Medicare Expands Coverage of Cardiac Defibrillators

The Centers for Medicare and Medicaid Services (CMS; Baltimore) has announced a significant expansion of its reimbursement coverage for implantable cardioverter-defibrillators (ICDs) . Under the new guidelines, Medicare recipients with mild-to-moderate heart disease may now be eligible to receive the stopwatch-sized implants that regulate cardiac rhythm to ensure that the heart is pumping blood adequately. Before the new ruling, coverage was limited mostly to patients with more severe heart disease, including those that had previously suffered sudden cardiac arrest (SCA).

The decision to expand coverage was based primarily on the findings of a long-term study of more than 2500 patients sponsored by National Institutes of Health (NIH; Bethesda, MD) which found that ICDs reduced deaths by 23% in heart disease patients including those that had not experienced SCA. The findings of the study, “Sudden Cardiac Death in Heart Failure” (SCD-HeFT), were initially reported in March 2004, at the annual scientific session of the American College of Cardiology (ACC; Bethesda, MD).

CMS’s Tunis: A careful review.

In a conference call with analysts at the close of the ACC meeting, Sean Tunis, MD, chief medical officer for CMS, expressed a positive response to the study, specifically citing its well-controlled design and duration. He indicated that the agency would carefully review all the findings and would likely make its ruling on a expansion of coverage by the end of May.

Yet, CMS was virtually silent on the issue until September 28, 2004, when the agency announced preliminary approval of expanded coverage for ICDs, and indicated that final approval would not come until results of the SCD-HeFT study were published in a peer-reviewed medical journal.

The results were published in the January 20, 2005, issue of the New England Journal of Medicine, with the CMS announcement on final approval coming a week later on January 27.

McClellan: Avoiding risks, promptly.

Commenting on the agency’s announcement, CMS administrator Mark B. McClellan, MD, PhD, said that the coverage decision “demonstrates our determination to save lives by making prompt coverage decisions using new medical evidence, and to improve the evidence available to doctors and patients to help them get the greatest benefits while avoiding unnecessary risks and costs.”

Under the expanded coverage, CMS will require ICD recipients’ doctors and hospitals to supply detailed demographic and clinical data into confidential registries that will be used to study outcomes and further determine indications for—and optimal use of—ICDs. In a prepared statement, CMS also said that “some future Medicare coverage decisions may also link coverage to the collection of additional prospective clinical data.”

On the issue of data registries, Tunis said CMS “will continue to work with experts and stakeholders to identify the best ways to support the development of this information to help our beneficiaries get even better care.”

The agency further noted that its Council on Technology and Innovation is developing a draft guidance document “to ensure that the coverage process reflects a systematic, science-based approach that is predictable and transparent.”

Ignagni: Paving the way.

Karen Ignagni, president and CEO of America’s Health Insurance Plans (Washington, DC), a trade association representing 1300 private medical insurance firms that provide coverage to more than 200 million Americans, said, “We support the decision by CMS to establish data registries as an important step in the transition to an evidence-based healthcare system. We hope that the CMS announcement paves the way for future postmarketing surveillance of medical devices and drugs.”

The CMS decision is expected to push private insurers to expand coverage of ICDs in accordance with the new guidelines, particularly in light of the fact that coronary heart disease is the greatest cause of death in the United States. According to the Mayo Clinic (Rochester, MN), more than 400,000 die annually from sudden cardiac arrest.

The decision to expand ICD coverage is projected to cost Medicare $2 billion over the next five years. More than 30,000 recipients per year are now expected to receive ICDs at an average cost of up to $40,000, which includes the device, doctor fees, and all hospital charges.

U.S. manufacturers of the devices are expected to gain from the CMS decision to expand coverage, including market leader Medtronic Inc. (Minneapolis), Guidant Corp. (Indianapolis), and St. Jude Medical Inc. (St.Paul, MN). Guidant is on track to be acquired by Johnson & Johnson Inc. (New Brunswick, NJ) later this year.

Medtronic’s Mahle: Critical action.

Steve Mahle, president of Medtronic’s cardiac rhythm management division, said, “Securing financial reimbursement for ICDs in this newly eligible patient population is a critical action to reduce the number of unnecessary deaths from sudden cardiac arrest.”

© 2005 Canon Communications LLC

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