Friday, March 1, 2013

Florida’s Medicaid Program Receives Settlement Payment from Pharmaceutical Company: Healthpoint Ltd for ointment Xenaderm


By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
The Florida Attorney General’s (AG) Medicaid Fraud Control Unit (MFCU), 46 other states and the federal government reached a $48 million agreement with pharmaceutical company Healthpoint Ltd., on February 25, 2013. According to the Florida AG, the settlement is in response to allegations of misrepresenting the regulatory status of an ointment used to treat skin conditions and submitting false Medicaid claims. Florida’s Medicaid program will receive almost $900,000 of the settlement.
Pharmaceutical Company Allegedly Submitted False Claims to Medicaid.
According to the Department of Justice (DOJ), Healthpoint launched the ointment for the treatment of nursing home patients with bed sores. The settlement resolves allegations that Healthpoint marketed the ointment, Xenaderm, without the approval of the Food and Drug Administration (FDA) by modeling it on a pre-1962 drug that the FDA never reviewed. The DOJ states that the main ingredient in Xenaderm was determined by the FDA to be less-than-effective for its intended use. The government contends those determinations render the ointment ineligible for Medicaid reimbursements. Healthpoint is accused of knowingly submitting false claims to Medicaid programs.
The settlement is th result of litigation by the United States Attorney’s Office for the District of Massachusetts, the DOJ and fifteen (15) states, including Florida.
Responding to a Medicaid Audit.
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