title: The federal audit of implantable cardioverter-defibrillator implants: lessons learned.
abstract: The federal government has investigated a large number of institutions regarding concerns that implantable cardioverter-defibrillator procedures were performed in violation of the criteria set forth in a National Coverage Determination. We describe our experience and responses to such an audit, as well as the to complexities and nuances of practicing evidence-based medicine in the setting of heavy regulatory oversight.
authors.affiliation: Arrhythmia Institute, Valley Health System, Columbia University College of Physicians & Surgeons, New York, NY 10019, USA. jss7@columbia.edu
authors.forename: Jonathan S
authors.initials: JS
authors.lastname: Steinberg
authors.forename: Suneet
authors.initials: S
authors.lastname: Mittal
mesh_terms: D017147:Defibrillators, Implantable / Q000592:standards*; D019317:Evidence-Based Medicine; D035082:Federal Government; D005260:Female; D006323:Heart Arrest / Q000628:therapy; D006801:Humans; D008297:Male; D008485:Medical Audit / Q000331:legislation & jurisprudence*; D017751:Safety Management / Q000331:legislation & jurisprudence*; D014481:United States