In the course of 24 hours, two federal district courts, one in Missouri and one in Louisiana, issued preliminary injunctions that prevent the Centers for Medicare and Medicaid Services (CMS) from implementing and enforcing its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (IFR) applicable to certain Medicare and Medicaid-certified providers and suppliers. The collective effect of these decisions is to temporarily enjoin the IFR on a nationwide basis, pending appeals to the Sixth and Eighth Circuit Courts of Appeal, which could be consolidated much like the litigation involving the OSHA Emergency Temporary Standard (ETS) vaccination/testing mandate that was stayed by the Fifth Circuit Court of Appeals.
On November 29, 2021, Judge Matthew Schelp of the U.S. District Court for the Eastern District of Missouri issued a preliminary injunction against the IFR effective in 10 states.1 More specifically, Judge Schelp enjoined the IFR with respect to providers and suppliers affected by the mandate in Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming. Just as providers and suppliers were digesting the implications of the limited nature of this injunction, Judge Terry Doughty of the U.S. District Court for the Western District of Louisiana issued a preliminary injunction on November 30, 2021, that applies to all states other than the 10 states insulated by the Eastern District of Missouri’s preliminary injunction.2
Both judges concluded that the IFR likely exceeds the authority delegated by Congress to the Secretary of the U.S. Department of Health and Human Services and, by extension, to CMS. As a result, they determined that a preliminary injunction was necessary to preserve the status quo pending further appeals or until the cases can be heard on their merits.
The IFR not only mandates that employees of the 21 types of providers and suppliers covered by the rule be fully vaccinated by January 4, 2022, or be granted a medical or religious exemption, the expansive definition of “staff” subject to the mandate captures students, trainees, volunteers, licensed practitioners, and individuals providing care, treatment, or other services to the patients, and/or facilities of such providers or suppliers under contract or other arrangements. Furthermore, the IFR does not include an alternative testing option as contained in the now-stayed OSHA ETS. The IFR’s reach has had providers and suppliers scrambling to implement compliant policies and procedures since it was published in the Federal Register on November 5, 2021. More importantly, providers and suppliers have raced to notify contractors and vendors, many of whom were unaware that the mandate would apply to their employees by extension, in order to work through the numerous legal and logistical challenges presented by the broad reach of the IFR.
While the preliminary injunctions entered into this week take the initial pressure off with respect to an impending December 6, 2021, deadline for staff to receive at least the first dose of a COVID-19 vaccine or apply for an exemption, the ultimate fate of the IFR will be decided in the appellate courts. Although recent decisions have been skeptical of all forms of federal vaccine mandates, we recommend that Medicare and Medicaid certified providers and suppliers potentially covered by the IFR use the additional time provided by these injunctions to complete their preparations for compliance with the IFR in its present form and to be prepared to pivot depending on the outcome of the appellate process.
Of course, we will continue to monitor and report on these developments.
 State of Missouri v. Biden, No. 4:21-cv-01329-MTS (E.D. Mo. Nov. 29, 2021).
 State of Louisiana v. Becerra, No. 3:21-CV-03970 (W.D. La. Nov. 30, 2021).