The U.S. Department of Justice said Practice Fusion Inc., of San Francisco, will pay $145 million to settle criminal and civil investigations for admittedly seeking and receiving kickbacks from “a major opioid company.” The kickbacks were paid in exchange for Practice Fusion’s practice of steering physicians to prescribe the opioids via the company’s electronic health records (EHRs), which was achieved by allowing the opioid manufacturer to help select the guidelines for alerts in clinical decision support software used in the EHRs. Practice Fusion will pay $118.6 million to the states and to the federal government for the kickbacks and for misrepresenting the capabilities of the EHR software. Another $26 million will be paid in fines and forfeitures. Allscripts Healthcare Solutions Inc., of Chicago, which acquired Practice Fusion in February 2018, had made note of the situation in an August 2019 Securities and Exchange Commission filing. In that filing, Allscripts noted that Practice Fusion was in receipt of a request for documents from the U.S. attorney’s office for the District of Vermont in 2017, following which the Department of Justice had filed seven additional requests for documents and information.
The U.S. FDA said it will hold an April 1 meeting regarding medical device safety communications at its White Oak campus in Silver Spring, Md. The meeting will not review the threshold by which the FDA issues safety communication, but instead will review the methods of communication and the timeliness of those communications. The meeting will be webcast, but those intent on attending in person must register by 4:00 p.m. Eastern, March 18, 2020.
Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said Advamed is “actively working with the Chinese and U.S. governments on the growing public health concern posed by the coronavirus.” Whitaker was responding to a Jan. 27 FDA statement in which the agency requested that sponsors of diagnostics contact the agency regarding emergency use authorizations for the Wuhan coronavirus. He said Advamed is working with the FDA, the Centers for Disease Control and Prevention and other agencies at the federal government as well as the Chinese national government to ensure patient access to technologies to diagnose “and fight this deadly virus.”
The U.S. Federal Motor Carrier Safety Administration denied the petitions from four individuals who sought exemptions from rules that prohibit the operation of commercial vehicles by those with an implantable cardioverter defibrillator. The agency said that even though the applicant drivers have never needed a shock from the ICDs, the prospect that they may need one indicates that their health statuses do not meet the minimum requirement for safety. FMCSA also announced it would renew an exemption from an individual with a history of epilepsy, although 130 individuals were all denied an exemption due to visual field deficiencies.