On November 5, 2021, the Centers for Medicare & Medicaid Services (CMS) issued an Omnibus COVID-19 Health Care Staff Interim Final Rule implementing federal COVID-19 vaccination requirements for certain health care providers and suppliers. On the same date, the Occupational Safety and Health Administration (OSHA) published a COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS) that would have applied to private sector employers with 100 or more employees and, in some states like Washington, to private sector employers and to state and local government employers with 100 or more employees.

The CMS Interim Final Rule requires covered employees to be fully vaccinated by January 4, 2022. The OSHA ETS would require adoption of a vaccination policy and various other measures by December 5, 2021 and regular testing for covered employees who are not fully vaccinated as of January 4, 2022. However, on November 12, 2021 the Fifth Circuit Court of Appeals stayed (temporarily stopped) OSHA from taking any steps to implement or enforce the OSHA ETS “until further court order.” Numerous cases involving the OSHA ETS have since been consolidated into one case that has been assigned to the Sixth Circuit. A motion to dissolve the stay has been filed and final briefs on the motion are due on December 10, so the stay is likely to remain in place at least until then. Regardless of the outcome of the motion, it is likely that the legality of the OSHA ETS will ultimately be decided by the U.S. Supreme Court in the near future. In the meantime, employers need to decide how much groundwork to put into place, if any, to prepare for the OSHA ETS in case the stay is lifted on short notice.

The CMS rule is unaffected by the stay of the OSHA ETS. However, a federal District Court judge in Louisiana issued a preliminary injunction on November 30, 2021 stopping the U.S. Department of Health and Human Services and the Center for Medicare and Medicaid Services from implementing the CMS Interim Final Rule that would have required all Medicare and Medicaid certified providers and suppliers to be vaccinated against COVID-19. The injunction applies to all states (including Washington) that are not already covered by a previous injunction. The injunction will remain in place until the lawsuit is over unless it is modified or lifted by either the court that issued the injunction, the United States Court of Appeals for the Fifth Circuit, or the United States Supreme Court. Our initial assessment is that it is unlikely that the injunction will be lifted before the dates upon which the vaccines were going to be required (December 6, 2021 for one vaccine and January 4, 2021 to receive the second vaccine). However, the preliminary injunction does not prevent individual health care providers in Washington State from requiring proof of vaccination.

The CMS rule imposes vaccination requirements on staff of the following Medicare- and Medicaid-certified providers and suppliers:

  • Ambulatory surgical centers
  • Hospices
  • Psychiatric residential treatment facilities
  • Programs of all-inclusive care for the elderly
  • Hospitals
  • Long term care facilities, including skilled nursing facilities and nursing facilities, generally referred to as nursing homes
  • Intermediate care facilities for individuals with intellectual disabilities
  • Home health agencies
  • Comprehensive outpatient rehabilitation facilities
  • Critical access hospitals
  • Clinics, 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 and federally qualified health centers
  • End-stage renal disease facilities

The CMS rule directly applies only to the Medicare- and Medicaid-certified providers and suppliers listed above. It does not directly apply to other health care entities, such as physician offices. Importantly, the vaccination requirements are not limited to those staff who perform their duties within a formal clinical setting; they also apply to all staff who interact with other staff, patients, residents, clients, or PACE program participants in any location. The requirements do not apply to personal visitors, but do apply to contractors who visit the facility on a regular basis. Individuals whose work is 100% remote, such as those who provide fully remote telehealth or payroll services, are not subject to the vaccination requirements of the new CMS rule. Facilities are not required to ensure vaccination of vendors, volunteers, or professionals who infrequently provide ad hoc, non-health care services.

CMS has also clarified that the vaccination requirements apply to all of a member’s, provider’s, or supplier’s medical staff – notwithstanding their employment status with the provider or supplier. However, exemptions for staff must be allowed where required by law as a reasonable accommodation of a disability or sincerely held religious belief, observance, or practice under the Americans with Disabilities Act (ADA) or Title VII of the Civil Rights Act of 1964.

For additional details, see the CMS Omnibus Staff Vax Requirements – External FAQ, online at https://www.cms.gov/files/document/cms-omnibus-covid-19-health-care-staff-vaccination-requirements-2021.pdf and the OSHA COVID-19 Vaccination and Testing ETS website, https://www.osha.gov/coronavirus/ets2.

This update is a summary of a complex topic that is subject to change at any time, and should not be relied upon in lieu of legal advice. If you have any questions, please contact Karen Sutherland, Jennifer Berry, Casey Moriarty, or Mallory Barnes-Ohlson.