SVS members are encouraged to submit comments—due Aug. 10—to the Centers for Medicare & Medicaid Services (CMS) on its proposed national coverage determination on percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting.
The move would expand coverage to individuals previously only eligible for coverage in clinical trials; to standard surgical risk patients by removing coverage limitations to only high surgical risk individuals; remove facility standards and approval requirements; add formal shared decision-making with the individual prior to furnishing carotid stenting; and allow Medicare Administrative Contractors (MACs) discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7.
The SVS and the SVS Patient Safety Organization (PSO) are preparing comments to CMS. Members can submit remarks at vascular.org/CarotidNCD. These will focus on the issue that these changes are premature and will jeopardize patient safety, the Society reported.
“We should be informed by data from the conclusion of CREST-2 [Carotid revascularization and medical management for asymptomatic carotid stenosis trial],” the SVS said in a statement. “While we support shared decision-making, a validated tool does not currently exist. To evaluate the impact of this change, the continued collection of registry data needs to be part of any change to NCD20.7.
“We need clear definition for ‘Qualified Physician’ and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting.”