Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination
| Published date | 05 November 2021 |
| Record Number | 2021-23831 |
| Section | Rules and Regulations |
| Court | Centers For Medicare & Medicaid Services |
Federal Register, Volume 86 Issue 212 (Friday, November 5, 2021)
[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.
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\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)).
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\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\
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\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.
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\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.
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\161\ Section 1819(d)(4)(B) of the Act. Section 1919(d)(4)(B) is
nearly identical, but omitting ``well-being''.
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Since the onset of the PHE, we have revised the requirements for
LTC facilities through three IFCs focused on COVID-19 testing, data
reporting and vaccine requirements for residents and staff.
Specifically, we have published the following IFCs:
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.
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Sections 1905(c) and (d) of the Act gave the Secretary authority to
prescribe regulations for intermediate care facility services in
facilities for individuals with intellectual disabilities or persons
with related conditions. The ICFs-IID Conditions of Participation were
issued on June 3, 1988 (53 FR 20496) and were last updated on May 13,
2021 (86 FR 20448). There are currently 5,768 Medicare- and/or
Medicaid-certified ICFs-IID. As of April 2021, 4,661 of the 5,770 are
small (1 to 8 beds) in size, but there are 1,107 that are larger (14 or
more beds) facilities. These facilities serve over 64,812 individuals
with intellectual disabilities and other related conditions. All must
qualify for Medicaid coverage. While national data about ICFs-IID
clients is limited, we take an example from Florida where almost one
quarter of clients (23 percent) require 24-hour nursing services and a
medical care plan in addition to their services plans.\163\ Data from a
single State are not nationally representative and thus we are unable
to generalize, but it is illustrative.
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\163\ 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.
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Transplant centers, psychiatric hospitals, and swing beds are
governed by the infection control CoPs for hospitals, and are thus
subject to the staff vaccination requirements issued in this IFC. We
are particularly concerned about transplant center patients, who are
among the most severely immunocompromised individuals due to anti-
rejection medications that ensure the function of transplanted organs.
An additional member of the transplant ecosystem, Organ Procurement
Organizations (OPOs) coordinate and support donation, recovery, and
placement of organs. As OPO staff do not provide patient care, and
typically work in locations removed from health care facilities, we are
not issuing vaccination requirements for OPOs in this IFC. That said,
we note that the vaccination policies required in this IFC apply to all
individuals who provide care, treatment, or other services for the
hospital and/or its patients, under contract or other arrangement.
Accordingly, OPO staff members that provide organ transplantation
services directly to hospital and transplant center patients and
families must meet the vaccination requirements of this IFC.
For these reasons and the reasons set forth in section II.A. of
this IFC, we are adding a new regulatory requirement at Sec. 482.42(g)
related to establishing and implementing policies and procedures for
COVID-19 vaccination of all staff (including employees; licensed
practitioner; students, trainees, and volunteers; and other
individuals) who provide care, treatment, or other services for the
provider or its patients.
2. Critical Access Hospitals (CAHs)
CAHs are rural hospitals that have been designated as critical
access hospitals by the State, in a State that has established a State
Medicare Rural Hospital Flexibility Program. These hospitals have 25 or
fewer acute care inpatient beds (except as permitted for CAHs having
distinct part units under Sec. 485.647, where the beds in the distinct
part are excluded from the 25 inpatient-bed count limit specified in
Sec. 485.620(a)), must be more than 35 miles away from another
hospital, and provide emergency care services 24 hours a day, 7 days a
week. On average, acute patients stay in CAHs for less than 96 hours.
CAHs may be granted approval to provide post-hospital skilled nursing
care, may offer hospice care under the Medicare hospice benefit, and
may operate a psychiatric and/or rehabilitation distinct part unit of
up to 10 beds each. CAHs also administer general and specialty care
that cannot safely be provided in other settings, under the supervision
of physicians and licensed practitioners. They may operate as
independent institutions or as part of a larger health care system.
Generally, they serve to help ensure access to health-care services in
rural communities.
Section 1820 of the Act sets forth the conditions for certifying a
facility as a CAH to include meeting such other criteria as the
Secretary may require. Medicare-certified CAHs must meet the Conditions
of Participation (CoPs) at 42 CFR part 485 subpart F, originally issued
May 26, 1993 (58 FR 30630). These CoPs contain specific requirements
for infection control and prevention at Sec. 485.640. Much like a
standard hospital, infection control within a CAH is especially
important, because CAHs treat individuals with infectious diseases
(such as COVID-19) and healthy yet higher-risk individuals (for
example, pregnant and post-partum individuals, infants, transplant
recipients, etc.) within the same facility.
While organ transplants are not performed in CAHs, we note that
organ donors may be CAH patients, and organ donation and recovery may
occur in CAHs. We note that the vaccination policies required in this
IFC apply to all individuals who provide care, treatment, or other
services for the hospital and/or its patients, under contract or other
arrangement. Accordingly, OPO staff members that provide organ donation
and transplantation services directly to CAH patients and families must
meet the vaccination requirements of this IFC in the same manner as
they meet such requirements for hospitals.
For these reasons and the reasons set forth in section II.A. of
this IFC, we are adding a new regulatory requirement at Sec.
485.640(f) related to establishing and implementing policies and
procedures for COVID-19 vaccination of all staff (including employees;
licensed practitioner; students, trainees, and volunteers; and other
individuals) who provide care, treatment, or other services for the
provider or its patients.
3. Ambulatory Surgical Centers (ASCs)
ASCs are distinct entities that operate exclusively for the purpose
of providing surgical services to patients not requiring
hospitalization, and in which the expected duration of services would
not exceed 24 hours following an
[[Page 61578]]
admission. The surgical services performed in ASCs generally are
scheduled, non-life-threatening procedures that can be safely performed
in either a hospital setting (inpatient or outpatient) or in an ASC.
Currently, there are 6,071 Medicare-certified ASCs in the U.S.
Section 1833(i)(1)(A) of the Act authorizes the Secretary to
specify those surgical procedures that can be performed safely in an
ASC. Section 1832(a)(2)(F)(i) of the Act defines an ASC as a facility
``which meets health, safety, and other standards specified by the
Secretary in regulations . . .''.
The ASC Conditions for Coverage (CfCs) at 42 CFR part 416, subpart
C, are the minimum health and safety standards a center must meet to
obtain Medicare certification. The ASC CfCs were issued on August 5,
1982 (47 FR 34082), and the Conditions related to infection control
were last updated on November 18, 2008 (73 FR 68502, 68813). Section
416.51, Infection control, requires ASCs to maintain an infection
control program that seeks to minimize infections and communicable
diseases. In this IFC we are adding new Sec. 416.51(c) which requires
ASCs to meet the same COVID-19 vaccination of staff requirements as
those we are issuing for the other providers and suppliers identified
in this rule.
During the COVID-19 pandemic and PHE, hospitals moved many non-
elective surgical procedures to ASCs and other outpatient settings.
Such movement conserves hospital resources for treating severe COVID-
19, performing more urgent procedures, and caring for patients with
more critical health needs. Moreover, referring patients in need of
suitable procedures to ASCs limits the overall number of individuals
visiting the hospital setting, thereby inhibiting spread of infection.
ASCs also offer an alternative setting for outpatient surgery for
individuals reluctant to enter a hospital due to fears of COVID-19
exposure. Based on these and other factors, the demand for ASC services
has increased.\168\
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\168\ 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 (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.
---------------------------------------------------------------------------
\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.
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\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.
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BILLING CODE 4120-01-P
[[Page 61587]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.024
[[Page 61588]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.025
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.
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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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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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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.)
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\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\
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\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.
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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.
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\249\ https://aspe.hhs.gov/pdf-report/guidelines-regulatory-impact-analysis.
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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.)
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\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).
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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/.
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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.
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\260\ CDC Data Tracker at https://covid.cdc.gov/covid-data-tracker/#health-care-personnel_healthcare-deaths.
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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
