U.S. Health and Human Services (HHS) Secretary Xavier Becerra this morning announced his six appointees to the long-awaited 340B administrative dispute resolution (ADR) board.
The move will be welcomed by the 340B provider community, which has pushed for the creation of the panel since Congress mandated it in the Affordable Care Act over a decade ago. However, it is possible the panel may not be used to review the current petitions filed against six drug manufacturers which have denied or restricted 340B pricing when covered entities use contract pharmacies.
Until its May 17 determination that the companies were clearly violating the 340B statute, HRSA had been encouraging covered entities to file complaints through the ADR. Hospital groups have argued that the ADR is not the appropriate forum to resolve big picture disputes such as a company refusing to provide 340B pricing on all of its drug products or in instances where there is a clear violation of the statute.
The National Association of Community Health Centers (NACHC) and Ryan White Clinics for 340B Access (RWC-340B) both sued the Trump administration in an effort to force the government to finalize the ADR rule and start to use it to review complaints about the contract pharmacy standoff. Those suits are on hold while HHS is pursuing a more aggressive approach. On the other hand, PhRMA, the trade group for brand manufacturers, has sued HHS in an effort to strike the down the ADR rule altogether. That case is currently under review in federal district court in Maryland.
Becerra’s notice about his appointments was posted for public inspection at 8:45 a.m. Eastern on the Federal Register website. The notice will be formally published tomorrow.
The document is dated Monday June 21, and the appointments appear to be in effect.
In one of his last acts as HHS secretary, Alex Azar on Jan. 20 appointed six voting and two ex-officio non-voting members to the board. The very next day, the new Biden administration withdrew Azar’s notice of the appointments that was posted for public inspection.
Becerra retained two of Azar’s appointees for voting positions on the board, and both of Azar’s ex-officio non-voting appointees.
The six voting members are:
- Sean R. Keveney, Deputy General Counsel, the Office of the General Counsel, Department of Health and Human Services (one of the two holdovers from Azar’s picks)
- Andy J. Miller, National Complex Litigation and Investigations Division Attorney, the Office of the General Counsel, Department of Health and Human Services (the other Azar holdover)
- 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
- Cmdr. 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.
The two ex-officio non-voting members (both also Azar picks) are:
- Chantelle Britton, Senior Advisor, Office of Pharmacy Affairs, Health Resources and Services Administration, Department of Health and Human Services
- Julie Zadecky, Pharmacist, Office of Pharmacy Affairs, Health Resources and Services Administration, Department of Health and Human Services
The ADR board members’ terms are for two years and can be extended for additional terms “upon agreement by the member and the head of his or her operating/staff division,” the announcements says.
The four Azar appointees whom Becerra did not retain are:
- 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.
“All previous appointments to the board are revoked,” Becerra’s notice states, suggesting that Azar’s appointments to the board might have been in effect since January despite the new administration’s withdrawal of Azar’s public notice.
The 340B program final rule establishing the ADR board and process took effect Jan. 13. At least three 340B dispute resolution petitions have been filed with HRSA since the final rule went into effect:
- one by the NACHC on its members’ behalf against manufacturers Lilly, Sanofi, and AstraZeneca for their denials of 340B pricing on drugs dispensed by contract pharmacies
- one each by health centers Little Rivers Health Care in Vermont and FamilyCare Health Center in West Virginia, making similar claims against AstraZeneca. Little Rivers and FamilyCare are co-plaintiffs with RWC-340B in a lawsuit that sought to compel HHS to publish and implement the 340B ADR final rule and take enforcement action against drug companies that have that have restricted or denied the sale of 340B discounted drugs shipped to contract pharmacies.
On March 16, a federal district judge granted drug manufacturer Eli Lilly’s motion for a preliminary injunction stopping the HHS from implementing or enforcing its 340B ADR regulations against Lilly.
Sanofi is contesting the regulation’s legality and constitutionality in federal court. AstraZeneca is not, for now. Unless or until courts issue injunctions similar to the one that Lilly won, HRSA conceivably could at any time name three-member ADR panels to stare reviewing the petitions against those two companies. However, with its May 17 demand letters, the ADR may not be the venue to resolve the matter.