Medicare to Monitor New Defibrillator Data

WASHINGTON (Reuters) - Medicare officials plan to monitor a new database for more information about the use of a popular implantable heart device at 1,300 U.S. hospitals, the agency said on Thursday.

New data from the American College of Cardiology National Cardiovascular Data Registry will help the nation's insurance program for the poor and elderly "learn more about the use" of the implantable cardioverter defibrillators (ICD), officials said in a statement.

"The Medicare aggregate data from the ICD Registry will be made available to the public to better inform patients and physicians on the most appropriate ICD therapy. Better evidence means better decisions by doctors and patients," said Medicare chief Mark McClellan.

Medicare has been using its own database, called QNet, to gather such information since agreeing to pay for ICDs in January. It will use the new data in addition to its own information, they said.

ICDs are small stopwatch-sized devices implanted under the skin near the collarbone. They deliver electrical shocks to the heart to stop abnormal heartbeats and cost about $25,000 each.

Medicare decided to cover ICDs based on a landmark National Institutes of Health trial, funded by Medtronic Inc, called SCD-HeFT, that showed they saved lives in a broad group of cardiac patients.

But the agency still has questions it hopes the new data can help answer.

"The evidence on benefits of ICD implantation in certain subgroups was not as strong, and it is important for doctors to get better evidence on the use of these devices for these patients as well," the agency said.

"Many Medicare beneficiaries are older than the patients studied in SCD-HeFT, and many others who are at high risk of cardiac events do not closely match the characteristics of the group in which there was a clear benefit."

An agency spokesman could not immediately comment on how much use of the new registry would cost.

Officials will start using the new database, developed in part by the Heart Rhythm Society medical association, on April 1, 2006.