TIP: When offering repayment to manufacturers for noncompliant purchases, it helps to standardize the refund process by setting a target date for completion, maintaining detailed records, and developing an action plan for manufacturers that respond after the target date.
Understanding HRSA’s expected timeline for manufacturer repayments resulting from self-disclosures and/or HRSA audit findings offers a model timeline that can be used for repayments that do not involve HRSA, such as for noncompliant purchases identified during self-audits that do not meet the organization’s material breach threshold. HRSA expects corrective actions plans (CAPs) from self-disclosures and OPA audits to be completed within a six-month timeframe. During the six months, entities determine the full scope of the issue, correct it, and offer repayments to affected manufacturers, providing periodic progress reports along the way. Once the CAP is fully implemented, covered entities deliver a final report indicating how the issues were resolved and how they will work toward repayment with manufacturers in the future for any issues that had not been resolved at the end of the six months.
Given these expectations, a few themes emerge that can be applied to all instances of repayment:
- Set a target date to complete manufacturer repayments.
- Maintain records of repayment amounts and outreach attempts to monitor progress.
- Develop an action plan to work with manufacturers that respond after the target date.
Completing manufacturer repayments accurately and efficiently can be challenging for the following reasons:
- Historical drug pricing information may be difficult to access.
- Manufacturer refund contacts are often not publicly available.
- No statutorily defined process governs refunds of ineligible 340B discounts.
Refunding multiple manufacturers can be challenging to administer without appropriate resources.
Streamline the Refund Process: A Solution from Apexus
The Apexus Covered Entity Refund Service (CRS) helps covered entities streamline the refund process for noncompliance issues by:
- Ensuring accuracy
- Saving time
- Increasing efficiency
- Delivering auditable records
Apexus CRS draws on the expertise of Apexus in 340B compliance, transaction analysis, project management, and reporting to provide refund calculation, documentation, and closure.