340B Penny Pricing, Civil Monetary Penalty Revisions On Deck In Proposed Rule

The federal Health Resources and Services Administration aims to release a proposed rule in the near future on the 340B drug discount program that will revisit standards for calculating 340B drug prices and imposing civil money penalties on manufacturers who violate the rules.

The agency already had postponed implementation of the standards, which are strongly opposed by pharmaceutical manufacturers. Those standards were issued in January 2017. (Also see "340B ‘Penny Pricing’ Policy Formally Adopted By HHS; Overcharging Safe Harbors Created" - Pink Sheet, 6 January, 2017.) To gain time for more input, HRSA set an implementation date of July 1, 2018, though that date has not been made final