340B covered entity 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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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.

This Week in 340B: March 26 – April 1, 2024

by McDermott Will & Emery, Emily Jane Cook, Bryan Frederick, Patrick Moore and Kelsey Reinhardt | Apr 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+Consulting.

Issues at Stake: Contract Pharmacy; Medicare Payment; Other

In a case challenging Arkansas’ Act 1103, the defendant filed a notice of related cases, the plaintiff filed an opposition to the defendant’s notice of related cases and the defendant filed its answer to the plaintiff’s complaint.
In a case regarding a state law governing contract pharmacy arrangements, intervenor-defendants filed a brief of amici curiae in support of defendant State Attorney General’s cross-motion for summary judgment.
In a case against HRSA filed by a group of 340B Covered Entities seeking relief from HRSA’s recent change in its policy on child sites, the 340B Covered Entities filed their reply memorandum in support of their motion for summary judgement and opposition to HRSA’s cross-motion for 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 its opposition to the Medicare Advantage plan defendants’ motion to dismiss.

This Week in 340B: January 17 – 23, 2024

by Emily Jane Cook, Bryan Frederick and Patrick Moore | Jan 25, 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+Consulting.

Issues at Stake: 340B Covered Entities; Contract Pharmacy

In a qui tam False Claims Act action alleging that defendants failed to charge accurate ceiling prices to 340B Covered Entities, the parties filed a joint stipulation, which the court approved.
In two separate cases regarding a state law governing contract pharmacy arrangements, two plaintiff pharmaceutical companies filed combined replies in support of their motions for summary judgment and in opposition to cross motions for summary judgment.
In a case regarding a state law governing contract pharmacy arrangements, a proposed intervenor filed an opposed motion to intervene, and the court set forth a notice of motion setting for both the parties and the proposed intervenor.

This Week in 340B: October 31 – November 5, 2023

by Emily Jane Cook and Kelsey Reinhardt | Nov 9, 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 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: Contract Pharmacy, 340B Covered Entity

A number of 340B covered entities filed suit against HRSA, seeking relief from its requirement that child sites appear on a covered entity’s Medicare cost report and be registered as a child site in OPAIS before the locations can be considered part of the covered entity under the 340B Program.
In a case involving the definition of “patient,” the court issued an order ruling on the parties’ respective motions for summary judgment.
In two separate cases aiming to invalidate the same state law governing contract pharmacy arrangements, each plaintiff filed a motion for summary judgment and the parties in each case filed a joint motion to set the briefing schedule.
A state government agency filed a motion to dismiss a case attempting to invalidate a state law governing contract pharmacy arrangements.
A case alleging that a covered entity was improperly removed from the 340B Program was dismissed with prejudice following confirmation of the covered entity’s continued participation in the program.

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

This Week in 340B: October 24 – 30, 2023

by Emily Jane Cook and Kelsey Reinhardt | Nov 1, 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 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: 340B Covered Entity, Contract Pharmacy

In a case alleging that a state law governing contract pharmacy arrangements is preempted by federal law, the defendant filed its answer.
The state department of health filed a cross-motion to dismiss the plaintiff’s amended complaint in a case involving New York’s proposed “340B Carveout” plan.

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

HRSA Issues Notice Confirming 340B Registration Requirement

by Emily Jane Cook, Steven Schnelle and Jae Hyun Lee | Oct 27, 2023 | 340B

On October 26, the Health Resources and Services Administration (HRSA) published a Federal Register notice addressing the use of 340B drugs at off-campus hospital outpatient locations that have not yet appeared on a filed Medicare cost report. These locations are known as “unregistered child sites.”

In the notice, HRSA maintains that its prior policy allowing the use of 340B drugs at unregistered child sites was intended only to be a waiver during the COVID-19 public health emergency (PHE) and that the waiver is no longer needed. HRSA further explains that the waiver created challenges in its ability to oversee the integrity of the 340B program.

HRSA states in the notice that some covered entities believed that the use of 340B drugs at unregistered child sites was a permanent policy change. HRSA is providing two compliance options for covered entities that used 340B drugs at unregistered child sites after the end of the PHE:

For off-site outpatient locations that have appeared on a filed Medicare cost report with associated outpatient costs and charges, but have not yet registered in the Office of Pharmacy Affairs Information System (OPAIS), HRSA will allow registration in January 2024.
For off-site outpatient locations that began using 340B drugs prior to the publication of the notice, but have not yet appeared on a filed Medicare cost report with associated outpatient costs and charges, HRSA will allow their continued use of 340B drugs if the covered entities provide the following information to HRSA within [...]

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This Week in 340B: October 13 – 17, 2023

by Emily Jane Cook and Kelsey Reinhardt | Oct 17, 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 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: 340B Covered Entity, Contract Pharmacy

In a case involving the definition of “patient,” amici filed a reply brief in support of HHS.
The court issued a briefing and hearing schedule in a qui tam action.
In a case alleging that a covered entity was improperly removed from the 340B Program, the parties filed a motion to postpone briefing schedules and indicated that they anticipate settling.
A drug manufacturer filed a complaint to invalidate a state law governing contract pharmacy arrangements.

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

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