340B litigation Archives - HEALTH & LIFE SCIENCES NEWS

This Week in 340B: December 10 – 16, 2024

by Emily Jane Cook, Reuben Bank, Margaret Houtz, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Dec 18, 2024 | 340B

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; Other

A drug manufacturer filed suit against the Health Resources and Services Administration (HRSA) to challenge HRSA’s determination that its proposed rebate model violates the 340B statute.
In two HRSA audit process cases, HRSA filed a motion to dismiss for a lack of subject-matter jurisdiction and failure to state a claim.
In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, defendants filed a notice of non-opposition, and the court granted plaintiff’s motion for leave to file a second amended complaint and motion to file the second amended complaint under seal.
In an appealed qui tam action alleging that various drug manufacturers failed to charge accurate ceiling prices to 340B Covered Entities, the appellant filed a reply brief.
In four consolidated Kansas contract pharmacy cases, the parties filed a joint stipulation of dismissal without prejudice.
In eight cases challenging a proposed state law governing contract pharmacy arrangements in West Virginia, [...]

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This Week in 340B: December 3 – 9, 2024

by Emily Jane Cook, Reuben Bank, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Dec 11, 2024 | 340B

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: HRSA Audit Process; Contract Pharmacy; Other

In a Freedom of Information Act (FOIA) case, the Health Resources and Services Administration (HRSA) filed a reply in support of its cross-motion for partial summary judgment.
In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, the 340B Covered Entity filed a motion for leave to file its second amended complaint and the court ordered that the related party Medicare Advantage plans show cause why the motion for leave should not be granted.
In one HRSA audit process case, the plaintiff filed a motion for stay of agency action and preliminary injunction.
In two HRSA audit process cases, HRSA filed a motion to dismiss for a lack of subject-matter jurisdiction and failure to state a claim.
In a case challenging HRSA’s policy prohibiting all manufacturer conditions on 340B transactions, the court approved the parties’ motion for leave to file an amended complaint.
In four cases challenging a proposed [...]

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This Week in 340B: November 19 – December 2, 2024

by Emily Jane Cook, Reuben Bank, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Dec 4, 2024 | 340B

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: HRSA Audit Process; Contract Pharmacy; Other

In four Health Resources and Services Administration (HRSA) audit process cases, the plaintiffs filed motions for a temporary restraining order.
In four HRSA audit process cases, the courts approved a joint motion to withdraw the plaintiff’s previously-flied motion for a temporary restraining order.
In a Freedom of Information Act (FOIA) case, the drug manufacturer plaintiff filed a reply in support of its motion for summary judgment and opposition to defendants’ motion for partial summary judgment.
A drug manufacturer filed suit against HRSA to challenge HRSA’s disapproval of its proposed rebate model.
In eight cases challenging proposed state laws governing contract pharmacy arrangements in West Virginia and Missouri:
- WV: The court in four separate cases granted the parties’ joint motions and stipulations to delay proceedings for fourteen days to allow related courts to decide pending preliminary injunction motions in similar cases.
- MO: In two cases, the plaintiff filed suggestion in opposition to intervenor’s motion to [...]
  
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This Week in 340B: October 15 – 21, 2024

by Emily Jane Cook, Reuben Bank, Margaret Houtz, Jae Hyun Lee and Patrick Moore | Oct 23, 2024 | 340B

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; Other

In an appealed qui tam action alleging that various drug manufacturers failed to charge accurate ceiling prices to 340B Covered Entities, the appellees filed an answering brief.
In nine cases challenging proposed state laws governing contract pharmacy arrangements in Mississippi, Louisiana, Minnesota, West Virginia and Missouri:
- LA: The plaintiff filed an appeal.
- MN: The defendant in two related cases filed a reply in support of their motion to dismiss.
- WV: The defendant in three cases filed notices of supplemental authority
- MO:
  - In one case, three amici filed a motion for leave to file an amicus brief with the court, defendants filed a memorandum in support of their motion to dismiss, two intervenors filed a verified motion to intervene and suggestions in support, and plaintiffs filed a response to defendant’s motion to dismiss.
  - In another case, plaintiffs filed a response to defendant’s motion to transfer.
- MS: The defendant filed a reply in opposition to the plaintiff’s motion for [...]
  
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This Week in 340B: October 8 – 14, 2024

by Emily Jane Cook, Jae Hyun Lee, Deepika Raj and Kelsey Reinhardt | Oct 17, 2024 | 340B

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 eight cases challenging proposed state law governing contract pharmacy arrangements, in Louisiana, Missouri, Minnesota, and Kansas:
- LA: the Plaintiff filed an appeal.
- MO: amici filed a motion for leave to file an amicus brief in one case and Defendants filed a reply in support of its motion to transfer venue.
- KS: the court filed an order to consolidate all contract pharmacy cases for discovery purposes only.
- MN: the Plaintiffs in each of two cases filed an opposition to Defendant’s motion to dismiss.

Loper Bright and the 340B Statute

by Emily Jane Cook | Jul 11, 2024 | 340B

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, 2024

by McDermott Will & Emery, Emily Jane Cook, Kelsey Reinhardt, Bryan Frederick and Patrick Moore | Feb 15, 2024 | 340B

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+Consulting.

Issues at Stake: Contract Pharmacy; Medicare Payment; Other

In two separate cases regarding a state law governing contract pharmacy arrangements, defendant state attorney general filed a reply in support of defendant’s cross-motion for summary judgment.
In the same two separate cases regarding a state law governing contract pharmacy arrangements, intervenor-defendant state primary care association filed a reply in support of intervenor-defendant’s motion for summary judgment.
In a separate case regarding a state law governing contract pharmacy arrangements, plaintiff pharmaceutical company filed an opposition to intervenor-defendant state primary care association’s motion to intervene.
In a case challenging the New York Department of Health’s 340B Carveout plan, the Plaintiff’s submitted a memorandum in opposition to Defendants’ cross-motion to dismiss and in further support of their motion for a preliminary injunction.
A 340B Covered Entity filed a breach of contract claim against several related party Medicare Advantage plans, alleging that the company has failed to reimburse the covered entity after using rates based on the [...]

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This Week in 340B: November 28 – December 5, 2023

by Emily Jane Cook and Patrick Moore | Dec 6, 2023 | 340B

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 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.

Issues at Stake: Contract Pharmacy

In a case regarding a state law governing contract pharmacy arrangements, plaintiff state attorney general filed a memorandum of law in opposition to defendant’s motion to dismiss plaintiff’s second complaint.
In a separate case regarding a state law governing contract pharmacy arrangements, defendant commissioner of state insurance department filed a reply to plaintiff’s response to motion to dismiss.

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.

This Week in 340B: November 6 – 12, 2023

by Emily Jane Cook, Reuben Bank and Kelsey Reinhardt | Nov 15, 2023 | 340B

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 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.

Issues at Stake: Contract Pharmacy, Medicare Payment

In response to the final rule published on November 2, 2023 detailing a remedy for underpayment in light of the Supreme Court’s decision in AHA v. Becerra, the parties in 11 of the pending Medicare Payment Cut cases requested that the cases be further stayed by 100 days to allow for implementation of the final rule. The parties anticipate that the cases would be dismissed after the payments are made. Stay Orders were issued in six of the cases.
In a qui tam action against a group of drug manufacturers, the plaintiffs filed an amended complaint.
A case attempting to invalidate an Arkansas state law governing contract pharmacy arrangements was transferred to a judge who is presiding over a case with similar allegations.
In two separate cases attempting to invalidate the same Louisiana state law governing contract pharmacy arrangements, a non-profit comprised of community health centers filed a Motion to Intervene and an Answer in Intervention to the plaintiff’s complaint.

Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the
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