WASHINGTON - A device the size of a stopwatch could prevent hundreds of thousands of deaths by cardiac arrest, but its approval for Medicare beneficiaries has run into a snag.
The device - an implantable cardioverter defibrillator, or ICD - monitors the heartbeats of patients who are likely to suffer potentially fatal rapid heartbeats. The device acts like a pacemaker in mild cases of irregular heartbeats and delivers a shock in extreme cases. Such a device was implanted in Vice President Dick Cheney last year.
Approximately 300,000 Americans suffer from irregular heartbeats, and Medicare covers ICD implants. About 60,000 people have received ICD implants since they became available in 1985, according to Dr. Marshall Stanton, vice president and medical director for Medtronic Cardiac Rhythm Management, one of the device's three major manufacturers.
At issue now is whether Medicare will approve guidelines that would cover another 300,000 people, heart attack survivors whose hearts pumps blood at about one-half the normal rate - regardless of whether they also have irregular heartbeat conditions.
Successful study
A study published in the March issue of the New England Journal of Medicine showed that such patients had a 31 percent lower risk of cardiac failure after three years if they received an ICD. The four-year study - the Multicenter Automatic Defibrillator Implantation Trial II, or MADIT II - was discontinued last year because the results were considered so successful.
In July, the Food and Drug Administration approved the expanded use of ICDs for patients similar to those in the study. In September, the nation's major cardiac groups - the American College of Cardiology, the American Heart Association and the North American Society of Pacing and Electrophysiology- adopted practice guidelines recommending the use of ICDs for such patients.
Medicare has been studying a request to cover the expanded use of ICDs since late May. Most routine coverage issues are handled by Medicare's internal staff of doctors and administrators within 30 to 60 days, but complex questions are often referred to outside medical and technology review committees for recommendations.
In late September, Medicare extended its decision deadline for another 60 days, until Nov. 26. Late Wednesday, Medicare announced it was seeking a recommendation from the outside medical committee.
In a statement announcing the referral, the Centers for Medicare and Medicaid Services said it had received information from "cardiology experts and professional associations indicating that uncertainty remains regarding how to identify patients who are likely to benefit from ICD therapy.
"Many experts have indicated that currently available evidence does not clearly support the practice of implanting ICDs in all patients who meet the MADIT II criteria," the statement said.
Medicare did not estimate how long it would take for the panel to make a recommendation. After such recommendations are made, Medicare regulations call for it to make a decision within 60 days.
Stanton, who serves on one of Medicare's outside medical review panels, called Medicare's action "an incredible disservice. They could have made that decision four months ago. They need to make a decision. They have had this long enough."
It is unlikely another study of the effect of ICDs on this group of patients would be made again because the earlier study's results were so conclusive that it would be unethical to deny patients the life-saving technology for purposes of a study, Stanton said.
Dr. Mark Schoenfeld, professor of medicine at Yale University Medical School and president of the North American Society of Pacing and Electrophysiology, said "we are very disappointed by the delays ... because both patients and physicians are placed in a significant quandary" as to whether Medicare will cover such treatment.
"Patients may be denied treatment," Schoenfeld said. "We are terribly concerned about the delays in making a decision on this issue."
Costs
Manufacturers say questions asked by Medicare suggest the reason for the delay is cost.
The devices cost about $25,000. Expanding eligibility could double sales to about $4 billion, assuming that about 20 percent of those who are eligible for devices receive them, which is the current usage rate, Stanton said.
Medicare has been looking for a way to cover some, but not all, of those beneficiaries who meet the criteria, "but you can't subdivide it and say 'this is the group that really benefits and the others don't,'" Stanton said.
"They are looking for how not to spend money," Stanton said. "In essence, what [Medicare] is saying is that they know better than the professional organizations and the physicians and scientists."
Randy Burkholder, associate vice president of the Advanced Medical Technology Association - the medical manufacturers trade group commonly called AdvaMed - said Medicare is setting a bad precedent by considering cost in making a coverage decision.
"We don't believe that rationing care up front on the basis of cost is the way to go," Burkholder said.