The Department of Health and Human Services (HHS) has proposed revisions to its 2020 administrative dispute resolution (ADR) process for the 340B Drug Pricing Program. The ADR process allows covered entities and manufacturers to request agency intervention in disputes related to the 340B program. However, the ADR process cannot be utilized for disputes under federal court review until litigation concludes, meaning that the rule will not affect any ongoing 340B-related litigation.
The proposed rule includes a number of refinements to the existing 340B process, including:
- Streamlining the hearing process to make it more efficient and less formal;
- Removing the minimum threshold for damages (previously $25,000) before ADR can be sought;
- Placing 340B subject matter experts from the Health Resources and Services Administration Office of Pharmacy Affairs on ADR panels; and
- Requiring that parties undertake good faith efforts to resolve disputes before requesting ADR.
“An effective ADR process will be key to ensuring that all parties comply with the rules of the program,” said Tom Kraus, ASHP vice president of government relations. “It is important that this proposed rule results in a more efficient and impartial ADR process that allows the agency greater authority over program oversight, and allows safety net hospitals and clinics to challenge manufacturer efforts to undermine the program.”
ASHP is reviewing the proposed rule and will provide comments to HHS by the Jan. 30, 2023 deadline.