biospaceMarch 12, 2018
Tag: Abiomed
Medtech company Abiomed, Inc. will pay the U.S. government $3.1 million to settle allegations that the company sought to influence doctors to use the company’s line of heart pumps in a kickback scheme, the U.S. Department of Justice announced on Thursday.
Between 2012 and 2015 the DOJ alleged Danvers, Mass.-based Abiomed provided lavish meals to physicians at exclusive restaurants in order to sway them to use the company’s line of Impella Pumps, which have a cost of about $20,000 each. The Justice Department said some of the restaurants the company wined and dined the physicians at include Spago in Beverly Hills, Menton in Boston, Nobu in Los Angeles and New York’s Eleven Madison Park. The DOJ said the meals included large amounts of alcohol that were "inconsistent with legitimate scientific discussion." Abiomed also paid for the meals of spouses and significant others at these restaurants, "even though the spouses had no legitimate business purpose for attending the meal." Additionally, the DOJ said the costs of the meals exceeded the $150 per person guidelines established by Abiomed for meals. The announcement said one meal exceeded $450 per attendee. Also, the company attempted to cover up who attended these meals by using "generic names," or attempted to bolster the alleged number of guest at the meal by including fictitious names, the DOJ added.
United States Attorney Andrew E. Lelling said the $3.1 billion settlement with Abiomed should serve as a warning to medical device manufacturers "who try to improperly influence the treatment decisions of physicians."
"Providing doctors with lavish meals, or meals that focus on entertainment rather than education or science, can impair a physician’s independent medical judgment – something each and every patient is entitled to. My office will continue to investigate sales practices that interfere with that independent medical judgment and that heighten the risk of improper use of limited federal healthcare dollars," Lelling said in a statement.
While Abiomed will pay the fine, Reuters noted that in a filing with the U.S. Securities and Exchange Commission, the company said it did not admit liability in settling. Abiomed said the federal government’s probe revealed that the meals exceeding its $150 guideline made up less than 2 percent of the meals the company paid for, Reuters reported.
The Department of Justice was alerted to the alleged kickback scheme by a whistleblower.
An Abiomed spokesperson told the Boston Globe that the company was putting the matter behind it so it can focus on its heart recovery mission and "continue investing in innovation, education and clinical support to ensure we help improve patient outcomes."
In February Abiomed won expanded approval from the U.S. Food and Drug Administration for the use of its Impella 2.5 and Impella CP heart pumps during elective and urgent high risk percutaneous coronary intervention (PCI) procedures. The Abiomed pumps are also approved to treat certain advanced heart failure patients undergoing elective and urgent PCI procedures such as stenting or balloon angioplasty.
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