Can the Centers for Medicare and Medicaid Services continue to temporarily enforce a mandate requiring health care workers at Medicare- and Medicaid-certified facilities to be fully vaccinated against COVID-19 notwithstanding a district court injunction prohibiting the rule’s enforcement?
This case asks the Supreme Court to grant a stay of a district court injunction that currently blocks the Biden Administration from enforcing a mandate requiring certain healthcare workers to be fully vaccinated against COVID-19. The Biden Administration argues that the Supreme Court should issue a stay because the mandate is statutorily authorized, and its enforcement is in the public interest. The State of Missouri and nine other states (collectively “Missouri”) counter that the Supreme Court should reject the Biden Administration’s application for a stay and maintain enjoinment of the mandate throughout the pending litigation. The outcome of this case has significant implications for the Biden Administration’s pandemic-related authority and the role that the Supreme Court will play in either upholding or invalidating such authority.
Questions as Framed for the Court by the Parties
Whether the Supreme Court should issue a stay of the injunction issued by the United States District Court for the Eastern District of Missouri blocking a federal rule that requires all health care workers at facilities that participate in Medicare and Medicaid programs to be fully vaccinated against COVID-19 unless they are eligible for a medical or religious exemption.
On November 5, 2021, the Centers for Medicare and Medicaid Services’ (“CMS”), an agency within the Department of Health and Human Services (“HHS”), promulgated 86 Fed. Reg. 61,555, an Interim Final Rule with Comment Period (“IFC”) titled “Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination.” Missouri v. Biden at 1. The mandate requires almost all staff who work or volunteer at Medicare- and Medicaid-certified healthcare facilities to be fully vaccinated against COVID-19. Id. On November 10, 2021, the States of Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming (collectively “Missouri”) challenged the mandate in the United States District Court for the Eastern District of Missouri. Id. Missouri requested that the district court issue a preliminary injunction that would temporarily block CMS from enforcing the vaccine mandate. Id.
Before considering Missouri’s request for an injunction, the district court first noted that it had jurisdiction over the claims, rejecting the Biden Administration’s argument that the Medicare Act, 42 U.S.C. § 1395ii, bars the court from hearing the matter. Id. at 1–2. Next, in deciding whether to grant the preliminary injunction, the district court applied Dataphase Sys., Inc. v. C L Sys., Inc.’s four-factor balancing test. Id. at 2. The test weighs the moving party’s likelihood of success on the merits, the threat of irreparable harm to the moving party absent an injunction, the overall balance of equities and hardships, and whether the public interest supports an injunction. Id.
The district court first assessed the States’ likelihood of success on the merits of their argument that CMS exceeded its authority in enacting the mandate. Id. at 3. The court noted that because the mandate will have a wide-ranging impact and raises significant federalism concerns, an express grant of authority from Congress is required. Id. at 3–7. Congress did not provide such authority; and, the court held that it would not infer Congressional intent. Id. at 7. Moreover, the court indicated that Missouri would likely succeed on the merits because CMS did not abide by notice and comment requirements, CMS did not have “good cause” to bypass the requirements, and the mandate is arbitrary and capricious. See id. at 7, 11, 13–21.
Next, the district court found that Missouri would suffer irreparable harm absent an injunction. Id. at 22. The court indicated that enforcement of the mandate would hinder Missouri’s ability to enforce its own laws. Id. at 23. The court also pointed to potential harm that those receiving care in affected facilities would suffer because of the loss of unvaccinated staff. Id. at 23–24. Lastly, the court merged consideration of the balance of equities factor with the public interest factor, finding that although the public has an interest in reducing the transmission of COVID-19, maintaining the status quo pending final resolution of the case is in the public interest. Id. at 28-30. Upon weighing the four factors, the district court decided to grant the preliminary injunction. Id. at 31. The Biden Administration appealed the district court’s decision to the United States Court of Appeals for the Eighth Circuit.
Pending consideration and disposition of the appeal in the Eighth Circuit, the Biden Administration requested that the United States Supreme Court issue a stay of the injunction, allowing CMS to continue to enforce the mandate. On December 22, 2021, the Supreme Court decided to hear oral argument on the question of whether to issue the stay. This case is consolidated with Becerra v. Louisiana, in which the United States District Court for the Western District of Louisiana similarly enjoined enforcement of the mandate.
STATUTORY AUTHORIZATION THROUGH MEDICAID
Petitioner the Biden Administration contends that a stay of the injunction is proper because the Administration is statutorily authorized to issue the mandate. Brief for Petitioner, the Biden Administration at 18. Specifically, the Biden Administration argues that the Secretary of the Department of Health and Human Services (“HHS”) possesses the statutory authority to require facilities that participate in the Medicare or Medicaid programs to comply with restrictions that protect patient health and safety. Id. The Biden Administration asserts that the text of the Medicare Act, 42 U.S.C. § 1302(a), unambiguously vests authority in the Secretary of HHS to make rules that “may be necessary and efficient” to the administration of the Medicare and Medicaid programs. Id. at 19. The Biden Administration points to several provisions of the Medicare Act that recognize the HHS Secretary’s broad power to set standards that ensure patient health and safety. Id. The Biden Administration contends that the vaccine mandate is analogous to these provisions and similarly necessary to protecting patient health and safety. Id. at 20. The Biden Administration also posits that science and common sense support the conclusion that requiring healthcare staff to be vaccinated protects patients by reducing the likelihood of patient COVID-19 infection and providing greater assurance to patients that they are less likely to be exposed to the virus. Id. at 20–21. Moreover, the Biden Administration claims that vaccination requirements are consistent with both the history of the Medicare Act and public-health measures generally. Id. at 21–24. Accordingly, the Biden Administration argues that Congress did in fact authorize the mandate and that the district court erred in finding otherwise. Id. at 24–30.
Respondents the State of Missouri and nine other states (collectively “Missouri”) counter that a stay is improper because the mandate unequivocally lacks statutory authorization. Brief for Respondents, the States at 22. Missouri notes that the Biden Administration impermissibly applies an expansive reading to § 1302(a), which Missouri argues only recognizes a general responsibility of the HHS Secretary to maintain the Medicare and Medicaid programs. Id. at 24–25. Missouri claims that the authority recognized in § 1302(a) only permits the Secretary of HHS to promulgate practical rules such as billing procedures and cannot support a far-reaching and consequential vaccine mandate. Id. at 25. Missouri claims that because of the vaccine mandate’s broad and serious implications, Congress needed to provide the centers for Medicare and Medicaid Services with an express grant of authorization and that no such grant exists here. Id. Missouri points to several Supreme Court precedents for the proposition that agency decisions with significant economic and political ramifications must be made consistent with a clear showing that Congress has ordered the action. Id. at 22–23. Missouri asserts that the mandate will affect over two million healthcare staff, will reduce healthcare access for almost all Americans, places billions of dollars of federal funding at risk if facilities do not comply, and endangers the states’ own police power. Id. at 23–24. Accordingly, Missouri contends that the decision to require such widespread vaccination cannot be imposed and enforced without exceedingly clear Congressional authorization. Id. at 24. Furthermore, Missouri posits that even if Congress had authorized the mandate, the mandate is nonetheless unconstitutional under both the Spending Clause and the Non-Delegation Doctrine. Id. at 26–28.
THE ARBITRARY AND CAPRICIOUS STANDARD
The Biden Administration asserts that a stay should issue because the mandate is not arbitrary and capricious but rather is supported by extensive evidence of the efficacy of the vaccination requirement. Brief for Petitioner at 31. The Biden Administration argues that the district court erred when it determined that the Secretary of HHS failed to consider the effects of staff shortages brought on by the mandate. Id. The Biden Administration contends that the HHS Secretary did assess the possibility that some healthcare staff would quit instead of receiving the vaccine but concluded that this concern was not enough to outweigh the benefits of the nationwide vaccine mandate. Id. at 32. For instance, the Biden Administration notes that only 0.6% of the staff at the Houston Methodist Hospital system chose to resign when a vaccine mandate was imposed there. Id. Additionally, the Biden Administration posits that countervailing factors, such as reduced staff absenteeism resulting from COVID-19 infections, would yield a substantial benefit to healthcare facilities. Id. at 32. Moreover, the Biden Administration indicates that the vaccine mandate enjoys widespread support from leading healthcare associations. Id. at 33. The Biden Administration also asserts that the Secretary of HHS considered alternatives to a vaccination requirement, such as repeated testing, and determined that those alternatives would not adequately protect patients. Id. at 34.
Missouri counters that the mandate is arbitrary and capricious because the evidence overwhelmingly counsels against imposing a nationwide vaccine mandate. Brief for Respondents at 28. Missouri notes that the mandate disregards both patient well-being and access to care. Id. Specifically, Missouri argues that Biden Administration downplays the significant staff shortages that will result from mandating the COVID-19 vaccine, and that these shortages will only exacerbate the healthcare crisis that the already nation confronts. Id. at 28–29. Missouri contends that fewer healthcare workers necessarily means that patient care will suffer. Id. at 29. Moreover, Missouri posits that the Biden Administration ignores the particularly detrimental impact that the mandate will have on rural hospitals, which flouts the protections that the Medicare Act provides for rural populations in § 1302(b). Id. Furthermore, Missouri asserts that the Biden Administration does not provide any evidence that alternatives to a vaccine mandate cannot effectively guarantee both patient well-being and ensure access to care. Id. at 30. For instance, Missouri contends that a testing requirement would prevent the staff shortages that a vaccine mandate would generate. Id.
THE BALANCE OF EQUITIES AND IRREPARABLE HARM
The Biden Administration maintains that the balance of equities is in support of a stay because the interests of both the United States and the public will suffer irreparable harm if the mandate remains unenforceable. Brief for Petitioner at 37. The Biden Administration argues that considerations of public health warrant enforcement of the mandate, especially as the nation faces another winter spike in COVID-19 cases. Id. at 38. The Biden Administration contends that staff transmission of COVID-19 to patients can potentially result in thousands of deaths. Id. Moreover, the Biden Administration posits that this threat to human life significantly outweighs any harm that may result from healthcare workers quitting instead of receiving the vaccine. Id. Furthermore, the Biden Administration asserts that the other forms of harm Missouri points to as irreparable are either non-cognizable or outweighed by the Biden Administration’s compelling interest in enforcing the mandate. Id. at 39.
Missouri counters that preventing the Biden Administration from enforcing the mandate will not result in any irreparable harm to the Government or the public, but that irreparable harm will befall the states if the mandate is enforced. Brief for Respondents at 37. Specifically, Missouri argues that it will suffer irreparable harm to their sovereign, quasi-sovereign, and proprietary interests if the mandate is enforced. Id. Additionally, Missouri asserts that, in the mandate, the Biden Administration itself recognizes that the effectiveness of the vaccine in preventing transmission of the virus is not known. Id. at 38. Missouri maintains the Biden Administration’s claim that thousands of patients may die is speculative at best. Id. Moreover, Missouri contends that the mandate will hinder patient care because it will exacerbate staff shortages and potentially lead to the closure of facilities. Id. Accordingly, Missouri argue that the balance of equities supports declining the Biden Administration’s request for a stay of the injunction. Id.
PROTECTION OF HEALTHCARE STAFF
The Service Employees International Union and two other unions (collectively “the Unions”), in support of the Biden Administration, argue that the vaccine mandate protects not only patients, but also healthcare staff. Brief of Amici Curiae Service Employees International Union et al., in Support of the Biden Administration at 3. Specifically, the Unions argue that healthcare workers are at significant risk of exposure to the virus and that the death rate among healthcare staff during the first year of the pandemic supports this conclusion. Id. The Unions assert that stricter vaccination policies aimed at protecting workers can significantly mitigate the risks that they face, as recent healthcare facility outbreaks are often linked to under-vaccination among staff. Id. at 4. The American Medical Association and several other medical associations and academies (collectively “the Associations and Academies”), also in support of the Biden Administration, contend that COVID-19 vaccines are both a safe and effective way to reduce the alarming rate of transmission of COVID-19 in healthcare facilities. Brief of Amici Curiae American Medical Association et al., in Support of the Biden Administration at 10. The Associations and Academies posit that reputable studies and analyses reinforce the Biden Administration’s contention that the vaccine is the most effective method of saving lives. Id. at 10–11.
The Doctors for Disaster Preparedness and Eagle Forum Education & Legal Defense Fund (“the Doctors and Eagle Forum Fund”), in support of Missouri, counter that the COVID-19 vaccine mandate does not effectively protect workers because of the questionable nature of the vaccine’s efficacy. Brief of Amici Curiae Doctors for Disaster Preparedness and Eagle Forum Education & Legal Defense Fund, in Support of Missouri at 3. The Doctors and Eagle Forum Fund maintain that the COVID-19 vaccine itself has led to thousands of adverse reactions, hospitalizations, and deaths. Id. The Doctors and Eagle Forum Fund argue that the Biden Administration fails to consider the harms that the COVID-19 vaccine poses and ignores the data showing that even though most healthcare workers are are already vaccinated, COVID cases continue to surge. Id. at 4. The Doctors and Eagle Forum Fund posit that natural immunity and early treatment through medications such as hydroxychloroquine and ivermectin are more effective means of protecting healthcare staff than requiring them to receive the COVID-19 vaccine. Id. at 5.
EFFECT ON HEALTHCARE FACILITIES
Former Secretaries of Health and Human Services, former Administrators of the Centers for Medicare and Medicaid Services, and other former federal health officials (collectively “the Secretaries, Administrators, and officials”), in support of the Biden Administration, argue that the vaccine mandate benefits healthcare facilities through reduced COVID-19 hospitalizations and fewer staff shortages. Brief of Amici Curiae Former Secretaries of Health and Human Services, et al., in Support of the Biden Administration, at 12. The Secretaries, Administrators, and officials contend that healthcare facilities, already stretched thin, cannot afford to lose available staff who become infected with COVID-19 and must quarantine. Id. The Secretaries, Administrators, and officials assert that healthcare facilities exist to care for patients and that this care suffers immensely when staff shortages are abundant. Id. Additionally, the Secretaries, Administrators, and officials maintain that patients may be more likely to seek care at facilities that impose a staff-vaccination requirement. Id. at 14.
Baptist Homes & Healthcare Ministries (“BHHM”) and the Christian Life Commission of the Missouri Baptist Convention (“CLC MBC”), in support of Missouri, counter that the vaccine mandate will result in healthcare facilities suffering economic and constitutional harm. Brief of Amici Curiae Baptist Home & Healthcare Ministries and the Christian Life Commission of the Missouri Baptist Convention, in Support of Missouri at 5–8. BHHM and CLC MBC note that many healthcare workers, especially nursing home staff, are unlikely to receive the vaccine and will choose to quit, placing the economic viability of the facility at risk. Id. at 5–6. BHHM and CLC MBC also posit that healthcare facilities that fail to comply with the mandate risk losing significant Medicare and Medicaid funding. Id. at 7. Moreover, BHHM and CLC MBC contend that the vaccine mandate poses constitutional harms to religiously affiliated healthcare providers. Id. at 8. Specifically, BHHM and CLC MBC argue that the mandate violates the First Amendment because it infringes on the autonomy that religious institutions enjoy. Id.
- Sarah Fentem, Federal Judge Blocks Biden Administration COVID-19 Vaccine Mandate for Health Workers, St. Louis Public Radio (Nov. 29, 2021)
- Erin Mulvaney, Missouri Court Latest to Block Biden Contractor Vaccine Mandate, Bloomberg Law (Dec. 20, 2021).