# Medicare and Medicaid Programs; Policy and Regulatory Changes to the Omnibus COVID-19 Health Care Staff Vaccination Requirements; Additional Policy and Regulatory Changes to the Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) To Provide COVID-19 Vaccine Education and Offer Vaccinations to Residents, Clients, and Staff; Policy and Regulatory Changes to the Long Term Care Facility COVID-19 Testing Requirements > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2023-11449 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** June 5, 2023 - **Citation:** 88 FR 36485 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 416, 418, 441, 460, 482, 483, 484, 485, 486, 491, and 494 [CMS-3415-F, CMS-3414-F, CMS-3401-F] RIN 0938-AU75, 0938-AU57, 0938-AU33 Medicare and Medicaid Programs; Policy and Regulatory Changes to the Omnibus COVID-19 Health Care Staff Vaccination Requirements; Additional Policy and Regulatory Changes to the Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) To Provide COVID-19 Vaccine Education and Offer Vaccinations to Residents, Clients, and Staff; Policy and Regulatory Changes to the Long Term Care Facility COVID-19 Testing Requirements AGENCY: Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Final rule. SUMMARY: This final rule removes expired language addressing staff and patient COVID-19 testing requirements for LTC Facilities issued in the interim final rule with comment “Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” published in the September 2, 2020 Federal Register . The rule also finalizes requirements for these facilities to provide education about COVID-19 vaccines and to offer COVID-19 vaccines to residents, clients, and staff. In addition, the rule withdraws the regulations in the interim final rule with comment (IFC) “Omnibus COVID-19 Health Care Staff Vaccination” published in the November 5, 2021 Federal Register , and finalizes certain provisions of the “COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff” IFC, published in the May 13, 2021 Federal Register . DATES: The regulations in this final rule are effective on August 4, 2023. FOR FURTHER INFORMATION CONTACT: For press inquiries: CMS Office of Communications, Department of Health and Human Services, press@cms.hhs.gov. For technical inquiries: CMS Center for Clinical Standards and Quality, Department of Health and Human Services, (410)786-6633. SUPPLEMENTARY INFORMATION: I. Background A. Introduction On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (WHO) declared the “coronavirus disease 2019” (COVID-19) outbreak caused by “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2) a “Public Health Emergency of International Concern.” On January 31, 2020, pursuant to section 319 of the Public Health Service Act (PHSA) (42 U.S.C. 247d), the Secretary of the Department of Health and Human Services (Secretary) determined that a public health emergency (PHE) exists for the United States. On March 11, 2020, the WHO publicly declared COVID-19 a pandemic. The President of the United States declared the COVID-19 pandemic a national emergency on March 13, 2020. Pursuant to section 319 of the PHSA, the determination that a PHE continues to exist may be renewed at the end of each 90-day period. 1 The initial determination that a PHE for COVID-19 exists and had existed since January 27, 2020, lasted for 90 days, and was renewed by the Secretary on April 21, 2020; July 23, 2020; October 2, 2020; January 7, 2021; April 15, 2021; July 19, 2021; October 15, 2021; January 14, 2022; April 12, 2022; July 15, 2022; October 13, 2022; January 11, 2023; and February 9, 2023. 2 The COVID-19 PHE expired on May 11, 2023. 1 https://aspr.hhs.gov/legal/PHE/Pages/Public-Health-Emergency-Declaration.aspx. 2 https://aspr.hhs.gov/legal/PHE/Pages/default.aspx. COVID-19 has had significant negative health effects on individuals, communities, and the nation as a whole. Over a year ago, in September 2021, COVID-19 overtook the 1918 influenza pandemic as the deadliest disease in American history. 3 According to the Centers for Disease Control and Prevention (CDC), just over 6 million patients admitted to hospitals in the United States have been confirmed positive with COVID-19 infection since August 1, 2020, and approximately 1.1 million COVID-19 deaths have been reported in the United States as of April 14, 2023. In light of our responsibility to protect the health and safety of individuals receiving care and services from Medicare- and Medicaid-certified providers and suppliers, and CMS' statutory authority, as outlined in section I.E. of this final rule, to establish health and safety regulations, we have been compelled to act throughout the COVID-19 pandemic. While a comprehensive discussion of CMS' regulatory responses during the PHE is outside the scope and purpose of this final rule, we note that CMS issued several interim final rules with comment periods (IFCs) during the COVID-19 PHE to help minimize the spread and impact of SARS-CoV-2. Some of these IFCs established new health and safety standards, known as the Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements for Participation, for providers and suppliers who participate in the Medicare and Medicaid programs. Several of the policies in these IFCs have been further addressed in final rules and through the COVID-19 vaccination quality measures which have been proposed for adoption in multiple CMS quality reporting and payment programs (for example, the “Measures Under Consideration” (MUC) List issued by CMS on December 1, 2022). These IFCs, final rules, and quality reporting and payment programs reflect the scaled progression of CMS' response during the COVID-19 PHE as both the science and epidemiology pertaining to COVID-19 evolved. 3 https://www.statnews.com/2021/09/20/covid-19-set-to-overtake-1918-spanish-flu-as-deadliest-disease-in-american-history/. On September 2, 2020, we issued an IFC titled “Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” (85 FR 54820), otherwise known as the “LTC facility testing IFC.” This IFC revised regulations to strengthen CMS' ability to enforce compliance with Medicare and Medicaid long-term care facility requirements for reporting information related to COVID-19, established a new requirement for hospitals and critical access hospitals (CAHs) to track the incidence and impact of COVID-19, and established a new requirement for LTC facilities to test residents and staff for COVID-19 applicable for the duration of the PHE. We subsequently finalized provisions addressing the hospital and CAH COVID-19 reporting requirements in the final rule “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non-Qualified Deferred Compensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation” on August 10, 2022 (87 FR 48780) (“FY 2023 Hospital Inpatient Prospective Payment System final rule”). On May 13, 2021, we issued an IFC titled “Medicare and Medicaid Programs; COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff” (86 FR 26306), otherwise known as the “educate and offer IFC.” This IFC revised the requirements for LTC facilities and CoPs for ICFs-IID to require the provision of COVID-19 vaccination education and to offer vaccines to residents, clients, and staff. The IFC also revised the infection control requirements for LTC facilities to include COVID-19 data reporting. We subsequently finalized data reporting requirements for LTC facilities with revisions in the final rule “Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Model Expansion; Home Health and Other Quality Reporting Program Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; and COVID-19 Reporting Requirements for Long-Term Care Facilities,” published in the November 9, 2021 Federal Register (86 FR 62240, 62421) (“calendar year (CY) 2022 Home Health final rule”). These revisions established a sunset date for most COVID-19 reporting requirements for LTC facilities. Specifically, LTC facilities must report all required data until December 31, 2024, as determined by the Secretary. On November 5, 2021, we issued the interim final rule “Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination” (86 FR 61555), otherwise known as the “staff vaccination IFC.” This IFC revised the requirements that most Medicare- and Medicaid-certified providers and suppliers must meet to participate in the Medicare and Medicaid programs to include requirements regarding development and implementation of policies and procedures to ensure COVID-19 vaccination of staff. Throughout the COVID-19 PHE, we implemented and revised regulations to reflect lessons learned and emerging data and knowledge to protect the health and safety of individuals that receive care and services from Medicare- and Medicaid-certified providers and suppliers. For example, the educate and offer IFC-required LTC facilities and ICFs-IID that furnish care and services to populations identified at increased risk for severe health outcomes due to COVID-19 infection, to provide COVID-19 vaccination education and to offer vaccines to residents, clients, and staff. These requirements are generally referred to as the “educate and offer” provisions. Nonetheless, evidence continued to demonstrate that unvaccinated health care staff presented risks to patient safety across health care settings, and that too few health care staff were getting vaccinated. At the same time, the advent of a more contagious and severe variant (Delta)—and the recognition that additional variants were likely to emerge and, together with seasonal respiratory illnesses, increased the pressure on the health care system—indicated a need for CMS to take additional action. Accordingly, we issued the staff vaccination IFC, which required most Medicare- and Medicaid-certified providers and suppliers to ensure health care staff completed their COVID-19 primary vaccine series. As discussed in the educate and offer IFC and the staff vaccination IFCs, COVID-19 vaccination is one of the most important tools in the multi-pronged approach for reducing health system burden, safeguarding health care workers and the people they serve, and mitigating the overall impact of the COVID-19 pandemic. Food and Drug Administration (FDA)-approved and FDA-authorized COVID-19 vaccines in use in the United States are both safe and highly effective at protecting vaccinated people against severe COVID-19. 4 5 4 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html. 5 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/index.html. As conditions and circumstances of the COVID-19 PHE have evolved, so too has CMS' response. At this point in time, we believe that the risks targeted by the staff vaccination IFC have been largely addressed, so we are now aligning our approach with those for other infectious diseases, specifically influenza. Accordingly, CMS intends to encourage ongoing COVID-19 vaccination through its quality reporting and value-based incentive programs in the near future. The statute requires that the Secretary establish a pre-rulemaking process for the selection of certain quality measures for use by HHS. 6 The pre-rulemaking process requires that HHS make publicly available, not later than December 1 annually, a list of quality and efficiency measures HHS is considering to adopt, through the rulemaking process, for use in certain Medicare quality programs and for use in publicly reported performance information in any Medicare program. This list is known as the Measures Under Consideration (MUC) List. Table 1 shows the COVID-19 vaccination measures under consideration, as published on December 1, 2022, for patients and health care personnel, including measure title, measure description, and applicable quality programs. We note that on April 18, 2023, FDA revised the Emergency Use Authorizations (EUAs) for the Pfizer and Moderna mRNA vaccines to make several changes to the authorized dosing regimen and schedule. 7 Among other changes, the revised EUAs for the mRNA vaccines no longer refer to “primary series” and “booster” doses. In addition, previously unvaccinated individuals 6 years through 64 years of age (other than those with certain immunocompromising conditions) are only authorized to receive a single dose of a COVID-19 vaccine. They will not receive an mRNA “series.” These measures may be revised from their initial design but we include the MUCs here as an illustration of CMS's interest in pursuing implementation of measures that encourage uptake of COVID-19 vaccines. The use of such quality measures may ultimately affect ratings on the various “Compare” (such as “Hospital Compare”) websites and may affect payment in various “value-based purchasing” programs, but would not affect the ability of the provider or supplier to participate in the Medicare program. Information about the MUC List is available on the CMS Measures Management System (MMS) website at https://mmshub.cms.gov/measure-lifecycle/measure-implementation/pre-rulemaking/lists-and-reports. 6 See section 1890A(a) of the Act (42 U.S.C. 1395aaa-1(a)) and section 1890(b)(7)(B) of the Act (42 U.S.C. 1395aaa(b)(7)(B)). 7 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines. Table 1—COVID-19 Vaccination MUC for Use in Certain Medicare Quality Programs as Published December 1, 2022 Measure Description Quality programs Adult COVID-19 Vaccination Status Percentage of patients aged 18 years and older seen for a visit during the performance period who have ever completed or reported having ever completed a COVID-19 vaccination series and one booster dose Merit-based Incentive Payment System (MIPS). COVID-19 Vaccination Coverage Among Healthcare Personnel (HCP) (2022 revision) Percentage of healthcare personnel who are considered up-to-date on their COVID-19 vaccinations per the CDC's latest guidance Ambulatory Surgical Center Quality Reporting Program (ASCQR). Hospital Inpatient Quality Reporting Program (Hospital IQR Program). Hospital Outpatient Quality Reporting Program (Hospital OQR Program). Hospital Value-Based Purchasing Program (HVBP). Hospital-Acquired Condition Reduction Program (HACRP). Inpatient Psychiatric Facility Quality Reporting Program (IPFQR). Inpatient Rehabilitation Facility Quality Reporting Program (IRFQRP). Long-Term Care Hospital Quality Reporting Program (LTCHQRP). Prospective Payment System-Exempt Cancer Hospital Quality Reporting Program (PCHQRP). Skilled Nursing Facility Quality Reporting Program (SNFQRP). End-Stage Renal Disease Quality Incentive Program (ESRD QIP). COVID-19 Vaccine: Percent of Patients/Residents Who Are Up to Date Percentage of patients who are considered up-to-date on their COVID-19 vaccinations per the CDC's latest guidance Home Health Quality Reporting Program (Home Health QRP). SNFQRP. IRFQRP. LTCHQRP. Quality measures would provide a means to monitor COVID-19 vaccination rates among patients and health care personnel in multiple entities across the health system, including inpatient, outpatient, congregate care, and home-based care settings. Moreover, public reporting of quality measures increases the involvement of leadership in quality improvement, creates a sense of accountability, helps to focus organizational priorities, supports transparency, and provides a means of delivering important information to consumers. 8 8 https://qualitynet.cms.gov/inpatient/public-reporting/public-reporting. As discussed further in section I.E. of this final rule, section 902 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) requires that the publication of Medicare final regulations shall not exceed 3 years after publication of the preceding proposed or interim final regulation, except under exceptional circumstances. Thus, consistent with section 902 of the MMA, the requirements of the IFCs discussed in this rule would have expired if not finalized within 3 years of publication. As the COVID-19 pandemic has continued to evolve and circumstances have normalized, we have continued to evaluate the evolving clinical and epidemiological circumstances of the COVID-19 pandemic and the requirements issued in the IFCs, particularly those requirements that have not been finalized to date, for the purpose of determining the appropriate disposition of those requirements. The central consideration in our evaluation and determination is helping to protect the health and safety of individuals that receive care and services from Medicare- and Medicaid-certified providers and suppliers. This final rule addresses the disposition of regulations issued through three IFCs, specifically: the health care staff vaccination requirements issued in the staff vaccination IFC; the education and vaccine offering requirements issued in the educate and offer IFC; and the LTC testing IFC. Due to the broad scope and scale of the Omnibus COVID-19 Health Care Staff Vaccination IFC (staff vaccination IFC), we discuss it as the primary focus for policies addressed in this rule. Thus, throughout this document, we address the staff vaccination IFC first followed by the educate and offer IFC and the LTC testing IFC. B. Omnibus COVID-19 Health Care Staff Vaccination On November 5, 2021, we published the staff vaccination IFC, which revised the health and safety requirements that most providers and suppliers must meet to participate in the Medicare and Medicaid programs. The revisions established requirements regarding COVID-19 staff vaccination for the Medicare- and Medicaid-certified providers and suppliers included in the IFC. The following providers and suppliers were regulated by the staff vaccination IFC, listed in the numerical order of the relevant Code of Federal Regulations (CFR) sections: • Ambulatory Surgical Centers (ASCs)—§ 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 (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children's hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities)—§ 482.42(g). • LTC Facilities, including skilled nursing facilities (SNFs) and nursing facilities (NFs), generally referred to as nursing homes—§ 483.80(i). • ICFs-IID—§ 483.430(f). • Home Health Agencies (HHAs)—§ 484.70(d). • 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) and Medicare Federally Qualified Health Centers (FQHCs)—§ 491.8(d). • End-Stage Renal Disease (ESRD) Facilities—§ 494.30(b). We discuss the specific requirements of the staff vaccination IFC in section II.A. of this rule. In section III.A. of this final rule, we address the public comments submitted to CMS regarding the staff vaccination IFC. We then discuss the withdrawal of regulations pertaining to the staff vaccination IFC in section IV.A. of this rule. While the requirements established by the staff vaccination IFC were necessary to protect the health and safety of residents, clients, patients, and PACE Organization participants at the time of publication, circumstances of the COVID-19 pandemic have evolved, as has CMS' response, as discussed throughout this rule. As mentioned above, based on an evaluation of the evolving clinical and epidemiological circumstances of the COVID-19 pandemic, increased vaccine uptake, declining infection and death rates, decreasing severity of disease, increased instances of infection-induced immunity, public comments submitted to CMS, and the addition of COVID-19 vaccination quality measures to quality improvement and reporting programs, we believe regulations regarding COVID-19 vaccination of health care staff are no longer necessary. Therefore, in this rule, we are withdrawing language on COVID-19 health care staff vaccination requirements issued in the staff vaccination IFC. COVID-19 vaccination policies and procedures for health care staff will no longer be required under the CoPs, CfCs, and requirements. C. COVID-19 Vaccine “Educate and Offer” Requirements for LTC Facilities and ICFs-IID On May 13, 2021, CMS issued the educate and offer IFC, which revised the health and safety requirements that LTC facilities and ICFs-IID must meet to participate in the Medicare and Medicaid programs. The IFC established requirements that these facilities provide COVID-19 vaccination education to residents, clients, and staff, and to offer COVID-19 vaccines to these populations, referred to as the “educate and offer” provisions. The IFC also established additional infection control requirements for LTC facilities, as well as requirements to report certain COVID-19 data: these requirements have already been finalized through previous rulemaking (86 FR 62240). 9 We discuss these educate and offer provisions of the IFC in section II.B. of this rule. In section III.B. of this final rule, we address the public comments submitted to CMS regarding the educate and offer provisions. We then discuss the final regulatory changes pertaining to the educate and offer provisions in section IV.B. of this final rule. 9 https://www.federalregister.gov/documents/2021/11/09/2021-23993/medicare-and-medicaid-programs-cy-2022-home-health-prospective-payment-system-rate-update-home. Individuals living in congregate care settings, such as LTC facilities and ICFs-IID, are at greater risk than the general population for contracting SARS-CoV-2 and developing severe health outcomes due to COVID-19, 10 11 and they rely on facility staff to provide for their daily needs, including access to health care services such as vaccination. As discussed in section III.B. of this rule, public commenters acknowledge these risks. Consistent with our approach to staff vaccinations for COVID-19, we are moving to align our approach with existing regulations addressing other infectious diseases, such as influenza and pneumococcal disease. Therefore, we are finalizing the educate and offer requirements on a permanent basis. This complements the proposed adoption of the “COVID-19 Vaccine: Percent of Patients/Residents Who are Up to Date (Patient/Resident COVID-19 Vaccine) measure” and the “COVID-19 Vaccination Coverage among Healthcare Personnel (HCP COVID-19 Vaccine) measure” as issued in the “Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF); Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2024” proposed rule (88 FR 21316) (“2024 SNF Prospective Payment System proposed rule”). Given that the educate and offer provisions are existing requirements for LTC facilities and ICFs-IID, the requirements will remain effective after the publication date of this final rule. 10 https://www.cdc.gov/coronavirus/2019-ncov/your-health/understanding-risk.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fneed-extra-precautions%2Findex.html. 11 https://www.cdc.gov/coronavirus/2019-ncov/community/community-congregate-living-settings.html. D. COVID-19 Testing Requirement for LTC Facilities On September 2, 2020, CMS published the LTC facility testing IFC, which revised the infection control requirements that LTC facilities must meet to participate in the Medicare and Medicaid programs. This IFC established requirements applicable for the duration of the PHE for LTC facilities to test their staff and residents for COVID-19 based on parameters set forth by the Secretary in a manner consistent with current professional standards of practice. This IFC also established COVID-19 reporting requirements for hospitals and CAHs which have been finalized through previous rulemaking (87 FR 48780). As previously discussed, LTC facility residents are more susceptible to contracting COVID-19 and developing severe symptoms. This highlights the importance of practicing preventative measures in order to mitigate the risk of transmission and control the spread of COVID-19 among residents and staff of LTC facilities. At the time of publication, these provisions were necessary to protect the health and safety of both residents and health care personnel of LTC facilities, as there were limited treatments for COVID-19 and vaccines were not yet available. As the COVID-19 PHE has concluded, we are deleting expired text related to the LTC facility testing requirements effective the publication date of this final rule. CMS continues to emphasize the importance of practicing preventative measures in order to reduce the transmission of COVID-19. Moving forward, CMS aims to use quality reporting and value-based incentive programs to encourage health care facilities to practice preventative measures against COVID-19. We discuss the LTC facility testing requirements of the IFC in section II.C. of this rule. In section III.C. of this final rule, we address the public comments submitted to CMS regarding the LTC facility testing requirements. We then discuss the final regulatory changes pertaining to the educate and offer provisions in section IV.C. of this final rule. E. Statutory Authority Various sections of the Social Security Act (the Act) define the types of providers and suppliers that may participate in Medicare and Medicaid programs and list the requirements that each provider and supplier must meet to be eligible for participation. Statutory provisions applicable to each provider or supplier type either authorize the Secretary to establish other requirements as necessary to protect the health and safety of patients or, in some cases, to establish such additional criteria as the Secretary may require. Although the wording of such authority differs slightly between provider and supplier types, we have interpreted all of these provisions as at minimum permitting the Secretary to establish mandatory requirements to enhance the health and safety of patients. In addition, parallel Medicaid statutes provide authority to establish requirements to protect the health and safety of patients. Such requirements include the CoPs for providers, CfCs for suppliers, and requirements for LTC facilities. The CoPs, CfCs, and requirements are intended to protect public health and safety and promote high-quality care for all persons. Furthermore, the PHSA sets forth additional regulatory requirements that certain Medicare providers and suppliers are required to meet in order to participate. Table 2 lists the statutory authority by provider and supplier type for which we are issuing the requirements in this final rule: Table 2—Statutory Authority by Provider and Supplier Type Provider and supplier type Statutory authority Ambulatory Surgical Centers (ASCs) Sections 1832(a)(2)(F)(i), and 1833 (i)(1)(A) of the Act. Hospices Section 1861(dd) of the Act. Psychiatric Residential Treatment 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 (ICFs-IID) Section 1905(d)(1) of the Act. 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 Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (Organizations) Section 1861(p)(4)(A)(v) of the Act. 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 (FQHCs) Sections 1861(aa) and 1905(l)(2)(B) of the Act. End-Stage Renal Disease (ESRD) Facilities Section 1881(b)(1)(A) of the Act. We note that the appropriate term for an individual receiving care and services differs depending upon the provider or supplier type. For example, for hospitals and CAHs, the appropriate term is “patient,” but for ICFs-IID, it is “client.” Further, LTC facilities have “residents” and PACE Organizations have “participants.” In this final rule, the appropriate terms are used when discussing one or two provider or supplier types; however, when we are discussing three or more provider and supplier types, we use the general term “patient.” Similarly, despite the different terms used for specific provider and supplier entities (such as campus, center, clinic, facility, organization, or program), when we are discussing three or more provider and supplier types, we use the general term “facility.” F. Requirements for Issuance of Regulations Section 902 of the MMA amended section 1871(a) of the Act and requires the Secretary, in consultation with the Director of the Office of Management and Budget, to establish and publish timelines for the publication of Medicare final regulations based on the previous publication of a Medicare proposed or interim final regulation. Section 902 of the MMA also states that the timelines for these regulations may vary but shall not exceed 3 years after publication of the preceding proposed or interim final regulation except under exceptional circumstances. This final rule withdraws the regulatory provisions set forth on November 5, 2021, in the Omnibus COVID-19 Health Care Staff Vaccination IFC and deletes expired provisions set forth on May 13, 2021, in the LTC facility testing IFC. Also, this final rule finalizes the “educate and offer” provisions set forth on May 13, 2021, in the COVID-19 Vaccine Requirements for LTC Facilities and ICFs-IID Residents, Clients, and Staff IFC. This final rule has been published within the 3-year time limit imposed by section 902 of the MMA. G. Enforcement of Staff Vaccination Provisions Federal rules generally become effective 60 days after publication; however, the COVID-19 PHE expired on May 11, 2023. Our decision to terminate the omnibus facility staff vaccination requirements in this final rule reflect our determination that the emergency circumstances which occasioned these vaccination provisions no longer exist. Since facilities are no longer operating under PHE circumstances, and considering the lower policy priority of enforcement within the remaining time, we will not be enforcing the staff vaccination provisions between now and August 4, 2023. II. Provisions of the Interim Final Regulations In this section, we review the requirements issued in the staff vaccination IFC, the educate and offer IFC, and the LTC facility testing IFC. In section II.A. of this rule, we summarize and discuss the requirements of the staff vaccination IFC. We then summarize and discuss the educate and offer provisions in the educate and offer IFC in section II.B. of this final rule. Lastly, we summarize and discuss the LTC testing IFC in section II.C. of this final rule. A. Omnibus COVID-19 Health Care Staff Vaccination As discussed in section I. of this rule, we established COVID-19 staff vaccination requirements for most Medicare- and Medicaid-certified providers and suppliers in an IFC published in November 2021. Those provisions reflected a common set of requirements with no substantive regulatory differences across facility types, added to the CoPs, CfCs, and requirements, as applicable, under the relevant CFR section as listed in section I.B. of this final rule. Next, we briefly discuss these common provisions. We then discuss any additional revisions for specific provider and supplier types issued by CMS in the staff vaccination IFC due to unique circumstances. 1. Common Requirements in the Staff Vaccination IFC The IFC requires each applicable facility to develop and implement policies and procedures under which staff complete a primary COVID-19 vaccine series. Those vaccination policies and procedures must apply to current and new staff, to include volunteers and individuals under contract or arrangement, that provide any care, treatment, or other services for the facility or its patients, regardless of clinical responsibility or degree of anticipated patient contact. Vaccination is required for all staff that interact with other staff or patients in any location, such as clinics, homes, or other sites of care and services. As discussed in the IFC, some staff are not subject to the vaccination requirements, including but not limited to those who provide services 100 percent remotely and “one-off” vendors, volunteers, and professionals who infrequently provide ad hoc non-health care services, such as annual elevator inspection, delivery, and repair personnel. When determining whether to require COVID-19 vaccination of an individual who does not clearly fall within the classification of staff, we encouraged facilities to consider frequency of presence, services provided, and proximity to patients and staff. We also strongly encouraged facilities to facilitate the vaccination of all individuals who provide services infrequently and are not otherwise subject to the requirements in the IFC to the extent opportunity exists and resources allow. In the IFC, we required facilities to ensure that staff are “fully vaccinated” for COVID-19, defined as 2 weeks or more since completion of a primary vaccination series. We also required facilities to have a process for tracking and securely documenting the COVID-19 vaccination status of staff who obtain any booster doses as recommended by the CDC. For those staff who are not “fully vaccinated” for COVID-19, we required facilities to establish and implement a process that provides additional precautions to minimize the spread of COVID-19. The IFC required facilities to track and securely document the vaccination status of each staff member. All medical records, including vaccine documentation, were to be kept confidential and stored separately from an employer's personnel files, pursuant to the Americans with Disabilities Act (ADA) and the Rehabilitation Act. We described these documentation requirements in the IFC as an ongoing process due to the onboarding of new staff, and we provided examples of: (1) appropriate places for vaccine documentation, such as an immunization record, health information files, or other relevant documents; and (2) acceptable forms of proof of vaccination, such as a CDC COVID-19 vaccination record card (or a legible photo of the card) or documentation of vaccination from a health care provider, electronic health record, State immunization information system record, or a reasonable equivalent for those individuals vaccinated outside of the United States. Further, through the IFC, we required facilities to establish and implement a process by which staff may request an exemption from the COVID-19 vaccination requirement based on: (1) an applicable Federal law, such as the ADA, section 504 of the Rehabilitation Act, section 1557 of the Affordable Care Act (ACA), and Title VII of the Civil Rights Act that prohibit discrimination based on race, color, national origin, religion, disability, and sex, including pregnancy; and (2) recognized clinical contraindications to receipt of a COVID-19 vaccine. Facilities had to have a process for collecting and evaluating exemption requests, including tracking and securely documenting the required information. We acknowledged in the IFC that certain allergies or medical conditions may be clinical contraindications to receiving a COVID-19 vaccine, and we referred facilities to the CDC page “Use of COVID-19 Vaccines in the United States: Interim Clinical Considerations” which can be accessed at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html. The IFC required facilities to make contingency plans in consideration of staff who are not “fully vaccinated” to ensure that those staff will soon be vaccinated and will not provide care, treatment, or other services for the facility or its patients until such time as those staff complete a primary vaccination series for COVID-19 and are considered “fully vaccinated.” This planning must also address the safe provision of care and services by staff who request an exemption from vaccination that is under consideration and by staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical reasons. We discussed in the IFC that contingency planning may extend beyond the specific requirements of the rule, to address topics such as staffing agencies that can supply vaccinated staff if some of a facility's staff are unable to work. We also discussed special precautions to be taken in the event of, for example, a regional or local emergency declaration, such as for a hurricane or flooding, which necessitated the temporary utilization of unvaccinated staff, in order to assure the health and safety of patients. We also acknowledged in the IFC that facilities may already have contingency plans that meet the requirements in their existing emergency preparedness policies and procedures. 2. Additional Requirements in the Staff Vaccination IFC for Specific Provider and Supplier Types In addition to the common set of provisions issued in the staff vaccination IFC for all applicable facility types, we varied specific provisions of the regulations, where applicable, for specific provider and supplier types. These various provisions for specific provider and supplier types were necessary due to the unique content of regulations in place at the time the staff vaccination IFC was published, for Psychiatric Residential Treatment Facilities (PRTFs), HIT suppliers, RHCs/FQHCs; LTC facilities and ICFs-IID; and CORFs. As discussed in the staff vaccination IFC, PRTFs, HIT Suppliers, and RHCs/FQHCs did not have specific infection control and prevention regulations at the time the IFC was published. Therefore, for PRTFs at § 441.151(c)(3)(iii), HIT suppliers at § 486.525(c)(3)(iii), and RHCs/FQHCs at § 491.8(d)(3)(iii), we required a process for ensuring adherence to nationally recognized infection prevention and control guidelines intended to mitigate the transmission and spread of COVID-19. This process included the implementation of additional precautions for all staff who were not fully vaccinated for COVID-19. At the time the staff vaccination IFC was published, LTC facilities had existing regulations at § 483.80(d)(3)(v) that required facilities to educate all residents and staff about the COVID-19 vaccines and to offer the vaccines, when available. Likewise, at the time the IFC was published, ICFs-IID had existing regulations at § 483.460(a)(4)(v) that required facilities to educate all clients and staff about the COVID-19 vaccines and to offer the vaccine, when available. As discussed in section I. of this final rule, those requirements were established by the educate and offer IFC. In the staff vaccination IFC, we revised these requirements by removing language that could have been interpreted as a path by which staff members in LTC facilities and ICFs-IID could bypass the facility's vaccination policies and procedures. This change was necessary because retaining that language originally established by the educate and offer IFC would have been inconsistent with the goals of the staff vaccination IFC. In this final rule, we are finalizing the education and offering provisions of the educate and offer IFC, as amended by the staff vaccination IFC, and we refer readers to sections I., II.B., III.B., IV.B., V.B, and VI.B. of this final rule for additional information. Regulations in place at the time that the staff vaccination IFC was published for CORFs at 42 CFR 485.70(a) through (m) identified the qualifications required for personnel, including facility physician, licensed practical nurse, occupational therapist, occupational therapist assistant, orthotist, physical therapist, physical therapist assistant, prosthetist, psychologist, registered nurse, rehabilitation counselor, respiratory therapist, respiratory therapy technician, social worker, and speech-language pathologist. In addition, regulations at § 485.58(d)(4) stated that personnel who do not meet the qualifications specified in § 485.70 may be used by the facility in assisting qualified staff. In the staff vaccination IFC, we added § 485.70(n) which requires CORFs to develop and implement policies and procedures to ensure COVID-19 vaccination of all facility staff. As discussed in the IFC, we recognize that assisting personnel are used by CORFs, and we established our requirements at § 485.70(a) through (m) to provide a role for personnel that might not meet our education and experience qualifications. However, we did not believe this exception for employees who did not meet our professional requirements should have prohibited us from issuing staff qualifications referencing infection prevention, which we intended to apply to all personnel. Therefore, in the staff vaccination IFC, we revised § 485.58(d)(4) to state that personnel who did not meet the qualifications specified in § 485.70(a) through (m) may be used by the facility in assisting qualified staff. As noted previously in this rule, we are withdrawing the provisions of the staff vaccination IFC. B. COVID-19 Vaccine “Educate and Offer” Requirements for LTC Facilities and ICFs-IID Residents, Clients, and Staff As discussed in section I. of this final rule, on May 13, 2021, CMS issued the educate and offer IFC. This IFC revised the requirements for LTC facilities and CoPs for ICFs-IID to provide COVID-19 vaccination education and to offer vaccines to residents, clients, and staff, otherwise known as the “educate and offer” provisions. This IFC also established requirements for COVID-19 data reporting in LTC facilities. Subsequently, in the “Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Model Expansion; Home Health and Other Quality Reporting Program Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; and COVID-19 Reporting Requirements for Long-Term Care Facilities” final rule (86 FR 62240), we finalized the LTC facility reporting requirements from the educate and offer IFC at §  483.80(g)(1) through (3) with some minor modifications. 12 Given that this final rule addresses only the “educate and offer” provisions of the IFC, this section provides a summary of those specific requirements. 12 https://www.federalregister.gov/documents/2021/11/09/2021-23993/medicare-and-medicaid-programs-cy-2022-home-health-prospective-payment-system-rate-update-home. 1. LTC Facilities For LTC facilities, the educate and offer IFC established 42 CFR 483.80(d)(3) COVID-19 immunizations, under which facilities must develop and implement policies and procedures to ensure that all of the requirements set forth in that section are followed. Before offering a COVID-19 vaccine, all residents, resident representatives, and staff members are provided with education regarding the benefits, risks, and potential side effects associated with the vaccine. When a COVID-19 vaccine is available to the facility, each resident and staff member is offered a COVID-19 vaccine unless the immunization is medically contraindicated or the resident or staff member has already been immunized. In situations where COVID-19 vaccination requires multiple doses, the resident, resident representative, or staff member is provided with current information regarding those additional doses, including any changes in the benefits or risks and potential side effects associated with the COVID-19 vaccine, before requesting consent for administration of any additional doses. The regulation states that the resident or resident representative has the opportunity to accept or refuse a COVID-19 vaccine and change their decision. The original regulatory provisions as issued by the educate and offer IFC also permitted staff members to refuse vaccination. However, as discussed in section II.A. of this final rule, the reference to staff members in the refusal provision at § 483.80(d)(3)(v) was removed by the staff vaccination IFC published November 5, 2021. The resident's medical record is documented to reflect, at a minimum, that the resident or resident representative was provided education regarding the benefits and potential risks associated with COVID-19 vaccine; each dose of COVID-19 vaccine administered to the resident; or, if the resident did not receive a COVID-19 vaccine due to medical contraindications or refusal. For staff members, the facility maintains documentation related to COVID-19 vaccination that includes, at a minimum, that staff were provided education regarding the benefits and potential risks associated with COVID-19 vaccines; were offered a COVID-19 vaccine or information on obtaining a COVID-19 vaccine; and the COVID-19 vaccine status of staff and related information as indicated by the CDC's National Healthcare Safety Network (NHSN). In this final rule, we are finalizing the infection control requirements that LTC facilities must meet to participate in the Medicare and Medicaid programs as issued in the educate and offer IFC and amended by the staff vaccination IFC. By doing so, LTC facilities must continue to educate residents, resident representatives, and staff about COVID-19 vaccines and offer a COVID-19 vaccine to residents, resident representatives, and staff, as well as complete the appropriate documentation for these activities. This aligns with the newly-proposed resident and patient vaccination measures as proposed in the 2024 SNF Prospective Payment System proposed rule. 13 13 https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2024-skilled-nursing-facility-prospective-payment-system-proposed-rule-cms-1779-p. Since the COVID-19 pandemic began, many States have passed laws regarding COVID-19 vaccination. 14 Some States have required various individuals to take the vaccine while other States have prohibited the requirement of COVID-19 vaccination. Since LTC facility staff may be required to take a COVID-19 vaccine in some States, or by some employers, we believe it is inappropriate to include explicit permission to refuse in the regulations. In addition, as we noted in the staff vaccination IFC, retaining this language would be contrary to the goals of that IFC, which included protecting the health and safety of residents, clients, and staff. Hence, we are finalizing the provision as amended by the staff vaccination IFC, which provides, at § 483.80(d)(3)(vii) that the facility maintains documentation related to staff COVID-19 vaccination. The documentation must include, at a minimum, evidence that staff were informed about the risks and benefits of the COVID-19 vaccine. The facility must also document that staff were either offered the COVID-19 vaccine or provided with information on acquiring the COVID-19 vaccine. Lastly, the staff's COVID-19 vaccine statuses and any associated information must be documented and reported to the NHSN as indicated by CDC. 14 Pekruhn, D and Abbasi, E. “Vaccine Mandates by State: Who is, Who isn't, and How?” Leading Age. https://leadingage.org/workforce-vaccine-mandates-state-who-who-isnt-and-how/. Published on January 19, 2022. Accessed on January 17, 2023. 2. ICFs-IID For ICFs-IID, the educate and offer IFC established § 483.430(f), “COVID-19 Vaccination of facility staff,” and § 483.460(a)(4), the educate and offer provisions. Section 483.430(f) requires that each ICF-IID maintain documentation related to its staff that includes, at a minimum, documentation that the staff were provided education regarding the benefits and risks and potential side effects associated with the COVID-19 vaccine and were offered a COVID-19 vaccine or information on obtaining the COVID-19 vaccine. Section 483.460(a)(4) requires each ICF-IID to develop and implement policies and procedures to ensure that when a COVID-19 vaccine is available to the facility; each client and staff member is offered the COVID-19 vaccine unless the immunization is medically contraindicated or the client or staff member has already been immunized. Before offering a COVID-19 vaccine, all staff members, clients, and client representatives must be provided with education regarding the benefits and risks and potential side effects associated with the vaccine. In situations where COVID-19 vaccination requires multiple doses, the client, client's representative, or staff member must be provided with current information regarding each additional dose, including any changes in the benefits or risks and potential side effects associated with a COVID-19 vaccine, before requesting consent for administration of each additional doses. The regulation states that the client or client's representative has the opportunity to accept or refuse a COVID-19 vaccine and change their decision. The original regulatory provisions as issued by the educate and offer IFC also permitted staff members to refuse vaccination. However, as discussed in section II.A. of this final rule, the reference to staff members in the refusal provision at § 483.8460(a)(4)(v) was removed by the staff vaccination IFC published November 5, 2021. The ICF-IID must also ensure that the client's medical record is documented with, at a minimum, that the client or client's representative was provided education regarding the benefits and risks and potential side effects of COVID-19 vaccine and each dose of a COVID-19 vaccine administered to the client. The ICF-IID must also document if the client did not receive a COVID-19 vaccine due to medical contraindications or refusal. In this final rule, we are finalizing the requirements for COVID-19 vaccination of facility staff and “educate and offer” process that ICFs-IID must meet to participate in the Medicare and Medicaid programs, as first set out in the educate and offer IFC and amended by the staff vaccination IFC. By doing so, ICFs-IID must continue to educate clients, client representatives, and staff about COVID-19 vaccines and offer a COVID-19 vaccine to residents and staff, as well as document these activities. Since the COVID-19 pandemic began, and as noted above for LTC facilities, many States have passed laws regarding COVID-19 vaccination. 15 Some States have required various individuals to take the vaccine while other States have prohibited requiring COVID-19 vaccination. Since ICF-IID staff may be required to take a COVID-19 vaccine in some States, or by some employers, we believe it is inappropriate to include explicit permission to refuse in the regulations. As we stated above in section II.B.1. of this final rule, reinstating language that directly allows staff to refuse a COVID-19 vaccine would be contrary to the goals of these IFCs, to protect the health and safety of clients and staff in in ICFs-IID. One's ability to be exempt from a vaccination requirement per another statute (such as the ADA) is outside the scope and authority of this rulemaking. Hence, we are finalizing the refusal provision as amended by the staff vaccination IFC. 15 Pekruhn, D and Abbasi, E. “Vaccine Mandates by State: Who is, Who isn't, and How?” Leading Age. https://leadingage.org/workforce-vaccine-mandates-state-who-who-isnt-and-how/. Published on January 19, 2022. Accessed on January 17, 2023. C. COVID-19 Testing Requirement for LTC Facilities In the LTC facility testing IFC, we revised the LTC facility infection control requirements applicable for the duration of the PHE at § 483.80 to establish a new, term-limited requirement that LTC facilities to test their facility residents and staff for COVID-19, including individuals providing services under arrangement and volunteers. We required that resident and staff testing in LTC facilities for COVID-19 be conducted based on parameters set forth by the Secretary, applicable during the COVID-19 PHE. These requirements were established in accordance with CDC guidelines titled, Testing Guidelines for Nursing Homes, which explains the high risk of infection, illness, and death for LTC residents and the importance of testing in order to prevent COVID-19 from entering LTC facilities and preventing transmission. 16 Under this requirement, “staff” are considered any individuals employed by the facility, any individuals that have arrangements to provide services for the facility, and any individuals volunteering at the facility. We explained that we only expected individuals who were physically working on-site at the facility to be required to be tested for COVID-19. 16 https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Flong-term-care.html. At § 483.80(h)(1), we required that resident and staff testing for COVID-19 be conducted based on parameters set forth by the Secretary. These parameters may have included but were not limited to: testing frequency; the identification of any facility resident or staff diagnosed with COVID-19 in the facility; the identification of any facility resident or staff with symptoms consistent with COVID-19 or with known or suspected exposure to COVID-19; the criteria for conducting testing of asymptomatic individuals specified in this paragraph, such as the positivity rate of COVID-19 in a county; the response time for results; and other factors specified by the Secretary that help identify and prevent the transmission of COVID-19. At § 483.80(h)(2), we required that all residents and staff testing be conducted in a manner consistent with current professional standards of practice for conducting COVID-19 tests. This referred to those professional standards that apply at the time that the care or service is delivered, which we acknowledge have evolved and changed over the course of the COVID-19 pandemic. At § 483.80(h)(3)(i), we required that for each instance of resident or staff COVID-19 testing, which included testing of individuals providing services under arrangement and volunteers, the facility document that testing was completed and the results of each staff test. This documentation would have been located in the staff personnel record or the record or file that the facility maintains for individuals who are providing services under arrangement at the facility. Consistent with the documentation requirements we established for LTC facility staff, we required at §  483.80(h)(3)(ii) that the facility document in the resident's medical record that testing was offered, completed (as appropriate to the resident's testing status), and the results of each test. Due to the high transmission rate of COVID-19, we required at § 483.80(h)(4) that the facility take actions to prevent the transmission of COVID-19 when a resident or staff member, including individuals providing services under arrangement and volunteers, presented with symptoms consistent with COVID-19 or who tested positive for COVID-19. We expected facilities to restrict the access to the facility for any staff member—including individuals providing services under arrangement and volunteers—who presented with symptoms consistent with COVID-19 or who tested positive for COVID-19 until they were deemed to be safe to return to work. We expected facilities to take measures, including resident cohorting, to mitigate the transmission of the virus within the facility when facility residents presented with symptoms consistent with COVID-19 or who tested positive for COVID-19. We acknowledge that residents and staff may not have consented to being tested for COVID-19. Therefore, at § 483.80(h)(5) we required that the facility have procedures for addressing residents and staff, including individuals providing services under arrangement and volunteers, who refused or were unable to test for the virus. We required at § 483.80(h)(6) that the LTC facility coordinate with state and local health departments and Tribal representatives regarding the availability and obtaining of testing supplies and processing test results when necessary. Facilities may also have coordinated with their local certified laboratories covered under Clinical Laboratory Improvement Amendments (CLIA) on the availability of and obtaining of testing supplies and the processing of test results. Access to adequate testing supplies and arrangements for acquiring testing supplies must have been addressed by the facility's infection prevention and control plan. The testing plan must have included any arrangements that were necessary to conduct, process, and receive test results prior to the administration of the required tests. Since the conclusion of the PHE on May 11, 2023, these requirements are no longer applicable. III. Analysis of and Responses to Public Comments In this section, CMS discusses the public comments received for the COVID-19 testing requirement for LTC facilities, the staff vaccination IFC, and the “educate and offer” provisions of the COVID-19 Vaccine Requirements for LTC Facilities and ICFs-IID Residents, Clients, and Staff IFC (educate and offer IFC), published September 2, 2020, November 5, 2021, and May 21, 2021, respectively. We received public comments in response to all three IFCs, which we summarize and discuss in this section. In this final rule, we are withdrawing the health care staff COVID-19 vaccination provisions issued in the staff vaccination IFC and deleting the expired COVID-19 testing provisions of the LTC testing IFC. We are also finalizing the COVID-19 “educate and offer” provisions established in the educate and offer IFC. In this section we provide a summary of the public comments received and responses to them, and the policies we are finalizing. In section III.A. of this final rule, we discuss the comments and responses pertaining to the COVID-19 health care staff vaccination requirements. In section III.B. of this final rule, we discuss the comments and responses regarding the requirements for LTC facilities and ICFs-IID to educate residents, clients, and staff about COVID-19 vaccines and to offer COVID-19 vaccines when available. Lastly, in section III.C. of this final rule, we discuss the comments and responses concerning the COVID-19 testing requirements for LTC facilities. Due to the high volume of public comments, we have grouped them by themes and similarities for analysis and response. A. Omnibus COVID-19 Health Care Staff Vaccination (§§ 416.51(c), 418.60(d), 441.151(c), 460.74(d), 482.421(g), 483.80(d)(3)(v) and (i), 483.430(f), 483.460(v), 484.70(d), 485.58(d)(4), 485.70(n), 485.640(f), 485.725(f), 485.904(c), 486.525(c), 491.8(d), 494.30(b)) In response to this IFC, we received approximately 10,102 timely public comments. Of these, roughly 2/3 were virtually identical letters from individuals from around the country urging CMS to retract the rule. Of the remaining 3,175 unique comments, the majority were from individuals, while over 500 of those unique comments were from industry groups or individual commenters who were commenting as representatives of organizations, companies, and other entities. About 2,000 of these unique comments opposed the regulation, while the remainder of the commenters supported the regulation, some offering suggestions as to how CMS could improve the requirements. A summary of the major themes addressed by commenters and our responses follow. Comment: A significant minority of commenters agreed with our goal to ensure patient health and safety by establishing a COVID-19 health care staff vaccination requirement. Commenters stated that COVID-19 vaccination is evidence-based, safe, and the best way to prevent serious illness, hospitalization, death, and spread of infection. They indicated that vaccination of health care staff will provide much-needed workforce stability to the health care industry while decreasing demands associated with providing care to health care workers who contract COVID-19. Some of these commenters stated that patients who had delayed receiving care due to concerns of contracting COVID-19 during the provision of their care would now be able to obtain the care they needed. Some of these commenters recommended expanding the scope of the COVID-19 vaccination regulation to include other settings in which health care is provided, such as physician offices and others. Other commenters recommended that in addition to the primary vaccination series, the regulation should require boosters, which provide ongoing protection against COVID-19. Response: We appreciate the support from commenters and agree that a requirement for COVID-19 vaccination of health care staff was necessary to ensure timely access to care for patients. We also agree that the COVID-19 PHE placed unprecedented, challenging circumstances on the health care industry, and vaccination of health care staff lessened disruptions to care and operations. We commend health care facilities and their staff for their efforts throughout the COVID-19 pandemic, and we share a common commitment to assuring high-quality and safe care for patients, residents, clients, and participants. As noted in the IFC, the regulation applied only to those Medicare- and Medicaid-certified providers and suppliers listed. The IFC did not directly apply to other health care entities, such as physician offices, because those settings are not regulated by CMS. Most States have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that were not subject to the vaccination requirements in the IFC. We also noted that health care and other entities providing services under contract for a Medicare- and Medicaid-certified provider and supplier listed in the IFC were indirectly subject to the requirements of the rule. Moreover, we noted that entities not covered by the IFC may have been subject to other vaccination requirements, such as those issued by State governments for certain types of workplaces. We thank commenters for recognizing the importance of staying up-to-date with COVID-19 vaccines and boosters. Boosters have been an important part of protecting people from getting seriously ill or dying from COVID-19. 17 Additionally, the newer bivalent vaccines contain an Omicron component to offer better protection against COVID-19 caused by the Omicron variant and its subvariants than the earlier, monovalent vaccines. In April 2023, the EUAs for the bivalent vaccines were revised to simplify the vaccination schedule for most individuals, which included authorizing the current bivalent vaccines for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. 18 19 All individuals aged >6 months are recommended to receive at least one dose of bivalent vaccine for COVID-19 under current recommendations. 20 Additional information regarding vaccine guidance can be found at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html. 17 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html. 18 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines. 19 https://www.yalemedicine.org/news/covid-19-variants-of-concern-omicron#:~:text=Omicron%20and%20its%20subvariants,and%20multiply%20in%20other%20countries. 20 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html (accessed May 1, 2023). At the time the IFC was issued, the CDC did not include boosters in their definition of “fully vaccinated.” Instead, a person was considered to be fully vaccinated 2 weeks after receiving the last dose of a primary vaccine series. 21 Since the IFC was issued, CDC shifted to using the terminology “up to date”. Individuals 6 years of age and older are considered “up to date” when they have received one updated Pfizer-BioNTech or Moderna COVID-19 vaccine. 22 As of May 2, 2023, the CDC recommends that individuals 6 months of age and older receive a dose of updated (bivalent) vaccine. Certain individuals, depending on age and level of immunocompromise, may receive additional doses. 23 24 21 https://www.cdc.gov/media/releases/2021/p0308-vaccinated-guidelines.html. 22 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html. 23 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html. 24 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html. We agree with commenters that vaccines continue to be one of the most effective preventative practices against severe COVID-19; however, the effectiveness of the “original” or monovalent vaccines to prevent severe COVID-19 hospitalization and death has remained high, effectiveness to prevent less severe disease has diminished. As previously noted, for reasons discussed throughout this preamble, including declining infection rates and deaths, declining severity, and significant vaccination uptake, we are withdrawing the health care staff COVID-19 vaccination provisions of the IFC. In lieu of regulatory requirements and as previously noted, CMS intends to continue support and encouragement for health care staff vaccinations through other mechanisms, including quality programs. We encourage individuals to stay up-to-date with their COVID-19 vaccines in accordance with CDC recommendations ( https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html#recommendations ). Comment: While many commenters supported the COVID-19 vaccination requirements, the majority of commenters stated that CMS did not have the statutory authority to infringe on the personal rights of health care staff to choose vaccination or not. These commenters described the requirements as an overreach of CMS authority and a violation of personal freedoms and bodily autonomy. Several individual commenters expressed concerns that the vaccination requirements may run afoul of certain fundamental medical ethics doctrines around informed consent and freedom from coercion. Response: We appreciate the feedback from commenters. Although we are withdrawing the health care staff COVID-19 vaccination provisions of the IFC for the reasons discussed throughout this preamble, we disagree with the comments regarding CMS' statutory authority to issue the rule. In Biden v. Missouri, the Supreme Court stayed injunctions prohibiting the rule from going into effect, holding that “the Secretary's rule falls within the authorities that Congress has conferred upon him.” 25 26 Since that ruling, two plaintiff States voluntarily dismissed challenges to the rule, and Federal courts have dismissed two other cases. 27 28 We also note that the staff vaccination IFC permitted individual exemptions consistent with applicable Federal laws. 25 https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. 26 https://www.cms.gov/newsroom/press-releases/statement-cms-administrator-chiquita-brooks-lasure-us-supreme-courts-decision-vaccine-requirements. 27 State of Louisiana v. Becerra, No. 3:21-cv-3970 (W.D. La. Dec. 2, 2022). 28 Griner v. Biden 2:22CV149 DAK-DBP (D. Utah Oct. 13, 2022). We acknowledge the difficulties that health care workers have faced and continue to face throughout the COVID-19 pandemic. CMS has great appreciation for health care workers and other frontline workers across the world as they have dealt with limited resources and extraordinary demand for their time and services. Due to the changing circumstances of the pandemic previously discussed in this final rule, we are withdrawing the health care staff COVID-19 vaccination provisions of the IFC. In lieu of regulatory requirements and as previously noted, CMS intends to continue supporting and encouraging for health care staff vaccinations through other mechanisms, including its quality programs. Comment: Many commenters stated that the requirements would contribute to and exacerbate staffing shortages, particularly in rural areas, negatively impacting care and access to care. These commenters expressed concern that the staff vaccination requirements would cause a mass flight of unvaccinated health care workers from the industry. This was of particular concern for entities that provide long-term care services, specifically those facilities located in rural, frontier, and Tribal communities. Some individual commenters who identified themselves as licensed professionals, including but not limited to nurses, stated their intent to resign rather than comply, or that they had coworkers who intended to resign instead of comply. Additionally, some commenters noted that CMS was establishing overly burdensome expectations for already put-upon health care workers. For example, they noted that they were asked to wear personal protective equipment (PPE) if they were not vaccinated even though there were insufficient supplies, resulting in reuse, and emphasized how they had been directed to continue working to care for patients while ill with COVID-19 themselves due to staffing shortages. Some commenters suggested additional flexibilities in the vaccination requirements, such as the ability to opt-out for philosophical reasons and additional funding in order to help with these potential issues. Response: We thank commenters and health care workers for their continued dedication throughout the COVID-19 pandemic. Adequate staffing was a concern prior to the pandemic, and we recognize that the COVID-19 PHE simultaneously exacerbated and accelerated those trends. While these trends reflect a confluence of factors, including unprecedented stress, trauma, overwhelming loss associated with death of coworkers and patients (particularly for nurses who typically witness decline and death), and self-isolation or quarantine from families, we also understand commenters' concern that the requirements in the staff vaccination IFC would further add to those shortages. Available evidence continues to support the notion that staff vaccination requirements have not adversely affected health care staffing. 29 Using National Healthcare Safety Network (NHSN) data from June 6, 2021-November 14, 2021, one study showed that State-level COVID-19 vaccine requirements implemented prior to the publication of the IFC did not negatively impact health care staffing levels in those States. 30 Specifically, staffing shortages peaked nationally during the Omicron wave, with nearly one in three facilities reporting a shortage in January 2022. Staffing shortage rates have fallen since then, and remained relatively stable through March 2022, even after the implementation of the staff vaccination IFC. 31 Further, data and analysis, including internal CMS analyses of facility payroll data postdating the implementation of the staff vaccination IFC, suggest that the rule did not have a negative impact on health care staffing. 29 See Biden v. Missouri, https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. 30 https://jamanetwork.com/journals/jama-health-forum/fullarticle/2794727?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=072922. 31 https://www.kff.org/coronavirus-covid-19/issue-brief/nursing-facility-staff-vaccinations-boosters-and-shortages-after-vaccination-deadlines-passed/. We acknowledge that staffing concerns remain throughout the health care system; however, we do not anticipate that the withdrawal of the health care staff COVID-19 vaccination requirements will meaningfully affect current challenges in staff recruitment and retention. Comment: Many commenters shared their belief that vaccines are unsafe and that they contain dangerous or potentially dangerous chemicals. These commenters also expressed concerns that Emergency Use Authorizations (EUAs) issued by the Food and Drug Administration (FDA) do not assure safety, because of the minimal length of development time. Some commenters noted that CMS or the employer should be liable for adverse effects of vaccination and that this should include lost wages in event of illness or death. Some commenters referenced the Vaccine Adverse Effect Response System (VAERS), noting that there have been nearly one million reported cases of adverse reactions to the various COVID-19 vaccines. These commenters expressed their disagreement with COVID-19 vaccination requirements based on these VAERS reports. Some commenters also referenced the Nuremburg Code, which prohibits adherents from performing medical experimentation in unwilling patients. These commenters stated a belief that the vaccines are truly experimental. Response: While we are withdrawing the staff vaccination requirements given changes in public-health conditions described throughout this preamble, we emphasize that COVID-19 vaccines have consistently been shown to be safe and effective. As of March 2023, more than 672 million doses of COVID-19 vaccine have been given in the United States under the most intense safety monitoring in US history. That monitoring by CDC, FDA, and other Federal agencies continues to demonstrate that COVID-19 vaccines are safe and effective. 32 Moreover, efforts to speed the vaccine development process have not sacrificed scientific standards, integrity of the vaccine review process, or safety. 33 Prior to issuance of an EUA, the original COVID-19 vaccines were evaluated in tens of thousands of study participants to generate the scientific data and other information needed to determine the vaccine's safety and effectiveness. 32 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html#:~:text=COVID%2D19%20vaccines%20are%20safe,safety%20monitoring%20in%20US%20history. 33 https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained#:~:text=Under%20an%20EUA%2C%20FDA%20may,are%20no%20adequate%2C%20approved%2C%20and. Comments regarding liability for adverse effects of vaccination or lost wages are outside the scope of this rule. We refer readers to the Department of Labor for issues regarding workplace injury and compensation. 34 We also refer readers to the Countermeasures Injury Compensation Program, which provides compensation for covered serious injuries or deaths that occur as the result of the administration or use of certain countermeasures and the National Vaccine Injury Compensation Program, which provides compensation to people found to be injured by certain vaccines. 35 36 37 34 https://www.fiercehealthcare.com/hospitals/supreme-court-vaccine-covid-19-healthcare-upholds-hhs-vaccine-requirement-for-healthcare#:~:text=Supreme%20Court%20upholds%20HHS'%20vaccine,large%20employer%20mandate%20%7C%20Fierce%20Healthcare. 35 https://www.hrsa.gov/cicp. 36 https://www.benefits.gov/benefit/641. 37 https://www.hrsa.gov/vaccine-compensation/about. Comment: Many commenters stated a belief that vaccines are ineffective. They shared how the incidence of COVID-19 infections among vaccinated individuals is high. These commenters also noted that this rule would be ineffective, because it did not apply to patients and visitors. Response: We acknowledge that COVID-19 vaccines will not prevent symptomatic infection in all vaccinated individuals; however, COVID-19 vaccines are highly effective in preventing serious illness, hospitalization, and death. As we discussed in the staff vaccination IFC, we believe it would be overly burdensome to require that facilities ensure COVID-19 vaccination for all individuals who enter (patients, visitors, mail carriers, etc.). However, while facilities are not required to ensure vaccination status of every individual, they may choose to extend COVID-19 vaccination requirements beyond those persons that we consider to be “staff” as defined in IFC. We did not prohibit such extensions and encouraged facilities to require COVID-19 vaccination for these individuals as reasonably feasible. We strongly encourage facilities, when the opportunity exists and resources allow, to facilitate the vaccination of all individuals who provide services infrequently or provide educational opportunities about vaccination for those individuals. Further, as previously discussed, CMS intends to continue support and encouragement for health care staff vaccinations through quality measurement programs. Comment: Some commenters stated that vaccines contain fetal stem cells, the use of which conflicts with their religious beliefs. Other commenters indicated that contracted physicians with privileges are not covered under Title VII or ADA; therefore, they are unable to request religious exemptions. Industry, civil society groups, and individual commenters sought clarification regarding religious, medical, and administrative exceptions to the vaccination requirements. Some commenters stated that it would be helpful for CMS to create a standard on exemption requirements that would be broadly applicable nationwide. Some commenters asked for clarification on exemption requirements and recommended that CMS promulgate guidance. Other commenters noted that we should consider referencing the Equal Employment Opportunity Commission or similar nondiscrimination guidance (such as the Americans with Disabilities Act) in order to address these public concerns. Response: While we are withdrawing the staff vaccination requirements in this final rule, we note that the IFC required facilities to have policies and procedures regarding exemptions as required by civil rights and disability laws. Comment: Some commenters suggested that alternatives to vaccination be added to the requirements. These commenters emphasized that routine testing of staff for SARS-CoV-2 and use of PPE should be permitted in lieu of vaccination. Some commenters noted the ongoing mitigation efforts involving COVID-19 testing and PPE use, as well as required source controls which have improved over the course of the PHE. Some commenters suggested that CMS provide for additional flexibility by “grandfathering in” some of the vaccination requirements already in place among certain health systems. Some commenters suggested additional educational outreach, especially among communities with lower trust in the health care system, as well as an understanding of the logistical issues preventing prompt implementation of the requirements in the staff vaccination IFC at certain facilities. Other commenters supported additional educational outreach, time-limited testing options, and flexibility for “good-faith” efforts for facilities as they work toward compliance with the rule. Response: We thank commenters for their continued efforts in practicing complementary mitigation measures, especially at times when resources have been limited and as the pandemic continues to evolve. Our intention in issuing the staff vaccination IFC was to establish a set of requirements for all applicable facility types consistent with CDC recommendations in place at the time to assure patient health and safety. Since the onset of the PHE, the context in which people apply these preventive layers has changed. As the immediate impacts of the COVID-19 pandemic continue to evolve, so too does informed guidance, recommendations, and regulation. In the fall of 2021, circumstances required that CMS issue the IFC to protect the health and safety of patients. Current circumstances show that the IFC was effective in increasing rates of COVID-19 vaccination among health care staff and indicate that the need for such regulatory requirements has passed. We continue to explore different approaches to support and incentivize the use of effective combinations of preventive layers in particular circumstances and the best, most flexible way to support their application. CMS and other HHS agencies continue to engage in infection prevention and control and vaccine education efforts. Additionally, CMS continues to host stakeholder engagement calls to address ongoing concerns and questions. 38 CMS also continues to engage with key stakeholders in order to develop culturally-competent and person-centered guidance and resources to ensure that populations with unique needs or concerns are addressed and mitigated. Lastly, enforcement discretion is not within the scope of these regulations and is rather addressed in subregulatory guidance, which CMS continues to publish and release. 39 We encourage individuals to continue to follow CDC recommendations pertaining to infection prevention and control practices, and we note that while this final rule ends CMS's requirements regarding staff vaccination, it does not prohibit employers or states from initiating or maintaining their own vaccination requirements for health care staff. We also continue to support health care staff vaccinations through quality measurement programs. 38 https://www.cms.gov/outreach-education/partner-resources/coronavirus-covid-19-partner-resources. 39 https://www.cms.gov/covidvax. Comment: Some commenters stated that individuals with a prior COVID-19 infection should be exempt due to natural immunity. Many of these commenters claimed that they still had high levels of antibodies against COVID-19 in their most recent blood tests, and they questioned the necessity of vaccination, at least for as long as their antibody levels remain comparable to those who are vaccinated. Response: We acknowledge that previous COVID-19 infection may also contribute to protection against subsequent infection and associated severe, critical, or fatal COVID-19. 40 However, this does not mean infection-induced immunity can or should be substituted for vaccination. Exceptions based on infection-induced immunity are also challenging to apply and enforce fairly, as verification of a health care worker's prior infection or antibody levels may not be possible in all cases. Vaccination remains the safest option for acquiring immunity to COVID-19, particularly when the risks associated with vaccination are compared with well-known significant short and long-term consequences of COVID-19, which can include organ damage affecting the heart, kidneys, skin, and brain, as well as fatigue, shortness of breath, loss of smell, and muscle aches. 41 42 43 Additionally, people who have had COVID-19 are more likely to develop new health conditions such as diabetes, heart conditions, blood clots, or neurological conditions compared with people who have not had COVID-19. 44 40 https://www.cdc.gov/coronavirus/2019-ncov/your-health/reinfection.html. 41 https://www.thelancet.com/journals/lanam/article/PIIS2667-193X(22)00059-X/fulltext. 42 https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-long-term-effects/art-20490351#:~:text=Why%20does%20COVID%2D19%20cause,immune%20system%20can%20also%20happen. 43 https://www.nhs.uk/conditions/coronavirus-covid-19/long-term-effects-of-coronavirus-long-covid/. 44 https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects/index.html. Comment: Some commenters stated that COVID-19 is not a public health emergency and that the data upon which guidelines are issued are flawed, alleging inaccurate and inflated death counts. Commenters also pointed out that the overwhelming majority of infected individuals recover, unvaccinated individuals do not all become severely ill, and there are treatments available that should be encouraged and available for use (for example, some commenters stated beliefs that Ivermectin or Vitamin D and other pharmaceutical and nonpharmaceutical products are effective treatments for COVID-19). Response: While rates of infection, illness, and hospitalization have significantly declined, COVID-19 remains a public health challenge throughout the world. As discussed in section I. of this final rule, the WHO declared the COVID-19 outbreak an international public health emergency in January 2020 and a pandemic in March 2020. Likewise, a COVID-19 PHE declaration for the United States was made by the Secretary in January 2020, the President of the United States declared COVID-19 a pandemic in March 2020, and the Secretary has sustained a PHE declaration since January 2020 with the final renewal occurring on February 9, 2023. 45 In September 2021, COVID-19 related deaths in the U.S. surpassed the number of deaths from the 1918 influenza pandemic. 46 According to the CDC COVID Data Tracker, over 1.1 million COVID-19 deaths have been reported in the United States to date, whereas it is estimated that 675,000 American deaths occurred during the 1918 influenza pandemic. 47 48 45 https://aspr.hhs.gov/legal/PHE/Pages/default.aspx. 46 https://www.smithsonianmag.com/smart-news/the-covid-19-pandemic-is-considered-the-deadliest-in-american-history-as-death-toll-surpasses-1918-estimates-180978748/. 47 https://covid.cdc.gov/covid-data-tracker/#datatracker-home. 48 https://www.cdc.gov/flu/pandemic-resources/1918-commemoration/1918-pandemic-history.htm. Research also suggests that reported deaths associated with COVID-19 in the United States have been undercounted, not overcounted, since the start of the pandemic. These undercounts may be attributed to several factors, including that testing availability and criteria may have caused many cases to go unrecognized; COVID-19 may affect many body systems, and thus may not always be recognized as a cause of death; and COVID-19 may amplify pre-existing health conditions leading to death, but not be recognized as the cause of death by the medical certifier. 49 49 https://www.cdc.gov/nchs/covid19/faq.htm. We acknowledge that most individuals are fortunate enough to recover from COVID-19. However, many individuals are not fortunate enough to recover and many individuals die or experience symptoms of long COVID, with older adults facing the highest risk of becoming very sick from COVID-19. We are also grateful for the development of effective antiviral treatments, including Remdesivir (Veklury), nirmatrelvir co-packaged with ritonavir (Paxlovid), and molnupiravir (Lagevrio). 50 51 These drugs have also undergone rigorous testing. We note that the evolution of COVID-19 continues to present challenges to the development of both preventative drugs, including vaccines, and therapeutic treatments. It is important that more individuals be educated about these drugs in order for them to make informed decisions about their health and treatment options. 50 https://www.covid19treatmentguidelines.nih.gov/therapies/antivirals-including-antibody-products/summary-recommendations/. 51 https://www.fda.gov/media/155049/download. Some medications mentioned by commenters, such as Ivermectin and vitamin D, are not evidence-based treatments for COVID-19. The FDA has not authorized or approved Ivermectin for use in preventing or treating COVID-19 in humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea. Currently available data do not show that Ivermectin is effective against COVID-19 and taking large doses of Ivermectin is dangerous. 52 There is also insufficient evidence for the use of vitamin D for the prevention or treatment of COVID-19. 53 Individuals who are considering taking these medications as a treatment for COVID-19 should consult with their care team. 52 https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19. 53 https://www.covid19treatmentguidelines.nih.gov/therapies/supplements/vitamin-d/. Comment: Some commenters shared their belief that it is unprecedented to mandate COVID-19 vaccines when there are other existing vaccines that are more effective that are not mandated (that is, Hepatitis B, influenza, pneumococcal). Response: We thank commenters for recognizing the efficacy of certain vaccines, like the Hepatitis B, influenza, and pneumococcal vaccines. While we do not want to minimize the severity of these diseases, they were not the cause of the PHE declared at the time CMS issued the IFC. We also note that the regulation is not a government vaccine mandate placed on individuals but rather a Medicare and Medicaid funding condition for certain health care facilities that participate in either or both of those programs. As discussed in section H. of the staff vaccination IFC, many health care workers must already comply with employer or State government vaccination requirements (influenza, hepatitis B) or OSHA guidelines and are also required to complete screening procedures, such as tuberculosis screening. Additionally, many of these individuals met State and local vaccination requirements in order to attend school to complete the necessary education to be eligible for health care positions. While historically CMS has not required any health care staff vaccinations, we have established, maintained, and updated extensive health and safety requirements as part of the Conditions of Participation and Conditions for Coverage for Medicare- and Medicaid-certified providers and suppliers. These requirements largely focus on infection prevention and control standards, as we aim to protect the health and safety of patients, residents, clients, and participants. The transition CMS is making now, to make COVID-19 policies more like those for other communicable diseases, reflects the ongoing evolution of epidemiological and clinical circumstances; it does not imply that our issuance of the staff vaccination IFC was invalid or that CMS could not take such steps again in the future, if circumstances warrant. While we are withdrawing the provisions of the staff vaccination IFC, as previously noted, we intend to continue to support and encourage COVID-19 vaccination through our quality reporting and value-based incentive programs. CMS collaborated with the CDC to develop quality measures for both patient and health care vaccination to be used in appropriate quality programs. CMS included patient and health care personnel vaccination quality measures on the Measures Under Consideration (MUC) List issued on December 1, 2022. 54 55 54 https://mmshub.cms.gov/sites/default/files/2022-MUC-List-Overview.pdf. 55 https://mmshub.cms.gov/measure-lifecycle/measure-implementation/pre-rulemaking/lists-and-reports. Comment: Some commenters mistakenly believed this IFC was OSHA's rule, “COVID-19 Vaccination and Testing; Emergency Temporary Standard” (86 FR 61402) (also published November 5, 2021), which intended to require vaccination for employers with 100+ employees and addressed the emergency temporary standard (ETS) in comments submitted to CMS. 56 56 https://www.federalregister.gov/documents/2021/11/05/2021-23643/covid-19-vaccination-and-testing-emergency-temporary-standard. Response: The requirements in the staff vaccination IFC apply to only the Medicare- and Medicaid-certified providers and suppliers listed in the IFC. The IFC does not directly apply to other employers or entities, including other health care entities, such as physician offices, which are not regulated by CMS. Most States have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that are not subject to vaccination requirements under this IFC. Within the IFC, we briefly discussed the OSHA IFC, “Occupational Exposure to COVID-19; Emergency Temporary Standard” (86 FR 32376, June 21, 2021), that was applicable to health care settings at the time of publication, including but not limited to the providers and suppliers who must comply with the staff vaccination IFC, because the OSHA ETS and the IFC had complementary requirements. 57 Of note, OSHA did withdraw the vaccination and testing ETS, effective January 26, 2022. 58 59 For questions about OSHA laws, regulations, or rulemaking activities, we refer commenters to OSHA. 60 57 https://www.federalregister.gov/documents/2021/06/21/2021-12428/occupational-exposure-to-covid-19-emergency-temporary-standard. 58 https://www.osha.gov/coronavirus/ets2. 59 87 FR 3928, January 26, 2022 ( https://www.federalregister.gov/documents/2022/01/26/2022-01532/covid-19-vaccination-and-testing-emergency-temporary-standard ). 60 https://www.osha.gov/laws-regs. Comment: A few commenters noted that this rule was promulgated prior to consultation with Tribal entities, which they asserted is a violation of Executive Order (E.O.) 13175. Several organizations noted that Tribes believed that their treaty rights may have been violated by the promulgation of the rule. One commenter noted that they understand that the rule may be appropriate for non-Indian health providers but indicated that the Tribes they represent believe that it is not currently clear how the regulation would apply to those facilities that provide health care services to the American Indian and Alaska Native population. These commenters stated that CMS failed to consult with Tribes in accordance with the usual Indian consultation guidance. The commenters suggested that CMS extend the comment period and improve the consultative relationship between Tribal entities and CMS so that the perceived disregard for Tribal sovereignty does not happen again. Response: We thank the Tribes for their continued partnership with CMS. We recognize that American Indians and Alaska Natives (AI/AN) face unique health care needs and have been disproportionately impacted by COVID-19. 61 62 These commenters are incorrect in their assumption of a violation of E.O. 13175. That E.O. only applies to actions that “have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” The staff vaccination IFC, like almost all CMS rules, has none of these effects. This IFC applied only to certain health care providers and suppliers who voluntarily enrolled in the Medicare and Medicaid programs. Its provisions made no distinctions as to ownership status of any facility, whether owned or administered by a private organization, State or local government, or tribe. Furthermore, the commenters identified no specific government-to-government effects from the rulemaking that would adversely affect tribes. CMS continues to engage with external stakeholders and strives towards providing, supporting, and fostering culturally-competent and person-centered care for these populations. 61 https://www.kff.org/coronavirus-covid-19/issue-brief/covid-19-cases-and-deaths-by-race-ethnicity-current-data-and-changes-over-time/. 62 https://www.cdc.gov/mmwr/volumes/71/wr/mm7122a2.htm. Comment: Some provider groups asked for clarification or additional guidance on what would or would not be acceptable in terms of employer enforcement so that they could stay within the bounds of State privacy laws. For example, a large medical center noted concerns about their ability to comply with both the IFC and a State law that explicitly prevented employers from requiring COVID-19 vaccinations as a condition of employment. Response: As discussed in the staff vaccination IFC, we understand that some States and localities have established laws that would seem to prevent Medicare- and Medicaid-certified providers and suppliers from complying with the requirements of this IFC. While the requirements outlined in the staff vaccination IFC remain in force, we intend, consistent with the Supremacy Clause of the United States Constitution, that this nationwide regulation preempts all conflicting State and local laws as applied to Medicare- and Medicaid-certified providers and suppliers. However, as previously noted, we are withdrawing the health care staff COVID-19 vaccination provisions. Comment: Some commenters noted that the COVID-19 staff vaccination requirements placed an undue burden on facilities. These commenters stated that it would be overly burdensome to manage individual requests for exemption either due to religious beliefs or clinical contraindications to receiving the vaccine. They also noted that it would be resource-intensive to comply with the vaccination requirements that included contracted staff. Response: As noted in the preamble of the IFC, we made efforts to mitigate the burden on providers by not requiring that each provider and supplier ensure COVID-19 vaccination for all individuals who entered the facility or setting of care, because we believed such a requirement would be overly burdensome. Moreover, CMS did not require that staff who functioned in a fully remote capacity be vaccinated for COVID-19 if they did not physically enter the building or interact with patients or other staff. Experience since the publication of the staff vaccination IFC shows that facilities could, indeed, meet these requirements. When implementing these requirements, CMS ensured there was a reasonable balance between burden and the need for celerity to realize health and safety benefits. Comment: Many commenters noted that the IFC's definition of “fully vaccinated” was confusing and questioned whether booster doses would or should be included in the definition and required going forward. Some of these commenters shared that there was confusion in the messaging coming from CMS regarding boosters and potential discrepancies between the IFC and contemporary information aids coming from other parts of the executive branch. Likewise, some commenters noted that the CDC did not include boosters in its definition of “fully vaccinated” at the time that the rule was issued. Other commenters recommended that CMS recognize the importance of booster shots and consider including boosters in the definition of “fully vaccinated” once the CDC updates its guidance. Some commenters also pointed to research that suggests the importance of boosters in maintaining immunity over time. Several individual commenters stated that the need for boosters would make the rule impracticable or that it proved the ineffectiveness of the vaccines. Response: Like the SARS-COV-2 virus itself, the science of preventing and treating COVID-19 and the tools available to prevent and treat it continue to evolve. Thus, the recommendations and guidance have similarly changed as well. Currently, CDC recommends that people ages 6 months and older receive at least 1 bivalent mRNA COVID-19 vaccine. The number of recommended bivalent doses varies by age, vaccine, previous COVID-19 vaccines received, and the presence of moderate or severe immune compromise. As discussed elsewhere in this rule, CMS now believes that other levers available to us (for example, quality measures) offer the most effective means to balance a need for flexibility, encourage HCP vaccination, and protect patient safety in the post-PHE phase of COVID-19. In addition, as of March 30, 2023, 90.5 percent of counties, districts, or territories in the United States had a low community level of COVID-19. Further, as of March 29, 2023, the current 7-day average of weekly new cases decreased 9.2 percent compared with the previous 7-day average. 63 Therefore, we are withdrawing the health care staff COVID-19 vaccination provisions. 63 https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/past-reports/033123.html#:~:text=COVID%2D19%20Community%20Levels*,with%20a%20low%20Community%20Level. Comment: Many commenters requested clarification as to which facility types the rule applies. Individuals associated with Emergency Medical Services (EMS) and ambulance services requested additional guidance on how they fit within the rule, because they were not among the facility types listed in the rule. Other groups, particularly in long-term care, asked whether contractors (a one-off or incidental plumber, or a fully remote administrative staff worker, for example) would be required to be vaccinated in order for the facility to be considered in compliance. Some commenters recommended that CMS align the definition of “staff” with previous LTC facility testing rules as a means of reducing confusion and as a means of helping those facilities align their current vaccine requirements with those required under the rule. Response: We are withdrawing the health care staff COVID-19 vaccination provisions. We strongly encourage facilities, when the opportunity exists and resources allow, to facilitate the vaccination and education of all individuals who provide services infrequently or frequently. Comment: Some commenters suggested that new anti-viral treatments may become more important as tools once they become commercially available. They asked that CMS include guidance in this rule, or issue another rule which would clarify some of the different payment aspects of these treatments and more. Response: We recognize and acknowledge the important role of new treatment therapies that have recently become available, as previously discussed in this rule. However, payment for these treatments is outside the scope of this rule. We emphasize the importance of vaccination, as access to these new therapies may vary. Further, these therapies do not replace the preventive benefits of vaccination. Final Decision: After inspection of public comments on the health care staff vaccination requirements and in consideration of the factors discussed throughout this rule, we are withdrawing the health care staff COVID-19 vaccination provisions. This final rule addresses CMS' statutory responsibility to implement regulations necessary to protect the health and safety of patients while demonstrating our commitment to approaches that reflect evolving information. B. COVID-19 Vaccine “Educate and Offer” Requirements for LTC Facilities and ICFs-IID Residents, Clients, and Staff (§§ 483.80(d), 483.430(f), 483.460(a)(4)) In response to the educate and offer IFC, we received 68 public comments. Twenty-six of these comments addressed the “educate and offer” provisions, sharing support for these requirements due to the increased risk of infection and complications for LTC residents and ICF-IID clients due to their medical conditions and residence in congregate care settings. Public commenters also addressed the reporting requirements, which we addressed in the CY 2022 Home Health Prospective Payment System final rule (86 FR 62240, 62392). Comment: The majority of commenters emphasized that residents of LTC facilities and clients of ICFs-IID are among the most susceptible to negative outcomes related to COVID-19 due to their medical conditions. These commenters noted that the residents and clients were at high risk for exposure, infection, complication, and death. Response: We thank commenters for recognizing the gravity of the COVID-19 pandemic and their appreciation for resident and client health and safety. We believe that all LTC Facility residents, ICF-IID clients, and the staff who care for them, should be provided with ongoing education about, and access to, vaccination against COVID-19. Further, we believe that entities responsible for the care of residents and clients of LTC facilities and ICF-IIDs must proactively pursue access to COVID-19 vaccination on behalf of their residents and clients, who often face challenges to independently accessing the vaccine, including mobility limitations, cognitive impairments, and other conditions. To support ongoing access to vaccinations for COVID-19, we are finalizing the provisions at §§ 483.80(d)(3), 483.430(f), and 483.460(a)(4) for LTC facilities and ICF-IIDs. Comment: Some commenters stated that communicating the pros, cons, and side effects of vaccination in a meaningful way to LTC facility residents was challenging and recommended that CMS provide additional guidance and standardized education materials for use. Response: We acknowledge that it can be challenging to convey this information clearly as the COVID-19 pandemic continues to evolve and new treatments and vaccines become available. Vaccination remains one of the most important methods to help prevent severe COVID-19, especially as individuals living and working in congregate living settings may have challenges with physical distancing and other preventive measures such as mask use. While it can be challenging to convey vaccine information clearly, this is especially important, as many ICF-IID clients have multiple chronic conditions and psychiatric conditions in addition to their intellectual disability, and many LTC Facility residents experience impaired mental status, which can impact a client's and resident's understanding or acceptance of the need for vaccination. Vaccine education allows for residents, clients, and their caregivers to be informed participants in their care and allows them to make the most appropriate decisions for themselves. Furthermore, CDC and FDA have developed a variety of clinical educational and training resources for health care professionals related to COVID-19 vaccines, and CMS recommends that nurses and other clinicians work with their LTC Facility's or ICF-IID's Medical Director and use CDC and FDA resources as sources of information for their vaccination education initiatives. 64 We acknowledge and thank the many CMS-certified ICF-IIDs and LTC facilities that are educating staff, residents, and clients, and are attempting to participate in vaccination programs. However, participation in these efforts is not universal, and we are concerned that many individuals are not receiving these important preventative care services. Because resident and client safety are of the utmost importance, we are finalizing the education requirements for LTC facilities at § 483.80(d)(3) and ICF-IIDs at §§ 483.430(f) and 483.460(a)(4). 64 https://www.cdc.gov/vaccines/covid-19/long-term-care/pharmacy-partnerships/administrators-managers.html. Comment: Several commenters expressed burden concerns due to high staff turnover rates, which have increased the amount of time needed to provide education and to offer the vaccine to staff. Response: We thank the staff for their hard work in complying with these requirements. We recognize that health care organizations have historically experienced staffing shortages and that this has been exacerbated by the pandemic, as discussed in section I. of the staff vaccination IFC. In addition to the previously mentioned resources available from CDC and FDA, CMS funds a network of Quality Improvement Organizations (QIOs), 65 which aim to improve the quality of care delivered to people with Medicare. Specifically, QIOs may provide assistance to Medicare beneficiaries by targeting small, low-performing, and rural Medicare-certified facilities most in need of assistance, and those that have low COVID-19 vaccination rates; disseminating accurate information related to access to COVID-19 vaccines to facilities; educating residents and staff on the benefits and risks of COVID-19 vaccination; understanding nursing home leadership perspectives and assist them in developing a plan to increase COVID-19 vaccination rates among residents and staff. 65 https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityImprovementOrgs. Ensuring that all LTC Facility residents, ICF-IID clients, and the staff who care for them are provided with ongoing opportunities to receive vaccination against COVID-19 is critical to ensuring that populations at higher risk of infection continue to be prioritized and receive timely preventive care during the COVID-19 pandemic. In the interest of health and safety for LTC facility residents and ICF-IID clients, and of staff in these settings, we are finalizing the provisions at § 483.80(d)(3) for LTC facilities and §§ 483.430(f) and 483.460(a)(4) for ICF-IIDs. Comment: Some commenters reported that it was difficult to identify the individuals that met the definition of “staff,” and therefore, were subject to the requirements. Response: The “educate and offer” provisions were written in a manner that allows for flexibility by covering a broad set of residential care entities. Additionally, since this IFC was initially published, CMS and other agencies across HHS have released additional guidance in an effort to address some of these questions and concerns about how to comply with these requirements. 66 Furthermore, CMS uses existing lines of communication with stakeholders in an effort to address some of these questions and concerns. Currently, CMS considers LTC facility and ICF-IID staff (regardless of whether there is a so-called “W-2” relationship) to be those who work in the facility on a regular basis (that is, at least once a week). We note that this includes those individuals who may not be physically in the LTC facility for a period of time due to illness, disability, or scheduled time off, but who are expected to return to work. LTC facilities and ICF-IIDs are not required to educate and offer vaccination to individuals who provide services less frequently, but they may choose to extend such efforts to them. We strongly encourage facilities, when the opportunity exists and resources allow, to provide education and vaccination to all individuals who provide services less frequently. A better understanding of the value of vaccination may allow staff to appropriately educate residents and their family members about the benefits of accepting the vaccine. Therefore, we are finalizing the requirements at §§ 483.80(d)(3), 483.430(f), and 483.460(a)(4). 66 https://www.cms.gov/outreach-education/partner-resources/coronavirus-covid-19-partner-resources. Comment: A few commenters suggested that CMS add provisions for paid time off for staff to receive the vaccine and recover from side effects. Response: We recognize commenters' concerns; however, CMS does not have the statutory authority to regulate paid time off for health care employees, and this falls outside the scope of this final rule. Final Decision: After consideration of the public comments we received on the educate and offer requirements, we are finalizing the requirements at § 483.80(d)(3) for LTC facilities and at §§ 483.430(f) and 483.460(a)(4) for ICF-IIDs, as established by the educate and offer IFC and amended by the staff vaccination IFC. The “educate and offer” requirements support our responsibility to protect and ensure the health and safety of residents and clients by enforcing the standards required to help each resident and client attain or maintain their highest level of well-being. Sections 1819(d)(3)(B) and 1919(d)(3) of the Act require that a facility must establish an infection control program that is designed, constructed, equipped, and maintained in a manner to protect the health and safety of residents, personnel, and the general public. We believe that the educate and offer requirements comply with these statutory requirements. We believe that this action strengthens our response to the COVID-19 pandemic and protects the health and safety of nursing home residents, ICF-IID clients, and their staff. C. COVID-19 Testing Requirement for LTC Facilities § 483.80(h) In response to this IFC we received approximately 169 comments, of which about 150 addressed the COVID-19 testing requirements for LTC facilities' staff and residents. Comment: Some comments acknowledged that testing for COVID-19 is important for preventing the disease from entering nursing homes, detecting cases quickly, and stopping the transmission to additional residents and staff. Response: We thank commenters for sharing their understanding of the importance of testing for COVID-19. While many new treatments and vaccines are now available, and we are deleting the expired testing requirements, we continue to emphasize the importance of practicing preventative measures in order to mitigate the spread of COVID-19. Comment: Many commenters discussed the need for accurate data for contact tracing and in order to understand the future trajectory of the COVID-19 virus. However, most comments expressed belief that the community infection rate is not an accurate method for calculating how often COVID-19 testing should be conducted. Several of these commenters explained that a high community rate may be skewed by isolated populations, such as incarcerated individuals or college and university students. Commenters noted that higher infection rates in these populations resulted in being required to test staff and residents twice weekly, which they believed did not yield additional information. A few of these commenters also noted that many of the LTC staff do not reside in the same county as the facility and thus are not living in a county with a similarly high community infection rate; therefore, they should not be subject to more frequent testing requirements. Response: We thank commenters for recognizing the importance of collecting accurate data and its use for informing an appropriate pandemic response. It is important for data to be measured and reported in a standardized manner. This allows for public health officials to compare disease occurrence across different populations in order to make informed policy decisions and to better understand the virus and its impact on health outcomes. We recognize that some locations, like prisons or college and university campuses, may represent “hot spots.” However, these populations are not truly isolated, and one may not presume that the SARS-CoV-2 virus will not spread to other populations or locations. Further, frequent testing for COVID-19 remains an important tool for mitigating the transmission of the virus. In some instances, an individual may test when the viral load is not high enough to be found on a test and the test result is negative. But this same individual may test again in the same week and receive a positive test result. Additionally, some people may test negative on an antigen test but positive on a PCR test. This means that they do have COVID-19, but their viral load is too low to result in a positive antigen test. 67 We recognize that many staff do not reside in the same county as the LTC facility at which they are employed. However, this does not negate the value of testing. While these individuals may be less likely to be exposed to the virus in the county in which they reside, the risk of exposure is not eliminated. In addition, because of the highly contagious nature of the SARS-CoV-2 virus, the transmission levels in the county in which they reside may increase significantly, subsequently increasing their risk of exposure. 67 https://publichealthmdc.com/blog/did-you-test-negative-when-sick-or-exposed-to-covid-heres-what-it-means#:~:text=If%20you%20test%20negative%20soon,be%20found%20on%20a%20test. Comment: The majority of comments stressed how these new testing requirements are diverting resources and adding an additional burden to the staff, who are already strained by the staffing shortage. These comments also discussed how it is challenging to comply with the requirements due to limited availability of PPE. Most of these comments emphasize that the frequent testing takes away valuable time from resident care and socialization, which is critical at a time when residents are not able to see their families. Many commenters also reported that the time frame to report test results was too limited and requested a 72-hour window to report test results. These comments discussed how it is challenging to comply with this requirement due to the increased turnaround time to receive results and the limited number of staff members. Response: We share sympathy for residents and their family members who were not able to gather in person. We also thank LTC facility staff and health care workers for their continued commitment to providing care for residents. Testing for COVID-19 helps to mitigate the transmission of the virus and thus improves patient outcomes and opportunities for socialization. As discussed in the LTC facility testing IFC, we note that there are many different tests available, and facilities have the flexibility and discretion to select the test that best suits their needs so long as the tests are conducted in accordance with nationally recognized standards and meet the response time for the test results as specified by the Secretary. In addition, the CDC has continued to update its guidance regarding infection control at https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Flong-term-care.html. Further, the CDC has published guidance on how to optimize PPE at https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/index.html. Comment: Several commenters expressed gratitude for the ability to access point-of-care (POC) testing supplies and equipment, but most of these commenters found it to be unreliable and shared that it frequently produced false positive results. These commenters expressed that this blanket approach may not be appropriate for all LTC facilities and suggested that the testing of staff should be reduced in order to appropriately allocate limited and costly testing supplies and resources. A few comments appealed for permission to utilize pool testing methods for the routine testing of all staff and to focus routine staff testing on those who have the greatest risk of exposure and transmission, such as those who have direct contact with patients. For example, commenters found it unreasonable for a staff member that works in the billing office—who has no face-to-face contact with residents or with staff who provide direct care to resi [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2023-11449. Public record. Not legal advice.