CMS Proposes No Expansion of CAS Coverage

September 11, 2009—The Centers for Medicare & Medicaid Services (CMS) issued its Proposed Coverage Decision Memorandum for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R7).

The complete document can be viewed on the CMS Web site (www.cms.hhs.gov). A 30-day comment period from September 11 to October 9 allowed for public comments on the proposed determination. After considering the public comments, CMS will make a final determination and issue a final decision memorandum.

In the proposed decision memorandum, CMS has determined to not expand coverage of carotid artery stenting for high-risk asymptomatic patients. In brief, CMS concluded that because there are no new completed, published randomized trials, and there are two nonsupportive registry studies, there is insufficient evidence to conclude that PTA of the carotid artery concurrent with stenting for asymptomatic patients with carotid artery stenosis ≥ 80% improves health outcomes compared to carotid endarterectomy or optimal medical therapy outside the clinical trial or postapproval study setting.

CMS stated that although available evidence suggests the potential for PTA of the carotid artery concurrent with stenting for asymptomatic patients with anatomic high risk factors with carotid artery stenosis ≥ 80% and symptomatic patients with carotid artery stenosis of 50% to 70% to improve health outcomes, CMS believes that currently published data are not sufficient to expand coverage beyond the currently covered patient populations.

Also in the memorandum, CMS proposes to revise the national coverage determination language requiring the use of embolic protection devices approved by the US Food and Drug Administration.

The implications of these proposed nonexpansions and revisions will be addressed in the November 2009 issue of Endovascular Today, which will focus on carotid artery stenting.