On December 2, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum (the “CMS Memo”) addressing survey and enforcement of the COVID-19 vaccine requirement applicable to Medicare and Medicaid participating healthcare providers and suppliers and their staff. The CMS Memo was issued in response to preliminary injunctions against the implementation and enforcement of the Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule  published on November 4, 2021, which requires staff working in Medicare or Medicaid certified providers and suppliers (including nursing facilities, hospitals, dialysis facilities and all other provider types covered by the rule) to have the shots necessary to be fully vaccinated against COVID-19 by January 4, 2022, and receive their first shot prior to December 6, 2021 (the “Rule”).

Current Status of the Rule

The U.S. District Court for the Eastern District of Missouri and the U.S. District Court for the Western District of Louisiana issued preliminary injunctions against the implementation and enforcement of the Rule on November 29 and November 30, 2021, respectively. The Eastern District of Missouri injunction applies to Alaska, Arkansas, Iowa, Kansas, Missouri, New Hampshire, Nebraska, Wyoming, North Dakota, and South Dakota. The Western District of Louisiana injunction applies nationwide, except for the states covered by the Missouri injunction.  Appeals of both injunctions by CMS are pending in the Eight Circuit and Fifth Circuit Courts of Appeals, respectively.

As a result of the injunctions and the pending appeals, CMS states in the CMS Memo that it will not enforce the Rule while there are court-ordered injunctions in place prohibiting its enforcement.  Although separate and apart from the Rule and the enforcement thereof, it is worth noting that, on December 7, 2021, the U.S. District Court for the Southern District of Georgia issued a nationwide injunction to enjoin enforcement of Executive Order 14042 (“EO 14042”) which requires that federal contractors and subcontractors performing work on certain federal contracts ensure that employees working on or in connection with those contracts are fully vaccinated against COVID-19.

The injunction to enjoin EO 14042 rests on the grounds that President Biden exceeded his delegated authority under the Federal Property and Administrative Services Act by issuing public health regulations. CMS, on the other hand, previously cited its broad authority to establish health and safety regulations and responsibility to protect the health and safety of Medicare and Medicaid beneficiaries receiving care and services from Medicare and Medicaid certified providers and suppliers as the basis for the Rule. Although one cannot predict the outcome of either of these matters, some have argued that CMS’s regulatory authority puts the Rule on firmer ground than EO 14042.

Implications for the Industry; State Enforcement of State Mandates

Given that CMS will need to go through the appeal process to allow the mandate to go into effect, we will likely not know about the status of the Rule for some time. As explained in the CMS Memo, although CMS, “remains confident in its authority to protect the health and safety of patients in facilities certified by the Medicare and Medicaid programs, it has suspended activities related to the implementation and enforcement of this [R]ule pending future developments in the litigation.”

Notwithstanding the injunctions against the Rule, the pending appeals, and CMS’s suspension of Rule enforcement pursuant to the CMS Memo, it is important to remember that, except in the case of those states which have passed laws prohibiting businesses from implementing COVID-19 vaccine mandates, any health facility can still require the vaccine for its staff, taking into account local rules about medical and religious exemptions.  As of December 7, 2021, 15 states[1] have issued a COVID-19 vaccine requirement for healthcare workers. Of the 15 states with healthcare worker vaccine requirements, only Delaware, Maryland, and New Jersey allow healthcare workers to undergo regular COVID-19 testing in lieu of getting a vaccine.  Therefore, in the listed states, healthcare providers are obligated to continue compliance with vaccine mandates as required by applicable state laws.

In those states in which there are no vaccine mandates for healthcare workers but for the mandate for Medicare- and Medicaid-participating providers,  the current state of the Rule likely leaves many entities that have already begun to implement the original mandate requirements unsure of whether to continue with such steps. While it is uncertain whether the Rule will go into effect or not, Medicare- and Medicaid-certified providers and suppliers that would be subject to the Rule should make every effort to work with their clinical leadership, counsel and their individual state Departments of Public Health to keep up-to-date on any developments.

As the proceedings related to enforcement of the Rule develops, we will continue to share the latest information.

This article is not an unequivocal statement of the law, but instead represents our best interpretation of where things currently stand.  This article does not address the potential impacts of the numerous other local, state and federal orders that have been issued in response to the COVID-19 pandemic, but which are not referenced in this article.

Check out Sheppard Mullin’s Coronavirus Insights Portal which aggregates the firm’s various COVID-19 blog posts on a broad range of topics. Click here to view and subscribe.


[1]              California, Colorado, Connecticut, Delaware, Illinois, Maine, Maryland, Massachusetts, Nevada, New Jersey, New Mexico, New York, Oregon, Rhode Island, and Washington.