The legal battle over COVID-19 vaccine mandates in healthcare continues, as federal judges have granted injunctions blocking the federal requirement. With similar challenges stalling the federal mandate for businesses with at least 100 employees, it is increasingly looking like these controversial attempts to stop the pandemic are headed to the highest court in the land.

“I see this mandate, as well as the OSHA mandate [for businesses], landing in the Supreme Court,” says vaccine advocate Lawrence Gostin, JD, a law professor at Georgetown University in Washington, DC. “The judiciary, including the Supreme Court, is hostile to vaccine mandates, so overall I am becoming less optimistic. I worry the courts will just dig in and ignore the clear legal, policy, and public health arguments in favor of mandates.”

Individual hospitals still may mandate vaccines as a condition of employment, as many do for measles and other infectious diseases, says Anne Marie Pettis, RN, BSN, CIC, president of the Association for Professionals in Infection Control and Epidemiology (APIC). “They could make it a condition of employment just like many hospitals have done previously for influenza. So, any organization could not do that.”

Individual states may try to issue bills for or against mandates, as New York state has done, requiring vaccination of employees of healthcare facilities.

“We were going to do weekly testing for those not vaccinated, but that did not fly because of the mandate in New York state,” says Pettis, director of infection prevention at University of Rochester (NY) Medicine. “APIC and other organizations have come out in favor of mandatory vaccinations in healthcare. We have been a little more hesitant about mandatory vaccinations across the board [to include businesses]. It’s so politically charged, and it may be a bit of an overreach for our organization.”

On Nov. 5, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule requiring healthcare worker immunizations.1 In the rule, CMS asserted its authority to establish health and safety standards under its Conditions of Participation, saying those who fail to comply with the vaccination rule face the full gamut of penalties. These include fines, denial of payment for new admissions, or “termination of the Medicare/Medicaid provider agreement.” Referring to states that have established laws against vaccine mandates, CMS also cited the Supremacy Clause in the U.S. Constitution in arguing federal regulations will pre-empt such state laws.

The mandate applies to hospitals, long-term care (LTC), skilled nursing facilities, ambulatory surgical centers, hospices, psychiatric residential treatment, home care, and other healthcare settings. Overall, the vaccine requirement applies to 17 million healthcare workers and approximately 76,000 medical facilities. In addition to medical contraindications, the COVID-19 vaccine requirements are subject to existing federal antidiscrimination laws.

“Certain allergies; recognized medical conditions; or religious beliefs, observances, or practices, may provide grounds for exemption,” CMS noted. For those exempted under such grounds, CMS requires healthcare facilities to “have a process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19.”

As of Dec. 10, 2021, the National Academy for State Health Policy (NASHP), a nonpartisan group, reported 23 states have adopted vaccine mandates, six states have banned mandates in healthcare, and five states have specified in law that healthcare facilities are exempt from state bans.2

In addition, under the Biden Administration’s directive, the Occupational Safety and Health Administration (OSHA) requires employers with 100-plus employees to mandate COVID-19 vaccinations and requires any unvaccinated workers to undergo weekly testing.

Citing the national shortage of nurses and other issues, 22 states have joined in two separate lawsuits demanding the Biden administration and the CMS halt their mandate of COVID-19 vaccination for healthcare workers.

One suit was signed by the respective attorneys general of Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota, and New Hampshire. A similar suit was filed on Nov. 15, 2021, by 12 states: Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma, South Carolina, Utah, and West Virginia.

Timeline of Legal Blockade

According to the National Academy for State Health Policy, here is a timeline of the ensuing court action that effectively has blocked the federal mandates pending appeal:

  • Nov. 12, 2021: The U.S. Court of Appeals for the Fifth Circuit temporarily halted OSHA’s rule for COVID-19 vaccination or a test out option for companies with 100+ employees.
  • Nov. 29, 2021: The U.S. District Court for the Eastern District of Missouri blocked the CMS regulation for healthcare workers in 10 states.
  • Nov. 30, 2021: The U.S. District Court for the Western District of Louisiana granted a nationwide preliminary injunction, halting the federal vaccination mandate for healthcare workers.
  • Dec. 7, 2021: The U.S. District Court Judge for the Southern District of Georgia issued a preliminary nationwide injunction to halt the Biden administration’s vaccine mandate for federal contractors.

The successful arguments by plaintiffs in the healthcare suits included that mandating COVID-19 vaccines will create an exodus of healthcare workers, one that ultimately will endanger patients in chronically understaffed facilities. Another point was that the healthcare mandates violate the Social Security Act provision on patient welfare and patient access to care. “By forcing a significant number of healthcare workers to take the shot(s) or exit the Medicare and Medicaid workforce, CMS’s vaccine mandate harms access to (and thus quality of) patient care,” the plaintiffs argued.3

REFERENCES

  1. 86 Fed Reg 61,555 (2021).
  2. National Academy for State Health Policy. State efforts to ban or enforce COVID-19 vaccine mandates and passports. Updated Dec. 10, 2021. https://www.nashp.org/state-lawmakers-submit-bills-to-ban-employer-vaccine-mandates/
  3. Louisiana et al v. Becerra et al. U.S. District Court Western District of Louisiana. Nov 15, 2021.