United Therapeutics Settles FCA Suit for $210M

United Therapeutics (UT), a Maryland-based pharmaceutical company which produces and distributes drugs for treating pulmonary arterial hypertension, has settled allegations that it illegally paid kickbacks to Medicare patients through its charitable foundation.

In its effort to sell more pulmonary arterial hypertension drugs (including Adcirca, Remodulin, Tyvaso, and Orenitram), the company used a non-profit foundation (The Caring Voice Coalition) to pay the co-pays of thousands of Medicare patients taking its drugs. Co-pays are often required for drugs covered under Medicare parts B or D, and may be substantial for expensive medications. The Anti-Kickback statute prohibits pharmaceutical companies  from offering anything of value to induce Medicare patients to purchase the companies’ drugs.

From 2010 to 2014, UT obtained data from its foundation on how many patients on pulmonary arterial hypertension drugs the foundation had assisted, and how much it had spent on each patient. The government alleged that UT then used this data to decide how much to donate to the foundation. UT had also not allowed Medicare patients to participate in its separate “free drug program,” while  the program was open to other financially needy patients, even if the Medicare patients could not afford the co-pays on the drugs. Instead, UT referred the needy Medicare patients to its foundation, resulting in the charity covering only the co-pay (and not the entire cost of the drug) and in claims to Medicare to cover the remainder.

In addition to the $210M, UT has signed a corporate integrity agreement with the Department of Health and Human Services. The agreement will run five years and mandate that UT implement measures to ensure that arrangements with patient-assisting programs are legal. The agreement will also mandate audits by an independent review organization.

Tagged in: Anti-Kickback and Stark, FCA Federal, Medicare, Pharma Fraud,