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 20 – 26, 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; Medicare Payment; Other

  • In a case challenging HRSA’s position on contract pharmacy arrangements, the parties filed a joint status report.
  • In a breach of contract and unfair business practices case related to the activities of the 340B Prime Vendor, the United States Court of Appeals for the Ninth Circuit ruled in favor of the defendant, ruling that the plaintiff did not have a private right of action.
  • In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, the court denied the defendants’ motion to dismiss the first amended complaint.
  • In 16 cases challenging proposed state laws governing contract pharmacy arrangements in Arkansas, the District of Columbia, Maryland, Minnesota, Missouri, and West Virginia:
    • AR: The court denied the plaintiff’s motion to compel compliance with certain subpoenas and denied the respondents’ motion to quash those subpoenas.
    • DC:
      1. In two cases challenging state laws governing contract pharmacy arrangements, the [...]

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CMS Recommends That Hospitals Adopt Updated EMTALA Signage

The Centers for Medicare and Medicaid Services (CMS) recently announced the release of updated model signage for use by Medicare-participating hospitals to inform patients of their rights under the Emergency Medical Treatment and Labor Act (EMTALA). Hospitals are encouraged – but not required – to adopt the updated signage by September 13, 2024.

The new model signage is available in the “Downloads” section of CMS’s EMTALA webpage in Medicaid-participating and non-Medicaid-participating versions. CMS prepared the updated signage to assist hospitals in informing patients of their rights under EMTALA. The signage identifies that patients can file a complaint if they believe their rights under EMTALA have been violated.

EMTALA Required Signage

The new model signage is “recommended” for hospitals to meet their obligations to post EMTALA-specific signage. 42 CFR § 489.20(q) requires hospitals to display signage in a “conspicuous” location likely to be encountered by individuals entering the emergency department or waiting for examination and treatment. The content of required EMTALA signage has historically been expected to be presented in a font size readable from a 20-foot distance. The signage must:

  • Specify the rights of individuals with emergency medical conditions and women in labor who come to the emergency department for healthcare services;
  • Indicate whether the facility participates in Medicaid; and
  • Use clear language and simple terms in languages that are understandable by the populations served by the hospital.

The new model signage contains these elements, but [...]

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This Week in 340B: August 13 – 19, 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 seven cases challenging proposed state laws governing contract pharmacy arrangements:
    • The plaintiff filed an opposition to the respondents’ motion to quash its subpoenas; the court granted a purported intervenor’s motion to intervene; the intervenor filed a motion to dismiss; the intervenor filed an answer in intervention to the plaintiff’s amended complaint; and a respondent filed an additional motion to quash a subpoena issued by the plaintiff.
    • 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.
    • The plaintiff filed an amended complaint and a reply memorandum in support of its motion for preliminary injunction.
    • The plaintiff filed a motion for leave to file a surreply in response to defendants’ reply in support of their motion to dismiss, and defendants filed a [...]

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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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