The government has decided to expand its coverage for surgically implanted heart-shocking devices for people with weakened hearts, in what could be the most expensive single decision in Medicare's history, federal officials said yesterday.
More than half a million Americans with the progressive heart-weakening condition known as congestive heart failure could be eligible for the battery-powered implants and accompanying surgery under the plan, which Medicare officials said they will roll out in the next week or so.
The devices, known as implantable cardioverter-defibrillators, or ICDs, sense heart rhythm abnormalities and deliver shocks to the heart when potentially fatal flutters occur.
The Medicare decision, however, will be significant for more than its cost, which officials said yesterday could be about $3 billion a year. It also represents the most aggressive effort yet to use the federal insurance plan for the elderly as a backdoor way to learn more about what works and what does not in medicine.
As a condition of coverage, Medicare will insist on collecting ongoing information about patients' health, which may help the program decide over time whether ICDs help certain types of patients.
The plan is part of an evolving federal effort to prevent a replay of recent events in which physicians and patients were surprised to learn that some popular anti-inflammatory drugs and antidepressants have more side effects than previously recognized. Given the huge numbers of patients who receive drugs and medical devices through Medicare, officials said, long-term data collection by the program can be a powerful complement to the modest follow-up efforts made by manufacturers and the Food and Drug Administration.
"Hopefully this will both ensure that patients get the best care as quickly as possible and also we'll continue to get smarter and learn more about unanticipated safety problems and how to use these technologies most effectively," said Sean Tunis, chief clinical officer at the Centers for Medicare and Medicaid Services.
Medicare has covered ICDs for patients who had already suffered potentially fatal disturbances in their heart rhythms. But officials decided to expand the coverage because of new evidence that ICDs can save the lives of many people who are at increased risk for such episodes but have not yet suffered them.
Cost looms large
The plan to collect long-term data raises subtle questions about the line between medical care and research. It is unethical under federal and international human research guidelines to demand participation in research as a condition of receiving medical care. While Medicare always requires some medical information from patients to ensure eligibility, experts in medical ethics said expanded efforts to peg coverage to data collection would have to be watched closely to ensure they do not cross the line.
Issues of cost also loom large -- especially amid concerns over Medicare's fiscal condition, given skyrocketing health care costs and the aging population. An analysis conducted by Duke University researchers found that, at about $30,000 for the device and the surgery, coverage for patients with mild to moderate congestive heart failure would be at least as cost-effective as other coverage Medicare typically offers -- even counting the fact that up to 80 percent of implanted patients are expected to never need a shock.
But those estimates look only at how much it costs to give a patient an extra year of high-quality life, not at the cost to society overall. If just 20 percent of eligible patients got the devices -- the percentage of use among patients eligible for current defibrillator treatments -- it would cost the government about $3 billion a year. Full participation could cost $15 billion or more.
That would be about equal to all other outpatient Medicare expenditures combined.
"Because the number of people can be huge, the effect on the system can be enormous," said Ezekiel Emanuel, chairman of the department of clinical bioethics at the National Institutes of Health. "That's an issue we haven't been able to grapple with very well. How do you set priorities?"
The coverage decision coincides with today's publication, in the New England Journal of Medicine, of results from a major study of ICDs sponsored by the National Institutes of Health.
Comparing therapies
Involving more than 100 medical institutions in the United States and Canada and more than 2,500 patients with mild to moderate congestive heart failure, the study aimed to clarify how best to prevent sudden cardiac arrest in such patients -- who typically are left breathing heavily after even modest activity because their hearts are functioning at low efficiency. Cardiac arrest is especially common in such patients, often after a bout of rhythm abnormality.
It differs from a heart attack, in which the heart stops beating because of an interruption of the flow of blood to the heart.
The new study compared three therapies.
One group received standard care for congestive heart failure, including ACE inhibitor medicines and, in many cases, beta blockers and statins.
A second group received standard care plus daily doses of amiodarone (brand name Cordarone), a drug proved to correct potentially deadly rhythm abnormalities -- or arrhythmias -- after they occur. Although the drug is widely prescribed to people with congestive heart failure, it has never been tested to see whether it can prevent, as opposed to treat, the flutters that so often kill those patients.
Patients in the third group had ICDs surgically implanted near their left shoulder. The device, about the size of a credit card but thicker, can send 750-volt shocks to a heart that has descended into an arrhythmic state known as ventricular defibrillation, the extremely rapid but useless kind of beat that is the hallmark of sudden cardiac death. The devices are already approved by the FDA for use in people who have survived such an event. But their lifesaving value in people merely at increased risk had never been proved before the study published today.
The devices were made and provided by Medtronic Inc., a major manufacturer of implantable cardiac devices, which had no role in the analysis or publication of results.
Surprisingly, after about four years of treatment, amiodarone offered no survival benefit and may even have precipitated some deaths.
"We believed putting patients on this drug was a good thing. This study proved that to be incorrect," said Richard Luceri, director of the arrhythmia center at Holy Cross Hospital in Fort Lauderdale, Fla., who implanted many of the study's ICDs.
But while 29 percent of the patients receiving standard therapy died during the study, only 22 percent of those with ICDs died. That seven-percentage-point difference amounts to a 23 percent reduction in the number of deaths. That suggests that tens of thousands of lives could be saved each year with wider use of ICDs.
Risks vs. benefits
The saved lives came with a cost: Because the vast majority of ICDs never needed to fire, many people underwent modest but real risks for no benefit. Infections and other significant problems appeared in 14 percent of patients who got the devices.
"The problem is, you don't know who is the one who's going to drop dead and who's not," said study leader Gust H. Bardy, director of the Seattle Institute for Cardiac Research.
The Medicare follow-up could help answer that question. The new study suggested, for example, but could not prove, that the one-third of study participants who were most severely ill were not helped by their ICDs.
At the same time, data trends in the study suggest that many of those whose ICDs never went off are likely to be saved by the devices in years to come. Although the study itself has formally ended, such hints could be confirmed or debunked with ongoing Medicare-required data collection.
