In an advisory opinion posted June 13 (Advisory Opinion 13-03), the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) stated that a laboratory services leasing arrangement between an independent clinical laboratory and physician practices could potentially violate the Anti-Kickback Statute (AKS) even if the leased laboratories did not serve federal health care patients. The OIG stated that arrangements that carve out federal health care programs “implicate, and may violate, the Anti-Kickback Statute by disguising remuneration for federal health care program business through the payments of amounts purportedly related to non-federal health care program business.”
The advisory opinion noted the OIG’s “long-standing concern” about arrangements where parties exclude federal health care referrals or business from “otherwise questionable financial arrangements.” This is consistent with previous OIG advisory opinions, which have held that carving out Medicare and Medicaid patients from a business model does not insulate the arrangement from AKS liability.
The Anti-Kickback Statute
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