January 2005 | Vol. 23, No. 1

Medicare Announces Expanded Coverage for Carotid Artery Stenting

The Centers for Medicare & Medicaid Services (CMS) on Dec. 17, 2004 announced it intends to expand Medicare coverage of carotid artery stenting to patients who are at high risk if they were to undergo the alternative procedure, a surgery known as carotid endarterectomy or CEA.

CEA is a surgical procedure used to prevent stroke in which the surgeon removes fatty deposits or plaques from the carotid arteries, the two main arteries in the neck supplying blood to the brain. Carotid artery stenting is a less invasive, alternative procedure to CEA, in which a catheter is used to place the stent that will widen the narrowed artery.

Proposed Medicare coverage for carotid artery stenting is restricted to patients who would be at high risk of complications from CEA, and who have symptomatic narrowing of the carotid artery of 70 percent or more. Coverage will also be made available to asymptomatic high risk patients who are enrolled in prospective clinical studies.

To help ensure optimal patient outcomes, the proposed decision will limit coverage of carotid stenting to facilities and providers who have demonstrated competence in performing the evaluation, procedure, and necessary follow-up care.

CMS intends to ensure facility and provider competence and to protect patient safety by collecting procedure related data through a national evaluation system (registry). Competency will be based on published clinical guidelines that outline physician training standards and facility support requirements for carotid artery stenting.

"This decision to expand coverage of carotid artery stenting to high risk patients will provide Medicare beneficiaries with broader access to the latest technology available for management of their carotid artery disease," said Sean Tunis, M.D., CMS' chief medical officer. "We are determined to help to reduce the incidence of stroke in our population, while also ensuring patient safety and quality of care by monitoring facility and provider performance. We are also committed to using this data to provide better evidence to doctors and patients as they make critical decisions about their care."

Previously, CMS only covered percutaneous transluminal angioplasty of the carotid artery concurrent with stent placement in clinical trials being conducted prior to Food and Drug Administration (FDA) approval (so-called Category B Investigational Device Exemption [IDE] clinical trial) and more recently in FDA required post approval studies. Carotid artery stenting to treat indications not included in this expansion of coverage, such as asymptomatic carotid stenosis or symptomatic disease with less narrowing (50-70 percent) is still eligible for coverage under these policies.