The Ten Year Wait is Over: HRSA Releases 340B Dispute Resolution Final Rule

The 340B Program, named after its section within the 1992 Public Health Service Act, allows covered entities to stretch their scarce federal resources as far as possible, by setting  a ceiling price on the sale of covered outpatient drugs from participating pharmaceutical manufactures to covered entities. With the passage of the Patient Protection and Affordable Care Act in 2010, 340B’s oversight agency, the Health Resources and Services Administration (“HRSA”) within the Department of Health and Human Services (“HHS”), was directed to establish an administrative dispute resolution (“ADR”) process. Covered entities and pharmaceutical manufactures would then use the ADR process to settle claims such as drug overcharging, diversion, or duplicate discounts. It took ten years, but HHS has finally taken action. Read More ›