On November 5, the Biden-Harris Administration published an emergency regulation, the Omnibus COVID–19 Health Care Staff Vaccination Rule, requiring staff at covered health care facilities to be vaccinated against COVID-19 (the “Regulation”). The Regulation took immediate effect upon publication.

Under the Regulation, covered facilities (“Facilities”) are required to have a process or policy in place that ensures that all applicable staff are fully vaccinated against COVID-19 over two phases. Unlike the Occupational Safety and Health Administration’s (“OSHA”) emergency temporary standard requiring worker vaccinations for any employers with 100 or more employees or, in the alternative, weekly testing for those who remain unvaccinated,¹ the Regulation does not contain any testing alternative and simply requires staff vaccinations.² Facilities that fail to comply with the Regulation would be ineligible for Medicare payment and could face civil money penalties and/or termination from the Medicare and Medicaid program.

Facilities include Medicare and Medicaid-certified providers that are subject to Centers for Medicare & Medicaid Services’ (“CMS”) health and safety regulations. These include hospitals, ambulatory surgery centers, hospices, community mental health centers, home health agencies, comprehensive outpatient rehabilitation facilities, and others.

The Regulation does not apply to doctors’ offices or practice groups, assisted living facilities, group homes, or schools (that may, for example, receive Medicaid funding). As such, staff who work at these types of businesses are not required to be vaccinated under the Regulation.

The Regulation’s requirements entail two phases. In the first phase, all Facility staff must have received, at a minimum, the first dose of a vaccine prior to providing any care, treatment, or other services within 30 days of the Regulation’s publication. Within 60 days of the Regulation’s publication (i.e., the second phase), all Facility staff must have completed a primary vaccination series. The Regulation defines a completed primary vaccination series as the administration of a single-dose vaccine (such as the Janssen (Johnson & Johnson) COVID-19 Vaccine) or the administration of all required doses of a multi-dose vaccine (such as the Pfizer-BioNTech COVID-19 Vaccine (interchangeable with the licensed Comirnaty Vaccine) or the Moderna COVID-19 Vaccine). The Regulation does not require staff to receive vaccination booster shots.

This vaccination requirement applies to staff working at a Facility, regardless of clinical responsibility or patient contact. The requirement includes all current staff as well as any new staff who provide any care, treatment, or other services for the Facility and/or its patients. This includes Facility employees, licensed practitioners, students, trainees, and volunteers. Additionally, this also includes individuals who provide care, treatment, or other services for the Facility and/or its patients under contract or other arrangements. The requirements apply to staff who work offsite as well (e.g., those who may care for patients as part of a home health program), except for fulltime teleworking employees.

Regarding enforcement, CMS states that it anticipates working directly with the state survey agencies to regularly review compliance with the Regulation. CMS expects state survey agencies to conduct onsite compliance assessments. While onsite, surveyors will likely review the Facility’s COVID-19 vaccination policies and procedures, the number of resident and staff COVID-19 cases, and a list of all staff and their vaccination status. This information, in addition to interviews and observations, will likely be used to determine the compliance of the Facility with the Regulation.