Evzio maker agrees to pay $12.7 million in false claims and kickbacks case

Abstract

Last week, Virginia‐based pharmaceutical manufacturer kaléo Inc. agreed to resolve allegations that it caused the submission of false claims for the drug Evzio, a naloxone product used to reverse opioid overdose. The Department of Justice also charged the company with providing kickbacks to prescribers. Evzio was the highest‐priced version of naloxone on the market, and insurers frequently required the submission of prior authorization requests before they would approve coverage for Evzio. “The United States contends that, between March 14, 2017 and April 30, 2020, kaléo directed doctors prescribing Evzio to send prescriptions to certain preferred pharmacies that in turn submitted false claims for Evzio to Medicare, the TRICARE program and the Federal Employees Health Benefits Program. In particular, the pharmacies allegedly submitted false and misleading prior authorization requests for Evzio and dispensed Evzio without collecting or attempting to collect co‐pays from government beneficiaries. The United States contends that kaléo knew of, or deliberately ignored, this pharmacy misconduct but nevertheless kept directing business to these pharmacies.” The government also alleged that “Evzio sales representatives provided doctors' offices with frequent deliveries of food and beverages, as well as occasional holiday gifts, even when there was no connection to any educational or other business event.” “When a pharmaceutical manufacturer knowingly engages with bad actors, they hurt the federal healthcare system — and they can expect us to see it,” said Acting United States Attorney Nathaniel R. Mendell. “Today's settlement is our latest signal to pharmaceutical manufacturers that my office does not tolerate health care fraud and will continue to pursue enforcement.”