Medical Device Daily Washington Editor

WASHINGTON — In what is most certainly a boon for patients and a boom for manufacturers of implantable cardioverter defibrillators (ICDs), the Centers for Medicare & Medicaid Services (CMS; Baltimore) said last week that it would expand coverage of the devices.

The agency's move, announced late Thursday afternoon, should come as no shock following the publication of results of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) released in the Jan. 20 issue of the New England Journal of Medicine. Results of the 2,500-patient trial found that ICDs cut the risk of death in heart failure patients by 23%.

The trial was sponsored by the National Institutes of Health (NIH; Bethesda, Maryland) and funded by ICD manufacturer Medtronic (Minneapolis) and drug maker Wyeth Pharmaceuticals (Madison, New Jersey).

“Our expanded coverage for devices to prevent sudden death in people with heart disease will save thousands of lives each year and improve the quality of life for America's seniors,“ said CMS Administrator Mark McClellan, MD.

McClellan said the increased use of the devices “strikes a blow“ against the leading cause of death among older Americans.

CMS expects that the expansion will increase the number of Medicare beneficiaries eligible for an ICD by one-third, upwards of 500,000 people, with at least 25,000 additional patients in the first year of coverage, potentially saving up to 2,500 lives. Stephen Hammill, MD, president of the Heart Rhythm Society (Washington) called the CMS decision “terrific.“

“The expansion of coverage gives more patients access,“ Hammill told Medical Device Daily. “There really is not another type of medical device that has gone through more extensive testing than has the [implantable] defibrillator and every trial consistently shows benefit.“

Hammill said that since private insurance companies will likely follow the government's coverage lead, this is a “landmark“ decision. He also said there was little safety concern with defibrillator technology beyond the risks associated with any surgical procedure. To further ensure safety, Hammill said he was encouraged that CMS supports credentialing and certification by appropriate national organizations for physicians who insert ICDs

The agency's move provides coverage for the population studied in the SCD-HeFT trial, including patients with heart failure and poor function of their left ventricle. The study divided heart-failure patients into three groups, all three of which received conventional drug therapy.

One was a control group that received conventional drugs. Another group received conventional drugs plus an anti-arrhythmia drug, and a third group received conventional drugs plus an ICD. The goal of the study was a 25% drop in mortality from all causes for the groups with ICDs and anti-arrhythmia medication.

The findings suggest that about 600,000 Americans with this heart condition could be at risk for sudden cardiac arrest and should be protected by an ICD, which shocks the heart out of a rapid, chaotic heart rhythm that otherwise can lead to death within minutes.

CMS said that careful analysis of the new data from SCD-HeFT in combination with data from all previous ICD trials showed that patients with a certain finding on electrocardiograms of their heart, called a narrow QRS, also may derive “a small but measurable, significant benefit“ from having an ICD.

The expanded decision will include patients with left ventricular ejection fraction of 35% or less, due to either ischemic or non-ischemic cardiomyopathy independent of QRS duration. It also includes Class IV patients who meet criteria for cardiac resynchronization therapy.

In addition, CMS removed the “shock-only“ language and requirement as requirement for coverage and will now allow ICDs capable of pacing.

Hammill said that newer ICDs are able to painlessly “pace“ the heart back into rhythm without a violent shock. Older models lacked that function.

As part of the coverage decision, CMS will require the submission of specific demographic, clinical, provider and device data into a data registry at the time of the procedure. This data will be collected in the agency's QNET registry system and archived.

Plans call for the development of a second registry that will follow ICD patients post-procedure. CMS said it was working with cardiology specialty societies, product manufacturers, health plans and experts from the clinical community to develop the registry. The Heart Rhythm Society and the American College of Cardiology (Bethesda, Maryland) are part of the group working on the new system.

Leaders from the ICD industry also have agreed to support additional studies to address some remaining questions on the optimal use of ICDs, including identification of patient populations that benefit most from the devices, CMS said.

“With more accurate information, clinicians can do more to ensure that patients at the highest risk who can benefit most from the device can get them,“ said Sean Tunis, MD, chief medical officer for CMS. “We will continue to work with experts and stakeholders to identify the best ways to support the development of this information to help our beneficiaries get even better care.“

Steve Mahle, president of Medtronic's Cardiac Rhythm Management business, said his company appreciated CMS's “thorough, open and timely approach“ to the coverage decision.

“Securing financial reimbursement for ICDs in this newly eligible patient population is a critical action to reduce the number of unnecessary deaths from sudden cardiac arrest,“ Mahle said.

In addition to Medtronic, Guidant (Indianapolis) and St. Jude Medical (St. Paul, Minnesota) both make ICDs and stand to benefit from expanded reimbursement.

According to Joanne Wuensch, industry analyst for Harris Nesbit (New York), the coverage expansion could serve as a catalyst for more than a 20% jump in market growth for ICDs.

Wuensch's report said that after lower-than-expected ICD sales results from both St. Jude and Guidant in 4Q04, the new reimbursement claim could “reinvigorate“ the market, allowing for ICD market growth of 24.2% this year, 22.8% in 2006 and 22.6% in 2007.

According to the NIH, coronary heart disease is the single most common cause of death in the U.S. Sudden death, frequently from heart arrhythmias, is estimated to account for about 50% of all coronary heart disease deaths.

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