Medicare to pay for more heart devices

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Medicare will soon fund implantable heart devices for thousands more patients, after publication of a landmark study finding the devices can save more lives, top agency officials said in a medical journal on Wednesday.

Results of 2,500-patient trial, which found the devices cut the risk of death in heart failure patients by 23 percent, were published in the New England Journal of Medicine’s Jan. 20 issue.

Officials at Medicare, the health insurance program for the elderly, said in an accompanying editorial the findings will lead to a major policy shift. The government will now pay for the devices for 500,000 patients, or two to three times more than were previously eligible.

Medicare’s blessing is key because of the technology’s $25,000-plus price tag. Most patients who get an implantable cardioverter-defibrillator (ICD) are over the age of 65 and thus qualify for the federal health insurance program for 41 million elderly and disabled.

“Cost is obviously a major incremental expense, but just because a technology is expensive doesn’t mean it’s not valuable,” said Sean Tunis, chief medical officer for Medicare. The agency “is poised to expand its ICD coverage substantially,” he said.

The National Institutes of Health study, funded by manufacturer Medtronic Inc. and drug maker Wyeth, was first presented last year at a major medical meeting. In September, CMS said it would expand coverage, pending the study’s publication in a major medical journal.

Medicare had been waiting for the full results and publication before issuing its final decision, which Tunis said is now expected around Jan. 27.

LIFESAVING SHOCK

Implantable cardioverter defibrillators, or ICDs, are pager-sized devices implanted under the skin near the collarbone and connected to the heart with insulated wires. The devices deliver a forceful shock that jolts a racing heart back into normal rhythm.

The trial, called the Sudden Cardiac Death in Heart Failure Trial, or SCD-HeFT, was the first major study to include heart failure patients whose condition was the result of clogged arteries, as well as from a variety of other conditions such as a heart rhythm disturbance,

The 2,521-patient study measured whether ICDs reduce the number of deaths from sudden cardiac arrest in patients with moderate heart failure, when compared with patients who received only conventional drug therapy.

It also tested whether the drug amiodarone could prevent deaths from sudden cardiac arrest, which claims 450,000 lives a year, making it the No. 1 killer in America.

Sudden cardiac arrest is caused by an extreme disturbance in the heart’s natural electrical rhythms, as opposed to a heart attack, which typically occurs when the heart muscle does not get enough blood.

In addition to Medtronic, Guidant Corp. and St. Jude Medical Inc. both make ICDs and stand to benefit from expanded reimbursement.

EXPANDED COVERAGE

The government currently spends $1 billion per year for some 40,000 ICDs in patients.

“In my practice, Medicare will now pay for 1 in 3, or 1 in 4 patients” who need the device, said Marc Silver, a cardiologist at Raleigh Cardiology Associates in North Carolina, who had patients enrolled in the study.

With the changes, nearly all will be covered, he said.

“A lot of people are waiting for this,” he said.

After discussions with doctor groups and manufacturers, Medicare is now likely to pay for the device for very sick patients in a small subgroup that were not included in the original recommendation, Tunis added.

“We are certainly very inclined in that direction,” he said.

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