A favorite question the last five or ten years - if CMS pays you for one test (let's say CRC screening) can the lab provide an additional report (let's say kidney cancer screening)? Does it imply Anti Kickback Statute concerns?
See an article on June 10, 2026, at National Law Review, that OIG's viewpoint is favorable with terms and conditions.
Find the 9-page decision - issued May 15 - online here:
https://oig.hhs.gov/documents/advisory-opinions/11669/AO-26-11.pdf
I'm not a lawyer, neither is Chat GPT, but here's its mini summary.
- OIG Advisory Opinion 26-11 blesses, narrowly, an arrangement in which a Medicare-covered blood-based CRC screening test is accompanied by a free supplemental multi-cancer detection report generated from the same blood sample.
- OIG found both AKS and Beneficiary Inducement CMP risk: the free report is valuable remuneration that could steer patients toward the company’s CRC test/lab and could generate follow-up physician visits. Still, OIG would not sanction because the risk was low: the patient already needed an independent physician order for the covered CRC test; no extra blood draw or Medicare payment was triggered; physicians were not paid; the company used neutral, limited educational materials; and several included cancers lack USPSTF-recommended screening options.
- Guardrails/failure points: this is requester-specific, fact-specific, and non-precedential. It could fail if facts change, if the MCD test becomes FDA-approved/covered, if marketing becomes promotional or DTC, if physicians are rewarded, if extra reimbursed services are induced, or if competing labs are disadvantaged.
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Sidebar: Longer AI article.