HEALTH & LIFE SCIENCES NEWS

This Week in 340B: August 19 – 25, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Deepika Raj and Kelsey Reinhardt | Aug 27, 2025 | 340B

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation. Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the 340B Litigation Tracker.

Issues at Stake: Contract Pharmacy; Other

In one case challenging a Utah bill, the plaintiff filed a notice of supplemental authority and the government filed a response to the notice of supplemental authority.
In two cases challenging a Nebraska bill, the court granted the government’s unopposed motion to consolidate the cases. In one case, the plaintiffs filed an amended complaint.
In one case challenging a Missouri bill, the plaintiffs filed an amended complaint for declaratory and injunctive relief.
In a case challenging an Arkansas state law, the drug manufacturer filed a sealed motion for summary judgment.
In a case by a covered entity against an insurance company alleging breach of contract, the insurance company filed a reply in support of its motion to dismiss for failure to state a claim.
In four cases challenging Oregon, Maine, and Oklahoma state laws governing contract pharmacy arrangements:
- Oklahoma: In one case, the defendant filed a response in opposition to plaintiff’s motion for preliminary injunction and in another case, the plaintiff filed [...]
  
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This Week in 340B: August 12 – 18, 2025

by Emily Jane Cook and Kelsey Reinhardt | Aug 21, 2025 | Uncategorized

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation. Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the 340B Litigation Tracker.

Issues at Stake: Contract Pharmacy

In three cases challenging Oklahoma, Colorado, and Maine state laws governing contract pharmacy arrangements:
- Oklahoma: The defendant filed a response in opposition to plaintiff’s motion for preliminary injunction.
- Colorado: The plaintiff filed a motion for preliminary injunction.
- Maine: The plaintiff filed a motion for preliminary injunction.
Two drug manufacturers filed two separate complaints in Maine and South Dakota to challenge state laws governing contract pharmacy arrangements.

HRSA issues 340B rebate model pilot program guidance, requests comments

by Emily Jane Cook | Aug 13, 2025 | 340B

The Health Resources and Services Administration (HRSA) issued a notice announcing the application process for the 340B rebate model pilot program and requesting public comment. The notice sets the parameters of 340B rebate models that HRSA will be willing to review and approve. Approved 340B rebate models may be implemented as early as January 1, 2026.

While participation in the 340B rebate model pilot program is voluntary for manufacturers, participation appears to be mandatory for 340B covered entities with regard to the 340B rebate models that HRSA approves. HRSA indicated that it may modify or expand the pilot in future years.

The guidance is materially more favorable to 340B covered entities than the 340B rebate models that certain drug manufacturers proposed or attempted to implement in late 2024. The pilot will limit 340B rebate models to drugs that have been selected for the Medicare drug price negotiation program (MDPNP) and appears to further limit 340B rebate models to drugs that are billed to patients’ prescription drug benefit plans. However, the notice explicitly states that the 340B rebate model plans will apply to drugs selected for the MDPNP, regardless of payor – in other words, they will not be limited to Medicare Part D.

Stakeholders should carefully review the 340B rebate models described in the notice and consider submitting comments to HRSA. HRSA will accept comments through August 30, 2025.

Summary of the notice

Manufacturers that would like to participate in the pilot must submit applications describing their [...]

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This Week in 340B: August 5 – 11, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Margaret Houtz, Jae Hyun Lee, Deepika Raj, Kelsey Reinhardt and Nadine Tejadilla | Aug 13, 2025 | 340B

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation. Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the 340B Litigation Tracker.

Issues at Stake: Medicare Payment Cut; Rebate Model; HRSA Audit Process; Medicare Payment; Contract Pharmacy

In a case challenging Medicare payment cuts, the action was dismissed with prejudice.
In five appealed cases related to rebate models, amici and intervenors filed briefs in support of the government.
In a case by a covered entity against an insurance company alleging breach of contract, the insurance company filed a motion to dismiss for failure to state a claim.
In another case by a covered entity against an insurance company alleging breach of contract, the covered entity filed a response in opposition to the insurance company’s motion to dismiss.
In a case by a covered entity challenging the government’s decision to allow a manufacturer’s audit, the court granted the government’s motion to dismiss and granted the drug manufacturer’s motion to file an amicus brief.
In a case challenging 2022 Medicare payment rates for 340B drugs, the court denied the plaintiff’s motion for summary judgment and granted the government’s cross-motion to [...]

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This Week in 340B: July 29 – August 4, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Margaret Houtz, Jae Hyun Lee, Deepika Raj and Nadine Tejadilla | Aug 6, 2025 | 340B

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation. Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the 340B Litigation Tracker.

Issues at Stake: Rebate Model; Contract Pharmacy

In five appealed cases related to rebate models, the defendant-appellees filed their briefs.
In a case against the Health Resources and Services Administration (HRSA) challenging its certification of a group of entities as 340B-eligible, the court denied the government’s partial motion to dismiss.
In a case challenging a Nebraska state law governing contract pharmacy arrangements, the plaintiff filed a brief opposing defendant’s motion to dismiss.
In a case challenging a Hawaii state law governing contract pharmacy arrangements, the plaintiff filed a preliminary injunction.
Three drug manufacturers and one trade association of drug manufacturers each filed four separate complaints to challenge state laws governing contract pharmacy arrangements in Oregon, Nebraska, and North Dakota.