OIG Greenlights Concierge Program Refund Arrangement
7/1/2026
On May 22, 2026, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued a favorable advisory opinion regarding an orthopedic surgeon’s proposed warranty program.
The surgeon proposes to offer a concierge program in which patients could elect to pay for certain non-covered services and products that would improve surgical recovery and outcomes. Under the proposed arrangement, the surgeon would warrant that, if a patient substantially complies with the concierge program, the patient would not require revision surgery within two years of the initial surgery. If revision surgery is nevertheless required, the surgeon would refund the concierge program fees paid in connection with the initial surgery.
The proposed arrangement implicates the federal Anti-Kickback Statute (AKS) because the surgeon would be offering patients the possibility of a refund of concierge fees, which could induce patients to choose the surgeon for surgical services reimbursable by federal health care programs. However, the OIG concluded that the refund would satisfy the warranty safe harbor under the AKS, including the requirements that the surgeon and patients report and disclose the refund and that the surgeon does not condition the refund on the patients’ exclusive use of, or minimum purchase of, any of the surgeon’s items or services.
Related Practices: Healthcare Law
Related Attorney: Joseph M. Gorrell, Edward Hilzenrath
Related Industry: Healthcare
