In this episode, Greg and Rob are joined by returning guest, healthcare attorney Emily Cook. They discuss a recent court ruling (Premier v HHS) that vacated HRSA’s 2013 GPO Prohibition policy notice that addresses compliance with inventory replenishment models, covering insights into the court’s opinion, what it means in terms of potential process changes for covered entities, and compliance considerations given that GPO Prohibition is still a statutory requirement for hospital eligibility in the 340B Program. They’ll also touch on thoughts related to the process of reporting 340B pricing access issues to HRSA based on manufacturer actions.

Premier v. HHS court opinion:  https://law.justia.com/cases/federal/district-courts/district-of-columbia/dcdce/1:2024cv03116/27447…

340B Price Unavailability – How to Report to HRSA:  340B Price Unavailability - How to Report to HRSA | HRSA