Pharmacist and Two Pharmacies Agree to Pay $1 Million to Resolve Allegations of False Claims for Anti-Overdose Drug | OPA

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.

“We expect the submission of truthful and non-misleading documentation by all those involved in the delivery of health care goods or services, including pharmacies that submit claims for pharmaceutical products,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “This settlement demonstrates the department’s continuing commitment to preventing fraud in Medicare and other taxpayer-funded health care programs.”

“Taxpayers pay a huge amount of money for federal health care programs, and they expect that money will be spent honestly and effectively – especially when it comes to expensive therapies,” said Acting U.S. Attorney Nathaniel R. Mendell for the District of Massachusetts. “Our job is to find and stop misconduct like this, which hurts those programs and cheats us all.”

“When health care providers put their own financial gain above honest billing of Medicare, they violate the basic trust the public extends to health care professionals,” said Special Agent in Charge Phillip M. Coyne of the U.S. Department of Health and Human Services, Office of the Inspector General (HHS OIG). “Our agency, working with our law enforcement partners, will continue to root out all forms of waste, fraud and abuse in our federal health care programs.”

“Pharmacies that take shortcuts to increase their profits by submitting false claims for expensive drugs increase medical costs for all of us,” said Special Agent in Charge Joseph R. Bonavolonta of the FBI Boston Division. “Today’s settlement should deter anyone thinking about abusing our federal health care programs that so many rely on for their health care needs.”

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 investigation and resolution of this matter illustrates the government’s emphasis on combating health care fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse and mismanagement can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).

The matter was handled by Trial Attorney Sarah Arni of the Justice Department’s Civil Division and Assistant U.S. Attorneys David Derusha and Abraham George for the District of Massachusetts.

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