SCAI Comments on CMS National Coverage Determination for Carotid Artery Stenting

“SCAI is a non-profit professional association with over 4,500 members representing the majority of practicing interventional cardiologists and cardiac catheterization teams in the U.S. This includes interventional cardiologists with expertise in carotid artery disease that is treated with optimized medical therapy, and when appropriate to reduce risk, carotid artery stenting (CAS). Such comprehensive management of atherosclerotic vascular disease has become standard practice in contemporary cardiovascular medicine and interventional cardiology fellowship training programs, and CAS is an integral part of the therapeutic armamentarium. SCAI promotes excellence in invasive and interventional cardiovascular medicine through education, advocacy, and the advancement of quality standards to enhance patient care. For that reason, we have a strong interest in ensuring that Medicare coverage policy for CAS aligns with the available and voluminous data and the current state of technology for the management of atherosclerotic bifurcation carotid artery disease.

“SCAI strongly support updating NCD 20.7 to broaden Medicare beneficiary access to PTA and CAS and to remove facility and operator requirements consistent with the current state of the published literature and standard clinical practice. The current CAS NCD was last reconsidered in 2009 and does not reflect the significant advances that have occurred. Consequently, the current coverage is limiting access for many patients who would potentially benefit from CAS. The limitation forces some patients into higher-risk surgical procedures and negatively impacts clinical outcomes.

“Since 2009, there has been significant innovation in available devices, publication of numerous randomized controlled trials (RCTs) and observational studies, accumulation of extensive real-world clinical experience by a variety of operators from different specialties, and widespread participation in national quality improvement initiatives. Clinical equipoise between CAS and carotid endarterectomy (CEA) has been supported by four RCTs reported since 2010, consistently demonstrating equivalence in procedural outcomes, long-term stroke prevention, and durability. Thus, patient selection criteria in the NCD should be updated to mirror the results from this extensive body of clinical research and to parallel CEA access by expanding to include patients at standard surgical risk, patients with symptomatic carotid artery stenosis of at least 50%, and patients with asymptomatic carotid artery stenosis of at least 70%. Furthermore, with the accumulated clinical experience and extensive evidence now supporting CAS, the facility and operator requirements can be appropriately handled through hospital credentialling processes and medical society guidelines as those requirements are handled for other well-established procedures. Along with the Society of Vascular Medicine, SCAI has published a multidisciplinary expert consensus statement on physician training and credentialing guidance to facilitate the safe and effective incorporation of CAS into clinical practice. Other professional societies, alone or in collaboration, have also published guidelines and expert consensus statements on carotid artery revascularization in a similar manner as other well-established procedures.”