BOSTON, Ms. – The U.S. Attorney’s Office announced today that pharmaceutical company Actelion Pharmaceuticals US, Inc. (Actelion), a seller of pulmonary arterial hypertension (PAH) drugs, has agreed to pay $360 million to resolve allegations that it violated the False Claims Act by paying kickbacks to Medicare patients through a purportedly independent charitable foundation.
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”). 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 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.
Actelion sells a number of PAH drugs, including Tracleer, Ventavis, Veletri, and Opsumit. As part of today’s settlement, the government alleged that Actelion used a foundation as a conduit to pay the co-pay obligations of thousands of Medicare patients taking Actelion’s PAH drugs. By doing so, the government alleged, Actelion was able to induce patients to purchase its drugs when the prices Actelion had set for those drugs otherwise could have posed a barrier to purchases.
The government alleges that in 2014 and 2015, Actelion routinely obtained data from the foundation detailing how many patients on each Actelion drug the foundation had assisted, how much the foundation had spent on those patients, and how much the foundation expected to spend on those patients in the future. Actelion used this information to budget for future payments to the foundation on a drug-specific basis and to confirm that its contribution amounts to the foundation were sufficient to cover the copays of patients taking Actelion’s drugs, but not of patients taking other manufacturers’ PAH drugs. Actelion engaged in this practice even though the foundation warned the company against receiving data concerning the foundation’s expenditures on copays for Actelion’s drugs.
Meanwhile, the government also alleged that Actelion had a policy of not permitting Medicare patients to participate in its free drug program, which was open to other financially needy patients, even if those Medicare patients could not afford their copays for Actelion’s drugs. Instead, to generate revenue from Medicare and induce purchases of its drugs, the government alleged that Actelion referred such Medicare patients to the foundation, which allowed the patients’ copays to be paid and resulted in claims to Medicare for the remaining cost.
“Using data from a foundation that it knew it should not have, Actelion effectively set up a proprietary fund to cover the co-pays of just its own drugs,” said United States Attorney Andrew E. Lelling. “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, Actelion raised the price of its main PAH drug, Tracleer, by nearly 30 times the rate of overall inflation in the United States.”
“This settlement, as do prior settlements concerning similar misconduct, make clear that the government will hold accountable drug companies that pay illegal kickbacks,” said Assistant Attorney General Joseph H. Hunt of the Department Justice’s Civil Division. “Pharmaceutical companies cannot have it both ways—they cannot continue to increase drug prices while engaging in conduct designed to defeat the mechanisms that Congress designed to check such prices and then expect Medicare to pay for the ballooning costs.”
“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.”
“Today’s settlement against Actelion is a victory for the public and underscores the FBI’s commitment to safeguarding the financial integrity of the Medicare program,” said Harold H. Shaw, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division. “Simply put, the goal of the FBI’s Health Care Fraud program is to ensure that patients receive the appropriate treatments and therapies according to their medical needs, without corrupt or profit-driven influence of drug manufacturers.”
On June 16, 2017, after the conduct alleged in today’s settlement agreement, Johnson & Johnson acquired Actelion. Johnson & Johnson was not involved, directly or indirectly, in the alleged conduct and the allegations above do not relate in any way to Johnson & Johnson.
U.S. Attorney Lelling, Assistant Attorney General Hunt, HHS-OIG SAC Coyne, and FBI SAC Shaw 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 Office, and by Trial Attorneys Augustine Ripa and Sarah Arni of the Justice Department’s Civil Division.
SOURCE: news provided by JUSTICE.GOV on Thursday, December 6, 2018.