News Briefs: May 10, 2021

Wilson Asfora, M.D., a neurosurgeon in Sioux Falls, South Dakota, and two of his medical device distributorships, Medical Designs LLC and Sicage LLC, have agreed to pay $4.4 million to settle false claims allegations, the Department of Justice said May 4.[1] The settlement resolves allegations that for a decade Asfora accepted illegal payments to use certain medical devices and submitted claims for medically unnecessary surgeries. The case also has an open payments program angle. According to the settlement, Asfora and his wife owned Carnaval Brazilian Grill, a restaurant in Sioux Falls. Asfora asked sales personnel from Medtronic USA Inc., a medical device company, to pay for events at the restaurants. The sales personnel were marketing SynchroMed II intrathecal infusion pumps to Asfora and other doctors in South Dakota. “Those events often featured lavish meals and alcohol, with multicourse tasting menus and wines paired to each course, and were held in an open area of the restaurant not conducive to medical discussions,” DOJ alleged. Medtronic sales personnel shelled out $87,000 on 130 events at Asfora’s restaurants. According to the settlement, DOJ alleged that “Asfora knowingly and willfully solicited and received kickbacks in the form of payments to his restaurant in return for his use of Medtronic’s SynchroMed II intrathecal infusion pumps, in violation of the [Anti-Kickback Statute]. Asfora also implanted the SynchroMed II intrathecal infusion pumps when the applicable drug did not need to be administered by an implanted infusion pump, resulting in non-reimbursable claims for medically unnecessary items and services.” The settlement added that DOJ alleges Sicage and Medical Designs failed to report to CMS payments and transfers of value to Asfora and his wife as required under the open payments program. The defendants did not admit liability.

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