HHS OIG Advisory Opinion 26-01: Commercial‑Only Cost‑Sharing Waivers for a New Colorectal Screening Test Do Not Trigger AKS or Beneficiary Inducement Risk

Key Takeaways

• Coverage and beneficiary class drive the outcome. Because the manufacturer’s colorectal screening test currently has minimal federal program coverage and the waiver is limited to commercially insured patients, OIG concluded that the proposed cost sharing does not involve AKS or Beneficiary Inducements CMP remuneration.
• Not all carve‑outs are created equal. Although OIG typically views carve‑out structures with suspicion (fearing that such structures may disguise remuneration for federal healthcare program business through the payment of amounts purportedly related to non-federal healthcare program business), OIG distinguished this program based on the test’s limited federal coverage, a commercial‑only design, and the absence of prescriber payments or cost‑shifting to federal programs.
• Future coverage changes could flip the risk profile. OIG expressly warned that if federal programs begin covering the test with beneficiary cost‑sharing obligations, waiving that cost‑sharing could present new AKS and Beneficiary Inducements CMP concerns and lead to a different conclusion.

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 26‑01 (“AO 26‑01” or the “Opinion”) addressing a colorectal cancer screening test manufacturer’s proposal to waive any applicable cost sharing for certain commercially insured patients who receive a test manufactured and performed by the manufacturer (the “Proposed Arrangement”). OIG concluded that the Proposed Arrangement would not generate prohibited remuneration under either the federal Anti-Kickback Statute (“AKS”) or the Beneficiary Inducements civil monetary penalty (“CMP”) statute.

The Advisory Opinion

In AO 26‑01, OIG considered a request from a manufacturer that produces and performs an FDA‑approved stool‑based RNA colorectal cancer screening test for adults age 45 and older at average risk. The manufacturer certified that the test is the first and only FDA‑approved, non‑invasive, stool‑based RNA colorectal cancer screening test and that no other laboratory performs it. Although the U.S. Preventive Services Task Force (“USPSTF”) gives colorectal cancer screening an overall grade A or B recommendation for most adults aged 45-75, the USPSTF colorectal cancer screening guideline — which has not been updated since 2021 — identifies other stool‑based and imaging tests and does not yet include this new RNA‑based test. The manufacturer told OIG it plans to seek inclusion of stool‑based RNA tests in the USPSTF recommendation when the guidelines are next updated.

Because commercial health insurers must cover USPSTF grade A and B preventive services without cost‑sharing, the manufacturer expects that some commercial plans will impose cost‑sharing — typically between $100 and $135 — for the test, while not imposing cost‑sharing on competing tests that are specifically named in the USPSTF recommendation. By contrast, federal coverage is minimal: no federal healthcare program covers the test except fee‑for‑service Medicaid in 16 states and certain Medicaid managed care organizations, and the manufacturer certified that most state Medicaid programs do not require cost‑sharing for laboratory tests. Where Medicaid or an MMCO does require cost‑sharing, the manufacturer is either prohibited by contract from collecting it or already waives it under a separate financial assistance policy that was not at issue in the opinion.

Under the Proposed Arrangement, the manufacturer would waive any applicable cost‑sharing for “eligible patients,” defined as commercially insured individuals who receive the test and who do not otherwise qualify under the manufacturer’s financial assistance policy. The waiver would apply uniformly to all eligible patients, regardless of which provider ordered the test, and would not be tied to any other healthcare items or services. The manufacturer certified that it would comply with applicable billing rules, would not shift the costs of the waivers to any federal healthcare program, and would not offer or pay any remuneration to ordering prescribers in connection with the program. The arrangement would continue only until the USPSTF updates its colorectal cancer screening recommendations to include the test, at which point the manufacturer expects commercial plans to cover it without cost‑sharing and the waiver program would become unnecessary.

OIG concluded that, on these facts, the Proposed Arrangement would not generate prohibited remuneration under the AKS or Beneficiary Inducements CMP and that it would not impose administrative sanctions. OIG reasoned that the AKS is not implicated because there is no remuneration offered to induce the purchase of items or services reimbursable by a federal healthcare program, and the Beneficiary Inducements CMP is not implicated because there is no offer or transfer of remuneration to Medicare or state program enrollees that could influence their selection of a provider or service.

Analysis

OIG has addressed a similar colorectal screening-related incentive in Advisory Opinion 23‑03, which involved prepaid cards for returning a stool‑based DNA kit rather than waiving commercial cost‑sharing for the test itself.

In AO 23‑03, the requestors proposed providing a prepaid card of up to $75 to patients, including Medicare and state program beneficiaries, who returned a colorectal screening kit. OIG treated the card as remuneration that implicated both the Beneficiary Inducements CMP and the AKS. OIG then found that the arrangement fit within the Beneficiary Inducements CMP “Preventive Care Exception” (in part because the test is a USPSTF‑recommended preventive screening) and that, given tight safeguards (including remuneration given at most once every 36 months, and limited promotion of the card to patients or providers), it posed minimal AKS risk even though the test is widely reimbursable by federal programs.

In AO 26‑01, OIG takes a different path. The stool‑based RNA test is not yet included in the USPSTF colorectal screening recommendation and is covered only in narrow state Medicaid settings. The waiver applies only to commercially insured patients, and the manufacturer is already prohibited or contractually constrained from collecting Medicaid cost‑sharing. Therefore, OIG concludes the arrangement “would not generate prohibited remuneration” under either statute, because there is effectively no federal benefit to influence and no remuneration offered to Medicare or state program enrollees. OIG distinguishes this from problematic “carve‑out” models (that may disguise remuneration for federal healthcare program business through the payment of amounts purportedly related to non-federal healthcare program business) and cautions that if federal coverage expands and beneficiaries owe cost‑sharing for the test, waiving that cost‑sharing could raise different issues.

Together, the opinions show that:

1. when federal programs already cover a USPSTF‑recommended test, OIG is likely to treat patient incentives as remuneration and then ask whether a preventive‑care exception and strong safeguards can contain risk (23‑03); and
2. when a new test sits largely outside federal coverage and a program is confined to commercial patients, OIG may instead conclude that the cost‑sharing relief does not create AKS/CMP remuneration in the first place (26‑01).

Conclusion

Advisory Opinions 26‑01 and 23‑03 show that OIG’s answer depends heavily on coverage and who receives the benefit. When a screening test is already USPSTF‑recommended and widely covered by federal programs, OIG treats patient incentives as remuneration and then looks to narrow exceptions and safeguards to manage risk. When a new test has minimal federal coverage and waivers are limited to commercially insured patients, OIG may instead conclude there is no AKS or Beneficiary Inducements CMP remuneration at all — but with a clear warning that expanded federal coverage could change that result. Organizations should work closely with experienced counsel to structure, monitor, and periodically re‑evaluate any patient‑facing financial relief programs. For more information on AO 26-01 or related issues, please contact AGG Healthcare partners Jason Bring and Jerad Rissler.