The Centers for Medicare & Medicaid Services (CMS) has published the Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule, requiring vaccination of all staff at health care facilities that participate in the Medicare & Medicaid programs, regardless of responsibility or patient contact.
The following summarizes who must abide by the regulations and what covered providers/suppliers need to complete by the Phase 1 deadline of Dec. 6, 2021, and Phase 2 deadline of January 4, 2022.
Who is covered by the Health Care Staff Vaccination Rules?
The rules cover current and new staff, including employees, licensed practitioners, students, trainees, volunteers and individuals who provide care, treatment or other services for the facility and/or its patients under contract or other arrangement, who are present at the following Medicare and Medicaid certified providers and suppliers:
- Ambulatory surgery centers
- Community mental health centers
- Comprehensive outpatient rehabilitation facilities
- Critical access hospitals
- End-stage renal 2 disease facilities
- Home health agencies
- Home infusion therapy suppliers
- Intermediate care facilities for individuals with intellectual disabilities
- Rehabilitation agencies and public health agencies as providers of outpatient physical therapy and speech-language pathology services
- Psychiatric residential treatment facilities
- Programs for All-inclusive Care for the Elderly (PACE) organizations
- Rural health clinics/federally qualified health centers
- Long term care facilities, including skilled nursing facilities and nursing facilities
Who is NOT covered by the Health Care Staff Vaccination Rules?
(1) Staff who provide services 100% remotely for one of the entities listed above and have no direct contact with patients and other staff.
(2) Staff of the following providers/suppliers:
- Religious nonmedical health care institutions
- Organ procurement organizations
- Portable x-ray suppliers
(3) Staff of facilities not subject to CMS health and safety regulations including:
- Assisted living facilities,
- Group homes
- Medicaid home care and home- and community-based service providers
What Do You Need to Accomplish by December 6, 2021 (Phase 1)?
(1) Establish a process or policy to vaccinate all employees
- ALL staff must be vaccinated or deemed exempt from vaccination requirements; there is no option to test unvaccinated staff.
- If there is a state or local law prohibiting vaccine mandates, the facility/provider must follow CMS regulations pursuant to the Supremacy Clause of the U.S. Constitution
(2) Establish a process or policy by which staff may request a medical or religious exemption from the vaccine.
(3) Establish a process or policy to track and securely document vaccination status of each staff member, including those for whom there is a temporary delay in vaccination because of a recent receipt of monoclonal antibodies or convalescent plasma.
(4) Establish a process or policy ensuring the implementation of additional precautions to mitigate the transmission and spread of COVID-19 for all staff who are not fully vaccinated.
(5) Ensure staff at all health care facilities covered by the regulation have received, at a minimum, the first dose of a primary series COVID-19 vaccine (Pfizer or Moderna) or the single dose COVID-19 vaccine (Johnson & Johnson).
What Do You Need to Accomplish by January 4, 2022 (Phase 2)?
All applicable staff must be fully vaccinated for COVID-19, except staff who have been granted exemptions from COVID-19 vaccination or workers for whom COVID-19 vaccination must be temporarily delayed.
Staff will be deemed to have met the 60-day deadline if they receive the second/final dose of a primary vaccination series by the 60th day even though they will not be considered “fully vaccinated” until 14 days after the second dose.
Further details and analysis to follow.