On September 9, 2026, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) published Advisory Opinion 26-18 (“AO 26-18”), a favorable advisory opinion considering a proposed paid referral service that would connect patients identified as having potential hearing loss with hearing providers (the “Arrangement”) operated by a company whose parent manufactures medical devices used in ear, nose and throat (“ENT”) care (“Requestor”). OIG concluded that although the Arrangement would implicate the federal Anti-Kickback Statute (“AKS”), it would not impose sanctions because the Arrangement would be protected by the AKS regulatory safe harbor for referral services. AO 26-18 highlights the importance of open participation, cost-based fees, provider independence and transparent written patient disclosures.
Background
Under the proposed Arrangement, the Requestor would operate a referral service connecting patients requiring specialized ear and hearing care with participating groups of audiologists, hearing aid specialists and ENT specialists. Each participating group would pay a set membership fee to participate in the referral service (“Referral Program”).
Under the proposed Arrangement:
- Primary care clinicians would use a medical device which combines a digital otoscope, earwax removal technology and a hearing assessment program (“Hearing System”) to identify patients with potential hearing loss.
- When a patient demonstrates potential hearing loss, subject to the patient’s consent, the primary care provider could refer the patient to specialized audiological services. The referral could then be transmitted to a hearing provider participating in the Referral Program.
- The referred hearing provider would review the patient’s hearing assessments and provide services according to its independent and objective clinical opinion.
- Hearing providers would participate in the Referral Program by paying an annual membership fee that would not be based on or vary with the volume or value of referrals generated or accepted.
- Pertinent patient disclosures would be made to eligible patients regarding the nature of the Referral Program to maintain patient autonomy in deciding whether to provide consent.
Analysis
OIG concluded that the Arrangement would implicate the AKS because participating hearing providers would pay the Requestor a fee to receive referrals for services that could be reimbursable by a federal health care program. However, based on the Requestor’s certifications, the OIG stated that the fees that would be paid to the Requestor per the Arrangement would be protected by the AKS referral services safe harbor. The conditions for meeting the referral services safe harbor under the Arrangement would be satisfied as follows:
- The Referral Program would not exclude any qualifying individual or entity from participation.
- Any payment by a participating group would be based only on the cost of operating the Referral Program and would not be based on the volume or value of referrals or other business generated. The annual fee would be established regardless of the number of referrals or whether a patient receives care as a result of a referral.
- The Referral Program would not impose requirements on the manner in which participating hearing providers furnish services to referred patients, including clinical protocols, product restrictions or pricing requirements.
- Required safe harbor disclosures would be provided to each patient in writing before a referral is made, and the Requestor would maintain a signed written record of those disclosures. The patient also would be required to consent before the referral is transmitted.
Importantly, OIG did not address the separate financial arrangement between the Requestor and the primary care clinicians using the Hearing System. Accordingly, AO 26-18 should not be read as approving that aspect of the parties’ relationships.
Practical Takeaways
Entities considering similar referral programs should recognize that a fixed participation fee alone is not sufficient to satisfy the referral services safe harbor. Such entities should ensure that (i) participation criteria are objective and applied consistently; (ii) fees are based only on documented operating costs; (iii) participating professionals retain independent control over the clinical services they furnish; and (iv) all required patient disclosures are provided and documented. As with all OIG advisory opinions, AO 26-18 is specific to the Requestor and the facts of the proposed Arrangement.
For more information about this AO 26-18 or the topic in general, please contact:
- Ritu Kaur Cooper at (202) 370-9584, or rcooper@hallrender.com;
- Erin Drummy at (317) 977-1414 or edrummy@hallrender.com;
- Alyssa James at (317) 429-3640 or ajames@hallrender.com;
- Carolina Wirth at (202) 780-2989, or cwirth@hallrender.com;
- Taylor Moorer at (202) 370-9584, or tmoorer@hallrender.com; or
- Your primary Hall Render contact.
Special thanks to Compliance Advisor Melissa La Motta for her assistance in the preparation of this alert.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
