Medical device maker Medtronic will pay the United States government $2.8 million to resolve allegations under the False Claims Act that Medtronic caused physicians to submit false claims to federal health care programs for a medical procedure known as “SubQ stimulation,” the Justice Department announced on February 6.
The lawsuit alleged that Medtronic caused physicians from more than 20 states to submit false claims to federal health care programs, including Medicare and TRICARE, for the investigational and non-reimbursable SubQ stimulation procedure from 2007 through 2013, according to the DOJ. SubQ stimulation involves implanting a spinal cord stimulation device beneath the skin near an area where pain occurs, typically in the lower back. The device emits electrical impulses that cause a “tingling” to ameliorate chronic pain.
The government says the device’s safety and efficacy had not been established by the Food and Drug Administration (FDA), but Medtronic promoted the device in various ways, including sponsoring on-site training programs for physicians and customers. Acting Assistant Attorney General Joyce R. Branda said, “Today’s settlement demonstrates our commitment to ensure that beneficiaries of federal health care plans, including Medicare recipients and military families, receive medical treatments that have been proven safe and effective.”
The civil settlement resolves a lawsuit filed under the whistleblower provision of the False Claims Act. Private parties may bring lawsuits on behalf of the government for false claims and potentially receive a portion of what the government recovers. This lawsuit was filed by a former Medtronic sales representative, who will receive $602,000, according to the DOJ.
Scott J. Lampert Special Agent in Charge of the Department of Health and Human Services’ Office of Inspector General (HHS–OIG) said, “Patients should be able to trust that their health care providers only use – and bill Medicare for – medical procedures that have been shown to be safe and effective.” He said the agency will “continue to pursue medical device makers that ignore requirements designed to protect patient health and federal health care programs.”