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Hosted by Virtue 340B · 🇺🇸 US · EN-US · 22 episodes
Established thought leaders with verified media credentials.
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.
Virtue 340B hosts Katy's 340B Compass: Compliance Made Clear, a education show with 22 episodes published.
Strong 340B oversight starts with knowing where exposure exists and whether your methodology can be explained, documented, and validated. In this episode, Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, disc
Manufacturer data-sharing discussions often assume that the requested information has already been sent to payers. Katy Lees explains why that is not always true, especially when 340B eligibility is determined after clai
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 stakeholderunderstandin
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 Katy unpacks how outdated guidance, manufacturer challenges, and recent cou
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 obliga
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 doc
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 o
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 pos
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 pharmac
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
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: afte
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 co
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 Med
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 w
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 soluti
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
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 exp
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 pha
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
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 p
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Katy's 340B Compass: Compliance Made Clear is hosted by Virtue 340B. The show is categorised under education and has published 22 episodes.
Katy's 340B Compass: Compliance Made Clear has published 22 episodes.
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