Doctor giving a senior woman vaccination

The issue is far from settled legally, as challenges to the hold loom in two federal appeals courts.

Since the onset of the pandemic, many organizations have struggled with a range of competing interests while trying to provide safe, medically necessary patient care, protecting the health and safety of hospital and medical staff, and managing supply chains and margins.

Eventually, vaccines arrived. At this time, as many as 70 percent of eligible American adults have signed up, lined up, and received vaccines. The reasons for non-vaccination range from religious to complaints that the vaccination is too new to straight-up conspiracy theories.

Many healthcare organizations applauded the Centers for Medicare & Medicaid Services (CMS) when it announced a policy to fight COVID-19 that will “drive even more progress and result in millions of Americans getting vaccinated, protecting workers, preventing hospitalization, saving lives, and strengthening the economy.” Yet the policy met with near-instantaneous legal challenges.

CMS found its regulatory authority for the rule in the Conditions of Participation. The basics of the mandate are:

  • This is an interim final rule with comment period. The rule is effective immediately, but there is comment period until Jan. 4.
  • Virtually all healthcare workers are required to be fully vaccinated no later than Jan. 4.
  • The rule allows for exemptions and reasonable accommodations for religious reasons (as required under the Civil Rights Act) or medical reasons (as required under the Americans with Disabilities Act, or ADA).
  • The rule allows no “testing alternative.”
  • Enforcement of the rule will be through state surveys, either:
    • Assessment during the standard recertification survey; or
    • During (and this is a direct quote) “all complaint surveys”
  • Surveyors will review COVID-19 cases over the last four weeks and create a list of all staff and their vaccination status.
  • The penalty for hospital non-compliance is termination although facilities would have an opportunity to come into compliance.

But the mandate has been brought to a halt, at least temporarily. District courts in Missouri and Louisiana issued injunctions blocking enforcement of CMS’s rule. Together these rulings comprise a nationwide injunction. The essential holdings from both courts are:

  • First, CMS had acted outside its authority;
  • Second, CMS bypassed proper notice-and-comment protocols;
  • Third, the mandate is arbitrary and capricious; and
  • Last, the plaintiffs would likely prevail at trial and would face irreparable harm if enforcement was not enjoined.

As of last Friday, appeal notices have been filed in both the 8th and 5th circuits.

It is possible that the mandates will return. Hospitals should use this time to assess staffing if that happens. Hospitals should also plan for rigorous compliance with the documentation requirements associated with medical and religious exemptions. Hospitals must manage the disparities between ADA-mandated medical exemptions and Civil Rights Act-mandated religious exemptions. Hospitals must be able to show that medical exemptions are provided by a qualified provider, consistent with recognized contraindications to vaccination. Documentation regarding religious exemptions should align with sincerely held religious beliefs. Denial of either exemption should be expected to lead to litigation. Finally, hospitals should prepare for complaints from vaccinated staff that not enough is being done to protect them from unvaccinated staff. This may lead to complaints to the Occupational Safety and Health Administration (OSHA) or state agencies.

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