Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting

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Summary of Changes With the exception of clarifications regarding the use of embolic protection devices and the facility certification and recertification process, we have elected not to implement the changes in covered indications for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting that were outlined in the proposed decision memorandum. Therefore, coverage for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting remains as follows: Patients who are at high risk for carotid endarterectomy (CEA) and who also have symptomatic carotid artery stenosis ≥ 70%. Coverage is limited to procedures performed using FDA approved carotid artery stenting systems and embolic protection devices; Patients who are at high risk for CEA and have symptomatic carotid artery stenosis between 50% and 70%, in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (Medicare NCD Manual 310.1), or in accordance with the National Coverage Determination on CAS post approval studies (Medicare NCD Manual 20.7); Patients who are at high risk for CEA and have asymptomatic carotid artery stenosis ≥80%, in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (Medicare NCD Manual 310.1), or in accordance with the National Coverage Determination on CAS post approval studies (Medicare NCD Manual 20.7). CAS is only covered when used with an embolic protection device and is, therefore, not covered if deployment of the distal embolic protection device is not technically possible. The five facility certification requirements are also unchanged. We modified the process for completing facility certification and recertification in the NCD Manual. This modification includes specific data submission requirements for facility recertification as well as a timeline for this process. CAS for patients who are not at high risk for CEA remains covered only in FDA-approved Category B IDE clinical trials under 42 CFR 405.201 or under the clinical trial policy. This decision only changes coverage criteria in section B4 of the Medicare NCD Manual for CAS (20.7). Coverage as determined in the other sections of 20.7 will continue without modification. The NCD language can be found in Appendix B of this decision memorandum.

Decision Memo: To: Administrative File: CAG 00085R3 Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting From: Steve Phurrough, MD, MPA Director, Coverage and Analysis Group Marcel Salive, MD, MPH Director, Division of Medical and Surgical Services Sarah McClain, MHS Lead Analyst Joseph Chin, MD, MS Lead Medical Officer Rosemarie Hakim, PhD, MS Epidemiologist Subject: Coverage Decision Memorandum for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting Date: April 30, 2007 I. Decision Summary of Changes With the exception of clarifications regarding the use of embolic protection devices and the facility certification and recertification process, we have elected not to implement the changes in covered indications for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting that were outlined in the proposed decision memorandum. Therefore, coverage for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting remains as follows: Patients who are at high risk for carotid endarterectomy (CEA) and who also have symptomatic carotid artery stenosis ≥ 70%. Coverage is limited to procedures performed using FDA approved carotid artery stenting systems and embolic protection devices; Patients who are at high risk for CEA and have symptomatic carotid artery stenosis between 50% and 70%, in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (Medicare NCD Manual 310.1), or in accordance with the National Coverage Determination on CAS post approval studies (Medicare NCD Manual 20.7); Patients who are at high risk for CEA and have asymptomatic carotid artery stenosis ≥80%, in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (Medicare NCD Manual 310.1), or in accordance with the National Coverage Determination on CAS post approval studies (Medicare NCD Manual 20.7). CAS is only covered when used with an embolic protection device and is, therefore, not covered if deployment of the distal embolic protection device is not technically possible. The five facility certification requirements are also unchanged. We modified the process for completing facility certification and recertification in the NCD Manual. This modification includes specific data submission requirements for facility recertification as well as a timeline for this process. CAS for patients who are not at high risk for CEA remains covered only in FDA-approved Category B IDE clinical trials under 42 CFR 405.201 or under the clinical trial policy. This decision only changes coverage criteria in section B4 of the Medicare NCD Manual for CAS (20.7). Coverage as determined in the other sections of 20.7 will continue without modification. The NCD language can be found in Appendix B of this decision memorandum. II. Background Each year about 700,000 people in the United States experience a new or recurrent stroke. About 500,000 of these are first attacks and 200,000 are recurrent attacks (Thom, 2006). The term stroke refers to a “group of cerebrovascular disorders in which part of the brain is transiently or permanently affected by ischemia or hemorrhage, or in which one or more blood vessels of the brain are primarily affected by a pathologic process, or both” (Topol, 2002). There are three main categories of strokes: cerebral infarction (greater than 80%), intracerebral hemorrhage, and subarachnoid hemorrhage. Of the cerebral infarctions, “20% to 30% are due to atherothrombosis or thromboembolism from the extracranial or intracranial vessels” (Topol, 2002). Treatment of carotid artery stenosis is important in preventing stroke. Currently, three mechanisms are commonly used to treat carotid stenosis; medical therapy, carotid endarterectomy (CEA), and carotid artery stenting (CAS). CEA is a surgical procedure used to prevent stroke in which the surgeon removes fatty deposits or ulcerated and stenotic plaques from the carotid arteries, the two main arteries in the neck supplying blood to the brain. Although carotid artery stenosis is an important risk factor, it was estimated that “approximately 20% and 45% of strokes in the territory of symptomatic and asymptomatic carotid arteries with 70% to 99% stenosis, respectively, are unrelated to carotid stenosis” (Barnett, 2000). In these patients, optimal medical therapy would be most important since CEA does not reduce lacunar and cardio embolic strokes. Carotid artery stenting is performed with a catheter, usually inserted through the femoral artery, and threaded up to the carotid artery beyond the area of narrowing. A distal embolic protection device or filter is usually placed first to catch emboli or debris that may dislodge during the procedure. A self-expandable or balloon-expandable, metal mesh stent is then placed to widen the stenosis and the protection device is removed. On August 2, 2006, CMS accepted a formal request for a national coverage analysis (NCA) for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting. In the past six years, CMS has expanded coverage of PTA and CAS through three separate NCDs. Under the current NCD, patients at high risk for CEA who have symptomatic carotid artery stenosis ≥ 70% are covered for procedures performed using FDA-approved CAS systems and embolic protection devices in facilities approved by CMS to perform CAS procedures. In addition, patients at high risk for CEA with symptomatic carotid artery stenosis between 50% and 70% and patients at high risk for CEA with asymptomatic carotid artery stenosis ≥ 80% are covered in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (Medicare NCD Manual 310.1), or in accordance with the NCD on CAS post approval studies (Medicare NCD Manual 20.7 B3). Under the existing policy, CMS also required that each facility certify every two years that it meets the minimum facility standards outlined in the March 17, 2005 NCD. Those standards are summarized here. Please reference the Medicare National Coverage Determinations (NCD) Manual 20.7B4 for the complete facility standards: Facilities must have necessary imaging equipment, device inventory, staffing, and infrastructure to support a dedicated carotid stent program. Advanced physiologic monitoring must be available in the interventional suite. Emergency management equipment and systems must be readily available in the interventional suite. Each institution should have a clearly delineated program for granting carotid stent privileges and for monitoring the quality of the individual interventionalists and the program as a whole. The facility or a contractor to the facility must collect and analyze data on all carotid artery stenting procedures done at that particular facility. CMS allows initial certification that these standards are met if a letter is submitted to CMS attesting that: The facility was an FDA approved site that enrolled patients in prior CAS IDE trials, such as SAPPHIRE, and ARCHER; or The facility is an FDA approved site that is participating and enrolling patients in ongoing CAS IDE trials, such as CREST; or The facility is an FDA approved site for one or more FDA post approval studies; or The facility is a non-FDA approved facility that meets the minimum facility standards; The requestor, Guidant Endovascular Solutions, which has since become part of Abbott Neurovascular Laboratories, requested the following changes to the CAS coverage policy: Provide coverage of CAS for the treatment of carotid artery disease in high surgical risk patients who are symptomatic with ≥ 50% stenosis or asymptomatic ≥ 80% stenosis and determined by the treating physician to require carotid revascularization. Remove the language in the current policy stating the patient be a poor candidate for CEA ‘in the opinion of a surgeon.’ CMS used this opportunity to explore the possibility of establishing a more formal facility recertification process. In the proposed decision released on February 1, 2007 ( http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=194 ), CMS proposed the following changes to the current NCD: Restrict the current coverage for patients who are at high risk for carotid endarterectomy (CEA) and have symptomatic carotid artery stenosis ≥ 70% to patients who are less than 80 years of age; Expand coverage to patients who are at high risk for CEA and have asymptomatic carotid artery stenosis ≥ 80% and are less than 80 years old; Establish that the surgeon performing the surgical consultation that determines a patient’s high risk status must be properly credentialed to perform CEA as determined by the facility. CMS proposed the following clarifications to the current NCD: CAS is only covered when used with an embolic protection device and is, therefore, not covered if deployment of the distal embolic protection device is not technically possible; The five facility certification requirements are unchanged. We propose to modify the process for completing the certification and recertification process in the NCD Manual. CMS proposed to maintain current coverage for CAS as follows: Patients at high risk for CEA who have symptomatic carotid artery stenosis between 50-70%; Patients who are > 80 years of age with either symptomatic stenosis ≥ 70% or asymptomatic stenosis ≥ 80% in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), the clinical trial policy (Medicare NCD Manual 310.1), or the National Coverage Determination on CAS post approval studies (Medicare NCD Manual 20.7B3); CAS for patients who are not at high risk for CEA in the opinion of a surgeon credentialed to perform carotid endarterectomy remains covered only in FDA-approved Category B IDE clinical trials under 42 CFR 405.201 or under the clinical trial policy. III. History of Medicare Coverage History of Medicare Coverage for Percutaneous Transluminal Angioplasty Over the past six years, Medicare has expanded coverage for PTA and stenting of the carotid artery. Medicare first covered PTA of the carotid artery concurrent with stent placement in accordance with the FDA-approved protocols governing Category B Investigational Device Exemption (IDE) clinical trials and later in FDA required post approval studies (Medicare NCD Manual 20.7B2, B3). Current Medicare Coverage of Percutaneous Transluminal Angioplasty Effective March 17, 2005, Medicare expanded coverage of PTA of the carotid artery when performed on patients at high risk for CEA who also have symptomatic carotid artery stenosis ≥70% only when performed in a CMS approved facility for CAS with FDA-approved carotid artery stenting systems and embolic protection devices (Medicare NCD Manual 20.7B4). Effective November 6, 2006, Medicare established coverage for PTA and stenting of intracranial vessels for the treatment of cerebral artery stenosis ≥50% in patients with intracranial atherosclerotic disease when furnished in accordance with FDA-approved protocols governing Category B IDE clinical trials. All other indications for PTA with or without stenting to treat obstructive lesions of the vertebral and cerebral arteries remain noncovered. Reconsideration Guidant Corporation/Abbott Vascular Solutions requested that CMS reconsider the current coverage policy for CAS. They specifically request broad coverage for high surgical risk patients meeting the FDA-approved indications for use as well as the removal of the language ‘in the opinion of a surgeon’ in the current NCD. Discussion of Related NCDs Medicare's NCD for PTA concurrent with carotid stenting can be found in NCD Manual 20.7. Medicare’s NCD for PTA concurrent with carotid stenting in FDA post approval studies can also be found at NCD Manual 20.7B3. Benefit Category For an item or service to be covered by the Medicare program, it must meet one of the statutorily defined benefit categories outlined in the Social Security Act. PTA of the carotid artery concurrent with stenting, at a minimum, falls under the benefit category set forth in section §1861(b)(3) (inpatient hospital services), a part A benefit under §1812(a)(1) and §1861(s)(1) (physician services), a part B benefit. This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service. IV. Timeline of Recent Activities Date Action August 2, 2006 CMS accepts Guidant Corporation/Abbott Vascular Solutions’ formal NCD reconsideration request for expanded coverage of carotid artery stenting with distal embolic protection. The tracking sheet is posted and the initial 30-day public comment period begins. September 1, 2006 Initial 30-day public comment period closes. Comments are posted on website. February 1, 2007 Proposed decision memorandum is posted and the 30-day public comment period begins. April 30, 2007 Final decision memorandum posted. NCD becomes effective. V. FDA Status Currently, five carotid stenting systems, comprised of the balloon angioplasty, stent, and embolic protection device, are approved for market by the FDA. These FDA-approved carotid stent systems are indicated for the improvement of lumen diameter in patients with occlusive carotid artery disease who are considered at high risk for adverse events from CEA and are 1) symptomatic with ≥ 50% stenosis; or 2) asymptomatic with ≥ 80% stenosis. VI. General Methodological Principles When making national coverage decisions, CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service falling within a benefit category is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. The critical appraisal of the evidence enables us to determine to what degree we are confident that: 1) the specific assessment questions can be answered conclusively; and 2) the intervention will improve health outcomes for patients. An improved health outcome is one of several considerations in determining whether an item or service is reasonable and necessary. A detailed account of the methodological principles of study design that the agency utilizes to assess the relevant literature on a therapeutic or diagnostic item or service for specific conditions can be found in Appendices. In general, features or clinical studies that improve quality and decrease bias include the selection of a clinically relevant cohort, the consistent use of a single good reference standard, and the blinding of readers of the index test, and reference test results. Public comments sometimes cite the published clinical evidence and give CMS useful information. Public comments that give information on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less useful for making a coverage determination. CMS uses the initial public comments to inform its proposed decision. CMS responds in detail to the public comments on a proposed decision when issuing the final decision memorandum. VII. Evidence A. Introduction In this reconsideration, we considered studies and evidence that were published after the prior decision that addressed carotid artery stenting in 2005 (NCD 20.7B(4)). 1 There have been several studies reported since the prior decision. The most commonly considered health outcomes have included mortality, stroke, myocardial infarction and adverse events. As noted in the prior decision, patients enrolled in the clinical studies have been generally classified by the presence or absence of symptoms from their carotid artery stenosis. This continues to be an appropriate distinction given the differing risks of stroke, indications for treatment, and benefits of intervention. Since this is a reconsideration, we have taken the opportunity to re-examine not only what was restricted but also what was covered, the requirements of coverage, and aspects of physician training and facility certification. Following the classification of the prior decision, this National Coverage Analysis (NCA) focuses on the following main questions: Is the evidence sufficient to conclude that PTA with carotid artery stenting improves health outcomes for patients who are at high risk for CEA surgery with symptomatic carotid artery stenosis ≥ 50%? Is the evidence sufficient to conclude that PTA with carotid artery stenting improves health outcomes for patients who are at high risk for CEA surgery with asymptomatic carotid artery stenosis ≥ 80%? In addition, during the review of the evidence, a striking finding about the outcomes of CAS in patients ≥ 80 years of age became apparent and indicated the need for an additional coverage question as follows: Is the evidence sufficient to conclude that PTA with carotid artery stenting improves health outcomes for patients who are at high risk for CEA surgery and ≥ 80 years of age? B. Discussion of evidence reviewed 1. Literature Search Because this is a reconsideration, CMS focused on reported studies since the prior decision and searched PubMed from 2005 to present. General keywords included carotid artery and stenting or stent. Studies must have presented original data, examined primary health outcomes and been published in peer-reviewed English language journals. Abstracts were excluded. 2. External technology assessments and clinical reviews Grant MD . Angioplasty and stenting of the cervical carotid artery with embolic protection of the cerebral circulation. TEC Assessments, 2007; 22(1). In press. The Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) reevaluated PTA and carotid artery stenting with distal embolic protection. Similar to the 2005 results, the TEC concluded: “use of carotid artery angioplasty and stenting with or without embolic protection of the cerebral circulation for patients with carotid artery stenosis does not meet the TEC criteria”(http://www.bcbs.com/betterknowledge/tec/press/actions-taken-by-the-medical-1.html). Blue Cross and Blue Shield Association Technology Evaluation Center. Angioplasty and Stenting of the Cervical Carotid Artery with Distal Embolic Protection of the Cerebral Circulation. Assessment Program Volume 19, No. 15 February 2005. The Blue Cross and Blue Shield Medical Advisory Panel made the following judgments about whether carotid artery angioplasty and stenting with or without distal embolic protection meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria to reduce stroke risk from symptomatic or asymptomatic carotid stenosis: A single FDA approved device is currently available. Several other devices are under consideration. Available evidence does not permit conclusions on outcomes of CAS with DEP for any indication considered in the assessment. Available evidence is insufficient to permit conclusions as to whether CAS with DEP improves net health outcomes. Whether CAS with DEP is as beneficial as either CEA or optimal medical management for high surgical risk patients cannot be determined since available evidence is insufficient to permit conclusions. Whether CAS with DEP improves health outcomes has not yet been demonstrated in the investigational setting. Based on these conclusions, the BCBS Medical Advisory Panel determined that the use of carotid artery angioplasty and stenting with or without distal embolic protection for patients with carotid artery stenosis does not meet the TEC criteria. Bates ER, Babb JD, Casey DE, Cates CU, Duckwiler GR, Feldman TE, Gray WA, Ouriel K, Peterson ED, Rosenfield K, Rundback JH, Safian RD, Sloan MA, White CJ. ACCF/SCAI/SVMB/SIR/ASITN 2007 clinical expert consensus document on carotid stenting: a report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents (ACCF/SCAI/SVMB/SIR/ASITN Clinical Expert Consensus Document Committee on Carotid Stenting). J Am Coll Cardiol 2007;49:126 –70. This clinical expert consensus document was “intended to provide a perspective on the current state of carotid artery stenting (CAS).” It reviewed similar issues to those addressed in this decision, such as clinical evidence on CEA and CAS, recommendations, high surgical risk criteria, training and credentialing. The authors reported: “Carotid artery stenting is a reasonable alternative to CEA, particularly in patients at high risk for CEA.” For CEA, the group noted the American Heart Association recommendations (See following references: Goldstein, 2006 and Sacco, 2006). Goldstein LB, Adams R, Alberts MJ, Appel LJ, Brass LM, Bushnell CD, Culebras A, DeGraba TJ, Gorelick PB, Guyton JR, Hart RG, Howard G, Kelly-Hayes M, Nixon JVI, Sacco RL. Primary prevention of ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council: Cosponsored by the Atherosclerotic Peripheral Vascular Disease Interdisciplinary Working Group; Cardiovascular Nursing Council; Clinical Cardiology Council; Nutrition, Physical Activity, and Metabolism Council; and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Stroke 2006;37:15831633. This guideline provided “an overview of the evidence on various established and potential stroke risk factors and provides recommendations for the reduction of stroke risk.” Specifically for asymptomatic carotid stenosis, the authors stated: “It is recommended that patients with asymptomatic carotid artery stenosis be screened for other treatable causes of stroke and that intensive therapy of all identified stroke risk factors be pursued (Class I, Level of Evidence C). The use of aspirin is recommended unless contraindicated because aspirin was used in all of the cited trials as an antiplatelet drug except in the surgical arm of 1 study, in which there was a higher rate of MI in those who were not given aspirin (Class I, Level of Evidence B). Prophylactic carotid endarterectomy is recommended in highly selected patients with high-grade asymptomatic carotid stenosis performed by surgeons with < 3% morbidity/mortality rates (Class I, Level of Evidence A). Patient selection should be guided by an assessment of comorbid conditions and life expectancy, as well as other individual factors, and be balanced by an understanding of the overall impact of the procedure if all-cause mortality is considered as one of the end points, and it should include a thorough discussion of the risks and benefits of the procedure with an understanding of patient preferences. Carotid angioplasty–stenting might be a reasonable alternative to endarterectomy in asymptomatic patients at high risk for the surgical procedure (Class IIb, Level of Evidence B); however, given the reported periprocedural and overall 1-year event rates, it remains uncertain whether this group of patients should have either procedure.” Sacco RL, Adams R, Albers G, et al. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: A statement for healthcare professionals from the American Heart Association/American Stroke Association Council on Stroke: Co-Sponsored by the Council on Cardiovascular Radiology and Intervention: The American Academy of Neurology affirms the value of this guideline. Stroke 2006:37;577-617. This guideline provided “recommendations on the prevention of ischemic stroke among survivors of ischemic stroke or transient ischemic attack.” Specific recommendations were as follows: 1. “For patients with recent TIA or ischemic stroke within the last 6 months and ipsilateral severe (70% to 99%) carotid artery stenosis, CEA by a surgeon with a perioperative morbidity and mortality of < 6% (Class I, Level of Evidence A) is recommended. For patients with recent TIA or ischemic stroke and ipsilateral moderate (50% to 69%) carotid stenosis, CEA is recommended, depending on patient-specific factors such as age, gender, comorbidities, and severity of initial symptoms (Class I, Level of Evidence A). When the degree of stenosis is < 50%, there is no indication for CEA (Class III, Level of Evidence A) (Table 4).” 2. “When CEA is indicated for patients with TIA or stroke, surgery within 2 weeks is suggested rather than delaying surgery (Class IIa, Level of Evidence B).” 3. “Among patients with symptomatic severe stenosis ( > 70%) in whom the stenosis is difficult to access surgically, medical conditions are present that greatly increase the risk for surgery, or other specific circumstances exist such as radiation-induced stenosis or restenosis after CEA, CAS is not inferior to endarterectomy and may be considered (Class IIb, Level of Evidence B). CAS is reasonable when performed by operators with established periprocedural morbidity and mortality rates of 4% to 6%, similar to that observed in trials of CEA and CAS (Class IIa, Level of Evidence B).” 4. “Among patients with symptomatic carotid occlusion, EC/IC bypass surgery is not routinely recommended (Class III, Level of Evidence A).” Cremonesi A, Setacci C, Bignamini A, et al. Carotid artery stenting. First Consensus document of the ICCS-SPREAD Joint Committee. Stroke 2006;37:2400-2409. Cremonesi and colleagues presented an evidence-based guideline and consensus document on CAS for the Italian Consensus Carotid Stenting (ICCS)/SPREAD [Stroke Prevention and Educational Awareness Diffusion] group [a multidisciplinary association representing > 30 scientific societies and patient organizations in the field of cardiovascular disease, which, during the last 7 years, has released 4 editions of evidence-based guidelines for stroke prevention and treatment (http://www.spread.it)]. The consensus document addressed “the main issues related to methodology, definition of symptomatic and asymptomatic carotid stenosis, indication and procedures for carotid artery stenting, including the use of devices for preventing procedural embolic complications.” In addition, the group addressed “credentials and competency for physician qualifications to perform vascular angioplasty and stent placement, including training, acceptable complication rates and certification.” The report states: “Given that current evidence is still insufficient, endarterectomy should not be systematically replaced with endovascular procedures for the elective correction of carotid stenosis.” Recommendation 3: Grade A (At least 1 meta-analysis, systematic review, or RCT rated as 1++ and directly applicable to the target population; or systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results). “CAS, if performed with adequate procedural quality levels, should be used instead of endarterectomy in the presence of severe vascular or cardiac comorbidities or specific conditions.” Recommendation 4: Grade B (A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or extrapolated evidence from studies rated as 1++ or 1+). The group defined high risk as the following: “Conventionally, high risk for surgery is suspected in the presence of: Specific conditions: contralateral laryngeal nerve palsy; radiation therapy to the neck; previous CEA with recurrent restenosis; high cervical internal carotid/below the clavicle common carotid lesions; severe tandem lesions; age > 80 years; severe pulmonary disease. Severe vascular and cardiac comorbidities: congestive heart failure (New York Heart Association class III/IV) and/or known severe left ventricular dysfunction; open heart surgery needed within 6 weeks; recent myocardial infarction ( > 24 hours and < 4 weeks); unstable angina (Canadian Cardiovascular Society class III/IV); contralateral carotid occlusion. This definition of high risk, however, is not evidence based and is not universally shared.” For physician training, the group states: “Once the basic skill for catheter-based intervention has been achieved by the already-active interventionist, the minimum recommended training to achieve competence is as follows: At least 150 procedures of supra-aortic vessel engagement (during diagnostic as well as interventional procedures) within 2 years, of which at least 100 as the primary operator; At least 75 carotid stenting procedures, of which at least 50 as the primary operator, within a 2-year fellowship. Recommendation 10: Grade GPP (Recommended best practice based on the clinical experience of the guideline development group, without research evidence); The minimum requirement to maintain technical skill (competence) is the number of 50 carotid stenting procedures performed and documented by each primary operator per year. Recommendation 11: Grade GPP.” 3. Internal technology assessments Since this is a reconsideration of the 2005 policy, we focused our search on studies published or presented from the time of the prior decision. Two randomized trials, 5 case series or registry studies, 2 presentations, and 1 evidence based clinical guideline were considered. Chaer RA, Derubertis BG, Trocciola SM, et al. Safety and efficacy of carotid angioplasty and stenting in high risk patients. American Surgeon 2006;72:694-699. Chaer and colleagues reported the results of an observation study (vascular registry) of 545 patient who underwent CEA and 148 patients who underwent CAS. Patients were treated from 1997 to 2005 at 1 institution (outside US). All patients were considered at high risk for surgical intervention. Inclusion criteria were not specified. The main endpoint was cumulative death, stroke and MI within 30 days after the procedure, or death or ipsilateral stroke for the follow-up period. Mean age was 71 years for the CEA patients and 75 for the CAS patients. Women comprised 68% of the CEA group and 61% of the CAS group. Mean stenosis was 78% in the CEA group and 87% in the CAS group. Mean follow-up was 23 months and 18 months, respectively. The 30-day endpoint was 4% for the CEA group and 3.4% for the CAS group. All patients who underwent CAS received clopidogrel for at least 30 days. The authors concluded that “CAS is equivalent to CEA in safety and efficacy, even when performed in patients who may be at increased surgical risk” (Chaer et al., 2006). Gray WA, Hopkins LN, Yadav S, et al. Protected carotid stenting in high-surgical-risk patients: the ARCHeR results. J Vasc Surg 2006;44:258-269. Gray and colleagues reported the results of ARCHeR (Acculink for Revascularization of Carotids in High-Risk Patients) which was comprised of 3 case series studies of 581 patients who underwent CAS. Patients were treated from 2000 to 2003 at 48 centers (US and outside). All patients were considered at high risk for surgery. Eligibility criteria included symptomatic stenosis ≥ 50% or asymptomatic stenosis ≥ 80% by angiography. The primary endpoint was a composite of periprocedural (≤ 30 days) death, stroke, and myocardial infarction (MI), plus ipsilateral stroke between days 31 and 365. Cumulative results were presented. Mean age was 70 years. Men comprised 67% of the patients. Most patients had asymptomatic stenosis (76%). The overall 30-day stroke, death, and MI rate was 8.3%, with 13.0% for symptomatic patients and 6.8% for asymptomatic patients. The authors concluded: “The ARCHeR results demonstrate that extracranial carotid artery stenting with embolic filter protection is not inferior to historical results of endarterectomy and suggest that carotid artery stenting is a safe, durable, and effective alternative in high-surgical-risk patients” (Gray et al., 2006). The results of the ARCHeR studies were presented earlier and considered in our prior decision. Halabi M, Gruberg L, Pitchersky S, et al. Carotid artery stenting in surgical high-risk patients. Catheterization and Cardiovascular Interventions 2006;67:513-518. Halabi and colleagues reported the results of a case series of 116 patients who underwent CAS. Patients were treated from 1998 to 2004 at 1 facility (outside US). All patients were considered at high risk for surgery. Both symptomatic (≥ 60% stenosis) and asymptomatic (≥ 70% stenosis) patients were included but results were not presented by subgroups. Endpoints included death and stroke during inpatient stay, at 30 days and 12 months. Mean age was 71 years. Men comprised 62%. During the inpatient stay, there were 3 death and strokes (2.6%). At 30 days, there were 3 death and strokes (2.8%). At 1 year, there were 4 death and stokes (7.8%). The inpatient events occurred in patients that did not receive distal protection (3/67). The authors concluded: “These results support the use of carotid artery angioplasty and stenting in high-risk patients with significant primary or secondary carotid artery stenosis” (Halabi et al., 2006). Mas JL, Chatellier G, Beyssen B, et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med 2006;355:1660-1671. Mas and colleagues reported the results of a randomized noninferiority trial, the Endarterectomy versus Angioplasty in Patients with Symptomatic Sever Carotid Stenosis (EVA-3S). The primary endpoint was incidence of death and stroke with 30 days of intervention. Inclusion criteria included TIA (transient ischemic attack) or nondisabling stroke with 120 days of enrollment, and stenosis 60-99% as determined by NASCET (North American Symptomatic Carotid Endarterectomy Trial) criteria. There was no enrollment restriction based on surgical risk so patients who were at low or high risk for CEA were included in the study. Exclusion criteria included disabling stroke (modified Rankin score ≥ 3), severe tandem lesions, and life expectancy < 2 years. The trial started in November 2000 and was conducted in 30 centers (France). By September 2005, 527 patients were randomly assigned to CEA (n=262; 257 completed, 0 failed) or CAS (n=265; 247 completed, 13 failed). Mean age was 70 years. Men comprised 75% of the patients. Most patients (72%) had stenosis ≥ 80%. At the planned data analysis in September 2005, the safety committee recommended stopping enrollment. The 30-day incidence of any stroke or death was 3.9% in the CEA group and 9.6% in the CAS group, with a relative risk of 2.5 (95% confidence intervals = 1.2 to 5.1). Patients who underwent CAS without distal protection had a higher incidence of stroke or death compared to patients who underwent CAS with distal protection (25% versus 7.9%; p-value=0.03). The trial was stopped early for reasons of both “safety and futility” as noted. The authors concluded that in “patients with symptomatic carotid stenosis of 60% or more, the rates of death and stroke at 1 and 6 months were lower with endarterectomy than with stenting” (Mas et al., 2006). Several correspondences (Bonvini and Righini, Hamon and Riddell, Maree and Rosenfield) were published in response to the EVA-3S trial report. The authors mentioned that physician experience and use of distal embolic protection devices may have influenced the trial outcomes. Mas and colleagues replied with additional analyses that the 30-day risk of stroke or death did not differ significantly by physician CAS experience and that the 30-day risk of stroke or death was significantly higher in the CAS group compared to the CEA group when patients who did not receive distal embolic protection were excluded from the analysis (Mas et al., 2006). Park B, Mavanur A, Dahn M, Menzoian J. Clinical outcomes and cost comparison of carotid artery angioplasty with stenting versus carotid endarterectomy. J Vasc Surg 2006;44:270-276. Park and colleagues reported the results of a case series of 94 patients who underwent CEA (n=48) and CAS (n=46). Patients were treated from 2003 to 2005 at 1 institution (US). Eligibility criteria included asymptomatic stenosis ≥ 80% or symptomatic stenosis ≥ 50%, as measured by duplex ultrasound. Patient data were collected retrospectively. Endpoints included technical success, procedure related mortality, major adverse events, and costs. Mean age was 71 years. Men comprised 53% of the study population. There were no significant differences in technical success, 30-day mortality and stroke rates, and MI rate. The authors concluded: “CAS with neuroprotection was associated with clinical outcomes equivalent to those with CEA but had higher total hospital costs” (Park et al., 2006). Safian RD, Bresnahan JF, Jaff MR, et al. Protected carotid stenting in high-risk patients with severe carotid artery stenosis. J Am Coll Cardiol 2006;47:2384-2389. Safian and colleagues reported the results of a multicenter registry of 419 patients who underwent CAS [Carotid Revascularization with ev3 Arterial Technology Evolution (CREATE)]. The primary endpoint was a composite of death, ipsilateral stroke, procedure related contralateral stroke, and MI. Patients were treated in 2004 at 32 participating centers. All patients were considered high risk. Eligibility criteria included symptomatic stenosis ≥ 50% and asymptomatic stenosis ≥ 70%. Mean age was 74 years. Men comprised 61% of the study population. Most patients had asymptomatic stenosis (83%). The primary endpoint occurred in 26 patients (6.2%). There were 8 deaths, 14 nonfatal strokes, and 4 MIs. The authors concluded: “For some patients with severe carotid stenosis and high-risk features for carotid endarterectomy, carotid artery stenting with distal embolic protection is a reasonable alternative for revascularization” (Safian et al., 2006). The SPACE Collaborative Group. 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomized non-inferiority trial. Lancet 2006;368:1239-1247. The SPACE (Stent-Protected Percutaneous Angioplasty of the Carotid vs Endarterectomy) Collaborative Group reported the results of a randomized non-inferiority trial that compared CEA to CAS in patients with severe symptomatic carotid artery stenosis. The primary endpoint was ipsilateral stroke or death of any cause up to 30 days after treatment. Eligibility criteria included neurological or ocular symptoms such as amaurosis fugaz, TIA, stroke in the previous 180 days and severe stenosis ≥ 70% by duplex ultrasound, which corresponds to ≥ 50% according to NASCET criteria. There was no enrollment restriction based on surgical risk so patients who were at low or high risk for CEA were included in the study. The use of a distal embolic protection device was optional. From 2001 to 2006, 1200 patients were randomly assigned to CAS (n=605; 599 followed up and included in the analysis) or CEA (n=595; 584 followed up and included in the analysis). Patients were treated at 35 trial centers in Germany, Austria and Switzerland. Mean age was 68 years. Men comprised 72% of the study population. In the CAS group, embolic protection devices were used in 27% (151/567) of the procedures. At 30 days post procedure, the primary endpoint occurred in 41 (6.8%) patients in the CAS group compared to 37 (6.3%) in the CEA group (absolute difference = 0.51; 90% CI = -1.89 to 2.91). The authors concluded: “SPACE failed to prove non-inferiority of carotid-artery stenting compared to carotid endarterectomy for the periprocedural complication rate. The results of this trial do not justify the widespread use in the short-term of carotid-artery stenting for treatment of carotid-artery stenoses” (SPACE Group, 2006). Stanziale SF, Marone LK, Boules TN, et al. Carotid artery stenting in octogenarians is associated with increased adverse outcomes. J Vasc Surg 2006;43:297-304. Stanziale and colleagues reported the results of analysis of a prospective registry of carotid stent patients “to determine if octogenarian status affects periprocedural as well as 1-year outcomes.” From 1996 to 2004, the registry included 384 patients, including 260 from 10 trials, that were treated at 1 institution (US). Outcomes included periprocedural stroke, TIA, MI and death. There were 87 patients that were ≥ 80 years and 295 patients < 80 years. The investigators found that “All adverse outcomes were significantly higher in octogenarians compared with younger patients: 30-day stroke rate, 8.0% vs 2.7% (P = .02); 30-day stroke, myocardial infarction, or death, 9.2% vs 3.4% (P = .02).” The authors concluded: “Octogenarians undergoing carotid artery stenting are at higher risk than nonoctogenarians for periprocedural complications, including neurologic events and death. Major event-free survival at 1 year is also significantly better in nonoctogenarians. These risks should be weighed when considering carotid stenting in elderly patients” (Stanziale et al., 2006). Post Approval Studies Guidant Corporation. Carotid RX ACCULINK® / ACCUNET Post-Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE), 2006. Gray WA, Yadav JS, Verta P, et al . The CAPTURE registry: Results of carotid stenting with embolic protection in the post approval setting. Catheterization and Cardiovascular Interventions 2006; Published Online 12/14/2006 at: http://www3.interscience.wiley.com/cgi-bin/fulltext/113517832/HTMLSTARTW?CRETRY=1&SRETRY=0. In December 2006, Guidant Corporation presented the results of CAPTURE to CMS. CAPTURE was a registry study that was mandated by the FDA as part of the PMA approval granted in September 2004. The purpose of CAPTURE was to collect data on carotid artery stenting in patients at high risk for surgery using the Guidant carotid artery stent (ACCULINK) and embolic protection device (ACCUNET), when used by a broad group of physicians under commercial use conditions. The primary endpoint was a composite of death, stroke and MI within 30 days post-index procedure. Eligibility criteria included indications according to the FDA labeling, specifically symptomatic stenosis ≥ 50% and asymptomatic stenosis ≥ 80%. At the time of the report, there were 3500 patients enrolled in the registry through 140 study sites. Mean age was 73 years with 24% of patients ≥ 80 years. Men comprised 61% of the registry population. Most patients had asymptomatic stenosis (86%). The primary endpoint of all stroke, death and MI occurred in 6.3% of the patients. The endpoint was 13.0% for symptomatic patients and 6.8% for asymptomatic patients. There were no statistically significant differences reported for physician experience levels. Patients ≥ 80 years of age had significantly higher rates of death, strokes and the composite events (9.4%) compared to patients < 80 years (5.3%). Many of the CAPTURE findings that were presented to CMS were subsequently published online. Cordis Corporation. Carotid Artery Stenting with Embolic Protection in Patients at High Surgical Risk for Carotid Endarterectomy, 2006. In March 2006, Cordis Corporation presented the interim results of CASES-PMS (Carotid Artery Stenting Education System Post-Market Study) to CMS. CASES-PMS was a registry study to assess safety and efficacy of CAS with distal protection in high surgical risk patients using the Cordis carotid stent (PRECISE) and embolic protection device (ANGIOGUARD), when performed by physicians outside the setting of a controlled trial with various levels of CAS experience. The primary endpoint was a 30 day composite of all death, all stroke and MI. Eligibility criteria included symptomatic stenosis ≥ 50% and asymptomatic stenosis ≥ 80%. At the time of the report, there were 1479 patients enrolled in the registry through 73 participating centers. Most patients (78%; 1157/1479) had asymptomatic stenoses. The primary endpoint occurred in 4.8% of enrolled patients. It was 5.9% for symptomatic patients and 4.5% for asymptomatic patients. There were no significant differences by physician experience (number of procedures performed). Cordis Corporation. Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) 3 Year Results, 2006. In March 2006, Cordis Corporation presented the 3 year follow-up results for the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) trial which originally studied 334 patients. Similar to the published findings (Yadav et al., 2004), the CAS with embolic protection was not inferior to CEA. The 3 year cumulative percentage of death, stroke and MI was 26.2% for CAS patients and 30.3% for CEA patients (p=0.273). For the 3 year follow-up data, the number of patients included in the analysis for each group was not reported. The number of patients lost to follow-up was also not available. 4. MCAC Not applicable. 5. Guidelines Not applicable. 6. Professional Society Position Statements The American College of Cardiology, American Society of Interventional & Therapeutic Neuroradiology, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and the Society of Interventional Radiology published a joint consensus document as noted above (Bates et al., 2007) 7. Expert Opinion During the public comment period following the posting of the proposed decision memorandum, CMS received substantive comments from various professional societies who are deeply involved in carotid artery stenting issues. In this section we summarize comments offered by each group. American Academy of Neurology (AAN) The AAN objects to CMS’ proposal to cover asymptomatic patients at high risk for CEA who are less than 80 years of age with ≥ 80% stenosis. They contend that current data indicates a 30-day complication rate of death and stroke above the 3% level. They state that CAS is contraindicated unless the complication rate is below 3% and treated patients have a life expectancy of > 5 years. They also express concern about making decisions based on “registry” data, which “cannot determine efficacy.” The AAN supports CMS’ proposal to restrict coverage for symptomatic patients at high risk for CEA with ≥ 70% stenosis to patients < 80 years of age. They contend that higher periprocedural complication rates for high surgical risk, symptomatic patients age 80 and above have been seen in recent data. The AAN agrees with CMS’ proposal to require a surgeon credentialed to perform CEA to determine if patients are at high risk for CEA and suggests that a physician with expertise in stroke be involved in the decision making process prior to submitting patients to CAS. The AAN asserts that reimbursement for CAS should not be contingent upon placement of an embolic protection device (EPD). They note that while EPDs should be used whenever possible, on rare occasions, the benefit of CAS without an EPD outweighs the risk of the procedure. For these instances, operators should be required to document why an EPD was not used, but reimbursement should not be withheld. The AAN agrees with CMS’ intent to clarify the facility certification process, however they believe that the “omission of any mention of neurological and stroke services in the facilities requirements is a glaring error.” They contend that an acute stroke plan should be required for any facility with a CAS program. American Association of Neurological Surgery (AANS) and Congress of Neurological Surgeons (CNS) The AANS/CNS disagrees with CMS’ proposal to expand coverage to asymptomatic patients at high risk for CEA with ≥80% stenosis because available evidence does not support such an expansion of coverage. The AANS/CNS also disagrees with CMS’ proposal to restrict coverage for CAS in symptomatic patients at high risk for CEA with ≥ 70% to patients under the age of 80. They contend that despite poorer outcomes for octogenarians, this patient population can still benefit from CAS and should have this treatment option. The AANS/CNS supports CMS’ clarification requiring a surgeon credentialed to perform CEA to determine whether a patient is at high risk for CEA. The AANS/CNS disagrees with CMS’ proposed clarification requiring use of EPDs with all CAS procedures. They state that evidence supporting such a requirement for payment is lacking and contend that payment should be provided for cases in which the operator determines that placement of an EPD creates too much risk. The AANS/CNS supports facility certification and oversight but opposes transferring this role to SCAI-CAP because the plan does not involve neurology, neurosurgery or neuroradiolgy. They assert that a neutral body or one representing all involved specialties should assume such a role. American College of Cardiology (ACC) The ACC supports CMS’ proposal to expand coverage of CAS to asymptomatic patients at high risk for CEA with ≥ 80% stenosis, but opposes restricting coverage for patients age 80 and above. They assert that evidence does not conclusively explain why higher complication rates are seen in octogenarians and that restricting them from coverage may prevent them from receiving appropriate therapy. The ACC opposes CMS’ proposal to restrict coverage for symptomatic patients at high risk for CEA with ≥ 70% stenosis to patients < 80 years of age. They also disagree with CMS’ proposal to not expand coverage for symptomatic patients at high risk for CEA with 50-69% stenosis. The ACC maintains that patients age 80 and above should not be disqualified from coverage based solely on age, and such a limit in treatment options may result in harming these patients. They further contend that coverage of high surgical risk patients with ≥ 50% stenosis is supported by “globally accepted supporting evidence for non-inferiority and perhaps superiority of CAS to CEA in high surgical risk patients in randomized prospective multi-center controlled trial (SAPPHIRE), as well as multiple FDA approved, in