Circuits Split on CMS Vaccine Mandate, Highlighting “Great Significance” of Issue as It Heads to Supreme Court

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Three circuit court decisions issued in the past two weeks have considered the CMS vaccine mandate, bringing the issue – and similar vaccine mandate lawsuits – to the Supreme Court in the final weeks of the year. The CMS mandate generally requires that facilities certified to participate in Medicare or Medicaid ensure their staff are fully vaccinated against COVID unless the employee is exempt for medical or religious reasons. CMS issued the vaccine mandate on November 5, 2021. It went into effect immediately, with staff to be fully vaccinated by January 4, 2022.

On Monday, December 6, the Eleventh Circuit issued an opinion denying a motion filed by the State of Florida seeking an injunction pending an appeal to stay the CMS vaccine mandate. The Eleventh Circuit held that the mandate was likely authorized by Medicare and Medicaid statutes, that CMS had good cause to bypass notice and comment rules before issuing the mandate, and that Florida had failed to show the mandate was capricious and arbitrary.

  • The mandate was likely authorized by Medicare and Medicaid statutes, including 42 U.S.C. §§ 1395d(a) and 1395x(e)(9). For example, the Medicare statutes authorize payments to be made for “hospital services” and the statutory definition of “hospital” includes that an institution must meet any “requirements that the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services in the institutions.” By requiring healthcare workers to be vaccinated against a transmissible and highly deadly disease, the Secretary was imposing a “requirement” that was “necessary in the interest of the health and safety” of the patients who obtain services at federally funded Medicare and Medicaid facilities.
  • CMS had good cause to bypass notice and comment rules before issuing the mandate, which can be done “when [an] agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. § 553(b). The Secretary explained why there was good cause for dispensing with the notice and comment requirement in this instance, including the urgency presented by the ongoing pandemic, outbreaks associated with variants, and the oncoming influenza season. The Secretary also noted that delay “would endanger the health and safety of additional patients and be contrary to the public interest.”
  • Florida failed to show the rule was arbitrary and capricious. A rule is arbitrary and capricious if the factors the agency relied on are not what Congress would intend, if the agency failed to consider an important aspect of the problem, if the agency offers an explanation counter to the evidence, or if the action is so implausible it could not be ascribed to a difference in view or the product of the agency’s expertise. There was ample evidence supporting the Secretary’s determination that facility staff vaccinations would provide important protection for patients.

On Monday, December 13, the Eighth Circuit, in a one-page order, denied the federal government’s request to lift a Missouri district court’s preliminary injunction that had blocked the vaccine mandate in ten states – Missouri, Alaska, Arkansas, Iowa, Kansas, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming.  In granting the injunction, the Eastern District of Missouri held that the CMS mandate was beyond the scope of the congressionally delegated authority issued to CMS, that it improperly bypassed the notice and comment requirements, and that it was arbitrary and capricious, including because the rule came months after vaccines had become readily available.

On Wednesday, December 15, the Fifth Circuit upheld a Louisiana district court’s preliminary injunction as it relates to the 14 states named as plaintiffs in the case – Louisiana, Alabama, Arizona, Georgia, Idaho, Indiana, Kentucky, Mississippi, Montana, Ohio, Oklahoma, South Carolina, Utah, and West Virginia.  The Western District of Louisiana also held that the CMS mandate was beyond the scope of the agency’s authority, that it bypassed the notice and comment requirements, and that it was arbitrary and capricious.  Unlike the injunction issued in Missouri, however, the Louisiana injunction applied nationwide to all states other than those covered by the Missouri injunction.  This portion of the injunction was rejected by the Fifth Circuit, thereby limiting the injunction to the 14 named states.  In doing so, the Fifth Circuit concluded that the “vaccine rule is an issue of great significance currently being litigated throughout the country.”

On Thursday, December 16, the federal government asked the U.S. Supreme Court to stay the preliminary injunctions issued by the Louisiana and Missouri district courts. The Court set a deadline of December 30 at 4 p.m. for the challenger-states to submit briefs. This deadline applies both to challenges to the CMS vaccine mandate as well as challenges to the U.S. Occupational Safety and Health Administration (OSHA) vaccine mandates for workers at companies with 100 or more employees.

In the meantime, the CMS mandate remains enjoined in 25 states and not enjoined in the remaining 25 states. In that the mandate requires vaccinations by January 4, 2022, mere days after the deadline for briefing before the Supreme Court, the question of enforcement in the states in which it is in effect is unclear.  Faegre Drinker will continue to closely monitor all legal developments in this area.

About the Author: Mary E. Hershewe

Mary Hershewe is a Products Liability Associate residing in our Denver, Colorado, office. Mary works on state, federal and multidistrict litigations with a focus on products liability, consumer protection, commercial, and health and sciences litigation. She also specializes in defending major pharmaceutical and medical device companies against claims involving allegations of strict liability, negligence, failure-to-warn or consumer protection act violations.

About the Author: Melissa A. Merk

Melissa Merk represents pharmaceutical and medical device companies in complex civil litigation, with an emphasis on product liability defense. She has significant trial experience, including conducting examinations at trial, preparing company and expert witnesses for trial testimony, and participating in more than a dozen jury trials involving pharmaceutical products in state courts across the country.