by Ben Vernia | June 17th, 2023
On June 15, the Department of Justice announced that two Jacksonsville, Florida pharmacies had agreed to settle a whistleblower’s lawsuit for at least $7.4 million. According to DOJ’s press release:
The Justice Department announced today that Smart Pharmacy, Inc., SP2, LLC, and owner Gregory Balotin have agreed to pay at least $7.4 million to resolve lawsuits filed in Jacksonville, Florida, alleging they violated the False Claims Act by adding the antipsychotic drug aripiprazole to topical compounded pain creams to boost reimbursement and by routinely waiving patient copayment obligations. The settlement amount is based on the defendants’ ability to pay.
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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 a number of psychological conditions such as schizophrenia and Tourette’s disorder. The United States alleged that the defendants crushed aripiprazole pills approved for oral use and included them in compounded creams used topically for pain treatment, while knowing that there was not an adequate clinical basis to do so. The defendants allegedly included the drug in the pain creams to increase their profits on prescriptions paid for by Medicare Part D and TRICARE, the federal health care program for active duty military personnel, retirees, and their families. Both Medicare Part D and TRICARE reimburse pharmacies for the individual ingredients included in compounded drugs, thus defendants increased their reimbursement by adding aripiprazole to the combination of drugs used in their pain creams.
The government also alleged that the defendants improperly waived patient copayments to induce patients to accept the pain cream prescriptions. Although copayments may be waived in certain unique circumstances, such as on the basis of an individualized assessment of a patient’s financial hardship, the defendants allegedly routinely waived copayments without regard to patient need.
In connection with the settlement, Gregory Balotin has agreed to enter into a three-year integrity agreement with the Department of Health and Human Services Office of Inspector General (HHS-OIG), which includes an annual claims review by an independent review organization.
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The relators’ share of the settlement has not been determined, the government stated.
