Intracranial Stenting and Angioplasty

Existing literature (WASID, among others) has clearly shown that medical therapy to prevent stroke DOES NOT WORK for a significant subset of patients. Most notably, patients with intracranial atherosclerotic disease have a 22-24% chance of recurrent stroke within one year of their first event. The result is not only horribly detrimental to patients, but is also a major cost to society. An intracranial stent designed specifically for that purpose provides neurointerventionalists with a much needed tool to dramatically affect outcomes in thousands of patients for whom other options are simply not effective. Please reconsider the decision on reimbursement for this technology, which is quickly becoming a key tool in winning the war on stroke.

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We request that CMS grant coverage for the Wingspan under a humanitarian device exemption (HDE). This is "reasonable and necessary" because there are no other viable options. Stroke and potential stroke patients are at high risk and medical therapy (the WASID Study)proves ineffective. These patients are at risk of recurrent stroke in 45-70% of patients. Those patients treated with the Wingspan in the HDE Study had stroke rates less than 7% and no restenosis. Failure to act accordingly would severely limit patient access to this effective treatment nationwide, and particularly in community hospitals. (CAG-00085R2) Please reconsider labelling the Wingspan Stent in the HDE program.

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Preface: I attest to no financial interest in the referenced device, or in any business entity involved in its production or distribution.

As a staff interventional neuroradiologists at Baylor University Medical Center in Dallas—the first designated Stroke Center in North Texas—I have been fortunate to participate in the treatment of five chronic stroke patients since February of this year. Each of these patients, ranging in age from 46 to 78, presented with recurrent, debilitating cerebral ischemia secondary to vasoocclusive intracranial atherosclerosis. In every case, their symptoms were refractory to maximum medical therapy, including anticoagulant and antiplatelet regimens.

I say fortunate because the deployment of the device was uneventful in each case, and all patients have enjoyed subsequent return to full, asymptomatic function. Two of the cases have achieved six-month followup, with angiographic confirmation of complete restoration of luminal diameter to that of native, healthy vessels. It is no exaggeration to say that my youngest patient, age 46, faced certain death by loss of flow to his isolated posterior circulation due to occlusive and preocclusive plaques along his left and right intracranial vertebral arteries, respectively. He is back to full duty as a building tradesman, now four months post treatment.

I say fortunate because Baylor has voluntarily absorbed the costs of the procedure and related hardware, in anticipation of CMS revising payment status for intracranial angioplasty and stenting. Such generosity however cannot be maintained for long, nor should it be required.

Your staff have been very thorough in review of clinical experience and technological and regulatory developments regarding this treatment modality. Nevertheless, several flaws in their reasoning abrogate the conclusion which you reach and thus the guidelines you propose. First, the device in question is significantly different from those cited in prior published series. This balloon/stent system is built upon a platform specifically designed for intracranial access and administration. Furthermore, none of the previous devices referenced were self-expanding stents. This design feature provides superior flexibility and endoluminal coaptation, both of which can play a critical role in deployment of the device and in durability of favourable treatment outcomes. Many complications associated with previous devices can be attributed to the fact that these were coronary systems, whose performance characteristics are unsuitable for the intracranial milieu.

Adjunctive treatment with antiplatelet agents also was highly variable in earlier applications, as well. We now have a better appreciation of the utility of short-term postop platelet suppression as a means of protecting the endoluminal implant from local thrombotic phenomena and ensuring vessel patency until neoendothelialisation can occur.

At our institution, and per labeling by the manufacturer, a patient with a high grade intracranial arterial stenosis is a candidate for angioplasty and stenting only if and when they fail maximum medical therapy. By that, we mean that they sustain repetitive stroke symptoms or transient ischemic attacks despite anticoagulant and/or antiplatelet administration. In calling for a control group, you have ignored the obvious: These patients have acted as their own controls, and now may crossover into the interventional treatment group.

You pay for angioplasty and stenting in treatment of coronary and carotid stenosis. In contrast to those conditions, however, there is no well-established surgical option for patients with intracranial stenosis who fail conservative management. You did well to ignore the scientific record on external carotid to intracranial arterial bypass techniques; the briefest of surveys of neurosurgeons readily reveals their collective distaste for such an option, due to the abject long-term patency rates.

Finally, humanitarian or investigational exemption of medical devices from Federal regulations regarding premarket approval or notification is the exclusive purview of the Food and Drug Administration Center for Devices and Radiological Health. Your offer of reimbursement only in the setting of an Investigational Device Exemption is contradictory to FDA determination of HDE for this product, and seems at once both presumptuous and extortive.

Suppose, however, that you were successful in persuading CDRH to alter its determination. Roughly a score of centers would be permitted as study sites, and because of our modest numbers to date I can almost guarantee that neither Baylor nor any other North Texas hospital would be included. So, a cachement population of 6 million would no longer have access to this product, and its chronic stroke subset would be stripped of a significant treatment option.

There are hard realities of clinical medicine that obviate academic machinations. This is one of them. Do not deprive my patients of this hope.

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We have thankfully moved from a very poor prognosis for intracranial atherosclerotic stenoses when we could only offer medical therapy to a much better prognosis with the advent of safe and effective angioplasty techniques/tools. We now have yet another needful advance with safe delivery intracranial stents. This is an technical advance we don't want to deny our patients. The CMS population would be the greatest benfactor patient population. We need to support the use of intracranial stents with angioplasty. Thank you.

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NCA for Intracranial Stenting and Angioplasty (CAG-00085R2

It is my feeling, as well as the feeling of the neurologists at my instituition, Atlantic Health System, that balloon angioplasty and stenting represent an important treatment option for patients with symptomatic intracranial disease with greater than 50% stenosis. As several current studies have shown, the rate of recurrent stroke is high in this group of patients that are already receving medical therapy. Decling coverage puts a vunerable patient population who is dependent on medicare coverage at a disadvantage when considering their therapeutic options. Thank you for your consideration.

Ron Benitez, MD

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As a vascular and neurointerventional nurse coordinator; I encounter a lot of patients with intracranial stenosis who failed medical therapy and are looking forward to have intracranial balloon angioplasty and stenting performed. I urge the CMS to approve the reimbursement for this important therapeutic alternative to our patients. Many patients are under immense pressure when this is the only alternative but it is not covered by the CMS. The coverage will take away significant burden from the patients and their family and help in providing the best available therapy for the intracranial stenosis.

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I was deeply disappointed to learn of the pending CMS decision regarding intracranial angioplasty and stenting. While I understand the limitations of the data currently available, I believe that the preponderance of available evidence favors intracranial angioplasty and stenting for patients with medically refractory, severe intracranial stenosis. I recognize that more work needs to be done to determine the limitations of this treatment, but I feel that the dismal natural history for patients with severe symptomatic stenosis has been well laid out by the WASID study.

Accordingly, these patients should have available to them, without the real possibility of financial ruin, this treatment alternative which has been determined by the leading experts in this field to be of benefit. It is difficult for me to understand how CMS can review the same data as the FDA, well respected experts in the field and their professional societies and come away with a decision that does not better reflect expert opinion and better serve the patients affected by this decision. I can only conclude that a selective interpretation of the data has been adopted.

I urge CMS to reconsider their decision and cover patients with symptomatic, severe intracranial stenosis secondary to atherosclerosis.

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Atherosclerotic intracranial diseases carries a high risk of subsequent stroke despite treatment with aspirin and warfarin as shown by several studies. The 2 years risk in a symptomatic stenosis of 50% or more reaches 22% and if the stenosis is 70% or more it may approch 30% over 2 years period despite medical therapy. With new technology and procedural risk of less than 5% as shown in prospective studies; it is crucial to cover such an alternative endovascular therapy with balloon angioplasty and stenting to patients who indeed has been found to have symptomatic intracranial stenosis. Endovascular approach has been found to be effective and save in the peripheral vascular disease, coronary disease and carotid disease. Several propsective intracranial stenting studies and case series have also shown its effectiveness and safety. I urge the CMS to grant an approval and further modify the proposal to full approval of intracranial stenting and balloon angioplasty with more than 50% in those who had symptoms while on either antiplatelets or warfarin. It is very cumbersome on the patient and their family not to have this therapy covered by the CMS.

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Boston Scientific Corporation’s Neurovascular Group appreciates the opportunity to present these comments on the Centers for Medicare and Medicaid Services’ (CMS) proposed coverage decision on intracranial angioplasty and stenting.

Company Background
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 the following medical specialty areas:

To: The Centers for Medicare and Medicaid Services
Intracranial atherosclerosis is a potentially treatable cause of ischemic stroke, responsible for 70-90,000 strokes annually in the United States, about 5-10% of all strokes. Once established as a diagnosis, the annual stroke risk from intracranial atherosclerosis is estimated to be 3-15%. Even with optimal medical therapy (aspirin or warfarin), the stroke rate in such patients is estimated to be 8-12 % per year. The prevalence of symptomatic intracranial atherosclerotic disease varies among different ethnic groups, with higher rates reported in Hispanic, African American and Asian populations, which is the primary patient population that my institution serves.(1-6)

Optimal medical management of patients with symptomatic intracranial atherosclerotic disease had been the subject of a long standing debate between those favoring anticoagulation and those favoring anti-platelet therapy. Warfarin anticoagulation was shown recently to offer no benefit over aspirin in reducing risk for future stroke in patients who had experienced TIA or stroke related to significant intracranial arterial stenosis, but warfarin was associated with higher rates for death and hemorrhage. Importantly, patients in the trial had a high risk for subsequent stroke despite either medical treatment, 22% over a mean follow-up period of 18 months.(6)

There is a high (45%) risk for recurrent stroke in patients who have failed treatment with anti-platelet or anticoagulant therapy for symptomatic intracranial atherosclerotic disease¹. Advances in endovascular technology have made intracranial angioplasty and stenting for atherosclerotic stenoses technically feasible. Preliminary data on intracranial angioplasty and stenting from subset analysis of the SSYLVIA (Stenting of Symptomatic Atherosclerotic Lesion in the Vertebral or Intracranial Arteries) data have shown these procedures to be associated with high rates of re-stenosis.³ Despite this problem, intracranial angioplasty and stenting are currently offered as therapeutic options for symptomatic patients who have failed medical therapy, as well as for some asymptomatic patients with high-grade intracranial atherosclerotic stenoses, because of the poor prognosis for initial and recurrent stroke while on medical therapy alone.(1,7)

Medical device companies only recently have begun to develop balloon & stent devices designed specifically for arteries of the brain, which are expected to increase the safety and effectiveness of stent-assisted angioplasty in the brain. The first commercially available and FDA-approved such device (Wingspan Stent System) has become available to us just over the past year. Given the lack of alternative acceptable therapies for patients with intracranial atherosclerotic disease, and given the high prevalence of intracranial atherosclerotic disease in our local minority population, the current CMS decision for highly restricted coverage of intracranial angioplasty and stenting leaves many patients with no hope for preventing the catastrophic consequences of a hemispheric stroke. This ruling also puts our hospital in an extremely difficult and unfair position of either denying patients access to a treatment which has the potential for preventing a stroke, requiring the patients to cover the cost of the procedure themselves or having to absorb the cost of this procedure without compensation. . On behalf of the University of Chicago, and our patients, we request that you urge the Centers for Medicare and Medicaid Services (CMS) to broaden their Medicare coverage for intracranial angioplasty and stenting to include the FDA approved HDE indications.

Sincerely,

Avi Mazumdar, M.D.
Assistant Professor
Neuroradiology
University of Chicago Hospital

Bibliography

1. Thijs VN, Albers GW. Symptomatic intracranial atherosclerosis: outcome of patients who fail antithrombotic therapy. Neurology 2000;55:490-497.

2. Chimowitz MI, Kokkinos J, Strong J, et al. The Warfarin-Aspirin Intracranial Disease Study. Neurology 1995; 45:1488-1493.

3. SSLYVIA study investigators. Stenting of symptomatic atherosclerotic lesions in the vertebral or intracranial arteries (SSYLVIA): study results. Stroke 2004; 35: 1388-1392.

4. White H, Boden-Albala B, Wang C, et al., Ischemic stroke subtype incidence among whites, blacks, and Hispanics: the Northern Manhattan Study. Circulation 2005; 111:1327-1331.

5. Wityk RJ, Lehman D, Klag M, Coresh J, Ahn H, Litt B. Race and sex differences in the distribution of cerebral atherosclerosis. Stroke 1996;27:1974-1980.

6. Chimowitz MI, Lynn MJ, Howlett-Smith H, et al. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med 2005; 352: 1305-1316.

7. Gomez CR, Orr SC. Angioplasty and stenting for primary treatment of intracranial arterial stenoses. Arch Neurol 2001; 58: 1687-1690.

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My name is Jeffrey Farkas and I am the director of Interventional Neuroradiology at Maimonides Medical Center Brooklyn, NY. I am appealing to you to change your preliminary decision not to cover intracranial angioplasty and stenting unless the patient is enrolled in an IDE Study. The FDA decision to allow the use of the wingspan system, As a HDE was a momentous occasion for physicians that treat and prevent stroke, as well as for patients at high risk of recurrent stroke. Based on older studies such as W.A.S.I.D we have a fairly good basis that defines the risk of stroke in patients with intracranial stenosis greater than 50%. The recurrent stroke rate in patients with greater than a 70% stenosis at one year is 23% on medical therapy. (Kasner SE, Chimowitz MI, Lynn MJ et al. Predictors of Ischemic Stroke in the Territory of a Symptomatic Intracranial Arterial Stenosis. Circulation. 2006; 113:555-563. )What we need now is data on patients who have been treated with the wingspan device. Your review of the literature is extremely limited since the wingspan device is new and there is not much specific data regarding the long term outcome of these patients yet. Comparison with other studies that used coronary devices is not sufficient. My experience with the wingspan device has altered my treatment paradigm for patients with severe intracranial stenosis. This device is much safer and easier to use than the previous generation of devices. Most of the studies that you looked at involved coronary devices. The high morbidity from the procedure itself obviates the benefit in most cases. The wingspan device, which has a much higher safety profile, should be a consideration for patients with severe intracranial disease. Unfortunately if CMS does not provide payment for the procedure hospitals will not allow the procedure to be performed for economic reasons. This will in effect reverse the FDA decision to allow this product on the market as a H.D.E. The HDE approval should allow physicians to treat patients with limited options. C.M.S. should provide patients a reasonable option for patients to receive treatment while not fully committing to the unrestricted use of the device. As CMS has done in the past with Carotid artery stenting, limited payments need to be made available for these procedures while we gather more data. A carefully designed registry will allow us to treat patients now and still provide information for the future. I fear that because of the limited number of patients that need stenting and the significant difficulties in recruiting patients for IDE studies, that the current preliminary decision will effectively halt the treatment of intracranial atherosclerosis and stunt new and imaginative therapies that could help patients on a daily basis.The natural history of patients with recurrent strokes and intracranial stenosis is poor. With the approval by the FDA of the Wingspan HDE a window of opportunity has been opened for patients. CMS should allow this work to continue and prosper and not shut the window for economic reasons. Please reconsider your preliminary decision, allow payments for the wingspan stent system when appropriate clinical criteria are met and when the patients agree to be enrolled in a prospective uniform registry.

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Stroke is a devastating disease and is the number one cause of long term disability in this country. Options for patients with intracranial atherosclerotic disease who have failed medical therapy are limited. I ask CMS to provide reimbursement for stroke patients who have failed best available medical therapy and need access to angioplasty or angioplasty/stenting. With technology that is currently FDA HDE approved, the current proposal to limit reimbursement to just patients in an IDE trial would limit access to many patients that have no other options.

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AdvaMed appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) recent proposed decision memorandum involving intracranial stenting and angioplasty (CAG-00085R2). Our comments will not be focused on the specific technology per se. Rather, we will focus on non-coverage of new humanitarian use devices.

As you know, AdvaMed follows Medicare coverage activity very closely because of the impact it has on beneficiary access to state-of-the-art medical care. CMS has made considerable progress in recent years in improving the coverage process. We encourage you to further improve the coverage process by reconsidering the manner in which humanitarian use devices (HUDs) are addressed for purposes of Medicare coverage.

Technologies that have received HUD designations and humanitarian device exemptions (HDEs) from the FDA involve treatments for limited populations with no other viable treatment modality. Through the HDE approval process, Congress and the FDA have promoted the development of technologies that treat orphan diseases. Similarly, CMS’s national Medicare coverage process should support Medicare beneficiary access to these technologies. First, such access can be promoted by providing national coverage for the limited number of beneficiaries who meet the medical conditions and specifications required to be considered for humanitarian use devices and are enrolled in clinical trials to demonstrate safety leading to an HDE. Second, CMS should provide prompt coverage of such technologies for qualified Medicare beneficiaries after an HDE has been granted by the FDA.

AdvaMed recommends that CMS reconsider its approach to coverage of HUDs. We look forward to working with you to ensure patient access to these important medical technologies.

Sincerely,

Ann-Marie Lynch

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“NCA for Intracranial Stenting and Angioplasty (CAG-00085R2)”

To whom it may concern within CMS,

Sunrise Medical Hospital and I would like to request that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

The current CMS clinical review does not address the high risk patients identified in the WASID study. Reference recent publications in peer-reviewed journals such as those below which presented ischemic stroke rates in medically refractory patients with symptomatic intracranial atherosclerotic disease:

(1) Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Study

According to this randomized prospective study of 569 patients, the risk of recurrent stroke at 1-year for patients with a ≥70% stenosis is 23% while on medical therapy.

(2) Thijs and Albers Study

In this retrospective cohort study of 52 patients, among patients who failed antithrombotic therapy, the subsequent rate of stroke or death was 45% per year, with median time to recurrent event or death at 36 days.

Thijs VN, Albers GW. Symptomatic intracranial atherosclerosis: outcome of patients who fail antithrombotic therapy. Neurology. 2000;55:490-7.

(3) Groupe d’Etude des Sténoses Intra-Crâniennes Athéromateuses Symptomatiques (GESICA) Study

This prospective, multi-center cohort study of 102 patients showed that despite medical treatment, the two-year rate of recurrent ischemic events in the territory of the stenotic artery was 38.2%.

Mazighi M et al. Prospective study of symptomatic atherothrombotic intracranial stenoses. Neurology. 2006;66:1887-1191.

The Wingspan HDE Study results show:

- Composite ipsilateral stroke or death rates of 4.4% (2/45) at 30-days and 7.0% (3/43) at six months
- No symptomatic restenosis at six months

Please give this procedure the appropriate reimursment.

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Re: NCA – Intracranial Stenting and Angioplasty (CAG-00085R2)

On behalf of Baylor University Medical Center, we kindly request that CMS issue an expeditious, positive national coverage decision for intracranial stenting and angioplasty in patients who receive treatment with the Humanitarian Use Device: the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter.

The current national non-coverage policy directly affects our hospital’s financial ability to provide this life-saving treatment to critically ill patients.

Most stroke patients with intracranial atherosclerotic disease are typically treated with medical therapy but in some cases this therapy is ineffective and patients are left at a high risk for another stroke. Studies have shown a recurrent stroke rate up to 24% in the first year after their stroke. If medical therapy fails, there are limited treatment options, and these individuals suffer compromised quality of life.

In the past decade, intracranial stenting and angioplasty have emerged as a promising therapy in symptomatic patients with high grade stenosis who fail medical therapy. On August 3, 2005, the Food and Drug Administration approved the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter under a Humanitarian Device Exemption. The Wingspan Stent System is the first marketed self-expanding stent specifically designed for the intracranial vasculature. In the Wingspan HDE clinical study, there was a 97.7% procedural success rate and at one year post procedure, 90% of the patients were free of strokes related to their treated lesions. Early U.S. experience reported at the recent American Stroke Association meeting shows a similar acute procedural profile.

In fact, we have treated numerous patients at Baylor who have suffered recurrent stroke attributable to severe intracranial atherosclerosis despite adequate medical therapy with intracranial angioplasty and stenting. It is important to recognize that many of these patients are still young with many years of productivity left if they are kept “stroke- free”. Reimbursement of these procedures will ultimately lead to reduced net costs by limiting further acute hospitalizations, long-term care costs and loss of productivity by reducing recurrent stroke rates. We perform angioplasty and stenting simply because it the medically appropriate treatment, however the financial losses incurred under the current non-coverage policy will preclude universal usage of this function-sparing and potentially life-saving procedures.

Under the current non-coverage policy, our institution is financially constrained in its ability to provide this treatment for intracranial atherosclerotic disease.

Intracranial angioplasty and stenting is performed in the hospital inpatient setting, usually under general anesthesia. Absent Medicare reimbursement, our institution assumes significant financial risks in treating these patients. Similar to craniotomy procedures, intracranial angioplasty interventions involve a full operating room contingency, including nursing, anesthesiologists, special procedure technologists, and circulating personnel. It is not economically feasible for the hospital to allow these procedures to be performed without reimbursement.

Baylor University Medical Center is a JCAHO certified primary stroke center and functions as the major comprehensive stroke center in the Dallas region. We are the main providers of neuroendovascular services in the region including intra-arterial revascularization, aneurysm clipping and arteriovenous malformation embolizations. The Baylor Stroke Program is committed to treatment of all patients with cerebrovascular disease and participates in the Dallas Stroke Network. In fact, Baylor University Medical Center receives the largest number of ambulance transported stroke patients within the network, treating more than 700 stroke patients annually. Our ability to perform intracranial angioplasty and stenting will have a definite impact of the Dallas community.

There is now enough evidence available to warrant national Medicare coverage for a treatment that benefits an orphan disease population.

The interventional professional societies, the American Society of Interventional and Therapeutic Neuroradiology, the Society ofInterventional Radiology, and the American Society of Neuroradiology, support health insurer coverage for the symptomatic medically refractory intracranial atherosclerotic disease patient population. Given that these patients lack other treatment options and face an unacceptable risk of another stroke, the availability of endovascular treatment using the Wingspan stent is critical to patient care, and CMS should provide coverage for these patients.

To continue to provide this life-saving treatment option, we request that CMS act quickly to reverse its non-coverage policy and ask for the following:

1) National Medicare coverage of PTA and stenting of cerebral arteries when performed in vessels with greater than or equal to 50% stenosis for patients who are refractory to medical therapy, concurrent with use of a device approved for marketing by the FDA (subject to any requirements established by the applicable FDA approval or clearance process) for this specific indication, and

2) National Medicare coverage for intracranial stenting and angioplasty within the context of a category B investigational device exemption (IDE) clinical trial.

Thank you again for your time and attention to this important public health policy initiative.

Sincerely,
Lise Labiche, MD
Director, Stroke Program
Baylor University Medical Center

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On behalf of Brigham and Women’s Hospital, Boston, MA, we thank CMS for issuing the national coverage proposal for intracranial stenting, a potentially lifesaving procedure that benefits intracranial atherosclerotic patients.

We would like to take this opportunity to point out that, apart from intracranial atherosclerosis, a condition known as arterial dissection could also be successfully treated with intracranial stenting. An arterial dissection is a tear in the lining of an artery that can be caused by 3 main factors: Trauma, Spontaneous, or Iatrogenic. When a  dissection has occurred, the walls of the artery separate and allow blood to flow into that space rather than into the lumen of the blood vessel. This causes either stenosis as the interior wall is forced centrally by the blood flow or hemorrhage if the exterior layers rupture. Stenosis decreases the flow in the blood vessel similar to stenosis caused by atherosclerotic disease. Dissections can be caused by trauma such as a car accident; genetic predisposition, often associated with patients with Marphan’s disease, that leads to development of weak spots in the arterial walls resulting in spontaneous dissection; and also by complications from atherosclerotic angioplasty procedures.

The stent secures the flap of arterial muscle to the wall so that blood cannot enter that space. It also provides support for that weakened portion of the vessel to withstand the normal radial and flow pressures from the blood stream. Restoring the integrity of the arterial wall and reducing stenosis within the vascular lumen preserves the cerebral blood flow and thereby brain function.

The Brigham and Women’s Hospital predominately performs stents for atherosclerotic disease. However, if a patient presents with ischemic stroke-like symptoms, often caused by a stenosis in an intracranial artery, the treatment could be an intracranial stent to resolve the stenosis. We believe that treatment for stenosis with a stent can be applied to both atherosclerotic disease and dissection. The diagnostic angiograms required to plan the treatment are performed directly before the treatment in the same setting.

We appreciate the opportunity to comment on this coverage decision. Please contact Cassandra Earley at 617-732-7257 with any further questions.
Sincerely,

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I have been involved in 2 cases that were performed by interventional neuro radiologists. They both were successful. Before this stent, there was nothing to offer these patients other than medications. Stroke recovery is so expensive not only to the patient and their family, but society in general. I am for any treatment that prevents strokes and keeps patients out of long-term care. However, I am not in favor of anybody but interventionally trained neuro interventionalists performing this procedure. I feel the same way about carotid stenting. You can not learn how to do this in a weekend. Karen Finnegan

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The American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS), and the American Society of Interventional and Therapeutic Neuroradiology (ASITN) appreciate the opportunity to provide input to the Centers for Medicare and Medicaid Services’ (CMS’) request for comments on the proposed decision memo for national Medicare coverage for intracranial stenting and angioplasty (CAG-00085R2), which was published on the CMS website on August 9, 2006.

Decreasing the high morbidity and mortality of stroke caused by symptomatic intracranial atherosclerotic disease (ICAD) remains very important to our societies. Intracranial angioplasty and stenting have proven to be beneficial for certain patients with ICAD. Conversely, medical therapy has been proven ineffective in these same patients. As you may be aware, our physician leaders and staff members met with Dr. Phurrough’s group on April 10, 2006 to explain the need for coverage for intracranial angioplasty and stenting. Subsequently, our physician leaders and staff spoke with Dr. Phurrough and his staff via teleconference on July 25, 2006. At that time, we reiterated the need to issue a positive coverage decision for endovascular treatment of certain patients with ICAD.

We are disappointed that CMS is proposing to limit coverage for intracranial stenting to those patients participating in an Investigational Device Exemption (IDE) clinical trial. We believe that access to this life- saving treatment is essential for patients who have failed other treatment and for whom intracranial stenting is the only remaining hope to prevent further strokes. We find it difficult to imagine that CMS would find coverage for these patients “not reasonable and necessary.” Clinical equipoise regarding medical vs. endovascular therapy for patients with symptomatic, > 50% arterial stenoses, who have failed medical therapy no longer exists. Therefore, it is highly inappropriate to continue to restrict coverage for endovascular therapy for such patients.

As stated in the Proposed Decision Memo, CMS has recently issued a plan to review its clinical trial policy for Medicare payment for patient treatment in conjunction with a humanitarian use device (HUD) and we are aware that CMS is in the process of reviewing comments on this issue. We believe that coverage for intracranial stenting, which was approved by FDA under a humanitarian device exemption (HDE), should be allowed and we believe CMS has the authority to cover this device now. Every day of delay represents a potential loss of life because our patients have to forgo the benefit of this lifesaving treatment.

On behalf of our professional societies and the patients that our members serve, we continue to urge CMS to issue a positive coverage decision and reiterate the points that we have stressed for the last year, which include the following:

Additional perspective on our position and clinical experience with interventions for this disease is provided below.

Intracranial Atherosclerotic Disease

Intracranial atherosclerotic disease is the narrowing and blockage of intracranial vessels, which results in reduced blood flow to the brain. ICAD is recognized as a significant risk factor for stroke, accounting for up to 10% of all ischemic strokes.¹ The majority of these patients are treated with medical therapy. However, there is a small population of patients who, despite medical therapy, remain at high risk for stroke.^2,3,4 Two recent publications from the Warfarin versus Aspirin for Symptomatic Intracranial Disease (WASID) trial, (a randomized trial comparing warfarin and aspirin for preventing stroke and vascular death in 569 patients with ICAD), showed that symptomatic intracranial stenosis of greater than or equal to 50% carries a high risk of stroke, whether treated by antiplatelet or anticoagulant medications. For patients who presented with a non-disabling stroke secondary to an intracranial stenosis of > 70%, 23% suffered a same vascular territory stroke within one year despite best medical management. Such a high failure rate for best medical therapy is very rare for the treatment of non-malignant diseases.

ICAD Treatment Options in Symptomatic Patients

Currently, patients with symptomatic intracranial atherosclerotic arterial stenosis have limited treatment options. Medical therapy has been proven ineffective at stroke prevention for a small subset of such patients. Based on data from a global, randomized controlled study, extracranial to intracranial arterial bypass surgery was also found to be ineffective.⁴

Endovascular intracranial angioplasty and/or stenting, has reported compelling clinical results in the past decade.^5,6 Most recently, the ASITN in conjunction with the Society of Interventional Radiology (SIR) and the American Society of Neuroradiology (ASNR) conducted a thorough review of the medical literature and released a joint position statement which supports: intracranial stenting and angioplasty for symptomatic patients with a > 50% intracranial stenosis. The position statement was concurrently published in the October 2005 issues of The Journal of Vascular & Interventional Radiology and The American Journal of Neuroradiology.^7,8

Case series reports of balloon angioplasty and stenting procedures have demonstrated technical success rates in the published literature of greater than 90 percent. The existing clinical evidence shows clear benefit of endovascular treatment in symptomatic patients with greater than or equal to 50% intracranial stenosis.

CMS had formulated the original national non- coverage policy for the ICAD patient population in 1994. The AANS, CNS, and ASITN agree that, at that time, the risk of treatment using the available technology and the relative lack of understanding regarding the natural history of ICAD supported the national non-coverage policy. However, there have been significant advances in medical knowledge, technology and techniques in the last ten years. The dismal natural history of ICAD has now been documented. These changes have rendered the existing non-coverage policy inappropriate.

Further, in August 2005, the Food and Drug Administration (FDA) approved the Wingspan Stent System with Gateway PTA Balloon catheter via Humanitarian Device Exemption (HDE). The HDE approval process is a streamlined FDA approval process that is meant to improve patient access to treatments for rare and orphan diseases based on the requirement of demonstrating safety and probable benefit of the technology. The FDA HDE approval process is supported by the fact that it otherwise would be statistically unfeasible to amass large clinical studies to prove clinical effectiveness whereas approval based on probable benefit is substantiated given that the HDE population faces no other treatment alternatives. Intracranial stenting represents a promising endovascular therapy in the management of ICAD in medically refractory patients with > 50% stenosis. Data from the Wingspan HDE clinical study are encouraging and clearly support its use in this underserved population. The Wingspan study’s 12 month clinical trial results, recently presented by the study’s principal investigator on February 17th at the International Stroke Conference indicate that 90% of patients participating in the study were free of strokes related to their treated lesions at one-year post-procedure.⁹ The majority of patients treated in the Wingspan study had an arterial stenosis of > 70% and had presented with stroke. In comparison, the one- year ipsilateral stroke rate among similar patients treated by medical therapy in WASID was 2.3 times as high.

Prior to the approval of the Wingspan stent system, the FDA had granted an HDE for the Guidant NeuroLink intracranial stent system in 2002. Guidant elected to discontinue manufacturing and selling this stent within the next year. Although we do not have access to official Guidant sources for documentation, we believe this stent system was withdrawn from the market because the lack of reimbursement for intracranial stenting made the project impossible to justify from a financial perspective. As we were made aware that the Wingspan and other stent systems were under development. AANS, CNS, ASITN, and a coalition of other medical societies, developed the recently approved CPT codes necessary to ensure that intracranial angioplasty and/or stenting will become available treatment options for certain patients with ICAD.

The results of the Wingspan clinical study and numerous publications on intracranial angioplasty and stenting show that intracranial angioplasty with or without stenting is a reasonable and necessary approach in the medically unresponsive ICAD population with > 50% stenosis.

Clinical Evidence Supports Medicare Coverage

Due to the lack of other viable treatment alternatives, the significant risks of stroke and death associated with not providing treatment, and the proven benefit of angioplasty and/or stenting in this patient population, we ask that the Centers for Medicare & Medicaid Services (CMS) remove the economic hardship on patients and hospitals by providing the following:

We hope that CMS will grant our request for coverage so that Medicare patients, who have limited treatment options, will have access to this life-saving technology as soon as possible. We thank you for your consideration of this critical health policy issue.

Sincerely,

Donald O. Quest, MD, President
Richard G. Ellenbogen, MD, President
American Association of Neurological Surgeons
Congress of Neurological Surgeons Gary M. Nesbit, MD, President
American Society of Interventional and Therapeutic Neuroradiology Staff Contact
Catherine Jeakle Hill
Senior Manager for Regulatory Affairs
AANS/CNS Washington Office
725 15th Street, NW
Suite 800
Washington, DC 20005
Office: 202-628-2072
Fax: 202-628-5264
Email: chill@neurosurgery.org
Marie Williams
Executive Director
American Society of Interventional & Therapeutic
Neuroradiology
3975 Fair Ridge Drive, Suite 400 North
Fairfax, Virginia 22033
703-691-2272 phone
703-691-1855 fax
Email: williams@asitn.org

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I am a Neuro Interventionalist in Tacoma, WA and will be unable to offer my patients a treatment option when they have failed medical therapy. The limited ruling allowing for IDE coverage only will truly limit this patient population to a treatment that could prevent a secondary major stroke. The inability to offer the Wingspan Stent to this group of patients will only decrease the quality of life when this group of patients has a major stroke that could have been prevented with this treatment option. I hope for the patients sake you review and cover use of this device.

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I would strongly encourage extended coverage by CMS for this critical patient population that has failed medical therapy and is truly out of options without the Wingspan Stent coverage policy. I practice at the University of Washington and Harborview in Seattle and see a small subset of patients that have failed medical therapy and until the Wingspan Stent became available often times progressed to a devastating stroke that can now be prevented with this stent system. By limiting coverage this will put a segment of the population at risk for a stroke that could put these patients in long term care facilities that will be a much greater burden on the system then the stent alone.

Please reconsider your policy ruling and allow for CMS coverage with this system that will prevent patients from quality of life ending strokes.

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We are a high volume stroke center and make the commitment to 24/7 coverage for the entire region surrounding Kansas City. We serve all patients regardless of their ability to pay. We have 15 patients with critical intracranial arterial stenosis who have failed medical therapy awaiting this treatment. They all have a significant risk of stroke within the next year. They range in age from 35 to 85. Without hope of reimbursement, we cannot possible address this need and it is likely several will have life threatening or disabling strokes resulting in far more pay out in health care dollars. Please reconsider the ruling.
MMRymer, MD
Mid America Brain and Stroke Institute

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The high recurrent stroke and death rates in medically treated patients with intracranial stenosis highlights the inportance of developing newer treatment modalities for this condition. With the current clinical studies performed it has been demostrated that intracranial stenting can be performed with acceptable risk of periprocedural stroke and death in patients with intracranial atherosclerosis. This procedure should bereimbursable for symptomatic patients with >50% stenosis who have failed medical therapy

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As a neurointerventional neurosurgeon deeply involved in the care of patients suffering with devastating cerebrovascular disease, I request that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication. This includes patients that have hemodynamically significant intracranial arterial stenosis who have suffered a stroke in the distribution of the stenotic artery or patients with intermittent neurological deficits in that vascular distribution that fail to resolve with maximal medical management.

I kindly request that you extend coverage to the above population. In addition I highly support the CMS recommendation for national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial, to truly determine in a randomized prospective trial the efficacy of intracranial angioplasty and stent treatment for this highly vulnerable patient population.

CMS's current coverage review for the Wingspan® Stent System reflects a rigid application of the "reasonable and necessary" test in making national coverage policy. The "reasonable and necessary" standard should be less stringent in cases of HDE devices where there are no other viable treatments. The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

While the detailed review of evidence cited many relevant studies, I want to emphasize that CMS's clinical review did not address the high risk patients identified in the WASID study. (Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Study According to this randomized prospective study of 569 patients, the risk of recurrent stroke at 1-year for a patient with greater than or equal to 70% intracranial stenosis are 23% while on medical therapy. Kasner SE, Chimowitz MI, Lynn MJ et al. Predictors of Ischemic Stroke in the Territory of a Symptomatic Intracranial Arterial Stenosis. Circulation. 2006; 113:555-563). Nor was the data reviewed from another prospective trial of the natural history in these patients considered: Groupe d'Etude des Sténoses Intra- Crâniennes Athéromateuses Symptomatiques (GESICA) Study. This prospective, multi-center cohort study of 102 patients showed that despite medical treatment, the two-year rate of recurrent ischemic events in the territory of the stenotic artery was 38.2%. Mazighi M et al. Prospective study of symptomatic atherothrombotic intracranial stenoses. Neurology. 2006;66:1887-1191. Additionally a less robust but still important study needs to be included in the natural history data that I would request be considered in comparing the natural history to the potential risk. In this retrospective cohort study of 52 patients, among patients who failed antithrombotic therapy, the subsequent rate of stroke or death was 45% per year, with median time to recurrent event or death at 36 days. Thijs VN, Albers GW. Symptomatic intracranial atherosclerosis: outcome of patients who fail antithrombotic therapy. Neurology. 2000;55:490-7

The above cited studies, while not definitive, certainly serve to reinforce clinician’s impression that this patient subgroup has a devastating result with the current state-of-art medical management. Looking at the support data submitted to the FDA that resulted in the HDE approval of the Wingspan® Stent System with Gateway™ PTA Balloon Catheter in treated patients there was composite ipsilateral stroke or death rates of 6.7 (3/44) at 30-days and 11% (5/43) at six months with no symptomatic restenosis at six months. The impact that the current proposed rule would have if implemented into a final decision would be enormous. Current clinical practice includes the use of intracranial angioplasty and stent placement in the above stated clinical population. The impact on hospital resources asked to absorb the cost of this complex technology will ultimately result in significantly limited patient access.

Our Kentucky Legislature Adopted Resolution SR 211 on March 14, 2006: A RESOLUTION urging the development of a statewide system of stroke care. I am greatly concerned that the proposed CMS coverage decision, if made permanent, would substantially decrease for those of us in the front line our ability to offer all possible avenues of treatment for our most affected patients.

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Stroke is the leading cause of disability in the United States and affects over 750,000 patients yearly, at a cost of over $50 billion. Intracranial atherosclerosis is more common in Asian patients, Hispanics, and African Americans. We need to have a means of treating those patients with refractory symptoms of intracranial disease with angioplasty and stenting procedures to hopefully avoid long term disability from stroke. The use of the wingspan deviced and other dvices have been shown to be safe and should be allowed in the treatment of patients who are at high risk.

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I am very concerned about the CMS recommendation to only provide coverage for the Wingspan Intracranial Stent and Gateway PTA Balloon when used in an IDE trial. Intracranial atherosclerotid disease can have devastating consequences for patients, and standard medical care is generally ineffective. I, along with other physicians treating these patients over the years have often been forced to resort to off-label usage of other devices and medical treatments prior to the introduction of the Wingspan system, in order to prevent life-theatening stroke. The Wingspan system is by far an easier and safer solution for these patients. The CMS decision will no doubt pressure many physicians to deny patients the option of the Winspan system or to use coronary stent systems off-label, which can be ineffective or dangerous for intracranial applications. I am fully supportive of prospective trials to better understand the results of using this system compared to other treatments, but I fear that patients will suffer if they are forced to endure ineffective or dangerous treatments in the meantime, due to the the lack of reimbursement for the Wingspan. It is also a tragic fact that minorities such as African-Americans and Hispanics, as well as generally people without the financial means to pay for these treatments themselves are the most susceptible to this particular disease, and will not be able to afford to pay for this potentially life-saving treatment. I strongly urge that this decision be reconsidered so that physicians may be allowed to offer some hope of treatment for these patients.

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Patients with coronary atherosclerotic disease have a minimally invasive angioplasty and stenting option with CMS coverage. Patients with symptomatic carotid stenosis have a stenting alternative. Patients with peripheral vascular occlusive disease have a stenting option. However, patients with symptomatic intracranial stenosis do not have this treatment alternative with the CMS currently, except under IDE trial. The number of patients that have access to trials are few (limited number of centers), but the number of patients who need this treatment is great. What makes matters worse is that there is no surgical alternative for these patients either. Cerebral artery endarterectomy is hazardous and EC-IC bypass had not been shown to be beneficial in these patients. Yet the natural history for symptomatic cerebral atherosclerotic disease is TERRIBLE with medical therapy. Even the WASID trial has shown that medical alternatives such as warfarin are no better than aspirin. With any medical therapy trialed thusfar the one year recurrent stroke rate is approximately 10-20%, depending on the study subset.

The ASITN (National Neurointerventional Society) has recommended in their position statement, that intracranial angioplasty and stenting be considered for CMS coverage due to this terrible natural history, now that a safe, FDA approved stent is available for intracranial stenting (Wingspan). Most of the studies on intracranial angioplasty and stenting: SYLLVIA, Mori, Lylyk, etc. have all been done with stiffer, more dangerous coronary artery stainless steel stents. I can tell you from using it, that the Wingspan stent and upcoming newer generation intracranial stents from other companies are much safer, due to there flexible design and nitinol structure.

I strongly urge the CMS committee to revise their coverage decision to cover all patients with symptomatic intracranial stenosis >50% that is refractory to medical therapy. This is what I would want if I or my family member were a patient. And I think this is what the CMS committee member with a stroke or TIA due to atherosclerotic disease would want too.

It is inconceivable to me that stents in every other vascular territory of the body are covered by CMS (where there are welll established good surgical alternatives), but not in the brain (where there is no surgical alternative for patients refractory to medical therapy).

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I am writing in support of a positive coverage decision by the Center for Medicare and Medicaid Services with regard to intracranial angioplasty with stenting in the appropriate clinical setting. Intracranial stenosis has been shown to be a significant etiology of stroke, approximately 8-10% of all ischemic strokes. The WASID trial and other studies have demonstrated that medical therapy is inadequate in many cases, with up to 24% of patients acquiring another stroke in the year following their initial stroke. Besides atheroembolic events, these patients can be subject to ischemic symptoms from normal variations in blood pressure if leptomeningeal or other collateral circulation is not well developed.

According to Abou-Chebl et al., Stroke 2005;36(12):e165-8., Henkes et al., Neuroradiology 2005;47(3):222-8., Kim et al, AJNR Am J Neuroradiol 2005;26:1381-1388 and the FDA’s Wingspan Summary of Safety and Probable Benefit in 2004, intracranial angioplasty with stenting has been shown to improve the outcomes of patients, certainly in patients with greater than 50% stenosis who have failed medical therapy. The ASITN and ASNR, after reviewing the literature objectively, have also made statements in favor of intracranial angioplasty and stenting in the appropriate clinical setting. Considering the clinical data gathered to date, intracranial angioplasty and stenting is a necessary treatment in the appropriate clinical setting, and will continue to be performed at capable institutions regardless of the CMS decision. It is only fair that these institutions should not bear the cost of such lifesaving measures.

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Abiomed appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) recent proposed decision memorandum involving intracranial stenting and angioplasty (CAG-00085R2). Our comments will not focus on the merits of the proposed coverage decision per se, but rather the approach taken by CMS to cover a humanitarian device.

Abiomed ABIOMED, Inc. develops, manufactures and markets medical technology designed to restore, recover or replace the pumping function of the failing heart. Established in 1981, ABIOMED is committed to putting patients first by providing a range of therapeutic medical devices aimed atsupporting patients through acute heart failure and if necessary, through the final stages of life. The company’s AbioCor® Implantable Replacement Heart received approval from the Food and Drug Administration (“FDA”) as an HDE (“humanitarian device exemption”) less than one week ago. The device is the first totally implantable replacement organ brought to market and one of a handful of devices granted HDE status.

As CMS is aware, HDE technologies such as the intracranial stent and AbioCor involve treatments for small numbers of individuals with no other viable treatment options. In fact, these technologies represent the most advanced of the advanced medical technologies. Regardless of other innovations, HDEs are unique in their applicability and potential utilization because of the selective, well defined patient populations for which they are designed. Without access to these devices, patients with treatable conditions will have virtually no other known treatment course with any proven results.

Congress and the FDA have explicitly encouraged the development and furtherance of HDE devices by providing a clear regulation pathway to market. Abiomed is concerned that given the opportunity to design a coverage policy for HDE devices, CMS has refused to do so with the proposed coverage decision for the intracranial stent. While the solution to provide reimbursement of the stent through a clinical trial is laudable, the larger question of the appropriate “bar” by which HDE devices will be considered for coverage remains unanswered. Given their limited use and narrow patient population, Abiomed believes a “reasonable and necessary” standard may not be the best approach and would strongly encourage CMS to provide guidance as to a reasonable standard by which HDE’s can be reviewed for coverage. Otherwise, HDEs by their very nature and definition, will continue to fall short of the evidentiary requirements for a national coverage decision.

We encourage CMS to work closely with Abiomed and other companies who have an HDE device or one soon to be designed, for input and further recommendations as to a reasonable standard for coverage.

Sincerely,

Gwen Mayes, JD, MMSc
Director of Government Relations and
Reimbursement
Abiomed, Inc.
gmayes@abiomed.com
978-821-4662

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I am a neurointerventionist working at Washington Hospital Center in Washington, D.C. I am wrting to request reversal of the CMS non-coverage policy for intracranial angioplasty and stenting using the humanitarian use device: the Wingspan Stent System with Gateway PTA Balloon Catheter.

The non-coverage policy directly put financial constrains on my institution, and other institutions, leading to restriction in the utilization of this potentially life-saving procedure. Many, if not all, physicians commenting on this issue have expressed their concerns about the bottomline patient care.

In addition to the impediment of patient care, the non-coverage policy is also detrimental to medical research. If a medical breakthrough is not appreciated or rewarded, nobody will spent the effort on medical invention. Why the medical industry should invest the R&D if there is zero financial incentive? Therefore, this non-coverage policy not just affect this particular procedure, it has deeper impact upon medical research as a whole.

Thank you for your attention to this urgent and important health care issue.

Sincerely,

Ai-Hsi ("I-C") Liu, M.D.

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I am writing to request that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the use of the Wingspan stent and gateway balloon under the current HDE indication. Intracranial stenosis is a common cause of acute stroke. The natural history of intracranial stenosis > 70% is exceptionally poor despite maximal medical therapy. Prevention of acute stroke due to intracranial stenosis would save taxpayers a huge expense, particularly as the population ages. Experience with the wingspan stent has demonstrated both safety and efficacy. Therefore, CMS should grant coverage for this stent and balloon dilation system to reduce the burden on an overly taxed medical system. Also, CMS should provide coverage for intracranial angioplasty for vasospasm due to the plethora of literature which demonstrates effectiveness and safety.

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The ability to treat patients with intracranial atheromatous disease has been one of the major unsolved problems in the treatment of stroke. Until the Wingspan system became available for physician use, there was no safe and effective device that could be safely delivered to the brain and open these severely narrowed arteries. Unless CMS allows coverage for this device and treatment, physicians will just be left watching most of their patients develop severe brain strokes that otherwise could have been prevented. There is now sufficient experience with this device to support its use in the setting described by the IFU for the device.

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I would like to begin by stating that it is quite encouraging that CMS give consideration for reimbursement for intracranial angioplasty and stenting. Though the decision to approve reimbursement for the use of this technology in the setting of IDE trials demonstrates that there is a lack of randomized evidence-based data to support intracranial angioplasty and stenting, this does not mean that the technology may have a role in a very specific population. By limiting the availability of this technology, my concern is that those patients who have no other options (i.e. refractory to all other available means of treatment)may be denied the one chance at changing the natural history of their disease. After all, isn't that why the HDE exists? Perhaps allowing internal hospital registries and third-party registries as "pilot" evidence for future studies should be considered as appropriate for reimbursement for a brief time period. Thereafter, reimbursement for the procedure can be reassessed.

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I would like to request that CMS reconsider their stance on disallowing reimbursement for the intracranial and vertebral stenting. The societies that you have quoted in your Proposed Decision Memo, I'm sure, has submitted documentation that supports evidence that these stenting systems and procdures do in fact benefit the patient in both the short and long term. Working in an acedemic facility, we tend to see and treat patients that are of a higher risk factor than most hospitals. Many of the patients receiving these procedures are transferred here from other facilities because they can not perform the service. Not allowing reimbursement puts an additional financial burden not only on the hospitals (because they have to pay for the high dollar stents), physicians (because of the time it takes to perform these services and can not see or treat other patients which also creates a higher risk of liability), but eventually the patient (because Medicare does not allow the service and we obtain ABN's and make the patient responsible for the charges incurred). This is a procedure that benefits the patient and CMS all around; the patient does not have to come back in for additonal services because they received an inferior procedure (because they could not afford to pay for this) and Medicare does not have to pay for the additonal services either. By not covering these stenting systems and procedures, CMS is creating a ripple effect with other insurance companies that tend to follow CMS guidelines in what they will cover. So, not only are you effecting the elderly and indigent population, you are effecting all ages of patients from all walks of life. I strongly incourage you to reconsider your position on these services.

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I disagree with this decision, the government agencies should communicate better with one another. We have an approved device and no reimbursement. This is forcing physicians to use devices off label. Wingspan provides an option to treat patients who have failed medical management and have no other treatment options. As pointed out in the Boston Scientific response, Wingspan and Gateway already show superior results to Warfarin. This puts an undo burden on the physicians and hospitals.

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As a neurosurgeon with cerebrovascular and endovascular specialization, I have studied, witnessed and provided the therapeutic options available to patients with intracranial atherosclerotic disease (ICAD). Up to this point, I have achieved some satisfaction knowing that I have provided the best available therapy to those patients in need. This is, of course, despite my disappointment when recurrent or worsening symptoms occur. This incidence of symptom recurrence and further morbidity that is intimately associated with ICAD has been well documented by my colleagues in previous comments.

My biggest concern in reviewing the recent decision by the CMS was that I could no longer provide the best available therapy for my patients. This is primarily a result of the significant financial burden placed on my hospital system and patients by the national non-coverage decision that will likely serve as a framework for private insurance to follow. This could be compounded by current CMS policy that could place payment for a stroke-related admissions at jeopardy if a Wingspan stent is placed during the same admission [1].

In a review of the comments that have been previously posted, it seems there is a general desire for the approval of the Wingspan Stent System with " Gateway PTA Balloon catheter for angioplasty and stenting "for patients with intracranial stenosis of "greater than or equal to 50% that are symptomatic "while on appropriate medical therapy. Additionally, most comments support the coverage for intracranial angioplasty and" stenting within the context of Category B" investigational device exemption (IDE) trials. Although I see the logic in the few dissentions presented, I agree with the sound rationale of the many other experienced practitioners who support this approach and, thus, lend my support along with the caveat below.

From an editorial standpoint, I would emphasize the need to step away from the politics of this issue to allow a sound financial and salubrious result from this deliberation. Like my colleague G. Lee Pride, I implore the CMS committee to consider appropriate subsets of patients (i.e. >75% asymptomatic stenosis and >50% symptomatic basilar artery lesions prior to medical therapy) that may be adversely affected by a global decision on this problem.

Thank you for the opportunity to provide input.

Sincerely,
Babu G. Welch
Assistant Professor of Neurosurgery
UT Southwestern Medical Center
Dallas, Texas

[1] Medicare Benefit Policy Manual. Chapter 120 "Services Related to and Required as a Result of Services Which are Not Covered Under Medicare", pages 31 -32.

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CMS's decision regarding intracranial angioplasty and stenting is taking a step backwards towards medical options for patients that would benefit from this. Coverage for the Wingspan Stent System is very critical in regards to giving patients access to treatment options for their condition. Sufficient evidence exists to support that the "reasonable and necessary" standard is being far too stringent if it is going to eliminate this as a medical option. For many of these patients, there is no other viable option for treatment. Several studies have proven that intracranial angioplasty, with or without stenting, can be safely performed, with the end result being drastic improvement in the patient stroke and death rate when compared to the rates of those treated with medical therapy for the same condition. There is a huge community of people that would fit into the category of needing the Wingspan, with many having little or no options otherwise. With studies supporting the use of this device, and with such promising clinical results in follow up care, I sincerely hope that CMS will retract their previous decision, and allow the medical community to offer this as a service to the patients.

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Dear CMS,

I extend this comment to you in order to express my opinion on your proposed coverage decision regarding intracranial angioplasty and stenting.After reviewing the proposed decision, I am very disappointed.

Intracranial stenting and angioplasty provide a method to decrease stroke risk in patients who have failed anticoagulation and antithrombotic therapies. There is no good alternative treatment for this population of patients, and the cost associated with this procedure would represent an overwhelming financial burden for both the patient and the treating institution.

I hereby request that you reconsider the proposed coverage policy.

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This message is being sent on behalf of Dr. Varoujan Kostanian, Department of Radiological Sciences, University of California Irvine.

The Wingspan Stent System represents an important advancement in the prevention and treatment of ischemic stroke. The fact coverage would still be denied for patients treated with this technology that fall within the FDA approved HDE indication is disappointing. Many times this is the last option for this patient population. The cost associated with this procedure for both the hospital and patient represents a significant financial burden.

I would strongly urge CMS to extend coverage for this patient population.

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This message is being sent on behalf of Dr. Fong Tsai, Chairman, Department of Radiological Sciences, University of California Irvine.

The Wingspan Stent System represents an important advancement in the prevention and treatment of ischemic stroke. The fact coverage would still be denied for patients treated with this technology that fall within the FDA approved HDE indication is disappointing. Many times this is the last option for this patient population. The cost associated with this procedure for both the hospital and patient represents a significant financial burden.

I would strongly urge CMS to extend coverage for this patient population.

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I work at UCI Medical Center and I deal with coding and reimbursement. After reviewing the CMS decision on reimbursement for intracranial stenting and angioplasty I am more than just disappointed. This proposal as outlined is not nearly enough. I urge CMS to reconsider this coverage decision to include the HDE population consistant with the FDA approved HDE indication. Not to mention the significant financial burden for not only the facitilty but the patient as well. It is my understanding that there is no alternative treatment option once the patient has failed medical therapy.

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The recent release of a dedicated intrcranial stent system has been a great advancement in the fight against symptomatic intracranial atheroscleosis. This patient subset has a disease that has a terrible natural history with few alternatives. These patients have already failed medical therapy and the only remaining option has been coronary devices which are difficult to utilize for this purpose and have a much higher potential for morbidity. I sincerely hope that you reconsider reimbursement for treatment of symptomatic intracranial stenosis with the Wingspan stent. Preliminary data with this device has already shown an improved success rate and short term outcomes over coronary devices.

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i see plenty of patients in my hospital in whom they have had TIAs or a CVA despite maximal medical therapy and have >50% intracranial stenosis in the vessel that irrigates the territory of the neurologic event and am unable to perform an intracranial angioplasty/stent because the hospital forbids it on reimbursemnt grounds. This is a procedure with very tight indications that when properly used can drastically change an individual's life. Please expand the coverage to those symptomatic individuals refractory to maximal medical management.

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“NCA for Intracranial Stenting and Angioplasty (CAG-00085R2)”

I have worked in the field of Interventional Neuroradiology for @ 15 years and been witness to the developement of several new innovative products for treatment of vascular disease. The Wingspan manufactured by Boston Scientific for the treatment of Carotid disease is a product we are anxiously waiting to use. It is the next step in successful treatment of patients with symptomatic narrowing of the carotid arteries. It is extremely important to get this kind of product into the hands of capable physicians as quickly as possible in order to improve the quality of care that they deliver. Thank you for your attention to this matter.

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I am a diagnostic neuroradiology fellow at the Massachusetts General Hospital in Boston. At Mass General we have a large stroke population and have aggressively treated stroke using intravenous and intra-arterial methods. I have helped put togther—as a fellow—many multidisciplinary conferences involving interventional neuroradiology/neuroradiology/stroke neurology/and neurosurgery. The staff spend quite a bit of time discussing appropriate treatments for the various patients. I have been part of the acute treatment of stroke. I think it would be prudent for CMS to allow treatment of symptomatic patients as they crescendo rather than after they develop a large infarct. Thank you for allowing me to make this comment.

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As the clinical nurse coordinator of the neuro-interventional radiology department@ Baylor University Medical Center in Dallas TX. I respectfully request that CMS re-think and expand it's reimbursement coverage for the treatment of ICAD using the Wingspan-Gateway System. Based on the fact that the WASID trial has shown that patients with a greater than 70% stenosis have at least a 25% chance of having a stroke within 1 year, and the fact that the Wingspan-Gateway System is FDA approved for patients that are REFRACTORY to medical therapy, meaning they have no other clinical option, we believe it is in the best interest of the patient that they be treated via angioplasty and stenting. Reimbursement from CMS should be provided at the very least for that subset of patients.

Respectfully,
Elizabeth Broyles RN

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I am the executive administrative assistant for the Interventional Neuroradiology Service at the Massachusetts General Hospital.

I have firsthand experience dealing with carotid registries and studies. The CMS ruling on carotids has made it very difficult for patients that have been seen by three services (interventional, neurology and surgery) and referred by all three for stenting to be treated in a timely fashion. I take the frustrated phone calls from patients and families wondering why they are denied access because of the need to be on a study.

I am very concerned that the patients that would need treatment the most, the patients at high risk for stroke will be put through the same type of thing with the new CMS policy on intracranial atherosclerotic disease.

Based on my personal experience dealing with patients in a similar model (carotid stents) I respectfully request that CMS amend its position to be more broadly inclusive.

That you for allowing people like me to submit comments to this website.

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I have been a nurse for over 25 years. I have been involved in neuroendovascular procedures for the last six years at the Massachusetts General Hospital.

I am concerned that the recent ruling by CMS will limit the use of neuroendovascular stents in the treatment of intracranial atherosclerotic disease. Patients that would likely benefit may be denied access to these therapies.

Stroke is a horrible disease and we should reach for opportunities to prevent people from suffering it ravages.

Thank you for the opportunity to make this comment.

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I am an interventional neuroradiology fellow at the Massachusetts General Hospital. In my previous capacity as a diagnostic neuroradiologist, I saw the ravages of stroke on patient's films. Now, I see it first hand in patients.

I believe that CMS should amend its decision expiditiously to allow broader coverage of ICAD treatment with Wingspan.

It is clear from the WASID data that there are significant limitations in the medical treatment of ICAD.

To deny care to patients because of a CMS policy seems unfair. I respectfully request the policy to be amended to allow broader coverage of ICAD.

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I am writing to request that CMS provide reimbursement for ischemic stroke patients with intracranial atherosclerosis who have failed best available medical therapy and need access to angioplasty or angioplasty/stenting. As that available technology is already FDA HDE approved, the current proposal to limit reimbursement to only patients in an IDE trial would limit access to many patients that have no other options. This would place undue burden on our UCSF patients, or more likely, simply limit access for many patients who could benefit from this therapy.

Thanks you for your consideration.

Joey English MD PhD
Assistant Professor, UCSF
Neurovascular and Neurocritical Care

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Our hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication. The FDA has recognized this as an HDE device, which has helped make this device accesible to more patients. The Wingspan® Stent System with Gateway™ PTA Balloon Catheter isindicated for patients with intracranial atherosclerotic disease who are refractory to medical therapy. This is a very small percentage of the total population, but it is the only treatment available for these patients. If this HDE device is not covered by Medicare, we, as a hospital, are forced to either absorb the cost or pass the cost on to the patient. This will definitely act as a barrier to patient access for this device and it will make it that much harder to further prove the device's effectiveness. In addition, if patient's decide not to get the treatment, because they cannot afford to pay for it, they may go on to have a stroke and incur an estimated $140,000 in lifetime care costs. These costs would be shared by CMS and the patient.

Thank you for your time and consideration of this proposal.

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On behalf of the Neurointerventional faculty at the University of Virginia, I am requesting that CMS grant national coverage for intracranial angioplasty and stenting cases involving the Wingspan Stent under its current HDE status. I forsee this device being an important part of our treatment for ICAD and hopethat CMS covers it accordingly. Up to now, there has never been an appropriate device for this disease, and I believe that this device is a very important addition to our armamentarium.

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I direct the division of neuroradiology at Montefiore Medical Center, and have worked in the field of neuroradiology for over 20 years.

For the patient population at risk for acute stroke from intracranial stenosis, there is no alternative treatment to the Wingspan Stent that is as effective, as minimally invasive, and as safe with respect to vascular complications.

The days and dollars lost due to devastating intracranial strokes are on a different scale exponentially, compared with the cost of reimbursement.

Limiting reimbursement to select populations served by select centers is an injustice to the populations at greatest risk for stroke: the elderly, hypertensives, diabetics, hyperlipidemic and obese populations. Only national Medicare coverage for the Wingspan Stent System with Gateway PTA Balloon Catheter will bring appropriate preventive treatment to a population heading down a road of disabity and dollars disaster. The Wasid study addresses this important population at high risk (Circulation 2006 vol 113) Additional studies have appeared in Neurology vols 55:490 and 66: 1187 providing both retrospective and prospectivedata respectively.

Existing and proposed coverage will severely affect access to treatment for a high risk group of patients, who will impose even higher costs on our healthcare system if they are destined to survive infarctions which might have been prevented.

At no other time other than the discovery of antibiotics and insulin would so little (in investment on your part) contribute so much to the health and well being and actually alter the survival of so many.

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Dear CMS,

As a physician who treats patients with complicated neurovascular disease, and who has some publications in this realm, I do come across patients who have failed medical therapy for intracranial atherosclerosis and whom we recommend for stenting. I am not in favor of treating patients with stents primarily, but I am in favor of providing stenting therapy to these refractory patients. I understand that CMS is undergoing consideration of reimbursement for intracranial stenting and I appeal to the panel to allow this with the restriction to failed medical therapy. Similar to carotid stenting, I think that reimbursement should be linked to physician validation that of specific circumstance. I am not in favor of physicians stenting asymptomatic disease or not following best medical therapy first as I think this is not proper utilization of resources; I do however believe this is an appropriate therapy for patients in whom primary and secondary medical prevention therapy has failed. I am happy to provide any additional comment if you feel this is of value.

Sincerely,
Wade Smith, MD, PhD
Professor of Neurology
UCSF

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To whom it may concern: Cerebral vascular stenosis remains a common cause of stroke and disability in the United States. While cerebral PTA does provide immediate arterial caliber improvement, its durability remains in question. Angioplasty alone is also innapropriate for certain disease processes. Because of these reasons, I recommend approval of stenting in addition to angioplasty. This treatment methodology is well proven in other organ systems (cardiac, carotid), and a CMS non coverage determination will severely limit its access to the patient population who needs it the most.As a neurosurgeon, i request that you provide coverage for this needed treatment modality

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I ask CMS to reconsider its proposed decision and provide reimbursement for stroke patients who have failed medical therapy and need access to angioplasty or angioplasty/stenting. With technology that is currently FDA HDE approved, the current proposal to limit reimbursement to just patients in an IDE trial would limit access to many patients that have no other options.

The natural history of intracranial atherosclerosis is very poor with strictly medical management. Despite aspirin and similar medications, many of these patients go on to have devastating strokes that are a huge personal and societal burden. Intracranial angioplasty seems to be an attractive option for some of these patients. It really ought to be covered.

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Dear Sir,

The preliminary decision on reimbursement of intracranial angioplasty and stenting is quite disappointing.

Intracranial atherosclerosis is a steadily growing problem and we are seeing more and more patients with this entity. Unfortunately, when the medical management is failing, these patients do not have many other options. We have had some gratifying results from intracranial angioplasty and stenting in such patients. Endovascular treatment in such situations is often lifesaving and required.

I therefore think and request that this decision be reconsidered and reversed.

Thank you,

Dheeraj Gandhi MD

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Patients treated with technologies granted humanitarian use device (HUD) designations and humanitarian device exemptions (HDEs) from the FDA do not have other treatment options. Currently, there is no set policy for determination of coverage on a national level and this left to the discretion of a local coverage determination (LCD). And indeed, in the majority of cases in the past, devices approved under HDE status have received coverage. One way of viewing this policy is that it maintains the individualized clinical decision-making in the context of the physician- patient relationship and allows for flexible evidence-based decision-making that enables Medicare contractors to use mechanisms that many private payers use to allow appropriate access to new technologies without granting unrestricted coverage. Although true, I would also suggest this underscores the ambiguity inherent in the reembursement process. The National Coverage Decision (NCD) on Clinical Trials (now called the "Clinical Research Policy") has problems which are well elucidated in the comments on the Clinical Trial Policy Reconsideration (CAG-00071R). The decision to approve the Wingspan device under an HDE but apply the previous NCD from March, 2005 is another specific example of these problems.

I strongly urge CMS to continue to support research and innovation for rare "orphan" diseases by covering the costs of services/items used in HUD clinical trials AND technologies granted HDE approval by the FDA. Denying coverage of devices with HDE status: (1) Places barriers to bringing innovative new technologies to market and (2) Creates either a barrier to access or a burden of expense for Medicare patients requiring treatment.

An HUD device is intended for unique, difficult-to-study populations where applying strict standards of evidence generation is not reasonable and therefore determination of coverage based on these standards does not seem reasonable. More appropriately, coverage should be extended to all patients receiving care in association with an HDE/HUD device as a policy, rather than applying a NCD which defeats the purpose of having the Humanitarian exemption.

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RE:NCA-Intracranial Stenting and Angioplasty CAG-00085R2)

We at Mount Sinai Hospital are writing to request revision to the recent CMS ruling regarding coverage for stenting and/or angioplasty for patients with symptomatic intracranial atherosclerotic disease (ICAD) who continue to have symptoms despite being on adequate medical amnagement. This ruling would affect patients treated with the Humanitarian Use Devices: Wingspan™ Stent System and Gateway™ PTA Balloon Catheter.

Current data indicates that angioplasty/stenting with the Wingspan/Gateway system is likely safer than other available methods for the invasive treatment of intracranial atheromatous lesions. In addition, it is likely to be superior to medical therapy for selected patients. CMS's policy would limit access for medically refractory patients with symptomatic intracranial atherosclerotic disease and the natural history of this disease process on medical therapy is dismal.

In order for stroke physicians to provide what most agree is a very promising treatment intervention for the prevention of stroke in a very high risk population (i.e. symptomatic ICAD), I urge you to expand the national Medicare coverage of stent-assisted angioplasty of cerebral arteries, to include the FDA- approved HDE indications for the Wingspan system.

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Since stroke is the leading cause of disability in the United States and affects over 700,000 patients yearly, with a high incidence of medically-refractory intracranial stenoses as etiology, it is reasonable to consider intracranial stenting for a select group of patients who are, from the clinical standpoint, more likely to develop recurrent severe strokes despite maximal medical therapy. Since recurrence is not only a TIA but may represent a disabling and fatal stroke, the current reimbursement strategies are unlikely to benefit the American population at large. In addition, newer stents, such as the Wingspan, due to its higher radial force, are more likely to reduce recurrences on the long-run than most of the old available stents. Any of those patients may represent one of our dearly known friends, family members and were us to try our best to help them, intracranial stenting and angioplasty are here to stay and will, most likely be part of the treatment for any of our patients. I think that, from the clinical standpoint, it is crucial that our current reimbursement policies better represent the critical population of patients we're trying to help. Not only trials will justify what the neurointerventional community is doing by default in our urge to address conflicting problems in our everyday practices.

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I have worked as a technologist for over a decade centered in two institutions. Both institution, while having different flavors dealt with many neurovascular patients. I am currently the operations manager for the Interventional Neuroradiology service at the Massachusetts General Hospital.

What has been constant through both of these practices is the care that goes into thinking about each and every one of the neurovascular patients. I am very concerned that our experience with CAS will be repeated. Access will be denied to deserving patients on the basis of lack of CMS coverage.

Being responsible to the hospital, I can share with you specifically that the CMS policy makes treatment with CAS unavailable to many patients because we can't bring the patients through the door. The doctors willingness to forego their fee does not affect the non-coverage decision. I believe this experience should not be repeated in the intracranial circulation.

Thank you for allowing me to make these comments.

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My name is Kim Carvalho. I am the technical manager for the interventional neuroradiology service at Massachusetts General Hospital. In that capacity I work with our INR specialists including Dr. Hirsch, Pryor, Rabinov and Nogueira. Unique in this practice amongst other practices in our department is that the doctors are from all of the neurologic disciplines. I am very impressed that patients are given the best opportunity to maximize non-interventional care with careful selection applied to each individual patient. I have had the opportunity in my capacity to be at regional meetings of the INR community and I am very impressed that these characteristics of caring for their patients are present throughout the broader aspect of the field. I would encourage CMS to broadly support endovascular therapy for intracranial atherosclerotic disease.

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To whom it may concern, I would like to request that CMS grant national Medicare coverage for intracranial angioplasty and intracranial stenting cases, At University of Michigan we have found that there are many patients who could benefit from this type of procedure. However, the issue of non coverage has prevented these patients from even hearing about this treatment option. All of the procedural cases where we have utilized intracranial stenting were in patients who had received maximal medical therapy and were faced with a high possibility of an impending stroke. These patients have no other option. I would appreciate your consideration of this matter.

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I have been an Interventional Radiology nurse for over 15 years, and have seen an incredible amount of medical breakthroughs in this profession.

I feel that the more profound advances have been in the Neurointerventional Radiology Dept. We are now dealing with stroke patients like the Cardiology Dept deals with heart attack patients. The Wingspan Stent is one of these medical advances that will increase productive life expectancies of patients that had no other options. It is a product that will continue to evolve and grow. The Wingspan Stent is to Neurosurgery and Neuroradiology, as the carotid stents are to Thoracic surgery and Cardiology.

Medicine needs to continually advance, and with this stent, it is definately moving in the right direction. For these reasons, I feel that these products should be recognized immediately.

Thank you for your time.

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Thank you for the opportunity to comment on the recent decision regarding Wingspan for intracranial atherosclerotic disease. I am the director of Vascular and Interventional Radiology at the Massachusetts General Hospital. I work closely with my NeuroInterventional Colleagues. I have been very involved at a seminal level in the world of carotid and other vessel stenting. In Europe, I was involved in the development and use of the only covered intracranial stent. I believe that the experience with CAS, which has limited access to patients who would clearly benefit from the procedure, should not be repeated in the intracranial vasculature.

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I request that CMS grant national Medicare coverage to intracaranial stenting and angioplasty cases using the Wingspan stenting system under the current Humanitarian Device Exception (HDE)labeled indication.

As a healthcare professional with over 20 years in the treatment of patients following CVA, I have seen the devastating effects that such an insult can have on individuals and on their loved ones. In the field of Speech Language Pathology, we work with those patients who lose the ability to effectively communicate, and sometimes the ability to communicate at all, due to CVA's. The approval of coverage for intracranial stenting will allow Medicare recipients to receive a treatment that can potentially free them from the loss of communication, and thus the loss of quality of life.

I strongly encourage you to consider this request and grant national Medicare coverage for Intracranial Stenting and Angioplasty.

Thank you for your attention to this important issue.

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Dear CMS committee members,

I found the discussion of the CMS coverage policy posted on the web to be very thoughtful. I believe the proposed coverage policy is overly restrictive and that this will lead to harm to patients and will result in greater overall costs to Medicare as a result of preventable non- fatal strokes. Patients with severe(>70%) symptomatic intracranial stenoses represent a small group of very high risk patients whose treatment should be covered.

An important, recent publication was left out of the CMS analysis: Marks, et al, Angioplasty for Symptomatic Intracranial Stenosis, Stroke 2006; 37:1016-1020. This study included 120 patients with >50% symptomatic intracranial stenoses with 97% follow-up for a mean of 42 months. This is a large, nonrandomized, retrospective study with nonetheless impressive results: 3.2% annual stroke rate in the treated territory and 4.4% overall including the peri-procedural period. While not a randomized trial, these results are impressive. 98% of the patients in this study had failed antiplatelet, anticoagulant or combination therapy.

These results are clearly better than the best available natural history as referenced and acknowledged in the CMS decision discussion. Other subgroup analyses (I believe from the WASID study) have found that patients who present with non-disabling stroke (as opposed to TIA) from symptomatic intracranial stenoses suffer a 23% chance of a recurrent stroke while on medical therapy within the first year following their presenting event. Unfortunately, I have been unable to find the reference for this result which was recently presented at the International Stroke Meeting in Orlando this year and has been widely quoted since. The paper by Thijs and Albers (Neurology 2000;55:490-497) has been referenced in the CMS discussion and demonstrated an extremely high incidence of TIA, stroke or death in patients on antithrombotic therapy for symptomatic intracranial stenosis.

It is true that better data are needed to further define the role of angioplasty/stenting for intracranial atherosclerotic stenoses. I would suggest that a coverage policy that pays for patients with symptomatic, severe(>70%) stenoses and requires patients with less severe symptomatic stenoses or with asymptomatic stenoses to be in a clinical trial to be covered would represent a more thoughtful and humane decision.

Frank Hellinger, MD, PhD
Director, Interventional Neuroradiology
Florida Hospital, Orlando
407 303 6924

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I would urge CMS to reconsider their preliminary decision regarding intracranial angioplasty. Recent data has shown intracranial angioplasty to be save and effective at preventing subsequent ischemic events (Marks et al, Stroke, 2006). The ability to offer endovascular therapy to patients with intracranial angioplasty may prevent strokes in patients in whom medical therapy has shown to be only prevent a portion of strokes.

The recent subgroup analysis of the WASID data (Kasner et al, Circulation, Jan 2006) showed a 25% 2 year stroke rate for patients with >70% stenosis and who presented with a stroke, on either Asprin or Warfarin.

Intracranial Angioplasty (and stenting, when appropriate) may significantly improve stroke free survival in the future in patients, and may prevent significant long-term disability. I would strongly urge CMS to consider covering this procedure.

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To whom it may concern,

I would like to commment on the following:NCA for Intracranial Stenting and Angioplasty(CAG-00085R2)

Scripps Memorial Hospital and myself strongly stress that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

The following publications in peer-reviewed journals present patients with symptomatic intracranial atherosclerotic disease:

1)Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) StudyAccording to this randomized prospective study of 569 patients, the risk of recurrent stroke at 1-year for patients with a ≥70% stenosis is 23% while on medical therapy.

Kasner SE, Chimowitz MI, Lynn MJ et al. Predictors of Ischemic Stroke in the Territory of a Symptomatic Intracranial Arterial Stenosis. Circulation. 2006; 113:555-563.

2) Thijs and Albers Study

In this retrospective cohort study of 52 patients, among patients who failed antithrombotic therapy, the subsequent rate of stroke or death was 45% per year, with median time to recurrent event or death at 36 days.

Thijs VN, Albers GW. Symptomatic intracranial atherosclerosis: outcome of patients who fail antithrombotic therapy. Neurology. 2000;55:

3)Groupe d’Etude des Sténoses Intra-Crâniennes Athéromateuses Symptomatiques (GESICA) Study

This prospective, multi-center cohort study of 102 patients showed that despite medical treatment, the two-year rate of recurrent ischemic events in the territory of the stenotic artery was 38.2%.

Mazighi M et al. Prospective study of symptomatic atherothrombotic intracranial stenoses. Neurology. 2006;66:1887-1191.

The Wingspan HDE Study shows results of:- Composite ipsilateral stroke or death rates of 4.4% (2/45) at 30-days and 7.0% (3/43) at six months- No symptomatic restenosis at six months

In conclusion,

This group of patients faces a high likehood of stroke or death due to narrowings of brain arteries. There are no viable options to halt the progression of their disease. Medical therapy with drugs has been shown to be ineffective. I believe that this stent system may offer life saving advantages in patients with severe intracranial atherosclerotic disease

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I would strongly urge CMS to extend coverage for all patients that fall within the FDA approved HDE indications for use with Wingspan and Gateway Balloon system. There is no other technology available for this group of patients and the cost associated with this procedure would represent a significant financial burden for both the patient and hospital. When you consider that the results of having a stroke create a huge financial and social burden to families and society, I think it would be important to encourage any new advancements in the treatment of stroke.

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The recient CMS descision not to grant national Medicare coverage for intercranial angioplasty and stenting cases involving the Wingspan Stent System with Gateway PTA Balloon catheter under HDE label indication reflects a rigid application of the "reasonable and necessary" HDE coverage policy in cases where there are no other vialbel treatments.

Several current studies have shown that patients treated with medical therapy alone suffered subsequent recurrance of symptoms or death in 23%-45% of cases, while patients treated with intercranial angioplasty and the Wingspan Stent System suffered subsequent episodes 4.4%-7% at six months.

In addition to limiting a technology and technique that has vast potential for improved patient outcomes after a cerebral event, the non- coverage of this technology puts further financial stain on the healthcare system as physicians and hospitals struggle with the economic impact of declining reimburssement and escalating healthcare costs.

I request that CMS grant national coverage for HDE label indication of the Wingspam Stent System and Gateway PTA Balloon Catheter in addition to the expanded coverage within the context of a Category B IDE clinical trial.

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I feel very stringely that this devide needs to be approved for coverage. The patients that need this device have no good alternative options. The challenge for having payment only to centers that have an IDE trial is that most patients will not have access to care. There is less than 400 physicians in the country that technicallt can perform/ use this device; by reducing that number to a few centers it would practically makes it not accessable to majority of patients. It is of note that almost all centers that have the technical expertise to use this device work in a multidisciplinary fashion that would eliminate over use and abuse of this device.

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"NCA for Intracranial Stenting and Angioplasty(CAG-00085R2)". Our hospital Scripps Memorial in San Diego strongly requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

we would greatly appreciate if you can extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial

sincerely

Augustin Rodriguez RT (R) (CT)(VI) Manager of Imaging Services

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Abbott Northwestern Hospital requests that Medicare reverse their non-coverage decision on Wingspan Stent system.

The FDA approved Wingspan under an HDE, which means they found it to be safe. As a breakthrough technology treating small patient populations without alternatives, Wingspan's HDE approval is sufficient to meet the reasonable and necessary standard for establishing Medicare coverage.

CMS's decision to deny national Medicare coverage to the Wingspan HDE population is undermining the intent of the HDE approval provision to provide life saving treatments for rare conditions.

Please re-consider your decision.

Thank you, Ron Tarrel, DO

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On behalf of Abbott Northwestern Hospital, we kindly request that CMS grant a positive national coverage decision for intracranial angioplasty and stenting while using the Wingspan stent system. Under the current non-coverage policy, our institution is financially constrained in its ability to provide this ICAD treatment.

There is enough clinical data to support the need for this life-saving device in a small patient population, and therefore we are asking CMS to reverse their decision.

Thank you for your consideration.

Sincerely, John Perl, MD

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My name is Joe DiBenidetto. I have been a vascular technologist with emphasis in neurovascular disease for 27 years at the Massachusetts General Hospital.

I have had many career opportunities. There are serveral reasons I have stayed in this narrow area all of these years.

1) the progression of technology to treat neurovascular disease in a minimally invasive fahion has changed the overall treatment of cerebrovascular disease. I cite as an example how pioneering work to treat cerebral aneurysms have resulted in countless changed lives that are now treated with coils rather than open surgery.

2) treatment of stroke. Our team will come in any time/any day to treat stroke patients acutely b/c of our belief in trying to help these patients

3) most importantly, I have stayed in this field because the doctors/nurses/nurse practioners and technologists are incredibally dedicated to the care of our patients. Our doctors never ask whether a patient has insurance. They spend considerable time making sure each patient is correct for the therapy. I think the current CMS policy will severely limit access of deserving patients by not allowing hospitals to electively admit patients for these procedures.

Thank you for allowing me to submit these comments.

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My comment to CMS is as follows. I am a technologist who works on a vascular interventional floor at the Massachusetts General Hospital. We work in close association with our neuroendovascular colleagues.

I am always impressed by the care they take in picking their patients for therapy. They are extremely dedicated practioners who carefully review the best treatment option for each patient. Within their service, there are radiologists/neurologists and neurosurgeons and this ensures that patients are given access to all potential options for their care.

I have seen the model of studies/registries being necessary by CMS mandate for carotid stenting approval. This has been limitingand I think in a non-beneficial wayto some of our patients.

Thank you for allowing me to comment.

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I would like to comment to CMS on the recent policy decision regarding the Wingspan Stent System for the treatment of Intracranial Atherosclerotic Disease.

I am the clinical coordinator on the Interventional Neuroradiology/Endovascular Neurosurgery Service at Massachusetts General Hospital. Every week, I am responsible for one of our conferences. This conference is a multidisciplinary affair with vascular neurologists, INR specialists, vascular neurosurgeons and diagnostic neuoradiologists present.

Patients for the elective treatment of intracranial atherosclerotic disease are reviewed in this multidisciplinary forum. Medical therapy has typically been maximized by experience stroke neurologists. Alternatives like bypass are considered by vascular neurosurgeons. Only then, are our patients considered for endovascular therapy.

I think it is important for CMS to make this therapy widely available to appropriately selected Medicare and Medicaid patients.

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I urge CMS to reconsider the decision regarding non-coverage for intracranial stenting for medically refractory symptomatic intracranial stenosis. We know that recurrent stroke rates for patients with high-grade stenoses are in excess of 20%. We have the ability to safely deploy stents in the intracranial circulation reducing this stenosis. While we do not know the long-term effects of these stents, we do know that the 1 year stroke rates following stenting were approximately 10% (Euro wingspan trial). Therefore, it remains unclear why there still exists a non-coverage issue for preventing 1 in 5 patients with severe stenosis from having potentially fatal or disabling strokes.

As we begin to collect more data on the Wingspan device, we can gain a better understanding of long-term vascular changes and stroke-risk reductions. In order to facilitate patient care and help advance our understanding, our group urges CMS coverage of this procedure.

Respectfully,

Elad Levy, MD

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Alexian Brothers Medical Center requests that CMS cover angioplasty and stenting of intracranial atherosclerosis in patients with symptoms refractory to medical therapy. Alexian Brothers Medical Center is a JCAHO-certified Primary Stroke Center and meets the Brain Attack Coalition guideline criteria for Comprehensive Stroke Center. With our sister hospital St. Alexius, we treat more than 700 patients annually who have had stroke or are at risk of stroke from arterial stenoses and occlusions. Some of these patients are at extremely high risk of stroke from stenoses of the intracranial arteries.

Patients with severe intracranial atherosclerotic stenoses (>70%), who are symptomatic despite medication, are at unacceptably high risk of having another stroke despite medical therapy (23% at one year as measured in the WASID study). In August, 2005 Boston Scientific received FDA approval via Humanitarian Device Exemption (HDE) for the Wingspan™ Stent System. Congress established the HDE program to increase patient access to new devices for rare conditions where treatment options are limited. The program limits the number of patients treated under each HDE approval to 4,000 patients a year. HDE use of the Wingspan stent requires patients must have already failed medical therapy - these are patients with grave prognoses if left managed with medication alone.

The August 9, 2006 preliminary rule by CMS, if finalized, would deny coverage to patients treated with the FDA-approved Wingspan stent system outside of Category B IDE trials. This is unfortunate, as this device has already met the FDA’s standard (safety plus probable benefit) which is the level of clinical evidence for the HDE process. Without reimbursement, hospitals and health care providers will have no option other than to 1) deny patients this service, leaving them subjected to the 23% risk of additional stroke within one year despite medication 2) require Medicare patients to cover the cost of the procedure themselves or 3) absorb the cost of the procedure without compensation.

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I am writing to urge CMS to issues a positive national coverage decision for Intracranial PTA and Stenting. As a physician working in hospital procurement, I routinely face the financial costs of performing such high tech life saving procedures. The high clinical worth of this technology is reinforced to me by our world renowned physicians who also have submitted their opinions to CMS. Lack of coverage puts our institution into a difficult position where these vital procedures become an enormous drain on the hospital finances. While the philosophy of putting patients first dictates that we opt for new and life saving treatments, their after effects on our budgets put our further ability to do that in doubt. Please reconsider the current coverage. Thank you.

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I am a technologist working with the neuroendovascular group at Massachusetts General Hospital. Our doctors spend a great deal of time vetting appropriate patients for the treatment of intracranial atheorsclerotic disease. In fact, at least once/week there is a meeting of all the doctors from multiple neuorologic specialties to discuss these types of cases. I have seen the doctors spend considerable time picking appropriate cases for treatment of intracranial atherosclerotic disease. I believe patients should be given an opportunity to benefit from appropriate therapies.

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As a Neuroradiology Chief Tech and a taxpayer; the expertise and technology required to protect you and me from ICAD strokes should be encouraged and reimbursed. Reimbursing for ICAD is likely another one of many expensive requests made of you. The fiscal cost in the long run and human cost in the grander picture are surely greater- I don't know your role and do not envy the complex decision-making process you are allowing me to add comments to. It is incumbent upon me though to remark that intracranial angioplasty and stenting offers tremendous long term fiscal cost savings and priceless human health gains like few other minimally invasive technologies ever have. Thank you.

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Although intracranial PTA/stenting is not yet supported by the type and volume of data associated with carotid endarterectomy or carotid stenting, it clearly follows similar logical pathways. If a patient has a symptomatic intracranial lesion which doesn't respond to antiplatelet agents, the natural history is poor. Intracranial PTA/stenting, while fraught with much higher complication rates than the analogous procedures in the neck, clearly improves the natural history of these dangerous lesions. I believe that a study to demonstrate superiority of intracranial angioplasty and stenting to best medical therapy is warranted; nonetheless, I feel that denying appropriate compensation to those operators performing reasonably indicated procedures is counterproductive in general to advances in medical and surgical care.

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Thank you for the opportunity to comment on the important patient care issue fo reimbursement for intracranial stenting and angioplasty.

The Interventional Radiology department of Cox Medical Center South strives to provide the highest quality care for our patients, while maintaining fiscal responsibility. We have a strong neuro practice, with a referral base of about 150 miles. We are a CMS-certified Carotid Artery Stenting facility. We strive to stay current in our practice, both in procedures and devices.

We have multiple patients each year that would benefit from intracranial stenting and angioplasty. Without available reimbursement, it would be very difficult to miantain inventory for the necessary devices for intracranial stenting and angioplasty. Patients would have their diagnostic procedure and then be sent home. The individualize device would be ordered and the patinet would be readmited for treatment at a later date. This leasd to huge patient inconvience, sub-optimal care and would increase the total cost of their care.

CMS now currently provides reimbursement for stenting of the carotid artery, in the extra-cranial portion of the vessel. Many of the patients that receive carotid stenting also have some stenosis intracranially. Successful long-term therapy for these patients would include dealing with the intracranial disease also.

We also see patients for aneurysm coiling that we cannot treat due to their intracranial stenosis. This leads to aneurysm clipping, which uses many more healthcare dollars, and ties up the bed for a longer stay.

I feel that our patient population in Southwest Missouri would greatly benefit from our use of intracranial stenting and angioplasty.

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I am a neurosurgeon in practice in Lexington Ky. We have performed numerous carotid stenting procedures under IDE research protocols. We have performed a small numbe of intracranial procedures. We agree with the proposedv policy, creating an IDE and noncoverage outside of approved trials, until sufficient evidence is accumulated to prove usefulness. Too early clinical coverage eliminates the incentive to complete valid clinical trials that prevent overuse, underuse, and misuse of the technique and device.

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As a physician that is intimately involved with treating patients who have had or are at risk for stroke, I am writing with utmost concern regarding the CMS coverage decision for intracranial angioplasty and stenting which was issued August 9, 2006. The coverage decision as issued limits coverage to patients being treated under a category B investigational device exemption. Unfortunately, the narrow scope of this coverage decision will exclude many patients who would benefit from this life saving procedure. Due to limitations of hospital resources, patients with symptomatic intracranial stenosis who are ineligible for IDE trial enrollment or for whom trial enrollment is unavailable may not be offered the option of intracranial angioplasty and stenting due to lack of reimbursement.

The narrow scope of the recent CMS coverage decision seems particularly contrarian given existing literature evidence for the dismal outcome of patients with symptomatic intracranial stenotic disease who are treated with maximal medical therapy and the strong existing evidence for the safety and efficacy of intracranial angioplasty and stenting. The Warfin-Aspirin Symptomatic Intracranial Disease Study showed a 23% one-year risk or recurrent stroke for patients treated with maximal medical therapy. The Thijs and Albers study demonstrated a 45% chance of recurrent stroke or death within an average of 36 days for patients who failed medical therapy. Meanwhile, a Boston Scientific phase I study of intracranial angioplasty and stenting has demonstrated using the Wingspan Stent and Gateway Balloon system only a 7% stroke and death rate for treated patients. This study was sufficient evidence of safety and efficacy for the FDA to approve these devices for the treatment of intracranial stenosis.

In summary, I strongly feel that the current restricted CMS coverage policy for intracranial angioplasty and stenting will act to exclude many patients for whom there are not sufficient alternative options from having this life saving and quality of life saving procedure. I would implore CMS to reconsider the current policy decision and act to broaden the scope of coverage.

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The current national non-coverage policy in essence withholds this potentially life saving treatment from many critically ill patients without other options available.Patients with intracranial atherosclerosis and flow limiting symptomatic stenoses have a stroke rate of 20-30%.The Wingspan stent system coupled with the Gateway balloon have a 98% procedural success rate and a 90% stroke-free clinical responce.There is a significant cost to IC PTA and stenting as it is done under general anesthesia in specialized high end neurointerventional fluoroscopy rooms.For those of us treating medically refractory intracranial vasocclusive disease, having access to this FDA approved device, but being unable to offer it to patients that cannot afford it presents a significant problem and creates a situation of inequity. I respectfully urge you to reconsider the national non-coverage policy that CMS has in place and reverse it for medically refractory patients with 50% or greater IC stenosis.

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According to a new study by Brown, Morgensen, et.al from the University of Michigan published August 16, 2006 in the online version of the journal Neurology, the total direct and indirect costs of stroke in the next 45 years will be $1.52 trillion for non-Hispanic whites, $313 billion for Latinos, and $379 billion for African-Americans. Aggressive efforts in stroke prevention and treatment are essential for the physical and economic health of Americans as well as the economic health of this country.

Intracranial angioplasty and stenting is a valuable addition to our treatment options, especially for those patients that are symptomatic and have greater than 50% stenosis. Potential risks of the procedure can be decreased by ensuring the procedure is performed by qualified and experienced interventional neuroradiologists.

Why must patients wait until they have a debilitating stroke before they can be given this treatment? Surely the direct cost of reimbursement for angioplasty/stenting can not be more than the direct and indirect costs that are currently expended on stroke care, not to mention the astronomical future costs. I urge you to approve coverage for this life-saving technology.

Faith Johnston, RN BSN
Neuroradiology Case Manager
Radiology Ltd
Tucson, AZ

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August 29, 2006

RE: NCA for Intracranial Stenting and Angioplasty (CAG-00085R2)

UCLA is one of the leading Stroke Centers in the United States. As such, we see several unfortunate patients per year who, while on appropriate medical therapy, are having neurological events (strokes and TIAs) due to intracranial atherosclerosis. The natural history of this group of patients is terrible and our prior treatment options were limited and of high risk. We now have a device that is specifically designed for these patients, and from the HDE study is shown to be far safer than our prior technologies. Therefore, we would like to make comments regarding the decision by CMS for coverage of intracranial angioplasty and stenting with the Wingspan Stent System and Gateway PTA Balloon Catheter. We would like to request that CMS grant national Medicare coverage for the procedure under the current Humanitarian Device Exemption (HDE) labeled indication.

As mentioned above, the population that is to benefit from this new treatment are those that have symptoms related to intracranial stenosis that are refractory to medical therapy. At our institution we see several patients per year who present with stroke or transient ischemic attacks due to intracranial atherosclerotic disease. Although a significant proportion can be stabilized on medical therapy, some subsequently have repeat symptoms, i.e. TIA or stroke, after institution of medical therapy. These patients were not addressed in CMS’s clinical review. The risk of stroke in this population is high as has been documented in various studies published in the literature (1-3). The WASID study which was a randomized study of 569 patients with intracranial stenosis, showed a risk of stroke at 1 year of 23% in this population (1). In a retrospective study of 52 patients with intracranial stenosis, those that had failed antithrombotic treatment had a subsequent rate of stroke or death of 45% per year, with median time to recurrent event or death at 36 days (2). In another prospective randomized trial of 102 patients, the two year rate of recurrent stroke in the territory of the diseased vessel was 38.2% (3).

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS's current decision reflects application of the "reasonable and necessary" test in making national coverage policy. The "reasonable and necessary" standard should be less stringent in cases of HDE devices as there are no other viable treatments. The FDA does recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices. We request that CMS rely on a similar standard of clinical evidence when considering coverage for HDE devices.

In the Wingspan HDE study, composite ipsilateral stroke or death rate was 4.4% (2/45) at 30-days and 7.0% (3/43) at six months. There were no symptomatic restenosis at six months. The data thus far indicates that the event rate is reduced compared to the natural history of the disease even with medical therapy.

In the past, we have treated these high risk patients with coronary balloons and stents. While this has benefited some patients, these devices are not flexible enough to treat most patients, certainly without serious risks of immediate complications. Therefore, we will use the Wingspan/Gateway system in these patients (30d stroke/death 4.4% is less than what we can achieve with coronary systems). However, since this cost is not reimbursable under current CMS guidelines, our hospital will suffer significant losses from treating these patients. This then affects our ability to provide all stroke care services, and affects patient access, diagnosis, and treatment in this most devastating of diseases. Therefore I urge you to reconsider the current non-coverage decision, to remove the financial burden currently placed on Stroke Centers such as ours.

1. Kasner SE, Chimowitz MI, Lynn MJ et al. Predictors of Ischemic Stroke in the Territory of a Symptomatic Intracranial Arterial Stenosis. Circulation. 2006; 113:555-563.

2. Thijs VN, Albers GW. Symptomatic intracranial atherosclerosis: outcome of patients who fail antithrombotic therapy. Neurology. 2000;55:490-7.

3. Mazighi M et al. Prospective study of symptomatic atherothrombotic intracranial stenoses. Neurology. 2006;66:1887-1191.

Reza Jahan, MD
Gary Duckwiler, MD
Fernando Vinuela, MD
Division of Interventional Neuroradiology
David Geffen School of Medicine at UCLA

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Currenlty there is no safe alternative for the treatment of symptomatic intracranial atherosclerotic disease in patients who experience stroke on blood thinners and antiplatelet agents. Wingspan is the first stent which is designed for the use in brain and has shown to be safe and efficacious.

My own experience in treating more than 40 patients with angioplasty and stenting for symptomatic intracranial atherosclerotic disease who are refractory to medical treatment is very promising. The periprocedural complications are 10%.

Wingspan unlike currenlty off-shelf used coronary stents are safer and easier to handle in the brain vasculature. A re-imbursement of the device and the procedure will safe thousands of patients from experiencing debilitating stroke.

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September 5, 2006
Re: NCA for Intracranial Stenting and Angioplasty(CAG-00085R2)

To Whom It May Concern:

I am a Physician Assistant working with an endovascular neurosurgeon, Joe Bernard M.D., in Charlotte, NC. We have treated approximately 15 patients with the Wingspan stent and Gateway balloon system. I have seen first-hand the remarkable improvement these patients have made with treatment using this incredible system.

Each of the patients we have treated was experiencing repeated, debilitating strokes, despite maximum medical therapy. After treatment with the Wingspan stent, not one of these patients has had a recurrent event or other complication. I can only imagine that the cost of the stent/balloon system is significantly less than the long term morbidity and mortality associated with repeated strokes.

I believe strongly that the lack of coverage of the Wingspan stent is a major impediment to patient access to this truly life-saving device. Please reconsider reimbursement of this device under the HDE indication. I believe it is imperative to responsible patient care to be able to provide this device and am proud to have helped save lives by using the Wingspan stent.

Sincerely,

Leah M Warren PA-C
Carolina Neurosurgery and Spine Assoc.
Charlotte, North Carolina Neurosurgery

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CMS's current coverage review for the Wingspan® Stent System reflects a rigid application of the "reasonable and necessary" test in making national coverage policy. The "reasonable and necessary" standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

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My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

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My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

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My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

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My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

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My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

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My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication. We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication. We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication. We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication. We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication. We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Less

My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

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My hospital requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

CMS’s current coverage review for the Wingspan Stent System reflects a rigid application of the “reasonable and necessary” test in making national coverage policy. The “reasonable and necessary” standard should be less stringent in cases of HDE devices where there are no other viable treatments.

The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

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pts with severe intracranial stenosis and symptoms have an approximate 25% major stroke rate over the next several years.....with medical therapy alone.....That is a high rate! We have the technology to address this high stroke rate....stents....most hde's have to go to the individual institutions review board on a case by case basis...so these procedures will be monitored closely ...progress says we have to offer this technology to pts....stenting has been the way to treat disease throughout the body . The time has come that cms has to come up to date with what physicians are doing to help pts. The high stroke rate of these pts with medical treatment is unacceptable!

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Dear Sirs, I am director of Neuroradiology and MRI at Suburban Hospital in Bethesda, MD and Consulting Physician to the National Institutes of Health, Stroke Center. Boston Scientific/Target has been at the forefront of medical innovation with respect to intracranial stenting and angioplasty. Both procedures are used to open or widen blood vessels into or feeding the brain, essential in the treatment of or prevention of devastating strokes. The recognition of these procedures and the devices by Medicare is essential in winning the battle against this very prevalant disease. Any questions, please feel free to contact me.

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I request that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

It is reasonable to extend coverage to qualified patients that fail medical management in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

According our best data on this subject, the WASID study, the risk of recurrent stroke at 1-year for patients with a greater than or equal to 70% stenosis is 23% while on medical therapy.

Data from the HDE study for the Wingspan system, showed that angioplasty and stenting is relatively safe and effective.

The number of patients who would qualify under the HDE approval, is small but significant. At our institution, we have recently encountered one patient who has 3 recent strokes while on medications and a known stenosis of his middle cerebral artery. For him, angioplasty and stenting is our next suggested step. For cases like these, CMS should grant Medicare coverage for the needed procedure.

Sincerely,

Johanna T. Fifi, MD

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Carolinas Medical Center , the flagship of the 4th largest healthcare system in the country, and myself, as a representative of a 17 physician neurosurgery group and an endovascular neurosurgeon respectfully request that national Mediacare coverage be granted to the Wingspan Stent/ Gateway Balloon System for medically refractory, symptomatic intracranial Atheroscerotic disease. I applaud the decision for coverage in a Category B IDE trial, but I urge you to reconsider & approve this for ALL patients that fit the above criteria. Numerous studies have been listed in the prior arguements for this position, & more appear in the journals every month. As a physiscian with experience in more than a hundred intracranial stents (mostly coronary) over the past 10 years, I can honestly tell you that this is the single largest breakthrough for stroke prevention this decade. The data will come with time, but this is a very small population. You don't have to do my job more than a week to see how recurrent stroke devastates families, patients, & our healthcare resources. This is clearly a case where common sense should justify the treatment until we can gather the data to prove it to everyone. This treatment works in every other vascular bed, & in my experience works incredibly well for preventing strokes. The lack of coverage for all patients, will turn back the clock & I suspect some will revert to using coronary devices again (which are stiffer & in my experience far riskier) to save the patient charges (since they're going to get stuck with the bill). This will be a step backwards. All of my patients are informed of the financial obligations with this treatment, & this is probably the largest impedement to their ability to be treated. The cost a stroke in one patient would likely pay for a years worth of treatments with the Wingspan / Gateway System at a major medical center. Those of us in the trenches, who do this for a living, are convinced so much that this is the best treatment that your decision won't change what we recommend as treatment, but it might limit who chooses to have it done based on their own personal finances. Certainly, we don't want to have this as a treatment for only those who can afford it, so I beg you to cover this for all appropriate patients.

Perhaps a reasonable plan would to only cover patients in an IDE trial starting 6 months or a year from now, recognizing that a well organized trial will take some time to set up. Until then, based on all of the specialty societies recommendations, the emerging data, the similarities to similar pathology in other vascular beds, it seems very reasonable to extend full coverage to all applicable patients so that personal finances aren't a major factor in whether or not your stroke can be prevented.

I'd like to sincerely invite any interested parties to visit our hospital who feel that they can't support the full approval of this to come & talk to a patient, see a Wingspan case & the dramatic difference I'm seeing every month. The science needs to be done, give us a little time, but consider how individually detrimental a decision of non-coverage will be to the stroke patient who decides not to be treated because it's too expensive to pay for out of pocket.

Respectfully,

Joe Bernard, MD

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RE:NCA-Intracranial Stenting and Angioplasty CAG-00085R2)

Dear Policy Committee Members-

I am again writing to respectfully request your assistance in revising the recently proposed CMS ruling of August 8, 2006 regarding national coverage for stenting and angioplasty in patients with symptomatic intracranial atherosclerotic disease (ICAD), who receive treatment with the Humanitarian Use Devices: Wingspan™ Stent System and Gateway™ PTA Balloon Catheter. Although this recent draft proposal has taken a very positive step forward in reversing the previous blanket non-coverage policy for intracranial angioplasty and stenting, I sincerely believe it is unnecessarily too restrictive, and consequently, will have an adverse impact on many Medicare patients who are likely to benefit from these devices.

I fully endorse the CMS proposal of national coverage for providing reimbursement of intracranial angioplasty and stenting in the setting of investigational IDE clinical trials. This is generally a very good policy, consistent with the goals of gathering scientific evidence of the efficacy of new therapeutic interventions. However, this proposed rule is in direct conflict with the FDA HDE ruling affirming the probable benefit of this new technology for improving health outcomes in an HDE patient population. It is certain that this policy, if enacted, would deny coverage for patients treated with the FDA-approved Wingspan Stent System, who may be (and should be) enrolled in clinical studies for the current FDA-approved HDE indications. Thus, the very types of patients the HDE program was designed to assist would not be eligible for coverage.

This proposed ruling puts doctors and hospitals in an extremely difficult and unfair position of either denying patients access to a treatment that clearly has the potential for preventing devastating and debilitating strokes, or requiring the patients to cover the cost of the procedure themselves. Even worse, both physicians and hospitals are forced into untenable ethical dilemmas to either absorb costs of the hospitalization or outright deny timely care frequently in an emergency setting of acute or subacute stroke that is the consequence of ICAD. We physicians are ethically compelled to treat these patients according to our judgement of the best available intervention, regardless of the CMS policy.

If CMS limits coverage of this procedure as proposed, access to this potentially life-saving technology for Medicare patients at high risk for stroke and/or death will be highly restricted and largely unavailable, leaving these people with no hope of preventing the potentially catastrophic, life-altering consequences of stroke. I believe that this short- sighted denial of coverage will only lead to further long-term cumulative rises in health care costs associated with rehabilitation and chronic skilled nursing care required for patients who survive their strokes from intracranial atherosclerosis (patients who go on to have a major stroke impose on average approximately $100,000-200,000 in lifetime care costs). This is particularly troubling because approval would not represent a huge financial burden to CMS, since the current HDE indication is for a relatively limited patient population (i.e. less than 4,000 patients annually). Would it not make good basic financial sense to reduce strokes in this very high-risk patient population by financing an effective intervention to prevent them in the first place?

In order for stroke physicians to continue providing what by most agree is a very promising intervention for preventing catastrophic stroke in a very high risk population (i.e. symptomatic ICAD), I urge you to expand the national Medicare coverage of stent-assisted angioplasty of cerebral arteries affected by ICAD, to include the FDA-approve HDE indications (i.e. symptomatic patients refractory to medical management who have a stenosis within a target cerebral artery with greater than or equal to 50% stenosis).

Thank you for your consideration of this request. If you have additional questions, please feel free to contact me at 319-356-4329 or email (john-chaloupka@uiowa.edu).

John C. Chaloupka, MD, FAHA, FACA
Professor and Director,
Division of Neuro-Interventional Radiology
University of Iowa Hospitals and Clinics
john-chaloupka@uiowa.edu
Phone: 319-356-7980
Fax: 319-356-2220

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Intracranial angioplasty and stenting is a potentially life-threatening procedure for a small number of patients with severe symptomatic intracranial stenosis, who usually have no alternative but to suffer a massive stroke. There is a current FDA-approved HUD/HDE device (Wingspan intracranial stent and Gateway intracranial angioplsty balloon), designed especially for this purpose, but without CMS leadership and funding recommendations, these patients will suffer, and the massive devastating strokes that occur without treatment will continue to drive up heath care costs including Rehab Hospitals and Nursing Homes. I have personally experienced outstanding success in preventing stroke with this device and so have many other Neuroendovascular specialists across the country.

The reason why this device required HDE approval rather than IDE approval is because of the very small numbers of patients who suffer from severe symptomatic intracranial stenosis. However, these few patients will significantly impact the health care system because of the devastrating neurological injury that they face if we are prohibited from performing intracranial angioplasty and stenting. Please reconsider and allow physicians to treat these patients, who have no other choice available to them.

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NCA for Intracranial Stenting and Angioplasty(CAG-00085R2)

On behalf of our Radiology Interventional Lab at Moses H. Cone Memorial Hospital in Greensboro, NC we would like to request that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan Stent System with Gateway PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We request that you extend coverage in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B investigational Device Exemption (IDE) clinical trial.

The Wingspan Stent and Gateway Balloon are FDA approved for intracranial use. The FDA recognizes an alternate level of safety and benefit in its approval process, and we would like to encourage CMS to rely on a similar standard of clinical evidence when considering coverage for HDE devices.

There are several clinical studies (Warfarin-Aspirin Symptomatic Intracranial Disease Study, Thijs & Albers Study, and the Wingspan HDE Study)that provide clinical evidence that patients benefit from treatment using the Wingspan Stent.

As an administrator, how can I not provide the best possible devices to our clinicians for the care of our patients. As a stroke center, we are all about caring and treating the patient with the best possible technology to minimize the affects of an ischemic event. In many cases, the success of an intervention in a stroke patient requires the immediate deployment of the Wingspan Stent and Gateway Balloon.

We appreciate this opportunity to share our support for this device and encourage your consideration to add the Wingspan Stent and Gateway Balloon to your national coverage policy.

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the wingspan device is the only stent made for the intracranial atherosclerotic disease. I have been placing stents in the intracranial circualtion for over a decade and the wingspan represents new technology that is unmatched in its flexibility and deliverability. AS a result I feel strongly that it has the best safety profile. Without this tool at our disposal, the treatment of intracranial atherosclerotic disease will continue to linger and patients will continue to have unnecessary disability and even die from stroke. Please help us save patient lives with this reveolutionary technology

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West Jefferson Medical Center and myself would like to request that CMS issue an expeditious response in favor of coverage for intracranial stenting and angioplasty.

There is a need for better therapy for these patients. They simply do not respond to medical therapy such as aspirin; and many of them only see minimal change from just angioplasty alone.As an INR, I would like to give these patients a better option and I believe that the Wingspan stent system is a step in the right direction.The WingSpan study says that there was an overall 97.7% procedure success rate in treating ICAD.

Please deeply consider providing a positive coverage. These patients are at a high risk of multiple transient ischemic attacks or even a major stroke.

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I am an INR at Our Lady of the Lake in Baton Rouge, Louisiana and I would like to thank you for hearing our request for a very important medical initiative. Patients that are suffering Intracranial Atherosclerosis are a sick patient population. Especially those that have suffered previous strokes, failed medical therapy and/or angioplasty. We would really appreciate a national coverage for treating ICAD with the WingSpan stent system.According to the Wingspan study, these patients have had no restonsis at their 6 month follow up and there was a 97.7% success rate. There is no other viable treatment when patients are this sick with ICAD. Please consider implementing a coverage.

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My hospital, Methodist University, in Memphis, Tennessee would be very appreciative of CMS granting a national coverage policy for the treatment of intracranial atherosclerotic disease; specifically, coverage involoving the current HDE device: Wingspan and Gateway.Many patients with this condition simply do not respond to medical therapy and need a better option or they risk another stroke.According to the WingSpan HDE study, these patients that were treated with balloon angioplasty and a stent, had no symptomatic restonosis at six months. This is a step in the right direction and a step in better treating this population of patients.

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I am writting as the Director of the NeuroScience and Spine Insitute, at Carolinas Medical Center, in Charlotte NC. We have treated 15 patients with the Wingspan Stent with excellent results, all in situations which had no viable options. The patients were at risk for massive infacts and thereby requiring long term care, but instead were able to be dicharged home. We are a 20 Neurosurgeon group who requests that CMS reconsider it,s current stance and allow reimbursnemt for the application of intracranial stents. thank you

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Intracranial stenosis is a deadly condition that has life threatening complications and is very common in blacks, asians and hispanic populations. I would like to request CMS to reconsider its decision about re-imbursement for Intracranial angioplasty and stenting as this decision will significantly impact the care we can offer our patients.

Intracranial stenosis from atherosclerosis is a very serious disease and the WASID trial was conducted to evaluate the role of best medical therapy in 569 patients with intracranial stenosis and found that despite best medical therapy 22.1% of the patients on aspirin with intracranial stenosis (>50% stenosis) over 1.8 years of follow-up developed ischemic stroke, brain hemorrhage, or death from vascular causes other than stroke and 21.8% of patients on warfarin over 1.8 years of follow-up developed ischemic stroke, brain hemorrhage or death from vascular causes other than stroke.

As you can see, best medical therapy is not enough for these patients and nearly 1 in 4 patients on medical therapy fail therapy and have life threatening complications. Clearly there is a need for an alterantive therapy for patients refractory to medical therapy.

Intracranial angioplasty and stenting enables the narrowed artery to be opened up so blood flow can be restored to the brain and thereby help decrease the risk of stroke and death. Previously, coronary stents have been used intracranially to stent the angioplastied lesions as we did not have any stent that was specific to the brain. The Wingspan Stent system and Gateway PTA balloon catheter is the first stent and balloon system that have been developed specifically for intracranial stenotic lesions. Finally our patients can now have a treatment that has been developed specific to the brain. The FDA weighed the risks and benefits of this intervention and approved the Wingspan Stent system and Gateway PTA balloon catheter as a Humanitarian Device exemption (HDE) so that thousands of patients can be benefited.

However, CMS's initial decision to not re-imburse this endovascular treatment makes it difficult to justify doing this treatment which is the only hope for thousands of patients who are refractory to best medical therapy. Labelling this treatment as an experimental treatment makes it economically very hard on the patients. It is important to note that intracranial stenosis is very prevalent in Blacks, Asians and Hispanics. Many of our patients are socio-economically not in a position to self pay this procedure. Given the evidence that is well documented in the literature about the harmful effects of this condition, the fact that medical therapy is not fool proof and the benefits of endovascular treatment, approving the re-imbursement for this endovascular treatment will offer a ray of hope for these very sick patients who truly need our help and compassion and all these patients irrespective of their socio-economic backgrounds deserve the highest level of medical care that our great nation can provide. I am sure CMS will recongnise this.

I urge CMS to strongly reconsider their decision and request them to approve re-imbursement for Wingspan Stent system and Gateway PTA balloon catheter as a treatment for patients with Intracranial stenosis (>50%) who are refractory to best medical therapy.

Thanking you

Sincerely

Vallabh Janardhan, MD
Stroke Neurologist, Neuro-Intensivist and Interventional Neurologist
Assistant Professor of Neurology, Neurosurgery and Radiology
University of Minnesota, Minneapolis

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On behalf of Mayo Clinic Arizona and our patients, we respectfully request that CMS issue an expeditious, positive national coverage decision for intracranial stenting and angioplasty in patients who receive treatment with the Humanitarian Use Device: the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter. The current national non-coverage policy directly affects our hospital’s financial ability to provide this treatment to critically ill patients.

Below, we provide clinical background and our institution’s current experiences in caring for patients with intracranial atherosclerotic disease (ICAD).

ICAD is the narrowing of blood vessels that supply blood to the brain, due to the build up of atherosclerotic plaque. The coverage is for patients with ICAD who have already suffered a transient ischemic attack or stroke while on medical therapy. Studies have shown that up to 10% of all strokes are due ICAD. This group of patients has a very high risk of subsequent death or stroke, and there is no current effective therapy. Stroke is the third leading cause of death in the U.S. (mortality rate, 7.6% at 30 days), and it is the leading cause of long-term disability. The annual cost is about $51billion in direct medical costs and indirect costs including losses in productivity. Prior data has shown that up to 10% of all strokes are due ICAD. Furthermore, the natural history of these patients who have failed medical therapy is dismal with up to 55.8% of patients having recurrent events while on medical therapy with a median time to new event at only 36days (Neurology. 2000 Aug 22; 55(4): 490-7). Even patients not previously on medical therapy have a high risk of new ischemic event or death, and can be up to 20-24% at one year (Neurology 1995; 45:1488-1493, Circulation. 2006; 113:555- 563, New England Journal of Medicine. 1985;313:1191- 1200). In the past decade, intracranial stenting and angioplasty has emerged as a promising therapy in symptomatic patients with high-grade stenosis who fail medical therapy. Until recently the only available devices were coronary devices that were not designed or indicated for use in intracranial arteries. On August 3, 2005, the Food and Drug Administration approved the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter under a Humanitarian Device Exemption. The Wingspan Stent System is the first marketed self-expanding stent specifically designed for the intracranial vasculature. In the Wingspan HDE clinical study, there was a 97.7% procedural success rate and at one-year post procedure, 90% of the patients were free of strokes related to their treated lesions. Early U.S. experience reported at the recent American Stroke Association meeting shows a similar acute procedural profile.

Our institution is a referral center for the treatment of stroke patients with intracranial atheromatous disease. We have found that the Wingspan Stent System has significantly increased the safety and efficacy of this procedure. This device has marked advantages over other approaches in terms of being able to safely open the brain artery and safely place the stent.

Under the current non-coverage policy, our institution is financially constrained in its ability to provide this ICAD treatment. Intracranial angioplasty and stenting is performed in the hospital inpatient setting, under general anesthesia. Like open craniotomy procedures, intracranial angioplasty interventions involve significant resources including a full operating room contingency (nursing personnel, anesthesiologists, special procedure technologists, and circulating personnel). It is not economically feasible for the hospital to allow these procedures to be performed without reimbursement. Without Medicare reimbursement, our institution assumes significant financial risks in treating ICAD patients.

The population most at need for this form of treatment are those patients in their 60’s and 70’s. Most of these patients have Medicare, limited incomes and would not be able to afford this procedure without support from their insurer.

All in our profession believe that there is now enough evidence available to warrant national Medicare coverage .The American Society of Interventional and Therapeutic Neuroradiology, the Society of Interventional Radiology, and the American Society of Neuroradiology, support health insurer coverage for the symptomatic medically refractory ICAD patient population. Given that these patients lack other treatment options and face an unacceptable risk of another stroke, the availability of endovascular treatment using the Wingspan stent is critical to patient care, and CMS should provide coverage for these patients.

To continue to provide this important treatment option, we respectfully request that CMS act quickly to reverse its non-coverage policy and ask for the following:

1) National Medicare coverage of PTA and stenting of cerebral arteries when performed in vessels with greater than or equal to 50% stenosis for patients who are refractory to medical therapy, concurrent with use of a device approved for marketing by the FDA (subject to any requirements established by the applicable FDA approval or clearance process) for this specific indication, and 2) National Medicare coverage for intracranial stenting and angioplasty within the context of a category B investigational device exemption (IDE) clinical trial.

Thank you again for your time and attention to this important public health policy initiative.

Sincerely,

Brian W. Chong, MD
Associate Professor
Mayo Clinic School of Medicine Director, Endovascular Surgical Neuroradiology

RS Zimmerman, MD
Medical Director, Mayo Clinic Hospital Chair, Patient Safety Subcommittee Consultant, Department of Neurosurgery

Bart M. Demaerschalk, MD, MSc, FRCPC
Director, Mayo Clinic Arizona Cerebrovascular Diseases Center
Assistant Professor of Neurology
Divisions of Cerebrovascular Diseases and Critical Care Neurology
Department of Neurology
Mayo Clinic Arizona

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Intracranial atherosclerotic disease is a serious medical condition with very limited therapeutic options. The introduction of an FDA- HDE approved device (the intracranial Wingspan stent) by Boston Scientific is a promising therapeutic alternative for patients who remain symptomatic from the condition despite maximal medical therapy. This was the intent of the HDE approval provision. The subsequent decision by CMS to deny national Medicare coverage for the Wingspan HDE population is inconsistent with this intention.

It is likely that the denial of this coverage will result in significant financial penalty for hospitals offering the new technology, and for their patients.

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September 1, 2006

Dear Sirs:

We are writing in support of reimbursement for CMS patients who undergo intracranial and stenting and angioplasty and vertebral stenting and angioplasty with the Wing Span device.

Repeatedly in the last few months since we began using this device, we have imposed tremendous stress and financial strain on patients who have failed maximal medical therapy and who are having terrifying intracranial posterior circulation strokes who require intervention with this device. We have to further stress these already frightened patients with the financial implications of the hospital bills and device-related bills for the use of this device because they do not currently reimburse for its use.

These patients in our experience have typically been in their late 60s to late 70s and have symptomatic vertebral basilar stenoses requiring urgent angioplasty and stenting in order to avoid continued or potentially or life ending stroke from both of these related to intracranial stenoses.

Others will eloquently speak to the scientific evidence for benefit for this intervention. We can simply point out to you that we are coming across this problem on a weekly basis and we are fighting with our hospital administrators to enable us to treat these patients. Some of these patients have been confronted by forms committing them to payment for their expenses prior to the procedures. Some of these patients are simply unable to pay these bills. We are not cowboys, we are not overly aggressive, we only intervene when we have to and there is clearly a need to cover this procedure for this patient population. This is what you would want for your parents and what we would want for my parents. This goes further than just Wing Span. Many of these patients can be adequately treated with angioplasty alone and do not require stent placement. We need you to allow us to do this. Over the past 8 years we have navigated a small 2.5, 2.75 or 3 mm balloon into the intracranial vasculature of people becoming moribund because of severe stenoses. It It is often possible to navigate a balloon into diseased and tortuous vessels in patient in whom it would be impossible to get a stent in that same location. We need reimbursement for that. We have done it, fortunately, safely, but only when absolutely necessary.

The patient population with vertebral artery origin stenoses also needs your assistance. The literature clearly shows that the stroke and death rate for patients who have failed the maximum medical therapy for vertebral artery stenosis and basilar artery stenosis far exceeds the risks of intervention. There is no surgical alternative. We have presented this data to the FDA and published it in the peer reviewed literature. We have treated 45 of these patients using coronary artery balloon balloon mounted stents. Again we only treat patients who have failed maximal medical therapy. On one occasion, a CMS patient's intervention was prolonged 10 days as we hashed out how the intervention would be payed for, as this was off label use and not covered. The patient could not go home as he was on heparin, and hypertensive therapy. Eventually we brought the hospital administrators before our ethics committee to gain the ability to him. We did this because many of our patients are already spending the most of their income on their health-related co-pays and cannot possibly be burdened with hospital expenses.

I understand your need for prudent analysis of the data and your need to be aware of industry lobbying that can affect opinions. Our opinions are not based on industry lobbying, but on our clinical experience of 8 years of running a busy stroke program at Johns Hopkins. You can visit us, review our cases and sit down and discuss with us at any time the comments made above. We applaud for example the prudence of your decision in reimbursing only symptomatic carotid stenting and not reimbursing asymptomatic carotid endovascular intervention. The same prudence and judgment is now required to approve angioplasty and stenting intracranially and in the vertebral artery.

Submitted respectively and most sincerely,

Kieran Murphy, M.D.
Associate Professor of Radiology
Director, Interventional Neuroradiologoy
Johns Hopkins Hospital
Baltimore MD

Eric Aldrich MD
Assistant Prof of Neurology
Medical Director of the Stroke Service
Johns Hopkins Hospital
Baltimore MD

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I write to request that you provide coverage for intracranial stenting for patients with symptomatic intracranial arterial stenosis.

The WASID Trial has proven that best medical therapy for symptomatic intracranial stenosis results in a greater than 21% two year risk of stroke. Sub-analysis revealed that women and patients with stenosis >70% are particularly at risk.

Good preliminary results have been obtained with the gateway/wingspan platform.

There is no doubt that this therapy recquired further evaluation. However, a high risk population who would most likely benefit from this procedure will be left untreated.

I would respectfully request that Medicare reconsider its decision not to provide coverage for intracranial stenting.

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Intracranial stenosis responsible for 10% all stroke leading 100,000 of stroke/year in USA. With the best mrdical treatment the chance of stroke and death is approximately 30 to 45% for intracranial stenosis. The wingspan stent is the only hope for those patients who have intracranial stenosis. In last 4 months I used 20 wingspan and saved those patient from a devastitating stroke and disability.I wanted to help more people, but my institution stoped me from doing for cases, since hospital can not get reimbrused and patient can not afford. I think my community and my relatives deserve better for treatment and prevention of a disabling stroke. Therefore, my request please make careful kind disition for those 100,000 people who had no other alternative of treatment for their serious disesse.

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Andrew J. Ringer, MD; Todd Abruzzo, MD; Thomas A. Tomsick, MD
For the Greater Cincinnati / Northern Kentucky Stroke Team

Re:NCA for Intracranial Stenting and Angioplasty(CAG-00085R2

As medical science and technology evolve, it becomes necessary to continually evaluate the appropriate application of this technology to medical practice. For many years, the prevention of stroke in patients with intracranial arterial stenosis has been limited to anticoagulation. Recent medical trials have made only small advances in the treatment of this potentially devastating disease [1-3]. Despite these advancements, patients with intracranial stenosis remain at high risk of stroke. In the WASID trial, for example, both treatment arms suffered a stroke rate of 15% at one year. Thus, medical therapy may fail a significant portion of patients with intracranial stenosis.

Trials to manage patients with intracranial stenosis by surgical means, specifically by bypassing the stenotic segment using a graft from the extracranial carotid artery, proved ineffective when applied to a broad population.[4] While ongoing studies are attempting to identify a subset of patients that may still benefit from bypass, these studies suffer from poor enrollment, indicating the small population that bypass may serve. This leaves the vast majority of patients with medically intractable intracranial stenosis without an accepted treatment option. In recent years, several medical centers have treated these high-risk patients with angioplasty with or without stenting. Initial results have been promising.[5, 6] Based largely upon these promising results, the FDA has approved the first angioplasty and stent system designed specifically for intracranial use and CMS has provided codes for these procedures.

What is now lacking is appropriate reimbursement for intracranial angioplasty and stenting. Development of a safe device for use in intracranial atherosclerosis requires considerable resources, the expertise necessary to use it requires considerable training and judgement, and the risk associated with the disease limits the personnel and centers capable and willing to provide the care. All of these factors place a burden on the medical community and the companies that provide our devices. Without a source for appropriate reimbursement, our patients are often left in the unenviable position of choosing between a risk of death and disability or great financial burden.

It is our firm opinion that intracranial angioplasty and stenting is an appropriate form of care for patients at risk of stroke from severe intracranial stenosis that has proven refractory to medical management. While one could make a strong argument that all cases of symptomatic severe intracranial stenosis deserve angioplasty or stenting, we do not believe that sufficient evidence exists to uniformly perform this procedure at the onset of medical therapy, such as is the case for carotid endarterectomy. Therefore, we recommend angioplasty and stenting for patients with intracranial stenosis of greater than or equal to 50% that is symptomatic while on appropriate medical therapy. These stringent criteria will limit the appropriate candidates and would not likely create an untoward burden on Medicare or Medicaid should the CMS agree to reimburse the procedures. We urge you to consider providing reimbursement for intracranial angioplasty and stenting and provide, for the first time, accessible and appropriate therapy to a patient population currently without appropriate options.

1. Diener, H.C., et al., Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial. Lancet, 2004. 364(9431): p. 331-7.
2. Chimowitz, M.I., et al., Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med, 2005. 352(13): p. 1305-16.
3. Creager, M.A., Results of the CAPRIE trial: efficacy and safety of clopidogrel. Clopidogrel versus aspirin in patients at risk of ischaemic events. Vasc Med, 1998. 3(3): p. 257-60.
4. Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. The EC/IC Bypass Study Group. N Engl J Med, 1985. 313(19): p. 1191-200.
5. Stenting of Symptomatic Atherosclerotic Lesions in the Vertebral or Intracranial Arteries (SSYLVIA): study results. Stroke, 2004. 35(6): p. 1388-92.
6. Marks, M.P., et al., Angioplasty for symptomatic intracranial stenosis: clinical outcome. Stroke, 2006. 37(4): p. 1016-20.

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We have a few patients who are in need of this new technology. I specifically have one patient who is very anxious because he has had a stroke already and would be a great candidate for this stent. He can not afford to cover the cost of this procedure on his own. He is currently managing on medications but the waiting and wondering associated with this have cause great anxiety to he and his family. He is limited in his daily life because of the worry. Please reconsider your decision to cover this procedure.

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On behalf of LSU Health Sciences in Shrevport, Louisiana, we are requesting that CMS issue a positive national coverage decision for intracranial stenting and angioplasty. The current non-coverage policy directly affects our hospital's financial ability to provide this life-saving treatment to our critically ill patients. Most ICAD patients are treated with medical therapy, but in many cases, this is not sufficient. These particular patients are left at a high risk of having another stroke. ICAD accounts for 8-10% of ischemic strokes in the United States.[1] Stroke is the third leading cause of death in the U.S. (mortality rate, 7.6% at 30 days), and it is the leading cause of long- term disability. The annual cost is about $51 billion in direct medical costs and indirect costs including losses in productivity. Until recently, we as physicians have not had a suitable stent to treat these patients that have high grade stenosis and fail medical therapy. In the Wingspan HDE clinical study, there was a 97.7% procedural success rate and at one year post procedure, 90% of the patients were free of strokes related to their treated lesions.[4] Given that these patients lack other treatment options and face unacceptable risk of another stroke, the availability of endovascular treatment using the WingSpan stent is critical to patient care, and CMS should provide coverage for these patients. Thank you for your time and attention to this very important public health policy initiative. Sincerely, Michael D. Williams, M.D.

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I approve of CMS restriction of payment for application of Wingspan technology and device application as proposed. However, I feel reimbursement for other procedures/device uses should follow similar logic. For example, use of Concentric Clot Removal device (whose approval was based on less compelling data than Wingspan) should be reimbursed only for those uses that follow its FDA label, where rtPA use is contraindicated or has failed. Furthermore, where a new DRG and payment schedule is created, a threat of abuse in expectation of higher payment exists. Where pre-approval studies have been performed and reported by principal investigators, clinical investigators with stock options or other significant financial interests in the company involved, conflicts of interest are expected. Creation of a new DRG for an application arising from just such a circumstance, prior to solid scientific evidence of efficacy and safety is not good policy. I would be more than glad to personally discuss the matter further.

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I disagree with Medicare's non coverage policy for intracranial angioplasty for patients with high grade stenosis of intracranial vessels. In patients who have stenosis and are symptomatic you are dooming them to stroke or death. I have to tell these patients that I cannot treat them because the procedures are non reimbursable. Industry is not willing to spend the money on IDEs because the market is too small. Medicare's decision defeats the purpose of HDE devices. Only life insurance companies have a true vested interest in keeping patients alive, they have to pay when the customer dies, health insurance companies and medicarenhave the opposite interest, their payments stop when the patient dies.

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I request that CMS reverse their boycott of payment for and lack of support for ICAD treatment with intracranial PTA/Stent placement. We have been performing this lifesaving procedure for years with excellent results and numerous scientific publications support this procedure as well. Just today I performed a PTA/stent in a diabetic 50 yo BF with recurrent TIAs and an 80% M1 stenosis with CT perfusion evidence of lack of cerebrovascular reserve and impending large R MCA stroke. I basically cost my hospital thousands of dollars to save this patient and this happens several times per month. Please help with this critical issue. Thanks for your time and assistance.

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Intracranial atherosclerotic disease is responsible for 10% of all strokes (~70,000 cases/ year in US). The WASID trial recently confirmed the very poor prognosis of patients with symptomatic intracranial atherosclerotic disease. As many as 50% will die or have another stroke if left untreated. The preliminary data from WingSpan treatment has shown that 90% of Wingspan patients were free of strokes related to their treated lesions 6 months after their treatment. Depriving patients from such treatment when we know that there is no other alternatives should be an option. Thanks for the opportunity of expressing my thoughts on this issue.

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I am the Director of Interventional Neuroradiology/Enodvascular Neurosurgery of Massachusetts General Hospital. We are a multispecialty group composed of specialists dedicated to the care of intracranial vascular disease. The WASID study was very helpful in determining the limitations of medical therapy in the treatment of ICAD. As meaningful interventional alternatives are becoming available, I believe that CMS should allow for these treatments to our appropriately selected patients. I am concerned that the expense of the devices/hospital stay/requisite medications will preclude certain patients that can benefit from these treatments should CMS not cover this type of treatment. I respectfully request that CMS grant national Medicare coverage to ICAS under the current HDE.

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As a physician who treats patients with medically refractory cerebrovascular occlusive disease, I kindly request that CMS issue an expeditious, positive national coverage decision for intracranial stenting and angioplasty in patients who receive treatment with the Humanitarian Use Device: the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter.

The current national non-coverage policy directly affects our team and hospital’s financial ability to provide this life-saving treatment to critically ill patients.

Below, we provide clinical background and our institution’s current experiences in caring for patients with intracranial atherosclerotic disease (ICAD).

ICAD is the narrowing of blood vessels within the brain due to the build up of plaque. ICAD accounts for 8-10% of all ischemic strokes in the United States. Stroke is the third leading cause of death in the U.S. (mortality rate, 7.6% at 30 days), and it is the leading cause of long- term disability. The annual cost is about $51billion in direct medical costs and indirect costs including losses in productivity.¹

Most ICAD stroke patients are typically treated with medical therapy but in some cases this therapy is ineffective and patients are left at a high risk for another stroke. Studies have shown a rate for some populations of 22.5% to as high as 24% in the year after their stroke. , , If medical therapy fails, there are limited treatment options, and these individuals suffer compromised quality of life.

In our insititution in the heart of Brooklyn, we serve a demographic population who is unfortunately at high risk for intracranial occlusive disease. The predominately African- American and Caribbean-American population we care for trends to have a much higher incidence of intracranial stenosis (more common than carotid stenosis) causing their strokes. These patients are often experiencing recurrent and further debilitating/devastating strokes despite maximal medical therapy. For this significant group of underserved patients, there have been few options, until now. With the exciting development of these new angioplasty and stenting technologies, these patients may now receive life- saving intervention to enhance their productive lives and limit their disability and rate of mortality.

In the past decade, intracranial stenting and angioplasty has emerged as a promising therapy in symptomatic patients with high grade stenosis who fail medical therapy. Until recently the only available devices were coronary devices that were not designed or indicated for intracranial use. On August 3, 2005, the Food and Drug Administration approved the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter under a Humanitarian Device Exemption. The Wingspan Stent System is the first marketed self-expanding stent specifically designed for the intracranial vasculature. In the Wingspan HDE clinical study, there was a 97.7% procedural success rate and at one year post procedure, 90% of the patients were free of strokes related to their treated lesions. Early U.S. experience reported at the recent American Stroke Association meeting shows a similar acute procedural profile.

Under the current non-coverage policy, our institution is financially constrained in its ability to provide this ICAD treatment.

Intracranial angioplasty and stenting is performed in the hospital inpatient setting, usually under general anesthesia. Absent Medicare reimbursement, our institution assumes significant financial risks in treating ICAD patients. Similar to craniotomy procedures, intracranial angioplasty interventions involve a full operating room contingency, including nursing personnel, anesthesiologists, special procedure technologists, and circulating personnel. It is not economically feasible for the hospital to allow these procedures to be performed without reimbursement.

As we described, we operate in an economically disadvantaged underserved community in the Flatbush/Midwood neighborhood of Brooklyn. As the only major Academic Health Center in Brooklyn, we receive many referrals for high-risk critically ill patients afflicted with this disease. From our early surveys, many of these patients, perhaps greater 50-60% are Medicare, Medicaid beneficiaries, or worse, Un-insured. The cost of doing these complex high risk interventions remains very high, with intense involvement of multiple teams (Interventional Neuroradiology, Stroke Neurology, Intensive Care, etc.), extensive hospital resources (INR operating room, staff, ICU, etc.), and the high price of new and evolving technology and equipment (balloons/stents). The cost per case can easily range in the 20K to 100K for these critically ill patients, with annual expenses for the institution ranging into the millions. Preventing recurrent devastating strokes, however, will save the institution, government, and society the much greater financial and social burden of caring for the devastated and disabled people affected with this disease.

Our Institution serves as the leading Academic Center in Brooklyn, and serves as the quarternary referral center for a population of greater than 3 Million people. We are committed to the highest standards of care and service and have developed one of the leading stroke programs in our community. We are the only medical center in our community that can provide advanced Interventional Neuroradiology and Endovacular Therapeutic options for our large underserved population. These people often have very few options, and rely heavily on the community and society to help provide important and critical services often only available to those with greater financial means.

The availability of this new FDA approved device for angioplasty and stenting may dramatically change the way in which we provide stroke- prevention therapy to our patients. It’s long term impact on the health of our population is difficult to determine, but potentially enormous. The CMS non-coverage policy may severely hamper our ability to provide these services for those people that need it the most and can least afford it, further exasperating the health care disparities our communities already suffer.

There is now enough evidence available to warrant national Medicare coverage for a treatment that benefits an orphan disease population.

The interventional professional societies, the American Society of Interventional and Therapeutic Neuroradiology, the Society of Interventional Radiology, and the American Society of Neuroradiology, support health insurer coverage for the symptomatic medically refractory ICAD patient population. Given that these patients lack other treatment options and face an unacceptable risk of another stroke, the availability of endovascular treatment using the Wingspan stent is critical to patient care, and CMS should provide coverage for these patients.

To continue to provide this life-saving treatment option, we request that CMS act quickly to reverse its non-coverage policy and ask for the following:

1) National Medicare coverage of PTA and stenting of cerebral arteries when performed in vessels with greater than or equal to 50% stenosis for patients who are refractory to medical therapy, concurrent with use of a device approved for marketing by the FDA (subject to any requirements established by the applicable FDA approval or clearance process) for this specific indication, and 2) National Medicare coverage for intracranial stenting and angioplasty within the context of a category B investigational device exemption (IDE) clinical trial.

Thank you again for your time and attention to this important public health policy initiative. If you have any questions, please feel free to contact me at 718 270 4141 or at sundeep.mangla@downstate.edu

Sincerely,

Sundeep Mangla, M.D.
Director of Interventional Neuroradiology
Director of Research, Department of Radiology
Visiting Associate Professor of Radiology,
Neurosurgery, and Neurology
SUNY Downstate Medical Center
450 Clarkson Ave, Box 1189
Brooklyn, NY 11203-2098
(718) 270-4141 or 2111 (office)
(718) 270-7241 (fax) smangla@downstate.edu

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"NCA for Intracranial Stenting and Angioplasty(CAG-00085R2)"

My hospital institution requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

Patients with ICAD have very limited options. Please reconsider the reimbursement on Wingspan.

Thank you.

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Regarding "NCA for Intracranial Stenting and Angioplasty(CAG-00085R2)"

My hospital institution requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

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Our own evolving data (Fiorella et al., ASNR presentation, 2006) indicates that PTAS with the Wingspan system is likely safer than other available technologies for the treatment of intracranial atheromatous lesions and is very likely to be superior to medical therapy for selected patients (symptomatic intracranial stenosis >70%; WASID data). CMS's policy would continue to limit access for medically refractory patients with symptomatic intracranial atherosclerotic disease and the natural history of this disease process on medical therapy is dismal.

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My hospital institution requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

If this is not reconsidered, there are patients with ICAD disease that will have no other FDA-approved alternative.

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My hospital institution requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

There is no other FDA approved device to treat ICAD. Therefore, please reconsider your position.

Thank you.

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My hospital institution requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

When there is no other FDA approved alternative for patients with ICAD disease, I think it should be our responsibility to make this device available.

Your attention to this matter is deeply appreciated.

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My hospital institution requests that CMS grant national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication.

We kindly request that you extend coverage to the above population in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

There are many patients in need of this device.

Thank you!

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I would ask the CMS to reconsider their decision regarding reimbursement for intracranial angioplasty and stent placement. I am seeing many patients with symptomatic intracranial stenosis with ongoing TIAs while on antiplatelet medication and/or warfarin. I believe they should be treated and the patients want treatment, however, my hospital will not allow me to treat them because of the financial loss associated with it. This should be reconsidered for the sake of the patients. Thanks, Brian Hoh, M.D., Assistant Professor of Neurosurgery and Radiology, University of Florida

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While I appreciate the proposed coverage decision for intracranial angioplasty and stenting the proposal, as written, is not enough. The fact that coverage would still be denied for patients treated with the Wingspan and Gateway balloon in the current FDA approved HDE population is disapointing. I urge the CMS to reconsider this coverage decision to include the HDE population consistent with the intent of the HDE approval provision to increase patient access to treatment options for rare conditions.

Fianlly, the current proposal, as written, will continue to present hospitals and patients with significant financial burdens and may deny this technology to those patients who have this as their only option.

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I am an Interventional Neuroradiologist and assistant professor of radiology and neurosurgery. I am also the director of endovascular services at West Virginia University Hospitals. Treatment of intracranial stenosis is of paramount importance in terms of stroke prevention. It is one of the most gratifying procedures to perform. I have had patients significantly debilitated because of their symptoms who were able to resume normal lifestyle and work after treatment of stenosis with the Wingspan stent. I have given several radio, television and news interviews regarding intracranial stenting in general and wingspan in particular.

We are the only center in the state of WV and the surrounding counties of PA, OH and MD who offer this treatment. I am now getting patients from everywhere. The last patient I treated was a veteran from our VA hospital who couldnt get out of bed because of his dizziness. He is now back to work. Intracranial stent for symptomatic stenosis can not only prevent stroke but also has significant economic advantages. A person who can become a functional member of the society is a lot better than being a burden on it.

I strongly urge CMS to be deliver a positive, favorable decision. Thank You

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It is dangerous to force practitioners to use a stent when angiopalsty alone is sufficient for 75% of intracranial stenoses; as the results from several centers have indicated (Marks et al, forthcoming paper by Wojak et al, and numerous others). I for one will have to drastically reduce the number of patients with lesions SYMPTOMATIC on medical therapy that receive treatment because many of these lesions cannot be reached with the WingSpan device. I believe that WingSpan is a step in the right direction, but it is like what happens when all you have is a hammer - everything seems like a nail. I am not ready to risk patient's lives to use this device. They will just have to have their strokes. The WASID data and the GESICA study suggest over 20% of them will, within 1 year (since all I treat are >70% lesions, most with stroke as presentation). This is a huge step backwards, since I have had a documented 1.8%/year stroke rate in my treated patients, all of whom are followed independently by neurologists, and some of whom we have been following for 10 years. 80% of my patients receive angioplasty alone. Who is going to explain to my neurologists that what we have been having success with all along is wrong?

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I am a neurosurgeon who treats patients with intracranial atherosclerotic disease. We have had several patients who have continued to fail medical therapy as in the WASID study, who have shown considerable improvement with primary angioplasty and or stent placement. I believe a large randomized study is necessary to prove the efficacy of these treatments, but I also feel that there is considerable evidence in the literature from single centers (including ours) which supports both of these therapies. In so being, I do not feel that these treatment should be withheld from symptomatic patients for finacial reasons when there are currently no IDE trials in which they can be enrolled.

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I just want to encourage the CMS to carefully consider allowing reimbursement for angioplasty and stenting for symptomatic intracranial stenosis. It is clear from the results of the WASID trial that there is NO acceptable medical therapy which is able to reduce the rate of stroke in patients with this disease who are symptomatic. Several single center studies published in journal such as the American Journal of Neuroradiology and Stroke have shown that angioplasty in the intracranial circulation can be performed with a high rate of technical success and a low rate of complication. More important, the patients that we treat with symptomatic disease who are not responding to medical therapy have excellent outcomes with low rates of recurrent stroke. It is very difficult as a physician managing this problem to conceive of having to tell patients who are having repeated symptoms while on medical therapy that there is nothing that I can do because the procedure I would perform is not reimbursable. I urge you to consider allowing reimbursement in those situations where patients have failed medical therapy and they have no other options available to them. Thank you for your consideration of my comments

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I have used the WingSpan stent in one patient this year who was having daily TIA's despite maximum medical therapy. There would have been no way to get a coronary stent into the position of the MCA stenosis previous to the WingSpan stent. After the patient was treated, the patients sypmtoms completely resolved and she now leads a normal daily life. Without the stent, this patient would have eventually had a life devastating stroke. This new device is crucial for intracranial atherosclerosis and reimbursement needs to be addressed ASAP

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Please consider granting national Medicare coverage to intracranial angioplasty and stenting cases involving the Wingspan Stent under the current Humanitarian Device Exemption (HDE) labeled indication. Using the "safety plus probable benefit" (rather than "reasonable and necessary") in your approval coverage of this HDE device would significantly enhance hospital resource allocation and therefore patient access. Clinical rationale is as follows:

Two separate recently reported prospective multicenter studies indicate a 1-year stroke risk of 23% for >70% stenosis when treated medically (WASID, Circulation. 2006; 113:555-563) and a 2-year recurrent ischemic event rate of 38.2% (GESICA, Neurology. 2006;66:1887-1191). This represents nearly 700 patients meticulously studied, across multiple centers, in two continents.This terrible natural history (despite best medical treatment) contrasts with the comparatively better outcomes following angioplasty/stenting in WINGSPAN (11% composite stroke/death @ 6 months) and other studies (13.1% composite 1-year stroke rate in SSYLVIA, Stroke 2004;35:1388; 5.6% recurrent stroke over a mean of 26 months f/u in Yu et al, Neurology 2005;64:1055–1057).

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Medical device technology is rapidly evolving particularly for the treatment of strokes. What was previously considered untreatable now has genunine and effective treatment options. As with most medical conditions, prevention is the best form of therapy. There now exists an excellent preventative device for stroke related to intracranial atherosclerosis. The device is approved for this purpose by the FDA but paradoxically is not covered for payment by medicare or some insurers. This is an unfortunately an intolerable situation for most patients and clinicians who see the great benefit of this treatment yet because of cost constraints cannot apply it. I would strongly urge that CMS approve payment or coverage for intracranial stenting and angioplasty meeting the appropriate indication criteria.

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To whom it may concern, Neurointerventional Surgery and Borgess Medical Center–a division of Ascension Health, requests that CMS grant national Medicare coverage toIntracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication. CMS's current coverage review for the Wingspan® Stent System reflects a rigid application of the "reasonable and necessary" test in making national coverage policy. The "reasonable and necessary" standard should be less stringent in cases of HDE devices where there are no other viable treatments. The FDA recognizes an alternate level of clinical evidence (safety plus probable benefit) in its approval process for HDE devices, and CMS should rely on a similar standard of clinical evidence when considering coverage for HDE devices.

Recent publications reflect the safety and feasibility of intracranial angioplasty at our institution among others; these data are cited in the following recent publications and have been presented at national conferences by our primary provider.
Publications:
Gupta, R., AL-ALI, F., Thomas, A., Horowitz, M., Barrow, T., Vora, N., Uchino, K., Hammer, M., Wechsler, L., Jovin, T., Safety, Feasibility and Short Term Follow-Up of Drug Eluting Stent Placement in the Intra and Extracranial Circulation, Submitted Stroke, May 2006, In Progress
Marks, MP, Wojak, JC., AL-ALI F., Jayaraman , M., Marcellus, MI, Connors, JJ., Do HM. Angioplasty for symptomatic intracranial stenosis: clinical outcome.Stroke. 2006 Apr 3: 7 (4):1016-20
Poster Presentations:
AL-ALI, F., Reddy, A., Barrow, T., Sciamanna, M. PHD , Feasibility and Safety of Intracranial Arteries Endovascular Re-vascularization Angioplasty and Stenting in Patients with Symptomatic Atherosclerotic Stenosis. Joint Section AANS/CNS Cerebrovascular Section/ASITN 9th Joint Annual Meeting Feb 17-20, 2006, Orlando, FL
AL-ALI. F., Reddy. A,, Barrow. T., Sciamanna. M PHD. Feasibility and Safety Middle Cerebral Artery Angioplasty in patients with Symptomatic Atherosclerotic Stenosis. Joint Section AANS/CNS Cerebrovascular Section/ASITN 9th Joint Annual Meeting Feb 17-20, 2006, Orlando, FL

In our progressive, 468 bed, community hospitalwe have treated twelve patients in the past 12-months using the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication. Of these twelve patients there were two who experienced complications which extended their hospitalization beyond the expected 24-hour stay.The 10 patients that were treated with intracranial angioplasty and/or stent using the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication, have a median age of 55 years and by reducing the risk of stroke in this young population a significant savings is demonstrated. In a Medicare claims comparison published by Samsa et al in Stroke 30: 338-349; 1999. Costs for at least 2 years after stroke were highest for younger patients. In the first 3-months after stroke, including the initial hospitalization the cost averaged $10,459 for all patients, during the 4th thru the 12th months the cost averaged $14,016.00 and in the second year the cost averaged $10,900.00 per patient. By effectively treating our ten young patients, we demonstrate a cost savings of at least $353,730.00 for hospitalization costs alone and this does not reflect the savings of medication costs, rehabilitation, or physician costs. Additionally, the data does not reflect the cost associated with the expected longevity of our patients’ survival, nor does it address the cost of lost years of productivity.

We respectfully request that you extend coverage to intracranial angioplasty and stenting cases involving the Wingspan® Stent System with Gateway™ PTA Balloon Catheter under the current Humanitarian Device Exemption (HDE) labeled indication, in addition to your recommendation to propose national coverage for intracranial angioplasty and stenting within the context of a Category B Investigational Device Exemption (IDE) clinical trial.

Respectfully, Susan Louis BS, RN, CNRN

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I advise CMS to reconsider this decision. We know conclusively that patients with >70% symptomatic intracranial stenosis have a very high rate of strokes in the affected territory, about 23% within the first year even with aspirin therapy (WASID). This is similar to the 2 year risk of medical therapy for patients with 70% or greater symptomatic carotid stenosis. Similar to patients with 70% or greater symptomatic carotid stenosis, the highest risk period for the patient with intracranial disease is within the first few weeks after the initial event. While the WINGSPAN trial did not have enough patients to prove efficacy for stroke reduction with intracranial stenting, it did demonstrate that the stent could be deployed with high technical success and low initial complications (only 2/45 patients or <5% 30 day ipsilateral stroke and death). This complication rate compares favorably with the complication rate for carotid endarterecomy in symptomatic patients with 70% or greater stenosis (5-6% in NASCET, NASCET II). Certainly no one would suggest that patients who have a symptomatic 70% carotid stenosis should not have a carotid endarterecomy. Why then would CMS suggest that patients with severe symptomatic intracranial stenosis be treated medically?

My recommendation is that CMS offer coverage for symptomatic patients with 70% or greater intracranial stenosis. I do not advise CMS to require "failed medical therapy." We know from WASID that the failure rate is high (23%). It does not make anymore sense to require failure of medical therapy in the situation of intracranial stenosis than it would to require failure of medical therapy in the case of symptomatic cervical carotid stenosis.

I would recommend that CMS not offer coverage for symptomatic stenosis less than 70% or for asymptomatic disease as I do not believe a strong case can be made for the superiority of stenting to medical treatment in these situations.

I agree with CMS that it is preferable to enroll patients in clinical trials to track complications and outcomes on patients who undergo intracranial stenting. However, not all centers who are capable of offering this treatment at a high level will be able to participate in the trials, and not all patients agree to be enrolled. There also may not me time to enroll some patients who are treated urgently. This requirement will deny access to some patients who would otherwise benefit from intracranial angioplasty or stenting.

I would like to provide two brief examples of recent patients of mine:

First, a 67 year old man with a severe vertebral/lower basilar stenosis who was admitted with a clear cut posterior circulation TIA (dysarthria, clumsiness of the right side, numbness of the right side, diplopia). He was on aspirin at the time of the event. He had a second TIA in the hospital on therapeutic heparin and after the addition of Plavix. He was taken to the angio suite within a few hours of his second event and the stenosis was stented. He was discharged 2 days later. I saw him in the office after 4 weeks and he had no additional events. Should we really not have offered this patient intracranial stenting?

Second, an otherwise healthy 83 year old man with an acute onset of right hemiparesis and fluent aphasia and occlusion of the inferior division of the left middle cerebral artery. He presented outside the window for intravenous tPA. His MRI showed a tiny amount of infarct on the diffusion image and a large perfusion abnormality involving most of the left temporal lobe. He was taken to the angio suite and a small amount of tPA was infused into the occlusion, which resulted in restored but slow flow (TIMI 2), due to the presence of a severe underlying stenosis. This was angioplastied with a 1.5 mm balloon which resulted in normal flow. The patient made a complete neurologic recovery. Should we really not have offered this patient intracranial angioplasty?

Thank you for your reconsideration of this matter.

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Although stenting for intracranial stenosis seems to be an expensive endeavor, two facts must be considered. First, the natural history of symptomatic intracranial stenosis seems to be unfavorable and cost of stenting would be far outweighed by the cost of the care incurred by a subsequent stroke. Second, stenting is currently the only alternative to patients with symptomatic intracranial stenosis who have failed medical therapy. The decision not to reimburse the Wingspan stent is short-sighted and does not look ahead to the suffering and cost borne by the patient with intracranial stenosis who has no viable alternative to the Wingspan stent for stroke prevention.

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August 28, 2006

RE: NCA for Intracranial Stenting and Angioplasty (CAG – 00085R2)

Dear CMS Associate:

I write to request that you provide coverage for intracranial stenting for patients with symptomatic intracranial arterial stenosis. Although I am certain you will receive many comments backed by references from the literature, let me provide you with a brief and simple statement as to why noncoverage for these patients will result in patients suffering severe strokes and Medicare costs far exceeding those, which would be incurred if intracranial stenting for this devastating disease were covered.

The WASID Trial has proven two things. (1) Coumadin is no more effective than aspirin in the treatment of symptomatic intracranial disease and is associated with a higher risk of hemorrhage, i.e., Coumadin is more dangerous. (2) Best medical therapy for symptomatic intracranial stenosis results in a greater than 21% two year risk of stroke, i.e., with aspirin therapy.

Preliminary experience with Wingspan stent for intracranial stenosis shows morbidity rates in the 5% to 10% range with low rates of restenosis and subsequent neurologic ischemic symptoms.

Although the Wingspan is approved on a humanitarian device exemption, there is no reimbursement for hospitals or physicians. For this reason, many patients needing treatment will be left at risk for stroke of greater than 21% over a two year period. This seems to me inexcusable given the fact that we have what appears to be a more effective treatment from preliminary studies.

I would submit that this treatment needs to be subjected to further study. This may be a situation in which patients entered in registries should be covered by Medicare. An investigation device exemption does not appear feasible given the HDE approval.

We are planning a company sponsored registry with independent oversight, which we would submit should be covered by CMS given the severity of the consequences of medical treatment alone.

It is estimated that between 7% and 10% of all ischemic strokes in the United States are caused by intracranial atherosclerotic disease.

It is a known fact that up to 80% of intracranial stenosis caused strokes are not preceded by any warning TIA’s. Intracranial atherosclerotic disease has many parallels to coronary artery disease for which stenting has proved safe and effective.

Preliminary results with the Wingspan stent are strongly suggestive of a relatively safe and efficacious procedure.

Assuming the 7% to 10% incidence of strokes caused by intracranial atherosclerotic disease and the fact that most of these patients are likely covered with aspirin, it makes sense to assume that a 50% reduction in the incidence of strokes due to intracranial atherosclerotic disease could be achieved by stenting (assuming a 10% one year morbidity associated with the Wingspan Stent).

I would respectively request that Medicare reconsider its decision not to provide coverage for intracranial stenting. That decision in my opinion is “penny wise and pound foolish”.

Sincerely,

L.N. Hopkins, M.D.Chairman and Professor

LNH/amp

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Dear CMS,

As an interventional neuroradiologist, I treat patients with intracranial arterial stenoses. We have been unable to perform intracranial stenting with the Wingspan device as our medical center is requiring that patients supply a bond in the amount of three times their hospitalization cost to allay our medical center's concern that the Wingspan stent and the entire hospitalization relating to it will not be covered by insurance. This is obviously an intimidating burden for patients. This situation has also forced my practice group to use off label coronary and other stents for patients in need of intracranial interventions. It is disappointing that CMS is only approving reimbursement for the Wingspan/Gateway for IDE trials, as the Wingspan/Gateway has FDA HDE approval. I encourage CMS to reconsider its ruling and approve reimbursement for Wingspan/Gateway for patients with intracranial stenoses.

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I am a practicing neuro interventional radiologist at UCSF Medical Center. I specialize in the diagnosis and treatment of acute ischemic stroke, and want to offer my patients, "state of the art" treatment for stroke. I am urging that CMS, reconsider its current ruling, to not fully reimburse payment to both hospitals and physicians, who use the FDA approved Wingspan Intracranial Stent System, and Gateway Balloon, for treatment of patients who have suffered a stroke, and are at high risk, for recurrent stroke and death. I am asking CMS to reconsider their rulilng, and to allow payment and reimbursement for the diagnosis and use of this device for stroke treatment.

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I'm requesting that CMS grant national coverage to intracranial angioplasty and stenting cases involving the Wingspan Stent System with Gateway PTA Balloon Catheter under the current humaniatarian Device Exemption label.

Our NeuroInterventional Lab performed 12 such procedures in the last 11 months. Following are the 3 month outcomes:

III. Follow up(3 months)

The size population size is limitd the outcomes are robust. This option assist those patients who are unable to achieve healthier results by practicing therapeutic lifestyes interventions.

Please reconsider your stance and allow this procedure and device to available to those patients at greatest risk. Thank you.

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I am a vasular Neurologist at the University of Pennsylvania and I am writing to ask CMS to grant national Medicare coverage to medically refractory intracranial angioplasty and stenting cases. There is high level evidence from the WASID study that patients with symptomatic intracranial disease are at tremendous risk of recurrence despite medical therapy; specific subgroups such as those with >70% stenosis and recent symptoms have a risk of recurrent stroke that exceeds 25% in the first year. Further, there is impressive preliminary evidence that the Wingspan intracranial stenting system is well tolerated and effective at revascularizing the symptomatic stenotic vessel. As a referral center, we see a large number of patients with medically refractory symptomatic intracranial stenosis and we have had a multitude of bad outcomes in patients who were treated medically. We have also used the Wingspan stent in 6 patients with willing insurance companies or who were willing to pay out of pocket and each patient has done well, with no recurrent events. I truly feel that his device saves lives and prevents strokes. Please contact me if you have any questions.Regards,Steven Messe, MD

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I am a neurointerventionalist in Des Moines, Iowa. My Boston Scientific rep informed me of the FDA approval of intracranial angioplasty and stenting but without any reinbursement by medicare. This is absurd. Please fix this problem if you want this potentially lifesaving procedure available. In addition, the overall medicare reimbursements for almost all technically difficult and time intensive neurointerventional procedures pales in comparison to the time and reimbursements for other radiology reimbursements, especially in Iowa... the lowest medicare reimbursed state in the nation.

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Covering this procedure because the FDA has given an HDE appears contrived. As stated, an HDE is for conditions that affect fewer than 4,000 individuals in the U.S. Also, as stated, Of the 900,000 strokes or transient ischemic attacks (TIAs), about 70,000 to 90,000 are caused by intracranial arterial stenosis (Chimowitz et al., 2005). I'm missing something; why did the FDA make the decision to provide an HDE for the device with numbers such as these, and then why did Medicare agree to cover based only on the HDE?

I obviously have missed something, but it seems as though strange decisions were made.

I agree that these individuals have little proven therapeutic options. But the reasoning by both the FDA and CMS appears obtuse.

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