The Biden-Harris Administration announced the release of two interim final rules: (1) a Centers for Medicare & Medicaid Services (CMS) rule requiring vaccination of staff of health care facilities subject to CMS health and safety standards, and (2) an Occupational Safety and Health Administration (OSHA) rule requiring employers with 100 or more employees to ensure each employee is fully vaccinated or tested for COVID-19 at least weekly. Both rules are effective November 5, 2021.
The CMS Omnibus COVID-19 Health Care Staff Vaccination Rule (CMS Rule) affects approximately 76,000 health care facilities and an estimated 17 million health care workers across the country. It requires health care facilities and suppliers that are subject to Medicare and Medicaid conditions of participation, conditions for coverage, or other applicable CMS health and safety requirements (Facilities) to ensure that their staff are fully vaccinated for COVID-19. Impacted provider types include, for example, hospitals, long-term care facilities and ambulatory surgery centers. However, the CMS Rule does not apply to locations not subject to CMS health and safety standards, such as physician and dental offices. Such facilities may still be separately subject to the OSHA COVID-19 Vaccination and Testing Emergency Temporary Standard (OSHA Rule). The OSHA Rule applies to all employers in the United States with 100 or more employees. Those requirements state that employees must either be fully vaccinated for COVID-19 or submit to COVID-19 testing at least weekly.
The deadline for compliance with vaccination requirements is the same across the CMS Rule and OSHA Rule: Facilities must ensure that workers receive either the first dose of a two-dose vaccine or a single-dose vaccine, or otherwise request an exemption from such requirements, by December 5, 2021 (Phase 1 of implementation). Except for those workers granted an exemption or delay in vaccination per Centers for Disease Control (CDC) recommendation, all staff must be fully vaccinated by January 4, 2022 (Phase 2 of implementation). The White House clarified that this January 4, 2022 vaccination deadline supersedes the deadline provided under the White House Safer Federal Workforce Task Force’s previously issued guidance (the previous deadline was December 8, 2021).
The CMS Rule mandates that Facilities’ vaccination policies extend to any current and new staff who provide care (including practitioners with admitting privileges, students and trainees), as well as any other employees, independent contractors or volunteers who are on-site at the facility regardless of whether or not they have clinical responsibilities or patient contact, such as administrators and environmental services staff. Staff that work off-site may be exempted only if they are 100 percent remote and do not have direct contact with patients or other staff. CMS also allows certain exemptions from the vaccine mandate for workers with recognized medical conditions for which COVID-19 vaccines are contraindicated (see CDC guidance here), in addition to exemptions for workers with religious beliefs, observances or practices. However, CMS does not allow for weekly COVID-19 testing as an alternative for vaccination.
CMS states that its rule preempts any inconsistent state or local laws, including those that curtail an employer’s authority to require vaccination of employees and those that provide for exemptions broader than exemptions contained in the CMS Rule. CMS and state survey agencies will review Facilities’ compliance with the CMS Rule vaccination requirements during on-site compliance reviews for standard recertification surveys and complaint surveys. Noncompliance with the CMS Rule is grounds for civil monetary penalties, payment denial, and/or termination from participation in Medicare and Medicaid.
Notably, various Republican governors have threatened to challenge both OSHA rules in court, but they have not yet stated whether challenges to the CMS Rule will follow.
For more information on the OSHA Rule, click here.