Teva Pharmaceuticals Agrees to Pay $425 Million to Resolve Kickback Allegations

BOSTON – Teva Pharmaceuticals USA, Inc. and Teva Neuroscience, Inc. (collectively Teva) have agreed to pay $425 million to resolve allegations that Teva paid kickbacks via two co-pay assistance foundations in violation of the Anti-Kickback Statute (AKS) and False Claims Act.

The government’s complaint, filed in 2020, alleged that from 2006 to 2017, Teva manipulated the co-pay foundation assistance system by conspiring with multiple third parties, including a specialty pharmacy and two allegedly independent co-pay assistance foundations, to direct its supposed charitable payments specifically to patients taking its own multiple sclerosis drug, Copaxone. At the same time, Teva steadily raised Copaxone’s price by thousands of dollars. The United States alleges that this conduct violated the AKS and caused the submission of false claims to Medicare. The settlement was reached after the government’s review of Teva’s financial disclosures concerning its financial condition.

This settlement is the latest in a string of enforcement actions against pharmaceutical companies that allegedly used third-party foundations as conduits to pay kickbacks. Since 2017, the United States Attorney’s Office in Massachusetts has collected over $1.4 billion from this enforcement initiative. The U.S. Attorney’s Office has also settled with four of the third-party foundations that participated in this conduct and a specialty pharmacy.  Today’s resolution with Teva is the largest co-pay assistance settlement to date.

When a Medicare beneficiary obtains a prescription drug covered by Medicare Part B or Part D, the beneficiary is often required to make a partial payment, which may take the form of a co-payment, co-insurance, or deductible (collectively “co-pays”). These co-pay obligations may be substantial for expensive medications. Congress included co-pay requirements in these programs, in part, to encourage market forces to serve as a check on health care costs, including the prices that pharmaceutical manufacturers can demand for their drugs. The AKS prohibits pharmaceutical companies 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 companies’ drugs.

“For far too long, Teva gamed the charitable foundation process by paying kickbacks through two foundations, and with the aid of a specialty pharmacy. Those kickbacks undermined the purpose of the Medicare co-pay system and violated the Anti-Kickback Statute,” said Acting United States Attorney Joshua S. Levy. “This Office has taken the leading role in cracking down on these highly lucrative schemes that drive up the cost of essential drugs by bringing multiple enforcement actions that have returned more than $1 billion to the Medicare system. We will continue to pursue these actions to ensure that all pharmaceutical companies play by the rules and to protect the American taxpayers.

“Kickbacks designed to induce referrals or purchases of healthcare goods or services distort physician and patient decision-making, thwart competition and bypass controls put in place to protect federal health care programs,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Justice Department is committed to pursuing those who engage in kickback violations, including drug manufacturers, to ensure that federal health care programs continue to serve the interests of taxpayers and program beneficiaries.”

“Pharmaceutical companies that disguise kickbacks as charitable donations to subsidize co-pays for their own drugs undermine a critical safeguard against the excessive inflation of drug prices.  The costs of these schemes are ultimately passed on to consumers and taxpayers,” said Roberto Coviello, Special Agent in Charge of the U.S. Department of Health and Human Services, Office of Inspector General. “Such conduct cannot be tolerated within our health care system, and we will continue to vigorously pursue such allegations.”

“Today’s record-breaking settlement with Teva Pharmaceuticals is a victory for the public and highlights the FBI’s commitment to safeguarding the financial integrity of the Medicare program,” said Jodi Cohen, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division. “Pharmaceutical companies that look to bolster their drug prices by paying illegal kickbacks – whether directly or indirectly – undermine taxpayer funded healthcare programs and compromise patient care. The FBI will continue to pursue these investigations until pharmaceutical companies stop engaging in this conduct.”

Acting U.S. Attorney Levy, Principal Deputy AAG Boynton, HHS-OIG SAC Coviello and FBI SAC Cohen made the announcement today. The matter was handled by Assistant U.S. Attorney Abraham R. George, Chief of the Civil Division; Assistant U.S. Attorneys Diane Seol and Evan Panich of the U.S. Attorney’s Office for the District of Massachusetts; and Trial Attorneys Douglas Rosenthal and Nelson Wagner of the Justice Department’s Civil Division.

The civil action in Massachusetts is captioned United States v. Teva Pharmaceuticals USA, Inc., et al., No. 20-cv-11548 (D. Mass.).