In this episode, 340B Report Associate Editors and Senior Writers Shannon Young and Will Newton break down the latest in 340B news, including the Health Resources and Services Administration's (HRSA) approval of the final drugmaker 340B rebate pilot plan; oral arguments in a key federal court case centered on 340B rebates; and Kalderos' official entrance into the 340B contract pharmacy claims clearinghouse space.

Key Topics Covered:

Final Rebate Pilot Model Plans Approved, Additional Details Unveiled

Will provides an in-depth look at HRSA's recent approval of Novartis' 340B rebate plan for Entresto—the final drug eligible for the upcoming pilot program. He also explains provider concerns about the pilot's rollout—including how manufacturers and their vendor defined the claims data field "340B ID"—and HRSA's response seeking to quell those concerns.

Appeals Court Hears Oral Arguments in Rebate Case

Will discusses oral arguments he attended at a Washington, D.C., federal appeals court that could shape the future of 340B rebates, including HRSA's rebate pilot. Attorneys for the drug industry, the federal government and trade group 340B Health debated who—if anyone—has authority to decide whether drugmakers can offer 340B pricing through a rebate. Will notes that all three sides faced tough questioning from the judges, who appeared well-versed in the nuances of the 340B program.

1st Drugmaker Transitions to Kalderos' Truzo Platform

Shannon breaks down the significance of drugmaker Alkermes' recent decision to transition its 340B contract pharmacy policy administration from Second Sight Solutions' 340B ESP platform to Kalderos' Truzo clearinghouse—making it the first drug manufacturer to do so. She also discusses the pushback the Alkermes' short timeline for the shift, which will go live Dec. 1, drew from 340B provider advocates.

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This week's episode is sponsored by RxParadigm. RxParadigm's mission is to cultivate innovative approaches and technologies that promote transparency and authenticity, leading to enhanced outcomes, reduced overall healthcare costs, and effective 340B program administration. We are very grateful to RxParadigm for its sponsorship.

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