The ICRs for this section would require each LTC facility to 
develop the policies and procedures needed to satisfy all of the 
requirements in this section. Current regulations at Sec.  483.80(d)(1) 
and (2) already require LTC facilities to have policies and procedures 
to educate, offer, and document vaccination status for residents 
regarding the influenza and pneumococcal immunizations. In addition, 
Sec.  483.80(d)(3) requires LTC facilities to educate, offer, and 
document the vaccination status for residents and staff for the COVID-
19 immunizations. Based upon our experience with LTC facilities, we 
believe some facilities have already developed policies and procedures 
requiring COVID-19 vaccination for staff, including COVID-19 vaccine 
mandates. However, we have no reliable means to estimate the number or 
percentage of LTC facilities that have already mandated vaccination. 
Hence, we will base our estimate for this ICR on all 15,401 LTC 
facilities.
    Each LTC facility would need to review its policies and procedures 
for Sec.  483.80(d) and modify them to comply with the requirements in 
this rule at Sec.  483.80(i) and obtain the appropriate review and 
approval. This would require conducting research and revising the 
policies and procedures as needed. We believe these activities

[[Page 61592]]

would be performed by the infection preventionist (IP), director of 
nursing (DON), and medical director for the first year and the IP in 
subsequent years as analyzed below.
    The IP would need to work with the DON and medical director to 
revise and finalize the policies and procedures. For the IP, we 
estimate this would require 2 hours initially to perform research and 
revise the policies and procedures to meet these requirements. 
According to Table 3, the IP's total hourly cost is $69. Thus, for each 
LTC facility, the burden for the IP would be 2 hours at a cost of $138 
(2 hours x 69). For the IPs in all 15,401 LTC facilities, the burden 
would be 30,802 hours (2 hours x 15,401 facilities) at an estimated 
cost of $2,125,338 (138 x 15,401).
    As discussed above, the revision and approval of these policies and 
procedures would also require activities by the DON and medical 
director. Both the DON and medical director would need to have meetings 
with the IP to discuss the revision, evaluation, and approval of the 
policies and procedures. We estimate this would require 1 hour for both 
the DON and medical director. According to Table 3, the total hourly 
cost for the DON is $96. The burden in the first year for the DON in 
each LTC facility would be 1 hour at an estimated cost of $96 (1 hour x 
96). The burden would be 15,401 hours (1 x 15,401) at an estimated cost 
of $1,478,496 (96 x 15,401) for all LTC facilities.
    For the medical director, we have estimated the revision of 
policies and procedures would also require 1 hour. According to the 
chart above, the total hourly cost for the medical director is $171. 
For each LTC facility, this would require 1 hour for the medical 
director during the first year at an estimated cost of $171 (1 hour x 
$171). the burden for all LTC facilities would be 15,401 hours (1 x 
15,401) at an estimated cost of $2,633,571 (171 x 15,401).
    Therefore, for all 15,401 LTC facilities in the first year, the 
estimated burden for the policies and procedures requirement would be 
61,604 hours (30,802 + 15,401 + 15,401) at a cost of $6,237,405 
(2,125,338 + 1,478,496 + 2,633,571).
2. Documentation and Storage
    Section 483.80(i) also requires LTC facilities to track and 
securely maintain the required documentation of staff COVID-19 
vaccination status. Any burden for modifying the facility's policies 
and procedures for these activities is already accounted for above. The 
PRA package submitted under OMB Control No. 0938-1363 already provides 
for the documentation burden for the IP for the LTC facility's 
infection prevention and control program (IPCP) under which the 
requirements in this rule will also be located. We believe the burden 
for the documentation requirements in this rule should be included in 
that burden. Therefore, we will not assess any additional burden for 
the documentation requirements in this rule.
    The requirements and burden will be submitted to OMB under OMB 
control number 0938-1363 (expiration date June 30, 2022).

F. ICRs Regarding the Development of Policies and Procedures for PRTFs 
Sec.  441.151(c), ``COVID-19 Vaccination of Facility Staff''

1. Policies and Procedures
    Section 441.151(c) requires psychiatric residential treatment 
facilities (PRTFs) to develop and implement policies and procedures to 
ensure their staff are vaccinated for COVID-19 and that appropriate 
documentation of those vaccinations are tracked and maintained. The 
PRTF must also have a contingency plan for all staff not fully 
vaccinated according to this rule.
    The ICRs for this section would require each PRTF to develop the 
policies and procedures needed to satisfy all of the requirements in 
this section. Current regulations for PRTFs do not address infection 
prevention and control or vaccinations. Hence, although we believe that 
at least some PRTFs have already addressed COVID-19 vaccination of 
their staff, we will assess the burden for all 357 PRTFs.
    We believe these activities would be performed by an RN and an 
administrator. According to Table 3, an RN's total hourly cost is $74. 
Since there are not any current requirements that address COVID-19 
vaccination, we estimate it would require 8 hours for the RN to 
research, draft, and work with an administrator to finalize the 
policies and procedures. Thus, for each PRTF, the burden for the RN 
would be 8 hours at a cost of $592 (8 hours x 74). For all 357 PRTFs, 
the burden would be 2,856 hours (8 hours x 357) at an estimated cost of 
$211,344 (592 x 357).
    As discussed above, the revision and approval of these policies and 
procedures would also require activities by an administrator. The 
administrator would need to work with the RN to develop the policies 
and procedures, and then review and approve the changes. We estimate 
this would require 2 hours. According to Table 3, the total hourly cost 
for the administrator is $122. Hence, for each PRTF, the burden would 
be 2 hours at an estimated cost of $244 (2 x 122). For all 357 PRTFs, 
the total burden would be 714 hours (2 x 357) at an estimated cost of 
$87,108 (357 x 244).
    Thus, the total burden for all 357 PRTFs to comply with the 
policies and procedures requirements in this IFC for policies and 
procedures is 3,570 hours (2,856 + 714) at an estimated cost of 
$298,452 (211,344 + 87,108).
2. Documentation and Storage
    Section 441.151(c) also requires PRTFs to track and securely 
maintain the required documentation of staff COVID-19 vaccination 
status. Any burden for modifying the facility's policies and procedures 
for these activities is already accounted for above. We believe that 
this would require an RN 5 minutes or 0.0833 hours to perform the 
required documentation an adjusted hourly wage of $74 for each 
employee. According to Table 3, PRTFs have 30,000 employees. Hence, the 
burden for these documentation requirements for all 357 PRTFs would be 
2,499 (0.0833 x 30,000) hours at an estimated cost of $184,926 (2,499 x 
74).
    Therefore, the total burden for all 357 PRTFs for this rule would 
be 6,069 (3,570 + 2,499) hours at an estimated cost of $483,378 
(298,452 + 184,926)
    The requirements and burden will be submitted to OMB under OMB 
control number 0938-0833 (expiration date May 31, 2022).

G. ICRs Regarding the Development of Policies and Procedures for ICFs-
IID Sec.  483.430(f), ``COVID-19 Vaccination of Facility Staff''

1. Policies and Procedures
    At Sec.  483.430(f), we require ICFs-IID to develop and implement 
policies and procedures to ensure their staff are vaccinated for COVID-
19 and that appropriate documentation of those vaccinations are tracked 
and maintained. The ICFs-IID must also have a contingency plan for all 
staff not fully vaccinated according to this rule.
    The ICRs for this section would require each ICFs-IID to develop 
the policies and procedures needed to satisfy all of the requirements 
in this section. Current regulations at Sec.  483.470(l) Standard: 
Infection control requires that the ICFs-IID must provide a sanitary 
environment to avoid sources and transmission of infections. The 
facility must also implement successful corrective action in affected 
problem areas, maintain a record of incidents and corrective actions 
related to infections, and prohibit employees with symptoms or sign of 
a communicable

[[Page 61593]]

disease from direct contact with clients and their food. Hence, ICFs-
IID should already have policies and procedures for infection 
prevention and control.
    We believe these activities would be performed by the RN. According 
to Table 3, an RN's total hourly cost is $69. Since there are not any 
current requirements that address COVID-19 vaccination, we estimate it 
would require 8 hours for the RN to research, draft, and work with an 
administrator to finalize the policies and procedures. Thus, for each 
ICFs-IID, the burden for the RN would be 8 hours at a cost of $552 (8 
hours x 69). For all 5,780 ICFs-IID, the burden would be 46,240 hours 
(8 hours x 5,780) at an estimated cost of $3,190,560 (552 x 5,780).
    As discussed above, the revision and approval of these policies and 
procedures would also require activities by an administrator. The 
administrator would need to work with the RN to develop the policies 
and procedures, and then review and approve the changes. We estimate 
this would require 2 hours. According to Table 3, the total hourly cost 
for the administrator is $96. Hence, for each ICFs-IID, the burden 
would be 2 hours at an estimated cost of $192 (2 x 96). For all 5,780 
ICFs-IID, the total burden would be 11,560 hours (2 x 5,780) at an 
estimated cost of $1,109,760 (5,780 x 192).
    Thus, the total burden for all 5,780 ICFs-IID to comply with the 
requirements for policies and procedures is 57,800 hours (46,240 + 
11,560) at an estimated cost of $4,300,320 (3,190,560 + 1,109,760).
2. Documentation and Storage
    Section 483.430(f) also requires ICFs-IID to track and securely 
maintain the required documentation of staff COVID-19 vaccination 
status. Any burden for modifying the facility's policies and procedures 
for these activities is already accounted for above. We believe that 
this would require an RN 5 minutes or 0.0833 hours to perform the 
required documentation at adjusted hourly wage of $69 for each 
employee. According to Table 3, ICFs-IID have 80,000 employees. Hence, 
the burden for these documentation requirements for all 5,780 ICFs-IID 
would be 6,664 (0.0833 x 80,000) hours at an estimated cost of $459,816 
(6,664 x $69).
    Therefore, the total burden for all 5,780 ICFs-IID for this rule 
would be 64,464 (57,800 + 6,664) hours at an estimated cost of 
$4,760,136 (4,300,320 + 459,816).
    The requirements and burden will be submitted to OMB under OMB 
control number 0938-1402 (expiration date September 30, 2024).

H. ICRs Regarding the Development of Policies and Procedures for HHAs 
Sec.  484.70(d), ``COVID-19 Vaccination of Home Health Agency Staff''

1. Policies and Procedures
    At Sec.  483.70(d), we require HHAs to develop and implement 
policies and procedures to ensure their staff are vaccinated for COVID-
19 and that appropriate documentation of those vaccinations are tracked 
and maintained. The HHA must also have a contingency plan for all staff 
not fully vaccinated according to this rule.
    The ICRs for this section would require each HHA to develop the 
policies and procedures needed to satisfy all of the requirements in 
this section. Current regulations at Sec.  483.70, Condition of 
participation: Infection prevention and control require each HHA to 
maintain and document an infection control program to prevent and 
control infections and communicable diseases. The HHA must follow 
accepted standards of practice, including the use of standard 
precautions to prevent the transmission of infections and communicable 
diseases. Thus, all HHA should already have infection prevent and 
control policies and procedures, but they likely do not comply with all 
of the requirements in this IFC.
    All HHAs would need to review their current policies and procedures 
and modify them to comply with all of the requirements in Sec.  
483.70(d), as set forth in this IFC. While we believe that many HHAs 
have already addressed COVID-19 vaccination with their staff, we have 
no reliable means to estimate that number. Therefore, we will assess 
the burden for these requirements for all 11,649 HHAs. We believe these 
activities would be performed by the RN and an administrator. According 
to Table 3, an RN in home health services total hourly cost is $73. 
Since there are not any current requirements that address COVID-19 
vaccination, we estimate it would require 8 hours for the RN to 
research, draft, and work with an administrator to finalize the 
policies and procedures. Thus, for each HHA, the burden for the RN 
would be 8 hours at a cost of $584 (8 hours x 73). For all 11,649 HHAs, 
the burden would be 93,192 hours (8 hours x 11,649) at an estimated 
cost of $6,803,016 (584 x 11,649).
    As discussed above, the revision and approval of these policies and 
procedures would also require activities by an administrator. The 
administrator would need to work with the RN to develop the policies 
and procedures, and then review and approve the changes. We estimate 
this would require 2 hours. According to Table 3, the total hourly cost 
for the administrator in home health services is $97. Hence, for each 
HHA, the burden would be 2 hours at an estimated cost of $194 (2 x 97). 
For all 11,649 HHAs, the total burden would be 23,298 hours (2 x 
11,649) at an estimated cost of $2,259,906 (11,649 x 194).
    Thus, the total burden for all 11,649 HHAs to comply with the 
policies and procedures requirements for policies and procedures is 
116,490 hours (93,192 + 23,298) at an estimated cost of $9,062,922 
(6,803,016 + 2,259,906).
2. Documentation and Storage
    Section 483.70(d) also requires HHAs to track and securely maintain 
the required documentation of staff COVID-19 vaccination status. Any 
burden for modifying the agency's policies and procedures for these 
activities is already accounted for above. We believe that this would 
require an RN 5 minutes or 0.0833 hours to perform the required 
documentation at adjusted hourly wage of $73 for each employee. 
According to Table 3, HHAs have 2,110,000 employees. Hence, the burden 
for these documentation requirements for all 11,649 HHAs would be 
175,763 (0.0833 x 2,110,000) hours at an estimated cost of $12,830,699 
(175,763 x 73).
    Therefore, the total burden for all 11,649 HHAs for this rule would 
be 292,253 (116,490 + 175,763) hours at an estimated cost of 
$21,893,621 (9,062,922 + 12,830,699).
    The requirements and burden will be submitted to OMB under OMB 
control number 0938-1299 (expiration date June 30, 2024).

I. ICRs Regarding the Development of Policies and Procedures for CORFs 
Sec.  485.70(n), ``COVID-19 Vaccination of Facility Staff''

1. Policies and Procedures
    At Sec.  485.70(n), we require CORFs to develop and implement 
policies and procedures to ensure their staff are vaccinated for COVID-
19 and that appropriate documentation of those vaccinations are tracked 
and maintained. Each CORF must also have a contingency plan for all 
staff not fully vaccinated according to this rule.
    The ICRs for this section would require each CORF to develop the 
policies and procedures needed to satisfy all of the requirements in 
this section. This IFC requires CORF staff to receive the COVID-19 
vaccine unless medically contraindicated as determined by a physician, 
advance practice registered nurse, or physician

[[Page 61594]]

assistant acting within their respective scope of practice as defined 
by and in accordance with all applicable State and local laws. Based 
upon our experience with CORFs, we believe some facilities have already 
developed policies and procedures requiring COVID-19 vaccination for 
staff unless medically contraindicated. However, each CORF will need to 
review their current policies and procedures and modify them, if 
necessary, to ensure compliance with the requirements in this IFC, 
especially that their policies and procedures cover all of the 
organization staff identified in this IFC. Hence, we will base our 
estimate for this ICR on all 159 CORFs. The CORF's governing body 
appoints an administrator who implements and enforces the facility's 
policies and procedures. Hence, we believe activities associated with 
this IFC would be performed by the administrator as analyzed below. The 
governing body would also need to review these policies and procedures, 
which would be included in its ``legal responsibility for establishing 
and implementing policies regarding the management and operation of the 
facility.''
    The administrator would conduct research to either modify or 
develop policies and procedures. For the administrator, we estimate 
this would require 8 hours initially to perform research and revise or 
develop the policies and procedures to meet these requirements. 
According to Table 3, the administrator's total hourly cost is $98. 
Thus, for each CORF, the burden for the administrator would be 8 hours 
at a cost of $784 (8 x 98). For the administrators in all 159 
organizations, the burden would be 1,272 hours (8 x 159) at an 
estimated cost of $124,656 (784 x 159).
    The administrator would need to spend time attending governing body 
meetings to discuss and obtain approval for the policies and 
procedures; however, that would be a usual and customary business 
practice. Therefore, activities for the administrator associated with 
governing body approval for the policies and procedures are exempt from 
the PRA in accordance with 5 CFR 1320.3(b)(2).
2. Documentation and Storage
    Section 485.70(n) also requires CORFs to track and securely 
maintain the required documentation of staff COVID-19 vaccination 
status. Any burden for modifying the facility's policies and procedures 
for these activities is already accounted for above. We believe that 
this would require an administrator 5 minutes or 0.0833 hours to 
perform the required documentation at adjusted hourly wage of $98 for 
each employee. According to Table 3, CORFs have 10,000 employees. 
Hence, the burden for these documentation requirements for all 159 
CORFs would be 833 (0.0833 x 10,000) hours at an estimated cost of 
$81,634 (833 x 98).
    Therefore, the total burden for all 159 CORFs for this rule would 
be 2,105 (1,272 + 833) hours at an estimated cost of $206,290 (124,656 
+ 81,634).
    The requirements and burden will be submitted to OMB under OMB 
control number 0938-1091 (expiration date November 30, 2022).

J. ICRs Regarding the Development of Policies and Procedures for CAHs 
Sec.  485.640(f), ``COVID-19 Vaccination of CAH Staff''

1. Policies and Procedures
    At Sec.  485.640(f), we require critical access hospitals (CAHs) to 
develop and implement policies and procedures to ensure their staff are 
vaccinated for COVID-19 and that appropriate documentation of those 
vaccinations are tracked and maintained. The CAH must also have a 
contingency plan for all staff not fully vaccinated according to this 
rule.
    The ICRs for this section would require each CAH to develop the 
policies and procedures needed to satisfy all of the requirements in 
this section. Current regulations at Sec.  485.640 Condition of 
participation: Infection prevention and control and antibiotic 
stewardship programs already require CAHs to have an infection 
prevention and control program (IPCP) and an infection preventionist 
(IP). The IPCP must have methods to prevent and control the 
transmission of infection within the hospital and between the hospital 
and other settings. Thus, all 1,358 CAHs should already have infection 
prevention and control policies and procedures. However, each CAH would 
need to review their current policies and procedures and modify them, 
if necessary, to ensure compliance with all of the requirements in this 
IFC, especially that their policies and procedures cover all of the 
eligible facility staff identified in this IFC. Based upon our 
experience with CAHs, we believe many CAHs have already developed 
policies and procedures requiring COVID-19 vaccination for staff. Since 
we have no reliable means to estimate the number of CAHs that may have 
already addressed COVID-19 vaccination of their staff, we will base our 
estimate for these requirements on all 1,358 CAHs.
    We believe these activities would be performed by the IP, the 
director of nursing (DON), and an administrator. The IP would need to 
research COVID-19 vaccines, modify the policies and procedures, as 
necessary, and work with the DON and administrator to develop the 
policies and procedures and obtain appropriate approval. For the IP, we 
estimate these activities would require 8 hours. According to Table 3, 
the IP's total hourly cost is $79. Thus, for each hospital, the burden 
for the IP would be 8 hours at a cost of $632 (8 hours x 79). For the 
IPs in all 1,358 CAHs, the burden would be 10,864 hours (8 hours x 
1,358) at an estimated cost of $858,256 (632 x 1,358).
    As discussed above, the revision and approval of these policies and 
procedures would also require activities by the DON and an 
administrator. We believe these activities would require 2 hours each 
for the DON and an administrator. According to Table 3, the total 
adjusted hourly wage for both the DON and an administrator is $122. 
Hence, for each CAH the burden would be 4 hours (2 x 2) at an estimated 
cost of $488 (4 x $122). The total burden for all 1,358 CAHs would be 
5,432 hours (4 x 1,358) at an estimated cost of $662,704 (1,358 x 488).
    Therefore, for all 1,358 CAHs the total burden for the requirements 
for policies and procedures is 16,296 hours (10,864 + 5,432) at an 
estimated cost of $1,520,960 ($858,256 + $662,704).
2. Documentation and Storage
    Section 485.640(f) also requires CAHs to track and securely 
maintain the required documentation of staff COVID-19 vaccination 
status. Any burden for modifying the CAH's policies and procedures for 
these activities is already accounted for above. Since we were unable 
to located a reliable number for CAH employees, the documentation 
burden for CAHs resulting from the documentation requirement in this 
rule is included in the hospitals' burden above.
    The requirements and burden for CAHs without DPUs will be submitted 
to OMB under OMB control number 0938-1043 (expiration date March 31, 
2024). The requirements and burden for CAHs with DPUs will be submitted 
to OMB under OMB control number 0938-0328(expired).

[[Page 61595]]

K. ICRs Regarding the Development of Policies and Procedures for 
Clinics, Rehabilitation Agencies, and Public Health Agencies as 
Providers of Outpatient Physical Therapy and Speech-Language Pathology 
Services (Organizations) Sec.  485.725(f), ``COVID-19 Vaccination of 
Organization Staff''

1. Policies and Procedures
    At Sec.  485.725(f), we require organizations to develop and 
implement policies and procedures to ensure their staff are vaccinated 
for COVID-19 and the appropriate documentation is tracked and 
maintained. The organization must also have a contingency plan for all 
staff not fully vaccinated according to this rule.
    The ICRs for this section would require each organization to 
develop the policies and procedures needed to satisfy all of the 
requirements in this section. Current regulations at Sec.  485.725(a) 
require organizations to establish an infection-control committee of 
representative professional staff with overall responsibility for 
infection control. This committee establishes policies and procedures 
for investigating, controlling, and preventing infections in the 
organization and monitors staff performance to ensure compliance with 
those policies and procedures. Based upon these requirements and our 
experience with organizations, we believe some organizations have 
already developed policies and procedures requiring COVID-19 
vaccination for staff unless medically contraindicated. However, since 
we have no reliable means to estimate how many organizations have done 
this, we will assess the burden for all 2,078 organizations. All 
organizations would need to review their current policies and 
procedures and modify them, if necessary, to ensure compliance with the 
requirements in this IFC.
    The types of therapists at each organization vary depending upon 
the services offered. For the purposes of determining the COI burden, 
we will assume that the therapist is a physical therapist. We believe 
activities associated with this IFC would be performed by a physical 
therapist and administrator. A physical therapist would need to conduct 
research on the COVID-19 vaccines and then develop or modify policies 
and procedures that comply with the requirements in this IFC. The 
physical therapist would need to work with an administrator to make the 
necessary revisions. For the physical therapist, we estimate this would 
require 8 hours to perform research and revise or develop the policies 
and procedures to meet these requirements. According to Table 3, the 
physical therapist's total hourly cost is $84. Thus, for each 
organization, the burden for the physical therapist would be 8 hours at 
a cost of $672 (8 x 84). For the physical therapists in all 2,078 
organizations, the burden would be 16,624 hours (8 x 2,078) at an 
estimated cost of $1,396,416 (672 x 2,078).
    As discussed above, the revision and approval of these policies and 
procedures would also require activities by the administrator. The 
administrator would need to have meetings with the physical therapist 
to discuss the revisions and draft any necessary policies and 
procedures, as well as approve the final policies and procedures. We 
estimate this would require 2 hours for the administrator. According to 
Table 3, the total hourly cost for the administrator is $98. The burden 
for the administrator in each organization would be 2 hours at an 
estimated cost of $196 (2 x 98). For the administrators in all 2,078 
organizations, the burden would be 4,156 hours (2 x 2,078) at an 
estimated cost of $407,288 (4,156 x 98).
    Therefore, for all 2,078 organizations, the total burden for the 
requirements for policies and procedures is 20,780 hours (16,624 + 
4,156) at an estimated cost of $1,803,704 (1,396,416 + 407,288).
2. Documentation and Storage
    Section 485.725(f) also requires organizations to track and 
securely maintain the required documentation of staff COVID-19 
vaccination status. Any burden for modifying the organization's 
policies and procedures for these activities is already accounted for 
above. We believe that this would require a physical therapist 5 
minutes or 0.0833 hours to perform the required documentation at 
adjusted hourly wage of $84 for each employee. According to Table 3, 
these organizations have 10,000 employees. Hence, the burden for these 
documentation requirements for all 2,078 organizations would be 833 
(0.0833 x 10,000) hours at an estimated cost of $69,972 (833 x 84).
    Therefore, the total burden for all 2,078 organizations for this 
rule would be 21,613 (20,780 + 833) hours at an estimated cost of 
$1,873,676 (1,803,704 + 69,972).
    The requirements and burden will be submitted to OMB under OMB 
control number 0938-0273 (expiration date June 30, 2024).

L. ICRs Regarding the Development of Policies and Procedures for CMHCs 
Sec.  485.904(c), ``COVID-19 Vaccination of Center Staff''

1. Policies and Procedures
    At Sec.  485.904(c), we require CHMCs to develop and implement 
policies and procedures to ensure their staff are vaccinated for COVID-
19 and that appropriate documentation of those vaccinations are tracked 
and maintained. Each facility must maintain documentation of their 
staff's vaccination status. Also, each facility must have a contingency 
plan for all staff not fully vaccinated according to this rule.
    The ICRs for this section would require each CHMC to develop the 
policies and procedures needed to satisfy all of the requirements in 
this section. Based upon our experience with CHMCs, we believe some 
centers have already developed policies and procedures requiring COVID-
19 vaccination for staff unless medically contraindicated. However, 
since we do not have a reliable means to estimate how many CMHCs have 
done so, we will estimate the burden based on all 129 CHMCs.
    Each CMHC will need to review their current policies and procedures 
and modify them, if necessary, to ensure compliance with the 
requirements in this IFC. Based on these requirements and our 
experience with CHMCs, we believe these activities would be performed 
by the CHMC administrator and a mental health counselor. The 
administrator would conduct research regarding the COVID-19 vaccines 
and then either modify or develop the policies and procedures necessary 
to comply with the requirements in this IFC. The administrator would 
send any recommendations for changes or additional policies or 
procedures to the mental health counselor. The administrator and mental 
health clinician would need to make the necessary revisions and draft 
any necessary policies and procedures. For the administrator, we 
estimate this would require 8 hours initially to perform research and 
revise or develop the policies and procedures to meet these 
requirements. According to Table 3, the administrator's total hourly 
cost is $113. Thus, for each CMHC, the burden for the administrator 
would be 8 hours at a cost of $904 (8 x 113). The burden for the 
administrators in all 129 CHMCs would be 1,032 hours (8 x 129) at an 
estimated cost of $116,616 (904 x 129).
    As discussed above, the revision and approval of these initial 
policies and procedures would also require activities

[[Page 61596]]

by the mental health counselor. The administrator would need to have 
meetings with the mental health counselor to discuss the revisions and 
draft any necessary policies and procedures. We estimate this would 
require 2 hours for the mental health counselor. According to Table 3, 
the total hourly cost for the mental health counselor is $118. The 
burden for the mental health counselor in each CHMC would be 2 hours at 
an estimated cost of $236 (2 x 118). For the mental health counselors 
in all 129 CMHCs, the burden would be 258 hours (2 x 129) at an 
estimated cost of $30,444 (129 x 236).
    Therefore, for all 129 CMHCs, the total burden for the requirements 
for policies and procedures is 1,290 hours (1,032 + 258) at an 
estimated cost of $147,060 (116,616 + 30,444).
2. Documentation and Storage
    Section 485.904(c) also requires CMHCs to track and securely 
maintain the required documentation of staff COVID-19 vaccination 
status. Any burden for modifying the center's policies and procedures 
for these activities is already accounted for above. We believe that 
this would require an administrator 5 minutes or 0.0833 hours to 
perform the required documentation at adjusted hourly wage of $113 for 
each employee. According to Table 3, CMHCs have 140,000 employees. 
Hence, the burden for these documentation requirements for all 129 
CMHCs would be 11,662 (0.0833 x 140,000) hours at an estimated cost of 
$1,317,806 (11,662 x 113).
    Therefore, the total burden for all 129 CMHCs for this rule would 
be 12,952 (1,290 + 11,662) hours at an estimated cost of $1,464,866 
(147,060 + 1,317,806).
    The requirements and burden will be submitted to OMB under OMB 
control number 0938-1245 (expiration date April 30, 2023).

M. ICRs Regarding the Development of Policies and Procedures for HIT 
Suppliers Sec.  486.525(c), ``COVID-19 Vaccination of Facility Staff''

1. Policies and Procedures
    Section 486.525(c) requires home infusion therapy (HIT) suppliers 
to develop and implement policies and procedures to ensure their staff 
are vaccinated for COVID-19 and that appropriate documentation of those 
vaccinations are tracked and maintained. The HIT supplier must also 
have a contingency plan for all staff not fully vaccinated according to 
this rule.
    The ICRs for this section would require each HIT supplier to 
develop the policies and procedures needed to satisfy all of the 
requirements in this section. Current regulations at Sec.  486.525 
already require that HIT suppliers provide their services in accordance 
with nationally recognized standards of practice. Thus, we believe most 
HIT suppliers should already have infection prevention and control 
policies and procedures, including COVID-19 vaccination. However, we 
have no reliable means to estimate how many suppliers have done so. 
Thus, we will base our burden estimate on all 337 HIT suppliers.
    All HIT suppliers would need to review their current policies and 
procedures and develop or modify them to comply with all of the 
requirements in Sec.  486.525(c) as set forth in this IFC. We believe 
these activities would be performed by the RN and an administrator 
working for the HIT supplier. According to Table 3, an RN working with 
for a HIT supplier would have a total hourly cost of $73. Since there 
are not any current requirements that address COVID-19 vaccination, we 
estimate it would require 8 hours for the RN to research, draft, and 
work with an administrator to finalize the policies and procedures. 
Thus, for each HIT supplier, the burden for the RN would be 8 hours at 
a cost of $584 (8 hours x 73). For all 337 HIT suppliers, the burden 
would be 2,696 hours (8 hours x 337) at an estimated cost of $24,601 
(337 x 73).
    The development and/or revision and approval of these policies and 
procedures would also require activities by an administrator. The 
administrator would need to work with the RN to develop the policies 
and procedures, and then review and approve the changes. We estimate 
this would require 2 hours. According to Table 3, the total hourly cost 
for the administrator working for a HIT supplier is $97. Hence, for 
each HIT supplier, the burden would be 2 hours at an estimated cost of 
$194 (2 x 97). For all 337 HIT suppliers, the total burden for the 
administrator would be 674 hours (2 hours x 337) at an estimated cost 
of $65,378 (337 x 194).
    Therefore, for all 337 HIT suppliers, the total burden for the 
requirements for policies and procedures is 3,370 hours (2,696 + 674) 
at an estimated cost of $89,979 (24,601 + 65,378).
2. Documentation and Storage
    Section 486.525(c) also requires HIT suppliers to track and 
securely maintain the required documentation of staff COVID-19 
vaccination status. Any burden for modifying the supplier's policies 
and procedures for these activities is already accounted for above. We 
believe that this would require an RN 5 minutes or 0.0833 hours to 
perform the required documentation at adjusted hourly wage of $73 for 
each employee. According to Table 3, HIT suppliers have 20,000 
employees. Hence, the burden for these documentation requirements for 
all 337 HIT suppliers would be 1,666 (0.0833 x 20,000) hours at an 
estimated cost of $121,618 (1,666 x 73).
    Therefore, the total burden for all 337 HIT suppliers for this rule 
would be 5,036 (3,370 + 1,666) hours at an estimated cost of $211,597 
(89,979 + 121,618).
    The requirements and burden will be submitted to OMB under OMB 
control number 0938-855B (expiration date March 31, 2024).

N. ICRs Regarding the Development of Policies and Procedures for RHCs 
and FQHCs Sec.  491.8(d), ``COVID-19 Vaccination of Staff''

1. Policies and Procedures
    At Sec.  491.8(d), we require RHCs/FQHCs to develop and implement 
policies and procedures to ensure their staff are vaccinated for COVID-
19 and that appropriate documentation of those vaccinations are tracked 
and maintained. Each RHC/FQHC must also have a contingency plan for all 
staff not fully vaccinated according to this rule.
    The ICRs for this section would require each RHC/FQHC to develop 
the policies and procedures needed to satisfy all of the requirements 
in this section. This IFC requires clinic or center staff to receive 
the COVID-19 vaccine unless medically contraindicated as determined by 
a physician, advance practice registered nurse, or physician assistant 
acting within their respective scope of practice as defined by and in 
accordance with all applicable State and local laws. Based upon 
experience with RHCs/FQHCs, we believe some clinics or centers have 
already developed policies and procedures requiring COVID-19 
vaccination for staff unless medically contraindicated. However, since 
we do not have a reliable means to estimate how many facilities have 
already done so, we will base the burden analysis for this estimate on 
all 15,317 RHC/FQHCs (4,933 RHCs and 10,384 FQHCs).
    Each RHC/FQHC will need to review their current policies and 
procedures and modify them, if necessary, to ensure compliance with the 
requirements in this IFC, especially that their policies and procedures 
cover all of the clinic or center staff identified in this IFC. Current 
regulations require a physician,

[[Page 61597]]

nurse practitioner, and physician assistant to participate in the 
development, execution, and periodic review of the policies and 
procedures.\222\ Moreover, the RHC/FQHC operates under the medical 
direction of a physician. Based on these requirements and our 
experience with RHCs/FQHCs, we believe activities associated with this 
IFC would be performed by the RHC administrator, physician, nurse 
practitioner, physician assistant, and medical director as analyzed 
below.
---------------------------------------------------------------------------

    \222\ 42 CFR 491.7.
---------------------------------------------------------------------------

    The administrator would conduct research to either modify or 
develop policies and procedures. The administrator would send any 
recommendations for changes or additional policies or procedures to the 
physician, nurse practitioner, and physician assistant. The 
administrator, physician, nurse practitioner, and physician assistant 
would need to make the necessary revisions and draft any necessary 
policies and procedures. The administrator would need to work with the 
medical director to obtain approval for the policies and procedures to 
be implemented. For the administrator, we estimate this would require 8 
hours initially to perform research and revise or develop the policies 
and procedures to meet these requirements. According to Table 3, the 
administrator's total hourly cost is $108. Thus, for each RHC/FQHC, the 
burden for the administrator would be 8 hours at a cost of $864 (8 x 
108). For the administrators in all 15,317 RHCs/FQHCs, the burden would 
be 122,536 hours (8 x 15,317) at an estimated cost of $13,233,888 (864 
x 15,317).
    As discussed above, the revision and approval of these initial 
policies and procedures would also require activities by the physician, 
nurse practitioner, physician assistant, and medical director. The 
administrator would need to have meetings with the physician, nurse 
practitioner, and physician assistant to discuss the revisions and 
draft any necessary policies and procedures. The administrator would 
also need to have meetings with the medical director to obtain approval 
for the policies and procedures. We estimate this would require 2 hours 
each for the physician, nurse practitioner, and physician assistant. 
For the medical director, we estimate 1 hour would be required to 
perform this function. According to Table 3, the total hourly cost for 
the physician is $212. The burden for the physician in each RHC/FQHC 
would be 2 hours at an estimated cost of $424 (2 x 212). For the 
physicians in all 15,317 RHCs/FQHCs, the burden would be 30,634 hours 
(2 x 15,317) at an estimated cost of $6,494,408 (424 x 15,317). The 
hourly cost for the nurse practitioner is $107. The burden for the 
nurse practitioner in each RHC/FQHC would be 2 hours at an estimated 
cost of $214 (2 x 107). For the nurse practitioners in all 15,317 RHCs/
FQHCs, the burden would be 30,634 hours (2 x 15,317) at an estimated 
cost of $3,277,838 ($214 x 15,317). The hourly cost for the physician 
assistant is $111. The burden for the physician assistant in each RHC/
FQHC would be 2 hours at an estimated cost of $222 (2 x 111). For the 
physician assistants in all 15,317 RHCs/FQHCs, the burden would be 
30,634 hours (2 x 15,317) at an estimated cost of $3,400,374 (15,317 x 
222). The hourly cost for the medical director is $212. The burden for 
the medical director in each RHC/FQHC would be 1 hour at an estimated 
cost of $212. For the medical directors in all 15,317 RHCs/FQHCs, the 
burden would be 15,317 hours (1 x 15,317) at an estimated cost of 
$3,247,204 (15,317 x 212).
    Therefore, for all 15,317 RHCs/FQHCs, the estimated burden 
associated with the policies and procedures requirement would be 
229,755 hours (122,536 + 30,634 + 30,634 + 30,634 + 15,317) at a cost 
of $29,653,712 (13,233,888 + 6,494,408 + 3,277,838 + 3,400,374 + 
3,247,204).
2. Documentation and Storage
    Section 491.8(d) also requires RHCs/FQHCs to track and securely 
maintain the required documentation of staff COVID-19 vaccination 
status. Any burden for modifying the clinic's or center's policies and 
procedures for these activities is already accounted for above. We 
believe that this would require an administrator 5 minutes or 0.0833 
hours to perform the required documentation at an adjusted hourly wage 
of $108 for each employee. According to Table 3, RHCs have 40,000 
employees and FQHCs have 110,000 employees for a total of 150,000 
employees. Hence, the burden for these documentation requirements for 
all 15,317 RHCs and FQHCs would be 12,495 (0.0833 x 150,000) hours at 
an estimated cost of $1,349,460 (12,495 x 108).
    Therefore, the total burden for all 15,317 RHCs and FQHCs for this 
rule would be 242,250 (229,755 + 12,495) hours at an estimated cost of 
$31,003,172 (29,653,712 + 1,349,460).
    The requirements and burden will be submitted to OMB under OMB 
control number 0938-0334 (expiration date March 31, 2023).

O. ICRs Regarding the Development of Policies and Procedures for ESRD 
Facilities Sec.  494.30(b), ``COVID-19 Vaccination of Facility Staff''

1. Policies and Procedures
    Section 494.30(b) requires the ESRD facilities to develop and 
implement policies and procedures to ensure their staff are vaccinated 
for COVID-19 and that appropriate documentation of those vaccinations 
are tracked and maintained. The ESRD facility must also have a 
contingency plan for all staff not fully vaccinated according to this 
rule.
    The ICRs for this section would require each ESRD facility to 
develop the policies and procedures needed to satisfy all of the 
requirements in this section. Current regulations at Sec.  494.30 
already require that ESRD facilities follow standard infection control 
precautions. Thus, all ESRD facilities should have infection prevention 
and control policies and procedures. We believe that many ESRD 
facilities have already addressed COVID-19 vaccination for their staff. 
However, we have no reliable means to estimate how many ESRD facilities 
have done so. Thus, we will base our burden estimate on all 7,893 ESRD 
facilities.
    All ESRD facilities would need to review their current policies and 
procedures and develop or modify them to comply with all of the 
requirements in Sec.  494.30(b) as set forth in this IFC. We believe 
these activities would be performed by the RN and an administrator. 
According to Table 3, an RN working with for an ESRD facility would 
have a total hourly cost of $73. Since there are not any current 
requirements that address COVID-19 vaccination, we estimate it would 
require 8 hours for the RN to research, draft, and work with an 
administrator to finalize the policies and procedures. Thus, for each 
ESRD facility, the burden for the RN would be 8 hours at a cost of $584 
(8 hours x $73). For all ESRD facilities, the burden would be 63,144 
hours (8 hours x 7,893) at an estimated cost of $4,609,512 (7,893 x 
584).
    The development and/or revision and approval of these policies and 
procedures would also require activities by an administrator. The 
administrator would need to work with the RN to develop the policies 
and procedures, and then review and approve the changes. We estimate 
this would require 2 hours. According to Table 3, the total hourly cost 
for the administrator at an ESRD facility is $97. Hence, for each ESRD, 
the burden for the administrator would be 2 hours at an estimated cost 
of $194 (2 x 97). For all ESRD facilities, the total burden would be 
15,786 hours

[[Page 61598]]

(2 x 7,893) at an estimated cost of $1,531,242 (7,893 x 194). Thus, the 
total burden for all ESRD facilities for the policies and procedures 
requirement would be 78,930 hours (63,144 + 15,786) at an estimated 
cost of $6,140,754 ($4,609,512 + $1,531,242).
2. Documentation and Storage
    Section 494.30(b) also requires ESRD facilities to track and 
securely maintain the required documentation of staff COVID-19 
vaccination status. Any burden for modifying the facility's policies 
and procedures for these activities is already accounted for above. We 
believe that this would require an RN 5 minutes or 0.0833 hours to 
perform the required documentation at an adjusted hourly wage of $73 
for each employee. According to Table 3, ESRD facilities have 170,000 
employees. Hence, the burden for these documentation requirements for 
all 7,893 ESRD facilities would be 14,161 (0.0833 x 170,000) hours at 
an estimated cost of $1,033,753 (14,161 x 73).
    Therefore, the total burden for all 7,893 ESRD facilities for this 
rule would be 93,091 (78,930 + 14,161) hours at an estimated cost of $ 
7,174,507 (6,140,754 + 1,033,753).
    The requirements and burden will be submitted to OMB under OMB 
control number 0938-0386 (expiration date March 31, 2024).
    Based upon the above analysis, the total burden for all of the ICRs 
in this IFC is 1,555,487 hours at an estimated cost of $136,088,221.
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BILLING CODE 4120-01-C
    If you comment on these information collection requirements, that 
is, reporting, recordkeeping or third-party disclosure requirements, 
please submit your comments electronically as specified in the 
ADDRESSES section of this IFC.
    Comments must be received on/by January 4, 2022.

V. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

VI. Regulatory Impact Analysis

A. Statement of Need

    The COVID-19 pandemic has precipitated the greatest public health 
crisis in the U.S. since the 1918 Influenza pandemic. The population of 
older adults, and LTC facility residents in particular, have been hard 
hit by the impacts of the pandemic. Among those infected, the death 
rate for older adults age 65 or higher was hundreds of time higher than 
for those in their 20s during 2020.\223\ Of the approximately 656,000 
Americans estimated to have died from COVID-19 through September 10, 
2021,\224\ 30 percent are estimated to have died during or after an LTC 
facility stay, although these numbers are decreasing as vaccination 
rates increase in residents and staff as shown in the CDC Data Tracker. 
Despite the recent nation-wide surge in infections from the Delta 
variant of COVID-19, uptake of vaccines and other measures (masking, 
screening visitors, and social distancing in particular) to prevent 
COVID-19, in combination with available therapeutic options to treat, 
has reduced COVID-19-related patient deaths in all settings. But 
reductions in COVID-19-related morbidity and mortality depend 
critically on continued success in vaccination of all health care staff 
and patients. The May 13, 2021 COVID-19 IFC (86 FR 26306) required 
offering vaccination to residents and staff, but did not mandate 
vaccination. Recently, however the Departments of Defense and Veterans 
Affairs staff, and civilian Federal Government employees have become 
subject to requirements similar to those imposed in this rule.\225\ 
This IFC will close a gap in current regulations for all categories of 
health care provider whose health and safety practices are directly 
regulated by CMS. Almost all CMS-regulated providers and suppliers 
disproportionately serve people who are older, disabled, chronically 
ill, or who have complex health care needs.\226\ Because the health 
care sector has such widespread and direct contact with hundreds of 
millions of patients, clients, residents, and program participants, the 
protective scope of this rule is far broader than the health care staff 
that it directly affects.
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    \223\ For updated data, see CDC daily updates of total deaths at 
https://www.cdc.gov/nchs/nvss/vsrr/COVID19/index.htm, and the Kaiser 
Family Foundation weekly updates on nursing home deaths at https://www.kff.org/coronavirus-covid-19/issue-brief/state-covid-19-data-and-policy-actions/, among other sources.
    \224\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
    \225\ https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5703.
    \226\ For data on the massive differences in healthcare usage by 
age, see the National Health Expenditure Date at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NHE-Fact-Sheet.
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B. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the

[[Page 61602]]

Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), 
Executive Order 13132 on Federalism (August 4, 1999), and the 
Congressional Review Act (5 U.S.C. 804(2)).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) Having an 
annual effect on the economy of $100 million or more in any 1 year, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with economically significant effects ($100 million or more in any 1 
year). We estimate that this rulemaking is ``economically significant'' 
as measured by the $100 million threshold, and hence also a major rule 
under the Congressional Review Act. Accordingly, we have prepared an 
RIA that, taken together with COI section and other sections of the 
preamble, presents to the best of our ability the costs and benefits of 
the rulemaking.
    This RIA focuses on the overall costs and benefits of the rule, 
taking into account vaccination uptake to date or anticipated over the 
next year that is not due to this rule, and estimating the likely 
additional effects of this rule on both provider staff and the patients 
with whom they come in contact. We analyze both the costs of the 
required actions and the payment of those costs. As intended under 
these requirements, this RIA's estimates cover only those costs and 
benefits that are likely to be the effects of this rule. There are also 
several unknowns that may affect current progress or this rule or both. 
These include the duration of strong vaccine protection with or without 
a booster shot and the possibility of new virus variants that reduce 
the effectiveness of currently authorized and approved vaccines. We 
cannot estimate the effects of each of the possible interactions among 
them, but throughout the analysis we point out some of the most 
important assumptions we have made and the possible effects of 
alternatives to those assumptions. The providers and suppliers 
regulated under this rule are diverse in nature, management structure, 
and size. That said, we believe that the costs faced by regulated 
entities will be very similar on a ``per person vaccinated'' basis. 
Tables 5 and 6 show the full scope of provider and supplier types, 
facility structures, and staff sizes, taking into account part-time 
staff (Table 5) and estimated staff turnover (Table 6). As explained 
earlier in the preamble, this rule includes facility contractors and 
consulting specialists as well as other persons providing part-time or 
occasional services to these providers and suppliers and their 
patients.
    In Table 5 we provide a rough estimate of the likely number of 
full-time employees and other employees and contractors subject to this 
rule. The ``total staff'' number in the rightmost column is the number 
of individual staff directly affected at the time this rule takes 
effect (adding the number of full-time employees to the number of part-
time employees, contractors, and other business persons who have 
recurring patient or staff interactions).
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[GRAPHIC] [TIFF OMITTED] TR05NO21.029

BILLING CODE 4120-01-C
    This rule presents additional difficulties in estimating both costs 
and benefits due to the high degree to which all current provider and 
supplier staff

[[Page 61604]]

have already received information about the benefits and safety of 
COVID-19 vaccination, and the rare serious risks associated with it. 
Despite this progress, the proportion of fully vaccinated health care 
staff has approached but not hit the 70 percent with significant 
variation among states. Moreover, among the general population more 
than 600,000 persons a day are currently being vaccinated with the 
first or second shot and about 100,000 a day have recovered from 
infection and are only in very rare cases still infectious. These 
changes reduce the risk to both health care staff and patients 
substantially, likely by about 20 million persons a month who are no 
longer sources of future infections.\227\ This in turn reduces the 
number of newly infected cases (currently about 100,000 a day and 
decreasing rapidly). Yet another variable of importance is the 
increasing number of providers and suppliers that are mandating 
employee vaccination, and the increasing number of states that are 
doing so as well. To characterize the baseline scenario of no new 
regulatory action, from which we estimate the incremental impacts of 
the interim final rule, we assume that when Phase 1 of this IFC goes 
into effect, 75 percent of provider staff, 90 percent of LTC facility 
residents, and 80 percent of all other patients and clients will have 
been vaccinated, and that these rates will improve over time as a 
result of both this rule and the other factors previously 
discussed.\228\
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    \227\ These data are taken from or calculated from the CDC COVID 
Data Tracker. For example, in recent weeks the number of new daily 
cases has been gradually decreasing from about 150,000 to about 
90,000. Once the disease runs its course, almost all these people 
will have recovered. Hence, we use the rough estimate that about 
100,000 a day have recovered in recent weeks.
    \228\ Among long term care residents, the vaccinated percentage 
is now very close to 90 percent, but other categories of patients 
are undoubtedly lower. That said, patients are heavily age-skewed 
towards higher ages where vaccination percentages are higher.
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    These numbers leave a large range for the likely effects of this 
rule over time. They do indicate, however, that many cases of death or 
severe illness can be prevented by increasing the number of vaccinated 
persons, both for those vaccinated and for others they might otherwise 
infect. As estimated in Table 6, the number of unvaccinated health care 
workers still remains in the millions despite recent progress. As 
discussed later in this analysis, we use the concept of the value per 
statistical life and per statistical case to capture this major 
potential benefit, as recommended by the Office of the Assistant 
Secretary for Planning and Evaluation based on standard practices in 
cost-benefit analysis.\229\
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    \229\ See ``Valuing COVID-19 Mortality and Morbidity Risk 
Reductions in U.S. Department of Health and Human Services 
Regulatory Impact Analyses, https://aspe.hhs.gov/reports/valuing-covid-19-risk-reductions-hhs-rias.
---------------------------------------------------------------------------

    One additional factor affecting our estimates is remaining life 
expectancy. Life expectancy varies by age, being about 40 years across 
an entire population, close to 80 years for a younger population, and a 
relatively fewer number of years for an older population. These 
numbers, of course, are overall averages and mask substantial 
differences by race and sex (among other factors), including access to 
affordable health care and prevalence of untreated or insufficiently 
controlled disease. Individuals with diabetes, for example, are 
disproportionately African American and disproportionately older, which 
leads to greater risks from kidney failure and other adverse health 
effects, including greater susceptibility to the ravages of COVID-
19.\230\ Health care staff of most types of providers and suppliers are 
of typical working ages. But hospital patients, LTC facility residents, 
ESRD patients treated for kidney failure, and most other patients are 
heavily weighted towards older ages and are disproportionately members 
of African American and Native American minority groups. This means 
that the morbidity and mortality reductions from this rule when they 
are adjusted for the age ranges affected disproportionally benefit 
racial minorities.
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    \230\ For an NIH summary of the racial disparities, see https://www.niddk.nih.gov/health-information/kidney-disease/race-ethnicity.
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    In particular, LTC facility residents are near the upper end of the 
age spectrum. For a statistically average LTC facility resident, the 
average pre-COVID-19 life expectancy if death occurs while in the 
facility is likely to be on the order of 3 years or fewer but taking 
into account residents who recover and leave the facility and those 
enrolled for skilled nursing services we estimate overall life 
expectancies to be about 5 years.\231\ We also estimate that 
vaccination reduces the chance of infection by about 95 percent, and 
the risk of death from the virus to a fraction of 1 percent.\232\ In 
Israel, of the first 2.9 million people vaccinated with two doses there 
were only about 50 infections involving severe conditions resulting 
from the virus after the 14th day and of these so few deaths that they 
were not reported in statistical summaries. These data also show that 
COVID-19 vaccines are effective for both older and younger recipients. 
Of those who have received a full primary vaccine series, after the 
14th day after vaccination only 46 people over the age of 60 became 
infected and had a severe case, compared to 6 people under the age of 
60. Given that these numbers are compared against 2.9 million 
recipients of the second dose, both rates are near zero.\233\
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    \231\ At age 80, the average life expectancy of a male is about 
8 years and of females about 10 years, or an overall average of 
about 9 years. Long term care nursing home residents, however, have 
shorter life expectancies because they have severe health problems 
or would not have been admitted to a facility. For those who remain 
in a facility until death the average life expectancy is about 2 
years. But some recover and leave so we have used 5 years as a 
reference point. See discussion at David B. Reuben, ``Medical Care 
for the Final Years of Life: When you're 83, It's not going to be 20 
years,'' JAMA, Dec. 23, 2009, 2686-2694.
    \232\ For patients in skilled nursing facilities, average length 
of stay is less than a month. Hence, turnover is far higher.
    \233\ See Dvir Aran, Estimating real-world COVID-19 vaccine 
effectiveness in Israel using aggregated counts, medRxiv, February 
28, 2021, at https://www.medrxiv.org/content/10.1101/2021.02.05.21251139v3.full.pdf and Noa Dagan et al, ``BNT162b2 mRNA 
Covid-19 Vaccine in a Nationwide Mass Vaccination Setting,'' The New 
England Journal of Medicine, 2/24/2021, at https://www.nejm.org/doi/full/10.1056/NEJMoa2101765.
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C. Anticipated Costs of the Interim Final Rule With Comment Period

    We note that our cost estimates assume that all additional 
vaccination costs for providers and suppliers regulated by this rule 
are due to this rule. We estimate on this basis because we have no 
reliable way to estimate how much of these costs might be equally due 
to independent employer decisions, to other Federal standards, to State 
and local mandates, or even to individual personal choices.
    In our cost estimates we cover all providers regulated by CMS for 
health and safety standards, but we often use LTC facilities for 
examples because they pose some of the greatest risks for COVID-19 
morbidity and mortality. As documented subsequently in this analysis 
and in a research report on this issue, about 1.5 million individuals 
work in LTC facilities at any one time.\234\ A number of these 
individuals work in multiple LTC facilities which may play additional 
roles in transmission.235 236 These individuals are at high 
risk both to become ill with COVID-19 and to transmit the SARS-

[[Page 61605]]

CoV-2 virus to residents or visitors, or among themselves. Far more 
than most occupations, LTC facility work requires sustained close 
contact with multiple persons daily.
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    \234\ Kaiser Family Foundation, COVID-19 and Workers at Risk: 
Examining the Long-Term Care Workforce, April 23, 2020, at https://www.kff.org/coronavirus-covid-19/issue-brief/covid-19-and-workers-at-risk-examining-the-long-term-care-workforce/.
    \235\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267626/.
    \236\ https://www.anderson.ucla.edu/faculty_pages/keith.chen/papers/WP_Nursing_Home_Networks_and_COVID19.pdf.
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    In Table 6 we present estimates of total numbers of staff 
individuals regulated under this rule, distinguishing between numbers 
at the beginning of a year and at any one time during the year, versus 
the much higher numbers when turnover is considered. In Table 6 we 
assume that the number departing each year is the same as the number 
entering each year, which is a reasonable approximation to changes in 
just a few years, but do not take account of the aging of the 
population over time. We note that our estimates do not include a 
deduction for the overlap among individuals who work in more than one 
LTC facility. We know that this number is substantial, but have no 
basis for estimating its precise magnitude and, more importantly, how 
it may change after this rule goes into effect and facilities change 
their staffing and hiring patterns. One recent study found about 17% of 
LTC nursing staff held second jobs, and another recent study found that 
about 5% held more than one LTC job. The second study, moreover, found 
that facilities with substantial staff sharing were disproportionally 
associated with as many as 49% of nursing home COVID-19 cases.\237\
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    \237\ See Courtney Harold Van Houtven, Nicole DePasquale, and 
Norma B. Coe, ``Essential Long-Term Care Workers Commonly Hold 
Second Jobs and Double- or Triple-Duty Caregiving Roles,'' Journal 
of the American Geriatrics Society, 27 April 2020, at https://agsjournals.onlinelibrary.wiley.com/doi/full/10.1111/jgs.16509 and 
M. Keith Chen, Judith A. Chevalier, and Elisa F. Long, ``Nursing 
home staff networks and COVID-19,'' PNAS, January 5, 2021, at 
https://www.pnas.org/content/118/1/e2015455118.
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BILLING CODE 4120-01-C
    These figures are approximations, because none of the data that is 
routinely collected and published on resident populations or staff 
counts focus on numbers of individuals residing or working in the 
facility during the course of a year or over time. Depending on the 
average length of stay (that is, turnover) in different facilities,

[[Page 61607]]

an average population at any one time of, for example, 100 persons 
could be consistent with radically different numbers of individuals, 
such as 112 individuals in one facility if one person left each month 
and was replaced by another person, compared to 365 if one person left 
each day and was replaced that same day by another person.
    As a specific example, we assume that about 90 percent of existing 
LTC facility residents and 75 percent of existing staff will have been 
vaccinated by the date Phase 1 of this IFC takes effect (we use the 
same or similar assumptions for all provider types). There will be many 
new persons in each category during the first full year of the 
regulation, and likely almost all of these will have been vaccinated 
elsewhere (for simplicity we also assume a base rate 95 percent for 
this group, almost all of whom will have previously worked in a health 
care facility requiring vaccination).
    As presented in the third numeric column of Table 6, the total 
number of employees or otherwise compensated individuals working in all 
these different facilities over the course of a year is about 13 
million persons, which is almost half again larger than the annual 
average number of staff shown in the first numeric column. A recent 
study, using data from detailed payroll records, found that median 
turnover rates for all nurse staff in long term care facilities is 
approximately 90 percent a year, although other estimates are far lower 
(see subsequent discussion).\238\ We have not seen figures this high 
for other provider types but some may approach this level--home health 
care is well known for high turnover rates.\239\ Of course, most of 
these persons will have been vaccinated through other means when they 
enter the facilities during the next year. That said, it is likely that 
there will be approximately 2.4 million staff at the beginning or 
during the first year after this rule is published who will require 
vaccination (rightmost column of Table 6), possibly preceded in some 
cases by counseling efforts or employer inducements.
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    \238\ Ashvin Gandhi et al, ``High Nursing Staff Turnover In 
Nursing Homes Offers Important Quality Information,'' Health 
Affairs, March 2021, pages 384-391.
    \239\ Ashvin Gandhi et al, ``High Nursing Staff Turnover In 
Nursing Homes Offers Important Quality Information,'' Health 
Affairs, March 2021, pages 384-391. Published estimates vary widely. 
For example, two recent sources said home health care staff turnover 
is about 65 percent. See https://www.hcaoa.org/newsletters/caregiver-turnover-rate-is-652-2021-home-care-benchmarking-study and 
https://www.leadingage.org/sites/default/files/Direct%20Care%20Workers%20Report%20%20FINAL%20%282%29.pdf.
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    While this IFC does not expressly require COVID-19 vaccine 
counseling or education, we anticipate that some providers and 
suppliers will conduct such activities as a part of their procedures 
for ensuring compliance with the provisions of this rule. Some staff 
counseling can take place in group settings and some will take place on 
a one-to-one level. What works best will depend on the circumstance of 
the employee and the best method for conveying the information and 
answering questions. Staff education, using CDC or FDA materials, can 
also take place in various formats and ways. Individualized counseling, 
staff meetings, posters, bulletin boards, and e-newsletters are all 
approaches that can be used. Informal education may also occur as staff 
go about their daily duties, and some who have been vaccinated may 
promote vaccination to others. Facilities may find that reward 
techniques, among other strategies, may help. For example, monetary or 
other benefits such as paid days off could be given to staff who agree 
to vaccination. Even simpler, the employer can bring vaccination 
providers onsite to vaccinate staff (or both staff and unvaccinated 
patients). Of importance in such efforts, the value of immunization as 
a crucial component of keeping patients healthy and well is already 
conveyed to staff about influenza and pneumococcal vaccines. COVID-19 
vaccine persuasion can build upon that knowledge. The most important 
inducement will be the fear of job loss, coupled with the examples set 
by fellow vaccine-hesitant workers who are accepting vaccination more 
or less simultaneously.
    One hundred percent success is unlikely. The HHS Guidelines for 
Regulatory Impact Analysis note that ``[i]n most cases, the analysis 
focuses on estimating the incremental compliance costs incurred by the 
regulated entities, assuming full compliance with the regulation, and 
government costs.'' These guidelines further recommend that 
``[a]nalysts should consider the uncertainty associated with an 
assumption of full compliance and provide analysis of alternative 
assumptions, as appropriate.'' \240\ In preparing this analysis, we 
have identified several significant sources of uncertainty for these 
full-compliance estimates, one of which stands out.
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    \240\ At https://aspe.hhs.gov/sites/default/files/private/pdf/242926/HHS_RIAGuidance.pdf, page 24.
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    If only one health care provider in an area required staff 
vaccination, then those who refuse vaccination could quit and obtain 
employment at another location in the same field or type of 
position.\241\ But with many employers already mandating vaccination, 
and with nearly all local (and distant) health care employers requiring 
vaccination under this rule, we expect that such effects will be 
minimized (with exceptions for medical or other exemptions as required 
by law). That said, currently there are endemic staff shortages for 
almost all categories of employees at almost all kinds of health care 
providers and supplier and these may be made worse if any substantial 
number of unvaccinated employees leave health care employment 
altogether. In this regard, we note that because CMS does not regulate 
health and safety in physician and dental offices, or in non-health 
care settings such as assisted living facilities, those entities may 
provide alternative places of employment for some of the staff 
currently working for providers and suppliers subject to this IFC who 
refuse vaccinations. On the other hand, staff shortages might be offset 
by persons returning to the labor market who were unwilling to work at 
locations where some other employees are unvaccinated and hence provide 
some risk, to those who have completed the primary vaccination series 
for COVID-19. Despite these uncertainties, we have developed an 
estimate of staffing disruption costs, primarily to provide a complete 
cost picture even if this element is particularly uncertain. We note 
that these costs and benefits are highly dependent on whether, for 
example, staff vaccination refusals in coming months are closer to 1 
percent than to 10 percent, and the extent to which increased 
confidence in the safety of working in a health care setting leads to 
offsetting increases in the return of former health care employees to 
the workforce. Both variables, in turn, may depend in significant ways 
on the overall labor market and on the ability of telehealth measures 
to replace in-person staff to patient encounters. The net outcomes of 
staff turnover over time could easily exceed or offset the 
administrative and vaccination costs we have estimated. We welcome 
comments and information on these issues.
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    \241\ See https://www.washingtonpost.com/local/covid-vaccine-mandate-hospitals-virginia/2021/10/01/b7976d16-21ff-11ec-8200-5e3fd4c49f5e_story.html, and .
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    The techniques for staff counseling, education, and incentives are 
so numerous and varied that there is no simple way to estimate likely 
costs. Staff hesitancy may and likely will change over time as the 
benefits of vaccination become clear to increasing numbers of 
individuals working in health care

[[Page 61608]]

settings. For purposes of estimation, we assume that, on average, one 
hour of staff time or the equivalent will be devoted to counseling or 
incentives for each unvaccinated staff person, at the same average 
hourly cost of about $75 estimated for RNs in the Information 
Collection analysis. We assume that these efforts occur during paid 
working hours and that all costs will be borne by the facility. Since 
we estimate that about 2.4 million employees will need to be vaccinated 
(or replaced) in the first year (rightmost column of Table 6), most in 
the first two months after this rule is published, total costs would be 
about $180 million. This estimate assumes that the 2.4 million will be 
some mix of existing and replacement staff. For example, if 95% of the 
existing unvaccinated staff were vaccinated, and 5% of the unvaccinated 
staff terminated, then in addition to the normal turnover of 2.7 
million new hires (second column of Table 6) an additional 114 thousand 
(.05 x 2,270) persons would need to be hired, with 95% of them already 
fully vaccinated and the remainder getting vaccinated as a condition of 
hiring. For purposes of this estimate we ignore the existence of 
exemptions.
    A third major cost component of compliance with this IFC is the 
vaccination, including both administration and the vaccine itself. We 
estimate that the average cost of a vaccination is what the government 
pays under Medicare: $20 x 2 = $40 for two doses of a vaccine, and $20 
x 2 for vaccine administration of two doses, for a total of $80 per 
employee. For purposes of estimation (and not reflecting any more 
knowledge than recent press accounts), we further assume that there 
will be a ``booster'' shot at the same cost, for a total vaccination 
cost of $120 per employee. While these vaccine costs are currently 
incurred by the Federal Government, we include them to provide an 
estimate of total costs, regardless of who pays. In addition, we expect 
that a significant amount of time--one hour on average--will be used 
per employee in vaccine planning, arrangement, and administration, and 
related activities for three vaccinations per currently unvaccinated 
employee. Together with the additional assumption that there will be an 
hour RN time or the equivalent needed for arranging or administering 
vaccination, at an average cost for that hour of $75, the total cost 
for vaccination compliance will be $195 per employee. We apply that 
cost to all currently unvaccinated employees. Like counseling and 
incentives, if 5% of the existing unvaccinated staff leave and are 
replaced by a slightly higher number of new hires than would otherwise 
be needed, a roughly equivalent fraction of the new hires will need to 
be vaccinated before they have patient contact. As a result, we 
estimate the total costs of vaccination to be approximately $466 
million (2,390,000 unvaccinated employees x $195). We note again that 
these estimates do not reflect the factor that multiple vaccine 
mandates already do or will soon apply to many and perhaps most 
providers covered by our rule (employers' own self-imposed mandates, 
State and local mandates, and OSHA ETS, among others). This means the 
costs of this rule are overestimated due to this factor, a conservative 
assumption.
    Our fourth and final major cost category is staffing and service 
disruptions. As discussed previously, it is possible there may be 
disruptions in cases where substantial numbers of health care staff 
refuse vaccination and are not granted exemptions and are terminated, 
with consequences for employers, employees, and patients. We do not 
have a cost estimate for those, since there are so many variables and 
unknowns, and it is unclear how they might be offset by reductions in 
current staffing disruptions caused by staff illness and quarantine 
once vaccination is more widespread. We believe, however, that the 
disruptive forces are weaker than the return to normality. As shown in 
Table 6, it is normal for there to be roughly 2.66 million new hires 
(column two) in the health care settings we address in this rule, 
compared to a baseline of roughly 10.4 million staff (column one). 
These new hires replace a roughly equal number of employees leaving for 
one reason or another. Health care providers are already in the 
business of finding and hiring replacement workers on a large scale. 
The terminated or self-terminated workers are not going to disappear. 
They still need to earn a living. Many of the non-clinical staff may 
will find employment situations in settings that are not subject to 
vaccination mandates. Cooks, for example, may migrate to restaurant 
jobs. But in those cases, a cook who would otherwise have been hired by 
a restaurant may find a newly vacant health care position requiring 
vaccination and accept (or more likely already have) vaccination. 
Similarly, nurses may find jobs in health care settings that are not 
subject to vaccination mandates, such as most schools or physician 
offices. But that means that nurses who would otherwise have been hired 
in schools or physician offices may find jobs in vacant jobs in health 
care settings requiring vaccination and accept (or more likely already 
have) vaccination. In a dynamic labor market such behaviors occur 
continuously on a massive scale. If net employment opportunities and 
job-seeking behaviors do not change (and there is no reason to believe 
they will), these continuous adjustments will leave health care 
providers and suppliers subject to this rule with their desired staff 
levels, and former employees who refused vaccination in jobs that do 
not require vaccination. Because job seeking and worker seeking are 
already operating on a massive scale in the health care sector, there 
is no reason to expect any massive new costs in such routine functions 
as advertising jobs, checking applicant employment history, 
familiarizing new employees with the nuances of the new employment 
setting, training, and all the other steps and costs involved in the 
normal workings of the labor market.
    As an example of the likely magnitude of hiring costs, one analysis 
of direct hiring costs for workers in the long-term care sector 
(including LTC facilities, home health care, and ICFs-IID) found that 
the direct costs of hiring new workers was on average about $2,500 in 
2004.\242\ Assuming that this amount should be raised to $4,000 based 
on inflation since then, that a comparable estimate for higher skills 
health care professions would be $6,000, and that health care workers 
covered by this rule are half lower skilled and half higher skilled, 
the recruitment and hiring cost for additional hires equal to 5 percent 
of the normal annual hiring total of 2.4 million workers would be $600 
million (an average of $5,000 x 120,000). (Costs could actually be 
lower because this study is almost a decade old and internet services 
have in recent years made recruitment and job application procedures 
far easier.)
---------------------------------------------------------------------------

    \242\ Dorie Seavey, The Cost of Frontline Turnover in Long-Term 
Care,'' Better Jobs Better Care Report, Washington, DC: Institute 
for the Future of Aging Services, American Association of Homes and 
Services for the Aging. 2004.
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    An additional cost category may result from COVID-19-related staff 
shortages, discussed extensively earlier in this IFC. Although, as 
noted earlier, COVID-related staff shortages are occurring absent the 
rule due to numerous factors, such as infection, quarantine and staff 
illness. Shortages at their most acute prevent facilities from 
admitting as patients, clients, residents, or participants persons they 
would normally admit for treatment of diseases or conditions that would 
in many cases result in death or serious disability. We

[[Page 61609]]

are not aware of any data that would enable a reasonably accurate 
estimate of the total medical morbidity and mortality involved, but it 
is certainly massive. While it is true that compliance with this rule 
may create some short-term disruption of current staffing levels for 
some providers or suppliers in some places, there is no reason to think 
that this will be a net minus even in the short term, given the 
magnitude of normal turnover and the relatively small fraction of that 
turnover that will be due to vaccination mandates. Moreover, the 
benefits of vaccination are not just the lives directly saved, but the 
resources that vaccination frees up because hospital, LTC facility, and 
rehabilitation beds are now available and because health care staff 
themselves are not being incapacitated or killed by COVID-19 infection. 
The data on cumulative COVID-19 cases among health care personnel show 
677,000 cases (most of which incapacitated workers at least 
temporarily), and 2,200 deaths, all of which permanently eliminated 
those workers as sources of future care.\243\
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    \243\ CDC Data Tracker, October 17, 2021 data, at https://covid.cdc.gov/covid-data-tracker/#health-care-personnel.
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    Table 7 shows all of the costs that we have estimated. As 
previously explained, much and perhaps most of these costs would be 
incurred under other concurrent mandates, including employer-specific 
decisions, other Federal standards, and some State and local government 
mandates. Since these efforts overlap in scope, reach, and timing, 
there is no basis for assigning most of these costs to this rule or any 
other similar rule.
[GRAPHIC] [TIFF OMITTED] TR05NO21.031

    There are major uncertainties in these estimates. One obvious 
example is whether vaccine efficacy will last more than the 
approximately 1 year proven to date and whether boosters are 
needed.\244\ Some in the scientific community believe that ``booster'' 
vaccinations after 6 or 8 months would be desirable to maintain a high 
level of protection against the predominant Delta version of the virus. 
Delta may be overtaken by other virus mutations, which creates another 
uncertainty. Booster vaccination or use of vaccines whose licenses or 
EUAs have been amended to address new variants would likely maintain 
the effectiveness of vaccination for residents and staff. At this time, 
as to second (and succeeding) year effects we assume no further major 
changes in vaccine effectiveness. Yet another uncertainty is treatment 
costs, with a recently announced antiviral pill that could potentially 
provide substantial reductions in severity of illness and subsequent 
treatment costs, on a time schedule as yet unknown.\245\
---------------------------------------------------------------------------

    \244\ For a discussion of this issue, see Sumathi Reddy, ``How 
Long Do Covid-19 Vaccines Provide Immunity?'', The Wall Street 
Journal, April 13, 2021, at https://www.wsj.com/articles/how-long-do-covid-19-vaccines-provide-immunity-11618258094.
    \245\ See Rebecca Robbins, ``Merck Says It Has the First 
Antiviral Pill Found to Be Effective Against Covid,'' The New York 
Times, October 1, 2021.
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D. Anticipated Benefits of the Interim Final Rule With Comment Period

    There will be more than 180 million staff, patients, and residents 
employed or treated each year in the facilities covered by this rule. 
In our analysis of first-year benefits of this rule we focus first on 
prevention of death among staff of facilities as well as on reduction 
in disease severity. Second, we focus on resulting benefits from 
avoiding infection by unvaccinated staff among patients served in these 
facilities, who are likely to benefit more substantially because 
patients receiving health care in such facilities are 
disproportionately older than working age adults and are therefore more 
susceptible to severe illness or death from COVID-19. A third group of 
beneficiaries are staff family members and caregivers and many other 
persons outside the health care settings who staff might subsequently 
infect if not vaccinated. We focus initially on LTC facilities because 
their residents and patients have been among the most severely affected 
by COVID-19 as well as illustrating all the estimating issues involved, 
but the same estimates, uncertainties, and calculations apply to all 
types of providers and suppliers in varying degrees.
    HHS's Guidelines for Regulatory Impact Analysis outline a standard 
approach to valuing the health benefits of regulatory actions. The 
approach for valuing mortality risk reductions is based on the value 
per statistical life (VSL), which estimates individuals' willingness to 
pay (WTP) to avoid fatal risks. The approach to valuing morbidity risk 
reductions is based on measures of the WTP to avoid non-fatal risks 
when specific estimates are available, and based on measures of the 
duration and severity of the illness, including quality of life 
consequences, when suitable WTP estimates are not available.\246\ Based 
on this approach, the Office of the Assistant Secretary for Planning 
and Evaluation published a report that develops an approach for valuing 
COVID-19 mortality and morbidity risk reductions.
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    \246\ As noted above, various populations are directly or 
indirectly affected by this rule. Lessened risk to patients due to 
staff vaccination, especially in a setting such as a LTC facility, 
is arguably an externality (a canonical market failure), and thus 
use of a VSL or VSLY estimate per avoided fatality or life extension 
does not represent a divergence from the concept of revealed 
preference. On the other hand, staff members' own risk raises the 
question of how to interpret their hesitation or unwillingness, in 
the absence of regulation, to accept an intervention that achieves 
extensive health protection for themselves, with little or no out-
of-pocket cost, and ever-lessening time or inconvenience cost; a 
simplistic revealed-preference monetization of the rule's effect 
would be that it yields minimal or negative benefits for such staff 
members, even the ones for whom it prevents or reduces severity of 
COVID-19 infection. However, given the dynamic nature of the 
pandemic, it may be that long-run equilibrium for COVID-19 vaccines 
has not been reached, in which case the simplistic approach just 
mentioned may be misleading--and the use of a standard VSL or VSLY 
for staff-member risk evaluation may reflect misunderstandings of 
either vaccine risks or vaccine benefits.

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[[Page 61610]]

    In addition to the avoided death and human suffering, one of the 
major benefits of vaccination is that it lowers the cost of treating 
the disease among those who would might otherwise be infected and have 
serious morbidity consequences. The largest part of those costs is for 
hospitalization. As discussed later in the analysis we provide data on 
the average costs of hospitalization of these patients (it is, however, 
unclear as to how much that cost will change over time due to improving 
treatment options).
    There is a potential offset to benefits that we have not estimated 
because we believe it is at this time not relevant in the U.S. If 
vaccine supplies did not meet all demands for vaccination, giving 
priority to some persons over others necessarily meant that some 
persons would become infected who would not have been infected had the 
priorities been reversed. In this case, however, the priority for older 
adults (virtually all of whom have risk factors) who comprise the 
majority of hospital inpatients and the vast majority of LTC facility 
residents has already been established and is largely met. This rule 
provides a priority for staff at a far lower risk of mortality and 
severe disease that benefits both groups.\247\ It achieves this benefit 
because by preventing the spread of COVID-19 from provider and supplier 
staff, it actually provides a higher mortality and morbidity reduction 
for patients at far higher risk than the staff who become 
vaccinated.\248\
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    \247\ The risk of death from infection from an unvaccinated 75- 
to 84-year-old person is 320 times more likely than the risk for an 
18- to 29-years old person. CDC, ``Risk for COVID-19 Infection, 
Hospitalization, and Death by Age Group'', at https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-age.html.
    \248\ We note that as long as most of the world's population 
remains unvaccinated, another variant of the vaccine might arise and 
create new risks or shifts in risks within the U.S. That said, the 
world-wide shortage of vaccines is essentially over taking into 
account both stocks and existing manufacturing capacity and the 
biggest problem abroad is getting the available vaccines rapidly 
into the billions of people who need them.
---------------------------------------------------------------------------

    The HHS ``Guidelines for Regulatory Impact Analysis'' explain in 
some detail the concept of Quality Adjusted Life Years (QALYs).\249\ 
QALYs, when multiplied by a monetary estimate such as the Value of a 
Statistical Life Year (VSLY), are estimates of the value that people 
are willing to pay for life-prolonging and life-improving health care 
interventions of any kind (see sections 3.2 and 3.3 of the HHS 
Guidelines for a detailed explanation). The QALY and VSLY amounts used 
in any estimate of overall benefits are not meant to be precise, but 
instead are rough statistical measures that allow an overall estimate 
of benefits expressed in dollars.
---------------------------------------------------------------------------

    \249\ https://aspe.hhs.gov/pdf-report/guidelines-regulatory-impact-analysis.
---------------------------------------------------------------------------

    Under a common approach to benefit calculation, we can use a Value 
of a Statistical Life (VSL) to estimate the dollar value of the life-
saving benefits of a policy intervention, for a person who more broadly 
represent a mixture of ages. We use the VSL of approximately $11.5 
million in 2021 as described in the HHS Guidelines, adjusted for 
changes in real income and inflated to 2020 dollars using the Consumer 
Price Index.\250\ Using LTC facilities as an example, and assuming that 
the average rate of death from COVID-19 (following SARS-CoV-2 
infection) at typical LTC facility resident ages and conditions is 5 
percent, and the average rate of death after vaccination is essentially 
zero, the expected value of each resident who would, in the absence of 
this rule, otherwise be infected with SARS-CoV-2 is about $575,000 
($11.5 million x .05). For staff, who are generally of working ages in 
roughly the same proportions as the population at large, the typical 
rate of death for the full course of two vaccines (or possibly three 
with a booster) is roughly 1 percent of the older adult rate, and the 
expected value for each employee receiving the same vaccinations is 
about $57,500 ($11.5 million x .005).\251\ For community residents who 
unvaccinated staff might infect, the resulting calculation is similar 
(actually somewhat lower because the risk of death from COVID-19 is 
even lower for those below employment ages).
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    \250\ We note that the VSL is based on a sample of individuals 
whose average age is 40, This leads to complexities in estimates for 
populations who are much younger or older, including LTC residents. 
See Lisa Robinson and James K. Hammit, ``Valuing Reductions in Fatal 
Illness Risks: Implications of Recent Research,'' Health Economics, 
August 2016, pp. 1039-1052.
    \251\ For the full likelihood distributions for all age ranges, 
see the CDC age distribution table previously referenced .
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    Under a second approach to benefit calculation, we can estimate the 
monetized value of extending the life of LTC facility residents, which 
is based on expectations of life expectancy and the value per life-
year. As explained in the HHS Guidelines, the average individual in 
studies underlying the VSL estimates is approximately 40 years of age, 
allowing us to calculate a value per life-year of approximately 
$590,000 and $970,000 for 3 and 7 percent discount rates respectively. 
This estimate of a value per life-year corresponds to 1 year at perfect 
health. (These amounts might reasonably be halved for average LTC 
facility residents, since non-institutionalized U.S. adults aged 80-89 
years report average health-related quality of life (HRQL) scores of 
0.753, and this figure is likely to be lower for LTC facility 
residents.\252\) Assuming that the average life expectancy of long term 
care residents is 5 years, the monetized benefits of saving one 
statistical life would be about $3.0 million ($590,000 x annually for 5 
years) at a 3 percent discount rate and about $4.8 million ($970,000 x 
annually for 5 years) at a 7 percent discount rate. Assuming that the 
average rate of death from COVID-19 (SARS-CoV-2 infection) at LTC 
facility resident ages and conditions is 5 percent, and the average 
rate of death after vaccination is essentially zero, the expected life-
extending value of each resident who would otherwise be infected is 
$150 thousand at a 3 percent discount rate and $240 thousand at a 7 
percent discount rate. A similar calculation can be made for staff and 
for the community residents they might infect, who will gain many more 
years of life but whose risk of death is far smaller since their age 
distribution is so much younger. Deaths from COVID-19 in unvaccinated 
LTC facility residents during 2020 were about 130,000, or close to one 
tenth of the average LTC facility resident census of 1.4 million, a 
huge contrast to the handful of deaths in the vaccination results from 
Israel.\253\ We do not have sufficient data so as to accurately 
estimate annual resident inflows and outflows over time, but it is 
clear that over two million new residents and over 700,000 new 
employees make the total number of individuals involved during the year 
far higher than point in time or average counts. Moreover, these counts 
do not include family members and other visitors, whose total visits 
certainly number in the millions.
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    \252\ Hanmer, J. W.F. Lawrence, J.P. Anderson, R.M. Kaplan, D.G. 
Fryback. 2006. ``Report of Nationally Representative Values for the 
Noninstitutionalized US Adult Population for 7 Health-Related 
Quality-of-Life Scores.'' Medical Decision Making. 26(4): 391-400.
    \253\ Deaths are from COVID-19 Nursing Home Data, CMS, Week 
Ending 2/21/2021, at https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg/.
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    Most of the preceding calculations address residential long-term 
care. Long term care residents are a major group within LTC facilities 
and are generally in the LTC facility because their needs are more 
substantial and they need assistance with the activities of daily 
living, such as cooking, bathing, and dressing. These long-term stays 
are

[[Page 61611]]

primarily funded by the Medicaid program (also, through long term care 
insurance or self-financed), and the custodial care services these 
residents receive are not normally covered by Medicare or any other 
health insurance.\254\ A second major group within the same facilities 
receives short-term skilled nursing care services. These services are 
rehabilitative and generally last only days, weeks, or months. They 
usually follow a hospital stay and are primarily funded by the Medicare 
program or other health insurance. The importance of these distinctions 
is that the numbers of residents and typical ages in each category 
regulated under this rule in each category are different. The average 
number of persons in facilities for long term care over the course of a 
year is about 1.2 million residents (as is the point-in-time number), 
and the total number of persons over the course of a year is about 1.6 
million. The average number in skilled nursing care at any one time is 
about 2 thousand persons, because the average length of stay is weeks 
rather than years and the median length of stay is days rather than 
weeks.\255\ The annual turnover in this group is such that about 2.3 
million residents are served each year. There is some overlap between 
these two populations and the same person may be admitted on more than 
one occasion. For purposes of this analysis (these are rough estimates 
because there are no data routinely published on patient and resident 
turnover or providing unduplicated counts of persons served), we assume 
that the expected longevity for each group is identical on average, and 
that a total of 3.9 million different persons are served each year. The 
employee staff are a third group and the direct target of these rules. 
Since both long-term and short-term residents are for the most part 
served in the same facilities, their care is managed and provided by 
the same facility staff.
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    \254\ For a discussion on this problem, see ``Medicare and You: 
at https://www.medicare.gov/medicare-and-you
    \255\ In fact, the average length of stay for skilled nursing 
care is about 25 days. See MEDPAC, Report to the Congress: Medicare 
Payment Policy, March 2019, ``Skilled nursing facility services,'' 
page 200.
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    These nursing facilities have about 950,000 full-time equivalent 
employees at any one time and another 100,000 visiting staff or the 
equivalent, all covered by this rule. For these persons, the average 
age is about 45, which creates two offsetting effects: they have more 
years of life expectancy than residents, but their risk of death from 
COVID-19 is far lower. For purposes of this analysis, we assume that 
vaccination against COVID-19 is effective for at least 1 year and use a 
1-year period as our primary framework for calculation of potential 
benefits, not as a specific prediction but as a likely scenario that 
avoids forecasting major and unexpected changes that are either 
strongly adverse or strongly beneficial. If we were adding up totals 
for benefits we would assume that the risk of death after COVID-19 
infection is likely only one-half of one percent (one tenth of the 
resident rate) or less for the unvaccinated members of this group, 
reflecting the far lower mortality rates for persons who are almost all 
in the 18 to 65 year old age ranges compared to the far older 
residents.\256\ We assume that the total number of individual employees 
is 50 percent higher than the full-time equivalent but that only half 
that number are primarily employed at only one nursing facility, two 
offsetting assumptions about the number of employees working at each 
facility (many employees are part-time consultants or the equivalent 
who serve multiple nursing facilities on a part-time basis). We further 
assume that employee turnover is 80 percent a year, lower than the 
results for nurses previously cited. Accordingly, we estimate that 80 
percent of 950,000, or 760,000, are new employees each year and must be 
offered vaccination (again, most are already vaccinated), for a total 
of 1,710,000 eligible employees over the course of a year. (This number 
would likely drop in future years as employers decide to hire only 
persons previously vaccinated and as vaccine uptake increases due to 
Federal, State, local, or employer requirements, as well as individual 
choice.)
---------------------------------------------------------------------------

    \256\ See the previously cited CDC report on risks by age group. 
In the age intervals used by CDC, the 40-49-year-old group is in the 
middle of typical employment age ranges. The risk of death in this 
age group is one tenth that of those aged 65-74. We emphasize with 
round numbers that nothing about these data is fixed and unlikely to 
change (for example, as better future treatments are used to treat 
severe cases).
---------------------------------------------------------------------------

    We have some data on the costs of treating serious illness among 
the unvaccinated who become infected, are hospitalized, and survive. 
Among those age 65 years or above, or with severe risk factors, over 30 
percent of those known to be infected required hospitalization in the 
first year of the pandemic.\257\ That fraction is far lower now as 
treatments have improved and as vaccinations have greatly reduced 
severity of the disease. Among adults aged 21 years to 64 years, about 
10 percent of those infected once required hospitalization, but that 
fraction is now far lower for the same reasons. For our estimates, we 
assume a 10 percent hospitalization rate among people aged 65 years or 
older in LTC facilities, reflecting both that their conditions are 
significantly worse than those of similarly aged adults living 
independently, and that pre-hospitalization treatments have improved. 
For staff we assume one fifth of this rate, or 2 percent. Using LTC 
facilities as our main example, the LTC facility candidates for 
vaccination in the first year covered by this rule, about three-fourths 
are age 65 years or above. Hence, the age-weighted hospitalization rate 
that we project is about 8 percent. Among those hospitalized at any 
age, the average cost is about $20,000.\258\
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    \257\ The New York Times ``Nearly One-Third of U.S. Coronavirus 
Deaths Are Linked to Nursing Homes, June 1, 2021.
    \258\ This is not a robust estimate but is supported by several 
sources. See for example Jiangzhuo Chen et al, ``Medical costs of 
keeping the US economy open during COVID-19,'' Scientific Reports, 
Nature.com, July 19 2020, at https://pubmed.ncbi.nlm.nih.gov/32743613/, and Michel Kohli et al, ``The potential public health and 
economic value of a hypothetical COVID-19 vaccine in the United 
States: Use of cost-effectiveness modeling to inform vaccination 
prioritization,'' Science Direct, February 12, 2021, at https://pubmed.ncbi.nlm.nih.gov/33483216/.
---------------------------------------------------------------------------

    To put these cost, benefit, and volume numbers in perspective, 
vaccinating one hundred previously unvaccinated LTC facility residents 
who would otherwise become infected with SARS-CoV-2 and have a COVID-19 
illness would cost approximately $18,000 ($183 x 100) in vaccination 
costs. Using the VSL approach to estimation would produce life-saving 
benefits of about $400,000 for these 100 people ($20,000 x 100 x .05), 
again assuming the death rate for those ill from COVID-19 of this age 
and condition is one in twenty. Reductions in health care costs from 
hospitalization would produce another $160,000 ($20,000 x 100 x .08) in 
benefits for this group assuming that 8 percent would otherwise be 
hospitalized. However, this comparison should be taken as necessarily 
hypothetical and contingent due to the analytic, data, and uncertainty 
challenges discussed throughout this regulatory impact assessment. 
Patient benefits are simply a consequence of fewer infections among 
staff. Vaccinating one hundred previously unvaccinated LTC facility 
employees would be higher than for staff. Life-saving benefits to 
employees would be about $5,300,000 ($10,600,000 VSL x 100 x .005) for 
100 people assuming that the death rate for these far younger 100 
people is 1 in 500 hundred. Reductions in health care costs from 
hospitalizations of employees would produce another $20,000 ($20,000 x 
100 x .01).

[[Page 61612]]

    There remain difficult questions of estimating (1) likely numbers 
of individuals in staff and patient categories who are likely to be 
unvaccinated when the rule goes into effect and (2) numbers of staff 
likely to be willing to accept vaccination in the coming months and 
years.\259\ Both sets of numbers vary substantially by provider and 
supplier type. LTC facility and home health care patients are on 
average both the oldest and most health-impaired of those in settings 
covered by this rule. At the other extreme, rural and other community-
care oriented health centers serve the full age spectrum and a lower 
fraction of severely health-impaired.
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    \259\ For a survey of the evidence on this issue, see Gillian K. 
Steelfisher et al, ``An Uncertain Public--Encouraging Acceptance of 
Covid-19 Vaccines,'' The New England Journal of Medicine, March 3, 
2021.
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    We do know that the life-saving benefits for staff are probably 
small but significant. During the entire period of COVID-19 infections, 
since March 2020, there have been over 2,000 health care staff deaths 
recorded by the CDC through October 3, 2021.\260\ Of these, the great 
majority were in the year 2020. Even during the recent Delta variant 
surge, health care staff deaths decreased to lower levels. 
Specifically, during the last 6 months, April through September 2021, 
total staff deaths were 202, an average of 34 per month and no clear 
trend (the last 4 weeks, all in September, 2021 produced fewer than 20 
deaths). This is not surprising as the most effective precautions other 
than vaccination--masks, social distancing, and ventilation--have been 
essentially universal in the health care sector during all of 2021. 
Even more importantly, vaccination rates are considerably higher than 
in the population at large (although still well below optimal levels). 
Yet, using the last 6 months of CDC Data Tracker information, on an 
annual basis more than 400 deaths could be expected. These data, 
moreover, are almost all among unvaccinated persons and are probably 
undercounted in current data.
---------------------------------------------------------------------------

    \260\ CDC Data Tracker at https://covid.cdc.gov/covid-data-tracker/#health-care-personnel_healthcare-deaths.
---------------------------------------------------------------------------

    A major caution about these estimates: None of the sources of 
enrollment information for these programs regularly collect and publish 
information on client or staff turnover during a year. These data have 
not previously been found useful in program management for individual 
agencies or programs, or when needed have been addressed through one-
time research projects. The estimates in this analysis are based on 
inferences from scattered data on average length of stay, mortality, 
job vacancies, news accounts, and other sources that by happenstance 
are available for one type of facility or type of resident or another. 
Nor do we have data on the number of persons in these settings who will 
be vaccinated through other means during the remainder of the year.
    All these data and estimation limitations apply to even the short-
term impacts of this rule, and major uncertainties remain as to the 
future course of the pandemic, including but not limited to vaccine 
effectiveness in preventing ``breakthrough'' disease transmission from 
those vaccinated, the long-term effectiveness of vaccination, the 
emergence of treatment options, and the potential for some new disease 
variant even more dangerous than Delta.
    Another unknown is what currently unvaccinated employees would do 
when the vaccination deadline is reached, and how rapidly those 
quitting rather than being vaccinated could be replaced. Even a small 
fraction of recalcitrant unvaccinated employees could disrupt facility 
operations. On the other hand, there have been significant reductions 
in provider and supplier staffing needs in some categories. For 
example, LTC facility admissions have declined in the last year, as 
families and caregivers sought to avoid the risks of exposing a care 
recipient to unvaccinated residents and staff in LTC facilities. The 
new vaccination requirement may reduce such fears and bring higher 
numbers of residents to these facilities and the essential services 
they provide. Again, we have no way to estimate such behavioral 
changes.
    Regardless, we believe it is clear that reductions in patient/
resident fatalities through avoiding staff-generated infections are 
both likely to be a significantly larger benefit from staff vaccination 
than direct benefits to staff. Staff vaccination will also provide 
significant community benefits when staff are not at work. Hence, total 
lives saved under this rule may well reach several hundred a month or 
perhaps several thousand a month for all three groups in total. Patient 
and resident benefits are especially likely to be many times higher 
because the risks of death and serious disease complications are so 
many times higher among older persons and people with multiple chronic 
conditions.
    As indicated by the preceding analysis, predicting the full range 
of benefits and costs in either the short run or the next full year 
with any degree of estimating precision is all but impossible. As the 
minimum benefit level needed for benefits to exceed costs, however, we 
estimate that either saving 120 lives, or preventing 600 hundred 
hospitalizations for serious illness, or any combination of these two 
magnitudes, would produce benefits that exceed our estimate of costs 
over the next year. There have been about 200 staff deaths in the last 
6 months and this is a likely undercount for this one category of 
persons alone, and potential life-saving benefits to more than 150 
million mostly elderly patients and residents (about 10 percent of whom 
are likely to remain unvaccinated) who are exposed to provider staff 
probably would be many times higher. We note, however, as discussed in 
the preceding section on costs, much of these benefits could be as well 
attributed to other concurrent and parallel vaccination mandates and 
campaigns.

E. Other Effects

1. Sources of Payment
    The initial costs of this rule fall almost entirely on health care 
providers and suppliers and are extremely small in comparison to the $4 
trillion a year spent on health care, mostly through these same 
entities. In particular, the costs of the vaccines are paid by the 
Federal Government and vaccine costs are about two-thirds of the total 
costs we have estimated. Moreover, through the treatment cost savings 
to the hospitals and other care providers resulting from the 
vaccinations that will be made due to this rule, significant savings 
would accrue to payers. It is likely that half or more of these savings 
would primarily accrue to Medicare given the age or disability status 
of most clients and Medicare's role as primary payer, but there would 
also be substantial savings to Medicaid, private insurance paid by 
employers and employees, and private out-of-pocket payers including 
patients and residents. In some rare cases funds under the CARES Act 
and the American Rescue Plan Act of 2021 might be available at State or 
local discretion, but it is hard to foresee any substantial budgetary 
impact on any insurance plan or service provider that would justify or 
require such assistance.
2. Regulatory Flexibility Act
    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. Under the RFA, ``small entities'' include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Individuals and states are not included in the 
definition of a small entity. For

[[Page 61613]]

purposes of the RFA, we estimate that most health care facilities are 
small entities as that term is used in the RFA because they are either 
nonprofit organizations or meet the SBA definition of a small business 
(having revenues of less than $8.0 million to $41.5 million in any 1 
year). HHS uses an increase in costs or decrease in revenues of more 
than 3 to 5 percent as its measure of ``significant economic impact.'' 
The HHS standard for ``substantial number'' is 5 percent or more of 
those that will be significantly impacted, but never fewer than 20.
    As estimated previously, the total costs of this rule for 1 year 
are about $1.3 billion, most of which is directly proportional to 
number of employees. Spread over 10.4 million full-time equivalent 
employees, this is about $125 per employee. Assuming a fully loaded 
average wage per employee of $90,000, the first-year cost does not 
approach the 3 percent threshold. Moreover, since much of these costs 
(in particular, the vaccine costs paid by the Federal Government) will 
not fall on providers or suppliers, the financial strain on these 
facilities should be negligible. Finally, as previously discussed, 
there are other concurrent mandates and much of these costs could as 
well be attributed to those efforts. Therefore, the Department has 
determined that this IFC will not have a significant economic impact on 
a substantial number of small entities and that a final RIA is not 
required. Finally, this IFC was not preceded by a general notice of 
proposed rulemaking and the RFA requirement for a final regulatory 
flexibility analysis does not apply to final rules not preceded by a 
proposed rule. Regardless, this RIA and the main preamble, taken 
together, would meet the requirements for either an Initial or Final 
Regulatory Flexibility Analysis.
3. Small Rural Hospitals
    Section 1102(b) of the Act requires us to prepare an RIA if a 
proposed rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. For purposes of this 
requirement, we define a small rural hospital as a hospital that is 
located outside of a metropolitan statistical area and has fewer than 
100 beds. Because this rule has only the small impact per employee 
calculated for RFA purposes, the Department has determined that this 
IFC will not have a significant impact on the operations of a 
substantial number of small rural hospitals. This IFC is also exempt 
because that provision of law only applies to final rules for which a 
proposed rule was published. That said, early indications are that 
rural hospitals are having greater problems with employee vaccination 
refusals than urban hospitals, and we welcome comments on ways to 
ameliorate this problem.
4. Unfunded Mandates Reform Act
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates will impose spending costs on State, 
local, or tribal governments, or by the private sector, require 
spending in any 1 year of $100 million in 1995 dollars, updated 
annually for inflation. In 2021, that threshold is approximately $158 
million. This rule contains no State, local, or tribal governmental 
mandates, but does contain mandates on private sector entities that 
exceed this amount. However, this IFC was not preceded by a notice of 
proposed rulemaking, and therefore the requirements of UMRA do not 
apply. The analysis in this RIA and the preamble as a whole would, 
however, meet the requirements of UMRA.
5. Federalism
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. This rule would pre-empt some State laws that prohibit 
employers from requiring their employees to be vaccinated for COVID-19. 
Consistent with the Executive Order, we find that State and local laws 
that forbid employers in the State or locality from imposing vaccine 
requirements on employees directly conflict with this exercise of our 
statutory health and safety authority to require vaccinations for staff 
of the providers and suppliers subject to this rule. Similarly, to the 
extent that State-run facilities that receive Medicare and Medicaid 
funding are prohibited by State or local law from imposing vaccine 
mandates on their employees, there is direct conflict between the 
provisions of this rule (requiring such mandates) and the State or 
local law (forbidding them). 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 grounds for exemptions than provided 
for by Federal law and are inconsistent with this IFC. In these cases, 
consistent with the Supremacy Clause of the Constitution, the agency 
intends that this rule preempts State and local laws to the extent the 
State and local laws conflict with this rule. The agency has considered 
other alternatives (for example, relying entirely on measures such as 
voluntary vaccination, source control alone, and social distancing) and 
has concluded that the mandate established by this rule is the minimum 
regulatory action necessary to achieve the objectives of the statute. 
Given the contagion rates of the existing strains of coronavirus and 
their disproportionate impacts on Medicare and Medicaid beneficiaries, 
we believe that vaccination of almost all staff of covered providers 
and suppliers is necessary to promote and protect patient health and 
safety. The agency has examined case studies from other employers and 
concludes that vaccine mandates are vastly more effective than other 
measures at achieving ideal vaccination rates and the resulting patient 
protections from morbidity and mortality. Given the emergency situation 
with respect to the Delta variant detailed more fully above, time did 
not permit usual consultation procedures with the States, and such 
consultation would therefore be impracticable. We are, however, 
inviting State and local comments on the substance as well as legal 
issues presented by this rule, and on how we can fulfill the statutory 
requirements for health and safety protections of patients if we were 
to exempt any providers or suppliers based on State or local opposition 
to this rule.

F. Alternatives Considered

    As discussed earlier in the preamble, a major substantive 
alternative that we considered was to limit COVID-19 vaccination 
requirements to full-time employees rather than to all persons who may 
provide paid or unpaid services, such as visiting specialists or 
volunteers, who are not on the regular payroll on a weekly or more 
frequent basis that is, individuals who work in the facility and in 
some cases infrequently or unpredictably, as well as individuals who 
are not on the payroll at all. We concluded that covering these persons 
would be readily manageable without creating major issues for 
compliance, enforcement, and record-keeping. We did not, however, 
include some categories of visitors who do not have a business 
relationship with the provider, such as family member visitors. There 
are also many issues such as social isolation and loneliness related to 
potential discouragement of visiting volunteers or family members.

[[Page 61614]]

    We also considered whether it would be appropriate to limit COVID-
19 vaccination requirements to staff who have not previously been 
infected by SARS-CoV-2. There remain many uncertainties about as to the 
strength and length of this immunity compared to people who are 
vaccinated, and--in recognizing that--the CDC recommends that 
previously infected individuals get vaccinated. Exempting previously 
infected individuals would have potentially reduced benefits while 
reducing costs, both roughly in proportion to the number affected. It 
would have also, complicated administration and likely require 
standards that do not now exist for reliably measuring the declining 
levels of antibodies over time in relation to risk of reinfection. 
Because of current CDC guidance and understanding of relevant 
scientific findings, we found that it was not warranted to exempt 
previously infected individuals.
    Another option would be to devise a standard with graduated 
compliance expectations such as 90 percent and then 95 percent and then 
100 percent of staff vaccinated and a time period in which to reach 
each level. A variation of this would be to put providers on a 
probationary period if they failed to reach 100 percent compliance by 
the date set in the rule, and were allowed additional time in which to 
cross that last threshold. Yet another variation would be to reduce 
payment to providers and suppliers not meeting the standard after the 
initial deadline. We recently put a phased system in place for Organ 
Procurement Organizations (OPOs), so we are not reflexively opposed to 
such options.\261\ Nonetheless, there are two major arguments against 
such a system in the context of this rule. First, to have any 
usefulness the time periods would have to have a reasonably extensive 
duration, such as a month each. But that would be almost the same as 
extending this rule's deadline for an extra several months. We do not 
believe that extending the deadline to extend the employment of staff 
who will simply delay vaccination or final refusal to the last possible 
moment is in the interest of other staff, patients, and patients who 
would utilize the provider for needed health care if they did not fear 
unvaccinated staff. Second, it would not only delay the achievement of 
both staff and patient safety, but encourage procrastination. For those 
few staff absolutely unwilling to accept vaccination, it would simply 
delay the day of final action and the day of hiring a vaccinated 
replacement. In the case of the OPO rule, an entire organization had to 
be slowly reformed to achieve compliance. In the context of this rule, 
and the lives at stake, there is no obvious ethical or managerial 
reason to give a relative handful of vaccination-resisting individuals 
more time until they leave the organization. It would give management 
more time to find replacements, but it is not at all clear that this 
would be a fruitful grace period.
---------------------------------------------------------------------------

    \261\ See Medicare and Medicaid Programs: Organ Procurement 
Organizations Conditions for Coverage: Revisions to the Outcome 
Measure Requirements for Organ Procurement Organizations, 85 FR page 
77898, December 2, 2020.
---------------------------------------------------------------------------

    As for a variation reducing payment to non-performing providers, 
perhaps by 20 percent per patient over some applicable time period, 
this would arguably provide something better than an ``all of nothing'' 
removal from provider status. It would require legislation but that is 
not a barrier to meeting E.O. 12866 analysis standards and in some 
rules may be essential to a valid benefit-cost analysis. The problem 
with this variation, however, is that for most providers and suppliers 
is it unlikely to be a realistic choice. Rather than accept lower 
payment levels, management can simply terminate the unvaccinated 
employees, a power they have with or without the reduced payment 
alternative. Moreover, it would be hard to devise a system that treated 
equally and fairly providers of all sizes--whether with 5 or 50 
employees. We further note that CMS already has and uses discretion in 
enforcement when inspectors find a violation. Termination of provider 
status is not normally an immediate consequence, as entities are 
typically given the opportunity to correct deficiencies. Regardless, we 
welcome comments on this overall option and its variations, and on the 
closely-related option of simply adding a month to the compliance 
deadline in this rule. We considered what standards to apply regarding 
proof of compliance with exemptions requests base on medical 
contraindications and religious objections. We decided to establish 
minimal compliance burdens for both categories of exemptions. This 
decision on the evidentiary standards could be revisited should an 
abuse problem arise on a significant scale. This may open the door to 
forged documents or false statements, and therefore validation of such 
claims raises administrative costs. Accordingly, we have allowed for 
relatively relaxed standards for verification in our administrative 
provisions and cost estimates but may reconsider in the future. We 
considered alternative timelines for implementation but decided that 
this would not only delay badly needed live-saving compliance, but also 
provide little real management benefit to providers and suppliers. 
Staff have had almost a year to consider COVID-19 vaccinations that are 
in their own interests as well as vital to patient protections and the 
protection of other workers. In this regard we note that one of the 
claimed barriers to vaccination has recently been removed, now that one 
vaccine is now no longer emergency-authorized, but fully licensed. We 
believe our requirements provide more than enough time for reasonable 
counselling and other management measures.
    Finally, we considered requiring daily or weekly testing of 
unvaccinated individuals. We have reviewed scientific evidence on 
testing and found that vaccination is a more effective infection 
control measure. As such, we chose not to require such testing for now 
but welcome comment. Of course, nothing prevents a provider from 
exercising testing precautions voluntarily in addition to vaccination. 
We note that nothing in this rule removes the obligation on providers 
and suppliers to meet existing requirements to prevent the spread of 
infection, which in practice means that these entities may also conduct 
regular testing alongside such actions as source control and physical 
distancing. CMS will continue to review the evidence and stakeholder 
feedback on this issue.
    These and some lesser options are presented and discussed in the 
main preamble. We do not have reliable dollar estimates for either 
costs or benefits of any alternatives, for the reasons already 
discussed in the RIA regarding the options we chose. We welcome 
comments on these or other options.

G. Accounting Statement and Table

    The Accounting Table summarizes the quantified impact of this rule. 
It covers only 1 year because there will likely be many developments 
regarding treatments and vaccinations and their effects in future years 
and we have no way of knowing which will most likely occur. A longer 
period would be even more speculative than the current estimates. 
Nonetheless, assuming no major unforeseen events that would impinge on 
our estimates, we would expect lower costs in future years if for no 
other reason than increases in the fraction of new hires already 
vaccinated as well as other positive results from the President's plan 
or individual vaccination decisions. We further note

[[Page 61615]]

that the vaccinations, and hence the benefits and costs, estimated for 
this rule are more or less simultaneously being created voluntarily by 
some employers (self-mandates), through the OSHA vaccination rule 
applicable to employers of 100 or more persons, and by some State or 
local mandates. There is no simple and non-arbitrary way to disentangle 
which vaccination benefits and which vaccination costs are due to which 
source.
    As explained in various places within this RIA and the preamble as 
a whole, there are major uncertainties as to the effects of current 
variants of SARS-CoV-2 on future infection rates, medical costs, and 
prevention of major illness or mortality. For example, the duration of 
vaccine effectiveness in preventing COVID-19, reducing disease 
severity, reducing the risk of death, and the effectiveness of the 
vaccine to prevent disease transmission by those vaccinated are not 
currently known. These uncertainties also impinge on benefits 
estimates. For those reasons we have not quantified into annual totals 
either the life-extending or medical cost-reducing benefits of this 
rule and have used only a 1-year projection for the cost estimates in 
our Accounting Statement (our first-year estimates are for the last two 
months of 2021 and the first ten months of 2022). We also show a large 
range for the upper and lower bounds of potential costs to emphasize 
the uncertainty as to several major variables, such as changes in 
voluntary vaccination levels, longer term effects, and others 
previously discussed. We welcome comments on all of our assumptions and 
welcome any additional information that would narrow the ranges of 
uncertainty or guide us in any important revisions to the requirements 
established in what is an ``interim'' final rule.
[GRAPHIC] [TIFF OMITTED] TR05NO21.032

    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.
    Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & 
Medicaid Services, approved this document on October 19, 2021.

List of Subjects

42 CFR Part 416

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 418

    Health facilities, Hospice care, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 441

    Aged, Family planning, Grant programs--health, Infants and 
children, Medicaid, Penalties, Reporting and recordkeeping 
requirements.

42 CFR Part 460

    Aged, Citizenship and naturalization, Civil rights, Health, Health 
care, Health records, Incorporation by reference, Individuals with 
disabilities, Medicaid, Medicare, Religious discrimination, Reporting 
and recordkeeping requirements.

42 CFR Part 482

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

42 CFR Part 483

    Grant programs--health, Health facilities, Health professions, 
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting 
and recordkeeping requirements, Safety.

42 CFR Part 484

    Administrative practice and procedure, Grant programs--health, 
Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

[[Page 61616]]

42 CFR Part 485

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

42 CFR Part 486

    Administrative practice and procedure, Grant programs--health, 
Health facilities, Home infusion therapy, Medicare, Reporting and 
recordkeeping requirements, X-rays.

42 CFR Part 491

    Grant programs--health, Health facilities, Medicaid, Medicare, 
Reporting and recordkeeping requirements, Rural and urban areas.

42 CFR Part 494

    Diseases, Health facilities, Incorporation by reference, Medicare, 
Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 416--AMBULATORY SURGICAL SERVICES

0
1. The authority citation for part 416 continues to read as follows:

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


0
2. Amend Sec.  416.51 by adding paragraph (c) to read as follows:


Sec.  416.51   Conditions for coverage--Infection control.

* * * * *
    (c) Standard: COVID-19 vaccination of staff. The ASC must develop 
and implement policies and procedures to ensure that all staff are 
fully vaccinated for COVID-19. For purposes of this section, staff are 
considered fully vaccinated if it has been 2 weeks or more since they 
completed a primary vaccination series for COVID-19. The completion of 
a primary vaccination series for COVID-19 is defined here as the 
administration of a single-dose vaccine, or the administration of all 
required doses of a multi-dose vaccine.
    (1) Regardless of clinical responsibility or patient contact, the 
policies and procedures must apply to the following center staff, who 
provide any care, treatment, or other services for the center and/or 
its patients:
    (i) Center employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the center and/or its patients, under contract or by other arrangement.
    (2) The policies and procedures of this section do not apply to the 
following center staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services outside of the center setting and who do not have any direct 
contact with patients and other staff specified in paragraph (c)(1) of 
this section; and
    (ii) Staff who provide support services for the center that are 
performed exclusively outside of the center setting and who do not have 
any direct contact with patients and other staff specified in paragraph 
(c)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (c)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine, prior to staff providing any 
care, treatment, or other services for the center and/or its patients;
    (ii) A process for ensuring that all staff specified in paragraph 
(c)(1) of this section are fully vaccinated, except for those staff who 
have been granted exemptions to the vaccination requirements of this 
section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations;
    (iii) 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;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status of all staff specified in paragraph (c)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the center has 
granted, an exemption from the staff COVID-19 vaccination requirements;
    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions from vaccination, 
has been 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, and for further ensuring that such 
documentation contains:
    (A) All information specifying which of the authorized or licensed 
COVID-19 vaccines are clinically contraindicated for the staff member 
to receive and the recognized clinical reasons for the 
contraindications; and
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the center's COVID-19 
vaccination requirements based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

PART 418--HOSPICE CARE

0
3. The authority citation for part 418 continues to read as follow:

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


0
4. Amend Sec.  418.60 by adding paragraph (d) to read as follows:


Sec.  418.60   Condition of participation: Infection control.

* * * * *
    (d) Standard: COVID-19 Vaccination of facility staff. The hospice 
must develop and implement policies and procedures to ensure that all 
staff are fully vaccinated for COVID-19. For purposes of this section, 
staff are considered fully vaccinated if it has been 2 weeks or more 
since they completed a primary vaccination series for COVID-19. The 
completion of a primary vaccination series for COVID-19 is defined here 
as the administration of a single-dose vaccine, or the administration 
of all required doses of a multi-dose vaccine.

[[Page 61617]]

    (1) Regardless of clinical responsibility or patient contact, the 
policies and procedures must apply to the following hospice staff, who 
provide any care, treatment, or other services for the hospice and/or 
its patients:
    (i) Hospice employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the hospice and/or its patients, under contract or by other 
arrangement.
    (2) The policies and procedures of this section do not apply to the 
following hospice staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services outside of the settings where hospice services are provided to 
patients and who do not have any direct contact with patients, patient 
families and caregivers, and other staff specified in paragraph (d)(1) 
of this section; and
    (ii) Staff who provide support services for the hospice that are 
performed exclusively outside of the settings where hospice services 
are provided to patients and who do not have any direct contact with 
patients, patient families and caregivers, and other staff specified in 
paragraph (d)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (d)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the hospice and/or its patients;
    (ii) A process for ensuring that all staff specified in paragraph 
(d)(1) of this section are fully vaccinated, except for those staff who 
have been granted exemptions to the vaccination requirements of this 
section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations;
    (iii) 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;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status of all staff specified in paragraph (d)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the hospice 
has granted, an exemption from the staff COVID-19 vaccination 
requirements;
    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions from vaccination, 
has been 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, and for further ensuring that such 
documentation contains:
    (A) 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
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the hospice's COVID-19 
vaccination requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC 
SERVICES

0
5. The authority citation for part 441 continues to read as follows:

    Authority:  42 U.S.C. 1302.


0
6. Amend Sec.  441.151 by adding paragraph (c) to read as follows:


Sec.  441.151   General requirements.

* * * * *
    (c) COVID-19 Vaccination of facility staff. The facility must 
develop and implement policies and procedures to ensure that all staff 
are fully vaccinated for COVID-19. For purposes of this section, staff 
are considered fully vaccinated if it has been 2 weeks or more since 
they completed a primary vaccination series for COVID-19. The 
completion of a primary vaccination series for COVID-19 is defined here 
as the administration of a single-dose vaccine, or the administration 
of all required doses of a multi-dose vaccine.
    (1) Regardless of clinical responsibility or resident contact, the 
policies and procedures must apply to the following facility staff, who 
provide any care, treatment, or other services for the facility and/or 
its residents:
    (i) Facility employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the facility and/or its residents, under contract or by other 
arrangement.
    (2) The policies and procedures of this section do not apply to the 
following facility staff:
    (i) 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 specified in paragraph (c)(1) of 
this section; and
    (ii) Staff who provide support services for the facility that are 
performed exclusively outside of the center setting and who do not have 
any direct contact with residents and other staff specified in 
paragraph (c)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (c)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the facility and/or its 
residents;
    (ii) A process for ensuring that all staff specified in paragraph 
(c)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been

[[Page 61618]]

granted exemptions to the vaccination requirements of this section, or 
those staff for whom COVID-19 vaccination must be temporarily delayed, 
as recommended by the CDC, due to clinical precautions and 
considerations;
    (iii) A process for ensuring that the facility follows nationally 
recognized infection prevention and control guidelines intended to 
mitigate the transmission and spread of COVID-19, and which must 
include the implementation of additional precautions for all staff who 
are not fully vaccinated for COVID-19;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status of all staff specified in paragraph (c)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the facility 
has granted, an exemption from the staff COVID-19 vaccination 
requirements;
    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions from vaccination, 
has been 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, and for further ensuring that such 
documentation contains:
    (A) 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
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the facility's COVID-19 
vaccination requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

PART 460--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)

0
7. The authority citation for part 460 continues to read as follow:

    Authority:  42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f).


0
8. Amend Sec.  460.74 by adding paragraph (d) to read as follows:


Sec.  460.74   Infection control.

* * * * *
    (d) COVID-19 Vaccination of PACE organization staff. The PACE 
organization must develop and implement policies and procedures to 
ensure that all staff are fully vaccinated for COVID-19. For purposes 
of this section, staff are considered fully vaccinated if it has been 2 
weeks or more since they completed a primary vaccination series for 
COVID-19. The completion of a primary vaccination series for COVID-19 
is defined here as the administration of a single-dose vaccine, or the 
administration of all required doses of a multi-dose vaccine.
    (1) Regardless of clinical responsibility or participant contact, 
the policies and procedures must apply to the following PACE 
organization staff, who provide any care, treatment, or other services 
for the PACE organization and/or its participants:
    (i) PACE organization employees;
    (ii) Licensed practitioners providing services on behalf of the 
PACE organization;
    (iii) Students, trainees, and volunteers providing services on 
behalf of the PACE organization; and
    (iv) Individuals who provide care, treatment, or other services on 
behalf of the PACE organization, under contract or by other 
arrangement.
    (2) The policies and procedures of this section do not apply to the 
following PACE organization staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services for the PACE organization and/or its participants and who do 
not have any direct contact with participants and other PACE 
organization staff specified in paragraph (d)(1) of this section; and
    (ii) Staff who provide support services for the PACE organization 
and/or its participants and who do not have any direct contact with 
participants and other PACE organization staff specified in paragraph 
(d)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (d)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the PACE organization and/or its 
participants;
    (ii) A process for ensuring that all staff specified in paragraph 
(d)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been granted exemptions to the vaccination 
requirements of this section, or those staff for whom COVID-19 
vaccination must be temporarily delayed, as recommended by the CDC, due 
to clinical precautions and considerations;
    (iii) 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;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status of all staff specified in paragraph (d)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the PACE 
organization has granted, an exemption from the staff COVID-19 
vaccination requirements based on recognized clinical contraindications 
or applicable Federal laws;
    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions from vaccination, 
has been 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

[[Page 61619]]

defined by, and in accordance with, all applicable State and local 
laws, and for further ensuring that such documentation contains:
    (A) 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
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the PACE organization's COVID-19 
vaccination requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

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

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


0
10. Amend Sec.  482.42 by adding paragraph (g) to read as follows:


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

* * * * *
    (g) Standard: COVID-19 Vaccination of hospital staff. The hospital 
must develop and implement policies and procedures to ensure that all 
staff are fully vaccinated for COVID-19. For purposes of this section, 
staff are considered fully vaccinated if it has been 2 weeks or more 
since they completed a primary vaccination series for COVID-19. The 
completion of a primary vaccination series for COVID-19 is defined here 
as the administration of a single-dose vaccine, or the administration 
of all required doses of a multi-dose vaccine.
    (1) Regardless of clinical responsibility or patient contact, the 
policies and procedures must apply to the following hospital staff, who 
provide any care, treatment, or other services for the hospital and/or 
its patients:
    (i) Hospital employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the hospital and/or its patients, under contract or by other 
arrangement.
    (2) The policies and procedures of this section do not apply to the 
following hospital staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services outside of the hospital setting and who do not have any direct 
contact with patients and other staff specified in paragraph (g)(1) of 
this section; and
    (ii) Staff who provide support services for the hospital that are 
performed exclusively outside of the hospital setting and who do not 
have any direct contact with patients and other staff specified in 
paragraph (g)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (g)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the hospital and/or its 
patients;
    (ii) A process for ensuring that all staff specified in paragraph 
(g)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been granted exemptions to the vaccination 
requirements of this section, or those staff for whom COVID-19 
vaccination must be temporarily delayed, as recommended by the CDC, due 
to clinical precautions and considerations;
    (iii) 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;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status of all staff specified in paragraph (g)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the hospital 
has granted, an exemption from the staff COVID-19 vaccination 
requirements;
    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions from vaccination, 
has been 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, and for further ensuring that such 
documentation contains:
    (A) 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
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the hospital's COVID-19 
vaccination requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-.

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

0
11. The authority citation for part 483 continues to read as follows:

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


0
12. Amend Sec.  483.80 by revising paragraph (d)(3)(v) and adding 
paragraph (i) to read as follows:


Sec.  483.80   Infection control.

    (d) * * *
    (3) * * *
    (v) The resident or resident representative, has the opportunity to 
accept or refuse a COVID-19 vaccine, and change their decision; and
* * * * *

[[Page 61620]]

    (i) COVID-19 Vaccination of facility staff. The facility must 
develop and implement policies and procedures to ensure that all staff 
are fully vaccinated for COVID-19. For purposes of this section, staff 
are considered fully vaccinated if it has been 2 weeks or more since 
they completed a primary vaccination series for COVID-19. The 
completion of a primary vaccination series for COVID-19 is defined here 
as the administration of a single-dose vaccine, or the administration 
of all required doses of a multi-dose vaccine.
    (1) Regardless of clinical responsibility or resident contact, the 
policies and procedures must apply to the following facility staff, who 
provide any care, treatment, or other services for the facility and/or 
its residents:
    (i) Facility employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the facility and/or its residents, under contract or by other 
arrangement.
    (2) The policies and procedures of this section do not apply to the 
following facility staff:
    (i) 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 specified in paragraph (i)(1) of 
this section; and
    (ii) 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 specified in 
paragraph (i)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (i)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the facility and/or its 
residents;
    (ii) A process for ensuring that all staff specified in paragraph 
(i)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been granted exemptions to the vaccination 
requirements of this section, or those staff for whom COVID-19 
vaccination must be temporarily delayed, as recommended by the CDC, due 
to clinical precautions and considerations;
    (iii) 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;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status of all staff specified in paragraph (i)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the facility 
has granted, an exemption from the staff COVID-19 vaccination 
requirements;
    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions from vaccination, 
has been 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, and for further ensuring that such 
documentation contains:
    (A) 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
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the facility's COVID-19 
vaccination requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

0
13. Amend Sec.  483.430 by revising paragraph (f) to read as follows:


Sec.  483.430   Condition of participation: Facility staffing.

* * * * *
    (f) Standard: COVID-19 Vaccination of facility staff. The facility 
must develop and implement policies and procedures to ensure that all 
staff are fully vaccinated for COVID-19. For purposes of this section, 
staff are considered fully vaccinated if it has been 2 weeks or more 
since they completed a primary vaccination series for COVID-19. The 
completion of a primary vaccination series for COVID-19 is defined here 
as the administration of a single-dose vaccine, or the administration 
of all required doses of a multi-dose vaccine.
    (1) Regardless of clinical responsibility or client contact, the 
policies and procedures must apply to the following facility staff, who 
provide any care, treatment, or other services for the facility and/or 
its clients:
    (i) Facility employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the facility and/or its clients, under contract or by other 
arrangement.
    (2) The policies and procedures of this section do not apply to the 
following facility staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services outside of the facility setting and who do not have any direct 
contact with clients and other staff specified in paragraph (f)(1) of 
this section; and
    (ii) 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 clients and other staff specified in 
paragraph (f)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (f)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care,

[[Page 61621]]

treatment, or other services for the facility and/or its clients;
    (ii) A process for ensuring that all staff specified in paragraph 
(f)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been granted exemptions to the vaccination 
requirements of this section, or those staff for whom COVID-19 
vaccination must be temporarily delayed, as recommended by the CDC, due 
to clinical precautions and considerations;
    (iii) 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;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status of all staff specified in paragraph (f)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the facility 
has granted, an exemption from the staff COVID-19 vaccination 
requirements;
    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions from vaccination, 
has been 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, and for further ensuring that such 
documentation contains
    (A) 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
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the facility's COVID-19 
vaccination requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

0
14. Amend Sec.  483.460 by revising paragraph (a)(4)(v) to read as 
follows:


Sec.  483.460   Condition of participation: Health care services.

* * * * *
    (a) * * *
    (4) * * *
    (v) The client, or client's representative, has the opportunity to 
accept or refuse a COVID-19 vaccine, and change their decision;
* * * * *

PART 484--HOME HEALTH SERVICES

0
15. The authority citation for part 484 continues to read as follows:

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


0
16. Amend Sec.  484.70 by adding paragraph (d) to read as follows:


Sec.  484.70   Condition of participation: Infection prevention and 
control.

* * * * *
    (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The 
home health agency (HHA) must develop and implement policies and 
procedures to ensure that all staff are fully vaccinated for COVID-19. 
For purposes of this section, staff are considered fully vaccinated if 
it has been 2 weeks or more since they completed a primary vaccination 
series for COVID-19. The completion of a primary vaccination series for 
COVID-19 is defined here as the administration of a single-dose 
vaccine, or the administration of all required doses of a multi-dose 
vaccine.
    (1) Regardless of clinical responsibility or patient contact, the 
policies and procedures must apply to the following HHA staff, who 
provide any care, treatment, or other services for the HHA and/or its 
patients:
    (i) HHA employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the HHA and/or its patients, under contract or by other arrangement.
    (2) The policies and procedures of this section do not apply to the 
following HHA staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services outside of the settings where home health services are 
directly provided to patients and who do not have any direct contact 
with patients, families, and caregivers, and other staff specified in 
paragraph (d)(1) of this section; and
    (ii) Staff who provide support services for the HHA that are 
performed exclusively outside of the settings where home health 
services are directly provided to patients and who do not have any 
direct contact with patients, families, and caregivers, and other staff 
specified in paragraph (d)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (d)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the HHA and/or its patients;
    (ii) A process for ensuring that all staff specified in paragraph 
(d)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been granted exemptions to the vaccination 
requirements of this section, or those staff for whom COVID-19 
vaccination must be temporarily delayed, as recommended by the CDC, due 
to clinical precautions and considerations;
    (iii) 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;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status of all staff specified in paragraph (d)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the HHA has 
granted, an exemption from the staff COVID-19 vaccination requirements;

[[Page 61622]]

    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions from vaccination, 
has been 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, and for further ensuring that such 
documentation contains
    (A) 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
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the HHA's COVID-19 vaccination 
requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

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

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


0
18. Amend Sec.  485.58 by revising paragraph (d)(4) to read as follows:


Sec.  485.58   Condition of participation: Comprehensive rehabilitation 
program.

* * * * *
    (d) * * *
    (4) The services must be furnished by personnel that meet the 
qualifications of Sec.  485.70 and the number of qualified personnel 
must be adequate for the volume and diversity of services offered. 
Personnel that do not meet the qualifications specified in Sec.  
485.70(a) through (m) may be used by the facility in assisting 
qualified staff. When a qualified individual is assisted by these 
personnel, the qualified individual must be on the premises, and must 
instruct these personnel in appropriate patient care service techniques 
and retain responsibility for their activities.
* * * * *

0
19. Amend Sec.  485.70 by adding paragraph (n) to read as follows:


Sec.  485.70   Personnel qualifications.

* * * * *
    (n) The CORF must develop and implement policies and procedures to 
ensure that all staff are fully vaccinated for COVID-19. For purposes 
of this section, staff are considered fully vaccinated if it has been 2 
weeks or more since they completed a primary vaccination series for 
COVID-19. The completion of a primary vaccination series for COVID-19 
is defined here as the administration of a single-dose vaccine, or the 
administration of all required doses of a multi-dose vaccine.
    (1) Regardless of clinical responsibility or patient contact, the 
policies and procedures must apply to the following facility staff, who 
provide any care, treatment, or other services for the facility and/or 
its patients:
    (i) Facility employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the facility and/or its patients, under contract or by other 
arrangement.
    (2) The policies and procedures of this section do not apply to the 
following facility staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services outside of the facility setting and who do not have any direct 
contact with patients and other staff specified in paragraph (n)(1) of 
this section; and
    (ii) 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 patients and other staff specified in 
paragraph (n)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (n)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the facility and/or its 
patients;
    (ii) A process for ensuring that all staff specified in paragraph 
(n)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been granted exemptions to the vaccination 
requirements of this section, or those staff for whom COVID-19 
vaccination must be temporarily delayed, as recommended by the CDC, due 
to clinical precautions and considerations;
    (iii) 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;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status of all staff specified in paragraph (n)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the facility 
has granted, an exemption from the staff COVID-19 vaccination 
requirements;
    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions from vaccination, 
has been 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, and for further ensuring that such 
documentation contains
    (A) 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
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the facility's COVID-19 
vaccination requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions

[[Page 61623]]

and considerations, including, but not limited to, individuals with 
acute illness secondary to COVID-19, and individuals who received 
monoclonal antibodies or convalescent plasma for COVID-19 treatment; 
and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

0
20. Amend Sec.  485.640 by adding paragraph (f) to read as follows:


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

* * * * *
    (f) Standard: COVID-19 Vaccination of CAH staff. The CAH must 
develop and implement policies and procedures to ensure that all staff 
are fully vaccinated for COVID-19. For purposes of this section, staff 
are considered fully vaccinated if it has been 2 weeks or more since 
they completed a primary vaccination series for COVID-19. The 
completion of a primary vaccination series for COVID-19 is defined here 
as the administration of a single-dose vaccine, or the administration 
of all required doses of a multi-dose vaccine.
    (1) Regardless of clinical responsibility or patient contact, the 
policies and procedures must apply to the following CAH staff, who 
provide any care, treatment, or other services for the CAH and/or its 
patients:
    (i) CAH employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the CAH and/or its patients, under contract or by other arrangement.
    (2) The policies and procedures of this section do not apply to the 
following CAH staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services outside of the CAH setting and who do not have any direct 
contact with patients and other staff specified in paragraph (f)(1) of 
this section; and
    (ii) Staff who provide support services for the CAH that are 
performed exclusively outside of the CAH setting and who do not have 
any direct contact with patients and other staff specified in paragraph 
(f)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (f)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the CAH and/or its patients;
    (ii) A process for ensuring that all staff specified in paragraph 
(f)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been granted exemptions to the vaccination 
requirements of this section, or those staff for whom COVID-19 
vaccination must be temporarily delayed, as recommended by the CDC, due 
to clinical precautions and considerations;
    (iii) 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;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status of all staff specified in paragraph (f)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the CAH has 
granted, an exemption from the staff COVID-19 vaccination requirements 
based on recognized clinical contraindications or applicable Federal 
laws;
    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions from vaccination, 
has been 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, and for further ensuring that such 
documentation contains
    (A) 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
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the CAH's COVID-19 vaccination 
requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

0
21. Amend Sec.  485.725 by adding paragraph (f) to read as follows:


Sec.  485.725   Condition of participation: Infection control.

* * * * *
    (f) Standard: COVID-19 vaccination of organization staff. The 
organization that provides outpatient physical therapy must develop and 
implement policies and procedures to ensure that all staff are fully 
vaccinated for COVID-19. For purposes of this section, staff are 
considered fully vaccinated if it has been 2 weeks or more since they 
completed a primary vaccination series for COVID-19. The completion of 
a primary vaccination series for COVID-19 is defined here as the 
administration of a single-dose vaccine, or the administration of all 
required doses of a multi-dose vaccine.
    (1) Regardless of clinical responsibility or patient contact, the 
policies and procedures must apply to the following organization staff, 
who provide any care, treatment, or other services for the organization 
and/or its patients:
    (i) Organization employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the organization and/or its patients, under contract or by other 
arrangement.
    (2) The policies and procedures of this section do not apply to the 
following organization staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services outside of the organization setting and who do not have any 
direct contact with patients and other staff specified in paragraph 
(f)(1) of this section; and
    (ii) Staff who provide support services for the organization that 
are performed exclusively outside of the organization setting and who 
do not have any direct contact with patients and other staff

[[Page 61624]]

specified in paragraph (f)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (f)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the organization and/or its 
patients;
    (ii) A process for ensuring that all staff specified in paragraph 
(f)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been granted exemptions to the vaccination 
requirements of this section, or those staff for whom COVID-19 
vaccination must be temporarily delayed, as recommended by the CDC, due 
to clinical precautions and considerations;
    (iii) 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;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status for all staff specified in paragraph (f)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the 
organization has granted, an exemption from the staff COVID-19 
vaccination requirements;
    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions from vaccination, 
has been 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, and for further ensuring that such 
documentation contains
    (A) 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
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the organization's COVID-19 
vaccination requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

0
22. Amend Sec.  485.904 by adding paragraph (c) to read as follows:


Sec.  485.904   Condition of participation: Personnel qualifications.

* * * * *
    (c) Standard: COVID-19 vaccination of center staff. The CMHC must 
develop and implement policies and procedures to ensure that all center 
staff are fully vaccinated for COVID-19. For purposes of this section, 
staff are considered fully vaccinated if it has been 2 weeks or more 
since they completed a primary vaccination series for COVID-19. The 
completion of a primary vaccination series for COVID-19 is defined here 
as the administration of a single-dose vaccine, or the administration 
of all required doses of a multi-dose vaccine.
    (1) Regardless of clinical responsibility or client contact, the 
policies and procedures must apply to the following center staff, who 
provide any care, treatment, or other services for the center and/or 
its clients:
    (i) Center employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the center and/or its clients, under contract or by other arrangement.
    (2) The policies and procedures of this section do not apply to the 
following center staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services outside of the center setting and who do not have any direct 
contact with clients and other staff specified in paragraph (c)(1) of 
this section; and
    (ii) Staff who provide support services for the center that are 
performed exclusively outside of the center setting and who do not have 
any direct contact with clients and other staff specified in paragraph 
(c)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (c)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the CMHC and/or its clients;
    (ii) A process for ensuring that all staff specified in paragraph 
(c)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been granted exemptions to the vaccination 
requirements of this section, or those staff for whom COVID-19 
vaccination must be temporarily delayed, as recommended by the CDC, due 
to clinical precautions and considerations;
    (iii) 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;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status for all staff specified in paragraph (c)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the CMHC has 
granted, an exemption from the staff COVID-19 vaccination requirements;
    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions

[[Page 61625]]

from vaccination, has been 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, and for further 
ensuring that such documentation contains
    (A) 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
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the CMHC's COVID-19 vaccination 
requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED 
BY SUPPLIERS

0
23. The authority citation for part 486 continues to read as follows:

    Authority:  42 U.S.C. 273, 1302, 1320b-8, and 1395hh.


0
24. Amend Sec.  486.525 by adding paragraph (c) to read as follows:


Sec.  486.525   Required services.

* * * * *
    (c) COVID-19 Vaccination of facility staff. The qualified home 
infusion therapy supplier must develop and implement policies and 
procedures to ensure that all staff are fully vaccinated for COVID-19. 
For purposes of this section, staff are considered fully vaccinated if 
it has been 2 weeks or more since they completed a primary vaccination 
series for COVID-19. The completion of a primary vaccination series for 
COVID-19 is defined here as the administration of a single-dose 
vaccine, or the administration of all required doses of a multi-dose 
vaccine.
    (1) Regardless of clinical responsibility or patient contact, the 
policies and procedures must apply to the following qualified home 
infusion therapy supplier staff, who provide any care, treatment, or 
other services for the qualified home infusion therapy supplier and/or 
its patients:
    (i) Qualified home infusion therapy supplier employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the qualified home infusion therapy supplier and/or its patients, under 
contract or by other arrangement.
    (2) The policies and procedures of this section do not apply to the 
following qualified home infusion therapy supplier staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services outside of the settings where home infusion therapy services 
are provided to patients and who do not have any direct contact with 
patients, families, and caregivers, and other staff specified in 
paragraph (c)(1) of this section; and
    (ii) Staff who provide support services for the qualified home 
infusion therapy supplier that are performed exclusively outside of the 
settings where home infusion therapy services are provided to patients 
and who do not have any direct contact with patients, families, and 
caregivers, and other staff specified in paragraph (c)(1) of this 
section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (c)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the qualified home infusion 
therapy supplier and/or its patients;
    (ii) A process for ensuring that all staff specified in paragraph 
(c)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been granted exemptions to the vaccination 
requirements of this section, or those staff for whom COVID-19 
vaccination must be temporarily delayed, as recommended by the CDC, due 
to clinical precautions and considerations;
    (iii) A process for ensuring that the facility follows nationally 
recognized infection prevention and control guidelines intended to 
mitigate the transmission and spread of COVID-19, and which must 
include the implementation of additional precautions for all staff who 
are not fully vaccinated for COVID-19;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status for all staff specified in paragraph (c)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the qualified 
home infusion therapy supplier has granted, an exemption from the staff 
COVID-19 vaccination requirements;
    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions from vaccination, 
has been 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, and for further ensuring that such 
documentation contains;
    (A) 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
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the qualified home infusion 
therapy supplier's COVID-19 vaccination requirements for staff based on 
the recognized clinical contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

[[Page 61626]]

PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES

0
25. The authority citation for part 491 continues to read as follows:

    Authority:  42 U.S.C. 263a and 1302.


0
26. Amend Sec.  491.8 by adding paragraph (d) to read as follows:


Sec.  491.8   Staffing and staff responsibilities.

* * * * *
    (d) COVID-19 vaccination of staff. The RHC/FQHC must develop and 
implement policies and procedures to ensure that all staff are fully 
vaccinated for COVID-19. For purposes of this section, staff are 
considered fully vaccinated if it has been 2 weeks or more since they 
completed a primary vaccination series for COVID-19. The completion of 
a primary vaccination series for COVID-19 is defined here as the 
administration of a single-dose vaccine, or the administration of all 
required doses of a multi-dose vaccine.
    (1) Regardless of clinical responsibility or patient contact, the 
policies and procedures must apply to the following clinic or center 
staff, who provide any care, treatment, or other services for the 
clinic or center and/or its patients:
    (i) RHC/FQHC employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the clinic or center and/or its patients, under contract or by other 
arrangement.
    (2) The policies and procedures of this section do not apply to the 
following clinic or center staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services outside of the clinic or center setting and who do not have 
any direct contact with patients and other staff specified in paragraph 
(d)(1) of this section; and
    (ii) Staff who provide support services for the clinic or center 
that are performed exclusively outside of the clinic or center setting 
and who do not have any direct contact with patients and other staff 
specified in paragraph (d)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (d)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the clinic or center and/or its 
patients;
    (ii) A process for ensuring that all staff specified in paragraph 
(d)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been granted exemptions to the vaccination 
requirements of this section, or those staff for whom COVID-19 
vaccination must be temporarily delayed, as recommended by the CDC, due 
to clinical precautions and considerations;
    (iii) A process for ensuring that the clinic or center follows 
nationally recognized infection prevention and control guidelines 
intended to mitigate the transmission and spread of COVID-19, and which 
must include the implementation of additional precautions for all staff 
who are not fully vaccinated for COVID-19;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status for all staff specified in paragraph (d)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the facility 
has granted, an exemption from the staff COVID-19 vaccination 
requirements;
    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions from vaccination, 
has been 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, and for further ensuring that such 
documentation contains;
    (A) 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
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the clinic's or center's COVID-
19 vaccination requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.

PART 494--CONDITIONS FOR COVERAGE FOR END-STAGE RENAL DISEASE 
FACILITIES

0
27. The authority citation for part 494 continues to read as follows:

    Authority:  42 U.S.C. l302 and l395hh.


0
28. Amend Sec.  494.30 by--
0
a. Redesignating paragraphs (b) and (c) as paragraphs (c) and (d) 
respectively, and
0
b. Adding a new paragraph (b).
    The addition reads as follows:


Sec.  494.30   Condition: Infection control.

* * * * *
    (b) COVID-19 Vaccination of facility staff. The facility must 
develop and implement policies and procedures to ensure that all staff 
are fully vaccinated for COVID-19. For purposes of this section, staff 
are considered fully vaccinated if it has been 2 weeks or more since 
they completed a primary vaccination series for COVID-19. The 
completion of a primary vaccination series for COVID-19 is defined here 
as the administration of a single-dose vaccine, or the administration 
of all required doses of a multi-dose vaccine.
    (1) Regardless of clinical responsibility or patient contact, the 
policies and procedures must apply to the following facility staff, who 
provide any care, treatment, or other services for the facility and/or 
its patients:
    (i) Facility employees;
    (ii) Licensed practitioners;
    (iii) Students, trainees, and volunteers; and
    (iv) Individuals who provide care, treatment, or other services for 
the facility and/or its patients, under contract or by other 
arrangement.
    (2) The policies and procedures of this section do not apply to the 
following facility staff:
    (i) Staff who exclusively provide telehealth or telemedicine 
services outside of the facility setting and who do not have any direct 
contact with

[[Page 61627]]

patients and other staff specified in paragraph (b)(1) of this section; 
and
    (ii) 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 patients and other staff specified in 
paragraph (b)(1) of this section.
    (3) The policies and procedures must include, at a minimum, the 
following components:
    (i) A process for ensuring all staff specified in paragraph (b)(1) 
of this section (except for those staff who have pending requests for, 
or who have been granted, exemptions to the vaccination requirements of 
this section, or those staff for whom COVID-19 vaccination must be 
temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination 
series for a multi-dose COVID-19 vaccine prior to staff providing any 
care, treatment, or other services for the facility and/or its 
patients;
    (ii) A process for ensuring that all staff specified in paragraph 
(b)(1) of this section are fully vaccinated for COVID-19, except for 
those staff who have been granted exemptions to the vaccination 
requirements of this section, or those staff for whom COVID-19 
vaccination must be temporarily delayed, as recommended by the CDC, due 
to clinical precautions and considerations;
    (iii) 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;
    (iv) A process for tracking and securely documenting the COVID-19 
vaccination status for all staff specified in paragraph (b)(1) of this 
section;
    (v) 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;
    (vi) A process by which staff may request an exemption from the 
staff COVID-19 vaccination requirements based on an applicable Federal 
law;
    (vii) A process for tracking and securely documenting information 
provided by those staff who have requested, and for whom the facility 
has granted, an exemption from the staff COVID-19 vaccination 
requirements;
    (viii) A process for ensuring that all documentation, which 
confirms recognized clinical contraindications to COVID-19 vaccines and 
which supports staff requests for medical exemptions from vaccination, 
has been 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, and for further ensuring that such 
documentation contains
    (A) 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
    (B) A statement by the authenticating practitioner recommending 
that the staff member be exempted from the facility's COVID-19 
vaccination requirements for staff based on the recognized clinical 
contraindications;
    (ix) A process for ensuring the tracking and secure documentation 
of the vaccination status of staff for whom COVID-19 vaccination must 
be temporarily delayed, as recommended by the CDC, due to clinical 
precautions and considerations, including, but not limited to, 
individuals with acute illness secondary to COVID-19, and individuals 
who received monoclonal antibodies or convalescent plasma for COVID-19 
treatment; and
    (x) Contingency plans for staff who are not fully vaccinated for 
COVID-19.
* * * * *

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-23831 Filed 11-4-21; 8:45 am]
BILLING CODE 4120-01-P