CMS Issues Vaccine Mandate Interim Final Rule; Interplay with NYS Vaccine Mandate to be Determined

November 5, 2021

The Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period today to require all eligible staff working in CMS-certified facilities to receive the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine by December 5, 2021. All eligible staff must be fully vaccinated—with two doses of Pfizer or Moderna or one dose of Johnson & Johnson—by January 4, 2022. The interim final rule provides for both medical and religious exemptions, as noted below.

GNYHA has communicated with the State to determine the State’s view on how its vaccine mandate for health care personnel interplays with the CMS interim final rule. The State is considering the question. Meanwhile, the Second Circuit Court of Appeals has not yet issued an opinion detailing its rationale for vacating the injunction barring the State from enforcing the mandate in connection with religious exemptions, which the Court issued on Friday in We the Patriots v. Hochul and Dr. A v. Hochul. The We the Patriots plaintiffs are seeking an emergency stay from the US Supreme Court.

GNYHA also participated on a CMS listening session during which officials reviewed key elements of the interim final rule, including the following:

  • Within 30 days; by December 5:
    • Ensure all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine or requested and/or been granted a lawful exemption
    • Have a process or plan for providing exemptions and accommodations for those who are exempt
    • Have a process or plan for tracking and documenting staff vaccinations
  • Within 60 days; by January 4:
    • Ensure all eligible staff are fully vaccinated with two doses of Pfizer or Moderna or one dose of Johnson & Johnson
  • Preemption of State and local laws
    • The CMS interim final rule preempts State and local laws to the extent that they provide broader grounds for exemptions than that provided under Federal law and are inconsistent with the interim final rule. (GNYHA has inquired of CMS and New York State officials but has not yet determined whether the CMS rule preempts the New York State vaccine mandate for health care personnel, which does not contain an express provision for religious exemptions.)
  • Eligibility
    • The CMS vaccination requirements apply to all current staff and new hires working at a Medicare-certified facility (hospitals, nursing homes, ambulatory surgery centers, among others) regardless of clinical responsibility or patient contact
    • Staff who perform duties offsite (e.g., home health and home infusion therapy) and individuals who enter the facility (e.g., physicians with admitting privileges and contractors) are subject to the requirement
    • The requirement does not apply to full-time telework staff and those performing ad hoc or infrequent work at a facility (e.g., repair personnel, among others)
  • Exemptions
    • The facility must have a process or plan in place for handling medical and religious exemption requests and for infection control mitigation strategies for staff who are granted an exemption. However, CMS said that these processes and policies are wholly at the facility’s discretion.
    • Medical exemptions should be granted in accordance with the Centers for Disease Control and Prevention’s recommendation of clinical considerations for COVID-19 vaccinations
    • Facilities should consult the US Equal Employment Opportunity Commission’s Updated COVID-19 Technical Assistance in considering processes and policies for reviewing religious exemption requests

Additionally, CMS noted that the interim final rule would not add new reporting requirements for providers. Enforcement of the requirements will be through facility recertification and/or complaint-driven surveys.