340B 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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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: 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: November 5 – 11, 2024

by Emily Jane Cook, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Nov 13, 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 nine cases challenging proposed state laws governing contract pharmacy arrangements in West Virginia, Missouri, Kansas, and the Fifth Circuit Court of Appeals:
1. MO: In one case, the proposed intervenors filed a motion to dismiss. In a second case, plaintiff filed suggestions in support of proposed intervenor’s motion to intervene.
2. KS: Amici filed a motion to file an amicus brief.
3. WV: Defendants in four separate cases filed identical motions to consolidate cases, along with supporting memoranda.
4. Fifth Circuit: Defendants in two separate cases filed reply briefs.

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: 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.

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