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 updates to the comment deadline on the Health Resources and Services Administration's (HRSA) 340B rebate guidance—and why 340B stakeholders say the agency's timeline is not long enough. They also reflect on the implications of a major ruling in an antitrust lawsuit that two health centers filed against drug manufacturers, which were among the first companies to impose 340B contract pharmacy restrictions. The team also discusses new 340B enrollment requirements for sexually transmitted disease (STD) clinics. And Will breaks down a new 340B Report analysis that raises questions about the controversial alliance between the National Association of Community Health Centers (NACHC) and Pharmaceutical Research and Manufacturers of America (PhRMA).

Key Topics Covered:

HRSA Extends Rebate Pilot Comment Period and HHS Touts Model Shannon offers a recap on HRSA's proposed 340B rebate pilot program, including which drugs would qualify and when manufacturers can deny claims. She discusses a legal filing in which the Health and Human Services (HHS) Department touts its rebate model pilot plan, and she highlights HRSA's recent deadline extension for public comments on the proposal. Ted notes 340B providers' concerns with the rebate model, and why they're asking the agency to extend its consideration timeline for such proposals.

Antitrust Case Ruling Sets Stage for Future Litigation Shannon highlights a recent federal appeals court ruling that 340B provider attorneys argue could open the door for future 340B-related lawsuits against drug manufacturers. The U.S. 2nd Circuit Court of Appeals overturned a lower court decision, unanimously ruling that an antitrust class action lawsuit can continue in a lower court. Two community health centers allege in the lawsuit that four major drugmakers illegally colluded to deny 340B pricing on insulin and other diabetes medicines through contract pharmacy restrictions. Ted discusses the legal background surrounding the case and its potential importance.

STD Clinic Lawsuits and New Eligibility Requirements Will breaks down multiple lawsuits related to the 340B eligibility of a Nevada-based STD clinic, including multiple sites that HRSA terminated and later reinstated. Shannon notes that a new HRSA proposal would require STD clinics and other 340B covered entities to submit new or more complete information to enroll in or be re-certified in the 340B program. The proposal came just weeks after Office of Pharmacy Affairs (OPA) Director Chantelle Britton hinted at changes affecting STD clinics.

Analysis Raises Questions about ASAP 340B Alliance Will discusses his recent analysis of the 340B reform alliance, called ASAP 340B, between the NACHC and PhRMA. Since the two groups formed their unlikely alliance in March 2023, the number of PhRMA member companies that have placed 340B restrictions on health centers has more than doubled—raising questions over how much the alliance has actually benefited NACHC members. Will also breaks down how NACHC's public posture on the alliance has appeared to shift, even as ASAP 340B continues its advocacy efforts and NACHC continues to be listed as one of its founding members.

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This week's episode is sponsored by VytlOne, the only independent provider of integrated pharmacy solutions. VytlOne leads the way in partnering with hospitals, health systems and health centers to unlock pharmacy revenue, strengthen local care, and reinvest in communities. Visit VytlOne to learn more.

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