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: August 6 – 12, 2024

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, a subscription product from McDermott+.

Issues at Stake: Contract Pharmacy

  • In a case challenging proposed state laws governing contract pharmacy arrangements, the plaintiff filed a motion for a preliminary injunction and suggestion in support of the motion.
  • In 5 cases challenging proposed state laws governing contract pharmacy arrangements:
    • The plaintiff filed a motion to compel compliance with a subpoena and a putative intervenor filed a reply in support of its motion to intervene;
    • The plaintiff filed a writ of certiorari to the Supreme Court;
    • Defendants filed omnibus memorandums in support of their motions to dismiss PhRMA’s claims and opposing PhRMA and AbbVie’s preliminary injunction motions in three related cases. In one of those three cases, defendants additionally filed a motion to dismiss for lack of subject matter jurisdiction.



This Week in 340B: July 30 – August 5, 2024

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, a subscription product from McDermott+.

Issues at Stake: Contract Pharmacy

  • A drug manufacturer filed suit against the Kansas attorney general to challenge a state law governing contract pharmacy arrangements.
  • A 340B Covered Entity filed suit against HRSA to challenge HRSA’s authorization of an audit request by a drug manufacturer.
  • In six separate cases challenging state laws governing contract pharmacy arrangements:
      1. A defendant filed a motion to dismiss and a notice of related cases;
      2. A defendant filed a motion to dismiss and a notice of related cases;
      3. A plaintiff filed an opposition to a putative intervenor’s motion to intervene; a putative intervenor filed a motion for leave to file a reply in support of its motion to intervene; four respondents filed a joint motion to quash subpoenas seeking non-party discovery; and a plaintiff filed a motion to compel compliance with a subpoena;
      4. Defendants filed a reply brief in support of their motion to dismiss the plaintiff’s complaint.
      5. A group of five amici filed [...]

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This Week in 340B: July 23 – 29, 2024

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, a subscription product from McDermott+.

Issues at Stake: Contract Pharmacy; Other

  • A drug manufacturer filed suit against the Kansas attorney general to challenge a state law governing contract pharmacy arrangements.
  • In an appealed qui tam action arguing that private parties can bring suits to enforce the 340B Statute, the appellant-relator filed its opening brief, and four amicis filed briefs in support of the appellant-relator.
  • In four cases challenging separate state laws governing contract pharmacy arrangements:
    1. The defendants filed a reply brief in support of their motion to dismiss plaintiff’s complaint, and the plaintiff filed a response to defendants’ motion to consolidate this case with three other similarly situated cases;
    2. The defendants filed a memorandum in support of their motion to dismiss plaintiff’s complaint;
    3. The parties filed a joint motion to stay proceedings; and
    4. The defendant filed a motion to stay proceedings.



This Week in 340B: July 16 – 22, 2024

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, a subscription product from McDermott+.

Issues at Stake: Contract Pharmacy; Other

  • In a case challenging a state law governing contract pharmacy arrangements, the plaintiff filed a motion to compel compliance with third-party subpoenas and a covered entity moved to intervene as a defendant.
  • In a case challenging a state law governing contract pharmacy arrangements, the plaintiff filed a memorandum in support of its motion for preliminary injunctive relief and in opposition to defendants’ motion to dismiss.
  • In a case challenging a state law governing contract pharmacy arrangements, the defendants filed a motion to dismiss and a memorandum of law in opposition to the plaintiffs’ motion for a preliminary injunction.
  • In an appealed qui tam action alleging that various drug manufacturers failed to charge accurate ceiling prices to 340B Covered Entities, the plaintiff-realtor filed its opening brief.
  • In a case challenging a state law governing contract pharmacy arrangements, the defendant filed its answer to the plaintiff’s complaint and the plaintiff filed a motion for preliminary injunction.
  • A drug [...]

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CMS Sneaks 340B Billing Proposals into Medicare Physician Fee Schedule: What 340B Stakeholders Need to Know

On July 10, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Medicare Physician Fee Schedule (MPFS) proposed rule, which includes proposals related to identification of Medicare Part B and Part D claims for 340B drugs in order to exclude them from inflation-related Medicare drug rebates established under the Inflation Reduction Act. Because MPFS is not often on the radar for 340B stakeholders, we want to make sure that folks are aware of the 340B-related provisions in the proposed rule and the deadline for submitting comments. We have excerpted the relevant pages of the MPFS proposed rule for ease of reference (the entire proposed rule is well over 2,000 pages and available here. The proposed rules are generally consistent with guidance materials previously released by CMS.

As described in more detail below, the CMS proposals would eventually require claims-level information reporting to exclude Medicare Part D 340B claims and use claim modifiers to exclude Part B claims. ALL 340B-covered entities are now expected to report claim-line modifiers for separately payable Medicare Part B drugs under guidance that was effective January 1, 2024.

Comments are due on September 9, 2024. We note that in light of the recent US Supreme Court decision in the Loper Bright case and the end of the Chevron doctrine, 340B stakeholders should consider submitting comments (both in support of the proposals and with alternatives that CMS should implement). Legal challenges to whatever rules CMS ultimately implements should be expected, and the [...]

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