The Centers for Medicare and Medicaid Services (“CMS”) announced significant changes to the COVID-19 regulatory landscape. In a final rule published June 5, 2023, CMS withdrew previous COVID-19 Health Care Staff Vaccination regulations requiring staff at Medicare- and Medicaid-participating facilities to be fully vaccinated against COVID-19. As a result, CMS will no longer require such facilities to maintain policies mandating that their staff be vaccinated against COVID-19 as a Condition of Participation, Condition for Coverage, or Requirement for Participation in the Medicare and Medicaid Programs. The final rule will officially take effect on August 4, 2023, but CMS will immediately stop enforcing these requirements against participating facilities.

CMS’ Reasoning

Although the staff vaccination mandates were originally set to sunset in November 2024, an assessment by CMS of the clinical and epidemiological circumstances of the COVID-19 pandemic demonstrated that regulations regarding COVID-19 vaccination of health care staff are no longer necessary. Specifically, CMS cites to increased vaccine uptake, declining infection and death rates, decreasing severity of disease, increased instances of infection-induced immunity, public comments, and its proposed implementation of COVID-19 vaccination-related quality measures to its quality improvement measures and reporting programs as circumstances that factored into its decision.

Due to the continued evolution of the circumstances surrounding COVID-19, CMS now plans to treat COVID-19 similarly to other respiratory viruses it characterizes as harmful but not necessarily emergent, like influenza. Accordingly, CMS intends to encourage ongoing COVID-19 vaccination through other mechanisms, including quality reporting and value-based incentive programs. In addition to quality measurement, CMS will provide assistance and education to health care providers and facilities through CMS-funded programs, and will collaborate with industry partners at the federal, state, and local level who can provide education and technical support.

Additional Changes Applicable to Long-Term Care Facilities

In addition to the withdrawal of the staff vaccination requirements, the final rule addresses two other regulatory mandates related to COVID-19. First, the final rule codifies certain infection control requirements, which will require certain health care facilities to continue educating and offering COVID-19 vaccines to residents and staff of long-term care facilities and intermediate care facilities for individuals with intellectual disabilities. This will align CMS’ approach to COVID-19 vaccination with its existing regulations addressing other infectious diseases, such as influenza and pneumococcal disease. Second, the final rule removes expired COVID-19 testing requirements imposed on residents and staff of long-term care facilities that predate the availability of reliable COVID-19 treatments and vaccines.

Conclusion

Suffice it to say, participating facilities will need to reevaluate their existing policies and procedures surrounding COVID-19 vaccination as of the publication of the final rule. Withdrawal of the COVID-19 staff vaccination requirements does not prohibit facilities from requiring staff vaccinations. CMS encourages health care employers to maintain evidence-based policies regarding staff vaccination for COVID-19 and other communicable diseases for which vaccination is available and recommended. Health systems and health care employers are permitted to continue requiring their workers to stay up to date on COVID-19 vaccinations, consistent with other Federal, State, and local laws. These prevention and mitigation measures are designed to be more flexible, allowing individual facilities to implement vaccination requirements in response to local trends. CMS anticipates that many health care facilities, if not most, will continue to maintain staff vaccination requirements.

If you have questions about the impact this final rule may have on your organization, please contact a member of Koley Jessen’s Health Law practice group.

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