340B covered entity Archives - HEALTH & LIFE SCIENCES NEWS

This Week in 340B: February 11 – 17, 2025

by Emily Jane Cook, Matthew David, Margaret Houtz, Jae Hyun Lee, Patrick Moore, Deepika Raj, Kelsey Reinhardt and Nadine Tejadilla | Feb 19, 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: Contract Pharmacy; Medicare Payment; Rebate Model

In a case challenging a proposed state law governing contract pharmacy arrangements in Missouri, the court granted in part and denied in part defendant’s and intervenor’s separate motions to dismiss.
In a breach of contract claim filed by a 340B covered entity against several related party Medicare Advantage plans, defendants filed a reply in support of their motion to compel plaintiff’s claims spreadsheets.
In five cases against the Health Resources and Services Administration (HRSA) alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
1. Five amicus briefs were filed in support of the drug manufacturer.
2. In four such cases, drug manufacturers filed a joint position statement on consolidation.
3. In one such case, a drug manufacturer filed a notice of opposition to consolidation and memorandum in opposition to intervenors.
4. In one such case, the government filed a position statement in support of consolidation.

This Week in 340B: February 4 – 10, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Margaret Houtz, Jae Hyun Lee, Patrick Moore, Kelsey Reinhardt and Nadine Tejadilla | Feb 12, 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; Rebate Model; Other

In a case brought by a 340B covered entity against the Health Resources and Services Administration (HRSA) alleging that HRSA prevented the covered entity from accessing the 340B Program, the covered entity filed a notice of voluntary dismissal.
In a case challenging HRSA’s policy prohibiting all manufacturer conditions on 340B transactions, plaintiffs filed a motion for summary judgment.
In a Freedom of Information Act (FOIA) case, the plaintiff filed a motion to strike HRSA’s motion for summary judgment.
In one HRSA audit process case, the plaintiff filed a brief in opposition to a drug manufacturer’s motion for leave to file as amicus curiae.
In four HRSA audit process cases, the parties filed joint stipulations that the government will provide to the plaintiffs thirty days’ written notice before termination of the plaintiffs from the 340B Program.
In five cases against HRSA alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
- In two cases, each [...]
  
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This Week in 340B: January 28 – February 3, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Jae Hyun Lee, Patrick Moore and Kelsey Reinhardt | Feb 5, 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 plaintiff filed a brief in opposition to the government’s motion to dismiss.
In a Freedom of Information Act (FOIA) case, the government filed a motion for summary judgment.
In a breach of contract claim filed by a 340B covered entity against several related party Medicare Advantage plans, defendants’ filed an amended answer and defenses to plaintiff’s second amended complaint, and plaintiff filed a response in opposition to defendants’ motion to compel plaintiff’s claims spreadsheet.
In several cases challenging HRSA’s policy prohibiting all manufacturer conditions on 340B transactions, the court granted the parties’ joint motion for a stipulated protective order.
In a case challenging a proposed state law governing contract pharmacy arrangements in West Virginia, the court granted plaintiff’s third motion for an extension of time to respond to defendants’ motion to consolidate.
In a case challenging HRSA’s policy prohibiting manufacturer rebate models, three [...]

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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 Audit Process; Other

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: December 17, 2024 – January 6, 2025

by Emily Jane Cook, Reuben Bank, Margaret Houtz, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Jan 9, 2025 | 340B

Find updates on 340B litigation from December 17, 2024 – January 6, 2025 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 Health Resources and Services Administration (HRSA) audit process case, the government filed a brief in opposition to the plaintiff’s motion for preliminary injunction and the plaintiff filed a reply brief in support of the same motion.
In four HRSA audit process cases, the plaintiffs filed responses to the defendants’ motions to dismiss and briefs in opposition to Johnson & Johnson Health Care System Inc.’s motions for leave to file as amicus curiae.
In an appealed case challenging a proposed state law governing contract pharmacy arrangements, the appellants filed their opening brief.
In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, plaintiffs filed a second amended complaint under seal with jury demand. Additionally, defendants filed an answer and defenses to plaintiffs’ second amended complaint
In a case challenging HRSA’s policy prohibiting manufacturer rebate models, defendants filed a consent motion to [...]

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

by Emily Jane Cook, Reuben Bank, Matthew David, 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, Matthew David, 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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California Ballot Proposition 34 Targets Spending by Certain 340B Covered Entities

by Emily Jane Cook and Patrick Moore | Nov 20, 2024 | 340B

Proposition 34 requires certain California healthcare providers to spend at least 98% of their net drug sale revenue on direct patient care. The measure targets certain providers who benefit from a federal drug discount program known as the 340B Program.

The 340B Program allows qualifying safety net healthcare providers who serve a disproportionate share of low-income and uninsured patients to purchase outpatient drugs at a significant discount. The intent of the 340B Program is to allow providers that participate in the program to offer more comprehensive services to patients and their communities.

The 340B Program does not dictate how eligible providers use revenue generated from sales of the discounted drugs. Proposition 34 imposes such restrictions.

Who Does It Affect?

Not all providers who participate in the 340B Program are affected by Proposition 34. It only applies to 340B providers that:

Spend more than $100 million on non-direct-care expenses.
Own and operate apartment buildings.
Have accumulated at least 500 severe health and safety violations in the past decade.

Currently, the AIDS Healthcare Foundation (AHF) is believed to be the only organization that meets these criteria.

Background and Controversy

Proposition 34 is one of the first state-level efforts to restrict use of savings generated from participation in the 340B Program. Opponents of Proposition 34 believe that it was on the ballot largely due to political and housing interest groups’ opposition to the president of AHF and certain spending by AHF under his leadership. AHF has become a significant player in [...]

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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.

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