HB 702 VACCINATION RESTRICTIONS: Enforcement of MCA 49-2-312 as it relates to COVID-19 vaccine against Montana healthcare facilities preliminarily enjoined for so long as CMS’s Interim Final Rule remains in effect… Molloy.
The 2021 Montana Legislature passed HB 702 which is codified at MCA 49-2-312 & 313. §312(1) makes it “an unlawful discriminatory practice” for any person, governmental entity, or public accommodation to deny benefits or services or condition such benefits or services “based on the person’s vaccination status or whether the person has an immunity passport.” (Timing suggests it is meant to address COVID-19 vaccination mandates or concerns but “vaccine” has a broader meaning: “a preparation that is used to stimulate the body’s immune response against diseases. Vaccines are usually administered through needle injections, but some can be administered by mouth or sprayed into the nose.” CDC Definition of Terms.) An “immunity passport” is “a document, digital record, or software application indicating that a person is immune to a disease, either through vaccination or infection and recovery,” while “‘vaccination status’ means an indication of whether a person has received one or more doses of a vaccine.” §312(5). The statute exempts schools and permits “health care facilities, 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. §312(2), (3). A “health care facility” “does not include offices of private physicians, dentists, or other physical or mental health care workers regulated under Title 37, including licensed addiction counselors.” §50-5-101(26). 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. §312(3). §312(4) prohibits private employers and others from imposing the requirement of an vaccine that is authorized under an “emergency use” designation.
The Exempted Facilities are included in §313. They are “exempt from compliance with 49-2-312 during any period of time that compliance with 49-2-312 would result in a violation of regulations or guidance issued by the centers for medicare and medicaid services or the centers for disease control and prevention.”
The Centers for Medicare & Medicaid Services (CMS) is responsible for establishing health & safety standards with which healthcare facilities must comply in order to receive Medicare and Medicaid funding. In 11/21 CMS issued an Interim Final Rule (IFR) which “requires most Medicare- and Medicaid-certified providers and suppliers to ensure that their staff are fully vaccination for COVID-19.” 86 Fed. Reg. 61,568. (The IFR “directly applies only to the Medicare- and Medicaid-certified providers and suppliers [identified in the Rule]. It does not directly apply to other health care entities, such as physician offices, that are not regulated by CMS.”) The IFR notes that employers must comply with federal anti-discrimination and civil rights protections and “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.” 2 groups of states including Montana challenged the IFR and courts in Louisiana and Missouri enjoined it. Biden v. Missouri (US 2022 per curiam). The 5th and 8th Circuits denied the US’ request for a stay of the preliminary injunction and the US successfully appealed the denial.
The Supreme Court determined that the Secretary of HHS did not exceed his authority in promulgating the IFR and that he issued it based on his “determination that a COVID-19 vaccine mandate will substantially reduce the likelihood that healthcare workers will contract the virus and transmit it to their patients.” It noted that “vaccination 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.”
CMS issued a “Guidance for the Interim Final Rule” 1/14/22 stating that it “specifically applies” to a number of states including Montana. It establishes benchmarks for compliance on 30-day, 60-day, and 90-day intervals with penalties for non-compliance. The 30-day deadline for compliance was 2/3/22. To be in compliance with the 30-day benchmark, facilities must demonstrate that policies & procedures are in place “for ensuring all facility staff, regardless of clinical responsibility or patient or resident contact are vaccinated for COVID-19” and 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 1st or 2nd requirement is not met the facility is not in compliance with the IFR. If a facility fails to meet the 30-day benchmark — or the 60- or 90-day benchmarks — it is subject to “enforcement actions” that include “plans of correction, civil monetary penalties, denial of payment, or termination.”
In the week after the Guidance issued surveys were conducted on 6 long-term care facilities and a home health agency. 5 were compliant with the IFR and 2 were noncompliant as to vaccination deficiencies.
Private physician offices, the MMA, and individuals sued the Montana AG and Commissioner of Labor. The Montana Nurses Association appeared as a Plaintiff-Intervenor. Plaintiffs seek to preliminarily enjoin enforcement of the statute. A motion hearing and argument occurred 3/3/22.
It is unclear whether Plaintiffs want to enjoin §313 in addition to §312. In any event, §313 is not enjoined because it is not preempted by CMS’s 11/21 IFR which “requires most Medicare- and Medicaid-certified providers and suppliers to ensure that their staff are fully vaccinated for COVID-19.” The plain text of §313 exempts compliance with §312 when such compliance would contradict “regulations or guidance issued by the centers for medicare and medicaid services or the centers for disease control and prevention.”
Nor can §313 be enjoined at this point on the basis that Plaintiffs are likely to succeed on the merits of their equal protection claim. They did not make any arguments as to those claims as they related to the preliminary injunction factors or irreparable harm and the public interest, and they made only passing reference to them as they relate to the balance of the equities. To the extent that they seek an injunction of §49-2-313, that request is denied.
In addressing §49-2-312 the threshold question is whether the preliminary injunction standard or more onerous permanent injunction standard applies. The former standard governs.
A preliminary injunction requires that a plaintiff “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.” Winter (US 2008). “To be entitled to a permanent injunction, a plaintiff must demonstrate: (1) actual success on the merits; (2) that it has suffered an irreparable injury; (3) that remedies at law are inadequate; (4) that the balance of hardships justify a remedy in equity; and (5) that the public interest would not be disserved by a permanent injunction.” Edmo (9th Cir. 2019). The Edmo standard is applicable when the court “advances the trial on the merits and consolidates it with the hearing” on a motion for preliminary injunction. Rule 65(a)(2). Where consolidation is considered “the court should provide the parties with clear and unambiguous notice of the intended consolidation either before the hearing commences or at a time which will afford the parties a full opportunity to present their respective cases.” ALPA (9th Cir. 1990). Rule 65(a)(2) makes clear that any consolidation may occur “before or after beginning the hearing on a motion for a preliminary injunction.”
After the Court issued notice that it was considering consolidation, Plaintiffs argued at the 3/3 hearing that consolidating the preliminary injunction hearing with a trial on the merits of Count VIII was appropriate. Count VIII alleges that §49-2-312 is preempted by 42 CFR Part 482 of which the IFR is part, so that §312 is invalid and unenforceable as a consequence of the Supremacy Clause. Defendants restated their objection to proceeding on the merits based in large part on timing. While the Court indicated that it was considering consolidation the day before the hearing was entirely permissible under Rule 65(a)(2), following argument and after reviewing the limited record, consolidation on the merits is not warranted. Accordingly, the preliminary injunction standard based on the familiar Winter factors applies.
Under the Winter evaluation each factor tips in Plaintiffs’ favor. Because of federal preemption they are likely to succeed on the merits of Count VIII. They also demonstrate that they are likely to suffer irreparable harm absent preliminary relief. The balance of equities and public interest both inure to Plaintiffs. As to the scope of the injunction, Defendants are correct that it should be narrow in duration and substance, so §49-2-312 is enjoined only so long as the IFR remains in effect.
Plaintiffs allege multiple preemption claims but the only one relevant is Count VIII: that §49-2-312 is preempted by the IFR. The language of the rule makes it likely that Plaintiffs will succeed in showing that it is “impossible for a private party to comply with both [the Montana] and federal requirements.” English (US 1990). For example, the Guidance requires that facilities demonstrate that all staff have received a vaccine for COVID-19 or applied for or received a qualifying exemption, while §49-2-312(3) prohibits healthcare facilities from meaningfully inquiring into the vaccination status of their employees. While the statute permits 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. §49-2-312(3)(b)(i). Basically, no meaningful answer is required. Consequently, even though the statute permits facilities to consider a 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 facility to prove compliance with the IFR. Without such data it will be nearly impossible for facilities to demonstrate compliance during the unannounced surveys that investigate records and interview staff.
Moreover, the Supreme Court in the recent Biden case noted that the IFR was implemented because it was “necessary to promote and protect patient health and safety in the face of the ongoing pandemic.” The “clear and manifest purpose” of the IFR is public health. By contrast, Defendants previously emphasized at the motion to dismiss stage an argument that Montana’s statutory scheme was enacted to promote one’s right to privacy, placing the individual’s interest on a pedestal of importance exceeding public healthy & safety in a pandemic. While those purposes are not inherently irreconcilable, the current codification of the State’s attempt to elevate individual privacy rights above all other rights is likely to be superseded by the clear purpose evinced in the IFR. Ultimately, given the clear preemption language in the Guidance, Plaintiffs have demonstrated they are likely to succeed on the merits of Count VIII as it relates to §49-2-312.
Plaintiffs must establish that the prospect of irreparable harm is not merely possible but that it is “likely.” Winter. Monetary injury alone is not usually considered “irreparable” in the context of an injunction. LAMCC (9th Cir. 1980). A significant concern is whether the moving party has an adequate remedy at law. Morales (US 1992). “When enforcement actions are imminent — and at least when repetitive penalties attach to continuing or repeated violations and the moving party lacks the realistic option of violating the law once and raising its federal defenses — there is no adequate remedy at law.” Id. A constitutional violation alone can suffice to show irreparable harm, as can the loss of business goodwill and reputation. American Trucking Ass’n (9th Cir. 2009).
The American Trucking Association challenged mandatory “Concession Agreements” implemented by California on the basis that they attempted to regulate “the price, route, or service of any motor carrier” in violation of the Federal Aviation Administration Authorization Act. It sought to preliminarily enjoin the agreements, which the Court denied largely based on its finding that they failed to establish irreparable harm. The 9th Circuit reversed on the basis that “a very real penalty attaches to the motor carriers regardless of how they proceed. That is an imminent harm.” The Court emphasized that the plaintiff could refuse to sign “the likely unconstitutional Concession Agreements” and likely face a loss of business goodwill, or it could sign the agreements, in which case “its plight is not much better” because it “will have been forced to sign an agreement to conditions which are likely unconstitutional because they are preempted” and “will be forced to incur such large costs which, if it manages to survive those, will disrupt and change the whole nature of its business in ways that most likely cannot be compensated with damages alone.” The 9th Circuit essentially determined that “motor carriers should not be required to adhere to the various unconstitutional provisions in the agreements, and are likely to suffer irrevocably if forced to do that or give up their business.”
Plaintiffs argue that the “impossible choice” of complying with either the IFR or §49-2-312, but not both, creates irreparable harm. They argue that they will sustain additional harm absent a preliminary injunction including potential termination from Medicaid and Medicare and resulting loss of healthcare capabilities to Montanans. Defendants respond that the alleged harm is too speculative and not “irreparable.” They emphasize that if the IFR preempts §49-2-312, “the Rule acts as an affirmative defense to any action taken by the State pursuant to the statute — a defense that may be raised throughout the administrative process before subjecting Plaintiffs to liability.” (Citing Whole Woman’s Health (US 2021).) They also argue that there is no evidence that compliance with the IFR will result in irreparable harm. That argument seems to be that if charged with wrongdoing, Plaintiffs would not be liable because their preemption argument is probably well-taken.
Plaintiffs demonstrate that irreparable harm is likely absent injunctive relief. Under the Guidance’s 30-, 60-, and 90-day benchmarks for compliance with the IFR, healthcare facilities that fail to demonstrate compliance may be subject to “enforcement action” such as civil monetary penalties. While Defendants correctly note that monetary penalties do not satisfy the irreparable harm showing on their own, like the plaintiff in American Trucking, Plaintiffs face more than mere monetary penalties. Failure to comply with the IFR could result in a wide range of penalties including termination of participation in Medicaid and Medicare. The Guidance also specifically targets Montana as a state to which the IFR and Guidance benchmarks apply. That callout increases the likelihood that penalties will be enforced.
Defendants submitted a letter from Montana Health Network that describes the “difficult position” in which Montana healthcare facilities find themselves given the contradiction between §49-2-312 and the IFR. This emphasizes the Hobson’s choice Montana’s healthcare facilities find themselves facing, similar to the choice in American Trucking. On one hand, facilities can comply with 49-2-312 and violate the IFR, which requires them to “risk being decertified by the CMS program.” But if they ignore the IFR “and continue billing Medicare and Medicaid they are committing fraud against the program which could result in steep fines and jail time for some of its employees.” On the other hand, MHN avers that compliance with the IFR would naturally result in the loss of goodwill for facilities in Montana because it will effectively shutter rural facilities and “because of this, many will forego care because of the inconvenience or impossibility of travel and added costs associated with it.”
Defendants’ suggested affirmative defense argument likewise fails. First, Whole Woman’s Health is inapposite to the argument that the IFR could defeat an action before the Montana Human Rights Commission. In noting that “applicable federal constitutional defenses always stand fully available when properly asserted,” the Supreme Court presumed that the body reviewing the claim would have the power to adjudicate constitutional questions. Montana Constitution Art. II §1 states that constitutional questions must only be decided by a judicial body and so the federal preemption defense would fail if raised before the HRC. Additionally, while Defendants are correct that the mere cost of litigation is not an irreparable harm, Standard Oil (US 1980), the irreparable harm stretches beyond the “mere cost of litigation.” Unlike the plaintiffs in Standard Oil, Plaintiffs will be penalized for complying with either the IFR or §49-2-312. They cannot be forced to choose between “two roads diverging in a wood” when they face dire consequences that could make “all the difference.”
The record shows that “a very real penalty attaches to the [healthcare facilities] regardless of how they proceed. That is an imminent harm.” American Trucking. The imminence of this harm is further demonstrated by the fact that CMS compliance surveys are occurring and noncompliance is being documented. “We cannot defy the mandate by continuing to employ unvaccinated workers without punitive action being taken by the CMS.” The harm of non-compliance is also likely to be irreparable. If facilities comply with §49-2-312 they risk termination from the CMS program. And given that Plaintiffs have shown they are likely to succeed on the merits of their preemption claim, ignoring the IFR means complying with a statute that is “likely unconstitutional because it is preempted.” Id. This kind of constitutional injury shows a likelihood of irreparable harm. Plaintiffs have therefore shown that irreparable harm will result absent injunctive relief.
Where the government is the opposing party, the 3rd & 4th factors of the preliminary injunction inquiry merge, so the balance of the equities and the public interest are considered together. Nken (US 2009). Considerations for balancing the equities include whether “the impact of an injunction reaches beyond the parties, carrying with it a potential for public consequences.” Boardman (9th Cir. 2016). While “the public interest may be declared in the form of a statute,” Golden Gate Rest. Ass’n (9th Cir. 2008), “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.” Arizona Dream Coalition (9th Cir. 2014). In addition, Montana has an interest in administering its police power to “protect the public health and the public safety.” Jacobson (US 1905). But its police power is circumscribed by principles of federalism and “the mode or manner in which those results are to be accomplished is within the discretion of the state, subject to the condition that no rule prescribed by a state, nor any regulation adopted by a local governmental agency acting under the sanction of state legislation, shall contravene the Constitution of the United States.” Id. There is also a public interest in a functioning society. “Real liberty for all could not exist under the operation of a principle which recognizes the right of each individual to use his own, whether in respect of his person or his property, regardless of the injury that may be done to others.” Id.
As Defendants argue, codification of HB 702 in §§ 49-2-312 & 313 in some way expresses the public’s interest because the Legislature passed it. Golden Gate. But as Plaintiffs point out, it is inherently against the public interest to allow a state statute to violate federal law, Arizona Dream Coalition, and Plaintiffs have shown that §49-2-312 is likely a violation of federal law based on the preemption question.
Each party also emphasizes the purported consequences to public health should the adverse party’s requested relief be granted. According to Plaintiffs, the public is best served by enjoining the law because healthcare facilities would then be able to ensure that all staff are vaccinated against COVID-19 or have approved accommodation requests. According to Defendants, the public would be best served by allowing the statute to actively remain on the books, to protect Montanans from fear of losing their jobs, and protect individual choice, even in a pandemic. Given that the State’s police power should operate to “protect the public health and the public safety” and also submit to federal law in the event of conflict, the scales tip in favor of Plaintiffs’ argument concerning public health. As Jacobson recognized, certain restraints on an individual are occasionally reasonable to promote the common good and actualize the public interest in a civil society. Therefore, while there is undeniably tension between the IFR and §49-2-312, principles of federalism, including the Supremacy Clause, elevate the interests expressed in the IFR to favor Plaintiffs.
“Crafting a preliminary injunction is an exercise of discretion and judgment, often dependent as much on the equities of a given case as the substance of the legal issues it presents.” Int’l Refugee Assistance Project (US 2017). A preliminary injunction should be crafted to “meet the exigencies of the particular case.” Id. The preliminary injunction here is limited to the law set forth in §49-2-312 and will only be in place so long as the IFR remains in effect. Because all Montana facilities receiving CMS funds must comply with the IFR, enforcement of §49-2-312 is enjoined against all such facilities. The parties shall notify the Court within 10 days of any changes to or expiration of the IFR.
Montana Medical Association et al v. AG Knudsen et al, 44 MFR 275, 3/18/22.
Justin Cole & Kathryn Mahe (Garlington Lohn & Robinson), Missoula, for Plaintiffs; Raphael Graybill (Graybill Law Firm), Great Falls, for MNA; Alwyn Lansing, Brent Mead, David Dewhirst, and Christian Corrigan (AG’s Office), and Emily Jones (Jones Law Firm), Billings, for Defendants.