On November 5, 2021, the Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) issued the Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination (CMS Mandate), which requires the staff of 21 types of Medicare and Medicaid healthcare providers and suppliers to receive one COVID-19 vaccine by December 6, 2021, and to receive the second vaccine by January 4, 2022. However, two recent rulings by federal courts in Missouri and Louisiana have issued injunctions to allow legal challenges brought by several Republican-led states to make their way through federal courts, prohibiting CMS from enforcing the Mandate.

How did we get here?

In response to the COVID-19 pandemic, CMS issued six previous rulings addressing regulations, data reporting, and infection control requirements to protect healthcare workers from exposure to COVID-19. The June 21, 2021 Healthcare Emergency Temporary Standard (ETS) required healthcare workers to develop a plan for each workplace, which included patient screening, protective equipment, aerosol procedures, physical distancing, physical barriers, cleaning and disinfecting, ventilation, health screening, training, recordkeeping, and reporting.

Just before the CMS Mandate was issued, the Occupational Safety and Health Administration (OSHA) implemented regulations (OSHA Mandate) requiring business owners with 100 or more employees to require their employees to either get vaccinated or to submit to weekly testing. The CMS indicated that the CMS Mandate was complementary to the OSHA Mandate. Both rules were immediately challenged in the courts by Republican-led states. OSHA suspended enforcement of its mandate after a federal appeals court issued a stay ordering it to do so on November 12, 2021.

The CMS Mandate implemented the COVID-19 vaccinations in two phases. The first vaccine was to be required by December 6, 2021, and the second vaccine was required by January 4, 2022. The CMS Mandate also required that medical providers and suppliers “track and securely document” the vaccination status of each staff member, including storing staff members’ medical records showing proof of vaccination.

Legal Challenges

Challenges to the CMS Mandate by Republican-led states quickly followed. In a ruling issued on November 29, 2021 in St. Louis, Missouri, U.S. District Judge Matthew T. Schelp issued a preliminary injunction to halt the CMS Mandate in 10 states, finding that the argument that the CMS lacked authority to implement the requirement likely has merit. Judge Schelp also ruled that CMS improperly bypassed notice and comment requirements, questioned whether there was enough data about transmissibility and vaccination status, and stated that he believed the CMS Mandate may be arbitrary and capricious.

Thereafter, on November 30, 2021, Louisiana U.S. District Judge Terry A. Doughty followed up with his own ruling in a case brought by 14 other states, ruling that a nationwide injunction prohibiting the implementation of the CMS Mandate was necessary. Judge Doughty relied on the injunction issued by the Fifth Circuit enjoining the implementation of the OSHA Mandate and agreed with Judge Schelp that the CMS likely lacked authority to implement CMS Mandate, stating that “[t]here is no question that mandating a vaccine to 10.3 million healthcare workers is something that should be done by Congress, not a governmental agency. It is not clear that even an Act of Congress mandating a vaccine would be constitutional. Certainly, CMS does not have this authority by a general authorization statute.” The scope of Judge Doughty’s injunction applies nationwide except for those 10 states which fell under Judge Schelp’s similar injunction issued a day earlier.

What this all means

These two rulings are the latest setbacks for the Biden administration’s efforts to combat the COVID-19 pandemic by increasing vaccination rates through mandates and requirements. For the time being, there is no requirement that employees of Medicare and Medicaid providers and suppliers receive the COVID-19 vaccination; nor is there a requirement for employers with over 100 employees to set up a mandatory vaccine protocol under federal law. However, with the emergence of the new Omicron variant, increasing infection rates, and emerging court rulings, employers should stay tuned.