Carotid Artery Stenting

Dear CMS,

I am writing this in response to your proposed coverage of carotid artery stenting (CAS). My personal experience with CAS involves, over the past 5 years, more than 100 cases as pricipal investigator for 3 trials at my institution and as co-investigator for 6 other trials at another facility.

It is to my dismay that there is no plan to cover asyptomatic severe carotid stenosis in patients that are at high risk for adverse outcome when undergoing carotid endartherectomy.The SAFFIRE data clearly supports that CAS issafer with individuals that have CHF,COPD, serious angina pectoris.

What will happen is that americans with asyptomatic severe carotid stenosis will have adverse events from surgery that will cause chronic disability and further burden the medicare sytem.Furthermore, you will deprive individuals a procedure that is superior to surgery if you have these high risk surgical criteria,and we have beyond any reasonable doubt by evidence based medicineestablished these criteria.I suspect there will be an avalache of law suits against physicians that have adverse surgical outcomes that didn't offer CAS for their high risk asymptomatic severe stenosis patients.

Please act in fashion that puts our patients first and put special intrests aside.

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The American Academy of Neurology supports the majority of the elements of the "proposed decision" and compliments CMS for their careful review.

Together with a number of other medical societies the AAN is in favor of expanding the comorbid conditions which make carotid stent appropriate for patients with symptomatic carotid stenosis. These additions include: severe pulmonary disease (FEV1 <30%); high cervical ICA lesions or CCA lesions below the clavicle which would require jaw dislocation to access surgically; recent MI (>24 hours and <4 weeks);open heart surgery needed within six weeks; Contralateral laryngeal nerve palsy which can be severely disabling if it becomes bilateral; tracheotomy; and prior radical neck dissection.

Together with the other societies the AAN strongly endorses that an independent neurological assessment by a qualified stroke physician should be a provision of the final coverage decision. We strongly maintain that Medicare’s final CAS coverage decision should require an independent neurological evaluation by a stroke physician before and after the procedure. We believe such assessments will help ensure that only appropriately selected patients receive CAS and that the CAS procedures meet the necessary efficacy and outcome measures.

The Stroke Systems Task Force is concerned that the periprocedural risk in asymptomatic patients enrolled in the Sapphire trial exceeded 3%. The 3% periprocedural risk has previously been determined from endarterectomy trials as the limit above which intervention is no longer of net benefit in patients with asymptomatic carotid stenosis. The patients enrolled in Sapphire were "high risk" for surgery due to their comorbidities. However, there is no evidence that the enrolled asymptomatic patients were at any higher risk of stroke due to their carotid disease than previously studied cohorts (~11% stroke risk spread over 5 years). The true benefit (years free of disabling stroke)which motivates surgical or endovascular intervention in a group of asymptomatic patients does not occur until years after the procedure. The expected higher mortality rate due to the medical co-morbidities in the "high risk" patients would also be expected to decrease the chance that benefit would occur in this population as a result of either CAS or CEA. Given the current evidence, the AAN's Stroke Systems Task Force therefore endorses the CMS ruling to generally limit carotid stenting to patients with symptomatic carotid disease who are at high risk for surgery. Given the data from this first prospective study of intervention in surgically high risk patients, physicians must stongly consider whether it is best to confine stroke prevention treatment in such patients to an optimal medical regimen. Identification of a asymptomatic subgroup with a much higher carotid-associated stroke risk, within their expected lifespan, would be necessary to recommend either CAS or CEA in the patients considered high risk for CEA. Further studies are clearly needed.

The American Academy of Neurology (AAN) represents over 95% of the Neurologists in the United States, 60% of whom have practices substantially devoted to stroke patient care. Vascular Neurology is the sole stroke specialty accredited by the American Board of Medical Specialties.

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Thank you for the opportunity to comment on the issue of coverage for carotid artery stenting (CAS). As a neurosurgeon with experience in over 100 stenting procedures and in endarterectomy (CEA), I would like to share the perspective of an unbiased practitioner. Specifically, I would address two major topics.

The first is the use of unique clinical and anatomical indications for stenting. CAS was developed as an alternative method to CEA for repairing carotid stenosis. As such, the anatomical criteria are felt to be no different by most experienced practitioners. As there is sound, scientific evidence that repair of carotid stenosis with CEA is beneficial to patients with symptomatic stenosis >50% and asymptomatic stenosis >60%, it is quite reasonable to use the same criteria for CAS. No available data from large clinical trials would suggest that the benefit of CAS is lost with stenosis < 70% or in asymptomatic statements. I would, therefore, respectfully disagree with the committees decision to exclude these patients.

The other major topic I would like to address is the method of definition for a high risk patient. The current statement would essentially require that a surgeon experienced in CEA declare a patient high risk before the patient would qualify for CAS. On this topic, I would agree with the committee. While general criteria for high risk patients have been defined in previous clinical trials (i.e. contralateral carotid occlusion, recurrent stenosis, prior neck dissection or radiation, and cardiac disease with EF < 30%), each patient must be considered individually. Likewise, surgical expertise and availablility may vary by community. What may be equally important, however, is the emphasis that such a process would place on cooperation and collaberation within the medical community. By necessitating a team approach, our patients may benefit from multiple medical opinions to achieve better overall care.

Thank you once again for the opportunity to comment.

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This comment is sent by the Society for Vascular Surgery.

The Society for Vascular Surgery represents over 2,300 physicians in the United States. SVS offers the following comments regarding reconsideration of the Medicare National Coverage Policy for percutaneous transluminal angioplasty of the carotid artery concurrent with stenting (CAG-00085R, dated December 18, 2004). First and foremost, SVS appreciates the extensive effort expended by the CAG to develop this important coverage policy. The SVS response will follow the four public comment bullet points outlined in the Draft Decision Memo.

The Society for Vascular Surgery thanks CMS and the CAG for their objective assessment of the carotid stent issue. We are available at any time for telephone or in-person discussions regarding our comments.

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Thank you for the opportunity to comment on CMS’ draft decision memorandum for carotid artery stenting with embolic protection.

St. Luke’s Episcopal Hospital, home of the Texas Heart Institute is an acute care teaching hospital located in the Texas Medical Center, Houston, Texas. Over 350 IRB approved high-risk carotid artery stent procedures have been performed at our institution. At our institution, only physicians with extensive carotid angiography and CES experience are credentialed to perform carotid artery stenting.

CMS has proposed “CAS with embolic protection is reasonable and necessary for patients who are at high risk for CEA and who also have symptomatic carotid artery stenosis ³ 70%.”

We are concerned with CMS’ proposal to limit coverage to just symptomatic patients, despite recent publications of trials reporting the benefits gained by asymptomatic patients. Asymptomatic patients need to be included in the coverage of CEA with embolic protection. In the SAPPHIRE trial, in which this institution was a clinical site, was published in the New England Journal of Medicine on October 7, 2004. Both symptomatic and asymptomatic patients who were at high-risk were enrolled in the trial. The published results showed that carotid artery stenting with embolic protection, in patients at high risk for CEA, is not inferior to CEA in a combined patient population of symptomatic and asymptomatic patients with carotid artery stenosis, of whom 70% were asymptomatic. A subgroup analysis of asymptomatic patients showed significant superiority (P<0.02) for carotid artery stenting with embolic protection versus CEA in terms of cumulative combined primary end- point of major adverse events at one-year, as well as a combined incidence of death, myocardial infarction and stroke in the periprocedural period that was almost 50% lower in patients treated with stenting and embolic protection versus CEA. The SAPPHIRE trial demonstrated that there was benefit to both symptomatic and asymptomatic patients.

Results of the Asymptomatic Carotid Surgery Trial (ASCT) were published in The Lancet, May 8, 2004. In this trial investigators studied the outcomes of patients with asymptomatic carotid artery stenosis with best current medical therapy versus CEA. The trial results demonstrated a much more favorable outcome for patients with immediate CEA than those who were treated with best medical therapy and deferred CEA with almost a 50% reduction in events in the immediate surgical treatment arm.

CMS has proposed, “patients at high risk for CEA are defined as having significant comorbidities. In addition to the significant comorbid conditions noted by CMS, renal failure, extensive peripheral vascular disease, and valvular heart disease should be included.

CMS has proposed that stenosis must be measured by Doppler ultrasound or carotid artery angiography and documented the medical record. Further, “if the stenosis is measured by ultrasound prior to the procedure, then the degree of stenosis should be confirmed by angiography at the start of the procedure. If the stenosis is determined to be less than 70% by angiography, then CAS should not proceed.”

Ultrasound is a good screening test and should be used as the initial screening procedure to determine the degree and type of stenosis. Angiography should be used as the gold standard to determine the degree of stenosis prior to CAS.

CMS has proposed that “CAS with embolic protection is reasonable and necessary only if performed in facilities and by physicians who have been determined to be competent in performing the evaluation, procedure, and follow- up necessary to ensure optimal patient outcomes. We propose that competency will be determined through a national evaluation process by a recognized entity using approved standards. Standards will include specific physician training standards, facility support requirements and an ongoing data collection system to evaluate outcomes during a required reevaluation.”

We support the proposal that physicians who have been determined to be competent in performing do so in facilities equipped to support CAS with embolic protection. On January 4th, 2005, the Journal of American College of Cardiology published competency guidelines, technology and training requirements. The Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and the Society for Vascular Surgery developed this statement. Medical practice organizations should set the standard for training and competency. Hospitals must continue to determine privileging for their own facility based upon published Medical Society training and competency guidelines. In addition, hospitals must have a quality assurance program specifically designed to assess the results of carotid interventions. The use of standardized instruments and definitions would provide high quality review and enhance patient safety.

We appreciate the opportunity to provide our comments.

Sincerely,

Zvonimir Krajcer, M.D.
Clinical Professor of Medicine
Baylor College of Medicine
The University of Texas Health Science Center

Ali Mortazavi, M.D.
Director, Inverventional Cardiology
Kelsey-Seybold Clinic

Neil Strickman, M.D.
Interventional Cardiologist
St. Luke’s Episcopal Hospital

Arup Achari, M.D.
Interventional Cardiologist
St. Luke’s Episcopal Hospital

Emerson Perin, M.D.
Interventional Cardiologist
St. Luke’s Episcopal Hospital

Peggy Keus
Assistant Director Diagnostic Testing and
Business Operations
St. Luke’s Episcopal Hospital

Kristen Turner
Vice President
St. Luke’s Episcopal Hospital

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I read with interest your proposal for Carotid Artery Stenting (CAS) reimbursement. I recognize that as an individual practitioner, my voice is small and probably will not be heard. Nonetheless, I felt compelled to respond to your proposal for reimbursement. Unfortunately, this topic is politically charged for one simple reason—advancement in technology that forces physicians of different disciplines and different backgrounds to compete for the same patient. This ultimately leads to turmoil between physicians, and subsequently delays in bringing forth improved technology to patients. You did not see the same degree of controversy when general surgeons went from doing open cholecystectomy to laparoscopic procedures, because it was the same physicians doing the procedure.

From a scientific standpoint, your argument posted on your website does a reasonable job of summarizing the literature. However, I feel there are notable gaps in your proposal, and intangible elements that you don’t even comment on.

First of all, I would like to remind you that stroke is the 3rd leading cause of death and number 1 cause of permanent disability in the United States. If you have know someone that has had a stroke, you know what a devastation it is to render a normal functional human being into a dependent object that may require help with simple activities such as getting dressed— things you and I take for granted. There is NO TREATMENT for patients POST-STROKE to restore them to their pre-stroke state. While physical therapy and rehabilitation may improve their functional status, once the damage is done, the damage is done. Thrombolysis is the only stroke approved therapy, but this has a very small window of opportunity, and <10% of patients actually are provided this treatment. In other words, the vast majority of patients are simply “observed” and “supported” through the stroke. Doesn’t that sound strange, that we believe we are so sophisticated, yet the best we have to offer patients in the midst of a stroke is to stand there and hold their hand? Therefore, it seems as though we should make every effort to PREVENT strokes from happening, this is the only way that we will reduce the incidence of this terrible disease. Medical management is helpful in reducing the risk of stroke, but clearly, medical therapy alone is inadequate in advanced disease—these patients require a revascularization procedure to lower their risk of stroke.

Second, Carotid Endarterectomy (CEA), first done in the 1950’s, was performed unopposed, despite objection, without any proof of safety or efficacy for nearly 40 YEARS—the whole time being generously reimbursed—until several studies (NASCET, ACAS, European study, etc) established the BENEFIT of revascularization in preventing stroke. The clinical significance of these studies can be debated, but the statistical significance has been published and I believe is difficult to refute. The Asymptomatic Carotid Atherosclerosis Study (ACAS) (JAMA, 1995;273(18):1421-1428) clearly established the benefit of CEA for asymptomatic patients in preventing stroke at 5 years (5.1% vs 11.0%, 53% relative risk reduction, 95% CI: 22% to 72%) in patients with >60% stenosis. The North American Symptomatic Carotid Endarterectomy Trial (NASCET) clearly demonstrated a statistical advantage of CEA vs medical therapy with a gradation of benefit based on the degree of stenosis: 70-99% stenosis, p<0.001, 50-69% stenosis, p=0.045, <50% stenosis, p=0.16(NS) (NEJM, 1991;325(7):445-453, and NEJM, 1998;339(20):1415-1425). Thus, it is rather obvious that carotid revascularization prevents strokes in ASYMPTOMATIC PATIENTS WITH >60% STENOSIS OR SYMPTOMATIC PATIENTS WITH >50% STENOSIS.

Third, while you clearly focused on the stroke and/or death rates in the CEA and CAS studies listed on your website, you also blatantly ignored the “other” complications. For example, in NASCET the stroke/death rate was only 5.8%, however, when you start counting cranial nerve palsies, wound hematomas/infections, myocardial infarctions, arrhythmias, congestive heart failure, etc the complication rate jumps to 26.2%!! Minimally invasive therapies are revolutionizing medicine—laparoscopic procedures, CT guided biopsies, and endovascular therapies are now commonplace. The benefits are obvious—less pain/discomfort, shorter hospital stay, quicker recovery time, patient preference— patients DO NOT WANT TO BE CUT OPEN if the same thing can be done with a minimally invasive approach. I would ask you to come and talk to any of my patients and explain to them why they should be filleted open when a small puncture in their groin can get the job done. The same logic explains why the number of coronary artery bypass grafting (CABG) procedures is plummeting across the country and there is an explosion in the number of percutaneous coronary revascularization procedures. In other words, your analysis clearly ignores the inherent benefit of a minimally invasive procedure over an open surgical procedure, and you completely overlook the intangible advantage simply because this is not analyzable in the methods section of the manuscript.

Forth, I look at the global picture of carotid revascularization, and consider CEA and CAS to be two methods that accomplish the same goal. Therefore, based on your proposal on CAS reimbursement, I have to believe that you only support revascularizing symptomatic patients with >70% stenosis. Does that mean you will stop reimbursing CEA except for the same limitations? You are entirely hypocritical to continue your current CEA reimbursement policy. You try and quote the literature in your proposal, but you bend the truth to fit your needs—let’s face it, your limited reimbursement for CAS is not based on science, but your perception of cost savings. Ironically, CAS costs less than CEA. Not reimbursing for symptomatic patients with 50-69% stenosis, unmistakably disregards the phase 2 NASCET data, and also emphasizes your lack of understanding of the pathophysiology of stroke in patients with carotid disease—atheroembolization. While it is true that the risk of stroke increases with the degree of stenosis, the morphology of the plaque plays a more important role—an ulcerated, complex embolizing 50% stenosis deserves more aggressive treatment than a smooth, tubular 80% stenosis. Capping the plaque with a stent, or removing it surgically accomplishes the same endpoint by preventing further embolization. Therefore, it is a TREMENDOUS DISSERVICE TO PATIENTS to not reimburse CAS for a symptomatic 50-69% stenosis. Likewise, ACAS was without much doubt in providing benefit to asymptomatic patients with >60% stenosis. Your argument that there seems to be a lack of consensus on the benefit of CEA should imply that you will stop reimbursement for CEA in asymptomatic patients. Furthermore, not providing reimbursement for CAS in asymptomatic patients due to increased events in the asymptomatic patients in Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial is statistically flawed—that study was not powered to look at that subgroup of patients.

Finally, limiting the reimbursement for CAS will only drive up the cost of healthcare. I see CAS as a replacement for CEA in most patients, the same way coronary stenting has replaced CABG. There are only a fixed number of patients that need carotid revascularization, substituting one procedure for another is relatively cost neutral. Limiting reimbursement will ultimately require more large-scale, multi-million dollar studies for additional indications that will mostly be paid for by industry and will subsequently translate the cost to patients—THIS CYCLE MUST STOP. You need to have fiscal responsibility in recognizing how you are causing a skyrocketing cost increase to the healthcare system by not paying for it the first time around.

In summary, I believe your initial proposal is a reasonable start, but clearly needs to be modified. The current accepted standards for carotid revascularization (via CEA) are: A SYMPTOMATIC PATIENT WITH >50% STENOSIS, OR AN ASYMPTOMATIC PATIENT WITH >70% STENOSIS. Carotid artery stenting is simply a replacement for carotid endarterectomy, if you are going to reimburse for CEA, then you need to reimburse the same indications for CAS.

Don’t let this continue to be a political battle and distract from good patient care, I don’t see you or anyone else arguing over whether or not to reimburse for renal artery stenting—why are you letting this become a differe

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The National Quality Assurance Committee (NCQA and the Society for Cardiovascular Angiography and Interventions (SCAI) are responding to the Centers for Medicare and Medicaid’s request for public comments on its December 17, 2004 Draft Decision Memorandum for Carotid Artery Stenting (CAG-00085R). SCAI is also providing consensus comments on the proposed coverage criteria as part of a multi-specialty group and a separate comprehensive communication.

NCQA is a private, not-for-profit organization dedicated to improving health care quality. NCQA is active in quality oversight and improvement initiatives at all levels of the health care system, from evaluating entire systems of care to recognizing individual providers who demonstrate excellence in key clinical areas. NCQA accredits and certifies a wide range of health care organizations covering 75 percent of the population enrolled in Health Maintenance Organizations (HMOs). As a leader in quality measurement, NCQA manages the evolution of Health Plan Employer Data and Information Set (HEDIS®) and contribute to the evolution of the Consumer Assessment of Health Plans Study (CAHPS® 3.0H) survey, the performance measurement tools used by more than 90 percent of the nation’s health plans. HEDIS is used by the majority of America's health plans, including both HMOs and Preferred Provider Organizations (PPOs), to measure performance on important dimensions of care and service.

The SCAI is the primary professional association representing over 3,200 invasive and interventional cardiologists nationwide. SCAI promotes excellence in cardiac catheterization and angiography through physician education and representation, clinical guidelines and quality assurance to enhance patient care.

We appreciate the efforts of Centers for Medicare and Medicaid Services (CMS) to ensure that Medicare patients have access to state-of-the-art medical care and are pleased that CMS is proposing to expand coverage of carotid stenting. We recommend that CMS's final coverage determination require facility and provider participation in a single national data registry and that it specify necessary criteria and key principles for governing the operations of such a registry. SCAI will make recommendations on appropriate coverage indications via a separate communication.

Leaders of our organizations and related professional societies have been considering how a national data registry on carotid stenting could assist CMS and physicians in assessing how best to treat patients with carotid artery disease and how to refine Medicare's coverage policy in the future.

The carotid stenting coverage decision provides a unique opportunity to mandate data gathering and reporting for an important new procedure. Given the relatively high mortality and morbidity rates associated with carotid stenting and alternative therapies, identified differences can be acted upon in ways that will significantly benefit patients. Additionally, since this coverage decision will apply to all covered indications for carotid stenting, the database will be able to collect complete data on all Medicare covered carotid stenting procedures.

Since multiple specialties will be involved, this experience will be more easily translatable to other medical procedures. The lessons learned here could be applied to the management of best to organize, oversee and manage such registries in the future.

The impending Medicare coverage decision regarding carotid stents presents both a challenge and an opportunity. Clinical trials have reported at least equivalent (if not superior) results for carotid stenting compared to carotid endarterectomy for well-defined patient populations and there is accumulating evidence from mandated post-marketing registries that the procedure can be performed by experienced operators with a high degree of safety. While there is excitement among professional societies about this new treatment modality, there is also concern. The good outcomes achieved in the current trials and mandated post-marketing registries require appropriate patient selection, superior technical skills, and careful follow-up. The challenge lies in ensuring that the high standards achieved in the clinical trials are met at every U.S. medical center that provides the procedure.

We strongly endorse the general approach proposed in the Draft Coverage Memorandum stating that the procedure can only be considered “reasonable and necessary” only when performed in facilities and by physicians who have been determined to be competent…“by a national evaluation process by a recognized entity using approved standards. Standards will include specific physician training standards, facility support requirements and data collection to evaluate outcomes during a required reevaluation.”

We believe that the final coverage decision should include detailed requirements on data collection, reporting and outcome evaluation and we recommend the following:

- Mandatory participation in a single, national registry. We recommend that the final coverage policy require, as a condition of coverage, that providers and facilities participate in a single, national multispecialty registry.

- Timely implementation. To ensure that the registry is operational as soon as possible after coverage is approved, we recommend that funding be provided to support the design and pilot implementation of the registry at facilities already engaged in the ongoing post-marketing surveillance studies and that the final decision include a per-patient payment to support the costs of the registry.

- Assurance of accurate, timely data and analyses. The potential benefits of the registry will only be achieved if the data and comparative outcome analyses meet high standards. This will require: (1) ensuring that all Medicare patients undergoing the procedure are included in the registry; (2) explicit, rigorous and audited data collection protocols; (3) ensuring adequate patient follow-up and unbiased outcome assessment; and (4) proper analysis and reporting of results to providers. A national registry must demonstrate to CMS its capacity to meet these standards through regular auditing by an organization that is independent of any single specialty society and that is publicly accountable.

We recognize that many issues surrounding a national carotid stent registry remain unresolved and will require substantial further attention, including governance, data ownership, and how the data will be used to foster continuous improvement of patient outcomes. We are excited about the possibility of working with CMS, FDA, AHRQ and others to help address these issues over the coming months.

Thank you once again for the opportunity to comment on this exciting and important decision.

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The Society for Cardiovascular Angiography and Interventions (SCAI) is the primary professional association representing 3,200 invasive and interventional cardiologists nationwide. SCAI promotes excellence in cardiac catheterization and angiography through physician education and representation, clinical guidelines and quality assurance to enhance patient care.

We appreciate the efforts of Centers for Medicare and Medicaid Services (CMS) staff to ensure that Medicare patients have access to state-of-the-art medical care and are pleased that CMS is proposing to expand coverage of carotid stenting. This letter supplements a multi- specialty consensus letter and focuses on issues where consensus could not be reached. We are also sending another joint letter dealing with the need for a multi-specialty data registry. Those communications are being delivered separately.

As advocates for our patients, both as a society and as individual physicians, we have significant concerns about several features of the Draft Decision, the specifics of which will be addressed in detail below. There are two particularly troubling aspects of the Draft, both of which are independent of the carotid coverage issue and have far-reaching implications. First, this coverage Draft Decision significantly encroaches on the physician’s ability, and obligation, to decide on an individual basis what is the optimal therapeutic course for his/her patient. Not all asymptomatic patients are alike, and individual physician judgment based on the available data serves as the cornerstone of the delivery of medical care; this Decision proposes otherwise, that patients’ care and interpretation of data is the purview of CMS. Physician latitude in patient care decision- making is a critical component of our profession and vitally important to the outcomes of our patients. Secondly, the Draft Decision as proposed raises questions as to process issues. In the dialogues that have taken place since the Decision was opened on June 18, 2005—-including CMS’ request for feedback prior to and during the Town Hall meeting—-there was no indication from CMS that it would significantly modify the FDA approval of carotid stent system. Therefore this Decision was drafted in relative isolation without appropriate opportunity for public input regarding the substantive issues such as omitting all asymptomatic high surgical-risk patients.

In general terms, the Decision severely limits patient access to carotid stenting in asymptomatic high surgical risk patients in need of carotid revascularization, thereby relegating them to one of two potential therapeutic courses: medical or surgical. Medical management has been suggested in this Draft as a viable substitute to revascularization in the patient with carotid stenosis. While we are strong supporters of aggressive medical therapy for all patients with or at risk of atherosclerotic disease, it remains unproven as to its effectiveness in high surgical- risk patients, and therefore should not be designated as a default strategy. Moreover, medical therapy has been proven demonstrably inferior to surgical revascularization in two trials a decade apart (ACAS 1995 and ACST 2004), both producing very similar results in terms of stroke reduction in the endarterectomy arms. Surgical revascularization is the other option remaining to these patients as a result of this Decision, and although endarterectomy in both randomized trials (SAPPHIRE) and registries (ARCHeR and others) has been demonstrated to result in statistically similar outcomes as stenting, there are strong trends suggesting it is an inferior approach in most high risk patients. As long as CEA is reimbursed for treatment of asymptomatic carotid stenosis and moderate symptomatic disease, CMS should be consistent and reimburse treatment options that are more effective and less invasive. It is obviously not beneficial to patients to cover a more invasive treatment for a disease and not cover an equally effective but less invasive treatment. The continued access to surgery, but not to stenting, for these patients is a fundamental flaw with the Draft Decision and a break in logic difficult to understand or explain to those in our care.

In the Draft, CMS has stipulated an impressive and aggressive approach to physician training, facilities preparedness, independent neurologic assessment of outcomes, rigorous adherence to data collection/submission, and meeting national standards of ongoing clinical competence. While acknowledging there are some potential logistical difficulties with the implementation of these requirements, the SCAI has been and continues to be very supportive of the measured expansion of this new and promising technology, and applauds the inclusion of these important oversight mechanisms.

Specifically:

Section II “Background”

• Stroke etiology in patients with both symptomatic and asymptomatic carotid stenosis was estimated to be unrelated to the carotid artery in 20%- 45% of events, suggesting revascularization’s effectiveness for stroke prevention may be blunted. However, actual event rates from such mixed groups of symptomatic and asymptomatic patients have been measured for up to 2.5 years in both the SAPPHIRE and ARCHeR trials and presented; these high surgical risk studies had approximately 25%-30% symptomatic patients. In SAPPHIRE, after the initial 30-day stroke rate, presumably from the stent or surgical procedure, the rate of ipsilateral stroke was a very low 1.2%/year. In ARCHeR, in 436 patients followed from 30 days to 2.5 years there were only 4 major strokes, for a remarkably low rate of <0.5%/year. It appears, then, that the actual rates of stroke following stenting are exceedingly low in these patients even those with significant comorbidities, thereby validating revascularization as an effective stroke preventative.

Section V “FDA Status”

• The April 21 FDA Advisory Panel deliberations are discussed; many of the signatories of this document (or their assignees) were also present at that meeting. CMS cites the commentary from both the public and the minority dissenting panel members advising/voting against approval of the device for asymptomatic patients as support for its exclusion of this patient cohort’s from coverage in the Draft Decision. However, while they recognized the uncertainties of both endarterectomy and stenting in the high- surgical risk asymptomatic patients, the Panel nevertheless voted to approve the device since parsing the SAPPHIRE data would not allow an otherwise valid statistical conclusion. This majority recommendation, along with the FDA approval that followed, would seem to be a more appropriate citation.

Sections VI and VII “General Methodological Principles” and “Evidence”

• The differences between FDA (“safe and effective”) and CMS (“reasonable and necessary”) mandates, and the caveat that “FDA PMA approval alone is not sufficient for making a determination concerning Medicare coverage” are outlined. The proposition that the symptomatic and asymptomatic populations should be considered separately due to their different natural histories is put forth. However logical this may seem, IDE studies for carotid stenting in this country was not divided along those “vertical” lines; rather the line was made “horizontally” between high and low surgical risk in order to assess this new technology where an established alternative (CEA) was present for normal surgical risk patients, but remained unproven in high surgical risk patients, with or without symptoms. That said, however, both SAPPHIRE and ARCHeR (as well as the US IDE registries that followed) are predominately populated by asymptomatic high surgical-risk patients, and their results largely reflect the outcomes of that group.
• The risk of stroke in an asymptomatic stenosis is 1%-2%/year up to the 80% lesion, but becomes 3%-5%/year with more severe stenosis (Lancet 1998;351:1379-87). Most trials examining treatment of asymptomatic stenosis lump lesser stenoses in with the more threatening ones, and which may result in a blunting of the treatment effect and underestimation of the natural history risk. These considerations are critical to any discussion of intervention in asymptomatic patients, and are erroneously detailed in this section. In this regard, there are several examples of non-peer reviewed assertions being cited with the same weight as articles published in major peer reviewed publications. Specifically, “Both ACAS and ASCT have definitively proved that there is no increasing risk with increasing degrees of stenosis in asymptomatic patients.” The citation for this is “Letter from AAN, AANS, ASITN, ASNR, CNS, AANS/CNS Cerebrovascular section, and SIR dated August 23, 2004 to Dr. Steve Phurrough” There is actually ample evidence of a relationship between the degree of stenosis and the risk of stroke for asymptomatic patients, just as there is for symptomatic patients. ACAS and ACST attempted to fractionate fairly small differences in stenosis on the basis of ultrasound, for example, ACST compared patients with 70% stenosis to those with 80% stenosis and did not find a significant difference. Given the limitations of US, this is not surprising; NASCET used angiography and was able to show a tight correlation between stenosis and stroke risk. If broader stenosis ranges are used, even ultrasound is able to show a correlation between degree of stenosis and risk with patients having 80% or greater stenosis having significantly higher risk than those with 60% or lower stenosis. (Chambers, NEJM,315(14):860-5, 1986; Norris, Stroke. 22 (12):1485-90, 1991)
• Before SAPPHIRE, no randomized trial in high-surgical risk patients had ever been performed, and no others since. In its asymptomatic arm, SAPPHIRE not only demonstrated improved major adverse outcomes (MAE) in the stent group over surgery at 30 days, but also achieved a statistically significant benefit vs. CEA at 360 days with ~1/2 the event rate (MAE 20.3% vs. 10.5%, p=0.04). Importantly in SAPPHIRE, the surgeons refused or deemed prohibitively risky for CEA over 400 patients, which were put into a stent registry during the course of this ~24 month trial. If carotid stenting is disallowed by CMS, what is the appropriate recommendation for these patients?
• CMS requires a net health benefit when considering coverage of new technologies. An important finding in the patients with peri- procedural minor strokes in the ARCHeR trial was the lack of neurologic deficit at 1-year follow- up; therefore the peri-procedural major stroke and death are the critical components of ultimate health benefit. In most of the >3000 patients in the carotid stent trials, the risk of major stroke and death was less than ~2.5% suggesting a net health benefit. Although the article cited by Brott, Roberts et al stated that the 30 day stroke and death rates in ARCHeR in the asymptomatic high surgical risk patients were “well above the AHA guidelines”, in fact the 30 day rates in this trial were never reported separately for the asymptomatic and symptomatic cohorts, so their conclusions cannot be validated nor incorporated.
• Moreover, the ARCHeR trial (approximately 75% asymptomatic patients) demonstrated a remarkably low rate of peri-procedural death and major ipsilateral stroke at 1 year, ~3.0%-3.5%. At 2.5 years, the asymptomatic cohort had an almost 96% freedom from such events, further proof of health benefit.
• In the over 3000 patients treated in US IDE registries reporting 30 day data thus far, which involve predominately asymptomatic high surgical risk patients, the MAE rates are continuing to fall; most recently the CABERNET trial reported 30 day MAE (stroke, death, MI) rate of 3.8%. The reasons for this are speculative but felt to be related to improved operator technique/experience, better patient selection, and possibly differences among devices.
• In addition, the CREST lead-in phase asymptomatic arm of over 500 patients including normal and high surgical risk patients has reported the 30 day stroke and death rate of 3.3%, which compares well to the normal-risk ACAS 2.2%.
• The other study citations which examine asymptomatic patient cohorts in a randomized fashion in the modern era (dedicated stents using embolic protection) demonstrate at least equivalency to CEA. The Carotid Wallstent trial should not be used in the CMS analysis; the stent was a non-dedicated tracheo-bronchial device, there was no embolic protection, and the operator training was poor. Most observers have discounted this trial’s result, but recognize its importantance in shaping subsequent trial and device design.
• The Coward citation of the Cochrane Database System Review states “There is also uncertainty about the potential for restenosis to develop and cause recurrent stroke after endovascular treatment”. In fact, there is ample evidence from both SAPPHIRE and ARCHeR trials out to 2.5 years that stenting has clinical and anatomic durability favorably comparing to endarterectomy.

Section VIII “CMS analysis”

• There appears to be a misunderstanding of the patient screening process in SAPPHIRE: “Of the 747 patients enrolled, only 334 were randomly assigned to the treatment groups. It is very unlikely this level of selectivity, where both a surgeon and an interventionalist must agree on treatment, will be available in actual practice outside a trial. The influence of this selection process is suggested by the results of the SAPPHIRE CAS registry, which showed a higher rate of major adverse events at 360 days for asymptomatic patients compared to asymptomatic patients in the randomized CAS treatment arm (15.7% versus 10.3%, respectively).” The surgeon and interventionalist had to agree on all patients in SAPPHIRE; the CAS registry patients were simply those which were felt to require revascularization but were deemed too high risk for surgery by the physician panel. The surgeons had to concur that the patient should be in the stent registry. The event rates are higher in these patients because they had the most co- morbid conditions but they are still lower than patients that were randomized to CEA. In discussing the SAPPHIRE trial, it is stated that “the patients that were randomized were highly selected” with approximately half the patients enrolled being randomized. The patients not randomized were in fact the most highly selected as they had to be reviewed and refused by the surgeon for operation. They were clearly at higher risk for surgery than the randomized high surgical risk cohort, predominately because of anatomic (post-radiation, prior CEA, high cervical lesions) and multiple medical comorbidities. It is expected, then, that their 1 year event rates will be higher given their baseline severity of illness. Moreover, the symptomatic status of these patients has not been reported (although there were significantly more patients with a history of stroke in the registry arm), so the proposed analysis of outcomes for non-randomized patients vs. the randomized arm outcomes is not possible.
• The comparator for the stent trials was CEA, but in this section the appropriateness of CEA for certain populations is brought into question. This is reasonable since not all populations have been tested vs. medical therapy, thus requiring clinical judgment in the recommendation for surgery, and by extension, stenting. Brott is quoted from Endovascular Today, a non-peer reviewed publication, asserting that aggressive medical treatment would obviate revascularization in many asymptomatic patients with severe disease. However, as for the lack of “optimal medical therapy” in the medical vs. CEA trials to date, this was adequately addressed in the ACST trial of over 3000 patients with more than 70% of patients on aspirin, antihypertensives, and statin medications, with event rates at 5-years double that of the surgical arm. ACST has demonstrated that Brott’s assertion is simply incorrect.
• Several editorials and commentary cited in this section suggest “best” or “tightly controlled” medical therapy may be a suitable alternative. It may be, but the data to date do not support it, and in the absence of such data CEA (and by extension stenting) is an appropriate strategy in selected patients. As an example of the difficulty in predicting the effects of medical therapy, a recent publication showed no reduction in coronary events for patients with pre-existing coronary disease when treated with ACE inhibitors. This was contrary to the prevailing wisdom and demonstrates the fallibility of such assumptions.

The SCAI recognizes the difficult decisions facing CMS on this subject. We also understand the uncertainty of stent intervention in some subsets of asymptomatic high surgical risk patients, based on the currently available data. However, the alternative treatment of these patients with surgery appears to be an inferior, and occasionally prohibitive, choice especially in cases involving anatomic risk. Clinical assessment of each patient based on their individual characteristics and the continuously emerging data, and then the appropriate and judicious application of the various treatment modalities—-medical, surgical, and stent—- tailored to their needs is necessary to provide the greatest benefit to the patient. It is also the cornerstone of medical decision-making. The proposed Draft Decision serves to apply a broad brush to an entire cohort of high surgical risk asymptomatic patients without recognizing the heterogeneity of this group and their individual needs, and by doing so chips away at this cornerstone and limits patient access to less invasive, effective therapy. We are aware of no such stipulations on other procedures where very similar issues are at play.

In summary, we believe the net health outcomes of patients will be benefited by CMS coverage of carotid stenting for both symptomatic and asymptomatic high surgical risk individuals. This is based on the documented natural history risk of severe stenosis, the stent results from SAPPHIRE and ARCHeR which are rapidly improving (e.g. CABERNET), and the poor surgical alternatives in many cases. The key to improving the net health benefits will be the appropriate application of the carotid stent technology in these patients, not its abolition. The question before CMS is will the net health benefit of its coverage population be improved with surgery, but without stenting, in high surgical risk asymptomatic patients? The physician training, facilities certification, neurologically audited outcomes measurement, and national database requirements established by this proposal are robust and should ensure appropriate tracking of operators and results and the SCAI is fully supportive of the implementation of these measures.

We appreciate the opportunity to provide feedback to CMS on this critically important subject. We look forward to working with you to improve Medicare’s coverage policy on carotid stenting. Please contact us or SCAI’s Senior Director for Advocacy and Guidelines, Wayne Powell @ 301 493- 2341 or wpowell@scai.org.

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As an investigator in the development of carotid artery stenting over the past decade, I find the recent proposal from Medicare regarding carotid artery stent coverage inappropriate. If allowed to proceed as written, it would obstruct our ability to deliver quality medical care to elder Americans.

There are numerous flawed assumptions and conclusions in the draft decision memo for carotid artery stenting that has recently been published.

The Sapphire trial in high-risk patients is the only randomized clinical trial that has been performed to date comparing carotid endarterectomy and carotid artery stenting in this high-risk patient population. It is unlikely that an additional randomized study will be performed based on the quality of this study and its findings.

A total of 307 patients were randomized of which 203 were asymptomatic. This trial included patients with greater than 50% stenosis if symptoms of TIA or CVA had occurred and also included patients with greater than 80% lesions in the asymptomatic population. The purpose of the trial was to determine if carotid stenting was equivalent to carotid endarterecomy.

Prior clinical randomized trials had shown that carotid surgery was superior to medical therapy, in these populations of patients (asymptomatic greater than 80% and symptomtic greater than 50%). These included the landmark NASCET trial published in 1991 in the New England Journal of Medicine and the ACAS clinical trial published in 1994 in JAMA, which studied respectively symptomatic, and asymptomatic patients.

Since medical therapy had been shown to be inferior to carotid surgery, it was not ethical to have a control group in the Sapphire trial. The draft decision for carotid artery stenting implies that the Sapphire trial was flawed because no medical therapy or control group was present. However, carotid surgery, having previously been shown to be better than medical therapy, was the “control” group

The primary end point of the trial was a composite of death/stroke/MI at thirty days.

The above end point was reached in 5.8% of the stent patients and 12.6% of carotid endarterectomy patients. (P <0.05) In the high-risk patient population including both asymptomatic and symptomatic patients, carotid artery stenting was safer than carotid endarterectomy.

The initial goal of the trial had been to show equivalency of carotid stenting with surgery. Not only was carotid artery stenting equivalent to carotid endarterectomy, it had approximately half the complication rate.

Furthermore, when one looks at the data more critically, every major end point was lower in the carotid stent group when compared with carotid endarterectomy. Death was 0.6% verses 2%, stroke 3.8% verses 5.3%, and MI 2.6% verses 7.3%.

In conclusion, this randomized clinical trial of high risk patients including both asymptomatic and symptomatic patients, which is the only study to date in this patient population and likely to be the only study performed, conclusively showed that carotid stenting was performed at a lower complication rate than carotid surgery for patients with 80% or greater stenosis in the asymptomatic population and greater than 50% stenosis in the symptomatic population.

If the current decision not to cover asymptomatic patients in high risk patients were not reversed, patients who fall into this category would be forced to have carotid surgery exposing them to twice the complication rate as noted above.

Clinical high risk factors in this trial included:

The FDA has made a recommendation that carotid stenting be approved for asymptomatic patients with greater than 80% stenosis and symptomatic patients with greater than 50% stenosis.

The only medically sound and appropriate decision is to follow those guidelines. Coverage must include asymptomatic patients with greater than 80% carotid stenosis as well as symptomatic patients with greater than 50% stenosis. Any other decision will impede access to quality care, increase complication rates in our elderly population, and serve to raise questions as to whether economic factors are driving this decision.

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I would like to express my disagreement with your proposed reimbursment policy for CAS. As an active member of a team which has been involved with large numbers of CAE and CAS and having the largest CAS numbers in the state of Connecticut, I find the inclusion criteria unfair for the excluded patients. Your criterias leave a large number of patients who are at a substantial risk for stroke with no alternative but the invasive method of treatment, surgery. If any of my parents have 50-70 symptomatic carotid disease, I would sure want them to go under the much less invasive CAS then CAE. Your proposed criteria robs patients from a less invasive but as much successful and safe alternative on the basis of MONEY. This I find very very unethical and unfair.

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The Executive Committee, CREST appreciates the opportunity to comment on your well written and carefully researched draft decision on carotid artery stenting. Definitions of symptomatic and high-risk patients are appropriate. Credentialing and training guidelines are documented. For your interest, CREST also has recently reviewed its credentialing experience (J Vasc Surg 2004; 40:952-7).

We have one important recommendation regarding comparative clinical trials on carotid endarterectomy and stenting. With the advancement in technology designed to facilitate performance of carotid stenting and anticipated results from clinical trials comparing these two procedures, ours being the largest in process, should findings support a conclusion that stenting is not significantly different, or equivalent to endarterectomy, stenting should also be approved for reimbursement. Should such results emerge, we hope that the findings will be clear enough to serve as a basis for future recommendations.

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The American College of Cardiology (ACC) appreciates the opportunity to comment on CMS’ proposal for coverage of carotid artery stenting (CAS), as outlined in the Draft Decision Memo for Carotid Artery Stenting (CAC-00085R). The ACC is a 31,000 member non-profit professional medical society and teaching institution whose mission is to advocate for quality cardiovascular care through education, research promotion, development and application of standards and guidelines, and to influence health care policy.

The ACC is a strong advocate for evidence-based medical practice, yet recognizes that clinical decisions are often made on the best medical judgment of the physician when data from randomized trials are not available to guide such decisions. In accordance with your request, we are submitting comments on four specific areas of the proposed CAS coverage decision, as delineated below.

1. Appropriate criteria, comorbid or chronic conditions for defining patients at high risk for carotid endarterectomy (CEA).

2. Criteria for appropriately defining symptomatic patients. The ACC agrees with the definition of symptomatic carotid stenosis, and with the use of the carotid angiogram to confirm stenosis severity before CAS.

3. Professional and facility standards for performing CAS. The ACC agrees that rigorous training and experience are required for CAS, and specifics for credentialing are delineated in previous publications from the Journal of the American College of Cardiology (as referenced in CAG-00085R) and SCAI/SVMB/SVS (Rosenfield K, Cowley MJ, Jaff MR, Ouriel K, Gray W, Cates CU, Feldman T, Babb JD,Gallagher A, Green R, Kent KC, Roubin GS, Weiner BH, White CW. SCAI/SVMB/SVS clinical competence statement on carotid stenting: training and credentialing for carotid stenting—multispecialty consensus recommendations, a report of the SCAI/SVMB/SVS writing committee to develop a clinical competence statement on carotid interventions.) We also agree with the requirements for an experienced team of physicians and ancillary personnel, state-of- the-art imaging and monitoring equipment, and the availability of expert diagnostic and support services.

4. Evaluation process for providers and facilities. The ACC fully supports the requirements for demonstration of competency, using national guidelines that have yet to be established. We urge CMS to support collaborative patient registries, and our hope and expectation is that physicians, hospitals, medical societies, and industry will work in coalition with the government to establish and support patient registries for long-term followup and ongoing quality assurance.

The ACC hopes that you will reconsider approval for asymptomatic high risk patients with severe carotid stenosis, to allow them access to carotid artery stenting. Carotid stents and protection devices are safe, have satisfied accepted American Heart Association criteria for carotid revascularization, and have been approved by the Food and Drug Administration for this purpose.

Thank you for your time and consideration. If you have any questions, please do not hesitate to contact me.

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Guidant Corporation welcomes the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) draft decision memo for carotid artery stenting (CAS). We commend the decision to modify the current national policy. However, we are concerned that the CMS proposal to not cover asymptomatic patients and to limit coverage of symptomatic patients will unduly restrict treatment options for patients who are at high risk of stroke. Additional treatment options are particularly important for this patient population given that surgery may present unacceptable risks and medical management may not always be effective. Contemporary clinical trial data clearly supports the superiority of carotid intervention over contemporary medical management alone in asymptomatic patients with significant carotid stenosis.

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The ASITN wishes to thank the Centers for Medicare and Medicaid for their thoughtful consideration of carotid artery angioplasty and stenting. We feel that this is a valuable procedure that can reduce the risk of stroke in the appropriate setting.

We agree with the CMS in their recommendations, and also believe that additional data to support expanded indications beyond the >70% symptomatic high surgical risk group is necessary. We also thank the CMS for continuing the policy for coverage for patients in ongoing trials. This will enable physicians to determine other groups of patients who will also benefit from this procedure.

We also believe that the definitions for a symptomatic patient are appropriate, that the medical conditions qualifying as comorbidities as defined by CMS were clearly reasoned, and that the procedure should be based on angiographic confirmation of the degree of stenosis.

CMS has asked for comments on the standards and evaluation process for providers and facilities. The ASITN feels that a national outcomes registry is necessary to assure that appropriate patients are treated and that the outcomes of Carotid Artery Stenting (CAS) do indeed achieve the goal of stroke reduction. We believe that physicians and institutions committed to performing this procedure should be required to enter all patients into this outcomes database as a criteria for reimbursement. This database should be maintained by an independent outcomes registry company with oversight by all medical specialties involved in this arena as well as governmental agencies wishing to be involved (such as NIH, etc.) Mandatory entry of patient data with independent oversight of patient selection and outcomes by a neurological specialist certified in NIHSS is necessary to obtain useful and trustworthy data. The details for this registry are as yet undetermined but have broad support among all relevant specialties.

In agreement with CMS, we believe that the foundation for safe and effective carotid angioplasty and stenting is sufficient neurological expertise to understand carotid atherosclerosis and appropriate treatment options, combined with superior diagnostic and procedural skills in carotid/cerebral angiography acquired during formally accredited and supervised ACGME training. Published documents describe both the facility and practitioner requirements (1.2,3) This knowledge and procedural competency are a fundamental baseline requirement to perform Carotid Artery Stenting (CAS). As is usual for all hospital-based procedures, appropriately acquired credentialing for cerebral angiography and carotid stenting is mandatory.

Additional practitioner pre-requisites to perform CAS should be a combination of the training and standards criteria set forth by the NeuroVascular Coalition (2) and ACC/SVS documents (4) (There are no formal Al-LA endorsed standards, as Al-IA did not endorse the ACC/SVS standards (4)) In other words, a practitioner would be eligible for device training if they have satisfactorily completed ACGME postgraduate neurodiagnostic training and have sufficient knowledge of the brain and cerebrovascular pathophysiology, have formal ACGME cerebral angiography training, have performed a minimum of 100 cerebral angiograms (NeuroVascular Coalition standards) ~4have performed a minimum of at least 25 (twenty-five) non—carotid self-expanding stent procedures or at least 13 CAS procedures as primary operator (ACC/SVS criteria (4)) For those physicians who did not receive adequate neuroangiographic training during their ACGME approved residency, appropriate training may be obtained by performance of 50 neuroangiographic procedures under the direct supervision and guidance of a qualified physician. Subsequent independent performance of 50 additional procedures with documented acceptable outcomes would demonstrate minimal competency with diagnostic neuroangiography.

Proven competency with diagnostic neuroangiography is one of the prerequisites to qualify the physician to begin training in interventional procedure such as CAS. Given the proven significant potential risks of diagnostic neuroangiography, physician self-instruction, weekend courses, Internet training, or instruction by an unqualified physician is not acceptable even for physicians with extensive catheter skills in other vascular territories since this procedure is not equivalent. The use of medical angiographic simulators to acquire neuroangiographic skills remains to be perfected, much less validated. While this technology seems promising, it cannot be considered a substitute for actual case experience gained during formal training. As currently designed, angiographic simulator training can actually induce poor habits. It should be noted that no ACGME training program has accepted this technology in lieu of actual case experience for residency training in any vascular bed for any endovascular procedure. Therefore, as with all other types of endovascular interventions, proven competency with actual catheters and full scale diagnostic angiography in the specific vascular territory under consideration is a fundamental prerequisite for education in all endovascular interventional procedures.

Before being eligible for reimbursement by CMS, a provider must complete FDA/CMS-mandated training for the specific devices. Practitioners meeting these criteria would then be able to perform CAS in appropriate patients as mandated for CMS reimbursement, and would also be expected to participate in the multisociety national registry when it is instituted.

We specifically agree with CMS that the depth of training for carotid stenting should be as rigorous as that required for coronary stenting, and believe that dedicated fellowship training as outlined by ACGME should be the sine qua non for all medical education that has substantial implications for patient well being. Specifically, CAS is already a specified procedure in a specific ACGME fellowship program with predefined training requirements (3) As CMS is aware, the number of practitioners currently capable of performing CAS in the United States is easily adequate to supply all the health care needs of patients for this elective procedure. Indeed, if 100% of symptomatic patients were to suddenly require CAS, that would still only be less than 100 patients per year per practitioner. Further growth of this field should be by means of standard ACGME-defined medical education processes.

Since the purpose of this elective procedure is stroke reduction and CAS has "stroke" as a potential complication, we strongly recommend that centers performing these procedures be, at minimum, certified by JCAHO as Primary Stroke Centers, if not Comprehensive Stroke Centers. The multispecialty statement from the Brain Attack Coalition defining Comprehensive Stroke Centers will be shortly forthcoming, as it has been submitted with final revisions to the journal Stroke last month. This document defines the physicians, services and facilities necessary to perform the full range of advanced stroke therapies and specifically includes physician and facility requirements for carotid artery stenting.

Similar to the Primary Stroke Center designation administered by JCAHO, we expect that the Comprehensive Stroke Center document will form the basis for certification of facilities by JCAHO for advanced cerebrovascular interventional treatments including carotid angioplasty and stenting. ACGME will also continue to define medical specialty training requirements.

We look forward to ongoing dialogue with the CMS to further clarify any issues or concerns that the agency may have.

Reference:

1. Barr 3D, Connors 33 3rd, Sacks D, Wojak 3C, Becker GJ, Cardella JF, Chopko B, Dion JE, Fox AJ, Higashida RT, Hurst RW, Lewis CA, Matalon TA, Nesbit GM, Pollock IA, Russell EJ, Seidenwurm DJ, Wallace RC; SIR Standards of Practice Committees. Quality improvement guidelines for the performance of cervical carotid angioplasty and stent placement. AJNR Am JNeuroradiol. 2003 Nov-Dec;24(10):2020-34.

2. Connors JJ 3rd, Sacks D, Furlan AJ, Selman WR, Russell EJ, Stieg PE, 1-ladley MN; NeuroVascular Coalition Writing Group. Training, competency, and credentialing standards for diagnostic cervicocerebral angiography, carotid stenting, and cerebrovascular intervention.
AJNR Am JNeuroradiol. 2004 Nov-Dec;25(10): 1732-41

3. ACGME. Program Requirements for Residency Education in Endovascular Surgical Neuroradiology. www.acgme.or~/down1oads/RRC nrocRecj/422pr403.pdf.

4. Creager MA, Goldstone J, Hirshfeld 1W Jr, Kazmers A, Kent KC, Lorell BH, Olin 3W, Rainer Pauly R, Rosenfield K, Roubin GS, Sicard GA, White CJ, Creager MA, Winters WL Ir, Hirshfeld JW Ir, Lorell BK, Merli G, Rodgers GP, Tracy CM, Weitz HH; American College of Cardiology; American Heart Association; American College of Physician Task Force on Clinical Competence. ACC/ACP/SCAI/SVMB/SVS clinical competence statement on vascular medicine and catheter-based peripheral vascular interventions: a report of the American College of Cardiology/American Heart Association/American College of Physician Task Force on Clinical Competence (ACC/ACP/SCAI/SVMB/SVS Writing Committee to develop a clinical competence statement on peripheral vascular disease). JAm Coil Cardiol. 2004 Aug 18;44(4):941-57.

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On behalf of the Society of Interventional Radiology (SIR) and its 4,000 members who practice vascular and interventional radiology, we appreciate the opportunity to review and comment upon the proposed coverage decision memorandum for carotid artery stenting (CAS) dated December 17, 2004. We commend you and your staff in the Coverage Analysis Group (CAG) for the thoughtful consideration of the issues related to carotid stenting. SIR strongly favors Medicare coverage of CAS for appropriate patients when provided by skilled physicians in properly equipped facilities. We agree with many of the draft coverage decision's proposed recommendations, but suggest changes in others.

SIR was an active participant in a multispecialty workgroup of the neurological, medical, surgical, interventional, and radiologic specialty societies involved in carotid occlusive disease. We support the recommendations from this workgroup, which were sent to CMS under separate cover. The major recommendations of this workgroup are reiterated briefly now:

1. SIR and the workgroup support CMS' proposed list of comorbidities and/or anatomic risk factors and recommend adding the following:

• Severe pulmonary disease (FEVI<30%);
• High cervical ICA lesions or CCA lesions below the clavicle;
• Adding >24 hours and <4 weeks to "recent MI";
• Open heart surgery needed within six weeks;
• Contralateral laryngeal nerve palsy;
• Tracheotomy; and
• Prior radical neck dissection.

2. SIR and the workgroup endorse the symptoms of carotid artery stenosis named in the draft coverage decision.

3. SIR and the workgroup support board certification and the use of standards in the national evaluation process, but question the timeliness of such a process.

4. SIR and the workgroup strongly recommend that CMS give serious and thoughtful consideration to a national CAS outcomes registry.

5. SIR and the workgroup recommend that CMS should require adherence to the NASCET imaging criteria and take steps to ensure quality imaging.

6. SIR and the workgroup believe an independent neurological assessment by a qualified practitioner should be a provision of the final coverage decision.

7. SIR and the workgroup support continuation of CMS' prior CAS coverage policy for research protocols on FDA-approved clinical trials.

In addition to those consensus comments from the multispecialty workgroup, SIR offers its own individual comments on the following topics:

• Professional and facility standards for performing PTA of the carotid artery with carotid stent placement;
• Degree of carotid artery stenosis;
• Coverage of asymptomatic patients; and
• CAS outcomes registry.

Professional and facility standards for performing PTA of the carotid artery with carotid stent placement

Professional Standards

SIR recommends that CMS take the appropriate steps to ensure that physicians wanting to provide CAS have the necessary catheter and imaging experience in the neurovascular system.

SIR has defined provider qualification and training requirements, which are outlined in the "Quality Improvement Guidelines for the Performance of Cervical Carotid Angioplasty and Stent Placement". This document also provides definitions of success and complications and acceptable thresholds for these outcomes. We appreciate CMS' acknowledgement of our Guidelines in the draft coverage decision. We believe that our Guidelines are a good starting point for a discussion of the CAS skill-set needed by physicians. SIR stands ready to work with CMS and other specialty organizations on a common set of professional standards.

Facility Standards

SIR recommends facilities wanting to provide CAS have the same infrastructure in place as required for carotid endarterectomy.

Again, SIR directs CMS to its Cervical Carotid Angioplasty and Stent Placement Guidelines that recommends:

• An appropriately equipped suite with high-quality angiographic imaging (with digital subtraction angiography) plus a high-resolution image intensifier allowing fine-detail intracranial imaging and digital capabilities, consistent with as low as reasonably achievable (ALARA) radiation safety guidelines;

• Immediate access to high-quality CT or magnetic resonance (MR) imaging in order to allow evaluation of any suspected complication (e.g., intracranial embolization, hemorrhage);

• Adequate physiologic monitoring equipment for use during and after the procedure, including equipment for cardiopulmonary resuscitation and temporary cardiac pacing;

• Prompt access to emergency medical, surgical, and interventional personnel and resources needed for management of medical or surgical complications; and

• A quality control and assurance program with documented policies and procedures.

Also, while not specifically described in our Guideline, we believe it would be reasonable to expect the following other requirements:

• An active carotid imaging program(s), including carotid/cerebral angiography and non-invasive imaging of the carotid;

• An active stroke program;

• Access to neurology/neurosciences;

• Access to vascular surgery and/or neurosurgery (including surgeons who perform carotid endarterectomy);

• An active interventional practice with carotid/neurological experience;

• An ICU, with ability to do aggressive management of blood pressure, heart rate, and puncture site;

• As part of the quality control and quality assurance, ongoing review of the case selection and case outcome is done; and

• A credentialing program.

Degree of carotid artery stenosis

SIR agrees with the 70 percent degree of stenosis required for Medicare coverage of carotid stenting as proposed in the draft coverage decision. We strongly suggest CMS revisit this issue once additional information on the benefits of treating lesser degrees of stenosis becomes available.

The best available evidence confirms that symptomatic patients with stenoses greater than 70 percent derive the greatest benefit from CEA and CAS. Additional studies are needed to demonstrate benefit in lesser stenoses.

Coverage of asymptomatic patients

SIR supports CMS' proposed position of covering only symptomatic patients. However, SIR believes that subgroups of asymptomatic patients also may benefit from CAS.

The currently available evidence demonstrates the benefit of intervention for symptomatic patients. We support CMS decision to cover symptomatic patients. However, there may be groups of asymptomatic patients (e.g., those with accelerating lesions) that also may benefit. Once more information becomes available on the benefits of CAS for asymptomatic patients, we encourage CMS to reassess its coverage decision to these additional patient groups.

American Academy of Neurology
American Association of Neurological Surgeons
American College of Cardiology
American College of Radiology
American Society of Interventional & Therapeutic Neuroradiology
American Society of Neuroradiology
Society for Cardiovascular Angiography and Interventions
Society for Vascular Medicine & Biology
Society of Interventional Radiology
The Congress of Neurological Surgeons

The undersigned neurological, medical, surgical, interventional, and radiologic specialty societies, representing slightly over 100,000 total physician members in the United States and the major organizations involved in the management, diagnosis, and treatment of carotid occlusive disease, offer the following consensus comments regarding the proposed coverage decision memorandum for carotid artery stenting (CAS) dated December 17, 2004. We appreciate the enormous effort expended by the Coverage Analysis Group (CAG) in developing the Memorandum and commend you and your staff for its thorough and thoughtful consideration of the issues related to carotid stenting.

The following comments deserve special consideration by CMS because they represent a unanimous and single voice of all major specialties with clinical expertise and interest in the realm of extracranial cerebrovascular disease. It is the consensus opinion of these societies that these revisions be incorporated in the CMS' final CAS coverage policy.

Our comments are organized in the following manner:

1. Those issues for which CMS is particularly interested in soliciting public comments, namely the:

The American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), representing organized neurosurgery in the United States, appreciate the opportunity to comment on the above referenced draft decision memorandum for Carotid Artery Stenting (CAS). We would like to commend CMS staff for their thorough and thoughtful review of the literature on CAS and for working closely with the medical community to develop this coverage policy. Clearly, CMS gave serious consideration to the February 3, 2004 letter from nine physician organizations to Sean Tunis, MD, and we look forward to continuing to work with CMS on this issue.

The AANS and CNS joined eight other specialty groups in a letter sent on January 17, 2005 to CM S regarding issues of general consensus on the above referenced draft decision Memorandum for CAS. While we support the comments made in that letter, we would also like to highlight several matters of particular concern to Neurosurgery.

These issues are:

We support the CMS proposal on these issues, as outlined in the above referenced memorandum, and we urge CMS to maintain its position on these issues in the final coverage policy.

Asymptomatic Patients

We agree with CMS that patients with asymptomatic carotid artery stenosis should not be covered, except under the IDE clinical trials policy or FDA required post market approval studies.

Symptomatic Patients

We agree with CMS that coverage of CAS with embolic protection for patients with symptomatic carotid artery stenosis of less than 70 percent should be limited to patients enrolled in clinical trials.

Surgical Consultation

AANS and CNS strongly support the requirement of a consultation with a surgeon who performs carotid endarterectomy (CEA) to establish risk for a CEA prior to consideration for CAS. This position was stated in the February 3, 2004 letter from the nine physician specialty groups to Dr. Tunis and again in the letter of October 1, 2005 from the AANS and CNS to Dr. Chin. We were very pleased to see that OMS has proposed that patients must be "poor candidates for CEA in the opinion of a surgeon" before considering coverage for CAS and we urge CMS to continue its support for a surgical consultation.

Independent Neurological Exam

We support the requirement for an independent neurological exam and believe that specific details for this requirement should be reasonable and based on objective criteria, such as familiarity with the NIH stroke scale certification.

Conclusion

Again, the AANS and CNS appreciate the hard work and careful consideration that CMS staff have given to this issue. We consider Medicare coverage of CAS to be an evolving issue, and as additional evidence from current and future clinical trials becomes available, we urge CMS to expand coverage of CAS in an appropriate manner.

Thank you for considering our recommendations

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Medtronic, Inc. is one of the world’s leading medical technology companies specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. We are committed to the continual research and development necessary to produce high quality products and to support innovative therapies that improve patients' health outcomes. We appreciate the opportunity to comment on the Carotid Artery Stenting (CAS) draft national coverage decision. While the draft NCD increases coverage of carotid artery stenting for certain patients who are at high risk of complications from carotid endarterectomy (CEA), we are concerned that the draft decision is too restrictive given the evidence available.

The exclusion of symptomatic patients with 50-69% stenosis is unnecessarily restrictive; these same patients are eligible for coverage of surgical endarterectomy, a procedure with no evidence of superiority to CAS. The second phase of the randomized NASCET trial demonstrated a significant reduction of stroke and other morbid effects in symptomatic patients treated with CEA. Furthermore the randomized SAPPHIRE trial and the non-randomized BEACH and ARCHeR trials demonstrated that CAS is in no way inferior to and may be superior to CEA. Together, these facts make it clear that CAS provides an option for patients at high risk for complication from CEA.

The exclusion of asymptomatic patients with greater than 80% stenosis is also unnecessarily restrictive; a significant body of evidence has shown that these patients are at increased risk for stroke and related morbidity and mortality. The ACST trial showed significant reduction in combined outcome of any type of stroke or perioperative death in the immediate CEA group compared with those patients treated medically until they became symptomatic (deferred group) (6.42% versus 11.78%) when studying patients with greater than 60% stenosis of the carotid artery. Based on these data which show survival curves crossing at 2 years, CEA, and by extension CAS in the asymptomatic patient with significant carotid artery narrowing are reasonable treatment options when life expectancy exceeds 2 years.

We believe that, within the parameters of the existing evidence base, the decision as to whether or not to treat, as well as how to treat, should be jointly made by the physician and patient, not by CMS. This is especially true in light of the fact that the risk of stroke is not just a function of the degree of stenosis but also the rate at which the stenosis has increased over time. Therefore, coverage of CAS should be extended to include surgical “high-risk” symptomatic patients with 50-69% stenosis as well as asymptomatic patients with greater than 80% stenosis.

Medtronic supports the role of specialty societies to create the guidelines and training for physicians and believes in developing qualified physicians to ensure the safety and appropriateness of CAS. It is our understanding that all of the specialty societies that will have physicians performing this procedure have posted rigorous standards to guide hospitals in the granting of privileges to perform this procedure.

While we wholeheartedly endorse strict adherence to rigorous training and quality standards for CAS procedures, we believe these objectives can be met by existing authorities and processes. We would oppose any new federal requirements developed by CMS that would have the effect of excluding specific providers from participation, or establishing the ability to remove that right to participate.

We look forward to working with you and other stakeholders to further refine and develop the proposed NCD for CAS.

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Abbott Laboratories, as a leading medical device manufacturer, welcomes the opportunity to share our views on the draft Decision Memo for Carotid Artery Stenting. As you are aware, Abbott recently completed the SECURITY Trial, which reported clinical outcomes following carotid artery stenting (CAS) in patients who were at high-risk for carotid endarterectomy (CEA). The study is currently undergoing review by the FDA for PMA approval (PMA# P040038).

Abbott commends CMS for expanding coverage of CAS with embolic protection for patients who are at high risk for CEA. We believe that this is an important first step in providing beneficiaries access to this new and important technology. We also appreciate the opportunity to provide comments on the draft decision. There are 3 specific areas where we would like to provide comments and specific recommendations for CMS to consider.

RECOMMENDATION 1: Expand the proposed coverage criteria to include patients with symptomatic carotid artery stenosis from ≥50% and <70%.

This recommendation is based upon the fact that:

This recommendation is supported by prospective, multi-center, randomized and registry clinical trials that have reported patient outcomes for this patient population. These studies include NASCET, SAPPHIRE, ARCHER and Abbott's SECURITY trial, among others.

a) CEA Reduces Stroke Risk in Patients with ≥ 50% and < 70% carotid stenosis.
Analysis of NASCET patients enrolled with a 50% to 69% carotid stenosis who underwent surgical revascularization demonstrated a reduction in stroke risk when compared to patients who received medical therapy. The five-year ipsilateral stroke rate for patients who were revascularized was 15.7% versus 22.2% in patients who were managed with medical therapy (p =0.045) 1/.

This risk reduction, while not as great as the benefit demonstrated in patients with a higher degree of stenosis, still affords a treatment benefit for these patients, and prevents 1 stroke for every 15 patients treated 1/. This corresponds to the prevention of approximately 5700 strokes in the US each year, avoiding $8 billion in costs to the US health care system 2/. Additionally, even a modest reduction in stroke risk can have a major impact on individual patients who are able to avoid the long-term disabilities and cost of treatment that is often associated with the occurrence of a stroke.

b) CAS is at least as effective as CEA in patients with ≥ 50% and < 70% stenosis.
The SAPPHIRE study compared clinical outcomes for high-risk patients who underwent revascularization with either CAS or CEA. In the randomized cohort, symptomatic patients with stenosis ≥ 50% and asymptomatic patients with stenosis ≥ 80% who were revascularized with CAS or CEA experienced a combined rate of stroke and death at 1 year of 11.9% and 19.9% respectively (p = 0.048)3/. This represents a nearly 50% reduction in stroke risk for this patient group. These results demonstrate that the outcomes of CAS are not inferior to the clinical outcomes and benefits of revascularization experienced with CEA, even with the inclusion of patients who are at high-risk for surgery.

The ARCHER and SECURITY trials reported similar results for high-risk patients treated with CAS. In both studies, symptomatic patients with carotid stenosis ≥ 50%, and asymptomatic patients with stenosis ≥ 80% were enrolled and treated with CAS. In ARCHER 2 and 3, a combined rate of death and ipsilateral stroke at 30 days of 7.20% and 6.21% respectively, were recently reported to the FDA in the Guidant PMA (#P040012) documentation for approval 4/. The SECURITY trial reported similar rates for this patient population, with a combined rate of death and ipsilateral stroke at 30 days of 7.21% 5/.

In reviewing the NASCET results, it is important to note that the benefits of revascularization were achieved in patients who were at 'standard risk' for surgery. Patients with high-risk anatomical or medical co-morbidities were excluded from enrolling in the study. Following the NASCET trial, advances in endovascular techniques and equipment have afforded this high-risk patient population the opportunity to benefit from endovascular revascularization, as demonstrated in the SAPPHIRE, ARCHER, and SECURITY trials. Thus, it is important to bear in mind that CAS achieved stroke risk reduction rates comparable to CEA, even when CAS was employed in a more challenging patient group than CEA.

c) Therefore, CAS for patients with ≥ 50% and < 70% stenosis warrants CMS coverage.
As demonstrated in the NASCET trial, surgical revascularization provides a benefit in patients with ≥ 50% and < 70% stenosis. Further studies have demonstrated the relative equivalence of endovascular revascularization with CAS to surgical revascularization with CEA. We therefore recommend that CMS expand CAS coverage to include high-risk symptomatic patients with stenosis ≥ 50% and < 70%. This expansion of coverage is reasonable given the clinical evidence, and necessary in order to provide an endovascular option for patients who are not surgical candidates.

RECOMMENDATION 2: Review coverage for asymptomatic patients with ≥ 80% stenosis when additional clinical evidence becomes available.

It important to note that ACAS and ACST demonstrated the benefits of revascularization in asymptomatic patients, and Abbott feels that asymptomatic patients with ≥ 80% stenosis may also benefit from CAS. As discussed during a recent meeting with CMS, Abbott's ACT 1 randomized clinical trial will compare the clinical outcomes of CAS to CEA in this patient population. We recommend that CMS consider providing coverage for asymptomatic patients if a clinical benefit is demonstrated in studies of this patient population.

RECOMMENDATION 3: CMS should utilize JCAHO as the recognized entity for the national evaluation process.

We urge CMS to utilize JCAHO for the national evaluation process. JCAHO evaluates and accredits more than 15,000 health care organizations in the United States. Joint Commission accreditation is recognized nationwide as a leading accreditation and currently is recognized by the Medicare program for hospitals meeting Medicare requirements for conditions of participation. We believe that utilizing JCAHO will reduce unnecessary burdens on hospitals and provide the level of oversight that CMS is seeking.

Again, we appreciate the opportunity to comment on this important decision memo. Please feel free to contact us if you have any questions or require additional information.

References:

1. Barnett JM, Taylor DW, Eliasziw M; et.al. Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. N Engl J Med 1998; Vol. 339: 1415-1425.
2. American Heart Association, Heart Disease and Stroke Statistics - 2004 Update, Dallas, TX: American Heart Association. 2003:1-52.
3. Yadav, JS; Wholey, MH; Kuntz, RE; et.al. Protected Carotid-Artery stenting versus Endarterectomy in High-Risk Patients. N Engl J Med 2004; Vol. 351: 1493-1501.
4. Guidant Corporation. FOI data on file. August 2004. Summary of Safety and effectiveness (PMA # P040012).
5. Abbott Vascular Devices Inc. SECURITY Trial Clinical Summary. September 2004 (PMA P040038).

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The draft is very partisan on 2 counts:

1. All high risk surgical patients: To ask for a formal surgical evaluation stating that the patient is a high risk candidate for surgery is irrational because the surgical opinion will always be biased. The surgeon has an inherent conflict of interest in favor of performing surgery. This is well demonstrated by the historical fact that many of these patients undergo CEA to date in spite of: a) higher complication rates than the original ACAS and NASCET trials populations and b) no controlled trial or registry data exists showing safety and efficacy of surgery in this patient population. Should there be a mandate on every CEA in a high risk patient to undergo opinion from an interventionalist that carotid artery stenting is not possible?

2. Asymptomatic high grade carotid stenosis in high surgical risk patients: While CEA for asymptomatic carotid stenosis in high risk surgical patients is paid for; carotid artery stenting in the same patient population is not. In spite of multiple demonstrations that carotid artery stenting is just as safe if not safer in this cohort. Should payment for CEA in this patient group also be denied?

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The data, both registry and randomized trials, supports the use of carotid stenting in high risk symptomatic and asymptomatic (ASX) patients alike. The major randomized trial of carotid stenting vs CEA (SAPPHIRE) included 71% Asymptomatic patients. To ignore this large group of asymptomatic patients when such trials as ACAS & ACST have shown benefit of surgery compared to medical therapy is unacceptable to both myself and my patients. Granted, these studies were done in low risk patients, but higher risk patients with progressive ASX disease such as those in Sapphire should not be ignored. CAVATAS, a low risk study comparing CEA to PTA of carotid with only 25% receiving carotid stents showed similar 30 day & 3 years outcomes as did a small randomized stent vs CEA study in Lexigton, KY. Further, the non-medicare carriers have recognized the equivalence in outcome (if not superiority in my personal opinion and experience) along with the dramatic decrease in morbidity of Carotid stenting in comparison to CEA and have universally began to pay for Carotid stenting in the state of Indiana based on routine medical necessity. At present there does exist a two tierred medical payment system, private insurance which is covering carotid stenting in ALL patients (high & low risk) and medicare which is essentially paying for it in rare pateints in an IDE clinical trial. This procedure is now an APPROVED, non- investigational proedure and should be reimbursed accordingly by CMS. To do otherwise is an injustice to our medicare population and undo harm & suffering on them for merely being beyond 65 years of age. I cannot tell you of the many times I have counseled pateints in my office who were NO option or No GOOD option for CEA patients with and without symptoms who had been turned down by the surgeons and sent to me for consideration of carotid stenting. To tell them that medicare will NOT pay for it when a multitude of specialists such as neurologists, neurosurgeons, cardiovascular surgeons, cardiologists and internists ALL agree for the need of the procedure due to some old political games between specialties is a travesty. Yes, we have done some of these procedures at our instituion without being paid, but many patients do not qualify for pure charity care at the hospital. In fact, I now have a list of over 20 patients waiting on funding to be approved who are hoping & praying they don't have a stroke while waiting, some are no option patients with symptoms others are ASX pts who have had surgery before and have vowed to me they will "NEVER go through that again". In fact, the pateints who have had both procedures are indeed our biggest cheer leaders for the Carotid stenting procedure. When I have asked patients to compare the two procedures, they universally state, "There is no comparison, why would anyone ever want a CEA with this alternative available." In closing, I strongly reccommend coverage for ALL medicare patients for carotid stenting as the medical community sees fit. Further if CMS doesn't feel the data is robust enough to cover low risk ASX patients with the far less morbid procedure of Carotid stenting, then perhaps you should not cover CEA in these patients (I personally believe both should be covered). Thank you for your consideration of this issue.
Hollace Chastain MD, FACC, CREST investigator
Fort Wayne Cardiology
1819 Carew St.
Fort Wayne, IN 46805
260-481-4700

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Carotid Artery Stenting(CAS) is equivalent(non inferior to) CEA in high risk patients. CEA is the standard of care for asymptomatic patients with carotid artery stenosis > 60 % in the US. The % stenosis appears to be important in determining stroke risk. If a high risk patient with > 80% Asx stenosis and a reasonable life expectancy desires revascularization(THE STANDARD OF CARE) he will have no choice but to undergo an invasive proceedure with higher risk than CAS (based on all FDA sponsored trials so far) This is counter to the best interests of the pt and society. I face these situations often as a Neurosurgeon who has large experience with both CEA and CAS... what do I tell my patients??? Witholding payment for low risk patients on the other hand makes sense until such time as CAS is proven to be non inferior to CEA in low risk trials. Thank you for allowing me to comment. LN hopkins MD

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Dear Sir or Madam,

It is not logical to pay for high risk asymptomatic patients to receive a CEA but not pay for a carotid stent. The recent SAPPHIRE study showed both to be euqivalent in the treatment of asymptomatic high risk patients.

I also wonder why a surgeon is required to determeine if a patient is high or low risk. There should be a collaberative effort of a cardiologist, surgeon, and other appropriate specialty such as pulmonology depending on the patient characteristics.

In fact, surgeon may be less appropriate than a non biased medical specialist to make the determination of high, intermediate, or low risk.

Thank you.

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Based on my experience in academic institutions and universities for almost 20 years and of having performed carotid stenting in almost 1000 patients the guideline as set by CMS for carotid stenting are inadequate and unacceptable in its present form.

These guidelines have to be supported by results not only based on trials which are conducted in some specialized centers with excellent results and minor and major complications of CEA < 6%. In reality, as most recent data at AHA show and our own experience in real life shows, the minor and major stroke risk associated with CEA exceed 10%. The patients treated do not only include high-risk patients, but also asymptomatic and symptomatic patients with stenosis > 50%.

Unfortunately in most of the centers a stroke neurologist is not involved in assesment of the patient, but the treating physician, generally not specialized in neurosciences, is in charge of the evaluation.

Thus, based on the natural history of asymptomatic atherosclerotic disease (a clear understanding of histolgic conversion to symptomatic disease is not known)and the riskts associated with CEA, following guidelines for stenting should be implemented:

1) asymptomatic patients > 80% stenosis
2) symptomatic patients > 50% stenosis or ulcerated plaques with <50% which may be associated with the presenting ipsilateral symptoms and MRI changes suggestive of lacunar infarcts
3) the decision whether a patient is a high-risk candidate for CEA can not be only the surgeons decision. This will be self-serving and should and will have legal implications for the treating physician.

The decision whether a patient is a better candidate for surgery or stenting has to involve following disciplines who are familiar with the nervous system:

1) neurologist
2) (neuro)surgeons
3) interventional (neuro)radiologist
4) internist

This will ensure a multi-disciplinary approach to a complex matter. The end organ which is the brain is not forgiving like other systems in the body. A more sophisticated approach is required.

Wakhloo, Lieber, Gounis, et al. Hemodynamics in carotid arterty atherosclerotic occlusive diesease, JVIR 2004

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1. Coverage should be extended to asymptomatic patients with stenosis equal to or greater than 80% meeting the high risk criteria. Recent CEA and CAS trials included these patients and the stent device has been approved by FDA for this indication. The ACAS trial showed benefit of revascularization in these patients.

2. Requiring a written surgical opinion to be considered a high risk surgical candidate when the patient meets established clinical and anatomic criteria, in my opinion, is not necessary. Despite published data most surgeons do not consider these patients high risk and would rather perform CEA, compromising patient safety and outcome.

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I am an interventional cardiologist and Director of a Cardiac Catheterization Laboratory. I spend most of my time in the practice of cardiac and peripheral interventional procedures. I have read the transcript of the FDA's Circulatory System Devices Panel meeting of April 21, 2004; I have read the CMS Draft Decision Summary CAG-00085R. I am familiar with the pertinent literature.

Four comments:

1) It is my opinion that criteria for coverage should reflect inclusion criteria of SAPPHIRE and ARCHER, ie that asymptomatic patients with carotid artery stenosis (CAS) > 80% and with symptomatic CAS > 50% should be covered. The number of symptomatic patients in SAPPHIRE and ARCHER is small, and I believe the only scientifically valid approach is to extend coverage to the patients actually studied in those two trials.

2) It is my opinion that consultation with a vascular surgeon and surgical "turn down" should NOT be a prerequisite for coverage. I say this because many vascular surgeons in practice say they operate routinely with good results on the type of patient enrolled in SAPPHIRE and ARCHER, and many vascular surgeons are critical of the design of the SAPPHIRE study and believe the study is invalid. CAS appropriate patients consulting vascular surgeons of these opinions would probably be denied the benefits of CAS if surgical "turn down" is a requirement for coverage. It is also true that the patients in the randomized arm of SAPPHIRE, those very patients in whom CAS was shown to be a reasonable alternative to endarterectomy, had to have acceptance (i.e., the opposite of "turn down") in order to qualify for the randomized arm. Therefore, it makes no logical or scientific sense to require vascular surgical consultation and "turn down" before CAS. It is appropriate to require documentation in the medical chart of anatomic and/or clinical conditions qualifying for high risk status, and I believe that these criteria must be strictly observed.

3) It is my opinion that an experienced interventional cardiologist already doing peripheral interventional procedures can be trained to safely perform CAS following the training criteria guidelines supported by the American College of Cardiology and other professional societies (as published in the Journal of the Americal College of Cardiology).

4) I favor careful and mandatory post procedure neurology evaluation and followup in a manner agreed upon by professional societies. On going data collection is crucial for further evaluation of safety and efficacy.

Ancil A. Jones MD
Director, Cardiac Catheterization Laboratory
Crozer Chester Medical Center
Chester PA 19013
Fellow, American College of Cardiology
Fellow, Society for Cardiac Angiography and Inverventions

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In high-risk patients, the SAPPHIRE study showed that carotid stenting was not inferior to carotid endarterectomy. In fact, it may be superior. Carotid endarterectomy has never been studied in high-risk patients outside of the SAPPHIRE study. I don't understand why...
1. ...high-risk asymptomatic patients with > 80% stenosis and symptomatic patients with 50-70% stenosis would continue to be covered for carotid endarterectomy but not stenting
2. ...vascular surgeons would need to provide approval for a carotid stent procedure. Given that surgical outcomes were no better in SAPPHIRE, it seems that any high-risk patient undergoing carotid revascularization should have both an interventionalist and vascular surgeon review which option is best (our proposed approach in Medford, Oregon). It seems the vascular surgeon should have an interventionalist write a note that CEA would be preferrable to stenting.

In short, the criteria applied to carotid stenting should also apply to endarterectomy.

I would also not be so restrictive with regards to the patients eligible for revascularization. If a patient is functional and has a life expectancy > 5 years, then I would consider revascularization in asymptomatic patients with > 80% stenosis and symptomatic patients with 50-70% stenosis. Practically speaking, stenting is clearly preferable to endarterectomy in patients with prior neck surgery, prior endarectomy, and X-ray therapy to the neck. If you don't equalize the coverage for both stenting and endarterectomy, you will shunt many patients better served by stenting to endarectomy. This will probably lead to worse outcomes. Patients deserve this additional revascularization option. The challenge will be ensuring that patients are approached in a thoughtful, responsible manner.

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I beleive that carotid stenting is another great advancement in the current era of medical technolgy. I agree with the criteria set by the Medicare/CMS that a Neurologist should be involved throughout the decision making and management process. However, the decisions by Medicare not to reimburse for asymptomatic disease stenting and assigning vascular surgeons as the "gatekeepers" to patients' health and well-being are controversial.

First of all, two-third of the patient population in almost all the major carotid stenting trials comprised of the "asymptomatic" patients. If you look at the carotid artery endarterectomy (surgical revascularization) reimbursement, it pays the surgeons to perform this procedure on "asymptomatic" patients. Carotid endarterectomy data shows that two- thirds of the patients upon whom this procedure is performed are "asymptomatic". The question is why the discrimination then? Just for a minute, think of someone close to you and imagine that first symptom in that person could be a lifelong debilitating/disabling stroke as it happens in 1/3rd of the patients. Last but not the least,this decision by Medicare defies not only the FDA's approval of such procedure but also the general consensus of multi-disciplinary specialities (Radiology, Vascular Surgery and Cardiology) that have endorsed stenting in asymptomatic patients with at least >80% blocked carotid arteries.

Secondly, historically cardiologists have taken up the responsibility for pre-operative cardiovascualr evaluation prior to non- cardiac surgery. So, why now vascualr surgeons (who actullay are going to be considered as competitive physicians in this field) are been given this new role of defining high-risk population. In addition, there is no precedence of getting a procedure certified by a competing specialty physician in any of the disease entities. Vascular surgeon's consultation is not paid either in this case. The question is why can't we make our decisions based on the FDA criteria for high-risk. And to do that you do not really need a vascular surgeon to tell you if a patient is high-risk or not.

It is somewhat bothersome to take away a basic right form the PATIENT to decide what is best for him/her after a detailed discussion with the physician and understanding the benefits, risks and alternatives to the various procedures. We all beleive in patient's autonomy in healthcare and it's also patient's basic right. So all patients should not be given the only option of undergoing surgery. Mortality from carotid endarterectomy is 3- fold higher when you look at the Medicare database compared to what vascular surgeons have traditionally reported.

In closing, I think that Medicare/CMS should revise the criteria for treating the asymptomatic disease and providing adequate reimbursement for this great advancement to grow and patient population to benefit from it. I am confident that Medicare/CMS will be considearte enough and come up with a decision soon for the betterment and well- being of the patients' health.

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Respected chair person
CMS

Re: Carotid stent, criteria for CMS

I think that limiting reimbursement for asymptomatic lesions is unprecedented - in any cardiovascular setting. Also, Surgery(carotid endarterectomy) is currently reimbursed for asymptomatic carotid stenosis - are you planning to roll back reimbursement for that?Additionally, A surgical opinion is unneccessary as a mandated requirement. Often times it is a multidisciplanary approach even today. I cannot recall a mandatory second opinion in any other procedure - this is un precedented and has no scientific or clinical basis. This is pandering to the surgical specialty

I will be happy to have some of my patients who have had surgery and carotid stent comment on the procedures and their experiences with it

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Carotid Stenting in "high risk" asymptomatic patients with >80% stenosis should be approved for payment. While the data could be stronger to support it's use there likely will never be another randomized trial looking at the high risk population. CREST will not answer the question for the high risk population.I agree that it may be that high risk patients do not benefit from revascularization over medical therapy but if this is the position that will be taken then CEA for high risk patients (or for any patients outside RCT data) should not be paid for either. Their are no adequate randomized trials of high risk asymptomatic patients to CEA vs. medical therapy yet it is paid for and performed with a higher frequency than for patients who meet ACAS ACST criteria. We have one adequate trial of CAS vs. CEA on high risk patients. Subgoup analysis of the symptomatics vs. asymptomatics outcomes is inappropriate to use as criteria for approval and payment from a statistical standpoint.I would applaud you if you demanded a study of CEA vs. CAS vs. medical therapy in ACAS/ACST ineledgible patients and put a moritorium on payment to either procedure outside the trial. But to continue to allow CEA when CAS may be better without any significant data to support this position is illogical.
Thank you,
Michael Rinaldi, MD, FACC
Director, Vascular Interventional Lab
Director, Carotid Stent Program
Interventional Cardiologist
The Sanger Clinic
Charlotte, NC

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10 years ago, I would have said that one was crazy to consider carotid artery stenting in any patient, given the plaque we removed at the time of surgery. However, with advances in catheter and stent technology, I believe that the time for carotid artery stenting has arrived. I would recommend that the CMS guidelines for the procedure be extended to symptomatic lesions greater than 50% and high- risk asymptomatic patients with greater than 80% stenosis. We have a large subset of patients that are very high- risk and currently are offered either medical management only and in some cases, carotid stenting. Finally, I believe this procedure should be intially done only in selected institutions and by physicians who have demonstrated technical expertise in advanced interventions. Arun Chervu MD Vascular Surgical Associates, P.C.

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RE: Carotid Stenting, High Risk Definition

Dear CMS Staff:

Completely opposed to have a surgeon’s written opinion whether a patient should qualify and meet definition for high risk. I think that Neurologists with expertise in stroke care will be the most indicated specialists to make this decision.

Stroke Neurologists have extensive training in the assessment and treatment of cerebrovascular disease and are in better position than surgeons to determine who is at high risk.

Sincerely,

Della Coupland, RN

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Thank you for the opportunity to comment on CMS’ draft decision memorandum for carotid artery stenting with embolic protection. We are very pleased by CMS’ decision to provide national coverage for carotid artery stenting procedures, following our request for such a change, and feel strongly that this less invasive approach will improve the quality of care for high risk patients.

We are, however, concerned with the narrow coverage proposed and feel that CMS’ coverage policy is inconsistent with results from the numerous clinical trials and peer-reviewed publications. Specific concerns and recommendations are addressed below.

1. CMS proposal: “Based on currently available evidence, we believe that there is insufficient evidence to conclude that CAS with embolic protection improves health outcomes for patients with severe asymptomatic carotid artery stenosis > 80% and who are at high risk for CEA. While we await the completion of ongoing clinical trials such as the CARESS Phase II trial, coverage for CAS with embolic protection for patients with asymptomatic carotid artery stenosis > 80% may be available under the IDE clinical trials policy or FDA required, post market approval studies.”

Comment:
We strongly believe there should be coverage of asymptomatic patients with >80% stenosis for many reasons.

• First, a recent major, multinational clinical trial conducted by a very highly regarded group of investigators studied the outcomes of patients with asymptomatic carotid artery stenosis with best current medical therapy versus CEA. Specifically, the Asymptomatic Carotid Surgery Trial (ACST), published in The Lancet, May 8, 2004, was a randomized clinical trial involving 3,120 patients that compared immediate carotid endarterectomy (CEA) to deferred CEA with optimal medical management for the treatment of asymptomatic patients with a substantial carotid narrowing. The trial results demonstrated a much more favorable outcome for patients with immediate CEA than for those who were treated with best medical therapy and deferred CEA with almost a 50% reduction in events in the immediate surgical treatment arm. There were highly significant differences in the percentage of total strokes (6.4% versus 11.8%; p< 0.0001) and also in the percentage of fatal or disabling strokes (3.5% versus 6.1%; p = 0.004) at 5 years in favor of immediate surgical intervention.
• Second, the SAPPHIRE trial, which was published in the New England Journal of Medicine on October 7, 2004, was a key required element for the decision to change the National Non- Coverage status of carotid artery stenting. It showed that carotid artery stenting with embolic protection, in patients at high risk for CEA, is non- inferior to CEA in a combined patient population of symptomatic and asymptomatic patients with carotid artery stenosis, of whom 70% were asymptomatic.
• Third, a subgroup analysis of the asymptomatic patients in the SAPPHIRE trial actually showed significant superiority (P< 0.02) for carotid artery stenting with embolic protection versus CEA in terms of the cumulative combined primary end-point of major adverse events at one-year, as well as a combined incidence of death, myocardial infarction and stroke in the periprocedural period (a key secondary end-point) that was almost 50% lower in the patients treated with stenting and embolic protection versus CEA.

Therefore, we are surprised that CMS is proposing to exclude the coverage of asymptomatic patients when the most recent data show the benefit of surgery over best medical therapy in this patient population (ACST) and the SAPPHIRE trial demonstrated a significant benefit of carotid stenting with embolic protection over CEA in asymptomatic patients at high risk of CEA.

2. CMS proposal: “The evidence is adequate to conclude that CAS with embolic protection is reasonable and necessary for patients who are at high risk for CEA and who also have symptomatic carotid artery stenosis ≥ 70%. Coverage is limited to these procedures using FDA approved carotid artery stenting systems and embolic protection devices. If the stenosis is measured by ultrasound prior to the procedure, then the degree of stenosis must be confirmed by angiography at the start of the procedure. If the stenosis is determined to be less than 70% by angiography, then CAS should not proceed.”

Comment:
Today, CEA/ surgery is performed almost exclusively based on ultrasound assessment. Therefore, it seems inappropriate to use a different standard for carotid artery stenting/interventional procedures. Furthermore, it would be problematic for both the patient and physician to expose the patient to the risk of angiography without the potential benefit of carotid artery stenting, only to be sent on to CEA.

It is well understood that surgeons do not perform routine diagnostic angiograms before CEA because they are unnecessary and increase the risk to the patient.

With respect to CMS’ proposal to limit coverage to only patients that have symptomatic carotid artery stenosis ≥ 70%, we believe there is also sufficient evidence to warrant coverage for symptomatic patients having carotid artery stenosis ≥ 50 - ≤ 69%.

• The major CEA trial to study this symptomatic patient population, the NASCET trial, studied patients with > 50 % diameter stenosis.

• Likewise, each of the FDA- approved, company-sponsored IDE clinical trials enrolled symptomatic patients with carotid artery stenoses of ≥ 50% rather than ≥ 70%. Therefore, it is surprising that CMS has chosen to use the higher degree of obstruction.

3. CMS proposal: “Patients at high risk for CEA are defined as having significant co-morbidities and/or anatomic risk factors (i.e., recurrent stenosis and/or previous radical neck dissection), and would be poor candidates for CEA in the opinion of a surgeon.”

Comment:
In the SAPPHIRE trial, the inclusion and exclusion criteria were clearly spelled out. These included detailed, specific medical or surgical co- morbid conditions that needed to be present for a patient to be considered at “high risk”. In the tightly controlled clinical trial setting, three parties, namely, the interventionalist, the neurologist and the surgeon, all had to agree that the patient met the inclusion criteria and did not meet the exclusion criteria. The patient was then determined to be eligible for randomization. At that point, either the surgeon or the interventionalist could declare whether they would indeed be willing to treat the patient. In the total cohort of patients who were deemed randomizable following this process, many more patients were then turned down for potential surgical treatment than for treatment by carotid stenting. Against this background, it is unclear why the phrase “would be a poor candidate for CEA in the opinion of the surgeon” is included above. We would submit that outside the confines of the randomized clinical trial setting, clearly defined criteria that spell out what constitutes “high risk” (as in the SAPPHIRE trial) should suffice.

4. CMS Proposal: “CMS has determined that CAS with embolic protection is reasonable and necessary only if performed in facilities and by physicians who have been determined to be competent in performing the evaluation, procedure and follow-up necessary to ensure optimal patient outcomes.”

Comment:
We believe that clinicians and associated personnel, that have both met the entry requirements and satisfied all stages of the competency requirements, in a rigorous training program should be deemed competent to perform the procedure. We believe that the very comprehensive Cordis CASES training program, that was developed in concert with a highly knowledgeable multidisciplinary team of physicians and has been reviewed in detail with you, meets CMS’ requirement for physician and hospital staff training. Individual hospitals will act as a further gate-keeper since appropriate credentialing remains the responsibility of the institution (s) where the physician intends to practice.

We appreciate the opportunity to provide our comments and we look forward to continuing to work with CMS to expand the number of patients eligible to receive the benefits of carotid artery stenting. We request that CMS revise its final coverage determination to reflect the above recommendations.

However, if CMS determines that they are not prepared to cover asymptomatic patients at this time, we recommend that they remain open to the presentation of additional data to support the coverage of asymptomatic patients at high risk of surgery as these data become available.

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Abide by the science and data from the trials you required. Seventy percent of the patients enrolled were asymptomatic- to only cover symptomatic patients excludes from service the majority of the patients which have been shown to benefit. Use high risk indicators and percent stenosis cutoffs which the FDA mandated in the trials. Do not put us physicians in the position of committing Medicare fraud in order to provide the appropriate care to our patients. Between fraud and patient care I will choose patients any day!

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To whom it may concern:

I am troubled that the proposed reimbursement decision by CMS is overly restrictive and flies in the face of physicians’ traditional latitude of practice so important to patients in this era of rapidly advancing technology. It is extremely unusual for CMS to limit reimbursement so restrictively and quantitatively – particularly when this limitation is not supported by recent clinical experience or data.

The initial policy of denying ANY payment for a patient hospitalized and undergoing carotid stenting was nearly unprecedented. It certainly would have been reasonable to deny payment for any professional free related to stent placement and to deny technical payments for the stent itself. But the denial of the entire hospitalization and angiogram was (and is) inappropriate and seemingly motivated by a desire to restrict the use of this technology and “punish” those whose judgment was the carotid stenting represented a true advance. In such instances in the past (e.g. aortic balloon valvotomy) there was no reimbursement for the valvotomy itself, but the entire hospitalization was not held hostage. Given that there is now an FDA-approved device for carotid stenting, this policy is untenable. CMS should reimburse for the clinical and angiographic portions of any appropriate procedure but fail to allow reimbursement (professional or technical) for the stenting portion unless guidelines are met (vide infra). Even this policy would be unusually restrictive. Carotid endarterectomy remains fully reimbursed and relatively unscrutinized for appropriateness by billing regulation, despite that fact that there is a continuum of benefit directly related to the degree of stenosis. If reimbursement for stenting should have to meet such strict criteria, shouldn’t endarterectomy also have to meet equally restrictive criteria? Should the surgeon and hospital who dare operate on an asymptomatic 59% stenosis also be denied payment and be subjected to CMS scrutiny. Even if one were to accept the concept of such a restrictive plan, many of the proposed parameters are inconsistent with what is appropriate. For example, the CMS draft decision does not propose payment for asymptomatic patients, despite approximately 70% asymptomatic enrollment in recent CAS and carotid endarterectomy (CEA) clinical trials. Note also that the FDA-approved indication for Guidant's Carotid Stent System includes high-surgical risk asymptomatic patients with stenosis greater than 80%. The proposed decision would also cover only symptomatic patients with stenosis greater than 70%. In comparison, all recent CAS clinical trials and the FDA-approved indication for the Guidant carotid stent system include symptomatic patients with stenosis greater than 50%. Further, CMS’s definition of “high-risk” includes a statement that a covered patient would be considered a poor candidate for CEA in the opinion of a surgeon. This definition is imprecise and could ultimately require a surgeon's written opinion and consensus for all CAS patient treatment. This too, is inappropriately restrictive in an era in which there is an FDA-approved device and in which there is a reasonable consensus that these two techniques have reached clinical equipoise in appropriate populations. There is also controversy in the drug –eluting stent era about which coronary patients are appropriate for multivessel coronary stenting vs. bypass surgery. Should a surgeon have to agree that a patient is inappropriate for CABG before PCI is even reimbursed? It is acknowledged that much, if not most, of the catheter-based management of cardiovascular disease involves the use of drugs and devices “off-label” – Certainly one need look no further than the huge numbers of “biliary” stents used to understand that their destination is often intravascular and not related to an occult and unprecedented outbreak of biliary disease. Yet despite appropriate concern, none of these devices has been made to focal point of such a campaign.

I urge CMS to adopt a reimbursement policy that is neutral to off label use (does not reimburse for the stent professionally or technically but does permit payment for hospitalization and angiography) and in which reimbursement guidelines are consistent with current clinical data and FDA device labeling.

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Boston Scientific Corporation appreciates the opportunity to comment on the Agency's draft decision memo for carotid artery stenting (CAG-0085R). We are providing comments to urge the Centers for Medicaid and Medicare Services (CMS) to reconsider and modify key aspects of the proposed decision prior to issuing a final decision.

We applaud and acknowledge the effort and thoughtfulness the Agency has put forth to come up with this proposal and we are in agreement with its emphasis on ensuring that beneficiaries are able to access a procedure that is reasonable and necessary, and improves net health outcomes. Before it makes its final coverage decision we want to remind the Agency that the intent of CAS is to avoid stroke in patients who are at risk for that disabling and deadly medical condition. Therefore, OMS should place its prime emphasis on how best to accomplish the avoidance of stroke given the research and data available to CMS at this point.

We believe CMS's draft decision too narrowly defines the high risk population and in so doing will unnecessarily restrict beneficiary access to a minimally invasive procedure that reduces the risk of stroke.

CMS requested comments on four major areas:

1. Appropriate criteria, including co-morbid conditions, for defining patients at high risk for surgery;
2. Criteria for appropriately defining symptomatic patients;
3. Professional and facility standards for performing CAS; and
4. Evaluation process for physicians and facilities

We have organized our comments to address each of these areas. Our general comments are expanded upon and supported in greater detail via a set of issue-specific "policy papers" that are included as attachments.

1. Appropriate criteria, including co-morbid conditions, for defining patients at high risk for surgery

Boston Scientific believes that the definition of "high risk" needs to capture a more comprehensive set of comorbid and anatomic criteria.

We believe the Agency should incorporate into its definition of high risk the comorbid and anatomic criteria that have been largely common to the Category B IDE high risk CAS clinical trials. (i.e. ArcheR, SAPPHIRE, BEACH, etc.) These criteria were based on medical community consensus and the FDA's clinical definition of the high-risk patient cohort (See Attachment A: Co-morbidities and Anatomic Criteria for Defining High Risk of Surgery for CAS).

We believe that the Agency should include asymptomatic patients with stenosis equal to or greater than 80% in its definition of high risk

We do not agree with the proposed exclusion of asymptomatic patients who are at high risk for carotid endartorectomy (CEA). We believe sound evidence is available to justify coverage for a subset of these patients. Further, in the absence of criteria for defining asymptomatic patients, we believe CMS will find it difficult at best to clearly and unambiguously define symptomatic patients in a manner that will be clear to the medical profession and the public. (See Attachment B: Coverage of Asymptomatic Patients)

2. Criteria for appropriatelv defining svmptomatic patients

CMS should cover symptomatic patients with stenosis between 50 and 69% in its definition of high risk.

While the Agency relies on results from NASCET, we would point out that the patients that were studied would not be equal in severity to patients enrolled in the recent CAS trials noted above. The NASCET patient population EXCLUDED most of the high risk criteria that was defined by these recent CAS studies (i.e. CHF, COPD, prior heart disease, renal disease, hypertension, and peripheral vascular disease.)

We also believe that the Agency took a very selective perspective of the '50-69% stenosis" subgroup (i.e. it looked at the female subgroup) and in so doing did not give appropriate recognition of the efficacy of CEA for this subgroup. A close review of the data clearly shows that the "symptomatic 50-69% population" did benefit when it received CEA instead of medical management.

3. Professional and facility standards for Performing CAS

Existing authorities and processes will allow the Agency to achieve its professional and facility objectives.

Professional standards

We believe beneficiaries will be best served by allowing the various medical professionals who perform CAS to develop and enforce standards appropriate to the type of patients their profession treats. (See Attachment C: Professional and Facility Criteria; and Evaluation Process.)

We agree with the Agency's statement that "...the training and experience required for CAS should be as rigorous as the training and experience required for coronary interventions, such as coronary artery stenting." Clearly, the major specialty societies agree that it is imperative that providers be appropriately trained to select patients, manage a case, and use the tools associated with this procedure in an effective manner that will result in high-quality care.

Facility Standards

CMS should not initially restrict access to CAS to only those sites that have conducted CAS high risk trials.

We believe the current Conditions of Participation (COP) for Hospitals are more than sufficient to assure that CAS will be performed safely, responsibly, and with good outcomes in Medicare beneficiaries. Not only will the COP guide hospitals, but in addition, hospitals will be guided in the granting of privileges by the rigorous specialty society standards that are publicly available. We believe these standards will serve beneficiaries well and no further regulation by CMS is warranted. (Again, please see Attachment C.)

We urge CMS not to delay coverage until JCAHO has formally established criteria for the certification of a hospital's ability to provide CAS services.

It is important that the Agency not delay coverage until JCAHO has formally established the criteria for the certification of a hospital's ability to provide CAS services. Beneficiaries will still be protected in the interim period before the formal JCAHO criteria have been established. That protection will occur via the Agency's Conditions of Participation, the pool of physicians actually trained in performing this procedure (who will likely be made up the most experienced physicians), and providers' accountability for the potential liability of adverse outcomes.

4. Evaluation process for Phvsicians and facilities

CMS should avoid duplication of outcomes data collection efforts.

It is clear that there will be a host of data collection efforts associated with the treatment of carotid artery stentosis via CAS. Hospitals will carry out their traditional role in tracking physician outcomes, the FDA has and will likely continue to mandate post market registries, and specialty societies and carotid procedure thought leaders will collect data in order to advance the quality of care their specialties provide. Therefore, we see no reason why an Agency-sponsored and distinct effort should be pursued to collect further data on this procedure. It would likely only be duplicative of other efforts and potentially put an unnecessary burden on facilities.

Boston Scientific Corporation appreciates your consideration of our comments and stands ready to work with you in any way that would be helpful to your consideration of this issue.

Attachment A
Co-morbidities and Anatomic Criteria for Defining High Risk of Surgery for CAS

Position

CMS should incorporate into its definition of high risk the comorbid and anatomic criteria that have been largely common to the Category B IDE clinical trials on CAS (i.e. BEACH, SAPPHIRE, ARCHeR, etc.). These criteria were based on medical community consensus and the FDA's clinical definition of the high-risk patient cohort.

Discussion

There are a number of comorbidities common to the multi-center carotid angioplasty with stenting (CAS) trials which we believe would form an acceptable framework for the coverage of CAS under the Medicare program. We also note that multiple physicians representing diverse subspecialties who treat patients with carotid artery disease share this view as documented in their individual comments to CMS.

The following could be used as part of your national instructions on CAS regardless of the general decision regarding symptomatic or asymptomatic patients. We suggest incorporating patients with these co-morbid conditions into the definition of patients at high risk of surgery:

Medical Conditions:

Anatomical conditions:

Attachment B
Coverage of Asymptomatic Patients

Position

CMS should include asymptomatic patients with stenosis equal to or greater than 80% in its definition of high risk.

Limiting coverage of carotid angioplasty with stenting (CAS) to symptomatic patients fails to recognize the main purpose and intent of the procedure the avoidance of stroke in patients who are at risk for that disabling and deadly medical condition. We believe a reasonable approach to coverage of CAS should place its prime emphasis on how best to accomplish the avoidance of stroke given the research and data available to CMS at this point.

Discussion

Evidence of medical need:

Given that the prime goal of CAS is to prevent or at a minimum reduce the chances of a stroke, limiting coverage to patients with symptoms does not appear to be a reasonable medical choice. The potential for stroke is primarily the degree to which the major arteries to the brain are likely to become blocked. The presence or absence of specific symptoms does not necessarily indicate the degree to which such blockage may exist and a stroke may occur. This is why the recent CAS clinical trials were designed to divide patients into high risk and standard risk subgroups, not symptomatic and asymptomatic populations.

As with a number of medical conditions, including those for which stenting is currently covered under the Medicare program, the presence of symptoms, while helpful in identifying patients at risk, is not the only factor which leads a physician to prescribe medical treatment. Absence of symptoms, while making identifying patients much more difficult, does not lead a physician to ignore an identified medical condition which, left untreated, could cause permanent disability or death.

Looking at this from another perspective, should the final policy not cover asymptomatic patients stand, the Agency will be denying CAS coverage to patients who all would agree have a high likelihood of an adverse event (e.g. those who are asymptomatic but who have bilateral disease and a comorbid condition).

The Agency's apparent willingness to rely on medical therapy for the asymptomatic beneficiaries also puts great faith in the likelihood of a patient who is not experiencing symptoms to comply with a medical therapy regime. While medical therapy compliance is an issue across a host of medical conditions, the potential of stroke and its resulting debilitations should encourage the Agency to allow alternative therapies which help to avoid this adverse outcome.

Difficulty of defining the covered population:

We believe it will be difficult for CMS to clearly and unambiguously define the excluded asymptomatic population.

First, CMS will need to list those symptoms that will make a patient "symptomatic" with respect to having this procedure covered. While a medical condition, such as the percentage of arterial stenosis, can be precisely defined, symptoms are another story. Since patients often present with different symptoms for the same condition, we believe the definition of "symptomatic" will take some time and generate considerable unnecessary controversy.

Second, CMS will have to determine some time period during which the covered symptoms occurred. It is not unusual for symptoms to "come and go" in some patients, at various lengths of time. Thus, for each of the above symptoms, CMS will need to determine some window of time during which the patient can be considered symptomatic in order to have CAS covered. It would also be prudent to clearly define such time period, for example, onset of symptoms until date of CAS, etc. This seems a monumental task that would seem likely to lead to unnecessary complexity for the Agency in implementing this policy, and significantly inhibit the ability of facilities to comply with it.

Finally, we believe that reliance upon the existence of symptoms, however reasonably CMS may define them, to determine coverage will unnecessarily exclude patients who have been proven to benefit from CAS.

The outcomes case for asymptomatic patients

Data from Boston Scientific's BEACH study, as well as the other studies of CAS, indicates a substantial net health benefit for asymptomatic patients. In BEACH, the 30 day MAE rate for asymptomatic patients was 5.2%. Further, the stroke rate for this population was 3.5%. It is important to remember that these patients as in all the recent CAS trials have an 80% or greater occlusion in their carotid arteries, a condition that few physicians can reasonably ignore. Given this advantage, taken together with the limitation to patients who are at high risk of the alternative open surgical procedure (CEA), it appears unreasonable to close this option to this limited number of patients.

There is also a solid history of trial results that can be extrapolated to demonstrate that the outcomes associated with CAS are superior to medical management. First, CAS was shown to be substantially equivalent to CEA in the treatment of asymptomatic patients (Brooks et al, Neurosurgery 2004)¹. Second, CEA versus medical management was shown to decrease stroke by one-half at five years for asymptomatic patients as well (ACAS, ACST)².

Since the Agency was willing to extrapolate to reach its conclusions on the role of CEA versus medical management in the symptomatic population, (i.e. CMS used and interpreted the NASCET data on CEA versus medical management to extrapolate that the 50-69% stenosis population would not benefit from CAS), we encourage the extrapolation of the above facts (i.e. Brooks, Neurosurgery 2004 and ACAS, ACST) to support the coverage of asymptomatic patients.

Also supporting the inclusion of asymptomatic> 80% stenosis population is the fact that in ACAS and ACST, the patient exclusion criteria (e.g. diabetes, heart disease, renal disease, and anatomically complex lesions) had the effect of studying an asymptomatic study population that could more aptly be characterized as moderate or even low risk. Had these studies included what might more typically be considered high risk patients, the benefit of CEA (and by extension, CAS) for asymptomatic patients would be further demonstrated.

Finally, the Agency expresses its concerns that there have not been any direct comparisons between CAS and medical therapy. While all stakeholders' understanding of how these two approaches compare would be enhanced by a head to head comparison, it is clear that the clinical community believes that both CEA and CAS are here to stay and we see little likelihood of anyone undertaking studies toward this end. We should not penalize beneficiary access to CAS by forcing them to wait for trial results that are unlikely to be pursued anytime in the near future.

Inconsistency of coverage decision:

CMS has, for the past two years, reimbursed CAS for asymptomatic patients under Category B IDE trials with excellent results. It has recently agreed to continue such reimbursement for CAS when done under FDA-mandated post-market surveillance. There was no caution or reluctance expressed in the decision to continue coverage for asymptomatic patients in the CMS decision for coverage of post-market surveillance patients. We believe it may be difficult for clinicians and beneficiaries to understand the reason for this inconsistency, and we question whether it represents good public policy in the absence of some explanation by CMS.

Attachment C
Professional and Facility Criteria
And
Evaluation Process for Physicians and Facilities

Position

Existing authorities and processes will allow the Agency to achieve its professional and facility objectives.

CMS should not initially restrict access to CAS to only those sites which have conducted CAS high risk trials.

We urge CMS not to delay coverage until JCAHO or other agencies have formally established criteria for the certification of a hospital's ability to provide CAS services.

CMS should avoid duplication of outcomes data collection efforts.

Discussion

Professional standards

We agree with the Agency's statement that "...the training and experience required for CAS should be as rigorous as the training and experience required for coronary interventions, such as coronary artery stenting." Clearly, the major specialty societies share that perspective and believe that it is imperative that providers be appropriately trained to select patients, manage a case, and use the medical devices and other supplies associated with this procedure in an effective manner that will result in high-quality care.

All of the physician specialties societies that will have physicians performing this procedure have posted rigorous standards to guide hospitals in the granting of privileges to conduct this procedure. A more general, or, on the other hand, a very specific but not comprehensive set of standards might offer more of a danger to patients than standards tailored to the type of practitioner who provides their care.

Facility Standards

We agree with the Agency that it is critical facilities have a state-of-the-art lab, equipment and emergency staff to provide this procedure. We concur with the Agency when it says that facilities should be certified by a nationally-sanctioned body as being appropriately staffed and equipped to perform CAS and that these facilities should collect outcomes data and be subject to on-going certification. These objectives can be met by existing authorities (i.e. JCAHO) and processes.

Further, we believe the current Conditions of Participation (COP) for Hospitals are more than sufficient to assure that CAS will be performed safely, responsibly, and with good outcomes in Medicare patients. Not only will the COP direct hospitals, but in addition, hospitals will be guided in the granting of privileges by the rigorous specialty society standards that are publicly available. We believe these standards will serve beneficiaries well and no further regulation by CMS is warranted.

Comparison to other services:

It must be noted that there is not only no compelling reason for special facility restrictions for this procedure, but that there are no special Medicare requirements for much more intricate and risky surgical procedures, including CEA. Similarly, there are also no special Medicare requirements for facilities in their provision of a vast spectrum of procedures that are generally considered riskier and require substantially more back up and support services than that required for CAS. We believe CMS could, if it has concerns over performance of CAS, easily incorporate the following broad requirements into its final instructions: high resolution imaging equipment, advance hemodynamic monitoring capabilities, and emergency management systems - including resuscitation equipment, vasoactive drugs and anesthesia support.

Limitation to clinical trial sites:

We have heard some interested parties advance the suggestion that the only facilities that should be able to initially offer CAS are those which were clinical trial sites. We believe it is fallacious to routinely expect that facilities in which research on a procedure has been performed to be the best or only facilities in which such a procedure should initially be covered. There are a number of reasons why research on a particular procedure is performed in one facility and not another, many of which have little to do with the relative merits of the facilities themselves.

For example, surgical procedures, such as CAS, are often performed where physicians take an interest in the particular procedure, rather than limited to facilities with some specialized surgical equipment. Moreover, the "selection" of both physicians and facilities to do research is dependent upon factors such as the interest of the physicians, the available operating suites for research, and the likelihood of enrolling sufficient patients. In addition, decisions of the hospital governing bodies as to the amount and type of research they are willing to support, and other factors not directly related to the level of competence of the facility may determine whether a particular procedure is researched in one facility or another.

Admittedly, over the course of their research the physicians involved become more expert in performing the procedure; however, they are usually involved in training others during the same period, many of whom also develop a high level of proficiency. These physicians may be from other facilities with equivalent surgical capabilities. There is no logical reason why they cannot "carry" the expertise they have gained to their facility. In addition, physicians who conduct research in one hospital may perform surgery in others, or may have moved from the research facility in which they studied to another facility in another state.

Finally, at this point, when a good deal of the "basic research" on GAS has been completed, some facilities and physicians who have been leaders in this effort will have moved on to other projects. Thus, to limit the procedure to facilities and physicians who have experience with the procedure may limit beneficiary access unnecessarily. We believe the best approach is to establish or accept proper physician training and experience standards, rather than to rely upon "bricks and mortar" limitations that will not necessarily reflect the best options for Medicare beneficiaries.

We urge CMS not to delay coverage until JCAHO has formally established criteria for the certification of a hospital's ability to provide CAS services.

It is important that the Agency not delay coverage until JCAHO has formally established the criteria for the certification of a hospital's ability to provide GAS services. Beneficiaries will still be protected in the interim period before the formal JCAHO criteria have been established. That protection will occur via the Agency's Conditions of Participation, the pool of physicians actually trained in performing this procedure (who will likely be made up the most experienced physicians), and providers' accountability for the potential liability of adverse outcomes.

Historical use of specialized facility criteria

We believe that the recent use of special facility requirements are not based upon a clear statutory premise, but rather an assumption of authority based decisions that were made in the infancy of Medicare's organ transplant program. These decisions were based solely upon the need to assure the efficient use of the scarce supply of human organs. CMS's predecessor, HCFA, specifically stated in response to comments on its heart transplant Notice that the requirements of that program were drawn solely for that purpose and did not represent any extension or expansion of the regulations set forth in the Conditions of Participation for Hospitals. (Federal Register, April, 1987.)

Subsequent decisions regarding the restriction of coverage for Left Ventricular Assist Devices devices was also predicated solely on the need to protect the integrity of the transplant approval program. (See HCFA Technology Advisory Committee minutes, July, 1995.) We do not believe these narrowly drawn decisions give CMS the authority to establish facility requirements beyond those currently posited in CMS regulations. Should OMS wish to expand and expound upon the Conditions of Participation for Hospitals to permit such requirements, we believe they should proceed through the standard rule-making process to develop such requirements prior to incorporating them into a coverage decision.

The Agency needs to avoid duplication of outcomes data collection efforts

It is clear that there will be a host of data collection efforts associated with the treatment of carotid artery stenosis via CAS. Hospitals will carry out their traditional role in tracking physician outcomes, the FDA has and will likely continue to mandate post market registries, and specialty societies and carotid procedure thought leaders will collect data in order to advance the quality of care their specialties provide. Therefore, we see no reason why an Agency-sponsored and distinct effort should be pursued to collect further data on this procedure. It would likely only be duplicative of other efforts and potentially put an unnecessary burden on facilities.

1 Brooks WI-I, McClure RR, Jones MR, et al. Carotid angioplasty and stenting versus carotid endarterectomy for treatment of asymptomatic carotid stenosis: A randomized trial in a community hospital. Neurosurgery 2004; 54:31 8-325.

2 ACAS refers to the Asymptomatic Carotid Arthrosclerosis Study and ACST refers to the Asymptomatic Carotid Surgery Trial.

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The indications of carotid stenting should be the same for carotid surgery, otherwise we will have a double standard for the two approved procedures.The indication should be asymptomatic patients with 80% or greater stenosis and symptomatic with 50% or greater stenosis.

The definition of "high risk" is well explained by the Archer and Sapphire trials. To have a vascular surgeon sign off on a patient (to be high risk) will have potential bias depending on the surgeon's experience and his/her willingness to work with the cardiologist. Likewise I know some surgeons will operate on asymptomatic patients with less than 80% stenosis on the basis of the carotid ultrasound alone. Should the vascular surgeon be monitored and be signed of by a cardiologist before they perform their surgery. If not, there is another double standard.

Carotid stenting had been shown to be safe in "high risk" patients. Logic tell us that carotid stenting should be safer than surgery in low risk patients. I believe that future clinical trials will support that.

Lastly, I believe these guidelines should be use to protect the patients and make available to them the newest technology for better medical care. The guidelines should not be use to protect one specialty vs another.

Thanks for your attention.

Thomas Pow, MD, FACC, FSCAI

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This CMS proposal for carotid stenting certainly seems specious on many levels:

1) The idea that a Vascular Surgeon is the only one who can determine whether or not a patient needs a stent (a procedure not traditionally performed by a vascular surgeon), is simply wrong AND discriminatory. Clearly, neurosurgeons, neurologists, general surgeons who perform vascular surgery, neurointerventional radiologists, interventional radiologists, cardiologists and vascular medicine internists ALL have reasonable ability to determine whether or not a patient is a high/low surgical risk and/or high/low stent risk. All of these specialties see patients, examine patients, have established clinics and all have the medical expertise needed to make approriate judsgements. To give one specialty decisive power over the determination of who gets a stent and who doesn't is not appropriate (particularly when that specialty may not have an interest in offering this type of procedure).

2) The problem with each patient needing an angiogram PRIOR to the placement of a stent is a clearly a safety issue. Patients now must undergo TWO angiograms and thusly incurs ADDITIONAL risk.

3) It really is not in the domain of a vascular surgeon to review the angiogram and make determinations of percent stenosis. This should be defined by the angiographer be they a VS, IR, NS, INR or Card.

4) Clearly, the SAPPHIRE trial shows the efficacy of stent placement in patients with s 50-60% symptomatic stenosis as well as in an asymptomatic 80% stenosis. CMS should follow this established study for both symptomatic and asymptomatic carotid stenosis. Other studies and registries, such as the German registry also support this data.

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Thank you for your thoughtful consideration of carotid stenting in high risk individuals; whereas I, as a NON-INVASIVE (that is I do not perform stenting) Cardiologist agree with those patients you have identified as potentially benefiting from carotid stenting, I BELIEVE THE DATA SUPPORTS A BROADER USE OF THIS MODALITY and ENCOURAGE RECONSIDERATION TO EXPAND COVERAGE.

ASYMPTOMATIC patients with greater than 80% stenosis. This is the standard of care in our community. SYPTOMATIC patients with greater than 50% stenosis. These patients should not be left untreated. CMS should consider using the Sapphire Trial criteria for "medically high risk" patients.

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I have reviewed the recent Draft Decision Memo for Carotid Artery Stenting (CAG-00085R), and I must object vigorously to one aspect, and would like the following comments to be included in the official public response log.

The memo indicates that CMS would only reimburse for carotid stent implantation in patients with symptomatic carotid disease. As I am sure you are aware, the majority of carotid revascularizations (both stents and endarterectomies) currently being performed in this country and around the world, are in asymptomatic patients. The data to support this approach is strong, based on the ACAS trial and the contemporary ACST trial in Europe (Lancet 2004; 363:1491). These trials show substantial decreases in the incidence of stroke when asymptomatic patients with severe carotid stenosis undergo endarterectomy.

The SAPPHIRE randomized trial, and the ARCHER registry that have lead to approval of the Cordis and Guidant carotid stent devices, as well as all of the other high risk registries of carotid stenting (BEACH, CABERNET, etc.), have included asymptomatic patients. In fact, greater than 50% of the patients in the trials of carotid stenting have been asymptomatic. When viewed in aggregate, the data from all of these trials very clearly demonstrate that results with carotid stenting are better than those with surgery in both symptomatic and asymptomatic patients who have clinical characteristics that indicate a high risk for complications with carotid endarterectomy. To restrict CMS coverage to the symptomatic subset flys in the face of logic. Under this policy for example, an patient with no neurologic symptoms who has class III CHF, prior neck radiation, contralateral occlusion, and a 90% restenotic lesion at the site of a prior endarterectomy would only have the options of doing nothing, or undergoing a very high risk surgical procedure. This, in the face of overwhelming data that carotid stenting would be much safer.

In our institution as well as many others around the country, appropriate patients who were deemed inoperable for endarterectomy have received carotid stents free of charge because of the CMS non-coverage decision from several years ago. Obviously, neither physicians nor hospitals can be expected to provide that type of pro-bono care going forward. Hundreds of investigators along with industry sponsors have invested countless hours and dollars to generate the data in the trials referenced above. It is extremely frustrating to have CMS apparently ignore all of that work and data, and arbitrarily restrict coverage to a subset of patients that represents less than half of the trial populations.

Strokes are often devastating events, and represent a major cause of death and disability among medicare beneficiaries. The data are clear that treating severe stenoses in asymptomatic patients can prevent strokes. In view of recent data it is clear that carotid artery stenting is preferable to surgery in those patients who meet defined criteria that classify them as being at high risk for compications following carotid endarterectomy. With the single word "symptomatic" this policy would restrict access to carotid stenting to less than half of the medicare beneficiaries who might benfit from the procedure.

I urge you to change this criterion prior to implementation.

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Dear Sir or Madam: I am disappointed and concerned regarding your proposal for carotid stent rembursement. The restrictions on coverage will prevent patients who need (and have been waiting for) this procedure from gaining access to it. Specifically:
1. The published randomized and registry trials include asymptomatic patients with stenoses greater than 80%. Based on ACAS this is a very conservative criterion. Why would such a patient be forced to have surgery if they have high risk criteria such as a high bifurcation, prior surgery or severe cardiac co-morbidity.
2. It is also standard of care to revascularize symptomatic patients with stenoses in the 50-70% range. Again, you are forcing those patients with high risk features to undergo an operation that studies demonstrate to be less safe.
3. The definition of high risk should not be based on an subjective assessment from a surgeon: it should be based on evidence based medicine and the presence or absence of the appropriate high risk fearures in the medical history. Last month I refused to give medical clearance to a pt scheduled to undergo a repeat CEA for an asymptomatic 40-50% stenosis. Should we rely on this particular surgeon to determine who should be stented and who should have surgery?

Your decision to set a precedent by limiting reimbursement for an FDA approved procedure to certain patient subsets is bold and reasonable. But we need to select the patient subsets in a manner consistent with the selection criteria in the pivotal trials.

Sincerely,

Louis I. Heller, MD

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The current guideline recommendations are too strict. Carotid artery stenting was developed to provide patients with a minimally, invasive treatment to prevent stroke and the data has clearly supported that this technique is safe and effective. Stenting can be offered to a much larger patient population than CEA because of its minimally invasive nature and low risk of complications. Denying this preventive treatment to asymptomatic patients and requiring that lesions be on the high end of hemodynamically significant puts many, many individuals at great risk unnecessarily. I think the focus has to be on assuring that competent physicians with good judgement, training, and experience provide this service but that the service be made readily available to patients who would have proven benefit from stenting. In addition, requiring a particular specialty physician or surgeon to be a "gatekeeper" puts them in an awkward position because there is the potential for significant bias. The individual physician who has clearly achieved and maintains competency in carotid artery stenting should be given the opportunity to work collaboratively with other health care professionals or independently as he or she sees fit to ensure that a quality, appropriate service is being provided to patients who could benefit from this treatment. This approach is really no different than what currently exists throughout medicine.

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(CAG-00085R)

1. State the requirements, like you have for high risk group, but any specialist could then make sure the patient meets that, not just a surgeon.

2. Approve treatment of asymptomatic pts who make up a large portion of current CAS surgical or stent trials with a significant stenosis (>70% or 80%). These pts would get surgery if not high risk or go through risky surgery if you do not approve it and increase morbidity/mortality.

3. Approve treatment of symptomatic pts with high risk for stenosis >50% or at worst 70%.

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1) No reimbursement just because the patient is not currently symptomatic is absurd and is a thinly veiled attempt to ration care. Asymptomatic patients make up the largest proportion of population that could benefit from this technique and to exclude them from stenting or require that they have CEA will not be cost effective for treatment. This proposed reimbursemnt strategy also makes no sense in that CEA is paid for in asymptomatic patients (with less randomized data to support!)

2)The 70% stenosis cut off for reimbursement needs to be better defined (angiography? MRA? Doppler? ECST or NASCET criteria?) We need to consider circumstances like contralateral occlusion that make a 50% stenosis more functionally significant.

3)Having surgical and independent neurological evaluations makes good sense in evaluating these patients for suitability for stenting. Programs with multispeciality involvement in the treatment of carotid patients should be prerequesite to approval. This only makes good sense for taking complete care of the patient as well as insuring proper training and credentialling of practicing physicians at the local institutions.

4) Finally, the governments role in "controlling" the roll-out of this innovative technique should be through certification of physician training, experience and committment to endovascular procedures for patient care to ensure that, at least initially, only skilled, high volume interventionalist working in a supportive environment with adequate neuro, vascular and ICU backup (similar to the trials) are involved. This gives this new procedure the best chance to gain broader experience and exposure in a medical community that may still be somewhat skeptical ofthe merits of this procedure and concerned about potential disasterous results that may occur from too aggressive and rapid implementation. This is NOT the time to cancel the post-marketing studies.

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I am concerned that CMS is proposing that reimbursement be restricted to very limited patient groups. There is clearly benefit in other patient groups, i.e. asymptomatic patients with very tight (>80% stenoses) and symptomatic patients with stenoses of 50-70% severity. This severely restricted guidelines will prevent many who would benefit from this therapy from receiving it and expose them to added risk or anesthesia and surgery. I urge you to allow reimbursement for all who would benefit to help expand this less invasive and beneficial technology

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This is the comment about carotid stent. I had oppurtunity to send pt. for enrolment in study at the center which was providing the services and also when we started the programe at our center under the strict guidelines. After discussing the experiences of pt. who allready had surgery and restenosed they said if it ever happens that they have to choose surgery over stent they will never allow any one to undergo surgery the response was so positive that in my view it will be highly unethical not to offer them both procedure and let them decide and i strongly belive that overwhlmingly more than 90% will choose the stenting.I request on behalf of pt. not to refrain them for this very effective and less invasive procedure.

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1- we should not talk about CAS versus CEA. We need to start talking who really need carotid Revascularzation ( CAS,or CEA).
2- in my openion the correct indication is far more important than the method of treatment.
3- establishing cause and effect between carotid disease and symptomes ( TIA, or stroke)is very often difficult and most of the time incorrect. Hence the importance of stroke related experiese is primodial to the team and the operator.
4- from all the trail available for everybody review two things come clear:
A- CAS is as safe or safer than CEA in high risk patients so why it is not safer in low risk patients.
B- the complication rate is directly related the expertise of the operator more than it is to type of operation ( CAE, or, CAS).

personally i think that we are doing already more carotid vasculaization than we maybe need. but the answere to this probleme is not by limiting the use of CAS using artifical guidlines but putting the debate of carotid revascularization at a higher sintific level.

The real question we need to ask is " WHO REALLY NEED CAROTID REVASCULAIZTION, AND NOT HOW". thank you.

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CAROTID STENTING WITH DISTAL EMBOLIC PROTECTION HAS BEEN PROVEN SAFE AND IS LESS INVASIVE THAN CAROTID ENDARTERECTOMY SURGERY. IT HAS COMPARED FAVORABLY IN HEAD-TO-HEAD TRIALS. THE SAME PATIENT POPULATIONS SHOULD BE INCLUDED IN THE CMS APPROVED GROUPS TO BE PROVIDED REIMBURSEMENT; AS BOTH PROCEDURES ARE SAFE AND EFFECTIVE. THIS INCLUDES AN OPPORTUNITY FOR PATIENTS WHO ARE ASYMPTOMATIC AND HAVE A SEVERE CAROTID STENOSIS AND PREFER TO HAVE AN INVASIVE INTERVENTIONAL PROCEDURE DONE (SUCH AS CAROTID STENTING) INSTEAD OF HAVING A SURGICAL INCISION BY CARODTID ENDARTERECTOMY.

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Many of us have learned of the recent CMS draft proposing coverage for carotid stenting only in symptomatic patients. This logic suggests we wait until an event has occurred before intervention, or, we perform open surgery. As you are aware, several clinical trials have decidedly shown a benefit in revascularization of asymptomatic patients in stroke prevention. Many, if not most patients who would benefit are going to be relegated to the surgical approach with its morbidity and mortality. CMS should reconsider their stance on this issue

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I have performed thousands of cerebral angiograms in my career, and nearly 100 angioplasty and stenting procedures.

I applaud the decision to exclude asymptomatic patients from reimbursement. I wish only the exclusion would extend to endarterectomy as well. The data supporting surgical treatment of asymptomatic patients is weak and benefits, if any, are meager. It is possible more patients are harmed from complications than benefit in terms of stroke prevention. This decision will certainly stir up the pot, but many neurointerventionalists who, like myself, have carefully analyzed the data, will support this position.

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I have reviewed the recent Draft Decision Memo for Carotid Artery Stenting (CAG-00085R), and I must object vigorously to one aspect, and would like the following comments to be included in the official public response log.

The memo indicates that CMS would only reimburse for carotid stent implantation in patients with symptomatic carotid disease. As I am sure youare aware, the majority of carotid revascularizations (both stents andendarterectomies) currently being performed in this country and around the world, are in asymptomatic patients. The data to support this approach is strong, based on the ACAS trial and the contemporary ACST trial in Europe(Lancet 2004; 363:1491). These trials show substantial decreases in the incidence of stroke when asymptomatic patients with severe carotid stenosis undergo endarterectomy.

The SAPPHIRE randomized trial, and the ARCHER registry that have lead to approval of the Cordis and Guidant carotid stent devices, as well as all of the other high risk registries of carotid stenting (BEACH, CABERNET, etc.),have included asymptomatic patients. In fact, greater than 50% of the patients in the trials of carotid stenting have been asymptomatic. Whenviewed in aggregate, the data from all of these trials very clearly demonstrate that results with carotid stenting are better than those withsurgery in both symptomatic and asymptomatic patients who have clinical characteristics that indicate a high risk for complications with carotid endarterectomy.

To restrict CMS coverage to the symptomatic subset flys in the face of logic. Under this policy for example, an patient with no neurologic symptoms who has class III CHF, prior neck radiation, contralateral occlusion, and a90% restenotic lesion at the site of a prior endarterectomy would only have the options of doing nothing, or undergoing a very high risk surgical procedure. This, in the face of overwhelming data that carotid stentingwould be much safer.

Hundreds of investigators along with industry sponsors have invested countless hours and dollars to generate the data in the trials referenced above. It is extremely frustrating to have CMS apparently ignore all of that work and data, and arbitrarily restrict coverage to a subset of patients that represents less than half of the trial populations.

Strokes are often devastating events, and represent a major cause of death and disability among medicare beneficiaries. The data are clear that treating severe stenoses in asymptomatic patients can prevent strokes. In view of recent data it is clear that carotid artery stenting is preferable to surgery in those patients who meet defined criteria that classify them as being at high risk for compications following carotid endarterectomy. With the single word “symptomatic” this policy would restrict access to carotid stenting to less than half of the medicare beneficiaries who might benfitfrom the procedure.

I urge you to change this criterion prior to implementation.

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Recent proposed CMS coverage excludes payment for asymptomatic patients!? High risk patients who are asymptomatic with significant stenosis are those most likely to benefit from this tested technology, particularly reoperation for restenosis, inaccessible surgical lesions, contralateral occlusion, or previous XRT. Please consider the known, solid data on stroke risk for asymptomatic patients with these types of lesions. This is the arena where CAS will prove very helpful at lowering stroke/MI/death.

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RE: High Risk Definition

Dear CMS Staff:

I totally oppose to have a surgeon written opinion whether a patient should qualify and meet definition for high risk. I think that Vascular Neurologists with expertise in stroke care will be the most indicated specialist to make this critical decision.

A Stroke Neurologist undergo extensive training and treatment of Cerebrovascular Disease and are better suited than surgeons to make this decisions.

Sincerely,
Rodney D. Soto, MD
Assistant Professor of Neurology
Program Director of Vascular Neurology Residency

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As a vascular medicine specialist and peripheral interventionalist I strongly feel that the data clearly supports the treatment of asymptomatic, severe carotid artery stenosis in high risk surgical patients with stent supported angioplasty with embolic protection. Based on the available data, there is no reason to allow symptomatic patients with carotid stenosis to be treated with stent supported angioplasty, yet not allow patients with asymptomatic disease to be treated in the same fashion.

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I was surprise with the CMS decision. It is not only that I disagree but also I have a hard time to understand the reasons for the decision. Even though very expensive, and sometime not completely sure it is the only way to accept a new indication, evidence-based medicine is the only way to prove that a specific treatment approach is appropriate and does not produce harm to our patients. Even after several registries as well as randomized trials have proved that carotid stenting is “at least” as good as carotid endarterectomy and it might be even better (decreases the incidence of myocardial infarction and peripheral nerve complications), CMS has decided that approximately 70% of the eligible patient with approved criteria by the FDA for carotid stenting will not be reimbursed. This means that patients will continue being treated by a more expensive alternative (carotid endarterectomy). Important to mention that the surgical results reported in the literature represent the best surgical outcome, which not necessarily represent the reality of most lower-volume centers.Once again a procedure that has been performed and accepted alternative treatment for several years in many European countries, with several thousand of patients treated, we will need to keep waiting without, in my honest opinion, a logical explanation. I hope the agency takes in consideration the importance of this procedure to prevent a devastating complication for the society and accept a today’s well established, safe and cost effective alternative treatment with carotid stenting in the “entire” evaluated high risk population.

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I donot understand when carotid endarterectomy is indicated for stenosis more than 70% and the data clearly shows equivalence of the procedures that CMS decides to pay only for high risk patients with carotid stenting. I donot unterstand the logic.The morbidity and mortality is markedly reduced with percutaneous procedures. It is also easy on the elderly patients. I think CMS should focus more on negotiating prices with manfacturers and drug companies, instead of denying treatment based on criteria which donot make any sense.

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I applaud CMR for agreeing to reimburse for Carotid Artery Stents( CAS).However, I believe an injustice will be done if some segments of patients with carotid artry disease are excluded. After many years of clinical observations, I believe that waiting for these patients to have symptoms(>70% stenosis and/or moderate occlusion with ulceration) will not help prevent a stroke with disability( that would cost alot more in the long run).Cardiologists have helped people live longer, and with more function over the last 20 years. I would like us to do the same for patients at risk for stroke. I can envision an emergency response team, like we do for an acute coronary occlusio(not that I suggest it be done at this stage without reasonable clinical studies).I would hate for vascular interventionalists and hospitals to be hobbled with restrictions for "asymptomatic" patients. Most patients have a limited comprehension and recollection of cerebrovascular embolic events. It brings to mind one of my latest patients== referred to me for chest pain on exertion, with a mildly abnormal stress test, bilateral carotid bruits, and peripheral bruits.. He had coronary artery disease, and peripheral vascular disease. Also had a 90-95% Right ICA and 60-70% Left ICA lesions.He denied any symptoms to me. Referral to a vascular surgeon resulted in him admitting to a history of momentary loss of half his vision! He still would have been operated,( or had a CAS procedure) with such significant angiographic findings,with or without any symptoms.Thank you allowing me give you some input into care and management of patients.

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I strongly agree with the proposed payment schedule. Carotid endarterectomy is one of the best studied procedures in medicine. It benefits society if carotid stenting is allowed only for those patients who it can clearly help but is not allowed to become the treatment of choice before its efficacy has been proven. There is no doubt that if CMS creates a loose set of criteria to justify payment for CAS, that interventionalists will find a way to justify CAS over CEA in all their patients, even if there is no data to justify this path. Renal artery stent placement has shown how many patients may be treated without efficacy. Once the data shows that CAS is as good or better than CEA, then CMS can expand its coverage. Forcing the interventionalists to get a surgeon's agreement that a patient is a poor candidate for surgery will hopefully limit the "drive by" carotid stent

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Dear Sir/Madam,

I have read your proposal about coverage of carotid stent procedure. I believe the decision is unfair and not necessarily based on all the facts that have been shown by recent trials. I urge you to strongly reconsider to revise it. The reason is the following:

You decided not to cover carotid stenting but to continue to cover carotid endarterectomy surgery, for high risk asymptomatic carotid stenosis patients, thus preventing majority of this population of patients from getting the potential benefit of this new therapy, carotid stenting. As you know, randomized trial such as SAPPHIRE clearly showed non-inferiority of the stent procedure in high-risk patients compared to surgery, and suggested even better and safer outcome compared to surgery. As you recall prior randomized trial showed, surgery is better than medical management of high degree carotid stenosis patients in preventing future CVA or TIA. Thus, it is only reasonable to deduce carotid stenting in high risk asymptomatic patient is more effective and safer treatment compared to surgery or medical management.

Thus, by your decision, majority of asymptomatic patients with high degree carotid artery stenosis with high-risk profile will be left to either medical management alone or carotid endarterectomy, which have been shown to be possibly inferior and more risky to carotid artery stenting treatment. Furthermore, you raised an interesting proposal to have "a surgeon's approval" of high-risk status, thus, giving "a surgeon" a power to "veto" the procedure. This strongly suggests that you may have yielded to a pressure from surgical colleague's negotiating power. What happens when a surgeon decides to put a stent? Will he self-approve his procedure? Or maybe his friendly surgical colleague may say OK to his procedure? In summary, your proposal is far from fair decision and I strongly urge you to reconsider this decision and I propose that carotid artery stent procedures for high-risk asymptomatic high degree (>=80%) stenosis (SAPPHIRE-like) patients to be covered by Medicare and Medicaid.

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It is unclear to me where your current indications for carotid artery stenting are derived. The NASCET data would indicate that symptomatic lesions >50% should be revascularized and the ACAS data suggest asymptomatic lesions >80% should be treated. All of the carotid stent trials have shown results that compare very favorably with the results of endarterectomy, both immediate and long term. These trials were all performed in higher risk patients, not the ideal patients treated in NASCET and ACAS. There is a tremendous demand from patients who would like to benefit from this non-surgical treatment; it is difficult to convince patients to have surgery these days when they know stenting is available. The people at CMS need to take the blinders off and make an objective decision that is in the best interests of patients, not in the best interests of the vascular surgery or interventional radiology lobby.

Sincerely,
Eric Johnson, M.D.

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I am quite disappointed at your current plans to not reimburse for higher risk, asymptomatic patients for carotid stenting. To be consistent, CMS should withdraw funding for carotid surgery on this group. Many high risk, asymptomatic patients will undergo surgeryand have unnecessary heart attacks and premature deathsbecause of this misguided and intellectually impoverished position. The proposed policy is a crude political compromise with no scientific basis, and this should be publically aknowledged.

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To whom it may concern:I have just become informed of the CMS decision that limits approval of carotid stenting to symptomatic patients alone. I feel compelled to respond to what I believe is an inappropriate and potentially injurious ruling.

To start, I am fellowship trained vascular phyisican Boarded in Cardiovascular Diseases. I direct the Interventional Vascular Lab in a large metropiltan hospital in Akron, Ohio and have been doing vascular medicne for 10 years.

That being said, It is my opinion that to qualify patients for Carotid Artery Stenting (CAS) for symptomatic symptoms alone fails to follow any logical line of reason. Asymptomatic patients have the same risk for untoward cardiovascular outcome as thos that are symptomatic! Perhaps their stroke rate is lower form the active lesion, but they still may have advanced cardiovascular disase or perhaps disadvantageous anatomy. These patients are currently being done surgically at increased risk or perhaps not at all. It is my opinion that this serves only to restrict the disemitization of new technology and does not truly serve out patients needs. The currently approved criteria for CAS is sufficently restrictive to ensure that those carotid lesions known to be safely treated with surgery still will be. This additional approval restriction will serve no higher purpose and definitely restrict the use of a potentially stroke and MI limiting therapy to a very high risk group of patients. I do not think it will survive the professional and Public outcry that is certain to follow. I strongly urge CMS to reconsider this ruling and democratize the use of CAS for high risk, asymptomatic patients as well.

Thank you for this forum thru which I may express my opinion.

J Pietrolungo DO MS FSVMB FACC

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70% of the ARCHER patients enrolled for carotid stenting were asymptomatic patients at high risk for surgery with stenosis at 80% or greater. The benefit of stenting has been shown to apply for them as well. I found not fair not to offer a less invasive ( and shown to be superior ) procedure to such patients. Also coverage should be extented to symptomatic patients with stenosis greater than 50% ( and not 70% as now stated by CMS . 50% stenosis in asymptomatic patient can be as dangerous as 70 or 80% long term.Having the vascular surgeon make the decision when to intervene with carotid stenting is like asking the cardiothoracic surgeon when and if to place a stent into a patient coronary artery by an interventionist. The vascular surgeon is not the appropriate physician to evaluate the overall clinical condition of a patient ( and define their risk strata ) when they are always consulting a cardiologist for medical clearance for their surgeries and have little experience in carotid angiograms as well.

Giuseppe Gioia, MD, FACC

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For surgically high risk patients, I disagree with the decision to extend coverage for carotid artery stenting only to patients with symptomatic stenoses >70% severity. For symptomatic patients with 60% stenosis it is the rationale procedure to use, and also for an asymptomatic >80% stenosis. I have patients who are clearly not surgical candidates based on criteria such as tracheomalacia or prior neck radiation who are effectively being denied the alternative (i.e. CAS) based on this decision. I used to proceed for these patients anyway, based on my belief regarding appropriate therapy, but now my hospital is limiting this procedure to covered patients only, since they do not want to cover the expense. I hope CMS will review and change this policy based upon considerations such as this.

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We request CMS to reconsider its position on coverage of carotid artery stenting, to include high risk asymptomatic patients with severe disease.Consider the patient who has severe (95%) restenotic disease of a previously endarterectomized carotid artery, and an occluded contralateral carotid artery. The surgical(stroke/mortality) risk of a redo- endarterectomy would be >10%. Cardotid stenting with distal protection carries a risk under 3-4%. Our vascular surgeon has even recommended carotid stenting as an alternative and has refused to operate on this patient. This patient is currently "asymptomatic" clinically. Do we then send this patient for a potentially life threatening surgical procedure just because there is no reimbursement for the stent procedure under current rules? Surely NOT!!!!

Surely, the coverage rules need to be broadened. Perhaps one way to do so would be to require angiographic (not MRA or CT angio) verification of anatomic stenosis severity before allowing the procedure in asymptomatic patients. The cutoff for intervention in this population might then be stenosis severity >or = to 80% by angiography, and documented high risk for carotid endarterectomy.Food for thought.

Manu Rajachandran, MD
Chair
Dept. of Vascular Medicine
Deborah Heart and Lung Center

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I am opposed to 2 aspects of your recent draft decision memorandum regarding reimbursement for carotid artery stenting.
1. Asymptomatic patients should be covered for carotid stenting. Approximately 70% of patients in recent carotid stenting and endarterectomy trials are asymptomatic. In addition, the current FDA carotid stent approval includes asymptomatic high risk patients with stenoses of greater than 80%.
2. Approval for symptomatic patients should allow down to 50% stenosis. This is in keeping with the recent carotid stenting studies and the FDA approval.

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From a reimbursement perspective it seems as if the new carotid stent CPT codes will have limited use based on the small population of patients who will fall under the high risk, symptomatic requirements in the CMS draft on carotid stenting. Asymptomatic patients will be forced to undergo carotid endarterectomy and those who are non-surgical candidates must opt for medical management as they have no other options. Also, the draft seems to be heavily biased toward vascular surgeons as they are the decision-makers who must give prior approval. Will a surgeon who considers carotid endarterectomy to be the "gold standard" have the ability to make an un-biased decision? If this were a requirement for all minimally invasive procedures would they even exist? I don't understand the rationale because to me it looks like a conflict of interests. Why is it that carotid endarterectomy is covered and reimbursed when it is a procedure that carries greater risk of morbidity and mortality? The data from the clinical trials supports the same coverage for carotid stenting. I would encourage CMS to take a closer look at the clinical trial data, which supports safety and efficacy, and reconsider a less restrictive set of parameters for carotid stenting.

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To Whom It May Concern:

As an interventional cardiologist, as a member of the American College of Cardiology Board of Trustees, as past president of the Society for Cardiac Angiography and Interventions, and as a physician taking care of patients, I am writing on behalf of the national coverage policy of carotid arterial stenting. This is an incredibly important group of patients and a exceedingly important coverage policy decision. I believe that it is flawed and that this will result in adverse patient outcomes for large numbers of patients.

At the present time, the potential draft decision does not allow payment for asymptomatic patients. This goes against all of the evidence, which is available, because approximately 70% of patients enrolled in the recent coronary artery stent trials and carotid endarterectomy clinical trials have been asymptomatic. This potential draft decision does not recognize this important point. In addition, one of the FDA approved carotid stent systems includes asymptomatic patients with stenosis greater than 80% in the IFU. This exclusion of asymptomatic patients therefore flies in the face of evidence as well as flies in the face of FDA approval.

The proposed CMS decision covers only symptomatic patients with stenosis greater than 70%. As is again true, this ignores very important datasets. All the recent coronary artery stent clinical trials and the FDA approved indication for one of the carotid stent systems includes symptomatic patients with stenosis great than 50%. It is not clear to me why the 70% stenosis was chosen when the trials include 50% stenosis.

The definition of high risk requires that a patient sees a surgeon and has written opinion and consensus for all carotid artery stent patients. That harkens back to the days of interventional cardiology 25 years ago when it was mandated by many institutions that all patients being considered for percutaneous coronary intervention be seen by a cardiac surgeon. This resulted in patient delays, resulted in patient confusion, and increased charges because of cardiac surgical consultation. It also led to the surgeon being the gatekeeper for medical cardiovascular patients. I do not think that is appropriate. I think that the decision can be made by the physician taking care of the patient as to what is the optimal therapy. That is the typical way that is practiced.

I do think this is a terribly important issue and consideration. Hopefully input will be heard so that these concerns can be addressed.

Sincerely,

David R. Holmes, Jr., MD

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I was surprise with the CMS decision. It is not only that I disagree but also I have a hard time to understand the reasons for the decision. Even though very expensive, and sometime not completely sure it is the only way to accept a new indication, evidence-based medicine is the only way to prove that a specific treatment approach is appropriate and does not produce harm to our patients. Even after several registries as well as randomized trials have proved that carotid stenting is “at least” as good as carotid endarterectomy and it might be even better (decreases the incidence of myocardial infarction and peripheral nerve complications), CMS has decided that approximately 70% of the elegible patient with approval by the FDA of the procedure will not be reimbursed. This means that patients will continue being treated by a more expensive alternative (carotid endarterectomy). Important to mention that the surgical results reported in the literature represent the best surgical outcome, which not necessarily represent the reality of most lower-volume centers.Once again a procedure that has been performed and accepted alternative treatment for several years in many European countries, with several thousand of patients treated, we will need to keep waiting without, in my honest opinion, a logical explanation. I hope the agency takes in consideration the importance of this treatment modality to prevent a devastating complication for the society and accept a today’s well established, safe and cost effective alternative treatment with carotid stenting in the “entire” evaluated high risk population.

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As an active interventional cardiologist at a prestigious University/Academic center I have seen the progression and slow acceptance of carotid stenting over the past few years. Now that the FDA has ultimately approved a highly successful procedure it is to my dismay that there continues to be hesitancy in allowing the vast majority of patients with symptomatic or asymptomatic carotid artery disease to undergo what has been shown to be better than surgical outcomes in the most difficult patients. To further limit its access to those 80% or more patients that undergo CEA currently is not to our patients best interest. Further, to have to ask for an approval from a non-interventional surgical service to move forward limits the opportunity to help one's patients. It is in the surgeon’s best interest to maintain this surgery as a cash producer. The slow nature of this procedures approval has been clearly from bureaucratic and surgical foot dragging because of the lucrative nature of this procedure. I only hope that the approval will encompass those patients that were in all registries and trials and allow this procedure to be performed only by those trained in a dedicated fellowship commensurate with their prior level of training.

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I have concerns about the very limited CMS approval of carotid stenting. Since stenting was found to be superior to surgical endarterectomy in high risk groups, it stands to reason that it would be at least non-inferior to surgery in low risk subsets. As well, since approval was only granted to symptomatic patients, CMS is excluding all assymtomatic high surgical risk patients, even though they were well represented in the randomized trials. Are we then to subject assymptomatic patients to the higher risk surgical option? What if the patient is your mother?? For CMS to ask for a surgical agreement that patients are high surgical risk is to assume that surgeons have no vested interest in the outcome of their opinions. Since carotid endarterectomy is 30-40% of a vascular surgeons' volume, he will fight tooth and nail to protect his "turf" In our community, the surgical view is that their is no patient whose risk is too high to operate, despite all the published data to the contrary. I thus urge CMS to reconsider its stand and to liberalize the indications and requirements for carotid stenting to ensure better and safer outcomes.

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I have been involved with carotid stenting for approximately 10 years. Along with my partner, Mark Wholey, M.D., we have encountered numerous situations in which "asymptomatic" patients had critical disease and were truly inoperable. In fact 25-30% of our patients have been referred by Vascular Surgeons. Patients with total occlusion on one side in the presnce of a critical contralateral surgical restenosis, but asymptomatic. We all know that disabling stroke is often the first presentation. What are we to tell these patients?? Yes we can fix you, but Medicare wont allow it. Yes it FDA approved, but Medicare wont allow it. This puts the physician in a very precarios position. I have actually had patients have a stroke while waiting to be enrolled in an investigational trial in order that there procedure be "covered".

Please reconsider expanding coverage to appropriate asymptomatic patients.

Thank you.

Gustav R. Eles, D.O., FACC, FSCAI, FSVMB, FACA

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I have performed caroti stenting since 1997 with IDE. I strongly object to a vascular surgeon providing a second opinion as to high disk CEA status - The "fox guarding the hen house" conflict. The criteria have been clearly established in archer and saphire trial. If you are asymptomatic with greater than 80% stenosis you need to be revascualrized and if you are high risk for CEA you should get stent. If you are symptomatic with 50 to 70 % stenosis you would get CEA - if you are high risk in this category the patient should not be deprived of the best and safest procedure which is stent.

Dan McCormick, DO, FACC, FSCAI
Director, Cardiac Cath Lab
Hahnemann University Hospital

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As an investigator in both the CAPTURE and CREST trials, I do not understand where Medicare has gotten the criteria for appropriate carotid stenting payment. While limits are VERY much appropriate, these criteria do not match any known trial so have no basis in research or anything else. An example is the requirement for 70% stenosis for symptomatic patients. No trial I am aware of uses this criteria. Everyone, including surgeons, uses the NASCET criteria of 50%.

Secondly, the exclusion of asymptomatic patients again defies the largest trial ever done in this group, ACAS, and at the least should include an 80% stenosis cutoff for asymptomatic carotid disease as this has been shown to be better than medical therapy. All ongoing carotid stent trials use this criteria for asymptomatic patients.

Finally, the requirement for surgical opinion in high risk pts. is unknown in any other payment decision by Medicare. Just last week, a surgeon tried to operate on a patient with no symptoms and a '50% lesion' on an ultrasound. The patient asked for a 2nd opinion by myself (a cardiologist) and full angiograms showed a 0% stenosis. I submit that requirement is the equivalent of asking the 'fox to guard the henhouse' and is clearly political rather than based on sound medical data. A better solution would be to require 2 forms of non-invasive testing with at least one by an independent reader (ie, 2 of 4 from ultrasound, MRA, CTA, or angiography.

Thank you,
Dr. Mark Sanz
Director of Cardiology
St. Patrick Hospital
Missoula, MT

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As someone who is very familiar with the literature, an advocate for minimally invasive techniques and yet aware of the potential problems with carotid stenting I raise some concern with its use. It is clear that in the right patient, ie. high risk, that it is appropriate. There is a problem with some interventionalist that veiw every patient as high risk. Until there are randomized studies showing that carotid stenting can be performed with an overall risk of less than 3%, it should clearly not be performed outside of a study protocol. Your most significant risks lie in the hands of certain cardiologists that have no fear and have no conscience and have the ability to overlook complications. This is potentially a good procedure done on the appropriate patients by scrupulous physicians.

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Your proposal for carotid stent coverage has generated significant anguish. I have been performing carotid stenting for the past 10yrs, been a Principal investigator for 14 clinical trials including SAPPHIRE and Archer, I have the following comments.

Not covering Asymptomatic >80% defies logic!
2/3 of carotid stent patients in clinical trials are asymptomatic and 2/3 of contemporary CEA is on asymptomatic patients
Your arbitrary choice of AHA thresholds for both low risk and high risk patients flies in the face of published evidence as accepted by FDA

FDA approved CAS for high risk asymptomatic patients >80% based on randomized data in the SAPPHIRE Trial as well as registry data from SAPPHIRE AND ARCHER with a total of 800 patients

All professional societies endorse treating asymptomatic (>80% cardiology, vascular surgeon, 90% radiology)

Vascular Surgeon As Gatekeeper
Per your proposal; Vascular surgeon would have to agree with high-risk definition
Radiation, restenosis, high cervical location, tracheotomy, recurrent laryngeal nerve palsy, contra-lateral occlusion, CCA ostial location, severe bilateral stenosis with age >80 (SELF EVIDENT)
Medical co-morbidities; Unstable angina, recent MI, Pre CABG, CHF, Severe COPD, Renal Failure (CARDIOLOGIT IS BETER QUALIFIED, HAS BEEN TRADITIONALLY 'CLEARING' PATIENTS WITH THESE CONDITIONS)
This proposal for vascular surgeon as gatekeeper
Defies tradition of cardiology clearance for medical co-morbidity
Anatomical co-morbidity is self evident!
Do you need a vascular surgeon to agree patient had restenosis after CEA or patient had radiated neck?
Why not use FDA approved definitions used in the approved trial? Current CMS mandate means the definition of high-risk is arbitrary and vary from institution to institution, surgeon to surgeon.
Medicare Database (Wennberg 2000) shows CEA mortality three times that of NASCET patients, more than reported by surgeons. Many older surgeons still believe there is no such thing as high risk case.
Is there any condition in medical practice where a competing physician has to certify a specific procedure?
Even the closest parallel of cancer treatment requires presentation in multidisciplinary tumor board but the decision is up to the patient!

What to do when surgeon contradicts interventionist?
Does patient have a right to choose treatment?
What is the legal exposure for surgeon/interventionist with a post operative complication?
How do you prevent turf fights?
Does vascular surgeon as interventionist need another vascular surgeon to certify high risk?

In summary the decision to limit coverage to only asymptomatics is extremely arbitrary and forces patients to be referred for higher risk CEA.

Requiring vascular surgeon to certify high risk is tatamount to invite turf for the sake of catching few who manipulate the system. Tighter peer review locally would do a better job than creating a national chaos. Current draft proposal would leave many disenfranchised patients exposed to no option but CEA!!

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I agree with the proposed restrictions on carotid artery stenting for symptomatic stenoses >= 70% in patients clearly defined as high risk for surgery. While I place carotid stents and feel that this is an important procedure, two important issues arise from the literature on carotid revascularization. First, we know that there are carotid endarterectomies done on patients with stenoses who are in reality at low risk for stroke. Our main problem is in risk stratification of patients with carotid disease. Many of the practitioners interested in beginning to perform CAS are focusing on asymptomatic patients who are at low risk for complications and who in reality may not need anything other than medical therapy. Before we start paying for lots of new procedures, lets see who needs them! Secondly, we don't know yet what the future of CAS is. It is difficult to recommend CAS as an equivalent procedure to endarterectomy if both are performed by experienced practitioners. The longterm durability of CAS has yet to be established. The devices, while useful, are still relatively crude and will have to be improved (particularly the embolic protection devices and the stents themselves). All we know from Sapphire, Archer, etc is that CAS is a reasonable alternative to surgery in high risk patients. Let's keep it that way until we know more....

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As an interventional radiologist, I endorse the idea that the CV surgeon should have the opportunity to consult and/or deem whether a patient is at "high risk". Patients will suffer if denied the option of a surgical consult or second opinion. The ability of cardiologists to self refer in this process (if allowed) will result in strokes and permanent neurologic impairment for large numbers of patients. Also, no operator should be allowed to perform this procedure without the ability to recognize and treat immediately with intracerebral thrombolysis. Most cardiologists lack or are unwilling to assume this critical responsibility.

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These 3 issues listed below are of serious cocern: Exclusion of Asymptomatic Patients: The CMS draft decision does not propose payment for asymptomatic patients, despite approximately 70% asymptomatic enrollment in recent CAS and carotid endarterectomy (CEA) clinical trials. Note also that the FDA-approved indication for Guidant’s ACCULINK™ Carotid Stent System includes high-surgical risk asymptomatic patients with stenosis greater than 80%.

Symptomatic with Greater Than 70% Stenosis: The proposed decision would cover only symptomatic patients with stenosis greater than 70%. In comparison, all recent CAS clinical trials and the FDA-approved indication for the RX ACCULINK Carotid Stent System include symptomatic patients with stenosis greater than 50%.

High-Risk Definition: CMS’s definition of high-risk includes a statement that a covered patient would be considered a poor candidate for CEA in the opinion of a surgeon. This definition may ultimately require a surgeon’s written opinion and consensus for all CAS patient treatment.

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I acctually agree with your proposal to limit payment for carotid artery stenting outside of trials to SYMPTOMATIC >70% who are high risk as defined by a surgeon. My group has M&M rates for Carotid Endarterectomy of asymptomatic and ~4% for symptomatic patients. This is far better than the published data for stenting. Stenting is being driven by non-surgeons and it simply doesn't make sense to stroke a lot of patients for the benefit of cardiologists and radiologists. I do my own angiography and am participating in the CAPTURE trial by Guidant, so I will do carotid stenting only in high risk patients where I believe the risk is less than with my open operation. But that is in the distinct minority of patients. Besides the higher stroke rate, stenting is MORE expensive than carotid endarterectomy since we do them under local and send the vast majority home the next day, angiography is needed in only ~1/3 of patients since we utilize ICAVL accredited vascular labs. Your proposed policy is in the best interest of the Medicare beneficiaries.

Kevin D. Martin, M.D.
Member, KY Medicare Carrier Advisory Committee
(AdminaStar Federal)

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After review of the latest proposal for reimbursement for carotid artery stenting, it is unclear to me why high risk, asymptomatic patients with carotid stenosis >80%, and high risk symptomatic patients with carotid stenosis 50-70% were excluded. These patients were clearly evaluated in the clinical trials looking at this procedure, and CAS was proven safe and at least equivalent to carotid endarterectomy. By not reimburing, these high risk surgical patients are potentially being deprived a therapy which may prevent stroke, or exposing them to undue risk of carotid surgery which has been deemed "high risk." I would urge CMS to reconsider this decision, and to change the criteria to include these patients in the group for reimbursement.

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To whom it may concern,

In regards to the proposed coverage policy for CAS, CMS appears to have disregarded the data that is currently available in the literature and has come to conclusions which are unfounded. First, the draft decision excludes payment for asymptomatic patients despite data clearly showing benefit in these patients with stenosis greater than 80%. Second, the data for symptomatic patients was obtained in patients with greater than 50% stenosis and the FDA approval of the acculink system includes these patients. Finally, and most disturbing, is the statement that a covered patient would be considered a poor candidated only with a surgeons opinion. This seems rather biased towards vascular surgery and in effect would exclude other vascular specialists from performing the procedure or being involved in the decision making process. If CMS is concerned about the welfare of their patients they would reconsider the above weaknesses in this proposal in order to assure the proper use of this excellent advance in patient care.

Sincerely,

Darren R. Hurst, M.D.
Co-Investigator
Capture Carotid Stenting Tria
lVascular and Interventional Associates.

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CMS should consider the following

1) Trials that led to the approval of CAS showed non-inferiority and likely benefit of CAS compared to CEA in symptomatic patients with stenosis greater than 50% and asypmtomatic patients with stenosis greater than 80%. Are we saying good by to evidence-based medicine???

2) I am not aware of any surgical program that trains their surgeon to assess surgical risk. They routinely send their patients to cardiologists for that purpose. Are we going to ask people to do a job that their not qualified to do??? If this criteria would have been in place for coronary stents, we would see a great number of cracked chests arround for single vessel disease. Is CMS determined to stop a natural progression towards minimally invasive approach???

3) Is CMS determined to continue to pay for higher cost procedure and not proceed with lower cost procedure with less pain for the patinet, less invesive procedure??? are we going backwards???

4) Are their too many surgeons on CMS board???

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Regarding the definition of "symptomatic": This should follow the definition as outlined in NASCET. The patient should have a TIA or non- disabling stroke with focal neurologic deficit referable to the territory of the stenotic vessel. Nonspecific symptoms such as dizziness should generally be excluded, unless the physician specifically diangosis a hypoperfusion syndrome. The event should have occured within the last 2 years, as after 2 years the artery behaves as an "asymptomatic" artery (the curves of "stroke-free survival" of untreated symptomatic and asymptomatic patients are parallel 2 years after the event).

Regarding determination of stenosis: The patient should have non-invasive imaging to include at a minimum a carotid ultrasound, in an accredited lab, indicating severe stenosis. As these patients are by definition "high risk", it is preferable in my opinion to confirm the stenosis and screen the remainder of the circulation with a non-invasive test such as CT angiography or magnetic resonance angiography (MRA). This allows one to avoid any unnecessary catheterizations (of the vertebrobasilar circulation, for example)and to formulate a complete plan for the stent procedure before the procedure. This makes the procedure faster and I believe safer. This is preferable, but I do not think required. A severe stenosis should be confirmed at angiography using standard NASCET measurement technique.

Regarding the degree of stenosis required for treatment: The "NASCET II" publication, a follow-up of the NASCET population, indicated a benefit for treating symptomatic patients with 50-69% stenosis (about 6% reduction over 5 years). The benefit was much smaller compared with stenosis over 70% and the statistical power of that benefit much less convincing. Nevertheless, it is common practice to treat symptomatic patients with greater than 50% stenosis with endarterectomy. One could argue (often correctly) that "high risk" patients in this group should be treated medically. However, if one makes the decision to treat a high risk patient with 50-69% stenosis with endarterectomy, I think it is unreasonable to assume that endarterectomy would have a lower complication rate than stenting, when this is clearly not the case for more severe stenois. In fact, there will clearly be patients where the "high risk" factor makes the risk of surgery greater, but not the risk of stenting (radiation for instance). It seems unwise to have a policy that would permit endarterectomy on a patient with neck radiation and a 65% stenosis and eliminate stenting as an alternative. Coverage for stenting should be extended to this group provided the "high risk" for endarterectomy is documented.

Regarding asymptomatic patients: The 5 year benefit of endarterectomy in asymptomatic patients is 5-6% according to ACASS. The results of the recently published European ACST trial are essentially the same when adjusted for surgical morbidity. Again, one could usually correctly argue that "high risk" patients should be treated medically. However, is it not reasonable to believe that the high risk patient will fair better with endarterectomy than stenting. Again, exclude coverage for both or allow both.

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1) It seems absurd to limit coverage for CAS to "high-risk endarterectomy" cases. While it is true that the majority of studies (SAPPHIRE, SECuRITY, etc,) have been done in that subgroup of patients, the results have been favorable to those expected with surgical therapy. The SAPPHIRE results are particularly convincing in that randomized cases show a better outcome with stenting compared to surgery.

2) The requirement that symptomatic patients have a >70% stenosis is unduly restrictive, since in the NASCET, benefit was found for those with stenoses over 50%. Since carotid disease creates morbidity and mortality through embolization rather than blood flow reduction (unless bilateral subocclusive stenosis is seen or isolated hemisphere with subocclusive stenosis) the severity of stenosis is a marker for important disease, useful in large studies but not in individual patients. Patients who have well documented embolic stroke without other demonstrable cause and a 50% or greater carotid stenosis, especially if ulcerated, should be considered targets for stent therapy, as theyu would be for endarterectomy.

3) Finally, on the basis of the ACAS data, restriction to symptomatic patients denies stroke protection in a large group of patients with severe disease (at least 80% stenosis) who would certainly be referred for endarterectomy.

Regarding the asked-for comments,

1) High risk patients could be defined as they are in NASCET exclusions: Age >79y, lesion unsuitable for CEA (high lesion, tandem lesions), previous ipsilateral CEA, previous contralateral CEA within 4 months, major surgery within one month, comorbidities including symptomatic pulmonary disease, chronic renal disease already on or near dialysis, unrevascularized important CAD with ETT or cath evidence of an ischemic territory, symptomatic CHF, significant liver disease, valvular heart disease atrial fibrillation, cancer with <5y expected survival.

2) Criteria for defining symptoms: either hard TIA or CVA by history in the affected hemisphere. If no history of TIA or CVA, then MRI showing embolic infarcts in territory of the affected carotid in concert with significant stenosis should be considered a "symptom equivalent" as would a positive stress test in an otherwise symptom-free coronary patient. Our goal here is to prevent stroke rather than to preserve turf for vascular surgeons.

3) Facility and operator standards are difficult. Clearly as a base the facility must have a)capacity for excellent MRA/MRI for both routine and emergency work. CTA could be substituted for MRA; however MRI must be available in case of periprocedural complications; b)a certified vascular duplex facility; c)an angio suite capable of high-quality imaging with digital subtraction, road-mapping; d) coordination with an identified neurology-stroke service, and an operator (either the interventionalist or a neuroradiologist) available to perform microcatheter neuro "rescue" should it become necessary; e) coordination with a vascular surgery service; f)expected volume of carodtid stenting procedures per annum should be at least 50; the facility should have a well-organized QA-QI process preferrably with multidisciplinary review (Cardiology, VIR, Vascular surgery).

4) Operator standards: I would use the SCAI/SVS/SVMB joint statement as published in Catheterization and Cardiovascular Interventions 64:1–11 (2005), but I would require at least 50 carotid angios and 20 carotid stents as primary operator as well as 75 angios and 50 stents total. In addition I would require yearly expected volumes of at least 25 carotid interventions and evidence of active practice of intervention in other vascular beds (normal criteria for interventional cardiologists or VIR or vascular surgeons). The operator should have demonstrable outcomes over time from QA/QI review that fall within acknowledged ACC/AHA suggested complication rates for symptomatic patients undergoing CEA. Facility and operator volumes should also be thresholds for continued credentialling as well as initial credentialling.

I would be happy to discuss this further with you and also offer guidance for the structuring od carotid training if you are interested.

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The CMS decision regarding carotid stenting should INCLUDE both asymptomatic and symptomatic patients as both sets of patients were included in the trials for devices which obtained FDA approval for carotid stenting with distal embolic protection. In addition the FDA approved indication is for 80% stenosis in asymptomatic patients.The degree of stenosis necessary for treatment in symptomatic or asymptomatic patients should also reflect those of the trials which resulted in FDA device approval, in other words 50% for symptomatic patients as stated in the FDA approval.The current indication should be for patients at high risk for carotid endarterectomy as was studied in the recent trials resulting in FDA approval.

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I have been involved in the development of carotid stenting with both preclinical animal work and clinical trials. I would like to submit the following comments for consideration and discussion.

1) Previous results from carotid endarterectomy trials are biased towards a low risk group of patients and cannot be generalized to the population of patients we currently see on a daily basis that are elderly with multiple comorbid conditions.

2) Patients with a greater than 80% carotid stenosis whether symptomatic or asypmtomatic should be considered for revascularization. Patients with a greater than 50% carotid stenosis should be considered for revascularization. Patients with a >50% stenosis with the presence of a contralateral occlusion should be considered for revascularization. The mode of revascularization should be determined on their surgical risk, as assessed by a cardiovascular specialist as the majority of these patients will have concomitant coronary artery disease, chronic pulmonary disease, and other medical high risk features. Carotid stenting, as demonstrated by the SAPPHIRE study is associated with less complications in patients with high medical risk.

3. There are patients with anatomic high risk features including post-endarterectomy restenosis, contralateral carotid occlusions, high bifurcations, hostile necks (post radiation therapy or radical neck surgery) that clearly have higher complications with endarterectomy than carotid stenting.

4. The determination of high risk status should not be left soley to the vascular surgeon who has an inherent bias towards endarterectomy.

5. Patients with a greater than 80% stenosis, whether symptomatic or asymptomatic are clearly at high risk for stroke, and should be revascularized. Note the FDA approval for carotid stents included patients that were asymptomatic with a greater than 80% stenosis.

6. Patients with a greater than 50% stenosis, that are symptomatic, are clearly at high risk of stroke and should be revascularized.

7. Carotid endarterectomy is being performed for patients as outlined above (>80% asymptomatic, >50% symptomatic) on a daily basis, and is being reimbursed by CMS. Why would this not be the same for carotid stenting?!

8. Both procedures should be done by physicians that are qualified, trained, and meet rigorous criteria for the performance of carotid revascularization. In particular, carotid stenting needs to be performed only by those that have had formal training. Please refer to a recent position paper by Kenneth Rosenfield et al.

9. Carotid stenting is a very good option for patients with medical and or anatomic high risk criteria, as demonstrated by the prospective randomized SAPPHIRE trial and numerous registries. This population of high risk patients will only continue to grow, and carotid stenting will ultimately be fiscally superior, as it will avoid the complications and prolonged hospitalizations that occur when there are complications following carotid endarterectomy.

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I am an intervention cardiologist performing carotid stenting and have been involved as an investigator in several past and ongoing trials (BEACH, Maveric, CREST, CAPTURE). I believe that the scope of the proposed reimbursement for carotid stenting with embolic protection (CAS/EPD)is too restrictive. The benefit of stroke prevention in asymptomatic disease is well proven in previous surgical trials (ACAS, ACST)for stenoses of 60% or greater. The SAPPHIRE trial included both symptomatic and asymptomatic patients who were at increased risk for carotid surgery. The conclusion of the trial was that carotid stenting with embolic protection was not inferior to carotid endarterctomy(CEA). Subgroup analysis according to presenting symptoms reveals no difference in major adverse events (death, stroke, MI) in the symptomatic group (16.8% in CAS/EPD group, 16.5% in CEA, N.S.) but a statistically significant advantage to stenting in asymptomatic patients (9.9% in stent CAS/EPD group, 21.5% in CEA, p = 0.02). I am therefore puzzled that the guidlines exclude this subgoup.My greatest concern is that the proposed reimbursement guidlines will lead to undertreatment of asymptomatic patients with severe or critical stenoses and coexisting clinical or anatomic conditions that make them high risk for surgery. These patients may be turned down for surgery because of risk and not offered stenting either because it is not reimbursible. Medical therapy would be the default treatment. We know that revascularization is superior to medical therapy at 5 years in both ACAS and ACST.Most patients are uncomfortable with the idea of waiting for the onset of symptoms if one of the symptoms is stroke (others being amaurosis or TIA).A good example would be an asymptomatic patient with a 95% carotid stenosis and a history of ipsilateral radical neck surgery and radiation therapy. If this patient did not have a history of prior radical neck surgery and irradiation, endarterectomy of an asymptomatic 95% stenosis would be standard of care and reimbursible by CMS. With his particular history though, stenting is the treatment of choice (as surgery entails increased risk)but alas, revascularization is no longer reimbursible because the patient is not symptomatic.I strongly believe that CAS/EPD should at this time be limited to high risk patients only but I feel equally strongly that this should include both symptomatic and asymptomatic patients.

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Multiple different practitioners are interested in performing carotid stenting. Many with different backgrounds and skill sets. It is unreasonable to expect patients or their decision makers to understand the differences between cardiologists, radiologists, vascular surgeons or neurologists with regard to their experience or expertise with this procedure.

CMS should take a role in stipulating the minimum standards with regard to the experience and technical expertise of the physician performing the procedure.

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It makes no sense for CMS to restrict coverage of the Cordis CAS system to symptomatic patients only when the landmark SAPPHIRE study, the only published randomized trial, showed benefit for both asymptomatic as well as symptomatic patients. Moreover, the Guidant CAS approved system is for both asymptomatic as well as symptomatic patients, and examined very similar patient cohorts.This restriction denies patients the documented benefits of the Cordis CAS system, and seems patently unfair to a quality company that has invested millions of dollars and years of effort to bring this vitally important therapy to a broader range of patients.

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I strongly support the proposed coverage decision by CMS. Stroke is the most feared complication of any medical procedure and stroke is a risk associated with stent-assisted carotid angioplasty and is considerable. The decision to limit coverage to those patients in whom the benefits of the procedure outweigh the risks is completely appropriate.

The decision to exclude asymptomatic patients is based on solid evidence. Those who argue that asymptomatic patients should be included because they were included in the SAPPHIRE and ARCHER trials are missing or ignoring the results of these very trials. The one-year results of SAPPHIRE clearly showed that for asymptomatic patients both stenting and endarterectomy caused more strokes than the natural history of asymptomatic carotid stenosis.

CMS is making a strong statement regarding their commitment to patient safety by choosing to limit coverage and insisting on competent operators. There are ongoing clinical trials and coverage can always be expanded if deemed appropriate on the basis of the results of these studies. Just as with inappropriate endarterectomy and poor results, it would be much more difficult to have to tighten the restrictions on performance of stenting when faced with an unacceptable number of procedural strokes and the subsequent human cost and increased cost of caring for the affected individuals.

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Contrary to the published data, the majority of surgeons performing CEA think that CAS is not equivalent to CEA. I think the CMS requirement of a a surgeon declaring a patient to be high- risk prior to stenting is absurd. CMS should do this only if it does not want patients to benefit from this less invasive form of therapy. Also there is no justification to limiting this to symptomatic patients. If CEA is recommended for asymptomatic patients with > 80% stenosis, I do not see any reason why CAS can not be performed in these patients. The basic question is whether CEA and CAS are equivalent or not. If they are, then they should be treated similarly in all patients meeting the inclusion criteria in published clinical trials .

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1. Co-morbidity criteria for defining pts at high risk for surgery have been well defined in several studies and should be universal. There is no need to add "high risk in the opinion of a vascular surgeon". This was not a pre-requisite in any study and would lead institutional variablility in the application of carotid stent procedures. A national standard is necessary.

2. Asymptomatic pts are currently undergoing endarterectomy for greater than 70% stenosis based on doppler. Sapphire and other studies have shown comparable or better results with lower long term MACE in high risk pts. undergoing carotid stenting. We should not exclude asymptomatic pts who have been shown to benefit from revascularization compared to medical therapy. If any form of revascularization is to be covered then stenting should also be covered in high risk patients. There is no data to show a better outcome with CEA compared to CS in asymptomatic patients.

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Your current criteria for payment for carotid stenting are a terrible crime. My patients will be very poorly served by the current draft. I beg you to change your policy to:
1) CMS should pay for medically high risk ASYMPTOMATIC patients with greater than 80% stenosis. This is the standard of care in our community.
2) CMS should pay for medically high risk SYPTOMATIC patients with greater than 50% stenosis.
3) CMS should use the Sapphire Trial criteria for "medically high risk" patients.

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I have reviewed the recent Draft Decision Memo for Carotid Artery Stenting (CAG 00085R), and I must object vigorously to one aspect, and would like the following comments to be included in the official public response log.

The memo indicates that CMS would only reimburse for carotid stent implantation in patients with symptomatic carotid disease. As I am sure you are aware, the majority of carotid revascularizations (both stents and endarterectomies) currently being performed in this country and around the world, are in asymptomatic patients. The data to support this approach is strong, based on the ACAS trial and the contemporary ACST trial in Europe (Lancet 2004; 363:1491). These trials show substantial decreases in the incidence of stroke when asymptomatic patients with severe carotid stenosis undergo endarterectomy.

The SAPPHIRE randomized trial, and the ARCHER registry that have lead to approval of the Cordis and Guidant carotid stent devices, as well as all of the other high risk registries of carotid stenting (BEACH, CABERNET, etc.), have included asymptomatic patients. In fact, greater than 50% of the patients in the trials of carotid stenting have been asymptomatic. When viewed together, the data from all of these trials very clearly demonstrate that results with carotid stenting are better than those with surgery in both symptomatic and asymptomatic patients who have clinical characteristics that indicate a high risk for complications with carotid endarterectomy.

To restrict CMS coverage to the symptomatic subset flys in the face of logic. Under this policy for example, an patient with no neurologic symptoms who has class III CHF, prior neck radiation, contralateral occlusion, and a 90% restenotic lesion at the site of a prior endarterectomy would only have the options of doing nothing, or undergoing a very high risk surgical procedure. This, in the face of overwhelming data that carotid stenting would be much safer.

In our institution as well as many others around the country, appropriate patients who were deemed inoperable for endarterectomy have received carotid stents free of charge because of the CMS non coverage decision from several years ago. Obviously, neither physicians nor hospitals can be expected to provide that type of pro bono care going forward. Hundreds of investigators along with industry sponsors have invested countless hours and dollars to generate the data in the trials referenced above. It is extremely frustrating to have CMS apparently ignore all of that work and data, and arbitrarily restrict coverage to a subset of patients that represents less than half of the trial populations. I think it is unacceptable that greater than 50% of the patients who would be best served by carotid stenting based on the data would not be able to receive the appropriate therapy based on this policy.

I urge you to change this criterion prior to implementation.

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Amazingly, they have stated they will only cover stenting in symptomatic patients, ie patients with recent TIA/CVA. The old ACAS study and the recent European ACST trial clearly show substantial decreases in incidence of stroke with carotid revascularization for asymptomatic patients with severe carotid stenoses (a preventative approach). The SAPPHIRE randomized trial and all of the registries of carotid stenting in patients deemed high risk for CEA surgery included asymptomatic patients. Over 50% of the patients who have received carotid stents to date in all of the published literature were asymptomatic. CMS proposes that those patients would have to have CEA or nothing. With a single word in this policy, they propose to deny the procedure to more than 50% of patients that we think would benefit based on recent trial data. Please rectify this problem.

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I believe that the SCIENCE behind the FDA approval of this device SUPPORTS:

1) Asymptomatic patients with a >80% stenosis

2) Symptomatic patiens with a >50% stenosis

Therefore, these should be reimburseable.

Also, all physicians with the skill to do this procedure is able to adequately determine if a patient is a high-surgical risk. This can be determined by any physician, not just a surgeon. The requirement would add to the cost of health care delivery, and unnecessary delay paitent care.

Sincerely,

Lawrence V. Hofmann, MD
Assistant Professor of Radiology and Surgery
The Johns Hopkins Medical Institutions

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Current recommendation by CMS: symptomatic carotid artery stenosis > 70% in the defined high risk group.

However, current indications for surgery (level I data) include symptomatic carotid stenosis >50%, and asymptomatic stenosis >80% (?>60%). Hence, if any of the high risk patients do not have a >70% symptomatic stenosis, they would be considered surgical candidates. Having done close to 200 carotid stents, I feel it would be a clinical error to subject certain high risk patients to a open surgical procedure, especially, radiation induced stenosis, recurrent stenosis, radical neck dissection, tracheotomy, and patients with unstable angina. Very few Vascular Surgeons would operate on this patient population. I am Vascular Surgeon and would not subject my patients in the above defined group to an open procedure; I would also feel uncomfortable sending them home with no therapy. For example, I saw a patient last week who had a CEA for a radiation induced stenosis, subsequently developed a patch infection had a second CEA and is now 8 months post-procedure. He was admitted with a TIA and a 64% ulcerated stenosis based on an angiogram. I doubt if any Surgeon would operate on him (he was sent to me by a Vascular Surgeon), and I doubt if anyone would send him home on medical therapy. He did have a successful stent placement, and I am sure many of us would like to offer this as a treatment option.

I certainly do not believe that we have data to support CAS as an alternative to CEA in all patients. However, I do strongly believe that the indications for treatment should remain the same (>50% symptomatic, >80% asymptomatic), for high risk patients with a reasonable live expectancy.

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Dear Sirs,I have red your draft decision memorandum for coverage policy of carotid artery stenting and as a cardiovascular specialist I have the following comments:
1. Most of the patients in all the recent carotid stenting and endarterectomy trials were asymptomatic. The recent FDA approval included high-risk surgical ASYMPTOMATIC patients with >80% stenosis. Most CEA done in the past 20 years were done on ASYMPTOMATIC patients based mainly on duplex ultrasound which often overestimates the degree of stenosis.
2.All recent CAS clinical trials as well as the recent FDA approval for the RX ACCULINK carotid stent system included symptomatic patients with >50% stenosis (not 70%).
3.A Cardiologist as well as a surgeon can make a definition of high surgical risk. You can not leave that decision only to the surgeon, it is biased.
4.The surgical endarterectomy trials, symptomatic and asymptomatic, were performed by the best surgeons on the lowest risk patients. On the other hand all the CAS trials were perfomed only on high risk surgical patients which would have been excluded from NASCET, ACAS,and ACST. In the ECST the major stroke rate in the surgical group was 37%!.
5. In the SAPPHIRE trial, the only randomized trial, the MACE rate was reduced by 50% at 1 year! in the patients who underwent CAS vs CEA.
6. The 3% perioperative complicatins in Asymptomatic patients and 6% in symptomatic patients should be adjusted to the risk profile of the patient and can not be used as a cut off in high risk surgical patients. A Trial of CAS in NASCET and ACAS eligible patients sould be done soon.

Sincerely,

Daniel Soffer, MD, FACC, FSCAI

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I applaud CMS's national policy for coverage for carotid artery stenting (CAS). However, there are discrepencies in coverage when compared to Carotid endaterectomy (CEA). First, I agree that coverage should be for high risk patients. Currently, your policy suggests that a surgeon make the decision of high risk. I believe that most specialists in the cardiovascular field can make that designation based on CMS guidelines without having to resort to a surgical consult. Second, CMS should cover CAS for asymptomatic 80% stenoses as well as symptomatic 50% stenoses for high risk patients. The large multicentered randomized trials have shown a benefit for these patients and this has been the standard of care for carotid revascularization with CEA. Currently, as your policy is written, it will not cover asymptomatic patients and symptomatic patients will only be covered if they have a stenosis of greater than 70%. This leaves patients in between the two designations to undergo the higher risk CEA. That's not right, and physicians should not have to send their patients for a proven higher risk procedure just to have it covered. Please reconsider.

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the proposed coverage decision does not properly take into account the available data. namely, the lack of coverage for asymptomatic patients (who would comprise a significant number benefiting from treatment), definition of significant stenosis as 70% or greater(which fails to include the large number with stenoses in the 50% range who have been shown to benefit from treatment) and requirement for "surgeon approval"(which might limit access to care if the available vascular specialist is not a surgeon) are all issues which need further comment or review in light of the available data.

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Hello,

I am a noninterventional, board certified cardiologist who sees a lot of patients with severe vascular disease. I will NOT be performing Carotid or any other type of stenting. I live in Dover DE where we do not actually have a board certified vascular surgeon. We do have general surgeons who perform vascular surgeries. The neurology group in town generally refers their CEA patients 50 miles away to Newark DE.

I forsee a major problem with CMS attempts to limit patients for this procedure by excluding payment for patients specifically included in the major clinical trials who were shown to have substantial benefits. Specifically, the only reason I can see to exclude asymptomatic pts with severe stenoses, symptomatic pts with moderate stenoses (50-69%)and to require a surgical referral is a misguided attempt to save money reminiscent of the initial limits put on ICD implantation after the MADIT-2 Trial. As you know, CMS has subsequently broadened their criteria for ICD reimbursement presumably because many pts who would have benefitted but were denied reimbursement because their QRS was less then 140 ms were dying.

If I send a patient 50 miles for a vascular surgery referral even when I feel the risk of surgery itself is too high I am guaranteed that patient will come back with a surgical scar possibly with complications as well with which I will have to deal. I am sure the patients lawyer would question why I am sending a patient for a potentially higher risk surgical procedure when there is a physician in town who has performed carotid stents for the last 10 years in trials. I am pretty sure CMS wont be paying the lawsuit damages levied against me for referring a patient for a risky procedure when there is a less risky alternative (in some patients)

I think CMS should put more thought into this. I think it likely CMS will be broadening their criteria in a few mos just as they did with ICDs once there is patient and physician outcry. Unfortunately this will be after quite a few patients have died. I am sure the FDA isn't appreciating the bad press they have been subjected to recently

Sincerely
David Ramos MD,
FACC

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I believe it is wrong to require a "surgeons" opinion that the patient is a high surgical risk for carotid artery stenting to be reimbursed. If surgeons were required to "sign-off" on all patients before they were allowed to receive a less invasive alternative to surgery then the progress of medical care in this country toward less invasive solutions would be markedly slowed if not halted completely.

I do agree with limiting reimbursement to symptomatic patients with >70% stenosis. The evidence for treating asymptomatic patients and those with less than 50% stenosis is very weak.

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As a Neurosurgeon who performs both carotid endarterectomy and carotid artery stenting, there are some positions of the recent CMS statement on carotid stenting reimbursement that I strongly disagree with, and some that I support. The exclusion of asymptomatic patients seems unreasonable. Most patients enrolled in recent clinic trials for carotid stenting were asymptomatic, and the FDA has approved a stent for this use. I understand the principle of not supporting the unrestricted use of stents in all cases of carotid stenosis. But in high risk patients with a high grade stenosis (70-80% +), I would strongly support its use in asymptomatic patients. I would like to support the definition of High Risk patients, and believe there should be documentation by a surgeon who performs endarterectomy that these patients are high risk. Recent stenting trials have shown a benefit of stenting in the high risk group. I believe the jury is still out in the low risk patient population. The CMS should re-evaluate this aspect of it, once more non-high risk stenting data is available.

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Sirs: Please consider that your proposed rule regarding carotid stenting will exclude asymptomatic patients from reimbursement for carotid stenting. First, this will exclude patients who have severe stenoses and are preop for coronary bypass, a group with proven high risk of non-treatment and a significantly higher risk of serious complication with endarterectomy. Second this ignores the data from trials which have shown efficacy in the treatment of patients at high risk for surgery because of comorbidities.Finally, high risk patients with less than 50% stenosis who are symtomatic have also been shown to benefit from stenting over surgery in clinical trials. Please include these patients groups as there are clearly established benefits to them.

Daniel E. Wertman M.D.
Medical Director
Regional Vascular Associates

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The proposed coverage for carotid stenting is inconsistent with the findings of the Sapphire randomized trial and the ARCHER registry. Reimbursement should cover asymptomatic patients with greater than or equal to 80 percent stenosis and symptomatic patients with greater or equal to 50 percent stenosis. Requiring a surgical opinion prior to the procedure is not a good option. In some institutions, some surgeons will NEVER give consent for carotid stenting even in the highest risk patient. These patients are therefore at twice as high a risk of complications from carotid endarterectomy as from carotid stenting. This is a major injustice to patients requiring carotid intervention.

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1. While I certainly agree with limitations on stenting asymptomatic stenoses, the ACAS study suggests that patients with stenoses >80% are certainly at high risk of stroke, and should be eligible for stent placement.

2.The requirement that the patient be refused by a surgeon is problematic in that carotid stents represent a threat to surgical income/practice. The surgeon is therefor not unbiased. I think it would make more sense to establish clinical parameters, such as EF, PFT parameters, CHF class, level of angina, etc, to determine high risk.Thank you for considering these comments.

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In a letter dated July 20, 2004 to Dr. Tunis at CMS, Presidents of the American College of Cardiology (Dr. Wolk), Society of Cardiac Angiography and Intervention (Dr. Cowley), and Society of Vascular Medicine and Biology (Dr. Jaff)identified the position of these vascular societies on carotid stenting. This letter expressed the feeling that carotid stenting was an appropriate technique for carotid revascularization in high risk patients with symptomatic and asymptomatic carotid stenosis, as according to criteria set forth in the SAPPHIRE and ARCHER trials. I do not think there are any data to support limiting the indications for carotid stenting to criteria other than those established by these high-quality randomized and registry study as described in the CMS document.

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I am very disturbed by the proposal for CMS to reimburse only for symptomatic patients for carotid stents(the data from SAPPHIRE and other registries show the benefits of decreased cardiovascular morbidity in stented patients very CEA whether they were symptomatic or not, with very low stroke rates. This is arbitrary and not warranted by the data. Also, the reg as written implies that the surgeons need to see the patients to determine what is cardiovascular (not surgical)risk. Again, surgeons have routinely downplayed the stroke and heart attack risk of CEA, which is much higher when non surgeons assess the patients. The data supports use of carotid stenting in all patients with the usual indications for carotid revascualarization who are at moderate or high risk of complications, that is those with significant coronary, pulmonary, or renal diseas.

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I very much appreciate the thoughtful evaluation that the FDA and CMS has given to novel therapies for carotid occlusive disease, specifically carotid angioplasty /stenting with cerebral embolic protection (CAS). This therapy has the opportunity to enhance our ability to help patients with high-grade carotid artery stenosis at high-risk for carotid endarterectomy (CEA).

While there are a number of relevant concerns regarding the treatment of patients with asymptomatic lesions, I believe that clinical data supports the interventional treatment of many of these patients — those with > 80% angiographic stenosis, especially with recurrent lesions following CEA, and especially at centers that can demonstrate, through prospective case series, an acceptable risk of stroke and death following CAS.

I would support the inclusion of asymptomatic patients in any future reimbursement schemes...

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1. The purpose of carotid revascularization,whether by stenting or by surgery, is to preventstroke. Several large randomized studies havedemonstrated 40-60% reduction in the risk ofstroke for carotid endarterectomy compared tomedical therapy in patients with symptomaticcarotid stenosis > 50% (NASCET, ECST) and forasymptomatic patients with carotid stenosis > 70%(ACST, ACAS).
2. In high-risk patients, carotid stenting isassociated with a 50% lower risk of majorcomplications compared to carotid endarterectomy.
3. Carotid stenting should be available to highrisk patients with "conventional" indications forsurgery...ie symptomatic patients with > 50%stenosis and asymptomatic patients with > 70%stenosis. Limiting carotid stenting to symptomaticpatients with > 70% stenosis will inappropriatelyexclude other high risk patients who meet standardclinical criteria for carotid stenting (allasymptomatic patients with stenosis > 70% and allsymptomatic patients with stenosis 50-70%).
4. Most patients who have high risk features arethose with serious cardiovascular and pulmonarydiseases. Vascular surgeons are unable to assessthe cardiovascular risk of any type of vascularsurgery in patients with heart disease. Thestandard of care to assess the cardiovascular riskis for the treating physician to refer the patientto a cardiologist, who is in the best position toassess the cardiovascular risk of surgery.Mandating that vascular surgeons assess the highrisk criteria for any patient being considered forany type of vascular surgery is contrary to allstandards of care in the US.

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Advancement of carotid stenting (CAS) is being motivated by profit sought by both industry and practitioners, especially practitioners currently not doing carotid surgery. Government reimbursement is planned at an extremely high level for CAS relative to the complexity of the procedure and will accelerate the aggressive (and likely unnecessary) expansion of the use of CAS. I am well aware of the predatory stance and case queues awaiting payment opportunities from a variety of practices. Knowing that patients are being identified for treatment but only when payment can be obtained says volumes regarding this new environment. The proposed limitations for payment related to CAS are weak and will be routinely outmaneuvered by all of the sophisticated planners (especially ones that measure EF in their own practice). It is premature to reimburse for the physician component of CAS! It is time to allow reimbursement to institutions so additional data and analysis can be accelerated. It is not too late to delete the payment plans to the physician which would still allow appropriate treatment, referral, and analysis to advance the cause for patient care. I expect an explosion of CAS, all related to government plans for reimbursement and not in any way related to patient care or research. If I turn out to be correct, the government will need to do a great deal of explaining to the patients caught in this storm and regarding the added deficit created by padding the pocketbooks of the most disingenuous segment of healthcare and medical industry.The government can avoid all of these problems by reassessing the dollar amount of the planned physician reimbursement.

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I am currently the Director of Interventional Cardiology at Hunterdon Medical Center in Flemington, New Jersey. As an Interventional Cardiologist who specializes in global endovascular management including carotid stenting I am shocked at the current draft decision on potential medicare re-imbursement for carotid stenting. There are a number of important issues that must be addressed. First off, the majority of patients who currently undergo carotid endarterectomy are ASYMPTOMATIC patients. This is depsite the fact that data supporting the utility and benefit of this over medical therapy (which at the time of the ACAS trial consisted of only ASA) is marginal at best subjecting patients to a risky surgical procedure that may result is stroke, death, and even myocardial infarction with little clincial benefit. Secondly, the thought that a surgeon has to determine the "high risk" nature of a patient is absurd. As most vascular surgeons are not cardiologists and generally require cardiology consultation to clear patients for surgical procedures this seems counte-intuitive. Thirdly, to require that a patient be symptomatic with a 70% lesion is leaving a substantial number of patients that would clearly benefit form this state of the art therapy that will become the gold standard for almost all patients eventually. Does this mean that a high risk aymptomatic patient with a 90% stenosis should undergo surgery???? Does that make any sense. All the data is quite convincing in favor of the stent procedure. Where has this been lost in this decision? How did the number 70% become the cut-off when almost all the trials for asymptomatic patients is 50%? And what are we to use to determine % stenosis. Is an ultrasound that suggests a 80-99% stenosis in a symptomatic patient enough to proceed with a stent procedure even if the pre-stent angio documents a 69.5% QCA? There are so mnay questions that I have but no time right now to formulate them. I would also like to do this at an hour where I have acces to exact referecnes to place in here to prove my points, however anyone that is responsible for this draft decision should know what I am referring to. This is a embarraassment and an insult to all the investigators that have spent countless hours and years of their lives dedicated to scientific evidence to advance medicine. This must be corrected in order to offer the best medical care and options for those patients especially at high surgical risk for vascular complications.

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As simple as I can possibly make it: The FDA has approved Carotid Artery Stenting (CAS) after much much debate and discussion for a subset of patients based on research delineating who will benefit from this therapy.CMS should authorize reimbursement for this FDA approved procedure in these patients.CMS should not rethink and reinterpret the information nor should they essentially remake the decision. This belongs in the Department of Redundancy Department of the US Government.However if the purpose of this power of reinterpretation of the data and limitation of the applicability of CAS is to limit the use of CAS, then all becomes very clear. Rationing exists in the health care system but seldom is it so obvious.I believe clearly that "high risk" patients can be identified and treated appropriately by physicians performing CAS, regardless of their specialty. It is not wise to require a stamp of approval by a vascular surgeon alone as to whether a patient is "high risk" for surgery or not. Non-surgeons, cardiologists in particular, spend their careers delineating whether patients are at high risk for surgical procedures. If those performing CAS are suspect, then the arbiter of the designation of "high risk" should be a neurologist or internist or some other "expert" outside of the vascular surgical or interventional cardiology or radiology field, ie someone who has no "stake" in the decision. This physician should also have very little else to do as he or she will be extremely busy settling arguments as to what constitutes "high risk".

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FIRST, IF SURGERY AND STENTING WERE EQUIVELANT IN THE OUTCOME FOE ASYMPTOMATIC PATIENTS,THEN WHY IS IT THHAT SURGERY IS FINE FOR THE ABOVE 80% AND NOT STENTING?

SECOND, WHY HAVE THE OK FROM A SURGEON TO PROCEED WITH HIGH RISK PATIENTS WHEN THE CRITERIA USED IN THE TRIALS ARE CLEARLY STATED. IT IS OBVIOUSLY A CONFLICT OF INTEREST TO HAVE THE SURGEON DECIDE WHAT PATIENT IS HIGH RISK AND WHAT IS NOT, SPECIALLY WHEN THE CRITERIA USED ARE CLEAR CUT .

I STRONGLY RECOMMEND THAT THE OVER 80% STENOSIS THAT ARE ASYMPTOMATIC SHOULD BE DONE BASED ON THE PATIENTS PREFENCE AND NOT THE SURGEON'S PREFERENCE.I ALSO BELIEVE THIS SHOULD BE REIMBURSILBE.

THANK YOU
SAMIR TURK
(INTERVENTIONAL CARDIOLOGIST)

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As a member of the American College of Cardiology peripheral vascular section and clinical director of peripheral vascular intervention for a large tertiary hospital I would like to comment on CMS proposed action. I have read your proposed coverage statement and must voice a negative opinion. I do not understand why CMS is ignoring scientific data in leau of what appears to be some type of political correctness and going against scientific trial data. It appears that CMS is more concerned with the welfare of the physicians interested in turf protecting than for the safety and welfare of the united states population. The SAPPHIRE trial included 70% asymptomatic patients that will be forced to undergo a higher risk surgical opinion due to this type of CMS decision. Certainly, this is not the public view held by the FDA which has approved a much broader and appropriate population. CMS then goes on to change what the defintion of a appropriate stenosis for treatment in even symptomatic individuals. How does CMS without a CMS trial impose this type of change.

We have for years treated common carotid stenoses in the thorax free of charge due to political infighting that CMS has played an active role.

I implore CMS to utilize the randomized scientifically valid data to make this decision and approve carotid stenting for reimbursment with the carotid stent trial guidelines and seperate themselves from this turf war in which you should not play a role.

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I would like to support Medicare and Medicaid Coverage for Carotid Artery Stenting. I feel that it is important to cover payment for asymptomatic patients with stenosis greater than 80%. Often, by the time symptoms present in this patient population, irreversible damage has occurred. Also, I feel that symptomatic patients with stenosis greater than 50% should be covered. Coverage of these patients could prevent higher medical costs in the future that may result due to complications related to the stenosis. Thank you for your consideration of my opinions and comments.

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Please consider that patients with carotid stenosis of lesions greater than 50% are appropriate candidates for stenting. Trial patients have done well with minimal complication rates compared to surgical invention. Also, patient recovery is much easier.

I do not feel a surgeon should have the final say in any patients care. Ultimately the patient should retain that right given all information. If he/she wishes to proceed with the interventionist, that should be allowed to occur.

I personally know a patient who has a carotid stent. He is doing well at 72 years. He felt he had no alternative until he found out and was enrolled in a study. He praises the stenting program for his life and all the things he has been give through this program.

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1. The proposed exclusion for asymptomatic patients will exclude a number of patients in whom CAS would be the safest method of treatment. It is not unreasonable to have a patient who is currently asymptomatic, present with a carotid stenosis that places them at a high risk of sudden occlusion (with possible embolization). This exclusion does not take into account the vast experience in recent clinical trials as well as current FDA approval for use of the Guidant device in asymptomatic stenoses of 80% or greater.
2. The exclusion of symptomatic lesions less than 70% stenosis will exclude a host of patients who have stenosis >50% and are at high risk for medical or surgical treatment. Patients in this category include post-operative patients, post-XRT patients, patients with neck tumors, and other potential patients. Given that the FDA has approved the Guidant device for 50% lesions should support reimbursement at this level.
3. While I think that it is noble to require a vascular surgeon to evaluate a patient, this requirement does not show valuation for the opinions and knowledge of other physicians with training and knowledge who are caring for patients with carotid disease such as Neurologists, Neuroradiologists and Interventional Radiologists.

I would urge CMS to attempt to coordinate reimbursement rules with already approved guidelines from the FDA. To do anything else will promote confusion among healthcare providers and patients and potentially force patients to take a risky or unwise course of treatment.

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Nice review of the literature and as I see it interesting "devil's advocate" viewpoint. Two comments: First, asymptomatic patients should be included in the coverage decision. For example, a patient asymptomatic with a progressive and critical stenosis should be offered the option of stenting if he or she is at increased risk of surgery. What is the alternative if CMS will not reimburse the procedure. What about if that patient is your father or mother?

Second, in my experience suggesting a surgeons' opinion before this procedure is flawed with multiple problems. For some surgeons there is no inoperable patients. What about if there is a disagreement between the surgeon and the interventionalist. What the neurologist and the primary care physician, and even the patient do? In my experience, disagreement will not be rare. Certainly, fertil ground for lawyers if there is a bad outcome. Remember the intense turf wars that exist. You will not find that in the literature but only in everyday practice of medicine.

In my opinion: I propose a more strict control over who and where these procedures are done. First to optimize results and second, to monitor indications and outcomes. Make sure that hospitals have a systematic QA, protocols and uniform and strict creedentialing criteria. Finally, there is only a few physicians either overdoing the procedure or even dishonest about taking care of patients. Do not make a decision that will affect the care of most of the carotid patient population but rather try to identify the "black sheep".Do not make a decision that will place competing groups of physicians interact in this way. There are many older surgeons that do not have a good handle on the most recent literature. A consultation with a surgeon to procedd with a stent is wrong.

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The CMS coverage only for symptomatic patients with carotid stenosis of greater than 70% is arbitrary. Efficacy for carotid stenting was established by two prospective trials which included a comparator arm (CEA). These were the SAPPHIRE and CARESS trials. The former trial included high risk asymptomatic patients. The later included a broad risk patient population including asymptomatic patients. There is no basis for the exclusion of asymptomatic patients from CAS and reimbursement for this procedure.

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1) We MUST include the high risk ASYMPTOMATIC patient for this technology to make any sense. Patients with 80% or greater stenoses that CANNOT have surgery should be included since the risk of strok (15-30%) is HIGHER then the risk of complications (2-10%) from the stent procedure. The cost of one stroke is 150,000 dollars financially, yet the ability to keep a life going without significant disability over that time is worth far more then the $150,000.
2) I AGREE that a SURGEON MUST sign on off on the procedure as a high surgical risk. Otherwise, Cardiologists will self refer all of their Carotid patients and claim they are "high" risk so they can do the procedure themselves. This should be seriously looked at as a major Stark violation, but in lieu of that, you have the opportunity to have patient get a FAIR assessment of their risk. Surgeons do NOT want to take on a high risk patient when there is an alternative. Cardiologists, despite a very very bad paper that was self serving, DO additional tests and interventions when THEY benefit finacially. They are NEW to the cerebral circulation and yet they instantly have taken over the field because they have total patient control. Surgeons must answer to internists, primary care physicians and skilled radiologist.
3) Symptomatic patients with lesions greater then 50% benefit from carotid endarterectomy. When the surgery is high risk, why deprive them of the opportunity to reduce their stroke risk with a stent when a surgeon believes it is reasonable???

In summary, keep the indications as they were for the trial and PUT THE SURGEONS IN CHARGE OF SIGNING OFF ON THE DECISION TO TREAT.

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CONGRATULATIONS!!! AS A NEUROINTERVENTIONAL RADIOLOGIST, ONE WHO HAS STUDIED, WRITTEN ABOUT AND TREATED CAROTID ARTERY DISEASE FOR TWENTY THREE YEARS, YOUR DECISION TO NOT REIMBURSE CAROTID STENTING IN ASYMPTOMATIC PATIENTS IS CORRECT, WISE AND A COURAGEOUS STATEMENT TO THE VENDORS AND DOCTORS WHO PUT DOLLARS AHEAD OF PATIENT SAFETY AND BENEFIT. THE BENIGN NATURAL HISTORY OF ASYMPTOMATIC CAROTID DISEASE, THE NEW MEDICAL TREATMENTS AVAILABLE (EG STATINS,MAKE THE RISK PROFILE FOR STENTING UNWARRANTED, .ESPECIALLY SINCE NO STENT TRIAL HAS SHOWN RISKS OF STENTING TO BE LESS THAN 3 %, THE LEVEL AT WHICH SURGERY IN SUCH PATIENTS MAY BE? WORTHWHILE. PLEASE DON'T BACK DOWN TO THE LOBBYING CAMPAIGN BEING MOUNTED BY THE VENDORS.

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1. Carotid stenting (CAS) should be available to treat symptomatic patients, even if the measured internal carotid artery stenosis is 50-70%. NASCET data and consensus opinion about the role of carotid endarterectomy (CEA) suggest that using a strict 70% threshhold for treatment is inappropriate. The draft policy would mean that patients with 50-70% stenoses would not be treated with CAS, even if they had recurrent neurologic symptoms, ulcerated plaques, or other compelling reasons to be treated. Also, even with the most precise techniques for angiographic measurements of carotid stenosis, there is some variability in the measurement. Too much emphasis on a specific degree of stenosis overlooks the problem of obtaining accurate and reliable measurements. Non-coverage for CAS would mean that even high-risk surgical patients would be either treated with CEA, or no therapy. I would recommend a 50% threshhold for treating symptomatic patients with CAS.

2. The definitions of "high-risk for CEA" are appropriate. Several papers in surgical journals have suggested the CAS trials used unreasonably broad definitions of "high risk" in their inclusion criteria.

3. There are dramatic differences in the proposed standards for clinical competence that have been suggested by different specialties. Examples of standards cited in the Draft Decision Memo for Carotid Artery Stenting differ substantially in what are recommended as prerequisite experience (>300% difference in case numbers required). Various specialty societies have advocated different standards, and their positions have been notoriously self-serving. CMS needs to either propose a standard, or let each institution or specialty establish their own. It will not be reasonable to have neuroradiologists dictating practice standards to interventional cardiologist or endovascular surgeons, as the later groups may actually have more experience with CAS than the neuroradiologists.

4. CMS is to be applauded for its careful consideration of the role of CAS in patients without neurologic symptoms. Despite the fact that large numbers of asymptomatic patients were enrolled in CAS registries, there are no data to suggest that CAS (a technique advocated for treating carotid disease in "high-risk" pateints) has any role in treating patients who are generally not treated with CEA. Patients with a limited longevity will not be expected to benefit from a prophylactic procedure. There may be subgroups of asymptomatic patients who deserve special attention, though. Specifically, CEA may be performed for asymptomatic disease for patients who are undergoing coronary artery bypass surgery (CABG). Treating high-risk asymptomatic patients with CAS prior to CABG might be preferable to staged or combined CEA and CABG.

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Greetings,I am the director of peripheral vascular intervention at St Joseph's Regional Medical Center in Paterson, N.J. I have concerns about the CMS draft for reimbursement for carotid stenting.

1. The exclusion of asymptomatic patients runs contrary to all the scientific data. 70% of enrollees in carotid stent trials are asymptomatic, and this subset of patients enjoyed a lower risk of complications that carotid endarterectomy. These scientific findings led to the FDA approval which INCLUDES asymptomatic patients. To deny reimbursement to this subset will CLEARLY lead to unneccessary complications when these patients undergo the HIGHER risk endarterectomy. This would appear unethical.

2. The requirement of symptomatic patients to have 70% stenosis also runs contrary to all the scientific data and the terms of the FDA approval, all of which support the value of carotid stenting for 50% lesions if symptomatic. To deny stenting to patients with 50-70%stenosis, will subject these patients to unneccessary complications from the higher risk endarterectomy. It is important to note that the published studies have indicated that stenting is LESS risky than endarterectomy in these patients. It would be unethical to deny reimbursement for the superior procedure.

3. The definition of what represents "high risk" is clearly defined in the FDA approval and the IFU for Guidant's Acculink system. There should be no requirement for a surgical consultation. There would be a clear conflict of interest if surgical consultants were required for every stent case, once again potentially leading to unneccessary complications if these patients underwent a HIGHER risk endartectomy.

The scientific data that shows stenting to be superior to endartectomy is not refutable. It is incumbent upon CMS to allow reimbursement under the terms of the FDA approval. To do otherwise will result in unneccessary strokes, myocardial infarctions for our patients.

Thank you for your consideration of these comments.

David E. Cohen, M.D.

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I totally agree that patients for caroitd stenting with high rsik status should be done after consultation of a surgeon who would decide that the surgery is of high risk to the patient. Otherwise allpatietns will be considered high risk by certain physician and there will be a surge of stenting and complications with wide indications that might drive the costs very high and will expose patients to risk that are unknown on the long run. Recurrence is still to be furthe evaluated . Long term data has to be available before appplying the procedure to everyone.

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