Pharmacy Agrees to Enter into Deferred Prosecution and Civil Settlement Agreements in Connection with Fraudulent Claims for Anti-Overdose Drug
BOSTON – Florida-based Solera Specialty Pharmacy has entered into a deferred prosecution agreement and has agreed, along with its Chief Executive Officer (CEO), to pay a $1.31 million civil settlement to resolve allegations that it submitted fraudulent claims to Medicare for Evzio, a high-priced drug used in rapid reversal of opioid overdoses.
According to the admissions of Solera and its CEO Nicholas Saraniti in the civil agreement, and Solera’s additional admissions in the criminal agreement, the pharmacy dispensed Evzio from January 2017 to May 2018. During that time, 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. Solera completed Evzio prior authorization forms in place of the prescribing physicians, including instances in which Solera staff signed the forms without the physician’s authorization and listed Solera’s contact information as if it were the physician’s. In addition, Solera submitted Evzio prior authorization forms that contained false clinical information to secure approval for the expensive drug. Finally, Solera waived Medicare beneficiary co-payment obligations for Evzio on numerous occasions without analyzing whether the patient had a genuine financial hardship.
Solera entered into a deferred prosecution agreement in connection with a criminal information charging the pharmacy with one count of health care fraud. Solera and its CEO, Saraniti, also entered into a civil settlement agreement and will pay the government $1.31 million to resolve claims under the False Claims Act.
“Taxpayers deserve honesty and integrity from those who profit from federal health care programs,” said United States Attorney Rachael S. Rollins. “This resolution will provide oversight to correct behavior and prevent it from happening again.”
“Pharmacies, like all Medicare providers, must submit accurate claims,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “This settlement demonstrates the department’s continuing commitment to preventing submissions of false claims by entities at all levels of the health care delivery chain.”
In connection with the settlement, Solera and Saraniti entered into a three-year Integrity Agreement (IA) with the U.S. Department of Health and Human Services Office of Inspector General. The IA requires, among other things, that Solera implement measures designed to ensure that its submission of claims for pharmaceutical products complies with applicable law relating to prior authorizations and collection of beneficiary co-payment obligations. In addition, the IA requires reviews by an independent review organization.
“The submission of truthful and accurate documentation by all parties involved in the delivery of health care goods or services is essential to the integrity of federal health care programs. This includes pharmacies that submit claims for pharmaceutical products,” said Special Agent in Charge Phillip M. Coyne of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “Along with our law enforcement partners, HHS-OIG is committed to preventing fraud in Medicare and other taxpayer-funded health care programs.”
“Today’s settlement resolves serious allegations that Solera submitted false and fraudulent claims to Medicare for their own financial gain, pilfering funds from a program intended to help those truly in need, while going behind the backs of prescribing physicians to secure approval for this expensive anti-overdose drug,” said Joseph R. Bonavolonta, Special Agent in Charge of the FBI Boston Division. “This is not a victimless crime—health care fraud is a crime against all of us who contribute hard earned income and taxes into the system. The FBI will continue to work with our law enforcement partners to ensure those who willingly defraud the American people are held accountable.”
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. The qui tam case is captioned United States ex rel. Socol v. Solera Specialty Pharmacy, LLC., 18-cv010050-RGS (D. Mass.) (under seal). In 2021, the department announced settlements with kaléo for $12.7 million and with other pharmacies for $1 million relating to the submission of false claims for Evzio.
U.S. Attorney Rollins, Principal Deputy AAG Boynton of the Justice Department’s Civil Division, HHS-OIG SAC Coyne and FBI Boston SAC Bonavolonta made the announcement today. Assistant U.S. Attorneys David J. Derusha, Abraham R. George, and Amanda P.M. Strachan of Rollins’s Office and Senior Trial Counsel Sarah Arni of the Justice Department’s Civil Division handled the matter.