The federal government is formally withdrawing the COVID-19 vaccine mandate for employees of CMS-certified healthcare facilities that was enacted in November 2021 and moving to treat the virus, from an oversight standpoint, more like the flu.
The Biden administration announced on May 1 that HHS would begin the process to end the COVID-19 vaccine requirement for employees of CMS-certified healthcare facilities. Requirements under the Omnibus COVID-19 Health Care Staff Vaccination rule were no longer enforced at the end of the day May 11, 2023, the same day the COVID-19 PHE ended, a CMS spokesperson told Becker's.
While CMS might be done enforcing the rule, it still needs to come off the books. To do so, CMS has issued an 82-page final rule formalizing the end of the vaccination requirement. In the final rule set to be published in the Federal Register June 5, HHS and CMS withdraw the 2021 vaccination requirement, outline reasoning for its end, and note upcoming plans to regulate healthcare workers' protections against COVID-19 as part of certain Medicare quality programs.
The final rule is set to take effect 60 days after the date it is published in the federal register. As scheduled, that would be Aug. 4. CMS told Becker's it will not enforce the vaccination requirement before the effective date of the rule — it is no longer in effect as of May 11.
"As conditions and circumstances of the COVID-19 PHE have evolved, so too has CMS' response. At this point in time, we believe that the risks targeted by the staff vaccination [interim final rule with comment] have been largely addressed, so we are now aligning our approach with those for other infectious diseases, specifically influenza," the 82-page final rule states. "Accordingly, CMS intends to encourage ongoing COVID-19 vaccination through its quality reporting and value-based incentive programs in the near future."
Hospitals' COVID-19 vaccination rates will effectively go from being a condition of participation in Medicare to being part of a quality reporting process, which hospitals are familiar with.
"CMS has been pretty clear that it no longer needs the condition of participation mechanism to follow through on the vaccination process," Mark Howell, director of policy and patient safety for the American Hospital Association, told Becker's. "It feels comfortable with the outlook that the quality measures provide. The [public health emergency] is over and COVID-19 has moved from pandemic to endemic stage, but that doesn't mean COVID is gone. It makes sense [CMS] would want some measurement there."
Hospitals and health systems would learn of the vaccination-related measures under consideration for inclusion in CMS programs by Dec. 1, the deadline by which HHS is required to publicly release a list of measures on the table for adoption in certain Medicare programs.
CMS, in its Hospital Inpatient Prospective Payment System proposed rule for fiscal year 2024, had proposed adjusting the measure for COVID-19 vaccination among healthcare personnel to go from reporting on the primary vaccination series only to reporting on the cumulative number of healthcare personnel who are up to date with recommended COVID-19 vaccinations.
Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association, said the association is prepared to give CMS feedback that recommends the shift from primary series to up-to-date vaccination reporting coincide with improvements to the recommended cadence of COVID-19 vaccinations. U.S. health officials proposed simplifications to COVID-19 vaccine protocol, making it more like the routine process for annual flu shots, earlier this year.
"There is a challenge with the measure right now in trying to figure out if someone is up to date in their vaccination," Ms. Foster told Becker's. "It is so haphazard. When we know everyone should have gotten their shot sometime between September and December, for instance, that will make it administratively much easier to know who has been vaccinated if they are up to date."
In the new final rule from HHS and CMS, the agencies note that withdrawal of the vaccination rule does not prohibit healthcare organizations from instating their own COVID-19 vaccination requirements for staff, consistent with other federal, state and local laws. It is likely that hospitals and health systems are in internal conversations and decision-making about what changes, if any, to make to their own individual COVID-19 vaccination requirements in light of the federal-level change.
The final rule from HHS and CMS also requires long-term care facilities to educate and offer the COVID-19 vaccine to residents, resident representatives and staff, as well as perform the appropriate documentation for these activities, as terms of participation in Medicare and Medicaid.