Medical Device Daily Associate Managing Editor

The federal Medicare program soon will fund implantable heart devices for thousands more patients, thanks to the publication of results of the landmark Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) study finding that the devices can save more lives.

Results of the 2,500-patient trial, which found that implantable cardioverter defibrillators (ICDs) cut the risk of death in heart failure patients by 23%, were published in the New England Journal of Medicine's Jan. 20 issue, though the data from the study were first disclosed at last March's American College of Cardiology (Bethesda, Maryland) scientific sessions in New Orleans (Medical Device Daily, March 10, 2004).

Perhaps the most important news came when officials from the Centers for Medicare & Medicaid Services (CMS; Baltimore) said in an accompanying editorial that the findings will lead to a major policy shift.

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.

Medicare had been waiting for the full results and publication in a major peer-reviewed journal before issuing its final decision, which is now expected around Jan. 27

“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 he co-authored with Sean Tunis, MD, chief medical officer of CMS.

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.

“These devices can save thousands of lives in our beneficiary population,“ McClellan said.

The Medicare program already covers the devices for 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, “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.

While the SCD-HeFT study, 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), was first presented in March, CMS waited until September to disclose that it would expand coverage, pending the study's publication in a major medical journal.

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 is coming 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 coverage 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 Medical Device Daily.

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.

The study, initiated in 1997 and sponsored by the NIH, 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.

“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 an editorial also in this week's issue of the NEJM, Alan Kadish, MD, a cardiologist at 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 drugs known as 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.

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.

Importantly, he noted that in a departure from its preliminary decision, CMS is expected to not require physicians to explain why a particular device is used to receive reimbursement, even though a registry is still a requirement. 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.

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