On June 5, 2023, the Centers for Medicare & Medicaid Services (CMS) published a final rule in the Federal Register that withdraws COVID-19 vaccination mandates for certain providers’ staff members and withdraws long-term care (LTC) facility COVID-19 testing requirements. This final rule becomes effective 60 days after the date of publication in the Federal Register, or Aug. 4, 2023.
In removing two prior COVID-19-era rules and revising a third — CMS issued a final rule for LTC facilities requiring vaccination education and an offer to vaccinate for LTC residents, clients and staff — CMS ends a controversial policy that threatened facilities with plans of correction, civil monetary penalties, denial of payment, and/or Medicare- or Medicaid- disenrollment. Healthcare providers no longer will face federal vaccination requirements but still may face state rules or may desire instead to continue their own mandates.
The vaccine mandate was announced Nov. 4, 2021, when CMS issued its interim final rule. This rule required COVID-19 vaccination for staff members (including volunteers, contractors and non-patient-facing employees) of healthcare facilities participating in Medicare and Medicaid, and staff members could not provide healthcare services after Jan. 4, 2022, unless they were vaccinated. But it was only after Jan. 13, 2022, that the U.S. Supreme Court permitted CMS to begin enforcing this interim final rule. As discussed in McGuireWoods’ Jan. 27, 2022, alert, since the Supreme Court’s ruling, testing could not be implemented in place of vaccination, and providers and suppliers had to meet various deadlines for staff vaccination. As an interim final rule, the vaccination mandate for Medicare- and Medicaid-certified providers and suppliers would have expired three years from the date of issuance without further agency action.
This final rule withdraws this expired language and effectively lifts the COVID-19 vaccination mandate for Medicare- and Medicaid-certified providers and suppliers. The White House foreshadowed this withdrawal in a May 1, 2023, announcement, discussed in an earlier McGuireWoods’ alert. Soon thereafter, President Joe Biden revoked Executive Order 14042, which required specified COVID-19 safety protocols for certain parties contracting with the federal government. This revocation signified the White House’s goal of supporting COVID-19 vaccination without mandating it via federal regulation.
Below are five key takeaways from CMS’ final rule.
- CMS will continue to champion vaccine administration. Although this final rule withdraws the COVID-19 staff vaccine mandates, CMS will continue to encourage Medicare- and Medicaid-certified providers to encourage their staff members, as well as patients and other industry participants, to receive COVID-19 vaccines. The agency specifically responded to public comments regarding safety concerns and the economic burden associated with COVID-19 vaccination by reiterating CMS’ support of vaccination and the importance of vaccination for public health. Ultimately, CMS hopes to align its approach to COVID-19 vaccinations with its approach to other infectious diseases by encouraging, rather than mandating, vaccination. This appears to reflect the Biden administration’s approach as well, as discussed above.
- CMS will use quality metrics to encourage vaccination. To incentivize continued vaccination efforts, the final rule specifically cites including reporting the percentage of vaccinated patients and healthcare staff as quality metrics. These quality metrics are included in various Medicare payment systems to reward providers meeting certain standards. This inclusion in the final rule reiterates CMS’ prior credence on quality metrics and may indicate CMS’ future approach as well. Therefore, the final rule demonstrates CMS’ commitment to relying on quality metrics as a means of monitoring COVID-19 vaccination rates among patients and healthcare staff. Specifically, CMS states that public reporting of said quality metrics will increase leadership involvement by focusing organizational priorities, supporting transparency, providing a means of delivering essential information to consumers and creating accountability. This demonstrates CMS’ emphasis on encouraging healthcare staff vaccinations through quality metrics programs and may lead to new metrics in subsequent rulemaking.
- CMS will exercise enforcement discretion in implementing the final rule. Federal rules generally become effective 60 days after publication; however, the COVID-19 public health emergency (PHE) expired May 11, 2023. CMS’ decision to terminate the facility staff vaccine requirements in the final rule reflects CMS’ determination that the emergency circumstances that occasioned the interim final rule provisions no longer exist. Thus, because facilities are no longer operating under PHE circumstances, and considering the lower policy priority of enforcement within the remaining time, CMS will not enforce staff vaccine provisions that remain effective in the regulations through the final rule’s effective date, Aug. 4, 2023.
- CMS did not explicitly include a right to refuse vaccination. CMS was careful to note that this final rule merely withdraws the vaccination mandate for medical staff, and it does not explicitly provide a right to refuse vaccination, despite some requests from public commenters. The agency noted that states, local governments and employers may have COVID-19 vaccine mandates in place, and this final rule does not take precedence over those mandates, although federal civil rights law (discussed in an April 6, 2021, post) may, with respect to individual staff members. In other words, medical staff may still be required to receive vaccination in compliance with local mandates.
- CMS solidified requirements for LTC facilities to educate and offer vaccinations. On May 13, 2021, CMS required LTC facilities to provide COVID-19 vaccination education to all patients, staff and LTC residents. Further, LTC facilities had to offer COVID-19 vaccines to those same populations. The final rule states that, to further align CMS’ approach with existing regulations that address other infectious diseases, CMS is finalizing requirements for LTC facilities to educate and offer vaccinations. As a holdover from the interim final rule, CMS allows for and encourages, but does not require, LTC facilities to extend the educate-and-offer-vaccine requirements to individuals providing services to those LTC facilities on an infrequent basis. The retention of these LTC requirements may serve as a benchmark for and lay the foundation for CMS’ approach to other infectious disease regulations.
As discussed in McGuireWoods’ May 3, 2023, alert, the PHE ended May 11, 2023. With the end of the PHE, certain emergency waivers and regulatory requirements under interim final rules with comments that were issued during the COVID-19 pandemic also will end. CMS issued guidance on May 1, 2023, laying out which emergency waivers ended May 11, 2023, and which other waivers will continue beyond the PHE. These changes to staff vaccination mandates are another step in the government’s efforts to shift away from the emergency rules during the PHE.
Similar to the end of federal mandates, several state vaccination requirements may no longer remain in place, such as in New York and Massachusetts. That said, where such state or local requirements remain in place, the local mandates may have an impact on healthcare professionals’ vaccination, separate from CMS’ requirements.
Moreover, some providers may believe the end of the COVID-19 vaccine mandates is premature. For example, providers in nursing homes voiced increased operational difficulties in protecting at-risk communities without the support of government mandates. Without federal mandates, however, providers may find it difficult to keep staff requirements in place — even if courts typically have allowed such requirements. Local conditions and vaccination views will similarly impact such choices now that the federal mandate has ended.
For questions about operational challenges in the post-government mandate era, state requirements, or the CMS final rule’s impact on Medicare- and Medicaid-certified providers, please contact any of the authors of this alert or a member of the firm’s healthcare or COVID-19 response teams.
The authors thank McGuireWoods summer associate Donald J. Kwasigroch for assistance preparing this legal alert. He is not licensed to practice law.