Attorney General Richard Cordray has announced that Ohio will receive $1.7 million as a result of nationwide settlements with two pharmaceutical manufacturers. The agreements resolve allegations that the companies were marketing certain drugs for uses that were not approved by the U.S. Food and Drug Administration (FDA).
“As a result of these improper marketing campaigns, the Medicaid program in Ohio was paying for drugs that had been prescribed for uses that were not approved,” said Attorney General Cordray. “These outcomes underscore the commitment of my office to vigorously pursue those who defraud the Ohio Medicaid program.”
In one case, Ortho-McNeil-Janssen Pharmaceuticals Inc. was promoting the sale of the drug Topamax for unapproved uses including treatment of bipolar disorder and drug and alcohol dependency. Topamax is approved by the FDA for use in the treatment of epileptic symptoms and to aid in the prevention of migraine headaches. The off-label marketing resulted in false claims for reimbursement being filed and government healthcare programs such as Medicaid overpaying for Topamax prescriptions.
The state settlement with Ortho-McNeil-Janssen Pharmaceuticals is part of a $75.3 million nationwide settlement between the company and all of the states and the federal government. The total state and federal recovery for Ohio will be about $3 million. Of that amount, $1.7 million will reimburse the state’s federal share of Medicaid. The remaining $1.3 million will be returned to the state of Ohio.
In the second case, pharmaceutical manufacturer Allergan Inc. was promoting the off-label use of Botox for patients suffering from headaches, pain, overactive bladders and muscle spasticity. Botox was initially approved by the FDA for specific medical conditions including crossed eyes, uncontrollable eye blinking, abnormal head and neck posture with involuntary contractions and underarm sweating.
The company’s marketing plan included coaching physicians to use a muscle spasm code in order to obtain reimbursement for this off-label use. Allergan also funded continuing medical education programs, honoraria and grants to health care professionals to promote off-label uses for Botox.
The state settlement with Allergan, Inc. is part of a $600 million nationwide settlement between the company and all the states and federal government. This settlement reimburses the federal government and participating states for excessive amounts paid by the Medicaid program as a result of Allergan’s improper off-label marketing campaign and other improper conduct. That amount also includes $350 million in criminal fines and $25 million in forfeiture to resolve an alleged misdemeanor violation of the federal Food, Drug and Cosmetic Act.
The total state and federal recovery for Ohio will be a little more than $1 million. About 60 percent of that will reimburse the state’s federal share of Medicaid. The remainder will be returned to the state of Ohio.
The National Association of Medicaid Fraud Control Units participated in the investigations and represented the interests of the states during negotiations with Allergan and with Ortho-McNeil-Janssen Pharmaceuticals.
The Ohio Attorney General’s Medicaid Fraud Control Unit (MFCU) investigates and prosecutes health care providers who defraud the state's Medicaid program. The MFCU also enforces Ohio laws protecting mentally or physically disabled or elderly citizens from financial exploitation, neglect and abuse in long-term care facilities.
Anyone who suspects patient abuse or neglect or Medicaid fraud can contact the Ohio Attorney General’s office at (800) 282-0515 or online at www.OhioAttorneyGeneral.gov