Health, Pharmaceutical and Biotechnology Alert: HRSA issues letter discussing ADAP 340B rebates; proposed rule expected

On 3 February 2014, the Office of Pharmacy Affairs (OPA) posted a letter to its 340B drug pricing programme website discussing 340B rebates paid to AIDS drug assistance programmes (ADAPs). OPA is part of the Health Resources and Services Administration (HRSA) and administers the 340B programme. The letter, which is not dated, is signed by HRSA administrator Doctor Wakefield.

The Wakefield letter addresses the ability of ADAPs, a type of 340B-covered entity, to claim 340B rebates from manufacturers when the ADAP does not itself purchase the drug but rather covers some amount of insurance-related cost sharing for the drug, in the form of an insurance premium, copayment or deductible expenditure. Notably, this letter appears to be the first time that the 340B programme itself has addressed this issue.

ADAPs are the only type of covered entity that can access the 340B discount via a rebate, an option created by HRSA in 1998 through a notice in the federal register…

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