Health Law Daily Wrap Up, ANTI-KICKBACK PROHIBITION—OIG ADVISORY OPINIONS: Low risk of fraud, abuse in arrangement providing free supplemental cancer screening report, (May 26, 2026)

By Patricia K. Ruiz, J.D.

The agency would not impose sanctions despite remuneration concerns.

The Office of Inspector General (OIG) has issued a favorable advisory opinion addressing a precision oncology company’s provision of a no-cost supplemental cancer screening report to patients undergoing a covered colorectal cancer test. Although the agency found the arrangement implicates both the federal Anti-Kickback Statute (AKS)and the beneficiary inducements civil monetary penalty (CMP), it concluded that administrative sanctions are not warranted. The opinion highlights specific safeguards and factual circumstances that led the OIG to determine the arrangement presents a sufficiently low risk of fraud and abuse (OIG Advisory Opinion, No. 26-11 (May 15, 2026)).

Arrangement. The OIG analyzed an arrangement under which the requestor, a laboratory offering a proprietary blood-based colorectal cancer (CRC) screening test, provides consenting patients with a free supplemental report derived from an additional algorithmic analysis performed on the same blood sample. The CRC screening test is Medicare-covered once every three years for eligible patients, while the supplemental report, based on an investigational multi-cancer detection (MCD) test, identifies risks for multiple cancer types but is not independently reimbursable.

The supplemental report is offered only to patients who meet specific criteria, including having a valid physician order for the CRC screening test, physician opt-in for additional results, and patient consent to receive the report and participate in a data collection initiative. The data collection component involves periodic requests for patients’ medical information over up to five years to support evaluation of clinical utility and future regulatory approval efforts.

Low risk of fraud and abuse. The OIG concluded that the arrangement involves “remuneration” in the form of a valuable service provided at no cost, which could potentially implicate both the AKS and the beneficiary inducements CMP. The agency further determined that no safe harbor applies and that the preventive care exception to the CMP is unavailable because neither the CRC screening test nor the MCD test is currently included in the U.S. Preventive Services Task Force recommendations. Despite these findings, the OIG declined to impose administrative sanctions under either statutory framework. The agency emphasized several factors supporting its determination that the arrangement presents a low risk of fraud and abuse.

Overutilization, inappropriate utilization. First, the OIG found the arrangement unlikely to drive overutilization or inappropriate utilization. The supplemental report is available only to patients already eligible for the CRC screening test and does not require additional specimens or testing beyond the existing blood draw. Because the MCD analysis is performed on the same sample and is not separately reimbursed, the arrangement does not increase costs to federal health care programs.

Distortion of clinical decision-making. Second, the OIG concluded the arrangement is unlikely to distort clinical decision-making. The laboratory certified that physicians receive no compensation tied to ordering the test or opting into the supplemental report, and that information about the report is conveyed through neutral, pre-approved materials rather than targeted or incentivized marketing. The agency also noted that multiple clinical considerations—such as patient eligibility, test performance, and follow-up requirements—inform providers’ selection of screening modalities.

Inappropriate steering, unfair competition. Third, the OIG determined that the arrangement is unlikely to result in inappropriate steering or unfair competition. Because the requestor is the only laboratory offering the CRC screening test at issue, patients selecting the test would necessarily use the requestor’s services regardless of the supplemental report. Additionally, for several cancers included in the supplemental report, no alternative USPSTF-recommended screening tests exist, limiting potential competitive harm. The agency also highlighted safeguards related to marketing practices. The requestor certified that it does not actively promote the supplemental report as a benefit, does not engage in direct-to-consumer advertising for it, and monitors for third-party promotion to mitigate inappropriate marketing.

No sanctions would be imposed. Based on these factors, the OIG concluded that although the arrangement would generate prohibited remuneration if the requisite intent were present, it would not impose sanctions under the AKS or the Beneficiary Inducements CMP. The agency reiterated that its determination is limited to the specific facts presented and applies only to the requestor’s arrangement.

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