PHARMA MANUFACTURER AGREES TO PAY $260M TO SETTLE LAWSUITS ALLEGING MEDICAID DRUG REBATE UNDERPAYMENTS, ILLEGAL KICKBACKS
On March 9, 2022, a pharmaceutical company agreed to pay $260 million to resolve allegations that it violated the False Claims Act (FCA) by knowingly underpaying Medicaid rebates due for its drug and paying illegal subsidies in violation of the federal anti-kickback statute (AKS). In 2019 and 2020, the government filed separate complaints detailing allegations that the manufacturer used a foundation as a conduit to pay illegal kickbacks in the form of copay subsidies for its drug so that it c ould market the drug as “free” to doctors and patients, resulting in increasing the price and underpaying rebates pursuant to the Medicaid Drug Rebate Program. In connection with the settlement, the company also entered into a five -year corporate integrity agreement with the US Department of Health and Human Services (HHS) Office of Inspector General (OIG). The corporate integrity agreement contains unique drug price transparency provisions and monitoring provisions focused on Medicaid rebate and patient assistance program activities.
We note an emerging trend involving intermediaries approaching hospitals and offering pharmaceutical manufacturer rebate arrangements concerning inpatient drugs and related inpatient drug dispensing data. A variation on this theme involves the intermediaries offering purchase arrangements concerning such data. These arrangements...
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https://www.natlawreview.com/article/healthcare-regulatory-check-april-2022-n...