Diabetic Shoe Company Agrees to Pay $5.5M to Resolve False Claims Act Allegations Regarding “Custom” Shoe Inserts

Foot Care Store, Inc. d/b/a Dia-Foot (Dia-Foot), a diabetic shoe company based in Wellington, Florida, and its President and CEO Robert Gaynor, have agreed to pay $5,538,338 to settle allegations that the company sold custom diabetic shoe inserts that were not actually custom-fabricated in accordance with Medicare standards. The agreement is part of a civil settlement that resolves claims brought under the False Claims Act. The United States alleged that between 2013 and 2018, Dia-Foot sold diabetic shoe inserts to customers nationwide, representing that many of those inserts were custom-made for an individual’s foot, when the inserts were actually made using generic foot models. The inserts were dispensed to diabetic patients who had a prescription from a healthcare provider and who believed they were getting a custom product. According to the government, despite fabricating the inserts using generic models, Dia-Foot billed Medicare and Medicaid for the custom version, or sold the inserts to other providers who then billed government healthcare programs for custom inserts. This allowed Dia-Foot to produce and sell more inserts and increase profits by cutting corners. The government also alleged that Dia-Foot advertised to customers that it was proud to be Medicare-compliant and had received Medicare approval for its custom diabetic shoe inserts, even though Dia-Foot received the Medicare approvals based on false information.

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