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
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This Week in 340B: September 24 – 30, 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: HRSA; Contract Pharmacy

  • In a case challenging HRSA’s policy prohibiting all manufacturer conditions on 340B transactions, the parties filed a joint status report.
  • In six cases challenging proposed state laws governing contract pharmacy arrangements in Louisiana, Missouri, and Maryland:
    • LA: The court ruled on motions for summary judgement.
    • MO: Proposed intervenors filed a motion to intervene and a motion to dismiss with suggestions in support of each motion. In a second case, plaintiff filed suggestions in opposition to reassign or transfer the case to a different forum.
    • MD: The plaintiffs filed a reply in support of their motion for expedited discovery, and a notice of appeal of the court’s decision to deny their motion for preliminary injunction.



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Loper Bright and the 340B Statute

In its Loper Bright decision last week, the Supreme Court of the United States likely opened opportunities for further legal challenges to the Health Resources and Services Administration’s (HRSA’s) interpretation and application of the 340B statute. Going forward, we expect that much of the 340B statute will be subject to interpretation by federal courts.

HRSA’s historic policies that are not the “best” interpretation of the statutory language may not survive legal challenges. Where HRSA retains the authority to regulate the 340B program, it will be required to demonstrate that it is acting based on “reasoned decision-making.”

Examples of what the application of the new Loper Bright standard might look like in practice, as applied to provisions in the 340B statute:

  • Definition of “Patient”: The 340B statute does not define “patient.” The 340B statute states in relevant part that “a covered entity shall not resell or otherwise transfer the drug to a person who is not a patient of the entity.” Under Loper Bright, a court will likely decide, without deference to HRSA, who qualifies as a patient. A court is not required to defer to HRSA’s statutory interpretation.
  • Requirements for Registration of DSH Hospital Child Sites Prior to Use of 340B Drugs: The 340B statute defines disproportionate share hospital (DSH) hospital covered entities as “a subsection (d) hospital (as defined in section 1886(d)(1)(B) of the Social Security Act) that [meets certain additional requirements set forth in the statute related to ownership, DSH percentage and GPO purchasing].” The 340B statute [...]

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This Week in 340B: February 7 – 13, 2023

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.

Issues at Stake: Contract Pharmacy; HRSA Audit Process; Medicare Payment Cuts
Where Things Stand:

  • In one contract pharmacy case, the court ordered a stay pending the D.C. Circuit Court’s ultimate decision in Novartis Pharmaceuticals Corp. v. Johnson and United Therapeutics Corp. v. Johnson.
  • The 340B Covered Entity plaintiff in one case asked that the court take specific discovery actions with respect to its challenge of the definition of “patient.”
  • Six Medicare payment cut cases were ordered stayed until May 19, 2023, pending a decision in AHA v. Becerra regarding remedies.
  • In three Medicare payment cut cases, the district court judge has signaled her inclination to transfer the cases to the judge handling most other Medicare payment cut cases, and has asked for the parties to enter any objections to a transfer.

Get more details on these 340B cases with the 340B Litigation Tracker, a subscription product from McDermott+Consulting.




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This Week in 340B Litigation: January 2 – 9, 2023

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.

  • Issues at Stake in Developments Last Week: Medicare Payment; HRSA Audit Process
  • Where Things Stand:
    • A Confidentiality Order issued in one case, ordering that certain administrative record and discovery material may be treated as confidential and setting forth the terms and procedure for designating such documents as confidential.
    • Five cases will remain stayed pending a decision in AHA v. Becerra on remedies for the now-vacated 340B Medicare payment cuts. The Court also ordered that the parties in these cases file a Joint Status Report on or before April 10, 2023.
    • Parties in three cases filed a Joint Status Report in their respective courts, requesting that their cases remain stayed pending a remedies decision in AHA v. Becerra.

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+Consulting.




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