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The CMS Vaccine Mandate at the Supreme Court: A Hippocratic Imperative

  • Eli Y. Adashi
    Correspondence
    Requests for reprints should be addressed to Eli Y. Adashi, MD, MS, Professor of Medical Science, Brown University, 222 Richmond Street, Providence, RI, 02903.
    Affiliations
    Professor of Medical Science, Brown University, Providence, RI
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  • I. Glenn Cohen
    Affiliations
    Deputy Dean and James A. Attwood and Leslie Williams Professor of Law, Harvard Law School, Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Mass
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      On January 13, 2022, in a 5-4 decision in Biden v. Missouri, the U.S. Supreme Court stayed 2 lower court decisions enjoining the Centers for Medicare and Medicaid Services (CMS) vaccine mandate. The mandate, now in effect, requires all facilities that participate in Medicare and Medicaid to ensure that their staff is vaccinated against coronavirus disease 2019 (COVID-19) absent medical and religious exemptions.

      Biden v. Missouri, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. Accessed February 15, 2022.

      The injunction that the Supreme Court dissolved would have blocked the enforcement of the mandate in a total of 24 states.

      Biden v. Missouri, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. Accessed February 15, 2022.

      The Supreme Court made it plain that the CMS vaccine mandate is “consistent with the fundamental [Hippocratic] principle of the medical profession: first, do no harm.”

      Biden v. Missouri, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. Accessed February 15, 2022.

      A White House statement issued in the wake of the Supreme Court decision captured the same spirit in stating that the mandate “will save lives: the lives of the patients who seek care in medical facilities, as well as the lives of doctors, nurses, and others who work there.”

      White House. Statement by President Joe Biden On the U.S. Supreme Court's Decision on Vaccine Requirements. Available at: https://www.whitehouse.gov/briefing-room/statements-releases/2022/01/13/statement-by-president-joe-biden-on-the-u-s-supreme-courts-decision-on-vaccine-requirements/. Accessed February 15, 2022.

      We review the CMS vaccine mandate, discuss its legal journey to this point, and explore the Hippocratic dimension thereof.
      On November 5, 2021, the Department of Health and Human Services (HHS) issued an Interim Final Rule titled “Omnibus COVID-19 Health Care Staff Vaccination.” It is here that CMS specified the “COVID-19 vaccination requirements for staff at the included Medicare- and Medicaid-certified providers and suppliers.”

      Federal Register. Centers for Medicare & Medicaid Services. Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination. https://www.federalregister.gov/d/2021-23831. Accessed February 15, 2022.

      The providers and suppliers deemed subject to the CMS mandate ranged from “hospitals to hospices and rural health clinics to long-term care facilities (including skilled nursing facilities and nursing facilities, collectively known as nursing homes).”

      Federal Register. Centers for Medicare & Medicaid Services. Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination. https://www.federalregister.gov/d/2021-23831. Accessed February 15, 2022.

      The CMS mandate also included Ambulatory Surgical Centers, Home Health Agencies, Community Mental Health Centers, Home Infusion Therapy Suppliers, and End-Stage Renal Disease Facilities.

      Federal Register. Centers for Medicare & Medicaid Services. Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination. https://www.federalregister.gov/d/2021-23831. Accessed February 15, 2022.

      All told, the CMS vaccination mandate is estimated to apply to a total of 17 million health care workers at 76,000 health care facilities. Those to be vaccinated encompass not only medical personnel but also individuals who work in the facility on a regular (that is, at least once a week) basis.

      Federal Register. Centers for Medicare & Medicaid Services. Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination. https://www.federalregister.gov/d/2021-23831. Accessed February 15, 2022.

      Full vaccination status was defined by the CMS mandate as “having received a single-dose vaccine or all doses of a multi-dose vaccine.”

      Federal Register. Centers for Medicare & Medicaid Services. Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination. https://www.federalregister.gov/d/2021-23831. Accessed February 15, 2022.

      Additional doses or booster shots were not required.

      Federal Register. Centers for Medicare & Medicaid Services. Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination. https://www.federalregister.gov/d/2021-23831. Accessed February 15, 2022.

      Allowances were also made to accommodate “employees who request and receive exemption from vaccination because of a disability, medical condition, or sincerely held religious belief, practice, or observance.”

      Federal Register. Centers for Medicare & Medicaid Services. Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination. https://www.federalregister.gov/d/2021-23831. Accessed February 15, 2022.

      The case made its way to the Supreme Court when the federal government sought a stay of the injunctions granted on November 29, 2021, by the District Court for the Eastern District of Missouri to 10 states (Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming). A similar injunction was issued on November 30, 2021, by the District Court for the Western District of Louisiana to 14 additional states (Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma, South Carolina, Utah, West Virginia, Kentucky, and Ohio).

      CASETEXT. State of Missouri v. Biden, No. 4:21-cv-01329-MTS (E.D. Mo. Nov. 29, 2021). Available at: https://casetext.com/case/issouri-v-biden-1. Accessed February 15, 2022.

      ,

      CASETEXT. State of Louisiana v. Becerra, No. 3:21-CV-03970 (W.D. La. Nov. 30, 2021). Available at: https://casetext.com/case/state-v-becerra-20. Accessed February 15, 2022.

      The five Supreme Court justices who stayed the injunctions and allowed the mandate to go forward in their per curiam (unsigned, joint) opinion, began by noting that the “most basic” and “core mission” of CMS is to “ensure that the healthcare providers who care for Medicare and Medicaid patients protect their patients’ health and safety.”

      Biden v. Missouri, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. Accessed February 15, 2022.

      In support of that mission, the court recognized that Congress authorized the Secretary of the Department of HHS to promulgate (as a condition for Medicare and Medicaid participation) “requirements as [he] finds necessary in the interest of the health and safety of individuals who are furnished services in the institution.”

      Biden v. Missouri, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. Accessed February 15, 2022.

      The Court characterized the mandate as a “straightforward and predictable example of the ‘health and safety’ regulations that Congress has authorized the Secretary to impose.”

      Biden v. Missouri, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. Accessed February 15, 2022.

      Pointing to the Hippocratic imperative, the court concluded that “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.’”

      Biden v. Missouri, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. Accessed February 15, 2022.

      In a footnote, the court acknowledged that the statutory support was less clear for extending the mandate to nonhospital facilities where the relevant statute did not include the “health and safety” language. However, noting that “end-stage renal disease clinics and home infusion therapy suppliers—represent less than 3% of the workers covered by the rule,” the court declared that it will not “let the infusion-clinic tail wag the hospital dog.”

      Biden v. Missouri, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. Accessed February 15, 2022.

      The court acknowledged that the Secretary of HHS did not follow the traditional notice-and-comment rulemaking period, but instead, issued an interim final rule that was effective immediately. The court, nevertheless, found this decision to satisfy the “good cause” standard in that the Secretary of HHS found that “further delay would endanger patient health and safety given the spread of the Delta variant and the upcoming winter season.”

      Biden v. Missouri, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. Accessed February 15, 2022.

      There were two dissenting opinions, one authored by Justice Clarence Thomas and one authored by Justice Samuel Alito (each joined by the other as well as by Justices Neil Gorsuch and Amy Coney Barrett). Justice Thomas's dissent found the statutory authorization too vague to allow the agency to “force healthcare workers, by coercing their employers, to undergo a medical procedure they do not want and cannot undo.”

      Biden v. Missouri, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. Accessed February 15, 2022.

      It was Justice Thomas's position that “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.”

      Biden v. Missouri, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. Accessed February 15, 2022.

      Justice Alito's opinion focused its criticism on the conclusion that the agency had “good cause to avoid notice-and-comment rulemaking” and chastised the majority for “shift[ing] the presumption against compliance with procedural strictures from the unelected agency to the people they regulate.”

      Biden v. Missouri, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. Accessed February 15, 2022.

      In was in that context that Judge Alito wondered how an agency such as CMS can “regulate first and listen later, and then put more than 10 million healthcare workers to the choice of their jobs or an irreversible medical treatment.”

      Biden v. Missouri, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. Accessed February 15, 2022.

      What is striking about the Supreme Court decision is that it was announced, and that the case was argued, alongside a related case challenging the Occupational Safety and Health Administration's (OSHA) test-or-vaccinate mandate.

      National Federation of Independent Business v. Department of Labor, Occupational Safety and Health Administration, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a244_hgci.pdf. Accessed February 15, 2022.

      In that case, Chief Justice John Roberts and Justice Brett Kavanaugh joined the dissenters in the CMS case to grant a stay against the mandate based on the claim that it exceeded OSHA's statutory authority. The grant of authority to OSHA was, if anything, broader than that granted to CMS. Indeed, one can imagine a world where the results of these two cases were flipped. What made the difference? Plausibly, it was the Supreme Court's internalization of the Hippocratic imperative and the view that it was decidedly the province of HHS to adopt disease-control measures including vaccine mandates if it concluded that it would protect patient safety. Justice Elena Kagan, at oral arguments, captured this ethos bluntly when stating that “All the Secretary is doing here is to say to providers, you know what? Basically the one thing you can't do is to kill your patients. So you have to get vaccinated so that you're not transmitting the disease that can kill elderly medical—Medicare patients, that can kill sick Medicaid patients. I mean, that seems like a pretty basic infection prevention measure. You can't be the carrier of disease.”

      U.S. Supreme Court. Transcript, Biden v. Missouri. Available at: https://www.supremecourt.gov/oral_arguments/argument_transcripts/2021/21a240_l537.pdf. Accessed February 15, 2022.

      To be sure, the Hippocratic imperative is hardly a binding legal doctrine. Moreover, this world outlook is unlikely to be in keeping with that espoused by the vaccine hesitancy movement wherein notions of state rights, liberty, and individual autonomy feature prominently. Others, however, may hold the view that the CMS vaccination mandate is sensible, beneficent, scientifically grounded, and intent on reducing harm. Seen in this light, having the Supreme Court on the side of Hippocratic beneficence is just what the doctor ordered.

      References

      1. Biden v. Missouri, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf. Accessed February 15, 2022.

      2. White House. Statement by President Joe Biden On the U.S. Supreme Court's Decision on Vaccine Requirements. Available at: https://www.whitehouse.gov/briefing-room/statements-releases/2022/01/13/statement-by-president-joe-biden-on-the-u-s-supreme-courts-decision-on-vaccine-requirements/. Accessed February 15, 2022.

      3. Federal Register. Centers for Medicare & Medicaid Services. Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination. https://www.federalregister.gov/d/2021-23831. Accessed February 15, 2022.

      4. CASETEXT. State of Missouri v. Biden, No. 4:21-cv-01329-MTS (E.D. Mo. Nov. 29, 2021). Available at: https://casetext.com/case/issouri-v-biden-1. Accessed February 15, 2022.

      5. CASETEXT. State of Louisiana v. Becerra, No. 3:21-CV-03970 (W.D. La. Nov. 30, 2021). Available at: https://casetext.com/case/state-v-becerra-20. Accessed February 15, 2022.

      6. National Federation of Independent Business v. Department of Labor, Occupational Safety and Health Administration, 595 U.S. _ 2022. Available at: https://www.supremecourt.gov/opinions/21pdf/21a244_hgci.pdf. Accessed February 15, 2022.

      7. U.S. Supreme Court. Transcript, Biden v. Missouri. Available at: https://www.supremecourt.gov/oral_arguments/argument_transcripts/2021/21a240_l537.pdf. Accessed February 15, 2022.