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

1. Means of determining high risk: Surgeon being the determinant of high risk? Based on the current CMS guidelines, at our hospital, an oversight committee composed of neurologist, interventional radiologist, internal medicine, vascular surgeon, interventional cardiologist, general cardiologist determines high risk for surgery based on the anatomical and physiological criteria.

How is a surgeon going to be more honest and reliable than the existing system of such an oversight committee?

Keeping in view 2 important issues:

It is 'res ipsa loquitar' that this particular requirement is being put in only to protect the turf for vascular surgeons. The only unknown is whether that is a selloff to this lobby or inadvertent requirement brought in by influential surgeons misguiding the process.

Interestingly, we can imagine no data showing that a surgeon would triage risk better than an oversight committee. Again underscoring the fact that this is a whimsical requirement placed for ulterior motive by a lobby.

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Dear CMS

Re: CAS with EP Medicare coverage

Thank you for allowing me to comment on the proposed coverage decision for Carotid stenting. You have heard most of the arguments from all of the interested parties and I have seen most of their letters as well. It is quite clear that their is enough data out there to artfully construct an argument on either side of each issue.

As a practitioner of CEA for 30 years I became frustrated with the need for an alternative in the mid eighties and first performed carotid angioplasty in 1987 in a medical high risk pt with "bull neck" on whom I did not want to perform CEA.

Since 1994 I have been involved in over 2000 CAS procedures and have been on the executive committee of almost every CAS trial. I believe the less invasive procedure will largely replace CEA in the distant future. For now however we have come to realize that the 2 procedures are complementary and when unbiased decision making is applied, the results can be excellent...so to withhold CAS in high risk patients with severe stenosis would condemn these pts to the wrong operation. That would indeed be the wrong thing to do in spite of pleas from organized Neurosurgery, Neuroradiology and Neurology to the contrary.

Elderly patients are currently a conundrum. Recent data from many sources clearly shows an increased risk and I can understand your position in limiting reimbursement in octogenarians to accumulate more data. However I would encourage you not to "throw out the baby with the bath water." The risk of stroke rises precipitously as we get older and NASCET showed the greatest absolute risk reduction of almost any group for CEA (30%) in pts age 75-79. In addition, there is mounting evidence that elderly patients with medical co morbidities are at increased risk for stroke way beyond the risk for low risk pts studied in ACAS and ACST (over 6% in ACSRS) There are experienced groups (among others,Settacci el al and Villalobos from our group) who have shown good results in octogenarians.

My observation is that we went through a phase recently where we had so much experience that we thought we could do CAS on anyone and we ignored the fact that technical success is not necessarily always SAFE. The CAPTURE data is a wake up call and we have started to look critically at our complications in octogenarians. In almost every case we find arch and or perilesional anatomy that should have steered us away from CAS towards CEA. We will publish this data soon and hopefully it will help others to withhold CAS in pts with unfavorable anatomy. From our data it is clear that asymptomatic pts with severe stenosis and favorable anatomy are excellent candidates for CAS and among the most important subgroup from a societal perspective as they are very high risk for stroke due to their age and compromised cerebrovascular reserve.

One issue which troubles me greatly is the proposal to require a surgical consult from someone credentialed to do CEA. I am a surgeon and I can see no benefit from having a heavily conflicted third party surgeon policing a competitive physician. This is really the "fox in the chicken coop." Most surgeons don't do CAS and believe that they can do high risk pts with good results even though the literature does not support them. To have these conflicted surgeons police their competition seems an oxymoron. The definition of high risk is well established in the literature and in the CAS registry inclusion criteria and in the ACAS and NASCET exclusion criteria. These high risk criteria can easily be audited if necessary and are far more objective than a conflicted surgical consult which will unnecessarily waste money and produce nothing except acrimony...and some surgeons will quietly rubberstamp the cardiologists request simply for the consult fee. Having conflicted people policing other physicians simply will not work. Similarly having neurologists police surgeons and interventionalists will not work as neurologists are also conflicted by their heavy bias toward medical therapy.

In sum, I support your approach to CAS reimbursement with the caveat that conflicted surgical policemen is a can of worms with little benefit and major headaches for you... And please don't give up on the octogenarians ...we will all be there some day god willing, and CAS (with more data and better technology) will be a life saver for us and a dollar saver for those that have to care for us.

Thank you

Nick Hopkins
Professor and Chairman
Dept of Neurosurgery

LN Hopkins MD
Professor of Radiology
State University of New York at Buffalo

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There are two critical issues at question here...that there be a required surgical assessment of high risk, and that being older than 80 conveys higher risk for carotid stenting versus endarterectomy. The reality is that there are multiple overlapping disciplines that are involved in carotid revascularization, whether it be stenting or endarterectomy. To give any one discipline the power to determine procedural appropriateness over any other discipline would create a major conflict of interest, would place patients in an awkward and unsafe position, would erode professional relations, and would frankly be unethical. One can only imagine the furor that would follow a suggestion that cardiologists or radiologists be given the ability to determine whether or not surgeons should be allowed to do a particular operation! This is a profession of honor and integrity, and those that do not abide by that code are removed from practice by the many existing systems in place at the local, state, and federal levels. As for the 80 year- old cut-off point please remember that this was a major inclusion point in the thousands of patients that were successfully treated with stenting and represents a group for which this less taxing procedure was developed. If the 80+ crowd are suddenly excluded from stenting, the result will be that they will either be denied revascularization (and left with the inherent risk of stroke) or forced in the direction of surgery (where we know the risks of stroke are elevated). In our own experience in over 600 carotid stent procedures, we have seen no significant increase in complications in octagenarians versus those younger (manuscript in prep). We all know that outcomes vary from surgeon to surgeon and that high volume operators typically have less complications. The same is true for interventionalists and perhaps procedures that carry such high stakes as carotid stenting should be directed to centers of excellence with documented outcomes...at least those that are the highest of the high risk!

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Dear Dr. Chin,

I am encouraged by the proposed expanded coverage for carotid artery stenting in the high risk population to include the asymptomatic patient with a greater than 80% stenosis.

I do however have concerns for the necessity of a surgical consultant to agree that the patient is high risk for surgery. The criteria to determine surgical risk are well documented and easily identified. I am afraid that high risk patients will not necessarily be classified that way by the vascular surgeon especially when he is not the stenting physician and can gain benefit from capturing a patient into his practice.

I urge CMS to consider removing the surgical consult from the criteria and allowing the high risk determination be made by the treating physician.

Warmest regards,

Robert L. Maholic, DO
Interventional Cardiologist
Hamot Heart Institute
Erie, PA

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I am an interventional cardiologist who performs carotid artery stenting (CAS). I appreciate that CMS is attempting to expand coverage. However, I strongly disagree with the requirement that ALL patients must have surgical consultation prior to CAS. There are a few times with complex patients that collaboration (including curbside consultation) with a vascular surgeon may be in a patients best interest. However, a federal mandate that requires consultation with a surgeon is excessive and burdensome.

Interventionalists can provide care and perform CAS without surgery consultation in the vast majority of patients:
- The criteria for high risk are well-detailed in several studies, reviews, and guidelines from specialty societies. Each patients' specific high risk features should be documented for review if necessary.
- Cardiologists are trained and skilled in preop evaluation including vascular patients and may be well-suited to determine risk of surgery vs. CAS. Curiously, in light of this new proposal, there is no requirement that all vascular patients have a preop cardiology consult.
- Many interventionalists have a large vascular practice. They may be quite knowledgeable about carotid disease and its management options and may be particularly skilled in CAS. There would be little added by a surgery consultation.
- Consulting surgeons may have a bias towards CEA and have a conflict of interest which may expose high risk patients to CEA. Some surgeons who perform CEA may be general surgeons or low volume operators such that their opinion or results of CEA may not be ideal.
- Requiring a surgical consultation will delay care as patients will have to see another doctor, have possible "confirmatory" tests in that doctor's office and then return to the first doctor. Many patients with carotid disease have a high level of anxiety and feel like they are a "time bomb" They would not like additional delays. I can't think of another cardiovascular condition that requires a surgical consult. The approach to evaluation and management of carotid disease is becoming similar to coronary disease; it would be absurd to require that every patient with coronary disease see a cardiac surgeon prior to a coronary stent.
- What will happen with reimbursement if the interventionalist and surgeon have differing opinions?

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February 28, 2007

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

RE: Proposed Decision for Carotid Artery Stenting CAG-00085R3

Dear Dr. Phurrough;

The Society for Vascular Surgery represents over 2,300 physicians in the United States. SVS offers the following comments regarding Proposed Decision of the Medicare National Coverage Policy for percutaneous transluminal angioplasty of the carotid artery with stenting, CAG-00085R3. SVS appreciates the thorough and ongoing effort expended by the CAG to allow responsible introduction of this exciting technology.

As CMS works to provide an evidence-based coverage policy for CAS, consideration of the following new studies is important. These were not included in the CMS CAS bibliography published in February 2007.¹

• Debing and Van den Brande undertook a prospective analysis of 1002 CEAs in Belgium to assess the 30-day complication rate in relation to the patients’ cardiovascular risk factors. The 30-day combined CEA minor and major stroke and death rate was 2.7%. While diabetes was an independent risk factor, the simultaneous presence of three cardiovascular risk factors was required to significantly raise the stroke/death rate. With 3 risk factors, stroke/death rate was 5.3%, p=0.012, OR=3.11.2
• Westvik et al used a statewide database in Connecticut to examine all symptomatic and asymptomatic non-federal CEAs in that state between 1991 and 2002. Complications for 14,288 CEAs included 0.5% mortality and 1.3% stroke.³
• Kragsterman et al reviewed CEA outcomes on all asymptomatic patients who underwent CEA in Sweden, 1994 to 2003. Data were culled from the Swedish Vascular Registry, and four validation methods were undertaken to assure accuracy. Of 6182 total CEAs during the interval, 671 patients were asymptomatic. Stroke or death in asymptomatic patients over the entire period (2.1%) improved to 0.9% (3/341) from 1999 to 2003 (P=0.026).⁴
• Cao et al performed a retrospectively matched case-control study of 301 CAS with EP subjects to an equal number of CEA patients. Matching was by gender, age, neurologic symptoms and coronary disease. The 30-day risk of stroke was higher for CAS patients (7.9% vs 2.3%; OR 5.2; 95% CI 1.7 to 18; P=0.001), and the disabling stroke/death rate was 2.6% for CAS and 1.3% for CEA (OR 2; 95% CI, 0.54 to 9.35; P=0.4).⁵
• Mureebe et al examined CAS and CEA hospital inpatient discharge data from California and New York for the year 2005. Comorbidities associated with, or those possibly affecting, the outcome of carotid intervention were analyzed. The population included 14,785 CEA and 2,554 CAS. Mortality for patients undergoing CAS was double that of CEA (CAS=1.41%, CEA=0.64%, p<0.0001). Post-procedural stroke for CAS was double that for CEA (CAS=2.19%, CEA=1.24%, p=0.002). When the analysis was focused on patients who met high risk criteria (n=7,996), multivariate logistic regression identified CAS as a predictor of peri-procedural stroke (odds ratio 1.82, 95% confidence interval: 1.262-2.625) and mortality (OR 2.604, 95% CI 1.583-4.284).⁶
• McPhee et al used a combination of ICD9 codes for carotid artery stenosis, CEA and CAS to identify and examine patients who underwent carotid revascularization in the National Inpatient Sample. The primary outcome measure was in-hospital mortality. By logistic regression analysis of 217,468 discharges during 2003-2004, controlling for diagnosis type and medical comorbidities, CAS was independently predictive of increased in-hospital mortality as compared to CEA (OR 2.66; 95% CI 1.63-4.34). Other significant factors included the diagnosis of stroke and the presence of congestive heart failure or renal failure but gender or hospital type (teaching vs. non) did not affect mortality rates.⁷

I. SVS strongly supports “the Opinion of a Surgeon”

The Proposed Decision states “we are proposing that we modify the standard to require that the patient’s high risk status be determined by a surgeon credentialed to perform CEA”. SVS strongly supports this proposed requirement. If CMS expands the CAS coverage policy to include asymptomatic high-surgical-risk patients, the credentialed CEA surgeon will provide clinical balance for thousands of enthusiastic CAS providers, some with little or no experience caring for carotid disease patients, many of whom are likely to forge extremely liberal interpretations of high surgical risk. This is especially important as an increasing body of literature demonstrates that several of the so-called “physiologic” cardiopulmonary high-risk indicators used in CAS investigations and registries do not have a negative impact on CEA morbidity or mortality. Therefore, SVS strongly supports the CMS proposal to mandate a pre-CAS surgical risk assessment by a CEA expert.

Based on two separate lines of evidence, SVS believes that experienced CEA surgeons can identify patients at high risk for surgery more accurately than any list of individual co-morbid factors. First, large population studies cited below indicate that individual “physiologic” risk factors do not appear to increase the morbidity or mortality of CEA. Second, as population based studies document increasingly excellent CEA outcomes, one conclusion is that surgeons are not only becoming more expert at the technical aspects of CEA, but they have become experts at choosing appropriate CEA patients. If surgeons can identify those who will undergo CEA safely, the converse must also be true; these surgeons are experts at identifying patients who are truly at high-risk for surgery. If individual cardiopulmonary risk factors do not increase the risk of CEA, the experienced CEA surgeon’s clinical judgment may help the most in making this distinction. Finally, the surgeon may also help answer the question “Is the high surgical risk patient best suited for CAS or for intensive medical therapy?”

As CMS attempts to objectify definitions of the high-surgical risk patient, consideration of the following data is important. These large studies failed to identify single cardiopulmonary or cardiovascular risk factors as markers for increase CEA complication rates.

• As detailed above, Debing and Van den Brande studied 1002 CEAs in Belgium to assess the 30-day complication rate in relation to the patients’ cardiovascular risk factors. 30-day combined CEA minor and major stroke and death rate was 2.7%. While diabetes was an independent risk factor, the simultaneous presence of three cardiovascular risk factors was required to significantly raise the stroke/death rate. With 3 risk factors, stroke/death rate was 5.3%, p=0.012, OR=3.11.2
• Stoner et al reviewed NSQIP data for all patients undergoing primary isolated CEA at 123 VA and 14 private sector hospitals from 2000-2003. Study end-points were any stroke, death or cardiac event. NSQIP is an extremely accurate database. All medical records are reviewed individually by highly trained nurses who are completely independent from any potential clinical influence. Outcome analysis of 13,622 mostly male patients demonstrated a composite stroke, death, or cardiac event rate of 4.0% and a stroke/death rate of 3.4%. Cardiopulmonary co-morbid features did not affect the composite outcome in this model.⁸

The following population based studies indicate that surgeons have become very competent at identifying (and avoiding) high-surgical risk patients, and therefore are well suited to identify appropriate CAS (or medical treatment) candidates.

• As detailed above, Westvik et al examined all symptomatic and asymptomatic non-federal CEAs performed in Connecticut between 1991 and 2002. Complications for 14,288 CEAs included 0.5% mortality and 1.3% stroke.³
• As detailed above, Kragsterman et al reviewed CEA outcomes on all asymptomatic patients who underwent CEA in Sweden, 1994 to 2003. Four validation methods were used to assure accuracy. Of 671 asymptomatic patients, stroke or death rate over the entire period (2.1%) improved to 0.9% (3/341) from 1999 to 2003 (P=0.026).⁴
• Matsen performed an administrative database review in Maryland and California, using several validation methods, to identify hospital complication rate. In California from 1999 to 2003, 232 in-hospital strokes occurred during 51,331 CEAs (0.45%). Annual death rate over this interval ranged from 0.78-0.91%. This represents a maximum of 1.36% in-hospital stroke or death rate for a symptomatic/asymptomatic blended population. In Maryland, the in-hospital stroke rate was 0.29-0.65% per year from 1996-2003, with annual death rates from 0.33-0.58%. Thus, for asymptomatic plus symptomatic patients the maximum Maryland in-hospital stroke or death rate was 1.23%.⁹
• Finally, in selected patients, CEA risk may be largely a function of concern for a general anesthetic. The role of regional (i.e. local) anesthesia has recently been proven an effective strategy to lower overall CEA risk.^8,10

Additional new information derives from a recent SVS survey on practice patterns, in which 78% of responding vascular surgery practices offer carotid stenting. This information serves to refute the argument that surgeons will attempt to protect surgical “turf”. SVS would be pleased to provide the details of this survey to CMS.

It may not be widely known, and is therefore important to point out, that the typical vascular surgeon provides medical treatment and subsequently follows many patients with moderate and severe carotid stenosis in whom the lack of symptoms and/or presence of comorbidities lead the seasoned practitioner to recommend against CAS or CEA. In conclusion, vascular surgeons are the only specialists involved in treatment of carotid disease who routinely provide all three carotid disease treatment modalities, including best medical therapy, CEA, and CAS. We believe, for these reasons, the CEA surgeon can provide the single most accurate and unbiased determination of the patient who will be at high risk for surgery.

II. SVS supports restricting coverage to exclude those ≥80 years of old

Rescinding coverage for octogenarians is the only responsible choice based on the available data. Through investigational protocols we must seek the means and methods to safely provide CAS for our very senior citizens, but until we do so, CAS in octogenarians should not be a routinely covered service.

III. SVS does not support expansion of coverage to asymptomatic patients with “physiologic” high-risk comorbidities.

CMS is proposing a significant expansion of CAS coverage to include asymptomatic patients at a point in time when (1) the newest Level 1 studies fail to show non-inferiority of CAS compared to CEA, and (2) the peri-procedural stroke/death rate from CAS appears to have reached a hopefully-temporary plateau at a level almost twice the 3% upper limit established by the AHA for treatment of asymptomatic carotid lesions. Simultaneously, contemporary population based studies of CEA demonstrate peri-procedural stroke or death rates <3% for asymptomatic patients (0.9% from Kragsterman et al; 2.28% from Halm et al).^4,10

In its September 2006 comment on CAS coverage, SVS recommended expansion into the asymptomatic patient cohort based on surgical data demonstrating above-baseline complication rates for CEA in patients with anatomic high-surgical risk factors. These include patients with:

• previous CEA with recurrent stenosis
• prior radiation therapy to neck or previous ablative neck surgery (e.g. radical neck dissection)
• surgically inaccessible cervical lesion, above C2
• CCA lesion below the clavicle
• contralateral vocal cord palsy
• presence of tracheostomy stoma
• contralateral internal carotid occlusion

SVS still believes and recommends that this is the only group of asymptomatic patients in whom CAS should be covered routinely. Reasons not to expand beyond this include elemental consideration that asymptomatic carotid stenosis in patients with truly limiting or manifest systemic comorbidities (e.g. malignancy with poor prognosis, advanced LV dysfunction such as LVEF <25%, advanced chronic kidney disease, or oxygen-dependent COPD) should be managed with optimal medical therapies and not carotid intervention of any kind. Such patients have limited life expectancies and accordingly will not benefit from treatment for asymptomatic carotid stenosis.

In addition, clinical logic defies treatment of carotid disease prior to treatment for coronary disease in patients with unstable angina. These patients need to undergo coronary evaluation and treatment before rushing to CAS. It is unreasonable to think that a person with unstable angina but no neurological symptoms should consider CAS prior to, or instead of, coronary artery treatment. These patients should undergo coronary evaluation with recognition that they harbor an asymptomatic carotid stenosis. If coronary bypass surgery (CABG) is indicated, a concomitant and effective management strategy is combined CEA and CABG, rather than CAS and CABG. While the logic may not be immediately apparent, it becomes so when one considers the negative impact of CAS-required anticoagulation (e.g. Plavix) on the outcome of CABG. Plavix substantially increases the incidence of post-CABG hemorrhage. For all the above-noted reasons, SVS recommends unstable angina be removed from the list of physiologic high-risk comorbidities that would allow for CAS coverage.

Note that this strategy of combined CEA/CABG is also germaine to the high-risk criterion “in need of open heart surgery”. The literature supports the safety/efficacy profile of a combined CEA/CABG surgical approach.¹¹ Additionally, in large database studies that provide propensity scoring, case controlled methodology explains the nature of risks incurred with intervention in such patients.¹²

SVS recommends that the category “Other conditions that were used to determine high risk for CEA in the prior carotid artery stenting trials and studies, such as ARCHER, CABERNET, SAPPHIRE, BEACH, and MAVERIC II.” be removed from the list of approved indications because this ill-defined marker opens the floodgate for indiscriminate application of CAS. If CMS hopes to provide reasoned diffusion of CAS, “Other conditions…” should be eliminated.SVS is also very concerned that expanded coverage based on insufficient data will have the unintended effect of eliminating ability to recruit for the randomized controlled trials that hold great promise in helping us determine the best application of CAS. Expansion of CAS coverage to include physiologic high-risk asymptomatic patients will make it nearly impossible to complete recruitment for crucially important RCTs such as CREST and ACT1. Many questions about CAS remain to be answered. CMS and other governmental agencies should support to the maximum possible extent, RCTs and other prospective objective scientific comparisons of CAS, CEA and medical therapy to help determine the optimal means to reduce stroke in specific subsets of symptomatic and asymptomatic Medicare beneficiaries.

IV. SVS agrees that CAS should NOT be expanded to cover symptomatic patients with 50-70% angiographic stenosis.

According to NASCET results for symptomatic patients with 50-70% stenosis published in 1998, the natural history risk for stroke with medical therapy is 22% at 5 years, or approximately 4.4% per year.¹³ These patients have a less foreboding natural history risk than symptomatic patients with 70-99% stenosis. In ARCHeR, the 30-day stroke, death and MI rate was 13.0% for symptomatic patients. This means that within 30-days of treatment, CAS results in more than half the morbidity and mortality of the entire 5-year experience of NASCET patients. Expansion to the 50-70% high-risk symptomatic group cannot be justified without convincing RCT data.

In the Proposed Decision, CMS reaffirms that CAS will be covered only when performed with an embolic protection device, denying the recommendation of SVS and other specialty societies for coverage of CAS without EP under extenuating clinical circumstances. Specifically, SVS recommends coverage for CAS without EP when: 1) the operator documents that, due to patient-specific anatomic findings, the risks of embolic protection exceed potential benefits, or 2) the operator documents reasonable attempts to deploy embolic protection and sites the technical reasons why this was not possible.

SVS acknowledges the fact that the data supporting coverage derives from studies of CAS with embolic protection, but CAS experts agree there are rare exceptions wherein CAS is undertaken most appropriately without EP. In these situations, the provider and the facility should be reimbursed.

The current policy forces the CAS provider to make a decision that pits payment directly against best medical care. For example, a 70 year-old patient with class IV congestive heart failure suffers a minor stroke and is found to have an 80% carotid stenosis. The CAS operator performs a diagnostic arteriogram confirming the severely stenotic lesion but additionally identified is an extremely tortuous internal carotid artery. Reasonable attempts to pass the Embolic Protection device through the tortuosity fail. The CAS operator then faces a dilemma. He/she can 1) abort the procedure thereby subjecting pt to natural history risk for stroke (~26% over 2 years), 2) attempt to force the embolic protection device into place risking distal artery injury, or 3) perform CAS without EP, foregoing payment to provider and facility. It is unreasonable that the CAS provider should forego payment for making the best patient care decision.

If CMS is concerned that providers will disregard the scientific literature, avoiding EP use during routine practice, it seems this could be effectively dealt with during the facility recertification process. Facilities could be recertified only if their providers maintain a high usage of EP, perhaps >95%. Providers could additionally be instructed to use coding modifiers demonstrating the unusual nature of the procedure. For instance, the CPT code for CAS without EP (37216) could be submitted with the “-22” unusual procedure modifier, and payment could be conferred only if circumstances were documented in the procedure dictation. In fact, CAS with vs. without EP could even be made into a pay-for-performance measure, requiring that at least 95% of CAS be performed with EP in order to meet quality performance guidelines.

In summary, SVS believes that clinical situations exist wherein CAS without EP provides the best clinical treatment for the patient. When this occurs, the CAS provider and facility should not be financially penalized for using good clinical judgment.

VI. SVS supports physician-based CAS facility recertification programs, but we do not support CMS exclusive delegation of this responsibility to SCAI CAP.

SVS appreciates the additional details provided by CMS regarding facility recertification, an event that lies in the immediate future for many facilities. SVS believes that recertification is an activity best assumed by specialty-neutral accrediting agencies, similar to those very successful efforts for noninvasive vascular laboratories, echocardiography facilities and nuclear medicine diagnostic labs (e.g. ICAVL, ICAEL, ICANL). These examples have all stemmed from truly “intersocietal” efforts rather than single-specialty programs.

SVS respects the initiative taken by SCAI in development of their Carotid Accreditation Program (SCAI-CAP), but we are concerned about its specialty-specific roots and cardiac cath-lab focus. Regarding the SCAI-CAP documents,^14,15 SVS finds the described level of our society’s involvement to be overstated. SVS has had very limited discussions with SCAI regarding SCAI CAP, and SVS leadership had not seen the SCAI-CAP accreditation program overview or the SCAI CAP program application prior to publication of the CMS Proposed Coverage rule on February 1, 2007.

SVS is committed to participation in a specialty-neutral initiative that would assume the CAS facility recertification role. This specialty-neutral entity could be established in parallel with SCAI-CAP, or perhaps the SCAI-CAP program could be folded into a more broad-based intersocietal effort. The biggest problem we see is continuation of the CMS program because it is difficult to envision many facilities choosing a rigorous and expensive non-CMS certification program when a less rigorous and cost-free direct CMS certification remains available. In order for independent certification / recertification programs to succeed, CMS will need to discontinue its direct certifying mechanism and endorse the independent program(s).

VII. SVS appreciates CMS’ recognition of the SVS Vascular Registry

SVS put forth a major effort to provide the Vascular Registry. We were pleased to see our efforts acknowledged in the CMS document, but more importantly, we view the Registry as a means to help solve some of the perplexing CAS problems. We hope to continue collaborative efforts with CMS to reap benefits for our cerebrovascular disease patients.

Conclusion

SVS thanks CMS CAG for their continued efforts to provide appropriate coverage for CAS. We are committed to the advancement of all forms of carotid therapy with the overall goal of reducing morbidity and mortality from stroke. We are available at any time for telephone or in-person discussions regarding our comments.

K. Craig Kent, M.D.
Presidentand the Executive Council ofThe Society for Vascular Surgery

References:

1. CMS Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R3).
2. Debing E, Van den Brande P. Does the type, number or combinations of traditional cardiovascular risk factors affect early outcome after carotid endarterectomy? Eur J Vasc Endovasc Surg 2006;31:622-6
3. Westvik HH, Westvik TS, Maloney SP et al. Hospital-based factors predict outcome after carotid endarterectomy. J Surg Res 2006;134:74-80
4. Kragsterman B, Parsson H, Lindback J et al. Outcomes of carotid endarterectomy for asymptomatic stenosis in Sweden are improving: Results from a population-based registry. J Vasc Surg 2006;44:79-85.
5. Cao P, De Rango P, Verzini F et al. Outcome of carotid stenting versus endarterectomy: a case-control study. Stroke 2006;37:1221-6.
6. Mureebe L, Egorova N, Fang C et al. Carotid angioplasty and stenting and carotid endarterectomy in the community: Analysis of outcomes using large data sets. Accepted for presentation at the Society for Vascular Surgery Annual Meeting, June 2007.
7. McPhee JT, Hill J, Eslamil M et al. Increased national in-hospital mortality following carotid stenting as compared to carotid endarterectomy. Accepted for presentation at the Society for Vascular Surgery Annual Meeting, June 2007.
8. Stoner MC, Abbott WM, Wong DR et al. Defining the high-risk patient for carotid endarterectomy: an analysis of the prospective National Surgical Quality Improvement Program database. J Vasc Surg 2006;43:285-95
9. Matsen SL, Chang DC, Perler BA et al. Trends in in-hospital stroke rate following carotid endarterectomy in California and Maryland. J Vasc Surg 2006;44:488-95.
10. Halm EA, Hannan EL, Rojas M et al. Clinical and operative predictors of outcomes of carotid endarterectomy. J Vasc Surg 2005;42:420-8.
11. Akins CW, Hilgenberg AD, Vlahakes GJ et al. Late results of combined carotid and coronary surgery using actual versus actuarial methodology. Ann Thorac Surg 2005;80:2091-7.
12. Ricotta JJ, Wall LP, Blackstone E. The influence of concurrent carotid endarterectomy on coronary bypass: a case-controlled study. J Vasc Surg 2005;41:397-401.
13. Barnett HJ, Taylor DW, Eliasziw M et al. Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. NEJM 1998;339:1415-25.
14. SCAI CAP Overview
15. SCAI CAP Program Application

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Too many patients have been treated inappropriately, being referred by confused PCPs to so called "catheter based interventionalists". I am a surgeon who performs both interventional procedures for extracranial carotid stenosis and carotid endarterectomy. Despite my group's 0.5% stroke rate for carotid surgery(including high risk and so called poor stent candidates) at the Hospital where all of our surgery is done, neurologists literally ignore the data and refer to both our group and interventionalists, misrepresenting the current review data concerning carotid stenting presented in the NEJM. It is time that the "purveyor" of quality,Medicare, allow the data to speak for itself. I am 100% in favor of the proposal to insure that the therapy being determined the most likely to favor a suuccessful outcome, be selected by those who are also qualified to perform carotid endarterectomy, as long as their surgical mortalitiy and complication rate are meeting the standard of care. I have seen patients undertreated and overtreated because of this wanton use of a good but abused therapy. Please act in favor of the patient's welfare, and refuse to allow the ability to simply pass a wire through a lesion to be the ticket to therapy!

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March 2, 2007

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Marcel Salive, MD, MPH
Director, Division of Medical and Surgical Services
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG 00085R3: Percutaneous TransluminalAngioplasty (PTA) of the Carotid Artery Concurrentwith Stenting – Proposed Changes, February 1, 2007

Dear Drs. Phurrough and Salive:

On behalf of the members of the American Societyof Interventional and Therapeutic Neuroradiology(ASITN), the Executive Committee would like toofficially respond to the aforementioned Centersfor Medicare and Medicaid Services (CMS) ProposedChanges, dated February 1, 2007. In brief, theproposal would involve the following changes:

1. restrict current coverage for high risk,symptomatic patients under 80 years of age with ≥70% carotid artery stenosis;
   
2. expand current coverage to high risk,asymptomatic patients under 80 years of age with ≥80% carotid artery stenosis;
   
3. Establish that a surgeon performing theconsultation be qualified to perform carotidendarterectomy as delineated by the facility;

and the following clarifications:

4. clarify that coverage is only applicable whenan distal embolic protection device is being used;
   
5. modify the process for facility certificationand recertification

As per your description, such modifications wereproposed based on recent data published since theprior decision in 2005 (NCD 20.7B4).

Previous history clearly demonstrates that thedecisions of CMS carry an incredible weight on theway the science and art of medicine is practicedin the United States, and possibly the world. Itis also clear that CMS has always strived to basedecisions on best possible clinical evidence. Thetreatment of carotid artery stenosis carries withit a tremendous burden in the current healthcareatmosphere and stands to potentially define howtechnological and patient care advances will beassessed, monitored and reimbursed in the future. We are thus very cognizant of the tremendousimpact this CMS proposal carries for patients withcarotid artery stenosis and the precedent it wouldset for future proposals.

First we would like to propose that CMS should usethe term “high surgical risk” and “normal surgicalrisk” patients when referring to the patientgroups defined by CMS. Many within the public andthe medical community continue to have difficultydiscerning “high surgical risk” from “high strokerisk” patients. With this in mind, the AmericanSociety of Interventional and TherapeuticNeuroradiology disagrees with the stated proposalsgiven the level of evidence that is currently inthe literature as these proposals would not be inthe patient’s best interest. Each of these latterpoints will be discussed in turn.

Point 1: Restrict current coverage for high risk,symptomatic patients under 80 years of age with ≥70% carotid artery stenosis

There is insufficient evidence to limit CAS topatients under age 80 who are symptomatic andtherefore at high risk for stroke. Unlike theasymptomatic population of patients (v.i.) thenatural history of symptomatic patients withhigh-grade stenosis is , in fact well known. NASCET reports an estimated two-year ipsilateralstroke rate of 26%. Therefore, the treatmentrisk, in an appropriately selected patient mustfair better than this 26%, two-year risk. Inthis proposed NCD, CMS has cited literaturedocumenting an increased morbidity and mortalityfor CAS in patients over the age of 80. Stanziale,et. al., and the report from the CAPTURE registry,document rates of stoke, death or MI of 9.2% and9.4% respectively in patients over the age of 80undergoing CAS.Though these rates weresignificantly greater than the rates for patientsunder 80, they are still less than the the naturalhistory for this population and as such should beoffered an alternative to CEA which in thehigh-risk octogenarian would not be prudent. Thusthe data should not prohibit and negate thepotential benefit of this procedure in allpatients over the age of 80. Rather, as will bediscussed, criteria need to be developed that willbetter risk-stratify such pateints in order tomaximize benefit for each patient in particularand the octagenarians in general.

Point 2: Expand coverage to high-risk asymptomaticpatients less than 80 years of age with ≥ 80%carotid artery stenosis.

Proposal CAG-00085R3 states that the primaryimpetus for this expansion in coverage is based onpublished evidence. However, the publishedevidence quoted as being in support of this changeincludes a number of case series and companyregistries, which may have bias that can confoundthe results and conclusions. Based on ACAS andACST, carotid endarterectomy (CEA) has been shownto be beneficial compared to aspirin in a normalsurgical risk asymptomatic patient if the 30 daystroke and death rate is less than 3%, howeverthere is no study of CEA or carotid angioplastyand stenting (CAS) versus medical therapy in highsurgical risk patients with asymptomatic carotidstenosis. Subjecting patients to a procedure witha risk that is notably higher than the medical armof ACAS and ACST (as is noted in the CAPTURETrial, CASES Trial and Safian et al.) without aclear understanding of this patient population’snatural history is not justified. Indeed, studiessuch as the SAPPHIRE Trial, with a combined 30-daystroke, death and MI rate of 5.5% for carotidstenting and 10.2% for carotid endarterectomy,suggest that CEA and CAS in high surgical riskpatients with asymptomatic disease needs to beformally evaluated in a trial setting against bestmedical management. This would requirereevaluating the current coverage forendarterectomy in the high surgical risk patientand developing a mechanism by which this can bebest studied. If a NCD for CEA in this setting isundertaken it will create the impetus to actuallystudy the efficacy of treatment.

Additionally, CMS raises a very important pointregarding what defines high surgical risk, as thelack of specific criteria may result in aninappropriate selection of patients for treatment. A clear delineation is needed as to whatconstitutes medical high surgical risk that maydecrease life expectancy so that patients wouldnot live long enough to see the reduced stroke anddeath benefit of CAS or CEA. These include (underyour current headings):

March 3, 2007

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Marcel Salive, MD, MPH
Director, Division of Medical and Surgical Services
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG 00085R3: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting – Proposed Changes,

February 1, 2007

Dear Drs. Phurrough and Salive:

The American Association of Neurological Surgery (AANS), the Congress of Neurological Surgeons (CNS), and the AANS/CNS Joint Section on Cerebrovascular Surgery appreciate the opportunity to comment on the proposed changes to Centers for Medicare and Medicaid Services (CMS) National Coverage Decision, dated February 1, 2007.

In brief, the proposal would involve the following changes:

As per your description, such modifications were proposed based on recent data published since the prior decision in 2005 (NCD 20.7B4). We have reviewed the data presented in the proposed changes to the NCD and will comment on each specific point.

Point 1: Restriction of coverage to high risk, symptomatic patients under 80 years of age with > 70% carotid artery stenosis. We disagree with this change. There is insufficient evidence to limit CAS to patients under age 80 who are symptomatic and therefore at high risk for stroke. In its proposed NCD, CMS cited literature documenting an increased morbidity and mortality for CAS in patients over the age of 80. Stanziale, et. al., and the report from the CAPTURE registry documented rates of stroke, death or MI of 9.2% and 9.4% respectively in patients over the age of 80 undergoing CAS. These rates were significantly greater than the rates for patients under 80. While this is compelling data that should be considered in every patient over the age of 80 who is being considered for CAS, it does not necessarily negate the potential benefit of this procedure in all patients over the age of 80. The natural history of medical management of patients with severe stenosis documented in NASCET, estimated two year ipsilateral stroke rates of 26%, in this age group. The proposed change to the NCD would limit access to potentially life saving therapy in this group of patients who have limited other options.

Point 2: Expand coverage to high-risk asymptomatic patients under 80 years of age with > 80% carotid artery stenosis. Proposal CAG-00085R3 states that the primary impetus for this expansion in coverage is based on published evidence. However, the published evidence quoted as supporting this change includes case series and company registries. Such data may have inherent bias that can confound the results and conclusions. There is solid class I evidence that carotid endarterectomy is beneficial in an average-risk asymptomatic patient if the 30 day stroke and death rate is less than 3% (based on ACAS and ACST). What is not clear in the literature is the natural history of high-risk patients with asymptomatic carotid stenosis. Subjecting patients to a procedure with a risk that is notably higher than ACAS and ACST (as is noted in the CAPTURE Trial, CASES Trial and Safian et al.) without a clear understanding of this patient population’s natural history is not justified. In the SAPPHIRE Trial the 30 day stroke and death rate in high risk asymptomatic patients undergoing CAS versus CEA was 5.4% versus 4.6% respectively. If acute myocardial infarction is included, the 30 day adverse event rate in asymptomatic high risk patients was 5.5% for CAS versus 10.2% for CEA. These results suggest a >3% 30 day stroke and death rate for both CAS and CEA in high risk asymptomatic patients but are based on a single underpowered RCT (SAPPHIRE). The apparent excess risk for CEA was due solely to myocardial infarction and cannot necessarily be extrapolated to other high risk subgroups or patients undergoing CEA with regional anesthesia.

There is insufficient evidence regarding the relative risk of CAS versus CEA in all asymptomatic high risk subgroups to suggest that either procedure is superior to best medical therapy. Accordingly, it would be inappropriate and not in the best interest of patient care, to change the CAS NCD to include asymptomatic high risk patients in any age group at this time. It would be appropriate for CMS to review its policies regarding CEA in high risk asymptomatic patients. In high risk asymptomatic patients, both CAS and CEA should be evaluated in a randomized clinical trial or other scientifically accepted methodology containing a medical control arm and statistically powered to determine efficacy.

Additionally, CMS raises a very important point regarding what defines high-risk, as the lack of specific criteria may result in an inappropriate selection of patients for treatment. Prior definitions of significant cardiac disease defined as CHF NYHA class III/IV or unstable angina (Canadian Cardiovascular Society class III/IV) or ejection fraction < 30% are specific and sufficient. A history of myocardial infarction should be specific for when the infarction occurred, such as within the past month. These criteria were, in fact, adopted by Cremonesi et al in the Italian multispecialty recommendations cited in the NCD. However, other categories of risk are not as well defined, but would include: high medical risk that may decrease life expectancy (such patients might therefore be more likely to benefit from best medical management), high surgical risk that does not necessarily alter life expectancy (prior carotid surgery, radiation to the neck and other risks which may favor carotid stenting), and/or high endovascular risk (which might preclude CAS). These risk categories should be better defined in order to render risk- stratification more objective.

Point 3: Establish that a surgeon performing the consultation be qualified to perform carotid endarterectomy as delineated by the facility. We agree with this clarification.

Point 4: Clarify that coverage is only applicable in the setting where a distal embolic protection device is used.

The evidence that is presented in support of this clarification is somewhat lacking in that much of the conclusions are extrapolations and inferences from registries and case series that do not address this conclusion as a primary endpoint. Kastrup et al. (Stroke 37:2312, 2006) recently reported that the incidence of new ipsilateral lesions on diffusion-weighted imaging (symptomatic and asymptomatic) was lower in patients undergoing stenting with a distal embolic protection device than patients without a distal protection device. However, as mentioned, most events were asymptomatic and this study allowed the physician to determine whether the device should be used. Most importantly, procedural complications (30-day ipsilateral major/minor stroke) were not statistically different in the two groups. This recent finding is supported in other published literature as well (Theiss et al.: Stroke 35:2134, 2004; SPACE collaborators: Lancet 368:1. 2006).

In high-risk, high-stenotic grade patients, the proposed modification by CMS might influence the physician adversely, by pressuring the physician to pass the device and thereby potentially increase the overall procedural complication rate which is already higher than the “average- risk” patient for carotid artery stenting – all in an attempt to remain compliant with CMS and be reimbursed.

In summary, the lack of sufficient data supporting the benefits of distal embolic protection device use does not justify the potential for increasing patient morbidity in trying to remain “compliant” with CMS criteria. We therefore suggest that CMS require that a distal protection device be used unless deemed inappropriately high risk by the treating physician.

Point 5: The five facility certification requirements are unchanged. We propose to modify the process for completing the certification and recertification process in the NCD Manual. We disagree with this clarification.

Regarding the potential transfer of authority for certification and recertification of facilities performing CAS, we are opposed to the proposal that these functions be performed by the Society for Cardiovascular Angiography and Interventions (SCAI). Although the SCAI is compromised of members dedicated to vascular interventions, the vast majority of such interventions involve the coronary and peripheral vessels. SCAI does not represent neurology, neurosurgery or neuroradiology. Oversite of certification and recertification of facilities must be performed either by a neutral body or a body representing all appropriate medical specialties. We are willing to participate in the development of such a multidisciplinary certification authority.

In conclusion, the American Association of Neurological Surgeons and the Congress of Neurological Surgeons opposes the proposed changes (CAG-00085R3) for the aforementioned reasons and would make the following suggestions:

Furthermore the societies recommend that further Class I evidence on the natural history of high- risk patients with asymptomatic carotid stenosis be obtained and analyzed prior to future modifications to the Percutaneous Transluminal Angioplasty of the Carotid Artery Concurrent with Stenting NCD.

Thank you for considering our recommendations.

Sincerely,

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While I am uncertain as to the general utility of asymptomatic carotid stenting, I do believe there is a role in highly selected situations. I strongly endorse the provision where an experienced surgeon decides the relative risk of endartectomy as that risk in most institutions is quite low ( Without this provision, non surgeons will artifically inflate the perceived risk in order to justify the only procedure they can offer (ie stenting). I preform both in my practice and I am very reluctant to offer asymptomatic individuals stenting ( 150 open CEA/year, 20 symptomatic stents/year, 2 asymptomatic patients in trial setting only). To approve the device without this important caveat will definetly cause suffering in patients who stroke after stenting who probably would have gained no benefit over medical rx in the first place. Do not allow the special interests of the device manufacturers and the cardiology lobby to blur the reality-no study has shown utility of carotid stenting in asymptomatic patients. Thank you.

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I believe that a decision by CMS to liberalize payment for Carotid Artery Angioplasty and Stenting to include asymptomatic patients, even in a post-market study, is an enormous mistake. I have been a co-investigator in the NASCET and ACAS trials and a principal investigator in SAPPHIRE, CREST and ACT I. I am a surgeon and in our department we do both endarterectomy and carotid angioplasty and stenting.

The stroke risk of asymptomatic stenosis of >80%is small The data to support endarterectomy for these patients is based on the ACAS trial which showed little benefit to men and no benefit to women. Additionally, medical therapy of ASCVD has improved significantly since ACAS so that one can probably justify a new trial with a medical therapy arm.

Using ACAS data in conjunction with the current data available for carotid stenting to justify approval of carotid artery stenting is simply scientifically invalid. There currently are two trials underway, CREST and ACT I, that if allowed to be completed will answer this question definitively. The proposed change jeopardizes the completion of those trials greatly and may prevent us from ever knowing whether carotid stenting is appropriate for anyone.

If CMS decides to follow this course, it will merely be bowing to industry pressure instead of protecting patient's health and the taxpayer's pocketbook. It will be inevitable that thousands of unnecessary procedures costing millions of dollars will be performed and that there will be no benefit to the public or individuals for that matter.

CMS should retain its current policies regarding carotid artery stenting until the results of CREST and ACT I are available.

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I heard a quote recently at a Grand Rounds that some were "blindsided" by recent developments pertaining to coronary stents. I think it is possible that the same thing may eventually be said about carotid stenting if the indications are loosened up. Too many procedures will be performed and by people who should not be doing them with more complications than will be reported, as has already happened around here. The same is true for carotid endarterectomy. There is information coming out that our ultrasound criteria indicating greater than 80% stenosis need to be revised upward also. I think it could end up being costly, detrimental, and lead to too many people doing too many carotid stents. Most of this push is primarily for financial gain in my opinion.

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Comments for CMS proposed changes

In the Opinion of a Surgeon The requestor also asked that CMS remove the language from the current NCD that requires patients eligible for CAS to be at high surgical risk in the opinion of a surgeon. We disagree. Both EVA- 3S and SPACE demonstrate the risks of CAS and the benefits of CEA when preformed by well-trained, highly qualified surgeons. We believe this data clearly demonstrates the need for an expert opinion and we are thus proposing that we modify the standard to require that the patient’s high risk status be determined by a surgeon credentialed to perform CEA. In addition, CAS for patients who are not at high risk for CEA in the opinion of a surgeon credentialed to perform carotid endarterectomy remains covered only in FDA-approved Category B IDE clinical trials under 42 CFR 405.201 or under the clinical trial policy. CMS believes that the most valuable information for non-high risk patient populations will be derived from randomized clinical trials (RCTs) and prefers that trials examining these patients are RCTs. The EVA-3S and SPACE randomized trials enrolled symptomatic patients with no restriction based on risk for CEA. Since both trials failed to show non-inferiority of CAS, evidence on safety and effectiveness from randomized clinical trials is needed for patients at low surgical risk. The CREST and ACT randomized trials are ongoing and should provide additional information in the near future. It appears as though CMS consideration of thisis being based on the recent data from both EVA-3S and SPACE. Crucial inconsistencies exist with this evaluation. The staement regarding failure to show “non- inferiority” in SPACE is troubling. First of all the trial was not powered to reach statistical significance. After 1200 patients were enrolled the events rates of stroke and death (41 CAS group and 37 in the CEA arm: 6.8% versus 6.34%) were so close that there was essentially no difference p=0.09.

The trial was stopped prematurely due to inadequate funding and because they realized that in oreder to potentially reach any difference that they needed more patients. Therefore, in this non-powered grossly flawed study on a number of fronts (see below) no statistical significance means eassentially not inferior. Next, the notion of well trained highly qualified surgeons. Simply because a surgeon performs CEA does not make him well trained and highly qualified in the setting of performing CEA. It has been demonstrated that most vascular surgeons in the US perform only 12-15 endarterectomies annually. The number of average CEA’s perfomed by the surgeons the year prior to enrolling patients in both EVA-3S and SPACE as well as SAPPHIRE, ACAS and NASCET were approxiamtely 25-30! Real world data from a number of registries outside of controlled randomized clinical trials has shown that event rates exceed AHA standards when applied to vascular surgeons universally who are not performing high volumes of CA and that event rates are at least doubled. And this was a reflection only of stroke and death. Myocardial infarction was not a pre- specified endpoint. When evaluting the aforementioned trials it is interesting that CMS has only taken into account the conclusions of the studies and not extracted crucial scientific facts that account for the differences in outcomes. First, operator experience. It has become clear that with appropriate training progrmas and careful dissemination to varying operator experience level CAS can be performed safely (reference CAPTURE 2500 database). In EVA-3S CAS operators had to perform only two CAS cases in order to be considered an experienced operator. In the study 13 patients were converted to CEA due to access problems??? Lending into the operators inexperience most likely with both procedural technique and case selection. The stent of choice the Wallstent, not even approved for use in the US for CAS, was the predominent stent used in the study.

The authors actually admit that certain enrolled patients were treated by physicians under the surpervision of a tutor. Second, the absence of the universal use of embolic protection devices. In EVA-3S and SPACE the use was of EPD not mandated and was absent in the majority of patients enrolled. Only 121 patients in SPACE out of 527 (27%) who underwent CAS received an EPD. How can one extrapolate that CAS was non- inferior when the techniques being used to asses its effectiveness that have become standard in practice in the US were not employed. No standardized stent technique was utilized either with almost 20% of patients in EVA 3-s receiving a direct stenting procedure. This is concerning because deployment of nitinol stents in significant lesions would result in substantial residual stenosis that would require aggressive psot-dilatation that usually translates into higher event rates. CMS in their coverage policy only reimburses CAS procedures if EPD’s were utilized because of the substantial complication rate cited by CMS when these devices are not utilized. “CAS is only covered when used with an embolic protection device and is, therefore, not covered if deployment of the distal embolic protection device is not technically possible” and “Coverage is limited to procedures performed using FDA approved carotid artery stents and embolic protection devices.”

Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting: CMS Website. Is CMS endorsing a studies that used methods and devices that are in direct contradistinction of what CMS previously reviewed and based their initial CAS coverage decision on? Next, with regards to vascular surgical pre-operative evalution for high risk is concerning for a number of reasons. This is not simply an anatomical assessment. Surgeons may be capable of fullfilling anatomic risk assesment but when it comes to pre-operative evalution to determine cardiopulmonary surgical risk for non-cardiac surgery standards dictate that this be performed by a cardiologist or other physician qualified to asses cardiac and pulmonary function. This may require pre-operative testing that requires interpretation and includes ECG, stress perfusion imaging, and echocardiographic imaging. A surgeon has no specific training that would allow him or her to compentently asses these studies. “A critical role of the consultant is to communicate the severity and stability of the patient's cardiovascular status and to determine whether the patient is in optimal medical condition, given the context of surgical illness.”

ACC/AHA Guideline Update for Perioperative Cardiovascular Evaluation for Noncardiac Surgery.

No where below in the ACC published guidelines is there provision that requires a nor recommends a vascular surgeon to determinecardiac risk for a procedure they are going to perform (see figure below)

Figure 1. Stepwise approach to preoperative cardiac assessment. Steps are discussed in text. *Subsequent care may include cancellation or delay of surgery, coronary revascularization followed by noncardiac surgery, or intensified care.

It is interesting that neither EVA-3S nor SPACE included myocardial infarction as a primary endpoint. CMS initial approval of CAS was based on a number of studies and registries that specifically included MI as an endpoint. In SAPPHIRE, the endpoint of MI is what truly allowed CAS to sit on a level playing field as the risk of MI in CAS was negligible, whereas in CEA it was strikingly high (2.9% CAS vs 7.1% CEA, SAPPHIRE study NEJM). MI is a well known potential complication of general anesthesia surgery, especially vascular surgery because the incidence of CAD in patients with PAD or severe carotid disease can be as high a 50%. Charlson et al (Charlson ME, MacKenzie CR, Ales K, Gold JP, Fairclough G Jr, Shires GT. Surveillance for postoperative myocardial infarction after noncardiac operations. Surg Gynecol Obstet. 1988;167:404-14) reported on 232 mostly hypertensive or diabetic patients undergoing elective noncardiac surgery. Serial ECGs and CK- MB were collected for 6 days postoperatively. The incidence of perioperative MI varied greatly depending on the diagnostic criteria used. A strategy using an ECG immediately after the surgical procedure and on the first and second days postoperatively had the highest sensitivity. Strategies including the serial measurement of CK-MB had higher false-positive rates without higher sensitivities. In contrast, Rettke et al (Rettke SR, Shub C, Naessens JM, Marsh HM, O'Brien JF. Significance of mildly elevated creatine kinase (myocardial band) activity after elective abdominal aortic aneurysmectomy. J Cardio- thorac Vasc Anesth. 1991;5:425-30) reported that overall survival was associated with the degree of CK-MB elevation in 348 patients undergoing abdominal aortic aneurysm repair, with higher levels associated with worse survival. Yeager et al (Yeager RA, Moneta GL, Edwards JM, Taylor LM Jr, McConnell DB, Porter JM. Late survival after perioperative myocardial infarction complicating vascular surgery. J Vasc Surg. 1994;20:598-606) evaluated the prognostic implications of a perioperative MI in a series of 1,561 major vascular procedures. These authors found that the incidence of subsequent MI and coronary artery revascularization was significantly higher in patients who suffered a perioperative MI, except in the subset who only demonstrated an elevated CK- MB without ECG changes or cardiovascular symptoms. CMS would be remiss and should strongly reconsider endorsing vascular surgeons as appropriate physicians to determine pre- operative cardiac and or pulmonary risk when their training does not allow for this skill nor due they screen routinely for post procedural MI. Also at the current time any and all patients desiring to undergo CAS need to have an evalution by a neurologist both pre and post procedure and at 30 days. Why are vascular surgeons exempt from having this same requirement to asses their outcomes?? “Finally, standard practice after CEA does not include routine evaluation by a neurologist. In a large meta- analysis of nearly 16,000 symptomatic patients with CEA, the 30-day risk of stroke and death was 7.7% if a neurologist evaluated the patient, and 2.3% if a vascular surgeon performed the evaluation”. Rothwell PM, Slattery J, Warlow CP. A systematic review of the risks of stroke and death due to endarterectomy for symptomatic carotid stenosis Stroke 1996;27:260-265

The fox guarding the henhouse is always a dangerous proposition. By establishing a guideline that mandates that one specialty “supervise” when both specialties perform the same procedure is a direct attempt by CMS to succumb to the political pressure from the vascular surgical community. How ironic is it that vascular surgeons are now partaking in CAS? Do they now have carte blanche to cherry pick what procedure they are to provide the patient since they can offer both? If so, is their a mechanism in place of how many consultations are required by independent physicians or will they be allowed to self refer? How does one ligitimately explain to a family doctor or internist the need for every patient referred for CAS needs to have not only a neurologic referral but a surgical one too?

How many patients will be placed at risk waiting months to see all these consultations? What happens when a high risk symptomatic patient is referred for CAS and requires urgent intervention and it becomes two or three months before he can have his procedure done. The wait to get in to see these consulting physicians may take an inappropriate amount of time. If that patient has a major disabling stroke while waiting for further consultation and the family wants answers to why in the U.S. does a patient have to wait for a proven procedure and could have this been prevented? Are we then obligated to provide the family with CMS contact information so they know where to begin the litigation process?? Especially since there in no preceedent for this and absolutely no data suggesting that patients have better outcomes or lower event rates when surgical consultation is obtained. CMS is doing the correct thing in their judicious asesment of how CAS technology gets disseminated and should be applauded for their efforts directed at patient care. However, the expansion of this technology and its’ applicability to patient care is inevitable. Making coverage decisions based on available data is in the scope of CMS’s mandate. Mandating that single specialty organizations police other single specialty groups would be unprecedented and in my mind outside the scope of CMS’s mandate.

Simply consider the potential and extraordinary consequences that could arise if this is agreed to. Will cardiothoracic surgeons one day be required to review every catheterization film to determine who has percutaneous coronary intervention or bypass? Will radiologists one day dictate to an emergency room physician who can get a CT scan of the head in patients presenting with headaches? I recommend you that you realize that one day we will all fall ill and require medical care at some point. How dissapointed will you be to find out that a potentially life saving treatment is available to you but because of a biased physician mandate you are not allowed to receive that treatment. And why? Well, two different specialties disagreed on the care you should receive and the tie breaker went to a physician without credentials to determine your medical risk ultimately disallowing coverage for your care. Just a thought.

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March 2, 2007

Steve Phurrough MD, MPA
Director, Coverage and Analysis Group
Marcel Salive MD, MPH
Director, Division of Medical and Surgical Services
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244

RE: Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting

Dear Drs. Phurrough and Salive:

The undersigned organizations wish to respond to the proposed NCD revision (CAG-00085R3) related to carotid artery stenting (CAS).

CMS proposes 3 changes to the NCD:

1) Restrict the current coverage for patients who are at high risk for carotid endarterectomy (CEA) and have symptomatic carotid artery stenosis > 70% to patients who are less than 80 years of age.

We disagree with this change. There is insufficient evidence to limit CAS to patients under age 80 who are symptomatic and therefore at high risk for stroke. In its proposed NCD, CMS cited literature documenting an increased morbidity and mortality for CAS in patients over the age of 80. Stanziale, et. al., and the report from the CAPTURE registry documented rates of stoke, death or MI of 9.2% and 9.4% respectively in patients over the age of 80 undergoing CAS. These rates were significantly greater than the rates for patients under 80. While this is compelling data that should be considered in every patient over the age of 80 who is being considered for CAS, it does not necessarily negate the potential benefit of this procedure in all patients over the age of 80. The natural history of medical management of patients with severe stenosis documented in NASCET, estimated two year ipsilateral stroke rates of 26% for this age group.

The proposed change to the NCD would limit access to potentially life saving therapy in this group of patients who have limited other options.

2) Expand coverage to patients who are at high risk for CEA and have asymptomatic carotid artery stenosis >80% and are less than 80 years old.

We disagree with this change. The undersigned unanimously agree that the evidence is currently insufficient to support coverage for CAS in asymptomatic high risk patients.

In order to show a net benefit in asymptomatic patients the accepted 30 day stroke + death rate in average risk patients must be < 3% based on ACAS and ACST. The additional studies cited by CMS since the original 2005 NCD, which was limited to symptomatic high risk patients, are case series or industry sponsored registries; none is a randomized controlled trial. The 30-day major event rates (mostly stroke) in the 3 largest studies cited (CAPTURE, CASES, Safian etal) were: 6.8%; 4.5%; and 6.2% respectively. In the largest registry, CAPTURE 3500, the 30-day stroke + death rate even in patients under age 80 was 4.1%.

Beyond procedural risk, as treating physicians we believe it remains unclear whether, in high risk asymptomatic patients, CAS or CEA is superior to concurrent medical therapy. CMS itself acknowledges that “...the outcomes of asymptomatic carotid artery stenosis with optimal medical therapy remain unclear and unstudied.” Thus, while subjecting asymptomatic patients to a significant procedural risk of stroke, without concurrent medical controls or a better understanding of the multiple natural histories comprising the high risk subset it is impossible to determine if the procedural risk can be justified by any long-term benefit.

At the time of the 2005 NCD, CMS challenged the medical community to gather outcomes data in medically treated asymptomatic high risk patients. This has not occurred for several reasons. There are 15 conditions lumped together under “high risk.” Five of these are cardiac; some are anatomic (e.g. high cervical bifurcation; contralateal occlusion; restenosis); some are related to malignancy (prior neck irradiation); and some involve other major organ dysfunction (renal, pulmonary). There may also be special circumstances such as patients requiring coronary intervention with concomitant carotid stenosis. The long-term benefit of CAS compared to best medical therapy is likely to differ for these various conditions and it will be impossible to conduct a RCT for each condition. Specific guidelines should be developed for each major high risk category. At a minimum these high risk criteria patients should be divided into 2 groups: those with less than 5-year life expectancy and those with greater than 5-year life expectancy based on actuarial or other objective natural history data. Other barriers include the lack of funding for medical outcomes proposals, the difficulty of conducting a randomized controlled high risk CAS trial which includes a medical arm, the mistaken belief that efficacy data can be provided through registries and that registry data will be sufficient to obtain expanded coverage.

Since CEA is already reimbursed and CAS appears at least as safe as CEA in high risk patients, CMS is obligated to address this disparity in coverage. One approach is to argue that since CAS is at least as safe as CEA in high risk patients, and CEA is already reimbursed, then CAS should also be reimbursed. The fallacy of this argument is that the coverage of CEA is not based on high risk trials but on average risk CEA trials such as NASCET, ECST, ACAS and ACST. Indeed, the term “high risk” specifically applies to high surgical risk and such patients were excluded from prior CEA trials. The 30 day adverse event rates in SAPPHIRE were actually higher among asymptomatic patients than among symptomatic high risk patients. In SAPPHIRE the 30 day stroke and death rate in high risk, asymptomatic patients undergoing CAS versus CEA was 5.4% versus 4.6% respectively. If acute myocardial infarction is included, the 30 day adverse event rate in asymptomatic high risk patients was 5.5% for CAS versus 10.2% for CEA. These results suggest a >3% 30 day stroke and death rate for both CAS and CEA in high risk asymptomatic patients but are based on a single underpowered RCT (SAPPHIRE). The apparent excess risk for CEA compared to CAS was due solely to myocardial infarction and cannot necessarily be extrapolated to other high risk subgroups.

The 2007 ACCF/SCAI/SVMB/SIR/ASITN Clinical Expert Consensus Document on Carotid Stenting (J Am Coll Cardiol, 2007; 49:126-170, doi:10.1016/j.jacc.2006.10.021) states: “Management is controversial for asymptomatic patients with severe carotid stenosis who are at high risk for CEA because they were excluded from the randomized trials of CEA and medical therapy. There are insufficient data in these high-risk patients to define the natural history of medically or surgically treated disease with respect to 5-year stroke-free survival, although the risks of CEA are clearly higher than in low-risk patients. It is important to recognize that the benefits of revascularization are negated if the risk of revascularization is high, and the fact that CEA is associated with more risk does not mandate that patients undergo CAS. There is a real need for additional studies of high-risk asymptomatic patients who are treated with best medical therapy, since this could be the best treatment option. In the meantime, to gather additional data, it is reasonable to enroll these high-risk patients in nonrandomized registries.”

There is thus broad expert consensus across many disciplines that there is insufficient evidence regarding the relative risk of CAS versus CEA in all asymptomatic high risk subgroups or that either procedure is superior to best medical therapy. Accordingly, it would be inappropriate and not in the best interest of patient care to change the CAS NCD to include asymptomatic high risk patients in any age group at this time. It would be appropriate for CMS to review its policies regarding CEA in high risk asymptomatic patients. The below-signed members of the Neurovascular Coalition recommends that both CAS and CEA be performed in high risk asymptomatic patients only within a randomized clinical trial or other scientifically accepted methodology containing a medical control arm and statistically powered to determine efficacy.

The proposed NCD revision could also significantly impede the completion of average risk efficacy trials such as CREST and ACT I. Completion of these trials is essential to determining the appropriate utilization of CAS.

3) Establish that the surgeon performing the surgical consultation that determines a patient’s high risk status must be properly credentialed to perform CEA as determined by the facility.

We agree with this change.

4) CAS is only covered when used with an embolic protection device and is, therefore, not covered if deployment of the distal embolic protection device is not technically possible.

We disagree with this clarification. An embolic protection device (EPD) should be used where technically feasible but reimbursement should not be contingent on use of an EPD. If an EPD is not used, the interventionist must document the reason

5) The five facility certification requirements are unchanged. We propose to modify the process for completing the certification and recertification process in the NCD Manual.

Regarding the potential transfer of authority for certification and recertification of facilities performing CAS, we are opposed to the proposal that these functions would be performed by the Society for Cardiovascular Angiography and Interventions (SCAI). Although the SCAI is comprised of members dedicated to vascular interventions, the vast majority of such interventions involve the coronary and peripheral vessels. SCAI does not represent neurology, neurosurgery or neuroradiology. Oversight of certification and recertification of facilities must be performed either by a neutral body or a body representing all appropriate medical specialties. We are willing to discuss development of such a multidisciplinary approach with you.

In conclusion, we wish to emphasize the multidisciplinary breadth of the organizations participating in this response including the major societies representing Neurology, Neurosurgery and Neuroradiology.

Sincerely,

American Academy of Neurology, Member, Neurovascular Coalition

American Association of Neurological Surgeons, Member, Neurovascular Coalition

American Society of Interventional & Therapeutic Neuroradiology, Member, Neurovascular Coalition

American Society of Neuroradiology, Member, Neurovascular Coalition

Congress of Neurological Surgeons, Member, Neurovascular Coalition

AANS/CNS Cerebrovascular Section, Member, Neurovascular Coalition

Invited Co-Signer,

Brain Attack Coalition

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"I am commenting to express my support for expanding Medicare coverage for carotid stenting for high-risk patients." In particularly, I feel that asymptomatic patients with greater than 80 percent stenosis should be included. Furthermore, I feel that age greater than 80 should be considered high risk.

I base my comments on more than 10 years experience with carotid stenting, having performed several hundred procedures, in our experience the complication rate for carotid artery stenting in asymptomatic high-risk patients is less than 2 percent. We also have participated in ARCHeR, BEACH, SAPPHIRE, CREST, CARESS, CREATE and CAPTURE carotid stent trials. We are currently enrolling in CAPTURE II and VIVA trials. The results of the Sapphire study clearly show that carotid stenting is non inferior to CEA in high risk patients, even if they are asymptomatic. The post-market studies show that carotid stenting can be safely performed. The majority of patients in these studies were asymptomatic. To exclude these patients from coverage would subject them to a higher risk procedure.

I would like to express a strong position against requiring that a surgeon determine the high risk status of carotid stent patients. The criteria that determine high risk have been well established in all of the pre-and post market trials. Most of these trials required a neurological evaluation but not a surgical consultation. Thank you for the opportunity to express my concerns.

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March 2, 2007

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

RE: Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting, CAG-00085R3

Dear Dr. Phurrough:

The Society of Thoracic Surgeons (STS), the largest organization representing cardiothoracic surgery, offers the following comments regarding Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting, CAG-00085R3 (Proposed Decision). As providers of approximately 28% of the total annual volume of carotid endarterectomy for Medicare beneficiaries, cardiothoracic surgeons have training and experience in the evaluation and management of cerebrovascular disease.

STS appreciates the thorough and precedent setting effort expended by the Coverage and Analysis Group and CMS to support the use of this exciting technology while protecting Medicare beneficiaries’ health interests.

1. STS believes the clinical evidence supports, and patient safety requires, “the Opinion of a Surgeon”

The Proposed Decision states, “we are proposing that we modify the standard to require that the patient’s high risk status be determined by a surgeon credentialed to perform CEA.”

STS strongly supports the requirement that the surgeon performing the consultation be properly credentialed to perform CEA as determined by his/her facility. This action is certain to protect patients from liberal interpretation of the physiologic “high-surgical risk” definitions, which could place them at higher risk for stroke and death with CAS compared to CEA. (Ref. 1).

Providers of CEA have shown exceptional ability to identify patients who can be treated with CEA safely, with reported mortality rates of (0.33-0.50%) and reported stroke rates of 0.29-1.3% (Refs. 2-4) in population based studies of mixed symptomatic and asymptomatic patients, with continued improvement over time (Ref. 4). The responsibility to correctly identify patients whose individual surgical risk may exceed the attendant risks of CAS therefore properly resides in the hands of these providers, who have proven able to identify patients with excess surgical risk.

Additionally, despite extensive research, the identification of clearly definable and discriminating physiological risk factors for CEA morbidity and mortality has been unsuccessful (Refs. 5, 6). Individual risk factors and combinations of risk factors, absent the judgment of CEA providers, are not sufficiently robust to provide adequate guidance used alone.

In reviewing the written and expressed opinions of industry regarding the proposed language, we urge the CAG to resist pressure to remove this language altogether. One needs to look no further than the current state of percutaneous coronary intervention, where labeling instructions are largely ignored, to see that additional safeguards from CMS are warranted.

2. STS supports restricting coverage to exclude those >80 years of age

Overwhelming data suggests very high stroke and death rates with CAS in this age group, well above any reported complication rates for carotid endarterecomy.

3. STS does not support expansion of coverage to asymptomatic patients with “physiologic” high-risk comorbidities.

STS supports the position established by the Society for Vascular Surgery, whose members are the single largest providers of CEA, and are also substantial providers of CAS, recommending coverage for asymptomatic patients with:

March 2, 2007

Dear Ms. Norwalk:

Boston Scientific Corporation's Peripheral Interventions Division appreciates the opportunity to present these comments and policy recommendations on the Centers for Medicare and Medicaid Services' (CMS) proposed decision memo for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting.

As the world's largest company dedicated to the development, manufacturing, and marketing of less-invasive therapies, Boston Scientific supplies medical devices and technologies used by physicians representing cardiac rhythm management, cardiovascular (including peripheral interventions and vascular surgery), endosurgery, and neuromodulation.

Executive Summary
Boston Scientific applauds CMS' proposal to expand Medicare coverage for carotid artery stenting (CAS) for patients who are at high risk for carotid endarterectomy (CEA) and who are asymptomatic with stenosis ≥80%. We agree with CMS that the available data strongly supports this expansion. In addition, Boston Scientific believes that CMS should give additional consideration to several elements of its proposed decision memo. In our comments, we request the following of CMS:

1. Provide coverage for high risk, symptomatic patients with stenosis 50%-69%;
   
2. Reverse non-coverage for certain procedures where physicians are unable to deploy embolic protection but CAS is of the best available option for the patient;
   
3. Establish certification and recertification requirements and processes that are easy to access for hospitals and other stakeholders, collect pertinent data, and offer flexibility in terms of ways that a facility can meet the criteria; and
   
4. In terms of the data collection element of the recertification process, CMS should first clearly articulate how the data collected as part of the recertification process is to be used and to whom it will be available. Also, if multiple parties are providing certification and recertification services, CMS should achieve standardization of the data elements that are collected, as well as foster the creation of an overarching operational architecture that allows for merging of data sets for analysis.

We agree with CMS that, at this time, clinical data suggest that octogenarians may be at higher risk of adverse events associated with CAS. However, we believe that continued data collection will provide guidance on appropriate patient selection criteria for octogenarians and that these data may lead to expanded coverage for this group in the future. Finally, with regards to the proposed requirement that a surgeon qualified to perform CEA determine whether a patient is at high risk for surgery, Boston Scientific defers to the relevant medical specialty societies and physicians to determine the most appropriate method for assessing patients' level of surgical risk.

CMS Should Cover High Risk, Symptomatic Patients with Stenosis 50%-69%
Boston Scientific urges CMS to expand coverage for CAS to high risk patients who are symptomatic with stenosis of 50%-69%. Overall, we believe that the clinical studies cited in the draft decision memo support the effectiveness to CAS in this population. We have two primary concerns with the analysis of evidence as described in the draft decision memorandum. First, we believe that the proposal to not cover this population relies on the comparison of two unlike populations. Second, the proposal utilizes data from two studies (SPACE and EVA-3S) that are not directly applicable to the patient group being considered for coverage). Finally, we present new, additional data to inform the appropriateness of covering this population.

Comparing unlike populations and New High Risk data
In its proposed decision memo, CMS questions the benefit of CAS for high risk, symptomatic patients with stenosis 50%-69% because the results of CAPTURE and CASES-PMS “… showed that symptomatic patients had higher 30-day adverse outcomes compared to asymptomatic patients.” However, comparing results for two distinct patient populations undergoing the same procedure is generally unreliable. The question to address when considering coverage for symptomatic patients is not whether symptomatic patients have higher adverse event rates than asymptomatic patients undergoing CAS. Rather, the critical questions should be whether CAS is non-inferior to CEA in the high risk, symptomatic patient population, and whether there is a health benefit associated with a CAS intervention in high risk, symptomatic patients with stenosis greater than or equal to 50%.

CAS trials are designed to show non-inferiority between CAS and CEA, not non-inferiority of CAS for symptomatic versus asymptomatic patients. In both CAPTURE and CASES-PMS, as well as BEACH, CABERNET, ARCHeR, SAPPHIRE, CREATE and other studies, investigators concluded that CAS is non- inferior to CEA for high risk, symptomatic patients with stenosis ≥50%, despite differences in the level of surgical risk for patients participating in CAS trials versus those in CEA trials.^{1,2,3,4,5,6,7,8,9} These findings are the basis of the FDA-approval and marketing of several carotid stenting systems, including Boston Scientific's NexStent® Carotid Stent.

While the health benefit of CEA for symptomatic patients with stenosis 50%-69% is smaller than the benefit in high risk, symptomatic patients with stenosis ≥70%, there was still a statistically significant improvement in stroke reduction in this patient population versus medical management (15.7% vs. 22.2%, p=0.045).¹⁰ Moreover, results from landmark CEA trials such as NASCET and ECST indicate that symptomatic patients with carotid stenosis greater than or equal to 50% showed benefit from CEA within the first two to three years after surgery.^11,12,13

Therefore, based on the results of the multiple studies noted above that show that CAS is non- inferior to CEA, which is known to provide a health benefit in symptomatic patients with stenosis greater than or equal to 50%, the evidence supports coverage of CAS for high risk, symptomatic patients with stenosis between 50% and 69% whose comorbidities may prevent them from being eligible for surgical intervention.

Using Data from SPACE and EVA-3S
CMS also relies on findings from the SPACE and EVA-3S trials, in explaining its decision not to expand coverage for high risk, symptomatic patients with stenosis 50%-69%. As representatives of CMS acknowledged during podium presentations and panel discussions at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in October, 2006, as well as in the draft coverage decision, both of these studies are characterized by significant design and execution issues.¹⁴ These issues are numerous and have been well documented in peer- reviewed publications and discussed at professional meetings.^15,16,17,18 Although the most prominent issues associated with SPACE and EVA- 3S relate to physician training and experience bias as well as inconsistent use of embolic protection, perhaps the most relevant issues that specifically pertain to the CAS coverage reconsideration are:

• Both studies included not only high surgical risk but also non-high surgical risk patients; and
• Both studies were stopped early thereby limiting their power to address the question of non-inferiority. This increases the likelihood of Type-II statistical error (i.e., the failure to show non-inferiority when in fact non- inferiority is the truth [a.k.a. a false negative conclusion]). Of note, these trials were stopped early because early results indicated that very large sample sizes would be required to prove non-inferiority, and not because of any evidence from interim analysis that there were important differences in outcome between CAS and CEA.

Because of these important flaws, the SPACE and EVA-3S provide no reliable information about the presence or absence of clinical benefit from CAS for high risk, symptomatic patients (or any patients) from these studies. As a result, the results of these studies should be interpreted with extreme caution and should not be applied to a coverage decision for the high risk, symptomatic 50-69% stenosis patient population. Please refer to Appendix A for additional information on the issues associated with EVA-3S and SPACE.

New High Risk Data from BEACH and CABERNET Support Expanded Coverage
Boston Scientific has recently conducted additional analyses of both its BEACH and CABERNET pivotal trial data that provide further evidence of benefit from CAS in high risk, symptomatic patients with stenosis of 50%-69%. We are attaching subset analyses of data from these clinical trials which provide additional evidence in support of covering this patient population. While data from these trials have been presented at professional meetings, the subset analyses represent an additional layer of detail regarding the outcome of CAS in high risk, symptomatic patients under age 80 with stenosis of 50%-69%. Analysis of BEACH and CABERNET data for the population being considered yielded the following findings:

• In Boston Scientific's comments to CMS dated September 1, 2006, we provided data from an analysis of pivotal primary endpoint data for high risk, symptomatic patients with stenosis 50%-69% that indicated one year morbidity and mortality (primary endpoint) for patients of all ages (including octogenarians) of 8.6% (n=35). The rate of stroke, death or Q-wave MI at 30 days was 5.7% (n=35).¹⁹
• The CABERNET trial had the following primary endpoints, which differentiates it from other PMA trials including BEACH, ARCHeR and SECuRITY:
• All stroke, death and MI at 30 days plus all death, stroke and MI from 31-365 days
  
• All stroke, death and MI at 30 days plus ipsilateral stroke and any death related to ipsilateral stroke from 31-365 days

The results from CABERNET were presented at the 2007 International Symposium on Endovascular Therapy (ISET) (See Appendix B for slide presentation). The composite 30-day endpoint of all stroke, death and MI for all patients participating in CABERNET was 3.9%, the lowest rate of adverse events of any CAS trial to date. The composite one year endpoint of all stroke, death and MI at 30 days (peri-procedural morbidity and mortality) plus all death, stroke and MI from 31-365 days was 11.9%, however the composite one year endpoint of all stroke, death and MI at 30 days plus ipsilateral stroke and any death related to ipsilateral stroke from 31- 365 days (1-year morbidity and mortality) was 4.7%. Notably, there were no neurologic deaths and no hemorrhagic deaths at the 30 day follow- up point.

Recent analysis by Boston Scientific of the pivotal primary endpoint data from CABERNET for high risk symptomatic patients with yielded the following findings:

Table 1: CABERNET Trial Data (Selected Patient Groups; provided in electronic mail copy)

While these studies were not powered to look specifically at the subset of high risk symptomatic patients being considered for coverage, the findings for these small groups of patients are consistent with non-inferiority with CEA, and they appear to be consistent with findings for the same group of patients in other clinical trials.

CMS' Coverage Policy Should Recognize that Embolic Protection Cannot Always be Deployed
Boston Scientific supports the use of embolic protection with FDA-approved carotid stents. Nonetheless, we acknowledge that there are situations when it is not possible to deploy embolic protection, yet it is in the patient's best interest undergo a CAS procedure.

In discussing this issue with physicians performing CAS procedures, several scenarios have come up that, given CMS' proposal to only pay for CAS if embolic protection is utilized, could prevent a patient from receiving effective treatment for their carotid artery disease. One such patient could be a patient with particularly tortuous vasculature that does not have a safe landing zone for the embolic protection device distal to the target lesion. Such a situation would present the physician with the following choices:

• Discontinue the procedure, thereby not addressing the risk associated with the patient's carotid stenosis after having employed guidewires and catheters that may increase the patient's risk for distal embolization. Since patients undergoing CAS must be at high risk for surgery and have moderate to critical stenosis, discontinuing the CAS procedure leaves the patient with no comparably effective treatment option; or
• Try to force the embolic protection device through the lesion and attempt to deploy it despite the lack of a safe landing zone, thereby placing the patient at risk for perforation or embolization in an effort to avoid placing the patient at financial risk for the intervention; or
• Proceed with stenting without embolic protection, foregoing payment for both the physician and the facility and potentially placing the patient at increased financial risk.

Suggestion for Addressing Embolic Protection in the CAS Coverage Policy
Clearly, none of the above-described choices are in the best interest of the patient. Therefore, we ask that CMS consider providing coverage for FDA-approved carotid stent placement without embolic protection when one of the following two circumstances occurs:

• When the risk of embolic protection deployment exceeds the benefits, but the perceived benefit of placing a carotid stent exceeds the risks associated with not using embolic protection; or
• When deployment of embolic protection is attempted unsuccessfully and placement of a carotid stent is in the best clinical interest of the patient.

1. Revise the coverage policy as described above, requiring physicians and facilities to document in patient records the reasons why embolic protection could not be deployed and the physician felt it was in the best interest of the patient to deploy a carotid stent;
   
2. Work with the Center for Medicare Management to implement coding edits that would require a physician encountering either covered scenario to report the CAS procedure using the CPT code for CAS without embolic protection (37216) with the ‘-22' modifier indicating unusual procedural services; and
   
3. Monitor the volume and nature of CAS cases where embolic protection is not utilized through the certification / recertification process. For example, as part of the revised certification / recertification process, facilities would be required to provide patient records for CAS cases where embolic protection was not used. In the event that the party certifying or recertifying the facility finds that providers are inappropriately performing CAS without embolic protection, certification or recertification could be denied.

Certification and Recertification Requirements and Processes Should Provide for Easy Access, Collect Pertinent Data and Offer Flexibility
Boston Scientific applauds CMS' efforts to maintain safety and quality of CAS programs through certification and recertification processes, and we admire the Society for Cardiovascular Angiography and Interventions' (SCAI) efforts to develop a prototype program for administering these processes. We support standards for quality and safety for CAS programs, as we recognize that using our devices in institutions where these standards are maintained will almost certainly result in better clinical outcomes over time.

At the same time, we believe that it is important that CMS clearly articulates how the data collected as part of the recertification process is to be used and to whom it will be available. We also request that whatever data collection and reporting requirements and processes CMS and its partners establish be easy to access for hospitals and other stakeholders. Moreover, we recommend that CMS and any group(s) administering the certification and recertification processes offer flexibility in terms of the ways that a facility can meet the criteria. For example, as CMS has proposed, facilities participating in registries or clinical trials may be subject to different thresholds of evidence requirements.

Finally, Boston Scientific also asks that if multiple parties are providing certification and recertification services, CMS and /or all approved certification bodies establish standardized data requirements, and processes, as well as an overarching operational architecture that allows for merging of data sets for analysis.

• Expand coverage for high risk asymptomatic patients under age 80 with ≥ 80% stenosis as proposed;
• Expand coverage for high risk symptomatic patients under age 80 with stenosis between 50% and 69% based on appropriate consideration of applicable evidence;
• Provide coverage for CAS cases where embolic protection cannot safely or technically be deployed but the placement of a carotid stent is in the best interest of the patient, using the coding system and certification / recertification processes to monitor and address situations where CAS is inappropriately performed without embolic protection;
• Clearly articulate how the data collected as part of the recertification process is to be used and to whom it will be available.
• Establish certification and recertification requirements and processes that are easy to access for hospitals and other stakeholders, collect pertinent data, and offer flexibility in terms of ways that a facility can meet the criteria.

We greatly appreciate the opportunity to comment on the proposed decision memorandum regarding the expansion of national coverage for carotid artery stenting.

Cc: Steve Phurrough, MD
Joseph Chin, MD
Barry Straube, MD
Sarah McClain
John Pedersen
Tom Meskan
Scott Reid
Maria Stewart

• Stopped early and, as a result, had reduction in powering, which increases likelihood of Type-II error, i.e. failure to show non-inferiority when in fact non- inferiority is the truth (a.k.a. a false negative conclusion)
  – EVA-3S designed for 900 @ 80% power (527 enrolled); stopped for safety
• Distal protection was only “[strongly] recommended” after February 2003 (50% trial duration)
  – 30 day stroke or death
  • Without DEP = 25% (5 of 20)
  • With DEP = 7.9% (18 of 227)
• If 7.9% rather than 9.6% is used:
  – Relative Risk = 2.0 (p = 0.07)
• Rates of MI were not assessed
  – (Reduced rate of MI was one source of benefit identified in the SAPPHIRE Trial)
• Only 30 day and 6 month follow up
  – (Despite trial ongoing since 2000)
• Experience bias
  – Vascular surgeons:
  • Required 25 CEAs in the year prior to study entry
  – Endovascular physicians:
• Required 12 carotid stents or 35 “supra- aortic stents” with at least 5 carotid stents
• Or, Allowed to receive training and credentialing “under supervision” as they enrolled patients in the trial
• Allowed to use new stents after only two cases
– No centralized training qualification process (local proctors pronounced the operators qualified)
– Approximately 2/3 of sites were under tutelage at the beginning of their randomized participation
• Enrollment Bias…
  – Total CEA case volumes were not discussed
  – Estimated < randomized
• Thirty hospitals
• Assuming only 1 vascular surgeon per hospital with the enrollment criteria minimum 25 cases/yr
• 4.75 years of enrollment = 3562.5 patients – 5 pts taken to OR (bailout)….2 strokes
• Slow enrollment resulted in limited investigator experience – 1.7 CAS patients/year/site
• Variable antiplatelet regimen – The standard of care is pre-procedure loading with clopidogrel plus aspirin, and post- procedure minimum one month of clopidogrel plus aspirin.
• In EVA-3S, only 82.9% of patients had dual antiplatelet therapy.
• No pre-dilation in >80% of procedures (standard in US)
• Significant (beyond local) anesthesia was employed in ~30% of procedures (estimated The following issues were addressed for SPACE:
• Stopped due to lack of continued funding, not safety or futility – Did not achieve statistical endpoint of non-inferiority due to this early termination
• SPACE designed for 1,900 @ 80% power (1200 enrolled); stopped for enrollment issues, funding; ended at 63% power
• Larger sample might have provided much tighter confidence intervals and more robust statistical data
• EPD was used in only 27% of patients – Nevertheless, results appear to be comparable between stent and surgery
• A quarter of potential SPACE collaborators were rejected after review of their track record – This exclusion will inevitably raise questions about generalizability , , Appendix B: CABERNET Data presented by James Joye, MD at ISET, January, 2007 (provided in electronic mail copy) End Notes (provided in electronic mail copy)

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I am providing comment regarding the proposed change in the National Coverage Decision for carotid angioplasty & stenting

March 1, 2007

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Marcel Salive, MD, MPH
Director, Division of Medical and Surgical Services

Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244

RE: Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R3)

Dear Dr. Phurrough and Dr. Salive:

The American Academy of Neurology (AAN) wishes to comment on the proposed changes to CMS’ National Coverage Decision for carotid artery stenting (CAS). The AAN represents over 20,000 neurologists and neuroscience professionals worldwide. Neurologists are the primary providers of stroke care and also serve as the major group working to lessen the burden of stroke through research and improved patient care. Vascular Neurology is an ACGME approved subspecialty of neurology dedicated to stroke. We wish to address separately each of the changes to the NCD proposed by CMS with regard to carotid stenting.

1. The AAN most emphatically objects to the approval of CAS in asymptomatic patients less than 80 years old with >80% stenosis who are high risk for carotid endarterectomy. Current data clearly indicates that the complication rate of death and stroke within 30 days exceeds the 3% level that has been established in multiple clinical trials of carotid revascularizaiton. Unless the procedure has a complication rate below 3% in patients with life expectancy greater than 5 years, the procedure is contraindicated. Based on the risk in the ACST study, CEA with a 30 day rate of stroke and death of < 3% requires 2 < years for a benefit over medical therapy in terms of stroke incidence, longer if benefit is calculated on stroke-free years, and longer still if benefit is calculated based on “disabling” stroke. The higher complication rates in asymptomatic patients at high risk for surgery undergoing CAS extend the time to achieve benefit even further. Allowing CAS in this asymptomatic patient group will lead to more stroke and death than it will prevent; an outcome clearly not intended by CMS. High risk for CEA does not necessarily confer high risk for stroke. The benefit of CEA over medical therapy in previous randomized studies does not necessarily apply to high surgical risk patients since such patients were not included in those studies. In addition, the use of “registry” data to supersede data from controlled clinical trial data is fraught with danger and inaccuracies. Registries cannot determine efficacy. This is especially true when the complications are not adjudicated by a neutral, well trained investigator. Many interventionalists are not trained to recognize the signs and symptoms related to ischemic brain disease; they are often so busy that they leave complication assessment to assistants who have not been trained in objective, neurologic assessment of stroke patients.

Rather than extend reimbursement coverage to asymptomatic high surgical risk patients treated with CAS, the American Academy of Neurology suggests that CMS review coverage for CEA in asymptomatic high surgical risk patients and consider a national coverage determination for this indication. In our opinion, current data are insufficient to justify CAS or CEA in asymptomatic high risk patients.

2. We support the CMS proposal to restrict coverage for CAS in patients with symptomatic stenosis >70% to patients < 80 years old. Recent data indicate a higher periprocedural complication rate for symptomatic patients over age 80 undergoing CAS.

3. CMS proposes that the surgeon responsible for determining ‘high risk’ status be credentialed in performing CEA. We agree with this change, but further recommend that a physician with documented training and expertise in stroke be involved in the decision making on risk/benefit assessment in patients prior to submitting the patient to CAS.

4. CMS proposes to cover CAS only when it is performed in conjunction with an embolic protection device (EPD). The AAN believes that an EPD should be used whenever technically feasible, but acknowledge that in some situations the risk of placing the EPD exceeds the potential benefit. Therefore, we do not believe reimbursement should be contingent upon use of EPD; but do believe that the operator should be required to document the reason for not using an EPD.

5. We agree with the CMS proposal to clarify the process of facility certification. The AAN feels that the omission of any mention of neurological and stroke services in the facilities requirements is a glaring error. The purpose of CAS is to prevent stroke, and the most common severe complications of CAS are ischemic stroke, and hyperperfusion syndrome with seizure and brain hemorrhage. The lack of a plan to advise objectively patients of the clinical trial evidence with respect to their stroke risk after CAS and to acutely treat patients who suffer stroke during or after CAS is medically indefensible. The absence of a stroke plan in the facilities requirements overemphasizes the procedure and ignores the primary goal: improving patient outcome. The AAN feels strongly that, an acute stroke plan should be required for any institution engaging in carotid artery stenting.

Thank you for your consideration of our comments.

Regards,

Thomas R. Swift, MD, FAAN
President, American Academy of Neurology

*Please note that these comments will also be submitted in letter form to the email address listed below.

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I am commenting to express my support for expanding Medicare coverage for carotid stenting for high risk patients. specifically, I feel that asymptomatic patients with greater than 80% stenosis should be included. Furthermore, I feel that age greater than 80 should be considered high risk.

I base my comments on greater than 7 years experieince with carotid stenting. Along with my colleagues at the Iowa Heart Center, carotid stenting procedures are performed on a regular basis. We have participated in ARCHeR,CREST AND Capture carotid stent trials, and are currently enrolling in Capture II and Sapphire trials. The results of the sapphire study clearly show that carotid stenting is non-inferior to CEA in high risk patients, even if they are asymptomatic. The post market study shows that carotid stenting can be safely performed. The majority of patients in these studies were asymptomatic. To exclude these patients from coverage would subject them to a high risk procedure.The criteria that determine high risk have been well established in all of the pre and post market trials. Most of these trials required a neurological evaluation but not a surgical consultation. The proposed requirement would make the procedure cumbsersome and more expensive. I would like to express a strong position against requiring that a surgeon determine the high risk status of carotid stent patients.

Thank you for the opportunity to express my concerns.

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I welcome the proposed expanded medicare coverage of Carotid artery stenting.

I am, however, concerned about the requirement that a vascular surgeon determine the patient's high risk status for CEA. In my experience there are very few, if any, surgeons who admit a patient to be a high risk CEA candidate even when established risk factors are obviously present. As such, I am afraid, several patients in the high risk category may not be offered the less invasive and safer procedure.

I would suggest this prerequisite be deleted from the proposed changes.

Thank you for the consideration.

Krishna Kumar, M.D., F.A.C.C.

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A gatekeeper model like this works only when the gatekeeper is uninvolved and unbiased, certainly not the case with a vascular surgeon passing judgment on his cardiology, neurointerventional, and radiology colleagues’ recommendations. The credentialing of surgeons performing CEA is a local phenomenon, and many surgeons so credentialed are not vascular surgical specialists but general surgeons serving their patients and communities by performing CEA, etc. Nevertheless, their expertise in this field may be quite limited, as will be their opinion. The bias of the surgeon toward a surgical procedure is obvious and this conflict of interest has the potential to expose patients to an operation (which is still reimbursed by CMS) that has a greater risk of complication than CAS would (e.g., patients with CEA restenosis), and with CMS explicit blessing. There are many surgeons who have adopted CAS as part of their practice armamentarium. Are these physicians immune to this rule by virtue of their duality, and thus unconstrained by any oversight? The logical extension of the requirement for a surgeon to qualify a patient as high-risk for carotid stenting will be a gradual erosion of other specialty involvement as referring physicians bypass the middle-man. The increased cost of these of these consultations will be borne by patients and CMS. This could represent a significant workload increase for the surgical community of seeing every high surgical risk patient referred to them for a second opinion considering the estimates of CAS activity in 2006 (~25,000 cases) of which the surgeon was directly involved in only ~25%-30%. The need for surgical consultation appears to be excessive given the clear, standardized, retrospectively verifiable definitions already in place through the current national coverage decision (NCD). Cardiology consultation for surgical clearance in selected patients with medical co-morbidities is a common, and appropriate, occurrence. The requirement for a surgeon to see these patients to assign risk, the majority are in fact based on medical condition, turns this traditional algorithm on its head; cardiologists are obviously trained to, and fully capable of, determining at-risk surgical patients. Vascular surgeons are not trained to assess the cardiopulmonary risk of these or any other patients undergoing vascular surgery.

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1. This initiative proposes oversight by a biased vascular surgeon with a bias toward toward a surgical procedure. This is not in the best interest of the patient.

2. Many of the vascular surgeons I work with are general surgeons who also do vascular surgery. They may or may not be qualified to perform CEA and certainly may or may not be qualified to pass judgment. Their expertise in this field may be quite limited, as will be their opinion.

3. There are many surgeons who have adopted CAS as part of their practice armamentarium. Are these physicians immune to this rule by virtue of their duality, and thus unconstrained by any oversight?

4. The logical extension of the requirement for a surgeon to qualify a patient as high-risk for carotid stenting is simply not justified. Physicians with extensive peripheral endovascular training and also training in cardiology/internal medicine are eminently more qualified to make this call.

5. The increased cost of these of these consultations will be borne by patients and CMS.

6. The need for surgical consultation appears to be excessive given the clear, standardized, retrospectively verifiable definitions already in place through the current national coverage decision (NCD).

7. Cardiology consultation for surgical clearance in selected patients with medical co-morbidities is a common, and appropriate, occurrence. The requirement for a surgeon to see these patients to assign risk, the majority are in fact based on medical condition, turns this traditional algorithm on its head; cardiologists are obviously trained to, and fully capable of, determining at-risk surgical patients. Vascular surgeons are not trained to assess the cardiopulmonary risk of these or any other patients undergoing vascular surgery.

8. There are no data that I am aware of demonstrating that a vascular surgeon provides any benefit to the patient or improves the safety of the treatment recommendation. The CMS requirement for a vascular surgery consultation is therefore not based on any factors to promote patient care or safety. This proposal is fundamentally flawed.

9. Using the same logic, an interventionalist could be required to evaluate every CEA contemplated in this country for a percutaneous alternative. There is little doubt that there are still high-surgical risk patients undergoing CEA today despite no or unsupportive data, and a potentially safer alternative.

10.. The patient will undoubtedly be caught between specialty conflict. The extra traveling involved and the delays in obtaining consultation (which at a recent survey of a vascular surgery department at a major metropolitan hospital was at least two weeks) are typically accompanied by significant anxiety and place significant burdens on family members having to take time out of work to transport/accompany their in definitive therapy. If these issues weren't onerous enough, there will be an excess of unnecessary strokes/deaths occurring as a result of a lack of timely, definitive therapy. Besides the obvious disability and disrupted lives, the potential liability issues for all involved are significant.

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Regarding vascular surgery consultation

High risk criteria have been established and published by CMS in a previous DECISION MEMORANDUM. These criteria were determined by data in the ARCHER, CABERNET,SAPPHIRE,BEACH AND MAVERIC II trials. There does not seem to be a compelling reason to have a second physician read the list and make a second assessment of this risk. It should also be noted that a majority of these patients, when referred for surgery, are already sent to another physician (cardiologist)who has specific training to determine these clinical risks.

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February 29, 2007

Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention Sarah McClain, MHS
Sarah.mcclain@cms.hhs.gov

Re: NCA (CAG-00085R3)

Dear Ms. McClain;

We appreciate the opportunity to comment on the National Coverage Analysis for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R3) established by a February 1, 2007 executive memorandum.The following comments on the National Coverage Analysis (NCA) are submitted for your consideration:

Mayo Clinic requests removing the current language which states a patient should be a poor candidate for carotid endarterectomy (CEA) “in the opinion of the surgeon”. To have the surgeon determine the patient’s high risk status could be considered a conflict of interest with the evaluating surgeon. Currently surgeons are required to see all patients to determine if they are suitable candidates for carotid endarterectomy procedures. Although surgeons are qualified to make this determination, cardiologists treating the patients are just as informed of the patient’s medical condition and should be allowed to make this decision because they are able to consider all risk stratification. This is especially true for vascular surgeons who do not have cardiology training or experience. We recommend removing this language because there is no substantial evidence to support this requirement.

Mayo Clinic requests removing the contingency on Medicare coverage of carotid artery stents used exclusively with an embolic protection device. Under the current CAS national coverage decision patients at high risk for CEA who have symptomatic carotid artery stenosis > 70% are covered when using FDA approved CAS systems used with an embolic protection device. We believe this may be a problem for patients who are truly high risk or inoperable, and by virtue of their anatomy the surgeon cannot place a distal embolic protection device, the patient could not be treated. The goal of the surgeon is to put a distal protection device in every patient, but it may not be technically feasible in all surgical cases. Many patients meet additional CAS criteria and coverage should be allowed. Medicare reimbursement should not be contingent on the use of the embolic protection device when surgical risks outweigh the benefits.

Mayo Clinic requests allowing coverage for patients who are greater than age 80 and not enrolled in a Category B Investigational Device Exemption (IDE) trial or FDA approved post approval study. We are concerned about the proposed coverage restriction for asymptomatic patients with stenosis > 80% and who are greater than 80 years of age where CAS would only be covered in the setting of a clinical trial or post approval study. We appreciate CMS proposal to expand this restriction to include symptomatic patients with stenosis >70% and who are greater than 80 years of age. However, this still only allows coverage of patients with > 80% stenosis over the age of 80 when CAS procedures are performed in a Category B Investigational Device Exemption (IDE) trial or FDA approved post approval studies, or in accordance with the clinical trial policy. We understand patients who are greater than age 80 are at higher risks for adverse events, as was seen in the preamble to the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), however some of the patients over age 80 will not meet this condition and will have no other options.

The discussion and evidence reviewed information is not open for comment in the proposed CAS analysis. Nevertheless, we believe that it is important to comment on the decision memo in section B 2, entitled Analysis External Technology Assessments and Clinical Reviews. This report states for physician training the minimum requirement to maintain technical skill and competence is fifty carotid stenting procedures performed and documented by each primary operator per year. We believe there are very few institutions and providers doing fifty carotid stenting cases per year and feel this number should accurately represent what CAS facilities are performing.

In summary, Mayo Clinic is requesting the following changes to the CAS coverage policy

• Remove the current language stating the patient be a poor candidate for CEA “in the opinion of the surgeon”.
• Remove the contingency for coverage for CAS used only with an embolic protection device.
• Include coverage for patients who are greater than age 80 and not enrolled in a Category B Investigational Device Exemption (IDE) trial or FDA approved post approval study.
• Decrease the procedure requirement for physician training from fifty carotid stenting procedures performed each year to a more accurate number.

Thank you for the opportunity to comment. We sincerely appreciate your consideration of these comments.

Very truly yours,

Ronald. Grousky
Director Medicare Strategy Unit
Mayo Clinic

cc. M. Brooks

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I have reviewed the proposals and find the issue of a surgeon determining if a potential carotid stent candidate is "high risk" to be unhelpful. SAPPHIRE study criteria clearly delineate what a high risk patient is and for the most part, these are due to cardiac or pulmonary issues. These are areas in which a vascular surgeon is not expert. Other criteria such as a radiation induced stenosis or a restenotic lesion are clear cut criteria for a carotid stent. I believe that the requirement for a surgeon to decide who is high risk is only going to be used to protect referrals and "clinical turf" and will expose medicare beneficiaries to a higher risk endarterectomy when a carotid stent is clearly the best and lowest risk option.

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I appreciate your efforts to place reasonable controls on the widespread implementation of CAS. The proposed curtailment of coverage for patients >80 yo is consistent with available data suggesting that complication rates from CAS are significantly higher in this subgroup. Available data also supports the proposed expansion of coverage to asymptomatic patients who are at high risk for complications from CEA.

My reservation about current guidelines (and the proposed changes) relates to the requirement that CAS operators consult a CEA surgeon for an opinion about the patient's risk for endarterectomy. As cardiologists, we have always, and for the foreseeable future, will always determine which patients are at high risk for cardiovascular complications in the perioperative period. Moreover, many, if not all surgeons, refuse to operate until we have 'cleared' a patient for surgery. I therefore find it unacceptable, even ludicrous, that cardiologists should be required to ask a surgeon who is at high risk. There are other ways to ensure that CAS is performed in appropriate patients without pandering to the political will of vascular surgeons trying to protect their turf. Indeed, ample provisions exist in the current guidelines for oversight by committees made up of surgeons and non-surgeons. I completely support these oversight provisions and believe that they are necessary to protect the well-being of our patients. It is unnecessary, however, to make surgeons the gate-keepers for carotid stenting.

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CAS Coverage Extension

I will address first the proposal for extension of coverage and second the language regarding surgical consultation.

Large randomized clinical trials have established carotid endarterectomy (CEA) as the standard treatment for symptomatic and asymptomatic carotid artery stenosis (1-4). Carotid artery stenting (CAS) has the advantage of being less invasive than CEA. The published 30 day risk of stroke with CEA for asymptomatic disease in normal risk patients is in the 2-3% range (3,4). The published risk for symptomatic patients is in the 4-7% range (1-2,9-10).

Enthusiasm for CAS grew with publication of the SAPPHIRE trial (Precise/Angioguard), a randomized trial demonstrating a lower 30 day stroke, death and myocardial infarction rate for CAS compared with CEA in certain populations with higher than normal risk for CEA (5). The 30 day stroke, death and myocardial infarction (MI) rate for CEA and CAS was 4.4% and 9.9%, respectively, the difference being entirely due to non-Q wave MI. Most patients (70%) were asymptomatic. This, in large part, led to CMS approval of CAS for severe symptomatic stenosis in “high risk” patients. CMS was appropriately cautious in its approach to asymptomatic patients. The BEACH trial investigated the use of the carotid wallstent and filter-wire EX/EZ in “high risk” patients, 75% of whom were asymptomatic. Results were not quite as good as SAPPHIRE. The 30 day stroke, death and MI rate was 5.8% overall, 5% for asymptomatic and 7.9% for symptomatic patients (6). These events were mostly due to stroke and death, as the MI rate was less than 1%. Results in the ARCHeR trial, (Acculink and Accunet) evaluating CAS in high risk patients were worse, with 30 day major adverse event rates of 6.8% for asymptomatic and 13% for symptomatic patients (7). The recently published CAPTURE trial was designed to assess the safety of CAS in “high risk” patients performed by physicians of varying specialty and expertise in the community. While the authors concluded that, “transfer of this new therapy to the community practice setting via carotid stent training programs is effective”, it is difficult to reconcile this statement with the results of CAPTURE. The patient population was 86% asymptomatic, and those patients had a 30 day stroke, death, and MI rate of 5.4%. Symptomatic patients fared much worse, with a 30 day stroke, death and MI rate of 12% (8). Operators were categorized as level 1, 2, or 3, in decreasing order of experience. The level 2 and 3 operators had death rates of 1.8% and 2.3%, respectively, and a major stroke and death rate of 2.9% and 3.4%, respectively. While the authors of CAPTURE reported no statistical difference in outcomes between the three groups, the trend in every important outcome measure except MI was towards higher complications in the lesser experienced operators. Recently published randomized trials comparing CAS and CEA in average risk symptomatic patients have had variable results. The SPACE trial failed to establish non-inferiority of CAS compared with CEA, although there was no significant difference in 30 day stroke and death between the techniques (6.3% for CEA and 6.8% for CAS) (9). A second randomized trial (EVA-3S) comparing CAS and CEA in symptomatic patients was stopped early due to a 3-fold higher stroke and death rate of CAS, 9.6% compared with 3.4% (10). EVA-3S has been correctly criticized for the lack of experience of the CAS operators.

Given the well-established 5 year ipsilateral stroke rate of just 11% for asymptomatic patients observed in both ACAS and ACST (3,4), 30 day major adverse event rates in asymptomatic patients routinely in excess of 5% must give some concern. The excessive 30 day major adverse event rates in symptomatic patients observed in ARCHeR, CAPTURE, and EVA-3S are nothing short of alarming.

Despite the dire results of the EVA-3S trial and the discouraging results of registries such as CAPTURE, carotid stenting may be both very safe and very effective in the community, provided adequate training and experience of the operators. However, the level of training and experience required to produce results comparable to or better than CEA is likely higher than previously thought. The current CMS policy of requiring clinical trial enrollment of “high risk” symptomatic patients with 50-69% stenosis and “high risk” asymptomatic patients facilitates further data collection with independent neurologic assessment, which is badly needed. CMS should also continue to support enrollment of average risk patients into the randomized trials (CREST and ACT I).

While I am a strong believer in CAS when performed by experienced operators, CMS should continue the present policy until a training and experience level is defined which will produce better results. I suggest that the major adverse event rate for “high risk” asymptomatic patients should be no higher than 4%, and for “high risk” symptomatic patients should be no higher than 7%. This is achievable with adequate training. Extension of the coverage policy at this time would have the beneficial effect of allowing experienced operators who are not participating in a trial to offer CAS to “high risk” patients who might benefit from CAS. However, such a decision risks inflicting on the public the unacceptably high complication rates published in CAPTURE (12% for symptomatic patients!) when the procedure is performed by less experienced operators.

Should CMS decide to extend coverage, I strongly advise CMS to insist on documentation of major adverse event rates of less than 4% for asymptomatic patients and less than 7% for symptomatic patients as a requirement for ongoing site certification.

1. Beneficial effect of carotid endarterectomy in symptomatic patients with high- grade carotid stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med 1991;325:445-53.
2. MRC European Carotid Surgery Trial. European Carotid Surgery Trialists’ Collaborative Group. Lancet 1991; 337:1235-43.
3. Anonymous. Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA. 1995;273:1421-1428.
4. Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: a randomized controlled trial. MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. Lancet 2004; 363:1491-502.
5. Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med 2004;351:1493-501.
6. White CJ, Iyer SS, Hopkins LN, Katzen BT, Russell ME. Carotid stenting with distal protection in high surgical risk patients: The BEACH trial 30 day results. Catheter Cardiovasc Interv 2006;67:503-512.
7. Gray WA, Hopkins LN, Yadav JS et al. Protected carotid stenting in high-surgical-risk patients: The ARCHeR results. J Vasc Surg 2006;44:258-268
8. Gray WA, Yadav JS, Verta P et al. The CAPTURE Registry: Results of Carotid Stenting with Embolic Protection in the Post Approval Setting. Catheter Cardiovasc Interv 2007; 69: 341-348
9. SPACE Collaborative Group. 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomized non- inferiority trial. Lancet 2006;368:1239-47
10. Mas JL, Chatellier G, Beyssen B, et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med 2006;355:1660-71.

Language Regarding Surgical Consultation

I favor deleting the requirement for surgical consultation for “high risk” patients.

The ability to counsel a patient regarding treatment options for carotid artery stenosis requires a thorough understanding of the clinical symptoms of carotid disease as well as alternative neurologic conditions which can mimick carotid symptoms, the imaging evaluation of the carotid arteries and the brain, the natural history of carotid disease, the medical treatment of carotid disease, and options for revascularization including endarterectomy and stent placement. This knowledge base can be acquired by physicians of many specialties, including vascular surgery, neurosurgery, cardiology, interventional radiology/neuroradiology, and neurology. One does not need to be able to perform a carotid endarterectomy in order to have a mastery of the literature and advise a patient appropriately. As an interventional neuroradiologist, I see a large number of patients with carotid disease in consultation both in the inpatient and outpatient setting, and the requirement for formal surgical consultation is discriminatory against my specialty and all other non-surgeons who are able to master the skill set necessary to counsel these patients.

The criteria which make a patient “high risk” for endarterectomy as defined by CMS are very objective. For example, anatomic factors such as ipsilateral previous CEA or radiation, and cardiac/pulmonary factors such as oxygen dependent emphysema, an ejection fraction less than 30%, and MI within 6 weeks are quite objective. Requiring that a patient be “high risk” for CEA “in the opinion of a surgeon with credentials to perform CEA” creates a situation where the ability to offer a patient CAS becomes subjective (i.e. the opinion of the surgeon). For example, a patient with previous ipsilateral CEA is a candidate for carotid stenting at one hospital, but is not a candidate at the hospital across town where the surgeon does not feel this is a significant risk. A patient with an ejection fraction of 20% is a candidate for CAS at one hospital, but not the one across town where the vascular surgeon for whatever reason is not a believer in the CAS procedure.

Patients with carotid disease need to be advised by physicians who understand the disease and treatment options—this is not synonymous with vascular surgery consultation.

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I don't believe that 80 years of age should be a cutoff as these patients over 80 may be at highest risk and may derive the most benefit from a less invasive approach.I don't believe a surgical opinion shoud be necessary for the procedure. That opinion, whether rendered by a physician credentialed or not in stenting, is subject to bias, particularly since most surgeons, though credentialed, are not as experienced in CA stenting. A physician-particularly an interevntional cardiologist is more experienced with interventional technologies and procedures. Perhaps an Interventional cardiology consult by a physician experienced in CA stenting should be required for a patient in whom a surgeon wants to do a carotid endarectomy on.

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Mandating that Vascular surgeons should be the only ones who decide if a patient is high risk for CEA seems quite unreasonable and illogical.

First of all there will be a clear conscious/ unconscious bias in doing son given that CEA is the only way vascular surgeons now how to treat severe carotid artery stenosis, allowing some of them to consider doing somewhat higher risk patients. This would result in compromise of care for such a patient and would not be acceptable even if it is for some cases.If anything it should be combined effort between the cardiologists, interventional radiologist and vascular surgery which allows for an unbiased view.

Also by nature of the training cardiologists have always been involved in medical/ surgical clearance for patients undergoing procedures where as the vascular surgeons are not trained for this kind of clearence. It would make more sense that the interventional cardiologist or radiologist clearly document why the patient is high risk for surgery.If we did the reverse where every patient needing CEA would first require a interventional cardiologist or radiologist to write in the chart that the patient was not high risk for CEA prior to allowing any surgeon to operate on that patient, I am sure this would be equally frustating for the vascular surgeons.

The bottom line is that this would confuse patients, would lead to ill-will between the specialities involved and would result in compromised care for the patients.As a physician, as an interventional cardiologist I am strongly opposed to this idea and hope that this decision is reconsidered, because it is not beneficial for our patients and at the end of the day that is what matters.
Saman Ghiasuddin MD

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As a vascular surgeon who is credentialed and experienced with carotid stenting, and who still performs CEA, I commend the inclusion of asymptomatic 80% patients, but have strong objection to the following:

1.Exclusion of 80 year old patients. Although higher risk in some studies, many 80 year olds remain at lower risk for stenting than for CEA, primarily dependent upon arch anatomy which is a feature that must be left to the clinical judgement of the performing physician - it cannot be legislated and be legitimate. I have performed many event free carotid stent procedures on patients older than 80, and have avoided stenting in others with prohibitively difficult arches.
2.This second STRONG objection involves the need for an exception to the coverage when carotid stenting is undertaken, but distal embolic protection becomes impossible. In those cases, the patient has already undergone much of the risk of the procedure (arch manipulation, crossing of the carotid lesion with a portion of the protection device and/or a buddy wire, anticoagulation, etc). By definition, these patients are already at high risk, if not prohibitive risk, for CEA, and coverage should be extended for these patients. They have no other legitimate options, nor do we as treating physicians. Eliminating the "bail-out" stent option without distal embolic protection, particularly for recurrent carotid disease or radiation induced stenosis, severely limits my ability to treat a given patient in the safest manner for their particular case. Perhaps additional documentation would be needed in these cases, but there are definitely occasions where this situation arises (I have had 2 such cases on recurrent carotid stenoses in the last 50 cases I have done; both patients had an uneventful course).

It is of critical importance that physician judgement be paramount in many of these cases. I personally have no particular preference for carotid stenting or carotid endarterectomy - they are both procedures I perform commonly, with great proficiency, and at the same reimbursement rate. However, I am capable of exercising better judgement for a given patient than can be executed by a blanket rule that simply excludes someone due to age alone, a premise that has been disproven time and again in surgery over the last 2 decades. My patients deserve the opportunity to have the best treatment for their overall clinical scenario, and the proposals above restrict that opportunity. Please reconsider these policies and provide a framework which does not handcuff skilled operators into performing a second choice procedure for a given patient.

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As a practicing vascular surgeon who is actively involved in treating patients with carotid occlusive disease, I perform both carotid endarterectomy and carotid stenting and I serve as local PI for CREST. From that background and within that framework, I applaude your current recommendations for changes in CMS coverage of CAS.

However, I urge that future coverage considerincluding the category of symptomatic, high-risk patients with ICA stenosis of 50-69%, so as to include those patients for whom carotid endarterectomy has been established as beneficial.

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While I welcome the expanded coverage for CAS I am concerned about the requirement of surgeon credentialed in CEA to determine which patients are high risk. There is concern that some surgeons will ignore most all risks and proceed with surgery even in clearly high risk patients such as prior CEA with restenosis and prior XRT or neck dissections because they categorically do not want to consider stent option. Would rather see the definition expanded to surgeons or endovascular specialists who are credentialled. As an Interventional cardiologist with endovascular training I refer many patients for surgical procedures but the visa versa does not hold.

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I have just read the new proposal for coverage of Carotid stenting procedures and I am alarmed about two important aspects of the regulations:

1. Why would it be necessary for a surgeon to certify that a patient qualified as high risk? It is good clinical practice for the interverntionalist )of whatever subspecialty) to be familiar with the criteria for designation of high risk, and to decide on the type of intervention, if any, with the refering neurologist. To involve a surgeon in all cases seems unnecessary, burdensome, and expensive.

2. I do not understand the almost wholesale exclusion of elderly patients, >80 years of age, from interventional procedures, especially when they may be the highest risk patients for surgical intervention.

Thank you.

Janet Strain, MD

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Carotid artery stenting has a huge volume of data to support it's use. Restricting it's use to "poor surgical candidates" as deemed by a surgeon will simply divert stent procedures to the vascular surgeons who are called upon to make the judgement of surgical risk. That requirement unfairly penalizes those practitioners who are not vascular surgeons but who have excellent training in determining patient risk factors. The criteria for inclusion (50% in symptomatic and 80% in asymptomatic) seem reasonable.

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It is unwise to require a patient to see a surgeon to determine if he or she is at high risk for carotid endarterectomy in order to approve a patient for a revascualarization option (Carotid Stenting with distal protection) that is less risky than surgery in competant hands. The current guidelines for high risk Carotid patients have been evaluated and agreed on by all parties involed in treating this disease and, although cumbersome, they are objective and useful. Derailing published guidelines to fall back on the personal opinion of an individual with an inherent conflict of interest is both a step backwards and unethical.

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1. We have done more than 400 CAS with 3-4% minor CVAs and no one procedure related major CVA or death. With independent neuro oversight in most patients. I encouraged the latter.

2. For most surgeons only inoperable patients (i.e. patients that they don't want to operate) are candidate for CAS. We had that rule for 1 or 2 years. It was a terrible liability. We had different opinions in many cases and patients were in the middle. Many examples of this. We stopped it!! Just wait for lawyers to get these cases if a bad outcome occurs.

3. Older than 80 was an INCLUSION criteria in our experience and we did not see major complications so far. Case selection is clue.

4. I don't think CMS should be restrictive in this way. This regulations will not work well. The restriction should be at the level of reported results at every Institution and individual operator. Only centers and operators with experience and good results should be providing this service. It is absolutely an operator dependent procedure. Protection device? Obviously necessary if possible. Again results is crucial aspect.

5. I believe that CMS is using wrong approach. I have been involved in this field for 15 years and I have seen the real world turf wars in my practice. This will have an oil-on-a-fire effect.

Luis Tami
Chief, Vascular Services Department
Cath Lab Director
Memorial HEalthcare Systems
South Broward County

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I feel the proposed changes are misdirected. While the published data for CAS do seem to suggest higher risk in the over 80 age group, there is no comparable data to indicate that this group will do better with surgical therapy. If a surgeon has declined to perform carotid endarterectomy on a patient over age 80 because of high surgical risk, and CAS is not covered, the patient effectively is denied any treatment for a potentially devasting condition (ie. massive stroke). I would be more comfortable with the current coverage policy which limits CAS to symptomatic patients at high risk for surgery. An asymptomatic patient with high surgical risk probably is not going to survive long enough to benefit from any intervention.

Thank you.

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I believe the proposal to restrict coverage for symptomatic carotid stenosis >70% to only those under 80 years of age is ill advised. This group of patients is covered now and despite the accumulating data that there are safety issues for older patients, setting an age limit for insurance coverage by medicare is discriminatory. We all rely on studies, scientific data and personal experience to guide our decision making, but we all also know there may be vast differences between individual 80 year olds with respect to their vasculature. I don't think reimbursement determinations by CMS should replace clinical judgement by physicians. This is overstepping your bounds.

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I represent the highest volume carotid stent center in Oklahoma-The University of Oklahoma and the VA Medical Center Oklahoma City. We have done about 170 cases with great results. We have treated the very old, the very sick and the uninsured with an event rate of less than 2% (verified by neurology review).The proposed changes to involve a vascular surgeon (in fact in most cases the reviewer will not be a vascular surgeon but rather a general surgeon) in the mandatory review of all cases is a terrible mistake and will injure american patients as they may become trapped in a turf war, have additional expenses or have an endartertectomy performed which has in high risk patients a proven higher rate of myocardial infarction. This type of review is unscientific and destructive to the patient physician relationship. Surgeons who perform this review have no training in how to assess complex cardiovascular risk. It may also lead to litigation-what if the surgeon says "no stent for you" and does an endartectomy and the patient has a myocardial infarction. Patients will know that the stent was recommended to avoid that particular risk and will want to seek remedy and will ask the referring cardiologist to ask as expert witness-which one will be obliged to do as one believed the stent was safer for that patient from a cardiac risk perspective. Patient autonomy is also at risk. Patients will not be able to obtain their preferred therapy-they will be at the whim of a biased reviewer-who perhaps can't determine what risk a patient with lets say hypertrophic cardiomyopathy is at with endarterectomy. This preprocedure review of this nature is unprecedented especially since the carotid stents are on the shelf and FDA approved.

These problems are magnified in our state of Oklahoma where patients have one of the highest rates of comorbid cardiovascular diease, diabetes and frequently travel long distances to see specialists. Our Native American population will be especially deprived if the proposed changes are introduced.

As regards coverage for those over the age of 80 years the SECURITY registry shows that those patients can be treated safely. The CREST lead in data has problems which Dr Roubin has addressed-some subspecialties had higher complication rates than cardiologists who currently in clinical practice do over 65% of all carotid stents.

Please provide coverage for this stroke preventing procedure in accordance with the approved indications and ongoing registries.Our patients deserve this and not to be trapped in a turf battle. Those patients of mine who know about this discussion are saddened that their ability to chose or avail of contemporary therapy may be impaired. CAPTURE and other registries have shown this treatment can be delivered safely in the community.

Thanks

Thomas A Hennebry

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Carotid artery stenting, when combined with a distal embolic protection device, is emerging as an alternative to carotid artery surgery. That surgery involves general anesthesis, wound recovery, frequent prolonged hoarseness, and significant discomfort during the surgical convalescent period. Importantly, the population undergoing the surgery, is, by definition, one with significant age, generalized vascular disease, and, usually important comorbid conditions, whether realized, or not. The ability to revascularize the carotid circulation by non-invasive interventional technologies is a major advance in humane patient management. To require a surgeon to admit that surgery is not wise, is, unrealistic. Don't send someone to a barber to ask if they need a haircut.Our hospital,Medical Center East in Birmingham, Alabama, like many cutting-edge institutions in this country, has a very sound record of successful carotid artery stenting. Please don't yield to inappropriate pressure in this very critical deliberation. Thank you.

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I find it surprising that CMS mandates that high risk status is to be determined by a surgeon credentialed to perform CEA. Considering an individual patient to be high risk for surgery can be and is usually the result of non-surgical causes such as advanced coronary disease, poor ventricular function, advanced COPD...etc. I find it surprising and illogical to ask the vascular surgeon about the risk of prolonged intubation after surgery in a patient with COPD or the risk of a peri-procedural myocardial infarction in a patient with advanced CAD. While it is reasonable for the surgeon to be aware of these problems, it is traditionally and appropriately the domain of the specialists in those areas e.g. the pulmonologist or the cardiologist. If the concern of CMS is that radiologists and cardiologists will assign the patients the status of high risk inappropriately just to perform the procedures themselves, then there should be mechanisms to audit and review documentation of the high risk status determination. This is not going to be solved by a surgeon reveiweing the medical problems of carotid disease patients.I believe this decision represents a significnt intrusion by the regulator in the realm of medical decision-making. By the same token, one can argue that CMS will require all patients undergoing CEA procedures to be seen by a cardiologist to rule out the possibility of a peri-procedural myocardial infarction which is the most common cause of early and late death in those patients. Or that reimbursement be denied unless troponin and other cardiac markers is checked in all patients undergoing CEA post-operatively. Why doesn't CMS mandate that a cardiac surgeon determines if a patient should undergo coronary stenting or CABG? Why doesn't the interventional radiologist determine the appropriateness of a proposed bypass revascularization before the vascular surgeon is allowed to do it?While the consultations between the different medical team members are frequent and common when dealing with high risk patients, I don't believe that this process should be regulated by CMS. Guidelines regarding determination of high risk status can be found in the clinical trial publications and possibly 'spelled-out' by CMS, but not the speciality of the physician who decides that.

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While those of us who have been involved in the randomized trials and registries involving CAS with EPD applaud CMS's consideration of expanding coverage for this vital procedure, we don't understand the need for or subscribe to the belief that a vascular surgeon should be the final arbiter of the appropriateness of this procedure. The criteria fdor what constitutes high-risk for CEA are very well established and accepted by all specialties involved in the care of these patients. Indeed, the multi-societal guidelines reflect this concensus of opinion.

Since multiple specialists now perform these procedures, the proposal that vascular surgeons are "judge and jury" would have obvious negative economic and political consequences for the other specialties that perform CAS. The potential for abuse of this power is great, and there would be potential for harm to the doctor-patient bond and confusion to patients, if an outside vascular surgeon is artitfically introduced into the mix. This proposal would undoubtedly result in a great deal of unnecessary health costs for the consultations that would be required. In short, it's a bad idea that will only serve to continue to restrict patients from receiving this valable and proven intervention.

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In general I commend CMS to the changes made. I think the time has come to reimburse high risk patients who are asymptomatic and restriced to ages < 80 as this is clearly supported by clinical data.

The recommendation however to solicit the consent of a surgeon as to determine "high risk status" has no basis in clinical trial data, and frankly illogical. In many instances I am consulted for preoperative clearance for carotid endarterectomy and I make the determination that the patient is at increased risk for the procedure and yet now I have to refer the decision back to the very same surgeon who asked me the question in the first place. In most instances the question being asked is not whether the patient is "inoperable" but whether the patient is "at increased risk of a vascular procedure". This is best answered by the cardiologist providing the assessment and NOT THE SURGEON, at least as it relates to the medical side of the high risk criteria. There are certainly anatomical high risk criteria which may be more suitably judged by the surgeon such as high cervical lesions or radiation induced stenoses or tracheostomy. That being said, many surgeons frankly call nothing high risk! Endarterectomy restenosis is a perfect example. There is plethora of surgical literature explaining how this can be done, but everyone admits it is more risky and difficult than carotid stenting for which this is an ideal scenario. The risk of abuse is present, no denying that, but exists on both sides of the fence and to adopt an illogical and unsupported criteria (referal to a surgeon to determine high risk)I think bespeaks politics more than medicine.

Finally what is the patient going to think of the additional need for referrals and the possible conflicts it is inevitable to create. Who is going to pay for the additional consults? Who is going to review the appropriateness of the consults and the outcomes of the CEA which were performed because the surgeon didn't agree with the interventional assessment. What does the vascular surgeon who does interventions do to maintain unbiased postions. Do they have to refer to an interventionalist to ensure that the carotid stent is appropriate.

I would ask and advise you to respectfully reconsider this portion of the new policy

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Although I enjoy a professional relationship with my vascular surgeons, I don't believe that requring all CAS patients to be evaluated for high-risk criteria by a VS to be in the best interest of patient care. High-risk criteria are well defined, and are not open for discussion. For example, a patient with a restenotic cartoid is high-risk, and does not require the local VS input. If we are to have an HONEST discussion regarding CEA vs. CAS in the local community, then all individuals presenting to the VS who meet high-risk CAS criteria should be re-evaluated by the independent local CAS-provider, prior to undergoing CEA.

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Cordis strongly supports the proposal set forth for comment by CMS to expand coverage for carotid artery stenting with emboli protection.

Further to our earlier correspondence of March 31st 2006, April 3rd 2006, June 5th 2006 and August 25th 2006 and in response to CMS initiating a final period of public comment pertaining to coverage for carotid artery stenting with emboli protection, we are writing to share the rationale for our support of the proposed expansion in coverage. This is based on substantial new and expanded data that were neither available at the time the current NCD was issued nor during the previous public comment period for this reopened NCD. We believe these data address the concerns that had previously been expressed with regards to expanding coverage for carotid artery stenting with emboli protection.

Specifically, we will address the question of durability of carotid stent safety and efficacy outcomes with additional analyses from the long-term (3-year) follow-up data from the SAPPHIRE study and the question of generalizability of these results with the final 30-day data from the CASES-PMS study and the preliminary 1-year data from the CASES-PMS study.

The Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) study is the only currently available, completed, prospective, randomized, controlled trial of carotid artery stenting with emboli protection vs. carotid endarterectomy in patients at high risk of carotid endarterectomy.

The SAPPHIRE study consisted of 774 patients in 29 centers that were evaluated by a panel of physicians comprised of an interventionalist, a surgeon and a neurologist. Both the surgeon and interventionalist determined that they could randomize 334 of the 747 patients.

Of these patients, 167 received carotid artery stenting with emboli protection using the Cordis PRECISE ® Nitinol Stent System and the Cordis ANGIOGUARD® Emboli Capture Guidewire and 167 received carotid endarterectomy. Of the remaining patients, 406 were deemed to constitute an unacceptable risk for surgery by a surgeon and were treated in a non-randomized carotid stent arm of the trial; 7 patients were deemed to represent an unacceptable risk for stenting and were treated in a non-randomized carotid endarterectomy arm. Inclusion criteria consisted of one or more high-risk surgical criteria and a carotid artery stenosis > 50% in symptomatic patients and > 80% in asymptomatic patients.

The trial had a non-inferiority design with a primary composite endpoint being cumulative incidence of death, stroke or myocardial infarction (MI) within 30 days after the procedure plus death or ipsilateral stroke between 31 days and 1 year. Yearly follow-up to 3 years was pre-specified. At 1-year, the SAPPHIRE study was successful in demonstrating the non-inferiority of carotid artery stenting with emboli protection to carotid endarterectomy. Clinical follow-up was available at 3 years on 80.6% (106/131) of the surviving stent patients and 70.8% (75/106) of the surviving endarterectomy patients.

The CASES-Post Market Surveillance (PMS) study, is an FDA required condition of approval study conducted in 73 centers throughout the US that enrolled 1,493 patients. It is worth noting that the CASES-PMS study was also done under an IDE with strict adherence to Good Clinical Practice and with identical inclusion and exclusion criteria to the SAPPHIRE study. As such, it provides very high quality information on patients treated in a more general setting that can readily be compared to the SAPPHIRE trial data.

The main objective of the CASES-PMS study was to assess the safety and efficacy of carotid artery stenting with emboli protection when performed by physicians in different settings, who have various levels of experience with carotid artery stenting and who have received training through the CASES™ (Carotid Artery Stenting Education System) training program. The extent of the training was determined by their level of experience with both carotid artery stenting with emboli protection and specifically the Cordis ANGIOGUARD® Emboli Capture Guidewire.

The key questions posed to Cordis in meetings with CMS after the initial NCD was issued are as follows: 1) Does carotid artery stenting with emboli protection prevent strokes as effectively as carotid endarterectomy? We believe this question is answered in the affirmative by the 3-year SAPPHIRE trial data; and 2) Are the results from the SAPPHIRE trial generalizable to a wide variety of centers and operators who have undergone appropriate training? We believe that this question is answered in the affirmative by the CASES-PMS 30-day and 1-year data.

We seek to address the final proposals raised by CMS with regards to coverage for carotid artery stenting with emboli protection. Available data from the SAPPHIRE and CASES-PMS trials together strongly support the expansion of coverage to include patients who are at high-risk for carotid endarterectomy and who have asymptomatic carotid artery stenosis > 80% or have symptomatic carotid artery disease with a diameter stenosis > 50%.

Broadly speaking we submit that the body of data now available (SAPPHIRE 3 year, CASES PMS 30-day and 1-year) confirm that carotid artery stenting with emboli protection is at least as effective as carotid endarterectomy at preventing the occurrence of stroke. The 3-year data from the SAPPHIRE study also showed a somewhat lower cumulative rate of revascularization for stent patients (3.0%, n= 4) compared to endarterectomy patients (7.1%, n=9). In the SAPPHIRE randomized trial, carotid stenting also resulted in a 1-day shorter hospital stay than carotid endarterectomy.

Figure 1: At 3-years, the SAPPHIRE Study demonstrated no significant difference in the cumulative percentage of major adverse events (all cause death, any stroke and/or myocardial infarction at 30-days post procedure and all cause death and/or ipsilateral stroke after 30-days post procedure) when comparing the randomized arms for carotid artery stenting with emboli protection in patients at a high risk for surgery (26.2%), to carotid endarterectomy (30.3%),(P=0.273). Therefore, we conclude that these data demonstrate that carotid artery stenting with emboli protection is both an effective and durable alternative to carotid endarterectomy in patients at a high risk for surgery. Figure 1: Source document: SAPPHIRE 3-Year data, Cordis data on file

Figure 2:The SAPPHIRE Study demonstrated no significant difference in the cumulative percentage of stroke to 30-days and ipsilateral stroke from 31-1080 days when comparing the randomized arms for carotid artery stenting with emboli protection in patients at a high risk for surgery (8.0%), to carotid endarterectomy (6.7%), (P=0.799).Therefore, we conclude that these data demonstrate that carotid artery stenting with emboli protection is as effective and durable as carotid endarterectomy in preventing stroke in treated patients who are at a high risk for surgery. Figure 2: Source document: SAPPHIRE 3-Year data, Cordis data on file

Figure 3:In the SAPPHIRE study at 3-years, both carotid artery stenting with emboli protection and carotid endarterectomy demonstrated the same rate of all strokes (9.0 %, 15/167). Even though the total rates of stroke are the same for both carotid endarterectomy and carotid artery stenting with emboli protection, there was a somewhat higher rate of major ipsilateral stroke (3.0% versus 1.2%) and major non-ipsilateral stroke (3.0% versus 0.6%) with carotid endarterectomy than with stenting. Conversely, there was a somewhat higher rate of minor ipsilateral stroke with stenting than with carotid endarterectomy (5.4% versus 2.4%). Therefore, while carotid artery stenting with emboli protection and carotid endarterectomy both show the same, relatively low, overall rate of stroke, the type of stroke seen in patients who received carotid artery stenting with emboli protection were more often of a less severe nature compared to patients who underwent carotid endarterectomy.

Figure 3. Source Document: SAPPHIRE 3-Year data, Cordis data on file

Figure 4:Between 30-days and 3-years the SAPPHIRE study demonstrated similar cumulative stroke rates when comparing carotid artery stenting with emboli protection (4.4%) and carotid endarterectomy (3.7%) in patients at a high-risk for surgery. These data are consistent whether one looks at all randomized patients collectively or randomized symptomatic or asymptomatic sub groups.Therefore, we conclude that carotid artery stenting with emboli protection has a comparable annual risk of stroke to carotid endarterectomy in both symptomatic and asymptomatic patients at a high risk for surgery. Figure 4: Source document: Cordis data on file

Figure 5:Further analysis of the 3-year SAPPHIRE data reveals a significant difference in the rate of cranial nerve injury with zero observed for CAS and 4.8% for CEA (P=0.01). This is consistent with the literature on CEA indicating a range of 3.0%-23.0% (Cunningham, E. J. et al., J Neurosurg 2004; 111(3):445-48). Therefore, we conclude that given the comparable efficacy and durability of CAS to CEA, the absence of cranial nerve injury in the SAPPHIRE trial further reinforces that CAS, when used as indicated by FDA labeling, is a reasonable option for the treatment of carotid artery disease. Figure 5: Source document: SAPPHIRE 1-year , FDA panel presentation

Figure 6:At 30-days, the CASES-PMS study (MAE = 5.0%) demonstrated similar outcomes to those patients enrolled in the randomized SAPPHIRE study (MAE = 4.8%). Therefore, we conclude that the results demonstrated by the prospective, controlled, randomized, multi-center SAPPHIRE study can be achieved across a broad geographic distribution, in academic and non-academic centers, in rural and urban centers and by physicians with varying levels of experience who have undertaken training appropriate to their experience through the CASES™ (Carotid Artery Stent Education System) training program. Figure 6: Source document: CASES-PMS 30 day data, Yadav, J. S., TCT 2006 Abstract

Figure 7:While the CASES-PMS study demonstrated the generalizability of the results gained from the SAPPHIRE study at 30-days, preliminary 1-year data demonstrate the durability of those outcomes with the CASES-PMS study demonstrating an almost identical cumulative percentage of MAE at 1-year (12.1%) as the carotid stent arm of the SAPPHIRE Study (12.2%).Therefore, we conclude that the preliminary data from the CASES-PMS study at 1-year demonstrate both the generalizability and durability of carotid artery stenting with emboli protection when compared to the results from the randomized SAPPHIRE study. Figure 7: Source document: CASES PMS preliminary 1-year data, Cordis data on file

Figure 8:Preliminary 1-year data from the CASES-PMS study also demonstrated a cumulative percentage of stroke to 30-days and ipsilateral stroke from 31-360 days (5.0%) as the carotid stent arm of the SAPPHIRE Study (4.9%), lower than the carotid endarterectomy arm of the SAPPHIRE study (5.8%).Therefore, we conclude that the preliminary data from the CASES-PMS study at 1-year demonstrate both the generalizability and durability of carotid artery stenting with emboli protection in preventing stroke when compared to the results from the randomized SAPPHIRE study. Figure 8: Source document: CASES PMS initial 1-year data, Cordis data on file

Figure 9:The CASES-PMS study demonstrated similar rates of major adverse events at 1-year following carotid artery stenting with emboli protection between academic sites (n=801, 12.7%) and non-academic sites (n=692, 10.7%). Therefore, we conclude that carotid artery stenting with emboli protection is safe and effective in both academic and non-academic institutions when physicians have undertaken training appropriate to their experience through the CASES™ (Carotid Artery Stent Education System) training program.

Figure 9: Source document: CASES PMS initial 1-year data, Cordis data on file

We now seek to address the specific points raised in the proposed decision memorandum:

I) Response to proposal to restrict coverage to patients who are at a high risk for carotid endarterectomy (CEA) and have symptomatic carotid artery stenosis >70%

The body of clinical evidence for the use of carotid artery stenting with emboli protection in patients at a high risk for surgery is considerable. There are now well in excess of 10,000 patients captured in these studies and registries. The vast majority of the surgical data, including ACAS, NASCET and ACST capture non-high risk patients, while this coverage decision is focused solely on the high-risk population. In fact, the exclusion criteria for these studies almost exactly match the inclusion criteria for the SAPPHIRE study as demonstrated below:

Figure 10:When looking at the inclusion and exclusion criteria of the landmark carotid endarterectomy studies, NASCET and ACAS, it becomes apparent that the exclusion criteria for NASCET and ACAS are effectively the inclusion criteria for the SAPPHIRE study.Therefore, due caution is required when comparing the outcomes for low-risk patients from the landmark surgical studies to the outcomes for high-risk patients seen in studies such as the randomized SAPPHIRE study and the CASES-PMS registry and in general when considering coverage for the high-risk patient population addressed by the proposed decision memorandum. Figure 10: Source document: FDA panel presentation

Figure 11:The SAPPHIRE Study shows the cumulative incidence of all stroke at 30-days plus ipsilateral stroke from 31-days to 3-years to be 5.0% for CAS vs. 3.2% for CEA, for symptomatic patients with a diameter stenosis >50%. By contrast, the 2-year stroke rates for the low-risk symptomatic patients in NASCET were 9% for CEA and 26% for medical therapy (NASCET, N Engl J Med 1991; 325:445-53.)Therefore, we conclude that the data strongly support the expansion of coverage for high-risk symptomatic patients to include those with a diameter stenosis >50%.

Figure 11: Source document: Cordis data on file

CMS has made reference to the EVA-3S and SPACE studies to support limiting coverage for symptomatic patients. However, it is important to recognize several key elements of these studies. While both studies are randomized, neither limits enrollment to only high-risk patients. The generalizability of these results to the coverage decision cohort is questionable for many reasons and should be considered in the context of the following concerns.

With regard to EVA-3S, (NEJM, 356;3, January 18th 2007):

The intended modification seems counter-intuitive for patient care, and will hamper the ability of physicians to provide optimal medical care to patinets who are high risk (and may benefit from carotid artery stenting) in a timely manner.

The decision makers must consider the patient's interest, as well as the feasibilty of 'always' obtaining a formal surgical consultation prior to a CAS procedure even when patinets aare high riska and studies have shown that CAS may be in the patinets interest.In case the patients do not fully meet the criteria for 'high risk' or it seems to the MD that patient may be better treated with a CEA or patients want to consider CEA, or there are other confounding factors, a surgical consultation is beneficial and often routine at many institutions, but mandating sugical consult prior to every CAS procedure is not a good solution.

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Regarding Administrative File: CAG 00085R3Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting:

We applaud CMS for considering expanded coverage of Carotid Artery Stenting in high risk patients. While we encourage collaboration with physician colleagues when it is necessary and in the patient's best interest, a Federal mandate that consultations be obtained in all cases is excessively and unnecessarily burdensome. This will lead to increased costs and certainly delays in treatment.

Thank you,
William Bachinsky
Director, Cardiac Catheterization Lab
Pinnacle Health @ Harrisburg Hospital
Harrisburg, PA

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It is not medically correct to have a surgeon determine whether a patient is suitable for surgery or not. This is not what surgeons are trained to do. In fact, much of my practice as a cardiologist is focused on assessing preoperative risk for surgeons. One could envision the ridiculous situation where a surgeon performing CEA determines that someone is not high risk for CEA then refers the same patient to the same cardiologist who performs CAS to assess preoperative risk. Cardiologists are experts in perioperative risk assessment in vascular patients not surgeons.

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I do not believe that the requirement for a surgical opinion is reasonable. This will add additional unnecessary cost to the evaluation, delay a necessary procedure and not add materially to the already established CMS criteria for CAS. To my knowledge this is not a requirement for any other CMS approved procedure and is based, in my opinion, on circular logic, i.e. since previous studies required a surgical opinion, it must also be required for the procedure outside a study. The opposite hypothesis, i.e. risk stratification using CMS criteria, is assumed to be inadequate without data to support that conclusion.

It is also somewhat superficial to assume that all surgeons performing CEA are trained vascular surgeons just because they a credentialed by their facility to perform the surgical procedure. This is an incorrect assumption.

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Dear Sirs I am proud of CMS to continue to care about this situation. Having performed > 600 procedures in clinical trials with my associates at the Texas Heart Institute, we can firmly state that the Stroke rate was ~ 1.0 %, mainly in the pre protection era. Restenosis ~ 4%. I have deep concerns about asking a vascular surgeon for his recommendation for a non surgical decision. This was not a part of any of the post marketing trial. This expense to pay for a surgeon and expect him to assign rights to an interventionalist will just not materialize. In this world of ever challenging economics, this burdon of an unbiased consult just is unrealistic. As all the trials have shown, in the hands of appropriately trained individuals with increasing technical skills and knowledge, I believe those who have the patients interests and desires at hand are the physicians who see the patient first and who have access to all medical modalities. I am shocked at the thought of asking my surgical colleague to render his opinion on high risk when we all know that most surgeons do not believe in high risk situations with minor exception an institute that has endovascular surgeons who can make the decision in either direction are blessed but not necessarily better with the end results I urge the committee to consider for the patient and outcomes, who is best suited to determine fair risk options. I beleive it is the primary medical physician not surgical one. They continuously take care of patients at high risk for all procedures both before and after whereas many surgeons move on to the next individual out of necessity. Your decision to allow the interventionalist to decide rather than ask for surgical help is a necessity for this program to move forwards. Thanks you for the time

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As an interventional cardiologist, I agree with the basic CMS guidelines for reimbursement of carotid artery stenting. However, the requirement that every patient visit with a vascular surgeon prior to stenting, even if they meet the Sapphire-based criteria on which CMS bases their reimbursement, is unnecessarily burdensome on the patient, the cardiologist, and the healthcare system in general.

It wastes time, money, and efforts by many individuals. Please reconsider the requirement that the patient see a surgeon prior to carotid artery stenting if they otherwise meet CMS criteria.

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Cardiology consultation for surgical clearance in selected patients with medical co-morbidities is a common, and appropriate, occurrence. The requirement for a surgeon to see these patients to assign risk, the majority are in fact based on medical condition, turns this traditional algorithm on its head; cardiologists are obviously trained to, and fully capable of, determining at-risk surgical patients. Vascular surgeons are not trained to assess the cardiopulmonary risk of these or any other patients undergoing vascular surgery.

There are no data to suggest that a vascular surgeon provides any benefit to the patient or improves the safety of the treatment recommendation. The CMS requirement for a vascular surgery consultation is therefore not based on any factors to promote patient care or safety

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I would like to comment on the proposal for PTA of the Carotid Artery. Specifically I would like to address the issue of requiring all potential PTA patients have a surgical consultation with a trained surgeon in carotid endarterectomy. A gatekeeper model like this works only when the gatekeeper is uninvolved and unbiased, certainly not the case with a vascular surgeon passing judgment on his cardiology, neurointerventional, and radiology colleagues’ recommendations. The credentialing of surgeons performing CEA is a local phenomenon, and many surgeons so credentialed are not vascular surgical specialists but general surgeons serving their patients and communities by performing CEA, etc. Nevertheless, their expertise in this field may be quite limited, as will be their opinion. The bias of the surgeon toward a surgical procedure is obvious and this conflict of interest has the potential to expose patients to an operation (which is still reimbursed by CMS)that has a greater risk of complication than CAS would (e.g., patients with CEA restenosis), and with CMS explicit blessing. There are many surgeons who have adopted CAS as part of their practice armamentarium. Are these physicians immune to this rule by virtue of their duality, and thus unconstrained by any oversight? The logical extension of the requirement for a surgeon to qualify a patient as high-risk for carotid stenting will be a gradual erosion of other specialty involvement as referring physicians bypass the middle-man. The increased cost of these of these consultations will be borne by patients and CMS. This could represent a significant workload increase for the surgical community of seeing every high surgical risk patient referred to them for a second opinion considering the estimates of CAS activity in 2006 (~25,000 cases) of which the surgeon was directly involved in only ~25%-30%. The need for surgical consultation appears to be excessive given the clear, standardized, retrospectively verifiable definitions already in place through the current national coverage decision (NCD).

Cardiology consultation for surgical clearance in selected patients with medical co-morbidities is a common, and appropriate, occurrence. The requirement for a surgeon to see these patients to assign risk, the majority are in fact based on medical condition, turns this traditional algorithm on its head; cardiologists are obviously trained to, and fully capable of, determining at-risk surgical patients. Vascular surgeons are not trained to assess the cardiopulmonary risk of these or any other patients undergoing vascular surgery. Patients andreferring doctors will often object to seeing additional consultants, particularly when patients are referred from physicians from remote areas or other institutions. This is particularly problematic if the patient is responsible for additional co-pay. When a cardiologist and a surgeon disagree as to patient risk, does the patient default to a CEA by the surgeon? Is third opinion sought? Moreover, there are significant implications if the interventionalist and the surgeon disagree as to patient risk and there is an untoward surgical outcome, even if there is no fault to ascribe. There are no data to suggest that a vascular surgeon provides any benefit to the patient or improves the safety of the treatment recommendation. The CMS requirement for a vascular surgery consultation is therefore not based on any factors to promote patient care or safety. It establishes a primacy of one specialty over another in where care expertise overlaps, which is without precedent in cardiovascular medicine. Using the same logic, an interventionalist could be required to evaluate every CEA contemplated in this country for a percutaneous alternative.

There is little doubt that there are still high- surgical risk patients undergoing CEA today despite no or unsupportive data, and a potentially safer alternative. Finally, and most importantly, the patient is being placed in a vulnerable position by this requirement. Not only will they be the potential position of being caught between specialties in conflict, but they are also very likely to be confused and upset by the differing opinions almost certain to result from multiple, mandatory and unsolicited consultations. The extra traveling involved and the delays in obtaining consultation (which at a recent survey of a vascular surgery department at a major metropolitan hospital was at least two weeks) are typically accompanied by significant anxiety and place significant burdens on family members having to take time out of work to transport/accompany their in definitive therapy. If these issues weren’t onerous enough, there will be an excess of unnecessary strokes/deaths occurring as a result of a lack of timely, definitive therapy. Besides the obvious disability and disrupted lives, the potential liability issues for all involved are significant.

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In regards to carotid stenting procedure, it seems highly illogical and cumbersome to have a surgeon evaluate a patient to determine if CEA is really high risk for the patient before patient could be treated percutaneously or the operator be reimbursed for carotid stenting.

This proposal means we already have established that CEA is preferred method of treatment for carotid artery disease but in reality this has not been established. On the contrary, we are observing that carotid stenting is becoming the preferred method over surgical treatment by the patients. Available data does not suggest clear cut superiority of CEA over CAS.

Carotid stenting technique is becoming more and more advanced not only by operator skills but also newer and better devices are coming into the market.

I strongly oppose the idea of surgical consultation prior to carotid stenting for any patient who is considered relatively optimum candidate for carotid stenting by a skilled and adequately trained physician.

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I agree with the majority of the decision analysis. Prior to expanding coverage, CMS should await validation trials to see if CAS is equal to surgical CEA in 'low risk' groups. It is in this group of patients that the lion's share of carotid interventions lie, and one that CMS should facilitate well designed post market trials to answer this heated debate. There is little doubt now that CAS and CEA are essentially equal in the high risk group, but stroke and major morbidity rates as shown in these trials would be abysmal in comparison to the very low stroke and complication rates in the 'routine' CEA patient in the hands of a competent surgeon. In fact, these data are easily retrievable in the Medicare files in most states ( the last time our site was audited the stroke rate was less than 1.0 percent!). I implore you to continue this process in an evidence based fashion, and realise that we surgeons that perform CAS, CEA, and medical therapy for carotid pathology are in the best position to recommend therapies to the patient based on what is in his or her absolute best interest. With this in mind, I only find fault with the octagenarian rule, since I do not believe that the small study size was ample to imply that patients over 80 will fare better with open surgery. I believe this decision should still be left to the physician in charge weighing all variables and co-morbidities in this challenging group of patients. I continue to be impressed by this promising technology and will continue to perform CAS on patients when I feel it is in their best medical interest.

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As a practicing vascular and endovascular surgeon who does both open carotid endarterectomy and carotid stenting I feel strongly that high risk assymptomatic individuals with > 80% stenosis should be covered by CMS. Individuals who are symptomatic and have a >50% stenosis should also be included as I would operate on these individuals. Also all individuals > 80 yrs of age should not be excluded. I think a better judge of those who should be excluded be based upon the type of aortic arch Type A, B covered and Type C excluded.

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Dear Sirs:

I would like to respond to the proposed carotid stenting coverage. I am a vascular surgeon actively involved in the treatment of carotid disease. We perform between 125 and 150 carotid interventions yearly performing both carotid endarterectomies and carotid stenting with MAE rates of less than 1% for both procedures. We have received top rankings from healthgrades.com for our results the last several years. We believe the key to our success is patient selection. We do not do a difficult carotid stenting if the patient would be an easy carotid endarterectomy.

I would be support of expanding coverage of carotid stenting for patients who are symptomatic with > 50% stenosis in patients who are really high risk. I believe however it is very important continue to have a vascular surgeon involved in determing which patients are really "high risk". I have seen many times in which a patient was deemed "high risk" for surgery by a cardiologist when in fact they were "low risk".

The recent New England Journal Medicine article reporting the poor results in the French study demonstrates the need for ongoing monitoring of this procedure. As a result of this study, the French government is no longer paying for carotid stenting.

I am supportive of carotid stenting. I believe, however that it needs to be performed on the right patients, for the right indications, by physicians appropriately trained and experienced in the care of carotid patients. I believe that the best way continues to be thru FDA monitored studies to help determine which patients are best treated with carotid stenting.

Expanding the indications and particularly allowing a number of inexperienced interventionalists to start expanding in this field, I believe could result in a number bad outcomes and could like the French experience cause a moritorium on coverage.

Sincerely
Greg Schultz MD

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I strongly do not support the proposed changes. It is critical that Surgeons, that do CEA, evaluate these patients. A Cardiologist or Radiologist cannot make a determination of high risk - they have a strong bias in favor of CAS. A Surgeon can objectively determine the best treatment option for the patient. Also CMS should consider one important fact - how long have "must" Cardiologist been treating and managing carotid disease compared to Surgeons? The answer is not long. There interest in carotid disease is only recently because they can treat it with a stents. Surgeons have been treating carotid disease for over 50 years. I agree that patient greater than the age of 80 should not be considered for CAS - too high risk (data supports this). There is no data to support that CEA is associated with higher complications in the greater than 80 year old patient. Asymptomatics patients should not be covered at this point. There is too much data out there that is of concern that doesn't support the use of CAS(a couple of single center and 2 meta-analysis articles). I feel strongly that CEA can be done safely in most patients and I do offer CAS in a very selective group of my patients. The cost is significantly less for CEA vs CAS and the long-term durability is unproven with CAS. I can almost assure you that in the long-term CAS is going to "cost" American Healthcare significant more than CEA. I do both procedures and have no bias in my decision. Thanks and hopefully a decision is made that is best for patients and not certain specialist.

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The determination of whether or not a patient is at high surgical risk should be made according to the criteria used in previous FDA-approved clinical trials. A physician who plans to perform carotid stenting should not be required to have an "approved" surgeon deem the patient "high surgical risk". Some surgeons have gone on record as saying "no patient is high surgical risk". If a qualified interventionalist happens to be in a hospital where surgeons hold that opinion, then a beneficial procedure may be inappropriately restricted. Symptomatic patients with lesion severity greater than 50% have been shown to benefit from revascularization. They should be offered this therapy without prejudice.

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Retricting CAS to patients over 80 years of age is prejuditial against the elderly. It is generally thought the the higher stroke rate in this age group is secondary to the higher incidence of type 3 arches. Patients who are over 80 who have a type 1 or type 2 arch excluded based upon age alone. This is unjustified. Since these patients are high risk for surgery, they will have an effective treatment denied. This will lead to a higher incidence of CVA in this untreated group. CAS in the octogenarian should be left to the descretion of the physician.

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As a vascular surgeon, carotid stenting has a role. My biggest concern is that if we expand coverage to asymptomatic carotid vessels, we may see an explosion of carotid stenting done in alot of patients where it is not indicated. We must be careful of this. I would like to see a mandate that the vascular surgeons really select which patients are best for stenting and best for open surgery. Otherwise, endovascular specialists will run the table and be stenting everything they see or feel should be done. WE MUST REALLY LET THE SURGEONS HELP DIRECT THE PATIENT FLOW> I do this in my practice.

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1) I strongly disagree with the requirement of having a surgeon establish "high-risk" criteria prior to carotid artery stenting. High risk features are well established and tracked routinely per CMS requirement for local quality control purposes at most institutions which are carotid stent certified facilities. Mandating an additional surgical consult will unnecessarily increase complexity of patient management, add expense, and lead to often conflicting opinions. Referrals for CAS come from multiple sources including neurologist, internal medicine, cardiology, and vascular surgery. Mandating prior surgical consult will serve to stigmatize this highly effective treatment as still possibly "experiental" and label the operator as unable to assign proper risk stratification. There is also implied malpractice if one does not obtain surgical consult. As long as the physician performing carotid stenting is a qualified operator and proper documentation exists in chart as to the what high-risk features exist in that particular patient should suffice. Many local surgeons, especiall those who do not perform CAS, are extremly hostile towards this technology. As CMS is very well aware, no other technology has undergone such scrutiny and despite very promising data from both the research trials and clinical series, we continue to make this issue unnecessarily complex. Also what if a surgeon himself is performing CAS, will he be eligible to determine high-risk eligibility himself, or will he also require second-opinion. Cardiologist have long screened patients to deem their eligibility for surgical vs. percutaneous revascularization techniques for coronary artery disease and I do not see why a different set of standards need to be developed for carotid circulation.

2) I fully agree with extending the procedure to > 80% asymptomatic patient population.

3) Blanket exclusion of patients > 80 years of age for coverage for carotid stenting, when such standards do not apply to CEA is not called for. It is well known that risk of CAS, for that matter any procedure, is higher in octagenerians. An operator should discuss various options and risk benefit ratio in patients > 80 years of age before embarking on any revascularization strategy and a cautionary statement should be added to the CMS approval rather that exclusion. Moreover, it is not the chronological age but functional age that is more important in determing whether treatment should be offered, and covered, for a subset of patient population. High-risk features for CEA are more common in patients >80 years of age and excluding CMS payment to this subset will do disservice to this growing segment of population.

4) CMS should clarify that assigning accurate stenosis severity just based on contrast angiography is not always feasible. In patients with restenotic lesions, eccentric lesions at bifurcation, accurate stenosis severity measurement is ofter troublesome. Alternative /complementary modalities, such as intravascular ultrasound and Duplex velocities data should be used appropriately, on a individualized basis

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An 81 year old man presents with crescendo TIAs and is found to have a 95% stenosis of the appropriate internal carotid artery. He has a history of throat cancer treated with laryngectomy and radiation. His history is also remarkable for COPD and an ischemic cardiomyopathy. He is referred by a vascular surgeon for carotid stenting.

Respectfully, many of us wonder whether the CMS decision to not cover this procedure is based entirely on evidence based medicine? Physicians and institutions continue to care for these patients without reimbursement because it is the right thing to do. This would be true even if the stenosis was 65%, or if a distal protection device could not be placed despite all efforts.

Does this proposal save lives or save money?

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1. Clarification of the degree of stenosis for symptomatic patients should be made similar to that of CEA, > or equal to 50% in appropriately selected pts as per AHA guideline for CEA. We are all aware the benefit is larger & more robust for > or equal to 70%, but most pts in our area with a clear cut TIA or minor, non-disabling stroke are routinly referred to CEA.

2. NO coverage for patients > or equal to 80 yrs old is NOT right. This is clear cut age discrimination and rationing in my opinion. I am aware of the fact that NO data exists to prove these pts live longer in studies, but stroke is a MAJOR concern for ALL of my 80 yr old pts. They do not care if they die suddenly at this age, but they absolutely do NOT want to have a major disabling stroke & linger in the nursing home.

3. No payment for CAS without embolic protection likewise is not correct. It should be covered at a reduced reimbursement. I am not endorsing routine CAS without embolic protection, but some pts clearly need treatment with CAS where the embolic device won't pass due to technical issues & no available device will work, yet the pt needs intervention. I recently (last 6 mos) proctored 2 cases performed by a vascular surgeon where NO device would cross, but the pts could NOT have CEA (Lesion not accessible & prior radiated neck). Both pts had experienced recurrent TIA's on maximal medical therapy. Their cases were completed with PTA/stent only with NO major complications.

4. Lastly, the CEA surgeon doing a mandatory consult to say "It's too risky" and to essentially give permission is also not right. If however, CMS feels this is mandatory, THEN I believe the surgeons should likewise obtain "permission" to perform CEA from an appropriate specialist in carotid management such as a neurologist or cardiologist. Specifically, I would also suggest that the surgeons be required to discuss ALL options in the informed consent process to include CAS and in particular CAS/CEA trials available in the area. I have routinely found that certain surgeons who do not want to consider CAS or "lose their pt to a randomized trial" seem to never mention CAS to the pts. Finally, I think the adoption of ASX pt coverage is a good move to give pts all options. The recent discussion about the inferiority of CAS to CEA is curious when published in a high profile journal that many surgeons have "latched onto & quote frequently", but the VAST amount of previous registry data and randomized data support CAS as better or at least as good as CEA, that data is dismissed or is said by the surgical community to be biased.

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Why mandate a surgical consult? Usually the surgeon (or anesthesiologist) will consult IM, cardiology, or pulmonary to determine the patient's risk. Usually the surgeon declines due to anatomic factors while the physician performing PTA/stent feels the patient is high risk due to medical reasons. The Saphire trial and Archer registries have established what mkes patients "high-risk" due to both anatomic and medical reasons. I have no problem with the remainder of the proposal and am concerned about the recent SPACE and EVA-3S study results in symptomatic patients.

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I applaud CMS for carefully considering the available medical data in determining payment for carotid artery stenting. However, the requirement that a vascular surgeon evaluate the patient prior stenting to allow payment by CMS is simply restraint of trade. Cardiologists and Interventional Radiologists, who perform the stenting portion only, would have to send the patient to a vascular surgeon who also may perform carotid stenting. Thus CMS would be giving the surgeon an unfair competetive advantage. The decision of whether a patient is at high risk to undergo general anesthesia is a medical one and requires no special surgical knowledge. This knowledge is widely available and requires no surgical training. Cardiology residency training may put them in an optimal position to determine ones cardiovascular risk. In fact, many surgeons require "cardiac" clearance by a cardiologist prior to surgery. There is no science to this rule and it should not be included in the final draft.

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As an interventionalist who routinely performs carotid stent procedures with embolic protection, I support your coverage of carotid stenting.

However, I STRONGLY oppose your proposal to include an additional surgical consultation outside of the accepted high risk anatomical and clinical criteria already established in the SAPPHIRE trial. It makes NO sense to fly in the face of a randomized study with defined criteria which outline "high risk" to now require additional documentation from a potentially biased surgical opinion regarding carotid stenting. I suggest if the patients meets the criteria by which FDA and CMS approved and covered carotid stenting that NO additional opinion needs to be rendered in the patients care.

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I agree with the proposal except:

1. I do not think asypmptomatic, high risk patients should be covered yet outside a trial or PMS, since physicians may tend to liberalize the definition of "high risk," in order to increase volume and this would most certainly be self serving.

2. I do think high risk, symptomatic patients with 50-69% stenosis should have regular coverage, as this is not uncommonly encountered and may be the only option open to this population.

3. I do think symptomatic, high risk patients over the age of 80 should have regular coverage, since, again, this may be their only option for treament and would most likely be at higher risk for surgery than for carotid stenting.

4. CAS should have regular coverage if an attempt is made at passing a distal protection device but fails and a stent can still be implanted.

5. I am a little unclear about the "surgery consulting" portion. I do not think there should be a requirement to obtain a vascular surgery consult prior to stenting as local situations are vastly different ranging from financial dependency between different specialties to overt non-cooperation between the two or three specialties.

Thank-you for allowing me to comment.

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I am a cardiovascular surgeon who performs open carotid endarterectomy under regional anesthesia. This approach allows surgery on individuals with very poor pulmonary function. I cannot remember denying the operation for this reason. The patient can sit in a semi-Fowler's position (I don't think this is possible on most interventional radiology tables). I do endovascular procedures and find it very important that the patient be still. This may require more sedation than is necessary for an open procedure. This obviates the benefit to the pulmonary compromised patient.

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1)Very pleased with expanded coverage for asymptomatic patients with surgeon approval.

2)Need to expand coverage for symptomatic 50-59% stenosis at high risk for surgery since this is approved for surgery in non-high risk patients, and CAS has similar risk for stroke as surgery. You are forcing these patients to go to surgery when they are at high risk for surgery. This increases overall bad outcomes for patients and overall expense for Medicaire system.

3)Embolic protection devices are critical but there are rare cases when they cannot be placed because of anatomical factors and this should not prevent stenting. I myself have not had a case yet that EPD (embolic protection device) could not be placed but I am sure one will eventually arise. You could require attempt at placement and if you think necessary require no more than a certain percent of all cases a physician performs may be without EPD (eg. no more than 10% without EPD). This would help prevent any abuse of the system.

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I am commenting to express my support for expanding Medicare coverage for carotid stenting for high risk patients. Specifically, I feel that asymptomatic patients with greater than 80% stenosis should be included. Furthermore, I feel that age greater than 80 should be considered high risk.

I base my comments on greater than my 8 years experience with carotid stenting, having performed several hundred procedures. We have participated in ARCHeRrcher, Beach, EXACT, CASES and Capture carotid stent trialstrends, and are currently enrolling in Exact, Capture II and ACT I trials. The results of the Sapphire study clearly show that carotid stenting is superior to CEA in high risk patients, even if they are asymptomatic. The post market studies show that carotid stenting can be safely performed. The majority of patients in these studies were asymptomatic. To exclude these patients from coverage would subject them to a higher risk procedure.

I would like to express a strong position against requiring that a surgeon determine the high risk status of carotid stent patients. The criteria that determine high risk have been well established in all of the pre and post market trials. Most of these trials required a neurological evaluation but not a surgical consultation. The proposed requirement would make the procedure cumbersome and more expensive. The conditions that make patients high risk have been well established in the clinical trials. The opinion of a surgeon is not necessary to make the determination of high risk. I feel that age greater than 80 should also be considered at high risk.

Thank you for the opportunity to express my concerns.

Charles M. Zacharias, Jr., M.D.
Medical Director
Cardiac Cath Lab
St. Mary’s Hospital
Richmond, VA

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I don't agree with the statement that a surgeon should make the determination of high risk, let alone be a surgeon with experience in CEA surgery. These are the ones who are learning CAS now and there is financial incentive involved. The best physician to determine who would benefit and who would be high risk is the neurologist who does not have financial incentive unless involved in a study. I would not support any stipulation that states a vascular surgeon must be the one to determine high risk

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I agree with the requirement of a surgeon credentialled to perform carotid surgery to determine surgical high risk status. I don't feel that a physician who is not credentialled in his/her institution to do carotid surgery can fairly and objectively determine this.

I do not agree with no coverage if no protection device is used. If attempts are made to use protection, and the treating physician feels that no other options exist, it may be in the patients best interest to proceed with unprotected stenting. No randomized data exists to show the efficacy of protected stenting versus unprotected carotid stenting. The riskiest part is oftentimes gaining sheath or guide access into the carotid. If a patient is high risk for open surgery and attempts to use a protection device have been made, even if unsuccessful, then the procedure should be covered.

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In the opinion of a surgeon:

Unfortunately CMS is overinterpreting the results of a randomized trial(s) conducted to evaluate non-inferiority of one procedure versus another procedure for treating carotid stenosis in a symptomatic population. Under no circumstances was this an evaluation of surgical opinions and cannot be generalized. In fact, SPACE was weak at best with a conditional power of 52%, that is no better than a coin flip that their conclusions are accurate and the absolute difference of .51% certainly is inconclusive. There was only a tendency towards better results in the carotid endarterectomy group, except for the most injurious outcomes - hemorrahagic stroke and death. I am concerned that the randomized trial, however weak, either for funding lack or otherwise, is being considered useful in discriminating physician judgement in the case of "in the opinion of a surgeon" clause.

Agin, in EVA3S the study design has a differnce of only four events in over 600 patients does not qualify as a discriminartor of physician judgement, in fact, it would easily be arguable that physiciaqn judgement is very good whether a surgeon identifies patients at high risk or the cardiologist or interventionist describes high risk. This risk element is based on comorbidities that are pre-defined from a historical perspective and seem to hold true regardless of who documents the high-risk characteristics.

Further, patients are considered "high-risk" for both anatomic and physiologic reasons. The majority of clinical trials including registries and controlled randomized trials did not did not specify surgical review for high risk status. These trials include MAVERiC,CARESS,CAFE,CSSA,ARCHeR,SHELTER,CABERNET BEACH, EVA-3S, SPACE, SAPPHIRE, and the ongoing trials CREST and recently completed CAPTURE trial. Indeed, amongst asymptomatic patients considered high risk for surgery the argument is compelling that stenting is comparable to endarterectomy as CMS concludes. Whether carotid stenting is the best or equivalent choice for high risk symptomatic patients is still unanswered. The surgeons input although not unimportant seems to be moot regarding who is high risk and the subject will never likely be studied.

At this point I strongly disagree with the "in the opinion of the surgeon who is credentialed to perform endarterectomy" clause due to lack of science and confusion of the issue as how to best treat patients. We are all interested in good outcomes and as a interventional cardiologist who has a depth of critical decision making I think CMS is presumptuous in their determination.

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I commend CMS on reconsidering the current reimbursement decision for CAS in high risk surgical patients. However, I am concerned about two portions of this decision.

1.I STRONGLY disagree with the provision that the determination of "high-risk" be done by a surgeon who is credentialed in CEA. Many surgeons do not perform CAS and as such, have a negative incentive to even consider a patient for CAS. Instead they ONLY offer the procedure they perform, i.e. CEA. As an interventional cardiologist who performs CAS, I always discuss both options with my patients and let them decide on which procedure they prefer.This seldom happens when a patient sees a surgeon who does not do CAS.

Additionally, as a cardiologist, I am acutely aware of who is high-risk for surgery. In fact, often I must evaluate these patients for CEA clearance. As such, I find it offensive that I am not trusted to make such a decision on CAS patients. Why doesn't CMS require all high risk patients see an interventionalist before CEA to decide if they are better served with CAS? Current CMS guidelines are clear on who is high risk, any physician who is credentialed in CAS should be allowed to make this determination and document such in the medical record for payment.

2.The decision to limit coverage to patient < 80 years of age is inappropriate. To my knowledge, no randomize trial has shown CEA to be superior to CAS in such patients. The SAPPHIRE Trial included patients >80 as did other registries (i.e. ARCHER,etc) and no differences were noted. Recent trials have suggested increased risk of CAS in these patients, but we have surgical trials that show similar increased risk. If patients > 80 are at increased risk for both procedures, why does not CMS limit CEA payment in these patients? I feel unless randomized trials suggest an advantage of CEA over CAS in patients 80, we should not exclude these patients from CAS.

Thank you for your time and attention.

Sincerely,

Daniel Dulas, MD Chief, Dept of Cardiology Mercy and Unity Hospitals Mpls, MN

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Eliminate the requirement that a surgeon determine if the patient is high risk. In our city, sugeons are not trained in endovascular techniques. The only time they would not operate is when anesthesia would refuse to provide anesthesia. Our surgeons would never agree that anyone was too high risk. This requirement empowers surgeons to eliminate carotid stenting unless that surgeon is trained to perform the procedure. CMS must know that by favoring surgery they will deny this procedure to patients depending upon where they reside.

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I think the current proposed policy on CAS reimbursement is wrong.

It discriminates against the elderly (over 80 years) in which we and other major centers have had similiar complication rates as in the 60-80 age group.

Secondly it is not correct to have a vascular surgeon qualify patients as high risk. Many have no desire to see carotid stent succeed. That is partly why the results from the French EVA-3 trial were so poor; many of the interventionalists were surgeons with less than 5- cases experience. Having a second party with alternative or biased interest determine patient status is wrong. Furthermore,it will start a bad precedent: maybe all surgical procedures including endarterectomy should have an interventionalist approval beforehand. With complication rate over 12% for symptomatic patients in the SAPHIRE study, I am surprised reimbursement for CEA has not been as thoroughly scrutinized as CAS.

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In our institution the risk of cea has consistently run 8-10% although the surgeons have always quoted 2%. Our risk with cas in HIGH RISK patients is currently running less than one percent. It is becoming increasingly hard to refer a patient for cea knowing that it has a higher morbidity and a less durable outcome, as well as being much more invasive.

Secondly, surgeons are usually requesting cardiology "clearance" for their cases. Now suddenly, they are to become the experts on medical risk of surgery vs. percutaneous techniques? Thus I think your fourth bullet point is counterintuitive to standard medical practice in the United States.

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I am a vascular surgeon that performs both carotid endarterectomy (CEA) and carotid stenting. I am concerned that the premise that carotid artery stenting (CAS)is appropriate for treatment of asymptomatic patients who are "high risk" for CEA may be flawed. Extant data from suggests that CEA is only beneficial for asymptomatic patients who can have the operation performed with low morbidity and mortality risk AND who have a reasonable life expectency. If the patient is sick enough to be considered "high risk," the obvious concern is that they won't live long enough to benefit from the prophylactic intervention. This was the problem with with VA trial of CEA for asymptomatic patients. Even though the operative outcomes were adequate, survival in the cohort was limited, and no benefit could be demonstrated for the operation.

I think the initial decision to limit Medicare payment from CAS was very prudent. This provided the needed incentive for addition data collection in clinical trials (registries). While I believe there may be data in the future that can guide decision making in both high and low risk groups, there has been very little new data from the US experience to justify broadening the indications to "high risk" asymptomatic patients. No one can has shown that this expensive and risky intervention is better than aspirin and statins.

I fully support continued use of CAS in all cases for which the systems have FDA approval, but I think the CMS decision to limit reimbursement, pending additional data, is the necessary impetus to continued data collection.

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I am a vascular surgeon who performs both CEA and carotid stents. I object to the present criteria for performing asymptomatic carotid stents.

First-what criteria are used to determine the degree of stenosis? Is is duplex, cerebral angiography, or MRA? I contend only a cerebral angiogram or a carotid duplex from an ICAVL accredited lab should be used for determination.

Second-CMS is underestimating the leverage a cardiologist holds over a cardiac surgeon who may also perform CEA. That surgeon is unlikely to disapprove of a carotid stent when he knows that cardiologist will cease to refer him patients for CABG.

Third-in my practice location cardiologists are performing an enormous volume of asymptomatic carotid stents for dubious indications. Unless stringent criteria are in place I only see this misuse of carotid stents to worsen. I strongly endorse a moratorium on asymptomatic carotid stents at this time until more careful verifiable criteria are in place.

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It is encouraging to see the steps that CMS is taking re carotid stenting, however I must object strongly to two of the proposed recommendatons. First of all, to restrict carotid stenting to patients younger than 80 is foolish, short sighted, and in effect denying apprpriate medical care to a huge segment of the population. The # of octagenarians who lead active and productive lives is increasing steadily. Their age alone makes them high risk for carotid endarterectomy,or any standard surgical procedure for that matter, especially one that requires general anesthesia. Furthermore, in terms of cost to the national medical system, the cost of carotid stenting, even for large #'s of octagenarians, is trivial compared to the cost of caring for a stroke, including long hospital stays in th ICU as well as the cost of rehab, not to mention the miserable quality of life that results once a stroke has occured. Secondly, asking or requiring a vascular surgeon to make the decision as to whether or not a patient is high risk for CEA is asking the fox to guard the chicken coupe. Vascular surgeons are loosing business; carotid stenting is not in their best financial interest. Too many vascular surgeons are overly conservative and would like things to remain as they are; fortunately medicine and science moves on; we don't use leaches and blood letting any more, and in 2007, we should not be treating carotid disease as we did in the 1950's. To compare the current surgical (CEA) and medical (carotid stenting) literature is a major mistake. The statistics reported in the most cited surgical literature are misleading. The classic reports are from the best surgeons at the best centers; the statistics reported in no way reflect the statistics of the average vascular surgeon at the average community hospital, which are far worse. . Furthermore, the neurlogic evaluatuions pre and post CEA in most of the studies are cursory at best. On the other hand, the excellent statistics for carotid stenting occur even with numerous operators with a broad range of expertice, from novice to expert, and in spite of intense neurologic scrutiny pre and post procedure. A classic example of people's (surgeons) hidden agendas is the New England Journal of Medicine's recent publishing of a european study which had terrible results for carotid stenting. I don't have the reference in front of me but the article made headlines everywhere, including the lay-press. The editors of the NEJM should be ashamed of themselves for allowing this incredibly poorly done study to be published. 75% of the patients enrolled had no distall protection. This is not the standard of care in the US; even the janitor in my cath lab knows that not using distal protection for carotid stenting is a mistake; furthermore, a large # of operators in this study were performing their 1st carotid stent. How could anyone legitimately try and compare the results of a first time operator to the results of an experienced vascular surgeon? This article was garbage but since it was in the NEJM, too many people view it as gospel.People need to wake up and realize that CEA is something thatwe should be very soon reading about in medical history books. Having a vascular surgeon review and judge which cases are high risk is purely an attempt to avoid and delay the inevitable.

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I believe asking the surgeont determine if the case is high risk is great disservice to the patient. Each surgeon is different and not all are ethical. This like taking the cow to the butcher...what is the butcher going to do with a cow but slaughter it...so, i hope that assymptomatic are added with having being high rik not by a surgeon but a qualified doctor that both or either procedure (CEA or stent)...the trials are done and they told us who is high risk...why now should we ask the surgeon if the patient is high risk or not...This is bad and an insult to us who perform carotid stent for over seven years without a single stroke. I belive that surgeon did not come out clean with the nascet trial...how could they come out clean on this without the neurologist being neutral and sees each patient before either stenting or cea. I hope we can do carotid stenting on assymptomatic patients who are deemed high risk by the literature and not by a surgeon on thier subjective feeling..since most do not keep up with the literature.thanks

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I certainly agree with the notion that coverage should be expanded to include >80% asymptomatic patients. I do not see the point of excluding people older than age 80. The need to obtain approval of a vascular surgeon is absolutely rediculous and is essentially an attempt ov the vascular surgery community to eliminate this procedure from the practices of cardiologists and radiologists. I personally do not believe that CAS should be withheld from patients who are considered non-high risk for CEA. Clearly, CAS is a safe procedure in the hands of a properly trained individual and most likely safer in many cases than CEA in the hands of a marginally trained individual. No restrictions exist on CEA to my knowledge.

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I am responding to the proposed changes regarding carotid stenting for stroke prevention. I am an interventional cardiologist and clinical trialist, with approximately 800 carotid stent cases performed over the last 9 years, mostly in clinical trials and registries. Importantly, more than 100 of my patients were over age 80 with a number over age 90 at the time of carotid stent implantation. Our single center experience has demonstrated significantly better outcomes than the multicenter trials and registries, and carotid stenting has become the treatment of choice by our specialists, with surgical endarterectomy typically reserved for poor stent candidates. I applaud the expansion of coverage to include high risk asymptomatic patients with stenoses > 80%. I also agree that we should continue data collection on octogenarians, particularly given the results of the CAPTURE 3,500 registry, the first community based registry of carotid stenting in the United States. I strongly object, however, to the mandating of a consultation by a surgeon, even a qualified credentialled surgeon. This decision would be poor policy for several reasons. Firstly, mandating consults undermines the credentialling process for a number of specialties including cardiology and radiology. The education, training and experience of interventionalists, along with monitoring of outcomes, will determine the success of the procedure to achieve stroke prevention. Although very few patients are inoperable, many are high risk. It doesn't require a surgeon to determine that a patient has a "hostile" neck. Similarly, it doesn't require a cardiologist to determine that the patient has an ejection fraction determine that a patient had a stroke. Does consultation and multidisciplinary planning have value? Absolutely yes. Is it a good idea to get a second opinion? Definitely. Consulting with a surgeon and/or a neurologist should be encouraged, particularly by less experienced carotid stent operators (the CAPTURE data reconfirmed that experience level was a good predictor of outcomes). But mandating consults is inappropriate, unnecessary, and costly. Furthermore, endarterectomy surgeons, particularly those that do not perform carotid stenting as well, have a conflict of interest that cannot be avoided. Our patients will be subjected to selection bias, and their outcomes will suffer. I would recommend that the language regarding consultation from a surgeon be dropped completely. We must move forward in an objective professional manner for the good of our patients.

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Medicare shoud expand the indications for carotid stenting to include patients below age 80 who are high risk.

Most importanty where we would be today if the Cardiac surgeons approval was needed 20 years ago for each coronary angioplasty/stent? We would be performing only bypass suregries in all patient with cornoary artery disease, wouldn't we.(STENT TECHNOLOGY WOULD NOT BE DEVELOPED AS IT IS TODAY)

That is the scenario today when CMS want to have a vascular surgeon's certification before carotid stenting is done by a cardiologist/radiologist. This is a grevious conflict of interest for the Vascular surgeon.

IT IS LIKE ONE SPECIAITY OF MEDCINE OVERLOOKING THE SHOULDER OF ANOTHER BY THE CMS MANDATE. CMS HAS OVERSTEPPED ITS CHARTER , INTERFERRING WITH THE PRACTICE OF MEDICINE.

The injection of this type of policy in practice of medicine is purely political and does nothing to enhance and provide new and good technologies to the MEDICARE BENEFICIARIES.

IN THE HISTORY OF MEDICARE THIS TYPE OF SHORTSIGHTED POLICY ,THAT A VASCULAR SURGEON HAS TO APPROVE A PROCEDURE PERFORMED BY A CARIOLOGIST/RADIOLOGIST HAS NEVER BEEN INSTITUTED IN THE PAST.

THIS NEEDS TO BE CORRECTED .

PLEASE DONOT DENY YOUR MEDICARE BENEFICIARIES ACCESS TO NEW AND GOOD TECHNOLOGY ,AS TOMMOROW IT COULD BE YOU OR YOUR FAMILY. PLEASE EXPAND THE INDICATIONS FOR THE CAROTID ARTERY STENTING ALSO.

THANKS.

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I have performed 22 CAS procedures at our approved facility, all with good angiographic and clinical results. These have generally been in elderly, high-risk, symptomatic patients. It is time to level the playing field and allow CAS in asymptomatic patients so that the benefits of this procedure can be realized in the same population of patients who undergo CEA. Nearly all CEA patients are asymptomatic, and most are LOW risk patients. Who wouldn't want a less invasive procedure that produces equal or better results with fewer complications (no scar, no wound infection, no hematoma, no cranial nerve palsy)? Give CAS a chance. Would you rather have a lap chole or an open cholecystectomy? The idea is the same except that both methods of cholecystectomy were performed by surgeons. With CAS, the less invasive procedure is performed by experienced interventional cardiologists or radiologists, while the old surgical procedure is performed by surgeons who have not learned the newer, less invasive endovascular techniques. These surgeons will lose business to the better, less invasive technique. Which procedure would you rather have? Openc chole or lap chole? CEA or CAS? Give CAS a chance. Level the playing field.

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Dear Sir/Madam,

Thank you for consideration of our public comments. I applaud expansion of coverage for the asymptomatic population but would take issue with a few things:

1) the age limit <80 I don't feel age is the only issue but rather recognized clinical and anatomic features such as tortuosity, heavy concentric calcification, collateral intracranial flow, and decreased cerebral reserve. I would propose that the age restriction be lifted and the decision on whether the case is suitable for a carotid stent be based on anatomic and clinical factors in the judgement of an experienced operator. Additionally, there is NO evidence I can find regarding Carotid Endartectomy in this population and the NASCET and ACAS age cutoff was <75 yet this has not led to a limitation in coverage for CEA. It seems rather unfair to hold us to a standard that our surgical colleagues do not need to meet.

PROPOSAL: either unrestrict age for CAS or restrict coverage of both CEA and CAS until a randomized trial or registry comparing the 2 modalities in the aged population is performed

2) Symptomatic stenosis >70: several randomized and postmarketing trials have had inclusion of >50% stenosis for symptomatic patients (SAPPHIRE, BEACH, CABERNET, EXACT, CAPTURE, etc) Outcomes have been similar with CEA and CAS and there is a Class I indication for CEA in primary stroke prevention for >60% stenosis based on NASCET.

PROPOSE: Cover symptomatic Stenosis >60% in patients at high risk for CEA - this will eliminate the conundrum of what to do with the patient who is at risk for surgery but has a stenosis between 60-70% - why should that patient be submitted to a procedure with increased risk when a lower risk alternative exists? (See SAPPHIRE data)

3) Requirement for Surgical agreement: I find this unnecessary if there is chart documentation of an accepted high surgical risk condition. To then further require a surgeon who may or may not have a conflict of interest as to the care of the patient to comment is an unnecessary step. I have had many cases where the patient had multiple comorbid conditions but was assured they were "OK for surgery" due to the fear of losing business to endovascular colleagues. There is no need for an interventional cardiologist to have a surgeons opinion before performing multivessel stenting in the coronary territory so why is this burden imposed on those who perform carotid stenting? It seems like a calculated political move and not one based on scientific merit and certainly not on current standards in other specialties. The question should be REVERSED and the surgeon should have to provide the patient with the option for a carotid stent if they are found to have high risk features as defined by CMS !!

PROPOSAL: 1) do away with requirement for surgical agreement of high risk if there is proper chart documentation of an objective high risk criteria

2) require patients undergoing CEA who are at high defined risk to be informed that there is a potentially less invasive procedure (CAS) that may be available to them!

4) With regard to recent trials and endpoints: SPACE, like prior CEA trials NASCET/ACAS/ECST did not include MI as an endpoint - this is incomprehensible as a symptomatic carotid stenosis is considered to be a coronary heart disease equivalent by ATP III guidelines : additionally data from SAPPHIRE show a signficant reduction in MI with CAS, a less invasive procedure without requirement for anesthesia. Nonetheless there was no statisitically significant difference in outcomes at 30d between CAS/CEA and I feel strongly that the results would have been more favorable to CAS if MI was included, with more "SAPPHIRE" like results.

I appreciate you consideration of my comments and look forward your future decision.

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I am Chairman of Surgery at a community hospital in Manchester NH who has both carotid artery surgery privileges and carotid stent priveleges.

1. Since patients at high medical risk have reduced longevity, they may not live long enough to gain a benefit in stroke reduction from carotid interventions. It may be reasonable to separate patients at high risk from anatomic factors (lesion above C2) from patients with high risk from compromised medical status ( decreased LVEF who have demonstrably decreased life expectency). Carotid stenting is patients who have decreased life expectency is unlikely to decrease stroke over time in this population given the low stroke rate over time (2%/yr) and the relatively high procedural stroke rate in most pubulished series of carotid stenting (avg 5%), and the unkown late stroke rate in patients treated with stenting.

2. The proposed criteria does not list how degree of carotid stenosis is to be determined. Most carotid diagnostic work is now done by ultrasound and most labs use either a 60-79% and 80-99%stenosis stratification , or they use 50-69% and greater than 70% stenosis stratification. Having different criteria for asymptomatic and symptomatic patients is likely to be confusing. Recent radiology literature suggests the breakpoint for >70% stenosis is very close to the previously used >80% stenosis. These criteria should be the same since labs utilizing a >70% stenosis category generally do not have enough data to reliably separate patients in to 10% increments

Thank you

Patrick A. Mahon, M.D., RVT

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Providing natinal coverage for carotid artery stetning for patients with high-risk asymptomatic carotid artery stenosis will surely expand patient's access to this less invasive therapuetic modality.

My concern is that the recommendation that the "high-risk" status be determined by consulting a surgeon who performs CEA will subject clinical decision making to the surgeon's experience and personal biases which can vary widely.

A more objective method of determining patient's "high risk" status should be based on the high risk criteria that were used in the various carotid stenting / CEA trials that were the basis for expanding coverage.

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I am an interventionalist doing these procedure on regular basis. Inability to offer an alternative to the patient with only option of undergoing open surgical procedure is not appropriate at this time of our understanding of these stent procedures. At this time, there has been appropriate amount of follow up presented in the post market study showing the safety and efficacy of the procedure. There is also the issue of many vascular surgeons doing endovascular procedures or leaving there practices to open vein clinics (as our vascular surgeon did). I therefore donot feel that this is affecting any physicians ability to work and provide for there families. This is truly a decision that ought to be for the best of the patients while there is still the opportunity for the patients to have endarterectomy done.

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Carotid Artery Stenting (CAS) has become a very useful and patient friendly treatment option for our patients across the Tampa Bay region. When confronted with the option of having a carotid endarterectomy vs. CAS I have never met anyone who decided to have an open surgery. Patients are discharged in a much shorter period of time, and they are in better physical condition. We used to call CAS a compassionate use procedure, only to be used in the most urgent of situations, now many medical professionals feel that this should be the treatment of 1st choice.

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This is a technology, while somewhat controversial should be de-politized.

"Symptomatic High Risk Patients: Coverage restricted to patients less than 80 years old; those patients greater than 80 years old must be in a post market study. "

I don't think it should be restricted. Risks and benefits need to be weighed on an INDIVIDUAL basis, and that is best left to the operator and patient. There must be full disclosurethat would be something to make the use of stenting contingent upon.

"Asymptomatic High Risk Patients: Expand coverage to all asymptomatic patients (≥80% stenosis) under the age of 80 (previously no coverage of this group unless enrolled in a post market study); patients over 80 years old must continue to be enrolled in a post market study for coverage."

I agree.

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The role of carotid angioplasty and stenting still needs to be defined for the treatment of carotid occlusive disease. Specifically, in asymptomatic patients, level I evidence is still lacking and will be available once the CREST trial is completed. This will ensure that patients are getting the proper treatment, with no conflict of interest on the part of the treating physician, and will hopefully avoid a premature decision similar to the current situation. Currently, CMS approval for stenting is for symptomatic patients, and more than one recent level I evidence suggest that endarterectomy is safer than stenting for this patient population (EVA-3S, SPACE trials). It will be in the best interest of patients to await results of the CREST trial. Those high risk patients can be safely treated in the meantime with endarterectomy, as evidenced by multiple high risk trials, and are certainly not being deprived from therapeutic interventions.

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I agree with the proposed expanded coverage to include asymptomatic patients with high surgical risk and lesion severity of at least 80%. This logically mirrors the clinical study information available to date which indicates stenting is a reasonable option.

I realize the data was not so compelling for those over 80 years of age, but by choosing not to cover the very elderly we would be committing them to endarterectomy by default without proven superiority in an adequate randomized trial. Surgeons are experts in surgical skill and disease states treated commonly by surgery, but not necessarily in the medical conditions contributing to post operative complications. This is why consultation from medical specialties preop is the norm to assess patient's risk. I am against having the surgeons assess this risk as they are not, in my opinion in the best position to do so.

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It would be a grave disservice to patients if physicians performing CAS do not consult a surgeon with proper credentialling to perform CEA to determine "high risk" status. Non-neurosurgeons/vascular surgeons who do not have the requisite training in extracranial carotid disease and seek to treat a lesion simply because they have a treatment modality at their disposal place patients at significant risk. While the inclusion criteria for "high risk" previously published is an excellent guideline, relying solely on them without the input of an expert in the disease process will allow some practitioners to perform CAS in a vacuum without quality assurance. I hope that the current standard of including a surgeon credentialled in CEA in the decision-making process will not be lowered.

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Based on available data, I think CMS should support covering carotid Artery Stenting (CAS) for patients who are at high surgical risk and have 1. symptomatic carotid disease with >50% stenosis, or, 2. asymptomatic carotid disease with >80% stenosis.

Additionally, the 'high surgical risk criteria" are well documented in the literature. Therefore, I strongly believe that CMS should delete language from the current policy stating that a patient should be determined to be a poor candidate for carotid endarterectomy (CEA) "in the opinion of a surgeon", since this may provoke conflict of interest. Instead, interventionalists who perform CAS should be mandated to clearly document the high-risk critreion for each patient in the chart which can always be reviewed if needed.

Finally, I believe patients who are > 80 years of age should ONLY be considered for carotid revascularization (CAS or CEA) in the setting of randomized trials since both CEA and CAS have significant complications in such patients.

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I applaud reconsideration of coverage of carotid stenting to include high risk surgical patients (i.e. anatomical or morbid surgical fields). This liberalizes carotid stenting to cover a population of patients at higher risk for CEA, as considered by surgeons. It is important to underscore that surgeons should determine the anatomic or surgical condition of "high risk".

I am a board certified vascular surgeon and I perform both carotid stenting and CEA. I have often collaborated on stenting with non-surgical interventionalist colleagues and it has been my observation that they often determine a carotid lesion as "high" risk when in fact it is perfectly accessible by surgery. My point is that interventionalists who are not surgeons may not be uniquely qualified to determine anatomical high risk.

A strategy that may uninvolve vascular surgeons in the management of carotid stenosis could unneccessarily result in an increase in carotid artery stenting in medicare beneficiaries better suited for observation or CEA. There exists no level one evidence to currently support CS as equivalent therapy to CEA. Surgeons have effectively managed this disease state for over forty years with a documented level of self-scrutiny that is unparallelled in medical literature.

I appreciate the consideration for liberalization to include true surgical high risk as this reflects potentially best medical practice for the medicare beneficiaries I treat, and await the final CMS determination expectantly.

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To have a surgeon determine whether the patient is high risk and hence suitable for the competing new technology(CAS) rather than the endarterectomy option that the surgeon will perform himself,is a serious CONFLICT OF INTEREST and is likely to prevent patients who are likely to benefit from the carotid stents from even being offered that service as an option.This limits patient choice and harms patient care.Determination of HIGH RISK should be based on OBJECTIVE CRITERIA as published in randomised trial and not left to the ARBITRARY 'opinion of a surgeon' who has a conflict of interest anyway.CMS will be going on a slippery slope of taking over decisions regarding treatment options from the so far sacred doctor-patient relationship by ordering a different physician-'the surgeon' to be the decision maker.The other insurance companies can take a cue and have 'their physicians'second guess decisions made jointly by the doctor-patient team.In fast evolving and technology intensive healthcare the new technology(e.g. carotid stents) will never get a chance and will be suppressed if the STAKEHOLDERS(vascular surgeons) in the existing therapy(carotid endarterectomy)are the GATEKEEPERS.Their self interest will prevent them from letting new technoogy grow because it takes business away from them.CRITERIA for decision making regarding definition of HIGH RISK suddenly become FINANCIAL rather than MEDICAL;TURF-BATTLE based rather than healthy competetion of TECHNOLOGIES. That is a DISSERVICE to patient care and science.This trend if extended could stifle innovation and development of new therapies in medicine. CMS doesnot need that legacy. Thank you.

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Dear Sir/Madam,

I have three comments in the regard to the CAS coverage proposal by CMS.

First comment: A double standard exists in the CMS proposed changes to the NCD for CAS. As is known, specific CMS guidelines have been established for the coverage of CAS. These guidelines supersede any physician opinion as to the benefit of CAS over CEA. Yet, only a surgeon's opinion is needed determine a patient's high risk status for CEA. Fairness and objectivity demand that CMS guidelines for CEA should obviate the necessity for a surgical opinion in patients who are being considered for CAS.

Second comment: To my knowledge, no randomized prospective studies have directly compared CAS to CAS plus embolic protection. Placing an embolic protection system (EPS) adds an initial step and potential complicating device that only theoretically adds benefit during CAS. Excluding payment because EPS cannot be performed during CAS, is not good advice. With comparative trials aside, any patient who cannot have EPS-CAS and who is deemed high risk for CEA would not have any surgical management option for carotid occlusive disease. Furthermore, such a reimbursement policy is likely to encourage, not discourage, further risky attempts at placing an EPS during a difficult CAS a scenario that often has bad patient outcomes.

Third comment: Any physician not trained and credentialed to treat acute stroke with endovascular surgery has no business performing CAS. To allow the cardiology specialty to oversee the nation's quality of CAS is a slap in the face to the specialty that pioneered both CAS and intracranial stroke thrombolysis and thrombectomy Interventional Neuroradiology.

Thank you.

Walter S. Lesley, M.D.

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I am very disappointed to see coverage extend to asymptomatic patients. There is no evidence of benefit in this population, other than the SAPPHIRE study. This study lacked a control arm, and the morbidity and mortality in the stent arm very likely exceeds medical therapy.

The greater than 80% stenosis also makes no sense, as randomized studies have shown that this group is at no higher risk than asymptomatic patients with lesser degrees of stenosis.

Finally, the restriction to the use of protection devices smacks of favortism to industry - there is no evidence that these devices make angioplasty any safer. Just more expensive and more revenue for vendors.

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