HEALTH & LIFE SCIENCES NEWS

340B Rebate Models and Medicare Part D 340B Claims: What 340B Covered Entities Need to Know for 2026

by Emily Jane Cook | Nov 10, 2025 | 340B, Hospitals & Health Systems, Reimbursement

340B covered entities should carefully review the approved 340B rebate models and the 2026 Medicare Physician Fee Schedule (MPFS) Final Rule provisions on new CMS processes for identifying Medicare Part D claims for 340B drugs.

While the current scope may seem limited or not applicable to certain 340B covered entities, now is the most important time to evaluate the implications of these programs if expanded to all 340B drugs and all 340B covered entities in order to ensure that the concerns of 340B covered entities are appropriately addressed.

340B Rebate Models

As a reminder, although the only drugs currently subject to the 340B rebate models are those that will be subject to the Medicare Part D negotiated prices, the 340B rebate models extend to all 340B covered entity types, all payors and all locations of dispensing/administration of the selected drugs. While the current 340B rebate models are being implemented under a “pilot program,” it is highly likely that 340B rebate models will be expanded to many more drugs in the coming years (possibly even during 2026).

Since the announcement of the approved 340B rebate models, the software platform that will be used for all rebate models approved to-date, Beacon, has released additional information about the implementation of the rebate models and details about operational aspect of the rebate models. All covered entities should familiarize themselves with the Beacon platform and rebate model as soon as possible and should be paying close attention to the [...]

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This Week in 340B: October 28 – November 3, 2025

by Emily Jane Cook, Reuben Bank, Abygail Hoey, Matthew David, Sydney Merritt Martinez and Kelsey Reinhardt | Nov 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: Contract Pharmacy; Other

In one case by a trade association of drug manufacturers challenging a Maine state law governing contract pharmacy arrangements, the plaintiff filed a reply in support of its motion for preliminary injunction.
In one case by a trade association of drug manufacturers challenging a Rhode Island state law governing contract pharmacy arrangements, the defendant filed a memorandum in objection to plaintiff’s motion for preliminary injunction.
In one case brought by a drug manufacturer challenging a Hawaii state law governing contract pharmacy arrangements, the defendant filed a reply memorandum in support of the defendants’ motion to dismiss.
In one case brought by a drug manufacturer challenging a Colorado state law governing contract pharmacy arrangements, the court denied the plaintiffs’ motion for a preliminary injunction.
In one case brought by a trade association for drug manufacturers challenging a Colorado state law governing contract pharmacy arrangements, the defendants filed a reply to response to the defendants’ motion to dismiss.
In one case brought by [...]

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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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