HEALTH & LIFE SCIENCES NEWS

340B Rebate Models Approved for January 2, 2026 Implementation

by Emily Jane Cook | Nov 3, 2025 | 340B

On October 30, 2025, the Office of Pharmacy Affairs (OPA) posted information on its website announcing that they have approved 340B rebate models applicable to eight drug manufacturers. Consistent with the August Federal Register Notice announcing the 340B Rebate Model Pilot Program, the approved rebate models will apply to nine of the 10 drugs selected for the Inflation Reduction Act (IRA) negotiated drug prices for Medicare Part D, effective January 1, 2026. The rebate models announced on October 30 will also be effective January 1, 2026.

In addition to required claim level data fields to be submitted for the selected drugs when dispensed in a retail setting, OPA/HRSA has now provided information about the data fields that will be required for in-hospital dispensing of the selected drugs. A chart of the data fields that will be required for submission to manufacturers to obtain 340B rebates is now available on the OPA/HRSA website, linked above.

The information currently available about the rebate models from OPA/HRSA is quite limited. OPA/HRSA appears to be generally deferring to Beacon, the IT platform vendor that will be operationalizing all of the rebate models announced on October 30, to provide operational details of the rebate models. As of October 30, however, there was also very limited information available from the Beacon website.

The McDermott team is continuing to review the available information about the approved 340B rebate models, including how claims for drugs subject to the rebate [...]

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This Week in 340B: October 21 – 27, 2025

by Emily Jane Cook, Matthew David, Abygail Hoey and Sydney Merritt Martinez | Oct 30, 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; Other

In one case brought by a drug manufacturer challenging a Tennessee state law governing contract pharmacy arrangements, the plaintiff filed a brief in opposition to defendant’s motion to dismiss.
In one case brought by a drug manufacturer challenging a Colorado state law governing contract pharmacy arrangements, the plaintiff filed a brief in opposition to the defendants’ motion to dismiss.
In one case by a trade association of drug manufacturers challenging a Maine state law governing contract pharmacy arrangements, an Amici brief was filed in support of defendants’ opposition to plaintiff’s motion for preliminary injunction.
In one case by a covered entity against an insurance company alleging breach of contract, the insurance company filed an answer to the covered entity’s complaint.

This Week in 340B: October 14 – 20, 2025

by Emily Jane Cook, Matthew David, Abygail Hoey, Margaret Houtz, Sydney Merritt Martinez and Nadine Tejadilla | Oct 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 Models; Other

In one case brought by a drug manufacturer challenging a North Dakota state law governing contract pharmacy arrangements, the plaintiff filed a motion for summary judgment.
In one case brought by a drug manufacturer challenging a Tennessee state law governing contract pharmacy arrangements, the defendant filed a response to the plaintiff’s notice of supplemental authority, and in another similar case, a group of amici filed an amicus brief in support of defendant’s motion to dismiss.
In [three] consolidated appealed cases related to rebate models, the plaintiff-appellants filed an unopposed motion to unseal a portion of the administrative record.
In one case brought by a trade association for drug manufacturers challenging a Colorado state law governing contract pharmacy arrangements, the plaintiff filed a brief in opposition to the defendants’ motion to dismiss.
In one case brought by a drug manufacturer challenging a Hawaii state law governing contract pharmacy arrangements, the defendant filed a memorandum in opposition to the plaintiff’s [...]

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This Week in 340B: October 7 –13, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Jae Hyun Lee, Deepika Raj and Kelsey Reinhardt | Oct 16, 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 brought by a drug manufacturer challenging a North Dakota state law governing contract pharmacy arrangements, the defendants filed their answer.
In one case brought by a drug manufacturer challenging a Missouri state law governing contract pharmacy arrangements, the plaintiff-appellant filed their reply brief.
In one case brought by a drug manufacturer challenging an Oklahoma state law governing contract pharmacy arrangements, the plaintiff filed a motion for preliminary injunction.
In one case brought by a trade association of drug manufacturers challenging a Rhode Island state law governing contract pharmacy arrangements, the plaintiff filed a motion for preliminary injunction.
In one case brought by a drug manufacturer challenging a Maine state law governing contract pharmacy arrangements, the court granted the parties’ motion to stay pending resolution of the plaintiff’s appeal.
In one case brought by a drug manufacturer challenging a Colorado state law governing contract pharmacy arrangements, a group of amici filed a supplemental amicus curiae brief in support [...]

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This Week in 340B: September 30 – October 6, 2025

by Emily Jane Cook, Reuben Bank, Matthew David and Kelsey Reinhardt | Oct 8, 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 a state law governing contract pharmacy arrangements in Utah, two plaintiffs filed a response to the government’s notice of supplemental authority, one plaintiff filed a notice of supplemental authority, and one defendant filed a notice of supplemental authority in support of their motion to dismiss.
In a case by a drug manufacturer challenging an Arkansas state law governing contract pharmacy arrangements, the court denied the intervenor-defendant’s motion for judgment on the pleadings.
A trade association for drug manufacturers filed a cases in Oregon and a case in Rhode Island to challenge state laws governing contract pharmacy arrangements.
A drug manufacturer filed a case in Maine and a case in Oklahoma to challenge state laws governing contract pharmacy arrangements.
In one case by a drug manufacturer challenging a Colorado state law governing contract pharmacy arrangements, the plaintiff filed a motion for preliminary injunction.
In one case by a trade association for drug manufacturers challenging a Colorado state law [...]

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