The COVID-19 response illustrates steps officials should take to ensure the effectiveness of vaccine mandates.
The COVID-19 pandemic was the worst public health emergency of the last century. Despite aggressive attempts to contain the virus by social isolation, masking, and medical management, over 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 public health emergency over. Of those that perished, there was a particularly tremendous loss among the elderly, immunocompromised, and those in nursing homes.
In December 2020, the U.S. Food and Drug Administration issued emergency use authorizations for the Pfizer-BioNTech and Moderna COVID-19 vaccines. Despite the widespread availability of the vaccines at no cost, their adoption varied considerably. For this reason, physicians 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 their workers were fully vaccinated against COVID-19 as a condition of participating in the Medicare and Medicaid programs. The Social Security Act provides that facilities participating in Medicare must meet certain requirements and that the HHS Secretary may impose additional requirements deemed necessary to protect the health and safety of patients in hospitals, nursing homes, and other CMS-certified facilities.
HHS’s emergency declarations authorized its component agencies, such as CMS, to issue new health and safety regulations. In addition, outside of public health emergencies, CMS has the authority to oversee healthcare delivery systems. CMS issued its vaccine mandate based on substantial evidence demonstrating that the prevalence of nursing home COVID-19 cases was related to low levels of vaccination among care staff. Furthermore, evidence that many nursing homes were not implementing standard infection control practices accelerated vaccine mandate drafting and execution.
The Administrative Procedure Act requires that agencies that wish to forgo notice-and-comment rulemaking during a public health emergency must demonstrate that undergoing notice-and-comment would be “impracticable, unnecessary, or contrary to the public interest.” The Biden Administration concluded on this basis that it could create an emergency regulation to require vaccines in nursing homes. Nevertheless, as CMS was developing its emergency regulation, nursing homes expressed concern that the mandate could trigger widespread staff shortages because workers would refuse to receive the vaccine. The industry feared that a staffing shortage could lead to worse health outcomes for residents.
While developing the vaccine mandate, the CMS Center for Clinical Standards and Quality convened several listening sessions from all corners of the healthcare industry. During this feedback period, several states issued their own vaccine mandates in both nursing homes and hospitals, and individual nursing home chains and hospital systems also proposed vaccine mandates. This patchwork approach further complicated efforts to limit the spread of COVID-19.
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