Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination, 61555-61627 [2021-23831]
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Authority: 33 U.S.C. 941; 29 U.S.C. 653,
655, 657; Secretary of Labor’s Order No. 12–
71 (36 FR 8754), 8–76 (41 FR 25059), 9–83
(48 FR 35736), 1–90 (55 FR 9033), 6–96 (62
FR 111), 3–2000 (65 FR 50017), 5–2002 (67
FR 65008), 5–2007 (72 FR 31160), 4–2010 (75
FR 55355), 1–2012 (77 FR 3912), or 8–2020
(85 FR 58393), as applicable; and 29 CFR
1911.
Sections 1918.90 and 1918.110 also issued
under 5 U.S.C. 553.
Section 1918.100 also issued under 49
U.S.C. 5101 et seq. and 5 U.S.C. 553.
12. Add subpart K to part 1918 to read
as follows:
■
Subpart K—COVID–19.
Sec.
1918.107–1918.109 [Reserved]
1918.110 COVID–19.
1918.107 through 1918.109 [Reserved]
§ 1918.110
COVID–19.
The requirements applicable to
longshoring work under this section are
identical to those set forth at 29 CFR
1910.501.
PART 1926—SAFETY AND HEALTH
REGULATIONS FOR CONSTRUCTION
Subpart B—Applicability of Standards
16. Amend § 1928.21 by adding
paragraph (a)(8) to read as follows:
■
§ 1928.21 Applicable standards in 29 CFR
part 1910.
(a) * * *
(8) COVID–19—§ 1910.501, but only
with respect to—
(i) Agricultural establishments where
eleven (11) or more employees are
engaged on any given day in hand-labor
operations in the field; and
(ii) Agricultural establishments that
maintain a temporary labor camp,
regardless of how many employees are
engaged on any given day in hand-labor
operations in the field.
*
*
*
*
*
[FR Doc. 2021–23643 Filed 11–4–21; 8:45 am]
■
13. The authority citation for part
1926 is revised to read as follows:
BILLING CODE 4510–26–P
Authority: 40 U.S.C. 3704; 29 U.S.C. 653,
655, and 657; and Secretary of Labor’s Order
No. 12–71 (36 FR 8754), 8–76 (41 FR 25059),
9–83 (48 FR 35736), 1–90 (55 FR 9033), 6–
96 (62 FR 111), 3–2000 (65 FR 50017), 5–
2002 (67 FR 65008), 5–2007 (72 FR 31159),
4–2010 (75 FR 55355), 1–2012 (77 FR 3912),
or 8–2020 (85 FR 58393), as applicable; and
29 CFR part 1911.
Sections 1926.58, 1926.59, 1926.60, and
1926.65 also issued under 5 U.S.C. 553 and
29 CFR part 1911.
Section 1926.61 also issued under 49
U.S.C. 1801–1819 and 5 U.S.C. 553.
Section 1926.62 also issued under sec.
1031, Public Law 102–550, 106 Stat. 3672 (42
U.S.C. 4853).
Section 1926.65 also issued under sec. 126,
Public Law 99–499, 100 Stat. 1614 (reprinted
at 29 U.S.C.A. 655 Note) and 5 U.S.C. 553.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Subpart D—Occupational Health and
Environmental Controls
■
COVID–19.
The requirements applicable to
construction work under this section are
identical to those set forth at 29 CFR
1910.501 Subpart U.
PART 1928—OCCUPATIONAL SAFETY
AND HEALTH STANDARDS FOR
AGRICULTURE
15. The authority citation for part
1928 is revised to read as follows:
■
Authority: Sections 4, 6, and 8 of the
Occupational Safety and Health Act of 1970
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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
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment
period.
AGENCY:
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.
SUMMARY:
14. Add § 1926.58 to read as follows:
§ 1926.58
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(29 U.S.C. 653, 655, 657); Secretary of Labor’s
Order No. 12–71 (36 FR 8754), 8–76 (41 FR
25059), 9–83 (48 FR 35736), 1–90 (55 FR
9033), 6–96 (62 FR 111), 3–2000 (65 FR
50017), 5–2002 (67 FR 65008), 4–2010 (75 FR
55355), or 8–2020 (85 FR 58393), as
applicable; and 29 CFR 1911.
Section 1928.21 also issued under 49
U.S.C. 1801–1819 and 5 U.S.C. 553.
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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 https://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.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
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 press@
cms.hhs.gov.
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: https://
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.
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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:
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• Ambulatory Surgical Centers (ASCs)
(§ 416.51)
• Hospices (§ 418.60)
• Psychiatric residential treatment
facilities (PRTFs) (§ 441.151)
• Programs of All-Inclusive Care for the
Elderly (PACE) (§ 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) (§ 482.42)
• Long Term Care (LTC) Facilities,
including Skilled Nursing Facilities
(SNFs) and Nursing Facilities (NFs),
generally referred to as nursing homes
(§ 483.80)
• Intermediate Care Facilities for
Individuals with Intellectual
Disabilities (ICFs–IID) (§ 483.430)
• Home Health Agencies (HHAs)
(§ 484.70)
• Comprehensive Outpatient
Rehabilitation Facilities (CORFs)
(§§ 485.58 and 485.70)
• Critical Access Hospitals (CAHs)
(§ 485.640)
• Clinics, rehabilitation agencies, and
public health agencies as providers of
outpatient physical therapy and
speech-language pathology services
(§ 485.725)
• Community Mental Health Centers
(CMHCs) (§ 485.904)
• Home Infusion Therapy (HIT)
suppliers (§ 486.525)
• Rural Health Clinics (RHCs)/Federally
Qualified Health Centers (FQHCs)
(§ 491.8)
• End-Stage Renal Disease (ESRD)
Facilities (§ 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
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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
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 postCOVID 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
1 https://www.phe.gov/emergency/events/
COVID19/Pages/2019-Public-Health-and-MedicalEmergency-Declarations-and-Waivers.aspx.
2 https://covid.cdc.gov/covid-datatracker#datatracker-home.
3 https://www.statnews.com/2021/09/20/covid19-set-to-overtake-1918-spanish-flu-as-deadliestdisease-in-american-history.
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Given recent estimates of
undiagnosed infections and underreported deaths, these figures likely
underestimate the full impact.4 In
addition, these figures fail to capture the
significant, detrimental effects of postacute illness, including nervous system
and neurocognitive disorders,
cardiovascular disorders,
gastrointestinal disorders, and signs and
symptoms related to poor general wellbeing, 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
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
4 https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC8354557/.
5 https://jamanetwork.com/journals/jamanet
workopen/fullarticle/2784918.
6 https://pubmed.ncbi.nlm.nih.gov/34469474/.
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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
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
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-varianttransmission-cdc-chickenpox.
9 https://www.cdc.gov/coronavirus/2019-ncov/
hcp/infection-control-recommendations.html.
10 https://www.cms.gov/files/document/qso-2108-nltc.pdf.
11 https://www.cms.gov/files/document/qso-2107-psych-hospital-prtf-icf-iid.pdf.
12 https://www.cms.gov/files/document/qso-2038-nh-revised.pdf.
13 https://jamanetwork.com/journals/jamanet
workopen/fullarticle/2770287.
14 https://jamanetwork.com/journals/jamanet
workopen/fullarticle/2777317.
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.
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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
19 https://www.medrxiv.org/content/10.1101/
2021.02.16.21251625v1.
20 https://jamanetwork.com/journals/jama/full
article/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
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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
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
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-influenzavaccination-of-healthcare-personnel/E83D4D87
FBBBD80C66A2A4926D00F4B8.
34 https://www.cdc.gov/phlp/publications/topic/
vaccinationlaws.html.
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-vaccinatedpeople.html#ref43.
37 https://www.medrxiv.org/content/10.1101/
2021.08.20.21262158v1.full.pdf.
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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
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
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.
42 Roberts, S., Aniskiewicz, M., Choi, S., Pettker,
C., & Martinello, R. (2021). Correlation of healthcare
worker vaccination on inpatient healthcareassociated 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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for ongoing healthcare-associated
COVID–19 transmission risk is
sufficiently alarming in and of itself to
compel CMS to take action.
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
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
44 https://jamanetwork.com/journals/
jamainternalmedicine/fullarticle/2769096).
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-HOMEHEALTH-CARE-ON-THE-FRONTLINES-OF-COVID19-AND-CONTINUES-TO-BE-IN-A-FRAGILEFINANCIAL-STATE.pdf.
48 https://www.urban.org/sites/default/files/
publication/103651/delayed-and-forgone-healthcare-for-nonelderly-adults-during-the-covid-19pandemic_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
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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 postacute 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
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-crowdedfrom-covid-1-in-5-american-families-delays-healthcare.
54 https://www.ahcancal.org/News-andCommunications/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.
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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–
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/coviddata/covidview/; accessed September 24,
2021.
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61559
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
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.
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
61 https://www.cdc.gov/mmwr/volumes/70/wr/
mm7037e1.htm?s_cid=mm7037e1_w.
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/ltcvaccination-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/retailpharmacy-program/.
67 https://www.cdc.gov/vaccines/imz-managers/
coverage/covidvaxview/interactive.html..
68 https://covid.cdc.gov/covid-data-tracker/
#health-care-personnel.
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reinfections.69 Consequently, CDC
recommends that all people be
vaccinated, regardless of their history of
symptomatic or asymptomatic SARS–
CoV–2 infection.70
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
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-vaccinesus.html#CoV-19-vaccination.
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/
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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.
It is essential to reduce the
transmission and spread of COVID–19,
and vaccination is central to any multipronged 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 FDAauthorized 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.
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
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#000000externalicon.
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.
77 https://www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/fully-vaccinated-people.html.
Accessed 10/14/2021.
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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
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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
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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.
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
78 https://www.osha.gov/coronavirus/ets.
Accessed 10/6/2021.
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are screened prior to entry, and people
with suspected or confirmed COVID–19
are not permitted to enter, (4) welldefined 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, offsite 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
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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.
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
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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
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.
81 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/safety/safety-of-vaccines.html#
:∼:text=Millions%20of%20people%20in%20the,
monitoring%20in%20US%20history.
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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
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
82 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/distributing/steps-ensure-safety.html.
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-healthpolicy/issue-brief/racial-diversity-within-covid-19vaccine-clinical-trials-key-questions-and-answers/.
85 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/expect/after.html.
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(ACIP) and CDC have concluded the
lifesaving benefits of COVID–19
vaccination outweigh the risks or
possible side effects.86
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
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.
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-preparednessand-response/coronavirus-disease-2019-covid-19/
comirnaty-and-pfizer-biontech-covid-19-vaccine.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Throughout this rule, we will use the
terms ‘‘additional dose’’ and ‘‘booster’’
to differentiate between the two use
cases outlined above.
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.
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’’ (vsafe) 93 to self-report on one’s health
after receiving a COVID–19 vaccine. Vsafe 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 vsafe information sheet telling them how
to enroll in v-safe or they can register at
https://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.
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
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.
91 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/different-vaccines.html.
92 https://www.fda.gov/emergency-preparednessand-response/coronavirus-disease-2019-covid-19/
covid-19-vaccines.
93 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/safety/vsafe.html.
94 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/faq.html.
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.
98 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/fully-vaccinated.html. Accessed 10/16/
2021.
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61563
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/clinicalconsiderations/covid-19-vaccinesus.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
99 https://www.who.int/emergencies/diseases/
novel-coronavirus-2019/covid-19-vaccines.
Accessed September 14, 2021.
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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 nonFDA approved or authorized vaccine,
and a vaccine listed by WHO for
emergency use.
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, FDAapproved, 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.
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
100 https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/fully-vaccinated-guidance.html.
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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
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
101 https://www.cdc.gov/vaccines/covid-19/
clinical-considerations/covid-19-vaccines-us.html#
Accessed 9/14/2021.
102 https://www.fda.gov/news-events/pressannouncements/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
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)).
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
106 https://www.fda.gov/emergencypreparedness-and-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization.
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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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
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
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
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.
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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safeguarding patients, residents, clients,
PACE program participants, and staff.
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
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
122 https://www.hematology.org/newsroom/pressreleases/2021/joint-statement-in-support-of-covid19-vaccine-mandates-for-all-workers-in-health.
123 https://press.aarp.org/2021-8-12-New-AARPAnalysis-Shows-Nursing-Homes-Vaccination-RatesStill-Well-Short-of-Benchmark-as-COVID-CasesTrend-Upwards.
124 https://justiceinaging.org/justice-in-agingsupports-mandatory-covid-vaccinations-in-longterm-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.
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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 nonprofit 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
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
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127 Ibid.
128 https://www.ahcancal.org/News-andCommunications/Press-Releases/Pages/
AHCANCAL-Issues-Policy-Statement-RegardingCOVID-19-Vaccinations-of-Long-Term-CarePersonnel.aspx. Accessed 10/16/2021.
129 https://news.christianacare.org/2021/09/safecare-safe-workplace-we-are-vaccinated/. Accessed
10/15/2021.
130 https://www.delawareonline.com/story/news/
health/2021/09/27/christianacare-fires-employeesnot-complying-vaccine-mandate/5887784001/.
Accessed 10/15/2021.
131 https://www.houstonmethodist.org/leadingmedicine-blog/articles/2021/jun/houstonmethodist-requires-covid-19-vaccine-forcredentialed-doctors/. Accessed 10/15/202021.
132 https://www.novanthealth.org/home/about-us/
newsroom/press-releases/newsid33987/2576/
novant-health-update-on-mandatory-covid-19vaccination-program-for-employees.aspx. Accessed
10/15/2021.
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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.
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
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.
A confluence of structural and
epidemiological factors has also
contributed to disparate risk for COVID–
19 infection, severe illness, and death in
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.
135 https://www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/underlying-evidencetable.html.
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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 longstanding 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
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.
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.
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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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.
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
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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
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 Medicaidcertified 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
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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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 Medicaidcertified 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
143 https://wwwnc.cdc.gov/eid/article/26/8/200679_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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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.
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.
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.
These Federal laws continue to apply
during the PHE and, in some instances,
require employers to offer
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-youshould-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.
149 Genetic Information Nondiscrimination Act of
2008. Public Law 110–233.
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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.
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
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/ S22132600(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.
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/M213150. 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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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.
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
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
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.
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.
155 https://theconversation.com/half-ofunvaccinated-workers-say-theyd-rather-quit-thanget-a-shot-but-real-world-data-suggest-few-arefollowing-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-healthwatch/despite-protests-98-henry-ford-hospitalworkers-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/M213150. 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-workersmandate.html.
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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)
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• 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) homebased 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.’’
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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.
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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 § 483.80(h),
established for the LTC facility COVID–
19 testing requirements in the
September 2, 2020 COVID–19 IFC. As in
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the May 13, 2021 COVID–19 IFC, we
considered applying the § 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 § 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 § 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
§ 483.80(h). In addition to facilityemployed 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
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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
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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
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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
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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-covidvac/). This is a generic Excelbased 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
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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-clinicalconsiderations.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.
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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-19and-ada-rehabilitation-act-and-othereeo-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://
160 https://www.eeoc.gov/laws/guidance/section12-religious-discrimination.
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downloads/RELIGIOUS%20REQUEST%
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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
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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–
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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.
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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
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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
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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.
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D. Residential Congregate Care Facilities 1819 and 1919 of the Act, Medicare- and
Medicaid-participating LTC facilities
Individuals residing in congregate
‘‘must meet such other requirements
care settings such as LTC facilities,
relating to the health, safety, and wellintermediate care facilities for
individuals with intellectual disabilities being of residents or relating to the
physical facilities thereof as the
(ICFs-IID), and psychiatric residential
Secretary may find necessary.’’ 161 More
treatment facilities for individuals
specifically,
the infection control
under 21 years of age (PRTFs),
requirements for LTC facilities are based
regardless of health or medical
on sections 1819(d)(3)(A) (for skilled
conditions, are at greater risk of
nursing facilities) and 1919(d)(3)(A) (for
acquiring infections. This higher risk
nursing facilities) of the Act, which both
applies to most bacterial and viral
require that a facility establish and
infections, including SARS–CoV–2.
maintain an infection control program
Staff working in these facilities often
designed to provide a safe, sanitary, and
work across facility types (that is, LTC
comfortable environment in which
facilities, group homes, assisted living
residents reside and to help prevent the
facilities, in home and communitydevelopment and transmission of
based services settings, and even
disease and infection.
different congregate settings within the
Since the onset of the PHE, we have
employer’s purview), and for different
revised the requirements for LTC
providers, which may contribute to
facilities through three IFCs focused on
virus transmission. Other factors
COVID–19 testing, data reporting and
impacting virus transmission in these
vaccine requirements for residents and
settings might include: Clients or
residents who are employed outside the staff. Specifically, we have published
the following IFCs:
congregate living setting; clients or
• The first IFC, ‘‘Medicare and
residents who require close contact with
Medicaid Programs, Basic Health
staff or direct service providers; clients
Program, and Exchanges; Additional
or residents who have difficulty
understanding information or practicing Policy and Regulatory Revisions in
Response to the COVID–19 Public
preventive measures; and clients or
Health Emergency and Delay of Certain
residents in close contact with each
Reporting Requirements for the Skilled
other in shared living or working
Nursing Facility Quality Reporting
spaces.
Program’’ (FR27550) was published on
1. Long Term Care Facilities (Skilled
May 8, 2020. The May 8, 2020 COVID–
Nursing Facilities and Nursing
19 IFC established requirements for LTC
Facilities)
facilities to report information related to
Long term care (LTC) facilities, a
COVID–19 cases among facility
category that includes Medicare skilled
residents and staff, we received 299
nursing facilities (SNFs) and Medicaid
public comments. About 161, or over
nursing facilities (NFs), also collectively one-half of those comments, addressed
called nursing homes, must meet the
the requirement for COVID–19 reporting
consolidated Medicare and Medicaid
for LTC facilities set forth at § 483.80(g).
requirements for participation
• The second IFC, ‘‘Medicare and
(requirements) for LTC facilities (42 CFR Medicaid Programs, Clinical Laboratory
part 483, subpart B) that were first
Improvement Amendments (CLIA), and
published in the Federal Register on
Patient Protection and Affordable Care
February 2, 1989 (54 FR 5316). These
Act; Additional Policy and Regulatory
regulations have been revised and
Revisions in Response to the COVID–19
added to since that time, principally as
Public Health Emergency’’ (FR54873)
a result of legislation or a need to
was published on September 2, 2020.
address specific issues. The
The September 2, 2020 COVID–19 IFC
requirements were comprehensively
strengthened CMS’ ability to enforce
revised and updated in October 2016
compliance with LTC facility reporting
(81 FR 68688), including a
requirements and established a new
comprehensive update to the
requirement for LTC facilities to test
requirements for infection prevention
facility residents and staff for COVID–
and control.
19. We received 171 public comments
CMS establishes requirements for
in response to the September 2, 2020
acceptable quality in the operation of
COVID–19 IFC, of which 113 addressed
health care entities. LTC facilities are
the requirement for COVID–19 testing of
required to comply with the
LTC facility residents and staff set forth
requirements in 42 CFR part 483,
at § 483.80(h).
subpart B, to receive payment under the
Medicare or Medicaid programs. In
161 Section 1819(d)(4)(B) of the Act. Section
addition to several discrete
1919(d)(4)(B) is nearly identical, but omitting ‘‘wellbeing’’.
requirements set out under sections
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• 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
§§ 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 §§ 483.430, Facility Staffing
requirements, and 483.460, Health Care
Services for Clients.
Under § 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)
(§ 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 § 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 § 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
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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 § 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 § 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
§§ 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.
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.
Currently, the Conditions of
Participation: ‘‘Health Care Services’’ at
§ 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
§ 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 §§ 441.151 through
441.182, and the Condition of
Participation on the use of restraint and
seclusion at § 483.350 through
§ 483.376.
163 https://www.floridaarf.org/assets/Files/ICF-
162 https://www.cdc.gov/coronavirus/2019-ncov/
need-extra-precautions/.
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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
§ 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
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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. Medicareparticipating 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
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
§ 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.
164 https://www.nytimes.com/live/2021/09/23/
world/covid-delta-variant-vaccine#covid-alaskahospital, accessed 10/18/2021.
165 https://www.healthline.com/health-news/howsurging-delta-variant-is-leading-to-rationed-care-athospitals, accessed 10/18/2021.
166 https://www.aamc.org/news-insights/worstsurge-we-ve-seen-some-hospitals-delta-hot-spotsclose-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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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
§ 485.647, where the beds in the distinct
part are excluded from the 25 inpatientbed count limit specified in
§ 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
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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 § 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
§ 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
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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
§ 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 nonelective 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
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
168 https://www.beckersasc.com/asc-news/5-wayscovid-19-affected-ascs-in-2020.html. Accessed 10/
17/2021.
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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
§ 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 lifesustaining services to individuals
without kidney function, including
dialysis, medication, routine
evaluations and monitoring, nutritional
counselling, social support, and organ
transplantation evaluation and referral.
Section 1881(b)(1)(A) of the Act
authorizes the Secretary to pay only
those dialysis facilities ‘‘which meet
such requirements as the Secretary shall
by regulation prescribe for institutional
dialysis services and supplies . . .’’ also
known as CfCs. The ESRD facility CfCs
at 42 CFR part 494 are the minimum
health and safety rules that all
Medicare- and Medicaid-certified
dialysis facilities must meet in order to
participate in the programs. The ESRD
CfCs were initially issued in 1976 and
were comprehensively revised in 2008
(73 FR 20370). There are currently 7,893
Medicare-certified ESRD facilities in the
U.S., serving over 500,000 patients.
Routine dialysis treatments, typically
delivered 3 times per week, remove
toxins from a patient’s blood and are
necessary to sustain life. Dialysis
treatments are most often delivered in
the ESRD facility but can be performed
by the patients themselves at home, or
in the patient’s nursing facility with
assistance. ESRD facilities serve patients
whether they are diagnosed with
COVID–19 or not, and people receiving
dialysis cannot always be adequately
distanced from one another during
treatment. In-center dialysis precludes
social distancing because it involves
being in close proximity (<6 feet) to
caregivers and fellow patients for
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extended periods of time (12–15 hours
per week). Because dialysis patients are
not able to defer dialysis sessions, incenter dialysis patients are at increased
risk for developing COVID–19 due in
part to difficulty maintaining physical
distancing.169 Many ESRD patients are
also residents of LTC facilities or other
congregate living settings, which is also
a risk factor for COVID–19.170 Further,
individuals with kidney failure on
dialysis may have a higher risk of worse
outcomes.171
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
For these reasons and the reasons set
forth in section II.A. of this IFC, we are
adding a new regulatory requirement at
§ 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,
169 Am J Kidney Dis. 2020 Nov;76(5):690–695.e1.
doi: 10.1053/j.ajkd.2020.07.001. Epub 2020 Jul 15.
170 https://www.jhunewsletter.com/article/2020/
09/hopkins-finds-dialysis-patients-at-greater-riskof-covid-19.
171 CJASN March 2021, 16 (3) 452–455; DOI:
https://doi.org/10.2215/CJN.12360720.
172 https://www.synas.plus/nhsn/covid19/dialvaccination-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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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
§ 410.110 and conditions for Medicare
payment of partial hospitalization
services at 42 CFR 424.24(e).
Currently there are 129 Medicarecertified 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 § 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
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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
§ 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 inperson 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.
Currently, there are 159 Medicarecertified CORFs in the U.S. Section
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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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 § 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 § 485.58(d)(4), state that
personnel that do not meet the
qualifications specified in § 485.70 may
be used by the facility in assisting
qualified staff. We recognize this
sentence is inconsistent with newly
added § 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 § 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
§ 485.58(d)(4) to state that personnel
that do not meet the qualifications
specified in § 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
§ 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
§ 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.
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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) crossreferences 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 § 405.2401(b).
The definition at § 405.2401 includes an
entity that has entered into an
agreement with CMS to meet Medicare
Program requirements under § 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 § 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
176 https://www.hrsa.gov/coronavirus/ruralhealth-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/healthcenter-program. Accessed 10/6/2021.
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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.
Currently, there are 4,933 Medicareand 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 § 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
§ 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.
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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 speechlanguage 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 speechlanguage pathology services’’ for
consistency with current regulatory
language. Patients receive services from
organizations due to loss of functional
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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 inperson 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 threedimensional 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.
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 infectioncontrol committee with responsibility
for overall infection control. We are
adding new paragraph (f) to § 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
§ 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
179 American Physical Therapy Association. May
2021. Impact of COVID–19 on the Physical Therapy
Profession Over One Year.
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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 lifesustaining, 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
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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, §§ 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
§ 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
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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 §§ 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
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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
§ 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 therapyassociated 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, §§ 486.500 through
486.525.
The nature of the home setting
presents different challenges than incenter services as well as the
administration of the particular
medications. The items and equipment
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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, § 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
§ 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
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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
§ 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
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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
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61583
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–19associated 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.
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
180 https://emergency.cdc.gov/han/2021/
han00447.asp.
181 Internal estimates based on data published at
https://www.cdc.gov/coronavirus/2019-ncov/coviddata/covidview/; 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.
185 https://covid.cdc.gov/covid-data-tracker/
#datatracker-home.
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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
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.
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
186 https://www.cdc.gov/flu/professionals/acip/
background-epidemiology.htm.
187 Ibid.
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.
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/fluseason.htm.
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more infectious and has greater rates of
mortality, hospitalizations, and severe
illness than influenza. Accordingly, it is
imperative that the risk for healthcareassociated 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 longterm 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
194 Ibid.
195 https://www.aamc.org/news-insights/pressreleases/major-health-care-professionalorganizations-call-covid-19-vaccine-mandates-allhealth-workers. Accessed 10/06/2021.
196 https://www.kff.org/coronavirus-covid-19/pollfinding/kff-covid-19-vaccine-monitor-september2021/. Accessed 10/06/2021.
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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 Deltavariant-driven surging case counts
beginning in summer 2021;
demonstrated efficacy, safety and realworld 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.
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.
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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
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
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/ltcvaccination-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.
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.
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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.
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
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/.
214 https://www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/fully-vaccinated-people.html.
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61585
outcomes including hospitalization and
death. The ASPE analysis of individuallevel 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 nowdominant Delta variant.216 217
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
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/coronaviruscovid-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-vaccinatedpeople.html#ref43.
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among unvaccinated individuals with
primary infections.220
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 healthcare 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
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220 https://www.medrxiv.org/content/10.1101/
2021.08.20.21262158v1.full.pdf.
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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:
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• 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.
BILLING CODE 4120–01–P
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–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
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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:
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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
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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
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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
§ 416.51(c), ‘‘COVID–19 Vaccination of
Staff’’
1. Policies and Procedures
At § 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
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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 × $77). For the ICPs
in all 6,071 ASCs, the burden would be
48,568 hours (8 × 6,071) at an estimated
cost of $3,739,736 ($616 × 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 × $98). For the
administrators in all 6,071 ASCs, the
burden would be 12,142 hours (2 ×
6,071) at an estimated cost of $1,189,916
($196 × 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.
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Hence, the burden for these
documentation requirements for all
6,071 ASCs would be 16,660 (0.0833 ×
200,000) hours at an estimated cost of
$1,282,820 (16,660 × $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
§ 418.60(d), ‘‘COVID–19 Vaccination of
Facility Staff’’
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1. Policies and Procedures
At § 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 § 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 § 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
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and procedures. Thus, for each hospice,
the burden for the RN would be 8 hours
at a cost of $632 (8 hours × $79). For all
5,556 hospices, the burden would be
44,448 hours (8 hours × 5,556) at an
estimated cost of $3,511,392 ($632 ×
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 × $122). For all
5,556 hospices, the total burden would
be 11,112 hours (2 × 5,556) at an
estimated cost of $1,355,664 (5,556 ×
$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
× 340,000) hours at an estimated cost of
$2,237,438 (28,322 × 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 § 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
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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
§ 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 × $74). For all 141 PACE
organizations, the burden would be
1,128 hours (8 hours × 141) at an
estimated cost of $83,472 (592 × 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 ×
122). For all 141 PACE organizations,
the total burden would be 282 hours (2
× 141) at an estimated cost of $34,404
(141 × $244).
Thus, the total burden for all 141
PACE organizations to comply with the
requirements for the policies and
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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 × 10,000) hours at an estimated
cost of $61,642 (833 × 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
§ 482.42(g), ‘‘COVID–19 Vaccination of
Hospital Staff’’
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1. Policies and Procedures
At § 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 § 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
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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 × 79).
For the IPs in all 5,194 hospitals, the
burden would be 41,552 hours (8 hours
× 5,194) at an estimated cost of
$3,282,608 (632 × 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 × 2) at an estimated
cost of $488 (4 × $122). The total burden
for all 5,194 hospitals would be 20,776
hours (4 × 5,194) at an estimated cost of
$2,534,672 (5,194 × 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)
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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 ×
6,070,000) hours at an estimated cost of
$39,944,849 (505,631 × 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 § 483.80(i), ‘‘COVID–19
Vaccination of Facility Staff’’
1. Policies and Procedures
At § 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
§ 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, § 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
§ 483.80(d) and modify them to comply
with the requirements in this rule at
§ 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
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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 × 69). For the IPs in all
15,401 LTC facilities, the burden would
be 30,802 hours (2 hours × 15,401
facilities) at an estimated cost of
$2,125,338 (138 × 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 × 96). The burden
would be 15,401 hours (1 × 15,401) at
an estimated cost of $1,478,496 (96 ×
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 × $171). the burden for
all LTC facilities would be 15,401 hours
(1 × 15,401) at an estimated cost of
$2,633,571 (171 × 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
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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
§ 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 × 74). For all
357 PRTFs, the burden would be 2,856
hours (8 hours × 357) at an estimated
cost of $211,344 (592 × 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
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would be 2 hours at an estimated cost
of $244 (2 × 122). For all 357 PRTFs, the
total burden would be 714 hours (2 ×
357) at an estimated cost of $87,108 (357
× 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 × 30,000) hours at an
estimated cost of $184,926 (2,499 × 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
§ 483.430(f), ‘‘COVID–19 Vaccination of
Facility Staff’’
1. Policies and Procedures
At § 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
§ 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
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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 × 69). For all 5,780 ICFsIID, the burden would be 46,240 hours
(8 hours × 5,780) at an estimated cost of
$3,190,560 (552 × 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 × 96). For all 5,780 ICFs-IID,
the total burden would be 11,560 hours
(2 × 5,780) at an estimated cost of
$1,109,760 (5,780 × 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 ICFsIID 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 ×
80,000) hours at an estimated cost of
$459,816 (6,664 × $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).
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H. ICRs Regarding the Development of
Policies and Procedures for HHAs
§ 484.70(d), ‘‘COVID–19 Vaccination of
Home Health Agency Staff’’
1. Policies and Procedures
At § 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 § 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 § 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 × 73). For all
11,649 HHAs, the burden would be
93,192 hours (8 hours × 11,649) at an
estimated cost of $6,803,016 (584 ×
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
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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 × 97). For
all 11,649 HHAs, the total burden would
be 23,298 hours (2 × 11,649) at an
estimated cost of $2,259,906 (11,649 ×
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
× 2,110,000) hours at an estimated cost
of $12,830,699 (175,763 × 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
§ 485.70(n), ‘‘COVID–19 Vaccination of
Facility Staff’’
1. Policies and Procedures
At § 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
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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 × 98). For the administrators
in all 159 organizations, the burden
would be 1,272 hours (8 × 159) at an
estimated cost of $124,656 (784 × 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
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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
× 10,000) hours at an estimated cost of
$81,634 (833 × 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
§ 485.640(f), ‘‘COVID–19 Vaccination of
CAH Staff’’
1. Policies and Procedures
At § 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 § 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
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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 × 79).
For the IPs in all 1,358 CAHs, the
burden would be 10,864 hours (8 hours
× 1,358) at an estimated cost of $858,256
(632 × 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 × 2) at an estimated cost
of $488 (4 × $122). The total burden for
all 1,358 CAHs would be 5,432 hours (4
× 1,358) at an estimated cost of $662,704
(1,358 × 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).
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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) § 485.725(f), ‘‘COVID–
19 Vaccination of Organization Staff’’
1. Policies and Procedures
At § 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
§ 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
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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 × 84). For the
physical therapists in all 2,078
organizations, the burden would be
16,624 hours (8 × 2,078) at an estimated
cost of $1,396,416 (672 × 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 × 98). For the
administrators in all 2,078
organizations, the burden would be
4,156 hours (2 × 2,078) at an estimated
cost of $407,288 (4,156 × 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 × 10,000) hours at an estimated
cost of $69,972 (833 × 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).
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L. ICRs Regarding the Development of
Policies and Procedures for CMHCs
§ 485.904(c), ‘‘COVID–19 Vaccination of
Center Staff’’
1. Policies and Procedures
At § 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 × 113). The burden
for the administrators in all 129 CHMCs
would be 1,032 hours (8 × 129) at an
estimated cost of $116,616 (904 × 129).
As discussed above, the revision and
approval of these initial policies and
procedures would also require activities
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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 × 118). For the mental health
counselors in all 129 CMHCs, the
burden would be 258 hours (2 × 129) at
an estimated cost of $30,444 (129 × 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 × 140,000) hours at an
estimated cost of $1,317,806 (11,662 ×
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 § 486.525(c), ‘‘COVID–19
Vaccination of Facility Staff’’
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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
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policies and procedures needed to
satisfy all of the requirements in this
section. Current regulations at § 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 § 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 ×
73). For all 337 HIT suppliers, the
burden would be 2,696 hours (8 hours
× 337) at an estimated cost of $24,601
(337 × 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 × 97). For all
337 HIT suppliers, the total burden for
the administrator would be 674 hours (2
hours × 337) at an estimated cost of
$65,378 (337 × 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
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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 ×
20,000) hours at an estimated cost of
$121,618 (1,666 × 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 § 491.8(d), ‘‘COVID–19
Vaccination of Staff’’
1. Policies and Procedures
At § 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,
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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.
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
× 108). For the administrators in all
15,317 RHCs/FQHCs, the burden would
be 122,536 hours (8 × 15,317) at an
estimated cost of $13,233,888 (864 ×
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 × 212). For the
222 42
CFR 491.7.
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physicians in all 15,317 RHCs/FQHCs,
the burden would be 30,634 hours (2 ×
15,317) at an estimated cost of
$6,494,408 (424 × 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 × 107). For the
nurse practitioners in all 15,317 RHCs/
FQHCs, the burden would be 30,634
hours (2 × 15,317) at an estimated cost
of $3,277,838 ($214 × 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
× 111). For the physician assistants in
all 15,317 RHCs/FQHCs, the burden
would be 30,634 hours (2 × 15,317) at
an estimated cost of $3,400,374 (15,317
× 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 × 15,317) at an
estimated cost of $3,247,204 (15,317 ×
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 × 150,000) hours at an
estimated cost of $1,349,460 (12,495 ×
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).
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O. ICRs Regarding the Development of
Policies and Procedures for ESRD
Facilities § 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 § 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 § 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 × $73). For all ESRD
facilities, the burden would be 63,144
hours (8 hours × 7,893) at an estimated
cost of $4,609,512 (7,893 × 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 × 97). For all ESRD facilities,
the total burden would be 15,786 hours
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(2 × 7,893) at an estimated cost of
$1,531,242 (7,893 × 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
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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
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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 × 170,000) hours at an estimated
cost of $1,033,753 (14,161 × 73).
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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
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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
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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–19related 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
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.
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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.
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
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/ResearchStatistics-Data-and-Systems/Statistics-Trends-andReports/NationalHealthExpendData/NHE-FactSheet.
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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
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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
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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 parttime 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 fulltime 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 fulltime employees to the number of parttime 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
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benefits due to the high degree to which
all current provider and supplier staff
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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
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
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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Evaluation based on standard practices
in cost-benefit analysis.229
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.
In particular, LTC facility residents
are near the upper end of the age
spectrum. For a statistically average LTC
facility resident, the average preCOVID–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
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/valuingcovid-19-risk-reductions-hhs-rias.
230 For an NIH summary of the racial disparities,
see https://www.niddk.nih.gov/health-information/
kidney-disease/race-ethnicity.
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.
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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
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 SARS232 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.
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-andworkers-at-risk-examining-the-long-term-careworkforce/.
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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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.
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
BILLING CODE 4120–01–P
237 See Courtney Harold Van Houtven, Nicole
DePasquale, and Norma B. Coe, ‘‘Essential LongTerm 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
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resident populations or staff counts
focus on numbers of individuals
residing or working in the facility
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during the course of a year or over time.
Depending on the average length of stay
(that is, turnover) in different facilities,
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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.
While this IFC does not expressly
require COVID–19 vaccine counseling
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-rateis-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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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.
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
240 At
https://aspe.hhs.gov/sites/default/files/
private/pdf/242926/HHS_RIAGuidance.pdf, page
24.
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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 inperson 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.
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
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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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 × 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 × 2 = $40 for
two doses of a vaccine, and $20 × 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
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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
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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 jobseeking 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 ICFsIID) 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 × 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.)
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
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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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
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.
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
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.
243 CDC Data Tracker, October 17, 2021 data, at
https://covid.cdc.gov/covid-data-tracker/#healthcare-personnel.
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-docovid-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.
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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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
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 lifeprolonging and life-improving health
care interventions of any kind (see
sections 3.2 and 3.3 of the HHS
Guidelines for a detailed explanation).
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/coviddata/investigations-discovery/hospitalizationdeath-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 worldwide 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.
249 https://aspe.hhs.gov/pdf-report/guidelinesregulatory-impact-analysis.
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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.
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 ×
.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 × .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).
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.
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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(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.
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
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 Qualityof-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-HomeData/bkwz-xpvg/.
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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 shortterm 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.
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
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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vaccination against COVID–19 is
effective for at least 1 year and use a 1year 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.)
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 prehospitalization 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
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 × 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 × 100 × .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 × 100 × .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 × 100 × .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 × 100
× .01).
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).
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 costeffectiveness modeling to inform vaccination
prioritization,’’ Science Direct, February 12, 2021,
at https://pubmed.ncbi.nlm.nih.gov/33483216/.
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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 healthimpaired 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 healthimpaired.
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.
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
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.
260 CDC Data Tracker at https://covid.cdc.gov/
covid-data-tracker/#health-care-personnel_
healthcare-deaths.
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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
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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
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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,
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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
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61613
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 recordkeeping. 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.
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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
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.
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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 vaccinationresisting 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.
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
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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
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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 costreducing 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.
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.
42 CFR Part 418
42 CFR Part 482
Health facilities, Hospice care,
Medicare, Reporting and recordkeeping
requirements.
Grant program—-health, Hospitals,
Medicaid, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 441
42 CFR Part 483
42 CFR Part 460
42 CFR Part 416
Health facilities, Health professions,
Medicare, Reporting and recordkeeping
requirements.
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Aged, Family planning, Grant
programs—health, Infants and children,
Medicaid, Penalties, Reporting and
recordkeeping requirements.
Jkt 256001
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.
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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.
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05NOR2
ER05NO21.032</GPH>
List of Subjects
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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
1. The authority citation for part 416
continues to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395hh.
2. Amend § 416.51 by adding
paragraph (c) to read as follows:
■
§ 416.51 Conditions for coverage—
Infection control.
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*
*
*
*
*
(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.
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(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 singledose 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
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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
3. The authority citation for part 418
continues to read as follow:
■
Authority: 42 U.S.C. 1302 and 1395hh.
4. Amend § 418.60 by adding
paragraph (d) to read as follows:
■
§ 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.
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(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 singledose 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;
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(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
5. The authority citation for part 441
continues to read as follows:
■
Authority: 42 U.S.C. 1302.
6. Amend § 441.151 by adding
paragraph (c) to read as follows:
■
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§ 441.151
61617
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 singledose 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
E:\FR\FM\05NOR2.SGM
05NOR2
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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
VerDate Sep<11>2014
22:27 Nov 04, 2021
Jkt 256001
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 ALLINCLUSIVE CARE FOR THE ELDERLY
(PACE)
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).
8. Amend § 460.74 by adding
paragraph (d) to read as follows:
■
§ 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.
PO 00000
Frm 00218
Fmt 4701
Sfmt 4700
(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 singledose 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
E:\FR\FM\05NOR2.SGM
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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
9. The authority citation for part 482
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1395hh, and
1395rr, unless otherwise noted.
10. Amend § 482.42 by adding
paragraph (g) to read as follows:
■
§ 482.42 Condition of participation:
Infection prevention and control and
antibiotic stewardship programs.
jspears on DSK121TN23PROD with RULES2
*
*
*
*
*
(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;
VerDate Sep<11>2014
22:27 Nov 04, 2021
Jkt 256001
(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 singledose 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
PO 00000
Frm 00219
Fmt 4701
Sfmt 4700
61619
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
11. The authority citation for part 483
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1320a–7, 1395i,
1395hh and 1396r.
12. Amend § 483.80 by revising
paragraph (d)(3)(v) and adding
paragraph (i) to read as follows:
■
§ 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
*
*
*
*
*
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05NOR2
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(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 singledose 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
VerDate Sep<11>2014
22:27 Nov 04, 2021
Jkt 256001
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.
PO 00000
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Fmt 4701
Sfmt 4700
13. Amend § 483.430 by revising
paragraph (f) to read as follows:
■
§ 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 singledose 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,
E:\FR\FM\05NOR2.SGM
05NOR2
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
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
VerDate Sep<11>2014
22:27 Nov 04, 2021
Jkt 256001
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.
■ 14. Amend § 483.460 by revising
paragraph (a)(4)(v) to read as follows:
§ 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
15. The authority citation for part 484
continues to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395hh.
16. Amend § 484.70 by adding
paragraph (d) to read as follows:
■
§ 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
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Fmt 4701
Sfmt 4700
61621
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 singledose 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;
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(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
17. The authority citation for part 485
continues to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395(hh).
18. Amend § 485.58 by revising
paragraph (d)(4) to read as follows:
■
§ 485.58 Condition of participation:
Comprehensive rehabilitation program.
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*
*
*
*
*
(d) * * *
(4) The services must be furnished by
personnel that meet the qualifications of
§ 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 § 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
VerDate Sep<11>2014
22:27 Nov 04, 2021
Jkt 256001
care service techniques and retain
responsibility for their activities.
*
*
*
*
*
■ 19. Amend § 485.70 by adding
paragraph (n) to read as follows:
§ 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 singledose 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,
PO 00000
Frm 00222
Fmt 4701
Sfmt 4700
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
E:\FR\FM\05NOR2.SGM
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
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.
■ 20. Amend § 485.640 by adding
paragraph (f) to read as follows:
§ 485.640 Condition of participation:
Infection prevention and control and
antibiotic stewardship programs.
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*
*
*
*
*
(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
VerDate Sep<11>2014
22:27 Nov 04, 2021
Jkt 256001
recommended by the CDC, due to
clinical precautions and considerations)
have received, at a minimum, a singledose 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
PO 00000
Frm 00223
Fmt 4701
Sfmt 4700
61623
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.
■ 21. Amend § 485.725 by adding
paragraph (f) to read as follows:
§ 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
E:\FR\FM\05NOR2.SGM
05NOR2
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
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 singledose 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
VerDate Sep<11>2014
22:27 Nov 04, 2021
Jkt 256001
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.
■ 22. Amend § 485.904 by adding
paragraph (c) to read as follows:
§ 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
PO 00000
Frm 00224
Fmt 4701
Sfmt 4700
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 singledose 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
E:\FR\FM\05NOR2.SGM
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
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
23. The authority citation for part 486
continues to read as follows:
■
Authority: 42 U.S.C. 273, 1302, 1320b–8,
and 1395hh.
24. Amend § 486.525 by adding
paragraph (c) to read as follows:
■
§ 486.525
Required services.
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*
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*
*
(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
VerDate Sep<11>2014
22:27 Nov 04, 2021
Jkt 256001
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 singledose 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
PO 00000
Frm 00225
Fmt 4701
Sfmt 4700
61625
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.
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PART 491—CERTIFICATION OF
CERTAIN HEALTH FACILITIES
25. The authority citation for part 491
continues to read as follows:
■
Authority: 42 U.S.C. 263a and 1302.
26. Amend § 491.8 by adding
paragraph (d) to read as follows:
■
§ 491.8
Staffing and staff responsibilities.
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*
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*
(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
VerDate Sep<11>2014
22:27 Nov 04, 2021
Jkt 256001
clinical precautions and considerations)
have received, at a minimum, a singledose 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
PO 00000
Frm 00226
Fmt 4701
Sfmt 4700
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
27. The authority citation for part 494
continues to read as follows:
■
Authority: 42 U.S.C. l302 and l395hh.
28. Amend § 494.30 by—
a. Redesignating paragraphs (b) and
(c) as paragraphs (c) and (d)
respectively, and
■ b. Adding a new paragraph (b).
The addition reads as follows:
■
■
§ 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
E:\FR\FM\05NOR2.SGM
05NOR2
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
jspears on DSK121TN23PROD with RULES2
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 singledose 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
VerDate Sep<11>2014
22:27 Nov 04, 2021
Jkt 256001
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
PO 00000
Frm 00227
Fmt 4701
Sfmt 9990
61627
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
E:\FR\FM\05NOR2.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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: https://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\
---------------------------------------------------------------------------
\1\ https://www.phe.gov/emergency/events/COVID19/Pages/2019-Public-Health-and-Medical-Emergency-Declarations-and-Waivers.aspx.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
---------------------------------------------------------------------------
\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/;
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/.
\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 https://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/). 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/.
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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\ https://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 (<6 feet) to
caregivers and fellow patients for extended periods of time (12-15
hours per week). Because dialysis patients are not able to defer
dialysis sessions, in-center dialysis patients are at increased risk
for developing COVID-19 due in part to difficulty maintaining physical
distancing.\169\ Many ESRD patients are also residents of LTC
facilities or other congregate living settings, which is also a risk
factor for COVID-19.\170\ Further, individuals with kidney failure on
dialysis may have a higher risk of worse outcomes.\171\
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\169\ Am J Kidney Dis. 2020 Nov;76(5):690-695.e1. doi: 10.1053/
j.ajkd.2020.07.001. Epub 2020 Jul 15.
\170\ https://www.jhunewsletter.com/article/2020/09/hopkins-finds-dialysis-patients-at-greater-risk-of-covid-19.
\171\ CJASN March 2021, 16 (3) 452-455; DOI: https://doi.org/10.2215/CJN.12360720.
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Dialysis health care personnel are considered a priority population
for vaccination by the Advisory Committee on Immunization Practices
(ACIP), yet ESRD facilities are currently reporting low COVID-19
vaccination coverage among ESRD facility health care personnel, at less
than 63 percent as of September 26, 2021.\172\ Ensuring health care
personnel have access to COVID-19 vaccination is critical to protect
both them and their medically fragile patients.\173\
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\172\ https://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/;
accessed September 24, 2021.
\182\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html,
accessed October 18, 2021.
\183\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm?s_cid=mm7037e1_w, accessed October 18, 2021.
\184\ https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination, accessed October 18, 2021.
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We recognize that newly reported COVID-19 cases, hospitalizations,
and deaths have begun to trend downward at a national level;
nonetheless, they remain substantially elevated relative to numbers
seen in May and June 2021, when the Delta variant became the
predominant strain circulating in the U.S.\185\ And while cases are
trending
[[Page 61584]]
downward in some states, there are emerging indications of potential
increases in others--particularly northern states where the weather has
begun to turn colder. This is not surprising: Respiratory virus
infections typically circulate more frequently during the winter
months, with peaks in pneumonia and influenza deaths typically during
winter months.\186\ Similarly, the U.S. experienced a large COVID-19
wave in the winter of 2020. Approximately 1 in 3 people 12 years of age
and older in the U.S. remain unvaccinated--and they could pose a threat
to the country's progress on the COVID-19 pandemic, potentially
incurring a fifth wave of COVID-19 infections.\187\
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\185\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
\186\ https://www.cdc.gov/flu/professionals/acip/background-epidemiology.htm.
\187\ Ibid.
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The onset of the 2021-2022 influenza season presents an additional
threat to patient health and safety. Although influenza activity during
the 2020-2021 season was low throughout the U.S.,\188\ the intensity of
the upcoming 2021-2022 influenza season cannot be predicted. Several
factors could make this flu season more severe; these include return to
school by children with no prior exposure to flu (and therefor lower
immunity), waning protection over time from previous seasonal influenza
vaccination, and the fact that adult immunity (especially among those
who were not vaccinated last season) will now partly depend on exposure
to viruses two or more seasons earlier.189 190 COVID-19
vaccination thus remains an important tool for decreasing stress on the
U.S. health care system during ongoing circulation of influenza. As
previously noted, health system strain can adversely impact patient
access to care and care quality.
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\188\ CDC. FluView. Weekly influenza surveillance report.
Atlanta, GA: U.S. Department of Health and Human Services, CDC.
Accessed February 11, 2021. https://www.cdc.gov/flu/weekly/index.htm.
\189\ https://www.medrxiv.org/content/10.1101/2021.08.29.21262803v1.
\190\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7029a1.htm.
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Furthermore, data on the health consequences of coinfection with
influenza and SARS-CoV-2 are limited. Preliminary evidence suggests
that a combination of infections with influenza and SARS-CoV-2 would
result in more severe health outcomes for patients than either
infection alone.191 192 193 However, COVID-19 is more
infectious and has greater rates of mortality, hospitalizations, and
severe illness than influenza. Accordingly, it is imperative that the
risk for healthcare-associated COVID-19 transmission be minimized
during the influenza season. Influenza is most common during the fall
and winter with the highest incidence of cases reported between
December through March.\194\ COVID-19 vaccines require time after
administration for the body to build an immune response. Hence, given
that the influenza season is imminent, a staff COVID-19 vaccination
requirement for the providers and suppliers identified in this rule
cannot be further delayed. The impact of unvaccinated populations on
the health-care system and the inconsistent web of State, local, and
employer COVID-19 vaccination requirements have established a pressing
need for a consistent Federal policy mandating staff vaccination in
health care settings that receive Medicare and Medicaid funds. The
current patchwork of regulations undermines the efficacy of COVID-19
vaccine mandates by encouraging unvaccinated workers to seek employment
at providers that do not have such patient protections, exacerbating
staffing shortages, and creating disparities in care across
populations. This includes workers moving between various types of
providers, such as from LTC facilities to HHAs and others, creating
imbalances. As discussed in section I. of this IFC, we have received
numerous requests from diverse stakeholders for Federal intervention to
implement a health-care staff vaccine mandate.\195\ Of particular note,
several representatives of the long-term care community (not limited to
Medicare- and Medicaid-certified LTC facilities) expressed concerns
about inequities that would result from imposition of a mandate on only
one type of provider and strongly recommended a broad approach.\196\
While there is opposition to the vaccine mandate, a combination of
factors now have persuaded us that a vaccine mandate for health care
workers is an essential component of the nation's COVID-19 response,
the delay of which would contribute to additional negative health
outcomes for patients including loss of life. These include, but are
not limited to, the following: Failure to achieve sufficiently high
levels of vaccination based on voluntary efforts and patchwork
requirements; ongoing risk of new COVID-19 variants; potential harmful
impact of unvaccinated healthcare workers on patients; continuing
strain on the health care system, particularly from Delta-variant-
driven surging case counts beginning in summer 2021; demonstrated
efficacy, safety and real-world effectiveness of available vaccines;
FDA's full licensure of the Pfizer-BioNTech's Comirnaty vaccine; our
observations of the efficacy of COVID-19 vaccine mandates in other
settings; and the calls from numerous stakeholders for Federal
intervention. Moreover, a further delay in imposing a vaccine mandate
would endanger the health and safety of additional patients and be
contrary to the public interest.
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\191\ https://academic.oup.com/cid/article/72/12/e993/6024509?login=true.
\192\ https://onlinelibrary.wiley.com/doi/epdf/10.1002/jmv.26163.
\193\ https://www.cdc.gov/flu/about/season/flu-season.htm.
\194\ Ibid.
\195\ https://www.aamc.org/news-insights/press-releases/major-health-care-professional-organizations-call-covid-19-vaccine-mandates-all-health-workers. Accessed 10/06/2021.
\196\ https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-september-2021/. Accessed 10/06/2021.
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We note that health care workers were among the first groups
provided access to vaccinations, which were initially authorized for
emergency use. EUA status may have been a factor in some individual
decisions to delay or refuse vaccination. The Pfizer-BioNTech COVID-19
vaccine was first authorized for emergency use on December 11, 2020.
The vaccine continues to be available in the U.S. under EUA, and the
EUA was subsequently amended to include use in individuals 12 through
15 years of age, to allow for the use of an additional dose in the
primary series for certain immunocompromised individuals, and to allow
for use of a single booster dose to be administered at least 6 months
after completion of the primary series in certain individuals. FDA has
issued EUAs for two additional vaccines for the prevention of COVID-19,
one to Moderna (December 18, 2020) (indicated for use by individuals 18
years of age and older), and the other to Janssen (Johnson & Johnson)
(February 27, 2021) (indicated for use by individuals 18 years of age
and older). Fact sheets for health care providers administering vaccine
are available for each vaccine product from FDA. However, on August 23,
2021, FDA licensed Pfizer-BioNTech's Comirnaty Vaccine. Health care
workers whose hesitancy was related to EUA status now have a fully
licensed COVID-19 vaccine option. Despite this, as noted earlier,
health care staff vaccination rates remain sub-optimal in too many
health care facilities and regions. For example, national COVID-19
vaccination rates for LTC facility, hospital, and ESRD facility staff
are 67 percent, 64 percent, and 60 percent, respectively. Moreover,
these averages obscure sizeable regional differences.
[[Page 61585]]
LTC facility staff vaccination rates range from lows of 56 percent to
highs of over 90 percent, depending upon the State. Similar patterns
hold for ESRD facility and hospital staff.197 198 199
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\197\ LTC facility rates derived from data reported through
CDC's NHSN and posted online at the Nursing Home COVID-19
Vaccination Data Dashboard: https://www.cdc.gov/nhsn/covid19/ltc-vaccination-dashboard.html; accessed September 15, 2021.
\198\ Dialysis facility rates derived from data reported through
CDC's NHSN and posted online at the Dialysis COVID-19 Vaccination
Data Dashboard: https://www.cdc.gov/nhsn/covid19/dial-vaccination-dashboard.html; accessed September 15, 2021.
\199\ Hospital data come from unpublished analyses of data
reported to HHS and posted on HHS Protect.
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Over half a million COVID-19 cases and 1,900 deaths among health
care staff have been reported to CDC since the start of the PHE.\200\
When submitting case-level COVID-19 reports, State and territorial
jurisdictions may identify whether individuals are or are not health
care workers. Since health care worker status has only been reported
for a minority of cases (approximately 18 percent), these numbers are
likely gross underestimates of true burden in this population. COVID-19
case rates among staff have also grown in tandem with broader national
incidence trends since the Delta variant's emergence. For example, as
of mid-September 2021, COVID-19 cases among LTC facility and ESRD
facility staff have increased by over 1400 percent and 850 percent,
respectively, since their lows in June 2021.\201\ Similarly, the number
of cases among staff for whom case-level data were reported by State
and territorial jurisdictions to CDC increased by nearly 600 percent
between June and August 2021.\202\ Because they are at greater risk for
developing COVID-19 infection and severe disease,203 204 205
unvaccinated staff present a risk of exacerbating ongoing staffing
shortages--particularly during periods of community surges in SARS-CoV-
2 infection, when demand for health care services is most acute. Health
care staff who remain unvaccinated may also pose a direct threat to
patient, resident, workplace, family, and community safety and
population health. Data from CDC's National Healthcare Safety Network
(NHSN) have shown that case rates among LTC facility residents are
higher in facilities with lower vaccination coverage among staff;
specifically, residents of LTC facilities in which vaccination coverage
of staff is 75 percent or lower experience higher crude rates of
preventable SARS-CoV-2 infection.\206\ Similarly, several articles
published in CDC's Morbidity and Mortality Weekly Reports (MMWRs)
regarding nursing home outbreaks have also linked the spread of COVID-
19 infection to unvaccinated health care workers and stressed that
maintaining a high vaccination rate is important for reducing
transmission.207 208 209 And multiple studies have
demonstrated SARS-CoV-2 transmissions between health-care workers and
patients in hospitals, despite universal masking and other
protocols.210 211 212 213 Acute and LTC facilities engage
many, if not all, of the same health care professionals and support
services of other provider and supplier types. As a result, while
similarly comprehensive data are not available for all Medicare- and
Medicaid-certified provider and supplier types, we believe the LTC
facilities experience may generally be extrapolated to other settings.
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\200\ https://covid.cdc.gov/covid-data-tracker/#health-care-personnel; accessed September 24, 2021.
\201\ Analysis of dialysis facility and nursing home data
reported through NHSN.
\202\ Ibid. 110.
\203\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
\204\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm?s_cid=mm7037e1_w.
\205\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm?s_cid=mm7034e4_w.
\206\ https://emergency.cdc.gov/han/2021/han00447.asp.
\207\ COVID-19 Outbreak Associated with a SARS-CoV-2 R.1 Lineage
Variant in a Skilled Nursing Facility After Vaccination Program--
Kentucky, March 2021.'' April 21, 2021. Available at https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e2.htm.
\208\ Postvaccination SARS-CoV-2 Infections Among Skilled
Nursing Facility Residents and Staff Members--Chicago, Illinois,
December 2020-March 2021.'' April 30, 2021. Available at https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e1.htm.
\209\ Effectiveness of the Pfizer-BioNTech COVID-19 Vaccine
Among Residents of Two Skilled Nursing Facilities Experiencing
COVID-19 Outbreaks--Connecticut, December 2020-February 2021.''
March 19, 2021. Available at https://www.cdc.gov/mmwr/volumes/70/wr/mm7011e3.htm.
\210\ Klompas M, Baker MA, Griesbach D, et al. Transmission of
SARS-CoV-2 from asymptomatic and presymptomatic individuals in
healthcare settings despite medical masks and eye protection. Clin
Infect Dis. 2021. [PMID: 33704451] doi:10.1093/cid/ciab218.
\211\ https://www.medrxiv.org/content/10.1101/2021.02.16.21251625v1.
\212\ https://jamanetwork.com/journals/jama/fullarticle/2773128.
\213\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8349432/.
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The efficacy of COVID-19 vaccinations has been demonstrated.\214\
An ASPE report published on October 5, 2021, found that COVID-19
vaccines are a key component in controlling the COVID-19 pandemic.
Clinical data show vaccines are highly effective in preventing COVID-19
cases and severe outcomes including hospitalization and death. The ASPE
analysis of individual-level health data and county-level vaccination
rates found that higher county vaccination rates were associated with
significant reductions in the odds of COVID-19 infection,
hospitalization, and death among Medicare fee-for-service (FFS)
beneficiaries between January and May 2021. Further, comparing the
rates of these outcomes to what ASPE modeling predicted would have
happened without any vaccinations, we estimate COVID-19 vaccinations
were linked to estimated reductions of approximately 107,000
infections, 43,000 hospitalizations, and 16,000 deaths in our study
sample of 25.3 million beneficiaries. The report also noted that the
difference in vaccination rates for those age 65 and older between the
lowest (34 percent) and highest (85 percent) counties and states by the
end of May highlights the continued opportunity to leverage COVID-19
vaccinations to prevent COVID-19 hospitalizations and deaths.\215\
Vaccines continue to be effective in preventing COVID-19 associated
with the now-dominant Delta variant.216 217
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\214\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
\215\ https://aspe.hhs.gov/sites/default/files/documents/c5d0dde224c224dd726694367846b609/aspe-covid-medicare-vaccine-analysis.pdf. Accessed 10/06/2021.
\216\ https://www.nejm.org/doi/full/10.1056/nejmoa2108891.
\217\ https://www.mayoclinic.org/coronavirus-covid-19/covid-variant-vaccine.
\218\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm?s_cid=mm7034e4_w.
\219\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html#ref43.
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In addition to preventing morbidity and mortality associated with
COVID-19, the vaccines also appear to be effective against asymptomatic
SARS-CoV-2 infection. A recent study of health care workers in 8 states
found that, between December 14, 2020, through August 14, 2021, full
vaccination with COVID-19 vaccines was 80 percent effective in
preventing RT-PCR-confirmed SARS-CoV-2 infection among frontline
workers.\218\ Emerging evidence also suggests that vaccinated people
who become infected with Delta have potential to be less infectious
than infected unvaccinated people, thus decreasing transmission
risk.\219\ For example, in a study of breakthrough infections among
health care workers in the Netherlands, SARS-CoV-2 infectious virus
shedding was lower among vaccinated individuals with breakthrough
infections than
[[Page 61586]]
among unvaccinated individuals with primary infections.\220\
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\220\ https://www.medrxiv.org/content/10.1101/2021.08.20.21262158v1.full.pdf.
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As noted earlier in this section, a combination of factors,
including but not limited to failure to achieve sufficiently high
levels of vaccination based on voluntary efforts and patchwork
requirements, potential harm to patients from unvaccinated health-care
workers, and continuing strain on the health care system and known
efficacy and safety of available vaccines, have persuaded us that a
vaccine mandate for health care workers is an essential component of
the nation's COVID-19 response. Further, it would endanger the health
and safety of patients, and be contrary to the public interest to delay
imposing it. Therefore, we believe it would be impracticable and
contrary to the public interest for us to undertake normal notice and
comment procedures and to thereby delay the effective date of this IFC.
We find good cause to waive notice of proposed rulemaking under the
APA, 5 U.S.C. 553(b)(B), and section 1871(b)(2)(C) of the Act. For
those same reasons, as authorized by the Small Business Regulatory
Enforcement Fairness Act of 1996 (the Congressional Review Act or CRA),
5 U.S.C. 808(2), we find it is impracticable and contrary to the public
interest not to waive the delay in effective date of this IFC under
section 801 of the CRA. Therefore, we find there is good cause to waive
the CRA's delay in effective date pursuant to section 808(2) of the
CRA.
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement (ICR) is
submitted to the Office of Management and Budget (OMB) for review and
approval. The ICRs in this section will be included in an emergency
revision of the information collection request currently approved under
the appropriate OMB Control number. All PRA-related comments received
in response to this IFC will be reviewed and addressed in a subsequent,
non-emergency, submission of the information collection request. The
emergency approval is only valid for 6 months. Within that 6-month
approval period, CMS will seek a regular, non-emergency, approval and
as required by the PRA, this action will be announced in the requisite
60-day and 30-day Federal Register notices.
In order to fairly evaluate whether an information collection
should be approved by OMB, section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires that we solicit comment on the following
issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs):
For the estimated costs contained in the analysis below, we used
data from the U.S. Bureau of Labor Statistics (BLS) to determine the
mean hourly wage for the positions used in this analysis.\221\ For the
total hourly cost, we doubled the mean hourly wage for a 100 percent
increase to cover overhead and fringe benefits, according to standard
HHS estimating procedures. If the total cost after doubling resulted in
0.50 or more, the cost was rounded up to the next dollar. If it was
0.49 or below, the total cost was rounded down to the next dollar. The
total costs used in this analysis are indicated in Table 3.
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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
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[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.
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\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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[GRAPHIC] [TIFF OMITTED] TR05NO21.029
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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.
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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-P
[[Page 61606]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.030
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
These nursing facilities have about 950,000 full-time equivalent
employees at any one time and another 100,000 visiting staff or the
equivalent, all covered by this rule. For these persons, the average
age is about 45, which creates two offsetting effects: they have more
years of life expectancy than residents, but their risk of death from
COVID-19 is far lower. For purposes of this analysis, we assume that
vaccination against COVID-19 is effective for at least 1 year and use a
1-year period as our primary framework for calculation of potential
benefits, not as a specific prediction but as a likely scenario that
avoids forecasting major and unexpected changes that are either
strongly adverse or strongly beneficial. If we were adding up totals
for benefits we would assume that the risk of death after COVID-19
infection is likely only one-half of one percent (one tenth of the
resident rate) or less for the unvaccinated members of this group,
reflecting the far lower mortality rates for persons who are almost all
in the 18 to 65 year old age ranges compared to the far older
residents.\256\ We assume that the total number of individual employees
is 50 percent higher than the full-time equivalent but that only half
that number are primarily employed at only one nursing facility, two
offsetting assumptions about the number of employees working at each
facility (many employees are part-time consultants or the equivalent
who serve multiple nursing facilities on a part-time basis). We further
assume that employee turnover is 80 percent a year, lower than the
results for nurses previously cited. Accordingly, we estimate that 80
percent of 950,000, or 760,000, are new employees each year and must be
offered vaccination (again, most are already vaccinated), for a total
of 1,710,000 eligible employees over the course of a year. (This number
would likely drop in future years as employers decide to hire only
persons previously vaccinated and as vaccine uptake increases due to
Federal, State, local, or employer requirements, as well as individual
choice.)
---------------------------------------------------------------------------
\256\ See the previously cited CDC report on risks by age group.
In the age intervals used by CDC, the 40-49-year-old group is in the
middle of typical employment age ranges. The risk of death in this
age group is one tenth that of those aged 65-74. We emphasize with
round numbers that nothing about these data is fixed and unlikely to
change (for example, as better future treatments are used to treat
severe cases).
---------------------------------------------------------------------------
We have some data on the costs of treating serious illness among
the unvaccinated who become infected, are hospitalized, and survive.
Among those age 65 years or above, or with severe risk factors, over 30
percent of those known to be infected required hospitalization in the
first year of the pandemic.\257\ That fraction is far lower now as
treatments have improved and as vaccinations have greatly reduced
severity of the disease. Among adults aged 21 years to 64 years, about
10 percent of those infected once required hospitalization, but that
fraction is now far lower for the same reasons. For our estimates, we
assume a 10 percent hospitalization rate among people aged 65 years or
older in LTC facilities, reflecting both that their conditions are
significantly worse than those of similarly aged adults living
independently, and that pre-hospitalization treatments have improved.
For staff we assume one fifth of this rate, or 2 percent. Using LTC
facilities as our main example, the LTC facility candidates for
vaccination in the first year covered by this rule, about three-fourths
are age 65 years or above. Hence, the age-weighted hospitalization rate
that we project is about 8 percent. Among those hospitalized at any
age, the average cost is about $20,000.\258\
---------------------------------------------------------------------------
\257\ The New York Times ``Nearly One-Third of U.S. Coronavirus
Deaths Are Linked to Nursing Homes, June 1, 2021.
\258\ This is not a robust estimate but is supported by several
sources. See for example Jiangzhuo Chen et al, ``Medical costs of
keeping the US economy open during COVID-19,'' Scientific Reports,
Nature.com, July 19 2020, at https://pubmed.ncbi.nlm.nih.gov/32743613/, and Michel Kohli et al, ``The potential public health and
economic value of a hypothetical COVID-19 vaccine in the United
States: Use of cost-effectiveness modeling to inform vaccination
prioritization,'' Science Direct, February 12, 2021, at https://pubmed.ncbi.nlm.nih.gov/33483216/.
---------------------------------------------------------------------------
To put these cost, benefit, and volume numbers in perspective,
vaccinating one hundred previously unvaccinated LTC facility residents
who would otherwise become infected with SARS-CoV-2 and have a COVID-19
illness would cost approximately $18,000 ($183 x 100) in vaccination
costs. Using the VSL approach to estimation would produce life-saving
benefits of about $400,000 for these 100 people ($20,000 x 100 x .05),
again assuming the death rate for those ill from COVID-19 of this age
and condition is one in twenty. Reductions in health care costs from
hospitalization would produce another $160,000 ($20,000 x 100 x .08) in
benefits for this group assuming that 8 percent would otherwise be
hospitalized. However, this comparison should be taken as necessarily
hypothetical and contingent due to the analytic, data, and uncertainty
challenges discussed throughout this regulatory impact assessment.
Patient benefits are simply a consequence of fewer infections among
staff. Vaccinating one hundred previously unvaccinated LTC facility
employees would be higher than for staff. Life-saving benefits to
employees would be about $5,300,000 ($10,600,000 VSL x 100 x .005) for
100 people assuming that the death rate for these far younger 100
people is 1 in 500 hundred. Reductions in health care costs from
hospitalizations of employees would produce another $20,000 ($20,000 x
100 x .01).
[[Page 61612]]
There remain difficult questions of estimating (1) likely numbers
of individuals in staff and patient categories who are likely to be
unvaccinated when the rule goes into effect and (2) numbers of staff
likely to be willing to accept vaccination in the coming months and
years.\259\ Both sets of numbers vary substantially by provider and
supplier type. LTC facility and home health care patients are on
average both the oldest and most health-impaired of those in settings
covered by this rule. At the other extreme, rural and other community-
care oriented health centers serve the full age spectrum and a lower
fraction of severely health-impaired.
---------------------------------------------------------------------------
\259\ For a survey of the evidence on this issue, see Gillian K.
Steelfisher et al, ``An Uncertain Public--Encouraging Acceptance of
Covid-19 Vaccines,'' The New England Journal of Medicine, March 3,
2021.
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We do know that the life-saving benefits for staff are probably
small but significant. During the entire period of COVID-19 infections,
since March 2020, there have been over 2,000 health care staff deaths
recorded by the CDC through October 3, 2021.\260\ Of these, the great
majority were in the year 2020. Even during the recent Delta variant
surge, health care staff deaths decreased to lower levels.
Specifically, during the last 6 months, April through September 2021,
total staff deaths were 202, an average of 34 per month and no clear
trend (the last 4 weeks, all in September, 2021 produced fewer than 20
deaths). This is not surprising as the most effective precautions other
than vaccination--masks, social distancing, and ventilation--have been
essentially universal in the health care sector during all of 2021.
Even more importantly, vaccination rates are considerably higher than
in the population at large (although still well below optimal levels).
Yet, using the last 6 months of CDC Data Tracker information, on an
annual basis more than 400 deaths could be expected. These data,
moreover, are almost all among unvaccinated persons and are probably
undercounted in current data.
---------------------------------------------------------------------------
\260\ CDC Data Tracker at https://covid.cdc.gov/covid-data-tracker/#health-care-personnel_healthcare-deaths.
---------------------------------------------------------------------------
A major caution about these estimates: None of the sources of
enrollment information for these programs regularly collect and publish
information on client or staff turnover during a year. These data have
not previously been found useful in program management for individual
agencies or programs, or when needed have been addressed through one-
time research projects. The estimates in this analysis are based on
inferences from scattered data on average length of stay, mortality,
job vacancies, news accounts, and other sources that by happenstance
are available for one type of facility or type of resident or another.
Nor do we have data on the number of persons in these settings who will
be vaccinated through other means during the remainder of the year.
All these data and estimation limitations apply to even the short-
term impacts of this rule, and major uncertainties remain as to the
future course of the pandemic, including but not limited to vaccine
effectiveness in preventing ``breakthrough'' disease transmission from
those vaccinated, the long-term effectiveness of vaccination, the
emergence of treatment options, and the potential for some new disease
variant even more dangerous than Delta.
Another unknown is what currently unvaccinated employees would do
when the vaccination deadline is reached, and how rapidly those
quitting rather than being vaccinated could be replaced. Even a small
fraction of recalcitrant unvaccinated employees could disrupt facility
operations. On the other hand, there have been significant reductions
in provider and supplier staffing needs in some categories. For
example, LTC facility admissions have declined in the last year, as
families and caregivers sought to avoid the risks of exposing a care
recipient to unvaccinated residents and staff in LTC facilities. The
new vaccination requirement may reduce such fears and bring higher
numbers of residents to these facilities and the essential services
they provide. Again, we have no way to estimate such behavioral
changes.
Regardless, we believe it is clear that reductions in patient/
resident fatalities through avoiding staff-generated infections are
both likely to be a significantly larger benefit from staff vaccination
than direct benefits to staff. Staff vaccination will also provide
significant community benefits when staff are not at work. Hence, total
lives saved under this rule may well reach several hundred a month or
perhaps several thousand a month for all three groups in total. Patient
and resident benefits are especially likely to be many times higher
because the risks of death and serious disease complications are so
many times higher among older persons and people with multiple chronic
conditions.
As indicated by the preceding analysis, predicting the full range
of benefits and costs in either the short run or the next full year
with any degree of estimating precision is all but impossible. As the
minimum benefit level needed for benefits to exceed costs, however, we
estimate that either saving 120 lives, or preventing 600 hundred
hospitalizations for serious illness, or any combination of these two
magnitudes, would produce benefits that exceed our estimate of costs
over the next year. There have been about 200 staff deaths in the last
6 months and this is a likely undercount for this one category of
persons alone, and potential life-saving benefits to more than 150
million mostly elderly patients and residents (about 10 percent of whom
are likely to remain unvaccinated) who are exposed to provider staff
probably would be many times higher. We note, however, as discussed in
the preceding section on costs, much of these benefits could be as well
attributed to other concurrent and parallel vaccination mandates and
campaigns.
E. Other Effects
1. Sources of Payment
The initial costs of this rule fall almost entirely on health care
providers and suppliers and are extremely small in comparison to the $4
trillion a year spent on health care, mostly through these same
entities. In particular, the costs of the vaccines are paid by the
Federal Government and vaccine costs are about two-thirds of the total
costs we have estimated. Moreover, through the treatment cost savings
to the hospitals and other care providers resulting from the
vaccinations that will be made due to this rule, significant savings
would accrue to payers. It is likely that half or more of these savings
would primarily accrue to Medicare given the age or disability status
of most clients and Medicare's role as primary payer, but there would
also be substantial savings to Medicaid, private insurance paid by
employers and employees, and private out-of-pocket payers including
patients and residents. In some rare cases funds under the CARES Act
and the American Rescue Plan Act of 2021 might be available at State or
local discretion, but it is hard to foresee any substantial budgetary
impact on any insurance plan or service provider that would justify or
require such assistance.
2. Regulatory Flexibility Act
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. Under the RFA, ``small entities'' include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Individuals and states are not included in the
definition of a small entity. For
[[Page 61613]]
purposes of the RFA, we estimate that most health care facilities are
small entities as that term is used in the RFA because they are either
nonprofit organizations or meet the SBA definition of a small business
(having revenues of less than $8.0 million to $41.5 million in any 1
year). HHS uses an increase in costs or decrease in revenues of more
than 3 to 5 percent as its measure of ``significant economic impact.''
The HHS standard for ``substantial number'' is 5 percent or more of
those that will be significantly impacted, but never fewer than 20.
As estimated previously, the total costs of this rule for 1 year
are about $1.3 billion, most of which is directly proportional to
number of employees. Spread over 10.4 million full-time equivalent
employees, this is about $125 per employee. Assuming a fully loaded
average wage per employee of $90,000, the first-year cost does not
approach the 3 percent threshold. Moreover, since much of these costs
(in particular, the vaccine costs paid by the Federal Government) will
not fall on providers or suppliers, the financial strain on these
facilities should be negligible. Finally, as previously discussed,
there are other concurrent mandates and much of these costs could as
well be attributed to those efforts. Therefore, the Department has
determined that this IFC will not have a significant economic impact on
a substantial number of small entities and that a final RIA is not
required. Finally, this IFC was not preceded by a general notice of
proposed rulemaking and the RFA requirement for a final regulatory
flexibility analysis does not apply to final rules not preceded by a
proposed rule. Regardless, this RIA and the main preamble, taken
together, would meet the requirements for either an Initial or Final
Regulatory Flexibility Analysis.
3. Small Rural Hospitals
Section 1102(b) of the Act requires us to prepare an RIA if a
proposed rule may have a significant impact on the operations of a
substantial number of small rural hospitals. For purposes of this
requirement, we define a small rural hospital as a hospital that is
located outside of a metropolitan statistical area and has fewer than
100 beds. Because this rule has only the small impact per employee
calculated for RFA purposes, the Department has determined that this
IFC will not have a significant impact on the operations of a
substantial number of small rural hospitals. This IFC is also exempt
because that provision of law only applies to final rules for which a
proposed rule was published. That said, early indications are that
rural hospitals are having greater problems with employee vaccination
refusals than urban hospitals, and we welcome comments on ways to
ameliorate this problem.
4. Unfunded Mandates Reform Act
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates will impose spending costs on State,
local, or tribal governments, or by the private sector, require
spending in any 1 year of $100 million in 1995 dollars, updated
annually for inflation. In 2021, that threshold is approximately $158
million. This rule contains no State, local, or tribal governmental
mandates, but does contain mandates on private sector entities that
exceed this amount. However, this IFC was not preceded by a notice of
proposed rulemaking, and therefore the requirements of UMRA do not
apply. The analysis in this RIA and the preamble as a whole would,
however, meet the requirements of UMRA.
5. Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. This rule would pre-empt some State laws that prohibit
employers from requiring their employees to be vaccinated for COVID-19.
Consistent with the Executive Order, we find that State and local laws
that forbid employers in the State or locality from imposing vaccine
requirements on employees directly conflict with this exercise of our
statutory health and safety authority to require vaccinations for staff
of the providers and suppliers subject to this rule. Similarly, to the
extent that State-run facilities that receive Medicare and Medicaid
funding are prohibited by State or local law from imposing vaccine
mandates on their employees, there is direct conflict between the
provisions of this rule (requiring such mandates) and the State or
local law (forbidding them). As is relevant here, this IFC preempts the
applicability of any State or local law providing for exemptions to the
extent such law provides broader grounds for exemptions than provided
for by Federal law and are inconsistent with this IFC. In these cases,
consistent with the Supremacy Clause of the Constitution, the agency
intends that this rule preempts State and local laws to the extent the
State and local laws conflict with this rule. The agency has considered
other alternatives (for example, relying entirely on measures such as
voluntary vaccination, source control alone, and social distancing) and
has concluded that the mandate established by this rule is the minimum
regulatory action necessary to achieve the objectives of the statute.
Given the contagion rates of the existing strains of coronavirus and
their disproportionate impacts on Medicare and Medicaid beneficiaries,
we believe that vaccination of almost all staff of covered providers
and suppliers is necessary to promote and protect patient health and
safety. The agency has examined case studies from other employers and
concludes that vaccine mandates are vastly more effective than other
measures at achieving ideal vaccination rates and the resulting patient
protections from morbidity and mortality. Given the emergency situation
with respect to the Delta variant detailed more fully above, time did
not permit usual consultation procedures with the States, and such
consultation would therefore be impracticable. We are, however,
inviting State and local comments on the substance as well as legal
issues presented by this rule, and on how we can fulfill the statutory
requirements for health and safety protections of patients if we were
to exempt any providers or suppliers based on State or local opposition
to this rule.
F. Alternatives Considered
As discussed earlier in the preamble, a major substantive
alternative that we considered was to limit COVID-19 vaccination
requirements to full-time employees rather than to all persons who may
provide paid or unpaid services, such as visiting specialists or
volunteers, who are not on the regular payroll on a weekly or more
frequent basis that is, individuals who work in the facility and in
some cases infrequently or unpredictably, as well as individuals who
are not on the payroll at all. We concluded that covering these persons
would be readily manageable without creating major issues for
compliance, enforcement, and record-keeping. We did not, however,
include some categories of visitors who do not have a business
relationship with the provider, such as family member visitors. There
are also many issues such as social isolation and loneliness related to
potential discouragement of visiting volunteers or family members.
[[Page 61614]]
We also considered whether it would be appropriate to limit COVID-
19 vaccination requirements to staff who have not previously been
infected by SARS-CoV-2. There remain many uncertainties about as to the
strength and length of this immunity compared to people who are
vaccinated, and--in recognizing that--the CDC recommends that
previously infected individuals get vaccinated. Exempting previously
infected individuals would have potentially reduced benefits while
reducing costs, both roughly in proportion to the number affected. It
would have also, complicated administration and likely require
standards that do not now exist for reliably measuring the declining
levels of antibodies over time in relation to risk of reinfection.
Because of current CDC guidance and understanding of relevant
scientific findings, we found that it was not warranted to exempt
previously infected individuals.
Another option would be to devise a standard with graduated
compliance expectations such as 90 percent and then 95 percent and then
100 percent of staff vaccinated and a time period in which to reach
each level. A variation of this would be to put providers on a
probationary period if they failed to reach 100 percent compliance by
the date set in the rule, and were allowed additional time in which to
cross that last threshold. Yet another variation would be to reduce
payment to providers and suppliers not meeting the standard after the
initial deadline. We recently put a phased system in place for Organ
Procurement Organizations (OPOs), so we are not reflexively opposed to
such options.\261\ Nonetheless, there are two major arguments against
such a system in the context of this rule. First, to have any
usefulness the time periods would have to have a reasonably extensive
duration, such as a month each. But that would be almost the same as
extending this rule's deadline for an extra several months. We do not
believe that extending the deadline to extend the employment of staff
who will simply delay vaccination or final refusal to the last possible
moment is in the interest of other staff, patients, and patients who
would utilize the provider for needed health care if they did not fear
unvaccinated staff. Second, it would not only delay the achievement of
both staff and patient safety, but encourage procrastination. For those
few staff absolutely unwilling to accept vaccination, it would simply
delay the day of final action and the day of hiring a vaccinated
replacement. In the case of the OPO rule, an entire organization had to
be slowly reformed to achieve compliance. In the context of this rule,
and the lives at stake, there is no obvious ethical or managerial
reason to give a relative handful of vaccination-resisting individuals
more time until they leave the organization. It would give management
more time to find replacements, but it is not at all clear that this
would be a fruitful grace period.
---------------------------------------------------------------------------
\261\ See Medicare and Medicaid Programs: Organ Procurement
Organizations Conditions for Coverage: Revisions to the Outcome
Measure Requirements for Organ Procurement Organizations, 85 FR page
77898, December 2, 2020.
---------------------------------------------------------------------------
As for a variation reducing payment to non-performing providers,
perhaps by 20 percent per patient over some applicable time period,
this would arguably provide something better than an ``all of nothing''
removal from provider status. It would require legislation but that is
not a barrier to meeting E.O. 12866 analysis standards and in some
rules may be essential to a valid benefit-cost analysis. The problem
with this variation, however, is that for most providers and suppliers
is it unlikely to be a realistic choice. Rather than accept lower
payment levels, management can simply terminate the unvaccinated
employees, a power they have with or without the reduced payment
alternative. Moreover, it would be hard to devise a system that treated
equally and fairly providers of all sizes--whether with 5 or 50
employees. We further note that CMS already has and uses discretion in
enforcement when inspectors find a violation. Termination of provider
status is not normally an immediate consequence, as entities are
typically given the opportunity to correct deficiencies. Regardless, we
welcome comments on this overall option and its variations, and on the
closely-related option of simply adding a month to the compliance
deadline in this rule. We considered what standards to apply regarding
proof of compliance with exemptions requests base on medical
contraindications and religious objections. We decided to establish
minimal compliance burdens for both categories of exemptions. This
decision on the evidentiary standards could be revisited should an
abuse problem arise on a significant scale. This may open the door to
forged documents or false statements, and therefore validation of such
claims raises administrative costs. Accordingly, we have allowed for
relatively relaxed standards for verification in our administrative
provisions and cost estimates but may reconsider in the future. We
considered alternative timelines for implementation but decided that
this would not only delay badly needed live-saving compliance, but also
provide little real management benefit to providers and suppliers.
Staff have had almost a year to consider COVID-19 vaccinations that are
in their own interests as well as vital to patient protections and the
protection of other workers. In this regard we note that one of the
claimed barriers to vaccination has recently been removed, now that one
vaccine is now no longer emergency-authorized, but fully licensed. We
believe our requirements provide more than enough time for reasonable
counselling and other management measures.
Finally, we considered requiring daily or weekly testing of
unvaccinated individuals. We have reviewed scientific evidence on
testing and found that vaccination is a more effective infection
control measure. As such, we chose not to require such testing for now
but welcome comment. Of course, nothing prevents a provider from
exercising testing precautions voluntarily in addition to vaccination.
We note that nothing in this rule removes the obligation on providers
and suppliers to meet existing requirements to prevent the spread of
infection, which in practice means that these entities may also conduct
regular testing alongside such actions as source control and physical
distancing. CMS will continue to review the evidence and stakeholder
feedback on this issue.
These and some lesser options are presented and discussed in the
main preamble. We do not have reliable dollar estimates for either
costs or benefits of any alternatives, for the reasons already
discussed in the RIA regarding the options we chose. We welcome
comments on these or other options.
G. Accounting Statement and Table
The Accounting Table summarizes the quantified impact of this rule.
It covers only 1 year because there will likely be many developments
regarding treatments and vaccinations and their effects in future years
and we have no way of knowing which will most likely occur. A longer
period would be even more speculative than the current estimates.
Nonetheless, assuming no major unforeseen events that would impinge on
our estimates, we would expect lower costs in future years if for no
other reason than increases in the fraction of new hires already
vaccinated as well as other positive results from the President's plan
or individual vaccination decisions. We further note
[[Page 61615]]
that the vaccinations, and hence the benefits and costs, estimated for
this rule are more or less simultaneously being created voluntarily by
some employers (self-mandates), through the OSHA vaccination rule
applicable to employers of 100 or more persons, and by some State or
local mandates. There is no simple and non-arbitrary way to disentangle
which vaccination benefits and which vaccination costs are due to which
source.
As explained in various places within this RIA and the preamble as
a whole, there are major uncertainties as to the effects of current
variants of SARS-CoV-2 on future infection rates, medical costs, and
prevention of major illness or mortality. For example, the duration of
vaccine effectiveness in preventing COVID-19, reducing disease
severity, reducing the risk of death, and the effectiveness of the
vaccine to prevent disease transmission by those vaccinated are not
currently known. These uncertainties also impinge on benefits
estimates. For those reasons we have not quantified into annual totals
either the life-extending or medical cost-reducing benefits of this
rule and have used only a 1-year projection for the cost estimates in
our Accounting Statement (our first-year estimates are for the last two
months of 2021 and the first ten months of 2022). We also show a large
range for the upper and lower bounds of potential costs to emphasize
the uncertainty as to several major variables, such as changes in
voluntary vaccination levels, longer term effects, and others
previously discussed. We welcome comments on all of our assumptions and
welcome any additional information that would narrow the ranges of
uncertainty or guide us in any important revisions to the requirements
established in what is an ``interim'' final rule.
[GRAPHIC] [TIFF OMITTED] TR05NO21.032
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &
Medicaid Services, approved this document on October 19, 2021.
List of Subjects
42 CFR Part 416
Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 418
Health facilities, Hospice care, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 441
Aged, Family planning, Grant programs--health, Infants and
children, Medicaid, Penalties, Reporting and recordkeeping
requirements.
42 CFR Part 460
Aged, Citizenship and naturalization, Civil rights, Health, Health
care, Health records, Incorporation by reference, Individuals with
disabilities, Medicaid, Medicare, Religious discrimination, Reporting
and recordkeeping requirements.
42 CFR Part 482
Grant program---health, Hospitals, Medicaid, Medicare, Reporting
and recordkeeping requirements.
42 CFR Part 483
Grant programs--health, Health facilities, Health professions,
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting
and recordkeeping requirements, Safety.
42 CFR Part 484
Administrative practice and procedure, Grant programs--health,
Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
[[Page 61616]]
42 CFR Part 485
Grant programs--health, Health facilities, Medicaid, Privacy,
Reporting and recordkeeping requirements.
42 CFR Part 486
Administrative practice and procedure, Grant programs--health,
Health facilities, Home infusion therapy, Medicare, Reporting and
recordkeeping requirements, X-rays.
42 CFR Part 491
Grant programs--health, Health facilities, Medicaid, Medicare,
Reporting and recordkeeping requirements, Rural and urban areas.
42 CFR Part 494
Diseases, Health facilities, Incorporation by reference, Medicare,
Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 416--AMBULATORY SURGICAL SERVICES
0
1. The authority citation for part 416 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
2. Amend Sec. 416.51 by adding paragraph (c) to read as follows:
Sec. 416.51 Conditions for coverage--Infection control.
* * * * *
(c) Standard: COVID-19 vaccination of staff. The ASC must develop
and implement policies and procedures to ensure that all staff are
fully vaccinated for COVID-19. For purposes of this section, staff are
considered fully vaccinated if it has been 2 weeks or more since they
completed a primary vaccination series for COVID-19. The completion of
a primary vaccination series for COVID-19 is defined here as the
administration of a single-dose vaccine, or the administration of all
required doses of a multi-dose vaccine.
(1) Regardless of clinical responsibility or patient contact, the
policies and procedures must apply to the following center staff, who
provide any care, treatment, or other services for the center and/or
its patients:
(i) Center employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the center and/or its patients, under contract or by other arrangement.
(2) The policies and procedures of this section do not apply to the
following center staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the center setting and who do not have any direct
contact with patients and other staff specified in paragraph (c)(1) of
this section; and
(ii) Staff who provide support services for the center that are
performed exclusively outside of the center setting and who do not have
any direct contact with patients and other staff specified in paragraph
(c)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (c)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine, prior to staff providing any
care, treatment, or other services for the center and/or its patients;
(ii) A process for ensuring that all staff specified in paragraph
(c)(1) of this section are fully vaccinated, except for those staff who
have been granted exemptions to the vaccination requirements of this
section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations;
(iii) A process for ensuring the implementation of additional
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status of all staff specified in paragraph (c)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the center has
granted, an exemption from the staff COVID-19 vaccination requirements;
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable State and local laws, and for further ensuring that such
documentation contains:
(A) All information specifying which of the authorized or licensed
COVID-19 vaccines are clinically contraindicated for the staff member
to receive and the recognized clinical reasons for the
contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the center's COVID-19
vaccination requirements based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
PART 418--HOSPICE CARE
0
3. The authority citation for part 418 continues to read as follow:
Authority: 42 U.S.C. 1302 and 1395hh.
0
4. Amend Sec. 418.60 by adding paragraph (d) to read as follows:
Sec. 418.60 Condition of participation: Infection control.
* * * * *
(d) Standard: COVID-19 Vaccination of facility staff. The hospice
must develop and implement policies and procedures to ensure that all
staff are fully vaccinated for COVID-19. For purposes of this section,
staff are considered fully vaccinated if it has been 2 weeks or more
since they completed a primary vaccination series for COVID-19. The
completion of a primary vaccination series for COVID-19 is defined here
as the administration of a single-dose vaccine, or the administration
of all required doses of a multi-dose vaccine.
[[Page 61617]]
(1) Regardless of clinical responsibility or patient contact, the
policies and procedures must apply to the following hospice staff, who
provide any care, treatment, or other services for the hospice and/or
its patients:
(i) Hospice employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the hospice and/or its patients, under contract or by other
arrangement.
(2) The policies and procedures of this section do not apply to the
following hospice staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the settings where hospice services are provided to
patients and who do not have any direct contact with patients, patient
families and caregivers, and other staff specified in paragraph (d)(1)
of this section; and
(ii) Staff who provide support services for the hospice that are
performed exclusively outside of the settings where hospice services
are provided to patients and who do not have any direct contact with
patients, patient families and caregivers, and other staff specified in
paragraph (d)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (d)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care, treatment, or other services for the hospice and/or its patients;
(ii) A process for ensuring that all staff specified in paragraph
(d)(1) of this section are fully vaccinated, except for those staff who
have been granted exemptions to the vaccination requirements of this
section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations;
(iii) A process for ensuring the implementation of additional
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status of all staff specified in paragraph (d)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the hospice
has granted, an exemption from the staff COVID-19 vaccination
requirements;
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable State and local laws, and for further ensuring that such
documentation contains:
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the hospice's COVID-19
vaccination requirements for staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC
SERVICES
0
5. The authority citation for part 441 continues to read as follows:
Authority: 42 U.S.C. 1302.
0
6. Amend Sec. 441.151 by adding paragraph (c) to read as follows:
Sec. 441.151 General requirements.
* * * * *
(c) COVID-19 Vaccination of facility staff. The facility must
develop and implement policies and procedures to ensure that all staff
are fully vaccinated for COVID-19. For purposes of this section, staff
are considered fully vaccinated if it has been 2 weeks or more since
they completed a primary vaccination series for COVID-19. The
completion of a primary vaccination series for COVID-19 is defined here
as the administration of a single-dose vaccine, or the administration
of all required doses of a multi-dose vaccine.
(1) Regardless of clinical responsibility or resident contact, the
policies and procedures must apply to the following facility staff, who
provide any care, treatment, or other services for the facility and/or
its residents:
(i) Facility employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the facility and/or its residents, under contract or by other
arrangement.
(2) The policies and procedures of this section do not apply to the
following facility staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the facility setting and who do not have any direct
contact with residents and other staff specified in paragraph (c)(1) of
this section; and
(ii) Staff who provide support services for the facility that are
performed exclusively outside of the center setting and who do not have
any direct contact with residents and other staff specified in
paragraph (c)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (c)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care, treatment, or other services for the facility and/or its
residents;
(ii) A process for ensuring that all staff specified in paragraph
(c)(1) of this section are fully vaccinated for COVID-19, except for
those staff who have been
[[Page 61618]]
granted exemptions to the vaccination requirements of this section, or
those staff for whom COVID-19 vaccination must be temporarily delayed,
as recommended by the CDC, due to clinical precautions and
considerations;
(iii) A process for ensuring that the facility follows nationally
recognized infection prevention and control guidelines intended to
mitigate the transmission and spread of COVID-19, and which must
include the implementation of additional precautions for all staff who
are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status of all staff specified in paragraph (c)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the facility
has granted, an exemption from the staff COVID-19 vaccination
requirements;
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable State and local laws, and for further ensuring that such
documentation contains:
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the facility's COVID-19
vaccination requirements for staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
PART 460--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
0
7. The authority citation for part 460 continues to read as follow:
Authority: 42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f).
0
8. Amend Sec. 460.74 by adding paragraph (d) to read as follows:
Sec. 460.74 Infection control.
* * * * *
(d) COVID-19 Vaccination of PACE organization staff. The PACE
organization must develop and implement policies and procedures to
ensure that all staff are fully vaccinated for COVID-19. For purposes
of this section, staff are considered fully vaccinated if it has been 2
weeks or more since they completed a primary vaccination series for
COVID-19. The completion of a primary vaccination series for COVID-19
is defined here as the administration of a single-dose vaccine, or the
administration of all required doses of a multi-dose vaccine.
(1) Regardless of clinical responsibility or participant contact,
the policies and procedures must apply to the following PACE
organization staff, who provide any care, treatment, or other services
for the PACE organization and/or its participants:
(i) PACE organization employees;
(ii) Licensed practitioners providing services on behalf of the
PACE organization;
(iii) Students, trainees, and volunteers providing services on
behalf of the PACE organization; and
(iv) Individuals who provide care, treatment, or other services on
behalf of the PACE organization, under contract or by other
arrangement.
(2) The policies and procedures of this section do not apply to the
following PACE organization staff:
(i) Staff who exclusively provide telehealth or telemedicine
services for the PACE organization and/or its participants and who do
not have any direct contact with participants and other PACE
organization staff specified in paragraph (d)(1) of this section; and
(ii) Staff who provide support services for the PACE organization
and/or its participants and who do not have any direct contact with
participants and other PACE organization staff specified in paragraph
(d)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (d)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care, treatment, or other services for the PACE organization and/or its
participants;
(ii) A process for ensuring that all staff specified in paragraph
(d)(1) of this section are fully vaccinated for COVID-19, except for
those staff who have been granted exemptions to the vaccination
requirements of this section, or those staff for whom COVID-19
vaccination must be temporarily delayed, as recommended by the CDC, due
to clinical precautions and considerations;
(iii) A process for ensuring the implementation of additional
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status of all staff specified in paragraph (d)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the PACE
organization has granted, an exemption from the staff COVID-19
vaccination requirements based on recognized clinical contraindications
or applicable Federal laws;
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as
[[Page 61619]]
defined by, and in accordance with, all applicable State and local
laws, and for further ensuring that such documentation contains:
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the PACE organization's COVID-19
vaccination requirements for staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
0
9. The authority citation for part 482 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise
noted.
0
10. Amend Sec. 482.42 by adding paragraph (g) to read as follows:
Sec. 482.42 Condition of participation: Infection prevention and
control and antibiotic stewardship programs.
* * * * *
(g) Standard: COVID-19 Vaccination of hospital staff. The hospital
must develop and implement policies and procedures to ensure that all
staff are fully vaccinated for COVID-19. For purposes of this section,
staff are considered fully vaccinated if it has been 2 weeks or more
since they completed a primary vaccination series for COVID-19. The
completion of a primary vaccination series for COVID-19 is defined here
as the administration of a single-dose vaccine, or the administration
of all required doses of a multi-dose vaccine.
(1) Regardless of clinical responsibility or patient contact, the
policies and procedures must apply to the following hospital staff, who
provide any care, treatment, or other services for the hospital and/or
its patients:
(i) Hospital employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the hospital and/or its patients, under contract or by other
arrangement.
(2) The policies and procedures of this section do not apply to the
following hospital staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the hospital setting and who do not have any direct
contact with patients and other staff specified in paragraph (g)(1) of
this section; and
(ii) Staff who provide support services for the hospital that are
performed exclusively outside of the hospital setting and who do not
have any direct contact with patients and other staff specified in
paragraph (g)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (g)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care, treatment, or other services for the hospital and/or its
patients;
(ii) A process for ensuring that all staff specified in paragraph
(g)(1) of this section are fully vaccinated for COVID-19, except for
those staff who have been granted exemptions to the vaccination
requirements of this section, or those staff for whom COVID-19
vaccination must be temporarily delayed, as recommended by the CDC, due
to clinical precautions and considerations;
(iii) A process for ensuring the implementation of additional
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status of all staff specified in paragraph (g)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the hospital
has granted, an exemption from the staff COVID-19 vaccination
requirements;
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable State and local laws, and for further ensuring that such
documentation contains:
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the hospital's COVID-19
vaccination requirements for staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-.
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
0
11. The authority citation for part 483 continues to read as follows:
Authority: 42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r.
0
12. Amend Sec. 483.80 by revising paragraph (d)(3)(v) and adding
paragraph (i) to read as follows:
Sec. 483.80 Infection control.
(d) * * *
(3) * * *
(v) The resident or resident representative, has the opportunity to
accept or refuse a COVID-19 vaccine, and change their decision; and
* * * * *
[[Page 61620]]
(i) COVID-19 Vaccination of facility staff. The facility must
develop and implement policies and procedures to ensure that all staff
are fully vaccinated for COVID-19. For purposes of this section, staff
are considered fully vaccinated if it has been 2 weeks or more since
they completed a primary vaccination series for COVID-19. The
completion of a primary vaccination series for COVID-19 is defined here
as the administration of a single-dose vaccine, or the administration
of all required doses of a multi-dose vaccine.
(1) Regardless of clinical responsibility or resident contact, the
policies and procedures must apply to the following facility staff, who
provide any care, treatment, or other services for the facility and/or
its residents:
(i) Facility employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the facility and/or its residents, under contract or by other
arrangement.
(2) The policies and procedures of this section do not apply to the
following facility staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the facility setting and who do not have any direct
contact with residents and other staff specified in paragraph (i)(1) of
this section; and
(ii) Staff who provide support services for the facility that are
performed exclusively outside of the facility setting and who do not
have any direct contact with residents and other staff specified in
paragraph (i)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (i)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care, treatment, or other services for the facility and/or its
residents;
(ii) A process for ensuring that all staff specified in paragraph
(i)(1) of this section are fully vaccinated for COVID-19, except for
those staff who have been granted exemptions to the vaccination
requirements of this section, or those staff for whom COVID-19
vaccination must be temporarily delayed, as recommended by the CDC, due
to clinical precautions and considerations;
(iii) A process for ensuring the implementation of additional
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status of all staff specified in paragraph (i)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the facility
has granted, an exemption from the staff COVID-19 vaccination
requirements;
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable State and local laws, and for further ensuring that such
documentation contains:
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the facility's COVID-19
vaccination requirements for staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
0
13. Amend Sec. 483.430 by revising paragraph (f) to read as follows:
Sec. 483.430 Condition of participation: Facility staffing.
* * * * *
(f) Standard: COVID-19 Vaccination of facility staff. The facility
must develop and implement policies and procedures to ensure that all
staff are fully vaccinated for COVID-19. For purposes of this section,
staff are considered fully vaccinated if it has been 2 weeks or more
since they completed a primary vaccination series for COVID-19. The
completion of a primary vaccination series for COVID-19 is defined here
as the administration of a single-dose vaccine, or the administration
of all required doses of a multi-dose vaccine.
(1) Regardless of clinical responsibility or client contact, the
policies and procedures must apply to the following facility staff, who
provide any care, treatment, or other services for the facility and/or
its clients:
(i) Facility employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the facility and/or its clients, under contract or by other
arrangement.
(2) The policies and procedures of this section do not apply to the
following facility staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the facility setting and who do not have any direct
contact with clients and other staff specified in paragraph (f)(1) of
this section; and
(ii) Staff who provide support services for the facility that are
performed exclusively outside of the facility setting and who do not
have any direct contact with clients and other staff specified in
paragraph (f)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (f)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care,
[[Page 61621]]
treatment, or other services for the facility and/or its clients;
(ii) A process for ensuring that all staff specified in paragraph
(f)(1) of this section are fully vaccinated for COVID-19, except for
those staff who have been granted exemptions to the vaccination
requirements of this section, or those staff for whom COVID-19
vaccination must be temporarily delayed, as recommended by the CDC, due
to clinical precautions and considerations;
(iii) A process for ensuring the implementation of additional
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status of all staff specified in paragraph (f)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the facility
has granted, an exemption from the staff COVID-19 vaccination
requirements;
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable State and local laws, and for further ensuring that such
documentation contains
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the facility's COVID-19
vaccination requirements for staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
0
14. Amend Sec. 483.460 by revising paragraph (a)(4)(v) to read as
follows:
Sec. 483.460 Condition of participation: Health care services.
* * * * *
(a) * * *
(4) * * *
(v) The client, or client's representative, has the opportunity to
accept or refuse a COVID-19 vaccine, and change their decision;
* * * * *
PART 484--HOME HEALTH SERVICES
0
15. The authority citation for part 484 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
16. Amend Sec. 484.70 by adding paragraph (d) to read as follows:
Sec. 484.70 Condition of participation: Infection prevention and
control.
* * * * *
(d) Standard: COVID-19 Vaccination of Home Health Agency staff. The
home health agency (HHA) must develop and implement policies and
procedures to ensure that all staff are fully vaccinated for COVID-19.
For purposes of this section, staff are considered fully vaccinated if
it has been 2 weeks or more since they completed a primary vaccination
series for COVID-19. The completion of a primary vaccination series for
COVID-19 is defined here as the administration of a single-dose
vaccine, or the administration of all required doses of a multi-dose
vaccine.
(1) Regardless of clinical responsibility or patient contact, the
policies and procedures must apply to the following HHA staff, who
provide any care, treatment, or other services for the HHA and/or its
patients:
(i) HHA employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the HHA and/or its patients, under contract or by other arrangement.
(2) The policies and procedures of this section do not apply to the
following HHA staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the settings where home health services are
directly provided to patients and who do not have any direct contact
with patients, families, and caregivers, and other staff specified in
paragraph (d)(1) of this section; and
(ii) Staff who provide support services for the HHA that are
performed exclusively outside of the settings where home health
services are directly provided to patients and who do not have any
direct contact with patients, families, and caregivers, and other staff
specified in paragraph (d)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (d)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care, treatment, or other services for the HHA and/or its patients;
(ii) A process for ensuring that all staff specified in paragraph
(d)(1) of this section are fully vaccinated for COVID-19, except for
those staff who have been granted exemptions to the vaccination
requirements of this section, or those staff for whom COVID-19
vaccination must be temporarily delayed, as recommended by the CDC, due
to clinical precautions and considerations;
(iii) A process for ensuring the implementation of additional
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status of all staff specified in paragraph (d)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the HHA has
granted, an exemption from the staff COVID-19 vaccination requirements;
[[Page 61622]]
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable State and local laws, and for further ensuring that such
documentation contains
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the HHA's COVID-19 vaccination
requirements for staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS
0
17. The authority citation for part 485 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395(hh).
0
18. Amend Sec. 485.58 by revising paragraph (d)(4) to read as follows:
Sec. 485.58 Condition of participation: Comprehensive rehabilitation
program.
* * * * *
(d) * * *
(4) The services must be furnished by personnel that meet the
qualifications of Sec. 485.70 and the number of qualified personnel
must be adequate for the volume and diversity of services offered.
Personnel that do not meet the qualifications specified in Sec.
485.70(a) through (m) may be used by the facility in assisting
qualified staff. When a qualified individual is assisted by these
personnel, the qualified individual must be on the premises, and must
instruct these personnel in appropriate patient care service techniques
and retain responsibility for their activities.
* * * * *
0
19. Amend Sec. 485.70 by adding paragraph (n) to read as follows:
Sec. 485.70 Personnel qualifications.
* * * * *
(n) The CORF must develop and implement policies and procedures to
ensure that all staff are fully vaccinated for COVID-19. For purposes
of this section, staff are considered fully vaccinated if it has been 2
weeks or more since they completed a primary vaccination series for
COVID-19. The completion of a primary vaccination series for COVID-19
is defined here as the administration of a single-dose vaccine, or the
administration of all required doses of a multi-dose vaccine.
(1) Regardless of clinical responsibility or patient contact, the
policies and procedures must apply to the following facility staff, who
provide any care, treatment, or other services for the facility and/or
its patients:
(i) Facility employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the facility and/or its patients, under contract or by other
arrangement.
(2) The policies and procedures of this section do not apply to the
following facility staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the facility setting and who do not have any direct
contact with patients and other staff specified in paragraph (n)(1) of
this section; and
(ii) Staff who provide support services for the facility that are
performed exclusively outside of the facility setting and who do not
have any direct contact with patients and other staff specified in
paragraph (n)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (n)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care, treatment, or other services for the facility and/or its
patients;
(ii) A process for ensuring that all staff specified in paragraph
(n)(1) of this section are fully vaccinated for COVID-19, except for
those staff who have been granted exemptions to the vaccination
requirements of this section, or those staff for whom COVID-19
vaccination must be temporarily delayed, as recommended by the CDC, due
to clinical precautions and considerations;
(iii) A process for ensuring the implementation of additional
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status of all staff specified in paragraph (n)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the facility
has granted, an exemption from the staff COVID-19 vaccination
requirements;
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable State and local laws, and for further ensuring that such
documentation contains
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the facility's COVID-19
vaccination requirements for staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions
[[Page 61623]]
and considerations, including, but not limited to, individuals with
acute illness secondary to COVID-19, and individuals who received
monoclonal antibodies or convalescent plasma for COVID-19 treatment;
and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
0
20. Amend Sec. 485.640 by adding paragraph (f) to read as follows:
Sec. 485.640 Condition of participation: Infection prevention and
control and antibiotic stewardship programs.
* * * * *
(f) Standard: COVID-19 Vaccination of CAH staff. The CAH must
develop and implement policies and procedures to ensure that all staff
are fully vaccinated for COVID-19. For purposes of this section, staff
are considered fully vaccinated if it has been 2 weeks or more since
they completed a primary vaccination series for COVID-19. The
completion of a primary vaccination series for COVID-19 is defined here
as the administration of a single-dose vaccine, or the administration
of all required doses of a multi-dose vaccine.
(1) Regardless of clinical responsibility or patient contact, the
policies and procedures must apply to the following CAH staff, who
provide any care, treatment, or other services for the CAH and/or its
patients:
(i) CAH employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the CAH and/or its patients, under contract or by other arrangement.
(2) The policies and procedures of this section do not apply to the
following CAH staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the CAH setting and who do not have any direct
contact with patients and other staff specified in paragraph (f)(1) of
this section; and
(ii) Staff who provide support services for the CAH that are
performed exclusively outside of the CAH setting and who do not have
any direct contact with patients and other staff specified in paragraph
(f)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (f)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care, treatment, or other services for the CAH and/or its patients;
(ii) A process for ensuring that all staff specified in paragraph
(f)(1) of this section are fully vaccinated for COVID-19, except for
those staff who have been granted exemptions to the vaccination
requirements of this section, or those staff for whom COVID-19
vaccination must be temporarily delayed, as recommended by the CDC, due
to clinical precautions and considerations;
(iii) A process for ensuring the implementation of additional
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status of all staff specified in paragraph (f)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the CAH has
granted, an exemption from the staff COVID-19 vaccination requirements
based on recognized clinical contraindications or applicable Federal
laws;
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable State and local laws, and for further ensuring that such
documentation contains
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the CAH's COVID-19 vaccination
requirements for staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
0
21. Amend Sec. 485.725 by adding paragraph (f) to read as follows:
Sec. 485.725 Condition of participation: Infection control.
* * * * *
(f) Standard: COVID-19 vaccination of organization staff. The
organization that provides outpatient physical therapy must develop and
implement policies and procedures to ensure that all staff are fully
vaccinated for COVID-19. For purposes of this section, staff are
considered fully vaccinated if it has been 2 weeks or more since they
completed a primary vaccination series for COVID-19. The completion of
a primary vaccination series for COVID-19 is defined here as the
administration of a single-dose vaccine, or the administration of all
required doses of a multi-dose vaccine.
(1) Regardless of clinical responsibility or patient contact, the
policies and procedures must apply to the following organization staff,
who provide any care, treatment, or other services for the organization
and/or its patients:
(i) Organization employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the organization and/or its patients, under contract or by other
arrangement.
(2) The policies and procedures of this section do not apply to the
following organization staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the organization setting and who do not have any
direct contact with patients and other staff specified in paragraph
(f)(1) of this section; and
(ii) Staff who provide support services for the organization that
are performed exclusively outside of the organization setting and who
do not have any direct contact with patients and other staff
[[Page 61624]]
specified in paragraph (f)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (f)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care, treatment, or other services for the organization and/or its
patients;
(ii) A process for ensuring that all staff specified in paragraph
(f)(1) of this section are fully vaccinated for COVID-19, except for
those staff who have been granted exemptions to the vaccination
requirements of this section, or those staff for whom COVID-19
vaccination must be temporarily delayed, as recommended by the CDC, due
to clinical precautions and considerations;
(iii) A process for ensuring the implementation of additional
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status for all staff specified in paragraph (f)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the
organization has granted, an exemption from the staff COVID-19
vaccination requirements;
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable State and local laws, and for further ensuring that such
documentation contains
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the organization's COVID-19
vaccination requirements for staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
0
22. Amend Sec. 485.904 by adding paragraph (c) to read as follows:
Sec. 485.904 Condition of participation: Personnel qualifications.
* * * * *
(c) Standard: COVID-19 vaccination of center staff. The CMHC must
develop and implement policies and procedures to ensure that all center
staff are fully vaccinated for COVID-19. For purposes of this section,
staff are considered fully vaccinated if it has been 2 weeks or more
since they completed a primary vaccination series for COVID-19. The
completion of a primary vaccination series for COVID-19 is defined here
as the administration of a single-dose vaccine, or the administration
of all required doses of a multi-dose vaccine.
(1) Regardless of clinical responsibility or client contact, the
policies and procedures must apply to the following center staff, who
provide any care, treatment, or other services for the center and/or
its clients:
(i) Center employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the center and/or its clients, under contract or by other arrangement.
(2) The policies and procedures of this section do not apply to the
following center staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the center setting and who do not have any direct
contact with clients and other staff specified in paragraph (c)(1) of
this section; and
(ii) Staff who provide support services for the center that are
performed exclusively outside of the center setting and who do not have
any direct contact with clients and other staff specified in paragraph
(c)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (c)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care, treatment, or other services for the CMHC and/or its clients;
(ii) A process for ensuring that all staff specified in paragraph
(c)(1) of this section are fully vaccinated for COVID-19, except for
those staff who have been granted exemptions to the vaccination
requirements of this section, or those staff for whom COVID-19
vaccination must be temporarily delayed, as recommended by the CDC, due
to clinical precautions and considerations;
(iii) A process for ensuring the implementation of additional
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status for all staff specified in paragraph (c)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the CMHC has
granted, an exemption from the staff COVID-19 vaccination requirements;
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions
[[Page 61625]]
from vaccination, has been signed and dated by a licensed practitioner,
who is not the individual requesting the exemption, and who is acting
within their respective scope of practice as defined by, and in
accordance with, all applicable State and local laws, and for further
ensuring that such documentation contains
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the CMHC's COVID-19 vaccination
requirements for staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED
BY SUPPLIERS
0
23. The authority citation for part 486 continues to read as follows:
Authority: 42 U.S.C. 273, 1302, 1320b-8, and 1395hh.
0
24. Amend Sec. 486.525 by adding paragraph (c) to read as follows:
Sec. 486.525 Required services.
* * * * *
(c) COVID-19 Vaccination of facility staff. The qualified home
infusion therapy supplier must develop and implement policies and
procedures to ensure that all staff are fully vaccinated for COVID-19.
For purposes of this section, staff are considered fully vaccinated if
it has been 2 weeks or more since they completed a primary vaccination
series for COVID-19. The completion of a primary vaccination series for
COVID-19 is defined here as the administration of a single-dose
vaccine, or the administration of all required doses of a multi-dose
vaccine.
(1) Regardless of clinical responsibility or patient contact, the
policies and procedures must apply to the following qualified home
infusion therapy supplier staff, who provide any care, treatment, or
other services for the qualified home infusion therapy supplier and/or
its patients:
(i) Qualified home infusion therapy supplier employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the qualified home infusion therapy supplier and/or its patients, under
contract or by other arrangement.
(2) The policies and procedures of this section do not apply to the
following qualified home infusion therapy supplier staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the settings where home infusion therapy services
are provided to patients and who do not have any direct contact with
patients, families, and caregivers, and other staff specified in
paragraph (c)(1) of this section; and
(ii) Staff who provide support services for the qualified home
infusion therapy supplier that are performed exclusively outside of the
settings where home infusion therapy services are provided to patients
and who do not have any direct contact with patients, families, and
caregivers, and other staff specified in paragraph (c)(1) of this
section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (c)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care, treatment, or other services for the qualified home infusion
therapy supplier and/or its patients;
(ii) A process for ensuring that all staff specified in paragraph
(c)(1) of this section are fully vaccinated for COVID-19, except for
those staff who have been granted exemptions to the vaccination
requirements of this section, or those staff for whom COVID-19
vaccination must be temporarily delayed, as recommended by the CDC, due
to clinical precautions and considerations;
(iii) A process for ensuring that the facility follows nationally
recognized infection prevention and control guidelines intended to
mitigate the transmission and spread of COVID-19, and which must
include the implementation of additional precautions for all staff who
are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status for all staff specified in paragraph (c)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the qualified
home infusion therapy supplier has granted, an exemption from the staff
COVID-19 vaccination requirements;
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable State and local laws, and for further ensuring that such
documentation contains;
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the qualified home infusion
therapy supplier's COVID-19 vaccination requirements for staff based on
the recognized clinical contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
[[Page 61626]]
PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES
0
25. The authority citation for part 491 continues to read as follows:
Authority: 42 U.S.C. 263a and 1302.
0
26. Amend Sec. 491.8 by adding paragraph (d) to read as follows:
Sec. 491.8 Staffing and staff responsibilities.
* * * * *
(d) COVID-19 vaccination of staff. The RHC/FQHC must develop and
implement policies and procedures to ensure that all staff are fully
vaccinated for COVID-19. For purposes of this section, staff are
considered fully vaccinated if it has been 2 weeks or more since they
completed a primary vaccination series for COVID-19. The completion of
a primary vaccination series for COVID-19 is defined here as the
administration of a single-dose vaccine, or the administration of all
required doses of a multi-dose vaccine.
(1) Regardless of clinical responsibility or patient contact, the
policies and procedures must apply to the following clinic or center
staff, who provide any care, treatment, or other services for the
clinic or center and/or its patients:
(i) RHC/FQHC employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the clinic or center and/or its patients, under contract or by other
arrangement.
(2) The policies and procedures of this section do not apply to the
following clinic or center staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the clinic or center setting and who do not have
any direct contact with patients and other staff specified in paragraph
(d)(1) of this section; and
(ii) Staff who provide support services for the clinic or center
that are performed exclusively outside of the clinic or center setting
and who do not have any direct contact with patients and other staff
specified in paragraph (d)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (d)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care, treatment, or other services for the clinic or center and/or its
patients;
(ii) A process for ensuring that all staff specified in paragraph
(d)(1) of this section are fully vaccinated for COVID-19, except for
those staff who have been granted exemptions to the vaccination
requirements of this section, or those staff for whom COVID-19
vaccination must be temporarily delayed, as recommended by the CDC, due
to clinical precautions and considerations;
(iii) A process for ensuring that the clinic or center follows
nationally recognized infection prevention and control guidelines
intended to mitigate the transmission and spread of COVID-19, and which
must include the implementation of additional precautions for all staff
who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status for all staff specified in paragraph (d)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the facility
has granted, an exemption from the staff COVID-19 vaccination
requirements;
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable State and local laws, and for further ensuring that such
documentation contains;
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the clinic's or center's COVID-
19 vaccination requirements for staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
PART 494--CONDITIONS FOR COVERAGE FOR END-STAGE RENAL DISEASE
FACILITIES
0
27. The authority citation for part 494 continues to read as follows:
Authority: 42 U.S.C. l302 and l395hh.
0
28. Amend Sec. 494.30 by--
0
a. Redesignating paragraphs (b) and (c) as paragraphs (c) and (d)
respectively, and
0
b. Adding a new paragraph (b).
The addition reads as follows:
Sec. 494.30 Condition: Infection control.
* * * * *
(b) COVID-19 Vaccination of facility staff. The facility must
develop and implement policies and procedures to ensure that all staff
are fully vaccinated for COVID-19. For purposes of this section, staff
are considered fully vaccinated if it has been 2 weeks or more since
they completed a primary vaccination series for COVID-19. The
completion of a primary vaccination series for COVID-19 is defined here
as the administration of a single-dose vaccine, or the administration
of all required doses of a multi-dose vaccine.
(1) Regardless of clinical responsibility or patient contact, the
policies and procedures must apply to the following facility staff, who
provide any care, treatment, or other services for the facility and/or
its patients:
(i) Facility employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the facility and/or its patients, under contract or by other
arrangement.
(2) The policies and procedures of this section do not apply to the
following facility staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the facility setting and who do not have any direct
contact with
[[Page 61627]]
patients and other staff specified in paragraph (b)(1) of this section;
and
(ii) Staff who provide support services for the facility that are
performed exclusively outside of the facility setting and who do not
have any direct contact with patients and other staff specified in
paragraph (b)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (b)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care, treatment, or other services for the facility and/or its
patients;
(ii) A process for ensuring that all staff specified in paragraph
(b)(1) of this section are fully vaccinated for COVID-19, except for
those staff who have been granted exemptions to the vaccination
requirements of this section, or those staff for whom COVID-19
vaccination must be temporarily delayed, as recommended by the CDC, due
to clinical precautions and considerations;
(iii) A process for ensuring the implementation of additional
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status for all staff specified in paragraph (b)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the facility
has granted, an exemption from the staff COVID-19 vaccination
requirements;
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable State and local laws, and for further ensuring that such
documentation contains
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the facility's COVID-19
vaccination requirements for staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
* * * * *
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-23831 Filed 11-4-21; 8:45 am]
BILLING CODE 4120-01-P
