On November 29 and 30, 2021, two separate federal district courts—the Western District of Louisiana and Eastern District of Missouri—issued injunctions blocking enforcement of the Centers for Medicare and Medicaid Services (“CMS”) interim final rule (“vaccine mandate”) requiring healthcare worker vaccinations. In combination, these rulings result in a nationwide preliminary injunction prohibiting CMS from enforcing the vaccine mandate.

The CMS Vaccine Mandate

CMS issued the vaccine mandate on November 5, 2021. The mandate applied to a number of Medicare- and Medicaid-certified providers and suppliers, including hospitals, long-term care facilities, nursing homes, and others. The mandate contemplated implementation in two phases. For Phase 1, staff at all healthcare facilities covered by the regulation must have received, at a minimum, the first dose of a two-dose vaccine or a single-dose COVID-19 vaccine by December 5, 2021. For Phase 2, staff were to be fully vaccinated by January 4, 2022. Exceptions were permitted for those who were granted religious or medical exemptions from the COVID-19 vaccine, as well as for staff members for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC.

State of Missouri v. Biden (“Missouri Case”)

On November 10, 2021, ten states—Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming—filed a challenge to the CMS vaccine mandate in the U.S. District Court for the Eastern District of Missouri. The challengers also sought to preliminarily enjoin enforcement of the mandate.

On November 29, 2021, the Missouri District Court granted the plaintiffs’ request for a preliminary injunction, blocking enforcement of the vaccine mandate, for multiple reasons.

First, the court found CMS had acted outside of the scope of its congressional-delegated authority by issuing the vaccine mandate. Congress was required to provide “clear congressional authorization for this [CMS] mandate,” which the court found had not occurred. Clear congressional authorization was required given the mandate’s vast economic and political significance, and because the mandate significantly altered the balance between federal and state power.

Second, the court held that CMS had improperly bypassed the notice-and-comment requirements in issuing the vaccine mandate. Rules promulgated by administrative agencies like CMS typically must initially undergo a notice-and-comment period, during which stakeholders are afforded the opportunity to provide comments and suggestions on the contemplated rule. Notice and comment can be bypassed for “good cause.” Therefore, CMS argued that good cause existed to skip the notice-and-comment period for the vaccine mandate because of the continued prevalence of COVID-19 and the risk it poses in the healthcare setting. The court disagreed, finding that the COVID-19 pandemic did not provide sufficient emergency justification for CMS to skip the notice-and-comment period, and that CMS’s administrative failure in this regard provided an independent basis for enjoining the vaccine mandate.

Third, the court deemed the vaccine mandate arbitrary and capricious for a variety of reasons, including that the implementation of CMS’s rule occurred months after COVID-19 vaccines became readily available, and that the agency had previously expressed it would not issue such a mandate. Viewed collectively, these points constituted evidence of agency capriciousness, according to the court.

Last, the court held that the plaintiffs would face irreparable harm if the vaccine mandate were not enjoined. In making this determination, the court relied on their evidence that the vaccine mandate would “more than likely exacerbate the already-existing staffing problem,” particularly in rural areas of the country.

For all these reasons, the court issued a preliminary injunction blocking enforcement of the vaccine mandate in all 10 states that had challenged the rule.

State of Louisiana v. Becerra (“Louisiana Case”)

On November 15, 2021, a different coalition of 14 states—Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma, South Carolina, Utah, West Virginia, Kentucky, and Ohio—filed the Louisiana Case in the U.S. District Court for the Western District of Louisiana. The plaintiffs here challenged the legality of the CMS vaccine mandate on similar grounds as those in the Missouri Case.

On November 30, 2021, the court granted the plaintiffs’ motion for an injunction blocking the vaccine mandate. The court’s reasoning was similar to that in the Missouri Case. The court found that CMS had improperly bypassed the required notice-and-comment period, that CMS had exceeded its authority in issuing the vaccine mandate, and that the vaccine mandate was arbitrary and capricious.

However, the court went further than its Missouri counterpart and ordered a nationwide injunction against the vaccine mandate applicable to all states, except for those states already subject to the Missouri court’s injunction order.

Combined, these two orders block enforcement of the CMS vaccine mandate nationwide, pending further judicial review. The Biden administration asked both courts to stay enforcement of their respective injunctions pending appeal. In separate orders issued on December 1, 2021, however, both courts denied the administration’s requests. As such, the vaccine mandate remains enjoined nationwide.

Further, CMS has announced that it has suspended activities related to the implementation and enforcement of the vaccine mandate pending future developments in the litigations and appeals.

What’s next?

Both cases will now move through the appellate process. The Biden administration has already noticed appeals of both cases, the Missouri Case to the U.S. Court of Appeals for the Eighth Circuit, and the Louisiana Case to the U.S. Court of Appeals for the Fifth Circuit. The administration has also moved the Eighth Circuit for a stay of enforcement pending the appeal, and will likely do the same in the Fifth Circuit in short order.

The Eighth Circuit has also set a briefing schedule on the appeal. The Biden administration’s appellate brief is due by January 10, 2022, rendering it quite unlikely that the Eighth Circuit could issue a decision on the merits before the vaccine mandate’s original effective dates of December 5, 2021 and January 4, 2022.

What should covered entities do now?

The most conservative approach is to continue to undertake all necessary measures to comply with the CMS vaccine mandate, short of automatically terminating the employment of or barring unvaccinated workers, because the district courts’ rulings could be reversed or stayed pending appeal, resulting in reinstatement of the original compliance deadlines or modified deadlines. Were that to occur, good-faith efforts to comply with the vaccine mandate’s deadlines could offer legal protection in the event of an enforcement action. 

Entities should also continue to monitor legal developments in this area. One of the appellate courts may, in the coming days or weeks, temporarily lift one or both of the current injunctions. Littler is closely monitoring these cases and will provide periodic updates as new developments occur.

Finally, healthcare providers must continue to stay abreast of the hodgepodge of state vaccine-related orders, which are not directly affected by the injunctions to the CMS vaccine mandate.  Some of these state orders require that certain healthcare providers and staff be vaccinated while, on the other end of the spectrum, other states have passed laws limiting or banning vaccine mandates. And, while the CMS vaccine mandate purportedly preempts contrary state and local laws—such as those limiting or banning vaccine mandates—federal preemption does not apply so long as the CMS vaccine mandate is enjoined, meaning these state and local laws remain in effect until a court says otherwise.