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

This Week in 340B: March 18 – 24, 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

  • In a case by a drug manufacturer challenging a state law, the intervenor defendant filed a brief in support of its motion to compel discovery, and the drug manufacturer filed a brief in opposition to the intervenor’s motion for judgment on the pleadings.
  • In four cases against the Health Resources and Services Administration (HRSA) alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models, the intervenor defendants filed a cross motion for summary judgment and opposition to the plaintiff’s motion for summary judgment.
    • In one such case, 37 state and regional hospital associates filed a motion for leave to file an amici brief in support of HRSA.



This Week in 340B: March 11 – 17, 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; Other

  • In three appealed cases challenging a proposed Louisiana law governing contract pharmacy arrangements, the appellee filed a motion to consolidate.
  • In a case challenging the US Department of Health and Human Services (HHS) and the Health Resources and Services Administration (HRSA’s) decision to prevent drug manufacturers from unilaterally implementing rebate models, defendants filed a cross motion for summary judgment and opposition to the plaintiff’s motion for summary judgment.
  • In a case challenging HRSA’s policy limiting the circumstances in which covered entities can use their group purchasing arrangements to purchase non-340B drugs, the plaintiff filed a motion for summary judgment.
  • In three cases challenging a proposed state law governing contract pharmacy arrangements in Missouri, defendants and intervenors in each case filed answers to amended complaints.
  • In four cases against HRSA alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
    • In three cases, the defendants filed a cross motion for summary judgment and opposition to the [...]

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Unclaimed Property Laws and the Health Industry: Square Peg, Round Hole

Likely due to the tremendous number of healthcare mergers, acquisitions, and private equity deals that have been taking place, the industry has recently been the target of multistate unclaimed property audits. This increased scrutiny has highlighted many of the complexities and tensions that exist in this space. At almost every stage of the process, healthcare industry holders are pressured by state unclaimed property auditors and administrators to fit a square peg in a round hole – something both they and their advocates should continue to vigorously push back against.

Determining whether any “property” exists to report in the first instance can be a daunting task in an industry where multiple parties are involved in a single patient transaction that is documented by complex business arrangements between sophisticated parties, which are updated and accounted for on a rolling basis. Unclaimed property audits are conducted in a vacuum of one single holder and use standard document requests that were developed to apply to all businesses, creating unrealistic record retention and management expectations that almost never neatly align with healthcare industry laws or practices.

Making matters worse, unclaimed property auditors and voluntary disclosure agreement (VDA) administrators frequently do not have a detailed understanding of the complex healthcare privacy, billing, and payment practices, yet these practices materially impact how providers manage unclaimed property and when they report it. Getting them up to speed on these laws, practices, and procedures can be very time-consuming. For example, providers or their advisors may need to explain to [...]

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This Week in 340B: March 4 – 10, 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; HRSA Audit Process; Medicare Payment; Rebate Model

  • In a case appealing a decision on a state contract pharmacy law, two amicus briefs were filed in support of the defendant-appellant state.
  • In one Health Resources and Services Administration (HRSA) audit process case, the court granted motion to withdraw the plaintiff’s motion for preliminary injunction.
  • In a case challenging a Medicare Advantage plan’s response to 340B payment cuts, defendants’ motion to compel the production of a damages spreadsheet was granted in part and denied in part.
  • In six cases against HRSA alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
    • In five such cases, the court granted intervenor’s motion to intervene and a group of amici filed an amicus brief in support of the defendant.
    • In one such case, intervenors filed a notice of supplemental authority to which the plaintiff filed a response and a group of amici filed an amicus brief in support of the defendant.
  • [...]

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This Week in 340B: February 25 – March 3, 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: Antitrust; Contract Pharmacy; HRSA Audit Process; Rebate Model

  • In an antitrust class action case, the court granted the defendant’s motion to dismiss.
  • In an appealed case challenging a proposed state law governing contract pharmacy arrangements, a group of amici filed an amicus brief in support of appellees.
  • In an appealed case challenging a proposed state law governing contract pharmacy arrangements, defendants-appellants filed an opening brief.
  • In a Freedom of Information Act (FOIA) case, the plaintiff filed a reply in support of its motion to strike the government’s motion for summary judgment.
  • In one one Health Resources and Services Administration (HRSA) audit process case, the plaintiff filed a supplemental brief in support of the plaintiff’s motion for preliminary injunction.
  • A group of 340B covered entities filed a complaint against a group of commercial payors, alleging that the payors were in breach of their contracts by failing to pay the proper amounts for 340B-acquired drugs.
  • In three cases challenging a proposed state law governing contract [...]

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