In a recent Advisory Opinion (No. 26-01), the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) concluded that waiving cost sharing for certain commercially insured patients who receive a cancer screening test is permissible under the federal Anti-Kickback Statute.
The opinion pertains to a clinical laboratory test that screens for colorectal cancer and was approved by the U.S. Food and Drug Administration (FDA). The manufacturer certified that the test was the only FDA-approved, non-invasive, stool-based RNA test for colorectal cancer screening and the manufacturer had the only lab that performed the test. Also relevant is that commercial health insurers are required to cover (without cost sharing) preventative services with an “A” or “B” rating from the U.S. Preventative Services Task Force (USPSTF), but this specific test has not yet been approved by the USPSTF. As such, commercial insurers are likely to impose cost-sharing for this test, while similar competing tests approved by USPSTF are covered at no cost to the patient.
The manufacturer proposed to waive the cost-sharing amounts for commercially insured individuals who receive the test and do not otherwise qualify for the manufacturer’s financial assistance policy. This cost-sharing waiver would apply uniformly to all patients who receive the test, regardless of which provider orders the test or any other healthcare items or services that the patient may receive. The manufacturer certified that it would comply with all federal and state billing requirements and would not shift costs onto any federal healthcare program. The manufacturer also certified that no federal program currently covers the test. Therefore, OIG concluded that the proposal would not implicate the federal Anti-Kickback Statute because there would be no remuneration offered or given to induce patients to purchase an item or service that is reimbursable by a federal program.
Importantly, OIG acknowledged that this proposal is distinct from arrangements that attempt to “carve out” federal program patients. OIG has longstanding concerns about arrangements that carve out federal programs and disguise kickbacks through payments related to non-federal programs. This concern was not present in the case at hand because there would be no remuneration offered or paid to the providers who order the test.
Sign up to receive Rivkin Rounds at www.RivkinRounds.com.