Officials at the Centers for Medicare and Medicaid Services are proposing to expand coverage for carotid artery stenting to patients younger than 80 years old who are at high risk for carotid endarterectomy and have asymptomatic carotid artery stenosis of 80% or greater.
Under the proposed national coverage determination, a surgeon would perform a consultation to ascertain a patient's high-risk status.
The proposal also spells out coverage for patients 80 years of age and older with either symptomatic stenosis of 70% or greater or asymptomatic stenosis of 80% or greater. Because of safety concerns, carotid artery stenting would be allowed in this group only when it is performed in a Food and Drug Administration Category B Investigational Device Exemption trial, an FDA-approved postapproval study, or under Medicare clinical trial policy.
If finalized the proposal would replace the current CMS coverage policy under which patients at high risk for carotid endarterectomy (CEA) with asymptomatic carotid artery stenosis of greater than 80% can be covered only when carotid artery stenting procedures are performed in an FDA Category B Investigational Device Exemption trial, an FDA-approved postapproval study, or in accordance with Medicare clinical trial policy.
“CMS is committed to providing broader access to appropriate and innovative care to our beneficiaries in the management of their carotid artery disease,” Leslie Norwalk, acting CMS administrator, said in a statement.
Over the last 6 years, CMS officials have expanded coverage of percutaneous transluminal angioplasty and carotid artery stenting in three separate national coverage decisions. Most recently, in November 2006, CMS established Medicare coverage for percutaneous transluminal angioplasty and stenting of intracranial vessels for the treatment of cerebral artery stenosis of 50% or greater in patients with intracranial atherosclerotic disease as part of an FDA-approved Category B clinical trial.
In proposing the expansion of coverage for patients with asymptomatic carotid artery stenosis, CMS relied on evidence from external and internal technology assessments, clinical reviews, and postapproval studies.
Two postapproval studies (CAPTURE and CASES-PMS) showed that carotid artery stenting outcomes were similar by provider experience and in settings outside clinical trials. The trials also did not raise safety concerns about carotid artery stenting in asymptomatic patients with stenosis of 80% or greater, according to CMS.
CMS officials concluded that the evidence is “sufficient” to find that percutaneous transluminal angioplasty with carotid artery stenting improves health outcomes for patients who are at high risk for CEA surgery and have asymptomatic carotid artery stenosis of 80% or greater. However, carotid artery stenting is not covered in the absence of distal embolic protection, even when technical difficulties prevent it from being deployed, according to CMS.
The American Association of Neurological Surgeons was still reviewing the proposed coverage decision at press time. However, in comments to CMS in 2004, the group raised concerns about expanding Medicare coverage for carotid stenting to asymptomatic patients. At that time, the group said that the available data suggested that carotid angioplasty and stenting may be inferior to medical treatment for the prevention of stroke in asymptomatic patients.
At press time, the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions (SCAI) were both also reviewing the CMS coverage proposal. However, Dr. Michael J. Cowley, cochair of the carotid and neurovascular interventions committee for SCAI, said he sees the expansion of coverage as a step in the right direction.
However, he expects that the SCAI committee may have concerns about some aspects of the proposal.
The proposed coverage expansion was also praised by Boston Scientific, which markets the NexStent Carotid Stent and the FilterWire EZ Embolic Protection System. However, the company also said it would like to see broader coverage for high-risk symptomatic patients.
CMS, which is reviewing public comments received prior to the March 3 deadline for comments, is expected to issue a final decision sometime in May.