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 which paid illegal kickbacks in the form of copay subsidies for Acthar, so it could market the drug as “free” to doctors and patients despite increasing Acthar’s price astronomically. Mallinckrodt allegedly paid these illegal subsidies through three funds that it established at the foundation to the exclusion of other drugs. The government alleges that Mallinckrodt was the sole “donor” to these funds and routed Acthar patients there to receive virtually guaranteed copay subsidies to counteract doctor and patient concerns about the drug’s high cost. By doing so, Mallinckrodt marketed Acthar as “free” to patients and caused the submission of millions of dollars in false Acthar claims to Medicare. The subsidies it routed through these funds drove Acthar prescribing and was a proven method that negated concerns about the cost of the drug, allowing Mallincrkodt to continually raise its price.