According to a recent DOJ News Release, Kaléo, Inc. (Kaléo) has agreed to resolve allegations that it caused the submission of false claims for its opioid overdose reversal drug, known as Evzio and that it provided kickbacks to prescribers in an attempt to induce and reward their prescription of the drug. Kaléo has agreed to pay $12.7 million to settle the claims.
Evzio, one of several commercially available naloxone hydrochloride products marketed for rapid opioid reversal, was the highest-priced version of naloxone available, during the relevant period. Due to the high cost of the drug, prior authorization from insurers was frequently required. According to court documents, Kaléo allegedly encouraged its customers to use certain "preferred" pharmacies to obtain Evzio, in an attempt to circumvent obtaining proper authorizations. The alleged misconduct occurred between 2017 and 2020 when the preferred pharmacies allegedly submitted prior authorizations to insurers misrepresenting that the authorizations came from prescribing physicians. The government maintains that Kaléo "knew of, or deliberately ignored" the misconduct, which resulted in the submission of false claims to Medicare, the TRICARE program, and the Federal Employees Health Benefits Program.
The settlement also resolves kickback allegations involving the provision of food, beverages, and holiday gifts to doctors' offices by Kaléo sales representatives "to induce and reward their prescribing of Evzio." The gifts had no apparent connection to any educational or other business events.
Joseph R. Bonavolonta, Special Agent in charge of the Federal Bureau of Investigation, Boston Division states in the news release, “[t]oday’s settlement resolves allegations that Kaléo used gifts to incentivize and reward providers for prescribing the company’s pricey anti-overdose drug while turning a blind eye to pharmacies' fraudulent practices that fleeced taxpayer-funded health care programs — programs that all of us pay for and depend on. These unsavory tactics only fuel the FBI’s and our law enforcement partners’ commitment to aggressively root out those who seek to boost their bottom line at the expense of hard-working taxpayers.”
A copy of the News Release is available here.
For more information regarding DOJ enforcement, please see the Government Prosecutions section of the Enforcement Actions Database.