The injunction is one of two issued this week by federal courts against the new regulations, which had required hospitals to meet deadlines in early December and early January.
A federal judge has halted implementation of a new rule that would require all on-site staff in hospitals and most other healthcare settings to be vaccinated against COVID-19.
Judge Terry A. Doughty of the U.S. District Court for the Western District of Louisiana issued a preliminary injunction, writing that “the government defendants do not have the authority to implement the CMS mandate.”
Before the injunction, staff needed to receive the first dose of a two-dose vaccination series by Dec. 6 and then be fully vaccinated by Jan. 4. Hospitals also needed to have procedures in place for tracking staff vaccinations and permissible medical and religious exemptions by Dec. 6.
Failure to meet those deadlines would have put hospitals at risk of being penalized by CMS auditors. Expulsion from Medicare and Medicaid is among the possible consequences described in an interim final rule.
Update: On Dec. 1, the U.S. Department of Health and Human Services appealed the injunction to the U.S. Court of Appeals for the Fifth Circuit.
Among other points, Doughty wrote that CMS should have followed standard notice-and-comment procedures before finalizing the regulations. He also said such regulations exceed CMS’s statutory authority and likely meet the definition of arbitrary and capricious as claimed by the plaintiff states.
Although implementation of the final rule is paused, the case still must proceed to formal arguments before the court. An appeal of any resulting decision is likely, with the issue potentially reaching the Supreme Court.
Doughty's injunction was in response to one of two lawsuits filed by states against the new regulations. In the other case, a Missouri federal judge blocked the mandate from taking effect in the 10 states that filed the suit.
“Because it is evident CMS significantly understates the burden that its mandate would impose on the ability of healthcare facilities to provide proper care, and thus save lives, the public has an interest in maintaining the status quo while the merits of the case are determined,” wrote Judge Matthew T. Schelp (Doughty and Schelp were nominated by former President Donald Trump).
CMS seemed to anticipate some of the plaintiffs' arguments when it wrote the regulations, stating that the Administrative Procedure Act authorizes agencies to waive the usual procedures for proposed rulemaking in the event of “good cause that notice-and-comment procedures are impracticable, unnecessary or contrary to the public interest.” The interim final rule also states that “vaccine uptake among healthcare staff has not been as robust as hoped for and [has] been insufficient to protect the health and safety of individuals receiving healthcare services from Medicare- and Medicaid-certified providers and suppliers, particularly given the advent of the delta variant and the potential for new variants.”
Private-sector and state actions
Some of the nation’s largest health systems already were requiring staff to be vaccinated before the federal regulations were drafted. Examples include Advocate Aurora Health, Ascension Health, Atrium Health, Banner Health, CommonSpirit Health, Kaiser Permanente, Mass General Brigham, Mayo Clinic, Providence, Sutter Health and Trinity Health.
In addition, a handful of states have issued mandates for healthcare employees (among other workers), although some included an option to undergo regular testing in lieu of vaccination. Among those that have issued such regulations during the second half of 2021, according to the labor and employment law firm Littler, are California, Colorado, Illinois, Maine, Maryland, Massachusetts, New Jersey, New Mexico, New York, Oregon, Rhode Island and Washington.