Integrity Agreement for Device Company in Kickback Scheme

The HHS Office of Inspector has posted a corporate integrity agreement between the government and Minneapolis-based Cardiovascular Systems Inc. (CSI) that follows an $8 million fine the company paid to resolve alleged illegal kickbacks to induce physicians to use its medical devices. The government alleges that CSI violated the False Claims Act by providing marketing and other practice development services to physicians utilizing CSI’s devices to perform atherectomies, which are procedures that clear blockages restricting blood circulation in arteries. It says “CSI developed and distributed marketing materials to promote physicians utilizing CSI’s devices to referring physicians; coordinated meetings between utilizing physicians and referring physicians; and developed and implemented business expansion plans for utilizing physicians.” The corporate integrity agreement requires the company to engage in significant compliance efforts over the next five years, including engaging an independent review organization.