Lessons learned from COVID-19 | Regulation overview

The Covid-19 pandemic was the most serious threat to public health in the last century. Despite aggressive attempts to contain the virus through social isolation, masking, and treatment, more than 1.1 million Americans died between January 31, 2020, when the U.S. Department of Health and Human Services (HHS) declared COVID-19 a public health emergency. and March 11, 2023, when HHS declared the end of the public health emergency. Of the fatalities, particularly heavy losses were recorded among the elderly, those with weakened immune systems and those living in nursing homes.

In December 2020, the US Food and Drug Administration issued emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines against Covid-19. Despite the widespread availability of free vaccines, uptake has varied significantly. For this reason, doctors and public health officials soon called for a Covid-19 vaccine mandate.

In August 2021, President Joseph R. Biden directed the Centers for Medicare and Medicaid Services (CMS) to require nursing homes to ensure that employees are fully vaccinated against COVID-19 as a condition of participation in the Medicare and Medicaid programs. The Social Security Act provides that facilities participating in the Medicare program must meet certain requirements and that the Secretary of HHS may impose additional requirements deemed necessary to protect the health and safety of patients in hospitals, nursing homes, and other CMS-certified facilities.

HHS emergency declarations authorized its agencies, such as CMS, to issue new health and safety regulations. Additionally, outside of public health emergencies, CMS has the authority to oversee health care delivery systems. CMS issued the vaccination mandate based on substantial evidence showing that the incidence of COVID-19 cases in nursing homes was associated with low vaccination rates among care staff. Moreover, evidence that many nursing homes are not implementing standard infection control practices has accelerated the development and implementation of the vaccine mandate.

The Administrative Procedure Act requires that agencies that wish to opt out of establishing notice-and-comment rules during a public health emergency must demonstrate that submitting to notice-and-comment would be “impractical, unnecessary, or contrary to the public interest.” Based on this, the Biden administration concluded that it could create an emergency regulation requiring vaccinations in nursing homes. Nevertheless, as CMS develops emergency regulations, nursing homes have expressed concern that the regulation could result in widespread staffing shortages as workers refuse to take the vaccine. The industry was concerned that staffing shortages could lead to poorer health outcomes for residents.

In developing the vaccine mandate, CMS’s Center for Clinical Standards and Quality convened several listening sessions from all corners of the health care industry. During the feedback period, several states issued their own vaccination mandates for both nursing homes and hospitals, and individual nursing home chains and hospital systems also proposed vaccination mandates. This patchwork approach has further complicated efforts to curb the spread of Covid-19.

Hospitals and nursing homes were concerned that differences in state regulations could prompt staff to move to different states to avoid vaccination mandates. Several suppliers pushed for a national mandate. A marked increase in the percentage of nurses who sought employment through travel services during the public health emergency confirmed this concern. Several national leaders suggested that a national mandate would be useful for managing interstate variability.

Because of these concerns, CMS and HHS began examining the medical benefits of a national mandate for all health care facilities receiving Medicare funds. Data from the National Health Care Safety Network showed that Covid-19 case rates among long-term care facilities were higher in facilities with lower staff vaccination rates. The agencies also examined the legal basis of the mandate. Most importantly, they determined that systems would be needed to document medical and religious exemptions from vaccination requirements.

Ultimately, CMS issued its regulation in November 2021. Shortly thereafter, 14 states challenged the regulation, maintaining that CMS had exceeded its statutory authority under the Social Security Act. In January 2022, the United States Supreme Court, in a 5–4 decision, upheld the mandate, explaining that:

The Secretary of Health and Human Services has determined that the mandatory rollout of the Covid-19 vaccine will significantly reduce the likelihood of health care workers contracting the virus and transmitting it to their patients. He therefore stated that the vaccine rollout obligation is “essential to promote and protect patient health and safety” in the face of the ongoing pandemic. This principle therefore fits perfectly into the language of the Act.

Importantly, the Court found that the Secretary of HHS examined sufficient evidence to justify the decision to “(1) impose a vaccination mandate rather than a testing mandate; (2) require vaccination of employees with “natural immunity” to prior COVID-19 disease; and (3) moving away from the agency’s previous approach of merely encouraging vaccinations.”

After the Biden administration declared the end of the public health emergency in March 2023, CMS ended its vaccine mandate in August. Ultimately, the mandate did not significantly disrupt the health care ecosystem, and employee resignations resulting from the mandate did not result in adverse health effects across the country.

It is difficult to analyze the exact impacts of vaccine rollouts because many states and localities have already made vaccine rollouts mandatory. Nevertheless, there are at least three important lessons that public health officials can learn for the future from CMS’s experience in mandating Covid-19 vaccines.

First, it will be important to address the inconsistent manner in which states and local health care facilities adopt mandatory vaccination policies during any future pandemic. There should be a nationwide vaccine for health care facilities as soon as a safe and effective vaccine is approved. Early adoption can ensure uniformity across the country, which in turn can help prevent local staffing shortages. The federal government should also monitor and evaluate the impact of any such mandate and adjust how it is implemented as necessary.

Second, public health officials should actively gather evidence to demonstrate the health and safety consequences of unvaccinated staff in Medicare-certified facilities to justify the need to abandon notice-and-comment rulemaking. This evidence could also help justify a national vaccine mandate if challenged in court.

Finally, public health officials should develop and implement rigorous standards for who is exempt from vaccination requirements, balancing civil rights with health care concerns. Strict standards will help ensure that vaccines effectively reduce community transmission of the virus.

The political debate over vaccinations continues today, but these three lessons can help public health officials prepare for future public health emergencies.