The Department of Health and Human Services today issued a new proposed rule revising the 2020 final rule that established the 340B Administrative Dispute Resolution process. HHS notes that the proposed rule better aligns with the statutory requirements first put in place by the Affordable Care Act. The rule specifically proposes to:
- move the ADR process away from a trial-like proceeding and establish a more conventional administrative process;
- revise the ADR panel structure to consist of 340B program subject matter experts from the Health Resources and Services Administration’s Office of Pharmacy Affairs;
- ensure parties resolve disputes in good faith prior to invoking the ADR process;
- align the ADR process to statutory provisions on overcharges, duplicate discounts and diversion and;
- include a reconsideration process for parties dissatisfied with the 340B ADR panel decision.
The proposed rule notes that any dispute between 340B covered entities and drug manufacturers that are subject to federal court review would not be eligible for the ADR process until the court process concludes. Comments are due to HHS by Jan. 30, 2023. AHA is reviewing the proposed rule and will submit comments.