OIG Approves Hearing Referral Program Under Anti-Kickback Safe Harbor
The HHS Office of Inspector General issued Advisory Opinion 26-18 on September 9, 2026, approving a proposed arrangement connecting patients with potential hearing loss to participating audiologists, hearing aid specialists and ENT providers. A company whose parent makes ENT medical devices would operate the referral program, charging participating hearing providers a flat annual membership fee unrelated to referral volume or value. OIG found the arrangement implicates the Anti-Kickback Statute but qualifies for the referral services safe harbor because participation is open, fees are cost-based, providers retain clinical independence, and patients receive written disclosures and must consent before referral. OIG did not address the separate arrangement between the requestor and primary care clinicians using the underlying hearing-screening device.