CDU Washington Editor
CDU Associate

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 in late January that it would expand coverage of the devices.

The agency's move came 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).

The data from the study reported in NEJM were first disclosed at last March's American College of Cardiology (ACC; Bethesda, Maryland) scientific sessions in New Orleans.

Officials from CMS previewed the pending policy shift in an editorial accompanying the NEJM study report. Mark McClellan, MD, PhD, administrator of CMS, said the agency was "poised to expand" coverage of ICDs based on new research showing that they could increase the chances of survival in substantial numbers of elderly people on Medicare. "This policy change may increase the number of Medicare beneficiaries who are eligible for an ICD to more than 500,000, two to three times the number who are currently eligible," McClellan said in the NEJM article he co-authored with Sean Tunis, MD, chief medical officer at the agency.

"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," McClellan said in announcing the policy shift at month's end. He said increased use of the devices "strikes a blow" against the leading cause of death among older Americans.

Stephen Hammill, MD, president of the Heart Rhythm Society (Washington), called the CMS decision "terrific." He told Cardiovascular Device Update: "The expansion of coverage gives more patients access. There really is not another type of medical device that has gone through more extensive testing than has the 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 implant ICDs

Medicare's blessing is critical, particularly in light of the technology's price tag of more than $25,000. Most patients who get the devices are over the age of 65 and thus qualify for the federal health insurance program for 41 million elderly and disabled. Indeed, Medicare beneficiaries currently account for 80% of sudden deaths from heart problems in the U.S.

The Medicare program already covers the devices for some patients. But, McClellan noted, only 20% to 25% of those who are currently eligible receive them. The new coverage decision could increase Medicare spending by several billion dollars a year. Private insurers often follow Medicare's example, so they, too, may now pay for more of the defibrillators. The government currently spends roughly $1 billion per year for some 40,000 ICDs in patients.

McClellan said it appeared that many patients at high risk of sudden death did not receive the defibrillators. Thus, he wrote in the NEJM editorial, "many deaths could be avoided" if the devices were regularly provided to patients known to be at very high risk for sudden death.

Under the new policy, doctors and patients who want Medicare to pay for the defibrillators will have to agree to have information about their experience recorded in a national database. Data from such registries can help the government determine how the devices work in different types of patients.

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 as a 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 lack 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 ACC are part of the group working on the new system.

"This is the first time we have concrete evidence that many people with heart failure will die from sudden cardiac arrest if they don't have an implanted defibrillator," said Richard Luceri, MD, director of the Arrhythmia Center at Holy Cross Hospital (Fort Lauderdale, Florida) and a SCD-HeFT clinical investigator who implanted the most ICDs in the trial. "The evidence is overwhelming, and it's critical that this proven and easily implanted technology is used in this population to save lives. The medical community must now act to deliver ICD therapy to those at risk of sudden cardiac death."

In another editorial in the Jan. 20 issue of NEJM, Alan Kadish, MD, a cardiologist at the Northwestern University School of Medicine (Chicago), said research "showed that patients who received an ICD have a better outcome than those who were treated with medical therapies," including ACE inhibitors and beta blockers. The study confirmed the effectiveness of the defibrillators in "prolonging survival among patients with heart failure and coronary disease," Kadish said.

Leaders from the ICD industry 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 Tunis. "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 Joseph Smith, MD, chief medical officer of Guidant's Cardiac Rhythm Management business, while the decision came nearly a year after the SCD-HeFT results were first publicly disclosed, he said CMS has done "a very thorough job" in arriving at its decision. "The vagaries of the publication process notwithstanding, I think that CMS, on this occasion, has moved as quickly as one might have hoped and I think as quickly as the opportunities were open to them," he told CDU.

Smith said he also was heartened to see McClellan and Tunis mention the ejection fraction number of 35% or less the same one used in the study in their NEJM editorial as the potential cut-off for ICD implantation. In its September announcement, CMS had said it planned to limit coverage to patients whose hearts eject 30% or less of the blood each time they squeeze.

According to Joanne Wuensch, industry analyst for Harris Nesbit (New York), the coverage expansion could serve as a catalyst of 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.

Jason Mills, a medical technology analyst for First Albany Capital (San Francisco), wrote in a research report that the SCD-HeFT data publication and expansion of the ICD patient population is a "home run for the industry." He said that the expanded reimbursement could potentially increase the domestic high-power CRM device market by more than $600 million in 2005.

He also said that while the trial used single-chamber ICDs (because it started before dual-chamber/tiered-therapy devices had caught on), he believes that many surgeons will opt to implant SCD-HeFT patients with more advanced (and costly) devices, either dual-chamber ICDs or CRT-Ds.

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 heart disease deaths.