Tag Archives: Health Resource and Services Administration

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

Regulatory-Developments
A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Dug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when purchasing orphan drugs for a non-orphan use. In addition to its significant financial impact on hospital covered entities subject to the rule, … Continue reading this entry

HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June 17, 2015. The proposed rulemaking, required under the Affordable Care Act, address 340B drug ceiling price calculations and penalties that may be imposed … Continue reading this entry

HRSA Issues Interpretive Rule on 340B Drug Pricing Program

On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain hospital covered entities participating in the 340B Drug Pricing Program (340B Program). The new rule is available on HRSA’s website, and … Continue reading this entry