The definition of a “patient” has long been a foundational element of 340B compliance, but that foundation is now being challenged. In AbbVie v. HHS, the courts are being asked to weigh in on whether HRSA’s decades-old interpretation still aligns with the statute. At the same time, recent rulings are reinforcing limits on HRSA’s authority, including its ability to require child site registration as a condition of eligibility.
In this episode, Katy explores what’s at stake, from questions around overly broad patient criteria and program integrity concerns to the growing tension between manufacturers and covered entities. She breaks down how audit authority, operational practices, and eligibility assumptions may be affected, and who across your organization needs to pay attention.
As Principal 340B Compliance Advisor at Virtue 340B, Katy Lees brings clarity to a complex and evolving issue, helping organizations understand not just what’s changing, but how to think about risk, oversight, and defensibility moving forward.
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