The Apexus CRS team has provided answers to common questions related to refund calculations, fees, and the support provided to covered entities during the refund process. For further insight, noncompliance resolution guides and CRS case studies are provided.
COMMON Questions
Covered entities are required to complete two key items:
CRS Data Request
This form asks for the 11-digit NDC, the quantity of ineligible purchases, and a general timeframe for those purchases. These details are used to calculate refund amounts. For greater precision, you may also include optional information such as invoice numbers, invoice dates, and account identifiers.
CRS Manufacturer Letter Template
You will just need to include a brief explanation of your organization’s 340B noncompliance in the prewritten letter. Our team will review it to make sure it has the right level of detail to meet manufacturer expectations.
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.
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.
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.
Response times vary by manufacturer, but approximately 80% 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.
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.
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.
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.
As a best practice, covered entities should establish a standard internal schedule for submitting repayments to CRS—either as a one-time project or on a recurring basis. For consistency, we recommend adopting a standard cadence. 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.
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.
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.
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.
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.
Invoice pricing often reflects the price in effect when the order was placed. As a result, invoices generated early in a new quarter may still reflect the previous quarter's pricing if the order was placed before the new pricing became effective.
Simplify 340B Refunds with the Apexus Covered Entity Refund Service (CRS)
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.
Why Partner with CRS?
We understand the frustrations faced by covered entities and manufacturers when dealing with these issues. Resolving 340B compliance errors is a complex and arduous process, which is why we developed the Covered Entity Refund Service.
Partner with CRS to simplify the refund process and experience a multitude of benefits:
Accuracy: Our experienced CRS team ensures precise calculations and offers repayments to manufacturers on your behalf.
Efficiency: Say goodbye to the hours spent searching for manufacturer contacts. We maintain strong relationships with manufacturers to validate appropriate contact information, saving you valuable time, effort, and labor costs.
Fewer Transactions: Issue only one payment to Apexus. We'll process and distribute individual payments to each manufacturer on your behalf, and return all remaining amounts at the close of the project.
Closure: With an average manufacturer response rate of 98% per refund project, CRS reduces the risk of nonresponsive manufacturers contacting you later and allows you to stay focused on current work.
Auditable Records: Rest easy knowing that CRS delivers clear and fully auditable reports, providing transparency and peace of mind.
HOW MUCH DOES CRS COST?
There is no cost to sign up for CRS. Fees are charged during refund projects based on the number of manufacturers contacted. Estimated costs for refunds and CRS fees are provided upfront, ensuring transparency from the start. If multiple labeler codes roll up to one manufacturer, we send one letter and charge the fee only once. Projects are typically completed within two to four months.
Communication and organization were excellent throughout the whole process. We have completed several repayments before internally, and this was by far the best and easiest experience we have had. The process was quick and transparent and saved us hundreds of internal hours spent on the repayments before finding CRS.
Visit the Office of Pharmacy Affairs Information System (OPAIS) website to search for manufacturers. Filter by labeler code, manufacturer name, contact name, and status.
Search for drug manufacturer contact information for companies participating in the Medicaid Drug Rebate Program (MDRP). Each contact contains (optional) effective date; termination date (if applicable); and legal, invoice, and technical contact information.
Discover how our 340B team responded to the situation faced by a clinic when a routine electronic health record (EHR) billing update accidentally disrupted the way accumulations were calculated in the 340B split-billing software.
HOW CAN WE HELP?
Find more about what we do and how we can help you
Communication and organization were excellent throughout the whole process. We have completed several repayments before internally, and this was by far the best and easiest experience we have had. The process was quick and transparent and saved us hundreds of internal hours spent on the repayments before finding CRS. 