On May 20, 2026, the Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable opinion, AO 26-11, regarding an arrangement in which a precision oncology company (“Requestor”) offers eligible patients undergoing a colorectal cancer screening test (“CRC Screening Test”) a free supplemental report (“Supplemental Report”) to identify risk of other cancer types (the “Arrangement”). Although the Arrangement could generate prohibited remuneration under the Beneficiary Inducements Civil Monetary Penalty Law (“CMP”) and the federal Anti-Kickback Statute (“AKS”) if the requisite intent were present, the OIG concluded that it would not impose administrative sanctions on the Requestor with regard to the Arrangement.
Arrangement Details
For eligible patients, the Requestor provides a Supplemental Report in addition to the CRC Screening Test results ordered by the provider using the same blood sample. Eligibility is based on three factors: (1) the patient must have a valid CRC Screening Test order from a non-Requestor provider; (2) the ordering provider must opt-in to receive Supplemental Report results; and (3) the patient must consent to receive the Supplemental Report and to participate in data collection that is used to evaluate clinical utility for FDA authorization.
OIG’s Analysis
The OIG acknowledged that the Arrangement would implicate the AKS because the Requestor would offer remuneration (the free Supplemental Report) that could induce patients to receive CRC Screening Tests from the Requestor over other laboratories, and ordering providers may conduct federally reimbursable follow-up visits. Importantly, there is no applicable safe harbor, and the OIG noted “longstanding and continuing concerns regarding the provision of free items or services by individuals and entities to providers and patients that could lead to the ordering and provision of an item or service payable by Federal health care programs.”
The OIG also noted that the Arrangement would implicate the CMP and that the Preventive Care Exception would not apply because the tests and methods used in the Arrangement are not listed in the U.S. Preventive Services Task Force (“USPSTF”) Guide.
Despite AKS and CMP implications, the OIG stated that it would not impose sanctions because the Arrangement is unlikely to (1) result in overutilization or inappropriate utilization; (2) skew clinical decision-making; or (3) inappropriately result in steering or unfair competition.
- With respect to utilization, the OIG noted that the Supplemental Report is unlikely to increase Federal health care spending because it is only available for patients who are referred from a non-Requestor physician and who are already undergoing the CRC Screening Test – which is reimbursable once every 3 years. Further, the additional test that results in the Supplemental Report is not reimbursable and is performed on the same blood sample taken for the CRC Screening Test. The OIG acknowledged the test’s capacity to provide critical health information and that any additional medical care based on the Supplemental Report would stem from legitimate medical need.
- The OIG’s analysis regarding clinical decision-making was influenced by various Requestor certifications: “(i) physicians are not compensated for ordering the CRC Screening Test or for opting in to receiving the Supplemental Report; (ii) there is no targeted marketing campaign for the Supplemental Report; (iii) it does not market the Supplemental Report as a remunerative benefit to providers; and (iv) it makes information about the Supplemental Report available to physicians only through certain pre-approved materials that are written in a neutral and objective tone.” Additionally, the Requestor discloses limitations regarding the test’s efficacy in its marketing and educational materials.
- With respect to steering or unfair competition, the Requestor’s laboratory is the only one that performs the CRC Screening Test – which means that a patient’s election to undergo the test results in the patient selecting the Requestor’s laboratory, regardless of the Arrangement. Further, because there are currently no USPSTF-recommended screening tests for various types of cancers included in the Supplemental Report, there is limited risk that other laboratories would be disadvantaged by the Arrangement and “the potential disadvantage is likely outweighed by the potential benefit of the Arrangement.” Patient steering in this context is also limited by virtue of the Requestor (i) “not actively marketing the Supplemental Report as a benefit to providers” and (ii) not “engag[ing] in direct-to-consumer advertising or promotional activities for the Supplemental Report.”
Practical Takeaways
AO 26-11 approves an arrangement for a precision oncology company to offer a free additional cancer screening report to eligible patients who are already undergoing colorectal screening tests. Recognizing the critical impact of cancer screening, the OIG’s green light on a free supplemental report underscores the ability of providers to innovate and drive meaningful benefits to patients when careful measures are taken to prevent fraud and abuse.
The OIG relied heavily on the Requestor’s certifications that providers would not be compensated for participation, that marketing would remain neutral and limited and that providers and patients must affirmatively opt in. AO 26-11 reinforces that careful attention to marketing, compensation and participation requirements can significantly reduce compliance concerns under the AKS and CMP.
As with all OIG advisory opinions, AO 26-11 is specific to the Requestor’s 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 Compliance Advisor Melissa La Motta for her 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 give legal advice outside of an attorney-client relationship.
