While emphasizing the national threat of the pandemic and the safety and efficacy of the SARS-CoV-2 vaccines, the Centers for Medicare & Medicaid Services (CMS) came down to one bedrock reason healthcare workers now face mandated immunization: their ethical duty to protect patients.

“Patient safety is a central tenet of the ethical codes and practice standards published by healthcare professional associations, licensure and certification bodies, and specialized industry groups,” the CMS said in an Interim Final Rule published on Nov. 5, 2021.1 “Healthcare workers also have a special ethical and professional responsibility to protect and prioritize the health and well-being of those they are caring for, as well as not exposing them to threats that can be avoided. This holds true not only for healthcare professionals, but also for all who provide healthcare services or choose to work in those settings. The ethical duty of receiving vaccinations is not new, as staff have long been required by employers to be vaccinated against certain diseases.”

The CMS asserted its authority to establish health and safety standards under its “Conditions of Participation,” and said 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.”

In addition to hospitals, long-term care, and skilled nursing facilities, the vaccination mandate applies to ambulatory surgical centers, hospices, psychiatric residential treatment, homecare, and other healthcare settings. (See the CMS interim rule for the full list.) Overall, the vaccine requirement applies to about 17 million healthcare workers and approximately 76,000 medical facilities.

The CMS has set two deadlines for vaccination, the first effective one month after publication of the rule and the second a month later. Under these requirements, all staff must have received at least the first dose of a primary series (Pfizer, Moderna) or a single dose COVID-19 vaccine (Janssen) by Dec. 6, 2021, unless they have been granted an exemption for medical or religious reasons.

By Jan. 4, 2022, all non-exempt staff must have received the second shot in an immunization series. “We believe it is necessary to begin staff vaccinations as quickly as reasonably possible,” the agency states. In keeping with the Centers for Disease Control and Prevention, the CMS is not requiring the booster shot or including it in its definition of those fully vaccinated.

“Although an individual is not considered fully vaccinated until 14 days after the final dose, staff who have received the final dose of a primary vaccination series by the Phase 2 effective date are considered to have met the individual vaccination [requirement],” the CMS said.

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,” the 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.”

Serious Effect Feared

Less than a week after the rule was posted and opened for feedback, there were more than 180 comments — many from rural healthcare facilities or nursing homes that said the vaccine mandate will create a loss of staff that will severely compromise care or even shut them down. (See “CMS Warned of Mandate’s Threat to LTC, Rural Sites.”) As this report was published, the rule was open for comments until Jan. 4, 2022.

A vaccine proponent, Michael Matthews, MD, a family physician at Syringa Hospital and Clinics in Grangeville, ID, told CMS the mandate could close his facility.

“I [work] at a rural health clinic and an 11-bed independently owned critical-access hospital in a city of 3,200 people in one of the most remote, least population-dense areas in the lower 48 states,” he said.

Medical resources are scarce, and the people who live there are “fiercely independent” about things in general and the COVID-19 vaccine specifically, he said.

“This vaccine hesitancy holds true among our hospital and clinic staff, as many registered nurses, CNAs, radiology technicians, and medical assistants remain unvaccinated,” Matthews said. “Most are adamantly opposed to doing so.”

Although he tries to encourage vaccinations, Matthews said the mandate should be reconsidered for such remote facilities.

“I firmly believe that the least catastrophic way to pass through this pandemic is to vaccinate,” he said. “[But] when a nurse quits, we feel the stress of their absence. When this happens, there often is nobody to turn to [and] fill the gap. It does not take many nurses quitting before we lose our ability to keep our hospital and emergency department open.”

Although other commenters argued the mandate was constitutional overreach by the federal government, one anonymous post applauded CMS and reminded that many vaccines always have been required. “This vaccine is in no way different from any others given at the time we’re all born, at our three-month checkup, six-month, one-year, 18 months, annual flu shot, and so on,” the commenter said. “Without this mandate and without everyone getting vaccinated, this virus will forever continue to mutate.”

Still, there was sufficient debate about the ethics of vaccine mandates within the National Institutes of Health (NIH) for the NIH bioethics department to schedule a Dec. 1, 2021, live-streamed, roundtable discussion on the issue. The time of the event, which will be open to the public, had not been announced and was not on the NIH official “upcoming meetings schedule” as this report was filed. One of the issues apparently is the argument that the nation would be better served by letting more natural immunity develop. Speculation is that this event, if it had any effect on public policy, would fall primarily in the public sector, not healthcare settings.

The mandate is necessary in healthcare because unvaccinated staff not only pose a risk to admitted patients but contribute to the general pandemic trend of people avoiding medical care, the CMS emphasized in the rule.

“Nationwide, there are reports of individuals avoiding or forgoing healthcare due to fears of contracting COVID-19 from healthcare workers,” the rule states. In addition, CMS cited “anecdotal reports” that admitted patients are refusing care from unvaccinated healthcare workers.

The CMS has the broad backing of the medical community in mandating COVID-19 vaccines for healthcare workers, with more than 50 professional societies and associations supporting required immunizations in a joint statement.2

Signatories include the Association for Professionals in Infection Control and Epidemiology and the Society for Healthcare Epidemiology of America. Also signing off to support mandates for healthcare personnel were the American Academy of Pediatrics, American Medical Association, and the American Nurses Association.

Of course, numerous health systems and individual healthcare employers across the country have implemented SARS-CoV-2 vaccine mandates as a condition of employment.

“Despite the successes of these organizations in increasing levels of staff vaccination, there remains an inconsistent patchwork of requirements and laws that is only effective at local levels and has not successfully raised staff vaccination rates nationwide,” the CMS stated in the rule.

Some states have established laws against vaccine mandates, but CMS cited the Supremacy Clause in the Constitution in saying federal regulations will preempt such state laws.

As required by the CMS rule, hospitals and other healthcare facilities must track and document the vaccination status of all employees, including records of those granted exemptions.

“This documentation will be an ongoing process as new staff are onboarded,” the CMS stated.

The CMS plans to issue interpretive guidelines for the vaccine rule, which will include survey procedures. The facilities policies and procedures will be examined to ensure all components of the rule are in place.

“We will advise and train state surveyors on how to assess compliance with the new requirements among providers and suppliers,” the CMS rule states. “For example, the guidelines will instruct surveyors on how to determine if a provider or supplier is compliant with the requirements by reviewing the entity’s records. [They] will also instruct surveyors to conduct interviews [of] staff to verify their vaccination status.”

REFERENCES

  1. 86 Fed Reg 61555 (Nov. 5, 2021).
  2. Association for Professionals in Infection Control and Epidemiology. APIC signs on to joint statement in support of COVID-19 vaccine mandates for all workers in health and long-term care. https://apic.org/news/apic-signs-on-to-joint-statement-in-support-of-covid-19-vaccine-mandates-for-all-workers-in-health-and-long-term-care/