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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

HRSA Aims for Swift Dispute Resolution with new 340B ADR Final Rule

On April 18, 2024, HRSA released its 2024 340B Administrative Dispute Resolution (ADR) Final Rule (2024 ADR Final Rule) and it is largely favorable to covered entities (CEs) with pending ADR claims against drug manufacturers....more

CMS Proposes $9B in Relief for 340B Hospitals

340B Covered Entities (CEs) are getting a glimpse into what they can expect to be repaid due the fallout from CMS’ unlawful 340B payment reduction that was struck down by the U.S. Supreme Court in June 2022.  CMS discussed a...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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