Novartis Sued by U.S. for Fraud Over Payments to Pharmaci By Bob Van Voris - Apr 25, 2013 5:30 AM GMT+0800 Novartis AG (NOVN) was sued by the U.S. for allegedly making illegal payments to pharmacies for switching transplant patients to its drug Myfortic, the second time in less than three years the company has faced federal claims it used illegal kickbacks to increase sales. The U.S. sued Basel, Switzerland-based Novartis in federal court in Manhattan yesterday, claiming it violated the False Claims Act by paying kickbacks, disguised as rebates and discounts, to at least 20 pharmacies for switching patients to Myfortic from drugs sold by other companies. "Novartis caused the public to pay tens of millions of dollars for kickback-tainted drugs that were dispensed by pharmacists who were in cahoots with the company," Manhattan U.S. Attorney Preet Bharara said in a statement yesterday. The U.S. is seeking triple damages, restitution and civil penalties. In the statement, Bharara called Novartis "a repeat offender," saying the company had settled kickback claims less than three years ago.
2010 Settlement In September 2010, Novartis agreed to pay $422.5 million to resolve criminal and civil charges that it paid kickbacks and illegally promoted drugs for off-label uses. As part of the settlement, the company signed a five-year corporate integrity agreement with the Department of Health and Human Services, which required reforms including a compliance program relating to promotional activities. The 80-page agreement provides that Novartis may be barred from participation in federal health care programs, including Medicare and Medicaid, for a "material breach." The U.S. claims that Novartis offered the Myfortic kickbacks from 2005 to the present. In 2011, within months of signing the corporate integrity agreement, Novartis negotiated with Walgreen Co. (WAG) to try to get the drug store chain to join in the alleged illegal scheme, the government said. Novartis said in a statement yesterday that it disputes the government's allegations and will defend itself in the case. Julie Masow, a Novartis spokeswoman, declined to comment on the agreement with HHS. Jim Graham, a Walgreen spokesman, declined to comment.
Open Matter "This is an open matter," the HHS inspector general's office said in a statement today. The office declined to say whether Novartis violated the corporate integrity agreement or what actions the office may take. "Conduct that violates the False Claims Act may or may not violate the terms of a CIA," according to the statement. The agreements are focused on setting up compliance programs and don't guarantee a company won't violate the law, the inspector general's office said. By filing the civil complaint, the U.S. joined in a suit filed under seal against Novartis in 2011. The identity of the private plaintiff who filed the original lawsuit and documents filed before yesterday in the case remain under seal. Myfortic is an immunosuppressant drug used to help prevent organ rejection in kidney transplant patients. The drug's main competitors are Roche Holding AG (ROG)'s CellCept and, since 2009, generic versions of CellCept, according to the government. In 2011, the Medicare Part B reimbursement for Myfortic was more than twice that for generic CellCept, according to the government.
Anti-Kickback Statute The U.S. said it told Novartis and other drug companies in 1994 that offering financial benefits to pharmacies for influencing doctors to switch patients from one prescription drug to another could violate the federal anti-kickback statute. The complaint named five pharmacies that participated in the alleged scheme, including the outpatient pharmacy at Baylor Hospital in Dallas. "We are not a defendant, nonetheless we are looking into the allegations," Julie Smith, a Baylor Hospital spokeswoman, said today. In the 2011 negotiations with Walgreen, Novartis tried to get the drug store chain to encourage use of Myfortic, through its on-site pharmacies at transplant centers and its mail-order division, instead of CellCept and generic CellCept, in exchange for payments, according to Bharara's office. The complaint didn't say whether any deal was reached. The case is U.S. v. Novartis Pharmaceuticals Corp., 11-cv- 08196, U.S. District Court, Southern District of New York (Manhattan).
諾華因涉嫌向藥店支付回扣遭美國政府起訴 2013年04月24日 15:30:01來源： 南方網 北京時間4月24日午間消息，據外電報道，美國政府周二以醫療欺詐為名對瑞士制藥巨頭諾華制藥提起訴訟，稱諾華為了讓器官移植患者棄用其它公司藥品、轉而使用本公司的麥考酚酸酯緩釋片(Myfortic)向藥店支付回扣。據彭博社報道，美國政府周二在曼哈頓聯邦法庭對諾華發起訴訟，稱該公司支付回扣的行為違反了《虛假申報法》(False Claims Act)。諾華將回扣偽裝成返利和打折的形式支付給了至少20家藥店，讓患者從其它公司出售的藥品轉移至麥考酚酸酯緩釋片。美國政府在訴狀中稱，諾華此舉導致醫療保險和醫療補助項目需要支付數百萬美元虛報費用。曼哈頓聯邦檢察官普利特-巴拉拉(Preet Bharara)表示："由于藥店出于未公開的財務考慮而不是獨立臨床考慮給出的建議，數百或者可能數千器官移植患者已經接受了藥物更改。"美國政府尋求三倍損害賠償、退回以及民事處罰。巴拉拉在公告中稱諾華是一個"慣犯"，稱該公司曾在2年多前解決過回扣訴訟。2010年9月，諾華同意支付4.225億美元解決針對其支付回扣、非法營銷行為的刑事和民事訴訟。作為和解的一部分，諾華與美國健康與人類服務部(HHS)簽署了一份為期5年的企業誠信協議。根據這項長達80頁的協議，諾華需要實施改革，包括啟動一個營銷活動相關的合規項目。協議規定，如果諾華發生實質違約，可能會被拒絕參加美國聯邦醫療保健項目。HHS發言人唐納德-懷特(Donald White)未即刻回應詢問此事的語音郵件。諾華今日發布公告稱，對政府的指控進行了爭辯，並將在此案中為自身辯護，該公司發言人Julie Masow拒絕就與HHS簽署的協議置評。
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