Favorable Precision Oncology Advisory Opinion Imposes Limits on Supplemental Reports for Patients

On May 15, 2026, the U.S. Department of Health and Human Services, Office of Inspector General (OIG), issued a favorable advisory opinion, Advisory Opinion 26-11, analyzing an ongoing arrangement by a precision oncology company that offers a proprietary blood-based biomarker test for colorectal cancer (the CRC Screening Test) to provide consenting patients, including federal healthcare program beneficiaries, who receive the CRC Screening Test with a free supplemental report detailing the patient’s multicancer detection results. OIG concluded that the proposed arrangement implicates the federal Anti-Kickback Statute (AKS) and Beneficiary Inducement Statute (BIS) and does not fit within an available exception or safe harbor, but, based on certain key safeguards set forth below, presents sufficiently low risk of fraud and abuse. 

The Arrangement

The requestor offers, and performs at its laboratory, the CRC Screening Test, the first blood-based biomarker test approved by the U.S. Food & Drug Administration (FDA) for primary CRC screening. The CRC Screening Test is covered by Medicare once every three years for eligible patients and is ordered by a patient’s primary care provider.

The requestor has also developed an algorithmic analysis that identifies risk for multiple cancers (the MCD Test). The algorithm is part of an investigational test under development by the requester for submission to the FDA as an in vitro diagnostic medical device. For six of the cancer types covered by the MCD Test, there is currently no U.S. Preventative Services Task Force (USPSTF) recommended screening test due to lack of available screening tests where the benefits outweigh the harm. The MCD Test is run on the same blood sample used for the CRC Screening Test and is not separately reimbursable.

Under the ongoing arrangement, for consenting patients (including federal healthcare program enrollees), the requestor provides a supplemental report expressing the MCD Test results (the Supplemental Report) alongside the primary CRC Screening Test results at no additional charge. To be eligible for the Supplemental Report:

• The patient must have a valid order from an independent physician (not affiliated with the requestor) who will use the results in the patient’s care management.
• The ordering physician must opt in to receive results for cancers beyond CRC; and
• The patient must consent to participate in a data collection initiative to support the requestor’s FDA approval application for the MCD Test.

The requestor does not compensate physicians for ordering the CRC Screening Test or for opting in to receive the Supplemental Report. The Supplemental Report is available to any qualifying physician regardless of the volume or value of referrals. The requestor stated that it does not actively market the Supplemental Report to providers and does not engage in any direct-to-consumer advertising for the Supplemental Report. The arrangement will continue until the MCD Test receives FDA approval or Medicare coverage under a National Coverage Determination.

The Agency’s Analysis

OIG concluded that the Supplemental Report constitutes remuneration under both the AKS and the BIS in the form of a valuable service provided at no cost that could induce patients to select the CRC Screening Test and the requestor’s laboratory over alternative laboratories. Further, no AKS safe harbor applies, and the Preventive Care Exception to the BIS does not apply because neither the CRC Screening Test nor the MCD Test is currently listed in the USPSTF Guide to Clinical Preventive Services.

Nevertheless, OIG issued a favorable opinion based on three key findings:

1. Unlikely to Result in Overutilization or Inappropriate Utilization

   The Supplemental Report is available only to patients who already have a valid order for the CRC Screening Test. Because the MCD Test is run on the same blood sample as the CRC Screening Test and is not separately reimbursable, OIG concluded that providing the Supplemental Report does not increase costs to federal healthcare programs. While positive results could generate follow-up medical appointments, OIG found that any such appointments would be clinically driven and not inappropriately caused by the arrangement. OIG also noted the potential patient benefit of the Supplemental Report, particularly for the six cancer types for which no other USPSTF-recommended screening test exists.

2. Unlikely to Skew Clinical Decision-Making

   OIG found the arrangement unlikely to unduly influence healthcare providers’ ordering decisions given that physicians are not compensated for ordering the CRC Screening Test or opting in to receive the Supplemental Report, and there is no targeted marketing campaign, including marketing to providers, for the Supplemental Report.

3. Unlikely to Result in Inappropriate Steering or Unfair Competition
   
   Finally, OIG concluded that the Supplemental Report is unlikely to result in patient steering or unfair competition with respect to the CRC Screening Test because the requestor is the only laboratory that performs the CRC Screening Test, which is a proprietary test, and thus patients would have already selected the laboratory when they select the CRC Screening Test even in the absence of the arrangement. Further, for the six cancer types with no USPSTF-recommended screening test, OIG concluded that the patient benefit of obtaining the MCED Test results likely outweighs any competitive disadvantages. OIG also highlighted the importance of the requestor’s certification that it does not market or promote the availability of the Supplemental Report to providers or patients.

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Biotech companies and laboratories focused on precision medicine that are considering arrangements involving the provision of no-cost test results to patients or healthcare providers should carefully review the safeguards outlined by OIG in its related advisory opinions.