The Guidant RX Acculink Carotid Stent System was approved for use in patients at high risk for carotid endarterectomy (CEA) who were either symptomatic with a 50% or greater stenosis or asymptomatic with a greater than 80% stenosis. However, on December 17, Centers for Medicare and Medicaid Services (CMS) announced its draft decision proposing that Medicare coverage is restricted to patients at high risk for CEA with a carotid artery stenosis of 70% or more. CMS’s 30-day public comment period ran until January 17 2005 and has caused a furore in the vascular community and amongst the different societies.
In September CMS announced its intention to expand coverage of carotid artery stenting (CAS) with placement of an FDA approved carotid stent for patients in a large FDA-mandated, post approval study for the newly approved device. This meant that Medicare could pay for CAS carried out in those post approval studies overseen by the FDA. Previously CMS only covered CAS in Category B Investigational Device Exemption (IDE) clinical trials being conducted prior to FDA approval.
The latest CMS draft decision memo for CAS (CAG-00085R) expands coverage of CAS for patients at high risk for carotid surgery. The proposed Medicare coverage is restricted to patients at high risk for CEA with a carotid artery stenosis of 70% or more. Patients at high risk for CEA are defined as having significant comorbidities and anatomic risk factors such as recurrent stenosis or previous radical neck dissection, and would be poor candidates for CEA in the opinion of a vascular surgeon. Coverage will also be made available to asymptomatic patients who are enrolled in prospective clinical studies. CAS to treat indications not included in this expansion of coverage, such as symptomatic carotid stenosis or symptomatic disease with a stenosis 50%-70% are still eligible for coverage under the Category B IDE policies. CMS also states that the proposed coverage will limit the use of CAS to facilities and providers who have been determined to be competent in performing the evaluation, procedure and necessary follow-up care. The CMS statement indicates that this will help to ensure optimal patient outcomes and allow for evaluation and monitoring of provider and facility performance.
The proposed new CMS coverage policy is available for review at the CMS website (www.cms.hhs.gov/coverage). CMS’s 30-day public comment period ran until January 17 2005. CMS asked for comments to focus on the following issues: appropriate criteria, comorbid or chronic conditions for defining patients at high risk for CEA; criteria for appropriately defining symptomatic patients; professional and facility standards for performing PTA of the carotid artery with carotid stent placement; and, evaluation process for providers and facilities. Now the comment period has closed, CMS has 60 days to review the comments and issue a final coverage policy. The new CMS coverage policy should come into effect to coincide with the expected start date for enrolment for the post approval trial.
At ISET 2005 in Miami Dr Jay Yadav from the Cleveland Clinic addressed the issue of what it would take to advance carotid stenting and improve reimbursement. Dr Yadav criticized the draft CMS coverage decision. “CMS evaluates whether or not the intervention improves net health outcomes in the Medicare population at least as well as established treatments. Clearly this has not happened. Based on the current evidence for patients with symptomatic stenosis of 50-69%, the fundamental question of whether CEA should be performed for these patients has not been answered. If CEA cannot be generally recommended, then CAS, in turn, cannot be generally recommended.”Dr Yadav highlighted how the disunity amongst physicians and societies who have not spoken with a united voice has contributed to this outcome. For instance, the ASITN, whose immediate past President is Buddy Connors, has voiced concerns about the inappropriate use of this procedure on asymptomatic patients and maintains that medical therapy should be the standard of care for most patients with asymptomatic carotid stenosis. According to Dr Yadav the ASITN also believes that patients with asymptomatic carotid stenosis are rare. Vascular News also learnt that the Society for Interventional Radiology (SIR) tried to get all societies interested in CAS to sign a joint letter to CMS. The letter was submitted to the CMS during the public comment period with all the participating societies signing except the SVS, who refused to sign.
The refusal of CMS to extend Medicare coverage to asymptomatic patients appears to be the greatest area of contention. With regard to asymptomatic disease, although SAPPHIRE indicated that CAS was not inferior to CEA, the appropriateness of any procedure, CAS or CEA, remains unclear. Dr Henry Barnett was also quoted on the need for more evidence. “A trial of CE versus tightly controlled (as opposed to standard) medical care is one of the last remaining major trials still required to complete our knowledge of the role of CE in stroke prevention in asymptomatic patients”, said Barnett. In his talk Dr Yadav pointed out that this ignored the results of recent MRC Asymptomatic Carotid Surgery Trial (ACST) published last year in The Lancet, in which 3120 patients were randomized to CEA vs. medical treatment or deferred surgery. The 1560 immediate CEA patients had a 2.8% peri-operative stroke/death rate. “This trial used state of the art medical management such as anti-platelet therapy, statins and antihypertensives”, said Dr Yadav.
“Despite the fact that the high-risk patient trials for carotid stenting with emboli protection show that CAS is durable, safe and cost effective, the current CMS position is that CAS is reimbursed only for symptomatic patients with a stenosis greater than 70%. Whereas CEA is reimbursed for any patient who is symptomatic with a greater than 50% stenosis and asymptomatic with a stenosis greater than 60%. Medicare patients will continue to get CEA when they could benefit from a less invasive treatment which is at least as safe as CEA. This makes no sense.”
Vascular News also spoke to Dr Mark Wholey, one of the pioneers of carotid stenting. He criticized CMS for establishing a requirement that you must have the approval of a vascular surgeon in order to determine high risk for CEA. Patients at high risk for CEA are defined as having significant comorbidities and anatomic risk factors such as recurrent stenosis or previous radical neck dissection, and would be poor candidates for CEA in the opinion of a vascular surgeon. “If a vascular surgeon is necessary for approval to do carotid stenting, then the same logic would mean that a cardiac surgeon should be approving all percutaneous coronary interventions. We do not need a vascular surgeon to approve carotid stenting but a neurologist, who is unbiased, to monitor. Surgeons never had approval to do CEA. Science is overruling clinical judgement. In these situations we know what is right and clinical judgement is key. To send a patient home who is asymptomatic with preocclusive disease and a high grade lesion is to send that patient home with a stroke warrant. His son, Dr Michael Wholey, agreed. “A 90% stenosis in a patient who is asymptomatic is like having a loaded gun to your head. CMS is not trusting clinical judgement.”
In his talk at ISET L. Nelson Hopkins hypothesised that the CMS decision was because of their fear of “inappropriate widespread use.” The complications of CAS can be devastating and extremely expensive. CMS is terrified that there will be a lot of complications in high risk asymptomatic patients. Interspecialty discord allows the government to take control from physicians. CMS is wrong but they will probably come to their senses.”
There can be no doubt that the CMS decision is putting a brake on carotid stenting becoming the standard of care. It is less clear whether the decision is based solely on the lack of evidence for the benefit of intervention in asymptomatic patients or whether the real concern is to stop an explosion in the number of carotid stenting procedures carried out by less experienced, low volume interventionalists.