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 Cuts; ADR Rule; Other

• In six cases related to the Medicare payment cuts, the court ordered the cases stayed until March 3, 2024.
• In a case regarding a state law governing contract pharmacy arrangements, intervenor-defendant state primary care association filed an unopposed motion for leave to file a reply in support of its motion to intervene, an opposed motion for leave to file cross-motion for summary judgment and opposition to plaintiff’s motion for summary judgment. The state attorney general filed a cross motion for summary judgment and corresponding memorandum of law.
• In a separate case regarding a state law governing contract pharmacy arrangements, state attorney general filed a memorandum of law in opposition to defendant pharmaceutical company’s motion to dismiss the second complaint.
• In a case challenging the New York Department of Health’s 340B Carveout plan, the attorneys for both sides filed a stipulation of discontinuance as to one of the plaintiffs.
• In a qui tam False Claims [...]
  
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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 Cuts

• In six similar cases alleging improper cuts to Medicare payment rates for 340B drugs under the Outpatient Prospective Payment System, the parties filed joint status reports.
• In two similar cases alleging improper cuts to Medicare payment rates for 340B drugs under the Outpatient Prospective Payment System, the Plaintiffs filed a notice of dismissal.
• In two related cases regarding a state law governing Medicare payment cuts, both plaintiffs voluntarily dismissed their cases.
• In a case regarding a state law governing contract pharmacy arrangements, defendant state attorney general filed an Ex Parte Motion to extend deadlines.
• In the same case regarding a state law governing contract pharmacy arrangements, intervenor-defendant state primary care association filed a reply in support of its motion to intervene.(Contract Pharmacy)

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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