SEC Pursues Mallinckrodt Over Medicaid Reimbursement for Acthar Gel

The Securities and Exchange Commission (SEC) issued a subpoena to Mallinckrodt in August for documents relating to the company’s lawsuit against the Centers for Medicare & Medicaid Services, the company disclosed.

Mallinckrodt sued CMS in the U.S. District Court for the District of Columbia in May over the average manufacturer price (AMP) used to calculate Medicaid rebates the company would pay to state Medicaid agencies for its Acthar gel.

The drugmaker thought that the FDA’s approval of the gel for infantile spasms in 2010 made it eligible for a new AMP, as the agency allegedly indicated in 2012.

However, CMS objected and told the drugmaker in May that if it did not return to its original AMP, the company would be out of compliance with reporting requirements for the Medicaid drug rebate program.

Mallinckrodt said it is “cooperating with the SEC’s investigation.”