The U.S. Attorney for the Middle District of Florida has filed a complaint in federal court against Smart Pharmacy Inc., and SP2 LLC, respectively a compounding pharmacy in Jacksonville and its parent company.
The complaint alleges that the pharmacies improperly included aripiprazole, an antipsychotic drug, in compounded pain creams in order to boost the pharmacies’ reimbursement for the prescriptions and that the pharmacies routinely waived patient copayment obligations.
“Smart Pharmacy vigorously denies these allegations, and we are fully cooperating in order to quickly resolve this matter. We look forward to having the opportunity to defend ourselves properly in court,” said Brian Dickerson, attorney for Smart Pharmacy and a partner with FisherBroyles in Naples.
Aripiprazole, which is sold under the brand names Abilify, Abilify Maintena, and Aristada, is approved by the U.S. Food and Drug Administration to treat psychological conditions such as schizophrenia, Tourette’s disorder, irritability associated with autistic disorder and manic and mixed episodes associated with Bipolar I.
The complaint alleges that the defendants crushed aripiprazole pills and mixed them them into compounded creams used topically for pain treatment while knowing there was not an adequate clinical basis for adding aripiprazole to the compound.
By including the drug in the pain creams, the defendants substantially increased their reimbursement for prescriptions for the creams from Medicare Part D and Tricare, the federal health care program for active duty military personnel, retirees, and their families, according to the complaint.
The government’s complaint also alleges that the defendants improperly waived patient copayments. While copayments may be waived in certain circumstances, such as on the basis of financial hardship of the patient, the defendants are alleged to have routinely waived patient copayments without regard for whether a waiver was warranted.
On its website, Smart Pharmacy describes itself as having a “wide range of compounding specialties with a focus on topical pain creams and hormone therapy” and identifies itself as the “official pharmacy of the Jacksonville Jaguars.”
Smart Pharmacy’s retail store and compounding facility is at 14003 Beach Blvd.
“This complaint addresses alarming misconduct by some of the largest compounding pharmacies in our district. We intend to hold providers accountable under the False Claims Act when they put their own economic interests ahead of the medical needs of federal health program beneficiaries,” said U.S. Attorney for the Middle District of Florida Maria Chapa Lopez in a news release.
The lawsuits, United States ex rel. Sanchez v. Smart Pharmacy Inc., et al., and United States ex rel. Kohli v. Smart Pharmacy Inc., were originally filed in the U.S. District Court for the Middle District of Florida by Amy Sanchez and Ashok Kohli, two former employees of Smart Pharmacy.
They assert in their complaints that the federal government and State of Florida have sustained damages “in the millions of dollars” because of Smart Pharmacy’s alleged violations.
The lawsuits were filed under the qui tam or whistleblower provisions of the False Claims Act, which permit private parties to sue on behalf of the United States for false claims and to receive a share of any recovery. The Act permits the United States to intervene in such lawsuits, as the United States has done in these cases.
The case is being prosecuted by the Civil Division’s Commercial Litigation Branch and Assistant U.S. Attorney Collette Cunningham for the U.S. Attorney’s Office for the Middle District of Florida, with assistance from the Defense Criminal Investigative Service, the Department of Health and Human Services Office of Inspector General, the Department of Veterans Affairs Office of Inspector General, the Department of Labor Office of Inspector General and the Office of Personnel Management Office of Inspector General.