OIG Issues Favorable Advisory Opinion on Hearing Referral Service

On September 3, 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable Advisory Opinion regarding a proposed hearing treatment referral service owned and operated by a manufacturer of a handheld ear, nose, and throat (ENT) medical device. Under the arrangement, primary care clinicians, who pay a subscription fee for use of the device, would use the device to examine patients’ ears, remove earwax, and conduct an initial hearing assessment. If the assessment indicates abnormal hearing, the clinician could elect to refer the patient to the referral service. With the patient’s consent, the referral coordinator would verify that certain clinical criteria were met before forwarding a report to a participating group of audiologists, hearing aid specialists, or ENT specialists who pay the manufacturer an annual fee to participate in the referral service. The participating group and its affiliated practitioners would eventually treat the patient and report the treatment outcome to the referring primary care clinician.

Upon review, the OIG concluded that this arrangement would satisfy the referral services safe harbor and not violate the federal Anti-Kickback Statute because:

• Any group who meets the qualifications to participate in the referral services arrangement would not be excluded from participating.
• The annual fee paid by participating groups would be set in advance, be based on estimated operating costs of the referral service, and would be owed regardless of how many groups participate in the referral service or how many referrals a participating group generated.
• The referral service would not impose clinical protocols, product restrictions, or pricing demands.
• Each person seeking a referral would be provided with, and sign, the required disclosures under the safe harbor.