Solera Specialty Pharmacy Agrees to Enter into Deferred Prosecution Agreement; Company and CEO to Pay $1.31 Million for Submitting False Claims for Anti-Overdose Drug

Florida-based Solera Specialty Pharmacy has entered right into a deferred prosecution settlement 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 utilized in fast reversal of opioid overdoses.

According to Solera’s admissions within the legal and civil agreements, the pharmacy distributed Evzio from January 2017 to May 2018. During that point, Evzio was the highest-priced model of naloxone available on the market and insurers ceaselessly required the submission of prior authorization requests earlier than they’d approve protection for Evzio. Solera accomplished Evzio prior authorizations varieties rather than the prescribing physicians, together with situations through which Solera workers signed the varieties with out the doctor’s authorization and listed Solera’s contact info as if it had been the doctor’s info. In addition, Solera submitted Evzio prior authorization requests that contained false scientific info to safe approval for the costly drug. Finally, Solera waived Medicare beneficiary co-payment obligations for Evzio on quite a few events with out analyzing whether or not the affected person had a real monetary hardship.

“Pharmacies, like all Medicare providers, must submit accurate claims,” stated 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.”

“Taxpayers deserve honesty and integrity from those who profit from federal health care programs,” stated U.S. Attorney Rachael S. Rollins for the District of Massachusetts. “This resolution will provide oversight to correct behavior and prevent it from happening again.”

Solera entered right into a deferred prosecution settlement in reference to a legal info charging the pharmacy with one depend of well being care fraud. Solera and its CEO, Nicholas Saraniti, additionally entered right into a civil settlement settlement and can pay the federal government $1.31 million to resolve claims below the False Claims Act.

In reference to the settlements, Solera and Saraniti entered right into a three-year integrity settlement (IA) with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). The IA requires, amongst different issues, Solera implement measures designed to make sure that its submission of claims for pharmaceutical merchandise complies with relevant regulation referring to prior authorizations and assortment of beneficiary co-payment obligations. In addition, the IA requires opinions by an impartial evaluation group.

“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,” stated Special Agent in Charge Phillip M. Coyne of the 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,” stated Special Agent in Charge Joseph R. Bonavolonta 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 consists of the decision of claims introduced below the qui tam or whistleblower provisions of the False Claims Act by Rebecca Socol, a former worker of kaléo Inc., the producer of Evzio. Under these provisions, a non-public get together can file an motion on behalf of the United States and obtain a portion of any restoration. As a part of this decision, Ms. Socol will obtain $262,000 of the settlement quantity. The qui tam case is captioned United States ex rel. Socol v. Solera Specialty Pharmacy LLC., 18-cv010050-RGS (D. Mass.) (below seal). In 2021, the division introduced settlements with kaléo for $12.7 million and with different pharmacies for $1 million referring to the submission of false claims for Evzio.

The decision obtained on this matter was the results 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 help from the 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 determination of this matter illustrates the federal government’s emphasis on combating well being care fraud. One of probably the most highly effective instruments on this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse and mismanagement will be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).

The matter was dealt with by Senior Trial Counsel Sarah Arni of the Justice Department’s Civil Division and Assistant U.S. Attorneys David Derusha, Abraham George and Amanda P.M. Strachan for the District of Massachusetts.

The claims resolved by the settlement are allegations solely and there was no willpower of legal responsibility.

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