OIG Advisory Opinion on Cancer Detection Reports: Key Insights
On May 20, the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services released Advisory Opinion 26-11. This opinion addressed a precision oncology company's practice of providing a no-cost supplementary cancer detection report for patients already undergoing blood-based colorectal cancer screening. The OIG determined that this practice does not violate federal Anti-Kickback Statute or laws against inducements to beneficiaries, as the benefits outweigh potential risks.
The company offers the only FDA-approved blood-based biomarker test for colorectal cancer. Although covered by Medicare, the test is not yet included in the U.S. Preventive Services Task Force guidelines because it received FDA approval after the last guideline update. This distinction highlights the lag between scientific advancement and regulatory inclusion, a challenge often faced by innovative healthcare companies.
In addition to the existing test, the company has developed an investigational test aiming to identify risks for multiple cancers using the same blood specimen used in colorectal cancer testing. Notably, this assay holds an FDA breakthrough device designation and targets various cancers that contribute significantly to cancer-related deaths in the U.S.
Patients who consent can receive a free report detailing results from the investigational test alongside their colorectal cancer screening outcomes. The company ensures physicians are not compensated for ordering these tests, with all information about the supplemental report shared through pre-approved, neutral-tone materials.
The arrangement remains valid until either the investigational test receives FDA approval or is covered by Medicare. The OIG concluded that while providing a free valuable service could typically influence patient choices under federal law, this particular arrangement is justified by the potential patient benefits and the lack of over-utilization risks or excessive costs to healthcare programs.
For healthcare companies, the OIG's advisory opinion underscores an openness to diagnostic offerings leveraging breakthrough technologies, provided strict criteria concerning marketing and provider engagement are met. This decision can guide companies contemplating similar ventures, emphasizing the importance of transparent information sharing, absence of consumer-targeted promotions, and no referral-dependent incentives.
This decision, although specific to the circumstances of this Requestor, offers insights to guide similar future undertakings. As always, professional regulatory advice is recommended to navigate specific compliance issues in this evolving field.