Steven L. Mendelsohn, a rheumatologist based in Charlotte, North Carolina, has agreed to pay $549,554.26 to settle allegations that he submitted false claims to Medicare for arthritis drugs not approved by the Food and Drug Administration (FDA) for use in the United States. The announcement was made by U.S. Attorney Russ Ferguson.
The case centers on actions taken in 2019 when Dr. Mendelsohn allegedly sought Medicare reimbursement for immunosuppressive drugs administered intravenously to patients with rheumatoid arthritis. According to federal authorities, these drugs were purchased from sources not licensed or authorized as drug distributors and were intended for foreign markets rather than being FDA-approved for distribution in the U.S.
U.S. Attorney Russ Ferguson stated, “When patients receive intravenous drugs, they have no insight into what is being put inside their bodies. The FDA plays an important role in ensuring only safe and proper pharmaceuticals are used,” adding, “Dr. Mendelsohn sidestepped that oversight to buy cheaper drugs abroad yet receive full reimbursement from Medicare at the expense of the American taxpayer. This settlement holds him accountable and ensures that Medicare funds are only used for FDA-approved drugs.”
Kelly Blackmon, Special Agent in Charge at the Department of Health and Human Services Office of Inspector General (HHS-OIG), commented on the legal obligations of healthcare professionals: “Health care professionals are legally obligated to uphold the integrity of the Medicare program,” she said. “Protecting the safety of Medicare patients is essential, and HHS-OIG is committed to ensuring taxpayer dollars are not spent on unapproved or unauthorized treatments that put patients at risk.”
Acting Special Agent in Charge Juan Berrios from the FDA Office of Criminal Investigations Miami Field Office highlighted regulatory protections: “The FDA’s comprehensive regulatory framework is designed to ensure the safety, efficacy, and quality of drugs distributed to American consumers,” he said. “We commend the efforts of the Department of Justice to protect public health and hold accountable those who place profits over patient safety.”
Assistant U.S. Attorney Holly H. Snow led this civil enforcement action with support from both HHS-OIG and FDA criminal investigators.
Officials emphasized that these claims remain allegations only; there has been no determination of liability.
