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

On Nov. 5, 2021, CMS issued an interim final rule requiring healthcare worker immunizations.1 As this report was filed, neither the Biden administration nor CMS had responded to the lawsuits.

However, 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 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. (See the CMS interim rule for the full list.) Overall, the vaccine requirement applies to 17 million healthcare workers and approximately 76,000 medical facilities.

Under the deadline requirements by the CMS, 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, 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 stated. In keeping with guidelines by the Centers for Disease Control and Prevention (CDC), CMS is not requiring the booster shot nor 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],” CMS said.

Legal Challenges

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.”

The plaintiffs in the two separate state suits argue the vaccine mandate will create an exodus of healthcare workers that will ultimately endanger patients in chronically understaffed facilities.

“A natural and predictable consequence of the CMS vaccine mandate is that numerous state and private healthcare workers may be fired, retire, or quit their jobs,” claimed a lawsuit filed by 10 states on Nov. 11, 2021. “This injury is especially acute because of the already-critical healthcare workforce shortage that the plaintiff states are experiencing.”2

The suit was signed by the respective attorneys general of Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota, and New Hampshire.

“This case illustrates why the police power over compulsory vaccination has always been the province of — and still properly belongs to — the states,” the plaintiffs emphasized. “Vaccination requirements are matters that depend on local factors and conditions.”

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.

The second suit claims the mandate violates the Social Security Act, which focuses “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

“I think these challenges to CMS are likely to fail,” says Lawrence Gostin, JD, a law professor at Georgetown University in Washington, DC. “The argument that health workers will leave and there will be workforce shortages is flawed. First, workforce shortages are not legal arguments at all. They are policy issues.”

Although noting he does not think the mandates will weaken the healthcare workforce, Gostin says even if that happened, it would be irrelevant from a legal perspective.

“I think CMS is on strong legal grounds because it can set reasonable conditions on the receipt of Medicare and Medicaid funding,” he says. “Requiring vaccinations are clear and reasonable health and safety requirements.”

In a separate legal action on Nov. 12, 2021, a federal appeals court in New Orleans blocked the COVID-19 vaccination mandate for companies with 100 or more employees. That federal action, which is enforced by the Occupational Safety and Health Administration, allows weekly COVID-19 testing for those who decline vaccination. Lawyers for the Labor Department argued to no avail that delaying or stopping the business mandate could result in loss of life due to COVID. As this report was filed, the stay on the rule had not been lifted while the impact on businesses and the economy was further assessed. The American College of Emergency Physicians, the American Public Health Association, and many other medical groups and associations signed off on a letter urging businesses to embrace the mandate as the best way forward for the economy.

“When employers require workers to get vaccinated, vaccination rates increase to over 90%,” the groups wrote. “Courts have repeatedly supported the legality of employer mandates. We — physicians, nurses and advanced practice clinicians, health experts, and healthcare professional societies — fully support the requirement that workers at companies with [at least] 100 workers be vaccinated or tested.”4

Ethical High Ground

The CMS rule for healthcare, which does not offer the testing option, claimed the ethical high ground, underscoring the time-honored duty of medical providers to protect their 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,” CMS said in the rule. “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.”1

This is the crux of the issue, and one that may be critical in weathering legal challenges, says William Schaffner, MD, a vaccine advocate and a professor of preventive medicine at Vanderbilt University.

“I think mandates in the healthcare setting will prevail, and that’s a good thing,” he says. “I continue to believe that healthcare providers getting vaccinated is both a professional and an ethical obligation. This is a patient safety issue. It is also an issue of preparing ourselves so that we can provide care when it is needed so that we are not home sick and are able to function on the job.”

As with many other facilities acting before the CMS mandate, the university and hospital already have mandated COVID-19 vaccination for all employees.

“We are mandated here at Vanderbilt and we have achieved 99% success,” Schaffner says. “It’s been hard work, but it has been friendly, intensive, supportive, and collaborative.”

A critical component of the COVID-19 immunization drive was asking trusted senior faculty and administrators of color to contact reluctant workers in ethnic and racial communities.

“We are very proud to have achieved this kind of success,” Schaffner says. “We have lost very few employees, and the people who are exempted are exempted for valid reasons.”

Rural Hospitals, LTC Fear Shutdowns

The CMS healthcare mandate has received close to 1,000 comments as this report was filed, 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. The rule was open for comments until Jan. 4. While many commentors accused CMS and the Biden administration of constitutional overreach, others reminded that vaccines have always been required in healthcare.

“Of course, all healthcare workers should have to be vaccinated for COVID-19,” an unidentified physician from Ohio commented to CMS. “This is a public health issue, not a personal rights issue. Just like we have to get a TB test, flu shot, etc., we need to protect ourselves and our patients. For those who do not want to be vaccinated, perhaps they do not belong in healthcare, because clearly they don’t believe in the system or in science.”1

But even healthcare workers who are voluntarily fully vaccinated against COVID-19 warn of the unintended consequences of the federal vaccine mandate, particularly to LTC and rural facilities already hit hard by the pandemic.

In comments submitted to CMS, an unidentified infection prevention nurse at an LTC facility in South Dakota said the mandate could compromise resident care and halt new admissions due to inadequate staffing.

“I’m vaccinated — I’m an infection control nurse,” the commenter wrote. “I believe that the vaccine is helpful, but I don’t think it is right to force the vaccine on someone who doesn’t want it. Our facility has 100% of our residents fully vaccinated. We have 79 staff who are fully vaccinated, and 15 staff who aren’t vaccinated.”1 That is an 84% immunization rate, but the facility will be in trouble if those unvaccinated workers quit or have to be fired.

“My facility has the potential to lose 15 staff unless they qualify for a waiver,” the commenter wrote. “South Dakota has a serious shortage of licensed nursing staff as well as certified nursing assistants to care for our elders. This shortage isn’t new due to COVID. We struggle daily to find enough staff to work. We have had to reach out to very expensive staffing agencies to find staff. My facility is going to have to shut down a wing, move residents from one room (their home) to another room. How is that good for their emotional health? Give us some other testing options to keep our unvaccinated staff.”

Many other commenters made a similar request, some citing the weekly COVID-19 testing option that is allowed to non-healthcare businesses with 100 employees or more.

A vaccine proponent, Michael Matthews, MD, is a family physician at Syringa Hospital and Clinics in Grangeville, ID. Citing the extreme remoteness of his facility, Matthews told CMS the mandate could close his critical care hospital as employees quit. Idaho has one of the lowest vaccination rates in the country, and that attitude spills over to healthcare workers.

“I firmly believe that the least catastrophic way to pass through this pandemic is to vaccinate,” he wrote. “[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.”

Patients Refuse Care from Unvaccinated?

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

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

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.5 Signatories include the American Nurses Association and the American Medical Association.

Again, numerous health systems and individual healthcare employers across the country already 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,” CMS stated in the rule.

As required by the 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,” CMS stated.

CMS plans to issue interpretive guidelines for the healthcare vaccine requirements, 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,” CMS stated. “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] also will instruct surveyors to conduct interviews [of] staff to verify their vaccination status.”

REFERENCES

  1. Centers for Medicare & Medicaid Services. Medicare and Medicaid programs; omnibus COVID-19 health care staff vaccination. Federal Register. Nov. 5, 2021.
  2. Missouri et al v. Biden. U.S. District Court Eastern District of Missouri. Nov. 11, 2021.
  3. Louisiana et al v. Becerra et al. U.S. District Court Western District of Louisiana. Nov 15, 2021.
  4. American Public Health Association. Leading health experts and professional organizations: Businesses should support OSHA’s COVID vaccine mandate. Nov. 19, 2021.
  5. 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. July 22, 2021.