Medtronic has reached a settlement, that will result in payments of $2.8 million to resolve claims that the company illegally promoted the SubQ spinal cord stimulation devices for unapproved uses.
The U.S. Department of Justice announced the Medtronic SubQ stimulation settlement on February 6, resolving claims that the medical device manufacturer violated the False Claims Act from 2007 through 2011.
According to the allegations, Medtronic used “on-site training programs” for doctors and other methods to promote the use of its spinal cord stimulation devices for SubQ stimulation procedures, which involve placing the devices under the skin near an area of pain to provide electrical impulses meant to alleviate that pain. However, this procedure has never been approved by the FDA and has not been established as safe or effective.
The Justice Department claims that this means “Medtronic knowingly caused dozens of physicians located throughout more than 20 states to submit claims to Medicare and TRICARE for investigational medical procedures known as SubQ stimulation that were not reimbursable.”
The allegations came as the result of a whistleblower lawsuit brought by Jason Nickell, a former Medtronic sales representative. Under the Qui Tam provisions of the false claims act, Nickell will be rewarded $602,000 of the $2.8 million settlement for bringing the situation to the government’s attention.
“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,” Special Agent in Charge Scott J. Lampert, of the Department of Health and Human Services’ Office of Inspector General, said in the press release. “Our agency will continue to pursue medical device makers that ignore requirements designed to protect patient health and federal health care programs.”