340B covered entity Archives - HEALTH & LIFE SCIENCES NEWS

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 | Uncategorized

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 and Steven Schnelle | 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.

This Week in 340B: October 4 – 12, 2023

by Emily Jane Cook and Kelsey Reinhardt | Oct 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 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

In a case involving a 340B covered entity’s termination from the 340B program, the court granted the covered entity’s temporary restraining order.
In a case involving the definition of “patient,” HHS filed its reply brief in support of its cross-motion for summary judgment, and an amicus curiae brief was filed.

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

This Week in 340B: September 27 – October 3, 2023

by Emily Jane Cook, Ming Chuang and Kelsey Reinhardt | Oct 4, 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

The Ninth Circuit granted the prime vendor program appellee’s request for an extension to file its appellee brief.
A 340B Covered Entity filed suit against HHS, alleging it was improperly removed from the 340B Program.
Defendants in a qui tam action filed a Motion to Dismiss, which will be heard by the District Court for the Central District of California in December 2023.
The plaintiff in a case aiming to invalidate a state law governing contract pharmacy arrangements filed a First Amended Complaint.

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

This Week in 340B: September 20 – 26, 2023

by Emily Jane Cook, Ming Chuang and Kelsey Reinhardt | Sep 27, 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

The prime vendor program appellee in a Ninth Circuit case requested an extension to file its appellee brief.
In a case involving anti-trust and tort claims, the court denied the plaintiff’s Motion for a Temporary Restraining Order and Preliminary Injunction.
In a case involving the definition of “patient,” a national 340B advocacy organization filed an Amicus Brief.
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.

This Week in 340B: September 12 – 19, 2023

by Emily Jane Cook, Ming Chuang and Kelsey Reinhardt | Sep 20, 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

A medical group filed an antitrust case in Pennsylvania federal court against a 340B covered entity.
In a case involving the definition of “patient”, the covered entity filed a reply brief.
The covered entity appellant in a Ninth Circuit case filed its opening brief against the prime vendor program appellee.

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

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