The United States Department of Health and Human Services (“HHS”), through the Centers for Medicare and Medicaid Services (“CMS”), published a final rule on June 5 (the “Final Rule”), which, among other important actions, confirms the termination of all CMS requirements that staff of CMS-certified facilities be vaccinated for COVID-19. The Final Rule will be effective 60 days after its June 5 publishing date (the “Effective Date”).
Specifically, the Final Rule addresses three Interim Final Rules with Comment (“IFC”) implemented during the COVID-19 Public Health Emergency:
- 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 “Long-Term Care (“LTC”) Testing IFC.”
Staff Vaccination IFC
First, with respect to the Staff Vaccination IFC, CMS indicates its current position that regulations concerning “COVID-19 vaccination of health care staff are no longer necessary” and formalizes its withdrawal of health care staff vaccination requirements in the Staff Vaccination IFC. CMS makes clear that “COVID-19 vaccination policies and procedures for health care staff will no longer be required under” Conditions of Participation, Conditions for Coverage, and associated CMS requirements. The removal of the Staff Vaccination IFC reflects CMS’ decision to modify its approach to COVID-19 and treat it in alignment with its approach “for other infectious diseases, specifically influenza.” Although the Final Rule formally becomes effective on the Effective Date and vaccination mandates will no longer be a condition of participation in CMS programs, “CMS’s interest in pursuing implementation of measures that encourage uptake of COVID-19 vaccine” will express itself through utilization and monitoring of quality measures that “may affect payment in various ‘value-based purchasing’ programs.”
Educate and Offer IFC
Second, CMS finalized certain requirements of the Educate and Offer IFC, which generally requires LTC facilities and Intermediate Care Facilities (“ICFs”) for Individuals With Intellectual Disabilities (“ICFs-IID”) to provide COVID-19 vaccination education and offer vaccines to residents, clients and staff. Specifically, LTC facilities and ICFs-IID must continue such education of residents and staff and prepare the appropriate supporting documentation for these educational activities. For staff members, this includes maintaining documentation that, at a minimum, confirms:
- staff members were provided education regarding the benefits and potential risks associated with COVID-19 vaccines;
- staff members were offered a COVID-19 vaccine or information on obtaining a COVID-19 vaccine; and
- staff members’ COVID-19 vaccination status and related information as indicated by the CDC’s National Healthcare Safety Network.
LTC Testing IFC
Lastly, the Final Rule eliminates expired requirements for scheduled testing that were set forth in the LTC Testing IFC. Previously, IFCs required CMS-certified LTC facilities to conduct testing for COVID-19 in residents and staff, including individuals providing services under arrangement and volunteers, all in accordance with parameters set forth by the Secretary. The Final Rule removes all testing requirements set forth in the LTC Testing IFC, as such requirements have expired and were not renewed.