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.

Click here to see the press release from the AG’s office.

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.

To read the press release on the settlement from the DOJ, click here.

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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Pharmacist sentenced to 2 years Pa. steroids case

AP
PITTSBURGH — A pharmacist has been sentenced to 2½ years in federal prison after pleading guilty to helping a former Pittsburgh Steelers team doctor illegally distribute anabolic steroids in an investigation spun off from a national crackdown on the performance enhancing drugs.
William Sadowski, 47, of Robinson Township, pleaded guilty in November to conspiracy to possess with intent to distribute anabolic steroids and human growth hormones, or HGH, and was sentenced Tuesday by Senior U.S. District Judge Maurice Cohill Jr.
Sadowski has acknowledged helping Dr. Richard Rydze illegally distribute the body-building substances and other drugs used to prevent their negative side effects or, at least, mask their use. On Tuesday, the married father of two told the judge he let greed and profit cloud his judgment.
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After failures, DPH seeks 30 new staffers to boost inspection ability By Andy Metzger | State House News Service March 01, 2013

FITCHBURG — Interim Commissioner of Public Health Lauren Smith said Thursday that when she took over the depart­ment, following a deadly meningitis outbreak and the closure of a crime lab that shook confidence in the regulators, she engaged in a “frank and brutally honest introspection” with her staff.
One result of that introspection is a proposed $32 million budget increase at DPH, bringing the total amount to $549 million, which would allow for increased inspections and oversight of health care, hazardous material, and substance abuse facilities. That would fund 30 new ­positions and send $1 million to the Board of Registration in Pharmacy, Smith said.
“The public in general goes through its business, its daily life and appropriately assumes that the services, the restaurants, the beaches, the mammography machines, or everywhere it goes, that someone has looked at that, and someone has made sure that it’s OK,” said Smith. “Our role, as I see it, is to make sure that the public’s assumption that those things are well taken care of is actually true.”
The public’s confidence in pharmacies was shaken last year as hundreds fell ill around the country with ailments, includ­ing fungal meningitis, from tainted steroids produced at the New England Compounding Center in Framingham. That outbreak, which has sickened 714 and killed 48 by this week, led to changes within DPH, including unannounced inspections at the state’s 40 sterile compounding pharmacies. Many of those ­revealed that the alleged lack of proper protocols at the Framingham pharmacy was not unique.
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Obstetrics & Gynecology News - Qualitative and quantitative measures of various compounded formulations of 17-hydroxyprogesterone caproate |4471506

Obstetrics & Gynecology News - Qualitative and quantitative measures of various compounded formulations of 17-hydroxyprogesterone caproate |4471506