Duplicate discounts and diversion are two of the most persistent risks in pharmaceutical pricing, and in 2025, they’re under the microscope. HRSA audits are tougher, state-level carve-in/carve-out rules are more complex, and manufacturers are expected to prove not only that they have controls in place, but that those controls are effective.
These risks will be reviewed. Can your organization show it’s audit-ready?
Why It Matters
A single duplicate discount can ripple through your financials and compliance posture, and even small errors can become high-profile problems.
Manufacturers that lack strong prevention strategies risk:
- Costly duplicate discounts: Overlapping 340B and Medicaid rebates that erode margins.
- Diversion to ineligible sites: 340B drugs dispensed outside program rules.
- Audit penalties: Findings tied to weak monitoring or missing documentation.
- Damaged relationships: Disputes with covered entities and contract pharmacies over disputed claims.
- Best Price impact: 340B prices offered to non-eligible 340B entities can become a new Best Price.
Today’s Challenges
Manufacturers face a convergence of pressures, and without modernization, these issues leave organizations on the defensive when auditors arrive.
- Expanded 340B contracting: More covered entities and contract pharmacies, more complexity.
- Opaque data flows: Limited visibility into Medicaid managed care claims creates blind spots.
- Growing audit scope: HRSA expects not just data, but clear policies and defensible documentation.
- Patchwork state rules: Varying carve-in/carve-out policies add compliance complexity.
- Manual processes: Spreadsheets and siloed systems leave too much room for error.
Best Practices for 2025
Leading manufacturers are taking proactive steps to strengthen 340B compliance:
- Integrate Data in Real Time – Unify wholesaler, rebate, and Medicaid claims data into a single monitoring framework to quickly identify overlaps.
- Document Policies Clearly – Written policies on eligibility, duplicate discount prevention, and dispute resolution are as important as the data itself.
- Establish Cross-Functional Governance – Assign ownership across compliance, finance, and government pricing to ensure consistent oversight.
- Audit Internally, Before HRSA Does – Routine internal reviews of 340B eligibility and duplicate discount scrubbing not only surface risks but also build a defensible audit trail.
- Strengthen Medicaid Managed Care Monitoring – Ensure agreements and systems capture managed care claims accurately and promptly.
Staying Ahead of the Pressure
The stakes around duplicate discounts and diversion are only increasing. By embedding audit-ready controls, integrating real-time data, and maintaining clear documentation, manufacturers can reduce risk and protect revenue in one of the most closely watched programs.
In 2025, reactive fixes won’t cut it. Proactive, documented, and system-driven compliance is the only path to staying ahead.
Looking to Protect Against 340B Risks?
RLDatix Life Sciences helps manufacturers modernize duplicate discount prevention, prepare for HRSA audits, and strengthen compliance confidence. Talk with our team to see how we can help.