On November 30, 2021, the Western District of Louisiana entered an order prohibiting the U.S. Department of Health and Human Services and Centers for Medicare and Medicaid Services ("CMS") from implementing and enforcing the CMS COVID-19 Health Care Staff Vaccination Interim Final Rule ("Final Rule") that was issued on November 5, 2021. This preliminary injunction applies nationwide, with the exception of Alaska, Arkansas, Iowa, Kansas, Missouri, New Hampshire, Nebraska, Wyoming, North Dakota, and South Dakota, because these states were already under a preliminary injunction order dated November 29, 2021, from the Eastern District of Missouri.

The Louisiana order comes just a few days before December 5, 2021, the date covered providers were required to comply with Phase 1 of the Final Rule. With the vaccine mandate enjoined, healthcare providers must now comply with applicable state laws regarding COVID-19 vaccination. The preliminary injunction will remain in effect until either the Western District of Louisiana, United States Court of Appeals for the Fifth Circuit, or United States Supreme Court resolve the matter or enter a supplemental order.  The Missouri court’s order is already being challenged on appeal.  CMS has filed a notice of appeal with the Eighth Circuit Court of Appeals.  A briefing schedule, in that case, shows that a decision on whether the preliminary injunction was proper could be issued as late as March 2022.

What is a preliminary injunction?

A preliminary injunction is not a final ruling on the merits.  It means that the court found that the parties challenging the Final Rule presented sufficient evidence that they would be successful in challenging the authority of CMS to issue the Final Rule.  CMS has the right to appeal the determination by the federal court.  Any appeal of the Louisiana order would be heard by the Fifth Circuit Court of Appeals.  The losing party at that stage of the litigation could then appeal to the United States Supreme Court.  How quickly this would happen is uncertain.

What should you do?

Because this is only a temporary hold on the Final Rule that is likely to be challenged, those facilities covered by the mandate should continue to finalize policies and procedures required by the Final Rule.  However, until the preliminary injunction is lifted, facilities are not required to ensure employees are vaccinated prior to providing services for the facility.  Those facilities that are required to report vaccination status through NHSN should continue to do so.

Providers should also be aware of any potential state laws that may now apply.  Because the CMS Final Rule preempted any state law, many providers may not have anticipated compliance with those laws.