There were several recent important developments involving HRSA's 340B administrative dispute resolution system. | Credit: "File:Massimo Busacca, Referee, Switzerland (10).jpg" by Steindy (talk) 11:44, 19 June 2011 (UTC) is licensed under CC BY-SA 3.0

Updates on 340B Administrative Dispute Resolution Lawsuits and ADR Panel Hearings

The federal government and the two groups that sued it separately to force it to issue long delayed 340B administrative dispute resolution (ADR) regulations agreed last night to keep stays in place in both lawsuits until Jan. 3, 2022. Meanwhile, drug manufacturer AstraZeneca is seeking a stay in one set of ADR proceedings and the panel assigned to hear another set of ADR proceedings has issued a scheduling order.

The National Association of Community Health Centers (NACHC) is one of the two groups that sued to compel the U.S. Health and Human Services Department (HHS) to issue the 340B ADR final rule, which HHS did in December 2020 (the rule took effect in January 2021). Ryan White Clinics for 340B Access (RWC-340B) and three community health centers working with it make up the other group that sued.

On the day the ADR rule took effect, NACHC filed a single ADR petition against drug manufacturers Lilly, AstraZeneca, and Sanofi over the companies’ denials of 340B pricing when covered entities use contract pharmacies. A federal district judge in March enjoined HHS from enforcing or implementing its 340B ADR regulations with respect to Lilly. Last month, NACHC broke its petition into two—one against Lilly, the other against AstraZeneca and Sanofi. Early this month, the U.S. Health Resources and Services Administration (HRSA) assigned a three-member panel to hear the ADR petition against AstraZeneca and Sanofi.

On the day the ADR rule took effect, Open Door Community Health Centers in California in collaboration with RWC-340B filed an ADR petition against AstraZeneca only. In early February, Vermont health center Little Rivers Health Care and West Virginia health center FamilyCare Health Center, also in collaboration with RWC-340B, filed ADR petitions also against AstraZeneca only. Early this month, HRSA assigned three-member ADR panels to hear these petitions.

AstraZeneca Seeks Stay in RWC-340B Proceedings

On Oct. 20, AstraZeneca filed motions in the Open Door, Little Rivers, and FamilyCare ADR proceedings for an indefinite extension of time to file responses to those petitions. The manufacturer’s deadline appears to be Nov. 4. On Oct. 21, Little Rivers and FamilyCare opposed AstraZeneca’s motions in their ADR proceedings. On Oct. 22, Open Door opposed AstraZeneca’s motion in its ADR proceedings. The ADR panels have not yet ruled on AstraZeneca’s motions.

On Oct. 14, a federal district judge denied Sanofi’s request for a stay in the ADR proceedings involving NACHC. The judge explained she will hand down a ruling on or before Nov. 5 in Sanofi’s 340B contract pharmacy lawsuit against HHS.

ADR Panel in NACHC Proceeding Issues Scheduling Order

On Oct. 22, Sanofi disclosed in a filing in that lawsuit that two days earlier, the three-member ADR panel assigned to hear NACHC’s petition against Sanofi and AstraZeneca issued an initial scheduling order for the proceeding.

The filing gives the names of the three panelists: Glenn Clark, Public Health Advisor, HIV/AIDS Bureau, HRSA; Sean Keveney, Deputy General Counsel, the Office of the General Counsel, Department of Health and Human Services (HHS); and Timothy Lape, Division of Medicare Health Plans Operations, Medicare Branch, Centers for Medicare & Medicaid Services (CMS).

The panel ordered Sanofi and AstraZeneca to file a response to NACHC’s petition against them on or before Nov. 19 (30 days after the date of the initial scheduling order).

NACHC’s deadline to respond to those filings is Dec. 10 (21 days after Sanofi and AstraZeneca’s filings).

Sanofi and AstraZeneca have until Dec. 24 “to file an appropriate reply in support of any motion” (14 days after NACHC’s Dec. 10 deadline).

The three-member ADR panel said each side will be granted one 30-day extension “of any of the deadlines set forth above. Any further request for an extension must be by motion supported by good cause.”

We asked HRSA yesterday if the schedule that this ADR panel put in place will apply to all other ADR proceedings. It said that “all public information regarding the 340B ADR process will be posted to the OPA website, when it is available.”