ADR Rule Archives - HEALTH & LIFE SCIENCES NEWS

This Week in 340B: November 12 – 18, 2024

by Emily Jane Cook, Margaret Houtz, Jae Hyun Lee, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Nov 19, 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: ADR Rule; Contract Pharmacy; HRSA; Other

In a case challenging the Health Resources and Services Administration (HRSA’s) policy prohibiting all manufacturer conditions on 340B transactions, the plaintiff filed a first amended complaint for declaratory and injunctive relief.
In a case concerning the Alternative Dispute Resolution (ADR) rule, the parties filed a stipulation of dismissal.
In a contract pharmacy case, the defendants filed a cross motion for partial summary judgment and a motion in opposition to the plaintiff’s motion for summary judgment, and responded to a drug manufacturer’s motion for leave to file an amicus brief.
Two drug manufacturers each filed a complaint against HRSA to challenge HRSA’s decision not to allow their proposed rebate models.
In four cases challenging proposed state laws governing contract pharmacy arrangements in Missouri and Mississippi:
1. MO: In two cases, the court granted proposed intervenors’ motion to intervene and intervenors subsequently filed a motion for dismiss.
2. MS: In two cases, two separate groups of amici filed amicus briefs in [...]
  
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This Week in 340B: September 10 – 16, 2024

by Emily Jane Cook, Margaret Houtz, Jae Hyun Lee, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Sep 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, a subscription product from McDermott+.

Issues at Stake: ADR Rule; Medicare Payment; Contract Pharmacy; Other

In a case concerning the ADR Rule, the parties filed a joint status report.
In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, the court set trial for April 2026.
In an antitrust case filed by a Covered Entity against a group of drug manufacturers, the manufacturers filed a joint brief of defendant-appellees.
In a breach of contract claim filed by a complainant, the court issued a formal mandate for final judgment.
In 12 cases challenging a proposed state law governing contract pharmacy arrangements in West Virginia, Maryland, Mississippi, Missouri, and Kansas:
1. WV: Defendants in three cases filed notices of supplemental authority. In one of those cases, plaintiffs filed a response.
2. MD: Defendants filed a memorandum opposing plaintiff’s motion for expedited discovery.
3. MS: Plaintiffs in each of two cases filed their opening briefs in the Fifth [...]

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This Week in 340B: November 13 – 27, 2023

by Emily Jane Cook, Reuben Bank, Bryan Frederick and Patrick Moore | Nov 30, 2023 | 340B

We’re back from the Thanksgiving holiday with two weeks of 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: ADR Rule; Contract Pharmacy; Medicare Payment; Other

In a federal antitrust action, the parties filed a joint stipulation of dismissal.
In an appeal concerning obligations of the 340B Prime Vendor, the 340B Prime Vendor submitted its Appellee Brief.
In a case challenging the 340B Administrative Dispute Resolution (ADR) Rule, the parties filed a Joint Status Report.
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, stay orders were issued in three of the pending Medicare payment cut cases for 100 days to allow for implementation of the final rule. The parties anticipate that the cases would be dismissed after the payments are made.
In a case regarding a state law governing contract pharmacy arrangements, the state government agency filed a response in opposition to the defendant’s motion to dismiss.
In a separate case regarding a state law governing contract pharmacy arrangements, the state government agency filed its answer to the plaintiff’s first amended complaint.
In a separate case regarding a state law governing contract [...]

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This Week in 340B: January 9 – 16, 2023

by Emily Jane Cook and Reuben Bank | Jan 18, 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 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: Medicare Payment; ADR Rule; Definition of Patient
Where Things Stand:
- A District Court issued an opinion in AHA v. Becerra remanding the issue of remedies in the Medicare 340B payment cuts to HHS and declining to vacate the payment rule.
- Seven cases will remain stayed pending a decision in AHA v. Becerra regarding remedies for the now-vacated 340B Medicare payment cuts.
- Parties in one case challenging the ADR Rule, which is currently stayed, moved for the dismissal of the action without prejudice.
- Plaintiffs in one case related to the 340B definition of “patient” filed a Joint Motion to Seal the Certified Administrative Record.

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