A federal grand jury in the Western District of Tennessee has returned a second superseding indictment charging a 44-year-old gynecologist with crimes related to his performance of medically unnecessary gynecologic procedures. The indictment alleges that he used medical devices under unsanitary conditions and reused them on patients when he was required to dispose of or properly reprocess those devices.
According to the indictment, the defendant also billed Medicare and Medicaid as if the procedures were medically necessary and as if a new or properly reprocessed device had been used for each patient. The alleged conduct occurred between September 2019 and April 2024.
Earlier this year, the defendant faced similar charges, but a federal judge dismissed several counts after finding that they combined multiple alleged acts over extended periods instead of listing each act separately. The government has now refiled the charges, adding 27 new counts, each describing a single incident of adulteration or misbranding, as required by the court’s order.
Trial is scheduled to begin on December 1, 2025.
The case is being investigated by the US Department of Health and Human Services Office of Inspector General (HHS-OIG), the US Food and Drug Administration Office of Criminal Investigations (FDA-OCI), the Federal Bureau of Investigation (FBI), and the Tennessee Bureau of Investigation (TBI).
Compliance Perspective
Issue
Medical devices and supplies designated for single use must never be reused. All procedures performed on residents or patients must be medically necessary and supported by proper documentation. Performing unnecessary procedures or reusing disposable medical devices violates infection control standards and may constitute fraud if billed to Medicare or Medicaid as medically necessary services. Facilities are responsible for maintaining clear policies and oversight to ensure compliance with infection control and billing regulations.
Discussion Points
- Review your facility’s policies and procedures related to infection control, device reprocessing, and medical necessity. Ensure they clearly define requirements for single-use devices and documentation needed to support the medical necessity of each procedure. Collaborating with a compliance consultant for a focused mock survey or policy review can help identify gaps and ensure your practices align with current regulations.
- Provide ongoing training on infection control, medical necessity, and ethical billing practices, including identifying and reporting potentially unnecessary procedures or improper device use and reinforcing documentation requirements for Medicare and Medicaid claims. Med-Net Academy offers courses such as Understanding and Using the Medicare Triple Check Process, which ensures accurate billing, prevents false claims, reduces denied or adjusted claims, and aligns clinical documentation with financial data, and Maintaining Proper Infection Control Procedures, which covers CDC guidelines, hand hygiene, PPE and facemask use, proper patient placement, and safe aerosol-generating procedures.
- Regularly audit records to confirm that all medical devices are used and disposed of appropriately and that all billed procedures are supported by documentation demonstrating medical necessity. Consider using an external consultant or mock survey process to help verify compliance and identify areas for improvement before a regulatory survey. Use audit results to update policies, guide staff retraining, and strengthen overall compliance performance.
*This news alert has been prepared by Med-Net Concepts, Inc. for informational purposes only and is not intended to provide legal advice.*