rebate model Archives | 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 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: August 26 – September 1, 2025

by Emily Jane Cook, Reuben Bank, Jae Hyun Lee, Margaret Houtz, Deepika Raj and Kelsey Reinhardt | Sep 3, 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 six appealed cases related to rebate models, plaintiff-appellants filed their reply briefs.
In a case challenging a Tennessee state law governing contract pharmacy arrangements, the plaintiff filed an amended complaint and the defendant filed a reply in support of its motion to dismiss.
In a case challenging a Utah bill governing contract pharmacy arrangements, the defendant filed a response to the plaintiff’s notice of supplemental authority.
In a case challenging a Missouri state law governing contract pharmacy arrangements, amici filed an amicus brief in support of the defendants.
In a case challenging a Hawaii state law governing contract pharmacy arrangements, the plaintiff filed a reply brief to its motion for preliminary injunction.
A drug manufacturer filed two separate lawsuits in Hawaii and Tennessee to challenge state laws governing contract pharmacy arrangements.

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 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.

This Week in 340B: July 8 – 14, 2025

by Emily Jane Cook, Matthew David, Margaret Houtz, Jae Hyun Lee, Deepika Raj, Kelsey Reinhardt and Nadine Tejadilla | Jul 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: Rebate Model; Contract Pharmacy;

In five appealed cases related to rebate models:
- In five cases, the appellant filed its brief.
- In three cases, the plaintiff-appellants filed a reply in support of their emergency motion to dismiss the cross-appeals.
In one case challenging a state law in Tennessee, the defendant filed a response in opposition to the plaintiff’s motion for preliminary injunction, and the plaintiff filed a memorandum in opposition to the defendant’s motion to dismiss; and in a second case, the defendant filed a motion to dismiss.
In a case challenging a South Dakota bill, amici filed a brief in support of the government’s motion to dismiss.
In two cases challenging Nebraska’s state law governing contract pharmacy arrangements, the court granted amici’s motion for leave to submit a brief of amicus curiae and, in a second case, the defendant filed a motion to dismiss.
In one case challenging Missouri’s state law governing contract pharmacy arrangements, the court dismissed without prejudice [...]

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This Week in 340B: July 1 – 7, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Jae Hyun Lee, Margaret Houtz, Deepika Raj, Kelsey Reinhardt and Nadine Tejadilla | Jul 9, 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; Other; HRSA Audit Process; Contract Pharmacy

In five appealed cases related to rebate models:
- In four cases, an amended amicus brief was filed in support of the appellant drug manufacturers.
- In one case, a motion to consolidate was filed.
- In one case, the intervenor-appellees filed a response to appellant’s motion to dismiss their cross-appeal.
In a case by a covered entity against an insurance company alleging breach of contract, the insurance company filed a motion to dismiss and memorandum in support of its motion to dismiss.
In a case by a covered entity challenging the government’s decision to allow a manufacturer’s audit, the government filed a reply in further support of its motion to dismiss.
In a case challenging a South Dakota bill, the court granted leave to file an amici curiae brief in support of the government.
In four cases challenging a Utah bill, the government filed motions to dismiss and memoranda in support of their motions [...]

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This Week in 340B: June 24 – 30, 2025

by Emily Jane Cook, Matthew David, Margaret Houtz, Jae Hyun Lee, Deepika Raj and Kelsey Reinhardt | Jul 2, 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: Other; Rebate Model; Antitrust; Contract Pharmacy; GPO Prohibition

In a case by a covered entity against the government, the court denied the covered entity’s motion for preliminary injunction.
In four appealed cases against the government related to rebate models, the appellants filed an emergency motion to dismiss the cross appeals by intervenor-defendants, and four amicus curiae briefs were filed in support of the appellants.
In a case challenging a state Medicaid 340B carve-out plan, the court entered a stipulation of discontinuance without prejudice.
In one case against the government related to rebate models, the court issued its opinion which the plaintiff appealed, five amicus curiae briefs were filed in support of the plaintiff and two amicus briefs were filed in support of the defendants.
In an antitrust class action case, the defendant filed a reply memorandum in support of its motion to dismiss the plaintiff’s amended complaint.
In one case challenging a state law in Tennessee, the court denied the plaintiff’s motion for [...]

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This Week in 340B: June 17 – 23, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Margaret Houtz, Deepika Raj and Kelsey Reinhardt | Jun 25, 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; HRSA Audit Process

In five cases challenging Tennessee, Hawaii and Utah state laws governing contract pharmacy arrangements:
- Tennessee: In one case, amici filed an amicus curiae brief in opposition to plaintiff’s motion for preliminary injunction and in a second case, the plaintiff filed a motion for preliminary injunctive relief and the defendant filed a motion to dismiss.
- Hawaii: In one case, the plaintiff filed a motion for preliminary injunction.
- Utah: In three cases, the plaintiffs filed oppositions to the defendants’ motion to dismiss and replies in support of plaintiffs’ motions for preliminary injunctive relief.
In two appealed cases against the government related to rebate models, the court granted appellant’s motion to consolidate the cases with other similarly situated cases, and consolidated two additional cases as cross-appeals.
In three appealed cases against the government related to rebate models, the appellants filed opening briefs.
In two cases related to the HRSA audit process, the court granted defendants’ motion [...]

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