Upcoming Amendment to the COVID-19 PREP ACT

On Friday, April 14, HHS released a fact sheet about an upcoming amendment to the COVID-19 PREP Act declaration. This will be the eleventh amendment to the declaration and seeks to clarify issues around provider liability protections with the upcoming expiration of the national COVID-19 public health emergency. Please see the following link for the full announcement:  

Key changes under the upcoming amended declaration include:
  • Extending coverage for COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests. PREP Act immunity from liability will be extended through December 2024 to pharmacists, pharmacy interns, and pharmacy technicians to administer COVID-19 and seasonal influenza vaccines (to those individuals three and over, consistent with other requirements), and COVID-19 tests, regardless of any USG agreement or emergency declaration.
  • Extending coverage through December 2024 for Federal agreements. This includes all activities related to the provision of COVID-19 countermeasures that are 1) provided based on a federal agreement (including the vaccines and treatments purchased and provided by the USG), or 2) directly conducted by the USG, including by Federal employees, contractors, or volunteers.
  • Ending of coverage for certain activities. Once products are no longer distributed under a 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); and
    • COVID-19 vaccinations across state lines by licensed providers and pharmacists and pharmacy interns.
  • Ending of coverage for routine childhood vaccinations. Once no emergency is in effect, PREP Act coverage will no longer extend to all routine childhood vaccinations (ages 3 - 18) by pharmacists, pharmacy interns, and pharmacy technicians.
Some of the key features that will not change under the amended declaration include:
  • No immediate impact on USG distributed COVID-19 countermeasures. As noted above, the amended PREP Act declaration will not have any immediate impact on COVID-19 vaccines, treatments, and tests currently distributed by the USG–either now or when the COVID-19 PHE ends on May 11.
  • 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. In the case of Paxlovid, pharmacists are permitted to prescribe the treatment under certain circumstances. These oral antiviral treatments are available at over 40,000 provider locations, including over 35,000 retail pharmacies.
  • 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.



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