Note: This post was updated Nov. 18 with news of a second lawsuit.
The lawsuit says CMS didn’t have a good rationale for implementing the mandate and failed to follow required procedures for handing down such regulations. In comments it made in the rule, CMS seemed to anticipate the likelihood of such an action.
Ten states have sued the Biden administration to stop implementation of regulations requiring hospitals and most other healthcare providers to ensure all staff are vaccinated as a condition of participation in Medicare and Medicaid.
The regulations are set to take effect Jan. 4, by which time virtually all staff must have received a single-dose series or both doses of a two-dose series.
The 10 states filed suit in federal district court in Missouri, seeking to have the court “preliminarily and permanently” enjoin the rule.
The plaintiffs described the rule as “an unprecedented federal vaccine mandate” that threatens the job status of “millions of healthcare workers” and would “exacerbate an alarming shortage” of workers in the industry. They said any such government mandate should be under the jurisdiction of individual states.
The states cited the Administrative Procedure Act (APA), a 1946 law that establishes the process by which federal agencies set regulations. The new rule violates the APA by constituting an “arbitrary and capricious action” by CMS in response to the pandemic and amounting to an overreach of the agency’s authority, according to the suit. The plaintiffs also cite the lack of notice of proposed rulemaking as required by the APA.
Update: On Nov. 15, 12 states filed a separate lawsuit in Louisiana against the vaccine mandate. The states made similar arguments to those in the earlier filing, including that the mandate threatens the supply of healthcare workers and is unconstitutional. They called out the risk that could be posed to care access, saying the mandate would result in the termination of "millions" of staff.
The administration’s argument
The regulations state that the APA 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 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.”
CMS also said it has authority to override any state regulations that would prevent a vaccine mandate from being implemented.
“The bottom line is that this regulation preempts state law and/or state-issued executive orders under the Supremacy Clause of the United States Constitution,” Lee Fleisher, MD, chief medical officer with CMS and director of the agency's Center for Clinical Standards & Quality, said during a Nov. 4 stakeholder call.
The rule states, “Given the emergency situation with respect to the delta variant … time did not permit usual consultation procedures with the States, and such consultation would therefore be impracticable.”
One issue in the lawsuit will be whether CMS had a valid reason from a public-health standpoint to impose a mandate. In the rule, the agency spent a number of pages explaining its decision.
It said it “has considered other alternatives (for example, relying entirely on measures such as voluntary vaccination, source control alone and social distancing) and has concluded that the mandate established by this rule is the minimum regulatory action necessary to achieve the objectives of the [Medicare] statute. Given the contagion rates of the existing strains of coronavirus and their disproportionate impacts on Medicare and Medicaid beneficiaries, we believe that vaccination of almost all staff of covered providers and suppliers is necessary to promote and protect patient health and safety.”
What provider advocates think
The American Hospital Association (AHA), which has expressed support for hospitals that choose to mandate vaccination of staff, seemed to back the new rule when it was issued.
“Today’s vaccine-mandate regulations set clear expectations and streamline and simplify compliance requirements for healthcare providers,” Rick Pollack, AHA president and CEO, said Nov. 4 in a written statement.
America’s Essential Hospitals also voiced support for the mandate while acknowledging that implementation could have deleterious effects on the workforce. The rule “aligns with our commitment to vaccination as the best way to protect patients and keep caregivers safe,” President and CEO Bruce Siegel said in a written statement. “We appreciate the phased approach to compliance, and we ask the agency to release interpretive guidance as soon as possible to help providers comply with the new vaccine requirements. The pandemic continues to place immense pressure on staffing at our member hospitals, and we must guard against unintended consequences that make matters worse.”
Many of the plaintiff states in the lawsuit also were parties to a recently filed suit seeking to stop implementation of a companion rule by the Occupational Safety and Health Administration (OSHA) that requires any business with more than 100 employees to mandate either vaccination or weekly testing for all staff. A federal appeals court in Louisiana on Nov. 12 ordered the administration to stop implementation of that policy, saying it exceeds OSHA's statutory authority and is potentially unconstitutional.
The American Medical Association filed an amicus brief in that case in which it wrote, “The AMA’s extensive review of the medical literature demonstrates that COVID-19 vaccines authorized or approved by FDA are safe and effective, and the widespread use of those vaccines is the best way to keep COVID-19 from spreading within workplaces. A stay of OSHA’s Emergency Temporary Standards would therefore severely and irreparably harm the public interest.”