• Wed. May 25th, 2022

Health Administration

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COVID-19 Vaccine Mandates At The Supreme Court: Scope And Limits Of Federal Authority

On January 13, 2022, the U.S. Supreme Court published landmark rulings regarding the legality of COVID-19 vaccine mandates issued by two federal agencies. In NFIB v. OSHA, the Court stayed the enforcement of a rule—issued by the Occupational Safety and Health Administration (OSHA), a division of the U.S. Department of Labor—that imposed a vaccine-or-test mandate for employees in companies with more than 100 workers. The Court found that the parties challenging the rule were likely to ultimately succeed in having it struck down and it thus prevented the rule from going into effect while litigation over the rule continued.

In Biden v. Missouri, the Court allowed a rule—issued by the U.S. Department of Health and Human Services (HHS)—to proceed, finding that the rule was likely to survive litigation challenging its validity. The rule mandates COVID-19 vaccination, absent a medical or religious exemption, for all health care workers in institutions that receive federal funding for patients enrolled in Medicare or Medicaid.

Public reaction to the rulings has been swift and mixed. Some characterized the Court’s OSHA decision as an errant interpretation of OSHA’s mandate to protect the health and safety of workers, while others heralded the decision as a principled approach that limits agency overreach and preserves constitutional separation of powers on matters of public health. Regarding the HHS rule, some deemed the decision a slapdash expansion of HHS’s authority that inappropriately grants the agency the ability to issue a national vaccine mandate, while others applauded the ruling as a scientifically sound judgment that fits squarely within HHS’s authority and will unquestionably protect the health and safety of Medicare and Medicaid patients. These points have not been limited to debates in mainstream media outlets or around American dinner tables, they were enunciated by the justices in the majority and dissenting opinions of the cases.

As with other pandemic response policies, the OSHA and HHS mandates drive to the core of several fundamental interests, such as the scope and limits of federal public health powers and the proper balance between individual liberties and the public welfare. The policies also underscore the challenges the nation has faced throughout the pandemic, where health and public health risks are significant and any policy decision is certain to infringe upon some liberties or cause one form of societal harm or another. Regardless of how one may judge the practical implications of the cases, a close review of the decisions, which span 53 pages, is essential to understanding the scope and limits of federal public health authority.

The OSHA Rule And Decision

The OSHA rule was announced on September 9, 2021, two weeks after the U.S. Food and Drug Administration (FDA) issued its first approval for a vaccine to protect against COVID-19. Before the FDA approval, legal experts questioned the legality of mandates for vaccines authorized for emergency use via the FDA’s Emergency Use Authorization (EUA) pathway. Although the FDA and CDC were reported to have taken the position that mandates for EUA vaccines were illegal, some courts upheld such mandates issued by private employers for their employees. The distinction between the legality of mandates for EUA-authorized versus FDA-approved vaccines was tabled on August 23, 2021, the day the FDA issued its approval for Pfizer’s vaccine.

The OSHA rule was published on November 5, 2021. Employers were responsible for developing, implementing, and enforcing a COVID-19 vaccination policy: any covered employee who was not fully vaccinated was required to wear a face mask at all times at work and undergo weekly COVID-19 testing. However, employers were not required to offer the testing and masking option. And, for those that did, employers were not required to pay for weekly testing or provide employees with time off to purchase and administer the tests; rather, after obtaining and administering a weekly test, employees were responsible for reporting their results to their employer. If an employee did not comply with the requirements, their employer was responsible for removing them from the workplace. Fines on the employer for failing to do so ranged from $13,653 to $136,532 per employee.

Under the OSHA mandate, no state or local law could contradict or preempt the federal rule. Twenty-seven states, as well as several businesses and non-profit institutions, challenged the rule in federal courts across the country. One appellate court issued a stay that put the rule on pause, but a separate court lifted the stay and allowed the rule to take effect. Upon expedited review of the case and after a lengthy oral argument, in a 6-3 opinion the Supreme Court reinstated the stay, finding that OSHA likely exceeded its authority by issuing the mandate. There were four primary reasons for the Court’s ruling, some of which have overlapping principles.

Distinguishing Occupational Health From Public Health

OSHA, like all administrative agencies, is a creature of statute that only possesses the authority that Congress has provided. As the Court underscored, Congress must “speak clearly when authorizing an agency to exercise powers of vast economic or political significance.” The Court emphasized that “OSHA is tasked with ensuring occupational safety” and that the agency is permitted “to set workplace safety standards, not broad public health measures” (emphasis in the opinion). The Court recognized that COVID-19 is a risk that occurs in many workplaces, just as it is “at home, in schools, during sporting events, and everywhere else that people gather.”

The Court did not deem COVID-19 to be “an occupational hazard in most” workplaces, but rather characterized COVID-19 as a “universal risk” that “is no different from the day-to-day dangers that all face from crime, air pollution, or any number of communicable diseases.” As the Court indicated: “Permitting OSHA to regulate the hazards of daily life—simply because most Americans have jobs and face those same risks while on the clock—would significantly expand OSHA’s regulatory authority without clear congressional authorization.” Since the OSHA rule involves a vaccine mandate, it regulates not just what happens inside the workplace but also serves to “induce individuals to undertake a medical procedure that affects their lives outside the workplace.”

In a concurring opinion, Justice Gorsuch noted that the pandemic has been raging for over two years, that vaccines have been available for eleven months, and that Congress has enacted several major pieces of legislation aimed at combatting to COVID-19, none of which has afforded OSHA any authority to issue vaccine mandates. Indeed, on December 8, 2021, the U.S. Senate, by majority vote, disapproved of the OSHA vaccine-or-test mandate. As Justice Gorsuch explained, “OSHA claims the power to issue a nationwide mandate on a major question but cannot trace its authority to do so to any clear congressional mandate.” This factor was essential: since Congress has not authorized OSHA to issue rules that govern public health concerns, the agency exceeded its authority in issuing a mandate that, the Court described, as “a significant encroachment into the lives—and health—of a vast number of employees.” Historically, such matters have been governed at the state level by public health agencies.

In the dissenting opinion, Justices Breyer, Sotomayor, and Kagan argued that the Court was reading a limitation into the statute that did not exist. Specifically, there are no provisions that limit OSHA’s ability to issue rules where a health risk occurs inside and outside the workplace. The dissent illustrated the point by highlighting several areas, such as “risks of fire, faulty electrical installations, and inadequate emergency exits,” and posited that “a biological hazard—here, the virus causing COVID-19—is no different.” As the dissent explained, OSHA provided ample evidence that “COVID-19 poses special risks in most workplaces, across the country and across industries.” Specifically, OSHA determined that COVID-19 is “readily transmissible in workplaces because they are areas where multiple people come into contact with one another, often for extended periods of time.” 

As further evidence that the vaccine-or-test mandate falls within OSHA’s purview, the dissent highlighted that, last year, Congress appropriated $100 million for OSHA “to carry out COVID-19 related worker protection activities.” For the dissent, this allocation supports the position that Congress has acknowledged that COVID-19 poses workplace hazards which OSHA is authorized to address. As the dissent elaborated, “OSHA’s responsibility to mitigate the harms of COVID-19 in the typical workplace do not diminish just because the disease also endangers people in other settings.”

Failing To Account For Workplace-Specific Risks

Along with distinguishing occupational health hazards from public health concerns, the Court found the OSHA rule to be a blunt instrument that was not narrowly tailored to specific workplace hazards. For example, the rule applied the same to lifeguards and groundskeepers as it did to meatpackers and medics—as the Court highlighted, it “draws no distinction based on industry or risk exposure to COVID-19.” The Court acknowledged that OSHA has authority “to regulate occupation-specific risks related to COVID-19”; this includes situations where “the virus poses a special danger because of the particular features of an employee’s job or workplace.” In the Court’s view, however, OSHA took an “indiscriminate approach” that failed to account for the “crucial distinction between occupational risk and risk more generally.”

For the dissent, these distinctions were irrelevant, because the virus “causes harm in nearly all workplace environments.” The dissent further reasoned that the rule was appropriate because in workplaces, more than elsewhere, “individuals have little control, and therefore little capacity to mitigate risk.” The dissent contended that the Court should defer to OSHA’s findings, since the agency “has thoroughly evaluated the risks that the disease poses to workers across all sectors of the economy” and “has meticulously explained why it has reached its conclusions.” The dissenting justices acknowledged that “OSHA is not a roving public health regulator,” but argued that the agency has the authority “to protect employees from workplace hazards,” of which COVID-19 is one. The dissent pointed to OSHA’s findings, including hundreds of reports of workplace outbreaks, as well as the agency’s warning that new variants may further disrupt the workplace.

Unjustified Use Of Emergency Temporary Standard

The Court also took issue with the method by which OSHA issued the rule, via an “emergency temporary standard” (ETS). These emergency measures are permitted only in the narrowest of circumstances: there must be a “grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards” and the emergency rule must be “necessary to protect employees from such danger.”

Prior to the pandemic, ETSs involved dangers unique to certain workplaces, such as asbestos and rare chemicals. Of the nine previous occasions where OSHA issued an ETS, six were challenged in court and only one was upheld in full. No previous ETS was as broad or far-reaching as the COVID-19 vaccine-or-test mandate.

In a case from 2020, OSHA explained that the ETS provision “does ‘not authorize OSHA to issue sweeping health standards’ that affect workers’ lives outside the workplace.” Yet, as Justice Gorsuch explained in his concurring opinion, OSHA now contends that the emergency powers afford the agency “’almost unlimited discretion’ to mandate new nationwide rules in response to the pandemic so long as those rules are ‘reasonably related’ to workplace safety.” This, according to the Court, went too far.

The dissent took issue with these characterizations, noting that the statute “not just enables, but commands” OSHA to issue an ETS when a new hazard poses a grave danger in the workplace. As the dissent further explained, the majority has not disputed that COVID-19 is a new hazard that poses a grave danger in the workplace. The dissent also highlighted the exceptions that OSHA built into the rule, such as exclusions for employees who maintain religious or medical exemptions, or work entirely from home or outdoors. For the dissent, a vaccine-or-test mandate is necessary to address the dangers of COVID-19 in the workplace, a finding that OSHA made and the Court would be “not wise” to usurp.

The Separation Of Powers Doctrine

“The question before us is not how to respond to the pandemic,” Justice Gorsuch wrote, “but who holds the power to do so.” As he summarized, state, local, and national governments “all have roles to play in combatting the disease,” but the question for the Court was whether an administrative agency charged with protecting workplace safety was the proper vehicle for instituting a broad vaccine mandate that would impact over 84 million people. In its half century of existence, despite numerous communicable diseases, OSHA had never adopted a broad vaccine mandate. Moreover, as has been clear throughout the pandemic, states maintain general public health powers and have diverged considerably on how they have chosen to exercise those powers.

In his concurring opinion, Justice Gorsuch explained how the major questions doctrine and nondelegation doctrine are relevant to the separation of powers aspects of this case. Both aim to ensure that Congress remains the core lawmaking body for the federal government by limiting what powers Congress can delegate to agencies and requiring that agencies act only within the limits of a clear grant of authority from Congress. These doctrines are intended to ensure democratic accountability—as Justice Gorsuch detailed, “lawmakers may be tempted to delegate power to agencies to reduce the degree to which they will be held accountable for unpopular actions.”

The rules also are a check on administrative overreach, to guard “against unintentional, oblique, or otherwise unlikely delegations of the legislative power.” In short, as Justice Gorsuch wrote, the doctrines “serve to prevent government by bureaucracy supplanting government by the people.” While respecting the demands of the legal doctrines “may be trying in times of stress,” he explained, “if this Court were to abide them only in more tranquil conditions, declarations of emergencies would never end and the liberties our Constitution’s separation of powers seeks to preserve would amount to little.”

The dissent contended that issuance of the vaccine-or-test mandate falls squarely within OSHA’s responsibilities. As the dissent explained, “the administrative agency charged with ensuring health and safety in workplaces did what Congress commanded it to do: It took action to address COVID-19’s continuing threat in those spaces.” For the dissent, OSHA’s expertise in this realm cannot be reasonably debated: the agency employs “numerous scientists, doctors and other experts in public health, especially as it relates to work environments.” The Court’s decision, the dissent contended, “stymies the Federal Government’s ability to counter the unparalleled threat that COVID-19 poses to our Nation’s workers.”

The HHS Rule And Decision

On the same day that OSHA published its vaccine-or-test mandate, HHS published an interim final rule that amended the conditions of participation in Medicare and Medicaid. The rule requires that health care facilities ensure that their employees are vaccinated against COVID-19. The rule covers hospitals, long-term care facilities, ambulatory surgical centers, and other health care settings, and only permits medical or religious exemptions. It is estimated to impact ten million health care workers, and employers are required to fire non-compliant employees. Penalties on health care institutions are stiff—they include fines, denial of payment for new patient admissions, or termination of participation in Medicare and Medicaid.

As with the OSHA rule, a series of lawsuits challenged the HHS rule in federal courts throughout the country. Finding the HHS rule legally defective, courts in Missouri and Louisiana issued a stay of the rule and halted its enforcement. In a 5-4 decision, the Supreme Court reversed the stays. The Court held that infectious disease control measures, including vaccine mandates to protect against COVID-19, are likely encompassed by HHS’s ability to set conditions of participation in Medicare and Medicaid.

HHS issued the rule after finding that, in many health care institutions across the country, 35 percent or more of employees are unvaccinated. HHS determined that current vaccination rates increase the risk that Medicare and Medicaid patients will acquire COVID-19 in health care settings. According to HHS, this creates a serious threat to the health and safety of the patients, many of whom are particularly susceptible to acquiring and suffering from serious, if not life-threatening, complications from SARS-CoV-2.

Increasing vaccination rates among health care workers, according to HHS, will decrease the transmissibility of SARS-CoV-2 and decrease patients’ fear of exposure. As to the latter, HHS found that patients were forgoing seeking medically necessary care due to their fears of contracting COVID-19 in health care settings, thus further jeopardizing their health and safety. Because COVID-19 vaccines also significantly decrease disease severity in those who are vaccinated, a more highly vaccinated workforce would limit staff shortages in health care facilities, thus limiting COVID-19-related staffing disruptions. 

The Court deferred to HHS’s findings, noting that “health care workers and public health organizations overwhelmingly support” the rule. As the Court wrote, “it would be the very opposite of efficient and effective administration for a facility that is supposed to make people well to make them sick with COVID-19.” The Court pointed to several instances where HHS has mandated conditions that address the safe and effective provision of health care, such as mandating sanitary measures and setting post-operative care conditions. The Court also noted that “health care workers around the country are ordinarily required to be vaccinated for diseases such as hepatitis B, influenza, and measles, mumps, and rubella.” Although the Court recognized that HHS has never before instituted a vaccine mandate as part of an infection control protocol, the Court reasoned that HHS “has never had to address an infection problem of this scale and scope before.” The Court further noted that, with past infection control protocols, pre-existing state vaccine mandates often were sufficient to address the health and public health concerns.

Seeking to reconcile the OSHA and HHS cases, in the HHS opinion the Court concluded that the “challenges posed by a global pandemic do not allow a federal agency to exercise power that Congress has not conferred upon it. At the same time, such unprecedented circumstances provide no grounds for limiting the exercise of authorities the agency has long been recognized to have.”

In one of the two dissenting opinions in the HHS case, Justice Thomas contended that the statute only allows HHS to institute rules regarding the “administration” of Medicare and Medicaid, a limitation that does not encompass the power to issue a vaccine mandate as a condition of participation. Examples of such administrative conditions of participation, according to Justice Thomas, include requirements that hospitals provide 24-hour nursing services and maintain clinical records of patients. Justice Thomas further noted that the statutory provision that deals with infection control measures is found only in a section that encompasses long-term care facilities, and that there is no statutory basis for extending that provision to other health care settings.

As Justice Thomas further wrote, infection control measures historically have focused “on sanitizing the facilities’ environment, not its personnel.” This has included protocols regarding aseptic techniques, housekeeping services, and pest control. A vaccine mandate, according to Justice Thomas, is far different than such measures.

In terms of HHS’s legal authority, Justice Thomas argued that the government has relied upon “a constellation of statutory provisions,” none of which contains language that can be interpreted to include vaccine mandates. Congress “does not hide fundamental details of a regulatory scheme in vague or ancillary provisions,” he wrote. To illustrate his point, he cited a provision governing the Peace Corps, wherein Congress expressly authorized the issuance of vaccine mandates for Peace Corps volunteers.

Vaccine mandates “fall squarely within a state’s police power,” Justice Thomas concluded, and “if Congress had wanted to grant CMS authority to impose a nationwide vaccine mandate, and consequently alter the state-federal balance, it would have said so clearly. It did not.” “These cases are not about the efficacy or importance of COVID-19 vaccines,” Justice Thomas explained, “they are only about whether CMS has the statutory authority to force health care workers, by coercing their employers, to undergo a medical procedure they do not want and cannot undo.”

In a second dissenting opinion, Justice Alito argued that, “even if the Federal Government has the authority to require the vaccination of health care workers, it did not have the authority to impose that requirement in the way it did.” Justice Alito took issue with HHS’s decision to implement the rule without first conducting a notice and comment period, a procedure that is required for agency rulemaking and only can be excluded in rare and emergent circumstances. Siding with the lower courts in the case, Justice Alito found that HHS repeatedly delayed instituting a vaccine mandate, thus undermining the agency’s argument that “swift” action was necessary and the notice and comment period could be side-stepped.

This circumvention, Justice Alito wrote, is further problematic given the rapidly changing dynamics of the pandemic and the fact that the rule “put more than 10 million health care workers to the choice of their jobs or an irreversible medical treatment.” The dissenting justices warned that the HHS rule would lead to staffing shortages, as many health care workers would quit rather than succumb to a vaccine that they have refused for months. The majority dismissed this concern, pointing to studies that found individuals who initially had stated they would quit if a vaccine mandate were imposed often did not.

Cases In Context And What Comes Next

The OSHA and HHS cases provide important details surrounding the Supreme Court’s views on federal public health authority in general, and in particular on the Court’s views on the scope and limits of agency actions. For example, the Court did not eliminate OSHA’s ability to institute workplace-related COVID-19 measures, but rather explained that such measures should be limited to those that are narrowly tailored to specific hazards in certain jobs. Accordingly, OSHA can continue to play a role in addressing workplace-related COVID-19 risks, and focused workplace protections have a higher likelihood of being upheld. At the same time, nothing in the Court’s rulings prevents private companies from instituting their own workplace requirements; for example, within days of the rulings Apple announced that it was instituting a requirement that its employees receive a booster vaccine or face dismissal.

The Court’s decisions also make clear that broader mandates—whether they relate to vaccination, masking, or testing—must come from Congress or the states, unless there is clear statutory language that grants a federal agency the ability to issue such a mandate. This reliance on Congress and the states raises another question of whether federal and state lawmakers are up to the task of enacting laws that appropriately balance individual liberties and public health. As we have seen throughout the pandemic, public health issues have been hyper-politicized, and lawmakers have rarely taken the lead in instituting sensible measures. In light of the legislative gap, state and local public health authorities have been at the forefront of pandemic policy-making, though they typically follow the political will of the state’s governor.

At a broader level, many legal commentators have viewed these rulings as further evidence of a conservative Supreme Court chipping away at the deference that courts have long afforded to administrative agencies. In the context of the OSHA and HHS cases, this characterization is not entirely accurate: two Justices in the majority of the OSHA case (which overruled an agency action) joined the three justices in the dissent of OSHA case to form a majority in the HHS case (that affirmed agency discretion). At the same time, the two cases create uncertainty in the realm of pandemic policy and agency decision-making. In any given context, agencies cannot know which Supreme Court rationale—the majority in the OSHA case, or that in the HHS case—will prevail.

The OSHA and HHS decisions, though vastly important, are not the last word on the rules. As a procedural matter, the Supreme Court returned the cases to the lower courts, which will conduct a further review on the legality of the mandates. Depending on the lower court rulings, and the extent of government enforcement of the HHS rule, one or both cases may end up back at the Supreme Court. In the interim, however, President Biden announced that OSHA would withdraw the vaccine-or-test rule, thus ending that legal battle. As of the date of this article, the HHS rule remains in place and compliance deadlines are weeks away.

The United States has long maintained a patchwork system of public health authority that is split amongst local, state and federal authorities. These two cases underscore that dynamic and help elucidate what public health powers fall under the purview of federal administrative agencies.

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