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U.S. District Court Enters Nationwide Halt of CMS Vaccine Mandate

By Sean D. Hurley

On November 30, 2021, U.S. District Judge Terry Doughty of the U.S. District Court for the Western District of Louisiana granted a nationwide preliminary injunction enjoining the U.S. Department of Health and Human Services and the Center for Medicare and Medicaid Services (“CMS”) from implementing the vaccine mandate issued by CMS earlier this month. That mandate requires employees of Medicare and Medicaid certified healthcare facilities to have received the first dose of the COVID-19 vaccine by December 6, 2021, and the second dose by January 4, 2022.  Judge Doughty’s order was entered in a lawsuit filed by a coalition of 14 states challenging the CMS vaccine mandate.

In reaching its decision, the Court found that the Plaintiff states were likely to succeed on the merits of their claim. To that end, the Court noted that CMS would be unable to demonstrate why it should be excused in this instance from not following the traditional notice and comment procedure of administrative rulemaking, noting that “[i]t took CMS longer to prepare the interim final rule without notice than it would have taken to comply with the notice and comment requirement.” The Court also found that “mandating a vaccine to 10.3 million healthcare workers is something that should be done by Congress, not a government agency,” while noting further that “[i]t is not clear that even an Act of Congress mandating a vaccine would be constitutional.” According to the Court’s interpretation, in issuing its vaccine mandate, CMS failed to comply with various provisions of the Social Security Act by failing to consult with appropriate state agencies prior to issuing the mandate and failing to conduct a regulatory impact analysis.

The Court also concluded that the Plaintiffs states were likely to succeed in their claim that CMS acted arbitrarily and capriciously in issuing its vaccine mandate. Plaintiffs argued that the CMS mandate will have the effect of harming patient well-being due to staff shortages of healthcare providers. In support of that argument, Plaintiffs provided declarations of individuals verifying healthcare worker shortages, that a significant number of healthcare workers remain unvaccinated, and that “harm will be caused to these facilities in the event that even a few of the unvaccinated healthcare workers quit or are fired” as a result of the vaccine mandate. The Plaintiffs also provided a declaration showing the increased enforcement costs that would result if required to survey and enforce the mandate.

The Court found compelling Plaintiffs’ arguments that CMS failed to consider or arbitrarily rejected “obvious alternatives” to the mandate, including daily or weekly testing, wearing masks or shields, natural immunity and/or social distancing. The Court also commented that rejection of natural immunity as an alternative, specifically, to be “puzzling,” finding that CMS failed to provide any evidence upon which it relied in rejecting that alternative. The Court appeared to doubt the efficacy of the COVID-19 vaccines, altogether, or, at a minimum, questioned mandating a vaccine of limited effectiveness, stating: “If boosters are needed six months after being ‘fully vaccinated,’ then how good are the COVID-19 vaccines, and why is it necessary to mandate them?”

In addition to finding that the Plaintiffs were likely to succeed on the merits of their claims, the Court also found that, if it did not enjoin implementation of the CMS vaccine mandate, the Plaintiff states “will suffer irreparable injury by not being able to enforce their laws which have been preempted by the CMS Mandate, by incurring the increased cost of training and of enforcing the CMS Mandate, and by having their police power encroached.” The Court determined that the balance of equities and the public interest favors the issuance of a preliminary injunction.

In justifying the scope of the injunction, the Court stated that a nationwide injunction was necessary due to the need for uniformity. Therefore, the scope of the injunction applies nationwide, except for the states of Alaska, Arkansas, Iowa, Kansas, Missouri, New Hampshire, Nebraska, Wyoming, North Dakota, and South Dakota, since those ten states are already under a preliminary injunction order dated November 29, 2021, issued by the Eastern District of Missouri in a separate lawsuit challenging the CMS vaccine mandate. While this preliminary injunction remains in effect for the time being, the Court conceded that “[t]his matter will ultimately be decided by a higher court than this one.”

Meanwhile, the U.S. District Court for the Eastern District of Missouri employed similar rationale in issuing its own preliminary injunction that applies in the ten states excluded from Judge Doughty’s ruling. That Court found that “Congress has not provided CMS the authority to enact the regulation at issue here.” The Missouri Court also similarly found that CMS improperly bypassed the notice and comment procedure in issuing the vaccine mandate, noting that CMS’s delay in requiring mandatory vaccinations undermines it contention that COVID-19 is an emergency that provides CMS with “good cause” to dispense with notice and comment requirements. The Missouri Court further noted that “[o]ne could query how an ‘emergency’ could prompt such a slow response; such delay hardly suggests a situation so dire that CMS may dispense with notice and comment requirements and the important purposes they serve.”

The Missouri Court also concluded that the vaccine mandate is arbitrary and capricious, as “CMS lacks evidence showing that vaccination status has a direct impact on spreading COVID in the mandate’s covered healthcare facilities.” Similar to Judge Doughty, the Missouri Court also found that CMS failed to consider or rejected obvious alternatives to a vaccine mandate, without evidence. The Missouri Court was persuaded that the vaccine mandate is arbitrarily broad in scope, noting that the mandate applies to facilities’ staff equally, regardless of patient contact. The Court also found that CMS failed to properly consider all necessary reliance interests, looking only at evidence from interested parties in favor of the mandate while ignoring evidence from parties opposing the mandate, which the Court equated to placing “a rock on one side of the scale and a feather on the other.” The Plaintiffs in the Missouri case also presented evidence demonstrating that the mandate will “exacerbate the already-existing staffing problem,” with the Court finding that staff reductions caused by the mandate would case “a cascade of consequences.” The Missouri Court also noted that the mandate would cause economic losses in the Plaintiffs’ states that would be unrecoverable and irreparable.

It is expected that CMS will act quickly in appealing these preliminary injunctions to the U.S. Courts of Appeals for the Fifth and Eighth Circuits, respectively. In the meantime, should you have questions, please contact Michael A. Airdo at 312-506-4480 or [email protected] or Sean Hurley at 312-506-4455 or [email protected].