Medicaid Rebate Suit Focuses On FDA Approval Status Of Acthar's New Indication
US government says Mallinckrodt avoided millions in Medicaid rebates by claiming Acthar’s added indication was approved as a new NDA rather than a supplemental application.
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Under corporate integrity agreement, Mallinckrodt must post proposed list price increases for Acthar and other non-generic products along with a link to executive compensation. $234m settlement resolves allegations it underpaid Medicaid rebates resulting from Acthar price hikes.
Mallinckrodt must pay $650m in retroactive Medicaid rebate payments; case shows how application filings can impact CMS reporting requirements and price-based reimbursements.
The controversies have shown that, while it may be easy to scapegoat outliers, it is remarkably hard to lower a drug price by political fiat. It took a while, but now Makena, Daraprim and Acthar are all facing very different days of reckoning.