The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 26-11 (“Advisory Opinion”) on May 20, 2026. This favorable opinion concerns a precision oncology company (“Requestor”) providing free supplemental reports to patients based on its algorithmic analysis, which functions as a Multi-Cancer Detection Test (“Algorithmic Analysis”). Although OIG found that the Arrangement (defined below) implicates both the federal Anti-Kickback Statute (“AKS”) and the Beneficiary Inducements Civil Monetary Penalty Law (“CMP”), OIG approved the Arrangement, stating that the risk of fraud and abuse presented by the Arrangement is sufficiently low.
Background
The Requestor provides a proprietary blood-based biomarker test for colorectal cancer screening (“CRC Screening Test”). The CRC Screening Test is typically ordered by a patient’s primary care provider and is covered by Medicare once every three years for patients who meet the coverage requirements. For consenting patients, the Requestor runs the Algorithmic Analysis on the same blood sample used for the CRC Screening Test. The Requestor uses the results to provide a free supplemental report that includes a positive or negative result for each type of cancer (“Arrangement”).
Patients must meet the following requirements to be eligible for the Algorithmic Analysis:
- Patients must have a valid order for the CRC Screening Test from an independent physician who is not affiliated with Requestor and who will use the results in the management of the patient.
- The ordering physician must opt in to receive results for other cancers beyond colorectal cancer.
- The patient must sign a form consenting to receive the results of the Algorithmic Analysis and participate in a data collection initiative. The data collection initiative is intended to evaluate clinical utility and lend support for the Algorithmic Analysis’s application for U.S. Food and Drug Administration approval and future payor coverage.
Requestor made certain relevant certifications that helped the OIG arrive at a favorable ruling:
- Requestor does not actively market the supplemental report as a benefit to providers.
- Requestor does not participate in consumer advertising or promotional activities for the CRC Screening Test.
- Requestor has pre-approved materials, written in a neutral and objective tone, that describe the function and content of the supplemental report. This ensures physicians can make informed decisions about ordering the CRC Screening Test and electing to receive the supplemental report.
- Requestor instructs potential ordering physicians not to issue social media posts related to the free supplemental report.
OIG’s Analysis
In its Advisory Opinion, OIG stated that AKS and CMP are implicated because the free supplemental report is remuneration in the form of a valuable service (as evidenced by the fact that Requestor hopes for it to become reimbursable in the future) that Requestor provides at no cost to patients. Additionally, AKS and CMP are implicated because the free supplemental report could induce a patient to select Requestor’s CRC Screening Test and laboratory over others. It is also possible that the ordering physician could have a billable follow-up visit to discuss the results of the CRC Screening Test and supplemental report. Although OIG has longstanding concerns with free services that may lead to federally reimbursable services, OIG found that the Arrangement posed sufficiently low risk for the following reasons:
- The CRC Screening Test is reimbursable by Medicare for eligible patients once every three years, and the Algorithmic Analysis is run on the same blood sample used for the CRC Screening Test. Therefore, providing the supplemental report does not result in increased cost to Federal health care programs. OIG further stated that the benefit of early detection outweighs the burden of potential fraud and abuse presented by the Arrangement. Although the results of the supplemental report could result in future reimbursable services, the results would be based on clinical information and would not be inappropriately caused by the Arrangement.
- The Arrangement is unlikely to skew clinical decision-making because of the neutral pre-approved materials available to physicians about the supplemental report; further, physicians are not compensated for opting in or receiving the supplemental report.
- The Arrangement is unlikely to result in patient steering or unfair competition. Requestor’s laboratory is the only laboratory that performs the CRC Screening Test that can be used for the Algorithmic Analysis. Therefore, any time a patient selects the CRC Screening Test, the patient also automatically selects Requestor’s laboratory for analysis of the test. The OIG emphasizes that Requestor does not actively market the supplemental report as a benefit to providers, nor does Requestor engage in direct-to-consumer advertising or promotional activities.
Practical Takeaways
Although OIG found that AKS and CMP are implicated by the Arrangement, OIG stated that it will not impose sanctions on Requestor for providing the free supplemental report to consenting patients who participate in the CRC Screening Test. As with all OIG Advisory Opinions, this Advisory Opinion is specific to the facts of the Requestor’s Arrangement. Entities seeking to establish similar programs to that of the Arrangement should consult with qualified counsel.
For more information about this Advisory Opinion or the topic in general, please contact:
- Jennifer Skeels at 317-977-1497 or jskeels@hallrender.com;
- Alyssa James at 317-429-3640 or ajames@hallrender.com; or
- Your primary Hall Render contact.
Special thanks to Matt Moller, Summer Associate, for his assistance in the preparation of this alert.
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.
