CHA News Article

HRSA Issues Proposed Rule on 340B Drug Ceiling Prices and Penalties

The Health Resources and Services Administration (HRSA) has issued the attached proposed rule on drug ceiling prices and civil monetary penalties for manufacturers in the 340B Drug Pricing program. As required by the Affordable Care Act (ACA), the proposed rule would impose monetary sanctions — not to exceed $5,000 per instance — on drug manufacturers who intentionally charge a 340B hospital or other covered entity more than the ceiling price established under the procedures of the 340B program. The proposed rule also would require greater transparency in calculating the 340B ceiling drug prices to ensure that drug manufacturers are not overcharging 340B covered entities. Comments on the proposed rule are due Aug. 17.