In this episode, 340B Report Publisher and CEO Ted Slafsky and Associate Editors and Senior Writers Shannon Young and Will Newton break down the latest in 340B news, including the 1,000-plus public comments on the Health Resources and Services Administration’s (HRSA) 340B rebate pilot proposal, the 340B ACCESS Act’s reintroduction in Congress and a new Congressional Budget Office (CBO) report on 340B program growth, which has drawn criticism from provider advocates. Shannon and Will also provide updates on oral arguments in key federal cases that recently went before appeals court judges.

Key Topics Covered:

More than 1,000 Stakeholders Weigh-in on HRSA’s 340B Rebate Pilot Proposal

Will discusses the more than 1,200 stakeholder comments HRSA received over its contentious 340B rebate pilot proposal. He explains why hundreds of 340B providers urged the agency to abandon the rebate pilot altogether and discusses the drug industry’s push to expand the pilot to more drugs. Will also breaks down stakeholders’ concerns with the one-week turnaround between the comment due date and manufacturers’ deadline to submit rebate proposals.

CBO Report and ACCESS Act Reintroduction Take Center Stage on Capitol Hill

Shannon breaks down the latest version of the 340B ACCESS Act, a controversial 340B overhaul bill which two key House GOP lawmakers reintroduced on Sept. 10. She discusses how the National Association of Community Health Centers has backed off from supporting the measure, which contains many of the provisions included in the May 2024 original version that providers advocates have vocally opposed. Shannon notes that the bill’s reintroduction came one day after the nonpartisan CBO released a report on 340B program growth. Ted highlights provider advocates’ criticisms of the report and why they believe it misses the mark.

Appeals Courts Hear Arguments in Key 340B-Related Cases

Will breaks down a trio of oral arguments that recently took place in federal appeals courts over drug industry challenges to state 340B contract pharmacy access laws. The hearings centered on whether the 340B statute’s silence on drug delivery allows states to pass contract pharmacy access measures, and the judges asked tough questions of all parties. Shannon provides an update on recent oral arguments in a 5th Circuit Court of Appeals case surrounding a Centers for Medicare and Medicaid Services rule which could affect some hospitals’ 340B program eligibility. A group of Texas hospitals have challenged the rule. A Texas federal District Court in 2024 declared it “unlawful” and halted its enforcement. HHS appealed the decision.

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