On May 1, 2026, the Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 26-09 (“AO 26-09”), which opines on a pediatric dental and orthodontic service provider’s (“Requestor’s”) proposal to offer free orthodontic treatment for one patient per year at each of Requestor’s three practice locations (the “Proposed Arrangement”).
How the Proposed Arrangement Would Work
Requestor’s treating providers could nominate existing patients to receive the free service (the patients may not nominate themselves). Each year, Requestor would select one recipient at each of its three practice locations based on clinical need (40%), financial hardship (40%) and community impact (20%). Community impact would be determined by factors such as foster care status or single-parent household status. Patients could be eligible regardless of their insurance status, and insured patients must show insurance denial of orthodontic treatment to be eligible.
Requestor made certain relevant certifications to the OIG:
- Requestor would not bill any federal health care programs for the free service.
- The Proposed Arrangement is solely intended to provide charitable care to underserved pediatric patients and to highlight the impact of orthodontic treatment on oral and mental health.
- Requestor would not promote the Proposed Arrangement in a manner intended to attract or induce new patients.
- Requestor would not publicize its selection of patients from its existing patient base or otherwise represent an ongoing opportunity for selection.
- Requestor would not advertise or send targeted messages regarding the free service. It may, however, publicly reference the Proposed Arrangement in a limited capacity, such as on its website or social media, for the sole purpose of highlighting the community service aspect of the free service and its positive impact on recipients.
- There would be no requirement or expectation that recipients of the free service would obtain any future services or have any future business relationship with Requestor.
OIG’s Analysis
As an initial matter, the Federal Anti-Kickback Statute (the “AKS”) would be implicated because Requestor would offer remuneration (free orthodontia) to patients who could self-refer to Requestor for other federally reimbursable services. Additionally, the Beneficiary Inducements Civil Monetary Penalty Law (the “CMP”) would be implicated because the Proposed Arrangement could influence beneficiaries to select Requestor for federally reimbursable services. Although the OIG noted its longstanding and continuing concerns with respect to free items or services that may lead to federally reimbursable items or services, the OIG concluded that the Proposed Arrangement posed sufficiently low risk under these laws, and it would not impose sanctions for the following reasons:
- The Proposed Arrangement reduces the risk of patient steering because the free service is only available to existing patients who have already selected Requestor for their dental care.
- The Proposed Arrangement is not likely to lead to inappropriate utilization or increased costs to federal health care programs because Requestor would not bill any federal health care program for the free service. Additionally, the eligibility criteria factors do not incentivize increased utilization of services, and patients would not be required to obtain any additional services from Requestor.
- The Proposed Arrangement has additional features that reduce its risk under the AKS, including: (i) only one patient per practice per year would receive the free service and (ii) Requestor would only make limited public reference to the free service for the sole purpose of highlighting the community service aspect of the free service and its positive impact on recipients. Of note, the OIG stated that it would likely reach a different conclusion where a provider publicizes the fact that it selects from among its patient population to receive free services, or that it selects recipients for free services on an ongoing basis, as such actions would present a higher risk of patient steering and unfair competition.
Practical Takeaways
The federal AKS applies not only to physicians, but also to dental and orthodontic care providers. AO 26-09 approves an arrangement to provide a limited scope of free services to underserved pediatric patients under strict guardrails intended to reduce the risk of AKS and CMP enforcement. As with all OIG advisory opinions, AO 26-09 is specific to the facts of the Requestor’s proposed arrangement and certifications; entities should consult with legal counsel to determine if and how this opinion may be relied upon to assess AKS and CMP risk of a proposed arrangement. For help in understanding the impact of this Advisory Opinion or guidance assessing AKS or CMP risk under other arrangements, please contact:
- Erin Drummy at 317-977-1414 or edrummy@hallrender.com;
- Michael Fiedler at (248) 457-7810 or mfiedler@hallrender.com; or
- Your primary Hall Render contact.
Special thanks to summer associate Matthew Moller for his assistance in the preparation of this article.
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.