Updated May 10, 2023.
On May 1, 2023, CMS’ Center for Clinical Standards and Quality/Quality, Safety & Oversight Group published a memorandum for State Survey Agency Directors providing guidance on the end of the COVID-19 public health emergency (PHE). In addition to discussing several specific regulatory waivers and flexibilities that will terminate with the end of the PHE on May 11, the 23-page memo also addresses the future of staff vaccination requirements. The memo states:
In light of these developments and comments received on the interim final rule, CMS will soon end the requirement that covered providers and suppliers establish policies and procedures for staff vaccination. CMS will share more details regarding ending this requirement at the anticipated end of the public health emergency.
While short on details, this statement is the first indication the vaccination mandates will be ending “soon.” On May 2, CMS sent a final rule entitled “Omnibus COVID-19 Health Care Staff Vaccination” to the Office of Management and Budget for regulatory review prior to publication. It’s now a waiting game to see when this new rule will be published.
The memo also addresses compliance with emergency preparedness requirements, specifically annual testing requirements. The relevant conditions of participation require providers to perform annual testing exercises to ensure their emergency preparedness plans works and staff are trained appropriately. When a provider activates its plan to respond to an emergency event, however, the provider is exempt from next full-scale exercise (not exercise of choice) based on 12-month exercise cycle. As a result, many providers have not conducted testing during the PHE.
In the memo, CMS states providers are expected to return to normal operating status after the end of the PHE, including resumption of annual testing requirements. Specifically, inpatient providers must conduct a full-scale exercise within its annual cycle for 2023 and an exercise of choice. Outpatient providers either must conduct either a full-scale exercise or exercise of choice within its annual cycle for 2023 if scheduled to conduct full-scale exercise within 2024, or they must conduct an exercise of choice if scheduled during annual cycle for 2023 and resume a full-scale exercise requirement in 2024.
On May 3, CMS announced that Medicare Diabetes Prevention Program (MDPP) suppliers may continue to offer MDPP services virtually through December 31, 2023, as long as they maintain an in-person CDC organization code. This includes the ability to (a) collect weight measurements for Medicare patients either through virtual technology, self-reported weight measurements, or both; and (b) provide all services virtually with no limit to virtual sessions provided.
Another important end-of-the-PHE development is the Drug Enforcement Administration’s (DEA) publication of a temporary rule to extend PHE telehealth flexibilities regarding prescriptions of controlled substances through November 11, 2023. The temporary rule also provides that any practitioner-patient telehealth relationship established on or before November 11, 2023, will be governed by these same telehealth flexibilities through November 11, 2024. The DEA had published a proposed rule on March 1, 2023, that would have significantly curtailed the prescription of controlled substances based on a telehealth visit. After receiving more than 38,000 comments on the proposed rule, the DEA decided to extend the telehealth flexibilities for several months while it reviewed the comments and developed the final rule.
We have updated the PYA End of the PHE Checklist to incorporate these latest developments, as well as clarifications provided by CMS staff during the April 25, 2023, Office Hours on the Ending of the Public Health Emergency; CMS’ May 5 Frequently Asked Questions – CMS Waivers, Flexibilities, and the End of the COVID-19 Public Health Emergency; and HHS’ May 9 Fact Sheet: End of the COVID-19 Public Health Emergency. We’ve also included a new section addressing covered entities participating in the 340B program. You may access the checklist here, and information about the impact of the end of the PHE on the 304B program here.
For more information on the end of the PHE, visit our End-of-PHE Resources page.
If you would like assistance with evaluating regulatory impacts or any matter involving compliance, valuation, or strategy and transactions, one of our executive contacts would be happy to assist. You may email them below or call (800) 270-9629.
