HRSA Audit Process 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: September 3 – 9, 2024

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

Issues at Stake: Medicare Payment; HRSA Audit Process; Contract Pharmacy

In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, the Medicare Advantage plans filed its answer to the Covered Entity’s first amended complaint.
A 340B Covered Entity filed a complaint against HRSA challenging HRSA’s decision to approve a manufacturer’s request to audit the Covered Entity.
In seven cases challenging a proposed state law governing contract pharmacy arrangements in West Virginia, Mississippi, Arkansas, Minnesota, Maryland, and Missouri:
- WV: Defendants filed a reply in support of their motion to dismiss.
- MS: The court granted the parties’ joint motion to stay proceedings.
- MN: The defendant filed a motion to dismiss the plaintiff’s amended complaint.
- AR:
  ○ The intervenor filed a reply in support of its motion to dismiss.
  ○ An amicus filed a brief in support of the petitioner’s petition for a writ of certiorari
  before the US Supreme Court.
- MD: The defendants [...]
  
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This Week in 340B: December 21, 2023 – January 8, 2024

by Emily Jane Cook, Reuben Bank, Kelsey Reinhardt, Bryan Frederick and Patrick Moore | Jan 11, 2024 | 340B

We’re back from the holidays with updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country as we move into 2024. 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, HRSA Audit Process

In a case regarding a state law governing contract pharmacy arrangements, defendant pharmaceutical companies filed a reply memorandum of law in support of defendant’s motion to dismiss plaintiff state attorney general’s second complaint.
In two separate cases regarding a state law governing contract pharmacy arrangements, four amici moved for leave to file amicus briefs in support of defendant state attorney general’s cross-motions for summary judgment. In both cases, the court granted the motions for leave, and the amici then filed their amicus briefs with the courts.
In another case regarding a state law governing contract pharmacy arrangements, the parties filed and the court granted a joint motion to stay pending the ruling in a related case
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 [...]

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