OIG Issues Unfavorable Advisory Opinion on Medical Device Vendor’s Payment for Access to Third-Party Billing Portal

On July 1, 2025, the U.S. Department of Health and Human Services’ Office of Inspector General (“HHS-OIG”) issued Advisory Opinion No. 25-08, an unfavorable opinion finding that the Federal Anti-Kickback Statue (“AKS”) was implicated in a proposed arrangement where a medical device company would pay a third-party software vendor for access to an electronic billing portal used by specific provider-customers where purchase orders and invoice payments would be processed.

Background

The requestor, a medical device company, supplies “bill-only” surgical devices to hospitals and ambulatory surgery centers. These items are not part of a provider’s regular orders and are purchased in real time for specific procedures. While the device company typically manages billing and invoicing directly, some customers have adopted a third-party vendor’s software portal (the “Bill-Only Portal”) which effectively functions as an accounts receivable platform.  The medical device company represented to HHS-OIG that certain customers requested that it use the portal to facilitate purchases of bill-only devices.  Under the proposed arrangement, the device company would pay the vendor an annual licensing fee (approximately $395 per representative, with an estimated annual total of $1.2 million) to access the portal based on each sales representative working with customers who use of the portal as a condition of doing business.

The requestor certified that the portal is redundant to its existing accounts receivable processes and that it would not otherwise require or benefit from the vendor’s services. The sole reason for participating in the arrangement would be to retain or expand business with customers who have adopted the vendor’s portal.

HHS-OIG’s Findings

HHS-OIG determined that the proposed arrangement would implicate the AKS because payments to the vendor could constitute remuneration to customers, as the portal provides value to provider clients including cost savings and streamlined purchasing.  Additionally, the device company would gain access to a specific group of customers unavailable to competitors who are unwilling or unable to pay such fees, which could limit competition and inappropriately steer customers to purchase certain items.

HHS-OIG further found that the arrangement does not qualify for protection under any AKS safe harbor, because the device company conceded that the vendor’s fees were not commercially reasonable given the redundancy of the portal to the company’s existing systems.

Conclusion

HHS-OIG concluded that, if implemented with the requisite intent, the proposed arrangement would generate prohibited remuneration under the Federal anti-kickback statute and could result in sanctions, including civil monetary penalties and exclusion from Federal health care programs. 

Key Takeaways

The opinion underscores the importance of ensuring that payments for access to third-party platforms or services are commercially reasonable, necessary, and do not serve as a vehicle for inducing referrals or purchases reimbursable by Federal health care programs.

• Arrangements in which a supplier pays a third-party vendor for access to a platform required by provider customers may implicate the AKS, particularly where the arrangement is intended to retain or expand business.
• The absence of a commercially reasonable business purpose and redundancy of services heighten risk under the AKS.
• Such arrangements are unlikely to qualify for safe harbor protection if the services exceed what is reasonably necessary or if the payments could be viewed as remuneration to induce referrals or purchases.
• Providers and suppliers should carefully evaluate the structure and necessity of any payments to third-party vendors in connection with Federal health care program business.

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