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The U.S. Attorney’s Office announced this week that two pharmaceutical companies – Astellas Pharma US, Inc. (Astellas), and Amgen Inc. (Amgen) – have agreed to pay a total of $124.75 million to resolve allegations that they violated the False Claims Act by illegally paying the Medicare co-pays for their own high-priced drugs.

When a Medicare beneficiary obtains a prescription drug covered by Medicare Part B or Part D, the beneficiary may be required to make a partial payment, which may take the form of a co-payment, co-insurance, or deductible (collectively, co-pays). 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 Anti-Kickback Statute 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.

“According to the allegations in today’s settlements, Astellas and Amgen conspired with two co-pay foundations to create funds that functioned almost exclusively to benefit patients taking Astellas and Amgen drugs,” said United States Attorney Andrew E. Lelling. “As a result, the companies’ payments to the foundations were not ‘donations,’ but rather were kickbacks that undermined the structure of the Medicare program and illegally subsidized the high costs of the companies’ drugs at the expense of American taxpayers. We will keep pursuing these cases until pharmaceutical companies stop engaging in this kind of behavior.”

“When pharmaceutical companies use foundations to create funds that are used improperly to subsidize the copays of only their own drugs, it violates the law and undercuts a key safeguard against rising drug costs,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “These enforcement actions make clear that the government will hold accountable drug companies that directly or indirectly pay illegal kickbacks.”

“Kickback schemes can undermine our healthcare system, compromise medical decisions, and waste taxpayer dollars,” said Phillip Coyne, Special Agent in Charge, Office of the Inspector General of the Department of Health and Human Service’s Boston Regional Office.  “We will continue to hold pharmaceutical companies accountable for subverting the charitable donation process in order to circumvent safeguards designed to protect the integrity of the Medicare program.”

“As today’s settlements make clear, the FBI will aggressively go after pharmaceutical companies that look to bolster their drug prices by paying illegal kickbacks–whether directly or indirectly–to undermine taxpayer funded healthcare programs, including Medicare,” said Joseph R. Bonavolonta, Special Agent in Charge of the FBI Boston Division.

The government’s allegations in the two settlements announced today are as follows:

Astellas. Astellas sells Xtandi, an androgen receptor inhibitor (ARI) drug used to treat metastatic castration resistant prostate cancer (mCRPC) in patients who have failed chemotherapy. While there are other mCRPC drugs, none of the other major mCRPC drugs is an ARI. The government alleges that, during the period from July 2013 through December 2014, Astellas arranged for two foundations to operate ARI funds that covered mCRPC patients’ co-pays for ARIs, but not for other mCRPC drugs, and that Xtandi patients received nearly all of the assistance from these two funds. The government further alleges that, during the time that the ARI funds were open, Astellas promoted the existence of the ARI funds as an advantage for Xtandi over competing mCRPC drugs in an effort to persuade medical providers to prescribe Xtandi. During this period, Astellas raised the price of Xtandi at over 24 times the rate of overall inflation in the United States. Astellas has agreed to pay $100 million to resolve the government’s allegations.

Amgen. Amgen sells Sensipar, a treatment for secondary hyperparathyroidism (SHPT), and Kyprolis, a treatment of multiple myeloma. The government alleges that, in late 2011, Amgen stopped donating to a foundation that covered co-pays for patients taking any of several SHPT drugs and approached a new foundation about creating a fund that would cover only Sensipar patients’ Medicare co-pays. Amgen thereafter paid millions of dollars to this fund. Until June 2014, the fund helped only Sensipar patients, as Amgen had requested. Amgen allegedly covered the co-pays of Sensipar patients through this fund even though the cost of doing so exceeded the cost Amgen would have incurred by providing free Sensipar to the same patients. By enabling the fund to cover the copays of Medicare beneficiaries, Amgen caused claims to be submitted to Medicare and generated revenue for itself. During the period the fund covered only Sensipar, Amgen raised the price of Sensipar at over four times the rate of overall inflation in the United States.

The government further alleges that Amgen’s predecessor, Onyx Pharmaceuticals Inc. (Onyx), asked a different foundation to create a fund that, ostensibly, would cover health care related travel expenses for patients taking any multiple myeloma drug, but that, as Onyx and the foundation both knew, functioned almost exclusively to cover travel expenses for patients taking Kyprolis. The foundation also operated a second fund that covered co-pays for several multiple myeloma drugs, including Kyprolis. The government alleges that, for 2013, Onyx obtained data from the foundation on the multiple myeloma fund’s anticipated and actual expenses for coverage only of Kyprolis co-pays. Onyx then donated to the fund in an amount Onyx understood to be sufficient only to cover the co-pays of Kyprolis patients. Amgen has agreed to pay $24.75 million to resolve the government’s allegations.

Amgen and Astellas each entered five-year corporate integrity agreements (CIAs) with OIG as part of their respective settlements. The CIAs require the companies to implement measures, controls, and monitoring designed to promote independence from any patient assistance programs to which they donate. In addition, the companies agreed to implement risk assessment programs and to obtain compliance-related certifications from company executives and Board members.

To date, the Department of Justice has collected over $840 million from eight pharmaceutical companies (United TherapeuticsPfizerActelionJazz, Lundbeck, Alexion, Astellas, and Amgen) that allegedly used third-party foundations as kickback vehicles. The U.S. Attorney’s Office for the District of Massachusetts initiated each of these investigations.

U.S. Attorney Lelling, Assistant Attorney General Hunt, HHS-OIG SAC Coyne, and FBI SAC Bonavolonta made the announcement today. The U.S. Postal Inspection Service also assisted with the investigation. The matter was handled by Assistant U.S. Attorneys Gregg Shapiro and Abraham George, of Lelling’s Affirmative Civil Enforcement Unit, and by Trial Attorneys Augustine Ripa and Sarah Arni of the Justice Department’s Civil Division.

This is a press release from the US Department of Justice.

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