In a statement, Gilead indicated that it does not believe it violated the law and “had no intention of doing so,” saying, “Gilead made its donations following guidance issued by the U.S. The Department also has reached settlements with four foundations ( Patient Access Network Foundation, Chronic Disease Fund, The Assistance Fund, and Patient Services, Inc.) and a pharmacy (Advanced Care Scripts, Inc.) that allegedly conspired or coordinated with pharmaceutical companies on these kickback schemes. To date, the Department of Justice has collected over $1 billion from eleven pharmaceutical companies ( United Therapeutics, Pfizer, Actelion, Jazz, Lundbeck, Alexion, Astellas, Amgen, Sanofi, Novartis, and now Gilead) that allegedly used third-party foundations as kickback vehicles. Going a step further, the government also alleged that Gilead would refer Medicare patients to the foundation, which helped to generate revenue from Medicare and induce further purchases of the drug, and also resulted in claims to Medicare to cover the cost of Letairis. Gilead would also take the extra step and confirm that its payments were sufficient to cover the copays of patients taking Letairis – and only Letairis. The government further alleged that in pursuit of this scheme, Gilead would routinely get data from CVC that detailed how much the foundation had spent for patients on Letairis and would then use that information to determine how much to pay the foundation.
The DOJ alleges that Gilead used the foundation and its copay assistance as a way to induce patients to purchase Letairis because Gilead knew the prices it had set for the drug could otherwise pose a cost barrier for patients trying to access the drug.
reached a settlement agreement with the United States Department of Justice (DOJ) to resolve claims that it violated the False Claims Act by illegally using a foundation as a conduit to pay copays of thousands of Medicare patients.Īccording to the DOJ, from 2007 through 2010, Gilead made payments to Caring Voice Coalition (CVC), a 501(c)(3) foundation, which would then in turn, use those payments from Gilead to pay copays of patients who were prescribed Letairis, a drug approved for treatment of pulmonary arterial hypertension.
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