News from the Field

October 18, 2023—Societies and vascular specialty groups are sharing their reactions to the updated Centers for Medicare & Medicaid Services (CMS) national coverage decision (NCD) for carotid artery stenting(CAS), which was announced on October 11. The NCD is the first revisiting of CAS coverage in more than a decade and represents a significant expansion of Medicare’s coverage for the procedure.

With sentiments largely matching those of the statements made during the open public comment period supporting the then proposed expansion, the Society for Cardiovascular Angiography & Interventions (SCAI), the Society of Interventional Radiology (SIR), the Society of NeuroInterventional Surgery (SNIS), the Multi-Specialty Carotid Alliance (MSCA), and VIVA Foundation all applauded CMS’s final NCD. However, the Society for Vascular Surgery (SVS) voiced its concerns regarding the decision.

MSCA, which made the formal request for this consideration, stated that the CMS decision ensures that Medicare patients will have access to the full range of therapies that are available, including carotid endarterectomy (CEA), transfemoral carotid artery stenting (TF-CAS), transradial carotid artery stenting (TR-CAS), and transcarotid artery revascularization (TCAR). The Alliance also emphasized that optimal medical therapy (OMT) remains the foundation for treatment, and CAS, CEA, or TCAR should be offered only to those patients deemed appropriate for revascularization on top of OMT.

VIVA also tweeted its support of the decision, with the group saying it is “proud to have contributed to CMS’s decision to expand coverage for carotid artery stenting. From our 2017 Vascular Leader’s Forum to a JACC article & posted CMS commentary, advocacy for patients is at the center of our mission.”

At the society level, a SCAI statement responding to the final decision memorandum noted that the CMS decision is a response to not only the MSCA request but also comments received from SCAI and other organizations. Noting that CMS accepted the request to make the guidelines less restrictive, including expanding coverage and removing facility and operator requirements, the society stated, “SCAI is thrilled that CMS accepted our requested changes and created a policy to expand this procedure’s access for Medicare beneficiaries.”

SIR also voiced support for the decision in a statement to Endovascular Today: “SIR applauds the decision to expand coverage for PTA with CAS to include individuals of standard surgical risk, patients with symptomatic carotid artery stenosis ≥ 50%, and patients with asymptomatic carotid artery stenosis ≥ 70%. SIR supports the decision to remove operator and facility requirements, including mandating data collection as a facility criterion for CAS. We support the requirement for shared decision-making process among physicians and the patient in determining an appropriate treatment.”

SNIS provided the following comments to Endovascular Today: “SNIS appreciates the thoughtful consideration of this decision on the part of leadership of CMS. We believe that their thorough analysis led to a decision that is in the best interest of Medicare beneficiaries and the American public. SNIS will continue to advocate for appropriate care for our patients and looks forward to the safe and proper implementation of this decision.”

SVS, which was vocal during the comment period that expansion was premature, reiterated and elaborated on those sentiments in correspondence with Endovascular Today, noting that a comprehensive statement from the society is forthcoming. President Joseph Mills, MD, provided the following comments:

“The SVS is disappointed with the CMS decision to finalize its proposal for expanded coverage for PTA with CAS (NCD 20.7) without any substantive revisions. We believe the coverage expansion outlined in the updated NCD 20.7 is premature given the pending results of the National Institutes of Health-funded CREST 2 (The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Study) Trial and holds significant potential to increase risk in achieving quality of care and patient safety, particularly for our most vulnerable elderly patients.

“SVS remains concerned about the potential impact of this decision and will continue to stress the fundamental importance of vigilant reporting and monitoring of outcomes, requiring requisite training and experience in patient selection and performance of the procedure, and the need for a verified multispecialty ‘Shared Decision Making’ tool, which is referenced in the decision but does not yet exist. The SVS will continue to actively promote quality and safety for the care of vascular patients through its published guidelines, appropriate care documents, and Patient Safety Organization-Vascular Quality Initiative (PSO-VQI) Registry and quality initiatives such as the ACS-SVS Vascular Verification Program. The SVS will continue to make its tools and resources widely available.”

MSCA advised it will work with CMS, medical societies, and other professional medical organizations, industry partners, and patient representatives and urged all these stakeholders to cooperate to ensure the safe and proper implementation of the NCD. As stated in the MSCA press release, “Stroke remains a leading cause of death and disability. Collectively as a medical community, we must increase patient and provider awareness, support education and training, and promote research and innovation to reduce the incidence and impact of this disease.”