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FDAnews Device Daily Bulletin
Sept. 12, 2012 | Vol. 9 No. 179
DoJ Steps Closer to ICD Settlement, May Be Good News for Devicemakers
The outlook for companies making implantable cardiac defibrillators (ICDs) may have just gotten a bit brighter, as the U.S. Department of Justice (DoJ) took a significant step toward closing out its investigation of off-label use of ICDs in U.S. hospitals. On Aug. 30, the department began emailing a document to hospitals that lays out specific scenarios of ICD usage that would not be covered by Medicare and discusses whether DoJ would enforce penalties against the hospitals involved in each situation.
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