HRSA Archives - HEALTH & LIFE SCIENCES NEWS

This Week in 340B: January 21 – 27, 2025

by Emily Jane Cook, Reuben Bank and Matthew David | Jan 29, 2025 | 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; HRSA Audit Process

In a suit by a 340B covered entity against the Health Resources and Services Administration (HRSA), HRSA filed a response to show cause and a response to motion for a temporary restraining order (TRO) and preliminary injunction, and the covered entity filed a motion to enforce administrative stay.
In two HRSA audit process cases, the government filed reply briefs in further support of the government’s motion to dismiss.

This Week in 340B: January 14 – 20, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Jan 22, 2025 | 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; Rebate Model; Other

In one Health Resources and Services Administration (HRSA) audit process case, the government filed a motion to dismiss.
In two HRSA audit process cases, the government filed reply briefs in further support of the government’s motion to dismiss.
A drug manufacturer filed suit against HRSA to challenge HRSA’s disapproval of its proposed rebate model.
A 340B covered entity filed suit against HRSA, alleging that HRSA prevented it from accessing the 340B Program.
A 340B covered entity filed suit against HRSA to challenge HRSA’s determination that certain clinics were not eligible for the 340B program, and, in the same case, the court issued an administrative stay.
In three cases challenging proposed state laws governing contract pharmacy arrangements in Missouri and West Virginia:
- MO: Defendants and intervenors separately filed reply suggestions in support of the motion to dismiss.
- WV: Plaintiffs in two separate cases filed oppositions to defendants’ motions to consolidate

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: 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: October 29 – November 4, 2024

by Emily Jane Cook, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Nov 6, 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; Other

– A healthcare improvement company filed suit against HRSA to challenge HRSA’s policy limiting the circumstances in which covered entities can use their group purchasing arrangements to purchase non-340B drugs.

– A covered entity filed suit against an insurance company alleging that the insurance company failed to reimburse the covered entity for amounts it paid the covered entity using the unlawful Medicare rate of ASP minus 22.5%.

– In a contract pharmacy case, a drug manufacturer filed a motion for leave to file an amicus curiae brief in support of plaintiff’s motion for summary judgment.

– In eleven cases challenging proposed state laws governing contract pharmacy arrangements in Mississippi, West Virginia, Missouri, and Kansas:

MS: The plaintiff filed a rebuttal in support of its motion for preliminary injunction.
WV:

– In two cases, the parties filed joint motions for stays of deadlines.

– In two other cases, plaintiffs filed responses to defendants’ notices of supplemental [...]

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This Week in 340B: October 22 – 28, 2024

by Emily Jane Cook, Margaret Houtz, Patrick Moore and Deepika Raj | Oct 30, 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; Contract Pharmacy; Other

In an appealed qui tam action alleging that various drug manufacturers failed to charge accurate ceiling prices to 340B Covered Entities, an amicus brief was filed in support of the appellees.
In a case challenging HRSA’s policy prohibiting all manufacturer conditions on 340B transactions, the parties filed a joint status report.
In two cases challenging proposed Missouri state law governing contract pharmacy arrangements, the defendants filed a motion to dismiss and a memorandum in support thereof in one case and the defendants filed a reply in support of the defendant’s motion to dismiss in a second case. In addition, plaintiffs in the second case filed a memorandum in opposition to proposed intervenors’ motion to intervene.

This Week in 340B: September 24 – 30, 2024

by Emily Jane Cook, Margaret Houtz, Jae Hyun Lee, Patrick Moore and Deepika Raj | Oct 2, 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: 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.

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, 2023

by Emily Jane Cook, Reuben Bank and Kelsey Reinhardt | Feb 14, 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: 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.

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

by Emily Jane Cook and Kelsey Reinhardt | Jan 12, 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 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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