updated 1/27/2005 6:43:25 PM ET 2005-01-27T23:43:25

About 500,000 Medicare beneficiaries, some of whom have never suffered cardiac arrest, became eligible for coverage of expensive defibrillators Thursday in a move that could cost $2 billion over five years.

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The catch: Those covered for the roughly $30,000 procedure must agree to release details about their cases to a database shared by hospitals, Medicare officials said.

“It’s done in a way that preserves patient confidentiality,” said Mark B. McClellan, administrator of the Centers for Medicare and Medicaid Services, which administers Medicare and sets the terms of coverage. The data, he said, could help the medical community determine who is most helped by the device.

The new coverage and its terms became effective Thursday, McClellan said.

The decision increases the number of those eligible for implants by a third, to 500,000, he said. Because not all of those eligible will immediately seek the implants, called implantable cardioverter defibrillators, or ICDs, McClellan estimated that 25,000 people will receive and be covered for them in the first year.

Medicare has covered the devices for patients who already have suffered possibly fatal heart rhythms. Officials decided to expand the coverage in part because evidence suggests that they save the lives of people who are at risk of, but haven’t yet suffered, such episodes.

The agency also expanded coverage for ultrasounds for people suffering from fractures that aren’t healing properly, but only after surgery fails.

Studies find device works
The ICD decision is based on new clinical studies, including a government-funded survey last year that showed the technology significantly reduced deaths in patients with even mild heart disease.

McClellan said his agency paid close attention to a study published last week in the New England Journal of Medicine. It indicated that ICDs could save lives in people at risk of — and not just those who had survived — potentially fatal heart fluttering, called ventricular fibrillation.

The stopwatch-sized ICDs are implanted under the skin and detect irregularities in heart rhythm. When dangerous flutters occur, they deliver shocks to the heart to regulate it.

About 450,000 people die in the United States each year from sudden cardiac arrest. Coronary heart disease is the single most common cause of death in the United States. Sudden cardiac death is believed to account for half of all coronary heart disease deaths.

Private insurance providers applauded the decision because the government in essence endorsed making a database now shared by hospitals the basis for insurance coverage. That system, insurers say, would better direct the best treatment to the right people, improve care and save money.

Karen Ignagni, president and chief executive of America’s Health Insurance Plans, called the decision an important step toward a health care system based on documented evidence of specific therapies.

“We hope that today’s announcement paves the way for future post-marketing surveillance of medical devices and drugs,” she said.

The Medicare agency is accepting public comment before a Feb. 14 forum by its Council on Technology and Innovation as it drafts guidelines on linking coverage to data collection.

Minneapolis-based Medtronic Inc., Guidant Corp. of Indianapolis and St. Jude Medical Inc. of St. Paul make most defibrillators in the United States.

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