Riad “Ray” Zahr, a pharmacist in Dearborn, Michigan, along with two specialty pharmacies that Zahr formerly owned and operated, have agreed to pay the United States $1 million to resolve allegations that they submitted false claims for the drug Evzio. Evzio was an injectable form of naloxone hydrochloride indicated for use to reverse opioid overdose. 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 contended that, between Aug. 1, 2017, and June 30, 2019, Plymouth Towne Care Pharmacy dba People’s Drug Store (People’s Drug Store) and Shaska Pharmacy LLC dba Ray’s Drugs (Ray’s Drugs) submitted false claims for Evzio to Medicare. In particular, the government alleged that People’s Drug Store and Ray’s Drugs submitted false and misleading prior authorization requests for Evzio that contained clinical assertions for which the pharmacies lacked any factual basis. At times, Zahr and the pharmacies initiated Evzio prescriptions based on rudimentary patient lists with only basic biographical details.

Zahr and the pharmacies also included assertions in Evzio prior authorization requests purportedly authored by prescribing physicians regarding the comparative effectiveness of Evzio that the pharmacies or Zahr actually authored. The prescribing physicians did not review, sign or submit the prior authorizations at issue. The settlement also resolves allegations that Zahr, People’s Drug Store and Ray’s Drugs dispensed Evzio prescriptions to Medicare beneficiaries at times without collecting or attempting to collect co-payment obligations for Evzio, in violation of the Anti-Kickback Statute.

The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Rebecca Socol, a former employee of kaléo Inc., the manufacturer of Evzio. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. As part of this resolution, Ms. Socol will receive $200,000 of the settlement amount. The qui tam case is captioned United States ex rel. Socol v. Plymouth Towne Care Pharmacy, Inc., 18-cv010050-RGS (D. Mass.) (under seal). On Nov. 9, the department announced that kaléo agreed to pay $12.7 million to resolve allegations that kaléo caused the submission of false claims for Evzio.

The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section and the U.S. Attorney’s Office for the District of Massachusetts, with assistance from HHS OIG; the Department of Defense Criminal Investigative Service; the Office of Personal Management, Office of Inspector General; the FBI; and the U.S. Postal Service Office of Inspector General.

The claims resolved by the settlement are allegations only and there has been no determination of liability.