Author + information
- Received September 19, 2011
- Revision received November 11, 2011
- Accepted December 3, 2011
- Published online April 3, 2012.
- Jonathan S. Steinberg, MD⁎ ( and )
- Suneet Mittal, MD
- ↵⁎Reprint requests and correspondence:
Dr. Jonathan S. Steinberg, Valley Health System, Arrhythmia Institute, 5 Columbus Circle, Suite 1500, New York, New York 10019
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.
- CMS indications
- Department of Justice
- federal audit
- implantable cardioverter-defibrillator
- National Coverage Determination
Dr. Steinberg is a consultant for Medtronic, St. Jude Medical, and Cameron Health, and has received research support from Medtronic. Dr. Mittal is a consultant for Medtronic, Boston-Scientific, and Biotronik.
- Received September 19, 2011.
- Revision received November 11, 2011.
- Accepted December 3, 2011.
- American College of Cardiology Foundation