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
| Published date | 13 May 2021 |
| Record Number | 2021-10122 |
| Section | Rules and Regulations |
| Court | Centers For Medicare & Medicaid Services |
Federal Register, Volume 86 Issue 91 (Thursday, May 13, 2021)
[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 IIIDepartment of Health and Human Services----------------------------------------------------------------------- Centers for Medicare & Medicaid Services42 CFR Part 483-----------------------------------------------------------------------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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[[Page 26307]]
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
[[Page 26308]]
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
[[Page 26309]]
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.
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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.
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\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.
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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.
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\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/.
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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.
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\62\ https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.00957.
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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.
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\63\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7005e2.htm.
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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
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\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.
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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.
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\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.
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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/.
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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
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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.
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\78\ Ashvin Gandhi et al., ``High Nursing Staff Turnover In
Nursing Homes Offers Important Quality Information,'' Health
Affairs, March 2021, pages 384-391.
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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).
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\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.
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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\
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\81\ Examples of translation Apps include Google Translate,
iTranslate Voice 3, SayHi, TextGrabber, BrailleTranslater, and many
more.
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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/.
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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).
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\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.
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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.
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\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.
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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.
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\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.
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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.
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\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.
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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.
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Under a common approach to benefit calculation, we can use a Value
of a Statistical Life (VSL) to estimate the dollar value of the life-
saving benefits of a policy intervention, 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).
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\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/.
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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.
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\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.
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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.
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\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).
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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.
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\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.
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We have some data on the costs of treating serious illness among
the unvaccinated who become infected, are hospitalized, and survive.
Among those age 65 years or above, or with severe risk factors, 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\
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\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/.
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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\
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\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.
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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.
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\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/.
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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.
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\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.
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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]
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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.
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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
