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

Carotid artery stenting(CAS) should be approved as an alternative to carotid endarectomy(CEA). The data from Sapphire WW, Exact and Capture convincingly demonstrate that in real world situations CAS meets the criteria for 30 day stroke/death listed in the guidelines for performing CEA and that outcomes foe CAS continue to improve.

CAS trials are performed with prompt neurologic evaluation and evaluation of the occurrence of peri-op myocardial infarction. Data is available showing that the incidence of tia/stroke is higher when neurologists evaluate patients. Many of the CEA trials were done without timely neurologic evaluation. Could the rate of stroke/tia in these trials be higher than reported?

Nontheless, the CAS trials discussed above present data in over 8000 patients with outcomes meeting recommended end points for CEA. It seems to me that patients and physicians should have a choice in the treatment of carotid stenosis.

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In a day-long stakeholders meeting CMS convened in the summer of 2007 in which multiple Societies from multiple specialties were in attendance and contributed, the following two items were agreed to as requisites to expanded CAS coverage, in line with FDA labeling of at least 6 approved CAS systems: 1) if CAS outcomes in high surgical risk patients were able to conform with the established and widely accepted AHA guidelines for asymptomatic treatment with CEA (that is, < 3% stroke and death at 30 days), and 2)if consensus among the various Societies could be achieved on expansion of coverage for this group.

A great deal of time, effort and money has been expended to toward these goals, and they have been successfully achieved, with at least 2 peer-reviewed publications of very large patient databases of outcomes better than the AHA standard. And every Society that commented in the lead-up to this decision agreed to expansion of coverage.

The most recent draft decision now not only puts CMS in breach of its own public commitment to expand this coverage, and but also thousands of patients at unreasonable and unnecessary risk of surgery with unfavorable outcomes based on their anatomic and physiologic co-morbidities. That does not improve the net health benefit of your beneficiaries, which is your primary directive.

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October 10, 2009

Joseph Chin, MD, MS
Medical Officer
Division of Medical and Surgical Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21224

VIA Electronic Submission

RE: Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R7)

Dear Dr. Chin:

The Society for Cardiovascular Angiography and Interventions (SCAI ) and American College of Cardiology (ACC) are pleased to respond to CMS' proposed decision memo for Percutaneous Transluminal Angioplasty of the Carotid Artery Concurrent with Stenting (CAG-000-85R7).

We appreciate the opportunity to meet with CMS staff to discuss the issues addressed in this national coverage analysis both prior to release of the proposed decision memo and during the public comment period. As noted in the proposed decision memo, our organizations urged CMS to expand coverage to be consistent with the United States Food and Drug Administration's (FDA) approved indications for carotid stent devices in patients who are at increased perioperative risk for carotid endarterectomy (CEA) complications due to currently defined anatomic and comorbid factors¹ and who have either symptomatic carotid artery stenosis of 50-99% or asymptomatic carotid artery stenosis of ≥80%.. We believe that current evidence is sufficient to determine that this coverage expansion would offer net health benefit to Medicare patients and demonstrates that provision of carotid stenting to this patient population is reasonable and necessary.

Our comments dated April 17 provide an extensive discussion of the evidence supporting our recommendations. Rather than repeat that discussion, this letter will focus on two issues raised during our most recent meeting with CMS staff: the non-inferiority outcome of the SAPPHIRE randomized trial and the increased stroke and death rate among patients over 80 years of age.

SAPPHIRE Outcomes
SAPPHIRE ¹² was a randomized controlled trial comparing carotid artery stenting (CAS) with carotid endarterectomy (CEA) in 167 'high surgical risk' patients in each arm, with both groups having independent neurological exams before and after their procedures. About 20% of patients in both arms were ≥ 80 yrs old. There were an additional 407 patients 'refused' surgery as being too high risk, who underwent stenting in a 'registry' arm. The primary end point of the study was the cumulative incidence of a major cardiovascular event (MCE) at 1 year - a composite of death, stroke, or myocardial infarction within 30 days after the intervention or death or ipsilateral stroke between 31 days and 1 year. At one-year for the randomized (intention to treat) group the number of patients with the primary endpoint (MAE) was 12.2% for CAS vs 20.1% for CEA (p = 0.053), showing CAS to be non-inferior to CEA. When examined as treatment received, however, results for stenting were superior to surgery with a 30 day stroke and death rate of 12.0% for CAS patients and 20.1% for CEA (p = 0.048). In addition, 5.7% of surgical patients experienced cranial nerve palsy. Among randomized asymptomatic patients the 1 year MCE was 10.5% for CAS and 20.3% for CEA (p = 0.04). Within the randomized symptomatic group the 1 year MCE for CAS was 16.3% compared to 20% for CEA (p = 0.052).

The only randomized trial for high surgical risk patients that will ever be done (SAPPHIRE) demonstrated non-inferiority for carotid stents but when analyzed by treatment received demonstrated that CAS was superior to surgery. In the interventional community, there is no longer a belief that there is the clinical equipoise for many high surgical risk patients to be randomized to a non-stent option. Again, this data clearly supports CAS as a possible alternative to surgery, depending on the physician and patient''s preference.

The SAPPHIRE trial results have been confirmed, extended and the results of CAS have been improved upon in more than 8,000 peer reviewed post-market surveillance trial patients. ^3,4 CAPTURE-2 and EXACT 3 were post-market surveillance high surgical risk 'real world' registries for CAS. There were 6,320 patients treated at 280 US sites by 672 operators of widely varying skill sets and practice settings. The 30 day stroke and death rate was 4.1% in EXACT and 3.4% for CAPTURE-2. The 30 day stroke and death rate in the symptomatic < 80 yrs patients was 5. 3%, which meets NASCET {Barnett, 1998 #89} driven AHA guidelines {Biller, 1998 #134}. The 30 day stroke and death rate for symptomatic <80 yrs patients was 2.9% which also meets ACAS {Executive Committee for the Asymptomatic Carotid Atherosclerosis Study (ACAS), 1995 #365} driven AHA guidelines {Biller, 1998 #134}.

SAPPHIRE WORLDWIDE⁴ was a post-market surveillance CAS high surgical risk registry that enrolled 2,001 patients in 216 US and Canadian sites that were stratified by low, medium, and high volume centers. The overall 30 day stroke and death was 4.0% with an the asymptomatic anatomic high risk 30 day stroke and death rate of 1.8% and an asymptomatic comorbid high risk rate of 3.0%. For symptomatic patients with anatomic high surgical risk the 30 day stroke and death risk was 4.5% and for those with medically comorbid high risk conditions the 30 day stroke and death rate was 8.3%. %. For NASCET comparable patients (< 80 years) the 30 day stroke and death rate for symptomatic patients (n = 409) was 5.4%, and for the asymptomatic (n = 1,702), ACAS comparable patients (<80 years), the 30 day stroke and death rate was only 2.7%. Once again, the comparable CAS group in more than 2,000 patients confirming the randomized Sapphire data and meeting the AHA guidelines for 30 day outcomes with carotid revascularization {Biller, 1998 #134}.

Access to Treatment Options for High Surgical Risk Patients
No additional studies regarding the high surgical risk population are anticipated because the existing data on thousands of clinical trial patients is sufficient to conclude that randomization of this patient population would be inappropriate. This current coverage policy is creating a two-tiered system with CAS not available to many Medicare patients without the means to self-pay. We urge you to bring Medicare coverage in line with the vast majority of commercial insurance carriers that extend coverage for CAS to be consistent with the United States Food and Drug Administration's (FDA) approved indications for carotid stent devices in patients who are at increased perioperative risk for carotid endarterectomy (CEA) complications due to currently defined anatomic and comorbid factors and who have either symptomatic carotid artery stenosis of 50-99% or asymptomatic carotid artery stenosis of ≥80%.

Patients Over 80 Years of Age
The second issue CMS raised was the increased rate of stroke and death in the over-80 population. Not all patients can safely undergo CEA due to a variety of unfavorable anatomical and/or comorbid risk factors ^5-15. Patients excluded from the NASCET ^{16, 17} and ACAS ¹⁸ studies and have been shown to have much higher rates of morbidity and mortality. ¹⁹ Complication rates for carotid endarterectomy in high surgical risk patients may rise above the 10% maximum recommended by the American Heart Association⁵.

The pivotal carotid stent registries in high surgical risk patients, designed with the oversight and approval of the U.S. Food and Drug Administration, have employed objective performance criteria (OPC) which estimated one-year endpoints for carotid stents (i.e. stroke and death) in the 10% to 15% range, based upon the published literature for CEA complications in high risk patients ^{7, 9, 10, 20-23}. Anatomic high surgical risk patients with features such as scarring after prior neck operations, prior radiation therapy to the neck ²³, contralateral laryngeal nerve palsy or chronic tracheostomy stoma have been labeled as having 'hostile necks'. Other anatomic limiting features for CEA include spinal immobility, prior cervical spine surgery, short obese necks, and intrathoracic or intracranial lesion locations. Radiation arteritis is an uncontested high risk factor with 50% of these CEA patients having an occluded carotid artery within 3 years ²⁴. Patients with a prior ipsilateral CEA are at higher risk for complications, particularly cranial nerve injury ^{5, 9, 25, 26}. Patients with contralateral carotid occlusions are also at increased risk of complications for CEA ^{8, 10, 27}.

Physiologic high surgical risk medical comorbidities such as unstable angina ^{8, 28}, congestive heart failure ^{7, 8, 27}, the concurrent need for coronary artery bypass graft or valve-replacement surgery ^{6, 7, 14, 28}, severe renal dysfunction ^{8, 11, 29}, and advanced lung disease constitute increased risk factors for surgery patients ^{7, 8, 28}. Older age is a significant predictor of poor outcome after CEA with patients ≥ 75 years experiencing higher rates of stroke and death at 30 days, late neurologic death, and composite morbidity and mortality at 1 year ^19,30. Increased procedural risk may be attributable in part to a number of factors commonly associated with advanced age such as decreased cerebral reserve, excessive vessel tortuosity, and heavy calcification. ³¹ Because atherosclerosis is systemic disease, it is expected that older patients with carotid atherosclerosis will have more extensive coronary and renal vascular disease than younger patients.

Because the very elderly (> 80 years) patients have been excluded from most clinical trials evaluating CAS, little data exist to guide a physician faced with caring for an octogenarian with carotid artery stenosis. In a series of 528 consecutive patients undergoing CAS without the use of emboli protection device (EPD) Roubin et al found an almost three-fold higher complication rate in patients ≥ 80 years compared to those ≤ 80 years ³². The lead-in phase of the Carotid Revascularization Endarterectomy versus Stent Trial (CREST) raised concern among clinicians by showing a 12.1% stroke or death rate at 30 days following CAS ³³. Significantly higher frequencies of tortuosity and calcification of the arch vessels and elongation of the (Type III) aortic arch have been described in the elderly that contribute to the higher procedural risk of complications. ^{34, 35}

However, significantly lower one-month stroke and death rates in an octogenarian population have been published from several groups ^{34, 36-39}. In 151 procedures in ≥ 80 year old patients, the 30 day stroke and death rate for asymptomatic patients was 2.6% and for symptomatic patients was 5.1%, both within the AHA Guidelines ³⁹. Another recent study reported a 30 day stroke and death rate of 2.7% for 126 ≥ 80 year old CAS patients³⁶. These large registries of CAS patients with independent neurologic assessment is convincing evidence that the very elderly (≥ 80 years) can safely undergo CAS with stroke and death rates comparable to younger patients. The key to obtaining these excellent results is that CAS be performed by high-volume, experienced operators who exercise restraint regarding patient selection.

The SCAI and ACC believe that the concerns CMS has raised about outcomes for the octogenarian population highlight the important role of robust data collection, quality improvement and accreditation programs for carotid revascularization (both CAS and CEA). We have requested a meeting with CMS staff to facilitate the implementation and expansion of rigorous accreditation and data registries for carotid revascularization facilities.

Embolic Protection Devices
SCAI and ACC support CMS's proposal to revise the language concerning embolic protection devices to include both proximally and distally placed FDA approved and cleared embolic protection devices. As noted in the memo, FDA has recently approved new devices in this category. We agree that the coverage language should reflect the newer devices.

Comments from the Blue Cross Blue Shield Association
We were surprised to see negative coverage recommendations from the Blue Cross Blue Shield Association (BCBSA) in the proposed coverage decision. That organization's Technology Evaluation Center is currently reconsidering its negative assessment of carotid stenting and as that group frequently reminds its critics, it does not make coverage decisions, it provides technology assessments. There are significant differences between the two efforts. When actually making coverage decisions, most commercial BCBSA plans cover carotid stenting consistent with FDA approved indications. We will be happy to provide CMS staff with our summary of current local coverage decisions. Therefore, it seems that most components of the BCBSA believe that expanded coverage is warranted.

Conclusion
There is now overwhelming evidence supporting CAS in selected patients as a valid alternative to CEA in patients with high risk anatomic or comorbid features. CAS offers an important treatment option to candidates for carotid artery revascularization in order to prevent stroke, who are identified as high-risk for CEA through anatomic or comorbid characteristics. Under the current Medicare coverage policy, only symptomatic patients with 70> stenosis or those patients who qualify for or are able to access an approved clinical trial or post-market approval study are able to consider this option and many of those post-market surveillance trials are rapidly closing. The SCAI and ACC believe that current evidence supports removal of this restriction on coverage. We urge CMS to expand Medicare coverage consistent with the FDA's approved indications for high surgical risk patients.

We also wish to acknowledge the efforts of Chris White MD FACC, FSCAI in developing these comments and hereby express our appreciation.

Thank you for the opportunity to comment on this proposed decision.

Sincerely,

[endorsed .pdf version sent via email]

Steve Bailey, MD, FSCAI
President
Society for Cardiovascular Angiography and Interventions

[endorsed .pdf version send via email]

Alfred Bove, MD, PhD, FACC
President
American College of Cardiology

cc: Barry Straub, MD, CMS
Tamara Syrek Jensen, CMS
Sarah McClain, MHS, CMS
Christopher White, MD, SCAI
Christopher Cates, MD, SCAI
Bonnie Weiner, MD, SCAI
Rebecca Kelly, ACC
Wayne Powell, SCAI
Dawn R. Hopkins, SCAI

References

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The recent denial of an approval process for carotid artery stenting (CAS) in the high surgical risk patients with carotid artery occlusive disease is unconscionable. This is especially true in the high anatomic risk patients who do not have a surgical option. Best medical management may be acceptable for patients with 60% stenosis but patients with 80% stenosis with limited intracranial collateralization is basically sending these patients home with stroke or death warrant. You have asked for published data and we have provided it. You have asked for proof of safety and efficacy and we have provided that as well. I will not waste your time or my time by reviewing the data once again. Patients are begging us for the procedure and we are forced to deny them. The FDA has approved CAS and you still deny it. I can only conclude that CMS is being influenced by a vocal minority or is terribly uninformed. Obviously you are not taking advantage of knowledgeable consultants. Is it going to take a congressional investigation before you see the light? Few procedures in the history of medicine have had such resistance by a single agency. This does not make sense.

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October 10, 2009

Tamara Syrek Jensen, JD
Acting Director - Medicare Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard, Mail Stop C1-09-06
Baltimore, MD 21244

Re: CMS proposed decision memo on percutaneous transluminal angioplasty of the carotid artery with stenting (CAS) (CAG-00085R7)

Dear Ms. Syrek Jensen:

Boston Scientific Corporation is pleased to provide comments on the Proposed Decision Memo issued by the Centers for Medicare and Medicaid Services (CMS) on percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting (CAS) (CAG-00085R7).

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices. For close to 30 years, Boston Scientific has advanced the practice of less-invasive medicine by providing a broad and deep portfolio of innovative products, technologies and services across a wide range of medical specialties. This product portfolio includes a carotid artery stent and embolic protection device that are used to provide percutaneous treatment for patients considered at high risk for open surgery (ie. carotid endarterectomy).

Requested Action
Boston Scientific, based on the data published and summarized in our previous comment letter, continues to urge CMS to reverse its Proposed Decision and instead expand coverage for carotid stenting to include all beneficiaries at high risk from Carotid Endarterectomy (CEA) because of anatomic or physiological risk factors. If CMS decides to finalize its proposal, beneficiaries at high surgical risk will face a choice of settling for no intervention, undergoing a procedure for which they are at greater risk of adverse outcomes, or pay out of pocket for a non-covered stenting procedure.

Our position is based on the following factors:

• Recently published clinical trial evidence^1,2 demonstrates that CAS achieves or comes very close to the AHA-suggested rates of major adverse events for high risk populations (less than 6% for symptomatic, 3% for asymptomatic). Results described in the Gray article for all high risk patients (including about 23% ≥ 80 years) were 6.4% for symptomatic and 3.2% for symptomatic, which compares very favorably with the AHA guidelines intended only for low surgical risk patients under 80. The Gray data subpopulation analysis for high risk patients under 80 years, shows the death and stroke rates are 5.3% for symptomatic patients and 2.9% for asymptomatic patients. The high risk, under 80 patient subgroup results not only surpass the AHA thresholds but do so with sicker patients. (Please note: AHA guidelines are based largely on results of a trial of CEA which enrolled low surgical risk patient under age 75.)
• The American Heart Association supports expansion of coverage to all high risk patients
• Most physician specialty societies whose members treat patients with carotid artery disease support expansion of coverage to all high risk patients; and
• CAS is a preferred option over CEA for high surgical risk patient ≥80 years according results recently published in three peer-reviewed manuscripts.^3,4,5

AHA Thresholds Based on Younger, Less Risky, Less Diseased Population
CMS is evaluating the quality of the evidence against the American Heart Association thresholds for patients with carotid artery stenosis. Given the lack of better benchmarks, we think the AHA thresholds are a reasonable guide if the differences in populations are taken into account. The AHA thresholds were based on studies of younger, less risky populations. It is inappropriate to use the AHA benchmark to assess success of CAS in high-risk, older patients. The 3% threshold for asymptomatic patients is based upon data from the Asymptomatic Carotid Surgery Trial (ACAS) which examined patients at conventional risk, not high-risk undergoing surgery for asymptomatic carotid artery disease (stenosis of 60%-99%). Many patients in the ACAS trial had lesser degrees of stenosis and were mostly under 75 years of age.

With respect to the AHA’s 6% threshold for symptomatic patients, this figure was derived from the North American Symptomatic Carotid Endarterectomy Trial (NASCET). Patients in this study were under 80 years of age, while more than 20% of the patients from the recently published studies were over 80 years. Again, a rigid application of this threshold would not take the differences in patient age and risk into account.

Status Quo Proposal Effectively Restricts Coverage
Over the next few months, future high-surgical risk beneficiaries who would have had access to CAS as part of an IDE trial, a post-approval study, or a post-approval extension study may lose coverage because enrollment in these studies is nearly complete. Once enrollment is complete, Medicare’s policy, if unchanged, would effectively provide coverage only for a very small portion of the subpopulations currently eligible to access this treatment, leaving many patients (those without symptoms and 80% or greater stenosis and symptomatic patients with 50%-69% stenosis) to have less treatment options than when Medicare initiated clinical study coverage of carotid stenting in 2001.

Mixed Signals from CMS on Use of Data, Clinical Outcomes Benchmarks
The current proposed Decision Memo appears to create a new threshold of data for expanding coverage that is significantly higher than most stakeholders understood from previous decisions.

We also note that new evidence should be given more weight than previous trials. Recently published trial results reflect the improvements in CAS technology and provider experience. The recently published registries (EXACT, CAPTURE 2, and SAPPHIRE WW) are real world data with robust sample size, showing consistent results that should be recognized as valid which may provide better guidance than older trials which may not reflect contemporary outcomes

Medical Therapy Comparison Not Realistic
While we appreciate that CMS believes that a randomized controlled trial comparing CAS to optimal medical therapy would better inform its coverage consideration, the practical challenges associated with such a trial would be very problematic. Chiefly, the positive peer-reviewed published clinical studies cited above create a dilemma for physicians and beneficiaries who might be asked to participate in a medical therapy versus CAS trial. In essence, it seems unlikely that physicians would view such a study as ethical and less likely that patients would be willing to participate in the medical therapy arm when a more immediate, clinically proven intervention is available.

Moreover, current medical therapy is intended to slow the progression of the disease or its recurrence after invasive treatment but it would not be able to resolve a physical obstruction to blood flow.

*****

In closing, Boston Scientific urges CMS to expand coverage for CAS for all beneficiaries with high risk factors. In doing so, CMS will allow high risk beneficiaries to avoid the added risk associated with CEA while still providing access to revascularization as supported by clinical findings.

We greatly appreciate the opportunity to comment on the Proposed Decision Memo. Please call Tom Meskan at 763-494-2016 or me at 508-650-8681 if you have any questions.

Sincerely,

Parashar Patel
Vice President, Health Economics and Reimbursement

cc: Joseph Chin, MD
Sarah McClain, MHS
Marcel Salive, MD, MPH
Barry Straube, MD

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I belive coverage for CAS should be expanded. This procedure is safe and effective in the right hands and for the right patients. Coverage should be expanded to give physicians and patients the choice of therapy that is best for them.

After reading all the comments here I don''t think we need to continue to go over the data regarding CAS. At the end of the day we need to be able to do what is right for the patient.

Regarding cost, we as providers need to be open and transparent to make sure that this procedure is not being done inappropriately. Data should still be collected for a ''real world'' database.

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I have been doing the CAS on high risk patients for the past 4-5 years as part of the CAPTURE I, CAPTURE II, & CHOICE Trials with complication rates of less than 2%. These are very high risk patient and I would say has saved our govt a lot of money by not sending them to surgery. Make the surgeons do a REAL study (with neurology evaluations)and see if THEY can match the results you have collected from the CAS trials. Americans deserve a less invasive, nonscarring option. Don''t be bullied by the Surgical lobby, encourage them to learn to do the CAS procedure- it''s better in every way- no pain, no wound recovery, home next day, lower cost, lower risk. I have reviewed the data- there is not a single advantage to CEA in patients whose anatomy is amenable to CAS. Remember if you eleminate this excellent procedure you or a family member will likely bear a large scar on their neck. Can you live with that? Our low risk patients are BEGGING us not to send them to surgery. Please evaluate the data honestly and make sure both sides have been held to the same standards.

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October 9, 2009

Tamara Syrek Jensen, JD
Acting Director, Coverage and Analysis Group
Coverage and Analysis Group
Centers for Medicare and Medicaid Services,
7500 Security Boulevard,
Baltimore, MD 21244

RE: Proposed Decision Memorandum for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R7)

Dear Ms. Jensen,

Cordis Corporation welcomes the opportunity to comment on this proposed decision memorandum.

Our comment letter dated April 17, 2009 provides our substantive comments on the clinical evidence in support of expanding CMS’ coverage on Carotid Artery Stenting (CAS) with emboli protection in beneficiaries who are at high risk for carotid endarterectomy (CEA). While Cordis Corporation has continued enrollment in the SAPPHIRE Worldwide (Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy) registry, no additional publications on the clinical data have been generated during the period elapsed between the closing of the comment period and the posting of the Proposed Decision Memorandum on September 10, 2009.

We remain concerned that CMS’ review of existing clinical evidence has not yielded an expansion of coverage for patients at high risk for CEA. Of particular concern is the notion that CMS will require randomized controlled clinical trials to support further expansion of coverage. As post-approval extension studies draw to a close, Medicare beneficiaries will have limited access to CAS.

Cordis Corporation and other industry stakeholders have requested an in-person meeting to discuss the Proposed Decision Memorandum in detail. We appreciate your evaluation of this request and look forward to the meeting.

Please feel free to contact us with any questions regarding this most important coverage topic.

Sincerely,

Ryan H. Saadi, M.D., M.P.H.
Vice President, Health Economics, Reimbursement and Strategic Pricing
Cordis Corporation
Phone (908) 541-4250
E-mail: rsaadi@its.jnj.com

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October 9, 2009

Tamara Syrek Jensen, JD
Acting Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Ms. Syrek Jensen:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) proposed national coverage determination (NCD) for proposed national coverage determination (NCD) for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R7). America's Health Insurance Plans (AHIP) is the national association representing nearly 1,300 member companies providing health insurance coverage to more than 200 million Americans. We are pleased to submit these comments on behalf of our members.

General Comments
AHIP and our member plans support CMS's efforts to ensure that Medicare beneficiaries receive access to safe and effective procedures, treatments, and medical devices that can improve health outcomes, as determined by current and robust clinical evidence. Our members strongly support CMS revising the current NCD for PTA of the carotid artery concurrent with stenting (NCD 20.7). In addition, the coverage determination should state that coverage of these procedures be limited to those performed using carotid artery stents approved by the Food and Drug Administration (FDA) and FDA approved or cleared embolic protection devices. Our members consider both premarket review and approval by the FDA as minimum pre-requisites for consideration of coverage. We additionally acknowledge that, at this time, CMS is not proposing to revise the current populations and indications covered within this NCD and support this decision.

Thank you for the opportunity to provide these comments.

Sincerely,

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October 9, 2009

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

Re: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R7).

Dear Dr. Salive,

Abbott would like to provide comments on the proposed decision memo for the reconsideration of coverage for PTA of the carotid artery concurrent with stent placement in Medicare beneficiaries who are at high risk for carotid endarterectomy (CEA) due to anatomic factors with asymptomatic carotid artery stenosis of ≥ 80%.

Abbott is a global, broad-based health care company devoted to discovering new medicines, new technologies and new ways to manage health. Our products span the continuum of care, from nutritional products and laboratory diagnostics through medical devices and pharmaceutical therapies. The company employs 72,000 people and markets its products in more than 130 countries. Abbott is the leader in carotid stenting and related clinical research, with over 14,000 high surgical risk patients participating in Abbott’s studies. Abbott is sponsoring or co-sponsoring two randomized clinical trials: CREST and ACT I. These randomized trials of CEA vs. carotid artery stenting (CAS) are designed to understand the benefits of carotid stenting in normal surgical risk patients. While this patient population is not applicable for this coverage decision, Abbott is the only company studying this population in such detail and is committed to working with CMS to understand the outcomes of CAS across various patient populations.

Abbott is disappointed with the proposed decision given the new published evidence from rigorously conducted post-market clinical trials demonstrating that 30 day death and stroke outcomes for high surgical risk patients are in line with the American Heart Association (AHA) guidelines for intervention of 3% for asymptomatic patients and 6% for symptomatic patients. In the last reconsideration decision in 2008, CMS indicated that it would reconsider expanding coverage once data from contemporary FDA post-market trials was published and, in fact, it was CMS itself that initiated the current reconsideration process as a self generated request. Furthermore, the proposed decision is at odds with the positions expressed by physician societies and other key stakeholders, all of whom have expressed support for some degree of expanded coverage. Lastly, at a CAS stakeholders meeting called by CMS in June 2007, there was agreement among the various and wide-ranging participants, including CMS, that if CAS could be shown to meet AHA guidelines for the high-surgical risk population, CMS would support expanded coverage.

We do not agree with the CMS conclusion that the body of randomized trials and post-approval studies does not demonstrate that carotid stenting can be performed in line with AHA intervention guidelines. In addition, we do not agree that coverage for the high-risk population should only be expanded based on data from randomized controlled trials. Lastly, we believe that CMS has misinterpreted some data in its analysis of the evidence from published post-market clinical trials. We urge CMS to reconsider its draft decision and to finalize expanded coverage for carotid stenting for the high-risk population with asymptomatic carotid artery stenosis of≥ 80% to assure patient access to a needed therapy. At a minimum, we urge CMS to expand coverage for beneficiaries with asymptomatic carotid artery stenosis of ≥ 80% who are at high risk for surgery due to anatomic factors.

Our detailed comments follow.

Patient Need for an Alternative Treatment to Surgery

Abbott continues to believe that the expansion of coverage for patients at high risk for CEA with asymptomatic stenosis of ≥ 80% is appropriate in order to assure that Medicare beneficiaries with carotid artery disease who are at high risk for surgery are provided access to an alternative treatment to CEA. In the case of those beneficiaries with selected anatomical risk factors, CEA is a relative or absolute contraindication. Absent coverage for carotid stenting, beneficiaries could face a high surgical risk or significant out of pocket expenses for carotid stenting. We note that all relevant physician societies (American College of Cardiology, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine, Society for Vascular Surgery, Society of Interventional Radiology and numerous neurology related societies), the American Heart Association and numerous individual physicians expressed support for some degree of expanded coverage during the initial comment period in the reconsideration process.

Evidence from Randomized Controlled Trials vs. Registry Trials

In the draft decision memo, CMS suggests that coverage for the high-risk population should only be expanded based on data from randomized controlled trials and that data from FDA post-approval trials is insufficiently rigorous to support expanded coverage. We believe that CMS insistence on data from randomized controlled trials to determine coverage for the high-risk population is unrealistic given the history of clinical trials to study benefits of carotid stenting for the high-risk population and the need to achieve equipoise in designing a clinical trial. Even within the SAPPHIRE trial, sponsored by Cordis, there were patients who were not treated within the randomized portion of the study due to their high risk co-morbid or anatomic risk factors. This resulted in the study enrolling a single arm where patients could be treated by CEA (n=7) or CAS (n=406). The CAS registry was quite large since these patients were deemed at high risk for CEA and could not ethically be randomized. ARCHeR and SeCURITY were 2 other single arm high risk studies designed to avoid exposing this population to the risks of CEA. This is evidence that there are good reasons why single arm studies can be a required and valid mechanism to gather treatment and outcome data on a given population.

Given the overwhelming Investigational Device Exemption (IDE) data from 10 different FDA sanctioned studies representing outcomes from well over 3,000 high-risk patients as well as the over 10,000 patients with published data in post-market “real-world” studies, the scientific basis for a randomized study of these patients is limited, and creates a lack of adequate equipoise in the minds of investigators who would be needed to enroll such a trial. We believe it is reasonable that CMS base carotid stenting coverage for the high-risk population on the extensive FDA IDE and the real-world trial data available and which was requested by CMS.

Evidence Supporting the Expansion of Coverage

As detailed in our communication during the initial comment period, with publication of the results of the Abbott CAPTURE 2 and EXACT post-approval trials¹ and the Johnson & Johnson SAPPHIRE Worldwide post market trial², there is now an extensive body of peer-reviewed published high-quality evidence on carotid stenting outcomes for high-risk patients, including those with anatomical risk factors. To date, over 22,000 high-risk patients have been enrolled in manufacturer sponsored carotid stenting trials, with procedures performed by a broad range of hospitals and physicians reflecting real world clinical experience. The contemporary CAPTURE 2 and EXACT post-approval trials involved 6320 patients, 280 hospitals and 672 physicians. This new evidence demonstrates the overall improvement of outcomes over time, as physicians continue to gain experience with the carotid stenting procedure.

Scientific Rigor of CAPTURE 2 and EXACT Post Approval Trials

EXACT was an Abbott FDA condition of approval post-market trial for the Xact stent system. The study recruited patients from November 2005 to April 2007, for a final analyzable cohort of 2,145 subjects. The last final report was sent to FDA on August 2008. CAPTURE 2 is an FDA approved post-market trial of the ACCULINK stent system. The study started recruiting subjects in March 2006 and is still enrolling. The August 2008 annual report to FDA comprised an analyzable cohort of 4,175 subjects.

Both studies were conducted in a scientifically rigorous manner. Patients were interviewed within 14 days prior to treatment and examined by an independent (non-operator) study neurologist, including assessment according to the National Institutes of Health Stroke Scale (NIHSS). A neurologist examination was repeated 24 hours and 30 days post-procedure to monitor for stroke and other adverse neurological clinical events. Death from any cause was counted towards the end-point. The primary endpoint for each study was a composite of death, any stroke, or myocardial infarction within 30 days of the procedure. Additional end-points included death and any stroke, death and major stroke, as well as stroke alone

The trials have independent adjudication of all strokes and suspected strokes by a Clinical Events Adjudication Committee (CEAC). The composition of the CEAC for each study is as follows:

• CAPTURE 2 - two Neurologists and at least one Interventional Cardiologist, Interventional Radiologist or Vascular Surgeon
• EXACT - one Neurologist, one Vascular Surgeon, and one Interventionalist

As a result of this independent neurological assessment and independent adjudication process, event rates reported are higher than if Abbott relied solely on interventionalist reported events. In fact, Abbott has found that the identification of strokes increases by approximately 50% with independent neurological assessment. These trials are also partially monitored, to the level of a NIH study, with approximately 10-15% monitoring.

CAPTURE 2 and EXACT 30-day Outcomes for High-Risk Patients

An analysis published in March 2009 in the American Heart Association journal Circulation: Cardiovascular Interventions examined data from the CAPTURE 2 and EXACT trials to determine if 30-day death and stroke outcomes for carotid stenting met the AHA guidelines for intervention, and to study outcomes in the subgroup of subjects with anatomical high risk features.

On the pooled population, Abbott analyzed two specific subsets. First, the subsets of both symptomatic and asymptomatic non-octogenarians were generated in order to allow for a rational comparison to the AHA guidelines. The guidelines were derived from the outcomes of the ACAS and NASCET studies that excluded octogenarians and used 30-day combined endpoint of the death and stroke rate.

The second subset of subjects were those who, regardless of age, had an anatomic high-surgical risk feature: history of CEA, radiation therapy to the neck or radical neck surgery, surgically inaccessible lesion at or above the C2 vertebra or below the clavicle, lesions obstructed by tumors in the neck, spinal immobility/inability to flex neck beyond neutral or kyphotic deformity, the presence of a tracheostomy stoma, contralateral laryngeal nerve palsy. This anatomic high-surgical risk group was analyzed in order to determine if a significant differential in outcomes was apparent based on the indications for the procedure, with the comparison group defined as patients with physiologic high-surgical risk features. The anatomic inclusions accounted for 431 patients (CAPTURE 2: 292 asymptomatic, 45 symptomatic; EXACT: 79 asymptomatic, 15 symptomatic), approximately 7% of the combined total of both studies.

Relevant patient demographic, clinical, and procedural data as well as information pertinent to post-procedural complications, in-hospital events, and post-discharge adverse events were prospectively documented on standardized electronic case report forms. No pre-specified hypotheses were performed in these studies, and subsequently no p-values were computed. Subgroup analyses by age and symptomatic status were pre-specified; results are presented with confidence intervals. However, subgroup analyses by anatomic risk factors were ad-hoc; results are presented with confidence intervals.

The study found that for the two post-approval trials combined, the 30-day death/stroke rate was 6.4% for all high-risk symptomatic patients and 3.2% for all high-risk asymptomatic patients, in line with the AHA guidelines for intervention of 6% and 3%. (Interestingly, these outcomes are almost identical to a recently published review of current New York state CEA outcomes.)³ For the CAS population under 80 years of age, the combined 30-day death and stroke rates were 5.3% for symptomatic patients and 2.9% for asymptomatic patients, within the AHA intervention guidelines. It should be noted that the high-risk non-octogenarian population is comparable in age to the population used to establish the AHA intervention guidelines and is thus the most appropriate high-risk patient population to examine if the AHA guidelines are met for carotid stenting. The combined 30-day death and stroke rate was 2.7% for asymptomatic patients with anatomic risk factors and 1.7% for symptomatic patients with anatomic risk factors, within the AHA intervention guidelines. Furthermore, for all patients under 80 years, both anatomic and physiologic subsets met or exceeded AHA guidelines.

*Hierarchical Events - Includes only the most serious event for each patient and includes only each patient's first occurrence of each event.
** Patients in the “<80 yo” category include both anatomic and comorbidity risk factors

CMS Evidence Analysis

While CMS appears to have listed all current sources of published evidence in the proposed decision memo, it seems that CMS gave more weight to studies with negative results and limited consideration to studies with positive results such as CAPTURE 2/EXACT and SAPPHIRE Worldwide. In addition, it appears that CMS has not considered the flaws in some studies with negative results and has misinterpreted some aspects of the CAPTURE 2/EXACT studies.

In the proposed decision, CMS assesses the evidence for 2 questions:

1. Is the evidence sufficient to cover asymptomatic high-risk patients with stenosis ≥ 80%?
2. Is the evidence sufficient to cover a) asymptomatic high-risk patients with anatomical risk factors and stenosis equal to or greater than 80% and b) symptomatic patients with stenosis between 50-70%

Asymptomatic high-risk patients with stenosis ≥ 80%

In proposing not to expand coverage for asymptomatic high-risk patients with stenosis equal to or greater than 80%, CMS cites the lack of randomized controlled trials for the high-risk population. As addressed in our comments above, we do not believe that it is realistic or ethical to require randomized controlled trials for patients at high risk for surgery. The achievement of AHA guidelines by very large and rigorously conducted post-market trials provides sufficient evidence to answer the question.

In addition, CMS cites the registry study by Sidawy that concludes that CAS is associated with a significantly higher rate of death, stroke or myocardial infarction compared to CEA. As explained in detail at our June 3 meeting with the CMS Coverage and Analysis Group, the Sidawy study has significant flaws which put its results into question. By definition, patients treated by CAS in the United States are at high risk for CEA while the CEA patients are a standard risk population. Therefore the two patient populations are not directly comparable. Also, when a patient is treated with CAS they invariably receive a neurological exam at 24 hours when most minor strokes are diagnosed. Patients treated with CEA have limited options to test neurological status due to the inherent attributes of the post-surgical care. As a result the carotid stent stroke rate may appear higher than the CEA stroke rate, as minor strokes are unlikely to be diagnosed post-surgery. The Sidawy study is a registry using self reported outcomes which has none of the clinical outcome assessment rigor found in the controlled post-approval studies CAPTURE 2 and EXACT.

CMS also cites the retrospective analysis on CAS by de Donato et al which finds that long term stroke and death rates for both asymptomatic and symptomatic standard risk patients are similar to what was found in the long term analysis of both ACAS and NASCET. This European study was undertaken solely to review the long term outcomes and the authors’ own conclusions state that CAS is a valid therapy in the long term and compares favorably to the durability of CEA within those same timeframes. The concern CMS poses by comparing the CAS outcomes at 1 year to the ACAS outcomes within the same timeframe is not valid. There are several inherent limitations to a retrospective analysis. By specifically looking for patients with long term data, the analysis is biased towards selecting patients with long term data only. The timeframe from which the data is reported is 1998 through 2006, an 8 year period which includes early CAS procedure experience. CAS was not performed with embolic protection in the earliest timeframes as seen with the SPACE and EVA-3S trials. Both of these factors make this study an invalid comparison. We also believe, in speaking with surgeons performing both CEA and CAS that the existence of CAS has improved outcomes for CEA since surgeons are now selecting only the best candidates for their operation, getting better outcomes for those patients, and treating high-risk patients with CAS.

CMS indicates that its decision not to expand coverage is consistent with the Cochrane Review by Ederle and the 2007 BlueCross BlueShield technology assessment of carotid stenting. We do not believe that the results of the Cochrane Review are directly relevant to this coverage decision as the study only examined randomized controlled trials and not single arm trials data. Most of the trials included in the review were for standard risk rather than the high-risk patients at issue in this NCD, and some of the trials, including EVA-3S and SPACE, had significant flaws. Nor is the BlueCross BlueShield technology assessment of carotid stenting relevant to this decision as it was conducted in 2007 before publication of the latest evidence from the FDA post-approval trials.

Importantly, CMS does not mention the very positive evidence from the CAPTURE2/EXACT and SAPPHIRE Worldwide trials in its analysis of whether evidence is sufficient to cover asymptomatic high-risk patients with stenosis ≥ 80%. This is surprising as both of these analyses and subsequent publications were undertaken based on specific feedback and requests from CMS. As noted above, the 30 day death and stroke rates in these studies are in line with the AHA guidelines requiring outcomes below 3% for asymptomatic patients and 6% for the symptomatic population.

Asymptomatic high-risk patients with anatomical risk factors and stenosis ≥ 80% and symptomatic high-risk patients with stenosis between 50-70%

CMS analyzed 3 studies in its assessment of whether the evidence is sufficient to cover asymptomatic high-risk patients with anatomical risk factors and stenosis ≥ 80%: CAPTURE 2/EXACT, SAPPHIRE Worldwide and the Sidawy registry analysis comparing CAS to CEA. As noted above, the results of the Sidawy study must be viewed with caution. While the 30 day death and stroke rates for asymptomatic patients with anatomical risk factors, as reported in the CAPTURE 2/EXACT and SAPPHIRE Worldwide trials, are within the AHA 3% guideline for intervention (2.7% and 1.8% respectively) , CMS concludes that “the 30 day adverse event rates appear to approach” the AHA recommendation. This conclusion is incorrect based on the results noted above.

CMS argues further that expanded coverage is not reasonable given the inherent flaws of registry studies and registry subgroup analyses. We believe that the CAPTURE 2/EXACT and SAPPHIRE Worldwide clinical trials should be given more weight than the Sidawy analysis due to the flaws in this latter analysis, and the strength of the post-market trials. We also believe that in the case of the carotid stenting high-risk population, it is reasonable that CMS base coverage on the extensive real-world data now available. While we agree that subgroup analyses must be interpreted with caution, the subgroups represented in the CAPTURE 2/EXACT data are derived from over 6,000 patients enrolled prospectively and monitored for events and adjudicated in the same manner as any rigorous, prospective clinical trial. In addition, we note that CMS has structured its coverage decisions by patient subset, therefore calling for subgroup analyses.

Lastly, CMS raises two issues related to the CAPTURE 2/EXACT trials that we would like to address. First, CMS expresses concern about the different proportion of patients classified as anatomic high-risk in the CAPTURE 2/EXACT trials as compared to the SAPPHIRE Worldwide trial. In the SAPPHIRE Worldwide trial, patients with contralateral occlusions were included in the analysis whereas in CAPTURE 2/EXACT, these patients were not. In addition, in the CAPTURE 2/EXACT analysis, patients were categorized as anatomic high-risk, exclusive of the presence of any co-morbidity (like prior MI, coronary artery disease, CHF, renal failure, COPD), in order to allow for a more precise estimate of 30-day outcomes in this population. These factors explain why the proportion of patients classified as anatomic high-risk was different between the SAPPHIRE Worldwide and CAPTURE 2/EXACT analyses.

Secondly, CMS criticizes the CAPTURE 2/EXACT trials for including an analysis of the 30 day death and stroke rates for the subgroup of patients under age 80. The study examines 30 day death and stroke rates for all high risk patients and for numerous patient subgroups including all asymptomatics, all symptomatics, asymptomatics with anatomic risk factors, symptomatics with anatomic risk factors, asymptomatics under age 80 and asymptomatics over age 80. As explained in our communication during the initial comment period and again during our June 3 meeting with CMS, event rates for patients under age 80 were analyzed because this population is comparable in age to the population used to establish the AHA intervention guidelines and is thus the most appropriate high-risk patient population to examine to determine if the AHA guidelines are met for carotid stenting.

With regard to coverage for symptomatic patients with stenosis between 50-70%, we note that the proposed decision memo does not include any specific analysis to support its conclusion that coverage should not be expanded to this population.

Conclusion

Abbott appreciates the opportunity to comment on the expansion of coverage of carotid stenting for the high-risk population. We believe that there is a distinct clinical need for carotid stenting as an alternative to surgery for high-risk beneficiaries. Given the current published data, it would be difficult to conduct a randomized controlled trial involving CAS for high-risk patients since equipoise cannot be achieved. Therefore, we believe it is reasonable that CMS base carotid stenting coverage for the high-risk population on the extensive FDA IDE and real-world trial data now available. This rigorously conducted peer-reviewed published post-market clinical trial data has demonstrated achievement of AHA guidelines and strongly supports the expansion of coverage. We urge CMS to expand coverage for carotid stenting to the high-risk population with asymptomatic carotid artery stenosis of ≥ 80% to assure patient access to a needed therapy. At a minimum, we urge CMS to expand coverage for beneficiaries with asymptomatic carotid artery stenosis of ≥ 80% who are at high risk for surgery due to anatomic risk factors. We look forward to continuing to work with CMS to assure appropriate access to carotid stenting for Medicare beneficiaries.

Sincerely,

/s/

cc:
V Tobiason, Sr. Director, Corporate Reimbursement
R White, Director, Health Technology Assessment and Market Access, Abbott Vascular

[1] 30-Day Outcomes for Carotid Artery Stenting in 6,320 Patients From Two Prospective, Multicenter, High Surgical Risk Registries William A. Gray, MD, Seemant Chaturvedi, MD, and Patrick Verta, MD Circulation: Cardiovascular Interventions. 2009 Published online before print March 6, 2009, doi:10.1161/CIRCINTERVENTIONS.108.823013

[2] D Massop, R Dave, C Metzger, W Bachinsky, M Solis, R Shah, G Schultz, T Schreiber, M Ashchi, R Hibbard Stenting and Angioplasty with Protection in Patients at High-Risk for Endarerectomy: SAPPHIRE Worldwide Registry First 2,001 Patients Catheterization and Cardiovascular Interventions Oct 15 2008

[3] Risk Factors for Perioperative Death and Stroke after Carotid Endarterectomy; Results of the New York State Study Halm, Turhim, Wang, Rockman, Riles and Chassin. Stroke 2009;40;221-229 Epub 2008 Oct 23.

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Tamara Syrek Jenson JD
Acting Director, Coverage & Analysis Group

Dr. Marcel Salive
Director, Division of Medical & Surgical Services
Office of Clinical Standards & Quality
Coverage & Analysis Group

Ref: CAS NCD CAG-000085R7

Dear Ms. Jenson and Dr. Salive,

We support the language change as published in the Proposed Decision dated September 10, 2009 for NCD CAG-00085R7 related to embolic protection devices. This proposed language clarifies that “The use of an FDA approved or cleared embolic protection device is required.”

We respectfully request that CMS reconsider its proposed decision and choose to match coverage for carotid artery stenting procedures with embolic protection to the FDA-approved indications as supported by the currently published clinical literature.

Sincerely,

Antoinette L. Sheen, MBA
Health Economics Group
Office: 928-864-2420
Cell: 928-699-6123
Email: asheen@wlgore.com

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Dear Sir,

The Data from my Carotid stenting in the Sapphire trial and those treated not in the Sapphire trial has shown me that Carotid stenting is safe and very effective for my patients.

I have had zero strokes and no complicationsin 65 plus patients treated. Those results are completely comparable to my open surgical carotid endarterectomies.

I realize that approving this procedure brings concerns of increased risk for patients and a different approach to approving Carotid stenting should be considered.

For those involved in studies, who have very few complications treating their patients, you should consider approving the procedure. For the other physicians who have not been involved in the procedure yet and want to start doing Carotid stenting, they should have a very strict credentialing criteria standards and proctoring before they can start.

Thank you for listening and I hope this procedure is approved, due to the advantage it gives me and my patients, for a safe outcome due to their high risk criteria, that would otherwise make many of these cases impossible to do surgically (CEA). Politics should not determine the approval, but the data we have, should.

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I would like to support carotid stenting for high risk patients. Patients recover more quickly with the stenting procedure than with surgery and require fewer days in the hospital. Also, they do not have to be off their anti-platelet medications for the stent. So many of these patients are on anti-platelets meds due to other conditions and coming off can be detrimental. Patients do not have to be put to sleep and their neurological status can be monitored more effectively when they are awake. I believe stenting is safer than surgery.

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Thank you for the 7th opportunity to provide commentary. Unfortunately, I am sensing CMS "fatigue" among my colleagues, and I noticed that the number of participants continues to dwindle. The analysis by CMS is fairly thorough, but lacks focus. Expanded reimbursement would apply to patients with anatomic features that make them poor endarterectomy candidates. Endovascular surgeons, as well as IC and IR physicians, need treatment options for our patients, rather than operating under duress or hoping for the best with medical therapy. With the current coverage, only academic or research centers can truly discuss the risks, benefits and alternatives and make the best informed decision for each of the patients. Coverage should match the FDA approved indications for the device(s), but at the very least, should include anatomic high surgical risk patients. Finally, it should be pointed out that carotid stenting is being held to a higher standard than surgical endarterectomy. The 3% and 6% complication rates have not been achieved by surgery in randomized controlled trials with independent neurologic assessment. In addition, cranial nerve damage, a neurologic complication limited almost exclusively to endarterectomy, has never been included in the composite MACE statistics. This nerve damage leaves the affected patient with disability similar to a stroke. I hope that CMS overcomes the quagmire of opinions that have been submittted and does the right thing for patients. Poor surgical candidates need carotid stenting available to help prevent stroke. This service should be available to medicare patients in community hospitals, treated by skilled and thoughtful physicians. Quality monitoring of outcomes, a requirement of CMS to perform carotid stenting, will remain essential. Thank you for your consideration.

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The current CMS policy will prevent many of my patients with critical asymptomatic carotid stenoses from proper treatment. This includes patients with disease which is difficult to access surgically, those with severe cardiac and pulmonary disease, restenosis after carotid endarterectomy, readiation-induced stenosis, those with trachiostomies, contralateral occlusion, etc. The only well designed study, the SAPPHIRE trial, has proven the value of carotid stenting. I currently treat patients via the SAPPHIRE WW registry. This trial will end in approximately one year, and I will no longer be able to give patients the care that I believe they deserve. Furthermore, I am unable to use proximal protection with flow reversal in these asymptomatic patients with crical disease. These high risk asymptomatic patients make up a significant percentage of patients being treated with endarterectomy.

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I support decisions limiting coverage to patient groups where the risk to patients of no intervention is high and the odds of providing benefit are good (thus assuring good clinical value). The medical device industry should be expected to push back. In my mind, as long as the decisions are based primarily on evidence of clinical value (and secondarily on total cost) this is a rational means to control cost and assure good outcomes. I suggest however, the "door is always open to better demonstrations of value" is a superior message to "procedure X is not covered". The clinical trials needed are themselves costly and I expect well designed and conducted trials would be eligible for coverage.

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I am in full agreement with the proposed policy to exclude high risk, asymptomatic patients for carotid stent/angioplasty for anything other than a legitimate clinical trial. A clinical trial must be a prospective, randomized trial and not simply a registry. At the presant time, the benefit of carotid endarterectomy over medical management in average risk asymptomatic patients is small. It is difficult to conceive of the need to carry out any intervention in a high risk, aymptomatic patient. At the presant time, carotid stent/angioplasty in average risk patients, either symptomatic or asymtomatic, is not justified by current data and particularly the prostpective randomized trials completed in europe. This may change once we have the results of the CREST trial which will be available early next year.

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Your decision not to cover asymptomatic carotid stenosis greater than 80% appears to be financial rather than in the best interest of the patient. There is little disagreement that a person with atherosclerotic carotid stenosis is more likely to suffer a stroke than one without stenosis; also that the person with the highest degree of stenosis is more likely to have a stroke than one with less. The question should the government healthcare system pay for prophylactic surgery or endovascular treatment before the lesion becomes symptomatic and at what degree of stenosis should the treatment line be drawn. As you know stroke is not like gastric ulcer, pneumonia or a urinary tract infection; a catastrophic, instantaneous life altering event can occur without any prodromal event. Drawing the line for treatment coverage at greater than 80% does not seem unreasonable. I know that I would not want to wait to see if I was going to suddenly die or suffer severe debilitation. I believe that the patient should have the option of deciding whether they will accept the risk of the intervention or awaiting the natural course of their lesion and that it should not be determined by their ability to pay the non-covered expense.

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It is ludicrous for CMS to dictate the care delivered to patients by limiting payment. While the data may need further study, there is without doubt, ample evidence to support the use of Carotid artery stenting in patients deemed too high risk for CEA. Carotid stenting, like any other modality, is at its best when used in the appropriate clinical setting and by those with the adequate training. It is inappropriate for CMS, a government bureaucracy, to dictate to clinical practitioners and patients the practice of medicine. While this process does need tight regulation and control, it should not be so greatly restricted that it becomes clinically unavailable. Based on available date, most would agree that in high risk symptomatic patients, carotid stenting when used appropriately is equally efficacious if not superior to CEA. It is routine practice for vascular surgeons to perform CEA on patients with greater than 70% carotid artery stenosis. Although the definite data may still be forthcoming, logic would dictate that the method of carotid repair, if applied in a regulated and safe fashion, should not be the determining factor as for the timing of carotid repair. Utilizing the rationale presented by CMS, than CEA should also be restricted in asymptomatic patients with 80% carotid stenosis. It is inappropriate to single carotid stenting! Carotid stenting is typically less traumatic, costly, and requires a shorter lenght of stay.

Respectfully,
Nima Amjadi, MD FACC
Chief Department of Cardiology
St. David’s South Austin Hospital

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I fully support the CMS decision to not approve routine coverage for stenting of asymptomatic carotid stenosis >80% with anatomic risk factors for endarterectomy. The benefit of carotid endarterectomy for asymptomatic disease, while well established, is overall much less than the benefit for symptomatic stenosis, with a much larger number needed to treat in order to prevent one stroke. The reduction in stroke risk in both US and European trials is from an approximately 2% per year risk to 1% per year risk when performed by surgeons with very low complication rates. However, the medical arm of these studies included only aspirin rather than other pharmacologic agents in widespread use now, did not include aggressive treatment of comorbid conditions such as hypertension and hypercholesterolemia, and did not emphasize "non-medical" treatment with exercise programs and weight loss. Assuming equivalency of CEA and stenting, the same principles apply. There is likely a statistically significant but very small benefit when compared to suboptimal medical management (aspirin alone). Compared to optimized medical management, this benefit likely disappears. Approval by CMS will lead to a deluge of stenting in elderly asymptomatic patients, all of whom will have some loosely applied definition of "unfavorable anatomy" for open surgery, and very few of whom would ever have a stroke in the first place.

As someone who performs carotid stenting, it pains me to see presentations and publications in which the majority of the patients are asymptomatic, because so many of these patients did not need to be treated and, if they knew the existing data, likely would choose to not be treated. More commonly though, they are told that they "could have a stroke at any minute" and are frightened into having the procedure done. Approval for coverage of asymptomatic disease would extend this pattern from the relatively confined boundaries of patients participating in clinical trials to the wide open expanse of general practice, where complication rates will be higher and efficacy rates will be lower. And this would be a disservice both to these future patients and to the American public as a whole.

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I applaud the decision by CMS to not exand coverage for carotid angioplasty and stenting. The federal government has invested a lot of money in the CREST study, and we should wait to see these results before changing any coverage decisions.

The SAPPHIRE and CAPTURE post-market registries are largely filled with asymptomatic patients who supposedly have >80% stenosis. If you were to audit these cases and objectively look at the degree of stenosis, I would bet that there is a large fraction who have this because of cases that I see getting presented at meetings and patients I see who have gotten their asymptomatic disease treated before being referred to me from another hospital. There are no central readers on these "studies", so the foxes are watching the hen house. I''m not sure if there is a way for CMS to rein this in, but it will likely get worse if reimbursement for stenting of asymptomatic stenosis is expanded.

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I agree with CMS NOT expanding the coverage for CAS until more data form the double brind randomized trail is available.

The fact remains that CEA can be performed with very low morbidity/ mortality in high risk patients with outstanding short AND LONG TERM data. This has been confirmed repeatedly. We all know that CAS has higher upfront risk of stroke and has higher rate of restenosis. The short-term data is poor compared to that of CEA.Until the data is compared apple to apple- expansion of coverage is not in the interst of people and the tax-payers.

The data for CEA is hard to match as you all know well.

The final question is if your mother or father or you needed carotid revascularization what would you want. If you can answer this very simple question honestly, you have your answer.Please donot let interest groups and rich companys looking to make a buck influence your decisions.

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I have been pursuing carotid endovascular intervention for the last 8 years for symptomatic and asymptomatic patients per registries, studies and practice. I have done several hundred of these procedures with a stroke rate that has been demonstrably better than the AHA guidelines. I protest the decision of CMMS not to provide coverage for the classes for which the FDA has approved these devices especially since that approval was and is based on sound medical evidence. I feel that this has been the most politicized decision I have encountered in my 25 year career. Thorough review of the literature can lead one only to conclude that CAS and CEA are equivalent procedure with respect to stroke and this has demonstrated in each trial in which I have participated.

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