AG Van Hollen: Announces settlement with Kos Pharmaceuticals to settle claims of off-label marketing and kickback violations

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Bill Cosh 608/266-1221

MADISON —Attorney General J.B. Van Hollen announced today that Wisconsin will receive $74,026.21 as the state share of a total of $178,956.14 attributable to Wisconsin Medicaid as part of a $9.4 million Medicaid settlement reached by various states, the federal government and Kos Pharmaceuticals, Inc. The settlement resolves allegations that the company engaged in kickback violations and off-label marketing of its cholesterol treatment drugs Advicor and Niaspan. The states and federal government jointly administer the Medicaid program.

“This is another of our committed efforts to hold accountable those who exploit public assistance programs,” Van Hollen stated. “First, taxpayers should know that their dollars are being used for the purposes they intended. Second, for every dollar that’s fraudulently obtained, there’s one dollar less for people who genuinely need it.”

This state settlement is part of a larger settlement reached between the United States Attorney’s Office for the Eastern District of Wisconsin, the United States Attorney’s Office for the Western District of Louisiana and the United States Department of Justice. The total settlement is $41,519,742.00. This includes the $9,477,567.00 Medicaid portion, a $28,682,175.00 component to settle civil claims for damages to the federal employees health benefits program, TRICARE and Veteran Administration programs. There is also a $3,360,000.00 criminal fine based on Kos’s entering into a Deferred Prosecution Agreement with federal authorities.

Kos manufactured and sold two prescription drugs that treat low levels of HDL, “good cholesterol”. The brand names of these drugs are Advicor and Niaspan. During most of the time period of this investigation Advicor and Niaspan were the only drugs available that worked to increase good cholesterol levels. Treatment regimen with medication seeks to raise the good cholesterol level, “HDL”, and to lower the bad cholesterol level, “LDL”.

The allegations resolved are that Kos engaged in off-label marketing of Advicor and Niaspan and paid kickbacks to doctors through the use of quality initiatives, coupon programs, preceptorships, and local Advisory Boards. Advicor was approved by the federal Food and Drug Administration (FDA) as an adjunctive or second line therapy after diet and lifestyle changes and other medications failed to lower overall cholesterol levels. Kos marketed Advicor as a first line therapy which was not a use approved by the FDA.

Kos was purchased by Abbott Laboratories in December 2006. In recognition of the fact that shortly after Kos was purchased, Abbott took steps to correct the offending conduct the federal government did not require Kos to enter into a Corporate Integrity Agreement as is customary in these cases.

The Medicaid Fraud Control and Elder Abuse Unit of the Wisconsin Department of Justice is a member of the National Association of Medicaid Fraud Control Units, which coordinated the states’ efforts on the settlement.