Deciding body (English)
Type of body
Type of Court (material scope)
Type of jurisdiction
Type of Court (territorial scope)
Further areas addressed
- Privacy and data protection
- Healthcare management (Covid related, excluding vaccination)
- Scope of powers of public authorities (legislative, executive etc.)
- Multilevel government and allocation of powers
Outcome of the decision
The case addressed a conflict between federal and state legislation on vaccination mandates, specifically Montana Code Ann. § 49-2-312(3) and the Centers for Medicare and Medicaid Services (CMS) interim final rule "Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination." The state legislation made it "an unlawful discriminatory practice" for any person, governmental entities, or public accommodation to deny benefits or services or condition such benefits or services "based on a person's vaccination status or whether the person has an immunity passport” while the federal rule required " most Medicare and Medicaid-certified providers and suppliers to ensure that their staff are fully vaccinated for COVID-19."
The Plaintiff sought injunction relief that would enjoin the state legislation, making it possible to assess the vaccination status of the staff and therefore be eligible for CMS financial support. Defendants argued the CMS interim final rule was invalid and Montana legislation had been tailored to protect citizens’ privacy. The Court reasoned that the requirements for injunctive relief were present in the case and partially granted the preliminary injunction.
Facts of the case
In early 2021, the Montana Legislature passed Montana House Bill 702 which made it "an unlawful discriminatory practice" for any person, governmental entities, or public accommodation to deny benefits or services or condition such benefits or services "based on a person's vaccination status or whether the person has an immunity passport." The statute specifically exempted schools from its requirements, and permitted "health care facility[ies], as defined in 50-5-101" to ask an employee or volunteer for their vaccination status, but the employee or volunteer need not answer such inquiry. A non-answer to a vaccine inquiry may be treated as an indication that an employee or volunteer is not vaccinated, and that indication may inform an employer's decision to implement reasonable accommodations.
In November 2021, the CMS issued an interim final rule entitled "Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination." The Interim Final Rule required " most Medicare and Medicaid-certified providers and suppliers to ensure that their staff are fully vaccinated for COVID-19" and noted that employers must comply with federal anti-discrimination and civil rights protections and must "provide appropriate accommodations, to the extent required by Federal law, for employees who request and receive exemption from vaccination because of a disability, medical condition, or sincerely held religious belief, practice, or observance." Two groups of states challenged the Interim Final Rule, and district courts in Louisiana and Missouri enjoined it. The Fifth and Eighth Circuits denied the government's request for a stay of the preliminary injunction, and the government successfully appealed the denial of the stay to the Supreme Court. The Supreme Court determined that the Secretary of Health and Human Services did not exceed its authority in promulgating the Interim Final Rule and determined that the Secretary issued the Interim Final Rule based on his "determin[ation] that a COVID-19 vaccine mandate will substantially reduce the likelihood that healthcare workers will contract the virus and transmit it to their patients." The Court also cited "conditions of participation" that were routinely imposed on healthcare workers. The Court noted that "[v]accination requirements are a common feature of the provision of healthcare in America: Healthcare workers are ordinarily required to be vaccinated for diseases such as hepatitis B, influenza, and measles, mumps, or rubella."
Subsequently, on January 14, 2022, CMS issued a memorandum titled "Guidance for the Interim Final Rule." The initial page of the memorandum explicitly stated that the "guidance in th[e] memorandum specifically applies" to a number of states, including Montana. The Guidance established benchmarks for compliance on 30-day, 60-day, and 90-day intervals. It also stated the penalties for non-compliance. Given that the Guidance was issued on January 14, 2022, the 30-day deadline for compliance was February 13, 2022. To be in compliance with the 30-day benchmark, facilities were to demonstrate two things: (1) that policies and procedures were in place "for ensuring all facility staff, regardless of clinical responsibility or patient or resident contact are vaccinated for COVID-19" and (2) that "100% of staff have received at least one dose of COVID-19 vaccine, or have a pending request for, or have been granted qualifying exemption, or identified as having a temporary delay as recommended by the CDC." If either the first or second requirement were not met, the facility would not be in compliance with the Interim Final Rule. If a facility failed to meet the 30-day benchmark—or the 60 or 90-day benchmarks—the facility was subject to "enforcement actions" that included "plans of correction, civil monetary penalties, denial of payment, [or] termination" depending on the extent of the violation and the type of facility. In the week after the Guidance was issued, surveys were conducted on seven facilities in Montana: six long-term care facilities and one home health agency. Five of these facilities were found to be compliant with the Interim Final Rule, while two of the facilities were noncompliant with respect to vaccination deficiencies.
The language of the Interim Final Rule makes it impossible for a private party to comply with both the Montana and federal requirements. For example, to comply with the Interim Final Rule, facilities must demonstrate that all staff have received a vaccine for COVID-19 or have applied for or received a qualifying exemption. On the other hand, Montana legislation prohibits health care facilities from meaningfully inquiring into the vaccination status of their employees. While the statute permits health care facilities to "ask an employee to volunteer the employee's vaccination or immunization status for the purpose of determining whether the health care facility should implement reasonable accommodation measures," it does not require that the employee respond. Consequently, even though the statute permits health care facilities to consider an employee's refusal to answer about his or her vaccination status as an indication that the employee is unvaccinated, that "consideration" is not a suitable substitute for the data required for a health care facility to prove compliance with the Interim Final Rule. Without such quantifiable data it will be nearly impossible for facilities to demonstrate compliance during the unannounced surveys that investigate the facilities' records and interview staff.
Type of measure challenged
- Local government measure
- National government measure
Measures, actions, remedies claimed
Individual / collective enforcement
Nature of the parties
Type of procedure
Reasoning of the deciding body
The Court reasoned that to succeed on a motion for a preliminary injunction, a plaintiff "must establish that he is likely to succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in his favor, and that an injunction is in the public interest."
Regarding the likelihood to succeed on the merits, the Court stated that because of the doctrine of federal preemption, the Plaintiff was likely to succeed. It also reasoned that the Plaintiff demonstrated that irreparable harm was likely to occur absent injunctive relief. Under the Guidance for compliance with the Interim Final Rule, health care facilities that failed to demonstrate compliance with the rule - in other words, facilities that failed to meet the 30-day, 60-day and 90-day deadlines for proving the staff had been vaccinated - may be subject to "enforcement action," such as civil monetary penalties. The harm of non-compliance was also likely to be irreparable, such as risk of termination from the Centers for Medicare and Medicaid Services - CMS program , which meant they would stop receiving financial assistance from the Federal Government.
Furthermore, the Court argued that "it would not be equitable or in the public's interest to allow the state to violate the requirements of federal law, especially when there are no adequate remedies available." The Court reasoned that the regulation of the State of Montana which prohibited discrimination based on vaccination status (Montana House Bill 702) should not prevail over federal law which required health facilities to prove that staff had been vaccinated (Interim Final Rule). It also reasoned that given that the police power of the State should operate to "protect the public health and public safety" and also submit to federal law in the event of a conflict. Finally, the Court reasoned that the Supreme Court recognized certain restraints on an individual were occasionally reasonable to promote the common good and actualize the public interest in a civil society. The Supreme Court in the Biden case * also noted that the Interim Final Rule was implemented because it was "necessary to promote and protect patient health and safety in the face of the ongoing pandemic" and that the "clear and manifest purpose" of the Interim Final Rule was public health. As for the scope of the injunction, the Court stated that Defendants were correct that it should be narrow in duration and substance, so the State of Montana House Bill 702 d would only be in effect so long as the Interim Final Rule remained in effect.
*JOSEPH R. BIDEN, Jr., PRESIDENT OF THE UNITED STATES, et al., APPLICANTS 21A240 v. MISSOURI, et al. XAVIER BECERRA, SECRETARY OF HEALTH AND HUMAN SERVICES, et al., APPLICANTS 21A241 v. LOUISIANA, et al.
Conclusions of the deciding body
The Court concluded that the Plaintiff was likely to succeed, had demonstrated that it was likely to suffer irreparable harm in the absence of preliminary relief, and that the balance of the equities and the public interest both inure to the Plaintiff. The preliminary injunction was granted, though, it was limited in application to the law set forth in § 49-2-312, and would only be in place so long as the Interim Final Rule remained in effect. In other words, the injunction was granted only in reference to health facilities, thus making it possible for the administration to assess the vaccination status of its workers. The decision did not invalidate the whole content of the State Of Montana House Bill 702, which prohibited discrimination regarding vaccination status.
Fundamental Right(s) involved
- Right to health (inc. right to vaccination, right to access to reproductive health)
- Right to privacy
Rights and freedoms specifically identified as (possibly) conflicting with the right to health
Balancing techniques and principles (proportionality, reasonableness, others)
The Court did not use balancing techniques, but based the decision on procedural law and case law.