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  • Washington Highlights

    Biden Administration Issues Vaccine Requirement Rules


    Ivy Baer, Senior Director and Regulatory Counsel

    The Department of Labor’s Occupational Safety and Health Administration (OSHA) and the Centers for Medicare & Medicaid Services (CMS) announced requirements regarding COVID-19 vaccinations for employees on Nov. 4. This follows President Joe Biden’s announcement of additional approaches the administration would take to further combat COVID-19 [refer to Washington Highlights, Sept. 10].

    Requirements to be fully vaccinated under both agencies’ rules are effective Jan. 4, 2022. The Biden administration policy requiring vaccinations for federal contractors has also been amended with a new compliance date of Jan. 4, 2022, to align with the CMS and OSHA regulations. There is a 60-day comment period for the CMS rule, and a 30-day comment period for the OSHA ETS. Both rules preempt any state law.

    Specifically, the CMS Interim Final Rule (IFR) states that by Dec. 5, 2021, health care facilities that participate in Medicare and Medicaid programs must establish a policy ensuring 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.” Eligible staff include facility employees, licensed practitioners, students, trainees, and volunteers.

    The CMS IFR revises several conditions of participation for covered providers, including 42 CFR § 482.42: Infection prevention and control and antibiotic stewardship programs that applies to hospitals. In addition to hospitals, facilities covered by the IFR include ambulatory surgery centers, critical access hospitals, home health agencies, hospitals, rural health clinics/federally qualified health centers, and long-term care facilities. The CMS requirements apply to staff who work offsite except those staff who provide services 100% remotely and have no direct contact with patients or other staff. Physicians with admitting privileges and/or who treat patients within a facility covered by the IFR are subject to the requirements.

    The IFR also allows for exemptions for medical conditions for which vaccinations are contraindicated and for religious beliefs, observances, or practices. Providers and suppliers are to establish exemptions as part of their policies and procedures.

    The OSHA vaccine requirements were issued as an Emergency Temporary Standard (ETS) and apply to employers with 100 or more employees. The ETS requires that employers develop and implement a mandatory vaccination policy or implement at least weekly COVID-19 testing for unvaccinated workers. Employers must comply with most requirements within 30 days and with testing requirements within 60 days of the ETS publication. The OSHA rule will not apply to workplaces covered by either the CMS rule or the federal contractor vaccination requirements.

    Biden issued a statement on the vaccination requirements, noting that “vaccination is the single best pathway out of this pandemic.” He added that, “Together, these rules will cover about 100 million Americans – two-thirds of all workers in America.“ The Biden administration also issued an accompanying fact sheet on the two vaccination policies.