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Katy's 340B Compass:
 Navigate 340B Compliance with Confidence

Join Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, as she unpacks the complexities of the 340B Program through practical insights, candid discussions, and clear guidance for covered entities.

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The 340B Program is complex — but it doesn’t have to feel overwhelming. Katy’s 340B Compass was created to help healthcare leaders, compliance officers, and 340B teams navigate the program with clarity and confidence. Each episode offers a fresh perspective, grounded in real-world experience and aligned with Virtue 340B’s mission of integrity and transparency.

Value Highlights:

  • Practical guidance on building compliant, sustainable 340B programs

  • Insights from independent audit and consulting expertise

  • Conversations that connect regulatory requirements to real-life operations

Explore the Compass Episodes

Browse Katy’s latest episodes and dive into the conversations that matter most to your program. From HRSA audit preparation to everyday compliance challenges, Katy provides actionable takeaways you can bring back to your team.

 

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Katy's 340B Compass

Welcome to Virtue 340B’s expert-led vlog with Katy Lees! In this vlog, we simplify 340B compliance and share best practices to help covered entities confidently navigate the program. Subscribe for biweekly 340B insights!

Katy's 340B Compass
Transparency is one of the most discussed — and often misunderstood — issues in the 340B program today. As policymakers, manufacturers, and covered entities call for more visibility into how the program operates, the question becomes: what does meaningful transparency actually look like? In this episode, Katy Lees explores the realities behind transparency conversations in 340B. She discusses the limitations organizations face when sharing data publicly, the operational challenges tied to medical claims data, and why standardized, neutral reporting frameworks may be necessary to prevent misleading conclusions. The discussion also touches on developments shaping the conversation, including the Albany Medical Center v. HRSA child site ruling, emerging state reporting laws, and evolving manufacturer data submission policies. As Principal 340B Compliance Advisor at Virtue 340B, Katy helps translate complex regulatory and operational issues into clear, practical insight. Her perspective helps healthcare leaders think through transparency in ways that support sound oversight and defensible decision-making. Visit Virtue 340B’s episode landing page to watch this episode and explore additional listening options.
Ep 14 - What does transparency in the 340B program mean to you?
The 340B policy environment continues to evolve — and the Winter Coalition meeting offered important signals about where oversight, manufacturer strategy, and federal engagement may be headed next. In this episode of Katy’s 340B Compass, Katy Lees shares firsthand takeaways from the conference, including discussions on Maximum Fair Price (MFP) implementation, 340B identification in Medicaid reporting, lessons emerging from the dispute process, audit roundtable insights, and the shifting rebate landscape. She also breaks down HRSA’s newly issued Request for Information (RFI) and what it could mean for the future direction of 340B rebate policy. This episode is especially relevant for health system executives, compliance leaders, pharmacy directors, and governance teams focused on program defensibility and operational clarity. As Principal 340B Compliance Advisor at Virtue 340B, Katy translates conference dialogue and regulatory movement into structured insight—helping organizations understand not just what was said, but what deserves attention now. Visit Virtue 340B’s episode landing page to watch this episode and explore additional listening and viewing options.
Ep 13 - Winter Coalition Insights & the 340B Rebate Reset
The start of the year has brought a wave of 340B developments, and just as many unanswered questions. In this episode of Katy’s 340B Compass, Katy Lees breaks down the most pressing policy shifts and operational uncertainties facing covered entities right now. From HRSA and HHS pausing rebate implementation, to the ongoing confusion around Medicare Transaction Facilitator (MTF) and Maximum Fair Price (MFP) requirements, Katy cuts through the noise to explain what’s changed, what’s stalled, and what providers should be watching closely. She also unpacks the CMS hospital survey decision, Eli Lilly’s evolving data-sharing stance, and the growing concern around HRSA’s silence. If you’re responsible for 340B compliance, strategy, or oversight, this episode is your February checkpoint. 👉 Subscribe for more 340B insights, drop your questions in the comments, and connect with Katy on LinkedIn.
Ep 12 - February Flashpoint: 340B Rebates, MFP Fallout, and other 340B Curveballs
Beginning January 2026, Medicare drug pricing reform under the Inflation Reduction Act (IRA) will begin reshaping how certain high-cost Medicare Part D drugs are reimbursed, introducing new compliance and operational complexity for 340B covered entities. In this episode of Katy’s 340B Compass, she breaks down the intersection of the IRA’s Maximum Fair Price (MFP) and the 340B Program, including: ✅ What the Maximum Fair Price (MFP) is and how it impacts Medicare Part D reimbursement ✅ Which drugs are included in the first MFP cohort starting in 2026 (Eliquis, Jardiance, Stelara, and more) ✅ Why federal rules prohibit manufacturers from providing both an MFP adjustment and a 340B discount on the same drug ✅ HRSA’s proposed 340B Rebate Model Pilot (and why it represented a major shift away from upfront 340B pricing) ✅ The current legal status: how litigation has paused implementation, but not the underlying duplicate discount risk ✅ Practical operational strategies covered entities can take now to prevent MFP duplicate discounts, especially given vendor limitations and manual control needs 📌 Key takeaway: Even though the rebate model is paused, covered entities remain responsible for preventing MFP duplicate discounts and ensuring rebates are not received on 340B-eligible prescriptions. 📥 Download the Slide Deck (Episode Toolkit) This episode’s slide deck is available here: https://virtue340b.com/ira-mfp-340b-rebate-pilot-program-guide-toolkit/ Subscribe for more compliance-driven 340B education and practical guidance designed to help covered entities strengthen oversight and stay audit-ready. #340B #InflationReductionAct #IRA #MFP #MedicarePartD #340BCompliance #HRSA #DuplicateDiscounts #DrugPricingReform
Ep 11 - MFP + 340B Compliance in 2026: Duplicate Discount Risk, Rebate Pilot Pause & What’s Next
In this episode of Katy's 340B Compass, 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, the U.S. District Court for the District of Maine issued a preliminary injunction on December 29, 2025, temporarily blocking HRSA’s 340B Rebate Model Pilot Program from going live on January 1, 2026. While implementation is paused, the readiness concepts discussed here remain highly relevant — and will help covered entities strengthen oversight, improve data integrity, and stay prepared for future changes. What You’ll Learn ✅ What the 340B Rebate Model Pilot Program was designed to test — and why it was paused ✅ Key operational considerations for aligning with rebate-based data submission requirements ✅ The importance of clean, reliable claim-level and purchasing data for rebate request workflows ✅ Practical ways to prepare now (without overhauling your entire program) Who This Is For This episode is designed for: 340B Program Leaders & Compliance Teams Pharmacy Leadership & Operations Finance / Revenue Integrity Covered entity executives responsible for program oversight
Episode 10 - 340B Rebate Model Pilot Program: Operational Readiness & Key Data Requirements
In this episode of Katy’s 340B Compass, Principal 340B Compliance Advisor Katy Lees breaks down the fundamentals of good faith inquiries, manufacturer disclosures, and material breach in the 340B program. Katy explains what to do when a manufacturer reaches out with a concern, how to communicate effectively, and the right way to respond when potential compliance issues arise. You’ll learn how to confirm receipt of an inquiry, evaluate potential duplicate discounts or diversion concerns, determine whether an issue rises to a material breach, and navigate the disclosure and repayment process with confidence. If you want practical guidance on maintaining transparency and accountability in your 340B program, this episode is for you. 👉 Subscribe for more compliance insights, leave a comment with your questions, and connect with Katy on LinkedIn to stay informed.
Katy’s 340B Compass – Ep 9 - Handling Good Faith Inquiries & Material Breach in 340B
Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, returns from a summer hiatus to unpack the major themes from her experience at the Medicaid Rebate Summit — and why the current process for managing duplicate discounts is fundamentally flawed. Katy shares eye-opening insights into how manufacturers rely on outdated Medicaid Exclusion File data, the operational realities for covered entities navigating carve-in and carve-out decisions, and why collaboration between stakeholders is the only way forward. She also delves deeply into the ongoing debate surrounding HRSA’s rebate pilot policy — questioning whether purchasing data should be included in the model — and offers practical advice for compliance leaders preparing for what’s next in the 340 B program. If you manage a 340B program or advise on compliance, you won’t want to miss this episode. 👉 Subscribe for more expert guidance, comment with your 340B questions, and connect with Katy on LinkedIn for ongoing insights.
Katy's 340B Compass - Ep 8 - Rethinking Duplicate Discounts: Fixing a Broken 340B System
In this episode of Katy’s 340B Compass, Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, tackles two timely topics for covered entities. First, she breaks down HRSA’s recently published pilot rebate policy and why submitting thoughtful comments by September 8 is critical for the future of the 340B program. Katy also shares alternative solutions she has proposed, such as a clearinghouse model for greater transparency without undermining the program. Next, Katy provides a practical walk-through of the annual 340B hospital recertification process. From coordinating with Authorizing Officials to validating Medicaid billing numbers and child site cost report data, she offers real-world tips to ensure accuracy, compliance, and audit readiness. Don’t miss this essential episode if you’re preparing for recertification or navigating policy changes. Subscribe to the channel, drop your questions in the comments, and connect with Katy on LinkedIn for more compliance insights.
Katy's 340B Compass Ep 7 - 340B Hospital Recertification & HRSA Rebate Policy Explained
What is a 340B clearinghouse—and why is everyone talking about it? In this episode of Katy’s 340B Compass, we break down the concept of a 340B clearinghouse: what it is, how it works, and why it could be the missing link in preventing duplicate discounts and strengthening program integrity. Join Katy F. Lees, 340B ACE, as she walks through: The core function of a 340B clearinghouse How it could help eliminate duplicate claims across covered entities The potential role of the Office of Pharmacy Affairs (OPA) Why it's time for a centralized, transparent data solution Challenges with medical claim integration—and the practical workaround Whether you're a 340B veteran or just trying to keep up with emerging policy ideas, this episode gives you a crystal-clear view of where the conversation is headed. 👉 Don’t forget to like, comment, and subscribe for more real-world 340B insights! #340B #340BExplained #340BClearinghouse #Katys340BCompass #DuplicateDiscounts #PharmacyCompliance #HealthPolicy #Virtue340B
Katy's 340B Compass - Ep 6 - The 340B Clearinghouse, Explained!
In this powerful episode of Katy’s 340B Compass, Katy tackles a topic every 340B stakeholder dreads—but must be prepared for: non-compliance. What should covered entities do when they identify 340B violations? How can you mitigate risk, respond with transparency, and turn a compliance issue into a learning opportunity? Katy walks you through: The immediate steps to take when non-compliance is identified The importance of internal reporting and self-disclosure Best practices to strengthen your audit readiness How to build a culture of accountability and continuous improvement Whether you're facing an issue now or proactively shoring up your compliance framework, this episode offers actionable advice and reassurance from one of the industry’s most trusted voices. 🔔 Subscribe to stay up to date on all things 340B. 📘 Visit us at virtue340b.com to learn more. #340B #Compliance #PharmacyLeadership #KatyCompass
Katy's 340B Compass Ep - 5 - How to Manage 340B Non-Compliance
In Episode 4 of Katy's 340B Compass, Katy breaks down the rising trend of 340B rebate models—a non-traditional approach where manufacturers reimburse covered entities for eligible 340B claims rather than providing point-of-sale discounts. 💡 In this episode, you’ll learn: What a 340B rebate model is and how it differs from standard 340B pricing Key drivers behind the industry’s shift toward rebate arrangements How covered entities can evaluate rebate opportunities while maintaining HRSA audit readiness 🔔 Subscribe to stay informed on the latest 340B insights with Katy’s monthly episodes.
Katy's 340B Compass - Ep - 4 - Decoding 340B Rebate Models
In Episode 3 of Katy’s 340B Compass, Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, shares strategies for building an effective 340B program oversight plan. Learn key tips for: Ensuring access to the right data for audit readiness Setting a routine cadence for claim reviews Preventing drug diversion and duplicate discounts Auditing contract pharmacy and mixed-use settings effectively Using data-driven targeting to identify higher-risk transactions Documenting oversight activities for HRSA audit preparedness Whether you're looking to strengthen your existing monitoring efforts or establish a new oversight program, this episode provides practical, actionable guidance. Stay tuned — in the next episode, Katy will cover what steps to take if you identify potential compliance issues during your audits! 🔔 Don’t forget to like, comment, and subscribe for more 340B compliance insights. 💬 Questions or topic suggestions? Submit them via our website, LinkedIn, or in the comments section! #340BCompliance #340BOversight #Virtue340B #340BPharmacy #HealthcareCompliance #ProgramIntegrity
Katy's 340B Compass Ep - 3 - Building a 340B Oversight Program
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