The Centers for Medicare & Medicaid Services (CMS) today proposed to expand coverage of implantable cardioverter defibrillators (ICDs), a move expected to save thousands of lives a year.
"With this announcement, we're once again taking a major step to save lives and improve the quality of life for America's seniors, " said HHS Secretary Tommy G. Thompson. "By increasing the use of defibrillators we are striking a blow against the leading cause of death among older Americans."
"This coverage decision demonstrates our determination to act promptly when convincing medical evidence shows that a technology can save and improve lives," said CMS Administrator Mark B. McClellan, M.D., Ph.D.
The expansion, when made final, will increase the number of Medicare beneficiaries eligible for an ICD by one-third, to nearly 500,000. CMS expects to provide this therapy to at least 25,000 patients in the first year of coverage, potentially saving up to 2,500 lives.
Coronary heart disease is the single most common cause of death in the United States. Sudden death, frequently from heart arrhythmias, is estimated to account for approximately 50 percent of all coronary heart disease deaths. An ICD is implanted in a patient's chest to monitor the heart's rhythm and deliver an electrical shock when a life-threatening arrhythmia is detected.
The expanded coverage for the implantable defibrillators is based on new clinical studies, showing for the first time that certain patients who have never had a heart attack are likely to benefit from these devices. The coverage decision was prompted by results of a well-designed trial, labeled the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), which was sponsored by the National Heart, Lung and Blood Institute. It is a prospective, randomized trial to compare the effectiveness of medication, implantable defibrillators and placebo on survival in patients with heart failure.
Based on the clinical trial results, the draft coverage decision recommends coverage for most of the population studied in the trial, including patients with heart failure and poor function of their left ventricle.
In addition, careful analysis of the new data from this trial in combination with data from all previous ICD trials showed that patients with a certain finding on electrocardiograms of their heart, called a narrow QRS, may also derive a small but measurable, significant benefit from having an ICD.
As part of the coverage decision, CMS will work with product manufacturers and experts from the clinical community, including the National Institutes of Health, to develop a practical registry that can track the progress of patients who receive the devices. The registry will also help develop additional evidence on who is most likely to benefit from the devices.
"Our support for some practical studies as part of our coverage decisions is designed to provide additional evidence to help doctors and patients get the most out of new technologies," McClellan said. "We want to help develop better information about which patients benefit most from having an ICD."
As part of this coverage decision, CMS is encouraging sponsors to pool their available data on the use of these devices, and allow an appropriate cardiology research institute to review the combined data and identify those hypotheses that need further testing. For example, these simple studies could provide additional insights about the specific characteristics of patients that lead to important clinical benefits from ICD placement.
The coverage decision is available on the CMS web site at https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=139. The draft is posted to allow 30 days for the public to submit comments to CMS. Directions for submitting comments are also available on the web site at http://www.cms.hhs.gov/coverage/8h.asp. This document is not the final policy. After the close of the comment period, CMS has 60 days to review the comments and issue a final policy.
"With more accurate information, patients at the highest risk who can benefit most from the device should be more likely to receive them, and patients who are unlikely to benefit would be able to avoid the unnecessary risk of having the device implanted," said Dr. Sean Tunis, the chief medical officer for CMS. "We are seeking input now on the best ways to support the development of this information to help our beneficiaries get even better care."