On November 29, 2021, a federal district court in Missouri issued a preliminary injunction blocking the implementation and enforcement of a rule promulgated by the Centers for Medicare and Medicaid Services (“CMS”) requiring employees of certain healthcare facilities to be vaccinated against COVID-19.[1] Unlike the Fifth Circuit’s stay of a vaccination requirement promulgated by OSHA, this preliminary injunction is limited in geographic scope to 10 states (Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming), but may nonetheless have an impact on litigation throughout the country regarding the CMS rule and other federal rules requiring the vaccination of certain categories of workers.

The CMS rule requires employees, volunteers, and contractors working at certain healthcare facilities to be vaccinated against COVID-19 and to have received at least the first dose of the vaccine by December 6, 2021.[2] In granting the injunction, the Missouri court held that the plaintiffs—a group of ten states—were likely to succeed on the merits of their claims that the CMS rule is invalid. The court held that CMS exceeded its rulemaking authority because its authority from Congress is limited to “the ‘administration’ of Medicare and Medicaid and the ‘health and safety’ of recipients,” and there was no clear authorization from Congress for a “politically and economically vast, federalism-altering, and boundary-pushing mandate.”[3] The court’s holding was based on its findings that the economic impact of the rule, with an estimated compliance cost of $1.38 billion, was significant; that healthcare and vaccination regulation was traditionally reserved to the states, rather than the federal government; and that whether Congress would even have the power to enact this vaccination requirement itself was a “tough question.”[4] Based on those findings, the court held that CMS did not have the power to enact the rule absent express authorization from Congress. In so holding, it appears that the court did not find persuasive the fact that much of healthcare regulation is federal, particularly for facilities, like those covered by the CMS rule, that are receiving federal funds. The court also rejected arguments from the federal government that, among other things, the rule did not undermine the federal-state balance of power because it is CMS’s “responsibility to ensure the health and safety of Medicare and Medicaid patients while they are receiving care at facilities funded by those programs.”[5]

The court also held that the plaintiff states were also likely to succeed on the merits because CMS promulgated the rule without a notice and comment period, in violation of the Administrative Procedure Act and the Social Security Act.[6] The court held that there was no “emergency” or “good cause” for bypassing the notice and comment requirement in light of what the court found was CMS’s delay in promulgating the rule, including because the rule came many months after the COVID-19 vaccines received emergency approval.[7] The court also held that CMS’s rule was arbitrary and capricious. In particular, the court found that CMS relied on inferences regarding healthcare facilities, rather than actual data, in promulgating the rule; rejected alternatives, such as frequent testing, without citing any evidence for this approach; and provided no evidence supporting the broad reach of the rule.[8] The court also stated that CMS had never previously required any other type of vaccine over the years, but was suddenly changing its position, and that it ignored the impact on workers who had relied for years on employer policies that did not require any sort of vaccination.[9]

The court also found that the plaintiff states that sued demonstrated irreparable harm based on the invasion of their sovereignty and ability to enforce their laws, as well as harm to the physical health and well-being of their states’ citizens as a result of staffing shortages at healthcare facilities anticipated as a result of the CMS rule.[10] The court further held that the balance of the equities and public interests weighed in favor of an injunction because, although “[t]he public has an interest in stopping the spread of COVID,” there is “little, if any, harm from maintaining the ‘status quo’” including because CMS itself had admitted that the “effectiveness of the vaccine to prevent . . . transmission . . . [is] not currently known.” By contrast, the court found that the mandate will have a “crippling effect” on healthcare facilities.[11]

Although the court’s order is limited in geographic scope, it remains to be seen whether the decision will have a broader impact in litigation in other jurisdictions relating to the CMS rule and other, similar federal rules. For example, a federal court in Florida denied Florida’s request to enjoin the CMS rule and reached conclusions quite different than those reached by the Missouri court.[12] Among other things, the Florida court rejected the notion that healthcare facilities would be “crippled” by the CMS rule, holding that these concerns were “speculative.” The Florida court rejected employee declarations of the type relied on by the Missouri court, holding that “statements regarding employees’ intent to resign are hearsay.”[13] The court also noted CMS’s contention that vaccination of healthcare facilities workers is necessary due to the “strain” of COVID-19 on the U.S. healthcare system[14]e.g., healthcare facilities may become short-staffed if their employees are unvaccinated and become infected with COVID-19 as a result. Other pending cases include a challenge to the CMS rule brought by Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma, South Carolina, Utah, and West Virginia in Louisiana federal court;[15]a challenge to the CMS rule brought by Texas in Texas federal court;[16] a multi-district litigation regarding challenges to the OSHA rule consolidated before the Sixth Circuit Court of Appeals;[17]and challenges to the vaccination rules promulgated by the Safer Federal Workforce Task Force for federal contractors and federal employees pending in federal courts in Florida and D.C.[18]