Katy's 340B Compass: Compliance Made Clear

The definition of a 340B “patient” is under legal scrutiny in AbbVie v. HHS, raising new questions about eligibility, audit risk, and oversight. Katy unpacks how outdated guidance, manufacturer challenges, and recent court rulings may reshape compliance expectations. This episode focuses on what leaders need to understand now to maintain clarity and defensibility. Visit Virtue 340B’s website to access the full episode and choose yo...

A federal court decision has vacated HRSA’s 2013 GPO policy, but what does that actually mean for your 340B program? Katy Lees unpacks the difference between inventory purchasing flexibility and ongoing compliance obligations, highlighting where risk remains. This episode focuses on practical implications for pharmacy operations, replenishment models, and audit exposure.

Visit Virtue 340B’s website to access the full episode and cho...

A court ruling is redefining how 340B eligibility isinterpreted—separating it from OPAIS registration. Katy Lees explains what this means for offsite locations, how to establish a defensible eligibility date, and why documentation and alignment across teams now matter more than ever.This episode focuses on practical, governance-driven decision-making in a changing environment.

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What does transparency really mean in the 340B program? In this episode, Katy Lees examines the growing push for more visibility into 340B operations—and the practical challenges behind it. She explores the limitations of contractual data, the complexity of medical claims, emerging state reporting requirements, and recent legal developments shaping the transparency debate. Katy also discusses why standardized, neutral reporting fra...

What did the Winter Coalition meeting signal about the future of 340B?

Katy Lees shares key insights on Medicare Fair Price implementation, 340B identification in reporting, dispute process developments, manufacturer positioning, and the evolving rebate landscape. She also unpacks HRSA’s new RFI and what it may indicate for rebate policy direction.

Designed for leaders who want clarity—not noise.

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February’s 340B updates are here—and they’re complicated.

In this episode, Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, breaks down paused rebate policies, MFP confusion for hospitals and contract pharmacies, CMS survey decisions, and manufacturer data-sharing challenges. Learn what’s changing, what’s unclear, and how covered entities should prepare next.
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Starting January 2026, the Inflation Reduction Act (IRA) will introduce Maximum Fair Prices (MFPs) for select high-cost Medicare Part D drugs—creating a new compliance intersection with the 340B Drug Pricing Program.

In Episode 11 of Katy’s 340B Compass, she walks through what these reforms mean for covered entities, including:

• What the MFP is and how it changes Part D reimbursement

• Why MFP and 340B discounts cannot apply to the s...

In this episode, Katy breaks down what covered entities need to know to prepare for a rebate-based 340B model, including the data elements, workflows, and operational controls that may be required. Important update: after this episode was recorded, a federal court issued a preliminary injunction (Dec. 29, 2025) temporarily blocking HRSA’s 340B Rebate Model Pilot Program from going live on Jan. 1, 2026. While implementation is pause...

What should you do when a manufacturer reaches out with a compliance concern? In this episode, Katy explains the fundamentals of good faith inquiries, manufacturer disclosures, and material breach. You’ll learn how to confirm receipt of an inquiry, evaluate potential diversion or duplicate discount issues, determine whether an issue rises to a material breach, and navigate disclosure and repayment with professionalism, transparency...

After attending the Medicaid Rebate Summit, Katy shares key themes and insights into why duplicate discount prevention is fundamentally flawed under current processes. She discusses how manufacturers rely on outdated Medicaid Exclusion File data, the operational realities of carve-in and carve-out decisions, and why stakeholder collaboration is essential. Katy also dives into the debate over HRSA’s rebate pilot policy and shares gu...

This episode covers two timely topics: HRSA’s pilot rebate policy and the annual 340B hospital recertification process. Katy explains why public comments matter and shares alternative approaches to support transparency without undermining the program. She also provides a practical walk-through of recertification steps, including coordination with Authorizing Officials, validating Medicaid billing numbers, and confirming child site ...