OIG Issues Favorable Advisory Opinion on Cost-Sharing Waivers for Commercially Insured Patients
3/1/2026
On January 13, 2026, the United States Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 26-01, approving a proposal by a manufacturer of a screening test for colorectal cancer to waive any cost-sharing obligations for commercially insured patients, concluding that the proposal would not violate the Federal Anti-Kickback Statute (AKS) or the Beneficiary Inducements Civil Monetary Penalty (CMP) provisions.
Although colorectal cancer screening tests are recommended by the U.S. Preventive Services Task Force (USPSTF), the manufacturer’s specific test is not yet included in its recommendations. As a result, many commercial insurers impose cost-sharing on patients who receive the test, while similar tests included in the USPSTF recommendations are covered without cost-sharing. Under the proposed arrangement, the manufacturer would waive cost-sharing for all eligible commercially insured patients who receive the test and do not otherwise qualify for its financial assistance program. The waiver would apply uniformly and would not be tied to other healthcare items or services. The manufacturer certified it would not shift any related costs to Federal health care programs. The proposed arrangement would end once the USPSTF updates its recommendations to include the test.
Related Practices: Healthcare Law
Related Attorney: Carol Grelecki, Edward J. Yun, Vanessa Coleman
Related Industry: Healthcare
