Gilead Sciences, Inc. (Gilead), based in Foster City, California, must pay $97 million to settle claims that it violated the False Claims Act by illegally using a foundation as a conduit to pay the copays of thousands of Medicare patients taking Gilead’s pulmonary arterial hypertension drug, Letairis, the Justice Department announced today.
“This settlement demonstrates the government’s commitment to hold accountable companies that pay illegal kickbacks, whether directly or through a third party,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Department of Justice’s Civil Division. “We will not allow permit pharmaceutical manufacturers to set unaffordable drug prices while circumventing important
“Like its competitors, Actelion and United Therapeutics, Gilead used data from CVC that it knew it should not have, and effectively set up a proprietary fund within CVC to cover the co-pays of just its own drug,” said U.S. Attorney Andrew E. Lelling for the District of Massachusetts. “Such conduct not only violates the anti-kickback statute, it also undermines the Medicare program’s co-pay structure, which Congress created as a safeguard against inflated drug prices. During the period covered by today’s settlement, Gilead raised the price of Letairis by over seven times the rate of overall inflation in the United States.”
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.
Under the Anti-Kickback Statute, a pharmaceutical company is prohibited 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.
Gilead sells Letairis, which is approved for the treatment of pulmonary arterial hypertension. The government alleged that Gilead used a foundation, which claims 501(c)(3) status for tax purposes, as a conduit to pay the copay obligations of thousands of Medicare patients taking Letairis and to induce those patients to purchase Letairis, because it knew that the prices Gilead set for Letairis could otherwise pose a barrier to those purchases. From 2007 through 2010, Gilead made payments to the foundation, which, in turn, used those funds to pay copays of patients prescribed Letairis. The government alleged that Gilead routinely obtained data from the foundation detailing how much the foundation had spent for patients on Letairis; it then used this information to decide how much to pay to the foundation and to confirm that its payments were sufficient to cover the copays of only patients taking Letairis. The government also alleged that, to generate revenue from Medicare and induce purchases of Letairis, Gilead referred Medicare patients to the foundation, which resulted in claims to Medicare to cover the cost of Letairis.