Medicare and Medicaid Programs; Policy and Regulatory Changes to the Omnibus COVID–19 Health Care Staff Vaccination Requirements (Federal Register, June 5, 2023)
Summary
A final rule of the Centers for Medicare and Medicaid Services (CMS) in the Federal Register, Vol. 88, No. 107, Monday, June 5, 2023, effective August 4, 2023. It withdraws the regulations of the 'Omnibus COVID-19 Health Care Staff Vaccination' interim final rule of November 5, 2021, removes expired COVID-19 testing language for long-term care facilities, and finalizes requirements that LTC facilities and ICFs-IID educate residents, clients and staff about COVID-19 vaccines and offer vaccination. CMS says the risks targeted by the staff vaccination rule have been largely addressed after the public health emergency (PHE) expired on May 11, 2023. It intends to encourage ongoing vaccination through quality reporting and value-based incentive programs instead.
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Full text
Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations 36485
§ 52.1670 Identification of plan. (c) * * *
* * * * *
EPA-APPROVED NEW YORK STATE REGULATIONS AND LAWS
State EPA
State citation Title/subject effective approval Comments
date date
* * * * * * *
Title 6, Part 227, Subpart 227–1 Stationary Combustion Installa- 2/25/2021 6/5/2023 • EPA approved finalized at [insert Federal
tions. Register citation].
* * * * * * *
* * * * * COVID–19 vaccines to residents, clients, PHSA, the determination that a PHE
[FR Doc. 2023–11684 Filed 6–2–23; 8:45 am] and staff. In addition, the rule continues to exist may be renewed at
BILLING CODE 6560–50–P withdraws the regulations in the interim the end of each 90-day period.1 The
final rule with comment (IFC) initial determination that a PHE for
‘‘Omnibus COVID–19 Health Care Staff COVID–19 exists and had existed since
DEPARTMENT OF HEALTH AND Vaccination’’ published in the January 27, 2020, lasted for 90 days, and
HUMAN SERVICES November 5, 2021 Federal Register, and was renewed by the Secretary on April
finalizes certain provisions of the 21, 2020; July 23, 2020; October 2, 2020;
Centers for Medicare & Medicaid ‘‘COVID–19 Vaccine Requirements for January 7, 2021; April 15, 2021; July 19,
Services Long-Term Care (LTC) Facilities and 2021; October 15, 2021; January 14,
Intermediate Care Facilities for 2022; April 12, 2022; July 15, 2022;
42 CFR Parts 416, 418, 441, 460, 482, Individuals with Intellectual Disabilities October 13, 2022; January 11, 2023; and
483, 484, 485, 486, 491, and 494 (ICFs–IID) Residents, Clients, and Staff’’ February 9, 2023.2 The COVID–19 PHE
IFC, published in the May 13, 2021 expired on May 11, 2023.
[CMS–3415–F, CMS–3414–F, CMS–3401–F] COVID–19 has had significant
Federal Register.
RIN 0938–AU75, 0938–AU57, 0938–AU33 DATES: The regulations in this final rule negative health effects on individuals,
are effective on August 4, 2023. communities, and the nation as a whole.
Medicare and Medicaid Programs; FOR FURTHER INFORMATION CONTACT: Over a year ago, in September 2021,
Policy and Regulatory Changes to the For press inquiries: CMS Office of COVID–19 overtook the 1918 influenza
Omnibus COVID–19 Health Care Staff Communications, Department of Health pandemic as the deadliest disease in
Vaccination Requirements; Additional and Human Services, press@ American history.3 According to the
Policy and Regulatory Changes to the cms.hhs.gov. Centers for Disease Control and
Requirements for Long-Term Care For technical inquiries: CMS Center Prevention (CDC), just over 6 million
(LTC) Facilities and Intermediate Care for Clinical Standards and Quality, patients admitted to hospitals in the
Facilities for Individuals With Department of Health and Human United States have been confirmed
Intellectual Disabilities (ICFs–IID) To Services, (410)786–6633. positive with COVID–19 infection since
Provide COVID–19 Vaccine Education SUPPLEMENTARY INFORMATION: August 1, 2020, and approximately 1.1
and Offer Vaccinations to Residents, million COVID–19 deaths have been
Clients, and Staff; Policy and I. Background reported in the United States as of April
Regulatory Changes to the Long Term A. Introduction 14, 2023. In light of our responsibility
Care Facility COVID–19 Testing to protect the health and safety of
On January 30, 2020, the International individuals receiving care and services
Requirements
Health Regulations Emergency from Medicare- and Medicaid-certified
AGENCY: Centers for Medicare and Committee of the World Health providers and suppliers, and CMS’
Medicaid Services (CMS), Department Organization (WHO) declared the statutory authority, as outlined in
of Health and Human Services (HHS). ‘‘coronavirus disease 2019’’ (COVID–19) section I.E. of this final rule, to establish
ACTION: Final rule. outbreak caused by ‘‘severe acute health and safety regulations, we have
respiratory syndrome coronavirus 2’’ been compelled to act throughout the
SUMMARY: This final rule removes (SARS–CoV–2) a ‘‘Public Health COVID–19 pandemic. While a
expired language addressing staff and Emergency of International Concern.’’ comprehensive discussion of CMS’
patient COVID–19 testing requirements On January 31, 2020, pursuant to regulatory responses during the PHE is
for LTC Facilities issued in the interim section 319 of the Public Health Service outside the scope and purpose of this
final rule with comment ‘‘Medicare and Act (PHSA) (42 U.S.C. 247d), the final rule, we note that CMS issued
Medicaid Programs, Clinical Laboratory Secretary of the Department of Health several interim final rules with
Improvement Amendments (CLIA), and and Human Services (Secretary) comment periods (IFCs) during the
Patient Protection and Affordable Care determined that a public health
ddrumheller on DSK120RN23PROD with RULES1
COVID–19 PHE to help minimize the
Act; Additional Policy and Regulatory emergency (PHE) exists for the United
Revisions in Response to the COVID–19 States. On March 11, 2020, the WHO 1 https://aspr.hhs.gov/legal/PHE/Pages/Public-
Public Health Emergency’’ published in publicly declared COVID–19 a Health-Emergency-Declaration.aspx.
2 https://aspr.hhs.gov/legal/PHE/Pages/
the September 2, 2020 Federal Register. pandemic. The President of the United
default.aspx.
The rule also finalizes requirements for States declared the COVID–19 pandemic 3 https://www.statnews.com/2021/09/20/covid-
these facilities to provide education a national emergency on March 13, 19-set-to-overtake-1918-spanish-flu-as-deadliest-
about COVID–19 vaccines and to offer 2020. Pursuant to section 319 of the disease-in-american-history/.
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36486 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations
spread and impact of SARS–CoV–2. Facilities for Individuals with the ‘‘educate and offer’’ provisions.
Some of these IFCs established new Intellectual Disabilities (ICFs–IID) Nonetheless, evidence continued to
health and safety standards, known as Residents, Clients, and Staff’’ (86 FR demonstrate that unvaccinated health
the Conditions of Participation (CoPs), 26306), otherwise known as the care staff presented risks to patient
Conditions for Coverage (CfCs), or ‘‘educate and offer IFC.’’ This IFC safety across health care settings, and
Requirements for Participation, for revised the requirements for LTC that too few health care staff were
providers and suppliers who participate facilities and CoPs for ICFs–IID to getting vaccinated. At the same time, the
in the Medicare and Medicaid programs. require the provision of COVID–19 advent of a more contagious and severe
Several of the policies in these IFCs vaccination education and to offer variant (Delta)—and the recognition that
have been further addressed in final vaccines to residents, clients, and staff. additional variants were likely to
rules and through the COVID–19 The IFC also revised the infection emerge and, together with seasonal
vaccination quality measures which control requirements for LTC facilities respiratory illnesses, increased the
have been proposed for adoption in to include COVID–19 data reporting. We pressure on the health care system—
multiple CMS quality reporting and subsequently finalized data reporting indicated a need for CMS to take
payment programs (for example, the requirements for LTC facilities with additional action.
‘‘Measures Under Consideration’’ (MUC) revisions in the final rule ‘‘Medicare Accordingly, we issued the staff
List issued by CMS on December 1, and Medicaid Programs; CY 2022 Home vaccination IFC, which required most
2022). These IFCs, final rules, and Health Prospective Payment System Medicare- and Medicaid-certified
quality reporting and payment programs Rate Update; Home Health Value-Based providers and suppliers to ensure health
reflect the scaled progression of CMS’ Purchasing Model Requirements and care staff completed their COVID–19
response during the COVID–19 PHE as Model Expansion; Home Health and primary vaccine series. As discussed in
both the science and epidemiology Other Quality Reporting Program the educate and offer IFC and the staff
pertaining to COVID–19 evolved. Requirements; Home Infusion Therapy vaccination IFCs, COVID–19
On September 2, 2020, we issued an Services Requirements; Survey and vaccination is one of the most important
IFC titled ‘‘Medicare and Medicaid Enforcement Requirements for Hospice tools in the multi-pronged approach for
Programs, Clinical Laboratory Programs; Medicare Provider reducing health system burden,
Improvement Amendments (CLIA), and Enrollment Requirements; and COVID– safeguarding health care workers and
Patient Protection and Affordable Care 19 Reporting Requirements for Long- the people they serve, and mitigating
Act; Additional Policy and Regulatory Term Care Facilities,’’ published in the the overall impact of the COVID–19
Revisions in Response to the COVID–19 November 9, 2021 Federal Register (86 pandemic. Food and Drug
Public Health Emergency’’ (85 FR FR 62240, 62421) (‘‘calendar year (CY) Administration (FDA)-approved and
54820), otherwise known as the ‘‘LTC 2022 Home Health final rule’’). These FDA-authorized COVID–19 vaccines in
facility testing IFC.’’ This IFC revised revisions established a sunset date for use in the United States are both safe
regulations to strengthen CMS’ ability to most COVID–19 reporting requirements and highly effective at protecting
enforce compliance with Medicare and for LTC facilities. Specifically, LTC vaccinated people against severe
Medicaid long-term care facility facilities must report all required data COVID–19.4 5
requirements for reporting information until December 31, 2024, as determined As conditions and circumstances of
related to COVID–19, established a new by the Secretary. the COVID–19 PHE have evolved, so too
requirement for hospitals and critical On November 5, 2021, we issued the has CMS’ response. At this point in
access hospitals (CAHs) to track the interim final rule ‘‘Medicare and time, we believe that the risks targeted
incidence and impact of COVID–19, and Medicaid Programs; Omnibus COVID– by the staff vaccination IFC have been
established a new requirement for LTC 19 Health Care Staff Vaccination’’ (86 largely addressed, so we are now
facilities to test residents and staff for FR 61555), otherwise known as the aligning our approach with those for
COVID–19 applicable for the duration of ‘‘staff vaccination IFC.’’ This IFC revised other infectious diseases, specifically
the PHE. We subsequently finalized the requirements that most Medicare- influenza. Accordingly, CMS intends to
provisions addressing the hospital and and Medicaid-certified providers and encourage ongoing COVID–19
CAH COVID–19 reporting requirements suppliers must meet to participate in the vaccination through its quality reporting
in the final rule ‘‘Medicare Program; Medicare and Medicaid programs to and value-based incentive programs in
Hospital Inpatient Prospective Payment include requirements regarding the near future. The statute requires that
Systems for Acute Care Hospitals and development and implementation of the Secretary establish a pre-rulemaking
the Long-Term Care Hospital policies and procedures to ensure process for the selection of certain
Prospective Payment System and Policy COVID–19 vaccination of staff. quality measures for use by HHS.6 The
Changes and Fiscal Year 2023 Rates; Throughout the COVID–19 PHE, we pre-rulemaking process requires that
Quality Programs and Medicare implemented and revised regulations to HHS make publicly available, not later
Promoting Interoperability Program reflect lessons learned and emerging than December 1 annually, a list of
Requirements for Eligible Hospitals and data and knowledge to protect the quality and efficiency measures HHS is
Critical Access Hospitals; Costs Incurred health and safety of individuals that considering to adopt, through the
for Qualified and Non-Qualified receive care and services from rulemaking process, for use in certain
Deferred Compensation Plans; and Medicare- and Medicaid-certified Medicare quality programs and for use
Changes to Hospital and Critical Access providers and suppliers. For example, in publicly reported performance
Hospital Conditions of Participation’’ on the educate and offer IFC-required LTC information in any Medicare program.
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August 10, 2022 (87 FR 48780) (‘‘FY facilities and ICFs–IID that furnish care This list is known as the Measures
2023 Hospital Inpatient Prospective and services to populations identified at
Payment System final rule’’). increased risk for severe health 4 https://www.cdc.gov/coronavirus/2019-ncov/
On May 13, 2021, we issued an IFC outcomes due to COVID–19 infection, to vaccines/safety.html.
5 https://www.cdc.gov/coronavirus/2019-ncov/
titled ‘‘Medicare and Medicaid provide COVID–19 vaccination
vaccines/effectiveness/index.html.
Programs; COVID–19 Vaccine education and to offer vaccines to 6 See section 1890A(a) of the Act (42 U.S.C.
Requirements for Long-Term Care (LTC) residents, clients, and staff. These 1395aaa–1(a)) and section 1890(b)(7)(B) of the Act
Facilities and Intermediate Care requirements are generally referred to as (42 U.S.C. 1395aaa(b)(7)(B)).
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Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations 36487
Under Consideration (MUC) List. Table mRNA vaccines no longer refer to vaccines. The use of such quality
1 shows the COVID–19 vaccination ‘‘primary series’’ and ‘‘booster’’ doses. measures may ultimately affect ratings
measures under consideration, as In addition, previously unvaccinated on the various ‘‘Compare’’ (such as
published on December 1, 2022, for individuals 6 years through 64 years of ‘‘Hospital Compare’’) websites and may
patients and health care personnel, age (other than those with certain affect payment in various ‘‘value-based
including measure title, measure immunocompromising conditions) are purchasing’’ programs, but would not
description, and applicable quality only authorized to receive a single dose affect the ability of the provider or
programs. We note that on April 18, of a COVID–19 vaccine. They will not supplier to participate in the Medicare
2023, FDA revised the Emergency Use receive an mRNA ‘‘series.’’ These program. Information about the MUC
Authorizations (EUAs) for the Pfizer and measures may be revised from their List is available on the CMS Measures
Moderna mRNA vaccines to make initial design but we include the MUCs Management System (MMS) website at
several changes to the authorized dosing here as an illustration of CMS’s interest https://mmshub.cms.gov/measure-
regimen and schedule.7 Among other in pursuing implementation of measures lifecycle/measure-implementation/pre-
changes, the revised EUAs for the that encourage uptake of COVID–19 rulemaking/lists-and-reports.
TABLE 1—COVID–19 VACCINATION MUC FOR USE IN CERTAIN MEDICARE QUALITY PROGRAMS AS PUBLISHED
DECEMBER 1, 2022
Measure Description Quality programs
Adult COVID–19 Vaccination Status Percentage of patients aged 18 Merit-based Incentive Payment System (MIPS).
years and older seen for a visit
during the performance period
who have ever completed or re-
ported having ever completed a
COVID–19 vaccination series
and one booster dose.
COVID–19 Vaccination Coverage Percentage of healthcare per- Ambulatory Surgical Center Quality Reporting Program (ASCQR).
Among Healthcare Personnel sonnel who are considered up- Hospital Inpatient Quality Reporting Program (Hospital IQR Program).
(HCP) (2022 revision). to-date on their COVID–19 vac- Hospital Outpatient Quality Reporting Program (Hospital OQR Pro-
cinations per the CDC’s latest gram).
guidance. 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 Re-
porting Program (PCHQRP).
Skilled Nursing Facility Quality Reporting Program (SNFQRP).
End-Stage Renal Disease Quality Incentive Program (ESRD QIP).
COVID–19 Vaccine: Percent of Pa- Percentage of patients who are Home Health Quality Reporting Program (Home Health QRP).
tients/Residents Who Are Up to considered up-to-date on their SNFQRP.
Date. COVID–19 vaccinations per the IRFQRP.
CDC’s latest guidance. LTCHQRP.
Quality measures would provide a regulations shall not exceed 3 years after receive care and services from
means to monitor COVID–19 publication of the preceding proposed Medicare- and Medicaid-certified
vaccination rates among patients and or interim final regulation, except under providers and suppliers.
health care personnel in multiple exceptional circumstances. Thus, This final rule addresses the
entities across the health system, consistent with section 902 of the MMA, disposition of regulations issued
including inpatient, outpatient, the requirements of the IFCs discussed
through three IFCs, specifically: the
congregate care, and home-based care in this rule would have expired if not
health care staff vaccination
settings. Moreover, public reporting of finalized within 3 years of publication.
quality measures increases the As the COVID–19 pandemic has requirements issued in the staff
involvement of leadership in quality continued to evolve and circumstances vaccination IFC; the education and
improvement, creates a sense of have normalized, we have continued to vaccine offering requirements issued in
accountability, helps to focus evaluate the evolving clinical and the educate and offer IFC; and the LTC
organizational priorities, supports epidemiological circumstances of the testing IFC. Due to the broad scope and
transparency, and provides a means of COVID–19 pandemic and the scale of the Omnibus COVID–19 Health
delivering important information to requirements issued in the IFCs, Care Staff Vaccination IFC (staff
consumers.8 particularly those requirements that vaccination IFC), we discuss it as the
As discussed further in section I.E. of have not been finalized to date, for the primary focus for policies addressed in
ddrumheller on DSK120RN23PROD with RULES1
this final rule, section 902 of the purpose of determining the appropriate this rule. Thus, throughout this
Medicare Prescription Drug, disposition of those requirements. The document, we address the staff
Improvement, and Modernization Act of central consideration in our evaluation vaccination IFC first followed by the
2003 (MMA) requires that the and determination is helping to protect educate and offer IFC and the LTC
publication of Medicare final the health and safety of individuals that testing IFC.
7 https://www.fda.gov/news-events/press- authorizes-changes-simplify-use-bivalent-mrna- 8 https://qualitynet.cms.gov/inpatient/public-
announcements/coronavirus-covid-19-update-fda- covid-19-vaccines. reporting/public-reporting.
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36488 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations
B. Omnibus COVID–19 Health Care to protect the health and safety of SARS–CoV–2 and developing severe
Staff Vaccination residents, clients, patients, and PACE health outcomes due to COVID–19,10 11
On November 5, 2021, we published Organization participants at the time of and they rely on facility staff to provide
the staff vaccination IFC, which revised publication, circumstances of the for their daily needs, including access to
the health and safety requirements that COVID–19 pandemic have evolved, as health care services such as vaccination.
most providers and suppliers must meet has CMS’ response, as discussed As discussed in section III.B. of this
to participate in the Medicare and throughout this rule. As mentioned rule, public commenters acknowledge
Medicaid programs. The revisions above, based on an evaluation of the these risks. Consistent with our
established requirements regarding evolving clinical and epidemiological approach to staff vaccinations for
COVID–19 staff vaccination for the circumstances of the COVID–19 COVID–19, we are moving to align our
Medicare- and Medicaid-certified pandemic, increased vaccine uptake, approach with existing regulations
providers and suppliers included in the declining infection and death rates, addressing other infectious diseases,
IFC. The following providers and decreasing severity of disease, increased such as influenza and pneumococcal
instances of infection-induced disease. Therefore, we are finalizing the
suppliers were regulated by the staff
immunity, public comments submitted educate and offer requirements on a
vaccination IFC, listed in the numerical
to CMS, and the addition of COVID–19 permanent basis. This complements the
order of the relevant Code of Federal
vaccination quality measures to quality proposed adoption of the ‘‘COVID–19
Regulations (CFR) sections:
• Ambulatory Surgical Centers improvement and reporting programs, Vaccine: Percent of Patients/Residents
(ASCs)—§ 416.51(c). we believe regulations regarding Who are Up to Date (Patient/Resident
• Hospices—§ 418.60(d). COVID–19 vaccination of health care COVID–19 Vaccine) measure’’ and the
• Psychiatric Residential Treatment staff are no longer necessary. Therefore, ‘‘COVID–19 Vaccination Coverage
Facilities (PRTFs)—§ 441.151(c). in this rule, we are withdrawing among Healthcare Personnel (HCP
• Programs of All-Inclusive Care for language on COVID–19 health care staff COVID–19 Vaccine) measure’’ as issued
the Elderly (PACE) Organizations— vaccination requirements issued in the in the ‘‘Medicare Program; Prospective
§ 460.74(d). staff vaccination IFC. COVID–19 Payment System and Consolidated
• Hospitals (acute care hospitals, vaccination policies and procedures for Billing for Skilled Nursing Facilities
psychiatric hospitals, hospital swing health care staff will no longer be (SNF); Updates to the Quality Reporting
beds, long term care hospitals, required under the CoPs, CfCs, and Program and Value-Based Purchasing
children’s hospitals, transplant centers, requirements. Program for Federal Fiscal Year 2024’’
cancer hospitals, and rehabilitation proposed rule (88 FR 21316) (‘‘2024
C. COVID–19 Vaccine ‘‘Educate and SNF Prospective Payment System
hospitals/inpatient rehabilitation
Offer’’ Requirements for LTC Facilities proposed rule’’). Given that the educate
facilities)—§ 482.42(g).
• LTC Facilities, including skilled and ICFs–IID and offer provisions are existing
nursing facilities (SNFs) and nursing On May 13, 2021, CMS issued the requirements for LTC facilities and
facilities (NFs), generally referred to as educate and offer IFC, which revised the ICFs–IID, the requirements will remain
nursing homes—§ 483.80(i). health and safety requirements that LTC effective after the publication date of
• ICFs–IID—§ 483.430(f). facilities and ICFs–IID must meet to this final rule.
• Home Health Agencies (HHAs)— participate in the Medicare and D. COVID–19 Testing Requirement for
§ 484.70(d). Medicaid programs. The IFC established LTC Facilities
• Comprehensive Outpatient requirements that these facilities
Rehabilitation Facilities (CORFs)— provide COVID–19 vaccination On September 2, 2020, CMS
§ 485.70(n). education to residents, clients, and staff, published the LTC facility testing IFC,
• Critical Access Hospitals (CAHs)— and to offer COVID–19 vaccines to these which revised the infection control
§ 485.640(f). populations, referred to as the ‘‘educate requirements that LTC facilities must
• Clinics, Rehabilitation Agencies, and offer’’ provisions. The IFC also meet to participate in the Medicare and
and Public Health Agencies as Providers established additional infection control Medicaid programs. This IFC
of Outpatient Physical Therapy and requirements for LTC facilities, as well established requirements applicable for
Speech-language Pathology Services as requirements to report certain the duration of the PHE for LTC
(Organizations)—§ 485.725(f). COVID–19 data: these requirements facilities to test their staff and residents
• Community Mental Health Centers have already been finalized through for COVID–19 based on parameters set
(CMHCs)—§ 485.904(c). previous rulemaking (86 FR 62240).9 We forth by the Secretary in a manner
• Home Infusion Therapy (HIT) consistent with current professional
discuss these educate and offer
Suppliers—§ 486.525(c). standards of practice. This IFC also
provisions of the IFC in section II.B. of
• Rural Health Clinics (RHCs) and established COVID–19 reporting
this rule. In section III.B. of this final
Medicare Federally Qualified Health requirements for hospitals and CAHs
rule, we address the public comments
Centers (FQHCs)—§ 491.8(d). which have been finalized through
• End-Stage Renal Disease (ESRD) submitted to CMS regarding the educate
and offer provisions. We then discuss previous rulemaking (87 FR 48780). As
Facilities—§ 494.30(b). previously discussed, LTC facility
We discuss the specific requirements the final regulatory changes pertaining
to the educate and offer provisions in residents are more susceptible to
of the staff vaccination IFC in section contracting COVID–19 and developing
II.A. of this rule. In section III.A. of this section IV.B. of this final rule.
Individuals living in congregate care severe symptoms. This highlights the
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final rule, we address the public
comments submitted to CMS regarding settings, such as LTC facilities and 10 https://www.cdc.gov/coronavirus/2019-ncov/
the staff vaccination IFC. We then ICFs–IID, are at greater risk than the your-health/understanding-risk.html?CDC_AA_
discuss the withdrawal of regulations general population for contracting refVal=https%3A%2F%2Fwww.cdc.gov
%2Fcoronavirus%2F2019-ncov%2Fneed-extra-
pertaining to the staff vaccination IFC in 9 https://www.federalregister.gov/documents/ precautions%2Findex.html.
section IV.A. of this rule. 2021/11/09/2021-23993/medicare-and-medicaid- 11 https://www.cdc.gov/coronavirus/2019-ncov/
While the requirements established by programs-cy-2022-home-health-prospective- community/community-congregate-living-
the staff vaccination IFC were necessary payment-system-rate-update-home. settings.html.
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Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations 36489
importance of practicing preventative the LTC facility testing requirements of Although the wording of such authority
measures in order to mitigate the risk of the IFC in section II.C. of this rule. In differs slightly between provider and
transmission and control the spread of section III.C. of this final rule, we supplier types, we have interpreted all
COVID–19 among residents and staff of address the public comments submitted of these provisions as at minimum
LTC facilities. At the time of to CMS regarding the LTC facility permitting the Secretary to establish
publication, these provisions were testing requirements. We then discuss mandatory requirements to enhance the
necessary to protect the health and the final regulatory changes pertaining health and safety of patients. In
safety of both residents and health care to the educate and offer provisions in addition, parallel Medicaid statutes
personnel of LTC facilities, as there section IV.C. of this final rule. provide authority to establish
were limited treatments for COVID–19 requirements to protect the health and
E. Statutory Authority
and vaccines were not yet available. As safety of patients. Such requirements
the COVID–19 PHE has concluded, we Various sections of the Social Security include the CoPs for providers, CfCs for
are deleting expired text related to the Act (the Act) define the types of suppliers, and requirements for LTC
LTC facility testing requirements providers and suppliers that may facilities. The CoPs, CfCs, and
effective the publication date of this participate in Medicare and Medicaid requirements are intended to protect
final rule. programs and list the requirements that public health and safety and promote
CMS continues to emphasize the each provider and supplier must meet to high-quality care for all persons.
importance of practicing preventative be eligible for participation. Statutory Furthermore, the PHSA sets forth
measures in order to reduce the provisions applicable to each provider additional regulatory requirements that
transmission of COVID–19. Moving or supplier type either authorize the certain Medicare providers and
forward, CMS aims to use quality Secretary to establish other suppliers are required to meet in order
reporting and value-based incentive requirements as necessary to protect the to participate. Table 2 lists the statutory
programs to encourage health care health and safety of patients or, in some authority by provider and supplier type
facilities to practice preventative cases, to establish such additional for which we are issuing the
measures against COVID–19. We discuss criteria as the Secretary may require. 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 Facilities (PRTFs) .............................. Section 1905(h)(1) of the Act.
Programs of All-Inclusive Care for the Elderly (PACE) Organizations .... Sections 1894(f), and 1934(f) 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 Individuals with Intellectual Disabilities Section 1905(d)(1) of the Act.
(ICFs–IID).
Home Health Agencies (HHAs) ................................................................ Sections 1861(m), 1861(o), and 1891 of the Act.
Comprehensive Outpatient Rehabilitation Facilities (CORFs) ................. Section 1861(cc)(2)(J) of the Act.
Critical Access Hospitals (CAHs) ............................................................. Section 1820(e)of the Act.
Clinics, Rehabilitation Agencies, and Public Health Agencies as Pro- Section 1861(p)(4)(A)(v) of the Act.
viders of Outpatient Physical Therapy and Speech-Language Pathol-
ogy 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 Qualified Health Centers Sections 1861(aa) and 1905(l)(2)(B) of the Act.
(FQHCs).
End-Stage Renal Disease (ESRD) Facilities ........................................... Section 1881(b)(1)(A) of the Act.
We note that the appropriate term for organization, or program), when we are vary but shall not exceed 3 years after
an individual receiving care and discussing three or more provider and publication of the preceding proposed
services differs depending upon the supplier types, we use the general term or interim final regulation except under
provider or supplier type. For example, ‘‘facility.’’ exceptional circumstances.
for hospitals and CAHs, the appropriate This final rule withdraws the
F. Requirements for Issuance of
term is ‘‘patient,’’ but for ICFs–IID, it is regulatory provisions set forth on
Regulations
‘‘client.’’ Further, LTC facilities have November 5, 2021, in the Omnibus
‘‘residents’’ and PACE Organizations Section 902 of the MMA amended COVID–19 Health Care Staff
have ‘‘participants.’’ In this final rule, section 1871(a) of the Act and requires Vaccination IFC and deletes expired
the appropriate terms are used when the Secretary, in consultation with the provisions set forth on May 13, 2021, in
discussing one or two provider or Director of the Office of Management
ddrumheller on DSK120RN23PROD with RULES1
the LTC facility testing IFC. Also, this
supplier types; however, when we are and Budget, to establish and publish final rule finalizes the ‘‘educate and
discussing three or more provider and timelines for the publication of offer’’ provisions set forth on May 13,
supplier types, we use the general term Medicare final regulations based on the 2021, in the COVID–19 Vaccine
‘‘patient.’’ Similarly, despite the previous publication of a Medicare
Requirements for LTC Facilities and
different terms used for specific proposed or interim final regulation.
ICFs–IID Residents, Clients, and Staff
provider and supplier entities (such as Section 902 of the MMA also states that
IFC. This final rule has been published
campus, center, clinic, facility, the timelines for these regulations may
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36490 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations
within the 3-year time limit imposed by contract or arrangement, that provide health care provider, electronic health
section 902 of the MMA. any care, treatment, or other services for record, State immunization information
the facility or its patients, regardless of system record, or a reasonable
G. Enforcement of Staff Vaccination
clinical responsibility or degree of equivalent for those individuals
Provisions
anticipated patient contact. Vaccination vaccinated outside of the United States.
Federal rules generally become is required for all staff that interact with Further, through the IFC, we required
effective 60 days after publication; other staff or patients in any location, facilities to establish and implement a
however, the COVID–19 PHE expired on such as clinics, homes, or other sites of process by which staff may request an
May 11, 2023. Our decision to terminate care and services. exemption from the COVID–19
the omnibus facility staff vaccination As discussed in the IFC, some staff are vaccination requirement based on: (1)
requirements in this final rule reflect not subject to the vaccination an applicable Federal law, such as the
our determination that the emergency requirements, including but not limited ADA, section 504 of the Rehabilitation
circumstances which occasioned these to those who provide services 100 Act, section 1557 of the Affordable Care
vaccination provisions no longer exist. percent remotely and ‘‘one-off’’ vendors, Act (ACA), and Title VII of the Civil
Since facilities are no longer operating volunteers, and professionals who Rights Act that prohibit discrimination
under PHE circumstances, and infrequently provide ad hoc non-health based on race, color, national origin,
considering the lower policy priority of care services, such as annual elevator religion, disability, and sex, including
enforcement within the remaining time, inspection, delivery, and repair pregnancy; and (2) recognized clinical
we will not be enforcing the staff personnel. When determining whether contraindications to receipt of a COVID–
vaccination provisions between now to require COVID–19 vaccination of an 19 vaccine. Facilities had to have a
and August 4, 2023. individual who does not clearly fall process for collecting and evaluating
within the classification of staff, we exemption requests, including tracking
II. Provisions of the Interim Final encouraged facilities to consider and securely documenting the required
Regulations frequency of presence, services information.
In this section, we review the provided, and proximity to patients and We acknowledged in the IFC that
requirements issued in the staff staff. We also strongly encouraged certain allergies or medical conditions
vaccination IFC, the educate and offer facilities to facilitate the vaccination of may be clinical contraindications to
IFC, and the LTC facility testing IFC. In all individuals who provide services receiving a COVID–19 vaccine, and we
section II.A. of this rule, we summarize infrequently and are not otherwise referred facilities to the CDC page ‘‘Use
and discuss the requirements of the staff subject to the requirements in the IFC to of COVID–19 Vaccines in the United
vaccination IFC. We then summarize the extent opportunity exists and States: Interim Clinical Considerations’’
and discuss the educate and offer resources allow. which can be accessed at https://
provisions in the educate and offer IFC In the IFC, we required facilities to www.cdc.gov/vaccines/covid-19/
in section II.B. of this final rule. Lastly, ensure that staff are ‘‘fully vaccinated’’ clinical-considerations/covid-19-
we summarize and discuss the LTC for COVID–19, defined as 2 weeks or vaccines-us.html. The IFC required
testing IFC in section II.C. of this final more since completion of a primary facilities to make contingency plans in
rule. vaccination series. We also required consideration of staff who are not ‘‘fully
facilities to have a process for tracking vaccinated’’ to ensure that those staff
A. Omnibus COVID–19 Health Care and securely documenting the COVID– will soon be vaccinated and will not
Staff Vaccination 19 vaccination status of staff who obtain provide care, treatment, or other
As discussed in section I. of this rule, any booster doses as recommended by services for the facility or its patients
we established COVID–19 staff the CDC. For those staff who are not until such time as those staff complete
vaccination requirements for most ‘‘fully vaccinated’’ for COVID–19, we a primary vaccination series for COVID–
Medicare- and Medicaid-certified required facilities to establish and 19 and are considered ‘‘fully
providers and suppliers in an IFC implement a process that provides vaccinated.’’ This planning must also
published in November 2021. Those additional precautions to minimize the address the safe provision of care and
provisions reflected a common set of spread of COVID–19. services by staff who request an
requirements with no substantive The IFC required facilities to track exemption from vaccination that is
regulatory differences across facility and securely document the vaccination under consideration and by staff for
types, added to the CoPs, CfCs, and status of each staff member. All medical whom COVID–19 vaccination must be
requirements, as applicable, under the records, including vaccine temporarily delayed, as recommended
relevant CFR section as listed in section documentation, were to be kept by the CDC, due to clinical reasons.
I.B. of this final rule. Next, we briefly confidential and stored separately from We discussed in the IFC that
discuss these common provisions. We an employer’s personnel files, pursuant contingency planning may extend
then discuss any additional revisions for to the Americans with Disabilities Act beyond the specific requirements of the
specific provider and supplier types (ADA) and the Rehabilitation Act. rule, to address topics such as staffing
issued by CMS in the staff vaccination We described these documentation agencies that can supply vaccinated
IFC due to unique circumstances. requirements in the IFC as an ongoing staff if some of a facility’s staff are
process due to the onboarding of new unable to work. We also discussed
1. Common Requirements in the Staff staff, and we provided examples of: (1) special precautions to be taken in the
Vaccination IFC appropriate places for vaccine event of, for example, a regional or local
The IFC requires each applicable documentation, such as an emergency declaration, such as for a
ddrumheller on DSK120RN23PROD with RULES1
facility to develop and implement immunization record, health hurricane or flooding, which
policies and procedures under which information files, or other relevant necessitated the temporary utilization of
staff complete a primary COVID–19 documents; and (2) acceptable forms of unvaccinated staff, in order to assure the
vaccine series. Those vaccination proof of vaccination, such as a CDC health and safety of patients. We also
policies and procedures must apply to COVID–19 vaccination record card (or a acknowledged in the IFC that facilities
current and new staff, to include legible photo of the card) or may already have contingency plans
volunteers and individuals under documentation of vaccination from a that meet the requirements in their
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Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations 36491
existing emergency preparedness III.B., IV.B., V.B, and VI.B. of this final Purchasing Model Requirements and
policies and procedures. rule for additional information. Model Expansion; Home Health and
Regulations in place at the time that Other Quality Reporting Program
2. Additional Requirements in the Staff the staff vaccination IFC was published Requirements; Home Infusion Therapy
Vaccination IFC for Specific Provider for CORFs at 42 CFR 485.70(a) through Services Requirements; Survey and
and Supplier Types (m) identified the qualifications Enforcement Requirements for Hospice
In addition to the common set of required for personnel, including Programs; Medicare Provider
provisions issued in the staff facility physician, licensed practical Enrollment Requirements; and COVID–
vaccination IFC for all applicable nurse, occupational therapist, 19 Reporting Requirements for Long-
facility types, we varied specific occupational therapist assistant, Term Care Facilities’’ final rule (86 FR
provisions of the regulations, where orthotist, physical therapist, physical 62240), we finalized the LTC facility
applicable, for specific provider and therapist assistant, prosthetist, reporting requirements from the educate
supplier types. These various provisions psychologist, registered nurse, and offer IFC at § 483.80(g)(1) through
for specific provider and supplier types rehabilitation counselor, respiratory (3) with some minor modifications.12
were necessary due to the unique therapist, respiratory therapy Given that this final rule addresses only
content of regulations in place at the technician, social worker, and speech- the ‘‘educate and offer’’ provisions of
time the staff vaccination IFC was language pathologist. In addition, the IFC, this section provides a
published, for Psychiatric Residential regulations at § 485.58(d)(4) stated that summary of those specific requirements.
Treatment Facilities (PRTFs), HIT personnel who do not meet the
suppliers, RHCs/FQHCs; LTC facilities qualifications specified in § 485.70 may 1. LTC Facilities
and ICFs–IID; and CORFs. be used by the facility in assisting For LTC facilities, the educate and
As discussed in the staff vaccination qualified staff. In the staff vaccination offer IFC established 42 CFR
IFC, PRTFs, HIT Suppliers, and RHCs/ IFC, we added § 485.70(n) which 483.80(d)(3) COVID–19 immunizations,
FQHCs did not have specific infection requires CORFs to develop and under which facilities must develop and
control and prevention regulations at implement policies and procedures to implement policies and procedures to
the time the IFC was published. ensure COVID–19 vaccination of all ensure that all of the requirements set
Therefore, for PRTFs at facility staff. As discussed in the IFC, forth in that section are followed. Before
§ 441.151(c)(3)(iii), HIT suppliers at we recognize that assisting personnel offering a COVID–19 vaccine, all
§ 486.525(c)(3)(iii), and RHCs/FQHCs at are used by CORFs, and we established residents, resident representatives, and
§ 491.8(d)(3)(iii), we required a process our requirements at § 485.70(a) through staff members are provided with
for ensuring adherence to nationally (m) to provide a role for personnel that education regarding the benefits, risks,
recognized infection prevention and might not meet our education and and potential side effects associated
control guidelines intended to mitigate experience qualifications. However, we with the vaccine. When a COVID–19
the transmission and spread of COVID– did not believe this exception for vaccine is available to the facility, each
19. This process included the employees who did not meet our resident and staff member is offered a
implementation of additional professional requirements should have COVID–19 vaccine unless the
precautions for all staff who were not prohibited us from issuing staff immunization is medically
fully vaccinated for COVID–19. qualifications referencing infection
At the time the staff vaccination IFC contraindicated or the resident or staff
prevention, which we intended to apply member has already been immunized.
was published, LTC facilities had to all personnel. Therefore, in the staff
existing regulations at § 483.80(d)(3)(v) In situations where COVID–19
vaccination IFC, we revised vaccination requires multiple doses, the
that required facilities to educate all § 485.58(d)(4) to state that personnel
residents and staff about the COVID–19 resident, resident representative, or staff
who did not meet the qualifications member is provided with current
vaccines and to offer the vaccines, when specified in § 485.70(a) through (m) may
available. Likewise, at the time the IFC information regarding those additional
be used by the facility in assisting doses, including any changes in the
was published, ICFs–IID had existing qualified staff.
regulations at § 483.460(a)(4)(v) that benefits or risks and potential side
As noted previously in this rule, we effects associated with the COVID–19
required facilities to educate all clients are withdrawing the provisions of the
and staff about the COVID–19 vaccines vaccine, before requesting consent for
staff vaccination IFC. administration of any additional doses.
and to offer the vaccine, when available.
As discussed in section I. of this final B. COVID–19 Vaccine ‘‘Educate and The regulation states that the resident
rule, those requirements were Offer’’ Requirements for LTC Facilities or resident representative has the
established by the educate and offer IFC. and ICFs–IID Residents, Clients, and opportunity to accept or refuse a
In the staff vaccination IFC, we revised Staff COVID–19 vaccine and change their
these requirements by removing As discussed in section I. of this final decision. The original regulatory
language that could have been rule, on May 13, 2021, CMS issued the provisions as issued by the educate and
interpreted as a path by which staff educate and offer IFC. This IFC revised offer IFC also permitted staff members
members in LTC facilities and ICFs–IID the requirements for LTC facilities and to refuse vaccination. However, as
could bypass the facility’s vaccination CoPs for ICFs–IID to provide COVID–19 discussed in section II.A. of this final
policies and procedures. This change vaccination education and to offer rule, the reference to staff members in
was necessary because retaining that vaccines to residents, clients, and staff, the refusal provision at § 483.80(d)(3)(v)
language originally established by the was removed by the staff vaccination
ddrumheller on DSK120RN23PROD with RULES1
otherwise known as the ‘‘educate and
educate and offer IFC would have been offer’’ provisions. This IFC also IFC published November 5, 2021. The
inconsistent with the goals of the staff established requirements for COVID–19 resident’s medical record is documented
vaccination IFC. In this final rule, we data reporting in LTC facilities. to reflect, at a minimum, that the
are finalizing the education and offering Subsequently, in the ‘‘Medicare and 12 https://www.federalregister.gov/documents/
provisions of the educate and offer IFC, Medicaid Programs; CY 2022 Home 2021/11/09/2021-23993/medicare-and-medicaid-
as amended by the staff vaccination IFC, Health Prospective Payment System programs-cy-2022-home-health-prospective-
and we refer readers to sections I., II.B., Rate Update; Home Health Value-Based payment-system-rate-update-home.
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36492 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations
resident or resident representative was maintains documentation related to staff also ensure that the client’s medical
provided education regarding the COVID–19 vaccination. The record is documented with, at a
benefits and potential risks associated documentation must include, at a minimum, that the client or client’s
with COVID–19 vaccine; each dose of minimum, evidence that staff were representative was provided education
COVID–19 vaccine administered to the informed about the risks and benefits of regarding the benefits and risks and
resident; or, if the resident did not the COVID–19 vaccine. The facility potential side effects of COVID–19
receive a COVID–19 vaccine due to must also document that staff were vaccine and each dose of a COVID–19
medical contraindications or refusal. either offered the COVID–19 vaccine or vaccine administered to the client. The
For staff members, the facility maintains provided with information on acquiring ICF–IID must also document if the client
documentation related to COVID–19 the COVID–19 vaccine. Lastly, the staff’s did not receive a COVID–19 vaccine due
vaccination that includes, at a COVID–19 vaccine statuses and any to medical contraindications or refusal.
minimum, that staff were provided associated information must be In this final rule, we are finalizing the
education regarding the benefits and documented and reported to the NHSN requirements for COVID–19 vaccination
potential risks associated with COVID– as indicated by CDC. of facility staff and ‘‘educate and offer’’
19 vaccines; were offered a COVID–19 process that ICFs–IID must meet to
2. ICFs–IID participate in the Medicare and
vaccine or information on obtaining a
COVID–19 vaccine; and the COVID–19 For ICFs–IID, the educate and offer Medicaid programs, as first set out in
vaccine status of staff and related IFC established § 483.430(f), ‘‘COVID–19 the educate and offer IFC and amended
information as indicated by the CDC’s Vaccination of facility staff,’’ and by the staff vaccination IFC. By doing
National Healthcare Safety Network § 483.460(a)(4), the educate and offer so, ICFs–IID must continue to educate
(NHSN). provisions. Section 483.430(f) requires clients, client representatives, and staff
In this final rule, we are finalizing the that each ICF–IID maintain about COVID–19 vaccines and offer a
infection control requirements that LTC documentation related to its staff that COVID–19 vaccine to residents and
facilities must meet to participate in the includes, at a minimum, documentation staff, as well as document these
Medicare and Medicaid programs as that the staff were provided education activities.
issued in the educate and offer IFC and regarding the benefits and risks and Since the COVID–19 pandemic began,
amended by the staff vaccination IFC. potential side effects associated with the and as noted above for LTC facilities,
By doing so, LTC facilities must COVID–19 vaccine and were offered a many States have passed laws regarding
continue to educate residents, resident COVID–19 vaccine or information on COVID–19 vaccination.15 Some States
representatives, and staff about COVID– obtaining the COVID–19 vaccine. have required various individuals to
19 vaccines and offer a COVID–19 Section 483.460(a)(4) requires each ICF– take the vaccine while other States have
vaccine to residents, resident IID to develop and implement policies prohibited requiring COVID–19
representatives, and staff, as well as and procedures to ensure that when a vaccination. Since ICF–IID staff may be
complete the appropriate COVID–19 vaccine is available to the required to take a COVID–19 vaccine in
documentation for these activities. This facility; each client and staff member is some States, or by some employers, we
aligns with the newly-proposed resident offered the COVID–19 vaccine unless believe it is inappropriate to include
and patient vaccination measures as the immunization is medically explicit permission to refuse in the
proposed in the 2024 SNF Prospective contraindicated or the client or staff regulations. As we stated above in
Payment System proposed rule.13 member has already been immunized. section II.B.1. of this final rule,
Since the COVID–19 pandemic began, Before offering a COVID–19 vaccine, all reinstating language that directly allows
many States have passed laws regarding staff members, clients, and client staff to refuse a COVID–19 vaccine
COVID–19 vaccination.14 Some States representatives must be provided with would be contrary to the goals of these
have required various individuals to education regarding the benefits and IFCs, to protect the health and safety of
take the vaccine while other States have risks and potential side effects clients and staff in in ICFs–IID. One’s
prohibited the requirement of COVID– associated with the vaccine. In ability to be exempt from a vaccination
19 vaccination. Since LTC facility staff situations where COVID–19 vaccination requirement per another statute (such as
may be required to take a COVID–19 requires multiple doses, the client, the ADA) is outside the scope and
vaccine in some States, or by some client’s representative, or staff member authority of this rulemaking. Hence, we
employers, we believe it is must be provided with current are finalizing the refusal provision as
inappropriate to include explicit information regarding each additional amended by the staff vaccination IFC.
permission to refuse in the regulations. dose, including any changes in the
C. COVID–19 Testing Requirement for
In addition, as we noted in the staff benefits or risks and potential side
LTC Facilities
vaccination IFC, retaining this language effects associated with a COVID–19
vaccine, before requesting consent for In the LTC facility testing IFC, we
would be contrary to the goals of that revised the LTC facility infection
administration of each additional doses.
IFC, which included protecting the control requirements applicable for the
The regulation states that the client or
health and safety of residents, clients, duration of the PHE at § 483.80 to
client’s representative has the
and staff. Hence, we are finalizing the establish a new, term-limited
opportunity to accept or refuse a
provision as amended by the staff requirement that LTC facilities to test
COVID–19 vaccine and change their
vaccination IFC, which provides, at their facility residents and staff for
decision. The original regulatory
§ 483.80(d)(3)(vii) that the facility COVID–19, including individuals
provisions as issued by the educate and
providing services under arrangement
ddrumheller on DSK120RN23PROD with RULES1
13 https://www.cms.gov/newsroom/fact-sheets/
offer IFC also permitted staff members
fiscal-year-fy-2024-skilled-nursing-facility- to refuse vaccination. However, as and volunteers. We required that
prospective-payment-system-proposed-rule-cms- discussed in section II.A. of this final resident and staff testing in LTC
1779-p. rule, the reference to staff members in
14 Pekruhn, D and Abbasi, E. ‘‘Vaccine Mandates 15 Pekruhn, D and Abbasi, E. ‘‘Vaccine Mandates
the refusal provision at
by State: Who is, Who isn’t, and How?’’ Leading by State: Who is, Who isn’t, and How?’’ Leading
Age. https://leadingage.org/workforce-vaccine-
§ 483.8460(a)(4)(v) was removed by the Age. https://leadingage.org/workforce-vaccine-
mandates-state-who-who-isnt-and-how/. Published staff vaccination IFC published mandates-state-who-who-isnt-and-how/. Published
on January 19, 2022. Accessed on January 17, 2023. November 5, 2021. The ICF–IID must on January 19, 2022. Accessed on January 17, 2023.
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Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations 36493
facilities for COVID–19 be conducted for individuals who are providing 11, 2023, these requirements are no
based on parameters set forth by the services under arrangement at the longer applicable.
Secretary, applicable during the facility. Consistent with the III. Analysis of and Responses to Public
COVID–19 PHE. These requirements documentation requirements we Comments
were established in accordance with established for LTC facility staff, we
CDC guidelines titled, Testing required at § 483.80(h)(3)(ii) that the In this section, CMS discusses the
Guidelines for Nursing Homes, which facility document in the resident’s public comments received for the
explains the high risk of infection, medical record that testing was offered, COVID–19 testing requirement for LTC
illness, and death for LTC residents and completed (as appropriate to the facilities, the staff vaccination IFC, and
the importance of testing in order to the ‘‘educate and offer’’ provisions of
resident’s testing status), and the results
prevent COVID–19 from entering LTC the COVID–19 Vaccine Requirements
of each test. Due to the high
facilities and preventing transmission.16 for LTC Facilities and ICFs–IID
transmission rate of COVID–19, we
Under this requirement, ‘‘staff’’ are Residents, Clients, and Staff IFC
required at § 483.80(h)(4) that the (educate and offer IFC), published
considered any individuals employed facility take actions to prevent the
by the facility, any individuals that have September 2, 2020, November 5, 2021,
transmission of COVID–19 when a and May 21, 2021, respectively. We
arrangements to provide services for the resident or staff member, including
facility, and any individuals received public comments in response
individuals providing services under to all three IFCs, which we summarize
volunteering at the facility. We arrangement and volunteers, presented
explained that we only expected and discuss in this section.
with symptoms consistent with COVID– In this final rule, we are withdrawing
individuals who were physically 19 or who tested positive for COVID–19. the health care staff COVID–19
working on-site at the facility to be We expected facilities to restrict the vaccination provisions issued in the
required to be tested for COVID–19. access to the facility for any staff staff vaccination IFC and deleting the
At § 483.80(h)(1), we required that member—including individuals expired COVID–19 testing provisions of
resident and staff testing for COVID–19 providing services under arrangement the LTC testing IFC. We are also
be conducted based on parameters set
and volunteers—who presented with finalizing the COVID–19 ‘‘educate and
forth by the Secretary. These parameters
symptoms consistent with COVID–19 or offer’’ provisions established in the
may have included but were not limited
who tested positive for COVID–19 until educate and offer IFC. In this section we
to: testing frequency; the identification
they were deemed to be safe to return provide a summary of the public
of any facility resident or staff
to work. We expected facilities to take comments received and responses to
diagnosed with COVID–19 in the them, and the policies we are finalizing.
measures, including resident cohorting,
facility; the identification of any facility In section III.A. of this final rule, we
to mitigate the transmission of the virus
resident or staff with symptoms discuss the comments and responses
within the facility when facility
consistent with COVID–19 or with pertaining to the COVID–19 health care
residents presented with symptoms
known or suspected exposure to staff vaccination requirements. In
consistent with COVID–19 or who
COVID–19; the criteria for conducting section III.B. of this final rule, we
testing of asymptomatic individuals tested positive for COVID–19.
discuss the comments and responses
specified in this paragraph, such as the We acknowledge that residents and
regarding the requirements for LTC
positivity rate of COVID–19 in a county; staff may not have consented to being
facilities and ICFs–IID to educate
the response time for results; and other tested for COVID–19. Therefore, at
residents, clients, and staff about
factors specified by the Secretary that § 483.80(h)(5) we required that the
COVID–19 vaccines and to offer
help identify and prevent the facility have procedures for addressing
COVID–19 vaccines when available.
transmission of COVID–19. At residents and staff, including
Lastly, in section III.C. of this final rule,
§ 483.80(h)(2), we required that all individuals providing services under we discuss the comments and responses
residents and staff testing be conducted arrangement and volunteers, who concerning the COVID–19 testing
in a manner consistent with current refused or were unable to test for the requirements for LTC facilities. Due to
professional standards of practice for virus. We required at § 483.80(h)(6) that the high volume of public comments,
conducting COVID–19 tests. This the LTC facility coordinate with state we have grouped them by themes and
referred to those professional standards and local health departments and Tribal similarities for analysis and response.
that apply at the time that the care or representatives regarding the
service is delivered, which we availability and obtaining of testing A. Omnibus COVID–19 Health Care
acknowledge have evolved and changed supplies and processing test results Staff Vaccination (§§ 416.51(c),
over the course of the COVID–19 when necessary. Facilities may also 418.60(d), 441.151(c), 460.74(d),
pandemic. At § 483.80(h)(3)(i), we have coordinated with their local 482.421(g), 483.80(d)(3)(v) and (i),
required that for each instance of certified laboratories covered under 483.430(f), 483.460(v), 484.70(d),
resident or staff COVID–19 testing, Clinical Laboratory Improvement 485.58(d)(4), 485.70(n), 485.640(f),
which included testing of individuals Amendments (CLIA) on the availability 485.725(f), 485.904(c), 486.525(c),
providing services under arrangement of and obtaining of testing supplies and 491.8(d), 494.30(b))
and volunteers, the facility document the processing of test results. Access to In response to this IFC, we received
that testing was completed and the adequate testing supplies and approximately 10,102 timely public
results of each staff test. This arrangements for acquiring testing comments. Of these, roughly 2⁄3 were
documentation would have been located supplies must have been addressed by virtually identical letters from
ddrumheller on DSK120RN23PROD with RULES1
in the staff personnel record or the the facility’s infection prevention and individuals from around the country
record or file that the facility maintains control plan. The testing plan must have urging CMS to retract the rule. Of the
included any arrangements that were remaining 3,175 unique comments, the
16 https://www.cdc.gov/coronavirus/2019-ncov/
necessary to conduct, process, and majority were from individuals, while
hcp/infection-control-recommendations.html?CDC_
AA_refVal=https%3A%2F%2Fwww.cdc.gov%
receive test results prior to the over 500 of those unique comments
2Fcoronavirus%2F2019-ncov%2Fhcp%2Flong- administration of the required tests. were from industry groups or individual
term-care.html. Since the conclusion of the PHE on May commenters who were commenting as
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36494 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations
representatives of organizations, would be applicable to physician office received one updated Pfizer-BioNTech
companies, and other entities. About staff and other staff in small health care or Moderna COVID–19 vaccine.22 As of
2,000 of these unique comments entities that were not subject to the May 2, 2023, the CDC recommends that
opposed the regulation, while the vaccination requirements in the IFC. We individuals 6 months of age and older
remainder of the commenters supported also noted that health care and other receive a dose of updated (bivalent)
the regulation, some offering entities providing services under vaccine. Certain individuals, depending
suggestions as to how CMS could contract for a Medicare- and Medicaid- on age and level of
improve the requirements. A summary certified provider and supplier listed in immunocompromise, may receive
of the major themes addressed by the IFC were indirectly subject to the additional doses.23 24
commenters and our responses follow. requirements of the rule. Moreover, we We agree with commenters that
Comment: A significant minority of noted that entities not covered by the vaccines continue to be one of the most
commenters agreed with our goal to IFC may have been subject to other effective preventative practices against
ensure patient health and safety by vaccination requirements, such as those severe COVID–19; however, the
establishing a COVID–19 health care issued by State governments for certain effectiveness of the ‘‘original’’ or
staff vaccination requirement. types of workplaces. monovalent vaccines to prevent severe
Commenters stated that COVID–19 We thank commenters for recognizing COVID–19 hospitalization and death
vaccination is evidence-based, safe, and the importance of staying up-to-date has remained high, effectiveness to
the best way to prevent serious illness, with COVID–19 vaccines and boosters. prevent less severe disease has
hospitalization, death, and spread of Boosters have been an important part of diminished. As previously noted, for
infection. They indicated that protecting people from getting seriously reasons discussed throughout this
vaccination of health care staff will ill or dying from COVID–19.17 preamble, including declining infection
provide much-needed workforce Additionally, the newer bivalent rates and deaths, declining severity, and
stability to the health care industry vaccines contain an Omicron significant vaccination uptake, we are
while decreasing demands associated component to offer better protection withdrawing the health care staff
with providing care to health care against COVID–19 caused by the COVID–19 vaccination provisions of the
workers who contract COVID–19. Some Omicron variant and its subvariants IFC. In lieu of regulatory requirements
of these commenters stated that patients than the earlier, monovalent vaccines. and as previously noted, CMS intends to
who had delayed receiving care due to In April 2023, the EUAs for the bivalent continue support and encouragement
concerns of contracting COVID–19 vaccines were revised to simplify the for health care staff vaccinations
during the provision of their care would vaccination schedule for most through other mechanisms, including
now be able to obtain the care they individuals, which included authorizing quality programs. We encourage
needed. Some of these commenters the current bivalent vaccines for all individuals to stay up-to-date with their
recommended expanding the scope of doses administered to individuals 6 COVID–19 vaccines in accordance with
the COVID–19 vaccination regulation to months of age and older, including for CDC recommendations (https://
include other settings in which health an additional dose or doses for certain www.cdc.gov/coronavirus/2019-ncov/
care is provided, such as physician populations.18 19 All individuals aged vaccines/stay-up-to-date.
offices and others. Other commenters >6 months are recommended to receive html#recommendations).
recommended that in addition to the at least one dose of bivalent vaccine for Comment: While many commenters
primary vaccination series, the COVID–19 under current supported the COVID–19 vaccination
regulation should require boosters, recommendations.20 Additional requirements, the majority of
which provide ongoing protection information regarding vaccine guidance commenters stated that CMS did not
against COVID–19. can be found at https://www.cdc.gov/ have the statutory authority to infringe
Response: We appreciate the support vaccines/covid-19/clinical- on the personal rights of health care
from commenters and agree that a considerations/interim-considerations- staff to choose vaccination or not. These
requirement for COVID–19 vaccination us.html. commenters described the requirements
of health care staff was necessary to At the time the IFC was issued, the as an overreach of CMS authority and a
ensure timely access to care for patients. CDC did not include boosters in their violation of personal freedoms and
We also agree that the COVID–19 PHE definition of ‘‘fully vaccinated.’’ Instead, bodily autonomy. Several individual
placed unprecedented, challenging a person was considered to be fully commenters expressed concerns that the
circumstances on the health care vaccinated 2 weeks after receiving the vaccination requirements may run afoul
industry, and vaccination of health care last dose of a primary vaccine series.21 of certain fundamental medical ethics
staff lessened disruptions to care and Since the IFC was issued, CDC shifted doctrines around informed consent and
operations. We commend health care to using the terminology ‘‘up to date’’. freedom from coercion.
facilities and their staff for their efforts Individuals 6 years of age and older are Response: We appreciate the feedback
throughout the COVID–19 pandemic, considered ‘‘up to date’’ when they have from commenters. Although we are
and we share a common commitment to withdrawing the health care staff
assuring high-quality and safe care for 17 https://www.cdc.gov/coronavirus/2019-ncov/ COVID–19 vaccination provisions of the
patients, residents, clients, and vaccines/stay-up-to-date.html. IFC for the reasons discussed
participants. 18 https://www.fda.gov/news-events/press- throughout this preamble, we disagree
As noted in the IFC, the regulation announcements/coronavirus-covid-19-update-fda- with the comments regarding CMS’
applied only to those Medicare- and authorizes-changes-simplify-use-bivalent-mrna- statutory authority to issue the rule. In
covid-19-vaccines.
Medicaid-certified providers and Biden v. Missouri, the Supreme Court
ddrumheller on DSK120RN23PROD with RULES1
19 https://www.yalemedicine.org/news/covid-19-
suppliers listed. The IFC did not variants-of-concern-omicron#:∼:text=O stayed injunctions prohibiting the rule
directly apply to other health care micron%20and%20its%20subvariants,and%
entities, such as physician offices, 20multiply%20in%20other%20countries. 22 https://www.cdc.gov/coronavirus/2019-ncov/
because those settings are not regulated
20 https://www.cdc.gov/vaccines/covid-19/ vaccines/stay-up-to-date.html.
clinical-considerations/interim-considerations- 23 https://www.cdc.gov/vaccines/covid-19/
by CMS. Most States have separate us.html (accessed May 1, 2023). clinical-considerations/covid-19-vaccines-us.html.
licensing requirements for health care 21 https://www.cdc.gov/media/releases/2021/ 24 https://www.cdc.gov/coronavirus/2019-ncov/
staff and health care providers that p0308-vaccinated-guidelines.html. vaccines/stay-up-to-date.html.
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Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations 36495
from going into effect, holding that ‘‘the resulting in reuse, and emphasized how health care staff COVID–19 vaccination
Secretary’s rule falls within the they had been directed to continue requirements will meaningfully affect
authorities that Congress has conferred working to care for patients while ill current challenges in staff recruitment
upon him.’’ 25 26 Since that ruling, two with COVID–19 themselves due to and retention.
plaintiff States voluntarily dismissed staffing shortages. Some commenters Comment: Many commenters shared
challenges to the rule, and Federal suggested additional flexibilities in the their belief that vaccines are unsafe and
courts have dismissed two other vaccination requirements, such as the that they contain dangerous or
cases.27 28 We also note that the staff ability to opt-out for philosophical potentially dangerous chemicals. These
vaccination IFC permitted individual reasons and additional funding in order commenters also expressed concerns
exemptions consistent with applicable to help with these potential issues. that Emergency Use Authorizations
Federal laws. Response: We thank commenters and (EUAs) issued by the Food and Drug
We acknowledge the difficulties that health care workers for their continued Administration (FDA) do not assure
health care workers have faced and dedication throughout the COVID–19 safety, because of the minimal length of
continue to face throughout the COVID– pandemic. Adequate staffing was a development time. Some commenters
19 pandemic. CMS has great concern prior to the pandemic, and we noted that CMS or the employer should
appreciation for health care workers and recognize that the COVID–19 PHE be liable for adverse effects of
other frontline workers across the world simultaneously exacerbated and vaccination and that this should include
as they have dealt with limited accelerated those trends. While these lost wages in event of illness or death.
resources and extraordinary demand for trends reflect a confluence of factors, Some commenters referenced the
their time and services. Due to the including unprecedented stress, trauma, Vaccine Adverse Effect Response
changing circumstances of the overwhelming loss associated with System (VAERS), noting that there have
pandemic previously discussed in this death of coworkers and patients been nearly one million reported cases
final rule, we are withdrawing the (particularly for nurses who typically of adverse reactions to the various
health care staff COVID–19 vaccination witness decline and death), and self- COVID–19 vaccines. These commenters
provisions of the IFC. In lieu of isolation or quarantine from families, expressed their disagreement with
regulatory requirements and as we also understand commenters’ COVID–19 vaccination requirements
previously noted, CMS intends to concern that the requirements in the based on these VAERS reports. Some
continue supporting and encouraging staff vaccination IFC would further add commenters also referenced the
for health care staff vaccinations to those shortages. Nuremburg Code, which prohibits
through other mechanisms, including its Available evidence continues to adherents from performing medical
quality programs. support the notion that staff vaccination experimentation in unwilling patients.
Comment: Many commenters stated requirements have not adversely
These commenters stated a belief that
that the requirements would contribute affected health care staffing.29 Using
the vaccines are truly experimental.
to and exacerbate staffing shortages, National Healthcare Safety Network
Response: While we are withdrawing
particularly in rural areas, negatively (NHSN) data from June 6, 2021–
the staff vaccination requirements given
impacting care and access to care. These November 14, 2021, one study showed
changes in public-health conditions
commenters expressed concern that the that State-level COVID–19 vaccine
described throughout this preamble, we
staff vaccination requirements would requirements implemented prior to the
emphasize that COVID–19 vaccines
cause a mass flight of unvaccinated publication of the IFC did not negatively
have consistently been shown to be safe
health care workers from the industry. impact health care staffing levels in
and effective. As of March 2023, more
This was of particular concern for those States.30 Specifically, staffing
than 672 million doses of COVID–19
entities that provide long-term care shortages peaked nationally during the
Omicron wave, with nearly one in three vaccine have been given in the United
services, specifically those facilities States under the most intense safety
located in rural, frontier, and Tribal facilities reporting a shortage in January
2022. Staffing shortage rates have fallen monitoring in US history. That
communities. Some individual monitoring by CDC, FDA, and other
commenters who identified themselves since then, and remained relatively
stable through March 2022, even after Federal agencies continues to
as licensed professionals, including but demonstrate that COVID–19 vaccines
not limited to nurses, stated their intent the implementation of the staff
vaccination IFC.31 Further, data and are safe and effective.32 Moreover,
to resign rather than comply, or that efforts to speed the vaccine
they had coworkers who intended to analysis, including internal CMS
analyses of facility payroll data development process have not sacrificed
resign instead of comply. Additionally, scientific standards, integrity of the
some commenters noted that CMS was postdating the implementation of the
staff vaccination IFC, suggest that the vaccine review process, or safety.33
establishing overly burdensome Prior to issuance of an EUA, the original
expectations for already put-upon rule did not have a negative impact on
health care staffing. COVID–19 vaccines were evaluated in
health care workers. For example, they tens of thousands of study participants
We acknowledge that staffing
noted that they were asked to wear to generate the scientific data and other
concerns remain throughout the health
personal protective equipment (PPE) if information needed to determine the
care system; however, we do not
they were not vaccinated even though vaccine’s safety and effectiveness.
anticipate that the withdrawal of the
there were insufficient supplies,
29 See Biden v. Missouri, https:// 32 https://www.cdc.gov/coronavirus/2019-ncov/
25 https://www.supremecourt.gov/opinions/
www.supremecourt.gov/opinions/21pdf/21a240_ vaccines/safety/safety-of-vaccines.html#:∼:text=
ddrumheller on DSK120RN23PROD with RULES1
21pdf/21a240_d18e.pdf. d18e.pdf. COVID%2D19%20vaccines%20are%
26 https://www.cms.gov/newsroom/press-releases/ 30 https://jamanetwork.com/journals/jama- 20safe,safety%20monitoring
statement-cms-administrator-chiquita-brooks- health-forum/fullarticle/2794727?utm_source=For_ %20in%20US%20history.
lasure-us-supreme-courts-decision-vaccine- The_Media&utm_medium=referral&utm_ 33 https://www.fda.gov/vaccines-blood-biologics/
requirements. campaign=ftm_links&utm_term=072922. vaccines/emergency-use-authorization-vaccines-
27 State of Louisiana v. Becerra, No. 3:21–cv–3970 31 https://www.kff.org/coronavirus-covid-19/ explained#:∼:text=Under
(W.D. La. Dec. 2, 2022). issue-brief/nursing-facility-staff-vaccinations- %20an%20EUA%2C%20FDA
28 Griner v. Biden 2:22CV149 DAK–DBP (D. Utah boosters-and-shortages-after-vaccination-deadlines- %20may,are%20no%20adequate
Oct. 13, 2022). passed/. %2C%20approved%2C%20and.
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36496 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations
Comments regarding liability for Comment: Some commenters stated been limited and as the pandemic
adverse effects of vaccination or lost that vaccines contain fetal stem cells, continues to evolve.
wages are outside the scope of this rule. the use of which conflicts with their Our intention in issuing the staff
We refer readers to the Department of religious beliefs. Other commenters vaccination IFC was to establish a set of
Labor for issues regarding workplace indicated that contracted physicians requirements for all applicable facility
injury and compensation.34 We also with privileges are not covered under types consistent with CDC
refer readers to the Countermeasures Title VII or ADA; therefore, they are recommendations in place at the time to
Injury Compensation Program, which unable to request religious exemptions. assure patient health and safety. Since
provides compensation for covered Industry, civil society groups, and the onset of the PHE, the context in
serious injuries or deaths that occur as individual commenters sought which people apply these preventive
the result of the administration or use of clarification regarding religious, layers has changed. As the immediate
certain countermeasures and the medical, and administrative exceptions impacts of the COVID–19 pandemic
National Vaccine Injury Compensation to the vaccination requirements. Some continue to evolve, so too does informed
Program, which provides compensation commenters stated that it would be guidance, recommendations, and
to people found to be injured by certain helpful for CMS to create a standard on regulation. In the fall of 2021,
vaccines.35 36 37 exemption requirements that would be circumstances required that CMS issue
Comment: Many commenters stated a broadly applicable nationwide. Some the IFC to protect the health and safety
belief that vaccines are ineffective. They commenters asked for clarification on of patients. Current circumstances show
shared how the incidence of COVID–19 exemption requirements and that the IFC was effective in increasing
infections among vaccinated individuals recommended that CMS promulgate rates of COVID–19 vaccination among
is high. These commenters also noted guidance. Other commenters noted that health care staff and indicate that the
that this rule would be ineffective, we should consider referencing the need for such regulatory requirements
because it did not apply to patients and Equal Employment Opportunity has passed. We continue to explore
visitors. Commission or similar different approaches to support and
Response: We acknowledge that nondiscrimination guidance (such as incentivize the use of effective
COVID–19 vaccines will not prevent the Americans with Disabilities Act) in combinations of preventive layers in
symptomatic infection in all vaccinated order to address these public concerns. particular circumstances and the best,
individuals; however, COVID–19 Response: While we are withdrawing most flexible way to support their
vaccines are highly effective in the staff vaccination requirements in application.
preventing serious illness, this final rule, we note that the IFC CMS and other HHS agencies
hospitalization, and death. required facilities to have policies and continue to engage in infection
As we discussed in the staff procedures regarding exemptions as prevention and control and vaccine
vaccination IFC, we believe it would be required by civil rights and disability education efforts. Additionally, CMS
overly burdensome to require that laws. continues to host stakeholder
facilities ensure COVID–19 vaccination Comment: Some commenters engagement calls to address ongoing
for all individuals who enter (patients, suggested that alternatives to concerns and questions.38 CMS also
visitors, mail carriers, etc.). However, vaccination be added to the continues to engage with key
while facilities are not required to requirements. These commenters stakeholders in order to develop
ensure vaccination status of every emphasized that routine testing of staff culturally-competent and person-
individual, they may choose to extend for SARS–CoV–2 and use of PPE should centered guidance and resources to
COVID–19 vaccination requirements be permitted in lieu of vaccination. ensure that populations with unique
beyond those persons that we consider Some commenters noted the ongoing needs or concerns are addressed and
to be ‘‘staff’’ as defined in IFC. We did mitigation efforts involving COVID–19 mitigated. Lastly, enforcement
not prohibit such extensions and testing and PPE use, as well as required discretion is not within the scope of
encouraged facilities to require COVID– source controls which have improved these regulations and is rather
19 vaccination for these individuals as over the course of the PHE. Some addressed in subregulatory guidance,
reasonably feasible. We strongly commenters suggested that CMS which CMS continues to publish and
encourage facilities, when the provide for additional flexibility by release.39 We encourage individuals to
opportunity exists and resources allow, ‘‘grandfathering in’’ some of the continue to follow CDC
to facilitate the vaccination of all vaccination requirements already in recommendations pertaining to
individuals who provide services place among certain health systems. infection prevention and control
infrequently or provide educational Some commenters suggested additional practices, and we note that while this
opportunities about vaccination for educational outreach, especially among final rule ends CMS’s requirements
those individuals. Further, as previously communities with lower trust in the regarding staff vaccination, it does not
discussed, CMS intends to continue health care system, as well as an prohibit employers or states from
support and encouragement for health understanding of the logistical issues initiating or maintaining their own
care staff vaccinations through quality preventing prompt implementation of vaccination requirements for health care
measurement programs. the requirements in the staff vaccination staff. We also continue to support health
IFC at certain facilities. Other care staff vaccinations through quality
34 https://www.fiercehealthcare.com/hospitals/
commenters supported additional measurement programs.
supreme-court-vaccine-covid-19-healthcare-
educational outreach, time-limited Comment: Some commenters stated
ddrumheller on DSK120RN23PROD with RULES1
upholds-hhs-vaccine-requirement-for- that individuals with a prior COVID–19
healthcare#:∼:text= testing options, and flexibility for
Supreme%20Court%20upholds%20HHS’% ‘‘good-faith’’ efforts for facilities as they infection should be exempt due to
20vaccine,large%20employer% work toward compliance with the rule. natural immunity. Many of these
20mandate%20%7C%20Fierce%20Healthcare.
35 https://www.hrsa.gov/cicp. Response: We thank commenters for 38 https://www.cms.gov/outreach-education/
36 https://www.benefits.gov/benefit/641. their continued efforts in practicing partner-resources/coronavirus-covid-19-partner-
37 https://www.hrsa.gov/vaccine-compensation/ complementary mitigation measures, resources.
about. especially at times when resources have 39 https://www.cms.gov/covidvax.
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Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations 36497
commenters claimed that they still had remains a public health challenge drugs have also undergone rigorous
high levels of antibodies against throughout the world. As discussed in testing. We note that the evolution of
COVID–19 in their most recent blood section I. of this final rule, the WHO COVID–19 continues to present
tests, and they questioned the necessity declared the COVID–19 outbreak an challenges to the development of both
of vaccination, at least for as long as international public health emergency preventative drugs, including vaccines,
their antibody levels remain comparable in January 2020 and a pandemic in and therapeutic treatments. It is
to those who are vaccinated. March 2020. Likewise, a COVID–19 PHE important that more individuals be
Response: We acknowledge that declaration for the United States was educated about these drugs in order for
previous COVID–19 infection may also made by the Secretary in January 2020, them to make informed decisions about
contribute to protection against the President of the United States their health and treatment options.
subsequent infection and associated declared COVID–19 a pandemic in Some medications mentioned by
severe, critical, or fatal COVID–19.40 March 2020, and the Secretary has commenters, such as Ivermectin and
However, this does not mean infection- sustained a PHE declaration since vitamin D, are not evidence-based
induced immunity can or should be January 2020 with the final renewal treatments for COVID–19. The FDA has
substituted for vaccination. Exceptions occurring on February 9, 2023.45 In not authorized or approved Ivermectin
based on infection-induced immunity September 2021, COVID–19 related for use in preventing or treating COVID–
are also challenging to apply and deaths in the U.S. surpassed the number 19 in humans or animals. Ivermectin is
enforce fairly, as verification of a health of deaths from the 1918 influenza approved for human use to treat
care worker’s prior infection or antibody pandemic.46 According to the CDC infections caused by some parasitic
levels may not be possible in all cases. COVID Data Tracker, over 1.1 million worms and head lice and skin
Vaccination remains the safest option COVID–19 deaths have been reported in conditions like rosacea. Currently
for acquiring immunity to COVID–19, the United States to date, whereas it is available data do not show that
particularly when the risks associated estimated that 675,000 American deaths Ivermectin is effective against COVID–
with vaccination are compared with occurred during the 1918 influenza 19 and taking large doses of Ivermectin
well-known significant short and long- pandemic.47 48 is dangerous.52 There is also insufficient
term consequences of COVID–19, which Research also suggests that reported evidence for the use of vitamin D for the
can include organ damage affecting the deaths associated with COVID–19 in the prevention or treatment of COVID–19.53
heart, kidneys, skin, and brain, as well United States have been undercounted, Individuals who are considering taking
as fatigue, shortness of breath, loss of not overcounted, since the start of the these medications as a treatment for
smell, and muscle aches.41 42 43 pandemic. These undercounts may be COVID–19 should consult with their
Additionally, people who have had attributed to several factors, including care team.
COVID–19 are more likely to develop that testing availability and criteria may Comment: Some commenters shared
new health conditions such as diabetes, have caused many cases to go their belief that it is unprecedented to
heart conditions, blood clots, or unrecognized; COVID–19 may affect mandate COVID–19 vaccines when
neurological conditions compared with many body systems, and thus may not there are other existing vaccines that are
people who have not had COVID–19.44 always be recognized as a cause of more effective that are not mandated
Comment: Some commenters stated death; and COVID–19 may amplify pre- (that is, Hepatitis B, influenza,
that COVID–19 is not a public health existing health conditions leading to pneumococcal).
emergency and that the data upon death, but not be recognized as the Response: We thank commenters for
which guidelines are issued are flawed, cause of death by the medical certifier.49 recognizing the efficacy of certain
alleging inaccurate and inflated death We acknowledge that most vaccines, like the Hepatitis B, influenza,
counts. Commenters also pointed out individuals are fortunate enough to and pneumococcal vaccines. While we
that the overwhelming majority of recover from COVID–19. However, do not want to minimize the severity of
infected individuals recover, many individuals are not fortunate these diseases, they were not the cause
unvaccinated individuals do not all enough to recover and many individuals of the PHE declared at the time CMS
become severely ill, and there are die or experience symptoms of long issued the IFC. We also note that the
treatments available that should be COVID, with older adults facing the regulation is not a government vaccine
encouraged and available for use (for highest risk of becoming very sick from mandate placed on individuals but
example, some commenters stated COVID–19. rather a Medicare and Medicaid funding
beliefs that Ivermectin or Vitamin D and We are also grateful for the condition for certain health care
other pharmaceutical and development of effective antiviral facilities that participate in either or
nonpharmaceutical products are treatments, including Remdesivir both of those programs. As discussed in
effective treatments for COVID–19). (Veklury), nirmatrelvir co-packaged section H. of the staff vaccination IFC,
Response: While rates of infection, with ritonavir (Paxlovid), and many health care workers must already
illness, and hospitalization have molnupiravir (Lagevrio).50 51 These comply with employer or State
significantly declined, COVID–19 government vaccination requirements
45 https://aspr.hhs.gov/legal/PHE/Pages/ (influenza, hepatitis B) or OSHA
40 https://www.cdc.gov/coronavirus/2019-ncov/ default.aspx. guidelines and are also required to
your-health/reinfection.html. 46 https://www.smithsonianmag.com/smart-news/
complete screening procedures, such as
41 https://www.thelancet.com/journals/lanam/ the-covid-19-pandemic-is-considered-the-deadliest- tuberculosis screening. Additionally,
article/PIIS2667-193X(22)00059-X/fulltext. in-american-history-as-death-toll-surpasses-1918-
42 https://www.mayoclinic.org/diseases- estimates-180978748/. many of these individuals met State and
ddrumheller on DSK120RN23PROD with RULES1
conditions/coronavirus/in-depth/coronavirus-long- 47 https://covid.cdc.gov/covid-data-tracker/ local vaccination requirements in order
term-effects/art-20490351#:∼:text=Why%20does #datatracker-home.
%20COVID%2D19%20cause,immune%20system 48 https://www.cdc.gov/flu/pandemic-resources/ 51 https://www.fda.gov/media/155049/download.
%20can%20also%20happen. 1918-commemoration/1918-pandemic-history.htm. 52 https://www.fda.gov/consumers/consumer-
43 https://www.nhs.uk/conditions/coronavirus- 49 https://www.cdc.gov/nchs/covid19/faq.htm. updates/why-you-should-not-use-ivermectin-treat-
covid-19/long-term-effects-of-coronavirus-long- 50 https:// or-prevent-covid-19.
covid/. www.covid19treatmentguidelines.nih.gov/ 53 https://
44 https://www.cdc.gov/coronavirus/2019-ncov/ therapies/antivirals-including-antibody-products/ www.covid19treatmentguidelines.nih.gov/
long-term-effects/index.html. summary-recommendations/. therapies/supplements/vitamin-d/.
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36498 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations
to attend school to complete the health care staff and health care in their assumption of a violation of
necessary education to be eligible for providers that would be applicable to E.O. 13175. That E.O. only applies to
health care positions. While historically physician office staff and other staff in actions that ‘‘have substantial direct
CMS has not required any health care small health care entities that are not effects on one or more Indian tribes, on
staff vaccinations, we have established, subject to vaccination requirements the relationship between the Federal
maintained, and updated extensive under this IFC. Within the IFC, we Government and Indian tribes, or on the
health and safety requirements as part of briefly discussed the OSHA IFC, distribution of power and
the Conditions of Participation and ‘‘Occupational Exposure to COVID–19; responsibilities between the Federal
Conditions for Coverage for Medicare- Emergency Temporary Standard’’ (86 FR Government and Indian tribes.’’ The
and Medicaid-certified providers and 32376, June 21, 2021), that was staff vaccination IFC, like almost all
suppliers. These requirements largely applicable to health care settings at the CMS rules, has none of these effects.
focus on infection prevention and time of publication, including but not This IFC applied only to certain health
control standards, as we aim to protect limited to the providers and suppliers care providers and suppliers who
the health and safety of patients, who must comply with the staff voluntarily enrolled in the Medicare
residents, clients, and participants. vaccination IFC, because the OSHA ETS and Medicaid programs. Its provisions
The transition CMS is making now, to and the IFC had complementary made no distinctions as to ownership
make COVID–19 policies more like requirements.57 Of note, OSHA did status of any facility, whether owned or
those for other communicable diseases, withdraw the vaccination and testing administered by a private organization,
reflects the ongoing evolution of ETS, effective January 26, 2022.58 59 For State or local government, or tribe.
epidemiological and clinical questions about OSHA laws, Furthermore, the commenters identified
circumstances; it does not imply that regulations, or rulemaking activities, we no specific government-to-government
our issuance of the staff vaccination IFC refer commenters to OSHA.60 effects from the rulemaking that would
was invalid or that CMS could not take Comment: A few commenters noted adversely affect tribes. CMS continues
such steps again in the future, if that this rule was promulgated prior to to engage with external stakeholders
circumstances warrant. While we are consultation with Tribal entities, which and strives towards providing,
withdrawing the provisions of the staff they asserted is a violation of Executive supporting, and fostering culturally-
vaccination IFC, as previously noted, we Order (E.O.) 13175. Several competent and person-centered care for
intend to continue to support and organizations noted that Tribes believed these populations.
encourage COVID–19 vaccination that their treaty rights may have been Comment: Some provider groups
through our quality reporting and value- violated by the promulgation of the rule. asked for clarification or additional
based incentive programs. CMS One commenter noted that they guidance on what would or would not
collaborated with the CDC to develop understand that the rule may be be acceptable in terms of employer
quality measures for both patient and appropriate for non-Indian health enforcement so that they could stay
health care vaccination to be used in providers but indicated that the Tribes within the bounds of State privacy laws.
appropriate quality programs. CMS they represent believe that it is not For example, a large medical center
included patient and health care currently clear how the regulation noted concerns about their ability to
personnel vaccination quality measures would apply to those facilities that comply with both the IFC and a State
on the Measures Under Consideration provide health care services to the law that explicitly prevented employers
(MUC) List issued on December 1, American Indian and Alaska Native from requiring COVID–19 vaccinations
2022.54 55 population. These commenters stated as a condition of employment.
Comment: Some commenters that CMS failed to consult with Tribes Response: As discussed in the staff
mistakenly believed this IFC was in accordance with the usual Indian vaccination IFC, we understand that
OSHA’s rule, ‘‘COVID–19 Vaccination consultation guidance. The commenters some States and localities have
and Testing; Emergency Temporary suggested that CMS extend the comment established laws that would seem to
Standard’’ (86 FR 61402) (also period and improve the consultative prevent Medicare- and Medicaid-
published November 5, 2021), which relationship between Tribal entities and certified providers and suppliers from
intended to require vaccination for CMS so that the perceived disregard for complying with the requirements of this
employers with 100+ employees and Tribal sovereignty does not happen IFC. While the requirements outlined in
addressed the emergency temporary again. the staff vaccination IFC remain in
standard (ETS) in comments submitted Response: We thank the Tribes for force, we intend, consistent with the
to CMS.56 their continued partnership with CMS. Supremacy Clause of the United States
Response: The requirements in the We recognize that American Indians Constitution, that this nationwide
staff vaccination IFC apply to only the and Alaska Natives (AI/AN) face unique regulation preempts all conflicting State
Medicare- and Medicaid-certified health care needs and have been and local laws as applied to Medicare-
providers and suppliers listed in the disproportionately impacted by COVID– and Medicaid-certified providers and
IFC. The IFC does not directly apply to 19.61 62 These commenters are incorrect suppliers. However, as previously
other employers or entities, including noted, we are withdrawing the health
other health care entities, such as 57 https://www.federalregister.gov/documents/ care staff COVID–19 vaccination
2021/06/21/2021-12428/occupational-exposure-to- provisions.
physician offices, which are not covid-19-emergency-temporary-standard.
regulated by CMS. Most States have 58 https://www.osha.gov/coronavirus/ets2.
Comment: Some commenters noted
separate licensing requirements for 59 87 FR 3928, January 26, 2022 (https://
that the COVID–19 staff vaccination
requirements placed an undue burden
ddrumheller on DSK120RN23PROD with RULES1
www.federalregister.gov/documents/2022/01/26/
54 https://mmshub.cms.gov/sites/default/files/ 2022-01532/covid-19-vaccination-and-testing- on facilities. These commenters stated
2022-MUC-List-Overview.pdf. emergency-temporary-standard). that it would be overly burdensome to
60 https://www.osha.gov/laws-regs.
55 https://mmshub.cms.gov/measure-lifecycle/
manage individual requests for
measure-implementation/pre-rulemaking/lists-and- 61 https://www.kff.org/coronavirus-covid-19/
exemption either due to religious beliefs
reports. issue-brief/covid-19-cases-and-deaths-by-race-
56 https://www.federalregister.gov/documents/ ethnicity-current-data-and-changes-over-time/. or clinical contraindications to receiving
2021/11/05/2021-23643/covid-19-vaccination-and- 62 https://www.cdc.gov/mmwr/volumes/71/wr/ the vaccine. They also noted that it
testing-emergency-temporary-standard. mm7122a2.htm. would be resource-intensive to comply
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Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations 36499
with the vaccination requirements that (for example, quality measures) offer the these therapies do not replace the
included contracted staff. most effective means to balance a need preventive benefits of vaccination.
Response: As noted in the preamble of for flexibility, encourage HCP Final Decision: After inspection of
the IFC, we made efforts to mitigate the vaccination, and protect patient safety public comments on the health care staff
burden on providers by not requiring in the post-PHE phase of COVID–19. In vaccination requirements and in
that each provider and supplier ensure addition, as of March 30, 2023, 90.5 consideration of the factors discussed
COVID–19 vaccination for all percent of counties, districts, or throughout this rule, we are
individuals who entered the facility or territories in the United States had a low withdrawing the health care staff
setting of care, because we believed community level of COVID–19. Further, COVID–19 vaccination provisions. This
such a requirement would be overly as of March 29, 2023, the current 7-day final rule addresses CMS’ statutory
burdensome. Moreover, CMS did not average of weekly new cases decreased responsibility to implement regulations
require that staff who functioned in a 9.2 percent compared with the previous necessary to protect the health and
fully remote capacity be vaccinated for 7-day average.63 Therefore, we are safety of patients while demonstrating
COVID–19 if they did not physically withdrawing the health care staff our commitment to approaches that
enter the building or interact with COVID–19 vaccination provisions. reflect evolving information.
patients or other staff. Experience since Comment: Many commenters
the publication of the staff vaccination requested clarification as to which B. COVID–19 Vaccine ‘‘Educate and
IFC shows that facilities could, indeed, facility types the rule applies. Offer’’ Requirements for LTC Facilities
meet these requirements. When Individuals associated with Emergency and ICFs–IID Residents, Clients, and
implementing these requirements, CMS Medical Services (EMS) and ambulance Staff (§§ 483.80(d), 483.430(f),
ensured there was a reasonable balance services requested additional guidance 483.460(a)(4))
between burden and the need for on how they fit within the rule, because In response to the educate and offer
celerity to realize health and safety they were not among the facility types IFC, we received 68 public comments.
benefits. listed in the rule. Other groups, Twenty-six of these comments
Comment: Many commenters noted particularly in long-term care, asked addressed the ‘‘educate and offer’’
that the IFC’s definition of ‘‘fully whether contractors (a one-off or provisions, sharing support for these
vaccinated’’ was confusing and incidental plumber, or a fully remote requirements due to the increased risk
questioned whether booster doses administrative staff worker, for of infection and complications for LTC
would or should be included in the example) would be required to be residents and ICF–IID clients due to
definition and required going forward. vaccinated in order for the facility to be their medical conditions and residence
Some of these commenters shared that considered in compliance. Some in congregate care settings. Public
there was confusion in the messaging commenters recommended that CMS commenters also addressed the
coming from CMS regarding boosters align the definition of ‘‘staff’’ with reporting requirements, which we
and potential discrepancies between the previous LTC facility testing rules as a
addressed in the CY 2022 Home Health
IFC and contemporary information aids means of reducing confusion and as a
Prospective Payment System final rule
coming from other parts of the executive means of helping those facilities align
branch. Likewise, some commenters (86 FR 62240, 62392).
their current vaccine requirements with
noted that the CDC did not include those required under the rule. Comment: The majority of
boosters in its definition of ‘‘fully Response: We are withdrawing the commenters emphasized that residents
vaccinated’’ at the time that the rule was health care staff COVID–19 vaccination of LTC facilities and clients of ICFs–IID
issued. Other commenters provisions. We strongly encourage are among the most susceptible to
recommended that CMS recognize the facilities, when the opportunity exists negative outcomes related to COVID–19
importance of booster shots and and resources allow, to facilitate the due to their medical conditions. These
consider including boosters in the vaccination and education of all commenters noted that the residents
definition of ‘‘fully vaccinated’’ once the individuals who provide services and clients were at high risk for
CDC updates its guidance. Some infrequently or frequently. exposure, infection, complication, and
commenters also pointed to research Comment: Some commenters death.
that suggests the importance of boosters suggested that new anti-viral treatments Response: We thank commenters for
in maintaining immunity over time. may become more important as tools recognizing the gravity of the COVID–19
Several individual commenters stated once they become commercially pandemic and their appreciation for
that the need for boosters would make available. They asked that CMS include resident and client health and safety.
the rule impracticable or that it proved guidance in this rule, or issue another We believe that all LTC Facility
the ineffectiveness of the vaccines. rule which would clarify some of the residents, ICF–IID clients, and the staff
Response: Like the SARS–COV–2 different payment aspects of these who care for them, should be provided
virus itself, the science of preventing treatments and more. with ongoing education about, and
and treating COVID–19 and the tools Response: We recognize and access to, vaccination against COVID–
available to prevent and treat it continue acknowledge the important role of new 19. Further, we believe that entities
to evolve. Thus, the recommendations treatment therapies that have recently responsible for the care of residents and
and guidance have similarly changed as become available, as previously clients of LTC facilities and ICF–IIDs
well. Currently, CDC recommends that discussed in this rule. However, must proactively pursue access to
people ages 6 months and older receive payment for these treatments is outside COVID–19 vaccination on behalf of their
at least 1 bivalent mRNA COVID–19 the scope of this rule. We emphasize the residents and clients, who often face
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vaccine. The number of recommended importance of vaccination, as access to challenges to independently accessing
bivalent doses varies by age, vaccine, these new therapies may vary. Further, the vaccine, including mobility
previous COVID–19 vaccines received, limitations, cognitive impairments, and
63 https://www.cdc.gov/coronavirus/2019-ncov/
and the presence of moderate or severe other conditions. To support ongoing
covid-data/covidview/past-reports/
immune compromise. As discussed 033123.html#:∼:text=
access to vaccinations for COVID–19,
elsewhere in this rule, CMS now COVID%2D19%20Community%20Levels*,with we are finalizing the provisions at
believes that other levers available to us %20a%20low%20Community%20Level. §§ 483.80(d)(3), 483.430(f), and
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36500 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations
483.460(a)(4) for LTC facilities and ICF– staff turnover rates, which have these requirements.66 Furthermore,
IIDs. increased the amount of time needed to CMS uses existing lines of
Comment: Some commenters stated provide education and to offer the communication with stakeholders in an
that communicating the pros, cons, and vaccine to staff. effort to address some of these questions
side effects of vaccination in a Response: We thank the staff for their and concerns. Currently, CMS considers
meaningful way to LTC facility hard work in complying with these LTC facility and ICF–IID staff
residents was challenging and requirements. We recognize that health (regardless of whether there is a so-
recommended that CMS provide care organizations have historically called ‘‘W–2’’ relationship) to be those
additional guidance and standardized experienced staffing shortages and that who work in the facility on a regular
education materials for use. this has been exacerbated by the basis (that is, at least once a week). We
Response: We acknowledge that it can pandemic, as discussed in section I. of note that this includes those individuals
be challenging to convey this the staff vaccination IFC. In addition to who may not be physically in the LTC
information clearly as the COVID–19 the previously mentioned resources facility for a period of time due to
pandemic continues to evolve and new available from CDC and FDA, CMS illness, disability, or scheduled time off,
treatments and vaccines become funds a network of Quality but who are expected to return to work.
available. Vaccination remains one of Improvement Organizations (QIOs),65 LTC facilities and ICF–IIDs are not
the most important methods to help which aim to improve the quality of required to educate and offer
prevent severe COVID–19, especially as care delivered to people with Medicare. vaccination to individuals who provide
individuals living and working in Specifically, QIOs may provide services less frequently, but they may
congregate living settings may have assistance to Medicare beneficiaries by choose to extend such efforts to them.
challenges with physical distancing and targeting small, low-performing, and We strongly encourage facilities, when
other preventive measures such as mask rural Medicare-certified facilities most the opportunity exists and resources
use. While it can be challenging to in need of assistance, and those that allow, to provide education and
convey vaccine information clearly, this have low COVID–19 vaccination rates; vaccination to all individuals who
is especially important, as many ICF–IID disseminating accurate information provide services less frequently. A
clients have multiple chronic conditions related to access to COVID–19 vaccines better understanding of the value of
and psychiatric conditions in addition to facilities; educating residents and vaccination may allow staff to
to their intellectual disability, and many staff on the benefits and risks of COVID– appropriately educate residents and
LTC Facility residents experience 19 vaccination; understanding nursing their family members about the benefits
impaired mental status, which can home leadership perspectives and assist of accepting the vaccine. Therefore, we
impact a client’s and resident’s them in developing a plan to increase are finalizing the requirements at
understanding or acceptance of the need COVID–19 vaccination rates among §§ 483.80(d)(3), 483.430(f), and
for vaccination. Vaccine education residents and staff. 483.460(a)(4).
allows for residents, clients, and their Comment: A few commenters
Ensuring that all LTC Facility
caregivers to be informed participants in suggested that CMS add provisions for
residents, ICF–IID clients, and the staff
their care and allows them to make the paid time off for staff to receive the
who care for them are provided with
most appropriate decisions for vaccine and recover from side effects.
ongoing opportunities to receive
themselves. Furthermore, CDC and FDA Response: We recognize commenters’
vaccination against COVID–19 is critical
have developed a variety of clinical concerns; however, CMS does not have
to ensuring that populations at higher
educational and training resources for the statutory authority to regulate paid
risk of infection continue to be
health care professionals related to time off for health care employees, and
prioritized and receive timely
COVID–19 vaccines, and CMS this falls outside the scope of this final
preventive care during the COVID–19
recommends that nurses and other rule.
pandemic. In the interest of health and Final Decision: After consideration of
clinicians work with their LTC Facility’s
safety for LTC facility residents and the public comments we received on the
or ICF–IID’s Medical Director and use
ICF–IID clients, and of staff in these educate and offer requirements, we are
CDC and FDA resources as sources of
settings, we are finalizing the provisions finalizing the requirements at
information for their vaccination
at § 483.80(d)(3) for LTC facilities and § 483.80(d)(3) for LTC facilities and at
education initiatives.64 We acknowledge
§§ 483.430(f) and 483.460(a)(4) for ICF– §§ 483.430(f) and 483.460(a)(4) for ICF–
and thank the many CMS-certified ICF–
IIDs. IIDs, as established by the educate and
IIDs and LTC facilities that are
educating staff, residents, and clients, Comment: Some commenters reported offer IFC and amended by the staff
and are attempting to participate in that it was difficult to identify the vaccination IFC. The ‘‘educate and
vaccination programs. However, individuals that met the definition of offer’’ requirements support our
participation in these efforts is not ‘‘staff,’’ and therefore, were subject to responsibility to protect and ensure the
universal, and we are concerned that the requirements. health and safety of residents and
many individuals are not receiving Response: The ‘‘educate and offer’’ clients by enforcing the standards
these important preventative care provisions were written in a manner required to help each resident and client
services. Because resident and client that allows for flexibility by covering a attain or maintain their highest level of
safety are of the utmost importance, we broad set of residential care entities. well-being. Sections 1819(d)(3)(B) and
are finalizing the education Additionally, since this IFC was 1919(d)(3) of the Act require that a
requirements for LTC facilities at initially published, CMS and other facility must establish an infection
ddrumheller on DSK120RN23PROD with RULES1
§ 483.80(d)(3) and ICF–IIDs at agencies across HHS have released control program that is designed,
§§ 483.430(f) and 483.460(a)(4). additional guidance in an effort to constructed, equipped, and maintained
Comment: Several commenters address some of these questions and in a manner to protect the health and
expressed burden concerns due to high concerns about how to comply with safety of residents, personnel, and the
64 https://www.cdc.gov/vaccines/covid-19/long- 65 https://www.cms.gov/Medicare/Quality- 66 https://www.cms.gov/outreach-education/
term-care/pharmacy-partnerships/administrators- Initiatives-Patient-Assessment-Instruments/ partner-resources/coronavirus-covid-19-partner-
managers.html. QualityImprovementOrgs. resources.
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Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations 36501
general public. We believe that the understand the virus and its impact on also thank LTC facility staff and health
educate and offer requirements comply health outcomes. We recognize that care workers for their continued
with these statutory requirements. We some locations, like prisons or college commitment to providing care for
believe that this action strengthens our and university campuses, may represent residents. Testing for COVID–19 helps
response to the COVID–19 pandemic ‘‘hot spots.’’ However, these populations to mitigate the transmission of the virus
and protects the health and safety of are not truly isolated, and one may not and thus improves patient outcomes
nursing home residents, ICF–IID clients, presume that the SARS–CoV–2 virus and opportunities for socialization. As
and their staff. will not spread to other populations or discussed in the LTC facility testing IFC,
locations. we note that there are many different
C. COVID–19 Testing Requirement for Further, frequent testing for COVID– tests available, and facilities have the
LTC Facilities § 483.80(h) 19 remains an important tool for flexibility and discretion to select the
In response to this IFC we received mitigating the transmission of the virus. test that best suits their needs so long as
approximately 169 comments, of which In some instances, an individual may the tests are conducted in accordance
about 150 addressed the COVID–19 test when the viral load is not high with nationally recognized standards
testing requirements for LTC facilities’ enough to be found on a test and the test and meet the response time for the test
staff and residents. result is negative. But this same results as specified by the Secretary. In
Comment: Some comments individual may test again in the same addition, the CDC has continued to
acknowledged that testing for COVID– week and receive a positive test result. update its guidance regarding infection
19 is important for preventing the Additionally, some people may test control at https://www.cdc.gov/
disease from entering nursing homes, negative on an antigen test but positive coronavirus/2019-ncov/hcp/infection-
detecting cases quickly, and stopping on a PCR test. This means that they do control-recommendations.html?CDC_
the transmission to additional residents have COVID–19, but their viral load is AA_refVal=https%3A%2F%2F
and staff. too low to result in a positive antigen www.cdc.gov%2Fcoronavirus%2F2019-
Response: We thank commenters for test.67 We recognize that many staff do ncov%2Fhcp%2Flong-term-care.html.
sharing their understanding of the not reside in the same county as the Further, the CDC has published
importance of testing for COVID–19. LTC facility at which they are guidance on how to optimize PPE at
While many new treatments and employed. However, this does not https://www.cdc.gov/coronavirus/2019-
vaccines are now available, and we are negate the value of testing. While these ncov/hcp/ppe-strategy/index.html.
deleting the expired testing individuals may be less likely to be Comment: Several commenters
requirements, we continue to emphasize exposed to the virus in the county in expressed gratitude for the ability to
the importance of practicing which they reside, the risk of exposure access point-of-care (POC) testing
preventative measures in order to is not eliminated. In addition, because supplies and equipment, but most of
mitigate the spread of COVID–19. of the highly contagious nature of the these commenters found it to be
Comment: Many commenters SARS–CoV–2 virus, the transmission unreliable and shared that it frequently
discussed the need for accurate data for levels in the county in which they produced false positive results. These
contact tracing and in order to reside may increase significantly, commenters expressed that this blanket
understand the future trajectory of the subsequently increasing their risk of approach may not be appropriate for all
COVID–19 virus. However, most exposure. LTC facilities and suggested that the
comments expressed belief that the Comment: The majority of comments testing of staff should be reduced in
community infection rate is not an stressed how these new testing order to appropriately allocate limited
accurate method for calculating how requirements are diverting resources and costly testing supplies and
often COVID–19 testing should be and adding an additional burden to the resources. A few comments appealed for
conducted. Several of these commenters staff, who are already strained by the permission to utilize pool testing
explained that a high community rate staffing shortage. These comments also methods for the routine testing of all
may be skewed by isolated populations, discussed how it is challenging to staff and to focus routine staff testing on
such as incarcerated individuals or comply with the requirements due to those who have the greatest risk of
college and university students. limited availability of PPE. Most of exposure and transmission, such as
Commenters noted that higher infection these comments emphasize that the those who have direct contact with
rates in these populations resulted in frequent testing takes away valuable patients. For example, commenters
being required to test staff and residents time from resident care and found it unreasonable for a staff member
twice weekly, which they believed did socialization, which is critical at a time that works in the billing office—who
not yield additional information. A few when residents are not able to see their has no face-to-face contact with
of these commenters also noted that families. Many commenters also residents or with staff who provide
many of the LTC staff do not reside in reported that the time frame to report direct care to residents—to be tested
the same county as the facility and thus test results was too limited and weekly.
are not living in a county with a requested a 72-hour window to report Response: We acknowledge that at the
similarly high community infection rate; test results. These comments discussed time of publication of this IFC, PPE and
therefore, they should not be subject to how it is challenging to comply with COVID–19 tests were limited, and we
more frequent testing requirements. this requirement due to the increased commend staff and health care workers
Response: We thank commenters for turnaround time to receive results and for their diligence working through
recognizing the importance of collecting the limited number of staff members. these challenges. We also recognize the
accurate data and its use for informing Response: We share sympathy for
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challenges of conducting testing and
an appropriate pandemic response. It is residents and their family members who discuss in the LTC testing IFC that
important for data to be measured and were not able to gather in person. We because COVID–19 was newly
reported in a standardized manner. This discovered, the standards of practice for
allows for public health officials to 67 https://publichealthmdc.com/blog/did-you-
testing for the virus may continue to
compare disease occurrence across test-negative-when-sick-or-exposed-to-covid-heres- change or evolve. Additionally, the CDC
what-it-means#:∼:text=If%20you%20test%
different populations in order to make 20negative%20soon,be%20found%20on provides guidance on proper specimen
informed policy decisions and to better %20a%20test. collection at https://www.cdc.gov/
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36502 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations
coronavirus/2019-ncov/lab/guidelines- their applicability ending with the end vaccination IFC. As discussed in section
clinical-specimens.html and https:// of the COVID–19 PHE, we are revising I.B. of this final rule, CMS intends to
www.cdc.gov/coronavirus/2019-ncov/ the CFR at § 483.80(h) to remove the encourage ongoing COVID–19
lab/lab-biosafety-guidelines.html. This expired text. As previously discussed, vaccination through other mechanisms,
rule does not address the manner in CMS encourages ongoing COVID–19 including its quality reporting and
which tests are conducted, so long as mitigation measures through its quality value-based incentive programs. CMS
they are conducted in a manner that is reporting and value-based incentive continues to develop and refine quality
consistent with current professional programs in the near future. measures for both patient and health
standards of practice. As such, this care personnel vaccination to be used in
IV. Provisions of the Final Regulation
comment regarding pool testing appropriate quality programs and
methods is not within the scope of the In this section, CMS discusses the included patient and health care
rule. Readers may find more requirements in this final rule. In personnel vaccination quality measures,
information regarding pooled testing at section IV.A. of this final rule, we such as those seen on the MUC list
https://www.cdc.gov/coronavirus/2019- discuss the withdrawal of regulations issued on December 1, 2022. In addition
ncov/lab/pooling-procedures. pertaining to COVID–19 vaccination of to quality measurement, CMS continues
html#anchor_1625241118971. health care staff. We then discuss final to provide assistance and education
Comment: The majority of regulations for LTC facilities and ICFs– through CMS-funded entities (including
commenters discussed the financial IID to provide COVID–19 vaccine QIOs, Hospital Quality Initiatives
burden of the COVID–19 testing education and offer vaccination to (HQICs), and ESRD Networks), as well
requirements and noted that this burden residents, clients, and staff in section as to work with Federal, State, local,
was unsustainable considering the IV.B. of this final rule. Finally, we and industry partners who can also
staffing shortages and economic impacts discuss the deletion of the expired provide education and technical
of the PHE. Some comments highlighted COVID–19 testing requirements of staff support.
that PCR tests cost about $130 and that and residents for LTC facilities. The withdrawal of the COVID–19 staff
testing costs accumulate quickly. For vaccination requirements from the CoPs,
A. Omnibus COVID–19 Health Care
example, several commenters shared CfCs, and requirements should not be
Staff Vaccination
that they were spending upwards of construed as a diminution of CMS
$28,000 per month on testing, in COVID–19 is a novel disease caused support for vaccination or for facilities
addition to their fixed costs. Due to the by an unpredictable and nimble virus, to require staff vaccination. Moreover,
financial burden, a significant number SARS–CoV–2. CMS implemented the withdrawal of the requirements from the
of comments indicated that the testing staff vaccination requirements in the CoPs, CfCs, and requirements for LTC
requirements should be accompanied by IFC to assure health and safety during facilities does not prohibit facilities
additional funding and bureaucratic a PHE declaration. However, from requiring staff vaccinations, and
support. Other comments suggested circumstances surrounding COVID–19 we encourage health care employers to
streamlining funding to LTC facilities in continue to evolve and CMS has maintain evidence-based policies
areas with greater prevalence of COVID– evaluated its policies pertaining to regarding staff vaccination for COVID–
19. COVID–19 on an ongoing basis. CMS 19 and other communicable diseases for
Response: We recognize that the continues to recognize that vaccines are which vaccination is available and
COVID–19 pandemic has strained the important for preventing severe recommended. Health systems and
economy and created many challenges. illnesses and promoting public health health care employers may continue to
Additional funding and bureaucratic and that the incidence of severe COVID– require that workers stay up to date on
support are not within the scope of this 19 has declined significantly since the COVID–19 vaccinations, consistent with
final rule. The CDC has also released IFC was issued. We believe that using other Federal, State, and local laws.
guidance for health care facilities that quality programs to promote vaccination Moreover, some States may require
are expecting or experience staffing is an approach more consistent with the COVID–19 vaccination of health care
shortages due to COVID–19 and current nature of SARS–CoV–2 (that is, staff. Facilities must maintain
provides recommendations on frequent mutation, potentially compliance with applicable State and
mitigation strategies and contingency necessitating new vaccines), and that it local laws pertaining to vaccination.
strategies at https://www.cdc.gov/ can now be treated more like other In this final rule, the substantive
coronavirus/2019-ncov/hcp/mitigating- harmful but not necessarily emergent provisions of the staff vaccination IFC
staff-shortages.html. respiratory viruses like influenza. are withdrawn. Table 3 lists the
Final Decision: After evaluation of Accordingly, we are withdrawing from regulatory locations from which staff
public comments on the COVID–19 the CFR the requirements regarding vaccination regulations are addressed in
testing requirements for residents and COVID–19 vaccination of health care this final rule by provider and supplier
staff of LTC facilities, and in light of staff as established under the staff type.
TABLE 3—WITHDRAWN REGULATIONS BY PROVIDER AND SUPPLIER TYPE
Revised
Provider and supplier type regulation
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Ambulatory Surgical Centers (ASCs) .................................................................................................................................................. § 416.51(c)
Hospices .............................................................................................................................................................................................. § 418.60(d)
Psychiatric Residential Treatment Facilities (PRTFs) ......................................................................................................................... § 441.151(c)
Programs of All-Inclusive Care for the Elderly (PACE) Organizations ............................................................................................... § 460.74(d)
Hospitals .............................................................................................................................................................................................. § 482.42(g)
Long Term Care (LTC) Facilities ......................................................................................................................................................... § 483.80(i)
Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs–IID) ........................................................................... § 483.430(f)
Home Health Agencies (HHAs) ........................................................................................................................................................... § 484.70(d)
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Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations 36503
TABLE 3—WITHDRAWN REGULATIONS BY PROVIDER AND SUPPLIER TYPE—Continued
Revised
Provider and supplier type regulation
Comprehensive Outpatient Rehabilitation Facilities (CORFs) ............................................................................................................ § 485.70(n)
Critical Access Hospitals (CAHs) ........................................................................................................................................................ § 485.640(f)
Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-language
Pathology Services (Organizations) ................................................................................................................................................. § 485.725(f)
Community Mental Health Centers (CMHCs) ..................................................................................................................................... § 485.904(c)
Home Infusion Therapy (HIT) Suppliers .............................................................................................................................................. § 486.525(c)
Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) ........................................................................................ § 491.8(d)
End-Stage Renal Disease (ESRD) Facilities ...................................................................................................................................... § 494.30(b)
B. COVID–19 Vaccine ‘‘Educate and Medicaid programs. By doing so, ICFs– the agency’s intent to align its
Offer’’ Requirements for LTC Facilities IID must continue to educate clients, regulations with current public health
and ICFs–IID Residents, Clients, and client representatives, and staff and conditions and would be independently
Staff offer the COVID–19 vaccine to clients administrable. Likewise, the agency
While the COVID–19 pandemic and staff, as well as perform the intends that the provisions within each
continues to evolve, effective vaccines appropriate documentation for these of these categories of regulatory changes
and therapies have also been developed. activities. All of the requirements of the be treated as severable. For example,
Vaccination still remains as one of the educate and offer IFC are being were a court to stay or invalidate
most important methods to help reduce finalized, except for the language withdrawal of the staff vaccination
severity of COVID–19. However, some referring to the ICFs–IID staff refusing requirement for one type of health care
individuals may face additional barriers the COVID–19 vaccine. We are facility, the agency intends that the
accessing COVID–19 vaccines. As finalizing this requirement as amended withdrawal of the requirement for other
previously discussed, many of the by the staff vaccination IFC. types of facilities would remain in
residents and clients of LTC facilities effect. Accordingly, the agency
C. COVID–19 Reporting Requirements considers each of the provisions
and ICF–IIDs are not able to for LTC Facilities
independently travel offsite in order to adopted in this final rule to be
receive a vaccine due to several factors As previously discussed, CMS severable; in the event of a stay or
including but not limited to disability, continues to evaluate and revise its invalidation of any part of the rule, or
cognitive impairment, low health policies pertaining to COVID–19 on an of any provision as it applies to certain
literacy, and/or functional reasons. ongoing basis, and in light of the facilities or in certain factual
Because some of these individuals may conclusion of the COVID–19 PHE, we circumstances, the agency’s intent is to
are deleting the expired COVID–19 otherwise preserve the rule to the fullest
have a low health literacy, education on
testing requirement for LTC facilities. possible extent.
COVID–19 vaccines is particularly
important. Vaccine education allows for We continue to emphasize the VI. Collection of Information
residents, clients, and their caregivers to importance of practicing infection Requirements
be informed participants in their care control measures in order to mitigate the
Under the Paperwork Reduction Act
and allows them to make the most spread of COVID–19 and other
of 1995, we are required to provide 30-
appropriate decisions for themselves. communicable respiratory diseases.
day notice in the Federal Register and
Therefore, it is important that we V. Severability solicit public comment before a
maintain the educate and offer collection of information requirement is
provisions for both LTC facilities and As described in further detail in the submitted to the Office of Management
ICF–IIDs. previous sections of this rule, this final and Budget (OMB) for review and
In this final rule, we are finalizing the rule relates to three separate IFCs: This approval. In order to fairly evaluate
infection control requirements at final rule (1) withdraws requirements of whether an information collection
§ 483.80(d) that LTC facilities must meet the November 2021 IFC regarding staff should be approved by OMB, section
to participate in the Medicare and vaccination; (2) deletes expired 3506(c)(2)(A) of the Paperwork
Medicaid programs. By doing so, LTC requirements of the September 2020 IFC Reduction Act of 1995 requires that we
facilities must continue to educate and regarding COVID–19 testing in LTC solicit comment on the following issues:
offer the COVID–19 vaccine to residents, Facilities, and (3) finalizes requirements • The need for the information
resident representatives, and staff, as of the May 2021 IFC requiring facilities collection and its usefulness in carrying
well as perform the appropriate to provide education about COVID–19 out the proper functions of our agency.
documentation for these activities. All vaccines and to offer COVID–19 • The accuracy of our estimate of the
of the requirements of the educate and vaccines to residents, clients, and staff. information collection burden.
offer IFC are being finalized, except for As reflected by the fact that they these • The quality, utility, and clarity of
the language referring to LTC facility three categories of requirements the information to be collected.
staff refusing the COVID–19 vaccine appeared in three separate IFCs, the • Recommendations to minimize the
provisions of this final rule that relate
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originally set forth at § 483.80(d)(3)(v). information collection burden on the
We are finalizing this language as to each of these three categories operate affected public, including automated
amended by the staff vaccination IFC. independently, and the agency intends collection techniques.
We are also finalizing the COVID–19 that they be treated as severable. If any In the staff vaccination IFC published
facility staffing and health care services one of these categories of regulatory November 5, 2021, the educate and offer
requirements at §§ 483.430(f) and changes were stayed or invalidated by a IFC published May 13, 2021, and the
483.460 that ICFs–IID must meet to reviewing court, the remaining LTC facility testing IFC published
participate in the Medicare and categories would continue to effectuate September 2, 2020, we solicited public
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36504 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations
comment on each of these issues for the were based on hourly wage data from (August 4, 1999), and the Congressional
following sections of this document that the Bureau of Labor Statistics for 2019. Review Act (5 U.S.C. 804(2)).
contain information collection These estimates remain unchanged in Executive Orders 12866 and 13563
requirements (ICRs). However, we did this final rule, which makes no direct agencies to assess all costs and
not receive any comments on these substantive changes to the regulations benefits of available regulatory
ICRs. issued in that interim final rule. alternatives and, if regulation is
The following analysis covers the necessary, to select regulatory
VII. Regulatory Impact Analysis approaches that maximize net benefits
ICRs for the Staff Vaccination, Educate
and Offer, and LTC testing A. Statement of Need (including potential economic,
requirements. As in the preamble above, environmental, public health and safety
The COVID–19 pandemic precipitated effects, distributive impacts, and
we will first analyze the ICRs for the the greatest health crisis in the U.S.
Staff Vaccination requirements first. equity). Executive Order 14094
since the 1918 Influenza pandemic. The (Modernizing Regulatory Review)
Under the Paperwork Reduction Act population of older adults, and LTC
of 1995 (PRA), we are required to amends section 3(f)(1) of Executive
facility residents in particular, were Order 12866 (Regulatory Planning and
provide 30-day notice in the Federal hard hit by the impacts of the pandemic.
Register and solicit public comment Review). The amended section 3(f) of
Among those infected, the death rate for Executive Order 12866 defines a
before a collection of information older adults age 65 or higher was
requirement is submitted to the Office of ‘‘significant regulatory action’’ as an
hundreds of times higher than for those action that is likely to result in a rule
Management and Budget (OMB) for in their 20s during 2020. Of the 1.1
review and approval. To fairly evaluate that may: (1) have an annual effect on
million deaths through April 2023, only the economy of $200 million or more in
whether an information collection about 6,912 were for ages 18–29,
should be approved by OMB, section any 1 year (adjusted every 3 years by the
compared to 850,000 for those age 65 or Administrator of the Office of
3506(c)(2)(A) of the Paperwork higher.69 Moreover, of the
Reduction Act of 1995 requires that we Information and Regulatory Affairs
approximately 1,130,662 Americans (OIRA) for changes in gross domestic
solicit comment on the following issues: estimated to have died from COVID–19
• The need for the information product), or adversely affect in a
through May 2, 2023, about 15 percent material way the economy, a sector of
collection and its usefulness in carrying
were estimated to have died during or the economy, productivity, competition,
out the proper functions of our agency.
after a LTC facility stay,70 a percentage jobs, the environment, public health or
• The accuracy of our estimate of the
that has decreased substantially from safety, or State, local, territorial, or tribal
information collection burden.
earlier levels as vaccination rates governments or communities; (2) create
• The quality, utility, and clarity of
increased for both residents and staff a serious inconsistency or otherwise
the information to be collected.
and as the availability and use of interfering with an action taken or
• Recommendations to minimize the
effective medications to reduce the rates planned by another agency; (3)
information collection burden on the
of hospitalization and death have materially alter the budgetary impacts of
affected public, including automated
rapidly grown.71 The proportion of the entitlement grants, user fees, or loan
collection techniques.
unvaccinated who have contracted the programs or the rights and obligations of
This rule contains no new
virus has also contributed to reducing recipients thereof; or (4) raise legal or
requirements and would sunset those
the rate of future infections and their policy issues for which centralized
promulgated by the staff vaccination IFC
severity. As a result of all these factors, review would meaningfully further the
and the LTC testing IFC. The original
the Biden Administration allowed the President’s priorities or the principles
estimates for the staff vaccination IFC
public health emergency declaration set forth in the Executive order, as
were 1,555,487 burden hours and
under section 319 of the Public Health specifically authorized in a timely
$136,088,221 for both the initial and
Service Act related to the COVID–19 manner by the Administrator of OIRA in
subsequent years. The dollar estimates
pandemic to end on May 11, 2023. each case.
were based on hourly wage data from
the Bureau of Labor Statistics for 2020. A regulatory impact analysis (RIA)
B. Overall Impact
must be prepared for ‘‘significant
The original estimates for the LTC We have examined the impacts of this regulatory actions’’ as defined in E.O.
testing IFC were $48,158,193 over the rule as required by Executive Order 12866 as amended by E.O. 14094. Based
estimated course of the PHE. The dollar 12866 on Regulatory Planning and on our estimates, OMB’s Office of
estimates were based on an estimated Review (September 30, 1993), Executive Information and Regulatory Affairs has
labor requirement of 2 minutes per test Order 13563 on Improving Regulation determined this rulemaking is
and hourly wage date from the Bureau and Regulatory Review (January 18, significant per section 3(f)(1) of E.O.
of Labor Statistics for 2019. Based on 2011), Executive Order 14094 on 12866 as measured by the threshold of
the termination of the COVID–19 PHE Modernizing Regulatory Review (April $200 million or more in any 1 year, and
and withdrawal of the vaccination and 6, 2023), the Regulatory Flexibility Act hence also a rule qualifying under the
testing requirements, these estimates are (RFA) (September 19, 1980, Pub. L. 96– definition in 5 U.S.C. 804(2) (Subtitle E
reduced to zero in all succeeding 354), section 1102(b) of the Social of the Small Business Regulatory
months and years.68 Security Act, section 202 of the Enforcement Fairness Act of 1996, also
The original estimates for the educate Unfunded Mandates Reform Act of 1995 known as the Congressional Review
and offer IFC were that first-year costs (March 22, 1995; Pub. L. 104–4), Act).
would be 1,277,874 burden hours and Accordingly, we have prepared an
ddrumheller on DSK120RN23PROD with RULES1
Executive Order 13132 on Federalism
$91,250,874. Subsequent year costs RIA that, taken together with the
were estimated at 866,580 burden hours 69 https://www.cdc.gov/nchs/nvss/vsrr/covid_ collection of information (COI) analysis
and $55,177,044. The dollar estimates weekly/index.htm. and other sections of this preamble,
70 https://covid.cdc.gov/covid-data-tracker/
presents to the best of our ability the
68 See ‘‘Statement of Administration Policy’’, #datatracker-home.
Executive Office of the President, January 30, 2023, 71 https://www.kff.org/policy-watch/over-200000- costs and benefits of the rulemaking. It
at https://www.whitehouse.gov/wp-content/ residents-and-staff-in-long-term-care-facilities-have- is important to understand, as explained
uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf. died-from-covid-19/. previously in this final rule, that this
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Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations 36505
rule is terminating only one of the IFCs encounters, but likely to be much on numbers of lives lost of either health
that were issued by CMS in response to lower—about 250 million—based on care staff or health care patients is
the COVID–19 pandemic. The number of different individuals. Thus, limited by the scope of such outcomes
requirements for COVID–19 testing of existing ‘‘educate and offer’’ in the analytic baseline (that is, the
LTC facility staff have already expired. requirements focus on both nursing future trajectory in this rule’s absence).
The educate and offer IFC is being made home staff and patients. While the number of health care staff
permanent, substantively unchanged. The original staff vaccination IFC and (whether called employees, workers, or
Hence, the staff vaccination IFC is the this final rule present substantial staff) dying from COVID–19 infections
only one substantively affected by this difficulties in estimating both costs and was already decreasing when the staff
rule. Relative to a hypothetical future in benefits due to the high degree to which vaccination IFC was issued, it has for
which this and the educate and offer all current provider and supplier staff the last year decreased to very low
IFC continue unchanged, this rule have already received information about levels, often zero, for weeks at a time.75
reduces costs through the withdrawal of the benefits and safety of COVID–19 An unknown fraction of these deaths
the omnibus staff vaccination vaccination and about the rare serious may have been vaccinated persons. Nor
requirements. It is economically risks associated with vaccination. What is there reason to believe that the
significant under section 3(f)(1) of E.O. is still uncertain is how staff or patient relatively few recently recorded deaths
12866 because the costs eliminated compliance with recommended from COVID–19 were due to workplace
exceed $200 million annually. vaccinations may change further over exposures, considering all the other
Due to the success of all three IFCs in time. Moreover, we do not know how locations at which workers might be
encouraging both staff and patient many persons in each of these groups exposed to the virus.76 That said, we
vaccination in health care settings, the has become ill with COVID–19, and still do not know how much of this
evolution of SARS–CoV–2 toward how many of these more than once, massive decrease in the mortality rate of
variants whose adverse health impacts before coming into close contact. Nor do infected populations was due to the
are on average less severe, and we know how these numbers are likely policy effects of the IFC itself, but with
improved medications and reduced to change in the next few years, whether the educate and offer rule now
stresses on hospitals and other health a new variant of the SARS–CoV–2 virus permanent, the fraction of staff and
care facilities, rates of severe illness and may emerge, or what new vaccines or patients unvaccinated close to single
of death have both radically decreased treatment options may become common digits (and never likely to have been
since the staff vaccination IFC was and with what effectiveness in much closer to zero given the various
issued. Of particular importance, the preventing infection, hospitalization, or legally available exemptions), there is
interactive effect of both staff and death. With all these unknown no plausible basis for estimating a
patient COVID–19 vaccination rates variables, we cannot predict with resurgence of deaths among either group
reaching or approaching 90 percent has confidence future COVID–19 morbidity absent some new and more virulent
helped each group protect the other. or mortality levels either with or COVID variant.
Vaccinating staff protects both staff and without better vaccination compliance. Perhaps the simplest way to
patients, as does vaccinating patients.72 However, we can estimate with some understand these effects is to consider
In this regard, we emphasize that our confidence a range of conditions in a that in the roughly 18 months since the
current and planned use of data on both hypothetical future in which the staff staff vaccination IFC rule was issued,
staff and patient vaccination rates will vaccination and educate-and-offer IFCs much and perhaps most of the originally
maintain consistent pressure on the remain unchanged (assuming no new estimated costs (implementation) and
health care providers and suppliers SARS–CoV–2 variant with higher or benefits (lives saved) have already been
regulated by CMS to maintain and lower health effects becoming realized. However, the many
improve current success rates. dominant, no new vaccine with higher uncertainties that still affect projections
As displayed in detail in Tables 5 and protection against the existing variant, into the future led us to restrict our cost
6 of the staff vaccination IFC, there are no major changes in vaccination horizons in the staff vaccination rule to
about 76,000 provider and supplier practices, and no major changes in one year and to eschew any mortality
entities regulated by CMS, and these treatments), simply by using current reduction estimate. In retrospect, it
facilities have about 13 million staff data and projecting no major changes in appears that while our cost estimates
during each year.73 But large as these these variables.74 may have been reasonably robust, any
numbers are, they are dwarfed by the estimate of lives saved would have
C. Anticipated Benefits and Costs
number of patients served. In total
Relative to a hypothetical future in 75 The CDC Data Tracker for Covid, ‘‘Cases and
across all provider and supplier types,
which the staff vaccination and educate- Deaths among Healthcare Personnel,’’ estimates the
but excluding hospital outpatient and total number of COVID-caused deaths among
and-offer IFCs remain in their current
emergency caseloads, CMS-certified healthcare workers since the pandemic began is
form—which is one of multiple relevant about 2,500, of which only about 200 have occurred
providers and suppliers serve over 100
analytic baselines—This rule imposes in the last year (February to February). Data at
million patients a year. Including
no new costs (other than the costs of https://covid.cdc.gov/covid-data-tracker/#health-
patients served as hospital emergency care-personnel_healthcare-deaths.
reading and acting on this final rule).
cases or as outpatient cases, the total 76 The Bureau of Labor Statistics estimates that
Instead, it reduces regulatory costs to there were about 5,000 annual fatal workplace
number of patients served is more than
health care providers and suppliers by injuries to workers in recent years. Accidents at
300 million based on number of
withdrawing the requirements imposed work are only one of many causes of worker
fatalities (for example, automobile injuries outside
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72 We note that there is additional protection
by the staff vaccination IFC issued in
of the workplace, non-occupational illnesses of all
because many and very likely most of the remaining November 2021. This final rule’s effect kinds, and heart attacks while at work). In
unvaccinated staff and patients previously have comparison, roughly 200 healthcare worker deaths
been infected by one or more COVID–19 variants, 74 For a list and discussion of past and present occurred from COVID–19, much and perhaps most
and therefore are less likely to experience severe COVID variants, one useful and current source is contracted outside the workplace. See CDC
COVID–19 in the near future. There are, however, Kathy Katella, ‘‘Omicron, Delta, Alpha and More: healthcare personnel data cited in preceding
no good data on the numbers or effects of these What To Know About the Coronavirus Variants,’’ footnote, in comparison ‘‘to ‘‘National Census of
infections. February 3, 2023, at https://www.yalemedicine.org/ Fatal Occupational Injuries in 2021’’ at https://
73 See 86 FR 61603 and 61606, November 5, 2021. news/covid-19-variants-of-concern-omicron. www.bls.gov/news.release/pdf/cfoi.pdf.
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36506 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations
likely been far too high. In particular, would have been needed to comply in future years than upfront, in large part
the reduced lethality of the Omicron future years. because the need for development of
variant of the virus and the available For purposes of estimating benefits policies, procedures, and educational
treatments for those ill from the virus from eliminating the implementation materials would be greatly reduced over
were the largest life savers by far.77 costs of the staff vaccination IFC, we time. Those future year estimates were
therefore estimate that the second- and then and remain uncertain for most of
Compliance Cost Reduction. In the third-year costs of the November 2021 the same reasons already discussed with
staff vaccination IFC we estimated staff vaccination IFC (if continued respect to the staff vaccination IFC. We
compliance and vaccination costs to be unchanged) would have been $691 have no basis for changing the overall
about $1.382 billion in the first year and million (0.5 * 1,382). Had we estimated estimated total future year compliance
declined to estimate costs in succeeding fourth and fifth (or later) years on the costs from the estimates made at that
years (see Table 7 in that rule).78 This same basis, costs near those levels time.
estimate attributed all implementation would presumably have continued. Changes in Worker Lives Saved or
costs to that rule, with no offsetting Subtracting an additional $4 million for Lost. Ending the staff vaccination IFC
assumption about spending that would the one-time costs of reading and acting could arguably reduce vaccination
otherwise have occurred. Thus, it on this final rule, the next year of levels among health care staff. However,
attributed the vaccine costs for benefits of this rule in costs reduced the direct effect of this regulatory
healthcare workers paid by the Federal from the estimated annual level in the change is not necessarily to reduce the
Government to be a result of that rule. November 2021 interim final rule would level of vaccination among health care
It omitted, however, potential increases be $687 million, followed by future staff, but to eliminate the government
in recruitment costs and a variety of years at $691 million (until something requirements for facilities to track and
potential business disruption costs for unforeseen changed). manage vaccination. We believe it
facilities that may have had difficulties We note that these cost (now benefit) possible, in fact, that provider and staff
hiring vaccinated workers. We estimates apply only to the mandatory self-interest will persuade current or
estimated with these omissions because nature of the rule addressing staff future vaccine-hesitant or newly hired
we had no reliable way to estimate how vaccination. As discussed in the next staff, or both, about the safety and
much of these costs might be due to section of this RIA, we believe it very effectiveness of current vaccines. This
independent employer decisions, to likely that many and probably most opportunity is particularly large for
other Federal standards, to State and health care providers and suppliers will booster shots, since only about 22
local mandates, or to individual continue to require or strongly urge staff percent of nursing home staff, and
personal choices. In retrospect, this was vaccination and that staff vaccination presumably a similar percentage for
rates will rise over time as new other provider types, have even
a reasonable estimate because we still
generations of workers who received obtained the first booster.80 Another
have no basis for ‘‘correcting’’ the
past vaccinations will be hired. The positive factor may be the influence of
original assumption. Moreover, if such
precise evolution of these trends will educational institutions that train future
costs were not paid by the government
depend on the many uncertainties care personnel in persuading or
directly, both public and private requiring their students to accept
already discussed, and the result may be
insurance would have covered most of higher or lower changes in costs than vaccination while in school, before
these costs in future years (and likely those anticipated at the time the interim taking jobs in the health care sector.
will cover them for voluntary final rule was issued (and thus higher or Finally, the willingness of health care
vaccinations). Regardless, a substantial lower savings than what is estimated employers to simply require vaccination
fraction of those costs would have been now). Given experiences to date, (in the vast majority of States where this
expected to recur each year, if for no however, we believe that the future is allowed) is a significant and
other reason than turnover among benefits (lives saved) of continuing the potentially highly positive factor.81
health care staff. However, since the staff vaccination requirements would The most influential variables in
first year included primary series have been low at the time of our predicting future lives saved or lost are
vaccination of all existing staff, estimate and very low if made in the likely to be the new SARS–CoV–2
succeeding years would have been light of recent experience. We continue variants that make the initial vaccines
lower in cost because the number of to believe, however, that reliable less effective in preventing COVID–19.
required vaccinations would largely be forecasts of morbidity and mortality However, the new variants have
incurred only for new workers, and only over any time horizon more than a few generally been less harmful for most of
some of these would not have been months cannot yet be made. those who have received vaccinations.
previously vaccinated through other We again note that the LTC testing Additional doses of COVID–19 vaccines
sources. Furthermore, only in the first requirements expired before publication provide protection against COVID–19
year would one-time costs (such as of this final rule. This rule was not a but immunity declines over time. These
reading the rule and creating policies factor in that expiration and we are all variables that interact, and their
and procedures to implement the rule) accordingly do not address the understanding by healthcare personnel
have been incurred. We therefore now estimated costs and benefits of that depends substantially on the
estimate that to maintain that rule only change. effectiveness of education and offering
about one-half of the first-year estimate The preceding discussion applies to
80 https://www.cdc.gov/nhsn/covid19/ltc-
the staff vaccination IFC. The May 2021
vaccination-dashboard.html.
ddrumheller on DSK120RN23PROD with RULES1
77 See W. Adjei et al., ‘‘Risk Among Patients educate-and-offer IFC is not being 81 The CDC has collected data on State laws either
Hospitalized Primarily for COVID–19 During the changed, and the original compliance prohibiting (often with exceptions) or mandating
Omicron and Delta Variant Pandemic Periods,’’ cost estimates in that rule included (often with exceptions) employer-or local
Morbidity and Mortality Weekly Report (MMWR), future year projections.79 These government-mandated COVID–19 vaccination or
September 16, 2022; at https://www.cdc.gov/mmwr/ testing. Few States and none of the larger States
volumes/71/wr/mm7137a4.htm. This report showed projections showed lower estimates for have created by law prohibitions that would apply
a two thirds reduction in mortality from the Delta to healthcare or long-term care employers. The
period to the Omicron period. 79 See Table 6 in that rule, at 86 FR 26330, May statutes mainly address compulsion by lower levels
78 86 FR 61609, November 5, 2021. 13, 2021. of government, such as cities or counties.
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Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations 36507
efforts by applicable health care the termination of the staff vaccination most worker infections undoubtedly
providers. Further, many Americans IFC is estimated to have minimal effects. come from contacts with infected
have been infected with COVID–19 and As discussed elsewhere in the individuals in external places such as
may have developed some level of preamble, we intend to establish sporting events, grocery stores, clubs,
infection-induced immunity, which measures on COVID–19 infection restaurants, and bars. But for health care
provides some protections as well. prevention to our quality improvement these patterns are even more complex.
Since the educate and offer measures for most types of health care The person who tests positive upon
requirements are being retained and will facilities. This is a far more flexible admission to a hospital most likely
be reinforced by new quality measures, system than detailed regulations and reached the hospital after contracting
as well as the extent to which future will allow tailoring of actions and the disease in another setting.
patients respond to high and low scores accomplishments down to the facility It is also true that there are many
on these measures, we believe that any level, responding in real-time to any more patient lives than staff lives at
overall change in morbidity and changes in SARS–CoV–2 variants, drug issue. While health care staff deaths
mortality from the repeal of the treatments, and other factors that from COVID–19 appear to have reached
provisions of the staff vaccination IFC improve either staff or patient health single digits on a weekly basis the total
would be smaller than what would outcomes, including innovations that national weekly number of COVID–19
result from repeal occurring protect either group through the other, deaths has been about 3,000 on average
(hypothetically) without the or both at once. For example, improved for over 6 months.87 Assuming no
continuation of education-and-offering ventilation systems have been change, the number of COVID–19 deaths
requirements. demonstrated to reduce airborne will be about 160,000 in 2023, about 5
Quite apart from changes in infections for any exposed persons, percent of the national total of about 3.5
vaccination levels from those either including staff, patients, and visitors.85 million annual deaths from all causes
originally estimated or currently in Therefore, and subject to all the (and half the COVID–19 number in
place, the morbidity and mortality of uncertainties and unknowns discussed 2020).
COVID–19 have changed substantially earlier in this analysis that might lead D. Other Effects
since 2021. In particular, the currently to higher or lower numbers, there is no
known reason to expect that repeal of There are no substantial budgetary
dominant strain of the virus results in effects of this final rule. Current
much lower levels of severity, thereby the staff vaccination IFC will lead to a
substantial or measurable increase or payments for vaccine are federally
lowering both hospitalizations and financed, and not driven by whether
death. Current treatment options reduce decrease in health care worker deaths,
despite the many uncertainties and there is a PHE for COVID–19 declared
severity levels even further.82 Assuming under section 319 of the Public Health
no further change in vaccination levels, unknowns involved.
Changes in Patient Lives Saved or Service Act. When the current budget
treatment options, or in COVID-caused for the vaccines runs out, private and
severity of illness, currently available Lost. Most of the same factors that apply
to staff apply with equal force to public health insurance will in most
information can be used to create rough cases assume the costs of vaccination,
estimates of conditions in a hypothetical patients. There are, however, several
key differences. First, CMS has long depending on future coverage decisions
future in which the IFCs remain in their by these insurance programs. Likewise,
current form. Most importantly, COVID- required that LTC facilities and IICFs–
IID both encourage and arrange there is little or no reason to expect that
caused deaths have fallen substantially the expiration of the LTC facility testing
since the levels measured in or before vaccination of patients with the annual
influenza vaccine and the IFC will have a consequential effect.
2021. According to CDC estimates, the
number of deaths caused by COVID–19 pneumococcal vaccine. These 1. Regulatory Flexibility Act
among healthcare workers has fallen requirements now include COVID–19 The RFA requires agencies to analyze
from dozens per week to close to zero.83 vaccination following the educate and options for regulatory relief of small
Specifically, in the last year (beginning offer IFC that we are now making entities, if a rule has a significant impact
of February 2022 through end of January permanent and thus no longer on a substantial number of small
2023) the number of known healthcare contingent on the scope or magnitude of entities. Under the RFA, ‘‘small
worker deaths per week has ranged from COVID–19 infections. These facilities entities’’ include small businesses,
0 to 4 (CDC says ‘‘less than 5’’) and are the most important locations for nonprofit organizations, and small
therefore has averaged about 2 per week, patient education, both to protect other governmental jurisdictions. Individuals
or a rate of approximately 100 per patients and to protect staff. and States are not included in the
year.84 Since a fraction of these deaths Second, the location where a patient
definition of a small entity. For
presumably were of those infected is treated or dies may have little or no
purposes of the RFA, we estimate that
outside the workplace, or among those relevance to where they became
most health care facilities are small
already vaccinated (given the percentage infected.86 This is true, of course, for
entities as that term is used in the RFA
of adults in the United States who have workers as well. Many and perhaps
because they are either nonprofit
received a COVID–19 vaccine), or both, 85 See CDC, ‘‘Ventilation in Buildings,’’ June
organizations or meet the SBA
2,2021 version, at https://www.cdc.gov/ definition of a small business (for most
82 https://www.idsociety.org/covid-19-real-time-
coronavirus/2019-ncov/community/ types of health care providers, having
learning-network/emerging-variants/emerging- ventilation.html, and Ehsan Mousavi et al, revenues of less than $8.0 million to
covid-19-variants/. ‘‘COVID–19 Outbreak and Hospital Air Quality: A
ddrumheller on DSK120RN23PROD with RULES1
83 https://covid.cdc.gov/covid-data-tracker/ Systematic Review of Evidence on Air Filtration
$41.5 million in any 1 year). HHS uses
#health-care-personnel_healthcare-deaths. and Recirculation,’’ American Chemical Society an increase in costs or decrease in
84 CDC’s website acknowledges that these data Public Health Emergency Collection, August 26,
have gaps and other imperfections, but the crucial 2020, at https://www.ncbi.nlm.nih.gov/pmc/ 87 See the Data Table for Weekly Death Trends in
point seems clear. From the full set of these sources, articles/PMC7489049/. CDC’s COVID Data Tracker. Only a handful of
however imperfect, the number of cases is down 86 Of course, this would not apply equally in all weeks have reached or exceeded 3,500 deaths since
substantially, and the number and rates of deaths health care settings. Quick outpatient visits and May 2022 as shown in this table, at https://
have decreased even further compared to the first long-term care residence would not show the same covid.cdc.gov/covid-data-tracker/#trends_
2 years of the pandemic. location of infection patterns. weeklydeaths_select_00.
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36508 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations
revenues to a provider of more than 3 requires that agencies assess anticipated Government uses, such as vaccine
to 5 percent as its measure of costs and benefits before issuing any research.
‘‘significant economic impact.’’ The rule whose mandates will impose In the population as a whole, as of
HHS standard for ‘‘substantial number’’ spending costs on State, local, or Tribal March 29, 2023, COVID–19 death rates
is 5 percent or more of those that will governments, or by the private sector, have decreased to about 323 a week,
be significantly impacted, but never require spending in any 1 year of $100 still far too high but a decreasing
fewer than 20. million in 1995 dollars, updated fraction of the 3.5 million annual and
This final rule was not preceded by a annually for inflation. In 2023, that 66,000 weekly deaths from all causes in
general notice of proposed rulemaking threshold is approximately $175 the United States.91 92 With regard to
and the RFA requirement for a final million. This final rule was not health care staff, the progress has been
regulatory flexibility analysis does not preceded by a notice of proposed even more rapid, with staff deaths
apply to final rules not preceded by a rulemaking, and therefore the attributed to COVID–19 trending
proposed rule. Regardless, this rule requirements of UMRA do not apply. downward since late 2021 and
would not trigger the RFA requirement. remaining relatively low over the past
Regardless, this rule contains no State,
As estimated previously, the total year.93 Given the many uncertainties as
local, or Tribal governmental mandates,
savings from this rule for future years to future events, and with the option of
nor any mandates on private sector
are about $691 million annually. Spread new emergency regulations available
over 13 million full-time equivalent entities that were not previously
under appropriate circumstances if
health care employees, this is about $53 included in prior rules. Moreover, it
progress is halted or reversed, a rule
per employee. Assuming a fully loaded saves rather than increases costs. The
tailored to future events could always be
average wage and support cost per analysis in this RIA and the preamble as created should the data justify such an
employee of $90,000,88 the annual a whole would, however, meet the action.
savings do not approach the 3 percent requirements of UMRA. While not otherwise addressed in this
threshold. Furthermore, the Department 4. Federalism RIA, we did consider whether it might
interprets the RFA’s definition of be appropriate to not finalize the
‘‘significant economic impact’’ as Executive Order 13132 establishes educate and offer IFC but as discussed
applying only to newly imposed adverse certain requirements that an agency in this rule recognize the importance of
effects, not to cost reductions or other must meet when it promulgates a ongoing access to vaccination for
savings. For these reasons, the proposed rule (and subsequent final individuals residing in congregate care
Department has determined that this rule) that imposes substantial direct settings. Additionally, we also
final rule will not have a significant effects on State and local governments, considered whether we could or should
adverse economic impact on a preempts State law, or otherwise has extend the LTC facility testing
substantial number of small entities and federalism implications. While the staff requirements that expired with the PHE,
that a final Regulatory Flexibility vaccination IFC did preempt some State and determined that there was no need
Analysis is not required. Regardless, the laws, those effects did not involve in the face of current standards of care
content of this RIA and the main ‘‘substantial direct costs’’ and this final that call for testing when clinically
preamble, taken together, would meet rule repeals those preemptions. indicated.
the requirements for a Final Regulatory Accordingly, the requirements of E.O.
Flexibility Analysis. F. Accounting Statement and Table
13132 do not apply to this final rule.
The Accounting Table (Table 4)
2. Small Rural Hospitals
E. Alternatives Considered summarizes the quantified impact of
Section 1102(b) of the Act requires us this rule. It covers only 3 years because
to prepare an RIA if a proposed or final While we considered retaining the there will likely be new developments
rule may have a significant impact on requirements established in the staff regarding treatments and vaccinations
the operations of a substantial number vaccination IFC, we believe that it has and their effects in future years and we
of small rural hospitals. For purposes of largely served its emergency purpose of have no way of knowing which will
this requirement, we define a small protecting the health and safety of most likely occur. A longer period
rural hospital as a hospital that is patients. As previously discussed in this would be even more speculative than
located outside of a metropolitan RIA, about 86 percent of nursing home the current estimates.
statistical area and has fewer than 100 staff have completed the original As explained in various places within
beds. This rule is exempt because that primary vaccination series, helping this RIA and throughout this final rule,
provision of law only applies to those reduce risk to patients.89 Moreover, there are major uncertainties as to the
final rules for which a proposed rule many and likely most of the remaining effects of current or possible future
was published. Because this rule has staff have previously been infected by variants of SARS–CoV–2 on future
only the small and positive impact per COVID–19 and benefit from some infection rates, medical treatments and
employee calculated for RFA purposes, protective immunity.90 We also note costs, and prevention of major illness or
the Department has determined that this that the subject addressed by this rule mortality. Even the duration of vaccine
rule will not have a significant impact is whether or not to extend and/or
on the operations of a substantial modify the staff vaccination IFC, not the 91 https://www.cdc.gov/coronavirus/2019-ncov/
number of small rural hospitals. array of actions pursued with the many covid-data/covidview/index.html.
92 Farida Ahmad et al, ‘‘Provisional Mortality
3. Unfunded Mandates Reform Act tools and venues which the Federal
Data—United States, 2021,’’ at https://
ddrumheller on DSK120RN23PROD with RULES1
pubmed.ncbi.nlm.nih.gov/35482572/.
Section 202 of the Unfunded 89 https://www.cdc.gov/nhsn/covid19/ltc- 93 https://covid.cdc.gov/covid-data-tracker/
Mandates Reform Act of 1995 (UMRA) vaccination-dashboard.html#anchor_ #health-care-personnel, Of 98,807,297 case reports
1638315381394. received by CDC, 13,207,516 (13.37 percent) have
88 This is the rounded weighted average annual 90 Reinfection of previously vaccinated persons or known healthcare personnel (HCP) status.
cost of healthcare employees as estimated in the of previously infected persons would make them a Completion of HCP status varied in case reporting
Totals line of Table 4 of the mandated vaccination temporary risk, but the frequency of this problem over time and is noted in the figure and table below.
interim final rule issued in November of 2021, op appears to be quite low. It remains, however, yet For the 1,145,831 cases of COVID–19 among HCP,
cit. another future unknown. death status is available for 636,341 (55.54 percent).
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Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations 36509
effectiveness in preventing COVID–19, actions (including the retention of the We also show a range (plus or minus 25
reducing disease severity, and risk of educate and offer IFC for LTC facilities percent) for the upper and lower bounds
death, by those vaccinated are not and ICFs–IID, which would have a life- of potential cost savings to emphasize
currently known with precision or extending effect relative to an analytic the uncertainty as to several major
certainty. These uncertainties also baseline in which the future is variables, including changes in
impinge on benefits estimates. For those characterized by a hypothetical absence voluntary vaccination levels, longer-
reasons we have not quantified into of that IFC 94) and have used only a 3- term effects, and others previously
annual totals the effects on mortality year projection for the cost savings discussed.
risk of this rulemaking or of other estimates in our Accounting Statement.
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 Lower bound Upper bound
estimate Discount rate Period
Year dollars (%) 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 discrimination, Reporting and 42 CFR Part 491
Executive Order 12866, this regulation recordkeeping requirements.
was reviewed by the Office of Grant programs—health, Health
42 CFR Part 482 facilities, Medicaid, Medicare,
Management and Budget.
Chiquita Brooks-LaSure, Grant program-health, Hospitals, Reporting and recordkeeping
Administrator of the Centers for Medicaid, Medicare, Reporting and requirements, Rural and urban areas.
Medicare & Medicaid Services, recordkeeping requirements.
42 CFR Part 494
approved this document on May 11, 42 CFR Part 483
2023. Diseases, Health facilities, Medicare,
Grant programs-health, Health Reporting and recordkeeping
List of Subjects facilities, Health professions, Health requirements.
42 CFR Part 416 records, Medicaid, Medicare, Nursing
homes, Nutrition, Reporting and For the reasons set forth in the
Health facilities, Health professions, recordkeeping requirements, Safety. preamble, the Centers for Medicare &
Medicare, Reporting and recordkeeping Medicaid Services amends 42 CFR
requirements. 42 CFR Part 484
chapter IV to remove expired language
Administrative practice and and finalize certain provisions issued in
42 CFR Part 418
procedure, Grant programs-health, the interim final rule published at 85 FR
Health facilities, Hospice care, Health facilities, Health professions, 54820 (September 2, 2020); to finalize
Medicare, Reporting and recordkeeping Medicare, Reporting and recordkeeping certain provisions issued in the interim
requirements. requirements. final rule published at 86 FR 26306
42 CFR Part 441 42 CFR Part 485 (May 13, 2021); and to withdraw the
regulations issued in the interim final
Aged, Family planning, Grant Grant programs—health, Health rule published at 86 FR 61555
programs-health, Infants and children, facilities, Medicaid, Privacy, Reporting (November 5, 2021) as set forth below:
Medicaid, Penalties, Reporting and and recordkeeping requirements.
recordkeeping requirements. PART 416—AMBULATORY SURGICAL
42 CFR Part 486
42 CFR Part 460 SERVICES
Administrative practice and
ddrumheller on DSK120RN23PROD with RULES1
Aged, Citizenship and naturalization, procedure, Grant programs—health,
■ 1. The authority citation for part 416
Civil rights, Health, Health care, Health Health facilities, Home infusion
records, Individuals with disabilities, therapy, Medicare, Reporting and continues to read as follows:
Medicaid, Medicare, Religious recordkeeping requirements, X-rays. Authority: 42 U.S.C. 1302 and 1395hh.
94 Relative to this without-IFC baseline, the
finalized requirements would also impose cost, as
estimated at the time of the IFC’s issuance.
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36510 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Rules and Regulations
§ 416.51 [Amended] PART 484—HOME HEALTH SERVICES Authority: 42 U.S.C. 1302 and 1395hh.
■ 2. Section 416.51 is amended by § 494.30 [Amended]
■ 14. The authority citation for part 484
removing paragraph (c). continues to read as follows: ■ 28. Section 494.30 is amended by
PART 418—HOSPICE CARE Authority: 42 U.S.C. 1302 and 1395hh. removing paragraph (b) and
redesignating paragraphs (c) and (d) as
§ 484.70 [Amended] paragraphs (b) and (c), respectively.
■ 3. The authority citation for part 418
continues to read as follows: ■ 15. Section 484.70 is amended by Xavier Becerra,
removing paragraph (d). Secretary, Department of Health and Human
Authority: 42 U.S.C. 1302 and 1395hh.
Services.
§ 418.60 [Amended] PART 485—CONDITIONS OF
[FR Doc. 2023–11449 Filed 5–31–23; 4:15 pm]
PARTICIPATION: SPECIALIZED
■ 4. Section 418.60 is amended by PROVIDERS BILLING CODE 4120–01–P
removing paragraph (d).
■ 16. The authority citation for part 485
PART 441—SERVICES: continues to read as follows: FEDERAL COMMUNICATIONS
REQUIREMENTS AND LIMITS Authority: 42 U.S.C. 1302 and 1395(hh). COMMISSION
APPLICABLE TO SPECIFIC SERVICES
§ 485.58 [Amended] 47 CFR Part 54
■ 5. The authority citation for part 441 ■ 17. Section 485.58 is amended in [WC Docket No. 21–93; DA 23–405; FR ID
continues to read as follows: paragraph (d)(4) by removing the last 142102]
Authority: 42 U.S.C. 1302. sentence.
Establishing Emergency Connectivity
§ 441.151 [Amended] § 485.70 [Amended] Fund To Close the Homework Gap
■ 6. Section 441.151 is amended by ■ 18. Section 485.70 is amended by
AGENCY: Federal Communications
removing paragraph (c). removing paragraph (n). Commission.
§ 485.640 [Amended] ACTION: Final rule.
PART 460—PROGRAMS OF ALL-
INCLUSIVE CARE FOR THE ELDERLY ■ 19. Section 485.640 is amended by SUMMARY: In this document, the
(PACE) removing and reserving paragraph (f). Wireline Competition Bureau (Bureau)
§ 485.725 [Amended] grants, in part, the Request for Waiver
■ 7. The authority citation for part 460 filed by the Schools, Health & Libraries
continues to read as follows: ■ 20. Section 485.725 is amended by
Broadband Coalition and the
Authority: 42 U.S.C. 1302, 1395,
removing paragraph (f). Consortium for School Networking
1395eee(f), and 1396u–4(f). § 485.904 [Amended] (collectively, the Petitioners). The
Bureau waives and extends the service
§ 460.74 [Amended] ■ 21. Section 485.904 is amended by
delivery date for certain applicants who
removing paragraph (c).
■ 8. Section 460.74 is amended by applied for Emergency Connectivity
removing paragraph (d). PART 486—CONDITIONS FOR Fund support for equipment, other non-
COVERAGE OF SPECIALIZED recurring services, and recurring
PART 482—CONDITIONS OF services during the first, second, and
SERVICES FURNISHED BY
PARTICIPATION FOR HOSPITALS third filing windows. The Bureau also
SUPPLIERS
waives and extends the service delivery
■ 9. The authority citation for part 482 ■ 22. The authority citation for part 486 date for recurring service requests for
continues to read as follows: continues to read as follows: first, second, and third filing window
Authority: 42 U.S.C. 1302, 1395hh, and Authority: 42 U.S.C. 273, 1302, 1320b–8, applicants that were approved for new
1395rr, unless otherwise noted. and 1395hh. construction services, but were unable
to use the full amount of their approved
§ 482.42 [Amended] § 486.525 [Amended] funding for monthly recurring services
■ 10. Section 482.42 is amended by ■ 23. Section 486.525 is amended by associated with the construction.
removing paragraph (g). removing paragraph (c). DATES: Effective June 5, 2023.
FOR FURTHER INFORMATION CONTACT: Kate
PART 483—REQUIREMENTS FOR PART 491—CERTIFICATION OF Dumouchel, Wireline Competition
STATES AND LONG TERM CARE CERTAIN HEALTH FACILITIES Bureau, (202) 418–7400 or by email at
FACILITIES Kate.Dumouchel@fcc.gov. The Federal
■ 24. The authority citation for part 491
continues to read as follows: Communications Commission
■ 11. The authority citation for part 483
(Commission) asks that requests for
continues to read as follows: Authority: 42 U.S.C. 263a and 1302. accommodations be made as soon as
Authority: 42 U.S.C. 1302, 1320a–7, 1395i, § 491.8 [Amended] possible in order to allow the agency to
1395hh and 1396r. satisfy such requests whenever possible.
■ 25. Section 491.8 is amended by
Send an email to fcc504@fcc.gov or call
ddrumheller on DSK120RN23PROD with RULES1
§ 483.80 [Amended] removing paragraph (d). the Consumer and Governmental Affairs
■ 12. Section 483.80 is amended by Bureau at (202) 418–0530.
PART 494—CONDITIONS FOR
removing paragraphs (h) and (i). COVERAGE FOR END-STAGE RENAL SUPPLEMENTARY INFORMATION: This is a
DISEASE FACILITIES synopsis of the Bureau’s Order in WC
§ 483.430 [Amended]
Docket No. 21–93; DA 23–405, adopted
■ 13. Section 483.430 is amended by ■ 27. The authority citation for part 494 May 12, 2023, and released May 12,
removing paragraph (f). continues to read as follows: 2023. Due to the COVID–19 pandemic,
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