HEALTH & LIFE SCIENCES NEWS

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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