CMS Proposes Coverage Expansion for Carotid Artery Stenting

July 13, 2023—The Centers for Medicare & Medicaid Services (CMS) released a decision memo proposing expanded coverage for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting (CAS), including that coverage of the procedure is 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 specified conditions.

Revisiting CAS coverage for the first time since 2009, the current reconsideration comes after a June 2022 request was made by the Multispecialty Carotid Alliance. In the CMS decision summary, the agency highlights that since 2009, five major randomized controlled trials comparing CAS and carotid endarterectomy (CEA) have been published, as well large registries and meta-analyses. “We propose that this new evidence, especially now for asymptomatic patients, suffices to demonstrate that CAS and CEA are similarly effective with respect to the composite primary outcomes of recent trials (which have included various combinations of disabling stroke, death, any stroke, and myocardial infarction) in patients with either standard or high surgical risk and who are symptomatic with carotid artery stenosis ≥ 50% or asymptomatic with stenosis ≥ 70%,” said CMS in its memo.

After initiating a national coverage analysis in January 2023, CMS received 193 comments during a previous public comment period, a summary of which is available at the CMS website, and developed the current proposed decision. A new 30-day public comment period is now open, and the comment function is available here.

As outlined in the proposed decision memo, the specified conditions covered would include the following:

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

For both conditions A and B above:

1. Independent neurological assessment before and after CAS must be performed to assess procedural risks.
2. Evaluation of the extent and severity of carotid artery stenosis must use one of the following noninvasive modalities for first-line imaging: duplex ultrasound, CTA, or MR angiography.
   • If duplex ultrasound is used as first-line imaging, CTA or MR angiography must also be performed to provide additional information about the aortic arch, and extra- and intra-cranial circulation, for better patient selection.
   • If either CTA or MR angiography is used as first-line imaging, no second-line imaging is required.
   • Intra-arterial digital subtraction (catheter) angiography must not be used for first-line imaging and may be used only when there is significant discrepancy between noninvasive imaging results.

Before providing a CAS procedure, the practitioner must engage in a formal shared decision-making interaction with the beneficiary. The shared decision-making interaction must involve the use of a validated shared decision-making tool and include the following:

• Discussion of all treatment options for carotid stenosis to ensure the beneficiary is familiar with and aware of all treatment options, including but not limited to procedures that fall within the parameters of this national coverage determination (NCD)
• Explanation of risks and benefits for each option specific to the beneficiary’s clinical condition
• Integration of clinical guidelines (eg, patient life-expectancy)
• Discussion and incorporation of beneficiary’s personal preferences and priorities in choosing a treatment plan

In addition to the coverage described, CMS notes that Medicare Administrative Contractors (MACs) may make reasonable and necessary determinations under section 1862(a)(1)(A) for any other beneficiary seeking coverage for PTA of the carotid artery concurrent with stenting.

CMS summarized its proposals, which affect NCD 20.7 sections B4 and D. The proposals will revise Medicare coverage for PTA of the carotid arteries concurrent with stenting by:

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 MAC discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7

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

During the current comment period, CMS is requesting comments regarding whether the shared decision-making interaction should require the use of a validated shared decision-making tool and/or if there are other options to achieve the goal of truly informed decision-making. The agency will respond to public comments in a final decision memorandum.

“After nearly 20 years of FDA approval for multiple carotid stent systems and multiple randomized trials totaling > 8,000 patients and showing equivalency to endarterectomy, CMS’ well-written proposed draft decision would give access to carotid stenting as an option in the management of carotid disease to Medicare beneficiaries—along with medical, endarterectomy, and transcarotid artery revascularization,” said William A. Gray, MD, in comments to Endovascular Today. “A potentially big step forward for the care of the carotid patient.”

Dr. Gray is System Chief of Cardiovascular Services at Main Line Health and President of Lankenau Heart Institute in Wynnewood, Pennsylvania, and a member of the Multispecialty Carotid Alliance.