Utah-based Dolor Technologies, LLC, entangled in legal woes, has agreed to settle allegations it sold a migraine treatment device in violation of the False Claims Act.
The device in question, known as the SphenoCath, pitched as a migraine miracle cure, was used for treatments not approved by the FDA, as reported by the Department of Justice on Monday.
According to the accusations, from July 2013 to July 2017, Dolor engaged in shady practices that led health providers to bill Medicare with false claims for the unapproved usage of the SphenoCath device.
The stickler is that the device was allegedly marketed for administering nerve blocks to the sphenopalatine ganglion—a procedure not authorized by the FDA.
Following Dolor's instructions, medical providers were encouraged, coached, and even instructed to use improper billing codes so Medicare would pay out for these illegitimate services.
In a damning statement obtained by the Department of Justice, U.S. Attorney Rachelle Aud Crowe came down hard on the malpractice.
"Device companies that evade the FDA approval process and improperly promote their products undermine the health of patients and the financial integrity of federal health care programs," she was quoted.
"This settlement demonstrates the commitment of our office and investigative partners to combat health care fraud against the Medicare Program."
In related developments, Dolor's former CEO, Mark Wright, pleaded guilty to charges of introducing misbranded and...
Kriti Sanon’s Do Patti song ‘Raanjhan’ landed in controversy after international band KMKZ accused composers Sachet-Parampara of plagiarism. The duo dismissed the claims as false, calling them a bi...