US Attorney for the Western District of Michigan Mark Totten announced that Derek Lado, D.O., and his Grand Rapids practice, Elite Medical Spine & Musculoskeletal Center PLLC (Elite), have agreed to pay $135,871.84 to resolve allegations that they violated the False Claims Act by using foreign, unapproved Botox to treat Medicare beneficiaries and then billing Medicare for those services. The United States alleged that Dr. Lado and Elite treated patients with Botox (onabotulinumtoxinA), a drug administered by injection that the U.S. Food and Drug Administration (FDA) has approved for a variety of treatments. However, beginning in August 2018, Dr. Lado and Elite began to purchase and use foreign, unapproved onabotulinumtoxinA for these treatments in order to cut costs. Government officials seized numerous packages of the foreign, unapproved drugs en route to Elite, and they warned the practice that it was importing adulterated and misbranded drugs. Despite these warnings and Medicare rules that the program denies coverage of drugs that have not received approval from the FDA, Dr. Lado knowingly used these foreign, unapproved drugs to treat Medicare beneficiaries and billed Medicare for those services.
