Katy's 340B Compass: Compliance Made Clear

Manufacturer audits require organization, clear communication, and careful attention to scope. Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, discusses practical ways covered entities can prepare, respond, document communications, ask clarifying questions, and stay focused on the approved drugs and timeframe under review. Visit Virtue 340B’s website to access the full episode and choose your preferred listening or viewing platform.

Audit readiness starts with everyday program control. In this episode, Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, shares practical guidance on preparing data, organizing documentation, assigning ownership, protecting sensitive information, and answering audit questions with clarity. Visit Virtue 340B’s website to access the full episode and choose your preferred listening or viewing platform.

340B growth is real, but the story behind it is more complex than dollar totals alone suggest. In this episode, Katy Lees examines how rising drug acquisition costs, patient complexity, and changes in care delivery shape the conversation around 340B spending. She offers practical insight for leaders seeking clearer oversight and more balanced policy discussions. Visit Virtue 340B’s website to access the full episode and choose your preferred listening or viewing platform.

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, discusses patient definition, offsite eligibility, duplicate discounts, Medicaid alignment, and recertification through a governance-focused lens. Visit Virtue 340B’s website to access the full episode and choose your preferred listening or viewing platform.

Katy Lees examines proposed cuts to 340B OPPS reimbursement and compares two emerging legislative frameworks: the SECURE 340B Act and the Integrity/Affordability draft. This episode helps leaders understand the oversight, financial, contract pharmacy, patient affordability, and operational considerations shaping today’s 340B policy environment. Visit Virtue 340B’s website to access the full episode and choose your preferred listening or viewing platform.

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 claim adjudication through accumulation, qualification, and replenishment processes. This episode offers practical insight for leaders evaluating risk, oversight, and operational realities. Visit Virtue 340B’s website to access the full episode and choose your preferred listening or viewing platform.

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.