Katy's 340B Compass: Compliance Made Clear

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.

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 Katy unpacks how outdated guidance, manufacturer challenges, and recent court rulings may reshape compliance expectations.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.

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.

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.

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.

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.

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.

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 reimbursementWhy 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 concernsHow litigation has temporarily paused the rebate pilot, preserving upfront 340B discounts—for nowWhat covered entities must do today to prevent MFP duplicate discounts and confirm MFP rebates are handled correctly for non-340B prescriptionsWhy vendor limitations may require manual controls and enhanced monitoring in the near termEven 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/

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 paused, the readiness concepts discussed remain highly relevant for strengthening data integrity, oversight, and preparedness for future changes.

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, and confidence.

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 guidance for compliance leaders preparing for what’s next in the 340B program.

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 cost report details for accuracy, compliance, and audit readiness.

What is a 340B clearinghouse—and why is it gaining attention? Katy breaks down what a clearinghouse could look like, how it might help eliminate duplicate claims across covered entities, and why a centralized data solution could strengthen program integrity. This episode also explores the potential role of OPA and the operational challenges of integrating medical claims, along with practical workarounds.

Non-compliance can happen in any 340B program—but how you respond matters. Katy walks through the immediate steps to take when a potential violation is identified, the importance of internal reporting and self-disclosure, and best practices for mitigating risk. This episode focuses on maintaining transparency, strengthening audit readiness, and building a culture of accountability and continuous improvement.

340B rebate models are becoming more common—and they operate very differently from traditional point-of-sale 340B pricing. In this episode, Katy explains how rebate models work, why manufacturers and stakeholders are exploring them, and what covered entities should consider when evaluating rebate opportunities. You’ll also learn how to maintain compliance and audit readiness when new reimbursement structures are introduced.

In Episode 3, Katy shares practical strategies for designing and strengthening a 340B oversight plan. Topics include ensuring access to the correct data, setting a routine cadence for claim reviews, auditing contract pharmacy and mixed-use settings, and using risk-based targeting to focus on higher-risk transactions. Katy also highlights best practices for documenting oversight activities to support HRSA audit preparedness.

Duplicate discounts are one of the most critical compliance risks in the 340B program. In this episode, Katy breaks down how duplicate discounts occur, how to prevent them, and what covered entities should monitor across Medicaid fee-for-service and managed care. You’ll also learn about public resources available to support compliance and how state and federal requirements impact your program.

This episode covers the essential cornerstones of the 340B program, including the program’s history, how eligibility works, and the operational mechanics of contract pharmacy. Katy also walks through the key compliance pillars every covered entity must manage—diversion, duplicate discounts, Medicaid Exclusion File considerations, GPO prohibition, and orphan drug exclusion—plus practical tips for building a strong oversight plan.

Welcome to Katy’s 340B Compass! In this introductory episode, Katy Lees (Principal 340B Compliance Advisor at Virtue 340B) shares the purpose of this series and what program leaders, pharmacy teams, and compliance stakeholders can expect in future episodes. We’ll break down complex 340B topics into practical guidance designed to strengthen oversight and support audit readiness.