National Coverage Analysis (NCA) View Public Comments

Carotid Artery Stenting

Public Comments

Commenter Comment Information
Zetterlund, MD FACC, Patrik Title: Interventional Cardiologist
Organization: Central Coast Cardiology
Date: 01/19/2005
Comment:

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

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Koroshetz, Walter Title: Chair, Stroke Systems Task Force
Organization: American Academy of Neurology
Date: 01/18/2005
Comment:

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

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Ringer, Andrew Title: Assistant Professor of Neurosurgery
Organization: University of Cincinnati / Mayfield Clinic
Date: 01/17/2005
Comment:

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

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Zwolak, Robert Date: 01/17/2005
Comment:

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

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Keus, Peggy Title: Assistant Director Diagnostic Testing Business Op
Organization: St. Luke's Episcopal Hospital
Date: 01/17/2005
Comment:

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

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Dippel, Eric Title: Interventional Cardiologist
Organization: Cardiovascular Medicine, PC
Date: 01/17/2005
Comment:

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

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O'Kane, Peggy Title: Executive Director
Organization: National Committee for Quality Assurance with SCAI
Date: 01/17/2005
Comment:

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,

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Cowley, Michael Title: President
Organization: Soc. for Cardiovascular Angiography and Interventions
Date: 01/17/2005
Comment:

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

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Petrossian, M.D., George Title: Director of Investigational Carotid Stent Program
Organization: St. Francis Hospital
Date: 01/17/2005
Comment:

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

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Arici, MD, Mel Title: CHIEF OF DIVISION OF INTERVENTIONAL/ENDOVASCULAR D
Organization: UNIVERSITY OF CONNECTICUT VASCULAR CENTER,
Date: 01/17/2005
Comment:

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

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Hobson II, M.D., Robert W. Title: Principal Investigator
Organization: CREST
Date: 01/17/2005
Comment:

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

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Wolk, Michael Title: President
Organization: American College of Cardiology
Date: 01/17/2005
Comment:

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

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Dorne, Howard Date: 01/17/2005
Comment:

The ACAS study showed that patients with asymptomatic stenoses benefit from surgery as compared to medical management. The recent carotid stent studies show that stenting is no worse than, and perhaps better than surgery. I do not agree with your proposed policy which would compel Medicare patients with asymptomatic high-grade carotid stenoses to undergo surgery. They should have the option of stent placement, as well.

Calvert, Barbara J. Title: Director, Reimbursement Strategies
Organization: Guidant Corporation
Date: 01/17/2005
Comment:

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

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Duckwiler, MD, Gary Title: President
Organization: American Society of Interventional & Therapeutic Neuroradiology
Date: 01/17/2005
Comment:

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

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Durham, Janette D. Title: MD, MBA
Organization: Society of Interventional Radiology
Date: 01/17/2005
Comment:

CAS outcomes registry

SIR supports linkage of payment for CAS to participation in an outcomes registry that includes independent neurologic evaluation.

SIR believes that an outcomes registry is necessary both to confirm the generalizability of current published outcomes of CAS to community practice and to encourage rigorous quality assurance. We believe that such a registry will only be of value if participation is universal and data on outcomes is reliable. Universal participation is likely to occur only if reimbursement is linked to participation, which we support. Reliable outcomes data will require independent neurologic evaluation before and after the procedure, which we strongly support. However, this may not be practical outside of a clinical trial. We believe that the evaluation may be performed by an independent medical provider certified in the use of the NIH stroke scale (which would include providers not specifically a neurologist), with further evaluation by a neurologist if the initial exam is abnormal. We do not anticipate that the registry will be necessary forever, but rather until CAS outcomes have been reliably determined in the community setting.

SIR is committed to working with all other interested specialties to develop a usable registry that will allow accurate reporting on all CAS procedures performed. We hope to work with CMS in the development of this registry, and expect to be ready to do so in the near future.

SIR appreciates the opportunity to comment upon CMS' draft coverage decision for carotid stenting.

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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

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Mabry, Michael R. Title: Assistant Executive Director for Policy
Organization: Multiple Organizations
Date: 01/17/2005
Comment:

We support continuation of CMS' prior CAS coverage policy for research protocols on FDA-approved clinical trials.

We recognize that Medicare final CAS coverage decision will limit beneficiary access to the procedure. There also are many unanswered clinical questions. The Memorandum proposed, for those patients not meeting the draft coverage criteria, CMS would maintain the current coverage policy of enrollment in FDA approved Category B IDE trials or as part of a CAS post-approval study. We support the Memorandum's position on this, as it would promote continued research. This will allow access to this technology for patients needing therapy but falling under a category currently unclear with respect to benefit from CAS.

The undersigned societies have provided these comments in an effort to ensure that the appropriate Medicare beneficiaries receive the best possible carotid stenting experience and outcome. We are committed to working with CMS towards this goal.

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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

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Ratcheson, Robert Title: MD, President
Organization: American Association of Neurological Surgeons
Date: 01/17/2005
Comment:

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

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Sugarman, Mitchell Title: Director, Global Reimbursement
Organization: Medtronic Vascular
Date: 01/17/2005
Comment:

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

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Tobiason, Virginia Title: Director, Corporate Reimbursement
Organization: ABBOTT
Date: 01/17/2005
Comment:

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

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Singh, Karandeep Title: Director Vascular Med and Endovasc. Interventions
Organization: Geisinger Medical Center
Date: 01/16/2005
Comment:

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

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Chastain MD, Hollace Title: Interventional Cardiologist/Vascular Disease
Organization: Fort Wayne Cardiology
Date: 01/16/2005
Comment:

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

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Kaminskas, David Date: 01/16/2005
Comment:

Carotid stenting has clearly proved its value. You are being too retrictive in your suggested coverage of carotid stenting. Asymtomatic 75% or greater lesions should be covered and symptomatic 50% or greater should also be covered. You are likely being infuenced by the surgical lobby. Would you rather have a major surgery or a relatively minor invasive procedure to accomplish the same thing.

dave kaminskas

Hopkins, Nick Title: chair, Dept of Neurosurgery,
Organization: SUNY Buffalo
Date: 01/16/2005
Comment:

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

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Slatton, M.D., Monte Date: 01/16/2005
Comment:

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

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Wakhloo, MD PhD, Ajay Title: Professor of Radiol, Neurolog. Surg, Biomed. Eng.
Organization: University of Miami School of Medicine
Date: 01/16/2005
Comment:

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

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Kumar, Krishna Title: M.D.
Date: 01/16/2005
Comment:

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

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Jones, Ancil Title: Director, Cardiac Catheterization Laboratory
Organization: Crozer Chester Medical Center
Date: 01/15/2005
Comment:

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

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Dauterman, Kent Title: Chief of Cardiology, Rogue Valley Medical Center
Organization: The Heart Clinic
Date: 01/15/2005
Comment:

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

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Bokhari, M. D., Syed Date: 01/15/2005
Comment:

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

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Martinez Arraras, Joaquin Date: 01/15/2005
Comment:
It seems inappropiate to so callously curtail the use of carotid stenting. The technology is proven, the advantages over surgical methods clear, and the indications for revascularization firmly established previously. The need for revascularization in patients with symptoms and stenoses greater than 50% has already been proven. Why deny the benefit of a less invasive approach to this patient.?. Why restrict the intervention to 80% or greater stenoses? How can you justify sentencing th

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Dohad, Suhail Title: Co-Director of endovascular institute
Organization: Cedars Sinai Medical Center
Date: 01/15/2005
Comment:

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

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Rinaldi, Michael Title: Director, Vascular Interventional Lab
Organization: The Sanger Clinic
Date: 01/15/2005
Comment:

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

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Chervu, Arun Organization: Vascular Surgical Associates, P.C.
Date: 01/15/2005
Comment:

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

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Halsey, James Title: Professor of Neurology
Organization: University of Alabama Dept. of Neurology
Date: 01/15/2005
Comment:
January 15, 2005
RE: Carotid Stenting, High Risk Definition
Dear CMS Staff:
I am opposed as well to have a surgeon’s 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 to make this critical decision. Stroke Neurologists undergo extensive training in the assessment and treatment of cerebrovascular disease and are better suited than surgeons to determine who

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Coupland, Della Title: Stroke Coordinator
Organization: Comprehensive Stroke Center
Date: 01/14/2005
Comment:

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

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Firth, Brian Organization: Cordis Corporation
Date: 01/14/2005
Comment:

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’

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Rizk, Youssef Title: DO
Date: 01/14/2005
Comment:

I as a practicing vascular surgeon feel that the same criteria that applies to a patient that is not high risk should apply to the patient that qualify for coratid stent. that means apply the NASCET criteria for intervention. which means asymptomatic >75% and symptomatic 65% or greater.

Cohn MD, Joel Title: Cardiovascular Interventionalist
Organization: Thoracic & Cardiovascular Institute
Date: 01/14/2005
Comment:

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

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Eisenhauer, Andrew Title: Director, Interventional Cardiovascular Medicine S
Organization: Brigham and Women's Hospital
Date: 01/14/2005
Comment:

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

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Rayan MD, Sunil Title: Vascular/Endovascular Surgeon
Organization: Scripps
Date: 01/14/2005
Comment:

I agree that physicians facile in both interventions (surgery and stenting) should decide the appropriateness of the procedure. I disagree with the fact that asymptomatic high risk patients with >80% stenosis are denied a potentially safe and beneficial therapy. Physicians with expertise in both procedures should be able to decide if stenting is appropriate in these cases.

Meskan, Tom Title: Director, Reimbursement and Outcomes Planning
Organization: Boston Scientific Corporation
Date: 01/14/2005
Comment:

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

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Pow, Thomas Date: 01/13/2005
Comment:

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

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aggarwal, sanjiv Title: cardiologist
Organization: medical group of fort wayne
Date: 01/13/2005
Comment:

1. The CMS should pay for medically high risk asymptomatic patients with greater than 80 % stenosis. This is the standard of care in our community as outlined by the Sapphire Trial Criteria.

2. CMS should pay for medically high risk patients who are symptomatic with greater than 50% stenosis.

3. The Sapphire Trial criteria should be used for medically high risk patients.

Weiss, Jeremy Title: Vascular and Interventional Radiologist
Organization: PERC
Date: 01/13/2005
Comment:

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

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ombrellaro, MD, mark Date: 01/13/2005
Comment:
Carotid artery stenting is supposed to be "equivalent" therapy to carotid endarterectomy and as such, should have the same indications. Since the generally accepted surgical interventional threshold, based on NASCET and ACAS trial data, is a 70 % carotid artery stenosis in either symptomatic or asysmptomatic patients, it is reasonable that this should be the minimum diameter stenosis required for carotid stenting. 50% diameter stenosis lesions have long been considered/proven those which are

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Dougherty, MD, Sarsfield Date: 01/13/2005
Comment:

I am very concerned that stenting will not be covered for asymptomatic patients despite evidence that fixing stenosis of 80% and greater is beneficial and prevents strokes. I also think is is very unfortunate that you deny symptomatic patients with stenosis in the 50-70% range despite clear evidence that fixing stenoses in this range prevents strokes.

Meilman, M.D., Henry Date: 01/13/2005
Comment:

Carotid artery stenting needs to be made available to patients shown to benefit from the procedure. This would include those asymptomatic patients with severe disease as described in the study protocols. Denying stenting is tantamount to a surgical assault on these patients with higher health care costs and morbidity. There is no rational reason to deny this therapy.

Wiest, John Title: Vascular Surgeon, Clinical Associate Professor
Organization: Providence Health Care System, Oregon Health and Science
Date: 01/13/2005
Comment:

I agree 100% with your proposed indications.

Mattson, Scott Title: Medical Director, Non-Invasive Cardiac Imaging
Organization: Medical Group of Fort Wayne
Date: 01/13/2005
Comment:

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

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Sivaram, Chittur A. Title: MD
Organization: University of Oklahoma Health Sciences Center
Date: 01/13/2005
Comment:

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

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Heller, MD, Louis Organization: St Josephs Hospital/Cardiovascular Group
Date: 01/13/2005
Comment:

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

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Briguglio, John Title: Chief, Angiography and Interventional Radiology
Organization: Lancaster Radiology Associates
Date: 01/13/2005
Comment:

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

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Balsara, Zubin Organization: St. Edward Hospital
Date: 01/13/2005
Comment:

(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

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Lowry, r w Title: Cath Lab Director
Organization: St Francis Hospital
Date: 01/12/2005
Comment:

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

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Bays, Ronald Date: 01/12/2005
Comment:

I do not believe that a contralateral carotid occlusion or a previous CEA with recurrent stenosis place a patient in a high risk category especially if performed by a competent vascular surgeon. The increase in risk for these subsets is much lower than it would be in a patien in CHF or unstable angin for example and should not be included in the high risk comorbid conditions list.

Banitt, Peter Title: Physician
Organization: Pacific Heart Associates
Date: 01/12/2005
Comment:

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

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Bays, Ronald Title: MD
Organization: Mid Mich Vascular
Date: 01/12/2005
Comment:

I believe that the criteria for high risk with regard to carotid stenting needs to be defined rather than leaving it to the discresion of the physician to just say a patient is high risk. I also do not think a proper study has been done between carotid stenting in high risk patients both symptomatic and asymptomatic vs. best medical treatment. A truly high risk patient would probably not be submitted for carotid endarterectomy by many vascular surgeons.

Arora, Dilip Date: 01/12/2005
Comment:

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

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Asfour, Abed Title: MD FACC
Organization: Henry Ford Health System
Date: 01/12/2005
Comment:

Greetings,
The reimbursment plan for CAS, does not go along with current scientific evidence.A you know the Saphire Trial, showed evidence in both symptomatic and asymptomatic patients.also the angiographic confirmation will increase the risk of procedure complications, which is also have been proven in the literature.we think doppler in combinatio to MRI or Ct scan should be sufficient.
Accept my full respect
Abed Asfour,MD FACC

al-ali, firas Title: Director of neuro-interventional surgery
Organization: Borgess Medical Center
Date: 01/12/2005
Comment:

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

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Flanigan, Preston Title: MD
Organization: Flanigan & Harward, A Medical Corporation
Date: 01/12/2005
Comment:

FDA approval includes stents for asymptomatic stenoses of > 80% thus there should be payment. Symptomatic patients with require carotid TEA, thus stents should be reimbursed also in this category.

SMITH, M.D., STAFFORD Title: CEO
Organization: SCRANTON HEART INSTITUTE, P.C.
Date: 01/12/2005
Comment:

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

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Giri, Satyendra Title: Director, Vascular Medicine Program
Organization: Baystate Medical Education & Research Foundation
Date: 01/12/2005
Comment:
Dear Sir/Madam,I am greatly disappointed by the recent CMS announcment that you intend to intends to limit expansion of coverage for carotid artery stenting with embolic protection only to patients who are at high risk for carotid endarterectomy, and who also have symptomatic narrowing of the carotid artery of 70 percent or more. This exclude an extremely important patient subset, and that is the asymptomatic patients with severe carotid stenosis who are at a significantly high risk for future

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Dykstra, Gary Title: DO, FACC
Date: 01/12/2005
Comment:

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.

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Willing, Steven Title: Associate Professor
Organization: School of Medicine
Date: 01/12/2005
Comment:

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

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Haas, Robert C. Title: MD
Organization: Heart Center of Tulsa
Date: 01/12/2005
Comment:

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

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Schooley, M.D., Chad Title: Physician
Organization: Parkside Cardiology
Date: 01/12/2005
Comment:

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

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Soto. M.D., Rodney Organization: The University of Alabama, Birmingham
Date: 01/12/2005
Comment:

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

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Navarro, Felipe Date: 01/12/2005
Comment:

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

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Arkonac, Burak Title: M.D., F.A.C.C.
Organization: St Francis Hospital
Date: 01/12/2005
Comment:
As an interventional cardiologist who follows patients after strokes, I hope to underline the importance of carotid stenting and the benefit of taking care of a significant stenosis before there is any damage or insult to the brain. More than 70% stenosis is an indication for surgery so should be for stenting too. I urge you to reconsider the carotid stent criteria that should keep us at the universal standard of care for aour patients. Thank you for your considerations.
Guzman, Luis Title: Director, Peripheral Intervention Program
Organization: University of Florida
Date: 01/12/2005
Comment:

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

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pucillo, anthony Title: associate prof of med new york med college
Organization: director of cath lab westchester med center
Date: 01/12/2005
Comment:

please reconsider the preliminary guidlines. Patients in our enviroment are consistantly requesting stenting for carotid disease instead of surgery. This is particularly true for the high risk patients which all the published data supports. I have been performing carotid stenting now for 4 yrs and I can honestly tell you the improved equipment makes this a predictably safe and effective procedure. It's time has come and we all need to recognize this.

Dempsey, Stephen Title: Cardiologist
Organization: Saratoga Cardiology Associates, PC
Date: 01/12/2005
Comment:

The decision to restrict carotid stenting benefits to high risk, symptomatic patients is innappropriate. In light of the wealth of data supporting carotid stenting as a safe and effective alternative to carotid endarterectomy, particularly in high surgical risk, asymptomatic patients with severe carotid stenosis coverage should be provided to all patients who are candidates for endarterectomy.

GOEL, SANJIV Title: MD
Date: 01/12/2005
Comment:

Carotid stenting should be approved for reimbursement for all carotid stenosis ,not only high risk ,because the data for high risk patient is good already and Non surgical treatment is better and cost effective than more expensive surgical emdartectomy.

SANJIV GOEL MD FACC

Hockstad, Eric Organization: KCCA
Date: 01/11/2005
Comment:

Why would you limit compensation to a subset of patients that benefit from carotid stenting? The study CMS accepted for carotid stenting included symptomatic patients with stenoses of >50%, and asymptomatic patients. The FDA approved a carotid stent program for patients with asymptomatic stenoses of >80%. It doesn't make sense to exclude patients who have been proven to benefit.

Ranginani, Anil Date: 01/11/2005
Comment:

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

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PATEL MD FACC, DILIP Title: MD FACC
Organization: CV
Date: 01/11/2005
Comment:

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

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mackrell, peter Title: MD
Date: 01/11/2005
Comment:

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,

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yamasaki, hiroshi Title: MD
Organization: member, ACC, AHA, ACP
Date: 01/11/2005
Comment:

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

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Johnson, Eric Title: Interventional Cardiologist
Organization: Cardiovascular Consultants Medical Group
Date: 01/11/2005
Comment:

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

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gimelli, giorgio Organization: university of Wisconsin Medical School
Date: 01/11/2005
Comment:

not covering asymptomatic stenosis is not supported by data and is arbitrary. Carotid stenting should be allowed in patients with >80% asymptomatic stenosis and >50% symptomatic, just like in the published trialsHow would CEA be justified in the asymptomatic patients?

GONZE MD, MARK Organization: VASCULAR SURGERY ASSOCIATES
Date: 01/11/2005
Comment:

I AM A VASCULAR SURGEON AND PERFORM BOTH CAROTID ENDARTERECTOMY AND CAROTID STENTING. I HAVE REVIEWED YOUR PROPOSED GUIDELINES AND AGREE WITH THEM AS WRITTEN. IN THE FUTURE WE MAY NEED TO LIBERALIZE THE GUIDELINES; HOWEVER WITH THIS NEW TECHNOLOGY I FEEL THAT BEING CONSERVATIVE WITH THE USE OF CAROTID STENTING WILL SERVE OUR PATIENTS.

Liu, Ming Organization: University of southern California
Date: 01/11/2005
Comment:

Asymptomatic high risk patients with severe carotid stenosis should be covered by Medicare.This is especially important in patients with coexiting coronary and carotid disease. Data are abundant in that this group of patients have a higher risk of periprocedural compliations with surgery. Carotid stenting is a much better and indicated therapy for this group of patients.

Klucznik, MD, Richard Title: Interventional neuroradiologist
Organization: Methodist Hospital
Date: 01/11/2005
Comment:

Please approve funding for carotid stenting as soon as possible. Knowledgeable patients are asking for stenting instead of surgery. It is a good procedure and both Guidant and Cordis have good devices. Since I am at a hospital that has been involved in the clinical trials, I can tell you that carotid stenting does and will have a positive impact in the treatment of carotid stenosis.

Carey, Daniel Title: M.D.
Organization: Cardiovascular Associates of Central Virginia
Date: 01/11/2005
Comment:

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

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Pietrolungo, DO, MS FSVMB, FACC, Joseph Title: Director of the Vasular Medicine and Intervention
Organization: The Heart Group, Inc.
Date: 01/11/2005
Comment:

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

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jessup, David Date: 01/11/2005
Comment:

Would like MMS to understand the benefit of CAS in all patient populations.

Mangla, Vivek Date: 01/11/2005
Comment:

It is imperative to allow patients access to minimally invasive methods which have been proven to be equally effective.

Gioia, Giuseppe Title: MD, FACC
Organization: Associated Cardiovascular consultants
Date: 01/11/2005
Comment:

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

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Dhadly, Mandeep Title: MD
Organization: University
Date: 01/11/2005
Comment:

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

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Rajachandran, Manu Title: Chair
Organization: Deborah Heart and Lung Center
Date: 01/11/2005
Comment:

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

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surabhi, satish Date: 01/11/2005
Comment:

Regarding the asymptomatic patients with carotid artery stenosis greater than 80%, what does the CMS expect will happen?. All of these patients will recieve carotid endarterectomy. So, not covering for carotid artery stenting does not decrease the total number of patients treated. It only deprives these patients an excellent, safe and less invasive treatment option.

Matsuura, John Title: Vascular Surgeon, MD
Date: 01/11/2005
Comment:
As a vascular surgeon, I wanted to reply to the recommendations for reimbursement for carotid artery stenting (CAG-00085R). I am in agreement with the criterion for "high risk patients", but I am concerned about the decision to exclude asymptomatic patients with high grade carotid lesions. Prior to the ACAS study, other investigators have found a higher risk of neurologic events in patients with severe carotid stenosis. Chambers and Norris (N Engl J Med 1986;315:860-5) identified a higher

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sichlau, michael Date: 01/11/2005
Comment:

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%

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wholey, roseanne Title: President
Organization: Roseanne R. Wholey and Associates
Date: 01/11/2005
Comment:

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

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Holmes, David Title: Consultant, Cardiovascular Diseases
Organization: Mayo Clinic
Date: 01/11/2005
Comment:

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

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Luis, Guzman Title: Director, Peripheral Interventional Program
Organization: University of Florida
Date: 01/11/2005
Comment:

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

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Toursarkissian, Boulos Title: Associate Professor
Organization: UTHSCSA
Date: 01/11/2005
Comment:

Dear Sirs, Your proposal for reimbursement guidelines for carotid stenting is very appropriate. I do open carotid surgery and stenting as well. I feel your proposal would allow a gradual introduction of new technology into clinical practice.

Gravereaux, Edwin Title: Director, Endovascular Surgery
Date: 01/11/2005
Comment:

How can you propose that carotid stent coverage NOT include asymptomatic, greater than 70% patients, when the surgical literature demonstrates a benefit to intervention over medical management. These patients routinely are offered surgical carotid endarterectomy, which is covered and reimbursed. Your coverage proposal seems arbitrary.

Garcia, Lawrence Title: Assitant Professor of Medicine, Harvard Med Sch
Organization: Beth Israel Deaconess Medical Center
Date: 01/11/2005
Comment:

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

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HOMAYUNI, ALI Title: MD FSCAI FACC FACP FASA CLIN ASSOC PROF SUNY BKLYN
Organization: SI HEART
Date: 01/11/2005
Comment:

THE CURRENT PROPOSED GUIDELINE SHOULD INCLUDE HOGH RISK ASYMPTOMATIC PATIENTS AS DELINEATED IN THE TRIALS CURRENTLY PUBLISHED AND PRESENTED. THE DATA SUPPORTS THE SAME COVERAGE AS FOR CAROTID ENDARTECTOMY.

Laufer, MD FACC, FRCPC, FACP, Nathan Title: Director Interventional Cardiology Fellowship
Organization: Banner Good Samaritan Regional Medical Center
Date: 01/10/2005
Comment:

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

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gallino, robert Date: 01/10/2005
Comment:

All of the major Carotid Stent Trials included Asymptomatic patients. The majority of patients undergoing surgery do not have symptoms. Please reconsider these patients for inclusion for treatment. It has clearly been shwon that stenting is safer than surgery, let us be able to treat and therby hopefullly prevent many stroke from occuring.
Robert Gallino MD
Director of Peripheral Interventions at the George Washington University Hospital

Kwolek, Christopher Title: Director, Endovascular Training
Organization: Division of Vascular and Endovascular Surgery
Date: 01/10/2005
Comment:

As a Vascular surgeon who performs both open vascular and endovascular procedures, I believe that coverage should be provided for Asymptomatic patients with progressive stenosis that is tighter than 80%, and Symptomatic patients with stenosis tighter than 50%. In addition, consensus should be reached by an independent neurologist and a surgeon that the patient would benefit from intervention and was high risk for surgical intervention at their institution.

Gustav, Eles Title: Dirctor of Peripheral Interventions
Organization: Allegheny General Hospital
Date: 01/10/2005
Comment:

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

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Wholey, Mark Title: M.D.
Organization: Pittsburgh Vascular Institute
Date: 01/10/2005
Comment:
The CMS draft on Carotid Stenting is unreasonably restrictive for allowing coverage in only high surgical risk symptomatic patients with greater than 70% stenosis. There is a concern that carotid artery stenting may have a worse outcome than the conventional medical management. Unfortunately there is no data to substantiate medical management being superior to the high risk asymptomatic subset that were enrolled in the trials. Furthermore, many of these patients, although asymptomatic, are

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Hodes, Jonathan Date: 01/10/2005
Comment:

I urge CMS to strongly consider coverage for assypmtomatic patients with 80% or greater stenosis and sypmtomatic patients with 50% or greater stenosis. Excluding these groups from coverage will significantly impact patient care and deny access of the covered population a safe and effective treatment to prevent stroke.

mccormick, daniel Title: director, cardiac cath lab
Organization: hahnemann university hospital
Date: 01/10/2005
Comment:

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

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Jeffery, Charles Title: M.D.
Organization: Radiology Consultants of Tulsa
Date: 01/10/2005
Comment:

Limiting of reimbursement to only symptomatic patients is contrary to long history of carotid therapy and would be a diservice to many patients that could benefit from the procedure.

Sanz, Dr. Mark Date: 01/10/2005
Comment:

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

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Schultz, Greg Date: 01/09/2005
Comment:

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

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Myla MD FACC FSCAI, Subbarao Title: Medical Director, CV Research
Organization: Hoag Memorial Hospital, Newport Beach
Date: 01/09/2005
Comment:

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

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Drooz, Alain Date: 01/09/2005
Comment:

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

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lesley, walter Title: Physician
Organization: Scott & White Clinic/Texas A&M University
Date: 01/08/2005
Comment:

It's high time Medicare began to reimburse for carotid stenting as this technique has now been shown with the ARCHER study (as well as numerous other smaller studies) to be as safe or safer, and more effective than carotid endarterectomy. Thank you.

Mori, Kurt Title: Chief of Service, Adult Radiology, Baptist Med.Ctr
Organization: ACR, SIR
Date: 01/07/2005
Comment:

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

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Calcote, Lois Date: 01/07/2005
Comment:

Exclusion of payment to asymptomatic patients with significant carotid stenosis (>50-60%)is something akin to denial of payment for the treatment of hypertention for those patients who have not yet had symptoms of myocardial infarctions or renal insuffiency. Does a person who the population of is mostly on a fixed income really have to endure a stroke before he derserves treatment?....How cruel!

Ammar, Richard Title: MD
Organization: Iowa City Heart Center
Date: 01/06/2005
Comment:

Dear Sir or Madam:
I urge you to consider appropriate payment forcarotid stenting procedures for symptomatic patients with greater than 50% stenosis or asymptomatic patients with greater than 70% stenosis. These are generally accepted guidelines for carotid surgery, and should be applied to appropriately selected patients for carotid stenting.

Petrella MD, FACC, FACP, Richard Title: Chief of Cardiology Hamot Medical Center
Organization: Medicor Associates
Date: 01/06/2005
Comment:

I am interventional cardiologist and was a Sapphire operator. I STRONGLY recommend covering both symptomatic and symptomatic patients. Most patients studied in SAPPHIRE and in the GUIDANT registry were asymptomatic, and both series showed a clear place for stenting.Also the determination of candidacy for the procedure should be left up to the interventionalist, not a surgeon.

Foster MD, Robert Title: Cardiologist
Organization: Birmingham Heart Clinic
Date: 01/06/2005
Comment:

I believe it is a the CMS should make their decisions based in clinical data as to who would benefit from CAS. In the trials these were high risk patients with symptomatic >50% or asymptomatic >80%. Why should you withhold this less invasive tool from a population of Americans who would benefit? Are you protecting a special interest group? Surgeons? When you have your stroke with a 70% stenosis, will you be satisfied when you are denied CAS.

McGarvey, Jr, MD, Joe Organization: Central Bucks Specialists, Inc.
Date: 01/06/2005
Comment:

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

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Martin, M.D., Kevin D. Title: vascular surgeon
Organization: The Cranley Surgical Associates
Date: 01/06/2005
Comment:

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

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Blitz, Lawrence Date: 01/06/2005
Comment:

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

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Hurst, Darren Title: Co-Director
Organization: Vascular and Interventional Associates
Date: 01/06/2005
Comment:

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

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Khan, A. Rizwan Title: M.D., F.A.C.C.
Date: 01/06/2005
Comment:

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

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Heck, Donald Title: MD
Organization: Forsyth Radiology Associates
Date: 01/05/2005
Comment:

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

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Wilentz, James Title: Dir. Cardiac Cath Labs and Interv. Cardiol.,
Organization: St. Luke's-Roosevelt Interventional Cardiology
Date: 01/05/2005
Comment:

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

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Wehman, Joseph Title: Endovascular Neurosurgery Fellow
Organization: Dept of Neurosurgery SUNY Buffalo
Date: 01/05/2005
Comment:

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

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silver, mitchell Title: cardiovascular interventionalist/vascular medicine
Organization: midohio cardiology and vascular consultants
Date: 01/04/2005
Comment:

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%

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Campsey, Michael Date: 01/04/2005
Comment:
The problems with the proposed coverage decision are at least two-fold. First, by failing to provide CAS coverage for asymptomatic, high-risk patients CMS will be forcing patients with high grade lesions to undergo CEA as per the current, well-established guidelines. As per the SAPPHIRE results, patients would be undergoing a procedure that carries a greater risk of morbidity and mortality. Fundamentally this is unethical. I believe that some consideration in the asymptomatic patient

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Laster, Steven Title: interventional cardiologist
Organization: Cardiovascular Consultants, Mid-America Heart Institute
Date: 01/04/2005
Comment:

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

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Dave, Rajesh Title: Director
Organization: Central PA Cardiovscular Research Institute
Date: 01/04/2005
Comment:
The Decision of CMS regarding Carotid Artery Stenting reimbursement coverage is unfortunate. First of all, CEA data as well as Carotid Stent data support treating symptomatic Carotid artery disease with more than 50% stenosis. In high risk patients, Carotid artery stenting have demonstrated supeior outcomes in Sapphire (the only randomized high risk trial). By this decision, we are restricting asymptomatic high risk patient's access to Carotid artery stenting. In the communities, most

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Simon, Daniel Date: 01/03/2005
Comment:

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

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Soukas, Peter Title: Director, Interventional Vascular Laboratory
Organization: Caritas St. Elizabeth's Medical Center
Date: 01/03/2005
Comment:

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

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Wojak, Joan Title: Medical Director, Neurosciences
Organization: Our Lady of Lourdes Regional Medical Center
Date: 01/03/2005
Comment:

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

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Heggunje, Prabhakara Title: Intervntional cardiologist
Organization: The Heart Group
Date: 01/03/2005
Comment:

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

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Dunning M.D., FACC, FSCAI, Dennis W Title: Director of Peripheral Vascular Interventions
Organization: West Michigan Heart
Date: 01/02/2005
Comment:

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

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Orlow, Steven Title: Physician
Organization: Heart Center Medical Group
Date: 01/02/2005
Comment:

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

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Ensley, M.D., Doug Title: Cardiology of Tulsa
Date: 12/30/2004
Comment:

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

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Bare, MD, Jane Date: 12/30/2004
Comment:

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

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Hofmann, MD, Lawrence V. Title: Assistant Professor of Radiology and Surgery
Organization: The Johns Hopkins Medical Institutions
Date: 12/29/2004
Comment:

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

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Kasirajan, Karthikeshwar Title: Assistant Professor of Surgery
Organization: Emory University School of Medicine
Date: 12/28/2004
Comment:

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

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Soffer, Daniel Title: MD, FACC, FSCAI
Organization: Lenox Hill Hospital
Date: 12/28/2004
Comment:

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

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Makris, Angelo Organization: Midwest Heart Specialists
Date: 12/28/2004
Comment:

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,

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soares, gregory Title: Director VIR
Organization: Rhode Island Hospital/Brown Medical School
Date: 12/28/2004
Comment:

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

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Goldenberg, Edward Date: 12/28/2004
Comment:

I am a clinical cardiologist. The indications for carotid stenting should be the same as for carotid endarterectomy. The basis for your decision should parallel the results of the recently published studies.

Brant-Zawadzki, Michael Date: 12/27/2004
Comment:

Excellent decision, should have Neurologist evaluate symptoms, not surgeon or interventionalist

Ramos, David Date: 12/27/2004
Comment:

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

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Gershon, Abner Title: Radiologist
Organization: University of Conn Health Center / Invision Medical, LLC
Date: 12/27/2004
Comment:

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.

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Alexander, Michael Title: Director, Duke Neurovascular Center
Organization: Duke University Medical Center
Date: 12/27/2004
Comment:

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

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Wertman, Daniel Date: 12/26/2004
Comment:

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

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Burma, M.D., Gerald Organization: Cardiovascular Clinic
Date: 12/25/2004
Comment:

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

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Shanley, Charles Title: Chief, Division of Vascular Surgery
Organization: Wayne State University School of Medicine
Date: 12/24/2004
Comment:

I fully support this rational approach to a novel therapy for carotid artery occlusive disease. Until we have better data as to effectiveness, it is most appropriate that the indications for carotid artery stenting be defined narrowly to that small subset of patients for which there is some (albeit poor) data to suggest safety. Bravo!!

Bass, James Date: 12/24/2004
Comment:

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

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safian, robert Date: 12/23/2004
Comment:

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

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Bendok, Bernard Organization: Northwestern Medical Faculty Foundation
Date: 12/23/2004
Comment:

I believe that reimbursement should be expanded to cover patients whom are felt to be candidates for stenting by a surgeon and stroke neurologists. Symptomatic patient's with greater than 50% stenosis and asymptomaticn patients with 80% or greater stenosis should be reimbursed.

Carey, Daniel Title: Director, Cardiac Cath Lab
Organization: Lynchburg General Hospital
Date: 12/23/2004
Comment:

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,

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Sullivan, Timothy Date: 12/23/2004
Comment:

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

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Safian, Robert Title: Director, Cardiac & Vascular Intervention
Organization: William Beaumont Hospital
Date: 12/23/2004
Comment:
  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

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naslund, thomas Title: Chief Vascular Surgery
Organization: Vanderbilt University Medical Center
Date: 12/23/2004
Comment:

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.

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Espinoza, Andrey Title: Director, Interventional Cardiology
Organization: Hunterdon Cardiovascualr Asssociates
Date: 12/23/2004
Comment:

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.

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Chaikof, Elliot Title: John E. Skandalakis Professor of Surgery
Organization: Emory University
Date: 12/22/2004
Comment:

The current draft recommendations appear appropriate. Unrestricted application of carotid stenting, especially among asymptomatic patients or among those deemed "high-risk" but not confirmed independently by a vascular surgeon would be a serious error at this time.

Padnick, Marvin Title: President
Organization: Phoenix Heart PLLC
Date: 12/22/2004
Comment:

I read with extreme dismay, the CMS coverage of carotid stenting and particularly the EXCLUSION of Asymptomatic patients. This decision is contrary to ALL Studies including the Sapphire, Crest Registry, Archer where 60% were asymptomatic. The requirement for surgical consultation first, suggests that surgery is a better procedure with less risk, which it clearly is NOT. The CMS decision is outrageous at best and smacks of too much surgical influence at best!!!!!!

Shuck MD, John W. Date: 12/22/2004
Comment:

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

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TURK, SAMIR Title: INTERVENTIONAL CARDIOLOGIST
Organization: TRINITY HEALTH
Date: 12/22/2004
Comment:

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

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Ansel MD FACC, Gary Title: Clinical Director of Peripheral Vasc Intervention
Organization: Riverside Methodist Hospital
Date: 12/22/2004
Comment:

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

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Simpson, Michael Title: M.D., Interventional Cardiologist
Date: 12/22/2004
Comment:

Please reconsider restrictions on Medicare coverage for carotid artery stenting procedures.It is inconsistent for Medicare to impose clinical restrictions such as requiring symptoms for lesions repeatedly shown in studies to represent significant risk. Importantly, the currently proposed restrictions will result in many patients being denied this new and safe procedure, and instead, subject them to unnecessary surgery, or no treatment at all.

Martin, Paula Date: 12/22/2004
Comment:

I believe that medicare should cover carotid stenting for symptomatic patients with > than 50% blockage. This could prevent future complications. I also believe the patient ought to have the right to make an informed decision as to whether to have surgery or stenting. The final decision should not be left up to the surgeon.

Hamby, Denise Title: Staff Development Instructor
Organization: AnMed Health
Date: 12/22/2004
Comment:

I would like you to consider reimbursement for greater than 50% lesions. Surgeons should not have the final say in the reccomendations of stenting. The patients should have the final decision.

Hoyle, Darlene Title: Instructor, Nursing Staff Development
Organization: Anderson Area Medical Center
Date: 12/22/2004
Comment:

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

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Little, Cindy Date: 12/22/2004
Comment:

Carotid Artery Stenting is a safe and life saving proceudre which should be reimbursed 100% by CMS. The safety factor is large and the lives saved and the quality of lives improved is tremndous. Thank you.

Spoon, Dianne Title: RN - Research Study Coordinator
Organization: Anderson Area Medical Center
Date: 12/22/2004
Comment:

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

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MCLAURIN, BRENT Title: Director of Research
Organization: Anderson Area Medical Center
Date: 12/22/2004
Comment:

Please reconsider the carotid reimbursement to reflect the trial data. To exclude asymptomatic high grade stenosis patients is criminal as they frquently have no other options. In this era of shrinking margins, my hospital system has informed me that I will not be allowed to provide this groundbreaking, evidence-based option for my patients without reimbursement.

Brent McLaurin, MD, FACC, FSCAI

Schwarze, Margaret Title: MD
Organization: University of Chicago
Date: 12/22/2004
Comment:

I love your new recommendations for CAS reimbursement. They are perfect and absolutely make sense for who should get carotid stenting. They are data based as well as based in good sound vascular practice. I would like to see more recommendations for other procedures like this put together in a thoughtful evidence based program such as this. By the way, I am a vascular surgeon, I do carotid stenting, I like the procedure and still I think your reimbursement is commendable.

Halin, Neil Title: Chief, Vascular/Interventional Radiology
Organization: Tufts New England Medical Center
Date: 12/22/2004
Comment:

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

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Bowser, Andrew Title: Vascular Surgeon
Organization: 81st Medical Group Keesler AFB
Date: 12/22/2004
Comment:
I am writing to support the majority of the cms draft for coverage of carotid stenting. I am a vascular surgeon and interventional radiologist for the air force who does carotid stenting and carotid endarterectomy. I believe the decision of a high risk patient must involve a surgeon and I wholeheartedly support that. I am concerned about the lack of coverage for asymptomatic patients in some categories. I believe a progressive asymptomatic stenosis >80%, especially in a patient with

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Lal, Brajesh Date: 12/22/2004
Comment:

I agree with all three proposals from CMS.

1. No trial has demonstrated a specific advantage of stenting over surgery in asymptomatic patients alone.

2. The definition of "high risk" must, appropriately, rest with the treating surgeon and not an interested interventionalist who would have a vested interest in labeling the patient high-risk.

Tami, Luis Date: 12/22/2004
Comment:

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

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Dahn, Michael Title: Chief of Vascular Surgery
Organization: Univ. of Connecticut Health Ctr.
Date: 12/21/2004
Comment:

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

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Gaylord, Gregg Title: Physican
Date: 12/21/2004
Comment:

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

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brant-zawadzki MD, michael Title: MD FACR
Date: 12/21/2004
Comment:

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

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Dawson`, David Organization: University of California, Davis
Date: 12/21/2004
Comment:

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

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Abbas, Jihad Title: Assistant Professor
Organization: Medical College of Ohio
Date: 12/21/2004
Comment:

I agree with the decison not to apply carotid stentign to high rik patients until it is judged as high risk by a speicialized surgeon. Other wise every one as we see around will be considered high risk

Cohen, M.D., David Title: Director, Peripheral Vascular Intervention
Organization: St. Joseph's Hospital and Regional Medical Center, Paterson, NJ
Date: 12/21/2004
Comment:

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

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Nazzal, Munier Title: Associate Professor
Organization: Medical College of Ohio
Date: 12/21/2004
Comment:

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 .

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