Neurosurgeon Wilson Asfora, MD of Sioux Falls, South Dakota, and two medical device distributorships that he owns, Medical Designs LLC and Sicage LLC, have agreed to pay $4.4 million to resolve False Claims Act allegations relating to illegal payments to Asfora to induce the use of certain medical devices, in violation of the Anti-Kickback Statute, as well as claims for medically unnecessary surgeries. Medical Designs and Sicage agreed to pay an additional $100,000 in penalties to settle allegations that they violated the Open Payments Program by failing to report to the Centers for Medicare & Medicaid Services (CMS) Asfora’s ownership interests and payments made to Asfora. Under the terms of the settlement agreement, Asfora, Medical Designs, and Sicage each will be excluded from participation in federal healthcare programs for a period of six years.
The settlement resolves allegations that over the course of nearly a decade, Asfora, Medical Designs, and Sicage knowingly and willfully engaged in three kickback schemes to allow Asfora to profit from his use of over a dozen devices in his medical procedures. In addition, the settlement resolves allegations that Asfora knowingly submitted false claims to federal healthcare programs for medically unnecessary procedures using the devices in which he had a financial interest.
This settlement also resolves Medical Designs’ and Sicage’s liability under CMS’ Open Payments Program, which was established by the Affordable Care Act and requires medical device companies to disclose to CMS physician ownership interests and certain payments or other transfers of value to a physician.
