On January 13, the Supreme Court handed down a pair of decisions on the CMS vaccine mandate rule and the OSHA vaccine-or-test rule. In short, the Court ruled in this opinion that CMS is not prohibited from implementing its vaccine mandate for Medicare-funded facilities (the Interim Final Rule or “IFR”). In a separate opinion, the Court held that OSHA may not enforce or implement its vaccine-or-test Emergency Temporary Standard (“ETS”) for employers with 100 or more employees. The rulings reversed decisions by the federal Courts of Appeal in the Fifth and Eighth Circuits, which had blocked CMS’s requirements, as well as the Sixth Circuit, which had lifted prior injunctions on OSHA’s vaccine-or-test ETS.

As a result, health care facilities covered by the CMS rule should immediately begin implementing their vaccine policies in accordance with the IFR requirements. In a January 13 statement, CMS clarified that the decision would not change the compliance deadlines for health care employers in the 25 states, territories and the District of Columbia, where the CMS IFR was already in effect. Those deadlines (January 27 and February 28, 2022) are described in more detail in in the Compliance Dates section of our earlier article here.

For now, it appears that the compliance deadlines are different for facilities in states where prior court rulings had put a hold on the CMS rule, as the CMS statement specifically stated as follows: “As a result of today’s decision, health care providers subject to the Omnibus Health Care Staff Vaccination rule in the 24 states (Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Utah, West Virginia, and Wyoming) covered by this decision will now need to establish plans and procedures to ensure their staff are vaccinated and to have their employees receive at least the first dose of a COVID-19 vaccine.” In terms of specific compliance deadlines for the facilities in the 24 “newly covered” states, we anticipate clarifying information to be issued in the near future via CMS Surveyor Guidance.

Employers and facilities not covered by the CMS rule should continue to ensure compliance with various state and local requirements for COVID-19 mitigation along with applicable guidance from the CDC.

In light of the Supreme Court ruling, OSHA would now have to defend its vaccine-or-test ETS on the merits before the lower federal courts. If a dispositive decision is entered in one of the cases, an appeal may make its way back before the Supreme Court.

Background

In an unconventional move, the Supreme Court heard oral argument on the OSHA and CMS cases before the full Court.

Because of the procedural posture of the emergency applications, the Supreme Court’s decision is technically limited in scope. The emergency order—part of the Court’s so-called “shadow docket”—remains in effect until the federal circuit courts can hear each case on the merits. A final merits disposition from a federal appellate court will displace the Supreme Court’s order.

The four consolidated cases before the Court involved two challenges to OSHA’s vaccine-or-test ETS and two challenges to CMS’s IFR. In the case of the OSHA ETS, the plaintiff business association submitted applications to the Supreme Court seeking a reinstatement of the stay previously dissolved by the Sixth Circuit. In the case of the CMS IFR, the government requested dissolution of the stay in effect for that rule in many states to prevent CMS from enforcing its vaccine requirements.

After the litany of nationwide OSHA cases were consolidated to the Sixth Circuit in a lottery, the Sixth Circuit lifted the stay on enforcement of OSHA’s ETS. OSHA then issued a statement that it would not take enforcement action on any part of the ETS until January 10, 2022 and would not enforce that COVID-19 vaccine and testing requirements until February 9, 2022 provided that employers were exercising “reasonable, good faith efforts to come into compliance with the standard.”

The CMS cases came before the Court after the Fifth Circuit and the Eight Circuit upheld district court decisions blocking implementation of the CMS vaccine mandate. In the first case, a district court in Louisiana issued a nationwide injunction against the rule, but the Fifth Circuit limited the scope of the order to only the plaintiff states. The Eleventh Circuit, however, has declined to block implementation of the CMS rule. The cases now return to the circuits for disposition.

Supreme Court Upholds CMS’s IFR for Health Care Facilities

In its January 13 order, the Supreme Court majority approved the federal government’s request to stay the injunctions entered by district courts against the CMS IFR. In finding that the IFR falls within the power vested within the Secretary of Health and Human Services, the Court agreed that the Secretary is specifically given the power to impose conditions that he “finds necessary in the interest of the health and safety of individuals” who are beneficiaries of Medicaid or Medicare. Apart from this IFR, the Secretary has “routinely” imposed conditions of participation that turn on actions of the health care workers within a covered entity, such as participation in “infection prevention and control guidelines” which historically were justified under this same authority.

With the rapid spread of COVID-19 despite previously implemented infection control guidelines, the Court noted that evidence suggests that portions of CMS’s patient population “forego seeking medically necessary care” because of a “fear of exposure” to COVID-19. This is coupled with the fact that some Medicare and Medicaid beneficiaries are of poor health, disabled or elderly, leading to a “particularly dangerous” set of symptoms from infection.

The Court stated that a vaccination mandate as a condition of payment “fits neatly” within the Secretary’s powers as a mechanism to ensure that health care providers are actively attempting to avoid spreading COVID-19 to their patients and further is like a “fundamental principle” of health care called for in the Hippocratic Oath stating, “first, do no harm.”

Supreme Court Blocks OSHA’s Vaccine-or-Test ETS

The Court’s order stays enforcement of OSHA’s ETS pending final disposition in the lower courts. The Court ruled that OSHA’s ability to regulate workplace hazards did not empower it to regulate a public health concern more broadly. Thus, OSHA’s vaccine-or-test ETS may well be beyond the scope of authority that Congress granted the agency. The Court noted it could “expect Congress to speak clearly when authorizing an agency to exercise powers of vast economic and political significance.”

In a concurring opinion Justice Gorsuch–joined by Justices Thomas and Alito–emphasized the role of the major questions doctrine in reigning the power of the federal government. Justice Gorsuch noted that the power to mandate vaccines was squarely within the scope of the states’ police powers.

Dissenting, Justices Breyer, Sotomayor and Kagan worried that the Court’s ruling may hinder mitigation of an unprecedented public health crisis. Though the Court (i.e., the majority opinion) ruled that Congress and states must play the central role in tackling a public health emergency, the dissenting Justices argued that Congress had authorized OSHA to do so.

Important Additional Reminder for Health Care Organizations

In late December 2021, OSHA “withdrew” most of the components of its healthcare-specific emergency temporary standard (“Healthcare ETS”) but said that covered employers must continue their recordkeeping and reporting obligations under that rule. At the same time, OSHA emphasized that it would continue to “vigorously enforce the general duty clause and its general standards, including the Personal Protective Equipment (‘PPE’) and Respiratory Protection Standards, to help protect healthcare employees from the hazard of COVID-19.” OSHA also noted that it was planning to propose a permanent standard for infectious diseases covering all industries in April 2022. The January 13 Supreme Court decisions do not affect what remains of OSHA’s Healthcare ETS.

Practical Takeaways

For employers, health care facilities and providers, the question now is: what next?

  • In practical terms, the “wait and see” window has closed. Although the Supreme Court’s decision technically dealt with lifting/reinstating lower court injunctions, the Court has clearly signaled that CMS’s IFR is valid and OSHA’s vaccine-or-test ETS is not valid. Thus, if the cases were to work their way back up through the federal judiciary “on the merits,” we most likely land on the same position where we find ourselves today.
  • Facilities covered by the CMS vaccine rule in the 25 states, territories and District of Columbia where the injunction had previously been lifted are regulated by the compliance dates that CMS included in its Guidance for the Interim Final Rule – Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination.
  • Per CMS, facilities covered by its vaccine rule in the 24 “newly covered” states where the rule had been enjoined “will now need to establish plans and procedures to ensure their staff are vaccinated and to have their employees receive at least the first dose of a COVID-19 vaccine.” We’ll closely monitor the anticipated CMS Surveyor Guidance that will likely spell out the specific compliance deadlines for the facilities in the “newly covered” states. Covered facilities should not delay compliance efforts, though, as we do not expect lengthy deadline extensions.
  • In states where restrictions on vaccine rules are in place (e.g., vaccine prohibition laws and vaccine “passport” laws), even health care organizations covered by the CMS rule should consult with counsel and monitor litigation developments on which rule controls, as issues of “preemption” may still need to be navigated.
  • Employers with 100 or more employees who would have been covered by the OSHA vaccine-or-test ETS need not comply with that rule at this time and the future “successful” prospects of that rule seem highly unlikely.
  • Employers covered by OSHA’s previous Healthcare ETS must continue to follow the recordkeeping and reporting obligations under that rule and should highly consider continuing to follow the related PPE and Respiratory Protection Standards as advised by OSHA.