FDAnews Device Daily Bulletin

NEW ICD REGISTRY LINKED TO MEDICARE SYSTEM, WILL HELP MONITOR ICDS

April 11, 2006
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The National ICD Registry became the official database for Medicare patients April 3, providing patients and physicians with more detailed information on implantable cardioverter defibrillators (ICD)s.

A partnership project of the American College of Cardiology Foundation and the Heart Rhythm Society, the registry collects detailed information on ICD implants to assess and improve the care of patients receiving ICDs. More than 1,300 hospitals are in the process of enrolling participants.

In January 2005, the Centers for Medicare & Medicaid Services (CMS) announced it would expand Medicare coverage of ICDs based on results of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), which substantiated the health benefits of the devices.

The decision to expand Medicare coverage of ICDs increases the number of eligible Medicare beneficiaries to nearly 500,000 and requires hospitals to submit data to an ICD registry as a requirement for coverage. The national ICD Registry replaces the previous CMS QNET registry, which expires April 30.

The registry not only includes information on patient demographics and the reason for the ICD, but now collects information on potential complications, length of hospital stay, indications for the device and diagnostic tests completed to identify patients as ICD candidates.

Now every U.S. hospital that implants ICDs, a total of roughly 1,400 facilities, needs to participate in the registry to get reimbursed by the CMS, said Stephen Hammill, chairman of the ICD registry steering committee. Hospitals will enroll 125,000 patients in the registry each year, he said.

The registry will collect data on CMS and non-CMS payers, including both primary and secondary cases. Primary cases are patients who have never displayed symptoms but are at high risk and implants are used to prevent sudden death. Secondary cases involve patients who have suffered blackout spells and/or cardiac arrest.

"This is the most ambitious effort that CMS has done to follow the effectiveness of a treatment that they have to approve for coverage," said Hammill.

In the past, the CMS would elect to pay for a device but never follow up on how well it performed, he said. The agency has recently begun to follow up informally with chemotherapy drugs and stents, he said.

(http://www.fdanews.com/ddl/33_15/)