As expected, on June 21, the Secretary of HHS appointed Alternative Dispute Resolution (ADR) Board members. ADR Board members are government representatives (not private stakeholders) from three government agencies: HHS Office of Inspector General (OIG), HRSA, and CMS. ADR Board members must have complex litigation, drug distribution, drug pricing, or 340B Program expertise. Six of the ADR Board members will be voting members on three person ADR Panels to resolve disputes under the 340B program. Two of the members are from the HHS OIG, two members are from HRSA, and two members are from CMS. The Secretary also appointed two ex-officio non-voting members from HRSA. These are the names and titles of the ADR Board members:
- Sean R. Keveney, Deputy General Counsel, the Office of the General Counsel, Department of Health and Human Services;
- Andy J. Miller, National Complex Litigation and Investigations Division Attorney, the Office of the General Counsel, Department of Health and Human Services;
- Glenn Clark, Public Health Advisor, HIV/AIDS Bureau, Health Resources and Services Administration, Department of Health and Human Services;
- CAPT Christina Meade, Area Regional Pharmacy Consultant, Office of Regional Operations, Health Resources and Services Administration, Department of Health and Human Services;
- CDR Timothy Lape, Division of Medicare Health Plans Operations, Medicare Branch, Centers for Medicare & Medicaid Services, Department of Health and Human Services;
- Adele Pietrantoni, Office of Program Operations and Local Engagement, Division of Drug and Health Plan Operations, Centers for Medicare & Medicaid Services, Department of Health and Human Services;
- Chantelle Britton, Senior Advisor, Office of Pharmacy Affairs, Health Resources and Services Administration, Department of Health and Human Services, as ex-officio, non-voting member; and
- Julie Zadecky, Pharmacist, Office of Pharmacy Affairs, Health Resources and Services Administration, Department of Health and Human Services, as ex-officio, non-voting member.
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 the 340B statute, that a covered entity has violated the prohibition on diversion or duplicate discounts. The ADR Panel reviews petitions on a case-by-case basis and has the authority to make final agency decisions that will be sent to the parties and to HRSA. After the final decision, HRSA will take enforcement actions or apply sanctions as appropriate, including referral to the OIG for its consideration of civil monetary penalties, as appropriate.
Former Secretary Alex Azar issued the first list of ADR Board appointees in the Federal Register on January 21, but the notice was withdrawn that same day due to the broad regulatory freeze issued by the Biden Administration. The long-awaited ADR Board member appointments come after certain drug companies filed lawsuits to invalidate the ADR regulations on various legal grounds. One court issued a decision enjoining (halting) enforcement of the ADR process against Eli Lilly. HHS has indicated that it intends to forge ahead with the ADR process.