PTA of the carotid artery was first performed in the 1980s for the purpose of treating atherosclerotic lesions of the carotid artery. However, limited scientific research did not demonstrate any medical benefit from this procedure. Because of these concerns, HCFA issued a national noncoverage policy whereby it announced that PTA is not covered, under Medicare, to treat obstructive lesions of the carotid, cerebral and vertebral arteries (Coverage Issues Manual §50-32).
In the late 1980s, clinicians began investigating the use of endovascular stents (placed in the carotid artery) for the treatment of carotid stenosis. In general, stent placement concurrent with angioplasty assures an adequate luminal diameter and patency of the vessel. In a minority of cases, the stent is placed without pre-dilation, although in most cases, pre-dilation using angioplasty is required. At the current time, there are no Food and Drug Administration (FDA) approved stents for use in the carotid artery.
Several large Investigational Device Exemption (IDE) studies have either been approved by the FDA or are in the approval process to investigate carotid artery stenting. The stents being used in these studies have been designated Category B IDEs by the FDA. Because of the existing noncoverage policy for PTA of the carotid artery, none of the services related to the angioplasty would be covered by Medicare for beneficiaries participating in these clinical trials, despite the stents’ designation as Category B devices.
HCFA recognizes that these clinical trials are designed to evaluate the safety and effectiveness of medical care, and are crucial to potentially improving clinical practice. Accordingly, HCFA is currently evaluating whether carotid angioplasty, when performed solely for the purpose of pre-dilation concurrent with carotid stent placement, should be considered a reasonable and necessary service when provided in the context of an approved Category B IDE clinical trial.
