340B Safety net providers laud the Secretary of Health and Human Services’ (HHS) appointment of the much-awaited 340B Alternative Dispute Resolution (ADR) Board on June 21, 2021. Members of the ADR Board will serve as ADR Panelists to resolve disputes between 340B safety-net providers and drug companies.
Beginning in the summer of 2020, several drug manufacturers have restricted or cutoff 340B pricing on drugs that are shipped to and dispensed by the safety-net providers’ contracted pharmacies. Safety-net providers contend that the manufacturers’ actions represent overcharges that must be addressed by HHS. Many of these safety-net providers have been severely limited in their ability to generate 340B savings and revenue because they cannot afford to establish their own in-house pharmacies and/or their patients are located many miles away.
Through lawsuits filed by several of these safety-net providers and their trade associations, in December 2020 HHS issued regulations to provide the statutorily required process for resolving disputes under the 340B program. The safety-net community has since filed numerous petitions to resolve the drug companies’ overcharges through the ADR process, but HRSA has not been able to adjudicate the ADR petitions because the Secretary had not appointed members to the ADR Board.
From the newly-appointed ADR Board members, the Administrator of HRSA may select three person ADR Panels to hear and resolve 340B-related disputes, including the safety-net providers’ claims that they have been overcharged by the certain drug companies. Once the three member ADR Panels have been selected, they will review petitions on a case-by-case basis. The ADR Panels have the authority to make final agency decisions that will be sent to the parties of the dispute and to HRSA. After the final decision, HRSA will take enforcement actions, which may include requiring drug companies to repay safety-net providers for overcharges on 340B drugs. HRSA may also apply sanctions as appropriate, including referral to the Office of Inspector General for its consideration of civil monetary penalties, as appropriate. Safety net providers are hopeful that the ADR Panels may provide relief against drug company overcharges.
The names and titles of the ADR Board members are:
- 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
