340B Archives - Page 2 of 11 - HEALTH & LIFE SCIENCES NEWS

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: January 9 – 16, 2024

by Emily Jane Cook, Reuben Bank and Patrick Moore | Jan 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, a subscription product from McDermott+Consulting.

Issues at Stake: Contract Pharmacy, Medicare Payment

In a case regarding a state law governing contract pharmacy arrangements, plaintiff pharmaceutical company filed a motion for summary judgment.
Two cases related to the Medicare payment cuts were stayed until February 19, 2024.

This Week in 340B: December 21, 2023 – January 8, 2024

by Emily Jane Cook, Reuben Bank, Kelsey Reinhardt, Bryan Frederick and Patrick Moore | Jan 11, 2024 | 340B

We’re back from the holidays with updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country as we move into 2024. 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, HRSA Audit Process

In a case regarding a state law governing contract pharmacy arrangements, defendant pharmaceutical companies filed a reply memorandum of law in support of defendant’s motion to dismiss plaintiff state attorney general’s second complaint.
In two separate cases regarding a state law governing contract pharmacy arrangements, four amici moved for leave to file amicus briefs in support of defendant state attorney general’s cross-motions for summary judgment. In both cases, the court granted the motions for leave, and the amici then filed their amicus briefs with the courts.
In another case regarding a state law governing contract pharmacy arrangements, the parties filed and the court granted a joint motion to stay pending the ruling in a related case
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 [...]

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This Week in 340B: December 6 – 20, 2023

by Emily Jane Cook and Patrick Moore | Dec 21, 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 pharmaceutical company and defendant state attorney general jointly filed a motion to set briefing schedule, whereby both parties agreed to proceed directly to cross-motions for summary judgment.
In a case regarding a state law governing contract pharmacy arrangements, defendant state attorney general filed: (1) a cross motion for summary judgment, (2) a statement of material fact to accompany the cross-motion for summary judgment, (3) a combined memorandum in opposition to motion for summary judgment and in support of cross motion for summary judgment, (4) a response to plaintiff pharmaceutical company’s statement of material facts. In the same case, a state primary care association joined as an intervenor-defendant and filed the following: (1) a cross motion for summary judgment on all of plaintiff pharmaceutical company’s claims and in opposition to plaintiff pharmaceutical company’s motion and opposition, (2) a memorandum of law in support of intervenor-defendant’s cross motion for summary judgment on all claims and in opposition to plaintiff’s motion for summary judgment on preemption claims, (3) a statement of material facts in support of intervenor-defendant’s cross motion, and [...]

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New HRSA 340B Program Resource Asserts Agency’s Position on “Patient” Definition

by Emily Jane Cook | Dec 21, 2023 | 340B

On December 14, 2023, Health Resources & Services Administration (HRSA) announced a new resource on the 340B Program website compiling resources associated with the 340B Program definition of “patient.” The website is available here. While the HRSA website compiling patient definition resources is new, none of the content is new. The website only provides links to existing HRSA and Apexus materials. The website makes clear that HRSA’s position is that it continues to rely on its 1996 guidance in interpreting the 340B Statute’s use of the term “patient.”

The timing of this new resource page in connection with last month’s decision in the Genesis case is likely not coincidental, as many 340B covered entities and other 340B Program stakeholders have been closely evaluating the 340B Program definition of “patient” following that decision. More information on the Genesis case is available in our analysis article here.

The release of this website could be an indication that HRSA intends to more closely review compliance with the 1996 definition of patient during audits of covered entities, although HRSA told the Government Accountability Office in 2020 that it did not have authority to issue audit findings of non-compliance based solely on guidance and acknowledged that the 340B statute does not provide criteria for determining patient eligibility.

Like the Genesis decision, the release of this new webpage provides another reminder for covered entities and other 340B Program stakeholders to revisit the concept of “patient” in the context of the [...]

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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.

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