HRSA is providing an update on the 340B Administrative Dispute Resolution (ADR) process. HRSA has developed a new webpage which includes all of the latest information on the 340B ADR process, including a list of frequently asked questions.
In accordance with section 340B(d)(3) of the Public Health Service Act (PHSA), HHS published an ADR final rule (PDF - 309 KB) on December 14, 2020 with an effective date of January 13, 2021. The final rule establishes a binding ADR process for certain disputes arising under the 340B Program. The purpose of the ADR process is to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after a manufacturer has conducted an audit as authorized by section 340B(a)(5)(C) of the PHSA, that a covered entity has violated the prohibition on diversion or duplicate discounts.
Specific steps about the ADR process are outlined in detail on the 340B ADR webpage. HRSA encourages stakeholders to review the ADR final rule (PDF - 309 KB) for additional information regarding the submission process and timelines