Title
Pre-Conference Workshop Option 2: Audits: Part 2: Audit Takeaways from Diversion and Duplicate Discount Findings
Room/Location
National Harbor 2-3
Track
Pre-Conference Workshops
Group(s)
Registered Workshop Attendees in Groups 1, 2, 3, 4, 5, 6, 10, 11 Only
Description
Please Note: This session requires separate registration and additional fees apply. Registration fees include breakfast and lunch, which will be served in the exhibit hall.
The 340B statute limits 340B drugs to outpatient individuals who are a “patient” of the 340B covered entity and protects manufacturers from paying a Medicaid rebate on a 340B discounted drug. HRSA’s 1996 patient definition guidelines are instructive for covered entity compliance with the prohibition against diversion, particularly following recent changes to HRSA’s audit enforcement rules to closely mirror 340B statutory requirements. We have seen flexibilities the last few years where qualifying prescriptions may originate resulting in new trends in diversion findings. We have recently seen communications from HRSA implicating a narrower use of 340B in child sites. HRSA continues to strictly audit the Medicaid Exclusion File (MEF) for entities using 340B drugs for Medicaid Fee-for-Service patients. This session will also examine other scenarios that result in duplicate discount findings and will address compliance best practices for patient eligibility and preventing duplicate discount findings.
Learning Objectives:
- Discuss the 1996 HRSA patient definition guidance and recent HRSA statements about using 340B drugs for new child sites
- Examine diversion and duplicate discount trends
- Describe compliance best practices for patient eligibility and Medicaid Exclusion File (MEF) accuracy