HRSA Proposed Rule on Calculating the 340B Ceiling Price and Penalties Related to 340B Drug Discount Program

June 18, 2015

Health Care Counsel (Atkins, Trunk) reported that "On June 17, 2015, the Health Resources and Services Administration (HRSA) published a long-awaited proposed rule setting forth revisions to the current regulations governing the 340B Drug Discount Program. ... The Proposed Rule addresses ... how drug manufacturers are supposed to calculate the "Ceiling Price" for covered outpatient drugs (340B drugs), ... how manufacturers should estimate the Ceiling Price for drugs new to the market and, if necessary, implement retroactive refunds or credits to covered entities who paid more than the Ceiling Price for such new covered drugs, ... the ability of the Health and Human Services Office of Inspector General (OIG) to subject manufacturers to civil monetary penalties (CMPs) for the knowing and intentional violation of 340B pricing rules, and ... revisions necessary to the current 340B regulations in light of the United States District Court decision in PhRMA v. HHS, No. 13-01501 (D.D.C. May 23, 2014), which invalidated 340B regulations regarding orphan drugs."