Medical Device Link.

Originally Published MX March/April 2005

BUSINESS NEWS

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 who 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 the National Institutes of Health (NIH; Bethesda, MD) which found who ICDs reduced deaths by 23% in heart disease patients, including those who had not experienced SCA. The findings of the study, "Sudden Cardiac Death in Heart Failure" (SCD-HeFT), 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.

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."

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) this year.

Copyright ©2005 MX