IMMEDIATE UPDATE: The Supreme Court Allows CMS’s Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule to Continue and Halts OSHA’s Emergency Temporary Standard

*This blog post updates the “Biden Administration Requires Vaccination for Medicare and Medicaid Certified Providers/Suppliers by January 2022: CMS Issues its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule” blog post of November 5, 2021

Supreme Court Decisions

On January 13, 2022, in response to numerous legal challenges premised on the lack or abuse of executive authority, the Supreme Court issued separate decisions that:

1. allows the Centers for Medicare and Medicaid Services’ (CMS) Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (IFR) to proceed forward nationally, and;

2. halts enforcement of the Department of Labor’s Occupational Safety and Health Administration’s (OSHA) COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS) nationally.

Both decisions are immediately effective.

Key Determinations of the Supreme Court

CMS IFR

In pertinent part, the Supreme Court determined that the Secretary of Health and Human Services has the statutory authority to impose conditions on providers and suppliers who receive Medicare and Medicaid funding in the interests of protecting the health and safety of patients who receive services from them. The Court accepted the Secretary’s position that (i) the COVID-19 vaccine mandate will substantially reduce the likelihood that healthcare workers will contract the virus and transmit it to their patients, and (ii) is necessary to promote and protect patient health and safety during the public health emergency.

The Court concluded that ensuring providers take steps to avoid transmitting COVID-19 to their patients is consistent with the fundamental principle of the medical profession: “first, do no harm.” The Court also concluded that it would be the opposite of effective administration for a provider or supplier that is supposed to make people well to make them sick with COVID-19.

OSHA ETS

The Supreme Court halted the OSHA ETS based on its determination that although Congress has given OSHA the power to regulate occupational dangers, it has not given that agency the power to regulate public health more broadly. The Court determined that although COVID-19 is a risk that occurs in many workplaces, it is not an occupational hazard in most (e.g., the virus spreads at home, in schools, during sporting events, and everywhere else that people gather). The Court determined that COVID-19 is akin to a universal risk that is no different from the day-to-day dangers that individuals face from air pollution or any number of communicable diseases.

The Court did, however, determine that OSHA has the authority to regulate occupation-specific risks related to COVID–19 through targeted workplace safety regulations (e.g., regulations targeted at researchers who work with the COVID–19 virus, or employees who work in particularly crowded or cramped environments) because the danger presented in such workplaces differs in both degree and kind from the everyday risk of contracting COVID–19 that all face.

Because the OSHA ETS fails to distinguish between occupational risk and risk more generally, the Court determined that it is an impermissible general public health mandate rather than an occupational safety or health standard.

Necessary Compliance Actions for Medicare Providers and Suppliers

Providers and suppliers who are certified under the Medicare and Medicaid programs and regulated by the CMS health and safety standards (i.e., “Conditions of Participation,” “Conditions for Coverage,” or “Requirements for Participation”) (“Covered Providers”) must have:

1. IFR safety policies and procedures in place, and;

2. all covered staff (i.e., workforce members who are not in fully remote positions) fully vaccinated by an FDA approved or authorized COVID-19 vaccine, absent medical or religious exemption.

Unless and until CMS issues clarifying guidance on the previously issued compliance deadlines, Covered Entities should plan to have (a) IFR safety policies and procedures in place and covered staff’s first vaccine shot by January 27, 2022, and (b) covered staff to be fully vaccinated by February 28, 2022. CMS also previously stated that Covered Providers who are not in 100% compliance by March 30, 2022 may be subject to enforcement action.

Steps to Ensure Compliance

1. Policy and Procedure Implementation – Covered Providers should draft and/or review the CMS IFR required safety policies and procedures and provide compliance training to Covered Providers’ workforce.

2. Risk Assessment – Covered Providers should evaluate their enterprise policies and procedures to mitigate enforcement risk. Downstream consequences of IFR compliance impact vendor contract obligations, employee health operations, supply chain processes, vendor credentialing, etc.

3. Enforcement Defense – Be prepared to defend against potential non-compliance and/or enforcement actions

Nixon Gwilt Law can help. Please contact us for a consultation.

What Happens Next?

Although the Supreme Court decisions technically remand the cases to the lower Federal courts for additional disposition, we do not expect the lower courts to issue any decisions that have a substantive legal impact on today’s Supreme Court decisions. In short, the CMS IFR is here to stay and the OSHA ETS, as is currently written, is unenforceable. Based on the position of the Biden administration to date, we anticipate OSHA issuing a new narrowly targeted emergency temporary standard based on today’s implicit guidance from the Supreme Court.