Long-Term Outcome of Defibrillator Recipients Included in the Federal Audit Conducted by the Department of Justice

Institutions across the United States have been subjected to a federal audit for defibrillator implantable cardioverter defibrillator [ICD] implantations that violated the Centers for Medicare and Medicaid payment policy. We examined the long-term outcome of ICD recipients whose implantation procedures were audited by the Department of Justice (DOJ). Patients (n = 225) included in the DOJ audit at the University of Pittsburgh Medical Center between the years 2003 and 2010 were followed to the end point of all-cause mortality. A cohort of 206 consecutive and contemporary ICD recipients not included in the federal audit served as controls. Compared with the controls, the audited cases were older (p <0.001), had more preserved ejection fraction (p <0.001), and were less likely to be implanted for a primary prevention indication (p = 0.001). They also had significantly shorter time from myocardial infarction (p <0.001) or revascularization (p <0.001) to ICD implantation. Over a median follow-up of 3.6 years, 187 patients died and 71 received ICD therapy for ventricular arrhythmias. Patients whose cases were audited had worse survival compared with controls (hazard ratio 1.41, 95% confidence interval 1.05 to 1.90, p = 0.023) even after correcting for differences in baseline characteristics (hazard ratio 1.46, 95% confidence interval 1.05 to 2.02, p = 0.023). Rates of appropriate and inappropriate ICD therapies were similar between the audited cases and controls. In conclusion, patients whose ICD implantations were audited by the DOJ have worse long-term survival compared with nonaudited control patients. These data support compliance with the Centers for Medicare and Medicaid guidelines when the individual patientʹs clinical condition allows it.