Pharmaceutical company Mallinckrodt agreed to pay approximately $260 million as part of a settlement announced Monday by the Department of Justice for underpaying Medicaid rebates and violating kickback laws regarding its drug Acthar.
Of the settlement total, $234.7 million will be paid to resolve the Medicaid rebate allegations and approximately $26.3 million will be paid to resolve the kickback allegations. Mallinckrodt, which filed for bankruptcy protection in October 2020, also entered a five-year corporate integrity agreement with the Department of Health and Human Services Office of Inspector General that will require it to establish a risk assessment program among other stipulations.
The settlement addresses multiple whistleblower lawsuits brought under the qui tam provisions of the False Claims Act, which allow private parties to sue on behalf of the government for the submission of false claims for government funds and to receive a share of any recovery. The whistleblower in the Medicaid rebate case will receive approximately $24.7 million, while whistleblowers that raised the kickback allegations will receive approximately $4.9 million.
The details: Although Acthar was approved in 1952, Mallinckrodt and its predecessor, Questcor Pharmaceuticals, began calculating and paying rebates as if Acthar was a new drug first marketed in 2013, according to the Justice Department. “Allegedly, this practice meant the companies ignored all pre-2013 price increases when...
Read Full Story:
https://www.complianceweek.com/regulatory-enforcement/mallinckrodt-to-pay-260...