key: cord-0759064-lcmcn7sk
authors: Adashi, Eli Y.; Cohen, I. Glenn
title: The CMS Vaccine Mandate at the Supreme Court: A Hippocratic Imperative
date: 2022-04-23
journal: Am J Med
DOI: 10.1016/j.amjmed.2022.03.041
sha: a92832f43de1ef0037f5ba48267713bdeacddb19
doc_id: 759064
cord_uid: lcmcn7sk

nan

Court made it plain that the CMS vaccine mandate is "consistent with the fundamental [Hippocratic] principle of the medical profession: first, do no harm." 1 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." 2 In this Commentary 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." 3 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)." 3 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. 3 All told, the CMS vaccination mandate is estimated to apply to a total of 17 million healthcare workers at 76,000 healthcare 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. 3 Full vaccination status was defined by the CMS mandate as "having received a single-dose vaccine or all doses of a multi-dose vaccine." 3 Additional doses or booster shots were not required. 3 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. 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." 1 In support of that mission, the has authorized the Secretary to impose." 1 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.'" 1 In a footnote, the court acknowledged that the statutory support was less clear for extending the mandate to non-hospital 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." 1 The Court acknowledged that the Secretary of HHS did not follow the 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." 1 There were two dissenting opinions, one authored by Justice Thomas, and one authored by Justice Alito (each joined by the other as well as by Justices Gorsuch and Barrett). Justice Thomas' 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." 1 It was Justice Thomas' position that "if Congress had wanted to grant CMS authority to impose a nationwide vaccine mandate, and consequently alter the statefederal balance, it would have said so clearly. It did not." 1 Justice Alito's opinion focused its criticism on the conclusion that the agency had "good cause to avoid notice-and-comment rulemaking" and chatized the majority for "shift[ing] the presumption against compliance with procedural strictures from the unelected agency to the people they regulate." 1 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." 1 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. 6 In that case, Chief Justice Roberts and Justice 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 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." 7 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.

Supreme Court's Decision on Vaccine Requirements

FEDERAL REGISTRER. 11/05/2021 Issue. Centers for Medicare & Medicaid Services. Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination

Occupational Safety and Health Administration, 595 U.S. _ 2022