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A Few Clarifications About the CMS Mandatory COVID-19 Vaccination Rule

Health & Life Sciences Sarah E. Coyne, Jon R. Kammerzelt, Rachel L. Dykema

As we described in our recent client alert, the Centers for Medicare and Medicaid Services (CMS) recently mandated that (almost) all health care workers in federally regulated facilities are vaccinated, pursuant to a timetable requiring the first dose of the vaccine by December 6, 2021, and the second vaccine (if applicable) by January 4, 2022.

  1. The first dose is required by December 6, 2021, not December 5, 2021! There were conflicting reports of when the first dose of the vaccine is required, under CMS’s mandate. CMS has clarified that because December 5, 2021 (30 days after publication in the Federal Register) is a Sunday, the first dose is required by December 6, 2021.

  1. There is a lawsuit! On Wednesday, November 10, 2021, ten states filed suit against CMS seeking to enjoin the rule, accusing the Biden administration of broadly over-reaching and infringing on personal liberties. The lawsuit was filed in the U.S. District Court for the Eastern District of Missouri, and was led by Missouri’s attorney general, Eric Schmitt, and the attorney general of Nebraska, Doug Peterson. The other eight states are Alaska, Arkansas, Iowa, Kansas, New Hampshire, North Dakota, South Dakota, and Wyoming. The lawsuit alleges that the mandate violates the Administrative Procedure Act (for skipping the note and comment period, among other issues) and other laws, and is unconstitutional. The lawsuit claims that there is a disparate impact on rural health care due to the increased staffing shortages in rural areas. While the lawsuit challenges whether CMS has authority to issue the rule, CMS does have broad authority to regulate the Medicare-certified facilities subject to the rule.

  1. Application of the CMS Rule and OSHA ETS to Integrated Health Care Systems. It is clear that hospitals are regulated under the CMS mandate, as are all other entities which are subject to the Medicare conditions of participation or conditions of coverage. However, there has been confusion regarding integrated delivery health care systems that have both hospitals (regulated by Medicare and clearly covered by the CMS mandate) and freestanding clinics (not regulated by the Medicare conditions of participation). Specifically, integrated health delivery systems are grappling with whether the providers working in those freestanding clinics are subject to the CMS mandate. CMS is clear that physician offices are not regulated by the mandate, given that they are not subject to the Medicare conditions of participation or conditions of coverage. However, if the providers at given freestanding clinics and offices interact with patients of the hospital or another Medicare certified entity covered by the CMS, those individual providers will be subject to the vaccination mandate. For individuals who work in physician offices but who do not interact with patients of the hospital or another Medicare certified entity covered by the CMS, the June OSHA Healthcare ETS codified at 29 CFR 1910.502 applies, which means that the OSHA Nov. 5 ETS does not apply. The main difference is that the November OSHA rule requires observed COVID testing and the June OSHA rule requires testing – but does not require that it be observed. There is still a question of what happens if (as predicted) the June OSHA rule expires in December, and whether the November OSHA rule will then apply, requiring observed testing for anyone in a freestanding clinic who is unvaccinated pursuant to an approved exemption or delay. All of this is complicated by the fact that OSHA and CMS are not explicitly aligned as to which rule applies when, although both agree that if an entity is Medicare-certified (like a hospital), the CMS mandate applies and is primary.

  1. Medicare-certified entities should distribute their vaccine mandate policies ASAP! If your entity is covered under the CMS mandate and if you did not previously mandate the vaccine for this broad group of individuals (employees, medical staff, privileged practitioners, students, trainees, vendors, etc.), you should be finalizing and distributing your policy now, so that staff know that they must receive their first dose of the vaccine no later than December 6, 2021, and the second dose (if applicable) by January 4, 2022.

If you have any questions regarding the CMS mandatory COVID-19 vaccination rule, please contact your local Quarles & Brady attorney, or:

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