Health Law Daily Wrap Up, ANTI-KICKBACK PROHIBITION—OIG ADVISORY OPINIONS: Referral service to connect audiology patients with hearing professionals would fall within the AKS safe harbor, (Sep 15, 2026)
By Jeffrey H. Brochin, J.D.
Arrangement under which Requestor would operate a Hearing Referral Service connecting patients requiring specialized ENT care with a group of Hearing Professionals (who pay a membership fee) would be protected by the safe harbor for referral services upon Requestor’s certification.
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has issued a favorable advisory opinion in response to the request of a Requestor whose Proposed Arrangement would allow for primary care clinicians (generally through their group practice) to pay a set subscription fee to Requestor for the use of the Hearing System when treating patients in their practice. Although the anti-kickback statue (AKS) has been interpreted to cover any arrangement where one purpose of the remuneration is to induce referrals for items or services reimbursable by a federal health care program, Congress has carved out exceptions (and the U.S. Department of Health and Human Services has promulgated safe harbor regulations) that specify certain practices that are not treated as an offense under the federal AKS and do not serve as the basis for administrative sanctions, (OIG Advisory Opinion, No. 26-18 (Sept. 9, 2026)).
Hearing System medical device. The parent company of Requestor manufactures an ENT medical device (Hearing System) which provides an ear and hearing health care platform that combines three different assessment and treatment tools into one hand-held portable system. The Hearing System: (1) acts as a high-definition digital otoscope that facilitates examination of the ear canal and ear drum, with the capability to capture and store high-definition images and video of the examination; (2) facilitates the use of a microsuction pump that removes cerumen (ear wax) from the ear canal; and (3) includes a hearing check program that allows a primary care clinician to perform an initial assessment of potential hearing loss through the Hearing System (collectively, the Hearing Services).
Proposed Arrangement. Under the Proposed Arrangement, Requestor would operate a Hearing Referral Service that would connect patients requiring specialized ear and hearing health care services furnished by an audiologist, hearing aid specialist, or ENT specialist (Hearing Professional) with a Hearing Professionals Group that had paid a set membership fee to participate in the Hearing Referral Service. The patient would then be able to receive specialized ear and hearing health care services, including, but not limited to, a diagnostic hearing evaluation, hearing aid fitting, and more advanced clinical interventions.
Primary Care Clinicians and the Hearing Referral Service. Primary care clinicians (generally through their group practice) would pay a set subscription fee to Requestor for the use of the Hearing System when treating patients in their practice; and, the primary care clinician would perform one or more of the above Hearing Services for a patient using the Hearing System. Upon performing a hearing check, the results of the hearing check would display on the screen of the Hearing System, and a software algorithm would review the patient’s audiogram results, triggering an option for the primary care clinician to select ‘Refer’ for the patient if the results of the hearing check were outside of normal hearing range, or the clinician could opt to end the session.
If the primary care clinician selected the ‘Refer’ option on the screen, information about the Hearing Referral Service would appear for review by the patient, which would explain: (i) the participation criteria for a Hearing Professionals Group to participate; (ii) how Requestor selects the Hearing Professionals Group to which it makes the referral; (iii) any restrictions that would exclude a Hearing Professionals Group (or its Hearing Professionals) from participating in the Hearing Referral Service; (iv) the nature of the relationship between Requestor and the Hearing Professionals Group; and (v) that the Hearing Professionals Group has paid a fee to Requestor to participate in the Hearing Referral Service.
AKS implication. The federal AKS makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce, or in return for, the referral of an individual to a person for the furnishing of, or arranging for the furnishing of, any item or service reimbursable under a federal health care program.
Here, under the Proposed Arrangement, Requestor would contract with one or more Hearing Professionals Groups that meet certain criteria, and each participating Hearing Professionals Group would pay an annual set fee—consistent with the estimated cost of operating the Hearing Referral Service—to participate in the Hearing Referral Service. The annual fee would be set in advance and paid regardless of the number of referrals that each Hearing Professionals Group receives through the Hearing Referral Service and regardless of whether a patient receives any Audiological Care from a Hearing Professional as a result of the referral. If more than one Hearing Professionals Group participated in the Hearing Referral Service, then the annual fee would be apportioned equally based on the number of Hearing Professionals affiliated with each Hearing Professionals Group. The Requestor further certified that it would implement a periodic reconciliation process (True-Up) to ensure that the annual fee paid by participating Hearing Professionals Groups would remain consistent with the operating costs of the Hearing Referral Service.
Safe harbor exception. The safe harbor exception to the AKS is afforded to those arrangements that precisely meet all of the conditions set forth in the safe harbor. Compliance with a safe harbor is voluntary, and arrangements that do not comply with a safe harbor are evaluated on a case-by-case basis. The OIG determined that the safe harbor for referral services is potentially applicable to the Proposed Arrangement because “remuneration” does not include any payment or exchange of anything of value between an individual or entity (participant) and another entity serving as a referral service (referral service), as long as all of the following conditions are met:
The referral service does not exclude as a participant in the referral service any individual or entity who meets the qualifications for participation;
Any payment the participant makes to the referral service is assessed equally against and collected equally from all participants and is based only on the cost of operating the referral service, and not on the volume or value of any referrals to or business otherwise generated by either party for the other party for which payment may be made in whole or in part under Medicare, Medicaid, or other Federal health care programs;
The referral service imposes no requirements on the manner in which the participant provides services to a referred person, except that the referral service may require that the participant charge the person referred at the same rate as it charges other persons not referred by the referral service, or that these services be furnished free of charge or at reduced charge.
The referral service makes five specific disclosures to each person seeking a referral, with each such disclosure maintained by the referral service in a written record certifying such disclosure and signed by either such person seeking a referral or by the individual making the disclosure on behalf of the referral service.
Based on the foregoing, the OIG concluded that the Proposed Arrangement would not generate prohibited remuneration under the federal AKS, and accordingly, the OIG would not impose administrative sanctions on Requestor in connection with the Proposed Arrangement under section 1128A(a)(7) of the Act.
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