05.08.14
On May 8, Natick, Mass.-based medical device maker Boston Scientific Corp. reported receiving subpoenas from the U.S. Department of Health and Human Services (HHS) looking for information about some of its implantable cardioverter defibrillators (ICDs). Boston Scientific officials said the company would cooperate with the request.
According to a regulatory filing by the company, in the subpoena (issued May 5), the government asked for documents related to the company's Cognix and Teligen ICDs—specifically information related to the performance of the devices between 2007 and 2009, and the operation of a "Physician Guided Learning Program," the filing said.
The subpoena was issued by HHS's Office of the Inspector General, which is responsible for identifying fraud and waste in government health programs such as Medicare and Medicaid.
This is not new territory for the medical device industry, which has been in the spotlight for some companies allegedly using kickbacks and other illegal incentives to gain market share and increase the use of their devices among physicians.
On May 7, St. Paul, Minn.-based St. Jude Medical Inc. released in a regulatory filing that the U.S. Department of Justice has issued the company a civil investigative demand from in April related to its cardiac devices. The DOJ is investigating St. Jude for allegedly paying inducements to doctors in exchange for implanting the firm's devices.
St. Jude also said it is working with the DOJ.
Late last year, Boston Scientific agreed to pay $30 million to settle DOJ allegations that Guidant Corp. (which Boston Scientific acquired in 2006) had knowingly sold defective defibrillators between 2002 and 2005 that were implanted in Medicare patients.
Minneapolis, Minn.-based Medtronic Inc. paid $23.5 million in 2011 to settle a DOJ investigation that the company had paid kickbacks to physicians to induce them to use the firm's pacemakers and defibrillators.
According to a regulatory filing by the company, in the subpoena (issued May 5), the government asked for documents related to the company's Cognix and Teligen ICDs—specifically information related to the performance of the devices between 2007 and 2009, and the operation of a "Physician Guided Learning Program," the filing said.
The subpoena was issued by HHS's Office of the Inspector General, which is responsible for identifying fraud and waste in government health programs such as Medicare and Medicaid.
This is not new territory for the medical device industry, which has been in the spotlight for some companies allegedly using kickbacks and other illegal incentives to gain market share and increase the use of their devices among physicians.
On May 7, St. Paul, Minn.-based St. Jude Medical Inc. released in a regulatory filing that the U.S. Department of Justice has issued the company a civil investigative demand from in April related to its cardiac devices. The DOJ is investigating St. Jude for allegedly paying inducements to doctors in exchange for implanting the firm's devices.
St. Jude also said it is working with the DOJ.
Late last year, Boston Scientific agreed to pay $30 million to settle DOJ allegations that Guidant Corp. (which Boston Scientific acquired in 2006) had knowingly sold defective defibrillators between 2002 and 2005 that were implanted in Medicare patients.
Minneapolis, Minn.-based Medtronic Inc. paid $23.5 million in 2011 to settle a DOJ investigation that the company had paid kickbacks to physicians to induce them to use the firm's pacemakers and defibrillators.