DENVER–Colorado Attorney General John Suthers today announced that the State of Colorado will receive approximately $221,430 as part of a settlement against Connecticut-based pharmaceutical manufacturer Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) for alleged kickbacks and off-label marketing campaigns. Of this amount, $104,000.00 will be returned to the federal government as its share of the Medicaid money recovered. Nationwide, BIPI will pay the federal and state governments a total of $95 million, of which $34 million will go to state Medicaid programs. The State of Colorado pays more than $4.5 billion each year for the medical care of 655,000 qualified recipients and an additional 85,000 children in the state’s Child Health Plan+ program.
“These funds represent another significant recovery for Colorado’s Medicaid program,” said Suthers. “Coupled with other recently announced drug settlement cases, pharmaceutical companies should be on notice that Colorado will not tolerate pharmaceutical companies breaking the rules and increasing the burden on important state programs that benefit children, the sick and those most in need.”
The settlement resolves allegations that BIPI unlawfully marketed the drugs Aggrenox, Combivent, Atrovent and Micardis for a variety of non-Food and Drug Administration (FDA)-approved indications. These included Aggrenox for certain cardiovascular events such as myocardial infarction and peripheral vascular disease; Combivent for use prior to another bronchodilator in treating Chronic Obstructive Pulmonary Disease; and Micardis for treatment of early diabetic kidney disease. The agreement also resolves allegations that the company paid kickbacks to health care professionals as inducement to prescribe.
While physicians are generally free to prescribe FDA-approved drugs for “off-label” uses, with few exceptions drug manufacturers are not permitted to directly promote or market their drugs for such uses. Moreover, Colorado and other Medicaid programs usually do not pay for prescriptions for off-label purposes.
The settlement resolves a whistleblower lawsuit filed in the United States District Court for the District of Maryland under the federal False Claims Act and parallel state statutes.
The Colorado Attorney General’s Medicaid Fraud Control Unit facilitated Colorado’s portion of the settlement. As part of the agreement, BIPI will enter into a corporate integrity agreement with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.