The Centers for Medicare & Medicaid Services (CMS) has released its final decision regarding National Coverage Determination (NCD) 20.7 covering carotid artery stenting (CAS), essentially confirming the coverage expansion outlined in July in a proposed decision memo.
CMS outlined in the decision memo, dated 11 October, that it had found “coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting is reasonable and necessary with the placement of a US Food and Drug Administration [FDA]-approved carotid stent with an FDA-approved or cleared embolic protection device” for Medicare patients who have symptomatic carotid stenosis ≥50% and asymptomatic carotid stenosis ≥70%.
In the July proposed decision, the federal agency detailed an expansion that would significantly broaden coverage for carotid stenting, expanding Medicare coverage to individuals previously only eligible for coverage in clinical trials, removing the limitation of coverage to only high-surgical-risk individuals, and removing facility standards and approval requirements.
What is next?
Looking ahead, new evidence is on the horizon for carotid artery stenosis patients, with data from the carotid revascularisation and medical management for asymptomatic carotid stenosis (CREST-2) trial due to be released next year. CREST-2 consists of two independent multicentre, randomised controlled trials of carotid revascularisation and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis.
Speaking on behalf of the Society for Interventional Radiology (SIR), immediate past president Parag Patel (Medical College of Wisconsin, Milwaukee, USA) provided the following comments:
SIR applauds the decision to expand coverage for PTA with CAS to include individuals of standard surgical risk, patients with symptomatic carotid artery stenosis ≥50%, and patients with asymptomatic carotid artery stenosis ≥70%.
SIR supports the decision to allow operators trained in performing these procedures to also complete the requisite neurologic assessments prior to and following treatmentThis underscores the expectation and requirement for ownership of the clinical management of the patients that we treat. We support the requirement for shared decision-making processes among physicians and the patient in determining an appropriate treatment.
This expansion will allow comparable therapies to be offered in a balanced discussion with patients as they determine with their doctors the best course of action. By expanding coverage to patients at standard surgical risk, Medicare is allowing all to benefit from the advantages of a minimally invasive procedure.
It is clear that we are improving in our knowledge and use of medical management—CREST-2 is comparing differences between intensive medical management (IMM) alone compared to CAS plus intensive medical management for patients with severe asymptomatic carotid stenosis. Prior studies have demonstrated positive results but were not followed long enough to sufficiently determine long-term benefits.
We should be in the business of disease prevention, and I suspect that we will see significant advantages with intensive medical management for many patients and likely prevention of many requiring any intervention at all.”