Evoke Neuroscience, Inc., of New York will pay $225,000, and its co-founder/CEO David Hagedorn, Ph.D., of Jacksonville, North Carolina, will pay $220,000, to resolve alleged False Claims Act violations for causing the submission of false claims to Medicare by promoting false billing codes for a “brain health” device. The settlement was announced today by United States Attorney Jacqueline C. Romero of the Eastern District of Pennsylvania.

Dr. Hagedorn, a psychologist, co-founded Evoke as a startup in approximately 2009. Evoke sold its “eVox” device primarily to general practitioner physicians. The device involves a 20-60 minute in-office application of a helmet with electrodes that purports to test certain brain functions. During Evoke’s initial startup phase, Dr. Hagedorn selected six billing codes for the eVox device.

The settlement resolves allegations that from January 1, 2013 through May 31, 2021, Evoke and Dr. Hagedorn promoted to health care providers six false billing codes for Medicare reimbursement for the eVox device. By promoting false billing codes to health care providers, Evoke and Dr. Hagedorn caused the providers to submit false claims to Medicare. The United States contends that none of the codes were ever appropriate for the eVox device as applied because the codes generally require a longer testing time, a specialized environment (e.g., soundproof/dark room), and can only be administered by a relevant specialist. Moreover, the United States contends that...

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