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The 340B Rebate Pilot: Voluntary for Manufacturers, Costly for 340B Covered Entities

Key Takeaways - HRSA’s 340B rebate pilot shifts financial and operational burden to covered entities, requiring upfront drug purchases with delayed, uncertain rebate recovery....more

SCOTUS Rejects Defense-Friendly Scienter Standard In Schutte Opinion

On June 1, 2023, the Supreme Court of the United States (SCOTUS) issued its much-anticipated opinion in United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, Inc. (Schutte), holding...more

DOJ Continues to Target Lab Sales Arrangements and Ordering Practices

Signaling its continued scrutiny of the laboratory industry, the Department of Justice (DOJ) entered into a settlement agreement with Texas lab Genotox Laboratories Ltd. last month related to compensation Genotox paid to...more

340B Price Restriction Development - HRSA Moves 340B ADR Complaints Forward

Recently, HRSA verbally confirmed that it has assigned Administrative Dispute Resolution (ADR) panelists, a key development to move a handful of pending ADR complaints forward. Those complaints contain allegations that drug...more

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