title: Long-term outcome of defibrillator recipients included in the federal audit conducted by the Department of Justice.
abstract: 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 patient's clinical condition allows it.
authors.affiliation: Department of Medicine, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Nasir
authors.initials: N
authors.lastname: Shariff
authors.affiliation: Department of Medicine, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Shiraz
authors.initials: S
authors.lastname: Rahim
authors.affiliation: Department of Medicine, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Jain
authors.affiliation: Department of Medicine, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: William
authors.initials: W
authors.lastname: Barrington
authors.affiliation: Department of Medicine, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address: sabas@upmc.edu.
authors.forename: Samir
authors.initials: S
authors.lastname: Saba
mesh_terms: D000368:Aged; D002423:Cause of Death / Q000639:trends; D054869:Clinical Audit / Q000331:legislation & jurisprudence*; D047548:Defibrillators; D035082:Federal Government; D005500:Follow-Up Studies; D006078:Government Programs / Q000331:legislation & jurisprudence*; D006801:Humans; D008297:Male; D012935:Social Justice / Q000331:legislation & jurisprudence*; D017180:Tachycardia, Ventricular / Q000401:mortality / Q000628:therapy*; D013997:Time Factors; D014481:United States / Q000453:epidemiology