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  • June 9, 2023
  • Alerts

CMS Issues Final Rule Ending COVID-19 Vaccination Requirements

On June 5, 2023, the Centers for Medicare and Medicaid Services (“CMS”) published a much anticipated Final Rule surrounding vaccination and related requirements surrounding the COVID-19 Public Health Emergency that: (1) eliminates COVID-19 vaccination requirements for the healthcare staff of covered providers and suppliers[1]; (2) requires long-term care (“LTC”) facilities and intermediate care facilities for individuals with intellectual disabilities (“ICFs-IID”) to continue furnishing residents, clients, and staff with COVID-19 vaccine education and offering COVID-19 vaccinations to these populations; and (3) withdraws expired COVID-19 testing requirements for LTC facilities. 
 
The Final Rule will be effective on or about August 4, 2023, and CMS does not intend to enforce staff vaccination requirements before the effective date. Notwithstanding CMS initiatives, providers must comply with any independent State and local laws that may enforce stricter COVID-19 requirements.  In line with the federal repeal of the CMS Vaccination Mandate, state vaccination mandates, like those required in New York and New Jersey, may be repealed or no longer enforced.  For example, New York has recommended repealing the vaccination mandate for health care providers and Department of Health will no longer be enforcing that requirement.  New Jersey recently rescinded the weekly COVID-19 testing requirement for unvaccinated staff, but covered providers are still required to maintain a policy that requires covered workers to provide adequate proof that they are up to date with their COVID-19 vaccinations. 
 
Elimination of Vaccination Requirements
 
The Final Rule eliminates COVID-19 staff vaccination requirements previously mandated by CMS and issued on November 5, 2021. According to CMS, the regulations are no longer necessary. As such, the Final Rule withdraws COVID-19 health care staff vaccination requirements for Covered Entities. 
 
“Educate and Offer” Requirements
 
On May 13, 2021, CMS issued a regulation which required LTC facilities and ICFs-IID to provide COVID-19 vaccination education to residents, clients, and staff (e.g., provide information regarding the benefits and potential side effects of the immunization), and offer COVID-19 vaccines to these populations (collectively the “Educate and Offer Requirements”). The regulation also required LTC facilities and ICFs-IID to appropriately document compliance with the Educate and Offer Requirements (e.g., noting in a resident’s medical record that they (1) received COVID-19 vaccination education; and (2) either received a COVID-19 immunization or did not receive a COVID-19 immunization).
 
According to the Final Rule, CMS is working to finalize the going forward “educate and offer” provisions on a permanent basis. In the interim, the regulations will remain effective. Consequently, LTC facilities and ICFs-IID must adhere to the Educate and Offer Requirements, and document compliance thereof.
 
Removal of COVID-19 Testing Requirements
 
The Final Rule removes expired COVID-19 testing requirements for LTC facilities mandated by a mandate issued on September 2, 2020. That mandate established requirements applicable to LTC facilities for the duration of the public health emergency, and required testing of staff and residents for COVID-19. The Final Rule withdraws expired COVID-19 testing requirements for covered LTC facilities.
 
Garfunkel Wild is available to guide domestic and foreign business with respect to the above-referenced rules and any applicable required filings.

Should you have any questions regarding the above, please contact the authors or the Garfunkel Wild attorney with whom you regularly work, or contact us at info@garfunkelwild.com.
 
[1] This includes Ambulatory Surgery Centers, Hospitals, Hospices, Psychiatric Residential Treatment Facilities, Programs of All-Inclusive Care for the Elderly Organization; 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); LTC Facilities, including skilled nursing facilities and nursing facilities; ICFs-IID; Home Health Agencies; Comprehensive Outpatient Rehabilitation Facilities; Critical Access Hospitals; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-language Pathology Services; Community Mental Health Centers; Home Infusion Therapy Suppliers; Rural Health Clinics and Medicare Federally Qualified Health Centers; and End-Stage Renal Disease Facilities (“Covered Entities”).