Alex Azar, at 8:45 a.m. Eastern yesterday in one of his last acts as U.S. Health and Human Services (HHS) secretary, appointed the six voting and two ex-officio non-voting members of the 340B program’s new administrative dispute resolution (ADR) board.
The HHS Office of the Secretary announced the naming of the board members late yesterday afternoon, about four hours after Azar’s resignation took effect, in a Federal Register public inspection notice. The formal Federal Register notice is expected later today.
The six voting members are:
- Andy J. Miller, National Complex Litigation and Investigations Division Attorney, the Office of the General Counsel, Department of Health and Human Services
- Sean R. Keveney, Deputy General Counsel, the Office of the General Counsel, Department of Health and Human Services
- Lori Roche, Acting Senior Advisor, Office of the Administrator, Health Resources and Services Administration, Department of Health and Human Services
- Susan Monarez, Director, Office of Planning, Analysis and Evaluation, Health Resources and Services Administration, Department of Health and Human Services
- Randy Brauer, the Office of Hearings and Inquiries, Centers for Medicare & Medicaid Services, Department of Health and Human Services
- James Slade, the Office of Hearings and Inquiries, Centers for Medicare & Medicaid Services, Department of Health and Human Services
The two ex-officio non-voting members are:
- Chantelle Britton, Senior Advisor, the Office of Pharmacy Affairs, Health Resources and Services Administration, Department of Health and Human Services
- Julie Zadecky, Pharmacist, the Office of Pharmacy Affairs, Health Resources and Services Administration, Department of Health and Human Services
The notice says the board members “shall serve a term of two years, to be extended for additional terms upon agreement by the member and the head of his or her Division.”
At least two 340B dispute resolution petitions have been filed with HRSA since the final rule establishing the system took effect Jan. 13: one by the National Association of Community Health Centers (NACHC) on its members’ behalf against manufacturers Lilly, Sanofi, and AstraZeneca for their denials of 340B pricing on drugs dispensed by contract pharmacies; and another by a Northern California health center against AstraZeneca for the same reason.
If HRSA decides to move forward with such petitions, the HRSA administrator will select three voting and one non-voting ADR board members to serve on a panel to review the petition and make a final agency decision.
The naming of the board clears the path for ADR panels to begin considering petitioners’ claims and opposing parties’ responses. It is unclear if President Biden’s nominee for HHS Secretary Xavier Becerra will want to put his own stamp on the ADR panel and make changes to the makeup of the group. His appointment is awaiting Senate approval. Azar was a vocal critic of many aspects of the 340B program although his General Counsel Robert Charrow sided on behalf of 340B providers in their current dispute with drug manufacturers over use of the 340B in contract pharmacies.
