[Federal Register Volume 88, Number 107 (Monday, June 5, 2023)]
[Rules and Regulations]
[Pages 36485-36510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11449]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 416, 418, 441, 460, 482, 483, 484, 485, 486, 491, and 
494

[CMS-3415-F, CMS-3414-F, CMS-3401-F]
RIN 0938-AU75, 0938-AU57, 0938-AU33


Medicare and Medicaid Programs; Policy and Regulatory Changes to 
the Omnibus COVID-19 Health Care Staff Vaccination Requirements; 
Additional Policy and Regulatory Changes to the Requirements for Long-
Term Care (LTC) Facilities and Intermediate Care Facilities for 
Individuals With Intellectual Disabilities (ICFs-IID) To Provide COVID-
19 Vaccine Education and Offer Vaccinations to Residents, Clients, and 
Staff; Policy and Regulatory Changes to the Long Term Care Facility 
COVID-19 Testing Requirements

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

ACTION: Final rule.

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SUMMARY: This final rule removes expired language addressing staff and 
patient COVID-19 testing requirements for LTC Facilities issued in the 
interim final rule with comment ``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'' 
published in the September 2, 2020 Federal Register. The rule also 
finalizes requirements for these facilities to provide education about 
COVID-19 vaccines and to offer COVID-19 vaccines to residents, clients, 
and staff. In addition, the rule withdraws the regulations in the 
interim final rule with comment (IFC) ``Omnibus COVID-19 Health Care 
Staff Vaccination'' published in the November 5, 2021 Federal Register, 
and finalizes certain provisions of the ``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'' IFC, published in the May 13, 2021 Federal 
Register.

DATES: The regulations in this final rule are effective on August 4, 
2023.

FOR FURTHER INFORMATION CONTACT: 
    For press inquiries: CMS Office of Communications, Department of 
Health and Human Services, [email protected].
    For technical inquiries: CMS Center for Clinical Standards and 
Quality, Department of Health and Human Services, (410)786-6633.

SUPPLEMENTARY INFORMATION:

I. Background

A. Introduction

    On January 30, 2020, the International Health Regulations Emergency 
Committee of the World Health Organization (WHO) declared the 
``coronavirus disease 2019'' (COVID-19) outbreak caused by ``severe 
acute respiratory syndrome coronavirus 2'' (SARS-CoV-2) 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. On March 11, 2020, the WHO publicly 
declared COVID-19 a pandemic. The President of the United States 
declared the COVID-19 pandemic a national emergency on March 13, 2020. 
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\ 
The initial determination that a PHE for COVID-19 exists and had 
existed since January 27, 2020, lasted for 90 days, and was renewed by 
the Secretary on April 21, 2020; July 23, 2020; October 2, 2020; 
January 7, 2021; April 15, 2021; July 19, 2021; October 15, 2021; 
January 14, 2022; April 12, 2022; July 15, 2022; October 13, 2022; 
January 11, 2023; and February 9, 2023.\2\ The COVID-19 PHE expired on 
May 11, 2023.
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    \1\ https://aspr.hhs.gov/legal/PHE/Pages/Public-Health-Emergency-Declaration.aspx.
    \2\ https://aspr.hhs.gov/legal/PHE/Pages/default.aspx.
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    COVID-19 has had significant negative health effects on 
individuals, communities, and the nation as a whole. Over a year ago, 
in September 2021, COVID-19 overtook the 1918 influenza pandemic as the 
deadliest disease in American history.\3\ According to the Centers for 
Disease Control and Prevention (CDC), just over 6 million patients 
admitted to hospitals in the United States have been confirmed positive 
with COVID-19 infection since August 1, 2020, and approximately 1.1 
million COVID-19 deaths have been reported in the United States as of 
April 14, 2023. In light of our responsibility to protect the health 
and safety of individuals receiving care and services from Medicare- 
and Medicaid-certified providers and suppliers, and CMS' statutory 
authority, as outlined in section I.E. of this final rule, to establish 
health and safety regulations, we have been compelled to act throughout 
the COVID-19 pandemic. While a comprehensive discussion of CMS' 
regulatory responses during the PHE is outside the scope and purpose of 
this final rule, we note that CMS issued several interim final rules 
with comment periods (IFCs) during the COVID-19 PHE to help minimize 
the

[[Page 36486]]

spread and impact of SARS-CoV-2. Some of these IFCs established new 
health and safety standards, known as the Conditions of Participation 
(CoPs), Conditions for Coverage (CfCs), or Requirements for 
Participation, for providers and suppliers who participate in the 
Medicare and Medicaid programs. Several of the policies in these IFCs 
have been further addressed in final rules and through the COVID-19 
vaccination quality measures which have been proposed for adoption in 
multiple CMS quality reporting and payment programs (for example, the 
``Measures Under Consideration'' (MUC) List issued by CMS on December 
1, 2022). These IFCs, final rules, and quality reporting and payment 
programs reflect the scaled progression of CMS' response during the 
COVID-19 PHE as both the science and epidemiology pertaining to COVID-
19 evolved.
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    \3\ https://www.statnews.com/2021/09/20/covid-19-set-to-overtake-1918-spanish-flu-as-deadliest-disease-in-american-history/.
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    On September 2, 2020, we issued an IFC titled ``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), otherwise known as the ``LTC facility 
testing IFC.'' This IFC revised regulations to strengthen CMS' ability 
to enforce compliance with Medicare and Medicaid long-term care 
facility requirements for reporting information related to COVID-19, 
established a new requirement for hospitals and critical access 
hospitals (CAHs) to track the incidence and impact of COVID-19, and 
established a new requirement for LTC facilities to test residents and 
staff for COVID-19 applicable for the duration of the PHE. We 
subsequently finalized provisions addressing the hospital and CAH 
COVID-19 reporting requirements in the final rule ``Medicare Program; 
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals 
and the Long-Term Care Hospital Prospective Payment System and Policy 
Changes and Fiscal Year 2023 Rates; Quality Programs and Medicare 
Promoting Interoperability Program Requirements for Eligible Hospitals 
and Critical Access Hospitals; Costs Incurred for Qualified and Non-
Qualified Deferred Compensation Plans; and Changes to Hospital and 
Critical Access Hospital Conditions of Participation'' on August 10, 
2022 (87 FR 48780) (``FY 2023 Hospital Inpatient Prospective Payment 
System final rule'').
    On May 13, 2021, we issued an IFC titled ``Medicare and Medicaid 
Programs; COVID-19 Vaccine Requirements for Long-Term Care (LTC) 
Facilities and Intermediate Care Facilities for Individuals with 
Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff'' 
(86 FR 26306), otherwise known as the ``educate and offer IFC.'' This 
IFC revised the requirements for LTC facilities and CoPs for ICFs-IID 
to require the provision of COVID-19 vaccination education and to offer 
vaccines to residents, clients, and staff. The IFC also revised the 
infection control requirements for LTC facilities to include COVID-19 
data reporting. We subsequently finalized data reporting requirements 
for LTC facilities with revisions in the final rule ``Medicare and 
Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate 
Update; Home Health Value-Based Purchasing Model Requirements and Model 
Expansion; Home Health and Other Quality Reporting Program 
Requirements; Home Infusion Therapy Services Requirements; Survey and 
Enforcement Requirements for Hospice Programs; Medicare Provider 
Enrollment Requirements; and COVID-19 Reporting Requirements for Long-
Term Care Facilities,'' published in the November 9, 2021 Federal 
Register (86 FR 62240, 62421) (``calendar year (CY) 2022 Home Health 
final rule''). These revisions established a sunset date for most 
COVID-19 reporting requirements for LTC facilities. Specifically, LTC 
facilities must report all required data until December 31, 2024, as 
determined by the Secretary.
    On November 5, 2021, we issued the interim final rule ``Medicare 
and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination'' 
(86 FR 61555), otherwise known as the ``staff vaccination IFC.'' This 
IFC revised the requirements that most Medicare- and Medicaid-certified 
providers and suppliers must meet to participate in the Medicare and 
Medicaid programs to include requirements regarding development and 
implementation of policies and procedures to ensure COVID-19 
vaccination of staff.
    Throughout the COVID-19 PHE, we implemented and revised regulations 
to reflect lessons learned and emerging data and knowledge to protect 
the health and safety of individuals that receive care and services 
from Medicare- and Medicaid-certified providers and suppliers. For 
example, the educate and offer IFC-required LTC facilities and ICFs-IID 
that furnish care and services to populations identified at increased 
risk for severe health outcomes due to COVID-19 infection, to provide 
COVID-19 vaccination education and to offer vaccines to residents, 
clients, and staff. These requirements are generally referred to as the 
``educate and offer'' provisions. Nonetheless, evidence continued to 
demonstrate that unvaccinated health care staff presented risks to 
patient safety across health care settings, and that too few health 
care staff were getting vaccinated. At the same time, the advent of a 
more contagious and severe variant (Delta)--and the recognition that 
additional variants were likely to emerge and, together with seasonal 
respiratory illnesses, increased the pressure on the health care 
system--indicated a need for CMS to take additional action.
    Accordingly, we issued the staff vaccination IFC, which required 
most Medicare- and Medicaid-certified providers and suppliers to ensure 
health care staff completed their COVID-19 primary vaccine series. As 
discussed in the educate and offer IFC and the staff vaccination IFCs, 
COVID-19 vaccination is one of the most important tools in the multi-
pronged approach for reducing health system burden, safeguarding health 
care workers and the people they serve, and mitigating the overall 
impact of the COVID-19 pandemic. Food and Drug Administration (FDA)-
approved and FDA-authorized COVID-19 vaccines in use in the United 
States are both safe and highly effective at protecting vaccinated 
people against severe COVID-19.4 5
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    \4\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html.
    \5\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/index.html.
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    As conditions and circumstances of the COVID-19 PHE have evolved, 
so too has CMS' response. At this point in time, we believe that the 
risks targeted by the staff vaccination IFC have been largely 
addressed, so we are now aligning our approach with those for other 
infectious diseases, specifically influenza. Accordingly, CMS intends 
to encourage ongoing COVID-19 vaccination through its quality reporting 
and value-based incentive programs in the near future. The statute 
requires that the Secretary establish a pre-rulemaking process for the 
selection of certain quality measures for use by HHS.\6\ The pre-
rulemaking process requires that HHS make publicly available, not later 
than December 1 annually, a list of quality and efficiency measures HHS 
is considering to adopt, through the rulemaking process, for use in 
certain Medicare quality programs and for use in publicly reported 
performance information in any Medicare program. This list is known as 
the Measures

[[Page 36487]]

Under Consideration (MUC) List. Table 1 shows the COVID-19 vaccination 
measures under consideration, as published on December 1, 2022, for 
patients and health care personnel, including measure title, measure 
description, and applicable quality programs. We note that on April 18, 
2023, FDA revised the Emergency Use Authorizations (EUAs) for the 
Pfizer and Moderna mRNA vaccines to make several changes to the 
authorized dosing regimen and schedule.\7\ Among other changes, the 
revised EUAs for the mRNA vaccines no longer refer to ``primary 
series'' and ``booster'' doses. In addition, previously unvaccinated 
individuals 6 years through 64 years of age (other than those with 
certain immunocompromising conditions) are only authorized to receive a 
single dose of a COVID-19 vaccine. They will not receive an mRNA 
``series.'' These measures may be revised from their initial design but 
we include the MUCs here as an illustration of CMS's interest in 
pursuing implementation of measures that encourage uptake of COVID-19 
vaccines. The use of such quality measures may ultimately affect 
ratings on the various ``Compare'' (such as ``Hospital Compare'') 
websites and may affect payment in various ``value-based purchasing'' 
programs, but would not affect the ability of the provider or supplier 
to participate in the Medicare program. Information about the MUC List 
is available on the CMS Measures Management System (MMS) website at 
https://mmshub.cms.gov/measure-lifecycle/measure-implementation/pre-rulemaking/lists-and-reports.
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    \6\ See section 1890A(a) of the Act (42 U.S.C. 1395aaa-1(a)) and 
section 1890(b)(7)(B) of the Act (42 U.S.C. 1395aaa(b)(7)(B)).
    \7\ https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines.

  Table 1--COVID-19 Vaccination MUC for Use in Certain Medicare Quality
                 Programs as Published December 1, 2022
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            Measure                Description        Quality programs
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Adult COVID-19 Vaccination      Percentage of      Merit-based Incentive
 Status.                         patients aged 18   Payment System
                                 years and older    (MIPS).
                                 seen for a visit
                                 during the
                                 performance
                                 period who have
                                 ever completed
                                 or reported
                                 having ever
                                 completed a
                                 COVID-19
                                 vaccination
                                 series and one
                                 booster dose.
COVID-19 Vaccination Coverage   Percentage of      Ambulatory Surgical
 Among Healthcare Personnel      healthcare         Center Quality
 (HCP) (2022 revision).          personnel who      Reporting Program
                                 are considered     (ASCQR).
                                 up-to-date on     Hospital Inpatient
                                 their COVID-19     Quality Reporting
                                 vaccinations per   Program (Hospital
                                 the CDC's latest   IQR Program).
                                 guidance.         Hospital Outpatient
                                                    Quality Reporting
                                                    Program (Hospital
                                                    OQR Program).
                                                   Hospital Value-Based
                                                    Purchasing Program
                                                    (HVBP).
                                                   Hospital-Acquired
                                                    Condition Reduction
                                                    Program (HACRP).
                                                   Inpatient Psychiatric
                                                    Facility Quality
                                                    Reporting Program
                                                    (IPFQR).
                                                   Inpatient
                                                    Rehabilitation
                                                    Facility Quality
                                                    Reporting Program
                                                    (IRFQRP).
                                                   Long-Term Care
                                                    Hospital Quality
                                                    Reporting Program
                                                    (LTCHQRP).
                                                   Prospective Payment
                                                    System-Exempt Cancer
                                                    Hospital Quality
                                                    Reporting Program
                                                    (PCHQRP).
                                                   Skilled Nursing
                                                    Facility Quality
                                                    Reporting Program
                                                    (SNFQRP).
                                                   End-Stage Renal
                                                    Disease Quality
                                                    Incentive Program
                                                    (ESRD QIP).
COVID-19 Vaccine: Percent of    Percentage of      Home Health Quality
 Patients/Residents Who Are Up   patients who are   Reporting Program
 to Date.                        considered up-to-  (Home Health QRP).
                                 date on their     SNFQRP.
                                 COVID-19          IRFQRP.
                                 vaccinations per  LTCHQRP.
                                 the CDC's latest
                                 guidance.
------------------------------------------------------------------------

    Quality measures would provide a means to monitor COVID-19 
vaccination rates among patients and health care personnel in multiple 
entities across the health system, including inpatient, outpatient, 
congregate care, and home-based care settings. Moreover, public 
reporting of quality measures increases the involvement of leadership 
in quality improvement, creates a sense of accountability, helps to 
focus organizational priorities, supports transparency, and provides a 
means of delivering important information to consumers.\8\
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    \8\ https://qualitynet.cms.gov/inpatient/public-reporting/public-reporting.
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    As discussed further in section I.E. of this final rule, section 
902 of the Medicare Prescription Drug, Improvement, and Modernization 
Act of 2003 (MMA) requires that the publication of Medicare final 
regulations shall not exceed 3 years after publication of the preceding 
proposed or interim final regulation, except under exceptional 
circumstances. Thus, consistent with section 902 of the MMA, the 
requirements of the IFCs discussed in this rule would have expired if 
not finalized within 3 years of publication.
    As the COVID-19 pandemic has continued to evolve and circumstances 
have normalized, we have continued to evaluate the evolving clinical 
and epidemiological circumstances of the COVID-19 pandemic and the 
requirements issued in the IFCs, particularly those requirements that 
have not been finalized to date, for the purpose of determining the 
appropriate disposition of those requirements. The central 
consideration in our evaluation and determination is helping to protect 
the health and safety of individuals that receive care and services 
from Medicare- and Medicaid-certified providers and suppliers.
    This final rule addresses the disposition of regulations issued 
through three IFCs, specifically: the health care staff vaccination 
requirements issued in the staff vaccination IFC; the education and 
vaccine offering requirements issued in the educate and offer IFC; and 
the LTC testing IFC. Due to the broad scope and scale of the Omnibus 
COVID-19 Health Care Staff Vaccination IFC (staff vaccination IFC), we 
discuss it as the primary focus for policies addressed in this rule. 
Thus, throughout this document, we address the staff vaccination IFC 
first followed by the educate and offer IFC and the LTC testing IFC.

[[Page 36488]]

B. Omnibus COVID-19 Health Care Staff Vaccination

    On November 5, 2021, we published the staff vaccination IFC, which 
revised the health and safety requirements that most providers and 
suppliers must meet to participate in the Medicare and Medicaid 
programs. The revisions established requirements regarding COVID-19 
staff vaccination for the Medicare- and Medicaid-certified providers 
and suppliers included in the IFC. The following providers and 
suppliers were regulated by the staff vaccination IFC, listed in the 
numerical order of the relevant Code of Federal Regulations (CFR) 
sections:
     Ambulatory Surgical Centers (ASCs)--Sec.  416.51(c).
     Hospices--Sec.  418.60(d).
     Psychiatric Residential Treatment Facilities (PRTFs)--
Sec.  441.151(c).
     Programs of All-Inclusive Care for the Elderly (PACE) 
Organizations--Sec.  460.74(d).
     Hospitals (acute care hospitals, psychiatric hospitals, 
hospital swing beds, long term care hospitals, children's hospitals, 
transplant centers, cancer hospitals, and rehabilitation hospitals/
inpatient rehabilitation facilities)--Sec.  482.42(g).
     LTC Facilities, including skilled nursing facilities 
(SNFs) and nursing facilities (NFs), generally referred to as nursing 
homes--Sec.  483.80(i).
     ICFs-IID--Sec.  483.430(f).
     Home Health Agencies (HHAs)--Sec.  484.70(d).
     Comprehensive Outpatient Rehabilitation Facilities 
(CORFs)--Sec.  485.70(n).
     Critical Access Hospitals (CAHs)--Sec.  485.640(f).
     Clinics, Rehabilitation Agencies, and Public Health 
Agencies as Providers of Outpatient Physical Therapy and Speech-
language Pathology Services (Organizations)--Sec.  485.725(f).
     Community Mental Health Centers (CMHCs)--Sec.  485.904(c).
     Home Infusion Therapy (HIT) Suppliers--Sec.  486.525(c).
     Rural Health Clinics (RHCs) and Medicare Federally 
Qualified Health Centers (FQHCs)--Sec.  491.8(d).
     End-Stage Renal Disease (ESRD) Facilities--Sec.  
494.30(b).
    We discuss the specific requirements of the staff vaccination IFC 
in section II.A. of this rule. In section III.A. of this final rule, we 
address the public comments submitted to CMS regarding the staff 
vaccination IFC. We then discuss the withdrawal of regulations 
pertaining to the staff vaccination IFC in section IV.A. of this rule.
    While the requirements established by the staff vaccination IFC 
were necessary to protect the health and safety of residents, clients, 
patients, and PACE Organization participants at the time of 
publication, circumstances of the COVID-19 pandemic have evolved, as 
has CMS' response, as discussed throughout this rule. As mentioned 
above, based on an evaluation of the evolving clinical and 
epidemiological circumstances of the COVID-19 pandemic, increased 
vaccine uptake, declining infection and death rates, decreasing 
severity of disease, increased instances of infection-induced immunity, 
public comments submitted to CMS, and the addition of COVID-19 
vaccination quality measures to quality improvement and reporting 
programs, we believe regulations regarding COVID-19 vaccination of 
health care staff are no longer necessary. Therefore, in this rule, we 
are withdrawing language on COVID-19 health care staff vaccination 
requirements issued in the staff vaccination IFC. COVID-19 vaccination 
policies and procedures for health care staff will no longer be 
required under the CoPs, CfCs, and requirements.

C. COVID-19 Vaccine ``Educate and Offer'' Requirements for LTC 
Facilities and ICFs-IID

    On May 13, 2021, CMS issued the educate and offer IFC, which 
revised the health and safety requirements that LTC facilities and 
ICFs-IID must meet to participate in the Medicare and Medicaid 
programs. The IFC established requirements that these facilities 
provide COVID-19 vaccination education to residents, clients, and 
staff, and to offer COVID-19 vaccines to these populations, referred to 
as the ``educate and offer'' provisions. The IFC also established 
additional infection control requirements for LTC facilities, as well 
as requirements to report certain COVID-19 data: these requirements 
have already been finalized through previous rulemaking (86 FR 
62240).\9\ We discuss these educate and offer provisions of the IFC in 
section II.B. of this rule. In section III.B. of this final rule, we 
address the public comments submitted to CMS regarding the educate and 
offer provisions. We then discuss the final regulatory changes 
pertaining to the educate and offer provisions in section IV.B. of this 
final rule.
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    \9\ https://www.federalregister.gov/documents/2021/11/09/2021-23993/medicare-and-medicaid-programs-cy-2022-home-health-prospective-payment-system-rate-update-home.
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    Individuals living in congregate care settings, such as LTC 
facilities and ICFs-IID, are at greater risk than the general 
population for contracting SARS-CoV-2 and developing severe health 
outcomes due to COVID-19,10 11 and they rely on facility 
staff to provide for their daily needs, including access to health care 
services such as vaccination. As discussed in section III.B. of this 
rule, public commenters acknowledge these risks. Consistent with our 
approach to staff vaccinations for COVID-19, we are moving to align our 
approach with existing regulations addressing other infectious 
diseases, such as influenza and pneumococcal disease. Therefore, we are 
finalizing the educate and offer requirements on a permanent basis. 
This complements the proposed adoption of the ``COVID-19 Vaccine: 
Percent of Patients/Residents Who are Up to Date (Patient/Resident 
COVID-19 Vaccine) measure'' and the ``COVID-19 Vaccination Coverage 
among Healthcare Personnel (HCP COVID-19 Vaccine) measure'' as issued 
in the ``Medicare Program; Prospective Payment System and Consolidated 
Billing for Skilled Nursing Facilities (SNF); Updates to the Quality 
Reporting Program and Value-Based Purchasing Program for Federal Fiscal 
Year 2024'' proposed rule (88 FR 21316) (``2024 SNF Prospective Payment 
System proposed rule''). Given that the educate and offer provisions 
are existing requirements for LTC facilities and ICFs-IID, the 
requirements will remain effective after the publication date of this 
final rule.
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    \10\ https://www.cdc.gov/coronavirus/2019-ncov/your-health/understanding-risk.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fneed-extra-precautions%2Findex.html.
    \11\ https://www.cdc.gov/coronavirus/2019-ncov/community/community-congregate-living-settings.html.
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D. COVID-19 Testing Requirement for LTC Facilities

    On September 2, 2020, CMS published the LTC facility testing IFC, 
which revised the infection control requirements that LTC facilities 
must meet to participate in the Medicare and Medicaid programs. This 
IFC established requirements applicable for the duration of the PHE for 
LTC facilities to test their staff and residents for COVID-19 based on 
parameters set forth by the Secretary in a manner consistent with 
current professional standards of practice. This IFC also established 
COVID-19 reporting requirements for hospitals and CAHs which have been 
finalized through previous rulemaking (87 FR 48780). As previously 
discussed, LTC facility residents are more susceptible to contracting 
COVID-19 and developing severe symptoms. This highlights the

[[Page 36489]]

importance of practicing preventative measures in order to mitigate the 
risk of transmission and control the spread of COVID-19 among residents 
and staff of LTC facilities. At the time of publication, these 
provisions were necessary to protect the health and safety of both 
residents and health care personnel of LTC facilities, as there were 
limited treatments for COVID-19 and vaccines were not yet available. As 
the COVID-19 PHE has concluded, we are deleting expired text related to 
the LTC facility testing requirements effective the publication date of 
this final rule.
    CMS continues to emphasize the importance of practicing 
preventative measures in order to reduce the transmission of COVID-19. 
Moving forward, CMS aims to use quality reporting and value-based 
incentive programs to encourage health care facilities to practice 
preventative measures against COVID-19. We discuss the LTC facility 
testing requirements of the IFC in section II.C. of this rule. In 
section III.C. of this final rule, we address the public comments 
submitted to CMS regarding the LTC facility testing requirements. We 
then discuss the final regulatory changes pertaining to the educate and 
offer provisions in section IV.C. of this final rule.

E. Statutory Authority

    Various sections of the Social Security Act (the Act) define the 
types of providers and suppliers that may participate in Medicare and 
Medicaid programs and list the requirements that each provider and 
supplier must meet to be eligible for participation. Statutory 
provisions applicable to each provider or supplier type either 
authorize the Secretary to establish other requirements as necessary to 
protect the health and safety of patients or, in some cases, to 
establish such additional criteria as the Secretary may require. 
Although the wording of such authority differs slightly between 
provider and supplier types, we have interpreted all of these 
provisions as at minimum permitting the Secretary to establish 
mandatory requirements to enhance the health and safety of patients. In 
addition, parallel Medicaid statutes provide authority to establish 
requirements to protect the health and safety of patients. Such 
requirements include the CoPs for providers, CfCs for suppliers, and 
requirements for LTC facilities. The CoPs, CfCs, and requirements are 
intended to protect public health and safety and promote high-quality 
care for all persons. Furthermore, the PHSA sets forth additional 
regulatory requirements that certain Medicare providers and suppliers 
are required to meet in order to participate. Table 2 lists the 
statutory authority by provider and supplier type for which we are 
issuing the requirements in this final rule:

       Table 2--Statutory Authority by Provider and Supplier Type
------------------------------------------------------------------------
       Provider and supplier type              Statutory authority
------------------------------------------------------------------------
Ambulatory Surgical Centers (ASCs).....  Sections 1832(a)(2)(F)(i), and
                                          1833 (i)(1)(A) of the Act.
Hospices...............................  Section 1861(dd) of the Act.
Psychiatric Residential Treatment        Section 1905(h)(1) of the Act.
 Facilities (PRTFs).
Programs of All-Inclusive Care for the   Sections 1894(f), and 1934(f)
 Elderly (PACE) Organizations.            of the Act.
Hospitals..............................  Section 1861(e)(9) of the Act.
Long Term Care (LTC) Facilities........  Sections 1819(d)(4)(B),
                                          1819(f)(1), and 1919(d)(4)(B)
                                          and (f)(1) of the Act.
Intermediate Care Facilities for         Section 1905(d)(1) of the Act.
 Individuals with Intellectual
 Disabilities (ICFs-IID).
Home Health Agencies (HHAs)............  Sections 1861(m), 1861(o), and
                                          1891 of the Act.
Comprehensive Outpatient Rehabilitation  Section 1861(cc)(2)(J) of the
 Facilities (CORFs).                      Act.
Critical Access Hospitals (CAHs).......  Section 1820(e)of the Act.
Clinics, Rehabilitation Agencies, and    Section 1861(p)(4)(A)(v) of the
 Public Health Agencies as Providers of   Act.
 Outpatient Physical Therapy and Speech-
 Language Pathology Services
 (Organizations).
Community Mental Health Centers (CMHCs)  Sections 1861(ff)(3)(b)(iv),
                                          1832(a)(2)(J), and 1866(e)(2)
                                          of the Act.
Home Infusion Therapy (HIT) Suppliers..  Section 1861(iii)(3)(D)(i)(IV)
                                          of the Act.
Rural Health Clinics (RHCs)/Federally    Sections 1861(aa) and
 Qualified Health Centers (FQHCs).        1905(l)(2)(B) of the Act.
End-Stage Renal Disease (ESRD)           Section 1881(b)(1)(A) of the
 Facilities.                              Act.
------------------------------------------------------------------------

    We note that the appropriate term for an individual receiving care 
and services differs depending upon the provider or supplier type. For 
example, for hospitals and CAHs, the appropriate term is ``patient,'' 
but for ICFs-IID, it is ``client.'' Further, LTC facilities have 
``residents'' and PACE Organizations have ``participants.'' In this 
final rule, the appropriate terms are used when discussing one or two 
provider or supplier types; however, when we are discussing three or 
more provider and supplier types, we use the general term ``patient.'' 
Similarly, despite the different terms used for specific provider and 
supplier entities (such as campus, center, clinic, facility, 
organization, or program), when we are discussing three or more 
provider and supplier types, we use the general term ``facility.''

F. Requirements for Issuance of Regulations

    Section 902 of the MMA amended section 1871(a) of the Act and 
requires the Secretary, in consultation with the Director of the Office 
of Management and Budget, to establish and publish timelines for the 
publication of Medicare final regulations based on the previous 
publication of a Medicare proposed or interim final regulation. Section 
902 of the MMA also states that the timelines for these regulations may 
vary but shall not exceed 3 years after publication of the preceding 
proposed or interim final regulation except under exceptional 
circumstances.
    This final rule withdraws the regulatory provisions set forth on 
November 5, 2021, in the Omnibus COVID-19 Health Care Staff Vaccination 
IFC and deletes expired provisions set forth on May 13, 2021, in the 
LTC facility testing IFC. Also, this final rule finalizes the ``educate 
and offer'' provisions set forth on May 13, 2021, in the COVID-19 
Vaccine Requirements for LTC Facilities and ICFs-IID Residents, 
Clients, and Staff IFC. This final rule has been published

[[Page 36490]]

within the 3-year time limit imposed by section 902 of the MMA.

G. Enforcement of Staff Vaccination Provisions

    Federal rules generally become effective 60 days after publication; 
however, the COVID-19 PHE expired on May 11, 2023. Our decision to 
terminate the omnibus facility staff vaccination requirements in this 
final rule reflect our determination that the emergency circumstances 
which occasioned these vaccination provisions no longer exist. Since 
facilities are no longer operating under PHE circumstances, and 
considering the lower policy priority of enforcement within the 
remaining time, we will not be enforcing the staff vaccination 
provisions between now and August 4, 2023.

II. Provisions of the Interim Final Regulations

    In this section, we review the requirements issued in the staff 
vaccination IFC, the educate and offer IFC, and the LTC facility 
testing IFC. In section II.A. of this rule, we summarize and discuss 
the requirements of the staff vaccination IFC. We then summarize and 
discuss the educate and offer provisions in the educate and offer IFC 
in section II.B. of this final rule. Lastly, we summarize and discuss 
the LTC testing IFC in section II.C. of this final rule.

A. Omnibus COVID-19 Health Care Staff Vaccination

    As discussed in section I. of this rule, we established COVID-19 
staff vaccination requirements for most Medicare- and Medicaid-
certified providers and suppliers in an IFC published in November 2021. 
Those provisions reflected a common set of requirements with no 
substantive regulatory differences across facility types, added to the 
CoPs, CfCs, and requirements, as applicable, under the relevant CFR 
section as listed in section I.B. of this final rule. Next, we briefly 
discuss these common provisions. We then discuss any additional 
revisions for specific provider and supplier types issued by CMS in the 
staff vaccination IFC due to unique circumstances.
1. Common Requirements in the Staff Vaccination IFC
    The IFC requires each applicable facility to develop and implement 
policies and procedures under which staff complete a primary COVID-19 
vaccine series. Those vaccination policies and procedures must apply to 
current and new staff, to include volunteers and individuals under 
contract or arrangement, that provide any care, treatment, or other 
services for the facility or its patients, regardless of clinical 
responsibility or degree of anticipated patient contact. Vaccination is 
required for all staff that interact with other staff or patients in 
any location, such as clinics, homes, or other sites of care and 
services.
    As discussed in the IFC, some staff are not subject to the 
vaccination requirements, including but not limited to those who 
provide services 100 percent remotely and ``one-off'' vendors, 
volunteers, and professionals who infrequently provide ad hoc non-
health care services, such as annual elevator inspection, delivery, and 
repair personnel. When determining whether to require COVID-19 
vaccination of an individual who does not clearly fall within the 
classification of staff, we encouraged facilities to consider frequency 
of presence, services provided, and proximity to patients and staff. We 
also strongly encouraged facilities to facilitate the vaccination of 
all individuals who provide services infrequently and are not otherwise 
subject to the requirements in the IFC to the extent opportunity exists 
and resources allow.
    In the IFC, we required facilities to ensure that staff are ``fully 
vaccinated'' for COVID-19, defined as 2 weeks or more since completion 
of a primary vaccination series. We also required facilities to have a 
process for tracking and securely documenting the COVID-19 vaccination 
status of staff who obtain any booster doses as recommended by the CDC. 
For those staff who are not ``fully vaccinated'' for COVID-19, we 
required facilities to establish and implement a process that provides 
additional precautions to minimize the spread of COVID-19.
    The IFC required facilities to track and securely document the 
vaccination status of each staff member. All medical records, including 
vaccine documentation, were to be kept confidential and stored 
separately from an employer's personnel files, pursuant to the 
Americans with Disabilities Act (ADA) and the Rehabilitation Act.
    We described these documentation requirements in the IFC as an 
ongoing process due to the onboarding of new staff, and we provided 
examples of: (1) appropriate places for vaccine documentation, such as 
an immunization record, health information files, or other relevant 
documents; and (2) acceptable forms of proof of vaccination, such as a 
CDC COVID-19 vaccination record card (or a legible photo of the card) 
or documentation of vaccination from a health care provider, electronic 
health record, State immunization information system record, or a 
reasonable equivalent for those individuals vaccinated outside of the 
United States.
    Further, through the IFC, we required facilities to establish and 
implement a process by which staff may request an exemption from the 
COVID-19 vaccination requirement based on: (1) an applicable Federal 
law, such as the ADA, section 504 of the Rehabilitation Act, section 
1557 of the Affordable Care Act (ACA), and Title VII of the Civil 
Rights Act that prohibit discrimination based on race, color, national 
origin, religion, disability, and sex, including pregnancy; and (2) 
recognized clinical contraindications to receipt of a COVID-19 vaccine. 
Facilities had to have a process for collecting and evaluating 
exemption requests, including tracking and securely documenting the 
required information.
    We acknowledged in the IFC that certain allergies or medical 
conditions may be clinical contraindications to receiving a COVID-19 
vaccine, and we referred facilities to the CDC page ``Use of COVID-19 
Vaccines in the United States: Interim Clinical Considerations'' which 
can be accessed at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html. The IFC required facilities 
to make contingency plans in consideration of staff who are not ``fully 
vaccinated'' to ensure that those staff will soon be vaccinated and 
will not provide care, treatment, or other services for the facility or 
its patients until such time as those staff complete a primary 
vaccination series for COVID-19 and are considered ``fully 
vaccinated.'' This planning must also address the safe provision of 
care and services by staff who request an exemption from vaccination 
that is under consideration and by staff for whom COVID-19 vaccination 
must be temporarily delayed, as recommended by the CDC, due to clinical 
reasons.
    We discussed in the IFC that contingency planning may extend beyond 
the specific requirements of the rule, to address topics such as 
staffing agencies that can supply vaccinated staff if some of a 
facility's staff are unable to work. We also discussed special 
precautions to be taken in the event of, for example, a regional or 
local emergency declaration, such as for a hurricane or flooding, which 
necessitated the temporary utilization of unvaccinated staff, in order 
to assure the health and safety of patients. We also acknowledged in 
the IFC that facilities may already have contingency plans that meet 
the requirements in their

[[Page 36491]]

existing emergency preparedness policies and procedures.
2. Additional Requirements in the Staff Vaccination IFC for Specific 
Provider and Supplier Types
    In addition to the common set of provisions issued in the staff 
vaccination IFC for all applicable facility types, we varied specific 
provisions of the regulations, where applicable, for specific provider 
and supplier types. These various provisions for specific provider and 
supplier types were necessary due to the unique content of regulations 
in place at the time the staff vaccination IFC was published, for 
Psychiatric Residential Treatment Facilities (PRTFs), HIT suppliers, 
RHCs/FQHCs; LTC facilities and ICFs-IID; and CORFs.
    As discussed in the staff vaccination IFC, PRTFs, HIT Suppliers, 
and RHCs/FQHCs did not have specific infection control and prevention 
regulations at the time the IFC was published. Therefore, for PRTFs at 
Sec.  441.151(c)(3)(iii), HIT suppliers at Sec.  486.525(c)(3)(iii), 
and RHCs/FQHCs at Sec.  491.8(d)(3)(iii), we required a process for 
ensuring adherence to nationally recognized infection prevention and 
control guidelines intended to mitigate the transmission and spread of 
COVID-19. This process included the implementation of additional 
precautions for all staff who were not fully vaccinated for COVID-19.
    At the time the staff vaccination IFC was published, LTC facilities 
had existing regulations at Sec.  483.80(d)(3)(v) that required 
facilities to educate all residents and staff about the COVID-19 
vaccines and to offer the vaccines, when available. Likewise, at the 
time the IFC was published, ICFs-IID had existing regulations at Sec.  
483.460(a)(4)(v) that required facilities to educate all clients and 
staff about the COVID-19 vaccines and to offer the vaccine, when 
available. As discussed in section I. of this final rule, those 
requirements were established by the educate and offer IFC. In the 
staff vaccination IFC, we revised these requirements by removing 
language that could have been interpreted as a path by which staff 
members in LTC facilities and ICFs-IID could bypass the facility's 
vaccination policies and procedures. This change was necessary because 
retaining that language originally established by the educate and offer 
IFC would have been inconsistent with the goals of the staff 
vaccination IFC. In this final rule, we are finalizing the education 
and offering provisions of the educate and offer IFC, as amended by the 
staff vaccination IFC, and we refer readers to sections I., II.B., 
III.B., IV.B., V.B, and VI.B. of this final rule for additional 
information.
    Regulations in place at the time that the staff vaccination IFC was 
published for CORFs at 42 CFR 485.70(a) through (m) identified the 
qualifications required for personnel, including facility physician, 
licensed practical nurse, occupational therapist, occupational 
therapist assistant, orthotist, physical therapist, physical therapist 
assistant, prosthetist, psychologist, registered nurse, rehabilitation 
counselor, respiratory therapist, respiratory therapy technician, 
social worker, and speech-language pathologist. In addition, 
regulations at Sec.  485.58(d)(4) stated that personnel who do not meet 
the qualifications specified in Sec.  485.70 may be used by the 
facility in assisting qualified staff. In the staff vaccination IFC, we 
added Sec.  485.70(n) which requires CORFs to develop and implement 
policies and procedures to ensure COVID-19 vaccination of all facility 
staff. As discussed in the IFC, we recognize that assisting personnel 
are used by CORFs, and we established our requirements at Sec.  
485.70(a) through (m) to provide a role for personnel that might not 
meet our education and experience qualifications. However, we did not 
believe this exception for employees who did not meet our professional 
requirements should have prohibited us from issuing staff 
qualifications referencing infection prevention, which we intended to 
apply to all personnel. Therefore, in the staff vaccination IFC, we 
revised Sec.  485.58(d)(4) to state that personnel who did not meet the 
qualifications specified in Sec.  485.70(a) through (m) may be used by 
the facility in assisting qualified staff.
    As noted previously in this rule, we are withdrawing the provisions 
of the staff vaccination IFC.

B. COVID-19 Vaccine ``Educate and Offer'' Requirements for LTC 
Facilities and ICFs-IID Residents, Clients, and Staff

    As discussed in section I. of this final rule, on May 13, 2021, CMS 
issued the educate and offer IFC. This IFC revised the requirements for 
LTC facilities and CoPs for ICFs-IID to provide COVID-19 vaccination 
education and to offer vaccines to residents, clients, and staff, 
otherwise known as the ``educate and offer'' provisions. This IFC also 
established requirements for COVID-19 data reporting in LTC facilities.
    Subsequently, in the ``Medicare and Medicaid Programs; CY 2022 Home 
Health Prospective Payment System Rate Update; Home Health Value-Based 
Purchasing Model Requirements and Model Expansion; Home Health and 
Other Quality Reporting Program Requirements; Home Infusion Therapy 
Services Requirements; Survey and Enforcement Requirements for Hospice 
Programs; Medicare Provider Enrollment Requirements; and COVID-19 
Reporting Requirements for Long-Term Care Facilities'' final rule (86 
FR 62240), we finalized the LTC facility reporting requirements from 
the educate and offer IFC at Sec.  483.80(g)(1) through (3) with some 
minor modifications.\12\ Given that this final rule addresses only the 
``educate and offer'' provisions of the IFC, this section provides a 
summary of those specific requirements.
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    \12\ https://www.federalregister.gov/documents/2021/11/09/2021-23993/medicare-and-medicaid-programs-cy-2022-home-health-prospective-payment-system-rate-update-home.
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1. LTC Facilities
    For LTC facilities, the educate and offer IFC established 42 CFR 
483.80(d)(3) COVID-19 immunizations, under which facilities must 
develop and implement policies and procedures to ensure that all of the 
requirements set forth in that section are followed. Before offering a 
COVID-19 vaccine, all residents, resident representatives, and staff 
members are provided with education regarding the benefits, risks, and 
potential side effects associated with the vaccine. When a COVID-19 
vaccine is available to the facility, each resident and staff member is 
offered a COVID-19 vaccine unless the immunization is medically 
contraindicated or the resident or staff member has already been 
immunized. 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.
    The regulation states that the resident or resident representative 
has the opportunity to accept or refuse a COVID-19 vaccine and change 
their decision. The original regulatory provisions as issued by the 
educate and offer IFC also permitted staff members to refuse 
vaccination. However, as discussed in section II.A. of this final rule, 
the reference to staff members in the refusal provision at Sec.  
483.80(d)(3)(v) was removed by the staff vaccination IFC published 
November 5, 2021. The resident's medical record is documented to 
reflect, at a minimum, that the

[[Page 36492]]

resident or resident representative was provided education regarding 
the benefits and potential risks associated with COVID-19 vaccine; each 
dose of COVID-19 vaccine administered to the resident; or, if the 
resident did not receive a COVID-19 vaccine due to medical 
contraindications or refusal. For staff members, the facility maintains 
documentation related to COVID-19 vaccination that includes, at a 
minimum, that staff were provided education regarding the benefits and 
potential risks associated with COVID-19 vaccines; were offered a 
COVID-19 vaccine or information on obtaining a COVID-19 vaccine; and 
the COVID-19 vaccine status of staff and related information as 
indicated by the CDC's National Healthcare Safety Network (NHSN).
    In this final rule, we are finalizing the infection control 
requirements that LTC facilities must meet to participate in the 
Medicare and Medicaid programs as issued in the educate and offer IFC 
and amended by the staff vaccination IFC. By doing so, LTC facilities 
must continue to educate residents, resident representatives, and staff 
about COVID-19 vaccines and offer a COVID-19 vaccine to residents, 
resident representatives, and staff, as well as complete the 
appropriate documentation for these activities. This aligns with the 
newly-proposed resident and patient vaccination measures as proposed in 
the 2024 SNF Prospective Payment System proposed rule.\13\
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    \13\ https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2024-skilled-nursing-facility-prospective-payment-system-proposed-rule-cms-1779-p.
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    Since the COVID-19 pandemic began, many States have passed laws 
regarding COVID-19 vaccination.\14\ Some States have required various 
individuals to take the vaccine while other States have prohibited the 
requirement of COVID-19 vaccination. Since LTC facility staff may be 
required to take a COVID-19 vaccine in some States, or by some 
employers, we believe it is inappropriate to include explicit 
permission to refuse in the regulations. In addition, as we noted in 
the staff vaccination IFC, retaining this language would be contrary to 
the goals of that IFC, which included protecting the health and safety 
of residents, clients, and staff. Hence, we are finalizing the 
provision as amended by the staff vaccination IFC, which provides, at 
Sec.  483.80(d)(3)(vii) that the facility maintains documentation 
related to staff COVID-19 vaccination. The documentation must include, 
at a minimum, evidence that staff were informed about the risks and 
benefits of the COVID-19 vaccine. The facility must also document that 
staff were either offered the COVID-19 vaccine or provided with 
information on acquiring the COVID-19 vaccine. Lastly, the staff's 
COVID-19 vaccine statuses and any associated information must be 
documented and reported to the NHSN as indicated by CDC.
---------------------------------------------------------------------------

    \14\ Pekruhn, D and Abbasi, E. ``Vaccine Mandates by State: Who 
is, Who isn't, and How?'' Leading Age. https://leadingage.org/workforce-vaccine-mandates-state-who-who-isnt-and-how/. Published on 
January 19, 2022. Accessed on January 17, 2023.
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2. ICFs-IID
    For ICFs-IID, the educate and offer IFC established Sec.  
483.430(f), ``COVID-19 Vaccination of facility staff,'' and Sec.  
483.460(a)(4), the educate and offer provisions. Section 483.430(f) 
requires that each ICF-IID maintain documentation related to its staff 
that includes, at a minimum, documentation that the staff were provided 
education regarding the benefits and risks and potential side effects 
associated with the COVID-19 vaccine and were offered a COVID-19 
vaccine or information on obtaining the COVID-19 vaccine. Section 
483.460(a)(4) requires each ICF-IID to develop and implement policies 
and procedures to ensure that when a 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. Before offering a 
COVID-19 vaccine, all staff members, clients, and client 
representatives must be provided with education regarding the benefits 
and risks and potential side effects associated with the vaccine. In 
situations where COVID-19 vaccination requires multiple doses, the 
client, client's representative, or staff member must be provided with 
current information regarding each additional dose, including any 
changes in the benefits or risks and potential side effects associated 
with a COVID-19 vaccine, before requesting consent for administration 
of each additional doses. The regulation states that the client or 
client's representative has the opportunity to accept or refuse a 
COVID-19 vaccine and change their decision. The original regulatory 
provisions as issued by the educate and offer IFC also permitted staff 
members to refuse vaccination. However, as discussed in section II.A. 
of this final rule, the reference to staff members in the refusal 
provision at Sec.  483.8460(a)(4)(v) was removed by the staff 
vaccination IFC published November 5, 2021. The ICF-IID must also 
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 risks and potential side effects 
of COVID-19 vaccine and each dose of a COVID-19 vaccine administered to 
the client. The ICF-IID must also document if the client did not 
receive a COVID-19 vaccine due to medical contraindications or refusal.
    In this final rule, we are finalizing the requirements for COVID-19 
vaccination of facility staff and ``educate and offer'' process that 
ICFs-IID must meet to participate in the Medicare and Medicaid 
programs, as first set out in the educate and offer IFC and amended by 
the staff vaccination IFC. By doing so, ICFs-IID must continue to 
educate clients, client representatives, and staff about COVID-19 
vaccines and offer a COVID-19 vaccine to residents and staff, as well 
as document these activities.
    Since the COVID-19 pandemic began, and as noted above for LTC 
facilities, many States have passed laws regarding COVID-19 
vaccination.\15\ Some States have required various individuals to take 
the vaccine while other States have prohibited requiring COVID-19 
vaccination. Since ICF-IID staff may be required to take a COVID-19 
vaccine in some States, or by some employers, we believe it is 
inappropriate to include explicit permission to refuse in the 
regulations. As we stated above in section II.B.1. of this final rule, 
reinstating language that directly allows staff to refuse a COVID-19 
vaccine would be contrary to the goals of these IFCs, to protect the 
health and safety of clients and staff in in ICFs-IID. One's ability to 
be exempt from a vaccination requirement per another statute (such as 
the ADA) is outside the scope and authority of this rulemaking. Hence, 
we are finalizing the refusal provision as amended by the staff 
vaccination IFC.
---------------------------------------------------------------------------

    \15\ Pekruhn, D and Abbasi, E. ``Vaccine Mandates by State: Who 
is, Who isn't, and How?'' Leading Age. https://leadingage.org/workforce-vaccine-mandates-state-who-who-isnt-and-how/. Published on 
January 19, 2022. Accessed on January 17, 2023.
---------------------------------------------------------------------------

C. COVID-19 Testing Requirement for LTC Facilities

    In the LTC facility testing IFC, we revised the LTC facility 
infection control requirements applicable for the duration of the PHE 
at Sec.  483.80 to establish a new, term-limited requirement that LTC 
facilities to test their facility residents and staff for COVID-19, 
including individuals providing services under arrangement and 
volunteers. We required that resident and staff testing in LTC

[[Page 36493]]

facilities for COVID-19 be conducted based on parameters set forth by 
the Secretary, applicable during the COVID-19 PHE. These requirements 
were established in accordance with CDC guidelines titled, Testing 
Guidelines for Nursing Homes, which explains the high risk of 
infection, illness, and death for LTC residents and the importance of 
testing in order to prevent COVID-19 from entering LTC facilities and 
preventing transmission.\16\ Under this requirement, ``staff'' are 
considered any individuals employed by the facility, any individuals 
that have arrangements to provide services for the facility, and any 
individuals volunteering at the facility. We explained that we only 
expected individuals who were physically working on-site at the 
facility to be required to be tested for COVID-19.
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    \16\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Flong-term-care.html.
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    At Sec.  483.80(h)(1), we required that resident and staff testing 
for COVID-19 be conducted based on parameters set forth by the 
Secretary. These parameters may have included but were not limited to: 
testing frequency; the identification of any facility resident or staff 
diagnosed with COVID-19 in the facility; the identification of any 
facility resident or staff with symptoms consistent with COVID-19 or 
with known or suspected exposure to COVID-19; the criteria for 
conducting testing of asymptomatic individuals specified in this 
paragraph, such as the positivity rate of COVID-19 in a county; the 
response time for results; and other factors specified by the Secretary 
that help identify and prevent the transmission of COVID-19. At Sec.  
483.80(h)(2), we required that all residents and staff testing be 
conducted in a manner consistent with current professional standards of 
practice for conducting COVID-19 tests. This referred to those 
professional standards that apply at the time that the care or service 
is delivered, which we acknowledge have evolved and changed over the 
course of the COVID-19 pandemic. At Sec.  483.80(h)(3)(i), we required 
that for each instance of resident or staff COVID-19 testing, which 
included testing of individuals providing services under arrangement 
and volunteers, the facility document that testing was completed and 
the results of each staff test. This documentation would have been 
located in the staff personnel record or the record or file that the 
facility maintains for individuals who are providing services under 
arrangement at the facility. Consistent with the documentation 
requirements we established for LTC facility staff, we required at 
Sec.  483.80(h)(3)(ii) that the facility document in the resident's 
medical record that testing was offered, completed (as appropriate to 
the resident's testing status), and the results of each test. Due to 
the high transmission rate of COVID-19, we required at Sec.  
483.80(h)(4) that the facility take actions to prevent the transmission 
of COVID-19 when a resident or staff member, including individuals 
providing services under arrangement and volunteers, presented with 
symptoms consistent with COVID-19 or who tested positive for COVID-19. 
We expected facilities to restrict the access to the facility for any 
staff member--including individuals providing services under 
arrangement and volunteers--who presented with symptoms consistent with 
COVID-19 or who tested positive for COVID-19 until they were deemed to 
be safe to return to work. We expected facilities to take measures, 
including resident cohorting, to mitigate the transmission of the virus 
within the facility when facility residents presented with symptoms 
consistent with COVID-19 or who tested positive for COVID-19.
    We acknowledge that residents and staff may not have consented to 
being tested for COVID-19. Therefore, at Sec.  483.80(h)(5) we required 
that the facility have procedures for addressing residents and staff, 
including individuals providing services under arrangement and 
volunteers, who refused or were unable to test for the virus. We 
required at Sec.  483.80(h)(6) that the LTC facility coordinate with 
state and local health departments and Tribal representatives regarding 
the availability and obtaining of testing supplies and processing test 
results when necessary. Facilities may also have coordinated with their 
local certified laboratories covered under Clinical Laboratory 
Improvement Amendments (CLIA) on the availability of and obtaining of 
testing supplies and the processing of test results. Access to adequate 
testing supplies and arrangements for acquiring testing supplies must 
have been addressed by the facility's infection prevention and control 
plan. The testing plan must have included any arrangements that were 
necessary to conduct, process, and receive test results prior to the 
administration of the required tests. Since the conclusion of the PHE 
on May 11, 2023, these requirements are no longer applicable.

III. Analysis of and Responses to Public Comments

    In this section, CMS discusses the public comments received for the 
COVID-19 testing requirement for LTC facilities, the staff vaccination 
IFC, and the ``educate and offer'' provisions of the COVID-19 Vaccine 
Requirements for LTC Facilities and ICFs-IID Residents, Clients, and 
Staff IFC (educate and offer IFC), published September 2, 2020, 
November 5, 2021, and May 21, 2021, respectively. We received public 
comments in response to all three IFCs, which we summarize and discuss 
in this section.
    In this final rule, we are withdrawing the health care staff COVID-
19 vaccination provisions issued in the staff vaccination IFC and 
deleting the expired COVID-19 testing provisions of the LTC testing 
IFC. We are also finalizing the COVID-19 ``educate and offer'' 
provisions established in the educate and offer IFC. In this section we 
provide a summary of the public comments received and responses to 
them, and the policies we are finalizing. In section III.A. of this 
final rule, we discuss the comments and responses pertaining to the 
COVID-19 health care staff vaccination requirements. In section III.B. 
of this final rule, we discuss the comments and responses regarding the 
requirements for LTC facilities and ICFs-IID to educate residents, 
clients, and staff about COVID-19 vaccines and to offer COVID-19 
vaccines when available. Lastly, in section III.C. of this final rule, 
we discuss the comments and responses concerning the COVID-19 testing 
requirements for LTC facilities. Due to the high volume of public 
comments, we have grouped them by themes and similarities for analysis 
and response.

A. Omnibus COVID-19 Health Care Staff Vaccination (Sec. Sec.  
416.51(c), 418.60(d), 441.151(c), 460.74(d), 482.421(g), 
483.80(d)(3)(v) and (i), 483.430(f), 483.460(v), 484.70(d), 
485.58(d)(4), 485.70(n), 485.640(f), 485.725(f), 485.904(c), 
486.525(c), 491.8(d), 494.30(b))

    In response to this IFC, we received approximately 10,102 timely 
public comments. Of these, roughly \2/3\ were virtually identical 
letters from individuals from around the country urging CMS to retract 
the rule. Of the remaining 3,175 unique comments, the majority were 
from individuals, while over 500 of those unique comments were from 
industry groups or individual commenters who were commenting as

[[Page 36494]]

representatives of organizations, companies, and other entities. About 
2,000 of these unique comments opposed the regulation, while the 
remainder of the commenters supported the regulation, some offering 
suggestions as to how CMS could improve the requirements. A summary of 
the major themes addressed by commenters and our responses follow.
    Comment: A significant minority of commenters agreed with our goal 
to ensure patient health and safety by establishing a COVID-19 health 
care staff vaccination requirement. Commenters stated that COVID-19 
vaccination is evidence-based, safe, and the best way to prevent 
serious illness, hospitalization, death, and spread of infection. They 
indicated that vaccination of health care staff will provide much-
needed workforce stability to the health care industry while decreasing 
demands associated with providing care to health care workers who 
contract COVID-19. Some of these commenters stated that patients who 
had delayed receiving care due to concerns of contracting COVID-19 
during the provision of their care would now be able to obtain the care 
they needed. Some of these commenters recommended expanding the scope 
of the COVID-19 vaccination regulation to include other settings in 
which health care is provided, such as physician offices and others. 
Other commenters recommended that in addition to the primary 
vaccination series, the regulation should require boosters, which 
provide ongoing protection against COVID-19.
    Response: We appreciate the support from commenters and agree that 
a requirement for COVID-19 vaccination of health care staff was 
necessary to ensure timely access to care for patients. We also agree 
that the COVID-19 PHE placed unprecedented, challenging circumstances 
on the health care industry, and vaccination of health care staff 
lessened disruptions to care and operations. We commend health care 
facilities and their staff for their efforts throughout the COVID-19 
pandemic, and we share a common commitment to assuring high-quality and 
safe care for patients, residents, clients, and participants.
    As noted in the IFC, the regulation applied only to those Medicare- 
and Medicaid-certified providers and suppliers listed. The IFC did not 
directly apply to other health care entities, such as physician 
offices, because those settings are not regulated by CMS. Most States 
have separate licensing requirements for health care staff and health 
care providers that would be applicable to physician office staff and 
other staff in small health care entities that were not subject to the 
vaccination requirements in the IFC. We also noted that health care and 
other entities providing services under contract for a Medicare- and 
Medicaid-certified provider and supplier listed in the IFC were 
indirectly subject to the requirements of the rule. Moreover, we noted 
that entities not covered by the IFC may have been subject to other 
vaccination requirements, such as those issued by State governments for 
certain types of workplaces.
    We thank commenters for recognizing the importance of staying up-
to-date with COVID-19 vaccines and boosters. Boosters have been an 
important part of protecting people from getting seriously ill or dying 
from COVID-19.\17\ Additionally, the newer bivalent vaccines contain an 
Omicron component to offer better protection against COVID-19 caused by 
the Omicron variant and its subvariants than the earlier, monovalent 
vaccines. In April 2023, the EUAs for the bivalent vaccines were 
revised to simplify the vaccination schedule for most individuals, 
which included authorizing the current bivalent vaccines for all doses 
administered to individuals 6 months of age and older, including for an 
additional dose or doses for certain populations.\18\ \19\ All 
individuals aged >6 months are recommended to receive at least one dose 
of bivalent vaccine for COVID-19 under current recommendations.\20\ 
Additional information regarding vaccine guidance can be found at 
https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html.
---------------------------------------------------------------------------

    \17\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html.
    \18\ https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines.
    \19\ https://www.yalemedicine.org/news/covid-19-variants-of-
concern-
omicron#:~:text=Omicron%20and%20its%20subvariants,and%20multiply%20in
%20other%20countries.
    \20\ https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html (accessed May 1, 
2023).
---------------------------------------------------------------------------

    At the time the IFC was issued, the CDC did not include boosters in 
their definition of ``fully vaccinated.'' Instead, a person was 
considered to be fully vaccinated 2 weeks after receiving the last dose 
of a primary vaccine series.\21\ Since the IFC was issued, CDC shifted 
to using the terminology ``up to date''. Individuals 6 years of age and 
older are considered ``up to date'' when they have received one updated 
Pfizer-BioNTech or Moderna COVID-19 vaccine.\22\ As of May 2, 2023, the 
CDC recommends that individuals 6 months of age and older receive a 
dose of updated (bivalent) vaccine. Certain individuals, depending on 
age and level of immunocompromise, may receive additional doses.\23\ 
\24\
---------------------------------------------------------------------------

    \21\ https://www.cdc.gov/media/releases/2021/p0308-vaccinated-guidelines.html.
    \22\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html.
    \23\ https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html.
    \24\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html.
---------------------------------------------------------------------------

    We agree with commenters that vaccines continue to be one of the 
most effective preventative practices against severe COVID-19; however, 
the effectiveness of the ``original'' or monovalent vaccines to prevent 
severe COVID-19 hospitalization and death has remained high, 
effectiveness to prevent less severe disease has diminished. As 
previously noted, for reasons discussed throughout this preamble, 
including declining infection rates and deaths, declining severity, and 
significant vaccination uptake, we are withdrawing the health care 
staff COVID-19 vaccination provisions of the IFC. In lieu of regulatory 
requirements and as previously noted, CMS intends to continue support 
and encouragement for health care staff vaccinations through other 
mechanisms, including quality programs. We encourage individuals to 
stay up-to-date with their COVID-19 vaccines in accordance with CDC 
recommendations (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html#recommendations).
    Comment: While many commenters supported the COVID-19 vaccination 
requirements, the majority of commenters stated that CMS did not have 
the statutory authority to infringe on the personal rights of health 
care staff to choose vaccination or not. These commenters described the 
requirements as an overreach of CMS authority and a violation of 
personal freedoms and bodily autonomy. Several individual commenters 
expressed concerns that the vaccination requirements may run afoul of 
certain fundamental medical ethics doctrines around informed consent 
and freedom from coercion.
    Response: We appreciate the feedback from commenters. Although we 
are withdrawing the health care staff COVID-19 vaccination provisions 
of the IFC for the reasons discussed throughout this preamble, we 
disagree with the comments regarding CMS' statutory authority to issue 
the rule. In Biden v. Missouri, the Supreme Court stayed injunctions 
prohibiting the rule

[[Page 36495]]

from going into effect, holding that ``the Secretary's rule falls 
within the authorities that Congress has conferred upon him.'' \25\ 
\26\ Since that ruling, two plaintiff States voluntarily dismissed 
challenges to the rule, and Federal courts have dismissed two other 
cases.\27\ \28\ We also note that the staff vaccination IFC permitted 
individual exemptions consistent with applicable Federal laws.
---------------------------------------------------------------------------

    \25\ https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf.
    \26\ https://www.cms.gov/newsroom/press-releases/statement-cms-administrator-chiquita-brooks-lasure-us-supreme-courts-decision-vaccine-requirements.
    \27\ State of Louisiana v. Becerra, No. 3:21-cv-3970 (W.D. La. 
Dec. 2, 2022).
    \28\ Griner v. Biden 2:22CV149 DAK-DBP (D. Utah Oct. 13, 2022).
---------------------------------------------------------------------------

    We acknowledge the difficulties that health care workers have faced 
and continue to face throughout the COVID-19 pandemic. CMS has great 
appreciation for health care workers and other frontline workers across 
the world as they have dealt with limited resources and extraordinary 
demand for their time and services. Due to the changing circumstances 
of the pandemic previously discussed in this final rule, we are 
withdrawing the health care staff COVID-19 vaccination provisions of 
the IFC. In lieu of regulatory requirements and as previously noted, 
CMS intends to continue supporting and encouraging for health care 
staff vaccinations through other mechanisms, including its quality 
programs.
    Comment: Many commenters stated that the requirements would 
contribute to and exacerbate staffing shortages, particularly in rural 
areas, negatively impacting care and access to care. These commenters 
expressed concern that the staff vaccination requirements would cause a 
mass flight of unvaccinated health care workers from the industry. This 
was of particular concern for entities that provide long-term care 
services, specifically those facilities located in rural, frontier, and 
Tribal communities. Some individual commenters who identified 
themselves as licensed professionals, including but not limited to 
nurses, stated their intent to resign rather than comply, or that they 
had coworkers who intended to resign instead of comply. Additionally, 
some commenters noted that CMS was establishing overly burdensome 
expectations for already put-upon health care workers. For example, 
they noted that they were asked to wear personal protective equipment 
(PPE) if they were not vaccinated even though there were insufficient 
supplies, resulting in reuse, and emphasized how they had been directed 
to continue working to care for patients while ill with COVID-19 
themselves due to staffing shortages. Some commenters suggested 
additional flexibilities in the vaccination requirements, such as the 
ability to opt-out for philosophical reasons and additional funding in 
order to help with these potential issues.
    Response: We thank commenters and health care workers for their 
continued dedication throughout the COVID-19 pandemic. Adequate 
staffing was a concern prior to the pandemic, and we recognize that the 
COVID-19 PHE simultaneously exacerbated and accelerated those trends. 
While these trends reflect a confluence of factors, including 
unprecedented stress, trauma, overwhelming loss associated with death 
of coworkers and patients (particularly for nurses who typically 
witness decline and death), and self-isolation or quarantine from 
families, we also understand commenters' concern that the requirements 
in the staff vaccination IFC would further add to those shortages.
    Available evidence continues to support the notion that staff 
vaccination requirements have not adversely affected health care 
staffing.\29\ Using National Healthcare Safety Network (NHSN) data from 
June 6, 2021-November 14, 2021, one study showed that State-level 
COVID-19 vaccine requirements implemented prior to the publication of 
the IFC did not negatively impact health care staffing levels in those 
States.\30\ Specifically, staffing shortages peaked nationally during 
the Omicron wave, with nearly one in three facilities reporting a 
shortage in January 2022. Staffing shortage rates have fallen since 
then, and remained relatively stable through March 2022, even after the 
implementation of the staff vaccination IFC.\31\ Further, data and 
analysis, including internal CMS analyses of facility payroll data 
postdating the implementation of the staff vaccination IFC, suggest 
that the rule did not have a negative impact on health care staffing.
---------------------------------------------------------------------------

    \29\ See Biden v. Missouri, https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf.
    \30\ https://jamanetwork.com/journals/jama-health-forum/fullarticle/2794727?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=072922.
    \31\ https://www.kff.org/coronavirus-covid-19/issue-brief/nursing-facility-staff-vaccinations-boosters-and-shortages-after-vaccination-deadlines-passed/.
---------------------------------------------------------------------------

    We acknowledge that staffing concerns remain throughout the health 
care system; however, we do not anticipate that the withdrawal of the 
health care staff COVID-19 vaccination requirements will meaningfully 
affect current challenges in staff recruitment and retention.
    Comment: Many commenters shared their belief that vaccines are 
unsafe and that they contain dangerous or potentially dangerous 
chemicals. These commenters also expressed concerns that Emergency Use 
Authorizations (EUAs) issued by the Food and Drug Administration (FDA) 
do not assure safety, because of the minimal length of development 
time. Some commenters noted that CMS or the employer should be liable 
for adverse effects of vaccination and that this should include lost 
wages in event of illness or death. Some commenters referenced the 
Vaccine Adverse Effect Response System (VAERS), noting that there have 
been nearly one million reported cases of adverse reactions to the 
various COVID-19 vaccines. These commenters expressed their 
disagreement with COVID-19 vaccination requirements based on these 
VAERS reports. Some commenters also referenced the Nuremburg Code, 
which prohibits adherents from performing medical experimentation in 
unwilling patients. These commenters stated a belief that the vaccines 
are truly experimental.
    Response: While we are withdrawing the staff vaccination 
requirements given changes in public-health conditions described 
throughout this preamble, we emphasize that COVID-19 vaccines have 
consistently been shown to be safe and effective. As of March 2023, 
more than 672 million doses of COVID-19 vaccine have been given in the 
United States under the most intense safety monitoring in US history. 
That monitoring by CDC, FDA, and other Federal agencies continues to 
demonstrate that COVID-19 vaccines are safe and effective.\32\ 
Moreover, efforts to speed the vaccine development process have not 
sacrificed scientific standards, integrity of the vaccine review 
process, or safety.\33\ Prior to issuance of an EUA, the original 
COVID-19 vaccines were evaluated in tens of thousands of study 
participants to generate the scientific data and other information 
needed to determine the vaccine's safety and effectiveness.
---------------------------------------------------------------------------

    \32\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/
safety-of-
vaccines.html#:~:text=COVID%2D19%20vaccines%20are%20safe,safety%20mon
itoring%20in%20US%20history.
    \33\ https://www.fda.gov/vaccines-blood-biologics/vaccines/
emergency-use-authorization-vaccines-
explained#:~:text=Under%20an%20EUA%2C%20FDA%20may,are%20no%20adequate
%2C%20approved%2C%20and.

---------------------------------------------------------------------------

[[Page 36496]]

    Comments regarding liability for adverse effects of vaccination or 
lost wages are outside the scope of this rule. We refer readers to the 
Department of Labor for issues regarding workplace injury and 
compensation.\34\ We also refer readers to the Countermeasures Injury 
Compensation Program, which provides compensation for covered serious 
injuries or deaths that occur as the result of the administration or 
use of certain countermeasures and the National Vaccine Injury 
Compensation Program, which provides compensation to people found to be 
injured by certain vaccines.\35\ \36\ \37\
---------------------------------------------------------------------------

    \34\ https://www.fiercehealthcare.com/hospitals/supreme-court-
vaccine-covid-19-healthcare-upholds-hhs-vaccine-requirement-for-
healthcare#:~:text=Supreme%20Court%20upholds%20HHS'%20vaccine,large%2
0employer%20mandate%20%7C%20Fierce%20Healthcare.
    \35\ https://www.hrsa.gov/cicp.
    \36\ https://www.benefits.gov/benefit/641.
    \37\ https://www.hrsa.gov/vaccine-compensation/about.
---------------------------------------------------------------------------

    Comment: Many commenters stated a belief that vaccines are 
ineffective. They shared how the incidence of COVID-19 infections among 
vaccinated individuals is high. These commenters also noted that this 
rule would be ineffective, because it did not apply to patients and 
visitors.
    Response: We acknowledge that COVID-19 vaccines will not prevent 
symptomatic infection in all vaccinated individuals; however, COVID-19 
vaccines are highly effective in preventing serious illness, 
hospitalization, and death.
    As we discussed in the staff vaccination IFC, we believe it would 
be overly burdensome to require that facilities ensure COVID-19 
vaccination for all individuals who enter (patients, visitors, mail 
carriers, etc.). However, while facilities are not required to ensure 
vaccination status of every individual, they may choose to extend 
COVID-19 vaccination requirements beyond those persons that we consider 
to be ``staff'' as defined in IFC. We did not prohibit such extensions 
and encouraged facilities to require COVID-19 vaccination for these 
individuals as reasonably feasible. We strongly encourage facilities, 
when the opportunity exists and resources allow, to facilitate the 
vaccination of all individuals who provide services infrequently or 
provide educational opportunities about vaccination for those 
individuals. Further, as previously discussed, CMS intends to continue 
support and encouragement for health care staff vaccinations through 
quality measurement programs.
    Comment: Some commenters stated that vaccines contain fetal stem 
cells, the use of which conflicts with their religious beliefs. Other 
commenters indicated that contracted physicians with privileges are not 
covered under Title VII or ADA; therefore, they are unable to request 
religious exemptions. Industry, civil society groups, and individual 
commenters sought clarification regarding religious, medical, and 
administrative exceptions to the vaccination requirements. Some 
commenters stated that it would be helpful for CMS to create a standard 
on exemption requirements that would be broadly applicable nationwide. 
Some commenters asked for clarification on exemption requirements and 
recommended that CMS promulgate guidance. Other commenters noted that 
we should consider referencing the Equal Employment Opportunity 
Commission or similar nondiscrimination guidance (such as the Americans 
with Disabilities Act) in order to address these public concerns.
    Response: While we are withdrawing the staff vaccination 
requirements in this final rule, we note that the IFC required 
facilities to have policies and procedures regarding exemptions as 
required by civil rights and disability laws.
    Comment: Some commenters suggested that alternatives to vaccination 
be added to the requirements. These commenters emphasized that routine 
testing of staff for SARS-CoV-2 and use of PPE should be permitted in 
lieu of vaccination. Some commenters noted the ongoing mitigation 
efforts involving COVID-19 testing and PPE use, as well as required 
source controls which have improved over the course of the PHE. Some 
commenters suggested that CMS provide for additional flexibility by 
``grandfathering in'' some of the vaccination requirements already in 
place among certain health systems. Some commenters suggested 
additional educational outreach, especially among communities with 
lower trust in the health care system, as well as an understanding of 
the logistical issues preventing prompt implementation of the 
requirements in the staff vaccination IFC at certain facilities. Other 
commenters supported additional educational outreach, time-limited 
testing options, and flexibility for ``good-faith'' efforts for 
facilities as they work toward compliance with the rule.
    Response: We thank commenters for their continued efforts in 
practicing complementary mitigation measures, especially at times when 
resources have been limited and as the pandemic continues to evolve.
    Our intention in issuing the staff vaccination IFC was to establish 
a set of requirements for all applicable facility types consistent with 
CDC recommendations in place at the time to assure patient health and 
safety. Since the onset of the PHE, the context in which people apply 
these preventive layers has changed. As the immediate impacts of the 
COVID-19 pandemic continue to evolve, so too does informed guidance, 
recommendations, and regulation. In the fall of 2021, circumstances 
required that CMS issue the IFC to protect the health and safety of 
patients. Current circumstances show that the IFC was effective in 
increasing rates of COVID-19 vaccination among health care staff and 
indicate that the need for such regulatory requirements has passed. We 
continue to explore different approaches to support and incentivize the 
use of effective combinations of preventive layers in particular 
circumstances and the best, most flexible way to support their 
application.
    CMS and other HHS agencies continue to engage in infection 
prevention and control and vaccine education efforts. Additionally, CMS 
continues to host stakeholder engagement calls to address ongoing 
concerns and questions.\38\ CMS also continues to engage with key 
stakeholders in order to develop culturally-competent and person-
centered guidance and resources to ensure that populations with unique 
needs or concerns are addressed and mitigated. Lastly, enforcement 
discretion is not within the scope of these regulations and is rather 
addressed in subregulatory guidance, which CMS continues to publish and 
release.\39\ We encourage individuals to continue to follow CDC 
recommendations pertaining to infection prevention and control 
practices, and we note that while this final rule ends CMS's 
requirements regarding staff vaccination, it does not prohibit 
employers or states from initiating or maintaining their own 
vaccination requirements for health care staff. We also continue to 
support health care staff vaccinations through quality measurement 
programs.
---------------------------------------------------------------------------

    \38\ https://www.cms.gov/outreach-education/partner-resources/coronavirus-covid-19-partner-resources.
    \39\ https://www.cms.gov/covidvax.
---------------------------------------------------------------------------

    Comment: Some commenters stated that individuals with a prior 
COVID-19 infection should be exempt due to natural immunity. Many of 
these

[[Page 36497]]

commenters claimed that they still had high levels of antibodies 
against COVID-19 in their most recent blood tests, and they questioned 
the necessity of vaccination, at least for as long as their antibody 
levels remain comparable to those who are vaccinated.
    Response: We acknowledge that previous COVID-19 infection may also 
contribute to protection against subsequent infection and associated 
severe, critical, or fatal COVID-19.\40\ However, this does not mean 
infection-induced immunity can or should be substituted for 
vaccination. Exceptions based on infection-induced immunity are also 
challenging to apply and enforce fairly, as verification of a health 
care worker's prior infection or antibody levels may not be possible in 
all cases. Vaccination remains the safest option for acquiring immunity 
to COVID-19, particularly when the risks associated with vaccination 
are compared with well-known significant short and long-term 
consequences of COVID-19, which can include organ damage affecting the 
heart, kidneys, skin, and brain, as well as fatigue, shortness of 
breath, loss of smell, and muscle aches.41 42 43 
Additionally, people who have had COVID-19 are more likely to develop 
new health conditions such as diabetes, heart conditions, blood clots, 
or neurological conditions compared with people who have not had COVID-
19.\44\
---------------------------------------------------------------------------

    \40\ https://www.cdc.gov/coronavirus/2019-ncov/your-health/reinfection.html.
    \41\ https://www.thelancet.com/journals/lanam/article/PIIS2667-193X(22)00059-X/fulltext.
    \42\ https://www.mayoclinic.org/diseases-conditions/coronavirus/
in-depth/coronavirus-long-term-effects/art-
20490351#:~:text=Why%20does%20COVID%2D19%20cause,immune%20system%20ca
n%20also%20happen.
    \43\ https://www.nhs.uk/conditions/coronavirus-covid-19/long-term-effects-of-coronavirus-long-covid/.
    \44\ https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects/index.html.
---------------------------------------------------------------------------

    Comment: Some commenters stated that COVID-19 is not a public 
health emergency and that the data upon which guidelines are issued are 
flawed, alleging inaccurate and inflated death counts. Commenters also 
pointed out that the overwhelming majority of infected individuals 
recover, unvaccinated individuals do not all become severely ill, and 
there are treatments available that should be encouraged and available 
for use (for example, some commenters stated beliefs that Ivermectin or 
Vitamin D and other pharmaceutical and nonpharmaceutical products are 
effective treatments for COVID-19).
    Response: While rates of infection, illness, and hospitalization 
have significantly declined, COVID-19 remains a public health challenge 
throughout the world. As discussed in section I. of this final rule, 
the WHO declared the COVID-19 outbreak an international public health 
emergency in January 2020 and a pandemic in March 2020. Likewise, a 
COVID-19 PHE declaration for the United States was made by the 
Secretary in January 2020, the President of the United States declared 
COVID-19 a pandemic in March 2020, and the Secretary has sustained a 
PHE declaration since January 2020 with the final renewal occurring on 
February 9, 2023.\45\ In September 2021, COVID-19 related deaths in the 
U.S. surpassed the number of deaths from the 1918 influenza 
pandemic.\46\ According to the CDC COVID Data Tracker, over 1.1 million 
COVID-19 deaths have been reported in the United States to date, 
whereas it is estimated that 675,000 American deaths occurred during 
the 1918 influenza pandemic.47 48
---------------------------------------------------------------------------

    \45\ https://aspr.hhs.gov/legal/PHE/Pages/default.aspx.
    \46\ https://www.smithsonianmag.com/smart-news/the-covid-19-pandemic-is-considered-the-deadliest-in-american-history-as-death-toll-surpasses-1918-estimates-180978748/.
    \47\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
    \48\ https://www.cdc.gov/flu/pandemic-resources/1918-commemoration/1918-pandemic-history.htm.
---------------------------------------------------------------------------

    Research also suggests that reported deaths associated with COVID-
19 in the United States have been undercounted, not overcounted, since 
the start of the pandemic. These undercounts may be attributed to 
several factors, including that testing availability and criteria may 
have caused many cases to go unrecognized; COVID-19 may affect many 
body systems, and thus may not always be recognized as a cause of 
death; and COVID-19 may amplify pre-existing health conditions leading 
to death, but not be recognized as the cause of death by the medical 
certifier.\49\
---------------------------------------------------------------------------

    \49\ https://www.cdc.gov/nchs/covid19/faq.htm.
---------------------------------------------------------------------------

    We acknowledge that most individuals are fortunate enough to 
recover from COVID-19. However, many individuals are not fortunate 
enough to recover and many individuals die or experience symptoms of 
long COVID, with older adults facing the highest risk of becoming very 
sick from COVID-19.
    We are also grateful for the development of effective antiviral 
treatments, including Remdesivir (Veklury), nirmatrelvir co-packaged 
with ritonavir (Paxlovid), and molnupiravir (Lagevrio).50 51 
These drugs have also undergone rigorous testing. We note that the 
evolution of COVID-19 continues to present challenges to the 
development of both preventative drugs, including vaccines, and 
therapeutic treatments. It is important that more individuals be 
educated about these drugs in order for them to make informed decisions 
about their health and treatment options.
---------------------------------------------------------------------------

    \50\ https://www.covid19treatmentguidelines.nih.gov/therapies/antivirals-including-antibody-products/summary-recommendations/.
    \51\ https://www.fda.gov/media/155049/download.
---------------------------------------------------------------------------

    Some medications mentioned by commenters, such as Ivermectin and 
vitamin D, are not evidence-based treatments for COVID-19. The FDA has 
not authorized or approved Ivermectin for use in preventing or treating 
COVID-19 in humans or animals. Ivermectin is approved for human use to 
treat infections caused by some parasitic worms and head lice and skin 
conditions like rosacea. Currently available data do not show that 
Ivermectin is effective against COVID-19 and taking large doses of 
Ivermectin is dangerous.\52\ There is also insufficient evidence for 
the use of vitamin D for the prevention or treatment of COVID-19.\53\ 
Individuals who are considering taking these medications as a treatment 
for COVID-19 should consult with their care team.
---------------------------------------------------------------------------

    \52\ https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19.
    \53\ https://www.covid19treatmentguidelines.nih.gov/therapies/supplements/vitamin-d/.
---------------------------------------------------------------------------

    Comment: Some commenters shared their belief that it is 
unprecedented to mandate COVID-19 vaccines when there are other 
existing vaccines that are more effective that are not mandated (that 
is, Hepatitis B, influenza, pneumococcal).
    Response: We thank commenters for recognizing the efficacy of 
certain vaccines, like the Hepatitis B, influenza, and pneumococcal 
vaccines. While we do not want to minimize the severity of these 
diseases, they were not the cause of the PHE declared at the time CMS 
issued the IFC. We also note that the regulation is not a government 
vaccine mandate placed on individuals but rather a Medicare and 
Medicaid funding condition for certain health care facilities that 
participate in either or both of those programs. As discussed in 
section H. of the staff vaccination IFC, many health care workers must 
already comply with employer or State government vaccination 
requirements (influenza, hepatitis B) or OSHA guidelines and are also 
required to complete screening procedures, such as tuberculosis 
screening. Additionally, many of these individuals met State and local 
vaccination requirements in order

[[Page 36498]]

to attend school to complete the necessary education to be eligible for 
health care positions. While historically CMS has not required any 
health care staff vaccinations, we have established, maintained, and 
updated extensive health and safety requirements as part of the 
Conditions of Participation and Conditions for Coverage for Medicare- 
and Medicaid-certified providers and suppliers. These requirements 
largely focus on infection prevention and control standards, as we aim 
to protect the health and safety of patients, residents, clients, and 
participants.
    The transition CMS is making now, to make COVID-19 policies more 
like those for other communicable diseases, reflects the ongoing 
evolution of epidemiological and clinical circumstances; it does not 
imply that our issuance of the staff vaccination IFC was invalid or 
that CMS could not take such steps again in the future, if 
circumstances warrant. While we are withdrawing the provisions of the 
staff vaccination IFC, as previously noted, we intend to continue to 
support and encourage COVID-19 vaccination through our quality 
reporting and value-based incentive programs. CMS collaborated with the 
CDC to develop quality measures for both patient and health care 
vaccination to be used in appropriate quality programs. CMS included 
patient and health care personnel vaccination quality measures on the 
Measures Under Consideration (MUC) List issued on December 1, 
2022.54 55
---------------------------------------------------------------------------

    \54\ https://mmshub.cms.gov/sites/default/files/2022-MUC-List-Overview.pdf.
    \55\ https://mmshub.cms.gov/measure-lifecycle/measure-implementation/pre-rulemaking/lists-and-reports.
---------------------------------------------------------------------------

    Comment: Some commenters mistakenly believed this IFC was OSHA's 
rule, ``COVID-19 Vaccination and Testing; Emergency Temporary 
Standard'' (86 FR 61402) (also published November 5, 2021), which 
intended to require vaccination for employers with 100+ employees and 
addressed the emergency temporary standard (ETS) in comments submitted 
to CMS.\56\
---------------------------------------------------------------------------

    \56\ https://www.federalregister.gov/documents/2021/11/05/2021-23643/covid-19-vaccination-and-testing-emergency-temporary-standard.
---------------------------------------------------------------------------

    Response: The requirements in the staff vaccination IFC apply to 
only the Medicare- and Medicaid-certified providers and suppliers 
listed in the IFC. The IFC does not directly apply to other employers 
or entities, including other health care entities, such as physician 
offices, which are not regulated by CMS. Most States have separate 
licensing requirements for health care staff and health care providers 
that would be applicable to physician office staff and other staff in 
small health care entities that are not subject to vaccination 
requirements under this IFC. Within the IFC, we briefly discussed the 
OSHA IFC, ``Occupational Exposure to COVID-19; Emergency Temporary 
Standard'' (86 FR 32376, June 21, 2021), that was applicable to health 
care settings at the time of publication, including but not limited to 
the providers and suppliers who must comply with the staff vaccination 
IFC, because the OSHA ETS and the IFC had complementary 
requirements.\57\ Of note, OSHA did withdraw the vaccination and 
testing ETS, effective January 26, 2022.58 59 For questions 
about OSHA laws, regulations, or rulemaking activities, we refer 
commenters to OSHA.\60\
---------------------------------------------------------------------------

    \57\ https://www.federalregister.gov/documents/2021/06/21/2021-12428/occupational-exposure-to-covid-19-emergency-temporary-standard.
    \58\ https://www.osha.gov/coronavirus/ets2.
    \59\ 87 FR 3928, January 26, 2022 (https://www.federalregister.gov/documents/2022/01/26/2022-01532/covid-19-vaccination-and-testing-emergency-temporary-standard).
    \60\ https://www.osha.gov/laws-regs.
---------------------------------------------------------------------------

    Comment: A few commenters noted that this rule was promulgated 
prior to consultation with Tribal entities, which they asserted is a 
violation of Executive Order (E.O.) 13175. Several organizations noted 
that Tribes believed that their treaty rights may have been violated by 
the promulgation of the rule. One commenter noted that they understand 
that the rule may be appropriate for non-Indian health providers but 
indicated that the Tribes they represent believe that it is not 
currently clear how the regulation would apply to those facilities that 
provide health care services to the American Indian and Alaska Native 
population. These commenters stated that CMS failed to consult with 
Tribes in accordance with the usual Indian consultation guidance. The 
commenters suggested that CMS extend the comment period and improve the 
consultative relationship between Tribal entities and CMS so that the 
perceived disregard for Tribal sovereignty does not happen again.
    Response: We thank the Tribes for their continued partnership with 
CMS. We recognize that American Indians and Alaska Natives (AI/AN) face 
unique health care needs and have been disproportionately impacted by 
COVID-19.61 62 These commenters are incorrect in their 
assumption of a violation of E.O. 13175. That E.O. only applies to 
actions that ``have substantial direct effects on one or more Indian 
tribes, on the relationship between the Federal Government and Indian 
tribes, or on the distribution of power and responsibilities between 
the Federal Government and Indian tribes.'' The staff vaccination IFC, 
like almost all CMS rules, has none of these effects. This IFC applied 
only to certain health care providers and suppliers who voluntarily 
enrolled in the Medicare and Medicaid programs. Its provisions made no 
distinctions as to ownership status of any facility, whether owned or 
administered by a private organization, State or local government, or 
tribe. Furthermore, the commenters identified no specific government-
to-government effects from the rulemaking that would adversely affect 
tribes. CMS continues to engage with external stakeholders and strives 
towards providing, supporting, and fostering culturally-competent and 
person-centered care for these populations.
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    \61\ https://www.kff.org/coronavirus-covid-19/issue-brief/covid-19-cases-and-deaths-by-race-ethnicity-current-data-and-changes-over-time/.
    \62\ https://www.cdc.gov/mmwr/volumes/71/wr/mm7122a2.htm.
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    Comment: Some provider groups asked for clarification or additional 
guidance on what would or would not be acceptable in terms of employer 
enforcement so that they could stay within the bounds of State privacy 
laws. For example, a large medical center noted concerns about their 
ability to comply with both the IFC and a State law that explicitly 
prevented employers from requiring COVID-19 vaccinations as a condition 
of employment.
    Response: As discussed in the staff vaccination IFC, we understand 
that some States and localities have established laws that would seem 
to prevent Medicare- and Medicaid-certified providers and suppliers 
from complying with the requirements of this IFC. While the 
requirements outlined in the staff vaccination IFC remain in force, we 
intend, consistent with the Supremacy Clause of the United States 
Constitution, that this nationwide regulation preempts all conflicting 
State and local laws as applied to Medicare- and Medicaid-certified 
providers and suppliers. However, as previously noted, we are 
withdrawing the health care staff COVID-19 vaccination provisions.
    Comment: Some commenters noted that the COVID-19 staff vaccination 
requirements placed an undue burden on facilities. These commenters 
stated that it would be overly burdensome to manage individual requests 
for exemption either due to religious beliefs or clinical 
contraindications to receiving the vaccine. They also noted that it 
would be resource-intensive to comply

[[Page 36499]]

with the vaccination requirements that included contracted staff.
    Response: As noted in the preamble of the IFC, we made efforts to 
mitigate the burden on providers by not requiring that each provider 
and supplier ensure COVID-19 vaccination for all individuals who 
entered the facility or setting of care, because we believed such a 
requirement would be overly burdensome. Moreover, CMS did not require 
that staff who functioned in a fully remote capacity be vaccinated for 
COVID-19 if they did not physically enter the building or interact with 
patients or other staff. Experience since the publication of the staff 
vaccination IFC shows that facilities could, indeed, meet these 
requirements. When implementing these requirements, CMS ensured there 
was a reasonable balance between burden and the need for celerity to 
realize health and safety benefits.
    Comment: Many commenters noted that the IFC's definition of ``fully 
vaccinated'' was confusing and questioned whether booster doses would 
or should be included in the definition and required going forward. 
Some of these commenters shared that there was confusion in the 
messaging coming from CMS regarding boosters and potential 
discrepancies between the IFC and contemporary information aids coming 
from other parts of the executive branch. Likewise, some commenters 
noted that the CDC did not include boosters in its definition of 
``fully vaccinated'' at the time that the rule was issued. Other 
commenters recommended that CMS recognize the importance of booster 
shots and consider including boosters in the definition of ``fully 
vaccinated'' once the CDC updates its guidance. Some commenters also 
pointed to research that suggests the importance of boosters in 
maintaining immunity over time. Several individual commenters stated 
that the need for boosters would make the rule impracticable or that it 
proved the ineffectiveness of the vaccines.
    Response: Like the SARS-COV-2 virus itself, the science of 
preventing and treating COVID-19 and the tools available to prevent and 
treat it continue to evolve. Thus, the recommendations and guidance 
have similarly changed as well. Currently, CDC recommends that people 
ages 6 months and older receive at least 1 bivalent mRNA COVID-19 
vaccine. The number of recommended bivalent doses varies by age, 
vaccine, previous COVID-19 vaccines received, and the presence of 
moderate or severe immune compromise. As discussed elsewhere in this 
rule, CMS now believes that other levers available to us (for example, 
quality measures) offer the most effective means to balance a need for 
flexibility, encourage HCP vaccination, and protect patient safety in 
the post-PHE phase of COVID-19. In addition, as of March 30, 2023, 90.5 
percent of counties, districts, or territories in the United States had 
a low community level of COVID-19. Further, as of March 29, 2023, the 
current 7-day average of weekly new cases decreased 9.2 percent 
compared with the previous 7-day average.\63\ Therefore, we are 
withdrawing the health care staff COVID-19 vaccination provisions.
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    \63\ https://www.cdc.gov/coronavirus/2019-ncov/covid-data/
covidview/past-reports/
033123.html#:~:text=COVID%2D19%20Community%20Levels*,with%20a%20low%2
0Community%20Level.
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    Comment: Many commenters requested clarification as to which 
facility types the rule applies. Individuals associated with Emergency 
Medical Services (EMS) and ambulance services requested additional 
guidance on how they fit within the rule, because they were not among 
the facility types listed in the rule. Other groups, particularly in 
long-term care, asked whether contractors (a one-off or incidental 
plumber, or a fully remote administrative staff worker, for example) 
would be required to be vaccinated in order for the facility to be 
considered in compliance. Some commenters recommended that CMS align 
the definition of ``staff'' with previous LTC facility testing rules as 
a means of reducing confusion and as a means of helping those 
facilities align their current vaccine requirements with those required 
under the rule.
    Response: We are withdrawing the health care staff COVID-19 
vaccination provisions. We strongly encourage facilities, when the 
opportunity exists and resources allow, to facilitate the vaccination 
and education of all individuals who provide services infrequently or 
frequently.
    Comment: Some commenters suggested that new anti-viral treatments 
may become more important as tools once they become commercially 
available. They asked that CMS include guidance in this rule, or issue 
another rule which would clarify some of the different payment aspects 
of these treatments and more.
    Response: We recognize and acknowledge the important role of new 
treatment therapies that have recently become available, as previously 
discussed in this rule. However, payment for these treatments is 
outside the scope of this rule. We emphasize the importance of 
vaccination, as access to these new therapies may vary. Further, these 
therapies do not replace the preventive benefits of vaccination.
    Final Decision: After inspection of public comments on the health 
care staff vaccination requirements and in consideration of the factors 
discussed throughout this rule, we are withdrawing the health care 
staff COVID-19 vaccination provisions. This final rule addresses CMS' 
statutory responsibility to implement regulations necessary to protect 
the health and safety of patients while demonstrating our commitment to 
approaches that reflect evolving information.

B. COVID-19 Vaccine ``Educate and Offer'' Requirements for LTC 
Facilities and ICFs-IID Residents, Clients, and Staff (Sec. Sec.  
483.80(d), 483.430(f), 483.460(a)(4))

    In response to the educate and offer IFC, we received 68 public 
comments. Twenty-six of these comments addressed the ``educate and 
offer'' provisions, sharing support for these requirements due to the 
increased risk of infection and complications for LTC residents and 
ICF-IID clients due to their medical conditions and residence in 
congregate care settings. Public commenters also addressed the 
reporting requirements, which we addressed in the CY 2022 Home Health 
Prospective Payment System final rule (86 FR 62240, 62392).
    Comment: The majority of commenters emphasized that residents of 
LTC facilities and clients of ICFs-IID are among the most susceptible 
to negative outcomes related to COVID-19 due to their medical 
conditions. These commenters noted that the residents and clients were 
at high risk for exposure, infection, complication, and death.
    Response: We thank commenters for recognizing the gravity of the 
COVID-19 pandemic and their appreciation for resident and client health 
and safety. We believe that all LTC Facility residents, ICF-IID 
clients, and the staff who care for them, should be provided with 
ongoing education about, and access to, vaccination against COVID-19. 
Further, we believe that entities responsible for the care of residents 
and clients of LTC facilities and ICF-IIDs must proactively pursue 
access to COVID-19 vaccination on behalf of their residents and 
clients, who often face challenges to independently accessing the 
vaccine, including mobility limitations, cognitive impairments, and 
other conditions. To support ongoing access to vaccinations for COVID-
19, we are finalizing the provisions at Sec. Sec.  483.80(d)(3), 
483.430(f), and

[[Page 36500]]

483.460(a)(4) for LTC facilities and ICF-IIDs.
    Comment: Some commenters stated that communicating the pros, cons, 
and side effects of vaccination in a meaningful way to LTC facility 
residents was challenging and recommended that CMS provide additional 
guidance and standardized education materials for use.
    Response: We acknowledge that it can be challenging to convey this 
information clearly as the COVID-19 pandemic continues to evolve and 
new treatments and vaccines become available. Vaccination remains one 
of the most important methods to help prevent severe COVID-19, 
especially as individuals living and working in congregate living 
settings may have challenges with physical distancing and other 
preventive measures such as mask use. While it can be challenging to 
convey vaccine information clearly, this is especially important, as 
many ICF-IID clients have multiple chronic conditions and psychiatric 
conditions in addition to their intellectual disability, and many LTC 
Facility residents experience impaired mental status, which can impact 
a client's and resident's understanding or acceptance of the need for 
vaccination. Vaccine education allows for residents, clients, and their 
caregivers to be informed participants in their care and allows them to 
make the most appropriate decisions for themselves. Furthermore, 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 or ICF-IID's Medical Director and use CDC and FDA resources 
as sources of information for their vaccination education 
initiatives.\64\ We acknowledge and thank the many CMS-certified ICF-
IIDs and LTC facilities that are educating staff, residents, and 
clients, and are 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 
preventative care services. Because resident and client safety are of 
the utmost importance, we are finalizing the education requirements for 
LTC facilities at Sec.  483.80(d)(3) and ICF-IIDs at Sec. Sec.  
483.430(f) and 483.460(a)(4).
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    \64\ https://www.cdc.gov/vaccines/covid-19/long-term-care/pharmacy-partnerships/administrators-managers.html.
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    Comment: Several commenters expressed burden concerns due to high 
staff turnover rates, which have increased the amount of time needed to 
provide education and to offer the vaccine to staff.
    Response: We thank the staff for their hard work in complying with 
these requirements. We recognize that health care organizations have 
historically experienced staffing shortages and that this has been 
exacerbated by the pandemic, as discussed in section I. of the staff 
vaccination IFC. In addition to the previously mentioned resources 
available from CDC and FDA, CMS funds a network of Quality Improvement 
Organizations (QIOs),\65\ which aim to improve the quality of care 
delivered to people with Medicare. Specifically, QIOs may provide 
assistance to Medicare beneficiaries by targeting small, low-
performing, and rural Medicare-certified facilities 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 
and risks 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.
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    \65\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityImprovementOrgs.
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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 pandemic. In the 
interest of health and safety for LTC facility residents and ICF-IID 
clients, and of staff in these settings, we are finalizing the 
provisions at Sec.  483.80(d)(3) for LTC facilities and Sec. Sec.  
483.430(f) and 483.460(a)(4) for ICF-IIDs.
    Comment: Some commenters reported that it was difficult to identify 
the individuals that met the definition of ``staff,'' and therefore, 
were subject to the requirements.
    Response: The ``educate and offer'' provisions were written in a 
manner that allows for flexibility by covering a broad set of 
residential care entities. Additionally, since this IFC was initially 
published, CMS and other agencies across HHS have released additional 
guidance in an effort to address some of these questions and concerns 
about how to comply with these requirements.\66\ Furthermore, CMS uses 
existing lines of communication with stakeholders in an effort to 
address some of these questions and concerns. Currently, CMS considers 
LTC facility and ICF-IID staff (regardless of whether there is a so-
called ``W-2'' relationship) to be those who work in the facility on a 
regular basis (that is, at least once a week). 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. LTC facilities and 
ICF-IIDs 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 education and 
vaccination to all individuals who provide services less frequently. A 
better understanding of the value of vaccination may allow staff to 
appropriately educate residents and their family members about the 
benefits of accepting the vaccine. Therefore, we are finalizing the 
requirements at Sec. Sec.  483.80(d)(3), 483.430(f), and 483.460(a)(4).
---------------------------------------------------------------------------

    \66\ https://www.cms.gov/outreach-education/partner-resources/coronavirus-covid-19-partner-resources.
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    Comment: A few commenters suggested that CMS add provisions for 
paid time off for staff to receive the vaccine and recover from side 
effects.
    Response: We recognize commenters' concerns; however, CMS does not 
have the statutory authority to regulate paid time off for health care 
employees, and this falls outside the scope of this final rule.
    Final Decision: After consideration of the public comments we 
received on the educate and offer requirements, we are finalizing the 
requirements at Sec.  483.80(d)(3) for LTC facilities and at Sec. Sec.  
483.430(f) and 483.460(a)(4) for ICF-IIDs, as established by the 
educate and offer IFC and amended by the staff vaccination IFC. The 
``educate and offer'' requirements support our responsibility to 
protect and ensure the health and safety of residents and clients by 
enforcing the standards required to help each resident and client 
attain or maintain their highest level of well-being. Sections 
1819(d)(3)(B) and 1919(d)(3) of the Act require that a facility must 
establish an infection control program that is designed, constructed, 
equipped, and maintained in a manner to protect the health and safety 
of residents, personnel, and the

[[Page 36501]]

general public. We believe that the educate and offer requirements 
comply with these statutory requirements. We believe that this action 
strengthens our response to the COVID-19 pandemic and protects the 
health and safety of nursing home residents, ICF-IID clients, and their 
staff.

C. COVID-19 Testing Requirement for LTC Facilities Sec.  483.80(h)

    In response to this IFC we received approximately 169 comments, of 
which about 150 addressed the COVID-19 testing requirements for LTC 
facilities' staff and residents.
    Comment: Some comments acknowledged that testing for COVID-19 is 
important for preventing the disease from entering nursing homes, 
detecting cases quickly, and stopping the transmission to additional 
residents and staff.
    Response: We thank commenters for sharing their understanding of 
the importance of testing for COVID-19. While many new treatments and 
vaccines are now available, and we are deleting the expired testing 
requirements, we continue to emphasize the importance of practicing 
preventative measures in order to mitigate the spread of COVID-19.
    Comment: Many commenters discussed the need for accurate data for 
contact tracing and in order to understand the future trajectory of the 
COVID-19 virus. However, most comments expressed belief that the 
community infection rate is not an accurate method for calculating how 
often COVID-19 testing should be conducted. Several of these commenters 
explained that a high community rate may be skewed by isolated 
populations, such as incarcerated individuals or college and university 
students. Commenters noted that higher infection rates in these 
populations resulted in being required to test staff and residents 
twice weekly, which they believed did not yield additional information. 
A few of these commenters also noted that many of the LTC staff do not 
reside in the same county as the facility and thus are not living in a 
county with a similarly high community infection rate; therefore, they 
should not be subject to more frequent testing requirements.
    Response: We thank commenters for recognizing the importance of 
collecting accurate data and its use for informing an appropriate 
pandemic response. It is important for data to be measured and reported 
in a standardized manner. This allows for public health officials to 
compare disease occurrence across different populations in order to 
make informed policy decisions and to better understand the virus and 
its impact on health outcomes. We recognize that some locations, like 
prisons or college and university campuses, may represent ``hot 
spots.'' However, these populations are not truly isolated, and one may 
not presume that the SARS-CoV-2 virus will not spread to other 
populations or locations.
    Further, frequent testing for COVID-19 remains an important tool 
for mitigating the transmission of the virus. In some instances, an 
individual may test when the viral load is not high enough to be found 
on a test and the test result is negative. But this same individual may 
test again in the same week and receive a positive test result. 
Additionally, some people may test negative on an antigen test but 
positive on a PCR test. This means that they do have COVID-19, but 
their viral load is too low to result in a positive antigen test.\67\ 
We recognize that many staff do not reside in the same county as the 
LTC facility at which they are employed. However, this does not negate 
the value of testing. While these individuals may be less likely to be 
exposed to the virus in the county in which they reside, the risk of 
exposure is not eliminated. In addition, because of the highly 
contagious nature of the SARS-CoV-2 virus, the transmission levels in 
the county in which they reside may increase significantly, 
subsequently increasing their risk of exposure.
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    \67\ https://publichealthmdc.com/blog/did-you-test-negative-
when-sick-or-exposed-to-covid-heres-what-it-
means#:~:text=If%20you%20test%20negative%20soon,be%20found%20on%20a%2
0test.
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    Comment: The majority of comments stressed how these new testing 
requirements are diverting resources and adding an additional burden to 
the staff, who are already strained by the staffing shortage. These 
comments also discussed how it is challenging to comply with the 
requirements due to limited availability of PPE. Most of these comments 
emphasize that the frequent testing takes away valuable time from 
resident care and socialization, which is critical at a time when 
residents are not able to see their families. Many commenters also 
reported that the time frame to report test results was too limited and 
requested a 72-hour window to report test results. These comments 
discussed how it is challenging to comply with this requirement due to 
the increased turnaround time to receive results and the limited number 
of staff members.
    Response: We share sympathy for residents and their family members 
who were not able to gather in person. We also thank LTC facility staff 
and health care workers for their continued commitment to providing 
care for residents. Testing for COVID-19 helps to mitigate the 
transmission of the virus and thus improves patient outcomes and 
opportunities for socialization. As discussed in the LTC facility 
testing IFC, we note that there are many different tests available, and 
facilities have the flexibility and discretion to select the test that 
best suits their needs so long as the tests are conducted in accordance 
with nationally recognized standards and meet the response time for the 
test results as specified by the Secretary. In addition, the CDC has 
continued to update its guidance regarding infection control at https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Flong-term-care.html. Further, the CDC has 
published guidance on how to optimize PPE at https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/index.html.
    Comment: Several commenters expressed gratitude for the ability to 
access point-of-care (POC) testing supplies and equipment, but most of 
these commenters found it to be unreliable and shared that it 
frequently produced false positive results. These commenters expressed 
that this blanket approach may not be appropriate for all LTC 
facilities and suggested that the testing of staff should be reduced in 
order to appropriately allocate limited and costly testing supplies and 
resources. A few comments appealed for permission to utilize pool 
testing methods for the routine testing of all staff and to focus 
routine staff testing on those who have the greatest risk of exposure 
and transmission, such as those who have direct contact with patients. 
For example, commenters found it unreasonable for a staff member that 
works in the billing office--who has no face-to-face contact with 
residents or with staff who provide direct care to residents--to be 
tested weekly.
    Response: We acknowledge that at the time of publication of this 
IFC, PPE and COVID-19 tests were limited, and we commend staff and 
health care workers for their diligence working through these 
challenges. We also recognize the challenges of conducting testing and 
discuss in the LTC testing IFC that because COVID-19 was newly 
discovered, the standards of practice for testing for the virus may 
continue to change or evolve. Additionally, the CDC provides guidance 
on proper specimen collection at https://www.cdc.gov/

[[Page 36502]]

coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html and 
https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html. This rule does not address the manner in which tests 
are conducted, so long as they are conducted in a manner that is 
consistent with current professional standards of practice. As such, 
this comment regarding pool testing methods is not within the scope of 
the rule. Readers may find more information regarding pooled testing at 
https://www.cdc.gov/coronavirus/2019-ncov/lab/pooling-procedures.html#anchor_1625241118971.
    Comment: The majority of commenters discussed the financial burden 
of the COVID-19 testing requirements and noted that this burden was 
unsustainable considering the staffing shortages and economic impacts 
of the PHE. Some comments highlighted that PCR tests cost about $130 
and that testing costs accumulate quickly. For example, several 
commenters shared that they were spending upwards of $28,000 per month 
on testing, in addition to their fixed costs. Due to the financial 
burden, a significant number of comments indicated that the testing 
requirements should be accompanied by additional funding and 
bureaucratic support. Other comments suggested streamlining funding to 
LTC facilities in areas with greater prevalence of COVID-19.
    Response: We recognize that the COVID-19 pandemic has strained the 
economy and created many challenges. Additional funding and 
bureaucratic support are not within the scope of this final rule. The 
CDC has also released guidance for health care facilities that are 
expecting or experience staffing shortages due to COVID-19 and provides 
recommendations on mitigation strategies and contingency strategies at 
https://www.cdc.gov/coronavirus/2019-ncov/hcp/mitigating-staff-shortages.html.
    Final Decision: After evaluation of public comments on the COVID-19 
testing requirements for residents and staff of LTC facilities, and in 
light of their applicability ending with the end of the COVID-19 PHE, 
we are revising the CFR at Sec.  483.80(h) to remove the expired text. 
As previously discussed, CMS encourages ongoing COVID-19 mitigation 
measures through its quality reporting and value-based incentive 
programs in the near future.

IV. Provisions of the Final Regulation

    In this section, CMS discusses the requirements in this final rule. 
In section IV.A. of this final rule, we discuss the withdrawal of 
regulations pertaining to COVID-19 vaccination of health care staff. We 
then discuss final regulations for LTC facilities and ICFs-IID to 
provide COVID-19 vaccine education and offer vaccination to residents, 
clients, and staff in section IV.B. of this final rule. Finally, we 
discuss the deletion of the expired COVID-19 testing requirements of 
staff and residents for LTC facilities.

A. Omnibus COVID-19 Health Care Staff Vaccination

    COVID-19 is a novel disease caused by an unpredictable and nimble 
virus, SARS-CoV-2. CMS implemented the staff vaccination requirements 
in the IFC to assure health and safety during a PHE declaration. 
However, circumstances surrounding COVID-19 continue to evolve and CMS 
has evaluated its policies pertaining to COVID-19 on an ongoing basis. 
CMS continues to recognize that vaccines are important for preventing 
severe illnesses and promoting public health and that the incidence of 
severe COVID-19 has declined significantly since the IFC was issued. We 
believe that using quality programs to promote vaccination is an 
approach more consistent with the current nature of SARS-CoV-2 (that 
is, frequent mutation, potentially necessitating new vaccines), and 
that it can now be treated more like other harmful but not necessarily 
emergent respiratory viruses like influenza. Accordingly, we are 
withdrawing from the CFR the requirements regarding COVID-19 
vaccination of health care staff as established under the staff 
vaccination IFC. As discussed in section I.B. of this final rule, CMS 
intends to encourage ongoing COVID-19 vaccination through other 
mechanisms, including its quality reporting and value-based incentive 
programs. CMS continues to develop and refine quality measures for both 
patient and health care personnel vaccination to be used in appropriate 
quality programs and included patient and health care personnel 
vaccination quality measures, such as those seen on the MUC list issued 
on December 1, 2022. In addition to quality measurement, CMS continues 
to provide assistance and education through CMS-funded entities 
(including QIOs, Hospital Quality Initiatives (HQICs), and ESRD 
Networks), as well as to work with Federal, State, local, and industry 
partners who can also provide education and technical support.
    The withdrawal of the COVID-19 staff vaccination requirements from 
the CoPs, CfCs, and requirements should not be construed as a 
diminution of CMS support for vaccination or for facilities to require 
staff vaccination. Moreover, withdrawal of the requirements from the 
CoPs, CfCs, and requirements for LTC facilities does not prohibit 
facilities from requiring staff vaccinations, and we encourage health 
care employers to maintain evidence-based policies regarding staff 
vaccination for COVID-19 and other communicable diseases for which 
vaccination is available and recommended. Health systems and health 
care employers may continue to require that workers stay up to date on 
COVID-19 vaccinations, consistent with other Federal, State, and local 
laws. Moreover, some States may require COVID-19 vaccination of health 
care staff. Facilities must maintain compliance with applicable State 
and local laws pertaining to vaccination.
    In this final rule, the substantive provisions of the staff 
vaccination IFC are withdrawn. Table 3 lists the regulatory locations 
from which staff vaccination regulations are addressed in this final 
rule by provider and supplier type.

      Table 3--Withdrawn Regulations by Provider and Supplier Type
------------------------------------------------------------------------
                                                              Revised
               Provider and supplier type                   regulation
------------------------------------------------------------------------
Ambulatory Surgical Centers (ASCs)......................            Sec.
                                                               416.51(c)
Hospices................................................            Sec.
                                                               418.60(d)
Psychiatric Residential Treatment Facilities (PRTFs)....            Sec.
                                                              441.151(c)
Programs of All-Inclusive Care for the Elderly (PACE)               Sec.
 Organizations..........................................       460.74(d)
Hospitals...............................................            Sec.
                                                               482.42(g)
Long Term Care (LTC) Facilities.........................            Sec.
                                                               483.80(i)
Intermediate Care Facilities for Individuals with                   Sec.
 Intellectual Disabilities (ICFs-IID)...................      483.430(f)
Home Health Agencies (HHAs).............................            Sec.
                                                               484.70(d)

[[Page 36503]]

 
Comprehensive Outpatient Rehabilitation Facilities                  Sec.
 (CORFs)................................................       485.70(n)
Critical Access Hospitals (CAHs)........................            Sec.
                                                              485.640(f)
Clinics, Rehabilitation Agencies, and Public Health                 Sec.
 Agencies as Providers of Outpatient Physical Therapy         485.725(f)
 and Speech-language Pathology Services (Organizations).
Community Mental Health Centers (CMHCs).................            Sec.
                                                              485.904(c)
Home Infusion Therapy (HIT) Suppliers...................            Sec.
                                                              486.525(c)
Rural Health Clinics (RHCs)/Federally Qualified Health              Sec.
 Centers (FQHCs)........................................        491.8(d)
End-Stage Renal Disease (ESRD) Facilities...............            Sec.
                                                               494.30(b)
------------------------------------------------------------------------

B. COVID-19 Vaccine ``Educate and Offer'' Requirements for LTC 
Facilities and ICFs-IID Residents, Clients, and Staff

    While the COVID-19 pandemic continues to evolve, effective vaccines 
and therapies have also been developed. Vaccination still remains as 
one of the most important methods to help reduce severity of COVID-19. 
However, some individuals may face additional barriers accessing COVID-
19 vaccines. As previously discussed, many of the residents and clients 
of LTC facilities and ICF-IIDs are not able to independently travel 
offsite in order to receive a vaccine due to several factors including 
but not limited to disability, cognitive impairment, low health 
literacy, and/or functional reasons. Because some of these individuals 
may have a low health literacy, education on COVID-19 vaccines is 
particularly important. Vaccine education allows for residents, 
clients, and their caregivers to be informed participants in their care 
and allows them to make the most appropriate decisions for themselves. 
Therefore, it is important that we maintain the educate and offer 
provisions for both LTC facilities and ICF-IIDs.
    In this final rule, we are finalizing the infection control 
requirements at Sec.  483.80(d) that LTC facilities must meet to 
participate in the Medicare and Medicaid programs. By doing so, LTC 
facilities must continue to educate and offer the COVID-19 vaccine to 
residents, resident representatives, and staff, as well as perform the 
appropriate documentation for these activities. All of the requirements 
of the educate and offer IFC are being finalized, except for the 
language referring to LTC facility staff refusing the COVID-19 vaccine 
originally set forth at Sec.  483.80(d)(3)(v). We are finalizing this 
language as amended by the staff vaccination IFC.
    We are also finalizing the COVID-19 facility staffing and health 
care services requirements at Sec. Sec.  483.430(f) and 483.460 that 
ICFs-IID must meet to participate in the Medicare and Medicaid 
programs. By doing so, ICFs-IID must continue to educate clients, 
client representatives, and staff and offer the COVID-19 vaccine to 
clients and staff, as well as perform the appropriate documentation for 
these activities. All of the requirements of the educate and offer IFC 
are being finalized, except for the language referring to the ICFs-IID 
staff refusing the COVID-19 vaccine. We are finalizing this requirement 
as amended by the staff vaccination IFC.

C. COVID-19 Reporting Requirements for LTC Facilities

    As previously discussed, CMS continues to evaluate and revise its 
policies pertaining to COVID-19 on an ongoing basis, and in light of 
the conclusion of the COVID-19 PHE, we are deleting the expired COVID-
19 testing requirement for LTC facilities. We continue to emphasize the 
importance of practicing infection control measures in order to 
mitigate the spread of COVID-19 and other communicable respiratory 
diseases.

V. Severability

    As described in further detail in the previous sections of this 
rule, this final rule relates to three separate IFCs: This final rule 
(1) withdraws requirements of the November 2021 IFC regarding staff 
vaccination; (2) deletes expired requirements of the September 2020 IFC 
regarding COVID-19 testing in LTC Facilities, and (3) finalizes 
requirements of the May 2021 IFC requiring facilities to provide 
education about COVID-19 vaccines and to offer COVID-19 vaccines to 
residents, clients, and staff. As reflected by the fact that they these 
three categories of requirements appeared in three separate IFCs, the 
provisions of this final rule that relate to each of these three 
categories operate independently, and the agency intends that they be 
treated as severable. If any one of these categories of regulatory 
changes were stayed or invalidated by a reviewing court, the remaining 
categories would continue to effectuate the agency's intent to align 
its regulations with current public health conditions and would be 
independently administrable. Likewise, the agency intends that the 
provisions within each of these categories of regulatory changes be 
treated as severable. For example, were a court to stay or invalidate 
withdrawal of the staff vaccination requirement for one type of health 
care facility, the agency intends that the withdrawal of the 
requirement for other types of facilities would remain in effect. 
Accordingly, the agency considers each of the provisions adopted in 
this final rule to be severable; in the event of a stay or invalidation 
of any part of the rule, or of any provision as it applies to certain 
facilities or in certain factual circumstances, the agency's intent is 
to otherwise preserve the rule to the fullest possible extent.

VI. Collection of Information 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 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    In the staff vaccination IFC published November 5, 2021, the 
educate and offer IFC published May 13, 2021, and the LTC facility 
testing IFC published September 2, 2020, we solicited public

[[Page 36504]]

comment on each of these issues for the following sections of this 
document that contain information collection requirements (ICRs). 
However, we did not receive any comments on these ICRs.
    The following analysis covers the ICRs for the Staff Vaccination, 
Educate and Offer, and LTC testing requirements. As in the preamble 
above, we will first analyze the ICRs for the Staff Vaccination 
requirements first.
    Under the Paperwork Reduction Act of 1995 (PRA), we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. To 
fairly evaluate whether an information collection should be approved by 
OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 
requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    This rule contains no new requirements and would sunset those 
promulgated by the staff vaccination IFC and the LTC testing IFC. The 
original estimates for the staff vaccination IFC were 1,555,487 burden 
hours and $136,088,221 for both the initial and subsequent years. The 
dollar estimates were based on hourly wage data from the Bureau of 
Labor Statistics for 2020. The original estimates for the LTC testing 
IFC were $48,158,193 over the estimated course of the PHE. The dollar 
estimates were based on an estimated labor requirement of 2 minutes per 
test and hourly wage date from the Bureau of Labor Statistics for 2019. 
Based on the termination of the COVID-19 PHE and withdrawal of the 
vaccination and testing requirements, these estimates are reduced to 
zero in all succeeding months and years.\68\
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    \68\ See ``Statement of Administration Policy'', Executive 
Office of the President, January 30, 2023, at https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf.
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    The original estimates for the educate and offer IFC were that 
first-year costs would be 1,277,874 burden hours and $91,250,874. 
Subsequent year costs were estimated at 866,580 burden hours and 
$55,177,044. The dollar estimates were based on hourly wage data from 
the Bureau of Labor Statistics for 2019. These estimates remain 
unchanged in this final rule, which makes no substantive changes to the 
regulations issued in that interim final rule.

VII. Regulatory Impact Analysis

A. Statement of Need

    The COVID-19 pandemic precipitated the greatest health crisis in 
the U.S. since the 1918 Influenza pandemic. The population of older 
adults, and LTC facility residents in particular, were hard hit by the 
impacts of the pandemic. Among those infected, the death rate for older 
adults age 65 or higher was hundreds of times higher than for those in 
their 20s during 2020. Of the 1.1 million deaths through April 2023, 
only about 6,912 were for ages 18-29, compared to 850,000 for those age 
65 or higher.\69\ Moreover, of the approximately 1,130,662 Americans 
estimated to have died from COVID-19 through May 2, 2023, about 15 
percent were estimated to have died during or after a LTC facility 
stay,\70\ a percentage that has decreased substantially from earlier 
levels as vaccination rates increased for both residents and staff and 
as the availability and use of effective medications to reduce the 
rates of hospitalization and death have rapidly grown.\71\ The 
proportion of the unvaccinated who have contracted the virus has also 
contributed to reducing the rate of future infections and their 
severity. As a result of all these factors, the Biden Administration 
allowed the public health emergency declaration under section 319 of 
the Public Health Service Act related to the COVID-19 pandemic to end 
on May 11, 2023.
---------------------------------------------------------------------------

    \69\ https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm.
    \70\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
    \71\ https://www.kff.org/policy-watch/over-200000-residents-and-staff-in-long-term-care-facilities-have-died-from-covid-19/.
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B. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), Executive Order 14094 on Modernizing Regulatory 
Review (April 6, 2023), 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). Executive 
Order 14094 (Modernizing Regulatory Review) amends section 3(f)(1) of 
Executive Order 12866 (Regulatory Planning and Review). The amended 
section 3(f) of Executive Order 12866 defines a ``significant 
regulatory action'' as an action that is likely to result in a rule 
that may: (1) have an annual effect on the economy of $200 million or 
more in any 1 year (adjusted every 3 years by the Administrator of the 
Office of Information and Regulatory Affairs (OIRA) for changes in 
gross domestic product), or adversely affect in a material way the 
economy, a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, territorial, or 
tribal governments or communities; (2) create a serious inconsistency 
or otherwise interfering with an action taken or planned by another 
agency; (3) materially alter the budgetary impacts of entitlement 
grants, user fees, or loan programs or the rights and obligations of 
recipients thereof; or (4) raise legal or policy issues for which 
centralized review would meaningfully further the President's 
priorities or the principles set forth in the Executive order, as 
specifically authorized in a timely manner by the Administrator of OIRA 
in each case.
    A regulatory impact analysis (RIA) must be prepared for 
``significant regulatory actions'' as defined in E.O. 12866 as amended 
by E.O. 14094. Based on our estimates, OMB's Office of Information and 
Regulatory Affairs has determined this rulemaking is significant per 
section 3(f)(1) of E.O. 12866 as measured by the threshold of $200 
million or more in any 1 year, and hence also a rule qualifying under 
the definition in 5 U.S.C. 804(2) (Subtitle E of the Small Business 
Regulatory Enforcement Fairness Act of 1996, also known as the 
Congressional Review Act).
    Accordingly, we have prepared an RIA that, taken together with the 
collection of information (COI) analysis and other sections of this 
preamble, presents to the best of our ability the costs and benefits of 
the rulemaking. It is important to understand, as explained previously 
in this final rule, that this

[[Page 36505]]

rule is terminating only one of the IFCs that were issued by CMS in 
response to the COVID-19 pandemic. The requirements for COVID-19 
testing of LTC facility staff have already expired. The educate and 
offer IFC is being made permanent, substantively unchanged. Hence, the 
staff vaccination IFC is the only one substantively affected by this 
rule. Relative to a hypothetical future in which this and the educate 
and offer IFC continue unchanged, this rule reduces costs through the 
withdrawal of the omnibus staff vaccination requirements. It is 
economically significant under section 3(f)(1) of E.O. 12866 because 
the costs eliminated exceed $200 million annually.
    Due to the success of all three IFCs in encouraging both staff and 
patient vaccination in health care settings, the evolution of SARS-CoV-
2 toward variants whose adverse health impacts are on average less 
severe, and improved medications and reduced stresses on hospitals and 
other health care facilities, rates of severe illness and of death have 
both radically decreased since the staff vaccination IFC was issued. Of 
particular importance, the interactive effect of both staff and patient 
COVID-19 vaccination rates reaching or approaching 90 percent has 
helped each group protect the other. Vaccinating staff protects both 
staff and patients, as does vaccinating patients.\72\ In this regard, 
we emphasize that our current and planned use of data on both staff and 
patient vaccination rates will maintain consistent pressure on the 
health care providers and suppliers regulated by CMS to maintain and 
improve current success rates.
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    \72\ We note that there is additional protection because many 
and very likely most of the remaining unvaccinated staff and 
patients previously have been infected by one or more COVID-19 
variants, and therefore are less likely to experience severe COVID-
19 in the near future. There are, however, no good data on the 
numbers or effects of these infections.
---------------------------------------------------------------------------

    As displayed in detail in Tables 5 and 6 of the staff vaccination 
IFC, there are about 76,000 provider and supplier entities regulated by 
CMS, and these facilities have about 13 million staff during each 
year.\73\ But large as these numbers are, they are dwarfed by the 
number of patients served. In total across all provider and supplier 
types, but excluding hospital outpatient and emergency caseloads, CMS-
certified providers and suppliers serve over 100 million patients a 
year. Including patients served as hospital emergency cases or as 
outpatient cases, the total number of patients served is more than 300 
million based on number of encounters, but likely to be much lower--
about 250 million--based on number of different individuals. Thus, 
existing ``educate and offer'' requirements focus on both nursing home 
staff and patients.
---------------------------------------------------------------------------

    \73\ See 86 FR 61603 and 61606, November 5, 2021.
---------------------------------------------------------------------------

    The original staff vaccination IFC and this final rule present 
substantial difficulties in estimating both costs and benefits due to 
the high degree to which all current provider and supplier staff have 
already received information about the benefits and safety of COVID-19 
vaccination and about the rare serious risks associated with 
vaccination. What is still uncertain is how staff or patient compliance 
with recommended vaccinations may change further over time. Moreover, 
we do not know how many persons in each of these groups has become ill 
with COVID-19, and how many of these more than once, before coming into 
close contact. Nor do we know how these numbers are likely to change in 
the next few years, whether a new variant of the SARS-CoV-2 virus may 
emerge, or what new vaccines or treatment options may become common and 
with what effectiveness in preventing infection, hospitalization, or 
death. With all these unknown variables, we cannot predict with 
confidence future COVID-19 morbidity or mortality levels either with or 
without better vaccination compliance. However, we can estimate with 
some confidence a range of conditions in a hypothetical future in which 
the staff vaccination and educate-and-offer IFCs remain unchanged 
(assuming no new SARS-CoV-2 variant with higher or lower health effects 
becoming dominant, no new vaccine with higher protection against the 
existing variant, no major changes in vaccination practices, and no 
major changes in treatments), simply by using current data and 
projecting no major changes in these variables.\74\
---------------------------------------------------------------------------

    \74\ For a list and discussion of past and present COVID 
variants, one useful and current source is Kathy Katella, ``Omicron, 
Delta, Alpha and More: What To Know About the Coronavirus 
Variants,'' February 3, 2023, at https://www.yalemedicine.org/news/covid-19-variants-of-concern-omicron.
---------------------------------------------------------------------------

C. Anticipated Benefits and Costs

    Relative to a hypothetical future in which the staff vaccination 
and educate-and-offer IFCs remain in their current form--which is one 
of multiple relevant analytic baselines--This rule imposes no new costs 
(other than the costs of reading and acting on this final rule). 
Instead, it reduces regulatory costs to health care providers and 
suppliers by withdrawing the requirements imposed by the staff 
vaccination IFC issued in November 2021. This final rule's effect on 
numbers of lives lost of either health care staff or health care 
patients is limited by the scope of such outcomes in the analytic 
baseline (that is, the future trajectory in this rule's absence). While 
the number of health care staff (whether called employees, workers, or 
staff) dying from COVID-19 infections was already decreasing when the 
staff vaccination IFC was issued, it has for the last year decreased to 
very low levels, often zero, for weeks at a time.\75\ An unknown 
fraction of these deaths may have been vaccinated persons. Nor is there 
reason to believe that the relatively few recently recorded deaths from 
COVID-19 were due to workplace exposures, considering all the other 
locations at which workers might be exposed to the virus.\76\ That 
said, we still do not know how much of this massive decrease in the 
mortality rate of infected populations was due to the policy effects of 
the IFC itself, but with the educate and offer rule now permanent, the 
fraction of staff and patients unvaccinated close to single digits (and 
never likely to have been much closer to zero given the various legally 
available exemptions), there is no plausible basis for estimating a 
resurgence of deaths among either group absent some new and more 
virulent COVID variant.
---------------------------------------------------------------------------

    \75\ The CDC Data Tracker for Covid, ``Cases and Deaths among 
Healthcare Personnel,'' estimates the total number of COVID-caused 
deaths among healthcare workers since the pandemic began is about 
2,500, of which only about 200 have occurred in the last year 
(February to February). Data at https://covid.cdc.gov/covid-data-tracker/#health-care-personnel_healthcare-deaths.
    \76\ The Bureau of Labor Statistics estimates that there were 
about 5,000 annual fatal workplace injuries to workers in recent 
years. Accidents at work are only one of many causes of worker 
fatalities (for example, automobile injuries outside of the 
workplace, non-occupational illnesses of all kinds, and heart 
attacks while at work). In comparison, roughly 200 healthcare worker 
deaths occurred from COVID-19, much and perhaps most contracted 
outside the workplace. See CDC healthcare personnel data cited in 
preceding footnote, in comparison ``to ``National Census of Fatal 
Occupational Injuries in 2021'' at https://www.bls.gov/news.release/pdf/cfoi.pdf.
---------------------------------------------------------------------------

    Perhaps the simplest way to understand these effects is to consider 
that in the roughly 18 months since the staff vaccination IFC rule was 
issued, much and perhaps most of the originally estimated costs 
(implementation) and benefits (lives saved) have already been realized. 
However, the many uncertainties that still affect projections into the 
future led us to restrict our cost horizons in the staff vaccination 
rule to one year and to eschew any mortality reduction estimate. In 
retrospect, it appears that while our cost estimates may have been 
reasonably robust, any estimate of lives saved would have

[[Page 36506]]

likely been far too high. In particular, the reduced lethality of the 
Omicron variant of the virus and the available treatments for those ill 
from the virus were the largest life savers by far.\77\
---------------------------------------------------------------------------

    \77\ See W. Adjei et al., ``Risk Among Patients Hospitalized 
Primarily for COVID-19 During the Omicron and Delta Variant Pandemic 
Periods,'' Morbidity and Mortality Weekly Report (MMWR), September 
16, 2022; at https://www.cdc.gov/mmwr/volumes/71/wr/mm7137a4.htm. 
This report showed a two thirds reduction in mortality from the 
Delta period to the Omicron period.
---------------------------------------------------------------------------

    Compliance Cost Reduction. In the staff vaccination IFC we 
estimated compliance and vaccination costs to be about $1.382 billion 
in the first year and declined to estimate costs in succeeding years 
(see Table 7 in that rule).\78\ This estimate attributed all 
implementation costs to that rule, with no offsetting assumption about 
spending that would otherwise have occurred. Thus, it attributed the 
vaccine costs for healthcare workers paid by the Federal Government to 
be a result of that rule. It omitted, however, potential increases in 
recruitment costs and a variety of potential business disruption costs 
for facilities that may have had difficulties hiring vaccinated 
workers. We estimated with these omissions because we had no reliable 
way to estimate how much of these costs might be due to independent 
employer decisions, to other Federal standards, to State and local 
mandates, or to individual personal choices. In retrospect, this was a 
reasonable estimate because we still have no basis for ``correcting'' 
the original assumption. Moreover, if such costs were not paid by the 
government directly, both public and private insurance would have 
covered most of these costs in future years (and likely will cover them 
for voluntary vaccinations). Regardless, a substantial fraction of 
those costs would have been expected to recur each year, if for no 
other reason than turnover among health care staff. However, since the 
first year included primary series vaccination of all existing staff, 
succeeding years would have been lower in cost because the number of 
required vaccinations would largely be incurred only for new workers, 
and only some of these would not have been previously vaccinated 
through other sources. Furthermore, only in the first year would one-
time costs (such as reading the rule and creating policies and 
procedures to implement the rule) have been incurred. We therefore now 
estimate that to maintain that rule only about one-half of the first-
year estimate would have been needed to comply in future years.
---------------------------------------------------------------------------

    \78\ 86 FR 61609, November 5, 2021.
---------------------------------------------------------------------------

    For purposes of estimating benefits from eliminating the 
implementation costs of the staff vaccination IFC, we therefore 
estimate that the second- and third-year costs of the November 2021 
staff vaccination IFC (if continued unchanged) would have been $691 
million (0.5 * 1,382). Had we estimated fourth and fifth (or later) 
years on the same basis, costs near those levels would presumably have 
continued. Subtracting an additional $4 million for the one-time costs 
of reading and acting on this final rule, the next year of benefits of 
this rule in costs reduced from the estimated annual level in the 
November 2021 interim final rule would be $687 million, followed by 
future years at $691 million (until something unforeseen changed).
    We note that these cost (now benefit) estimates apply only to the 
mandatory nature of the rule addressing staff vaccination. As discussed 
in the next section of this RIA, we believe it very likely that many 
and probably most health care providers and suppliers will continue to 
require or strongly urge staff vaccination and that staff vaccination 
rates will rise over time as new generations of workers who received 
past vaccinations will be hired. The precise evolution of these trends 
will depend on the many uncertainties already discussed, and the result 
may be higher or lower changes in costs than those anticipated at the 
time the interim final rule was issued (and thus higher or lower 
savings than what is estimated now). Given experiences to date, 
however, we believe that the future benefits (lives saved) of 
continuing the staff vaccination requirements would have been low at 
the time of our estimate and very low if made in the light of recent 
experience. We continue to believe, however, that reliable forecasts of 
morbidity and mortality over any time horizon more than a few months 
cannot yet be made.
    We again note that the LTC testing requirements expired before 
publication of this final rule. This rule was not a factor in that 
expiration and we accordingly do not address the estimated costs and 
benefits of that change.
    The preceding discussion applies to the staff vaccination IFC. The 
May 2021 educate-and-offer IFC is not being changed, and the original 
compliance cost estimates in that rule included future year 
projections.\79\ These projections showed lower estimates for future 
years than upfront, in large part because the need for development of 
policies, procedures, and educational materials would be greatly 
reduced over time. Those future year estimates were then and remain 
uncertain for most of the same reasons already discussed with respect 
to the staff vaccination IFC. We have no basis for changing the overall 
estimated total future year compliance costs from the estimates made at 
that time.
---------------------------------------------------------------------------

    \79\ See Table 6 in that rule, at 86 FR 26330, May 13, 2021.
---------------------------------------------------------------------------

    Changes in Worker Lives Saved or Lost. Ending the staff vaccination 
IFC could arguably reduce vaccination levels among health care staff. 
However, the direct effect of this regulatory change is not necessarily 
to reduce the level of vaccination among health care staff, but to 
eliminate the government requirements for facilities to track and 
manage vaccination. We believe it possible, in fact, that provider and 
staff self-interest will persuade current or future vaccine-hesitant or 
newly hired staff, or both, about the safety and effectiveness of 
current vaccines. This opportunity is particularly large for booster 
shots, since only about 22 percent of nursing home staff, and 
presumably a similar percentage for other provider types, have even 
obtained the first booster.\80\ Another positive factor may be the 
influence of educational institutions that train future care personnel 
in persuading or requiring their students to accept vaccination while 
in school, before taking jobs in the health care sector. Finally, the 
willingness of health care employers to simply require vaccination (in 
the vast majority of States where this is allowed) is a significant and 
potentially highly positive factor.\81\
---------------------------------------------------------------------------

    \80\ https://www.cdc.gov/nhsn/covid19/ltc-vaccination-dashboard.html.
    \81\ The CDC has collected data on State laws either prohibiting 
(often with exceptions) or mandating (often with exceptions) 
employer-or local government-mandated COVID-19 vaccination or 
testing. Few States and none of the larger States have created by 
law prohibitions that would apply to healthcare or long-term care 
employers. The statutes mainly address compulsion by lower levels of 
government, such as cities or counties.
---------------------------------------------------------------------------

    The most influential variables in predicting future lives saved or 
lost are likely to be the new SARS-CoV-2 variants that make the initial 
vaccines less effective in preventing COVID-19. However, the new 
variants have generally been less harmful for most of those who have 
received vaccinations. Additional doses of COVID-19 vaccines provide 
protection against COVID-19 but immunity declines over time. These are 
all variables that interact, and their understanding by healthcare 
personnel depends substantially on the effectiveness of education and 
offering

[[Page 36507]]

efforts by applicable health care providers. Further, many Americans 
have been infected with COVID-19 and may have developed some level of 
infection-induced immunity, which provides some protections as well. 
Since the educate and offer requirements are being retained and will be 
reinforced by new quality measures, as well as the extent to which 
future patients respond to high and low scores on these measures, we 
believe that any overall change in morbidity and mortality from the 
repeal of the provisions of the staff vaccination IFC would be smaller 
than what would result from repeal occurring (hypothetically) without 
the continuation of education-and-offering requirements.
    Quite apart from changes in vaccination levels from those either 
originally estimated or currently in place, the morbidity and mortality 
of COVID-19 have changed substantially since 2021. In particular, the 
currently dominant strain of the virus results in much lower levels of 
severity, thereby lowering both hospitalizations and death. Current 
treatment options reduce severity levels even further.\82\ Assuming no 
further change in vaccination levels, treatment options, or in COVID-
caused severity of illness, currently available information can be used 
to create rough estimates of conditions in a hypothetical future in 
which the IFCs remain in their current form. Most importantly, COVID-
caused deaths have fallen substantially since the levels measured in or 
before 2021. According to CDC estimates, the number of deaths caused by 
COVID-19 among healthcare workers has fallen from dozens per week to 
close to zero.\83\ Specifically, in the last year (beginning of 
February 2022 through end of January 2023) the number of known 
healthcare worker deaths per week has ranged from 0 to 4 (CDC says 
``less than 5'') and therefore has averaged about 2 per week, or a rate 
of approximately 100 per year.\84\ Since a fraction of these deaths 
presumably were of those infected outside the workplace, or among those 
already vaccinated (given the percentage of adults in the United States 
who have received a COVID-19 vaccine), or both, the termination of the 
staff vaccination IFC is estimated to have minimal effects.
---------------------------------------------------------------------------

    \82\ https://www.idsociety.org/covid-19-real-time-learning-network/emerging-variants/emerging-covid-19-variants/.
    \83\ https://covid.cdc.gov/covid-data-tracker/#health-care-personnel_healthcare-deaths.
    \84\ CDC's website acknowledges that these data have gaps and 
other imperfections, but the crucial point seems clear. From the 
full set of these sources, however imperfect, the number of cases is 
down substantially, and the number and rates of deaths have 
decreased even further compared to the first 2 years of the 
pandemic.
---------------------------------------------------------------------------

    As discussed elsewhere in the preamble, we intend to establish 
measures on COVID-19 infection prevention to our quality improvement 
measures for most types of health care facilities. This is a far more 
flexible system than detailed regulations and will allow tailoring of 
actions and accomplishments down to the facility level, responding in 
real-time to any changes in SARS-CoV-2 variants, drug treatments, and 
other factors that improve either staff or patient health outcomes, 
including innovations that protect either group through the other, or 
both at once. For example, improved ventilation systems have been 
demonstrated to reduce airborne infections for any exposed persons, 
including staff, patients, and visitors.\85\
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    \85\ See CDC, ``Ventilation in Buildings,'' June 2,2021 version, 
at https://www.cdc.gov/coronavirus/2019-ncov/community/ventilation.html, and Ehsan Mousavi et al, ``COVID-19 Outbreak and 
Hospital Air Quality: A Systematic Review of Evidence on Air 
Filtration and Recirculation,'' American Chemical Society Public 
Health Emergency Collection, August 26, 2020, at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489049/.
---------------------------------------------------------------------------

    Therefore, and subject to all the uncertainties and unknowns 
discussed earlier in this analysis that might lead to higher or lower 
numbers, there is no known reason to expect that repeal of the staff 
vaccination IFC will lead to a substantial or measurable increase or 
decrease in health care worker deaths, despite the many uncertainties 
and unknowns involved.
    Changes in Patient Lives Saved or Lost. Most of the same factors 
that apply to staff apply with equal force to patients. There are, 
however, several key differences. First, CMS has long required that LTC 
facilities and IICFs-IID both encourage and arrange vaccination of 
patients with the annual influenza vaccine and the pneumococcal 
vaccine. These requirements now include COVID-19 vaccination following 
the educate and offer IFC that we are now making permanent and thus no 
longer contingent on the scope or magnitude of COVID-19 infections. 
These facilities are the most important locations for patient 
education, both to protect other patients and to protect staff.
    Second, the location where a patient is treated or dies may have 
little or no relevance to where they became infected.\86\ This is true, 
of course, for workers as well. Many and perhaps most worker infections 
undoubtedly come from contacts with infected individuals in external 
places such as sporting events, grocery stores, clubs, restaurants, and 
bars. But for health care these patterns are even more complex. The 
person who tests positive upon admission to a hospital most likely 
reached the hospital after contracting the disease in another setting.
---------------------------------------------------------------------------

    \86\ Of course, this would not apply equally in all health care 
settings. Quick outpatient visits and long-term care residence would 
not show the same location of infection patterns.
---------------------------------------------------------------------------

    It is also true that there are many more patient lives than staff 
lives at issue. While health care staff deaths from COVID-19 appear to 
have reached single digits on a weekly basis the total national weekly 
number of COVID-19 deaths has been about 3,000 on average for over 6 
months.\87\ Assuming no change, the number of COVID-19 deaths will be 
about 160,000 in 2023, about 5 percent of the national total of about 
3.5 million annual deaths from all causes (and half the COVID-19 number 
in 2020).
---------------------------------------------------------------------------

    \87\ See the Data Table for Weekly Death Trends in CDC's COVID 
Data Tracker. Only a handful of weeks have reached or exceeded 3,500 
deaths since May 2022 as shown in this table, at https://covid.cdc.gov/covid-data-tracker/#trends_weeklydeaths_select_00.
---------------------------------------------------------------------------

D. Other Effects

    There are no substantial budgetary effects of this final rule. 
Current payments for vaccine are federally financed, and not driven by 
whether there is a PHE for COVID-19 declared under section 319 of the 
Public Health Service Act. When the current budget for the vaccines 
runs out, private and public health insurance will in most cases assume 
the costs of vaccination, depending on future coverage decisions by 
these insurance programs. Likewise, there is little or no reason to 
expect that the expiration of the LTC facility testing IFC will have a 
consequential effect.
1. 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 
most health care facilities are small entities as that term is used in 
the RFA because they are either nonprofit organizations or meet the SBA 
definition of a small business (for most types of health care 
providers, 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

[[Page 36508]]

revenues to a provider 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.
    This final rule was not preceded by a general notice of proposed 
rulemaking and the RFA requirement for a final regulatory flexibility 
analysis does not apply to final rules not preceded by a proposed rule. 
Regardless, this rule would not trigger the RFA requirement. As 
estimated previously, the total savings from this rule for future years 
are about $691 million annually. Spread over 13 million full-time 
equivalent health care employees, this is about $53 per employee. 
Assuming a fully loaded average wage and support cost per employee of 
$90,000,\88\ the annual savings do not approach the 3 percent 
threshold. Furthermore, the Department interprets the RFA's definition 
of ``significant economic impact'' as applying only to newly imposed 
adverse effects, not to cost reductions or other savings. For these 
reasons, the Department has determined that this final rule will not 
have a significant adverse economic impact on a substantial number of 
small entities and that a final Regulatory Flexibility Analysis is not 
required. Regardless, the content of this RIA and the main preamble, 
taken together, would meet the requirements for a Final Regulatory 
Flexibility Analysis.
---------------------------------------------------------------------------

    \88\ This is the rounded weighted average annual cost of 
healthcare employees as estimated in the Totals line of Table 4 of 
the mandated vaccination interim final rule issued in November of 
2021, op cit.
---------------------------------------------------------------------------

2. Small Rural Hospitals
    Section 1102(b) of the Act requires us to prepare an RIA if a 
proposed or final 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. This rule is exempt because that provision of law only 
applies to those final rules for which a proposed rule was published. 
Because this rule has only the small and positive impact per employee 
calculated for RFA purposes, the Department has determined that this 
rule will not have a significant impact on the operations of a 
substantial number of small rural hospitals.
3. 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 2023, that threshold is approximately $175 
million. This final rule was not preceded by a notice of proposed 
rulemaking, and therefore the requirements of UMRA do not apply. 
Regardless, this rule contains no State, local, or Tribal governmental 
mandates, nor any mandates on private sector entities that were not 
previously included in prior rules. Moreover, it saves rather than 
increases costs. The analysis in this RIA and the preamble as a whole 
would, however, meet the requirements of UMRA.
4. 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 effects on State and local 
governments, preempts State law, or otherwise has federalism 
implications. While the staff vaccination IFC did preempt some State 
laws, those effects did not involve ``substantial direct costs'' and 
this final rule repeals those preemptions. Accordingly, the 
requirements of E.O. 13132 do not apply to this final rule.

E. Alternatives Considered

    While we considered retaining the requirements established in the 
staff vaccination IFC, we believe that it has largely served its 
emergency purpose of protecting the health and safety of patients. As 
previously discussed in this RIA, about 86 percent of nursing home 
staff have completed the original primary vaccination series, helping 
reduce risk to patients.\89\ Moreover, many and likely most of the 
remaining staff have previously been infected by COVID-19 and benefit 
from some protective immunity.\90\ We also note that the subject 
addressed by this rule is whether or not to extend and/or modify the 
staff vaccination IFC, not the array of actions pursued with the many 
tools and venues which the Federal Government uses, such as vaccine 
research.
---------------------------------------------------------------------------

    \89\ https://www.cdc.gov/nhsn/covid19/ltc-vaccination-dashboard.html#anchor_1638315381394.
    \90\ Reinfection of previously vaccinated persons or of 
previously infected persons would make them a temporary risk, but 
the frequency of this problem appears to be quite low. It remains, 
however, yet another future unknown.
---------------------------------------------------------------------------

    In the population as a whole, as of March 29, 2023, COVID-19 death 
rates have decreased to about 323 a week, still far too high but a 
decreasing fraction of the 3.5 million annual and 66,000 weekly deaths 
from all causes in the United States.91 92 With regard to 
health care staff, the progress has been even more rapid, with staff 
deaths attributed to COVID-19 trending downward since late 2021 and 
remaining relatively low over the past year.\93\ Given the many 
uncertainties as to future events, and with the option of new emergency 
regulations available under appropriate circumstances if progress is 
halted or reversed, a rule tailored to future events could always be 
created should the data justify such an action.
---------------------------------------------------------------------------

    \91\ https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html.
    \92\ Farida Ahmad et al, ``Provisional Mortality Data--United 
States, 2021,'' at https://pubmed.ncbi.nlm.nih.gov/35482572/.
    \93\ https://covid.cdc.gov/covid-data-tracker/#health-care-personnel, Of 98,807,297 case reports received by CDC, 13,207,516 
(13.37 percent) have known healthcare personnel (HCP) status. 
Completion of HCP status varied in case reporting over time and is 
noted in the figure and table below. For the 1,145,831 cases of 
COVID-19 among HCP, death status is available for 636,341 (55.54 
percent).
---------------------------------------------------------------------------

    While not otherwise addressed in this RIA, we did consider whether 
it might be appropriate to not finalize the educate and offer IFC but 
as discussed in this rule recognize the importance of ongoing access to 
vaccination for individuals residing in congregate care settings. 
Additionally, we also considered whether we could or should extend the 
LTC facility testing requirements that expired with the PHE, and 
determined that there was no need in the face of current standards of 
care that call for testing when clinically indicated.

F. Accounting Statement and Table

    The Accounting Table (Table 4) summarizes the quantified impact of 
this rule. It covers only 3 years because there will likely be new 
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 this RIA and throughout this 
final rule, there are major uncertainties as to the effects of current 
or possible future variants of SARS-CoV-2 on future infection rates, 
medical treatments and costs, and prevention of major illness or 
mortality. Even the duration of vaccine

[[Page 36509]]

effectiveness in preventing COVID-19, reducing disease severity, and 
risk of death, by those vaccinated are not currently known with 
precision or certainty. These uncertainties also impinge on benefits 
estimates. For those reasons we have not quantified into annual totals 
the effects on mortality risk of this rulemaking or of other actions 
(including the retention of the educate and offer IFC for LTC 
facilities and ICFs-IID, which would have a life-extending effect 
relative to an analytic baseline in which the future is characterized 
by a hypothetical absence of that IFC \94\) and have used only a 3-year 
projection for the cost savings estimates in our Accounting Statement. 
We also show a range (plus or minus 25 percent) for the upper and lower 
bounds of potential cost savings to emphasize the uncertainty as to 
several major variables, including changes in voluntary vaccination 
levels, longer-term effects, and others previously discussed.
---------------------------------------------------------------------------

    \94\ Relative to this without-IFC baseline, the finalized 
requirements would also impose cost, as estimated at the time of the 
IFC's issuance.

Table 4--Accounting Statement--Classification of Estimated Costs and Savings Relative to an Analytic Baseline in Which the Staff Vaccination and Educate-
                                                       and-Offer IFCs Are Retained Into the Future
                                                                      [$ millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                               Units
                                                              Primary                                    -----------------------------------------------
                        Category                             estimate       Lower bound     Upper bound                    Discount rate
                                                                                                           Year dollars         (%)       Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits Annualized and Monetized ($millions/year)......            $690            $518            $862            2022               7       2023-2025
                                                                     690             518             862            2022               3       2023-2025
                                                         -----------------------------------------------------------------------------------------------
                                                          Benefits Notes: The benefits of this rule are the estimated reductions in costs from ending
                                                          requirements for mandatory staff vaccinations.
                                                         -----------------------------------------------------------------------------------------------
Costs (not annualized or monetized).....................  ..............  ..............  ..............            2022               7       2023-2025
                                                          ..............  ..............  ..............            2022               3       2023-2025
                                                         -----------------------------------------------------------------------------------------------
                                                          Costs Notes: The estimated effects of this rule on staff and patient lives saved or lost from
                                                          COVID-19 infections are not estimated.
                                                         -----------------------------------------------------------------------------------------------
Transfers...............................................                                               None.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.
    Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & 
Medicaid Services, approved this document on May 11, 2023.

List of Subjects

42 CFR Part 416

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

42 CFR Part 418

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

42 CFR Part 441

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

42 CFR Part 460

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

42 CFR Part 482

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

42 CFR Part 483

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

42 CFR Part 484

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

42 CFR Part 485

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

42 CFR Part 486

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

42 CFR Part 491

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

42 CFR Part 494

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

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV to remove expired language 
and finalize certain provisions issued in the interim final rule 
published at 85 FR 54820 (September 2, 2020); to finalize certain 
provisions issued in the interim final rule published at 86 FR 26306 
(May 13, 2021); and to withdraw the regulations issued in the interim 
final rule published at 86 FR 61555 (November 5, 2021) as set forth 
below:

PART 416--AMBULATORY SURGICAL SERVICES

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

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

[[Page 36510]]

Sec.  416.51  [Amended]

0
2. Section 416.51 is amended by removing paragraph (c).

PART 418--HOSPICE CARE

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

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


Sec.  418.60  [Amended]

0
4. Section 418.60 is amended by removing paragraph (d).

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

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

    Authority:  42 U.S.C. 1302.


Sec.  441.151  [Amended]

0
6. Section 441.151 is amended by removing paragraph (c).

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

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

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


Sec.  460.74  [Amended]

0
8. Section 460.74 is amended by removing paragraph (d).

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

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

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


Sec.  482.42  [Amended]

0
10. Section 482.42 is amended by removing paragraph (g).

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

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

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


Sec.  483.80  [Amended]

0
12. Section 483.80 is amended by removing paragraphs (h) and (i).


Sec.  483.430  [Amended]

0
13. Section 483.430 is amended by removing paragraph (f).

PART 484--HOME HEALTH SERVICES

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

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


Sec.  484.70  [Amended]

0
15. Section 484.70 is amended by removing paragraph (d).

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

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

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


Sec.  485.58  [Amended]

0
17. Section 485.58 is amended in paragraph (d)(4) by removing the last 
sentence.


Sec.  485.70  [Amended]

0
18. Section 485.70 is amended by removing paragraph (n).


Sec.  485.640  [Amended]

0
19. Section 485.640 is amended by removing and reserving paragraph (f).


Sec.  485.725  [Amended]

0
20. Section 485.725 is amended by removing paragraph (f).


Sec.  485.904  [Amended]

0
21. Section 485.904 is amended by removing paragraph (c).

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

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

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


Sec.  486.525  [Amended]

0
23. Section 486.525 is amended by removing paragraph (c).

PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES

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

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


Sec.  491.8  [Amended]

0
25. Section 491.8 is amended by removing paragraph (d).

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

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

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


Sec.  494.30  [Amended]

0
28. Section 494.30 is amended by removing paragraph (b) and 
redesignating paragraphs (c) and (d) as paragraphs (b) and (c), 
respectively.

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-11449 Filed 5-31-23; 4:15 pm]
BILLING CODE 4120-01-P