United States Intervenes in False Claims Act Lawsuit Against Mallinckrodt ARD LLD

by Andrew Murray | June 10th, 2019

On June 5, 2019, the Department of Justice announced that the United States has filed a complaint against pharmaceutical company, Mallinckrodt ARD LLC, alleging False Claims Act violations stemming from kickbacks related to the drug, Acthar Gel. The Press Release states:

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When a Medicare beneficiary obtains a prescription drug covered by Medicare, the beneficiary may be required to make a partial payment, which may take the form of a copayment, coinsurance, or a deductible (collectively “copays”). Congress included copay requirements in the Medicare program, in part, to serve as a check on health care costs, including the prices that pharmaceutical manufacturers can demand for their drugs. The Federal Anti-Kickback Statute prohibits a pharmaceutical company from offering or paying, directly or indirectly, any remuneration—which includes money or any other thing of value—to induce Medicare patients to purchase the company’s drugs. This prohibition extends to the payment of patients’ copay obligations.

The government alleges that Mallinckrodt used a foundation as a conduit to pay illegal kickbacks in the form of copay subsidies for Acthar so it could market the drug as “free” to doctors and patients while increasing its price. Mallinckrodt allegedly paid these illegal subsidies through three funds that Mallinckrodt had a foundation set up to pay Acthar Medicare copays to the exclusion of other drugs. The government alleges that Mallinckrodt then routed patients with Acthar prescriptions to these funds. Mallinckrodt allegedly made continuing payments as the sole “donor” to these funds, to keep subsidizing Acthar Medicare copays as it expanded its sales of the drug. The government alleges that the Company paid these subsidies to induce Medicare-reimbursed purchases of Acthar at its ever-increasing price, and used the subsidies to counteract doctor and patient concerns about the drug’s high cost and to market the drug as “free.” The government further alleges that since its acquisition of Acthar in 2001, Mallinckrodt had raised its price from approximately $50 to over $32,200 per 5 milliliter vial by the end of 2014.

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