340B Archives - Page 6 of 17 - HEALTH & LIFE SCIENCES NEWS

This Week in 340B: November 28 – December 5, 2023

by Emily Jane Cook and Patrick Moore | Dec 6, 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

In a case regarding a state law governing contract pharmacy arrangements, plaintiff state attorney general filed a memorandum of law in opposition to defendant’s motion to dismiss plaintiff’s second complaint.
In a separate case regarding a state law governing contract pharmacy arrangements, defendant commissioner of state insurance department filed a reply to plaintiff’s response to motion to dismiss.

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.

This Week in 340B: November 13 – 27, 2023

by Emily Jane Cook, Reuben Bank, Bryan Frederick and Patrick Moore | Nov 30, 2023 | 340B

We’re back from the Thanksgiving holiday with two weeks of 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: ADR Rule; Contract Pharmacy; Medicare Payment; Other

In a federal antitrust action, the parties filed a joint stipulation of dismissal.
In an appeal concerning obligations of the 340B Prime Vendor, the 340B Prime Vendor submitted its Appellee Brief.
In a case challenging the 340B Administrative Dispute Resolution (ADR) Rule, the parties filed a Joint Status Report.
In response to the final rule published on November 2, 2023 detailing a remedy for underpayment in light of the Supreme Court’s decision in AHA v. Becerra, stay orders were issued in three of the pending Medicare payment cut cases for 100 days to allow for implementation of the final rule. The parties anticipate that the cases would be dismissed after the payments are made.
In a case regarding a state law governing contract pharmacy arrangements, the state government agency filed a response in opposition to the defendant’s motion to dismiss.
In a separate case regarding a state law governing contract pharmacy arrangements, the state government agency filed its answer to the plaintiff’s first amended complaint.
In a separate case regarding a state law governing contract [...]

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This Week in 340B: November 6 – 12, 2023

by Emily Jane Cook, Reuben Bank and Kelsey Reinhardt | Nov 15, 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, Medicare Payment

In response to the final rule published on November 2, 2023 detailing a remedy for underpayment in light of the Supreme Court’s decision in AHA v. Becerra, the parties in 11 of the pending Medicare Payment Cut cases requested that the cases be further stayed by 100 days to allow for implementation of the final rule. The parties anticipate that the cases would be dismissed after the payments are made. Stay Orders were issued in six of the cases.
In a qui tam action against a group of drug manufacturers, the plaintiffs filed an amended complaint.
A case attempting to invalidate an Arkansas state law governing contract pharmacy arrangements was transferred to a judge who is presiding over a case with similar allegations.
In two separate cases attempting to invalidate the same Louisiana state law governing contract pharmacy arrangements, a non-profit comprised of community health centers filed a Motion to Intervene and an Answer in Intervention to the plaintiff’s complaint.

Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the
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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.

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.

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