HRSA Finalizes Revamped 340B Alternative Dispute Resolution (ADR) Rules

The Health Resources and Services Administration (HRSA) finalized its changes to the 2020 ADR rule intended to improve accessibility and limit administrative burden. Among its provisions: the ADR panels will comprise only Office of Pharmacy Affairs staff as opposed to staff from other agencies or other offices within HRSA; ADR claims will not be suspended if they relate to an issue pending in federal court; covered entities may bring claims related to manufacturer refusal to offer a 340B price or imposing conditions on accessing that price; and, ADR decisions will be binding on the entities involved and will not be precedential.