Proposed Rules Released Covering 340B Ceiling Prices and Manufacturer Penalties

June 17, 2015

The National Law Review (Cook, Ivill, Parise) reported that "On June 16, 2015, the U.S. Department of Health and Human Resources (HHS) and the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (Notice) related to the 340B Drug Pricing Program (340B Program)." The notice sets a system for calculating ceiling prices for 340B-eligible drugs as well as "implements civil monetary penalties for drug manufacturers that overcharge hospitals and other entities participating in the 340B Program (Covered Entities)."