CASE STUDY: FIXING 340B INVENTORY ERRORS DUE TO EHR BILLING CORRECTIONS

Background

The 340B Program relies on accurate data connections among clinical, billing, and inventory systems. Small, routine changes in documentation for administration or billing can cause larger ripples affecting 340B inventory management.

In this situation, a routine billing update in a clinic’s electronic health record (EHR) accidentally disrupted the way accumulations were calculated in the 340B split-billing software. That caused certain transactions to be accumulated incorrectly, which led to more 340B drugs being purchased than were supported by eligibility.

The Discovery

During a routine audit in October 2025, the clinic’s 340B team identified unusual accumulation trends in its split-billing software for the Infectious Disease Clinic. Approximately 70% of dispenses of NDC 12345-6789-01 were expected to qualify as 340B-eligible based on the clinic’s patient mix, yet 100% of purchases were made from the 340B account.

Upon further investigation, the team traced the issue to a recent EHR configuration change that modified charge code mapping. This update caused each dispense to be recorded as a full package size instead of the appropriate lower dose from a multi-dose vial, leading to inflated accumulation totals and subsequent overpurchasing.

Virtual Inventory Report – 10/14/2025

The 340B team determined that 17 vials had been accumulated inappropriately as 340B eligible from the infectious disease clinic. The issue was corrected on October 27, 2025, with a one-time adjustment in the split-billing software.

Virtual Inventory Report – 10/27/2025

The adjustment cleared the six previously available accumulations and revealed that 11 purchases had been made in error on the 340B account, resulting in a negative accumulation balance of 11 units.

Questions the Team Needed to Answer

To fully understand the problem, the team asked:

• Were other drugs affected by the same accumulation issue?
• Which 340B purchases were affected, and when did the purchases occur?
• Could unused accumulations in another virtual inventory associated with the same 340B ID help offset the negative balance?

How the Team Responded

The pharmacy and IT teams worked together to get to the bottom of the issue. Here’s what they did:

Identified Other Affected Drugs
Identified Other Affected Drugs Although only this NDC at the infectious disease clinic was directly affected by the EHR configuration change, a broader review of the split-billing software, which supports multiple outpatient areas, suggested that other drugs were affected. Following a detailed analysis, the team confirmed that 30 NDCs were affected in total.

Mapped the Timeline
It was determined that ineligible accumulations and purchases for all 30 NDCs occurred during September–October 2025.

Verified Affected Purchases
The team compared ineligible accumulations to 340B purchases to confirm which 340B transactions were affected.

Assessed for Material Breach
The issue was determined not to constitute a material breach according to the entity’s 340B policies and procedures requiring disclosure to HRSA, allowing the covered entity to proceed with internal corrective actions, including direct repayments to manufacturers, to address and document the findings.

Steps Taken to Fix the Issue

Once the full scope of the issue was clear, the 340B team moved quickly to correct it:

Updated System Logic: Fixed the charge code mapping in the EHR-to-split-billing software interface to prevent future accumulations from being affected.

Adjusted the Virtual Inventory: Manual accumulation adjustments were made to the 30 affected NDCs, which resulted in negative accumulations for 23 NDCs.

Determined Affected Purchases: Invoices were identified corresponding to ineligible purchases for 23 NDCs.

Corrective Actions Taken: The 340B team reviewed the inventory to identify which of the 23 affected NDCs were eligible for 340B product returns and reached out to the covered entity’s wholesaler to explore additional resolution options. The corrective actions were categorized as follows:

1. 7 NDCs: 340B drugs were returned to the wholesaler and repurchased at a non-340B price.
2. 10 NDCs: The wholesaler was able to reclassify the 340B purchases to reflect non-340B pricing using a credit/rebill process.
3. 6 NDCs: These products could not be returned or reclassified, so the 340B team calculated and issued repayments directly to the affected manufacturers.
   1. Invoice-level details, wholesaler acquisition cost (WAC), and 340B acquisition costs were used to calculate refund amounts.
   2. The team referenced the PVP Self Disclosure to HRSA and Manufacturer Template for correspondence.
   3. Manufacturer contact information was obtained using the 340B OPAIS Manufacturer Search and MDRP Drug Manufacturer Contacts resources.

Maintained Auditable Records: The 340B team documented all findings, corrective actions, and auditable details related to the affected accumulations and purchases.

Summary

• Conduct regular self-audits to identify and address issues promptly.
• Assess the broader impact to determine whether additional 340B purchases may be affected.
• Identify and correct the root cause to prevent recurrence.
• Evaluate whether the issue meets the threshold of a material breach requiring HRSA notification, or if it can be resolved through internal corrective action.
• Implement corrective measures such as split-billing software updates, wholesaler adjustments, or direct manufacturer repayments, as necessary.

Conclusion

For organizations facing similar challenges, a structured approach can help your team detect issues early and resolve them with confidence. Our comprehensive guide outlines a four-step action plan for the following:

• Identifying noncompliance through various audits
• Developing a corrective action plan
• Working with manufacturers and/or wholesalers for resolution
• Achieving successful closure

By following this action plan, health care organizations can better navigate complex 340B compliance issues and ensure accurate management of their virtual inventory. Download your guide to resolving noncompliance and achieving successful closure.

To learn more and schedule a meeting with an expert, visit apexus.com/CRS or email CoveredEntityRefunds@Apexus.com.

The Covered Entity Refund Service is a separate Apexus offering that is not a part of the 340B Prime Vendor Program or otherwise associated with the Prime Vendor Agreement between HRSA and Apexus.