Pedley: HRSA’s Power to Enforce 340B Guidance is Limited.Testoni: Some in Pharma Want to Make 340B a Rebate Program.

Pedley: HRSA’s Power to Enforce 340B Guidance is Limited

Testoni: Some in Pharma Want to Make 340B a Rebate Program

The federal official in charge of the 340B program today said again that although the U.S. Health Resources and Services Administration (HRSA) believes its 340B policies “are sound, HRSA is unable to enforce guidance unless there is a clear violation of the 340B statute.”

“HRSA places the highest priority on the integrity of the 340B program and continues to enforce the statute to the greatest extent possible,” HRSA Office of Pharmacy Affairs (OPA) Director Adm. Krista Pedley told those attending the 340B Coalition summer conference, which is being held online due to the COVID-19 pandemic. She said HRSA has “completed an evaluation of its audit process and other program integrity efforts as they relate to HRSA’s ability to enforce and require corrective action in a program that is primarily administered by guidance. HRSA’s enforcement ability is limited, as guidance does not provide HRSA appropriate enforcement capability.”


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