In December, Centers for Medicare and Medicaid Services issued a draft decision memo that advises expanding coverage of carotid artery stenting.
Currently, the stents are covered only in the context of a clinical trial. Under the proposed criteria, stents would be covered in high-risk candidates for endarterectomy and in patients who have symptomatic carotid artery stenosis of at least 70%.
The draft also addresses the competency requirements, noting that stenting should be performed “in facilities and by physicians who have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. … Competency will be determined through a national evaluation process by a recognized entity using approved standards.”
The Society for Cardiovascular Angiography and Interventions (SCAI) expressed appreciation for CMS's work on the guidelines. “CMS did a thoughtful job in making its decision,” said Joseph Babb, M.D., SCAI past president and chair of its advocacy committee. “But the society is also concerned that there were certain areas that did not seem to get adequate attention.”
In a letter to the agency, SCAI noted: “The decision severely limits patient access to carotid stenting in asymptomatic high surgical risk patients in need of carotid revascularization, thereby relegating them to one of two potential therapeutic courses: medical or surgical. While we are strong supporters of aggressive medical therapy for all patients with or at risk of atherosclerotic disease, it remains unproven as to its effectiveness in high-surgical-risk patients, and therefore should not be designated as a default strategy.”