Katy's 340B Compass: Compliance Made Clear
Virtue 340BNavigate 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 in... more
| Publishes | Daily | Episodes | 16 | Founded | 3 months ago |
|---|---|---|---|---|---|
| Number of Listeners | Category | Education | |||
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Latest Episodes
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 acros... more
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 comple... more
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 re... more
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, a... more
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 Com... more
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... more
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, e... more
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... more
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