HEALTH & LIFE SCIENCES NEWS

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.

This Week in 340B: July 22 – 28, 2025

by Emily Jane Cook, Margaret Houtz and Kelsey Reinhardt | Jul 30, 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

In four cases challenging Oklahoma, Colorado, and Tennessee state laws governing contract pharmacy arrangements:
- Oklahoma: In two cases, defendant filed its answer and in one of those cases, plaintiff also filed a motion for preliminary injunction.
- Colorado: In one case, plaintiff filed its reply in support of its motion for preliminary injunction.
- Tennessee: In one case, the plaintiff filed a reply in support of its motion for preliminary injunction, and the defendant filed a reply in support of its motion to dismiss.

This Week in 340B: July 15 – 21, 2025

by Emily Jane Cook, Matthew David, Jae Hyun Lee, Deepika Raj and Kelsey Reinhardt | Jul 23, 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; Rebate Model; Other

In two cases challenging a Nebraska state law governing contract pharmacy arrangements, amici filed briefs requesting the court grant defendant’s motion to dismiss.
In a case challenging a Colorado state law governing contract pharmacy arrangements, amici filed a brief in opposition to plaintiff’s motion for summary judgment.
In three appealed cases related to rebate models:
- In two cases, the court granted the plaintiff-appellant drug manufacturers’ motion to dismiss the cross-appeals.
- In one case, the court granted the plaintiff-appellant drug manufacturer’s motion to consolidate.
In a case by a covered entity against the government, the government filed an answer to the covered entity’s complaint.