On November 4, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued a press release that announced the availability of the display copy of the anticipated Interim Final Rule on COVID-19 Health Care Staff Vaccinations.  (See display copy.)   The Interim Final Rule will be published in the Federal Register tomorrow, November 5. Below is an initial outline of the key points of such interim final rule.

Facilities covered by this regulation include the following:

  • Ambulatory Surgical Centers
  • Hospices
  • Programs of All-Inclusive Care for the Elderly
  • Hospitals
  • Long Term Care facilities
  • Psychiatric Residential Treatment Facilities
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities
  • Home Health Agencies
  • Comprehensive Outpatient Rehabilitation Facilities
  • Critical Access Hospitals
  • Clinics (including 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/Federally Qualified Health Centers
  • End-Stage Renal Disease Facilities.

 

Covered facilities must establish a policy to ensure that all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 5, 2021.

All eligible staff must have received the necessary shots to be fully vaccinated – either two doses of Pfizer or Moderna or one dose of Johnson & Johnson – by January 4, 2022.

The regulations also provide for exemptions based on recognized medical conditions or religious beliefs, observances, or practices. Facilities must develop a similar process or plan for permitting exemptions in alignment with federal law (e.g., Americans with Disabilities Act, section 504 of the Rehabilitation Act, section 1557 of the Affordable Care Act, and Title VII of the Civil Rights Act, that prohibit discrimination based on race, color, national origin, religion, disability and/or sex, including pregnancy.) (See discussion starting on page 53 of the display copy.)

Providers and suppliers subject to the Interim Final Rule must track and securely document the vaccination status of each staff member, including those for whom there is a temporary delay in vaccination, such as on account of recent receipt of monoclonal antibodies or convalescent plasma. Vaccine exemption requests and outcomes must also be documented.  The rule requires an ongoing process that will apply as new staff are hired.

CMS indicated the Interim Final Rule will be enforced through its established survey and enforcement processes.  CMS plans to issue interpretive guidelines, which include survey procedures, on the Interim Final Rule and will advise and train state surveyors on how to assess compliance with the new requirements among providers and suppliers.

The CMS Press Release also included a link to a Frequently Asked Questions document, entitled “CMS Omnibus COVID-19 Health Care Staff Vaccination Final Rule” that should be helpful in further clarifying the content and requirements of the Interim Final Rule.