Katy's 340B Compass: Compliance Made Clear

Virtue 340B

Navigate 340B complexities with expert guidance. Hosted by Principal 340B Compliance Advisor Katy Lees, this biweekly audio series translates compliance regulations, such as duplicate discounts, rebate models, and audit preparation, into concise, actionable insights for pharmacy managers, compliance officers, and health system leaders. Each episode equips you with strategies to maintain program integrity. Subscribe now to stay informed and turn regulatory complexity into confident compliance.

  1. May 4

    Telling Your 340B Story: Defining and Communicating Value Clearly

    Communicating the value of your 340B program requires more than data—it requires clarity, alignment, and consistency. Katy Lees outlines how organizations can articulate program impact, strengthen stakeholderunderstanding, and translate social ROI into meaningful insight. A practical discussion for leaders focused on compliance, oversight, and operational visibility. Visit Virtue 340B’s website to access the full episode and choose your preferred listening or viewing platform.

    16 min

  2. Apr 20

    340B Patient Definition Under Fire: What Leaders Need to Know

    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 Katy unpacks how outdated guidance, manufacturer challenges, and recent court rulings may reshape compliance expectations.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 your preferred listening or viewing platform.

    25 min

  3. Apr 8

    Understanding the 340B GPO Court Ruling

    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 choose your preferred listening or viewing platform.

    11 min

  4. Mar 23

    340B Eligibility vs Registration Explained

    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. Visit Virtue 340B’s website to access the full episode and choose your preferred listening or viewing platform.

    16 min

  5. Mar 8

    What does transparency in the 340B program mean to you?

    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 frameworks may be necessary to improve clarity without creating misleading narratives. Visit Virtue 340B’s website to access the full episode and choose your preferred listening or viewing platform.

    29 min

  6. Feb 23

    Winter Coalition Takeaways & Rebate Policy Reset

    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. Visit Virtue 340B’s website to access the full episode and choose your preferred listening or viewing platform.

    26 min

  7. Feb 10

    February Flashpoint: 340B Rebates, MFP & Compliance Curveballs

    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.🎧 Follow the show and send in your questions for future episodes.

    25 min

  8. Jan 10

    MFP + 340B in 2026: Duplicate Discount Risk, Rebate Pilot Pause & Compliance Readiness

    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 same transaction (duplicate discount risk) HRSA’s proposed 340B Rebate Model Pilot and why it raised major operational and financial concerns How litigation has temporarily paused the rebate pilot, preserving upfront 340B discounts—for now What covered entities must do today to prevent MFP duplicate discounts and confirm MFP rebates are handled correctly for non-340B prescriptions Why vendor limitations may require manual controls and enhanced monitoring in the near term Even with the rebate pilot delayed, the compliance obligation remains; covered entities must actively prevent duplicate discounts and maintain audit-ready documentation. 📥 Download the Slide Deck (Episode Toolkit)https://virtue340b.com/ira-mfp-340b-rebate-pilot-program-guide-toolkit/

    35 min
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About

Navigate 340B complexities with expert guidance. Hosted by Principal 340B Compliance Advisor Katy Lees, this biweekly audio series translates compliance regulations, such as duplicate discounts, rebate models, and audit preparation, into concise, actionable insights for pharmacy managers, compliance officers, and health system leaders. Each episode equips you with strategies to maintain program integrity. Subscribe now to stay informed and turn regulatory complexity into confident compliance.

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