Third Amendment to the PREP Act Expiring Soon!

As previously discussed in the April 2024 Newsline article, New COVID-19 Booster Dose & The Final Frontier of the PREP Act, the Public Readiness and Emergency Preparedness Act (PREP Act) will expire as of December 31st, 2024, meaning the liability protections that enabled pharmacists, pharmacy interns, and pharmacy technicians to independently administer vaccines by means of the PREP Act will no longer exist. The following is an excerpt from the article:  

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As stated on the Administration for Strategic Preparedness & Response’s (ASPR) PREP Act Questions & Answers webpage, the amended PREP Act “authorize[s] pharmacists to continue to administer COVID-19 and seasonal influenza vaccines to individuals aged three and above and order and administer COVID-19 tests in accordance with an FDA license, approval, or authorization through December 31, 2024.”

With the end of the year’s quick approach, this leaves pharmacies not only confirming employees are compliant with annual federal obligations (see this month’s Newsline article, The Clock is Ticking: Complete Your Annual Training!), but also ensuring they are safeguarded, from both liability and audit risks, to continue to administer vaccines in the new year.

In the September 2024 Newsline article, Flu Shot Season – Are You Prepared?, the requisites of an audited vaccine prescription are discussed. Fittingly, the first requirement listed is “authority to administer”. Pharmacies need to either have a signed order from an authorized prescriber or have a signed protocol or collaborative practice agreement (CPA) that lists the specific vaccinations that can be administered. In some cases, this may require the pharmacy pursue an amended protocol/CPA with the supervising prescriber that includes COVID-19 vaccines or conduct a staff meeting to re-educate the team on the state regulations surrounding vaccine administration, such as age requirements and which staff members are allowed to administer COVID-19 and influenza vaccines.

PAAS National® is unable to forecast how PBMs will react to the conclusion of the PREP Act; however, our guidance is to ensure proper compliance is in place by the start of the new year to ward off preventable recoupments due to nonadherence of vaccination requirements.

PAAS Tips:

  • Be sure to follow your state’s laws in relation to what ages can be vaccinated or tested.
  • Follow your state specific laws and guidelines when determining who in the pharmacy can vaccinate and administer COVID-19 testing. 
  • Prior to sending PBMs audit responses that include vaccinations, reach out to PAAS National® to ensure all required paperwork is sent with the initial submission, alleviating subsequent work that needs to be done on appeal

Heaven Bennett, CPhT
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