In June, the Centers for Medicare and Medicaid Services (CMS) drew sharp criticism when it announced modest expansion of Medicare coverage for heart-shocking implantable defibrillators, or ICDs. Heart experts argue that clinical data from the Multicenter Automatic Defibrillator Implantation Trial (MADIT II)--as well as guidelines crafted by the American College of Cardiology, the North American Society of Pacing and Electrophysiology, and the American Heart Association--support more widespread use of the potentially lifesaving therapy.
"CMS is playing doctor," says NHW editor-in-chief Dr. Douglas Zipes. "It's inappropriate for CMS to make a decision that only physicians can make."
Dr. Zipes estimates that about 25 percent of the heart attack survivors who could benefit from an ICD will be denied therapy because of the CMS ruling, placing them at higher-than-necessary risk of sudden death. NHW asked Dr. Zipes about the economic impact of defibrillator therapy and what you can do to help more people take advantage of the advanced technology.
NHW: At the recent ACC meeting, you presented a major study on the cost of the ICD versus the years of life it saved. Could you provide an overview of your conclusions?
DZ: Based on published studies of the cost-effectiveness of ICD therapy, the additional cost per life year saved ranges between $30,000 and $185,000. In the U.S., we consider a cost of $20,000 and $40,000 cost per life year saved as very reasonable therapy.
If you have a population at great risk for sudden death, the impact of the ICD is much greater. Those studies that are very expensive in terms of life years saved--$185,000--did not have terribly sick patients, while those that showed $30,000 per life year saved had very sick patients. The upshot of all this is that we need to better select that population who would benefit most by the ICD. In so doing, we will increase that denominator--the extension of their lives--and therefore reduce the cost per life year saved. Can we afford it? Absolutely.
NHW: Are physicians being put into a position of deciding which patient gets a second chance for improved quality of life?
DZ: To some degree, yes. I published another study several years ago that was supported by Medtronic. We reviewed the records of 4 1/2 million Americans discharged from a hospital and looked for diagnoses that would fit ICD criteria for implantation. Basically, we found that only one-third of Americans who met existing ICD indications--prior to MADIT II--were actually receiving an ICD. We are underusing ICDs, never mind the argument about MADIT II.
NHW: Does the Holter monitor help in diagnosing patients who might be eligible for an ICD?
DZ: Probably not. We are starting to realize that arrhythmias that happen in the usual course of 24 to 48 hours are in general not very helpful.
NHW: In 2001, we spoke to you about your meeting with President Bush on the Patient's Bill of Rights. September 11 came along and changed the nation's focus. Should we revive the Patient's Bill of Rights so that all people can take advantage of the technology that can help improve their lives?
DZ: That certainly would be a very reasonable thing to do. We need to bring this issue to the people. Total expenditures for ICDs are about $2.3 billion, or 0.16 percent of the healthcare budget. If you consider ballpark figures of $100 billion in waste, fraud, abuse, etc., $2.3 billion is pretty tiny. Inappropriate antibiotic use costs an estimated $10 billion. We are talking about a very small amount for a known therapy that save lives. It would be very helpful for people to write to their congressmen.
NHW: What message do you want to bring to the public?
DZ: The main message is that almost one of every two Americans dies of heart disease. Of those who die of heart disease, almost half of them die of a heart rhythm problem. The vast majority of those with heart rhythm problems can be saved by an ICD. That pretty well puts it into perspective.
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