CMS says defib coverage could save thousands

At-risk and arrhythmias patients covered

A decision by the Centers for Medicare & Medicaid Services (CMS) to expand Medicare coverage of costly implantable cardioverter defibrillators (ICDs) will increase the number of Medicare beneficiaries eligible for an ICD by one-third, to nearly 500,000, and will require beneficiaries to release details about their cases to a database shared by hospitals.

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% of all coronary heart disease deaths. An ICD delivers an electrical shock when a life-threatening arrhythmia is detected. 

CMS expects to provide this therapy to at least 25,000 additional patients in the first year of coverage, potentially saving up to 2,500 lives, the agency said when the expanded coverage was announced in late January.

"Our expanded coverage for devices to prevent sudden death in people with heart disease will save thousands of lives each year and improve the quality of life for America’s seniors," CMS administrator Mark B. McClellan, MD, PhD, said in announcing the change. "By increasing the use of defibrillators, we are striking a blow against the leading cause of death among older Americans."

Medicare has covered ICDs for patients who already had suffered possibly fatal heart rhythms. CMS expanded the coverage to those who are at risk of potentially fatal arrhythmias, but haven’t suffered them yet.

The new coverage and its terms, which could cost $2 billion over five years, became effective at the end of January, McClellan reported.

As part of the coverage decision, CMS will require the submission of specific demographic, clinical, provider, and device data into a data registry at the time of the procedure. This process will ensure that patients are receiving high-quality, medically necessary care, and will also provide valuable new information about the optimal use of ICDs. The ICD Abstraction Tool is available on the Quality Network Exchange (QNET), a system that hospitals currently use to abstract and send quality measures to CMS.

"It’s done in a way that preserves patient confidentiality," said McClellan. These data, he added, could help the medical community determine who is most helped by the device.

CMS is working with cardiology specialty societies, product manufacturers, health plans, and experts from the clinical community to develop a follow-on registry that will continue to collect the important data the QNET registry has collected as well as other data that will answer additional important questions on the use of ICDs.

Leaders from the ICD industry also have agreed to support additional studies that will address some of the remaining questions on the optimal use of ICDs, including identification of patient populations that benefit most from ICDs, said McClelland.

The expanded ICD coverage was prompted by results of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), 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. The results were published in the New England Journal of Medicine in January.1

Based on the clinical trial results, the decision provides coverage for the population studied in the trial, including patients with heart failure and poor function of their left ventricle. In addition, the new data from this trial, in combination with data from all previous ICD trials, showed patients with a certain finding on electrocardiograms also may derive a small but measurable, significant benefit from having an ICD, McClellan said.

CMS also announced it would expand coverage on ultrasound stimulation for fractures that are not healing properly when the provider and patients are participating in a clinical trial approved by Medicare.

Ultrasound stimulation has been covered for Medicare beneficiaries with nonhealing fractures since 2000. The proposed coverage expansion would remove a requirement that surgery must have failed before ultrasound treatment would be covered, but only if the patient is enrolled in a prospective, comparative clinical trial with the goals of monitoring, evaluating, and improving clinical outcomes.

Reference

1. Sudden Cardiac Death in Heart Failure Trial. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Eng J Med 2005; 352:225-237.