Katy's 340B Compass: Compliance Made Clear

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.