The U.S. Department of Justice said Agendia Inc., of Irvine, Calif., has agreed to an $8.25 million settlement regarding an alleged scheme to bill the Medicare program for the company’s Mammaprint assay by circumventing the 14-day rule for physician-ordered tests. Agendia is alleged to have worked around the 14-day rule by two means, including canceling the order and asking the ordering physician to resubmit the order after 14 days had elapsed since the patient was discharged. The lawsuit was brought about by a qui tam relator, who worked for a hospital that was named in a separate qui tam action.
The U.S. FDA said it will hold a July 7 webinar for respirators for health care personnel use, to be co-hosted by the Centers for Disease Control and Prevention. The one-hour webinar, which will commence at noon U.S. Eastern time, is the third in a series of such webinars, and registration is not necessary for attendance.
Following last year’s request from Teva Pharmaceutical Industries Ltd., the FDA said it is withdrawing approval of the new drug application for Teva’s Zecuity (sumatriptan iontophoretic) transdermal system, which was approved in 2013 to treat acute migraine. Teva suspended sales, marketing and distribution of Zecuity in June 2016 as it investigated the cause of burns and permanent scarring associated with the system, according to an FDA notice published in the Federal Register.