Expert Tip from Apexus


TIP: Want to resolve negative 340B accumulations to improve your organization’s 340B compliance? Simplify your process for refunding manufacturers with the Apexus Covered Entity Refund Service (CRS).

Ineligible 340B purchases result from various situations, such as reversed claims, errors in eligibility data transmitted to 340B vendors, or inadvertent 340B purchases without supporting eligibility or accumulations. These errors may occur as a part of normal business practices. Even though most issues may not meet a material breach threshold requiring disclosure to HRSA, HRSA still expects noncompliance associated with diversion and duplicate discounts to be resolved with the manufacturer through repayment.

If ineligible purchases are identified early, there may be options to work with your wholesaler to return or credit and rebill the product. The credit-and-rebill process is typically restricted to within 3–6 months of the date of purchase; returns may have even shorter timeframes. Unfortunately, these solutions are not available for some products and cannot be used when the ineligible purchase was made prior to the respective timeframe restriction, such as more than 6 months ago. These situations typically require repaying manufacturers directly to ensure transparency.

Simplify the repayment process with CRS

Covered entities work with CRS to efficiently process repayments to manufacturers through a proprietary process, reducing time and effort spent correcting ineligible 340B purchases. Our experienced team ensures accurate repayment calculations and offers refunds to manufacturers on your behalf. With an average manufacturer response rate of 95%, CRS reduces the risk of nonresponsive manufacturers contacting you months after your repayment offer, so you can stay focused on your current work. CRS delivers a fully auditable report, providing transparency and peace of mind.

To sign up for CRS or learn more, visit


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