JACKSONVILLE, Fla. — A Jacksonville compounding pharmacy was sued in Federal court for allegedly filing false Medicaid and TRICARE claims.
The 85-page federal complaint was filed against Smart Pharmacy, Inc. SP2, LLC and the co-owner and pharmacist Gregory Balotin.
The document said as part of the scheme, the pharmacy developed compounded topical pain creams containing aripiprazole, an antipsychotic drug, to maximize the reimbursement they received from federal health care programs.
Aripiprazole is also sold under the brand names Abilify, Abilify Maintena, and Aristada. It’s commonly used to treat illnesses like schizophrenia or bipolar disorder.
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Doctor Marcus De Carvalho said aripiprazole is not FDA approved for treatment of pain.
He said antipsychotic medications, specifically aripiprazole, come with a side effect called EPS, which stands for extrapyramidal symptoms
“There’s one type of symptom called dystonia. What can happen there is that your muscles can clinch up. You can literally have an allergic reaction where your tongue swells up which can actually cause suffocation,” Dr. De Carvalho said.
According to the lawsuit, the FDA-approved label for all aripiprazole contains a boxed warning that “[e]lderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. [Aripiprazole] is not approved for the treatment of patients with dementia-related psychosis.”
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The lawsuit alleges Smart Pharmacy billers were instructed not to bill aripiprazole formulas for patients above the age of 75.
However, Smart Pharmacy allegedly dispensed compounded aripiprazole approximately 50 times to Medicare beneficiaries 76 years of age or older.
In at least 23 instances, the drug was allegedly dispensed to a Medicare beneficiary above the age of 80, and in at least three instances the drug was dispensed to a Medicare beneficiary above the age of 90.
The complaint claimed the pharmacy changed prescriptions without the providers’ authorization or obtained consent for a change under the false pretense that the originally prescribed formula was not covered by a patient’s insurance.
According to the document, they’re also accused of not taking patient co-payments in an effort to keep patients ordering medications which could be billed to Medicare.
“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, LLP in Naples.