WASHINGTON, D.C., October 15, 2004 — The Centers for Medicare and Medicaid Services (CMS) has asked the Heart Rhythm Society to lead an Implantable Cardioverter Defibrillator (ICD) Registry Working Group in response to its recent draft coverage decision for these medical devices.

As part of the draft coverage decision, CMS has proposed a national registry be implemented for primary prevention ICD therapy. Medical registries are often used to monitor medical conditions and outcomes after the implementation of prevention and treatment programs.

This working group’s charge is to provide recommendations to develop a national registry to follow Medicare/Medicaid patients receiving an ICD for primary prevention therapy.

Stephen Hammill, MD, FHRS to Chair, ICD Registry Working Group

“We commend CMS in their decision to expand access to these life-saving devices and recommend immediate implementation,” said Stephen C. Hammill, M.D., President of the Heart Rhythm Society, the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders.

The recommendations will address: (1) Feasibility of a mandatory national registry, (2)  Purpose of the registry including main questions to be answered, (3)  Design of registry, (4)  Patient and medical device data elements collected, (5)  Registry management, and (6)  Funding.

Confirmed members of the working group include representatives from the following organizations, academic centers, and companies:

· Heart Rhythm Society

· American College of Cardiology

· Heart Failure Society of America

· Duke Clinical Research Institute

· University of Pittsburgh Epidemiology Data Center

· Indiana University Krannert Institute of Cardiology

· Guidant

· Medtronic

· St. Jude

Meetings will be held in October and November, 2004. The presentation and submission of recommendations to CMS is expected by late November 2004.