In a decision that the Centers for Medicare and Medicaid Services (CMS; Baltimore) said reflects the latest evidence on the effective use of carotid stenting in reducing the occurrence of stroke, the agency said that it would consider expanding its coverage of the procedure. CMS cites stroke as the third leading cause of death in the United States and the leading cause of serious, long-term disability.

Under the proposed change, CMS would cover carotid artery stenting for symptomatic patients with 50% or greater carotid artery stenosis, or blockage, as well as asymptomatic patients with 80% stenosis. Symptoms of atherosclerosis include weakness, paralysis, visual problems, and speech difficulties. In addition, coverage would no longer require that a patient be designated as a poor candidate for carotid endarterectomy, a more-traditional procedure for removing blockages.

However, CMS expressed concern about carotid stenting in patients age 80 and over. Under the proposed change, the agency would limit coverage within that population to procedures performed in accordance with clinical studies.

In making the announcement earlier this month, CMS acting administrator Leslie V. Norwalk said, "CMS is committed to providing broader access to appropriate and innovative care to our beneficiaries in the management of their carotid artery disease."

CMS medical director Barry Straube, MD, added, "The evidence on carotid artery stenting demonstrates its effectiveness in improving health outcomes for certain patients."

The policy change would require hospitals to certify their competence with carotid stenting procedures. Straube said such a process would help CMS ensure patient safety and quality care for those undergoing the stenting procedure.

Medtech manufacturers of carotid stenting devices generally applauded the announcement from CMS, but some expressed concern that the agency did not go far enough in expanding coverage.

"This proposal reflects the growing consensus in the medical community that carotid artery stenting is an important treatment option for these patients," said John M. Capek, PhD, president of the vascular division at Abbott (Abbott Park, IL). "Abbott is committed to working with the medical community, FDA, and CMS to gather additional evidence to support broader patient access to carotid stenting."

John Pedersen, president of the peripheral intervention business at Boston Scientific Corp. (Natick, MA), said, "We are excited about the opportunity for expanded coverage for carotid stenting for asymptomatic patients at high risk for surgery. However, we believe that clinical data from our carotid stenting trials also support expansion of coverage for high-risk symptomatic patients."

Other carotid stent manufacturers include Cordis Corp. (Miami Lakes, FL), a Johnson & Johnson company; Medtronic Inc. (Minneapolis); and ev3 Inc. (Plymouth, MN). Last month, ev3's Protege RX carotid stent gained FDA approval. Cordis's carotid stent system has been deemed approvable by the agency but has not yet received final clearance. Medtronic's Exponent carotid stent received the CE mark for European and other international distribution in April 2006. The company expects to receive FDA approval later this year or in early 2008.

Carotid angioplasty uses a carotid stent and an embolic filter, which captures debris material that may become dislodged during the stenting procedure. The first carotid stent system to be approved by FDA was the Rx Acculink, manufactured by Guidant, which is now part of Boston Scientific. It entered the U.S. market in August 2004. Abbott acquired Guidant's stent business as part of the required divestiture associated with the company's acquisition by Boston Scientific.

Public comment on the CMS proposal to expand coverage of carotid stenting is open through March 3. If approved, the policy could go into effect as early as May of this year.

CMS' tracking sheet for the proposed policy change is available at www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=194 .

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