CMS NCD Expands Coverage for Carotid Artery Stenting

October 11, 2023—The Centers for Medicare & Medicaid Services (CMS) issued its new Decision Memo on the national coverage determination (NCD) for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting (CAS), representing a significant expansion in coverage of the procedure. The national coverage analysis, which was initiated in January 2023, marks the first revisiting of CAS coverage in the United States since 2009.

The Decision Memo is extensive, and CMS summarizes its key provisions as follows:

1. Expanding coverage to individuals previously only eligible for coverage in clinical trials.
2. Expanding coverage to standard surgical risk individuals by removing the limitation of coverage to only high surgical risk individuals.
3. Removing facility standards and approval requirements.
4. Adding formal shared decision-making with the individual prior to furnishing CAS.
5. Allowing Medicare Administrative Contractors discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7

The NCD specifies that patients undergoing carotid revascularization should receive optimal medical therapy, as well as lifestyle/behavioral modification counseling. However, it does not specify physician, care team, or facility requirements or performance criteria.

During the initial 30-day public comment period, from January 12 to February 11, 2023, CMS received 193 comments, which were published on the CMS website and considered for the proposed decision. CMS noted that the majority—146 comments—supported the expansion of coverage criteria in one or more areas. In July 2023, CMS posted its proposed Decision Memo and opened a second 30-day public comment period from July 11 to August 10. During this second period, CMS received 760 comments, which were more closely split on support and opposition to the proposed decision memorandum, the agency said. Of note, Society for Vascular Surgery leadership expressed concerns regarding the proposed expansion, which the society feels is premature and jeopardizes patient safety, urging members to share their concerns during the open comment period. Society leadership from other vascular, cardiology, and neurovascular specialties and organizations largely voiced support for expansion, although important caveats and requests for revision were voiced by members of each.

CMS extensively cataloged and summarized the nature of all concerns shared during the comment period and posted their responses to each, detailing how the agency weighed them and arrived at its decisions. These summaries can be found in Section VIII, Public Comment, of the NCD posting.

Ultimately, PTA of the carotid artery concurrent with stenting was found by CMS to be reasonable and necessary with the placement of an FDA-approved carotid stent with an FDA-approved or FDA-cleared embolic protection device, for Medicare beneficiaries under the following conditions:

• A. Patients with symptomatic carotid artery stenosis ≥ 50%; and
• B. Patients with asymptomatic carotid artery stenosis ≥ 70%

For both A and B above:

1. Neurological assessment by a neurologist or National Institutes of Health Stroke Scale certified health professional before and after CAS must be performed.
2. First-line evaluation of carotid artery stenosis must use duplex ultrasound.
3. CTA or magnetic resonance angiography, if not contraindicated, must be used to confirm the degree of stenosis and provide additional information about the aortic arch and extra- and intracranial circulation.
4. Intra-arterial digital subtraction (catheter) angiography may be used only when there is significant discrepancy between noninvasive imaging results, or in lieu of CTA or magnetic resonance angiography if these are contraindicated.

Additional provisions and qualifications are outlined in the Decision Memo, which is available online on the CMS website. Continued coverage of the NCD and its impact on practices will be included in future editions of Endovascular Today.