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 events from 2019 when Dr. Mendelsohn allegedly sought Medicare reimbursement for immunosuppressive drugs administered intravenously to his patients with rheumatoid arthritis. According to federal authorities, these drugs were intended for foreign markets and had not been purchased from licensed or authorized drug distributors in the United States. As such, they were not approved by the FDA for marketing or distribution domestically.
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. 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), emphasized the responsibility of healthcare professionals: "Health care professionals are legally obligated to uphold the integrity of the Medicare program. 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 added, "The FDA’s comprehensive regulatory framework is designed to ensure the safety, efficacy, and quality of drugs distributed to American consumers. 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 managed this civil enforcement matter with support from both HHS-OIG and the FDA Office of Criminal Investigations.
Authorities clarified that these resolved claims remain allegations only; there has been no determination of liability.
