Business Law

Biden v. Missouri, 595 U.S. ___, 2022 WL 120950 (U.S. Jan. 13, 2022) (Nos. 21A240 and 21A241)

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CMS may enforce interim final rule imposing COVID-19 vaccine mandate on Medicare and Medicaid facilities.

The Department of Health and Human Services (HHS), acting through the Center for Medicare and Medicaid Services (CMS), issued an interim final rule requiring healthcare facilities participating in Medicare or Medicaid to ensure their staff is vaccinated against COVID-19 to continue receiving federal funds. Two groups of States filed separate actions challenging the rule.  Federal district courts in Louisiana and Missouri enjoined enforcement of the rule. The Government asked the U.S. Supreme Court to stay the injunctions after the Fifth and Eighth Circuits declined to do so.

The Supreme Court stayed the lower court orders enjoining the interim final rule, allowing CMS to enforce it. The Court held that the rule fell within the authority Congress conferred on the HHS to impose conditions on Medicare and Medicaid facilities “necessary in the interest of the health and safety of individuals who are furnished services.”  42 U.S.C. § 1395x(e)(9).  HHS had concluded that a vaccine mandate was necessary to reduce the likelihood that healthcare workers transmitted COVID-19 to their patients. The Court determined this conclusion “fit neatly within the language of the statute.” The Court cited HHS’ longstanding historical practice of imposing safety conditions on participating Medicare and Medicaid facilities, including those that address the control of infectious diseases and relate to the specific duties of healthcare workers, as supporting a broad scope of authority conferred on HHS by Congress.  The Court next rejected the States’ argument that the interim rule was arbitrary and capricious, finding the Secretary did not fail to examine the relevant data or consider the potential staffing shortages the rule could cause.  Finally, the Court held that the HHS established good cause to dispense with normal notice and comment protocol because accelerating the rule’s issuance could reduce COVID-19’s impact before the impending winter flu season.  See 5 U.S.C. § 553(b)(3)(B). The HHS was not required to “consult with appropriate State agencies” under 42 U.S.C. § 1395z, or prepare a regulatory impact analysis, and 42 U.S.C. § 1395 could not be read so broadly as to prevent every condition that the HHS and CMS imposed on Medicare and Medicaid facilities.

Four Justices dissented in two separate opinions. Justice Thomas wrote that the Government had failed to make a strong showing (necessary to stay an injunction) that the HHS had statutory authority to issue the interim rule. The dissent reasoned that, under  42 U.S.C. § 1302(a) and 42 U. S. C. § 1395hh(a)(1), HHS was empowered only to publish rules to carry out the “administration” of Medicare and Medicaid, meaning its authority is limited to the “practical management and direction” of the programs. Compelling millions of healthcare workers to undergo an irreversible and unwanted medical procedure had only a “tangential” connection to Medicare and Medicaid management. The Government failed to cite any other statutes evincing clear Congressional authority for a nationwide vaccine mandate. Instead, vaccine mandates fall squarely within a State’s police power, absent Congress’s clear statement otherwise.

Justice Alito wrote that HHS failed to establish good cause for avoiding the notice-and-comment procedures. The agency’s own delays in issuing and implementing the rule cut against its asserted need to circumvent notice-and-comment. And CMS’s acknowledged uncertainty, coupled with the “‘rapidly changing nature of the current pandemic’” should have made it “more receptive to feedback, not less.” Avoiding notice-and-comment was not harmless, as it prevented States and regulated facilities from presenting evidence refuting or contradicting HHS’s justification for the rule.

The bulletin describing this appellate decision was originally prepared for the California Society for Healthcare Attorneys (CSHA) by H. Thomas Watson and Peder K. Batalden, who are certified appellate specialists and partners at Horvitz & Levy LLP, and is republished with permission.

For more information regarding this bulletin, please contact H. Thomas Watson, Horvitz & Levy LLP, at 818-995-0800 or

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