340B Drug Pricing Program
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Tuesday, May 3, 2022
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2:30 pm – 3:00 pm
The 340B Drug Pricing Program facilitates access to mandatory discounts on “covered outpatient drugs” for certain statutorily specified categories of healthcare providers, referred to as “covered entities.” As a condition of eligibility in the 340B Program, covered entities must not run afoul of two core program requirements: the prohibition against “diversion” (i.e., transferring a 340B drug to an individual who is not a “patient” of the covered entity) and “duplicate discounts” (i.e., obtaining a Medicaid drug rebate on a unit of product purchased through the 340B Program). Currently, there is limited guidance from the two relevant federal agencies — the Health Resources and Services Administration (HRSA) and the Centers for Medicare and Medicaid Services (CMS) — with respect to how full compliance with these prohibitions should be operationalized. As a result, any existing operational standards for 340B compliance are not universally used. Potential solutions will be discussed.
Track Session Speakers
- Kathleen Dynan Black, BS, MBA
- Director, Government Strategy
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- Pfizer
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