Following the CMS’ decision to limit expansion of carotid artery stenting (CAS) procedures, the vascular community has presented a united front urging the CMS to reconsider its approach to carotid artery stenting.A coalition of societies representing over 100,000 physicians in the US has written to the Centers for Medicare and Medicaid Services (CMS) regarding the latters’ decision to limit the expansion of coverage for carotid artery stenting.
In a draft decision in December last year, the CMS proposed that coverage should be expanded to Medicare patients at high-risk for carotid endarterectomy, with symptomatic carotid artery stenosis of 70% or more. This decision was reached despite FDA approval of Guidant’s RX Acculink Carotid Stent System in August 2004, which was approved for carotid artery stenting use in high risk patients who were either symptomatic with a 50% or greater stenosis or asymptomatic with a greater than 80% stenosis.
Medicare patients at high risk for carotid artery stenting 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 carotid endarterectomy in the opinion of a surgeon.
As for asymptomatic Medicare patients, those who are enrolled in a clinical trial will continue to be covered. carotid artery stenting indications not covered in the proposal include symptomatic carotid stenosis or asymptomatic disease with a stenosis of 50%-70%, although these indications were and continued to be covered under the Category B IDE research protocols.
The letter was in response to the CMS’ 30-day public comment period, which asked for comments to focus on the following issues: appropriate criteria, comorbid or chronic conditions for defining patients at high risk for carotid endarterectomy; 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.
The letter was submitted by the American Academy of Neurology, American Association of Neurological Surgeons, the American College of Radiology, the American College of Cardiology, the American Society of Interventional & Therapeutic Neuroradiology (ASITN), the American Society of Neuroradiology, the Society for Cardiovascular Angiography and Interventions, the Society for Vascular Medicine & Biology, the Society of Interventional Radiology (SIR) and the Congress of Neurological Surgeons.
Although the letter welcomed many of the draft coverage decisions and proposed recommendations, it did suggest that some revisions should be adopted.
The workgroup’s comments supported the CMS’ proposed list of comorbidities and/or anatomic risk factors named in the memorandum. However, the coalition recommended adding the following: Severe pulmonary disease (FEVI<30%); high cervical ICA lesions or CCA lesions below the clavicle; recent MI (>24 hours and >4 weeks); open heart surgery needed within six weeks; contralateral nerve plasty; tracheotomy; and prior radial neck dissection. The additional comorbid/anatomic factors are from the ARCHER and SAPPHIRE trials and include those that increase the likelihood of postoperative cardiopulmonary complications.
In addition, the letter supported the symptoms of cartoid artery stenosis given in the memorandum, which contain the following symptoms: Carotid transient ischemic attacks (distinct focal neurological dysfunction persisting less than 24 hours), focal cerebral ischemia producing a nondisabling stroke (modified Rankin scale <3 with symptoms for 24 hours or more), and transient monocular blindness (amaurosis fugax). Regarding the evaluation process for providers and facilities, the letter supported board certification and the use of standards in the national evaluation process. However, the letter stressed reservations that such a process was not immediately available, and that carotid artery stenting coverage should not be delayed while this process is developed and finalized. The coalition strongly recommended that the CMS give “serious and thoughtful” consideration to a national carotid artery stenting outcomes registry, which would provide important information to CMS, the health professions and patients. The coalition also encouraged the CMS to require adherence to the NASCET imaging criteria and take steps to ensure quality imaging. Since the degree of stenosis is one of the primary entry points into the proposed coverage, the quality and accuracy of duplex Doppler ultrasound or carotid artery angiogram are paramount. Therefore, final determination of the percentage of stenosis should be calculated from the angiographic images using the methodology used in NASCET. To achieve this, the coalition recommends laboratory/facility accreditation through a national accreditation organisation such as the Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL) or the ACR, allowing for sufficient time for the facilities to be accredited. Also welcomed was the support for an independent neurological assessment by a qualified practitioner and the continuation of CMS’ prior carotid artery stenting coverage policy for research protocols on FDA-approved clinical trials. This will ensure that only appropriate patients receive carotid artery stenting and that the carotid artery stenting procedures meet the necessary efficacy and outcome measures. Separately, SIR also appealed to the CMS to take the appropriate steps to ensure that physicians wanting to provide carotid artery stenting have the necessary catheter and imaging experience in the neurovascular system. Although SIR agreed with the 70% degree of stenosis required for Medicare coverage of carotid stenting, it strongly suggested that the CMS should revisit this issue once additional information on the benefits of treating lesser degrees of stenosis becomes available. In addition, SIR offered its own individual support to CMS’ proposed position of covering only symptomatic patients. However, SIR believes that subgroups of asymptomatic patients may also benefit from carotid artery stenting. Although the Society for Vascular Surgery did not sign the letter, due to concern over the language of neurological assessment, it was one of the primary instigators of the coalition and remains committed to further consultation with CMS and its industry partners. Dr Robert Zwolak, Chair, Practice Council, Society for Vascular Surgery told Vascular News, “Although SVS supports full and honest carotid artery stenting outcomes reporting, we were concerned that the wording of this letter suggested that every carotid artery stenting patient would need a neurology consultation prior to and after stent placement. Since stroke after carotid artery stenting is a complication that occurs in less than 6% of patients, say 1 of 20, if all underwent a pre and post neurology consultation that would be 38 unnecessary consults for every 20 carotid artery stenting patients. We don’t believe this to be an appropriate utilization of Medicare funds.” Comments from the medical community on the CMS decision and the Coalition’s response were mixed. Dr Jay Yadav, from the Cleveland Clinic, stressed at the recent ISET meeting in Miami that the disunity amongst physicians and societies may have contributed to reluctance of CMS to restrict the reimbursement levels for carotid artery stenting and its use for asymptomatic patients. With regard to asymptomatic disease, although SAPPHIRE indicated that carotid artery stenting was not inferior to carotid endarterectomy, the appropriateness of any procedure remains unclear. Yadav said, “Despite the fact that the high-risk patient trials for carotid stenting with emboli protection show that carotid artery stenting is durable, safe and cost effective, the current CMS position is that carotid artery stenting is reimbursed only for symptomatic patients with a stenosis greater than 70%. Whereas carotid endarterectomy 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 carotid endarterectomy when they could benefit from a less invasive treatment which is at least as safe as carotid endarterectomy. This makes no sense.” Dr John J. (Buddy) Connors III, Immediate Past President of ATSIN, has voiced his concerns about the inappropriate use of carotid artery stenting on asymptomatic patients and maintains that medical therapy should be the standard of care for most patients with asymptomatic carotid stenosis, not the least because the risk of stroke caused by the plaque itself is rare. Connors told Vascular News, “The risk of stroke caused by the plaque itself is about 1% per year. There is no increasing risk with increasing stenosis and this has been definitely proved. Any increase in incidence of stroke in sicker patients is from the heart or from smaller vessel disease in the brain, etc. Any comorbid conditions that increase the risk of surgery does not cause an increase in the risk of stroke from an asymptomatic carotid stenosis, but rather increases the risk of surgery.” This is a view supported by the American Academy of Neurology, the Stroke Council of the American Stroke Association and the American Heart Association. Moreover, although the refusal of CMS to extend Medicare coverage to asymptomatic patients appears to be the greatest area of contention, there were other criticisms of the decision. Dr Mark Wholey, one of the pioneers of carotid stenting, disapproved of the CMS establishing a requirement that you must have the approval of a vascular surgeon in order to determine high risk for carotid endarterectomy. “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 carotid endarterectomy. 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. Science is overruling clinical judgement,” Wholey said. According to Yadav, the CMS has not addressed the issue. “The CMS evaluates whether or not the intervention improves net health outcomes in the Medicare population at least as well as established treatments,” he said. “Clearly this has not happened. Based on the current evidence for patients with symptomatic stenosis of 50-69%, the fundamental question of whether carotid endarterectomy should be performed for these patients has not been answered. If carotid endarterectomy cannot be generally recommended, then carotid artery stenting, in turn, cannot be generally recommended.” There is consensus that the CMS has arrived at this decision for two reasons; a lack of evidence for the benefit of intervention in asymptomatic patients compared to medical therapy and to stop an explosion in the number of carotid stenting procedures carried out by less experienced, low volume interventionalists. The latter view was supported by Nelson Hopkins, who hypothesised that the CMS decision was because of their fear of “inappropriate” widespread use. “The complications of carotid artery stenting 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.”