Health Law Daily Wrap Up, ANTI-KICKBACK PROHIBITION—OIG ADVISORY OPINIONS: HHS-OIG green lights proposal to waive cost-sharing for cancer test, (Jan 23, 2026)

By Sherri M. Schroeder, J.D.

The test is “the first and only FDA-approved, non-invasive, stool-based RNA colorectal cancer screening test available to patients who are age 45 years or older and at average risk for developing colorectal cancer.”

HHS’s Office of Inspector General (HHS-OIG) has issued a favorable advisory opinion to the manufacturer of a colorectal cancer screening test who wants to waive any applicable cost-sharing amounts for commercially insured individuals who receive the test and who do not otherwise qualify for the manufacturer’s financial assistance policy. According to the opinion, the test is “the first and only FDA-approved, non-invasive, stool-based RNA colorectal cancer screening test available to patients who are age 45 years or older and at average risk for developing colorectal cancer.” Per HHS-OIG, the proposed arrangement would not generate prohibited remuneration under either the Federal anti-kickbacksStatute or the Beneficiary Inducements civil monetary penalty (CMP) provisions of the Social Security Act (the Act) or the exclusion authority of the Act (OIG Advisory Opinion, No. 26-01 (Jan. 13, 2026)).

Proposed arrangement. Under the proposed arrangement, the test manufacturer, who also is the only laboratory that performs the test in question, would waive any applicable cost-sharing amounts for commercially insured individuals who receive the test and who do not otherwise qualify for the manufacturer’s financial assistance policy. Such a waiver would apply uniformly to all eligible patients regardless of which provider orders the test and would not be tied to any other health care item or service. The manufacturer would also comply with all applicable federal and state billing requirements, would not shift any costs associated with the proposed arrangement onto any federal health care program, and would not offer or pay any remuneration to any ordering prescriber in connection with the proposed arrangement. The arrangement would continue until the U.S. Preventive Services Task Force (USPSTF) updates its colorectal cancer screening recommendations to include the test, regardless of what grade the test is assigned; the manufacturer also certified that it would seek inclusion of stool-based RNA colorectal cancer screening tests in the USPSTF’s next update to its guidelines.

Statutes. According to the Advisory Opinion, the Federal anti-kickback statute “would not be implicated because there would be no remuneration offered or given to induce any patient to purchase an item or service reimbursable by a Federal health care program.” Additionally, the Beneficiary Inducements CMP would not be implicated “because there would be no offer or transfer of remuneration to any Medicare or State health care program enrollee that could influence such individual to order or receive the Test or other items or services from” the manufacturer. While noting that the manufacturer would not offer or pay any remuneration to any ordering prescriber in connection with the proposed arrangement, the HHS-OIG also noted that they had previously given the opinion that offering a free test could confer value to a prescriber by enabling them to offer a service at no cost to them or their patients—”which may create an opportunity for providers to bill for other services.” However, here, “since the remuneration would be offered only to commercially insured patients, and any additional services also would be billed to commercial insurers, the opportunity for a prescriber to earn a fee through the Proposed Arrangement does not implicate the Federal anti-kickback statute.”

The advisory opinion also noted that although some of the commercially insured individuals could have federal health care program coverage as their secondary insurance, the manufacturer certified it would not bill federal health care programs in that scenario. Even if it did, the HHS-OIG stated that the federal health care program likely would deny coverage since the test is not currently covered by any federal health care programs except for a few state fee-for-service Medicaid programs. “Even in this circumstance,” opined the HHS-OIG, “the Federal anti-kickback statute would not be implicated because the cost-sharing waiver would not be remuneration given to induce the purchase of an item or service reimbursable by a federal health care program, nor would the Beneficiary Inducements CMP be implicated because there would be no offer or transfer of remuneration to any Medicare or State health care program enrollee that could influence such individual to order or receive the Test or other items or services for which payment might be made by Medicare or a State health care program from [the manufacturer].”

The HHS-OIG also took care to distinguish the proposed arrangement from other arrangements that “carve out” federal health care program business, which may implicate or violate the federal anti-kickback statute by disguising remuneration for federal health care program business through the payment of amounts purportedly related to non-federal health care program business. “[S]uch concerns are not present here because of the circumstances described above combined with the fact that [the manufacturer] would not offer any pay or remuneration to any ordering prescriber in connection with the Proposed Arrangement,” stated HHS-OIG.

Limitations. The opinion notes that it is limited in scope to the proposed arrangement, among other limitations. It cannot be relied upon by anyone other than the manufacturer, with no applicability to other arrangements or people. It cannot be introduced into evidence by anyone other than the manufacturer to prove they did not violate the stated provisions of the Act.

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