A Missouri doctor was sentenced to one year in prison for a healthcare fraud scheme, and he and his wife were ordered to repay $235,977. The doctor’s wife was sentenced to three years of probation. On over 1,000 occasions spanning nearly a decade, the doctor and his wife had their unwitting patients injected with cheaper, foreign Orthovisc that had not been approved by the Food and Drug Administration (FDA).
Assistant US Attorney Derek Wiseman said that the couple betrayed the trust of elderly and impoverished patients to fund a lavish lifestyle that included a $2 million mansion, two vacation houses, and four luxury cars. FDA-approved Orthovisc, which is sold by authorized distributors in the United States, comes in a pre-filled syringe. It is injected into the knee to relieve osteoarthritis pain and is available only by prescription.
The doctor and his wife concealed their actions from patients, employees, and publicly funded health insurance programs by, among other things, stonewalling questions from their chief of purchasing. After a shipment of foreign, unapproved injections was seized by the FDA, the couple had the next shipment sent to their home. The wife lied to her compliance officer and friend by telling her the injections came from a distributor in the US, and fraudulently persuaded the compliance officer that the Orthovisc had a required National Drug Code number.
Compliance Perspective
Issue
Injectable unapproved medical devices that are smuggled from unknown foreign sources and come from outside the secure supply chain can present a serious health risk to patients who receive them. Not only are the device components completely unknown, the conditions under which they are manufactured and held are outside the regulatory scrutiny of the legitimate supply chain. Billing federal healthcare programs for a more expensive medication than what was used constitutes a false claim. Failure to promptly report a false claim can result in lawsuits, fines, and other sanctions.
Discussion Points
- Review your medication management policies to ensure they include the requirement for purchasing all medications administered to residents from licensed pharmacies in the United States. Also review policies and procedures for preventing and reporting a false claim. Update as needed.
- Train appropriate staff about F755 Pharmacy Services requirements for obtaining medications only from US licensed pharmacies and their responsibility to ensure this is followed as they provide medications to residents. Train all staff on the False Claims Act and what can be considered a false claim. Include information on how to report concerns and suspected violations, and that prompt reporting is mandatory.
- Audit to ensure that all medications administered to residents are obtained from a licensed pharmacy in the US and properly labeled. Also periodically audit staff understanding to ensure that they are aware of what should be done if they suspect a false claim has occurred. Conduct audits of documentation and billing routinely to prevent and detect errors before they progress to a false claim.
*This news alert has been prepared by Med-Net Concepts, LLC for informational purposes only and is not intended to provide legal advice.*
