Assisted Living & Personal Care

The Food and Drug Administration (FDA) published notice in the Federal Register on March 13 with updates to guidance documents issued during the public health emergency (PHE). Specifically, the FDA outlines which guidance documents will end with the PHE and which will be extended for a limited amount of time. FDA states, “Importantly, the ending of the PHE . . .will not impact FDA’s ability to authorize devices (including tests), treatments or vaccines for emergency use. Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met.” Read more here.

Do you feel like you or your care team are wasting valuable time and resources to comply with regulations, policies, or other requirements that just don’t make sense? Join the LeadingAge PA government affairs team and colleagues from your region to share these challenges and directly inspire our mission to disrupt the status quo in the aging services ecosystem. Our goal is to give you more time to spend engaging with those you care for. Registration is now open for a virtual listening session in each region (view this map to decide which session is best for you): o Western: April 13, 9 a.m. – Register here! o Central: April 14, 10 a.m. – Register here! o Northern: April 24, 11 a.m. – Register here! o Southeast: May 2, 3 p.m. – Register here! Note: If unable to join on your region’s date, please feel free to join us on one of the other dates. All are welcome!

With the end of Continuous Coverage, Pennsylvania will begin the process of Medicaid (MA) redeterminations on April 1. The process will be spread over a 12-month period to update eligibility status for all MA participants. The CHC-MCOs will be conducting related outreach and education to providers in the coming months, and LeadingAge PA will continue to connect our members with resources and information as it becomes available. If there is something the CHC-MCOs can do to help make this process easier for your nursing community’s MA participants, please contact Director of Regulatory Affairs Anna Warheit who will share your suggestions with DHS and the MCOs. As a reminder, DHS has also shared a Communications Toolkit which may be useful as you work to communicate this information to your residents or participants and their representatives.

LeadingAge national continues to learn how the May 11 termination of the public health emergency (PHE) will impact our various provider settings. On a national nursing home stakeholder call on Feb. 22, the Centers for Medicare and Medicaid Services (CMS) provided clarification on how the end of the PHE impacts the regulatory waivers and interim final rules implemented during the COVID-19 PHE. Any waivers still in effect will terminate on May 11. Because the PHE is ending, the U.S. Dept. Of Health and Human Services (HHS) will not have the authority to extend waivers or approve new waivers, even on an individual basis, related to COVID-19. Interim final rules are effective for three years from the date of publication unless otherwise noted. While the COVID-19 testing rule will end with the PHE, CMS cautions providers that they will be required under infection prevention and control requirements to follow the Centers for Disease Control and Prevention’s (CDCs) nationally accepted standards, which currently include testing and other mitigation strategies related to COVID-19. Read more details in this LeadingAge article.