Common Questions

What information am I required to submit to Apexus to start the refund process?

Covered entities are required to complete two key items:

Launch your refund project to receive the CRS Data Request and CRS Manufacturer Letter Template.

When will we receive our refund calculation?

You will receive a detailed refund calculation within two weeks of submitting your data request. This initial analysis will include the total refund amount and the number of manufacturers involved. CRS will not proceed with the project until the covered entity has reviewed and approved this analysis.

How many payments do we submit to Apexus for the refund process?

Apexus issues two invoices as part of the refund process. The first invoice reflects the total refund amount which Apexus uses to distribute payments to manufacturers on your behalf. The second invoice, issued at the conclusion of the project, covers the Apexus service fee. Any unused funds that are not disbursed to manufacturers are returned to the covered entity upon project completion.

What documentation does CRS provide to support the refund and audit process?

CRS delivers a comprehensive refund calculation that includes invoice-level details and pricing for each product included in the refund, with totals summarized by manufacturer. A final summary and detailed report are also provided to serve as auditable records, helping the covered entity meet HRSA documentation expectations.

How quickly do manufacturers respond to refund offers?

Response times vary by manufacturer, but approximately 75% respond within 30 days. However, full resolution can take 2 to 4 months, as some manufacturers require additional time for internal review and approval. An Apexus CRS team member can offer a more customized timeline based on the manufacturers involved and the scope of your project.

What payment methods are used to deliver funds to manufacturers?

CRS disburses payments to manufacturers on behalf of the covered entity through ACH transfers or check payments, with international wire transfers used in certain cases. Comprehensive payment details are included in the final report issued at project completion to ensure transparency and maintain auditable records.

How does CRS support covered entities when manufacturers have questions about refund offers?

Due to our consistent calculation methods and established communication protocols, most manufacturers accept CRS refund offers without the need for further clarification. However, based on our experience, we can often anticipate which manufacturers may seek additional details. When questions do arise, we proactively inform your team and collaborate closely to ensure that all inquiries are addressed efficiently and thoroughly.

What should I do if a manufacturer does not respond to Apexus outreach?

Once the CRS communication protocol is completed, the refund offer is considered closed. However, manufacturers may still choose to accept the refund at a later date. Apexus provides detailed information on each nonresponsive manufacturer for your records and potential follow-up. Although uncommon, some manufacturers have claimed refunds after the fact. Nonresponses are generally—but not always—linked to lower refund amounts.

How often can repayments be submitted to CRS?

Repayments can be submitted at the covered entity’s discretion – either as a one-time project or on a recurring basis. For consistency, we recommend establishing a standard internal schedule. Because CRS fees are based on the number of manufacturers contacted, combining refunds from outpatient clinics or departments, retail pharmacies, and contract pharmacies helps streamline the process and improve cost-efficiency.

When do covered entities typically resolve negative accumulations in the 340B software related to manufacturer repayments?

Each covered entity approaches this process differently based on its internal 340B procedures. Some choose to resolve negative accumulations when the refund analysis is approved and manufacturer outreach begins, whereas others wait until all payments have been completed and the final report is received. An Apexus CRS team member can help you evaluate the pros and cons of each approach and determine the best timing for your organization.

Why are refunds typically calculated using wholesale acquisition cost (WAC) prices instead of other price points like Prime Vendor Program (PVP) sub-WAC contracts or group purchasing organization (GPO) pricing?

Refunds are generally calculated based on the reported WAC price at the time the ineligible 340B purchase occurred. WAC serves as the standard, non-contract market price used across all government pricing programs. Manufacturers sell their products to wholesalers at WAC, making it a consistent and verifiable benchmark. This keeps the repayment calculation transparent for all parties involved.

Can Apexus facilitate refunds for ineligible GPO purchases for covered entities subject to the GPO Prohibition (DSH, CAN, PED)?

Yes. Apexus can facilitate GPO refunds for covered entities subject to the GPO Prohibition. Compared with 340B refunds, GPO refunds require additional purchase data to be provided by the covered entity to determine the refund amount. CRS supports this process by providing historical WAC data based on the GPO invoice date.

Why are refunds based on full package sizes instead of partial quantities?

Refunds are calculated based on actual 340B sales. Because products are sold in full package sizes, refunds are rounded up to the nearest full package to reflect how the 340B sale impacted the manufacturer and to align with standard repayment practices.

Why do some purchases at the beginning of a quarter (e.g., a 7/2/2025 purchase) reflect 340B and WAC pricing from the prior quarter?

This can occur when the drug was ordered in the previous quarter, even if the invoice date falls in the new quarter. In such cases, pricing may still align with the prior quarter’s rates.