Deny the service in question b/c the medical records do not support Clarivein ablation as reasonable and necessary. Medicare considers Clarivein to be investigational, because although there are ongoing studies, the results are not conclusive, and additional peer-reviewed studies are necessary. The clinical efficacy in not a proven device it is only a sclerotherapy catheter with fangs to drag the vein wall, which is not approved for ligation of the saphofemoral junction. . The Centers for Medicaid and Medicare Services (CMS) Manual Publication 100-2 Chapter 16 Section
