The Omnibus COVID-19 Health Care Staff Vaccination rule requires covered healthcare providers and suppliers to ensure staff are fully vaccinated for COVID-19 unless individuals are exempt. CMS considers staff to be fully vaccinated once two or more weeks have passed since they completed a primary vaccination series. In turn, a primary vaccination series is defined as having received a single-dose vaccine or all doses of a multi-dose vaccine. Unlike the OSHA Emergency Temporary Standard released on November 9 that impacts all employers with more than 100 employees in all industries nationwide, the CMS Interim Final Rule does not allow for a testing option in lieu of vaccination.
Effective Date(s)
There are two compliance due dates for affected employers.
Phase One: December 4, 2021
Phase Two: January 4, 2022
Phase One Employer Requirements
Facilities covered by this emergency regulation must create a policy by December 4, 2021, ensuring all eligible staff have received either the first does of the twodose COVID-19 vaccines from Pfizer and Moderna or the single dose of the onedose COVID-29 vaccine from Johnson & Johnson prior to delivering care, treatment or services. CMS considers staff fully vaccinated if it has been two (2) or more weeks since they completed a primary vaccination series for COVID-19. A primary vaccination series is defined as having received a single-dose vaccine or all doses of a multi-dose vaccine.
As part of a facilities compliance with regulation, they must provide reasonable time and paid leave for employees to receive the vaccine and recover from side effects.
Any facilities where employees deliver healthcare services or healthcare support services must abide by the emergency regulation. This includes, but is not limited to:
- Ambulatory surgical centers
- Hospices
- Programs of All-Inclusive Care for the Elderly (PACE)
- Hospitals
- Long-term care facilities
- Clinics
- Community Mental Health Centers
Phase Two Employer Requirements
All staff must be vaccinated by January 4, 2022, as long as they interact with other staff, patients, residents, clients, or PACE program participations in any locations. This includes administrative staff, facility leadership, volunteers, and housekeeping and food services.
Staff who provide services 100 percent remotely will not have to get vaccinated per the emergency regulation.
Exemptions
Healthcare workers will be able to apply for an exemption from mandatory COVID-19 vaccinations based on “recognized medical conditions or religious beliefs, observations, or practices”. Facilities subject to compliance with the regulation must establish a similar process or plan for enabling exemptions in line with federal government’s law.
Penalties
Compliance with the regulation will be tracked using survey and enforcement processes. The standards established by the rule are new conditions of participation in Medicare and Medicaid, which means violation of the standards could jeopardize future participation and trigger a range of penalties and enforcement actions up to and including exclusions. Healthcare facilities found not complying with requirements by December 4th will be given a warning and a chance to comply. However, it is CMS’s goal to bring all healthcare providers into compliance. Potential fines have not yet been published.
