[Federal Register Volume 86, Number 91 (Thursday, May 13, 2021)]
[Rules and Regulations]
[Pages 26306-26336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10122]



[[Page 26305]]

Vol. 86

Thursday,

No. 91

May 13, 2021

Part III





Department of Health and Human Services





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 Centers for Medicare & Medicaid Services





42 CFR Part 483





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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; Final Rule

  Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Rules 
and Regulations  

[[Page 26306]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 483

[CMS-3414-IFC]
RIN 0938-AU57


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

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Interim final rule with comment period.

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SUMMARY: This interim final rule with comment period (IFC) revises the 
infection control requirements that long-term care (LTC) facilities 
(Medicaid nursing facilities and Medicare skilled nursing facilities, 
also collectively known as ``nursing homes'') and intermediate care 
facilities for individuals with intellectual disabilities (ICFs-IID) 
must meet to participate in the Medicare and Medicaid programs. This 
IFC aims to reduce the spread of SARS-CoV-2 infections, the virus that 
causes COVID-19, by requiring education about COVID-19 vaccines for LTC 
facility residents, ICF-IID clients, and staff serving both 
populations, and by requiring that such vaccines, when available, be 
offered to all residents, clients, and staff. It also requires LTC 
facilities to report COVID-19 vaccination status of residents and staff 
to the Centers for Disease Control and Prevention (CDC). These 
requirements are necessary to help protect the health and safety of 
ICF-IID clients and LTC facility residents. In addition, the rule 
solicits public comments on the potential application of these or other 
requirements to other congregate living settings over which CMS has 
regulatory or other oversight authority.

DATES: These regulations are effective on May 21, 2021.
    Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on July 12, 2021.

ADDRESSES: In commenting, please refer to file code CMS-3414-IFC.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3414-IFC, P.O. Box 8010, 
Baltimore, MD 21244-1850.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3414-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: Diane Corning, (410) 786-8486, Lauren 
Oviatt, (410) 786-4683, Kim Roche, (410) 786-3524, or Kristin 
Shifflett, (410) 786-4133, for all rule related issues.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: http://www.regulations.gov. Follow the search instructions on 
that website to view public comments. CMS will not post on 
Regulations.gov public comments that make threats to individuals or 
institutions or suggest that the individual will take actions to harm 
the individual. CMS continues to encourage individuals not to submit 
duplicative comments. We will post acceptable comments from multiple 
unique commenters even if the content is identical or nearly identical 
to other comments.

I. Background

    Currently, the United States (U.S.) is responding to a public 
health emergency 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 public health emergency (PHE) exists for 
the United States to aid the nation's health care community in 
responding to COVID-19 (hereafter referred to as the PHE for COVID-19). 
On March 11, 2020, the WHO publicly declared COVID-19 a pandemic. On 
March 13, 2020, 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; and January 7, 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\ Data from the Centers for Disease 
Control and Prevention (CDC) and other sources have determined that 
some people are at higher risk of severe illness from COVID-19.\2\
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    \1\ https://www.phe.gov/emergency/events/COVID19/Pages/2019-Public-Health-and-Medical-Emergency-Declarations-and-Waivers.aspx.
    \2\ Centers for Disease Control and Prevention. (2020). People 
at Increased Risk. Retrieved from: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html.
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    Individuals residing in congregate settings, regardless of health 
or medical conditions, are at greater risk of acquiring infections, and 
many residents and clients of long-term care (LTC) facilities and 
Intermediate Care Facilities for Individuals with Intellectual 
Disabilities (ICFs-IID) face higher risk of severe illness due to age, 
disability, or underlying health conditions. Nursing home residents are 
less than 1 percent of the American population, but have historically 
accounted for over one-third of all COVID-19 deaths.\3\
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    \3\ See The Long-Term Care COVID Tracker at https://covidtracking.com/nursing-homes-long-term-care-facilities, and the 
KFF State COVID-19 Data and Policy Actions at https://www.kff.org/coronavirus-covid-19/issue-brief/state-covid-19-data-and-policy-actions/#longtermcare. These data may understate the problem because 
some states do not count as nursing home deaths persons infected in 
nursing homes but transferred to hospitals and recorded as hospital 
deaths.

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A. COVID-19 in Congregate Living Settings

    Since there is no single official definition of congregate living 
settings, also referred to as residential habilitation settings, for 
purposes of this discussion we describe them as shared residences of 
any size that provide services to clients and residents. People living 
and working in these living situations may have challenges with social 
distancing and other mitigation measures, like mask use and 
handwashing, that help to prevent the spread of SARS-CoV-2. Residents, 
clients, and staff typically may gather together closely for social, 
leisure, and recreational activities, shared dining, and/or use of 
shared equipment, such as kitchen appliances, laundry facilities, 
vestibules, stairwells, and elevators. Residents in some congregate 
living facilities may also receive care from day habilitation 
facilities such as adult day health centers. Some congregate living 
residents require close assistance and support from facility staff, 
which further reduces their ability to maintain physical distance. 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, 
because of shared increased risk of disease.\4\
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    \4\ https://www.cdc.gov/vaccines/covid-19/phased-implementation.html#congregate-living-settings.
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    This rule establishes requirements for LTC facilities and ICFs-IID; 
however, we recognize that individuals in all congregate living 
settings may have had similar experiences and outcomes during the PHE 
as individuals living or staying in institutional settings. We 
acknowledge that many congregate living facilities may not fall into 
any single category or may be classified differently depending on the 
state in which they are located. We further note that some other 
congregate living settings, such as dormitories, prisons, and shelters 
for people experiencing homelessness, have also faced higher risks of 
disease transmission, and these settings are not within our scope of 
authority. CMS is seeking public comment on the feasibility of 
implementing vaccination policies for other Medicare/Medicaid 
participating shared residences in which one or more people reside such 
as but not limited to the following: Psychiatric residential treatment 
facilities (PRTFs), psychiatric hospitals, forensic hospitals, adult 
foster care homes (AFC homes), group homes, assisted living facilities 
(ALFs), supervised apartments, and inpatient hospice facilities.
    We considered extending the requirements included in this rule to 
other congregate living settings for which we have regulatory 
authority, including inpatient psychiatric hospitals (which are subject 
to the majority of Hospital Conditions of Participation, including 
Sec.  482.42, ``Infection Control'') and PRTFs, but have not included 
such requirements in this interim final rule because we believe it 
would not be feasible at this time. Individuals in psychiatric 
hospitals, for example, may only be in-patients for short periods, 
making appropriate provision of a two-dose vaccine series challenging, 
although a one dose vaccine product is also now authorized. Because we 
are not able to guarantee sufficient availability of single dose COVID-
19 vaccines at this time, or in the near future, to meet the potential 
demands of facilities with relatively short stays, we are focusing on 
facilities that have longer term relationships with patients and are 
thus also able to administer all doses of and track multi-dose 
vaccines. PRTFs only serve children and youth under the age of 21 
years, and there is not yet a COVID-19 vaccine authorized or licensed 
for people younger than the age of 16 years in the United States. We 
are seeking public comment on the feasibility of adding appropriate 
COVID-19 vaccination requirements for residents, clients, and staff of 
all congregate living facilities where CMS has regulatory authority and 
pays for some portion of the care and services provided. Specifically, 
we are interested in comments on potential barriers facilities may face 
in meeting the requirements, such as staffing issues or characteristics 
of the resident or client population, and potential unintended 
consequences. We welcome suggestions on how the regulations should be 
revised to ensure that congregate living within our regulatory 
authority are able to reduce the spread of SARS-CoV-2 infections.
    While congregate living settings are also often part of a state's 
and home and community-based services (HCBS) infrastructure. HCBS is an 
umbrella term for long term services and supports that are provided to 
people in their own homes or communities rather than institutions or 
other isolated settings. These programs serve a diverse population, 
including people with intellectual or developmental disabilities, 
physical disabilities, mental illness, and HIV/AIDS. Shared living 
arrangements within, and the sharing of staff across these and other 
settings can lead to increased risk of COVID-19 outbreaks. In addition, 
individuals living in these settings often have multiple chronic 
conditions that can increase the risk of severe disease and complicate 
treatment of, and recovery from, COVID-19. This makes the vaccination 
of clients and staff in these congregate living settings a critical 
component of a jurisdiction's vaccine implementation plan.
    In an effort to facilitate a comprehensive vaccine administration 
strategy, we encourage providers who manage Medicare and/or Medicaid 
participating congregate living settings (such as psychiatric hospitals 
or PRTFs) or settings in which Medicaid-funded HCBSs are provided 
(ALFs, group homes, shared living/host home settings, supported living 
settings, and others) to voluntarily engage in the provision of the 
culturally and linguistically appropriate and accessible education and 
vaccine-offering activities described in this IFC. Vaccine availability 
may vary based on location, and vaccination and medical staff 
authorized to administer the vaccination may not be readily available 
onsite at many congregate living or residential care settings. 
Therefore, facilities should consult state Medicaid agencies and state 
and local health departments to understand the range of options for how 
vaccine provision can be made available to residents, clients, and 
staff. In addition, we encourage state Medicaid agencies, in 
partnership with public health agencies, to collaborate with congregate 
living settings to ensure their involvement in vaccine distribution 
strategies, and to facilitate vaccination of beneficiaries and staff as 
efficiently as possible. Lastly, we request public comment on 
challenges congregate living settings might encounter in complying with 
these IFC provisions, including in reporting vaccine information to 
CDC's National Healthcare Safety Network (NHSN).
    We acknowledge the diversity and complexity of the needs of 
congregate living facilities. We understand that factors such as 
coordination of care with day habilitation sites, adult day health 
providers, hospice providers, and other entities, and also high rates 
of staff turnover may impede the implementation of a COVID-19

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vaccination program. To enhance our future efforts to support 
reasonable and effective COVID-19 vaccination programs in congregate 
living facilities, we seek public comment on a number of issues, 
including the following:
     Are there state or local vaccine policies, for COVID-19 
vaccines or otherwise, already in place for congregate living 
facilities and related agencies, such as adult day health programs, 
either in the licensing or certification requirements or elsewhere? How 
have they been helpful to your facility or program?
     Does your program or facility have vaccine policies? How 
are they structured and what challenges have you faced with regard to 
implementation? Do policies include residents, clients and staff?
     If a vaccine policy applied to both shared living and day 
programs for adult day health or day habilitation, for example, who or 
what entity should have the responsibility for ensuring that all 
residents and staff have access to COVID-19 vaccination? Is there 
existing or capacity for case management for individuals engaging with 
both residential care and programs that occur outside the residential 
setting?
     What barriers exist to the implementation of a COVID-19 
vaccination policy for residents and staff of congregate living 
facilities?
     How can equitable access to COVID-19 vaccine be ensured 
for residents and clients of congregate living facilities and related 
agencies?
     Are congregate living facilities currently facing 
challenges in tracking staff vaccination status? If so, explain.
     Has your State or county included residential and adult 
day health or day habilitation staff on the vaccine-eligible list as 
health care providers? What other impediments do staff face in getting 
access to vaccines?
    Where such data are available, we are requesting respondents 
include data indicating:
     The rate of admission to congregate living facilities.
     The average length of stay for residents of congregate 
living facilities.
     The variety and prevalence of comorbidities in individuals 
served that may increase their risk of severe illness from COVID-19.
     The rate of employee sharing between congregate living 
facilities and the rate of employee turnover.
    We acknowledge the lengths that congregate living and HCBS 
providers have gone to keep their residents, clients, and staff as safe 
as possible during the COVID-19 PHE, and request their input on ways 
that CMS and HHS can further support safety and reduce the risk of 
infection moving forward. This interim final rule with comment is one 
step in the broad effort to support those individuals at higher risk, 
in part because of living or working arrangements. Comments from 
congregate living providers, advocacy groups, professional 
organizations, HCBS providers (including day habilitation and adult day 
health providers), residents, clients, staff, family members, paid and 
unpaid caregivers, and other stakeholders will help inform future CMS 
actions.

B. ICFs-IID and COVID-19

    ICFs-IID, residential facilities that provide services for people 
with disabilities, vary in size. In such settings, several factors may 
facilitate the introduction and spread of SARS-CoV-2, the virus that 
causes COVID-19. Staff working in these facilities often work across 
facility types (that is, nursing home, group home, different congregate 
settings within the employer's purview), and for different providers, 
which may contribute to disease transmission. Other factors impacting 
virus transmission in these settings might include: Clients who are 
employed outside the congregate living setting; clients who require 
close contact with staff or direct service providers; clients who have 
difficulty understanding information or practicing preventive measures; 
and clients in close contact with each other in shared living or 
working spaces. ICF-IID clients with certain underlying medical or 
psychiatric conditions may be at increased risk of serious illness from 
COVID-19.\5\
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    \5\ https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html.
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    There are currently 5,768 Medicare- and/or Medicaid-certified ICFs-
IID, and all 50 States have at least one ICF-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. ICFs-IIDs were originally conceived as large 
institutions, but caregivers and policymakers quickly recognized the 
potential benefits of greater community integration, spawning the 
growth in the early 1980s of community ICFs-IID with between four and 
15 beds.\6\ The number of individuals residing in large public ICFs-IID 
has decreased steadily over time (from 55,000 total residents in 1997 
to approximately 16,000 as of April 2021). Many states have either 
closed a significant number of these facilities completely or downsized 
them through ``rebalancing'' efforts,\7\ and the impetus of the Supreme 
Court's Olmstead decision.\8\ Many ICF-IID clients have multiple 
chronic conditions and psychiatric conditions in addition to their 
intellectual disability, which can impact a client's understanding or 
acceptance of the need for vaccination. All must financially qualify 
for Medicaid assistance. While national data about ICF-IID clients is 
limited, we take an example from Florida, almost one quarter (23 
percent) require 24-hour nursing services and a medical care plan in 
addition to their services plans.\9\ Data from a single state is not 
nationally representative and thus we are unable to generalize, but it 
is illustrative and consistent with other states' trends. These co-
occurring conditions may increase the risks of infectious diseases for 
clients of ICFs-IID above the risk levels experienced by the general 
population. Clients and residents often live in close quarters. Some 
may not understand the dangers of the virus, or be able to 
independently comply with mitigation measures. Those who need help with 
activities of daily living cannot maintain their distance from staff 
and caregivers. During the PHE, some facilities have struggled to 
retain staff and, as noted above, some staff working in these 
facilities may also have more than one job that puts them at higher 
risk.\10\ Currently, the Conditions of Participation: ``Health Care 
Services'' at Sec.  483.460(a)(3), require ICFs-IID to provide or 
obtain preventive and general medical care as well as annual physical 
examinations of each client that at a minimum include the following: 
Evaluation of vision and hearing; immunizations; routine screening 
laboratory examinations as determined necessary by the physician, 
special studies when needed; and tuberculosis control, appropriate to 
the facility's population. While the existing requirements should 
ensure that ICFs-IID provide clients with a COVID-19 vaccine, we note 
that it does not address vaccine education. Further, we believe that 
the unprecedented risks associated with the COVID-19 PHE warrant direct 
attention. ICFs-IID have not historically been required to participate 
in national reporting programs to the extent that

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other health care facilities have. Despite the limited data available 
regarding COVID-19 cases or outbreak in ICFs-IID, we recognize the 
unique concerns for these facilities and their clients and staff. We 
note that CDC has established COVID-19 infection, prevention, and 
control guidance specific to group homes for individuals with 
disabilities, as noted earlier, recently released an updated guidance 
on vaccination and sub-prioritization that discusses this group.\11\
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    \6\ https://aspe.hhs.gov/system/files/pdf/76956/MFIS.pdf.
    \7\ https://www.medicaid.gov/sites/default/files/2019-12/mfp-rtc.pdf.
    \8\ https://www.ada.gov/olmstead/S.
    \9\ http://www.floridaarf.org/assets/Files/ICF-IID%20Info%20Center/ICFHandoutonwebsite2-14.pdf.
    \10\ https://www.medicaid.gov/medicaid/long-term-services-supports/workforce-initiative/index.html.
    \11\ https://www.cdc.gov/coronavirus/2019-ncov/community/group-homes.html.
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    CMS and other Federal agencies took many actions and exercised 
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 Social 
Security Act (``1135 waivers''). CMS may also waive requirements set 
out under section 1812(f) of the Social Security Act (the Act) 
applicable to skilled nursing facilities (SNFs) under Medicare 
(``1812(f) waivers''). The 1135 waivers and 1812(f) waivers allowed us 
to rapidly expand efforts to help control the spread of SARS-CoV-2.
    Currently, CMS has waived the following regulations for ICF-IIDs, 
with a retroactive effective date of March 1, 2020, and continuing 
through the end of the public health emergency declaration and any 
extensions, unless they are terminated earlier. CMS has waived the 
requirements at Sec.  483.430(c)(4), which requires the facility to 
provide sufficient Direct Support Staff (DSS) so that Direct Care Staff 
(DCS) are not required to perform support services that interfere with 
direct client care. We also waived the requirements at Sec.  
483.420(a)(11) which requires clients have the opportunity to 
participate in social, religious, and community group activities. 
Finally, we also waived, in part, the requirements at Sec.  
483.430(e)(1) related to routine staff training programs unrelated to 
the public health emergency. CMS has not waived Sec.  483.430(e)(2) 
through (4), which requires focusing on the clients' developmental, 
behavioral, and health needs and being able to demonstrate skills 
related to interventions for challenging behaviors and implementing 
individual plans.
    CMS recognizes that during the public health emergency ``active 
treatment'' may need to be modified. The requirements at Sec.  
483.440(a)(1) require that each client receive a continuous active 
treatment program, which includes consistent implementation of a 
program of specialized and generic training, treatment, health services 
and related services. CMS is currently waiving those components of 
beneficiaries' active treatment programs and training that would 
violate current state and local requirements for social distancing, 
staying at home, and traveling for essential services only.

C. LTC Facilities and COVID-19

    Long-term care facilities, a category that includes Medicare SNFs 
and Medicaid nursing facilities (NFs), 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 reviewed and updated in October 2016 
(81 FR 68688), including a comprehensive update to the requirements for 
infection prevention and control.
    Since the onset of the PHE, we have revised the requirements for 
LTC facilities through two interim final rules with comment periods 
(IFCs) to establish reporting and testing requirements specific to the 
mitigation of the current pandemic. The first IFC was the ``Medicare 
and Medicaid Programs, Basic Health Program, and Exchanges; Additional 
Policy and Regulatory Revisions in Response to the COVID-19 Public 
Health Emergency and Delay of Certain Reporting Requirements for the 
Skilled Nursing Facility Quality Reporting Program'' interim final rule 
with comment, which appeared in the May 8, 2020 Federal Register (85 FR 
27550) with an effective date of May 8, 2020 (hereafter referred to as 
the ``May 8th COVID-19 IFC'').\12\ The May 8th 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 in response to the May 8th COVID-19 IFC. 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 was the ``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'' interim final rule with comment, 
which appeared in the September 2, 2020 Federal Register (85 FR 54820) 
with an effective date of September 2, 2020 (hereafter referred to as 
the ``September 2nd COVID-19 IFC'').\13\ The September 2nd COVID-19 IFC 
strengthened CMS' ability to enforce compliance with LTC 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 2nd 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).
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    \12\ https://www.federalregister.gov/documents/search?conditions%5Bterm%5D=85FR27550#.
    \13\ https://www.federalregister.gov/documents/search?conditions%5Bterm%5D=85FR54820#.
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    Health care inequities faced by the general population, discussed 
further in Section I.D. of this rule, are also seen within LTC 
facilities. Despite the increased use of nursing homes by minority 
residents, nursing home care remains highly segregated. Compared to 
Whites, racial/ethnic minorities tend to be cared for in facilities 
with limited clinical and financial resources, low nurse staffing 
levels, and a relatively high number of care deficiency citations.\14\ 
Nursing homes with relatively high shares of Black or Hispanic 
residents were more likely to report at least one COVID-19 death than 
nursing homes with lower shares of Black or Hispanic residents.\15\
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    \14\ https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094.
    \15\ https://www.kff.org/070b9a9/.
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D. Current COVID-19 Vaccination Activities in LTC Facilities and ICFs-
IID

    Because of the expedient development of COVID-19 vaccines and their 
authorization for emergency use by the U.S. Food and Drug 
Administration (FDA), the requirements for LTC facilities and 
Conditions of Participation (CoPs) for ICFs-IID do not currently 
address issues of resident and staff vaccination education, or 
reporting COVID-19 vaccinations or therapeutic treatments to CDC. 
Nonetheless, many facilities across the country are educating staff, 
residents, and resident representatives; participating in vaccine 
distribution programs; and voluntarily reporting vaccine 
administration. However, participation in these efforts is not 
universal and we are concerned that many groups at higher risk of 
infection, specifically residents and clients of LTC facilities and 
ICFs-IID,

[[Page 26310]]

are not able to access COVID-19 vaccination. While all nursing homes 
across the U.S. (whether or not certified as a Medicare or Medicaid 
provider) were invited to participate in the COVID-19 vaccination 
Pharmacy Partnerships (discussed further in section II.A.1. of this 
rule), internal CDC data show that approximately 2,500 Medicare or 
Medicaid-certified LTC facilities (approximately 16 percent) did not 
participate in the Pharmacy Partnership program.
    Given the congregate living models of LTC facilities and ICFs-IID, 
and the higher risk nature of their residents and clients due to age, 
comorbidities, and disabilities, people living and working in these 
facilities are at high risk of COVID-19 outbreaks, with residents and 
clients seeing higher rates of incidence, morbidity, and mortality than 
the general population. Data submitted to CDC's NHSN and posted on 
data.cms.gov for the week ending April 11, 2021 shows cumulative totals 
of 647,754 LTC resident COVID-19 confirmed cases and 131,926 LTC 
resident COVID-19 confirmed deaths. Also, there have been at least 
569,502 total LTC staff COVID-19 confirmed cases and 1,888 total LTC 
staff COVID-19 confirmed deaths, on a cumulative basis. While we do not 
currently have data regarding the incidence of COVID-19 cases in ICFs-
IID, we believe that these facilities may have also experienced 
significant rates of infection and that these data are likely an 
underestimate. A FAIR Health study examined the relationship between 
preexisting comorbidities of COVID-19 and mortality in privately 
insured individuals as reported in a white paper, Risk Factors for 
COVID-19 Mortality among Privately Insured Patients: A Claims Data 
Analysis.\16\ The paper states that there are several possible reasons 
for the high COVID-19 mortality risk in people with developmental 
disorders and intellectual disabilities. These include greater 
prevalence of comorbid chronic conditions. We seek information from the 
public regarding the epidemiologic burden of COVID-19 on ICFs-IIDs, 
reporting COVID-19 data by ICFs-IID, existing barriers to reporting, 
and ways to enhance and encourage voluntary reporting of COVID-19-
related data to CDC's NHSN reporting module.
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    \16\ https://s3.amazonaws.com/media2.fairhealth.org/whitepaper/asset/Risk%20Factors%20for%20COVID-19%20Mortality%20among%20Privately%20Insured%20Patients%20-%20A%20Claims%20Data%20Analysis%20-%20A%20FAIR%20Health%20White%20Paper.pdf.
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    We also request comment on inequities in COVID-19 preventive care 
that may have been experienced by LTC facility residents and ICF-IID 
clients. This IFC aims to ensure that all LTC facility residents, ICF-
IID clients, and the staff who care for them, are provided with ongoing 
access to vaccination against COVID-19. The accountable entities 
responsible for the care of residents and clients of LTC facilities and 
ICFs-IID must proactively pursue access to COVID-19 vaccination due to 
a unique set of challenges that generally prevent these residents and 
clients from independently accessing the vaccine. These challenges 
create potential disparities in vaccine access for those residing in 
LTC facilities and ICFs-IID. CDC has recommended states place LTC 
facility residents and health care personnel into Phase 1a.\17\ Despite 
their inclusion in most states' tier 1 vaccine priority category, it is 
CMS's understanding that very few individuals who are residents of LTC 
facilities are likely able to independently schedule or travel to 
public offsite vaccination opportunities. People reside in LTC 
facilities and ICFs-IID because they need ongoing support for medical, 
cognitive, behavioral, and/or functional reasons. Because of these 
issues, they may be less capable of self-care, including arranging for 
preventive health care. Independent scheduling and traveling off-site 
may be especially challenging for people with low health literacy, 
intellectual and developmental disabilities, dementia including 
Alzheimer's disease, visual or hearing impairments, or severe physical 
disability. This situation is particularly concerning because people 
with intellectual or developmental disabilities are at a 
disproportionate risk of contracting COVID-19.\18\
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    \17\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations.html.
    \18\ https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-developmental-disabilities.html.
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    Similarly, there are large subpopulations of Americans who 
experience inequities on a regular basis in accessing quality health 
care beyond COVID-19 vaccination. Certain groups experience health and 
health care inequity, such as racial and ethnic minorities; members of 
religious minorities; lesbian, gay, bisexual, transgender, and queer 
(LGBTQ+) persons; people with disabilities; people living in rural 
areas; and others.
    The COVID-19 pandemic has exacerbated these health care inequities 
as the country faces a convergence of economic, health, and climate 
crises.\19\ Historical patterns of inequity in health care may persist 
despite the emphasis of public health officials on the need for 
equitable access to and utilization of preventive measures. Inequities 
have persisted through the COVID-19 PHE, with racial and ethnic 
minorities continuing to have higher rates of infection and 
mortality.\20\ Ensuring that all residents, clients, and staff of LTC 
facilities and ICFs-IID have access to COVID-19 vaccinations seeks to 
address some of those inequities and provide timely protection for 
these individuals.
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    \19\ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/.
    \20\ https://tcf.org/content/commentary/even-nursing-homes-covid-19-racial-disparities-persist/?agreed=1.
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    Ensuring that all LTC facility residents, ICF-IID clients, and the 
staff who care for them are provided with ongoing opportunities to 
receive vaccination against COVID-19 is critical to ensuring that 
populations at higher risk of infection continue to be prioritized, and 
receive timely preventive care during the COVID-19 PHE. This rule 
establishes penalties for non-compliance, in order to require 
facilities to educate about and offer vaccination to residents and 
staff.
    Based on the current rate of incidence of COVID-19 disease and 
deaths among LTC residents, we believe more action can be taken to help 
staff and residents avoid contracting SARS-CoV-2. LTC facility staff 
are also at risk of transmitting SARS-CoV-2 to residents, experiencing 
illness or death as a result of COVID-19 themselves, and transmitting 
it to their families, friends, unpaid caregivers and the general 
public. Asymptomatic people with SARS-CoV-2 may move in and out of the 
LTC facility and the community, putting residents and staff at risk of 
infection. Routine testing of LTC residents and staff, along with 
visitation restrictions, personal protective equipment (PPE) usage, 
social distancing, and vaccination for residents and staff are all part 
of CDC's Interim Infection Prevention and Control Recommendations to 
Prevent SARS-CoV-2 Spread in Nursing Homes.\21\ COVID-19 vaccines are a 
crucial tool for slowing the spread of disease and death among both 
residents, staff, and the general public. Based on the Food and Drug 
Administration's (FDA) review, evaluation of the data, and their 
decision to authorize three vaccines for emergency use, we recognize 
that these vaccines meet FDA's standards for an emergency use 
authorization (EUA) for safety and effectiveness to prevent

[[Page 26311]]

COVID-19 disease and related serious outcomes, including 
hospitalization and death. The combination of vaccination, universal 
source control (wearing masks), social distancing, and hand-washing 
offers further protection from COVID-19.\22\
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    \21\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html.
    \22\ https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html.
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    Similar to LTC facilities, due to the recent development and 
authorization of COVID-19 vaccines, the conditions of participation for 
ICF-IIDs do not currently address issues of client and staff vaccine 
education. Many CMS-certified ICFs-IID across the country are educating 
staff, clients, and client representatives, and attempting to 
participate in vaccination programs. However, participation in these 
efforts is not universal, and we are concerned that many individuals 
are not receiving these important preventive care services.

E. COVID-19 PHE and Vaccine Development

    Ensuring that LTC residents, ICF-IID clients, and staff have the 
opportunity to receive COVID-19 vaccinations will help save lives and 
prevent serious illness and death. On December 1, 2020, the Advisory 
Committee in Immunization Practices (ACIP) met and provided 
recommendations; CDC adopted ACIP's recommendation: That health care 
personnel and long-term care facility residents be offered COVID-19 
vaccination first (Phase 1a).\23\
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    \23\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm.
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    All COVID-19 vaccines currently authorized for use in the United 
States were tested in clinical trials involving tens of thousands of 
people and met FDA's standards for safety, effectiveness, and 
manufacturing quality needed to support emergency use authorization. 
The clinical trials included participants of different races, 
ethnicities, and ages, including adults over the age of 65.\24\ The 
most common side effects following vaccination are dependent on the 
specific vaccine that an individual receives, but the most common may 
include pain at the injection site, tiredness, headache, muscle pain, 
nausea, vomiting, fever, and chills.\25\ After a review of all 
available information, ACIP and CDC have determined the lifesaving 
benefits of COVID-19 vaccination outweigh the risks or possible side 
effects.\26\
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    \24\ https://www.kff.org/racial-equity-and-health-policy/issue-brief/racial-diversity-within-covid-19-vaccine-clinical-trials-key-questions-and-answers/.
    \25\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html.
    \26\ 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 authorized for use in the United 
States require either a single dose or a series of two doses given 
three to four weeks apart. Every person who receives a COVID-19 vaccine 
receives a vaccination record card noting which vaccine and the dose 
received. Vaccine materials specific to each vaccine are located on CDC 
and FDA websites. CDC has posted a LTC facility toolkit ``Preparing for 
COVID-19 Vaccination at your Facility'' at https://www.cdc.gov/vaccines/covid-19/toolkits/long-term-care/. This toolkit provides LTC 
administrators and clinical leadership with information and resources 
to help build vaccine confidence among residents, clients, and staff. 
CDC has also posted an ICF-IID toolkit ``Toolkit for people with 
Disabilities'' at https://www.cdc.gov/coronavirus/2019-ncov/communication/toolkits/people-with-disabilities.html. This toolkit 
provides guidance and tools to help people with disabilities and paid 
and unpaid caregivers make decisions, help protect their health, and 
communicate with their communities.
    While we are not requiring participation, we encourage individual 
residents, clients, and staff who use smartphones to use CDC's new 
smartphone-based tool called v-safe After Vaccination Health Checker 
(v-safe) to self-report on one's health after receiving a COVID-19 
vaccine. V-safe is a new program that differs from the Vaccine Adverse 
Event Reporting System (VAERS), which we discuss in the section I.F. of 
this rule. Individuals may report adverse reactions to a COVID-19 
vaccine to either program. Enrollment in v-safe allows individuals to 
directly report to CDC any problems or adverse reactions after 
receiving the vaccine. When an individual receives the vaccine, they 
should also receive a v-safe information sheet telling them how to 
enroll in v-safe. Individuals who enroll will receive regular text 
messages directing them to surveys where they can report any problems 
or adverse reactions after receiving a COVID-19 vaccine, as well as 
receive reminders for a second dose if applicable.\27\ We note again 
that participation in v-safe is not mandatory, and further that 
individual participation is not traced to or shared with specific 
health care providers.
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    \27\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html.
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F. FDA & Emergency Use Authorization (EUA) of COVID-19 Vaccines

    The FDA provides scientific and regulatory advice to vaccine 
developers and undertakes a rigorous evaluation of the scientific 
information through all phases of clinical trials; such evaluation 
continues after a vaccine has been licensed by FDA or authorized for 
emergency use.
    CMS recognizes the gravity of the current public health emergency 
and the importance of facilitating availability of vaccines to prevent 
COVID-19. An EUA (authorized under section 564 of the Federal Food, 
Drug, and Cosmetic Act) 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. The 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.\28\
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    \28\ https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
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    VAERS is a safety and monitoring system that can be used by anyone 
to report adverse events with vaccines. While the COVID-19 vaccines are 
being used under an EUA, vaccination providers, manufacturers, and EUA 
sponsors must, in accordance with the National Childhood Vaccine Injury 
Act (NCVIA) of 1986 (42 U.S.C. 300aa-1 to 300aa-34), report select 
adverse events to VAERS (that is, serious adverse events, cases of 
multisystem inflammatory syndrome (MIS), and COVID-19 cases that result 
in hospitalization or death).\29\ Providers also must adhere to any 
revised safety reporting requirements. FDA's EUA website includes 
letters of authorization and fact sheets and these should be checked 
for any updates that may occur. Additional adverse events following 
vaccination may be reported to VAERS. Adverse events will also be 
monitored through electronic health record- and claims-based systems 
(that is, CDC's Vaccine Safety Datalink and Biologicals Effectiveness 
and Safety (BEST)). On December 11, 2020, the U.S. Food and Drug 
Administration issued the first

[[Page 26312]]

EUA for a vaccine for the prevention of coronavirus disease 2019 
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2 
(SARS-CoV-2) in individuals 16 years of age and older. The EUA allows 
the Pfizer-BioNTech COVID-19 vaccine to be distributed in the U.S. FDA 
has now issued EUAs for three vaccines for the prevention of COVID-19, 
to Pfizer (December 11, 2020) (16 years of age and older), Moderna 
(December 18, 2020) (18 years of age and older), and Johnson & 
Johnson's Janssen (February 27, 2021) (18 years of age and older). Fact 
sheets for healthcare providers administering vaccine are available for 
each vaccine product from theFDA.\30\
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    \29\ Department of Health and Human Services. VAERS--Vaccine 
Adverse Event Reporting System. Accessed at https://vaers.hhs.gov/. 
Accessed on January 26, 2021.
    \30\ https://www.fda.gov/media/144637/download, https://www.fda.gov/media/144413/download, https://www.fda.gov/media/146304/download.
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    FDA is closely monitoring the safety of the COVID-19 vaccines 
authorized for emergency use. The vaccination provider is responsible 
for mandatory reporting to VAERS of certain adverse events as listed on 
the Health Care Provider Fact Sheet. The requirements for LTC 
facilities and ICFs-IID established by this IFC can be met by offering 
current and future COVID-19 vaccines authorized by FDA under EUA, or 
any COVID-19 vaccines licensed by FDA, as well as any COVID-19 vaccine 
boosters if authorized or licensed. We note that at this time, some LTC 
facility residents and ICF-IID clients may not be eligible to receive 
vaccination due to age (that is, they are younger than 16), but we 
anticipate that they may become eligible for vaccination if authorized 
use of COVID-19 vaccines is expanded in the future.

II. Provisions of the Interim Final Rule

    In order to help protect LTC residents and ICF-IID clients from 
COVID-19, each facility must have a vaccination program that meets the 
educational and information needs of each resident, resident 
representative, client, parent (if the client is a minor) or legal 
guardian, and staff member. The program should provide COVID-19 
vaccines, when available, to all residents and staff who choose to 
receive them. Consistent vaccination reporting by LTC facilities via 
the NHSN will help to identify LTC facilities that have potential 
issues with vaccine confidence or slow uptake among either residents or 
staff or both. The NHSN is the Nation's most widely used health care-
associated infection (HAI) tracking system. It furnishes states, 
facilities, regions, and the Government with data regarding problem 
areas and measures of progress. CDC and CMS use information from NHSN 
to support COVID-19 vaccination programs by focusing on groups or 
locations that would benefit from additional resources and strategies 
that promote vaccine uptake. CMS Federal surveyors and state agency 
surveyors will use the vaccination data in conjunction with the 
reported data that includes COVID-19 cases, resident deaths, staff 
shortages, PPE supplies and testing. This combination of reported data 
is used by surveyors to determine individual facilities that need to 
have focused infection control surveys. Facilities having difficulty 
with vaccine acceptance can be identified through examining trends in 
NHSN data; and the Quality Improvement Organizations (QIOs), groups of 
health quality experts, clinicians, and consumers organized to improve 
the quality of care delivered to people with Medicare, can provide 
assistance to increase vaccine acceptance. Specifically, QIOs may 
provide assistance to LTC facilities by targeting small, low 
performing, and rural nursing homes most in need of assistance, and 
those that have low COVID-19 vaccination rates; disseminating accurate 
information related to access to COVID-19 vaccines to facilities; 
educating residents and staff on the benefits of COVID-19 vaccination; 
understanding nursing home leadership perspectives and assist them in 
developing a plan to increase COVID-19 vaccination rates among 
residents and staff; and assisting providers with reporting 
vaccinations accurately.
    As discussed in detail below, we are revising the LTC facility 
requirements to specify that facilities must educate all residents and 
staff about COVID-19 vaccines, offer vaccination to all residents and 
staff, and report certain data regarding vaccination and therapeutic 
treatments to CDC via NHSN. Likewise, we are revising the ICF-IID 
Conditions of Participation to require that facilities must educate all 
clients and staff about COVID-19 vaccines and offer vaccination to all 
clients and staff. Reporting is not required for the ICFs-IID, however 
we strongly encourage voluntary reporting.
    Immunization education, delivery, and reporting for influenza and 
pneumococcal vaccines are already a routine part of LTC facilities' 
infection control and prevention plans. We also require LTC facilities 
to offer education on influenza and pneumococcal vaccines and to give 
the resident or the resident representative the opportunity to accept 
or refuse vaccine.\31\ LTC facilities must document a resident's uptake 
or refusal of influenza and pneumococcal immunization in the resident's 
medical record and report through a different electronic submission 
system, the Minimum Data Set (MDS). In order to standardize COVID-19 
infection control and prevention in LTC facilities, we are issuing 
these requirements for facilities to provide COVID-19 vaccine 
education, offer COVID-19 vaccination, and report COVID-19 vaccinations 
for LTC facility residents and staff.
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    \31\ Sec.  483.80(d).
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    We require ICFs-IID to provide or obtain health care services for 
clients, including immunization, using as a guide the recommendations 
of the CDC Advisory Committee on Immunization Practices or of the 
Committee on the Control of Infectious Diseases of the American Academy 
of Pediatrics.\32\ While the ICF-IID CoPs do not currently address 
specific vaccinations, the unprecedented risk of COVID-19 illness 
demands specific attention to protect clients. As discussed in section 
B.3. of this IFC, we are not issuing COVID-19 vaccination reporting 
requirements for ICFs-IID at this time due to current low rates of 
participation in NHSN by ICFs-IID and the delays that would be incurred 
by equipment acquisition (in some facilities) and NHSN enrollment, 
verification, and training.
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    \32\ https://pediatrics.aappublications.org/content/145/3/e20193995.
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A. Long-Term Care Facilities

1. Offer and Provide Vaccine to LTC Residents and Staff
    With this IFC, we are amending the requirements at Sec.  483.80 to 
add a new paragraph (d)(3). We require at new Sec.  483.80(d)(3)(i) 
that LTC facilities develop and implement policies and procedures to 
ensure that they offer residents and staff vaccination against COVID-19 
when vaccine supplies are available. We note that we are permitting but 
not requiring LTC facilities to provide the vaccine directly. They may 
also provide it indirectly, such as through arrangement with a pharmacy 
partner or local health department. Implementation of COVID-19 vaccine 
education and vaccination programs in LTC facilities will protect 
residents and staff, allowing for an expedited return to more normal 
routines, including timely preventive health care; family, caregiver, 
and community visitation; and group and individual activities. While we 
require that all residents and staff must be educated about the 
vaccine, we note that in situations, for example, where an individual 
has already received a

[[Page 26313]]

COVID-19 vaccine or has a known medical contraindication (that is, an 
allergy to vaccine ingredients or previous severe reaction to a 
vaccine), the facility is not required to offer vaccination to that 
person. CDC has posted ``Interim Clinical Considerations for Use of 
COVID-19 Vaccines Currently Authorized in the United States'' 
describing these clinical situations.\33\ CDC advice and guidance 
documents are periodically updated to reflect the latest information, 
and we cite this as an example, not as a regulatory requirement. At 
Sec.  483.70(i)(1), in accordance with accepted professional standards 
and practices, the LTC facility must maintain medical records on each 
resident that are complete and accurately documented. In order to 
maintain current information, refusal of a vaccine should be documented 
with the reason; if the resident received the vaccine(s) elsewhere that 
should also be documented.
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    \33\ https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
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    CDC established the Pharmacy Partnership for Long-term Care Program 
(Pharmacy Partnership), a national distribution initiative that 
provides end-to-end management of the COVID-19 vaccination process, 
including cold chain management, on-site vaccinations, and fulfillment 
of certain reporting requirements, to facilitate safer vaccination of 
the LTC facility population (residents and staff), while reducing 
burden on LTC facilities and jurisdictional health departments.\34\ 
Most LTC facility staff who had not received their COVID-19 vaccine 
elsewhere, or needed to complete a vaccine series, were also vaccinated 
as part of the program. At the time of publication, we do not have data 
on the Partnership accomplishments in vaccinating residents or staff, 
but as discussed in the Regulatory Impact Analysis (RIA) section of 
this rule, there is extensive turnover in both groups, establishing the 
need for ongoing vaccination policies and programs.
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    \34\ https://www.cdc.gov/vaccines/covid-19/long-term-care/pharmacy-partnerships.html and provide additional information on 
vaccination under this program: https://covid.cdc.gov/covid-data-tracker/#vaccinations-ltc
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    The Pharmacy Partnership is currently facilitating safe vaccination 
of some LTC facility residents and staff, while reducing the burden on 
LTC facilities. The facilities remain responsible for the care and 
services provided to their residents. CDC has expected pharmacy 
partners to provide program services on-site at participating 
facilities for approximately two months from the date of each 
facility's first vaccination clinic, concluding in all facilities by 
spring of 2021. Internal CDC data shows that 99 percent of 
participating SNFs had held their third (final) clinic as of March 15, 
2021. As the Pharmacy Partnership for LTC program comes to an end, it 
is important to ensure facilities have policies and procedures to 
provide continued access to COVID-19 vaccine for new or unvaccinated 
residents and staff, groups that will each exceed in magnitude over the 
course of this year a number larger than those offered vaccination 
during the Partnership's tenure. The Federal Government has also 
launched the Federal Retail Pharmacy Program, a collaboration between 
the Federal Government, states, and territories, and 21 national 
pharmacy partners and independent pharmacy networks representing over 
40,000 pharmacies nationwide, including LTC facility pharmacy 
locations. This collaboration is intended to enhance the opportunities 
for vaccine uptake in congregate living settings.
    For residents and staff who opt to receive the vaccine, vaccination 
must be conducted in a safe and sanitary manner in accordance with 
Sec.  483.80; and as required by the vaccine provider agreements, 
COVID-19 vaccination clinics must be conducted in a manner for safe 
delivery of vaccines during the COVID-19 pandemic.\35\ All facilities 
must adhere to current CDC infection prevention and control (IPC) 
recommendations. Screening individuals for currently suspected or 
confirmed cases of COVID-19, previous allergic reactions, and 
administration of therapeutic treatments and services is important for 
determining whether these individuals are appropriate candidates for 
vaccination at any given time. According to current CDC guidelines, 
anyone infected with COVID-19 should wait until infection resolves and 
they have met the criteria for discontinuing isolation.\36\ We note 
that indications and contraindications for COVID-19 vaccination are 
evolving, and LTC facility Medical Directors and Infection 
Preventionists (IPs) should be alert to any new or revised guidelines 
issued by CDC, FDA, vaccine manufacturers, or other expert 
stakeholders.
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    \35\ https://www.cdc.gov/vaccines/pandemic-guidance/index.html.
    \36\ Interim Guidance on Duration of Isolation and Precautions 
for Adults with COVID-19 [verbar] CDC, https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html.
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    Staff at LTC facilities should follow the recommended IPC practices 
described on CDC's website for LTC facilities.\37\ For example, the 
website currently has ``Long-Term Care Facility Toolkit: Preparing for 
COVID-19 in LTC facilities'' \38\ and the ``Interim Infection 
Prevention and Control Recommendations for Healthcare Personnel During 
the Coronavirus Disease 2019 (COVID-19) Pandemic.'' \39\ These 
recommendations, which emphasize close monitoring of residents of long-
term care facilities for symptoms of COVID-19, universal source 
control, physical distancing, hand hygiene, and optimizing engineering 
controls, are intended to help protect staff and residents from 
exposure.
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    \37\ https://www.cdc.gov/longtermcare/.
    \38\ https://www.cdc.gov/vaccines/covid-19/toolkits/long-term-care/.
    \39\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html.
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    Administration of any vaccine includes appropriate monitoring of 
vaccine recipients for adverse reactions. CDC has information 
describing IPC considerations for residents of long-term care 
facilities with systemic signs and symptoms following COVID-19 
vaccination. See ``Post-Vaccine Considerations for Residents,'' located 
at https://www.cdc.gov/coronavirus/2019-ncov/hcp/post-vaccine-considerations-residents.html. This information is also included on FDA 
fact sheets. Long-term care facilities must have strategies in place to 
appropriately evaluate and manage post-vaccination signs and symptoms 
of adverse events among their residents.
    CDC advises that COVID-19 vaccination providers document vaccine 
administration in their medical records system within 24 hours of 
administration and report administration data as specified in their 
vaccine provider agreements and to applicable local vaccine tracking 
programs (that is, Immunization Information System) as soon as 
practicable and no later than 72 hours after administration. While LTC 
facility staff may not have personal medical records on file with the 
employing LTC facility, all staff COVID-19 vaccinations must be 
appropriately documented by the facility in a manner that enables the 
facility to report in accordance with this rule (that is, in a facility 
immunization record, personnel files, health information files, or 
other relevant document). Updates to CDC's COVID-19 Vaccination Program 
Provider Agreement Requirements can be located on CDC's website.\40\
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    \40\ Centers for Disease Control and Prevention. CDC COVID-19 
Vaccination Program Provider Requirements and Support. Accessed at 
https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html. Accessed on January 26, 2021.

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[[Page 26314]]

2. COVID-19 Disease and Vaccine Education
a. LTC Facility Staff
    Given the new and emerging nature of COVID-19 disease, vaccines, 
and treatments, we recognize that education is critical. With this IFC, 
we are amending the requirements at Sec.  483.80 to add new paragraph 
(d)(3)(ii) to require that LTC facility staff are educated about 
vaccination against COVID-19. LTC facility staff are integral to the 
function of LTC facilities and the health and well-being of residents. 
For the purposes of COVID-19 vaccine education, offering, and 
reporting, we consider 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 2nd, 2020 COVID-19 IFC. This rule's 
description of LTC facility staff is limited to individuals working in 
the facility on a regular (at least weekly) basis, while the definition 
set out at Sec.  483.80(h) includes workers who come into the facility 
infrequently, such as a plumber who may come in only a few times per 
year. We considered applying the Sec.  483.80(h) definition to the 
vaccination and reporting requirements in this rule, but public 
feedback tells us the definition in paragraph (h) was overbroad for 
these purposes. Stakeholders report that there are many LTC facility 
staff and individuals providing occasional services under arrangement, 
and that the requirements may be excessively burdensome for the 
facilities to apply the definition at paragraph (h) because it includes 
many individuals who have very limited, infrequent contact with 
facility staff and residents. Stakeholders also report that providing 
the required education and offering vaccination to these individuals 
who may only make unscheduled visits to the facility would be extremely 
burdensome. That said, the description in this rule--individuals who 
work in the facility on a regular (that is, at least once a week) 
basis--still includes many of the individuals included in paragraph 
(h). In addition to facility-employed personnel, many facilities have 
services provided on-site, on a regular basis by individuals under 
contract or arrangement, including hospice and dialysis staff, physical 
therapists, occupational therapists, mental health professionals, or 
volunteers. Any of these individuals who provide services on-site at 
least weekly would be included in ``staff'' who must be educated and 
offered the vaccine as it becomes available. As established by this 
rule at Sec.  483.80(d)(3), LTC facilities are not required to educate 
and offer vaccination to individuals who provide services less 
frequently, but they may choose to extend such efforts to them. We 
strongly encourage facilities, when the opportunity exists and 
resources allow, to provide vaccination to all individuals who provide 
services less frequently.
    There are also individuals who may enter the facility for specific 
purposes and for a limited amount of time, such as delivery and repair 
personnel, or volunteers who may enter the LTC facility infrequently 
(less than once a week). We believe it would be overly burdensome to 
mandate that each LTC facility educate and offer the COVID-19 vaccine 
to all individuals who enter the facility. However, while facilities 
are not required to educate and offer vaccination to these individuals, 
they may choose to extend their education and offering efforts beyond 
those persons that we consider to be staff for purposes of this 
rulemaking. We do not intend to prohibit such extensions and encourage 
facilities to educate and offer vaccination to these individuals as 
reasonably feasible.
    We recognize that facilities may choose to use a broader definition 
of ``staff.'' We note that CDC defines ``staff'' in the NHSN as: 
Ancillary service employees, nurse employees, aide, assistant and 
technician employees, therapist employees, physician and licensed 
independent practitioner employees and other health care providers. 
Categories are further broken down into environmental, laundry, 
maintenance, and dietary services; registered nurses and licensed 
practical/vocational nurses; certified nursing assistants, nurse aides, 
medication aides, and medication assistants; therapists (such as 
respiratory, occupational, physical, speech, and music therapist) and 
therapy assistants; physicians, residents, fellows, advanced practice 
nurses, and physician assistants; and persons not included in the 
employee categories listed, regardless of clinical responsibility or 
patient contact, including contract staff, students, and other non-
employees.\41\
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    \41\ https://www.cdc.gov/nhsn/ltc/weekly-covid-vac/index.html.
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    We are requiring that LTC facility staff (that is, individuals who 
work in the facility on a regular basis) be educated about the benefits 
and risks and potential side effects of the COVID-19 vaccine. Educating 
staff further about the development of the vaccine, how the vaccine 
works, and the particulars of the multi-dose vaccine series is 
encouraged but not required. Broader understanding of the vaccine will 
support the national effort to vaccinate against COVID-19. Staff should 
be instructed about the importance of vaccination for residents, their 
personal health, and community health. Better understanding the value 
of vaccination may allow staff to appropriately educate residents and 
residents' family members and unpaid caregivers about the benefits of 
accepting the vaccine. While most residents in LTC facilities are 
isolated from the broader community during the PHE, staff travel to and 
from the facility and the community, presenting risks of transmitting 
the virus to or from residents, family members, other caregivers, and 
the public.
    We note that for LTC facilities that participated in the Federal 
Pharmacy Partnership for Long-Term Care Program, pharmacies worked 
directly with LTC facilities to ensure staff who received the vaccine 
also received an EUA fact sheet before vaccination. The EUA fact sheet 
explains the risks and possible side effects and benefits of the COVID-
19 vaccine they are receiving and what to expect.
    Staff education must cover the benefits of vaccination, which 
typically include reduced risk of COVID-19 illness and related serious 
COVID-19 outcomes, including hospitalization and death, the bolstered 
protection offered by completing a full series of multi-dose vaccines 
if used, and other benefits identified as research continues. Early 
data also suggests that vaccination offers reduced risk of 
inadvertently transmitting the virus to patients and other 
contacts.\42\ Staff education must also address risks associated with 
vaccination, which should include potential side-effects of the 
vaccine, including common reactions such as aches or fever, and rare 
reactions such as anaphylaxis.\43\ The low likelihood of severe side 
effects should be included in this education. If other benefits or 
risks or possible side-effects are identified in

[[Page 26315]]

the future, whether through research, or authorization or licensing of 
new COVID-19 vaccines, those facts should be incorporated into 
education efforts. Staff should also be informed about ongoing 
opportunities for vaccination, if they miss a Pharmacy Partnership 
clinic, for example, or initially declined vaccination but later decide 
to accept the vaccine. In addition to ongoing education and 
informational updates for all staff members, we expect that new staff 
will receive appropriate education on COVID-19 vaccines.
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    \42\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html.
    \43\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html.
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    CDC and FDA have developed a variety of clinical educational and 
training resources for health care professionals related to COVID-19 
vaccines, and CMS recommends that nurses and other clinicians work with 
their LTC facility's Medical Director and, and use CDC and FDA 
resources as sources of information for their vaccination education 
initiatives. The LTC Facility Toolkit: Preparing for COVID-19 
Vaccination at Your Facility has information and resources to build 
confidence among staff and residents.\44\ The FDA provides materials 
for industry and other stakeholder specific to the EUA process and the 
vaccines.\45\ Examples of educational and training topics include 
engaging residents in effective COVID-19 vaccine conversations, 
answering questions about consent for vaccine, common side effects, 
educating residents and staff about what to expect after vaccination, 
and the importance of maintaining infection prevention and control 
practices after vaccination. Each vaccine manufacturer is also 
developing educational and training resources for its individual 
vaccine. Building vaccine understanding broadly among staff, residents, 
and resident representatives, as well as dispelling vaccine 
misinformation and spreading information about successes in the program 
are critical to improving vaccine uptake rates, with potential for 
reducing vaccine hesitancy and the spread of misinformation.
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    \44\ https://www.cdc.gov/vaccines/covid-19/toolkits/long-term-care/.
    \45\ https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19.
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    The facility's vaccination policies and procedures must be part of 
the IPC program. Facilities can determine where they keep the 
documentation that demonstrates educational efforts and offering the 
vaccine to staff. Some examples of evidence of compliance may include 
sign in sheets, descriptions of materials used to educate, summary 
notes from all-staff question and answer sessions. There may be posters 
and flyers announcing appointments for vaccine clinic days or other 
opportunities to be vaccinated.
b. LTC Facility Residents and Resident Representatives
    With this IFC, we are amending the requirements at Sec.  483.80 to 
add a new paragraph (d)(3)(iii) to require that LTC facility residents 
or resident representatives are educated about vaccination against 
COVID-19. Explaining the risks and possible side effects and benefits 
of any treatments to a resident or their representative in a way that 
they can understand is the standard of care, and a patient right as 
specified at Sec.  483.10(c)(5). In LTC facilities, consent or assent 
for vaccination should be obtained from residents and/or their 
representatives as appropriate and documented in the resident's medical 
record. The residents or their representatives have the right to 
decline the vaccine, based on the resident's rights requirement at 
Sec.  483.10(c)(5) (regarding the resident's right to be informed of 
risks and benefits of proposed care). It is important to talk to 
residents and representatives to learn why they may be declining 
vaccination on their own behalf, or on behalf of the resident, and 
tailor any educational messages accordingly. Residents may not be 
forced or required to be vaccinated if the person or their 
representative declines.
    Resident representatives must be included as a component of the LTC 
facility's vaccine education plan, as the resident representatives may 
be called upon for consent and/or may be asked to assist in promoting 
vaccine uptake of the resident, as appropriate. We note that for LTC 
facilities participating in the Federal Pharmacy Partnership for Long-
term Care Program, pharmacies will work directly with LTC facilities to 
ensure residents who receive the vaccine also receive an EUA fact sheet 
before vaccination. The EUA fact sheet explains the risks or potential 
side effects and benefits of the COVID-19 vaccine they are receiving 
and what to expect.
    In addition to the topics addressed above for education of LTC 
facility staff, education of residents and resident representatives 
should cover that, at this time while the U.S. Government is purchasing 
all COVID-19 vaccine in the United States for administration through 
the CDC COVID-19 Vaccination Program, all LTC facility residents are 
able to receive the vaccine without any copays or out-of-pocket costs. 
The provider agreements for the CDC COVID-19 Vaccination Program 
specifically prohibit charging out-of-pocket fees to the vaccine 
recipient. Medicare pays for the administration of the COVID-19 vaccine 
to beneficiaries, and other public and private insurance providers are 
required to cover it as well. To ensure broad access to a vaccine for 
America's Medicare beneficiaries, CMS published an Interim Final Rule 
with Comment Period (IFC) on November 6, 2020, that implemented section 
3713 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act 
which required Medicare Part B to cover and pay for a COVID-19 vaccine 
and its administration without any cost-sharing (85 FR 71142, November 
6, 2020). Any vaccine that receives Food and Drug Administration (FDA) 
authorization, through an EUA, or is licensed under a Biologics License 
Application (BLA), will be covered under Medicare as a preventive 
vaccine at no cost to beneficiaries. The November 6th IFC also 
implemented section 3203 of the CARES Act that ensure swift coverage of 
a COVID-19 vaccine by most private health insurance plans without cost 
sharing from both in and out-of-network providers during the course of 
the PHE.\46\ The Provider Relief Fund Uninsured Program will also 
reimburse for administration of COVID-19 vaccine to individuals who are 
uninsured.\47\
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    \46\ 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).
    \47\ https://www.hhs.gov/coronavirus/cares-act-provider-relief-fund/index.html.
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    Education for residents and representatives must also provide the 
opportunity for follow-up questions and be conducted in a manner that 
is reasonably understood by the resident and the representatives.
3. LTC Facility Reporting
    With this IFC, we are amending the requirements at Sec.  483.80(g) 
to require that LTC facilities report to NHSN, on a weekly basis, the 
COVID-19 vaccination status and related data elements of all residents 
and staff. The data to be reported each week will be cumulative, that 
is, data on all residents and staff, including total numbers and those 
who have received the vaccine, as well as additional data elements. In 
this way, the vaccination status of every LTC facility will be known on 
a weekly basis. Data on vaccine uptake will be important to 
understanding the impact of vaccination on SARS-CoV-2 infections and 
transmission in nursing

[[Page 26316]]

homes.\48\ This understanding, in turn, will help CDC make changes to 
guidance to better protect residents and staff in LTC facilities. In 
addition, LTC facilities must also report any COVID-19 therapeutics 
administered to residents. CDC has currently defined ``therapeutics'' 
for the purposes of the NHSN as a ``treatment, therapy, or drug'' and 
stated that monoclonal antibodies are examples of anti-SARS-CoV-2 
antibody-based therapeutics used to help the immune system recognize 
and respond more effectively to the SARS-CoV-2 virus.
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    \48\ https://www.cdc.gov/nhsn/pdfs/covid19/ltcf/57.158-toi-508.pdf.
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    LTC administrators and clinical leadership are encouraged to track 
vaccination coverage in their facilities and adjust communication with 
residents and staff accordingly. Facilities reporting vaccinations to 
the NHSN Long-Term Care Facility Component \49\ or Healthcare Personnel 
Safety Component are encouraged to use the COVID-19 Vaccination module 
to track aggregate vaccination coverage in their facility, which can 
help target education efforts, plan resource needs, and update 
visitation and cohorting policies (that is, grouping residents within 
the facility while waiting for COVID-19 test results or showing signs 
of illness) as indicated by evolving public health guidelines. NHSN 
data will allow CDC to determine the number and percentage of staff and 
residents in each facility who have received the COVID-19 vaccine.\50\
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    \49\ Centers for Disease Control and Prevention--National 
Healthcare Safety Network. Surveillance for Weekly HCP & Resident 
COVID-19 Vaccination. Accessed at https://www.cdc.gov/nhsn/ltc/weekly-covid-vac/index.html. Accessed on January 26, 2021.
    \50\ https://www.cdc.gov/nhsn/ltc/weekly-covid-vac/index.html.
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    Our intent in mandating reporting of COVID-19 vaccines and 
therapeutics to NHSN is in part to monitor broader community vaccine 
uptake, but also to allow CDC to identify and alert CMS to facilities 
that may need additional support in regards to vaccine education and 
administration. These specific data collections replace and refine the 
current requirement, set out at Sec.  483.80(g)(1)(viii), based on the 
opportunities presented by the development and authorization of COVID-
19 vaccines and therapeutic treatments. If we identify a need to 
collect other specific data related to COVID-19, we will do this 
through appropriate rulemaking. The information reported to CDC in 
accordance with Sec.  483.80(g) will be shared with CMS and we will 
retain and publicly report this information to support protecting the 
health and safety of residents, staff, and the general public, in 
accordance with sections 1819(d)(3)(B) and 1919(d)(3) of the Act.
    Aggregate COVID-19 vaccination data collected as a result of this 
rulemaking will be made available to the public in the future. We note 
that until that time, individuals may request data per the Freedom of 
Information Act (FOIA) (5 U.S.C. 552), which provides that, upon 
request from any person, a Federal agency must release any agency 
record unless that record falls within one of the nine statutory 
exemptions and three exclusions (see https://www.foia.gov/faq.html for 
detailed information). Further, FOIA requires that agencies make 
available for public inspection copies of records, which because of the 
nature of their subject matter, have become or are likely to become the 
subject of subsequent requests for substantially the same information. 
We have received, and expect to continue to receive, COVID-19-related 
FOIA requests. Facility influenza vaccine data are available through 
CMS's Care Compare tool because these data are collected directly 
through the MDS, which feeds into the Care Compare tool. Data submitted 
through NHSN concerning COVID-19 testing and cases in LTC facilities is 
publicly posted on data.cms.gov.\51\
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    \51\ https://www.medicare.gov/care-compare/.
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    We are aware that COVID-19 vaccine information may be reported to 
local and state health departments, as well as by various pharmacy 
partners, and we believe direct submission of data by LTC facilities 
through NHSN will show actions and trends that can be addressed more 
efficiently on a national level. All state health departments and many 
local health departments already have direct access through NHSN to LTC 
facilities' COVID-19 data and are using the data for their own local 
response efforts. Thus, reporting in NHSN will, in many cases, serve 
the needs of state and local health departments. We request public 
comment on whether states are collecting COVID-19 vaccination data 
already, through other mechanisms.
    National reporting through NHSN, which is limited to enrolled 
health care providers, will allow CDC to examine vaccination coverage 
compared with community infection rates, to determine visitation and 
other COVID-19 infection prevention and control guidelines, including 
cohorting. Currently, low rates of voluntary use of NHSN for 
vaccination reporting precludes accurate estimates of vaccine coverage. 
Regular and required reporting into the NHSN and familiarity with the 
NHSN process will also increase the future capacity of facilities to 
report if new pandemics or other threats arise in the future.
    Pharmacy partners reported vaccination clinics they held in LTC 
facilities, and they have shared these data with CDC. Internal CDC data 
shows that 99 percent of participating SNFs had held their 3rd (final) 
clinic as of March 15, 2021. However, they have not continued to 
collect or report these data after their clinics concluded. 
Additionally, the pharmacy partners only collected numerator data (the 
number of residents and staff vaccinated), and not denominator data 
(the total number of residents and staff). Therefore, CDC cannot 
calculate the percentages of residents and staff vaccinated in each 
facility via the Federal Pharmacy Partnership data.
    NHSN provides the long-term means to collect these data now that 
the Pharmacy Partnership has finished and will allow for calculation of 
percentages of residents and staff vaccinated in every facility. We 
anticipate that the additional reporting burden to LTC facilities will 
be minimal. All LTC facilities are already required, at Sec.  
483.80(g), to report certain COVID-19 case and outcomes data to NHSN 
every week, and the new vaccination reporting is in the same NHSN 
reporting system they currently use. Finally, health departments for 
states, the District of Columbia, and territories all have access to 
NHSN data for their jurisdictions and can use these data to inform 
their own response efforts. Facilities can determine where they keep 
the documentation that should be collected so that they can comply with 
the NHSN COVID-19 vaccination reporting requirements for staff.
    Therapeutic treatments for COVID-19 administered to LTC residents, 
such as those in the form of monoclonal antibodies delivered 
intravenously, must now also be reported through NHSN in accordance 
with new Sec.  483.80(g)(1)(ix) so that CDC can appropriately monitor 
their use. This reporting of therapeutics requirement is similar to the 
requirement that hospitals must report information about therapeutics 
(85 FR 85866). Data on the use of therapeutics will be critical to help 
support allocation efforts to ensure that nursing homes have access to 
supplies and services to meet their needs. This requirement and burden 
will be submitted to OMB under OMB control number 0938-1363.

[[Page 26317]]

B. Intermediate Care Facilities for Individuals With Intellectual 
Disabilities

1. Offer and Provision of Vaccine to ICF-IID Clients and Staff
    With this IFC, we are redesignating the current Sec.  483.460(a)(4) 
to Sec.  483.460(a)(5) and adding a requirement at new Sec.  
483.460(a)(4)(i) to require that ICFs-IID offer clients and staff 
vaccination against COVID-19 when vaccine supplies are available. The 
vaccine may be offered and provided directly by the ICF-IID or 
indirectly, such as through a local health department, pharmacy, or 
doctor's office. Vaccines may be administered onsite or at other 
appropriate locations. Implementation of COVID-19 education and 
vaccination programs in ICFs-IID will help protect clients and staff, 
allowing an eventual return to more normal routines, including timely 
preventive health care; family, caregiver and community visitors; and 
group and individual activities. While we require that all clients and 
staff must be educated about the vaccine, we note that in situations 
where an individual has already received the vaccine or has a known 
medical contraindication (that is, an allergy to vaccine ingredients or 
previous severe reaction to a vaccine), the facility is not required to 
offer vaccination to that person.\52\
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    \52\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/specific-groups/allergies.html.
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    The client, parent (if the client is a minor), or legal guardian 
(collectively, ``representative'') has the right to refuse treatment 
based on the requirement at Sec.  483.420(a)(2) that states the 
facility must ensure the rights of all clients. Therefore, the facility 
must inform each client and/or the representative regarding the 
client's medical condition, developmental and behavioral status, 
attendant risks of treatment, and the right to refuse treatment. 
Clients and their representatives (on behalf of the client) have the 
right to refuse vaccination.
    For clients and staff who opt to receive the vaccine, vaccination 
must be conducted in a sanitary manner in accordance with CDC, FDA, 
Sec.  483.410(b) of the ICF-IID CoPs, and manufacturer guidelines. As 
required by the provider agreements, COVID-19 vaccination clinics must 
be conducted in a manner for safe delivery of vaccines during the 
COVID-19 pandemic.\53\ All facilities should adhere to current CDC IPC 
recommendations. Screening individuals for suspected or confirmed cases 
of COVID-19, previous allergic reactions, and administration of 
therapeutic treatments is important for determining whether they are 
appropriate candidates for vaccination at any given time. According to 
current CDC guidelines, anyone infected with COVID-19 should wait until 
infection resolves and they have met the criteria for discontinuing 
isolation.\54\ We note that indications and contraindications for 
COVID-19 vaccination are evolving, and the director of nursing (DON) or 
nursing staff of the facility should be alert to any new or revised 
guidelines issued by CDC, FDA, vaccine manufacturers, and other expert 
stakeholders.
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    \53\ https://www.cdc.gov/vaccines/pandemic-guidance/index.html.
    \54\ Interim Guidance on Duration of Isolation and Precautions 
for Adults with COVID-19 [verbar] CDC, https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html.
---------------------------------------------------------------------------

    Staff at ICFs-IID should follow the recommended IPC practices 
described on CDC's website for ICFs-IID. For example, the website 
currently has documents entitled ``Guidance for Group Homes for 
Individuals with Disabilities'' and the ``Interim Infection Prevention 
and Control Recommendations for Healthcare Personnel During the 
Coronavirus Disease 2019 (COVID-19) Pandemic''.55 56 These 
recommendations, which emphasize close monitoring of clients of group 
homes for individuals with disabilities or ICFs-IID for symptoms of 
COVID-19, universal source control, physical distancing, use of masks, 
hand hygiene, and optimizing engineering controls, are intended to 
protect staff, residents, and visitors from exposure to SARS-CoV-2.
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    \55\ https://www.cdc.gov/coronavirus/2019-ncov/community/group-homes.html.
    \56\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html.
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    Administration of any vaccine includes appropriate monitoring of 
vaccine recipients for adverse reactions. For the COVID-19 vaccines, 
safety monitoring is also being conducted.\57\ CDC has information 
describing IPC considerations for residents of ICF-IIDs with systemic 
signs and symptoms following COVID-19 vaccination. See ``Vaccine 
considerations for people with disabilities,'' located at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/disabilities.html. Post-vaccine considerations are listed out for 
consideration by ICFs-IID clinical staff. ICFs-IID must have strategies 
in place to appropriately evaluate and manage immediate post-
vaccination adverse reactions among any individuals who are vaccinated 
on site, and risks and potential side effects of vaccination on 
clients.
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    \57\ https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/covid-19-vaccine-safety-surveillance.
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    CDC advises that COVID-19 vaccination providers should document 
vaccine administration in their medical records within 24 hours of 
administration and report administration data as specified in their 
vaccine provider agreements and to applicable local vaccine tracking 
programs (that is, Immunization Information System). While an ICF-IID 
is unlikely to be a COVID-19 vaccination provider, all vaccinations 
should be appropriately documented. While ICF-IID staff may not have 
personal medical records with the ICF-IID, ICFs-IID participating in 
voluntary NHSN reporting should appropriately document staff 
vaccinations in a manner that enables the facility to report in 
accordance with NHSN guidelines (that is, in a facility immunization 
record, personnel files, health information files, or other relevant 
documentation).
2. COVID-19 Disease and Vaccine Education
a. ICF-IID Staff
    Given the new and emerging qualities of COVID-19 disease, vaccines, 
and treatments we recognize that education of clients and staff is 
critical. With this IFC, we are amending the conditions of 
participation at new Sec.  483.460(a)(4)(ii) to require that ICF-IID 
staff are educated about vaccination against COVID-19. ICF-IID staff 
are integral to the function of the ICFs-IID and the health and well-
being of clients. For the purposes of COVID-19 vaccine education and 
offering, we consider ICF-IID 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 ICF-IID for a period of time due to illness, disability, or 
scheduled time off, but who are expected to return to work. In addition 
to facility-employed personnel, many facilities have services provided 
on-site, on a regular basis by individuals under contract or 
arrangement, including hospice and dialysis staff, physical therapists, 
occupational therapists, behaviorists, mental health professionals, and 
volunteers. These individuals would be included in ``staff'' who must 
be educated and offered the vaccine as available.
    There are also individuals who may enter the facility for specific 
purposes and for a limited amount of time, such as delivery and repair 
personnel, or volunteers who may enter the ICF-IID

[[Page 26318]]

infrequently (meaning less than once weekly). We believe it would be 
overly burdensome to mandate that each ICF-IID educate and offer the 
COVID-19 vaccine to all individuals who enter the facility. However, 
while facilities are not required to educate and offer vaccination to 
these individuals, they may choose to extend their education and 
offering efforts beyond those persons that we consider to be ``staff'' 
for purposes of this rulemaking. We do not intend to prohibit such 
extensions and encourage facilities to educate and offer vaccination to 
these individuals as reasonably feasible.
    We recognize that facilities may choose to use a broader definition 
of ``staff.'' We note that CDC categorizes staff in the NHSN as: 
Ancillary service employees, nurse employees, aides, assistant and 
technician employees, therapist employees, physician and licensed 
independent practitioner employees and other health care providers. 
Categories are further broken down into environmental, laundry, 
maintenance, and dietary services; registered nurses (RNs) and licensed 
practical/vocational nurses; certified nursing assistants, nurse aides, 
medication aides, and medication assistants; therapists (such as 
respiratory, occupational, physical, speech, and music therapists) and 
therapy assistants; physicians, residents, fellows, advanced practice 
nurses, and physician assistants; and persons not included in the 
employee categories listed, regardless of clinical responsibility or 
patient contact, including contract staff, students, and other non-
employees.\58\
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    \58\ https://www.cdc.gov/nhsn/ltc/weekly-covid-vac/index.html.
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    For purposes of the CMS requirements related to COVID-19 education 
and vaccination issued in this rule, we believe that the NHSN 
definition may be impractical. In addition to regularly employed 
personnel, many facilities have services provided directly to residents 
under contract, such as physical therapy, occupational therapy, 
behavior therapy, case management, and mental health services. There 
are also individuals who may enter the facility for specific purposes 
and for a limited amount of time, such as delivery personnel, plumbers, 
and other vendors. Even regular volunteers may enter the ICF-IID 
infrequently. We do not believe that mandating these requirements for 
every individual who enters the facility at any time is necessary to 
protect the clients and staff. In addition, we believe it would be 
overly burdensome for the ICF-IID to educate and offer the COVID-19 
vaccine to all individuals who enter the facility. Staff and resources 
are limited in ICFs-IID, and therefore staff may not be available to 
educate and offer the vaccine to every individual that enters.
    We are requiring that ICF-IID staff (that is, individuals who are 
eligible to work in the facility on a routine, or at least once weekly, 
basis) be educated about the benefits and risks and potential side 
effects of the COVID-19 vaccine. Educating staff further about the 
development of the vaccine, how the vaccine works, and the particulars 
of multi-dose vaccine series is encouraged but not required. Broader 
understanding of the vaccine will support the national effort to 
vaccinate against COVID-19. Staff should be educated to help them 
understand the importance of vaccination for helping to safeguard 
clients, personal health, and broader community health. Better 
understanding of the value and safety of the vaccines will allow staff 
to appropriately educate clients and representatives about the benefits 
of accepting the vaccine.
    Staff education must cover the benefits and risks or possible side 
effects of vaccination, which typically include reduced risk of COVID-
19 illness, and related serious COVID outcomes, including 
hospitalization and death, the bolstered protection offered by 
completing a full series of multi-dose vaccines (if used), and other 
benefits identified as research and immunization continues. Staff 
education must also address risks associated with vaccination, which 
should include potential side-effects of the vaccine, including common 
reactions such as aches or fever, and rare reactions such as 
anaphylaxis. The low likelihood of severe side effects should be 
included in this education. If other benefits, risks, or side-effects 
are identified in the future, whether through research, or 
authorization or licensing of new COVID-19 vaccine products, those 
facts should be incorporated into education efforts. Staff should also 
be informed about ongoing opportunities for vaccination. Staff should 
be provided education on culturally appropriate ways to educate and 
share information with clients to prevent misinformation, confusion, or 
loss of credibility. In addition to ongoing education and informational 
updates for all staff members, we expect that new staff will be 
screened to determine vaccination status, and potential need for 
appropriate education on COVID-19 vaccines during their onboarding or 
orientation. CDC and FDA have developed a variety of clinical 
educational and training resources for health care professionals 
related to COVID-19 vaccines, and CMS recommends that nurses and other 
clinicians work with their ICF-IID's Medical Director and use CDC 
resources as the source of information for their vaccination education 
initiatives. Each manufacturer is also developing educational and 
training resources for its individual vaccine candidate. Building 
vaccine understanding broadly among staff, clients, and parent (if the 
client is a minor), or legal guardian or representative, as well as 
dispelling vaccine misinformation, are critical to vaccine uptake 
rates.
    The facility vaccination policies and procedures must be developed 
as part of the COVID-19 immunization requirements at Sec.  
483.460(a)(4). Facilities can determine where they keep the 
documentation that demonstrates educational efforts and offering the 
vaccine to staff. Some examples of evidence of compliance may include 
sign in sheets, descriptions of materials used to educate, and summary 
notes from all-staff question and answer sessions. There may be posters 
and flyers announcing appointments for vaccine clinic days or other 
vaccination opportunities.
b. ICF-IID Clients
    New Sec.  483.460(a)(4)(iii) requires that ICF-IID clients, or 
their representatives are educated about vaccination against COVID-19. 
Explaining the risks and benefits of any treatments to a client or 
representative in a way that they understand is the standard of care. 
In ICFs-IID, consent or assent for vaccination should be obtained from 
clients or representatives and documented in the client's medical 
record. It is important to talk to clients and representatives to learn 
why they may be declining vaccination and tailor educational messages 
accordingly, that is, by addressing specific questions or concerns.
    Clients of ICFs-IID and their representatives must be offered 
education about vaccine immunization development, administration, and 
evaluation. Representatives must be included as a component of the ICF-
IID's vaccine education plan as the representatives may be called upon 
for consent and/or may be asked to assist in encouraging vaccine uptake 
by the client.
    In addition to the topics addressed above for education of ICF-IID 
staff, education of clients and representatives should cover the fact 
that, at this time while the U.S. Government is purchasing all COVID-19 
vaccine in the

[[Page 26319]]

United States for administration through the CDC COVID-19 Vaccination 
Program, all ICF-IID clients are able to receive the vaccine without 
any copays or out-of-pocket costs. Currently Medicaid pays for the 
administration of the COVID-19 vaccine to beneficiaries, and other 
public and private insurance providers are required to cover it as 
well.
    Education for clients and representatives must also provide the 
opportunity for follow up questions, and be conducted in a manner that 
is reasonably understood by the clients and representatives. 
Information should be made available in accessible formats as 
appropriate for a facility's population. That is, educational materials 
and delivery must meet relevant standards in Section 504 of the 
Rehabilitation Act, which may include making such material available in 
large print, Braille, and American Sign Language, and using close 
captioning, audio descriptions, and plain language for people with 
vision, hearing, cognitive, and learning disabilities.
3. ICF-IID Voluntary Reporting
    While there would be great value in collecting more data about 
COVID-19 incidence and vaccinations in ICFs-IID, we are not mandating 
such data submission at this time. Currently there are only 
approximately 80 ICFs-IID participating in the NHSN or any other formal 
reporting program, although there are opportunities for ICFs-IID to 
enroll. Requiring all ICFs-IID to report to NHSN would create a new 
field of administrative burden for ICFs-IID, potentially requiring new 
equipment, administrative staff, and training. Further, reporting 
through NHSN would require time, likely several weeks to months, for 
the facilities not yet participating in NHSN to complete enrollment 
with CDC and appropriately train those staff who would be responsible 
for data submission, effectively making compliance within the effective 
date of this IFC nearly impossible. Based on the information we have 
received from stakeholders, we do not believe that ICFs-IID are 
administering therapeutics at this time. We encourage voluntary 
reporting as facilities are able to do so.

C. Enforcement

    Enforcement of the provisions of this IFC for LTC facilities will 
be similar to those requirements addressing influenza and pneumococcal 
vaccinations. We will impose civil money penalties if we determine that 
the facility has failed to report vaccination data.\59\ Education and 
vaccine administration must be reflected in facility policies and 
procedures, as well as in staff and resident records. In addition, NHSN 
reporting of vaccine and therapeutics must be reflected in facility 
policies and procedures, with evidence of data submission. For ICFs-
IID, education and administration of the vaccine must be reflected in 
facility policies and procedures, as well as in staff and client 
records. Updated guidance and information on reporting and enforcement 
of these new requirements will be issued when this IFC is published.
---------------------------------------------------------------------------

    \59\ Social Security Act. Section 1819(h)(2)(B)(ii). Accessed at 
https://www.ssa.gov/OP_Home/ssact/title18/1819.htm; and Social 
Security Act. Section 1919(h)(2)(A)(ii). Accessed at https://www.ssa.gov/OP_Home/ssact/title19/1919.htm. Both accessed on April 
28, 2021.
---------------------------------------------------------------------------

    We specify at Sec. Sec.  483.80(d)(3)(i) and 483.460(a)(4)(i) that 
COVID-19 vaccines must be offered when available. If a facility does 
not have access to the vaccine, we expect the facility to provide, upon 
request, evidence that efforts have been made to make the vaccine 
available to its residents or clients, and staff. For example, 
documentation of communications with the facility medical director, the 
local health department, or listing of vaccination sites may be used to 
show efforts to make the vaccine available to residents, clients, and 
staff. Similar to influenza vaccines, if there is a manufacturing 
delay, we ask the facility to provide sufficient evidence of such. The 
infection prevention and control plan is designed to allow for 
documentation of vaccine efforts. While Pharmacy Partnership clinics 
are currently the most common avenue for delivering COVID-19 vaccines 
to LTC facilities, we expect all facilities to be prepared to 
participate in other distribution programs (possibly through local 
health departments or traditional pharmacies) as the vaccine continues 
to become more widely available at a multiplicity of sites.
    If an individual resident, client, or staff member requests 
vaccination against COVID-19, but missed earlier opportunities for any 
reason (including recent residency or employment, changing health 
status, overcoming vaccine hesitancy, or any other reason), we expect 
facility records to show efforts made to acquire a vaccination 
opportunity for that individual. Although we are not establishing 
formal timeframes within which vaccination must be arranged for new 
residents, clients, or staff, we expect LTC facilities and ICFs-IID to 
support vaccination for these individuals as quickly as practicable. 
Further, we expect personnel records for facility staff and health 
records for residents and clients to reflect appropriate administration 
of any multi-dose vaccine series, including efforts to acquire 
subsequent doses as necessary.

III. Waiver of Proposed Rulemaking

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule before 
the provisions of the rule are finalized, either as proposed or as 
amended in response to public comments, and take effect, in accordance 
with the Administrative Procedure Act (APA) (Pub. L. 79-404), 5 U.S.C. 
553, and, where applicable, section 1871 of the Act. Specifically, 5 
U.S.C. 553 requires the agency to publish a notice of the proposed rule 
in the Federal Register that includes a reference to the legal 
authority under which the rule is proposed, and the terms and substance 
of the proposed rule or a description of the subjects and issues 
involved. Further, 5 U.S.C. 553 requires the agency to give interested 
parties the opportunity to participate in the rulemaking through public 
comment before the provisions of the rule take effect. Similarly, 
section 1871(b)(1) of the Act requires the Secretary to provide for 
notice of the proposed rule in the Federal Register and a period of not 
less than 60 days for public comment for rulemaking carrying out the 
administration of the insurance programs under title XVIII of the Act. 
Section 1871(b)(2)(C) of the Act and 5 U.S.C. 553 authorize the agency 
to waive these procedures, however, if the agency for good cause finds 
that notice and comment procedures are impracticable, unnecessary, or 
contrary to the public interest and incorporates a statement of the 
finding and its reasons in the rule issued. Section 553(d) of title 5 
of the U.S. Code ordinarily requires a 30-day delay in the effective 
date of a final rule from the date of its publication in the Federal 
Register. This 30-day delay in effective date can be waived, however, 
if an agency finds good cause to support an earlier effective date. 
Section 1871(e)(1)(B)(i) of the Act also prohibits a substantive rule 
from taking effect before the end of the 30-day period beginning on the 
date the rule is issued or published. However, section 
1871(e)(1)(B)(ii) of the Act permits a substantive rule to take effect 
before 30 days if the Secretary finds that a waiver of the 30-day 
period is necessary to comply with statutory requirements or that the 
30-day delay would be contrary to the public interest.

[[Page 26320]]

Furthermore, section 1871(e)(1)(A)(ii) of the Act permits a substantive 
change in regulations, manual instructions, interpretive rules, 
statements of policy, or guidelines of general applicability under 
Title XVIII of the Act to be applied retroactively to items and 
services furnished before the effective date of the change if the 
failure to apply the change retroactively would be contrary to the 
public interest. Finally, the Congressional Review Act (CRA) (Pub. L. 
104-121, Title II) requires a 60-day delay in the effective date for 
major rules unless an agency finds good cause that notice and public 
procedure are impracticable, unnecessary, or contrary to the public 
interest, in which case the rule shall take effect at such time as the 
agency determines. 5 U.S.C. 801(a)(3), 808(2).

A. COVID-19 and Populations at Higher Risk

    On January 30, 2020, the International Health Regulations Emergency 
Committee of the World Health Organization (WHO) declared the outbreak 
a ``Public Health Emergency of international concern.'' On January 31, 
2020, pursuant to section 319 of the PHSA, the Secretary determined 
that a PHE exists for the United States to aid the nation's health care 
community in responding to COVID-19. On March 11, 2020, the WHO 
publicly declared COVID-19 a pandemic. On March 13, 2020, the President 
declared the COVID-19 pandemic a national emergency.
    Over 569,000 individuals have lost their lives to COVID-19 in the 
United States as of April 27, 2021,\60\ including more than 131,000 LTC 
facility residents, or close to one tenth of the average national LTC 
facility resident census of 1.4 million.\61\ In recognition of the 
susceptibility of their residents, clients, and staff, LTC facilities 
and other congregate settings, including ICFs-IID, have been 
prioritized for vaccination. The data show that COVID-19 cases are 
declining in LTC facilities concurrently with increasing vaccination 
among residents and staff, but as noted below, we are concerned that 
the rate of vaccination in LTC facilities may slow in the absence of 
regulation and the conclusion of the Pharmacy Partnership program, 
especially in light of consistent, frequent resident and staff turnover 
in these facilities and the cold storage chain challenges that exist 
with two of the three currently available vaccines that make obtaining 
and providing the vaccine more challenging for small facilities that do 
not have the necessary storage equipment. Ensuring the health and 
safety of all Americans, including Medicare and Medicaid beneficiaries, 
and health care workers is of primary importance. This IFC directly 
supports that goal by requiring education about and offer of COVID-19 
vaccination for LTC facility and ICF-IID residents, clients, and staff. 
This IFC also requires reporting of COVID-19 vaccination status and use 
of COVID-19 therapeutics of LTC facility residents and staff, which 
will provide vital data that CMS, CDC, and other public health entities 
can use to target our outreach and resources in support of vaccination.
---------------------------------------------------------------------------

    \60\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
    \61\ LTC Facility deaths are from COVID-19 Nursing Home Data, 
CMS, Week Ending 3/28/2021, at https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg/.
---------------------------------------------------------------------------

B. Supporting Vaccine Distribution and Uptake

    In response to the COVID-19 pandemic, pharmaceutical developers 
around the world began development of vaccine that would prevent severe 
illness and death and they have produced several vaccines authorized 
for use in the United States. Because the first cohort of authorized 
vaccines require specialized handling, and LTC facility residents have 
been at higher risk of severe illness from COVID-19, CDC established 
the Pharmacy Partnership for Long-Term Care (LTC) Program, which has 
facilitated on-site vaccination of residents and staff at more than 
63,000 enrolled nursing homes and assisted living facilities while 
reducing the burden on facility administrators, clinical leadership, 
and health departments. At no cost to facilities, the program has 
provided end-to-end management of the COVID-19 vaccination process, 
including cold chain management, on-site vaccinations, and fulfillment 
of reporting requirements.
    While the Pharmacy Partnerships have had much success in ensuring 
timely vaccine access to many LTC facility residents and staff, we note 
that not all such individuals were able to receive vaccine under the 
program. Internal CDC data show that approximately 2,500 or about 16 
percent of CMS-certified SNFs (a subset of LTC facilities enrolled as 
Medicare providers) that are enrolled in NHSN did not participate in 
the Pharmacy Partnership program. LTC facility residents are unable to 
live independently, and generally are unable to access the vaccine 
without significant assistance from the facility in which they reside 
or from family members or caregivers. As we currently do not require 
LTC facilities to report vaccination status within their facility, we 
have no comprehensive way of knowing whether residents or staff of 
those facilities have acquired the vaccine through avenues outside the 
Partnerships. Ensuring that individuals residing in LTC facilities that 
did not participate in the Pharmacy Partnerships have access to 
vaccination against COVID-19 is critical so as to expeditiously ensure 
that residents are protected.
    Most LTC facilities participated in the Pharmacy Partnerships but 
the Partnerships concluded in March 2021. The Pharmacy Partnership 
program was designed as time-limited effort designed to quickly 
vaccinate thousands of facility residents per week.
    Ending the program without appropriate requirements to ensure 
facilities continue to seek vaccination opportunities for their 
residents and staff puts future incoming LTC facility residents and 
staff at risk. Turnover of both LTC facility residents (admissions and 
discharges) and staff can be significant. It is difficult to estimate 
the number of admissions and discharges in LTC facilities as 20 to 25 
percent of beds are often reserved for shorter term (weeks to months) 
rehabilitation stays, while other individuals reside in the facility 
for years. That said, resident turnover within a year may be 
significant, possibly up to 40 percent based on internal CMS estimates. 
Staff turnover is more easily considered, with some estimates as high 
as 100 percent for certain facilities within a year,\62\ and if a 
facility finds itself with a large portion of its community being 
unvaccinated, all residents and staff may again face a higher risk of 
infection, similar to the risk levels during the early months of the 
pandemic. For example, if final Partnership vaccination rates reach 
even 90 percent (an illustrative example as we do not have final or 
complete data) of the residents present in the first 3 months of 2021, 
turnover during the rest of the year may be such that by year-end as 
few as two-thirds of LTC residents present at some point during the 
year would have been vaccinated absent a continuing and effective 
effort.
---------------------------------------------------------------------------

    \62\ https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.00957.
---------------------------------------------------------------------------

    Turnover rates demonstrate there will be an ongoing need for new 
resident or staff vaccinations. For example, when the Pharmacy 
Partnership completes its time commitment, it is likely that it will 
have seen only about half of the persons who will reside or work in 
these facilities in 2021. Even if two-thirds of

[[Page 26321]]

all newly hired staff and newly admitted residents have been vaccinated 
when they start employment or begin residency, turnover is so high that 
we estimate an excess of two million persons may still need vaccination 
in the first year after this rule takes effect. It is critically 
important that facilities are required to continue to offer vaccination 
to their residents and staff on an ongoing basis.
    Also, we note that some individuals declined the vaccine when it 
was first offered; approximately 22 percent of LTC facility residents 
and 62 percent of LTC staff \63\ initially declined the vaccine, but 
provisional CDC data suggest that uptake increased over time as the 
safety and effectiveness of the vaccines has become better understood, 
and approaches that ameliorate vaccine hesitancy have been identified. 
For residents and staff who overcome vaccine hesitancy, it is critical 
to their health and well-being that they are able to get the vaccine 
when they are ready to receive it.
---------------------------------------------------------------------------

    \63\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7005e2.htm.
---------------------------------------------------------------------------

    All of the concerns that warrant immediate COVID-19 vaccination 
rulemaking for LTC facilities are also applicable to ICFs-IID. ICF-IID 
clients continue to be at high risk of serious illness from COVID-19 
due to their participation in congregate living and must have ongoing 
access to the vaccine. While there are no data regarding client and 
staff turnover rates in ICFs-IID, it is reasonable to assume that staff 
turnover rates may be as high as those in LTC facilities (see the RIA 
section of this preamble).

C. Data for COVID-19 Vaccine Reporting: Targeting Resources

    Our knowledge of the effects of COVID-19 vaccination in LTC 
facilities comes from several sources, including reporting by 
Partnership pharmacies and voluntary reporting by some facilities 
through NHSN. Direct voluntary vaccination reporting to NHSN by LTC 
facilities has been very low, with less than 20 percent of facilities 
reporting on vaccinations through NHSN. Unfortunately, we are unable to 
examine the effects of accepting or declining participation in the 
Pharmacy Partnerships because the data are incomplete for LTC 
facilities and ICFs-IID. Requiring LTC facilities to report on resident 
and staff vaccination status, in conjunction with the existing COVID-19 
testing data, would provide the data necessary to identify the outcomes 
of Pharmacy Partnership participation and determine vaccine uptake 
targets. It would also ensure we can identify and address barriers to 
completing a vaccination series, such as missed or declined second 
doses.
    If this lack of data continues, CDC will have insufficient 
information upon which to provide support to or revise COVID-19 
infection, prevention, and control measures for LTC facilities. While 
recommendations for routine staff testing could be linked to 
vaccination rates in each LTC facility (and thus reduce burden on 
facilities with adequate rates of vaccine coverage), CDC will not have 
enough data to assess a change in recommendation without full national 
participation in COVID-19 vaccination reporting by CMS-certified LTC 
facilities.
    Declining infection rates in LTC facilities in early 2021 suggest 
that vaccination, along with implementation of the full complement of 
non-pharmaceutical interventions, including engineering and 
administrative controls, has reduced the risk of illness and death from 
COVID-19 for LTC facility residents. Without the reporting mandate, CMS 
will have no timely way of monitoring whether LTC facilities are 
complying with the requirement to offer vaccination. Further, such 
mandatory reporting allows health care agencies and regulators to 
better evaluate the impact and importance of vaccination. Without a 
reporting requirement, we will have no way to identify those nursing 
homes with low vaccination rates so that they can be supported by 
educational outreach and their residents and staff protected by 
vaccination.
    Unfortunately, we have significant data gaps about the effects of 
COVID-19 and vaccination rates among ICF-IID clients, with fewer than 
80 ICFs-IID voluntarily reporting vaccination data through NHSN. While 
we recognize that it is impractical to require ICFs-IID to report 
COVID-19 information to NHSN immediately, we believe that encouraging 
voluntary reporting is a critical first step in gaining data to help us 
understand the effects of the pandemic on clients and staff, supporting 
uptake of COVID-19 vaccine in this community.

D. Moving Forward

    For the reasons discussed above, it is critically important that we 
implement the policies in this IFC as quickly as possible. As the 
nation continues to address the health impacts of COVID-19, we find 
good cause to waive notice and comment rulemaking as we believe it 
would be impracticable and contrary to the public interest for us to 
undertake normal notice and comment rulemaking procedures. For the same 
reasons, because we cannot afford sizable delay in effectuating this 
IFC, we find good cause to waive the 30-day delay in the effective date 
and, moreover, to make this IFC effective 10 calendar days after this 
rule is filed for public inspection in the Federal Register.
    In this IFC, we follow on policy issued in the September 2, 2020, 
COVID-19 IFC, which revised regulations to strengthen CMS' ability to 
enforce compliance with Medicare and Medicaid LTC facility requirements 
for reporting information related COVID-19 and established a new 
requirement for LTC facilities for COVID-19 testing of facility 
residents and staff. Since the publication of the September IFC, the 
FDA has issued EUAs for multiple vaccines developed to prevent the 
spread of SARS-CoV-2.
    We anticipate evaluating public input and evolving science before 
finalizing any requirements.
    For this IFC, we believe it would be impractical 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, we find it is impracticable and contrary to the public 
interest not to waive the delay in effective date of this IFC under the 
APA, 5 U.S.C. 553(d), section 1871(e)(1)(B)(i) of the Act, and the CRA, 
5 U.S.C. 801(a)(3). Therefore, we find there is good cause to waive the 
delay in effective date pursuant to the APA, 5 U.S.C. 553(d)(3), 
section 1871(e)(1)(B)(ii) of the Act, and the CRA, 5 U.S.C. 808(2).
    We are providing a 60-day public comment period.

IV. Collection of Information (COI) Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 (PRA) requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.

[[Page 26322]]

     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 comments 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 United States Bureau of Labor Statistics to determine the 
mean hourly wage for the positions used in this analysis. 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 .50 
or more, the cost was rounded up to the next dollar. If it was .49 or 
below, the total cost was rounded down to the next dollar. The total 
costs used in this analysis are indicated in the chart below.

                 Table 1--Total Hourly Costs by Position
------------------------------------------------------------------------
                                            Mean hourly
                Position                       wage         Total cost
------------------------------------------------------------------------
LTC and ICF-IID: RN/IP..................     \64\ $33.53             $67
LTC: Director of Nursing & ICF-IID:           \65\ 46.78              94
 Administrator..........................
LTC: Medical Director...................      \66\ 84.57             169
LTC: Financial Clerk....................      \67\ 20.40              41
------------------------------------------------------------------------

A. Long-Term Care Facilities
---------------------------------------------------------------------------

    \64\ Bureau of Labor Statistics. Occupational Employment and 
Wages, May 2019. 29-1141 Registered Nurses. Accessed at https://www.bls.gov/oes/current/oes291141.htm. Accessed on March 18, 2021.
    \65\ Bureau of Labor Statistics. Occupational Employment and 
Wages, May 2019. 11-9111 Medical and Health Services Managers. 
Nursing Care Facilities (Skilled Nursing Facilities). Accessed at 
https://www.bls.gov/oes/current/oes119111.htm. Accessed on February 
17, 2021.
    \66\ Bureau of Labor Statistics. Occupational Employment and 
Wages, May 2019. 29-1228 Physicians, All Other; and 
Ophthalmologists, Except Pediatric. General Medical and Surgical 
Hospitals. Accessed at https://www.bls.gov/oes/current/oes291228.htm#(5). Accessed on February 17, 2021.
    \67\ Bureau of Labor Statistics. Occupational Employment and 
Wages, May 2019. 43-3099 Financial Clerks, All Others. Accessed at 
https://www.bls.gov/oes/current/oes433099.htm. Accessed on March 23, 
2021.
---------------------------------------------------------------------------

1. ICRs Regarding the Development of Policies and Procedures for Sec.  
483.80(d)(3)
    At Sec.  483.80(d)(3), we require that LTC facilities develop 
policies and procedures to ensure that each resident and staff member 
is educated about the COVID-19 vaccine. Specifically, before offering 
the COVID-19 vaccine, all staff members and residents or resident 
representatives must be provided with education regarding the benefits 
and risks and potential side effects associated with the vaccine. When 
the vaccine is available to the facility, each resident and staff 
member is offered COVID-19 vaccine unless the immunization is medically 
contraindicated or the resident or staff member has already been 
immunized. If an additional dose of the COVID-19 vaccine that was 
administered, a booster, or any other vaccine needs to be administered, 
the resident, resident representative, and staff member must be 
provided with the current information regarding the benefits and risks 
and potential side effects for that vaccine, before the LTC facility 
requests consent for administration of that dose. The resident, 
resident representative, and staff member must be provided the 
opportunity to refuse the vaccine and change their decision if they 
decide to take the vaccine. Finally, the resident's medical record 
includes documentation that indicates, at a minimum, that the resident 
or resident representative was provided education regarding the 
benefits and potential risk associated with the COVID-19 vaccine, and 
that the resident either received the complete COVID-19 vaccine (series 
or single dose) or did not receive the vaccine due to medical 
contraindications or refusal. The estimates that follow are largely 
based on upon our experience with LTC facilities. However, given the 
uncertainty and rapidly changing nature of the pandemic, we acknowledge 
that there will likely need to be significant revisions over time as 
LTC facilities gain experience with these requirements. As previously 
discussed, we do not have current reporting data on facility compliance 
with COVID-19 vaccination best practices of the kinds established in 
this rule. We welcome comments that might improve these estimates.
    Based upon our experience with LTC facilities, we believe that some 
of these facilities have already developed the required policies and 
procedures. However, since we do not have any reliable method to make 
an estimate of how many or what percentage of LTC facilities have done 
so, we will base our estimate for this ICR on all 15,600 LTC facilities 
needing to develop new policies and procedures in order to comply with 
this requirement. These facilities also need to review the policies and 
procedures to ensure they are up-to-date and make any necessary 
changes. We believe these activities would be performed by the 
infection preventionist (IP), director of nursing (DON), and medical 
director in the first year and the IP in subsequent years as analyzed 
below.
    In the first year, the IP would need to develop the policies and 
procedures by conducting research and obtaining the necessary 
information and materials to draft the policies and procedures. The IP 
would need to work with the medical director and DON to develop and 
finalize the policies and procedures. For the IP, we estimate that this 
would require 10 hours initially to develop the policies and 
procedures, and one hour a month thereafter to review and make changes 
or updates as needed, for a total of 21 hours (10 hours initially and 1 
hour for the 11 months thereafter). According to Table 1 above, the 
IP's total hourly cost is $67. Thus, for each LTC facility the burden 
for the IP would be 21 hours at a cost of $1,407 (21 hours x $67). For 
the IPs in all 15,600 LTC facilities, the burden would be 327,600 hours 
(21 hours x 15,600 facilities) at an estimated cost of $21,949,200 
($1,407 x 15,600). For subsequent years, the IP would need to review 
the policies and procedures and make any updates or changes to them. 
Hence, we estimate that the IP would need 12 hours annually (1 hour x 
12 months) at a cost of $804 (12 hours x $67). For all LTC facilities, 
the annual burden would be 187,200 hours (12 x 15,600) at a cost of 
$12,542,400 (15,600 x $804).
    As discussed above, the development and approval of these policies 
and procedures would also require activities by the medical director 
and the DON. Both the medical director and the DON would need to have 
meetings with the

[[Page 26323]]

IP to discuss the development, evaluation, and approval of the policies 
and procedures. We estimate that this would require 4 hours for both 
the medical director and DON. According to Table 1 above, the total 
hourly cost for a medical director is $169. For each LTC facility, this 
would require 4 hours for the medical director during the first year at 
an estimated cost of $676 (4 hours x $169). For the first year, the 
burden would be 62,400 (4 x 15,600) at an estimated cost of $10,545,600 
($676 x 15,600). For subsequent years, the medical director might need 
to spend time reviewing or attending meetings to discuss any updates or 
changes to the policies and procedures; however, that would be a usual 
and customary business practice. Therefore, these activities for the 
medical director associated with updating or changing the policies and 
procedures are exempt from the PRA in accordance with 5 CFR 
1320.3(b)(2).
    For the DON, we have estimated that the development of policies and 
procedures would also require 4 hours. According to the chart above, 
the total hourly cost for the DON is $94. The burden in the first year 
for the DON in each LTC facility would be 4 hours at an estimated cost 
of $376 (4 hours x $94). The first year burden would be 62,400 hours (4 
x 15,600) at an estimated cost of $5,865,600 ($376 x 15,600). For 
subsequent years, the DON would likely need to spend time reviewing or 
attending meetings to discuss any updates or changes to the policies 
and procedures; however, that would be a usual and customary business 
practice. Therefore, these activities for the DON associated with 
updating or changing the policies and procedures are exempt from the 
PRA in accordance with 5 CFR 1320.3(b)(2).
    Therefore, for all 15,600 LTC facilities in the first year, the 
estimated burden for this ICR would be 452,400 hours (327,600 + 62,400 
+ 62,400) at a cost of $38,360,400 ($21,949,200 + $10,545,600 + 
$5,865,600).
    In subsequent years, all 15,600 LTC facilities would have the same 
burden. The burden for each LTC facility would be 12 hours at an 
estimated cost of $804 (12 hours x $67) for the IP. Hence, for all 
15,600 LTC facilities, the burden would be 187,200 (12 x 15,600) at an 
estimated cost of $12,542,400 ($804 x 15,600). The requirements and 
burden will be submitted to OMB under OMB control number 0938-1363 
(Expiration Date 06/30/2022).
2. ICRs Regarding LTC Facilities Offering the COVID-19 Vaccine and 
Obtaining and Documenting Consent for Sec.  483.80(d)(3)(ii) Through 
(iv)
    At Sec.  483.80(d)(3)(i), we require that the facility offer the 
COVID-19 vaccine to each staff member and resident, when the 
vaccination is available to the facility, unless the vaccine is 
medically contraindicated, the resident has already been vaccinated, or 
the resident or the resident representative has already refused the 
vaccine. We believe that the LTC facility will offer the vaccine to the 
staff or resident at the same time the facility provides the education 
required by Sec.  483.80(d)(3)(ii) and (iii). We note that for LTC 
facilities contracted with the Pharmacy Partnership, the education and 
offering of the vaccine are being done by the participating pharmacy. 
We assume that this cost is about the same as the preceding estimates, 
so that the first year costs would be about the same whether performed 
entirely in-house by facility staff or by pharmacy staff who visit the 
facility.
    We note that the LTC facility or the pharmacy would also have to 
offer the vaccine to the staff member or resident and have that staff 
member, resident, or resident representative, complete screening for 
any contraindication or precautions, and for the resident to consent to 
the vaccination or indicate refusal. These costs are not paperwork 
burden and are covered in the RIA that follows.
    As indicated in the next section, the facility must also ensure 
that the provision of the education and the resident's decision must be 
documented in the resident's medical record. If there is a 
contraindication to the resident having the vaccination, the 
appropriate documentation must be made in the resident's chart. 
Documentation regarding a resident's medical care is a usual and 
customary business practice for a health care provider. Therefore, this 
activity is exempt from the PRA in accordance with 5 CFR 1320.3(b)(2).
3. ICRs Regarding Staff Education Requirements in Sec.  
483.80(d)(3)(ii) Through (iv)
    At Sec.  483.80(d)(3)(ii), we require that the LTC facility provide 
all of its staff with education regarding the benefits and potential 
risks of the COVID-19 vaccine. This would require that the LTC facility 
develop or choose educational materials for this staff training. We 
expect that most if not all LTC facilities will use resources developed 
by other entities as there is a considerable amount of free information 
on COVID-19 and vaccines available online. The CMS Nursing Home COVID-
19 training program has five modules designed for the frontline 
clinical staff and ten modules for nursing home management staff 
(building maintenance staff and other support staff would not take 
these particular courses). The training is online, at http://QSEP.cms.gov, and is summarized in a CMS press release that can be 
found at https://www.cms.gov/newsroom/press-releases/cms-releases-nursing-home-covid-19-training-data-urgent-call-action. In addition, 
both CDC and FDA provide information on the COVID-19 vaccines 
online.68 69 Finally, we expect that trade publications and 
other public sources would provide training materials that might 
complement or substitute for the CMS materials. We believe this 
educational material would likely be selected by the IP. The IP would 
need to review the information available on the vaccines, determine 
what information needs to be presented to staff, and gather that 
information as appropriate for their facility's staff. We estimate that 
it would take an average of 4 hours for the IP to accomplish these 
tasks. Thus, for each LTC facility to meet this requirement would 
require 4 burden hours at an estimated cost of $268 (4 x $67). For all 
15,600 LTC facilities, the burden would be 62,400 burden hours (4 x 
15,600) at an estimated cost of $4,180,800 (4 x $67 x 15,600 
facilities).
---------------------------------------------------------------------------

    \68\ CDC. Communication Resources for COVID-19 Vaccines. Access 
at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/resource-center.html. Updated March 16, 2021. Accessed on March 23, 2021.
    \69\ FDA. COVID-19 Vaccines. Access at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines. Updated March 18, 2021. Accessed on March 23, 
2021.
---------------------------------------------------------------------------

    At Sec.  483.80(d)(3)(iii), we require that LTC facilities provide 
their residents or resident representatives with education regarding 
the benefits and risks and potential side effects associated with the 
COVID-19 vaccine. We believe that the education provided to staff and 
residents or resident representatives will be identical or virtually 
the same. Hence, we believe that it will not require any additional 
time or burden to develop the educational materials for the residents 
and resident representatives. According to Sec.  483.10(g)(3), the 
facility must ensure that information is provided to each resident in a 
form and manner the resident can access and understand, including in an 
alternative format or in a language that the resident can

[[Page 26324]]

understand. Thus, we expect that this required education would be in a 
language that the resident or the resident representative understands. 
Language translations for residents may be available in many facilities 
from staff, and are virtually always available on demand through 
services, such as Language Line. LTC facilities are already required to 
provide information in an alternative format or language the resident 
or resident representative understands. Any additional costs are minor 
and are discussed in more detail in the RIA below. At Sec.  
483.80(d)(3)(iv), we require that the LTC facility must provide to the 
staff, resident, or the resident representative, in situation where the 
vaccination process requires one or more doses of vaccine, up-to-date 
information regarding the vaccine, including any changes in the 
benefits or risks and potential side effects associated with the COVID-
19 vaccine, before requesting consent for administration of each 
additional vaccinations. This would require that the IP remains up-to-
date on information regarding COVID-19 vaccines and ensures the 
information provided to the resident and the resident representative 
before requesting consent for the administration of each additional 
dose of vaccine includes current information on the benefits and 
potential risks associated with the vaccine. We believe that this 
activity would require that the IP routinely review CDC and FDA 
websites for updates and make any necessary changes to the education 
materials used by the LTC facility. We estimate that this would require 
6 hours of an IP's time annually. Thus, for each LTC facility to meet 
this requirement would require 6 burden hours at an estimated cost of 
$402 (6 x $67). For all LTC facilities, the annual burden would be 
93,600 (6 hours x 15,600) hours at an estimated cost of $6,271,200 
($402 x 15,600). We estimate that the burden to the LTC facilities will 
be similar in subsequent years due to the large turnover in these 
facilities. The requirements and burden will be submitted to OMB under 
OMB control number 0938-1363 (Expiration Date 6/30/2022).
4. ICRs Regarding the Documentation Requirements in Sec.  
483.80(d)(3)(vi) and (vii)
    At Sec.  483.80(d)(3)(vi), we require that the facility ensure that 
the resident's medical record is documented with, at a minimum, that 
the resident or resident representative was provided education 
regarding the benefits and potential risks associated with the COVID-19 
vaccine and that the resident either received the COVID-19 vaccine, did 
not receive the vaccine due to medical contraindications, or refused 
the vaccine. This would require that a health care provider, probably a 
licensed nurse, would retrieve the resident's medical record and 
document that the education was provided and whether the resident or 
resident representative had consented or refused the vaccine or whether 
the vaccine was contraindicated. We estimate that this would require 
only a few seconds per resident, but estimate no costs as maintaining a 
medical record is a usual and customary business practice. Therefore, 
this activity is exempt from the PRA in accordance with 5 CFR 
1320.3(b)(2).
    As discussed above in section II.A. of this rule, the LTC facility 
would also be required to document that the required education was 
provided to its staff that must include the benefits and potential 
risks associated with of the COVID-19 vaccine as set forth in Sec.  
483.80(d)(3)(ii). Section 483.80(d)(3)(vii) sets forth that the LTC 
facility must maintain documentation on its staff regarding the 
education provided; that the staff person was offered the COVID-19 
vaccine or information on obtaining the vaccine, and his or her vaccine 
status and related information indicated by the NSHN. This would 
require that a staff person document the required information in the 
staff person's record. We estimate that this would require one half-
hour per month per facility. According to Table 1 above, the total 
hourly cost of a financial clerk is $41. For each LTC facility, we 
estimate that the burden for this activity would be 6 hours at an 
estimated cost of $246 ($41 x 12 x .5). For all LTC facilities, this 
would require 93,600 (12 x .5 x 15,600) burden hours at an estimated 
cost of $3,837,600 ($41 x 12 x .5 x 15,600). We estimate that the 
burden to the LTC facilities will be similar in subsequent years due to 
the large turnover in these facilities. The requirements and burden 
will be submitted to OMB under OMB control number 0938-1363.
5. ICRs Regarding the Reporting Requirements to CMS and CDC (NSHN) 
Sec.  483.80(g)(1)(viii) and (ix)
    Section 483.80(g)(1)(viii) requires LTC facilities to 
electronically report information about COVID-19 in a standardized 
format to the NHSN about the COVID-19 vaccine status of residents and 
staff, including total numbers of residents and staff, numbers of 
residents and staff vaccinated, numbers of each dose of COVID-19 
vaccine received, COVID-19 vaccination adverse events. The LTC facility 
must also report the therapeutics administered to residents for 
treatment of COVID-19.
    We believe the IP would do this weekly reporting to the NHSN, 
because this reporting would require information on the therapeutics 
that were administered to resident for treatment of COVID-19. We 
believe this additional reporting would require about 30 minutes or .5 
hour each week for the IP. Thus, for each LTC facility, this burden 
would be 26 hours (.5 x 52 weeks) at an estimated cost of $1,742 ($67 x 
26) annually. For all LTC facilities, the burden would be 405,600 hours 
(26 x 15,600) at an estimated cost of $27,175,200 ($1,742 x 15,600) 
annually.
    Thus, the total annual burden for all LTC facilities to comply with 
the requirements in this IFC in the first year is 1,107,600 (452,400 + 
62,400 + 93,600 + 93,600 + 405,600) hours at an estimated cost of 
$79,825,200 ($38,360,400 + $4,180,800 + $6,271,200 + $3,837,600 + 
$27,175,200). In subsequent years, the burden would be 780,000 hours 
(187,200 + 93,600 + 93,600 + 405,600) at an estimated cost of 
$49,826,400 ($12,542,400 + $6,271,200 + $3,837,600 + $27,175,200). See 
Table 2 below. The requirements and burden will be submitted to OMB 
under OMB control number 0938-1363.

                         Table 2--Total Cost for COI Requirements for All LTC Facilities
----------------------------------------------------------------------------------------------------------------
                                                            First year                   Subsequent years
                COI requirements                 ---------------------------------------------------------------
                                                   Burden hours        Costs       Burden hours        Costs
----------------------------------------------------------------------------------------------------------------
Sec.   483.80(d)(3) Developing Policies and              452,400     $38,360,400         187,200     $12,542,400
 Procedures.....................................
Sec.   483.80(d)(3)(ii) & (iii) Developing                62,400       4,180,800             N/A             N/A
 education materials for staff members and
 residents and residents' Representatives.......

[[Page 26325]]

 
Sec.   483.80(d)(3)(iv) Keeping vaccine                   93,600       6,271,200          93,600       6,271,200
 information up-to-date and Making necessary
 changes........................................
Sec.   483.80(d)(3)(vi) and (vii) Documentation           93,600       3,837,600          93,600       3,837,600
 requirements...................................
Sec.   483.83(d)(3)(viii) and (ix) NHSN                  405,600      27,175,200         405,600      27,175,200
 Reporting......................................
                                                 ---------------------------------------------------------------
    Totals......................................       1,107,600      79,825,200         780,000      49,826,400
----------------------------------------------------------------------------------------------------------------

B. Intermediate Care Facilities for Individuals With Intellectual 
Disabilities (ICF-IIDs)

1. ICRs Regarding the Development of Policies and Procedures for Sec.  
483.460(a)(4)
    At new Sec.  483.460(a)(4), we require that ICFs-IID develop 
policies and procedures to ensure that each client or client's 
representative and staff member is educated about the COVID-19 vaccine. 
Specifically, before offering the COVID-19 vaccine, all staff members 
and clients or client representatives must be provided with education 
regarding the benefits and risks and potential side effects associated 
with the vaccine. When the vaccine is available to the facility, each 
client and staff member is offered COVID-19 vaccine unless the 
immunization is medically contraindicated or the client or staff member 
has already been immunized. If an additional dose of the COVID-19 
vaccine that was administered, a booster, or any other vaccine needs to 
be administered, the client, client representative, and staff member 
must be provided with the current information regarding the benefits 
and risks and potential side effects for that vaccine, before the ICF-
IID requests consent for administration of that dose. The client, 
client's representative, and staff member must be provided the 
opportunity to refuse the vaccine and change their decision if they 
decide to take the vaccine. Finally, the client's medical record must 
include documentation that indicates, at a minimum, that the client or 
client's representative was provided education regarding the benefits 
and risks and potential side effects of the COVID-19 vaccine and each 
does of the COVID-19 vaccine administered to the client or if the 
client did not receive a dose due to medical contraindications or 
refusal.
    We believe that developing these policies and procedures would 
require a RN to gather the necessary information and materials and 
draft the policies and procedures. The facility must also ensure that 
these materials are in an accessible format for the client and his or 
her representative. It must be in a language that they understand and 
in a format that is accessible to them, such as Braille or large print 
for a person who is visually-impaired or in American Sign Language for 
a person who is hearing-impaired. The RN would need to work with an 
ICF-IID administrator who would likely provide input and guidance in 
developing the policies and procedures and would need to approve them 
before they go before the governing body for approval. For the RN, we 
estimate that this would require 5 hours initially, and 30 minutes or 
.5 hour a month thereafter to review for updated information to 
determine if any changes need to be made to the policies or procedures 
and then make any necessary changes. According to Table 1 above, the 
total hourly cost for an RN is $67. We estimate that for each ICF-IID, 
the burden would be 10.5 hours (5 hours initially + 5.5 (11 x .5)) for 
the RN during the first year at an estimated cost of $704 ($67 x 10.5 
hours). Assuming 5,772 ICFs-IID, for the first year the burden for all 
facilities would be 60,606 burden hours (10.5 x 5,772 facilities) at an 
estimated cost of $4,060,602 (10.5 x $67 x 5,772). In subsequent years, 
the burden for this activity for each facility would be 6 hours (.5 
hour x 12 months) at an estimated cost of $402 (6 x $67). In subsequent 
years the burden for all facilities would be 34,632 (6 x 5,772) burden 
hours at an estimated cost of $2,320,344 (6 x $67 x 5,772).
    For the ICF-IID administrator, we believe it would require 3 hours 
to work with the RN in developing the policies and procedures and give 
final approval before taking the policies and procedures to the 
governing body for approval. We believe that the administrator would 
likely make a salary similar to that of a manager in the LTC setting, 
like that for the DON salary as discussed above. Therefore, we estimate 
that an ICF-IID administrator's hourly mean salary is about $94. Thus, 
for each ICF-IID, the burden hours for the administrator would be 3 
hours at an estimated cost of $282 (3 x $94). For all 5,772 ICFs-IID, 
the total burden for the administrator would be 17,316 hours (3 x 5,772 
facilities) at an estimated cost of $1,627,704 ($282 x 5,772 
facilities).
    As discussed above, the ICF-IID administrator would need to obtain 
approval from the ICF-IID's governing board for the policies and 
procedures. Since the review and approval of policies and procedures 
should be encompassed within the governing board's responsibilities, 
this activity would be usual and customary and exempt from the 
information collection estimate. In addition, in subsequent years the 
ICF-IID administrator might need to spend time reviewing or attending a 
meeting to discuss any updates to the policies and procedures; however, 
that would also be a usual and customary business practice. Therefore, 
this activity is exempt from the PRA in accordance to 5 CFR 
1320.3(b)(2).
    Therefore, for all ICFs-IID, the total annual burden in the first 
year for the required policies and procedures would be 77,922 burden 
hours (60,606 + 17,316) at an estimated cost of $5,688,306 ($4,060,602 
+ $1,627,704). In subsequent years, the burden would only be for the RN 
and it would be 34,632 burden hours at an estimated cost of $2,320,344. 
The requirements and burden will be submitted to OMB under OMB control 
number 0938-New.
2. ICRs Regarding the ICFs-IID Offering the Vaccine and Obtaining and 
Documenting Consent in Sec.  483.460(a)(4)(i)
    At new Sec.  483.460(a)(4)(i), we require that the ICF-IID offer 
the COVID-19 vaccine to each staff member and client, when the 
vaccination is available to the facility, unless the vaccine is 
medically contraindicated, the client has already been vaccinated, or 
the client or the client representative has already refused the 
vaccine. We believe that the ICF-IID will offer the vaccine to the 
client or the client representative at the same time the facility 
provides the education required by new Sec.  483.460(a)(4)(ii). This 
activity would require that the ICF-IID offer the vaccine to the staff 
member or

[[Page 26326]]

resident and have that staff member, client, or client representative 
complete screening for any contraindication or precautions, and for the 
client or client representative consent to the vaccination or indicated 
refusal. This is not a paperwork burden and are covered in the RIA that 
follows.
3. ICRs Regarding the Education Requirements in Sec.  
483.460(a)(4)(ii), (iii), and (iv)
    At new Sec.  483.460(a)(4)(ii), we require that the ICF-IID provide 
all of its staff with education regarding the benefits and potential 
risks associated with of the COVID-19 vaccine. New Sec.  
483.460(a)(4)(iii) requires that the ICF-IIF to provide each client or 
the client's representative education regarding the benefits and risks 
and potential side effects associated with the vaccine. In addition, 
new Sec.  483.460(a)(4)(iv) requires that the ICF-IID, in situations 
where there is an additional dose of the COVID-19 vaccine that was 
administered, a booster, or any other vaccine needs to be administered, 
must provide the client, client's representative, and staff member with 
the current information regarding the benefits and risks and potential 
side effects for that vaccine, before the facility requests consent for 
administration of that dose. We believe that all of the education 
provided by the ICF-IID to the client, client's representative and the 
staff would be virtually identical.
    For the initial education, the ICF-IID would be required to develop 
educational materials by reviewing available resources on COVID-19 
vaccines. We expect that most if not all ICFs-IID will use resources 
developed by other entities as there is a considerable amount of free 
information on COVID-19 and its vaccines available online. For example, 
CDC and FDA provide information on the COVID-19 vaccines 
online.70 71 Finally, we expect that trade publications and 
other public sources would provide training materials. We believe this 
educational material would likely be selected by the RN. The RN would 
need to review the information available on the vaccines, determine 
what information needs to be presented to the client, client's 
representative and staff members, and gather that information as 
appropriate. An ICF-IID administrator would likely work with the RN and 
need to approve the final educational material. We estimate that it 
would initially require 7 hours and thereafter 6 hours annually to 
review for updates and make those changes to the educational materials 
for a total of 13 hours for the RN to accomplish these tasks in the 
first year. Thus, for each ICF-IID, the burden for the RN would require 
13 burden hours at an estimated cost of $871 (13 x $67). For all 5,772 
ICFs-IID so the burden for all facilities would be 75,036 burden hours 
(13 hours x 5,772 facilities) at an estimated cost of $5,027,412 (5,772 
hours x $871).
---------------------------------------------------------------------------

    \70\ See FN#71.
    \71\ See FN#72.
---------------------------------------------------------------------------

    For the education required in subsequent years, the RN would need 
to ensure that the information regarding COVID-19 vaccines that is 
provided to the staff, client and the client's representative before 
requesting consent for each additional dose of the vaccine is current. 
We believe that this activity would require the RN to routinely review 
CDC and FDA websites for updates and make any necessary changes to the 
education materials used by the ICF-IID. We estimate that this would 
require 6 hours of an IP's time annually. Thus, for each ICF-IID to 
meet this requirement would require 6 burden hours at an estimated cost 
of $402 ($67 x 6 hours). For all ICFs-IID, meeting this requirement 
would require 34,632 burden hours (6 hours x 5,772 facilities) at an 
estimated cost of $2,320,344 (5,772 x $402). The requirements and 
burden will be submitted to OMB under OMB control number 0938-New.
4. ICRs Regarding the Documentation Requirements in Sec.  
483.460(a)(4)(vi) and (f)
    At new Sec.  483.460(a)(4)(vi), the ICF-IID must ensure that the 
client's medical record is documented with, at a minimum, that the 
client or client's representative was provided education regarding the 
benefits and potential risks associated with the COVID-19 vaccine and 
that the resident either received the COVID-19 vaccine or did not 
receive the vaccine due to medical contraindications, or refused the 
vaccine. This would require that the RN to retrieve the client's 
medical record and document the required information. We estimate that 
this would require only a few seconds per client but estimate no costs 
as maintaining a medical record is a usual and customary business 
practice. Therefore, this activity is exempt from the PRA in accordance 
with 5 CFR 1320.3(b)(2).
    At new Sec.  483.460(f), the ICF-IID is required to, at a minimum, 
document that their staff were provided education regarding the 
benefits and potential risks associated with the COVID-19 vaccine and 
that each staff member was offered the vaccine or was provided 
information on how to obtain it. This would require that a staff person 
document that these tasks were accomplished. We estimate that this 
would require one quarter or 0.25 hour per month per facility and that 
this task would be performed by administrative staff, probably a 
financial clerk. According to Table 1 above, the total hourly cost for 
a financial clerk of $41. For each ICF-IID it would require 3 hours 
annually (0.25 x 12) at an estimated cost of $123 ($41 x 3 hours). For 
all ICFs-IID, the documentation requirements in this IFC this would 
require 17,316 burden hours (3 hours x 5,772 facilities) at an 
estimated cost of $709,956 annually (17,316 hours x $123).
    In total, we estimate that information collection burden for all 
ICFs-IID would be about 170,274 hours and $11,425,674 in the first year 
and 86,580 hours and $5,350,644 in subsequent years.

                           Table 3--Total Burden for COI Requirements for All ICFs-IID
----------------------------------------------------------------------------------------------------------------
                                                            First year                   Subsequent years
                 COI requirement                 ---------------------------------------------------------------
                                                   Burden hours        Costs       Burden hours        Costs
----------------------------------------------------------------------------------------------------------------
Sec.   483.460(a)(4) Developing the policies and          77,922      $5,688,306          34,632      $2,320,344
 procedures.....................................
Sec.   483.460(a)(4)(ii), (iii), and (iv)                 75,036       5,027,412          34,632       2,320,344
 Education requirements.........................
Sec.   483.460(a)(4)(v) and (f) Documentation             17,316         709,956          17,316         709,956
 requirements...................................
                                                 ---------------------------------------------------------------
    Totals......................................         170,274      11,425,674          86,580       5,350,644
----------------------------------------------------------------------------------------------------------------


[[Page 26327]]

    The total burden estimate for the information collection burden in 
both LTC facilities and ICFs-IID in the first year is 1,277,874 hours 
(1,107,600 + 170,274) at an estimated cost of $91,250,874 ($79,825,200 
+ $11,425,674) and in subsequent years the burden is estimated at 
866,580 hours (780,000 + 86,580) at a cost of $55,177,044 ($49,826,400 
+ $5,350,644). The requirements and burden will be submitted to OMB 
under OMB control number 0938-1363 for the LTC facilities and 0938-New 
for the ICFs-IID.

                      Table 4--Total COI Burden for LTC Facilities and ICFs-IID in This IFC
----------------------------------------------------------------------------------------------------------------
                                                            First year                   Subsequent years
                Type of facility                 ---------------------------------------------------------------
                                                   Burden hours        Costs       Burden hours        Costs
----------------------------------------------------------------------------------------------------------------
LTC Facility....................................       1,107,600     $79,825,200         780,000     $49,826,400
ICFs-IID........................................         170,274      11,425,674          86,580       5,350,644
                                                 ---------------------------------------------------------------
    Totals......................................       1,277,874      91,250,874         866,580      55,177,044
----------------------------------------------------------------------------------------------------------------

    If you comment on this 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 interim final rule.
    Comments must be received on/by June 14, 2021.

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.

VII. Regulatory Impact Analysis

A. Statement of Need

    The COVID-19 pandemic has precipitated the greatest economic crisis 
since the Great Depression, and one of the greatest health crises since 
the 1918 Influenza pandemic. Of the approximately 540,000 Americans 
estimated to have died from COVID-19 through March 2021,\72\ over one-
third are estimated to have died during or after a nursing home 
stay.\73\ The development and large-scale utilization of vaccines to 
prevent COVID-19 cases and have the potential to end future COVID-19-
related nursing home deaths. But this huge achievement depends 
critically on success in vaccination of nursing home residents and 
staff. This interim final rule will close a gap in current regulations, 
which are silent on the subject of vaccination to prevent COVID-19.
---------------------------------------------------------------------------

    \72\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
    \73\ 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.
---------------------------------------------------------------------------

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 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 progress to date or anticipated over 
the next year that is not due to this rule, and estimating the likely 
additional effects of this rule. 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. In the case of 
the COVID-19 PHE, there is rapid and massive improvement through 
vaccination, social distancing, treatment, and other efforts already 
underway, and this rule would have relatively small effects compared to 
these other efforts, past, present, and future. There are also a number 
of unknowns that may affect current progress or this rule or both. 
There are many unknowns (for example, whether vaccine protection lasts 
only one year rather than 3 years or more, and the possibility of 
variants that reduce the effectiveness of currently approved vaccines) 
and 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.

[[Page 26328]]

    This rule presents additional difficulties in estimating both costs 
and benefits due primarily to the fact that an unknown but significant 
fraction of current LTC staff and residents have already received an 
explanation of the benefits of vaccination to persons who are elderly 
or high risk from specific health conditions or both, and the rarely 
serious risks associated with vaccination (for example, the 
statistically negligible risk of severe allergic reactions to the 
vaccine). For a statistically average LTC resident, the average pre-
COVID 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 those 
who recover and leave the facility and those enrolled for skilled 
nursing services we estimate overall life expectancies to be about 5 
years.\74\ 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.\75\ (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 vaccine effectiveness rates are 
very high for both older and younger recipients. Of those receiving the 
second vaccine dose, after the 14th day 46 people over the age of 60 
became infected and had a severe case, compared to 6 people under the 
age of 60. Two million nine hundred thousand (2.9 million) people 
received a second dose; therefore both rates are near zero.) \76\
---------------------------------------------------------------------------

    \74\ 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 die 
while in a facility the average life expectancy is about two years. 
But some recover and leave so we have used five 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.
    \75\ For patients in skilled nursing facilities, average length 
of stay is less than a month. Hence, turnover is far higher.
    \76\ 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.
---------------------------------------------------------------------------

C. Anticipated Costs of the Interim Final Rule

    The previously calculated information collection costs of this rule 
are one of three major categories of cost. The second large cluster of 
costs are for the required resident, client, and staff education. In 
addition, we are requiring facilities to offer COVID-19 vaccines to 
residents, clients, and staff.
    As documented subsequently in this analysis and in a research 
report on this issue, about 1.5 million individuals work in nursing 
facilities at any one time.\77\ These individuals are at high risk both 
to become infected with COVID-19 and to transmit the SARS-CoV-2 virus 
to residents or visitors. Far more than most occupations, nursing home 
care requires sustained close contact with multiple persons on a daily 
basis.
---------------------------------------------------------------------------

    \77\ 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/.
---------------------------------------------------------------------------

    In Table 5, we present estimates of total numbers of individuals in 
the categories regulated under this rule, distinguishing among long-
term and shorter-term nursing facility residents, residents and staff, 
and numbers at the beginning of a year and at any one time during the 
year, versus the much higher numbers when turnover is taken into 
account. In this table 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.
    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, an 
average population at any one time of, for example, 100 persons would 
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.
    In Table 5, we assume it is likely that about 80 or 90 percent of 
LTC facility residents at the beginning of the year, and 60 or 70 
percent of the LTC facility staff at the beginning of the year, were 
vaccinated by the end of March, due mainly to the efforts of the 
Partnership. But there are many new persons in each category during the 
first three months (one fourth of the annual number shown in the second 
column) and likely fewer of these will have been vaccinated elsewhere. 
Hence, we assume that the percent of persons who were vaccinated by the 
end of March is only 70 percent of long-term care residents, 40 percent 
of skilled nursing care residents, and 60 percent of the LTC facility 
staff serving both types of residents. The estimated numbers for ICFs-
IID are lower because few residents or staff were eligible for 
vaccination from any source other than the Partnership in the first 
three months of the year. The estimated numbers of ICF-IID residents 
and staff, and turnover rates, are particularly rough estimates since 
there are no published sources that we have found that contain such 
estimates. We assume that staff turnover is about as high as in LTC 
facilities, but that resident turnover is considerably lower since 
resident mortality is not a major factor.
    The estimate that 53 percent of these LTC facility and ICF-IID 
populations as of the end of March were actually vaccinated is simply a 
weighted average of these numbers. The second and third sections of 
Table 5 show how these numbers are split between residents and staff, 
and LTC facilities and ICFs-IID, respectively. This table estimates 
that during the first year after the issuance of this regulation, as 
many people will be candidates for vaccination in these facilities as 
during the first three months of calendar year 2021 (see last column).

                                       Table 5--Estimates of Number and Vaccination Status of Residents and Staff
                                                                       [Thousands]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                Remaining        New
                                             Beginning    New during   Total for     Percent       Number      vaccination   candidates     Total first
                                              of year        2021        2021      vaccinated    vaccinated    candidates    1st quarter       year
                                               2021*                               by March 31   by March 31      2021          2022       candidates **
--------------------------------------------------------------------------------------------------------------------------------------------------------
Long-Term Care Residents..................        1,200          400       1,600            70         1,120           480           100             580
Skilled Nursing Care Residents............          200        2,100       2,300            40           920         1,380           525           1,905

[[Page 26329]]

 
LTC Facility Staff........................          950          760       1,710            60         1,026           684           190             874
ICF-IID Residents.........................          100           20         120            20            24            96             5             101
ICF-IID Staff.............................           75           60         135            20            27           108            15             123
                                           -------------------------------------------------------------------------------------------------------------
    Total Persons.........................        2,525        3,340       5,865            53         3,117         2,748           835           3,583
--------------------------------------------------------------------------------------------------------------------------------------------------------
Residents Total...........................        1,500        2,520       4,020            51         2,064         1,956           630           2,586
Staff Total...............................        1,025          820       1,845            57         1,053           792           205             997
                                           -------------------------------------------------------------------------------------------------------------
    Total Persons.........................        2,525        3,340       5,865            53         3,117         2,748           835           3,583
--------------------------------------------------------------------------------------------------------------------------------------------------------
LTC Facility Total........................        2,350        3,260       5,610            55         3,066         2,544           815           3,359
ICF-IID Total.............................          175           80         255            20            51           204            20             224
                                           -------------------------------------------------------------------------------------------------------------
    Total Persons.........................        2,525        3,340       5,865            53         3,117         2,748           835           3,583
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Beginning of Year is roughly identical to average for year when population is stable.
** Estimated number potentially needing vaccination in the first full year after March 31st.

    As presented in the third numeric column of Table 5, the total 
number of individuals either residing or working in all of these 
different facilities over the course of a year is about 5.9 million 
persons, which is more than twice the annual average number of 
residents or staff shown in the first numeric column. A new study, 
using data from detailed payroll records, found that median turnover 
rates for all nurse staff are approximately 90 percent a year.\78\ Due 
to these high turnover rates, LTC facilities will require significantly 
more resident or staff vaccines compared to the total number of 
residents and staff in the facility at the beginning of the year. For 
example, when the Pharmacy Partnership completed its time commitment in 
LTC facilities, it probably had seen only about half of the persons who 
will reside or work in these facilities in 2021. Of course, most of 
these persons will have been vaccinated through other means when they 
enter the facilities during the remainder of 2021. That said, it is 
likely that there will be over one million residents and staff during 
the first year after this rule is published who will need vaccination. 
Much of the immediate need for LTC resident and staff education has 
already been accomplished through the Pharmacy Partnership for Long-
Term Care Program. Even after the end of this program, remaining 
unvaccinated residents and staff will benefit from additional 
education, especially as additional information about vaccine safety 
and effectiveness is available. Some resident education can take place 
in group settings and some education will take place on a one-to-one 
level. What works best will depend on the circumstance of the resident 
and the best method for conveying the information and answering 
questions. Staff can use opportunities during normal day-to-day 
activities to educate the residents and their representatives (if they 
are present) on the immunization opportunities through the facility or 
its partners. Staff education, using CDC or FDA materials, can also 
take place in various formats and ways. Individualized counseling, 
resident meetings, staff meetings, posters, bulletin boards, and e-
newsletters are all approaches that can be used to provide education. 
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. In particular, the value of immunization as a crucial component 
of keeping residents healthy and well is already conveyed to staff in 
regard to influenza and pneumococcal vaccines. The COVID-19 vaccine 
education will build upon that knowledge.
---------------------------------------------------------------------------

    \78\ Ashvin Gandhi et al., ``High Nursing Staff Turnover In 
Nursing Homes Offers Important Quality Information,'' Health 
Affairs, March 2021, pages 384-391.
---------------------------------------------------------------------------

    The techniques for education and shared decision-making, where 
appropriate, are so numerous and varied that there is no simple way to 
estimate likely costs. Staff and resident hesitancy may and likely will 
change over time as the benefits of vaccination become clear to 
increasing numbers of participants in congregate settings. For purposes 
of estimation, we assume that, on average, 30 minutes of staff time 
will be devoted to education of each unvaccinated resident, resident 
representative, or staff person, at the same average hourly cost of 
$67.06 estimated for RNs in the Information Collection analysis. As for 
the recipients of such education, we assume that about three-fourths of 
them are residents, and one-fourth staff. We have little data on 
resident income but know that for most, Social Security or Supplemental 
Security Income are their principal sources of income.\79\ For 
estimating purposes, we assume that their time is worth about $10.02 an 
hour (median income of older adults without earnings is $20,440 
annually.\80\ Since residents are rarely in the labor market while in 
the facility, this base income has not been adjusted for fringe 
benefits or employer expenses. For staff, we estimate hourly costs of 
$27.38 based on BLS data for healthcare support occupations (median of 
$13.69, doubled to account for fringe benefits and overhead).
---------------------------------------------------------------------------

    \79\ Only about 13% have private sources of payment. See Jose 
Ness et al., ``Demographics and Payment Characteristics of Nursing 
Home Residents in the United States: A 23-Year Trend,'' Journal of 
Gerontology: MEDICAL SCIENCES, 2004, Vol. 59A, No. 11, pp. 1213-
1217.
    \80\ Average income from Federal Reserve of St. Louis at https://fred.stlouisfed.org/series/MEPAINUSA672N.
---------------------------------------------------------------------------

    We note that very little of this cost is likely to involve 
translation of documents, simply because very few documents are 
involved, and electronic and other assistance methods are so 
widespread. The vaccine information Fact Sheet required by FDA to be 
made available is already translated by FDA into the eight most common 
non-English languages in use in the United States and is downloadable 
online. (For the Moderna vaccine, for example, see https://www.modernatx.com/covid19vaccine-eua/providers/language-resources.) 
LanguageLine or similar services are always available on call if needed 
for an oral explanation of

[[Page 26330]]

a written document to someone who does not speak English. Many computer 
and phone applications (``Apps'') providing oral translations are 
available to assist those with language or vision problems, and hearing 
problems create no document translation requirements if a document in 
the reading language of that resident is available.\81\
---------------------------------------------------------------------------

    \81\ Examples of translation Apps include Google Translate, 
iTranslate Voice 3, SayHi, TextGrabber, BrailleTranslater, and many 
more.
---------------------------------------------------------------------------

    If we assume that 20 percent of residents and clients in LTC 
facilities and ICFs-IID decline vaccination, taking account of both 
those offered and declining the vaccine before this rule takes effect 
and those offered it again in the first year, 930,000 additional 
vaccination counseling and education efforts would be made to residents 
(4,020,000 including 630,000 in the first quarter of 2022 for a total 
of 4,655,000 total individual residents x .2). This figure implicitly 
assumes that a much higher take-up rate was achieved during the first 
three months of 2021, likely about 80 to 90 percent of all those 
residents reached by Pharmacy Partners and other early vaccination 
efforts, and that there will be more and more varied effort needed for 
the remainder, most of whom presumably declined the initial offer. It 
also assumes that only about half of year-end residents will have been 
vaccinated when this rule is issued even though most residents at the 
beginning of the year will have been vaccinated. Hence, there will be 
about 517,000 residents needing vaccine education and offers needed to 
be made in the first full year (20 percent of rightmost Residents Total 
column of Table 5).
    For education of staff, we make similar assumptions, except that 
early and anecdotal evidence suggests that a third or more are 
declining vaccination.\82\ This means that about an additional 332,000 
(one-third of 997,000) vaccination counseling and education efforts 
will need to be made to staff, including new hires, in the remainder of 
2021 and the first quarter of 2022.
---------------------------------------------------------------------------

    \82\ The Kaiser Family Foundation estimates as of February 22 
that to date 37 percent of all health care workers (not specific to 
LTC workers) have declined vaccination or decided to wait and see. 
See https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor/.
---------------------------------------------------------------------------

    Taken together, these estimates for both residents and staff 
suggest that total counseling and education efforts would be made for 
perhaps 849,000 persons after the rule is issued, two-thirds residents 
and one-third staff. Some of those offers would be accepted and some 
declined (these figures do not include offers made to persons already 
vaccinated but do include those newly admitted to or hired by these 
facilities). Total cost of the educational efforts themselves would be 
approximately $28,442,000 (849,000 persons x .5 hours x $67 hourly 
cost). Cost of resident time to participate would be an additional 
$2,449,000 (849,000 persons x .667 x .5 hours x $8.65 hourly cost) and 
of staff time to participate an additional $1,631,000 (849,000 persons 
x .333 x .5 hours x $27.38 hourly costs). Second- and third-year totals 
would be lower, perhaps about three-fourths as much, taking into 
account both fewer remaining unvaccinated needing these efforts, and a 
sensible reduction in efforts aimed at persons who refuse to consider 
vaccination. Hence, total cost of these educational efforts to both 
educators and recipients would be a total of $35,220,000 in the first 
year and $26,415,000 in the second and third years.
    The third major cost component 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 resident. This 
estimate is made for simplicity, ignoring newer and one-dose vaccines, 
since the great majority of recipients are Medicare beneficiaries and 
we have no data yet on likely use of newer vaccines.\83\ Assuming that 
the efforts to educate residents, clients, and staff succeed in raising 
the vaccinated percentage by 5 percent points over the course of the 
first year, calculated from the 70 percent (staff) to 80 percent 
(residents and clients) baseline likely to be achieved before this rule 
takes effect, total vaccination costs across these target groups 
resulting from this rule would be $23,460,000 ($80 x .05 x 5,865,000).
---------------------------------------------------------------------------

    \83\ Vaccine and vaccination costs are generally paid by the 
Federal Government. What the Government pays varies from vaccine to 
vaccine, by when purchased and in what quantities, and varies by 
payer or provider. $40 per dose is a rough estimate based on 
experience to date. As is the case for all drugs, cost estimates 
also vary depending on research and development costs as well as 
manufacturing cost. These estimates do not reflect use of the new 
Johnson & Johnson/Jannsen one-dose vaccine. See the Healthline 
article at https://www.healthline.com/health-news/how-much-will-it-cost-to-get-a-covid-19-vaccine.
---------------------------------------------------------------------------

    Finally, there is a cost category related to expenses not estimated 
as information collection costs because they meet an exception in the 
PRA for requirements that would be handled through ``usual and 
customary'' business practices. These exceptions are all discussed 
briefly in the ICR section of this preamble. Most of their costs are 
related mainly to recording in patient or personnel records for each 
resident and staff person that vaccine education, vaccine decision, and 
vaccinations for those accepting vaccination have all taken place. 
While there are large numbers of such record notations to be made, we 
estimate that they take only a few seconds per record. We have 
estimated that the added cost of these record-keeping functions as 
likely to be about 5 percent of all Information Collection costs.
    All these aggregate costs can be converted to per person numbers 
since it is individual persons who are vaccinated. Dividing the 
estimated first year costs by an estimated 5.380 million people (4.02 
million residents and 1.36 million workers) gives an average per 
resident or employee cost of $27.12 in the first year (159,056,000 
divided by 5,865,000).
    Another way to summarize these numbers is in terms of average cost 
per person newly vaccinated. Making the same assumption that about 5 
percent of total persons (and 10 percent of those unvaccinated) would 
be newly vaccinated as a result of this rule, cost per person would be 
$542 ($27.12 divided by .05). Table 6 summarizes the overall cost 
estimates.

                    Table 6--Estimate of Total Costs
------------------------------------------------------------------------
                                                             Costs in
              Cost category               Costs in first    succeeding
                                               year            years
------------------------------------------------------------------------
Developing NF Policies & Procedures.....     $38,360,000     $12,542,000
Developing Education Materials for             4,181,000              NA
 Residents and Staff....................
Keeping Vaccine Information Up-to-Date..       6,271,000       6,271,000
Documentation Requirements..............       3,838,000       3,838,000

[[Page 26331]]

 
NHSN Reporting to CDC and CMS...........      27,175,000      27,175,000
Subtotal, NF Information Collection.....      79,825,000      49,826,000
ICF-IID Information Collection..........      11,426,000       5,351,000
Subtotal Information Collection.........      91,251,000      55,177,000
Educating Residents & Staff *...........      35,220,000      26,415,000
Providing Vaccine to Residents and Staff      23,460,000      17,595,000
 **.....................................
Keeping Records of the Above Activities.       9,125,000       5,518,000
                                         -------------------------------
    Total Costs.........................     159,056,000     104,705,000
------------------------------------------------------------------------
* These costs assume only unvaccinated are educated about vaccination.
** These costs assume about 5 percent of total persons accept the
  vaccine offer (over half already vaccinated).

    While these estimates give the appearance of precision since they 
present costs to the nearest thousand dollars, this is simply the 
result of calculations based on numerical assumptions. There are major 
uncertainties in these estimates. One obvious example is whether 
vaccine efficacy will last more than the six months proven to date.\84\ 
Presumably, re-vaccination each year could maintain a high level of 
protection if vaccine protection wore off in a year. Re-vaccination or 
use of new and improved vaccines would likely maintain the 
effectiveness of vaccination for residents and staff. But the estimated 
costs of this rule would change in the table column for succeeding 
years to a level roughly equal to the first year estimate even if re-
vaccinations were to be necessary. For purposes of displaying the known 
second (and succeeding) year effects assuming no major changes in 
vaccine effectiveness, we have included in Table 5 (and the tables 
covering information collection costs) the predictable changes in 
second year cost estimates.
---------------------------------------------------------------------------

    \84\ For a discussion of this issue, see Sumathi Reddy, ``How 
Long To Covid-19 Vaccines Protect You?'', The Wall Street Journal, 
April 13, 2021, at https://www.wsj.com/articles/how-long-do-covid-19-vaccines-provide-immunity-11618258094.
---------------------------------------------------------------------------

D. Anticipated Benefits of the Interim Final Rule

    There will be over 5 million residents, clients, and staff each 
year in the LTC facilities and ICFs-IID covered by this rule. In our 
analysis of first-year benefits of this rule we focus on prevention of 
death among residents of LTC facilities and ICFs-IID, as well as on 
progress in reducing disease severity. We also focus only on benefits 
to the candidates for vaccination covered by this rule, not on possible 
benefits to family members, caregivers, or other persons who they might 
subsequently infect if not vaccinated.\85\ Reductions in resident, 
client, and staff mortality are benefits for which techniques exist 
(though with some uncertainty) to express estimates in dollar terms. 
One of the major benefits of vaccination is that it lowers the cost of 
treating the disease among those who would otherwise be infected and 
have serious morbidity consequences. The largest part of those costs is 
for hospitalization and they are very substantial. As discussed later 
in the analysis we do have data on the average costs of hospitalization 
of these patients (it is, however, unclear as to how that cost is 
changing over time with better treatment options). A lesser but still 
very substantial amount of these morbidity costs is for care of gravely 
ill patients within the nursing home, but reducing those costs is 
another benefit we are unable to estimate at this time.
---------------------------------------------------------------------------

    \85\ We note that as of this writing there remains a major 
unanswered question as to whether and if so to what extent 
vaccinated persons transmit COVID-19.
---------------------------------------------------------------------------

    There is a potential offset to benefits that we have not estimated. 
As long as vaccine supplies do not meet all demands for vaccination, 
giving priority to some persons over others necessarily means that some 
persons will become infected who would not have been infected had the 
priorities been reversed. In this case, however, the priority for 
elderly persons (virtually all of whom have risk factors) who comprise 
the vast majority of LTC facility residents, is prioritizing those at 
higher risk of mortality and severe disease over those whose risk of 
death is multiple orders of magnitude lower.\86\ As a result, there are 
some assumptions we make that could overstate benefits should the 
assumptions be overtaken by adverse events.
---------------------------------------------------------------------------

    \86\ 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.
---------------------------------------------------------------------------

    The HHS ``Guidelines for Regulatory Impact Analysis'' explain in 
some detail the concept of Quality Adjusted Life Years (QALYs).\87\ 
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.
---------------------------------------------------------------------------

    \87\ 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, such as this rule. We adopt 
the VSL of approximately $10.6 million in 2020 as described in the HHS 
Guidelines, adjusted for changes in real income and inflated to 2019 
dollars using the Consumer Price Index. Assuming that the average rate 
of death from COVID-19 (following SARS-CoV-2 infection) at nursing home 
resident ages and conditions is 5 percent, and the average rate of 
death after vaccination is essentially zero, the expected value of each 
resident receiving the full course of two vaccines who would otherwise 
be infected with SARS-CoV-2 is about $530,000 ($10,600,000 x .05).
    Under a second approach to benefit calculation, we can estimate the 
monetized value of extending the life of nursing home residents, which 
is based on expectations of life expectancy and the value per life-
year. As explained in the HHS Guidelines, the average

[[Page 26332]]

individual in studies underlying the VSL estimates is approximately 40 
years of age, allowing us to calculate a value per life-year of 
approximately $540,000 and $900,000 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 nursing home 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 nursing home 
residents.) \88\ Assuming that the average life expectancy of long-term 
care residents is five years, the monetized benefits of saving one 
statistical life would be about $2.5 million ($540,000 x annually for 5 
years) at a 3 percent discount rate and about $3.7 million ($900,000 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 nursing 
home 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 receiving the full course of two 
vaccines who would otherwise be infected is $125 thousand at a 3 
percent discount rate and $185 thousand at a 7 percent discount rate. A 
similar calculation can be made for staff, who will gain many more 
years of life but whose risk of death is far smaller since their age 
distribution is so much younger. Yet another calculation for clients of 
ICFs-IID would also result in many more years of life but far smaller 
risks of death since their age distribution is typically far younger 
than that of LTC residents. It is difficult to ascertain the number of 
ICF-IID clients that would be infected without vaccination. Deaths from 
COVID-19 in unvaccinated LTC residents to date are about 130,000, or 
close to one tenth of the average LTC resident census of 1.4 million, a 
huge contrast to the handful of deaths in the vaccination results from 
Israel.\89\ We do not have sufficient data so as to accurately estimate 
annual resident inflows and outflows over time, but it is clear that 
several hundred thousand new individuals each year make the total 
number served during the year far higher than point in time or average 
counts (see Table 5).
---------------------------------------------------------------------------

    \88\ 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.
    \89\ 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/.
---------------------------------------------------------------------------

    We do know that large numbers of residents or staff were vaccinated 
through the Pharmacy Partnership, which for nursing home residents 
relied most heavily on the CVS and Walgreens drug store chains. In its 
latest report, the Partnership reported that to date it had vaccinated 
about 2.2 million residents in long-term care facilities, although 
fewer than two thirds of these had received two doses.\90\ We do know 
that significant fractions of staff, perhaps one-third or more, have to 
date declined vaccination when offered.\91\ Progress has been very 
substantial, but many remain unvaccinated among both residents and 
staff. This interim final rule has significant potential to support 
further vaccinations as vaccination opportunities from other sources 
expand.
---------------------------------------------------------------------------

    \90\ See https://www.cdc.gov/vaccines/covid-19/planning/index.html.
    \91\ See the discussion and data in the CDC report ``Early 
COVID-19 First-Dose Vaccination Coverage Among Residents and Staff 
Members of Skilled Nursing Facilities Participating in the Pharmacy 
Partnership for Long-Term Care Program--United States, December 
2020-January 2021,'' at https://www.cdc.gov/mmwr/volumes/70/wr/mm7005e2.htm?s_cid=mm7005e2_x.
---------------------------------------------------------------------------

    The preceding calculations address residential long-term care. 
Long-term residents are a major group within nursing homes and are 
generally in the nursing home 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 primarily 
funded by the Medicaid program (also, through long-term care insurance 
or self-financed), and the residential care services these residents 
receive are not normally covered by Medicare or any other health 
insurance. 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 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 over a 
year is about 200,000 million persons, but the average length of stay 
is weeks rather than years.\92\ 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 
(although we have no documented basis for estimating those numbers), we 
assume that the expected longevity for each group is identical on 
average, and that a total of 3.9 million persons are served each year. 
We further assume that 20 percent of these are new residents each year 
who must be offered vaccination (most are already vaccinated, as 
discussed later in the analysis).
---------------------------------------------------------------------------

    \92\ 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. For these persons, the average age is about 50, which 
creates two offsetting effects: They have more years of life expectancy 
than residents, but their risk of from COVID-19 death is far lower. For 
purposes of this analysis, we assume that the vaccination is effective 
for at least one year, and use a one-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 mostly in the 30 to 65 year old age ranges 
compared to the far older residents.\93\ 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

[[Page 26333]]

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

    \93\ 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 are fixed and unlikely 
to change (e.g., as better future treatments are used to treat 
severe cases).
---------------------------------------------------------------------------

    As for ICFs-IID, there are about 6,000 facilities, serving about 
100,000 people at any one time, an average of about 15 people per 
facility.\94\ The age profile of these clients is similar to that of 
the adult population at large. Turnover rates are unknown, but likely 
to be substantial because these clients have many alternatives. We 
estimate 80 percent a year for turnover, the same as for nursing 
facilities. The costs and benefits of COVID-19 vaccination services for 
this group are roughly comparable to those of nursing home staff. There 
do not appear to be data on number of staff at these facilities, but 
based on the nature of the services provided it appears likely that the 
staff to client ratio is similar to that in other congregate settings 
(group homes, assisted living facilities), and likely to be about 
three-fourths of the client population, or about 75,000 full-time 
equivalent staff, with similar turnover patterns as well. Adding 80 
percent to allow for staff turnover, gives a total of 135,000 staff 
candidates for vaccination.
---------------------------------------------------------------------------

    \94\ By far the largest source of data related to ICF and other 
IID services is ``In-Home and Residential Long-Term Supports and 
Services for Persons with Intellectual or Developmental 
Disabilities: Status and Trends 2017'', at https://ici-s.umn.edu/files/aCHyYaFjMi/risp_2017.
---------------------------------------------------------------------------

    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, as many 
as 40 percent of those known to be infected required hospitalization in 
the first month of the pandemic. Among adults age 21 years to 64 years, 
about 10 percent of those infected required hospitalization.\95\ For 
our estimates, we assume a 20 percent hospitalization rate among people 
aged 65 years or older in nursing homes, reflecting both that their 
conditions are significantly worse than those of similarly aged adults 
living independently, and that pre-hospitalization treatments have 
improved. Of the LTC facility and ICF-IID 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 16 percent. Among those hospitalized at any age, the 
average cost is about $20,000.\96\
---------------------------------------------------------------------------

    \95\ There are few data sources for this statistic and, thus, it 
may be out of date. See MMWR, ``Preliminary Estimates of the 
Prevalence of Selected Underlying Health Conditions Among Patients 
with Coronavirus Disease 2019--United States, February 12-March 28, 
2020'', April 3, 2020, at https://www.cdc.gov/mmwr/volumes/69/wr/mm6913e2.htm#T2_down.
    \96\ 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 residents who would 
otherwise become infected with SARS-CoV-2 and have a COVID-19 illness 
would cost approximately $54,200 ($542 x 100) in paperwork, education, 
and vaccination costs. Using the VSL approach to estimation would 
produce life-saving benefits of about $2,650,000 for these 100 people 
($530,000 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 $320,000 
($20,000 x 100 x .16) in benefits for this group assuming that 16% 
would otherwise be hospitalized. However, this comparison is should be 
taken as necessarily hypothetical and contingent due to the analytic, 
data, and uncertainty challenges discussed throughout this regulatory 
impact assessment. As the discussion of other patient groups covered by 
this rule demonstrates, they present similar if not identical 
magnitudes of both costs and benefits for affected individuals 
(benefits from staff vaccinations, however, are far lower). 
Consequently, the primary medium- to long-run benefit-cost issue is not 
the general magnitude of likely effects on those who get vaccinated as 
a result of the rule, but the difficult questions of estimating (1) 
likely numbers of individuals in both client and staff categories who 
are likely to be unvaccinated when the rule goes into effect and (2) to 
be willing to accept vaccination in the coming months and years.\97\
---------------------------------------------------------------------------

    \97\ 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.
---------------------------------------------------------------------------

    Of particular importance is that the vaccination rates and raw 
numbers of people vaccinated take into account that in total only about 
half of those who will be residents and clients in these facilities at 
some time during the year have already been residents or clients during 
the months served by the Pharmacy Partnership effort. For example, our 
estimated vaccination rate as of March 31, 2021, for LTC residents 
assumes that about 90 percent of the residents in January through March 
will have been vaccinated. But given the turnover expected during the 
rest of the year, only about 70 percent of the annual total will have 
been vaccinated by the end of 2021, or by the end of the first year 
including the first quarter of 2022. As a result, about 3.6 million 
persons will be vaccination candidates subject to this rule over the 
first year. Some of these persons may have been vaccinated elsewhere, 
but the facilities regulated under this rule will need to query each 
incoming resident and it is likely that as many as a third of these 
will be candidates for COVID-19 vaccination. 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 the course of a year. The estimates here 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.
    There are also dimensions of positive and negative benefits in the 
medium- to long-run that we have not been able to estimate. For 
example, there is insufficient evidence as to whether the current or 
reasonably foreseeable vaccines will maintain their protective efficacy 
for more than six months.
    Until very recently, demand for COVID-19 vaccination has exceeded 
supply throughout the U.S.\98\ Especially in previous months, 
vaccination distribution policies giving priority to various groups 
(for example, aged, health care workers, and other essential services 
workers) has meant that those given priority have benefited to some 
extent at the expense of those in lower priorities. Regardless of 
priorities, we know that younger persons are much less likely to 
experience hospitalization or death after infection. For example, the 
risk of death among infected persons age 65 to 74 years is ten times 
greater

[[Page 26334]]

than the risk of death among infected persons age 40 to 49 years. Yet 
the average years of remaining life among younger persons at these ages 
is far greater than among older persons at higher ages. Age, however, 
is not anywhere near a perfect indicator of risk since, for example, 
health care workers and those with immune system disorders face 
elevated risks from exposure. Sorting out all these factors to reach 
either a qualitative or quantitative estimate of net benefits from any 
particular policy is extremely complex and is one reason why 
vaccination priorities have differed among the states and over time.
---------------------------------------------------------------------------

    \98\ The shortage issue has now largely been addressed, as is 
well illustrated in the recent removal of age restrictions designed 
to give highest priority in using limited vaccine supplies to the 
elderly and health care workers. See, for example, news stories: 
https://www.abc27.com/news/health/coronavirus/official-biden-moving-vaccine-eligibility-date-to-april-19/.
---------------------------------------------------------------------------

    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 disease transmission from those vaccinated, 
and the long-term effectiveness of vaccination.

E. Other Effects

1. Sources of Payment
    We anticipate that virtually all of the costs of this rule will be 
reimbursed from funds already appropriated under the CARES Act and the 
American Rescue Plan Act of 2021. For example, the amounts provided in 
the Provider Relief Fund is $7.4 billion, many times more than the 
relatively small costs of this rule. As previously discussed, if there 
are treatment cost savings to hospitals and other care providers as a 
result of the vaccinations that will be made due to this rule, the 
treatment cost savings would in turn result in savings to payers. It is 
likely that half or more of these savings would primarily accrue to 
Medicare given the elderly 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 residents.
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 purposes of the RFA, we estimate that 
many LTC facilities and most ICFs-IID 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.
    The average annual cost of a nursing home stay is about $271.98 per 
day or about $100,000 per year.\99\ As estimated previously, the 
average annual cost of this rule is about $24.70 per resident or staff 
person in the first year. This cost does not approach the 3 percent 
threshold. For ICFs-IID, one estimate of average annual costs per 
client is $140,000, also a level at which this rule does not approach 
the 3 percent threshold.\100\ Moreover, since most or all of these 
costs will be reimbursed through the CARES Act or other COVID-19 
funding sources, the financial strain on these facilities should be 
negligible and the likely net effect positive. Considering the cost 
savings from treating seriously ill residents, the financial impact is 
likely to be positive. Therefore, the Department has determined that 
this interim final rule 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.
---------------------------------------------------------------------------

    \99\ See Marcum Accountants & Advisors, A Five Year Nursing Home 
Statistical Analysis (2014 to 2018), at https://www.marcumllp.com/wp-content/uploads/marcum-five-year-nursing-home-statistical-analysis-2014-2018.pdf.
    \100\ See In-Home and Residential Long-Term Supports and 
Services for Persons with Intellectual or Developmental 
Disabilities: Status and Trends 2017, op cit, page 77.
---------------------------------------------------------------------------

3. Small Rural Hospitals
    Section 1102(b) of the Social Security Act requires us to prepare a 
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 no direct effects on any hospitals, the 
Department has determined that this interim final rule will not have a 
significant impact on the operations of a substantial number of small 
rural hospitals. This interim final rule is also exempt because that 
provision of law only applies to final rules for which a proposed rule 
was published.
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 does contain mandates on private sector entities, 
and we estimate the resulting amount to be about the same as this 
threshold in the first year. This IFC was not preceded by a notice of 
proposed rulemaking, and therefore the requirements of UMRA do not 
apply. The information 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. Nothing in this rule will have a substantial direct 
effect on state or local governments, preempt state laws, or otherwise 
have federalism implications.

F. Alternatives Considered

    As discussed earlier in the preamble, a major substantive 
alternative that we considered was to require vaccination activities 
(education and offering) for 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 infrequently. We also considered 
including visitors, such as family members. All these categories 
present major problems for compliance, enforcement, and record-keeping, 
as well as a multitude of complexities related to visit frequency, 
resident exposure, and vaccination management. Furthermore, the 
efficacy of such a policy would be difficult to establish. For example, 
vaccinating a one-time visitor on the day of their visit would not 
improve resident safety because the vaccine is not instantly effective 
upon administration. There are also ethical

[[Page 26335]]

issues related to potential discouragement of visiting volunteers or 
family members. Instead, we believe that such decisions are best left 
to each facility, in consideration of CMS and CDC guidance. Our 
expectation is that vaccination of regular visitors in any of these 
categories will be encouraged, whether or not the vaccinations are 
offered by the facility itself.

G. Accounting Statement and Table

    The Accounting Table summarizes the quantified impact of this rule. 
It covers only one 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.
    As explained in various places within the RIA and the preamble as a 
whole, there are major uncertainties as to the effects of COVID-19 on 
nursing and other congregate living facilities as well as the nation at 
large. For example, the duration of vaccine effectiveness in preventing 
infection, reducing disease severity, reducing the risk of death, and 
preventing disease transmission by those vaccinated are all currently 
unknown. 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 one-year projection for the cost estimates in our 
Accounting Statement (our estimates are for the last nine months of 
2021 and the first three months of 2022). We welcome comments on all of 
our assumptions and welcome any additional information that would 
narrow the ranges of uncertainty.

                                      Table 7--Accounting Statement: Classification of Estimated Costs and Savings
                                                                      [$ Millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                       Units
                                              Primary                                    ---------------------------------------------------------------
                Category                     estimate       Lower bound     Upper bound                   Discount  rate
                                                                                           Year dollars         (%)               Period  covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits: Lives Extended (not annualized  ..............  ..............  ..............            2020               7  First year.
 or monetized).
Reduced Medical Expenditures (not         ..............  ..............  ..............            2020               3  First year.
 annualized or monetized).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs: Annualized Monetized ($ million/              159             119             199            2020               7  First year.
 year).
                                                     159             119             199            2020               3  First year.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost Notes: Administrative costs from increased efforts to vaccinate residents and staff.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers...............................                                                       None.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.
    I, Elizabeth Richter, Acting Administrator of the Centers for 
Medicare & Medicaid Services, approved this document on April 22, 2021.

List of Subjects in 42 CFR Part 483

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

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR part 483 as set forth below:

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

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

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


0
2. Section 483.80 is amended by--
0
a. Revising the heading for paragraph (d);
0
b. Adding paragraph (d)(3);
0
c. Removing the word ``and'' at the end of paragraph (g)(1)(vii);
0
d. Revising paragraph (g)(1)(viii); and
0
e. Adding paragraph (g)(1)(ix).
    The revisions and additions read as follows:


Sec.  483.80  Infection control.

* * * * *
    (d) Influenza, pneumococcal, and COVID-19 immunizations-- * * *
    (3) COVID-19 immunizations. The LTC facility must develop and 
implement policies and procedures to ensure all the following:
    (i) When COVID-19 vaccine is available to the facility, each 
resident and staff member is offered the COVID-19 vaccine unless the 
immunization is medically contraindicated or the resident or staff 
member has already been immunized;
    (ii) Before offering COVID-19 vaccine, all staff members are 
provided with education regarding the benefits and risks and potential 
side effects associated with the vaccine;
    (iii) Before offering COVID-19 vaccine, each resident or the 
resident representative receives education regarding the benefits and 
risks and potential side effects associated with the COVID-19 vaccine;
    (iv) In situations where COVID-19 vaccination requires multiple 
doses, the resident, resident representative, or staff member is 
provided with current information regarding those additional doses, 
including any changes in the benefits or risks and potential side 
effects associated with the COVID-19 vaccine, before requesting consent 
for administration of any additional doses;
    (v) The resident, resident representative, or staff member has the 
opportunity to accept or refuse a COVID-19 vaccine, and change their 
decision;
    (vi) The resident's medical record includes documentation that 
indicates, at a minimum, the following:
    (A) That the resident or resident representative was provided 
education regarding the benefits and potential risks associated with 
COVID-19 vaccine; and
    (B) Each dose of COVID-19 vaccine administered to the resident; or

[[Page 26336]]

    (C) If the resident did not receive the COVID-19 vaccine due to 
medical contraindications or refusal; and
    (vii) The facility maintains documentation related to staff COVID-
19 vaccination that includes at a minimum, the following:
    (A) That staff were provided education regarding the benefits and 
potential risks associated with COVID-19 vaccine;
    (B) Staff were offered the COVID-19 vaccine or information on 
obtaining COVID-19 vaccine; and
    (C) The COVID-19 vaccine status of staff and related information as 
indicated by the Centers for Disease Control and Prevention's National 
Healthcare Safety Network (NHSN).
* * * * *
    (g) * * *
    (1) * * *
    (viii) The COVID-19 vaccine status of residents and staff, 
including total numbers of residents and staff, numbers of residents 
and staff vaccinated, numbers of each dose of COVID-19 vaccine 
received, and COVID-19 vaccination adverse events; and
    (ix) Therapeutics administered to residents for treatment of COVID-
19.
* * * * *
0
3. Section 483.430 is amended by adding paragraph (f) to read as 
follows:


Sec.  483.430  Condition of participation: Facility staffing.

* * * * *
    (f) Standard: COVID-19 vaccines. The facility maintains 
documentation related to staff that includes at a minimum, all of the 
following:
    (1) Staff were provided education regarding the benefits and risks 
and potential side effects associated with the COVID-19 vaccine.
    (2) Staff were offered COVID-19 vaccine or information on obtaining 
the COVID-19 vaccine.
0
4. Section 483.460 is amended by redesignating paragraph (a)(4) as 
paragraph (a)(5) and adding new paragraph (a)(4) to read as follows:


Sec.  483.460  Conditions of participation: Health care services.

    (a) * * *
    (4) The intermediate care facility for individuals with 
intellectual disabilities (ICF/IID) must develop and implement policies 
and procedures to ensure all of the following:
    (i) When COVID-19 vaccine is available to the facility, each client 
and staff member is offered the COVID-19 vaccine unless the 
immunization is medically contraindicated or the client or staff member 
has already been immunized.
    (ii) Before offering COVID-19 vaccine, all staff members are 
provided with education regarding the benefits and risks and potential 
side effects associated with the vaccine.
    (iii) Before offering COVID-19 vaccine, each client or the client's 
representative receives education regarding the benefits and risks and 
potential side effects associated with the COVID-19 vaccine.
    (iv) In situations where COVID-19 vaccination requires multiple 
doses, the client, client's representative, or staff member is provided 
with current information regarding each additional dose, including any 
changes in the benefits or risks and potential side effects associated 
with the COVID-19 vaccine, before requesting consent for administration 
of each additional doses.
    (v) The client, client's representative, or staff member has the 
opportunity to accept or refuse COVID-19 vaccine, and change their 
decision.
    (vi) The client's medical record includes documentation that 
indicates, at a minimum, the following:
    (A) That the client or client's representative was provided 
education regarding the benefits and risks and potential side effects 
of COVID-19 vaccine; and
    (B) Each dose of COVID-19 vaccine administered to the client; or
    (C) If the client did not receive the COVID-19 vaccine due to 
medical contraindications or refusal.
* * * * *

    Dated: May 10, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-10122 Filed 5-11-21; 11:15 am]
BILLING CODE 4120-01-P