April 18, 2023
On Friday, April 14, 2023, Xavier Becerra, Secretary of the U.S. Department of Health and Human Services (HHS), announced that in the coming weeks, he will issue an amendment to the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19.
As stated in an HHS fact sheet on this announcement, "The PREP Act declaration has been a key tool for ensuring that Americans have broad access to critical COVID-19 countermeasures including vaccines, tests, and treatments. The PREP Act declaration has provided flexibilities and protections for those individuals and entities who have been involved in providing these critical tools that have helped the United States get to a better place with COVID-19. For the past three years, much of the health care landscape-including pharmacies-has relied on these flexibilities and liability protections. By issuing this amendment, the Secretary of HHS intends to allow pharmacies to continue their critical roles in our response, even after certain products transition to traditional health care pathways. The end of the COVID-19 public health emergency alone does not automatically terminate PREP Act coverage for countermeasures."
Key changes planned to be included in the upcoming amended declaration include:
- Extending coverage for COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests
- Extending coverage through December 2024 for federal agreements
- Ending of coverage for certain activities: Once products are no longer distributed under a United States Government (USG) agreement, PREP Act coverage will no longer extend to the following activities:
- COVID-19 vaccination by non-traditional providers (e.g., recently retired providers and students)
- COVID-19 vaccinations across state lines by licensed providers and pharmacists and pharmacy interns.
- Ending of coverage for routine childhood vaccinations: Once there is no emergency in effect, PREP Act coverage will no longer extend to all routine childhood vaccinations by pharmacists, pharmacy interns, and pharmacy technicians.
Some of the key features that will not change under the amended declaration are described below:
- No immediate impact on USG distributed COVID-19 countermeasures
- No change to coverage for certain prescribing and dispensing of COVID-19 oral antivirals: The PREP Act will continue to offer liability immunity for pharmacists, pharmacy technicians, and pharmacy interns dispensing COVID-19 treatments, in accordance with a U.S. Food and Drug Administration (FDA) authorization, such as the oral antiviral treatments Paxlovid and Lagevrio.
- No change to the "Test to Treat" program: Pharmacists and other providers prescribing tests in the "Test to Treat" program will continue to receive liability protection under the PREP Act.
Click here to access the relevant HHS press release and for more information.
