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Press Release
Preet Bharara, the United States Attorney for the Southern District of New York, Diego Rodriguez, the Assistant Director-in-Charge of the New York Office of the Federal Bureau of Investigation (“FBI”), and Scott J. Lampert, Special Agent in Charge of the U.S. Department of Health and Human Services, Office of Inspector General's New York Regional Office (“HHS-OIG”) announced yesterday a $60 million settlement of a civil fraud lawsuit against ACCREDO HEALTH GROUP (“ACCREDO”) concerning a kickback scheme with NOVARTIS PHARMACEUTICALS CORP. (“NOVARTIS”) involving the prescription drug Exjade. In addition to filing a Notice of Intervention against and Stipulation and Order of Settlement and Dismissal with ACCREDO, the Government has elected to intervene against NOVARTIS over the same conduct previously filed by a whistleblower. As alleged in the lawsuit, NOVARTIS provided kickbacks, in the form of patient referrals and related benefits, to ACCREDO in exchange for ACCREDO’s recommending refills to Exjade patients. In connection with the scheme, the defendants understated the serious and potentially life-threatening side effects of Exjade when promoting the drug’s benefits to patients.
Simultaneous with the filing of the Notice of Intervention against ACCREDO, U.S. District Judge Colleen McMahon approved a settlement to resolve the United States’ claims against ACCREDO. Under that settlement, ACCREDO (i) agrees to pay $45,060,598.87 to the United States; (ii) admits numerous facts concerning its relationship with NOVARTIS; and (iii) agrees to cooperate with the United States in the prosecution of the claims against NOVARTIS. ACCREDO has also agreed in principle to pay $14,939,401.13 to a group of states to settle the states’ claims based on the same alleged conduct. In January 2014, the Government entered into a multimillion dollar settlement with another codefendant, Bioscrip Pharmacy, for similar conduct.
Manhattan U.S. Attorney Preet Bharara said: “This is the second substantial settlement with an alleged co-conspirator of Novartis in connection with a scheme that used the lure of kickbacks to co-opt a healthcare provider’s independence. As alleged in our intervention papers, Novartis used Accredo to promote refills under the guise of purported ‘counseling’ and ‘education,’ and in doing so, Novartis caused patients to receive one-sided advice that did not discuss Exjade’s serious, potentially life-threatening, side effects. This settlement with Accredo restores to the public fisc tens of millions of dollars paid out for kickback-tainted drugs.”
FBI Assistant Director-in-Charge Diego Rodriguez said: “Drug companies are required by law to provide safe and effective medications for the sole purpose of healing the ailments of their patients. Likewise, pharmaceutical companies are prohibited from employing tactics that could improperly influence a provider’s decisions. Through its relationship with Novartis, Accredo Health Group acted in its own best interest. It set aside the needs of its patients and intentionally adjusted its practices in order to conceal information from consumers. This scheme also placed a hefty price tag on our Medicare and Medicaid programs, causing more than tens of millions of dollars to be spent on Exjade shipments. Today’s settlement demonstrates the government’s commitment to protect our citizens from this type of fraud and ensure everyone receives the quality medical care they need.”
HHS-OIG Special Agent in Charge Scott J. Lampert said: “The conduct displayed by Accredo compromised patient care and undermined the integrity of our nation's health care programs. This settlement should serve as a warning to all providers that choose to let financial inducements cloud their medical judgment.”
As alleged in the Government’s second amended Complaint and in the relator’s third amended Complaint, NOVARTIS markets and manufactures Exjade, an iron chelation drug approved for use by patients who have iron overload resulting from blood transfusions. For approximately five years until 2012, NOVARTIS orchestrated a scheme whereby it offered kickbacks, in the form of patient referrals and other benefits to certain specialty pharmacies, including ACCREDO and Bioscrip, in exchange for increasing their Exjade refills through biased recommendations to patients. ACCREDO and Bioscrip were part of a NOVARTIS-created exclusive distribution network for Exjade called the Exjade Patient Assistance and Support Services (“EPASS”), and through this network NOVARTIS was able to refer Exjade patients to particular pharmacies within the network.
In particular, the Government has elected to intervene in the relator’s third amended Complaint with respect to its allegations concerning NOVARTIS and ACCREDO’s participation in an Exjade patient referral allocation scheme through which NOVARTIS gave ACCREDO additional patient referrals and related benefits in return for ACCREDO achieving the highest refill percentage for Exjade patients as compared to the refill percentages among Exjade patients at the other two pharmacies in the closed distribution network that NOVARTIS had established for Exjade.
As part of its settlement with the United States, ACCREDO made extensive factual admissions, including that:
The Government seeks treble damages and penalties under the False Claims Act for the tens of millions of dollars in reimbursements that Medicare and Medicaid paid for Exjade shipments that resulted from the kickback scheme involving NOVARTIS and ACCREDO.
The allegations of fraud stated in the Complaint were first brought to the attention of federal law enforcement by David Kester, the whistle-blower who filed a lawsuit under the False Claims Act. The False Claims Act permits the Government to recover up to three times the amount of damages incurred by the United States, plus civil penalties ranging from $5,500 to $11,000 per violation. Private parties who have knowledge of fraud committed against the Government may file suit on behalf of the Government and share in any recovery. The United States may then intervene and file its own lawsuit for treble damages and penalties, as it did in this case.
Mr. Bharara praised the investigative work of the, HHS-OIG, and the Medicaid Fraud Control Units for New York, Washington, California, and Ohio. He also thanked the Commercial Litigation Branch of the U.S. Department of Justice’s Civil Division in Washington, D.C., for its assistance in this case.
The case is being handled by the Office’s Civil Frauds Unit. Mr. Bharara established the Civil Frauds Unit in March 2010 to bring renewed focus and additional resources to combating healthcare and other types of frauds. Assistant U.S. Attorneys Li Yu, Rebecca C. Martin, David J. Kennedy, Jeffrey K. Powell, and Peter Aronoff are in charge of the case.