Pharmacy Fined for Submitting Fraudulent Claims to Medicare

Florida-based Solera Specialty Pharmacy has entered into a deferred prosecution agreement and agreed 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 Solera’s admissions in the criminal and civil agreements, 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 authorizations 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 information. In addition, Solera submitted Evzio prior authorization requests 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, Nicholas Saraniti, also entered into a civil settlement agreement and will pay the government $1.31 million to resolve claims under the False Claims Act.

In connection with the settlements, 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 (HHS-OIG). The IA requires, among other things, 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 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 $262,000 of the settlement amount. 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.