Boston Scientific Corp. received a subpoena this week from the Department of Health and Human Services (HHS), seeking information about the performance of some of its implanted cardiac defibrillators.
The May 5 subpoena came from HHS’s Office of the Inspector General, which responsible for identifying fraud and waste in government health programs such as Medicare and Medicaid, the according to the Wall Street Journal reports. The subpoena requested information about the 2008 launch of two brands of implanted cardiac defibrillators (ICDs) – Cognis and Teligen – Boston Scientific revealed in a regulatory filing made on Thursday. Also requested was information on device performance between 2007 and 2009 and information about the company’s Physician Guided Learning Program. Boston Scientific said it is cooperating with the request, according to the WSJ.
Boston Scientific makes a number of implantable heart devices, including defibrillators, pacemakers, and stents, which prop open narrowed or weakened arteries. Medtronic Inc. and St. Jude Medical Inc. are also major manufacturers of implantable heart devices. The WSJ reports that the entire industry has been under scrutiny for allegedly using illegal incentives to increase the use of their devices by physicians.
In October 2013, Boston Scientific agreed to pay $30 million to settle Department of Justice allegations that between 2002 and 2005 its subsidiary Guidant Corp. had knowingly sold defective defibrillators that were implanted in Medicare patients, the WSJ reports. (Boston Scientific acquired Guidant in 2006.) The Justice Department is investigating St. Jude for allegedly paying inducements to health care providers in exchange for implanting St. Jude’s devices, according to a company filing. In 2011, Medtronic paid $23.5 million in to settle Justice Department allegations that it paid illegal kickbacks to physicians to induce them to use Medtronic pacemakers and defibrillators in their cardiac patients.