In response to ongoing concerns regarding the safety and quality of care provided to vascular patients, the Society for Vascular Surgery (SVS) requested and conducted a call with the Centers for Medicare & Medicaid Services (CMS) on September 18, 2023. SVS President, Joeseph Mills led the call with a group of SVS clinical and research leaders. The call represented a continuation of SVS advocacy on this topic, with members having submitted over 200 letters in the open comment period, the vast majority of which expressed concerns about the impact of the decision on quality and patient safety.
SVS leaders provided additional data reinforcing the critical points in SVS’s written response:
- This decision appears premature given the advanced stage of the CREST 2 Trial which will answer many of the questions informing key aspects of any decision to change the coverage
- There is clear consensus evidence of increased risk of stroke with transfemoral carotid stenting, especially for symptomatic patients or patients of advanced age, and could add both substantial cost and increase number of strokes in the Medicare population
- 50-75 procedures are requisite to develop sufficient expertise to mitigate this risk of stroke
- Continuous monitoring of outcomes in a Registry should be an absolute requirement given the risk
CMS representatives were attentive and listened carefully, and noted a final decision had not been made yet but was expected in early October.