HEALTH & LIFE SCIENCES NEWS
HEALTH & LIFE SCIENCES NEWS
Exploring critical business and legal issues across the healthcare and life sciences industries
HEALTH & LIFE SCIENCES NEWS
Exploring critical business and legal issues across the healthcare and life sciences industries
340B
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This Week in 340B: July 29 – August 4, 2025

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.



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This Week in 340B: July 22 – 28, 2025

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.



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This Week in 340B: July 15 – 21, 2025

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.



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CMS CY 2026 proposed rules: 340B in PFS and OPPS

On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released the CY 2026 Outpatient Prospective Payment System (OPPS) proposed rule. The proposed rule includes a provision that would increase the reduction in OPPS payment rates to offset the lump sum payments previously paid to 340B hospitals from 0.5% to 2% and would accelerate the period of the reductions from 16 years to six years. This payment reduction would apply to most items and services and most hospitals paid under OPPS. The reduction is not limited to 340B hospitals. CMS also proposes to reduce payments under OPPS for drug administration at most off-campus hospital outpatient departments not already subject to site-neutral payments to the rate paid under the Medicare Physician Fee Schedule (PFS), representing an approximately 65% reduction in payments.  

CMS is accepting comments on this proposal through September 13, 2025

The proposed rule was published in the Federal Register on July 17, 2025 and is available here. Refer to pp. 33631-35 for information about the OPPS payment reduction to account for the 340B budget neutrality adjustment, pp. 33685-93 for information about the application of site neutral payments to hospital outpatient drug administration services and pp. 33653-54 and pp. 33832-33 for information about the hospital drug acquisition cost survey. 

Reduction in OPPS payment rates for most items and services 

The proposed OPPS payment reductions to recoup a portion of the 340B lump sum payments are the result of the prior 340B payment cuts being implemented in a “budget-neutral” manner. [...]

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This Week in 340B: July 8 – 14, 2025

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

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

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

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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This Week in 340B: June 10 – 16, 2025

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; Anti-Trust

  • A drug manufacturer filed a complaint challenging a Colorado state law governing contract pharmacy arrangements.
  • In two cases against the government related to rebate models, the plaintiffs filed a notice of appeal and in one of those cases intervenors filed a notice of cross appeal.
  • In two cases against the government related to rebate models, the court granted the plaintiffs’ motion to consolidate.
  • In a case by a covered entity challenging the government’s decision to allow a manufacturer’s audit, the covered entity filed a memorandum in opposition to the government’s motion to dismiss.
  • In a case challenging a South Dakota state bill, defendants filed a reply brief in support of their motion to dismiss.
  • In an antitrust class action case, the plaintiff filed a memorandum in opposition to the defendant’s motion to dismiss the plaintiff’s amended complaint.



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This Week in 340B: June 3 – 9, 2025

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; HRSA Audit Process; Other

  • In one case against the government related to rebate models, the intervenor defendants filed their reply.
  • In one case against the government related to rebate models, the plaintiff filed an emergency motion to consolidate and expedite.
  • In one contract pharmacy case, amici filed an amicus curiae brief in support of defendants’ motion to dismiss.
  • In a case by a covered entity challenging the government’s decision to allow a manufacturer’s audit, the drug manufacturer filed a motion for leave to file an amicus brief.
  • In four cases challenging state laws in Tennessee and Utah governing contract pharmacy arrangements:
    • Tennessee: A group of amici filed an amicus curiae brief in support of the defendant’s opposition to plaintiff’s motion for preliminary injunction.
    • Utah: The plaintiff in one case filed a motion for preliminary injunction and in two other cases, two separate groups of amici filed amicus curiae briefs.
  • A 340B covered entity filed two separate [...]

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