Intracranial Stenting and Angioplasty

Intracranial angioplasty and stenting has not yet been shown to reduce the risk of stroke in patients with symptomatic intracranial stenosis. A randomized trial is currently being launched to investigate this. I strongly urge that CMS reimburse for this procedure in carefully selected patients who are both refractory to medical treatment and are enrolled in a trial or registry. In my experience, nearly every patient who is a serious candidate for intracranial intervention is desperate for treatment and will agree to undergo angioplasty and stenting even though they, for all practical purposes, will eventually be billed for both the devices and the procedure. A practical benefit of a CMS decision to reimburse for this procedure is that these patients, who will be treated anyway, will be enrolled in a study. The clinical data resulting from these cases will serve to determine which patients actually do benefit from this procedure.

Less

March 15, 2008

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard, Mail Stop C1-09-06
Baltimore, MD 21244

Re: February 14, 2008 Proposed Decision Memorandum for Intracranial Stenting and Angioplasty (CAG-00085R5)

Dear Dr. Phurrough:

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

As the world’s largest company dedicated to the development, manufacturing and marketing of less-invasive therapies, Boston Scientific has advanced the practice of less-invasive medicine by providing a broad and deep portfolio of innovative products, technologies, and services across a wide range of medical specialties.

Boston Scientific has also dedicated significant research and development resources, clinical and regulatory expertise to develop products that serve small patient populations for whom treatment alternatives are nonexistent or ineffective. Intracranial stenting and angioplasty using the Wingspan® Stent System with Gateway® PTA Balloon, which was approved by the Food and Drug Administration (FDA) as a humanitarian use device (HUD), exemplifies this commitment to care for vulnerable populations, and we are proud of this innovative technology that has the potential to offer substantial benefits to patients.

Executive Summary
Boston Scientific is extremely disappointed with CMS’ proposed decision to not cover intracranial stenting with angioplasty within the context of an observational study, and respectfully urges CMS to reverse its position in its final decision.

The multi-center, multi-year prospective observational study proposed by Boston Scientific would provide a controlled research environment for the collection of robust safety and clinical event data for a vulnerable patient population at high risk for stroke and death. Specifically, the study would collect outcomes data on patients with 50-69% stenosis who have failed medical therapy. On multiple occasions, the observational study’s protocol, design and outcomes measures were discussed at length with CMS coverage staff in the days, weeks and months leading up to the proposed decision. We were extremely surprised and deeply discouraged to see our work and collaboration with CMS staff on the details of the study derailed by a flawed and unnecessarily restrictive interpretation of Medicare statutes.

Intracranial stenting and angioplasty using the Wingspan® stent system has been widely supported by interventional physicians and patient groups for years, and is available throughout Europe, Canada, Hong Kong, Argentina, China, Singapore, Thailand and Australia. It is also a service covered by many private health insurance plans, which have traditionally been very cautious in providing care using humanitarian use devices.

Almost three years after the FDA’s approval of the Wingspan stent system under a humanitarian device exemption (HDE), the majority of patients that could benefit from this unique and innovative technology are no closer to gaining access to this treatment under CMS’ proposal. In fact, the proposed coverage decision negates the intent of the HDE approval, impeding access to the technology for patients without other therapeutic options, and impeding the collection of additional data. Medicare beneficiaries face the prospect of forgoing the treatment or paying out of pocket for the procedure.

If CMS does not expand coverage for patients enrolled in the proposed observational study, as discussed below, patients with 50-69% stenosis who have already failed medical therapy may never have coverage for this promising treatment. We believe this would be a mistake, contrary to CMS policy goals and detrimental to vulnerable Medicare patients in the greatest need of treatment alternatives.

As discussed below, we believe that the Medicare statutes allow CMS to expand coverage for intracranial stenting and angioplasty performed as part of an observational study. We request that CMS expand coverage for this treatment when performed as part of an observational study that meets the criteria specified by CMS for other technologies that are covered in the context of clinical studies. If CMS chooses not to expand coverage, we respectfully request that CMS provide a full written explanation of its policy and legal rationales for not extending coverage under this request.

Disease State
Intracranial atherosclerotic disease (ICAD) accounts for 8-10% of all ischemic strokes in the United States. The stroke risk in patients with ICAD disease ranges from 7 to 24% per year. Patients with refractory ICAD who have diseased vessels with ≥ 50% stenosis have no other treatment options and face an unacceptable risk of another stroke. The availability of endovascular treatment such as the Wingspan stent may be critical to patients’ long term prognosis and quality of life. As many as half of ICAD patients not responding to medication suffer a stroke or other adverse medical event within a median time of 36 days, with half of these involving a major stroke or death within this time frame.¹ Stroke is the third leading cause of death in the U.S. and it is the leading cause of long-term disability.² The annual cost is about $65.5 billion in direct medical costs and indirect costs including losses in productivity.³

Response to Clinical Concerns Raised by CMS
CMS’ proposed decision includes an analysis of recently published Wingspan® clinical studies. While the studies cited in the discussion are relevant, CMS’ conclusions seem to be drawn largely on asymptomatic restenosis measures and less on clinical outcomes such as stroke and death rates, measures that CMS has required in determining the appropriateness of treatments and measures that we had proposed in our observational study as discussed with CMS.

The primary question for analysis posed by CMS in the memo states "Is the evidence sufficient to conclude that percutaneous transluminal angioplasty [(PTA)] and stenting of symptomatic intracranial artery stenosis ≥50% improves health outcomes?" The studies cited as evidence against Wingspan improving health outcomes are by Levy and colleagues⁴, Fiorella and colleagues⁵ and commentary by Kallmes and Cloft⁶ .

As stated in the proposed decision, Levy and colleagues reported "[t]he ISR (in-stent restenosis) rate with the Wingspan stent is higher in our series than previously reported, occurring in 29.7% of patients." Restenosis was also cited as the primary concern from Kallmes and Cloft. When interpreting these comments, it is critical for CMS to not view restenosis as an appropriate or reliable measure for determining whether the treatment "improves patient health outcomes."

Patient outcomes are almost universally defined as stroke and/or death at various time points or a change in score on a stroke/disability scale. For example, ICAD patients treated with medications alone continue to have stenosed lesions, but, appropriately, this is not considered when interpreting whether or not the medication was effective. For the stented patients from Levy and colleagues who experienced restenosis, the majority (76%) had not experienced any clinical symptoms at the time of the report. Furthermore, patients who presented with restenosis primarily presented with minor events such as TIAs or minor strokes. In a follow-up paper, Turk et al reported that "[t]he overall rate of ISR in patients after Wingspan treatment in our series thus far (29 of 93 lesions) is 31.2%, with a rate of symptomatic ISR of 9.7% (9 of 93 lesions)."⁷ (emphasis added) We would urge CMS to place the restenosis data as telling a small story within a much larger and more important context, namely the relief of symptoms and threat of stroke.

However the Turk et al paper provides further insight into the ISR for Wingspan patients. Specifically, angiographic restenosis appears to be concentrated in one lesion location, the supraclinoid segment of the ICA. Turk et al hypothesize that these supraclinoid ICA lesions represent more of an inflammatory arteriopathy than a primary atherosclerotic process. These lesions may fall somewhere within the spectrum of a "Moyamoya" type of arteriopathy, which characteristically occurs in younger patients, affects the supraclinoid ICA, and spares the posterior circulation⁸ . If this group of lesions (15/93) is excluded, symptomatic ISR drops to 3.9% (3/78)⁹. (emphasis added)

Also referenced by CMS, Fiorella and colleagues state that this procedure is invasive and involves significant risk (5-6% risk of stroke/death within 30 days). It is important to note, however, that these risks are miniscule compared to the risks these patients endure if they do not receive a stent. To put this relative risk in context, Thijs and Albers¹ clearly revealed that an ICAD patient who fails medical therapy has a substantially higher chance of suffering another event. This patient population is at high risk of severe and debilitating outcomes, and treatment with Wingspan® is a safe and viable approach to managing this risk. FDA approval of the Wingspan stent system under an HDE classifies the indicated patient population as a small group for whom no other viable treatment alternatives are available. Clearly what CMS has recognized to be inherent in the definition of "reasonable and necessary" would support coverage for this small high risk patient population

Reasons CMS Should Cover an Observational Study
We believe there are several compelling reasons why CMS should cover intracranial stenting and angioplasty cases performed as part of our proposed observational study. The observational study would complement the planned NIH-sponsored trial. Coverage would provide access to a technology offering crucial benefits under a controlled environment for beneficiaries who have already failed medical therapy. Data collected through an observational study could be used by CMS to make future coverage decisions as well as by clinicians to improve management of patients with ICAD. CMS’ proposal for this request is inconsistent with a recent proposal for another HDE technology.

Observational Study Would Complement NIH-Sponsored Clinical Trial
At several times during the reconsideration period, concerns were expressed by researchers and CMS about the need to ensure that the observational study would not detract from or in any way hinder patient enrollment in the National Institutes of Health (NIH) funded clinical investigational device exemption (IDE) trial (SAMMPRIS) expected to begin later this year.

Toward that end, the inclusion criteria of the observational study were modified to prevent any overlap with SAMMPRIS, and to ensure that the observational study proposed by Boston Scientific would evaluate a separate and distinct patient population from those enrolled in the NIH clinical trial. This important clinical trial will compare the Wingspan Stent System with Gateway Balloon Catheter to medical therapy alone in patients with stenosis of 70% or greater, while the observational study would examine on-label medically refractory patients with stenosis of 50-69%.

We strongly support the SAMMPRIS study and believe the observational study would complement SAMMPRIS trial findings, while permitting a treatment option for a vulnerable patient population with ICAD. In addition, we note that the principal investigators for SAMMPRIS support the design of our observational study.

In its proposed decision, CMS states that coverage of "non-IDE trials would provide useful evidence" concerning this procedure and noted that it has covered research studies in similar circumstances under its "coverage with evidence development" ("CED") concept. We concur with CMS on this point, and believe this bolsters rather than weakens the case for covering our observational study.

Coverage Provides Access for Beneficiaries
Almost three years after the FDA’s approval of the Wingspan® stent system under a humanitarian device exemption (HDE), the majority of patients that could benefit from this unique and innovative technology are no closer to gaining access to this treatment under CMS’ proposal. In fact, the final coverage decision negates the intent of the HDE approval, impeding access to the technology for patients without other therapeutic options, and impeding the collection of additional data.

If CMS does not expand coverage for patients enrolled in the proposed observational study, as discussed below, patients with 50-69% stenosis who have already failed medical therapy will likely never have coverage for this treatment that can reduce the risk of stroke. Expanding coverage through an observational study would provide these patients with access to intracranial stenting and angioplasty. Furthermore, the study would be conducted under a controlled environment, one that would include "additional patient safeguards", which CMS noted in its November 2006 decision memo in justifying coverage of intracranial angioplasty and stenting in Category B IDE trials.

Observational Study Data Would Guide Future Coverage and Improve Data for Better Clinical Management
The long-term outcomes data that would be collected in the proposed observational study will be useful in making future coverage decisions. We have proposed collecting long-term outcomes data, the type of data CMS encourages study sponsors to collect to inform coverage decisions. The data will also be useful to clinicians and others in determining treatment modalities for patients with 50-69% stenosis who have failed medical therapy. In fact, in its proposed decision, CMS states that "non-IDE trials would provide useful evidence as well" for intracranial angioplasty and stenting.

Recent CMS Coverage Decision on HUD Technology
On February 1, 2008, CMS proposed coverage of an observational study for artificial hearts, a technology that also has a previously existing Medicare non-coverage policy in effect, and that is approved by the FDA under an HDE.

We commend CMS for its proposed artificial heart decision, and believe that the coverage of the artificial heart observational study that addresses certain questions and meets certain criteria embodies the best of CMS’ CED policy. Under CED, extension of coverage for promising technology is provided in return for enhanced data collection to gain clinical evidence on the value of the treatment.

Still, the inconsistency in Medicare coverage proposals for FDA-approved HDE technologies is stark. We understand CMS views the existing coverage for Category B IDE trials for intracranial stenting as the differentiating factor, but from a practical standpoint of getting data collected on patients that could benefit, it looks as though in similarly situated if not identical cases, CED coverage is being granted for some technologies but not for others.

CMS’ Policy and Legal Rationales Inconsistent with Statute and Recent Decisions
We appreciate that CMS has never questioned the merits or value of expanded coverage for intracranial stenting and angioplasty. Instead, CMS has proposed not to expand coverage because of an unspecified legal interpretation, not previously articulated, that prohibits coverage from being expanded so long as coverage (albeit limited) exists under a different statutory authority.

CMS suggests that expanded coverage to non-IDE studies would constitute coverage with study participation (CSP), one form of CED, and that CSP is applicable only when the evidence is not adequate for coverage under section 1862(a)(1)(A) of the Social Security Act (SSA). Accordingly, CMS explains, "because coverage exists under §1862(a)(1)(A) for beneficiaries in certain IDE trials," that fact effectively "prevent[s] any further expansion for these individuals under section 1862(a)(1)(E)." Thus, it appears that CMS is contending that the existing coverage for intracranial angioplasty and stenting under section 1862(a)(1)(A) precludes coverage of this service for non-IDE studies conducted under the authority of section 1862(a)(1)(E) – i.e., that these two coverage provisions are mutually exclusive.

Basing the proposed decision on the assumption that these two coverage provisions are mutually exclusive erects a barrier when none in fact exists. Certainly, we would agree that where there is unconditional coverage for a service under section 1862(a)(1)(A), it would be inappropriate for CMS to seek to impose coverage conditions (thus effectively narrowing coverage) under section 1862(a)(1)(E). In this sense, the two coverage provisions may be seen as mutually exclusive. However, in order for this notion of mutual exclusivity to apply, the coverage under section 1862(a)(1)(A) must actually be available. Where, instead, CMS has determined that a procedure is reasonable and necessary under section 1862(a)(1)(A) only in certain circumstances – for example, only for patients undergoing the procedure as part of an IDE trial – this limited coverage in no way precludes the possibility of additional coverage in other circumstances under another authority, such as section 1862(a)(1)(E), subject to limitations appropriate for use of that authority.

In the case of intracranial angioplasty and stenting, the subgroup of patients for whom coverage is now sought is necessarily distinct from the patients for whom coverage is currently available. Thus, there is no overlap created by use of both coverage authorities, no impermissible narrowing of existing section 1862(a)(1)(A) coverage, and the idea of mutual exclusivity is simply inapplicable. Further, any conclusion that section 1862(a)(1)(A) and section 1862(a)(1)(E) are mutually exclusive in a situation such as this one is unsustainable under a plain reading of the text of the Medicare statute, the clear intent of Congress as reflected in the structure of the statute, and the agency’s own precedent which make clear that an item or service can be covered under both provisions. Ultimately, the "legal concerns" that seem to be impeding coverage here are unsupportable. Additionally, given that the statutory language does not require CMS to limit coverage to a single authority, it is very difficult to discern the policy decision to interpret the statue in this narrow fashion, particularly given that the result is to negate the application of the HDE authority to provide this technology to a small patient population without further clinical options.

There Is No Coverage Overlap that Would Prevent Coverage Under Section 1862(a)(1)(E)
Whether section 1862(a)(1)(A) and section 1862(a)(1)(E) are mutually exclusive in some circumstances is not relevant to this national coverage analysis because it involves a different set of patients than that for which coverage currently exists. Indeed, as detailed below, the individuals to whom coverage would be extended pursuant to our request cannot be covered under the current coverage in section 20.7(B)(5) of the Medicare National Coverage Determinations Manual. With no overlap between the current coverage and that now sought, CMS cannot claim that section 1862(a)(1)(A) coverage prevents section 1862(a)(1)(E) coverage.

As indicated in the above-referenced manual provision, the current coverage of PTA and stenting of intracranial arteries applies to "the treatment of cerebral artery stenosis ≥ 50% in patients with intracranial atherosclerotic disease when furnished in accordance with the FDA-approved protocols governing Category B IDE trials." The issue under consideration in this national coverage analysis is whether to expand on-label coverage for individuals who are not in an IDE trial because there is currently no coverage for those individuals. Providing coverage under section 1862(a)(1)(E) thus would be for an entirely different set of individuals (and for services provided under different conditions) than those who fall within the current 1862(a)(1)(A) coverage, as an individual is either in an IDE study or not.

Patients who would be eligible to participate in the study for which we are seeking coverage – medically refractory patients with intracranial artery stenosis ≥ 50% but less than 70% – would not be covered under the existing section 1862(a)(1)(A) coverage because they are not eligible for the only planned IDE study. In fact, the patients who would be enrolled in the study proposed by Boston Scientific may never be eligible for any IDE study for two reasons. First, the FDA almost certainly would not issue an IDE for a study of this patient population, since it falls completely within the HDE-approved indication for the Wingspan® stent. This is evident from the following portion of an FDA document entitled "Humanitarian Device Exemption (HDE) Regulation: Questions and Answers."¹⁰

Since Boston Scientific’s study is within the FDA-approved indication, the above makes clear that there is no role for an IDE. In fact, the FDA has informed us that it would not issue an IDE for a study of only on-label HDE patients. As a result, there can be no coverage for intracranial PTA and stenting for this on-label population (patients with 50-69% stenosis who are refractory to medical therapy) under the existing section 1862(a)(1)(A) coverage, and accordingly no reason not to extend coverage to these patients under section 1862(a)(1)(E).

Second, because of ethical reasons, this population could not be enrolled in an IDE study. As noted above, the FDA will only provide an IDE for the population if it is part of a new label indication. The only practical new label indication for this population would be for all patients with 50-69% stenosis, regardless of whether they are refractory to medical therapy. However, designing an IDE study for such a population would be challenging because almost all clinicians believe that individuals with 50-69% stenosis who have not had a stroke should first be managed on medical therapy. Undertaking such a study would raise ethical issues as well as enrollment issues, making such a study almost impossible.

There should be no question that CMS can make different coverage determinations for different patient populations. For instance, in the NCD on positron emission tomography for brain, cervical, ovarian, pancreatic, small cell lung, and testicular cancers, CMS found that the evidence was sufficient to support coverage without conditions in one patient population (newly diagnosed cervical cancer), but that for other patient populations (the other subject indications), the evidence was only sufficient to support coverage when the procedure was done as part of a clinical study.¹¹ Similarly, here, there are two separate populations to consider – patients who are in an IDE trial and those who are not and are never likely to be in an IDE trial. CMS can determine that, for the former patient population, there is sufficient evidence for section 1862(a)(1)(A) coverage and that, for the latter patient population, while the evidence may be insufficient to support coverage under section 1862(a)(1)(A), coverage under section 1862(a)(1)(E) is appropriate.

This type of analysis is supported by the agency’s guidance document on CED.¹² According to this document, if CMS decides that the evidence is adequate to determine that the item or service is reasonable and necessary under section 1862(a)(1)(A), it may find the item or service to be covered by Medicare. If the agency decides that there is limited evidence to support a decision to cover the item or service and that more evidence is needed, it may find that coverage is not reasonable and necessary under section 1862(a)(1)(A) and then could consider coverage under section 1862(a)(1)(E).

In November of 2006, the agency found that intracranial PTA with stenting for patients in an IDE trial is reasonable and necessary.¹³ The current analysis is focused on patients who are not in an IDE trial and the agency can once again proceed through the coverage chain in the CED guidance document – i.e., determine if the evidence for these individuals is sufficient to make a reasonable and necessary finding and, if not, assess whether coverage is available under section 1862(a)(1)(E). As a result, even if sections 1862(a)(1)(A) and 1862(a)(1)(E) were mutually exclusive, as CMS contends, this is not relevant to the disposition of this coverage issue because of the distinct patient populations that are subject to the current coverage policy and would be subject to the expanded coverage policy sought by Boston Scientific.

A Determination that Coverage Cannot be Provided under both Sections 1862(a)(1)(A) and 1862(a)(1)(E) Would Contravene the Language of the Statute and Congressional Intent, as well as CMS’ Prior Decisions
In the Proposed Decision, CMS notes that the clinical evidence Boston Scientific presented is "promising" and that additional information from "non-IDE trials would provide useful evidence as well". The agency also indicates that it has covered this type of research in other national coverage determinations through the CED concept, but that it cannot do so here because of the existence of coverage under section 1862(a)(1)(A) for the service at issue. The notion that the requested coverage cannot be granted through CED under the authority of SSA § 1862(a)(1)(E) because of the existing section 1862(a)(1)(A) coverage cannot be sustained when considering the Medicare statute, congressional intent, and the agency’s prior actions.

Reading coverage under section 1862(a)(1)(A) and section 1862(a)(1)(E) as mutually exclusive is contrary to the plain language of the statute. Section 1862(a)(1)(A) of the SSA states that, notwithstanding any other provision of the Medicare statute, coverage will not be available for an item or service unless it is reasonable and necessary for the diagnosis or treatment of an illness or injury, or to improve the functioning of a malformed body member. However, the law also contains exceptions under which a qualifying item or service can be covered even though it does not meet the reasonable and necessary test. These exceptions are described in section 1862(a)(1)(B)-(N), and one of them – section 1862(a)(1)(E) – permits coverage of research conducted pursuant to SSA § 1142.

Thus, section 1862(a)(1)(E) represents a Congressionally authorized expansion of coverage beyond that permitted under section 1862(a)(1)(A) by itself. To conclude that an item which is covered as "reasonable and necessary" in some, but not all circumstances, cannot be covered in those other circumstances under an otherwise applicable exception is to negate the expansion Congress intended to provide. The statute simply does not limit the availability of coverage under one of the exceptions only to items and services for which there is never, in any circumstances, coverage under section 1862(a)(1)(A). Rather than being mutually exclusive, section 1862(a)(1)(A) and the exceptions to it, including section 1862(a)(1)(E), were carefully crafted by Congress to provide for multiple bases for Medicare coverage of an item or service in a variety of situations.

CMS’ statement that coverage for patients in IDE trials under section 1862(a)(1)(A) is "preventing any further expansion [of coverage] for these individuals" is simply contrary to the plain text of the Medicare statute and contrary to the clear intent of Congress. The agency’s apparent position¹⁴ is that the section 1862(a)(1)(A) coverage afforded for intracranial stenting and angioplasty for patients who are in an IDE trial prevents section 1862(a)(1)(E) coverage for other patients. This position is irreconcilable with the Medicare statute and the intent of Congress that the latter provision offer an opportunity for Medicare coverage that otherwise would be prohibited under section 1862(a)(1)(A). Boston Scientific urges CMS to honor the statutory text and the intent of Congress and utilize section 1862(a)(1)(E) to facilitate the collection of even more "promising" information on intracranial stenting and angioplasty by authorizing coverage under CED, as it has done for other items and services.

In other contexts, CMS apparently has reached the same conclusion that we believe is compelled by a plain reading of the Medicare statute – that section 1862(a)(1)(A) and section 1862(a)(1)(E) are not mutually exclusive. In other words, CMS has made clear that the same item or service can be covered under section 1862(a)(1)(A) and section 1862(a)(1)(E).

This position is evident in the context of the CMS clinical trial policy, where coverage of an item or service that is part of a qualifying trial is authorized under section 1862(a)(1)(E) while the same item or service not furnished as part of a trial may be covered under section 1862(a)(1)(A). Since the agency first issued a national coverage determination on clinical trials, the basis for the authority for such coverage has been section 1862(a)(1)(E). Indeed, the first sentence of the initial NCD on clinical trials reads: "This national coverage policy is based upon the authority found in §1862(a)(1)(E) of the Social Security Act."¹⁵ Accordingly, an item or service that is covered pursuant to CMS’ clinical trial policy is covered under section 1862(a)(1)(E).

For example, the clinical trial policy provides for coverage under section 1862(a)(1)(E) for routine costs in clinical trials, which include "[i]tems or services that are typically provided absent a clinical trial (e.g., conventional care)."¹⁶ When the same "conventional care" is provided outside of the context of a clinical trial, it should be covered under section 1862(a)(1)(A). This seemingly clear implication from CMS instructions illustrates that the agency envisions that the same item or service could be covered under section 1862(a)(1)(A) and section 1862(a)(1)(E).

This rationale applies not just to conventional care, but also to the item or service under investigation in a trial. On July 9, 2007, CMS issued a final decision memorandum regarding clinical trial coverage in which it stated:

This clarification indicates that an item or service that is under investigation may be covered under the clinical trial policy (i.e., section 1862(a)(1)(E) coverage) provided that the same item or service would be covered outside the context of a clinical trial. Of course, coverage outside the context of a clinical trial would have to be section 1862(a)(1)(A) coverage, since that is a coverage requirement that applies to all items and services "[n]otwithstanding any other provision of this title . . . ." SSA § 1862(a).

As these examples demonstrate, under CMS’ clinical trial policy, the same item or service can be covered under section 1862(a)(1)(A) (when not part of a trial) and section 1862(a)(1)(E) (when part of a trial). Denying the coverage we seek under section 1862(a)(1)(E) because of the existence of section 1862(a)(1)(A) coverage thus would not only be contrary to the Medicare statute, but it would also represent arbitrary and capricious agency action.

We also cannot understand why CMS would be taking this approach in the context of a device that its sister agency has specifically recognized as one that should be made available to a small patient population for humanitarian reasons, as reflected in the granting of an HDE. It makes little sense for CMS to negate the FDA’s action to approve the HUD status for the Wingspan® stent by refusing at every turn the possibility of Medicare coverage of the device.¹⁷

The Agency’s Legal Concerns About the Use of CED Are Unfounded
As evidenced in the Proposed Decision, the agency’s apparent legal concerns with expanding coverage are inherently contradictory and unsupportable. On the one hand, CMS says that the existing evidence is inadequate to support coverage under section 1862(a)(1)(A) for patients who are not enrolled in an IDE trial. On the other hand, CMS indicates that the existence of section 1862(a)(1)(A) coverage precludes the application of CED here. The agency cannot have it both ways: either the evidence supports coverage under section 1862(a)(1)(A) for patients being treated within the scope of Boston Scientific’s intracranial stent labeling (and therefore outside of an IDE trial), or it does not, in which case there is no section 1862(a)(1)(A) coverage that can preclude the application of CED. Whichever direction the agency follows at this fork in the road, the path leads to coverage of intracranial angioplasty and stenting for patients in an observational study.

In the Proposed Decision, CMS acknowledges that the evidence we presented is "promising" but does not find that it supports coverage under section 1862(a)(1)(A). We disagree, particularly when the full body of evidence that supports the existing coverage for PTA and stenting is considered in addition to the more recent information submitted.

In the November 6, 2006, final decision memorandum on PTA and stenting, CMS found that the evidence we presented was adequate to support coverage for patients in an IDE trial. The rationale for requiring that a patient be in an IDE trial was not discussed extensively, but seems to have been based on a belief that the "additional patient safeguards" that are present with an IDE trial elevate the evidence to a sufficient level. We believe that the same additional patient safeguards are applicable when a device is used in a study, such as the one proposed by Boston Scientific, that requires Institutional Review Board (IRB) approval and informed consent. As such, we believe that the same evidence that CMS relied on to allow coverage conditioned on patients being in an IDE trial also could be relied on to allow coverage conditioned on patients being in a study that involves IRB approval consistent with 21 C.F.R. Part 56 and requires informed consent consistent with 21 C.F.R. Part 50.

Indeed, this is the approach the agency took in the context of a national coverage determination regarding carotid artery angioplasty and stenting. In that determination, the agency compared the relative patient protections in an IDE study with those available in a post-approval study in which an IRB would be utilized. In the decision memorandum,¹⁸ the agency said:

In that decision, CMS determined that the presence of an IRB provided a level of patient safeguards equivalent to those available in an IDE trial, and concluded that coverage of carotid PTA concurrent with stenting in those circumstances "is reasonable and necessary." NCD for Percutaneous Transluminal Angioplasty (PTA) (20.7), section B.3.

With regard to the coverage of intracranial angioplasty and stenting, the same evidence that supports the existing coverage for patients enrolled in an IDE trial would also be applicable to the patients enrolled in the observational study for which we seek coverage. Given that this study would include an IRB, providing what the agency has said is a level of patient safeguards equivalent to that available in an IDE trial, we believe that the evidence supports coverage for patients in the study under section 1862(a)(1)(A), just as CMS has determined that it supports the existing coverage for patients in IDE trials.

As noted above, we believe that CMS could take the position that the requested coverage is supportable under section 1862(a)(1)(A). Should CMS take a contrary view, as it has done in the proposed decision, an alternate coverage option must be via CED, under the authority of section 1862(a)(1)(E). As we understand it, CMS may believe that this option is not available on the grounds that the agency is legally precluded from utilizing CED absent an existing otherwise applicable national noncoverage determination. This legal reasoning is flawed and inconsistent with recent NCD issuances.

We also fail to see how the rationale for determining that there must be a total national noncoverage policy in place before CED can apply can be squared with the December 14, 2007 proposed coverage decision for continuous positive airway pressure therapy (CPAP) for obstructive sleep apnea (OSA). Coverage for CPAP is set forth in NCD Manual § 240.4 and the only national noncoverage provided therein has been for CPAP diagnosed by means of unattended portable multi-channel sleep study testing. In the recent proposed decision memorandum,¹⁹ CMS explained that this national noncoverage relates to diagnosis using "Type II Devices based on the 1994 ASDA classification." Under the proposed decision, CMS would have expand coverage for CPAP diagnosed by a number of unattended home sleep testing devices under section 1862(a)(1)(A), but would also allow for coverage under CED for patients with a clinical diagnosis of OSA but who have not had a polysomnography or a Type II, III, or IV home sleep testing. Clearly, this use of CED does not relate to and was unnecessary to overturn the national noncoverage of CPAP (CPAP diagnosed by a Type II device), yet the agency determined that it is legal to allow CED in this context. We fail to see a distinction between the CPAP proposed decision and the coverage for PTA and intracranial stenting that we now seek.

We also note that in a final decision released on March 13, 2008 (CPAP Therapy for OSA (CAG-00093R) to allow coverage of CPAP based upon a diagnosis of OSA by home sleep testing (HST), CMS reaches the same conclusion. In that final decision, CMS has "determined that the evidence is adequate to conclude that CPAP is reasonable and necessary under section 1862(a)(1)(A) of the Act for adult beneficiaries with OSA diagnosed by a clinical examination accompanied by a positive PSG, Type II HST, Type III HST or a Type IV HST measuring three of more channels." In the same decision, CMS also determined that "while we have not found adequate evidence to determine that CPAP is reasonable and necessary under § 1862(a)(1)(A) in beneficiaries who have a clinical diagnosis of OSA but have not had a positive PSG or a Type II, III, or IV (measuring three or more channels) HST , there is some evidence that suggests that other diagnostic tests or a clinical diagnosis alone may improve outcomes. Thus, we have determined that CPAP is covered in beneficiaries who have a clinical diagnosis of OSA but have not had a PSG or a Type II, Type III, or CMS recognized Type IV HST only when provided in a clinical study that meets the AHRQ requirements originally set forth in the proposed decision and finalized here [using section 1862(a)(1)(E) authority]." Clearly, CMS will now be covering CPAP using its authority under section 1862(a)(1)(A) and section 1862(a)(1)(E).

************************************************************************

No matter what coverage decision CMS ultimately makes, CMS has a broader responsibility with regard to coverage decisions which we do not believe it to be upholding – to establish and follow clear standards that are consistent with the Medicare statute governing the coverage decision-making process. While we recognize that CMS includes a rationale for its determinations in each decision memorandum, without clear guidance on how the standards for coverage are applied, the public must comb through the various decisions to ascertain the applicable standards. Moreover, even when that is attempted, no discernible patterns emerge. To the contrary, as noted above, CMS appears to change its approach and theories from decision to decision. The public has a right to know what the applicable standards are, and it is incumbent upon CMS to provide clear guidance that serves this important purpose. Therefore, we respectfully request that CMS provide a full written explanation of its policy and legal rationales for its final decision.

Boston Scientific is proud of its intracranial stenting technology that clinicians choose to use to extend and improve the lives of patients with ICAD at high risk of stroke and death. These physicians view providing this treatment option to their high-risk patients as an ethical imperative, and make a professional, informed decision to perform this service despite the current lack of Medicare coverage.

Finalizing the proposal as is would represent a missed opportunity for CMS, and set a legally flawed precedent that would reduce Medicare beneficiary access to innovative treatments within controlled study environments. It would also run counter to CMS’ stated policy goals of expanding coverage to promising therapies in return for increased data collection that would generate valuable clinical evidence.

We appreciate the opportunity to comment on the proposed national coverage decision for intracranial stenting and angioplasty, and we look forward to a positive resolution of this reconsideration for coverage. Please contact me at (508) 650-8681 or Parashar.Patel@bsci.com if you have any questions.

Sincerely,

Parashar B. Patel
Vice President, Health Economics and
Reimbursement
Boston Scientific Corporation

cc: Kerry Weems, Acting Administrator, CMS
Herb Kuhn, Deputy Administrator, CMS
Barry Straube, MD
Marcel Salive, MD
Joseph Chin, MD

Less

Based on the WASID trial, patients with intracranial stenosis 50 - 69% were at significant risk for CVA, even with appropriate medical therapy. The risk can be reduced with intracranial stenting based on the wingspan trial and other single center results. I would strongly recommend that CMS support studies and data collection to confirm the efficacy of intracranial stenting in this cohort of patients not covered by the sammpris trial. The cost of rehabilitation, nursing home placement, and long term hospitilizations can be reduced if we continue to prevent strokes instead of simply treating the aftermath of this devastating disease.

Less

Submitted Electronically to CAGinquiries@cms.hhs.gov

March 15, 2008

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

RE:  Proposed Decision Memorandum for Intracranial Stenting and Angioplasty (CAG-00085R5)

Dear Dr. Phurrough:

The Society for Cardiovascular Angiography and Interventions (SCAI) is a professional association representing over 4,000 invasive and interventional cardiologists.  SCAI promotes excellence in cardiac catheterization, angiography, and interventional cardiology through physician education and representation, and quality initiatives to enhance patient care.

We are responding to Proposed Decision Memorandum for Intracranial Stenting and Angioplasty that you posted on your web site on February 14, 2008.  Our organization simply doesn’t understand the legal rationale you cite in proposing to deny expanded coverage to Medicare beneficiaries for this life changing procedure.  Why does eligibility for coverage under more than one statute indicate that the Centers for Medicare and Medicaid Services (CMS) cannot expand coverage for this procedure?  This is counter-intuitive and it is not in the best interest of your beneficiaries and our patients.

The Society feels strongly that CMS must be more responsive to our patients’ needs and expand coverage for the treatment of patients with symptomatic intracranial atherosclerotic disease (ICAD).  These are patients that have either failed current best medical therapy, or in whom a trial of medical therapy is contra-indicated.  Specifically, there are two populations of patients that would benefit from the humanitarian provision of services and expansion of coverage by CMS.  The first is patients with acute ischemic stroke who are not candidates for intravenous thrombolysis in whom the risk-benefit assessment favors a rapid cerebral reperfusion (intra-arteriallysis, thrombectomy, or angioplasty ± stenting) strategy.  The second group is those patients with symptomatic ICAD with a ≥ 50% stenosis who have failed “best” medical therapy (aspirin) or in whom aspirin therapy is contraindicated.

For both of these populations of symptomatic patients, their prognosis and natural history without appropriate, targeted, and selective revascularization is grim.  The WASID trial tested current best medical therapy in symptomatic ICAD patients and found a 22% (1 in 5) risk of stroke, brain hemorrhage, or death from vascular causes other than stroke over 2 years.  These desperate patients  with no other options deserve an opportunity for percutaneous revascularization after failing best medical therapy,  and this approach seems very conservative and very reasonable pending randomized trials of intervention and medical therapy for de novo lesions.  Less than 2% of all strokes in the US are receiving IV thrombolysis.  Offering reperfusion therapy to those that are not candidates for thrombolysis seems like their only hope at minimizing a disabling, and often life-ending stroke.  Data cited in our original submission demonstrates the dramatic benefit for patients who receive catheter-based reperfusion therapy when they are not candidates for intravenous thrombolysis.

The risk to benefit ratio of expanding this coverage seems to dramatically tilt in favor of percutaneous revascularization.  Not offering this life-saving and stroke avoiding therapy to selected patients is not consistent with current paradigms of early reperfusion for acute myocardial infarction and acute coronary syndromes.  Why should treatment for acute brain ischemia lag behind the coronary arteries?  We need to be working on ways to train more physicians in cerebral intervention skills, and bring the level of stroke prevention and stroke therapy on par with the major advances seen with a national effort to reduce door to balloon time initiatives with heart attacks.  None of this can proceed, without CMS laying the foundation of coverage for this population of patients, but who are in desperate need of treatment.

Background
There is very real need to expand the coverage decision for percutaneous transluminal angioplasty (PTA) with stenting for acute ischemic stroke patients who are not candidates for intravenous thrombolysis but are candidates for endovascular revascularization and for symptomatic ICAD patients with ≥ 50% stenosis who are either not candidates for aspirin therapy, i.e. patients that cannot take aspirin, or have symptoms (TIA or stroke) despite receiving aspirin.  Multiple reports document the feasibility and safety of endovascular revascularization in hundreds of “no option” patients. ^1-13 There is no opportunity for a randomized trial in these patient subgroups, as there is no comparator or alternative therapy to offer clinical equipoise.  The standard of care, aspirin, the “best medical therapy” is either contraindicated or has proven ineffective in their cases, while surgical therapy for these lesions is not an option.  Expanding CMS coverage for an endovascular treatment option for this relatively small number of desperate “no option” patients is supported by the current evidence-base of case series and would also apply to the labeled indications of several US FDA approved devices (Merci thrombectomy device, Penumbra Device and the Wingspan stent), as well as appropriate off-label use of other approved devices and pharmaceuticals with demonstrated effectiveness.

Evidence
Acute ischemic stroke: Each year almost three-quarters of a million people experience a stroke.¹⁴ Stroke ranks as the number-one cause of adult disability in the United States. ¹⁵ The vast majority of strokes (87%) are ischemic in nature. Ischemic stroke is amenable to reperfusion therapy; however, the benefit for reperfusion therapy, as for treatment of myocardial infarction (MI), is time-limited and many lessons learned from treatment strategies in MI can be applied to acute ischemic stroke ¹⁶).

IV administration of rt-PA (0.9 mg/kg, maximum dose 90 mg) benefits patients who present within 3 hours of the onset of ischemic stroke.¹⁶ Despite the fact that IV thrombolysis with rt-PA is a Class I, Level of Evidence “A” recommendation, nationally only 2% of all ischemic stroke patients actually receive this therapy. ^{17, 18} However, the intracranial bleeding rate is 10-fold greater for thromboysis compared to placebo.  The incidence of intracranial hemorrhage is increased with larger strokes and those treated ≥ 3 hours.¹⁹ If IV thrombolysis is used outside of the guidelines (i.e., > 3 hours), the risk of complications is significantly increased.^20-22 Stroke patients with ICAD of the internal carotid or proximal middle cerebral artery (MCA), have a poor prognosis even with IV thrombolysis.¹⁷

Intra-arterial (IA) thrombolysis is an AHA/ASA Class I recommendation in selected patients if administered within 6 hours of the onset of stroke at an experienced stroke center with immediate access to cerebral angiography and qualified interventionalists.¹⁷ The Prolyse in Acute Cerebral Thromboembolism Trial (PROACT II), with a median time to treatment of 5.3 hours, randomized patients with a major neurological deficit and demonstrated poor outcomes for conservative therapy versus IA thrombolysis.²³ PROACT II demonstrated a benefit up to 6 hours after stroke onset in 180 patients with ICAD and occlusions of the middle cerebral artery.

The MERCI^{24, 25} and Multi MERCI²⁶ trials demonstrated benefit for mechanical thrombo-embolectomy using the FDA approved Merci® Retriever (Concentric Medical Inc, Mountain View, CA). These prospective, controlled, single-arm trials evaluated mechanical thrombo-embolectomy in acute stroke patients within 8 hours of presentation who had angiographically confirmed large-vessel occlusion (carotid terminus, middle cerebral (M₁, M₂), and vertebrobasilar arteries) in a broad cohort (no upper age or NIHSS limits).  Multi MERCI included use of the next-generation retriever and widened inclusion criteria to permit mechanical thrombo-embolectomy in patients who had failed IV t-PA.  In the MERCI trial, 60.3% (85/141) of patients achieved successful post-procedure revascularization. In Multi MERCI, 68.3% (112/164) achieved post-procedure revascularization.  Both trials demonstrated significantly better 90-day outcomes among successfully revascularized patients compared with nonrevascularized patients.

In a separate retrospective analysis of 19 patients with intracranial stenting of a vessel resistant to thrombolysis, a particularly difficult subset of stroke patients t he overall recanalization rate was 79% with six deaths ²⁷.  The median baseline NIHSS score of 16 (range, 15-22) improved to a median discharge NIHSS score of 5 (range, 2.5-11.5). These results suggest that ICAD stenting is an option for refractory cerebral arterial occlusions.

In another single center registry, 16 ischemic stroke patients not eligible for intravenous thrombolysis were treated with an angioplasty and stenting strategy.²⁸ Eligible stroke patients included 1) < 7 hours from symptom onset, 2) NIHSS ≥ 4 or they had involvement > 1/3 of the middle cerebral artery territory on a computed tomogram and 3) had no evidence of intracranial hemorrhage.  The most common reason for ineligibility for systemic thrombolysis was symptom onset > 3 hours (50%) followed by recent surgery (19%), recent gastrointestinal or genitourinary bleeding (19%) and recent arteriotomy at a non-compressible site (12%). 

The culprit lesion was located in the anterior circulation in 14 patients (87.5%) and in the posterior circulation in 2 patients (12.5%). Recanualization using direct angioplasty/stenting alone was successful in 3 patients.  Seven patients received IA thrombolysis alone and 6 others were treated with a combination of IA thrombolysis with adjunctive balloon angioplasty with stenting. Thrombolysis was used in an off-label manner with urokinase (337,500 ± 37,500 units) in 2 patients and t-PA (15.1 ± 8.0 mgs) in 11 patients.

Significant improvement in the neurologic status was demonstrated at last follow-up (p = 0.036).   Favorable outcome was achieved in most of the patients with 56% demonstrating a marked improvement in NIHSS and 38% achieving independent living at follow-up. There were four in-hospital deaths (25%). The rate of symptomatic intracranial hemorrhage and mortality was comparable to that seen in the intravenous thrombolysis studies suggesting safety of this strategy. These results suggest that ICAD angioplasty with stenting with or without IA thrombolysis is an effective and safe treatment option that should be made available to ischemic stroke patients who are not candidates for intravenous thrombolysis.

The Penumbra Device data presented at the recent International Stroke Meeting demonstrated that in the 125 patients studied and  who had treatment initiated within 8 hours of symptom onset, revascularization  could be accomplished in 81.6%.  The adverse event rate was  3.2% however symptomatic intracerebral hemorrhage occurred in 11.2% of patients and asymptomatic hemorrage in 16.8%.  Despite these findings, over half the patients had a greater than 4 point improvement in NIHSS by discharge and  modified Rankin Scores  less than 2 three months after their stroke.  Mortality from stroke, even in this population of large strokes at presentation remained approximately 30%.  These data are consistent with the premise that revascularization in patients experiencing large strokes reduces disability and therefore should be an option for patients in this setting who are not candidates or have failed conventional therapies.

As a result of the low incidence of early patient presentation to medical facilities (i.e., <3 hours), the rates of systemic administration of IV-tPA nationwide are in the low-single digits.  This demonstrates the need for alternative therapies for the majority of patients who are not eligible for effective systemic therapy.  Given the previously described improvement in outcomes in intra-cranial intervention for acute stroke, and the significant cost associated with the severely disabled stroke survivor, coverage of these procedures appears to be not only a clinically but also economically sound decision.

Symptomatic ICAD Patients refractory to medical therapy
The clinical presentation of patients with intracranial occlusive disease is one of stroke or repeated TIA’s in the absence of extracranial cerebrovascular diseases or a cardioembolic source.  The current standard of clinical care for selected patients in referral centers is to perform intracranial angioplasty with stent placement if patients have recurrent and refractory cerebrovascular symptoms (TIA or stroke), in the presence of a ≥ 50% suitable ICAD stenosis despite “best medical therapy” with aspirin.²⁹ In contrast to cervical carotid stenosis where carotid endarterectomy is the standard of care in average surgical risk patients, the surgical alternative for intracranial disease, extracranial/intracranial (EC/IC) bypass surgery, has not been effective.³⁰

Current “best medical therapy” was investigated in the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) study and revealed the annual risk of stroke in the affected area of a vertebral or basilar artery stenosis in patients treated with aspirin or warfarin was 7.8% and 10.7% respectively.^{29, 31} Despite the early enthusiasm for balloon angioplasty alone for intracranial atherosclerosis, without “bailout” stent placement this remains a procedure with a success rate of only about 70% in most series.^{32, 33}

While there are patients who occasionally will benefit from extracranial-to-intracranial bypass for occlusive cerebrovascular disease, there procedures can be significantly limited by the location of disease, the caliber of the recipient vessel, etc., and will not be a satisfactory solution in a significant number of cases, thus elevating even further the clinical option of endovascular therapies.

There have been no randomized trials of angioplasty and stenting in this population of patients who have failed “best medical therapy” and therefore no clinical equipoise with any other option exists.  Complications of endovascular therapy compare favorably with outcomes reported with aspirin or warfarin therapy in WASID and include an overall perioperative rate of stroke of 7.9%, perioperative mortality of 3.4% with a combined perioperative stroke or death of 9.5%. ³⁴

Balloon angioplasty with provisional stent placement is ideal for patients who have simple focal stenoses which are concentric and ≤ 5mm in length.¹³ Primary stenting is suitable for patients with high risk lesion morphology including marked eccentricity, lesion length ≥ 10 mm, and ≥ 90% angulation.  Contraindications to intracranial intervention include chronic occlusions more than 6 months old, long segment occlusions, and occlusion without visible vessels filling distally.

In summary, we feel the weight of the evidence suggests that it would be appropriate to cover angioplasty with stenting for 1) acute stroke patients who are not candidates for intravenous thrombolysis but are candidates for endovascular revascularization and 2) for symptomatic ICAD patients with ≥ 50% stenosis who are either not candidates for aspirin therapy, i.e. patients that cannot take aspirin, or have symptoms (TIA or stroke) despite receiving aspirin should definitely be expanded.  Multiple patient registries document the utility of endovascular revascularization in hundreds of these “no option” patients with acceptable complication rates and without coverage expansion to include angioplasty and stenting, many Medicare beneficiaries will be denied this potentially life-saving therapy.^1-13

I would also like to express my appreciation to the lead author on these comments, Christopher White, MD, FSCAI and Drs. William Gray and Christopher Cates who assisted in the development of these comments.  Our staff contact person on this issue is Wayne Powell and he may be reached at wpowell@scai.org or 202 741-9869 (a new phone number). 

Sincerely,

Bonnie H. Weiner, M.D., FSCAI,
President

CC:     Marcel Salive, MD, MPH
Director, Division of Medical and Surgical Services

Sandy Jones, RN, MS
Lead Analyst

Joseph Chin, MD
Lead Medical Officer

References

1. FDA. Wingspan Summary of Safety and Probable Benefit. (Humanitarian Device Exemption H050001). 2004.

2. Kessler IM, Mounayer C, Piotin M, Spelle L, Vanzin JR, Moret J. The use of balloon-expandable stents in the management of intracranial arterial diseases: a 5-year single-center experience. AJNR Am J Neuroradiol. 2005;26:2342-2348.

3. Abou-Chebl A, Bashir Q, Yadav JS. Drug-eluting stents for the treatment of intracranial atherosclerosis: initial experience and midterm angiographic follow-up. Stroke. 2005;36:e165-168.

4. Henkes H, Miloslavski E, Lowens S, Reinartz J, Liebig T, Kuhne D. Treatment of intracranial atherosclerotic stenoses with balloon dilatation and self-expanding stent deployment (WingSpan). Neuroradiology. 2005;47:222-228.

5. Kim DJ, Lee BH, Kim DI, Shim WH, Jeon P, Lee TH. Stent-assisted angioplasty of symptomatic intracranial vertebrobasilar artery stenosis: feasibility and follow-up results. AJNR Am J Neuroradiol. 2005;26:1381-1388.

6.Yu W, Smith WS, Singh V, Ko NU, Cullen SP, Dowd CF, Halbach VV, Higashida RT. Long-term outcome of endovascular stenting for symptomatic basilar artery stenosis. Neurology. 2005;64:1055-1057.

7. Hatano T, Tsukahara T, Ogino E, Aoyama T, Nakakuki T, Murakami M. Stenting for vertebrobasilar artery stenosis. Acta Neurochir Suppl. 2005;94:137-141.

8. Gomez CR, Misra VK, Liu MW, Wadlington VR, Terry JB, Tulyapronchote R, Campbell MS. Elective stenting of symptomatic basilar artery stenosis. Stroke. 2000;31:95-99.

9. Straube T, Stingele R, Jansen O. Primary stenting of intracranial atherosclerotic stenoses. Cardiovasc Intervent Radiol. 2005;28:289-295.

10. Lylyk P, Vila JF, Miranda C, Ferrario A, Musacchio A, Rufenacht D, Cohen JE. Endovascular reconstruction by means of stent placement in symptomatic intracranial atherosclerotic stenosis. Neurol Res. 2005;27 Suppl 1:S84-88.

11. Jiang WJ, Wang YJ, Du B, Wang SX, Wang GH, Jin M, Dai JP. Stenting of symptomatic M1 stenosis of middle cerebral artery: an initial experience of 40 patients. Stroke. 2004;35:1375-1380.

12. Stenting of Symptomatic Atherosclerotic Lesions in the Vertebral or Intracranial Arteries (SSYLVIA): study results. Stroke. 2004;35:1388-1392.

13. Mori T, Kazita K, Chokyu K, Mima T, Mori K. Short-term arteriographic and clinical outcome after cerebral angioplasty and stenting for intracranial vertebrobasilar and carotid atherosclerotic occlusive disease. AJNR Am J Neuroradiol. 2000;21:249-254.

14. Rosamond W, Flegal K, Friday G, Furie K, Go A, Greenlund K, Haase N, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell CJ, Roger V, Rumsfeld J, Sorlie P, Steinberger J, Thom T, Wasserthiel-Smoller S, Hong Y. Heart disease and stroke statistics2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2007;115:e69-171.

15. Sacco RL, Benjamin EJ, Broderick JP, Dyken M, Easton JD, Feinberg WM, Goldstein LB, Gorelick PB, Howard G, Kittner SJ, Manolio TA, Whisnant JP, Wolf PA. American Heart Association Prevention Conference. IV. Prevention and Rehabilitation of Stroke. Risk factors. Stroke. 1997;28:1507-1517.

16. White CJ, Cates CU, Cowley MJ, Weiner BH, Carpenter JS, Hopkins, LN, Jaff MR, Ramee SR, Rymer MM, Wholey MH. Interventional Stroke Therapy:  Current State of the Art and Needs Assessment. Catheterization and Cardiovascular Interventions 2007;70:471-476

17. Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med. 1995;333:1581-1587.

18. Adams HP, Jr., del Zoppo G, Alberts MJ, Bhatt DL, Brass L, Furlan A, Grubb RL, Higashida RT, Jauch EC, Kidwell C, Lyden PD, Morgenstern LB, Qureshi AI, Rosenwasser RH, Scott PA, Wijdicks EF. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Circulation. 2007;115:e478-534.

19. Demaerschalk BM, Yip TR. Economic Benefit of Increasing Utilization of Intravenous Tissue Plasminogen Activator for Acute Ischemic Stroke in the United States. Stroke. 2005;36:2500-2503.

20. Albers GW, Bates VE, Clark WM, Bell R, Verro P, Hamilton SA. Intravenous tissue-type plasminogen activator for treatment of acute stroke: the Standard Treatment with Alteplase to Reverse Stroke (STARS) study. Jama. 2000;283:1145-1150.

21.20. Lopez-Yunez AM, Bruno A, Williams LS, Yilmaz E, Zurru C, Biller J. Protocol violations in community-based rTPA stroke treatment are associated with symptomatic intracerebral hemorrhage. Stroke. 2001;32:12-16.

22. Buchan AM, Barber PA, Newcommon N, Karbalai HG, Demchuk AM, Hoyte KM, Klein GM, Feasby TE. Effectiveness of t-PA in acute ischemic stroke: outcome relates to appropriateness. Neurology. 2000;54:679-684.

23. Tanne D, Bates VE, Verro P, Kasner SE, Binder JR, Patel SC, Mansbach HH, Daley S, Schultz LR, Karanjia PN, Scott P, Dayno JM, Vereczkey-Porter K, Benesch C, Book D, Coplin WM, Dulli D, Levine SR. Initial clinical experience with IV tissue plasminogen activator for acute ischemic stroke: a multicenter survey. The t-PA Stroke Survey Group. Neurology. 1999;53:424-427.

24. Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, Pessin M, Ahuja A, Callahan F, Clark WM, Silver F, Rivera F. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: a randomized controlled trial. Prolyse in Acute Cerebral Thromboembolism. JAMA. 1999;282:2003-2011.

25. Smith WS, Sung G, Starkman S, Saver JL, Kidwell CS, Gobin YP, Lutsep HL, Nesbit GM, Grobelny T, Rymer MM, Silverman IE, Higashida RT, Budzik RF, Marks MP, for the MTI. Safety and Efficacy of Mechanical Embolectomy in Acute Ischemic Stroke: Results of the MERCI Trial. Stroke. 2005;36:1432-1438.

26. Smith WS. Safety of mechanical thrombectomy and intravenous tissue plasminogen activator in acute ischemic stroke. Results of the multi Mechanical Embolus Removal in Cerebral Ischemia (MERCI) trial, part I. AJNR Am J Neuroradiol. 2006;27:1177-1182.

27. Flint AC, Duckwiler GR, Budzik RF, Liebeskind DS, Smith WS. Mechanical thrombectomy of intracranial internal carotid occlusion: pooled results of the MERCI and Multi MERCI Part I trials. Stroke. 2007;38:1274-1280.

28 Levy EI, Ecker RD, Horowitz MB, Gupta R, Hanel RA, Sauvageau E, Jovin TG, Guterman LR, Hopkins LN. Stent-assisted intracranial recanalization for acute stroke: early results. Neurosurgery. 2006;58:458-463; discussion 458-463.

29. Ramee SR, Subramanian R, Felberg RA, McKinley KL, Jenkins JS, Collins TJ, Dawson RC, White CJ. Catheter-based treatment for patients with acute ischemic stroke ineligible for intravenous thrombolysis. Stroke. 2004;35:e109-111.

30. Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005;352:1305-1316.

31. 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;313:1191-1200.

32. Prognosis of patients with symptomatic vertebral or basilar artery stenosis. The Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Study Group. Stroke. 1998;29:1389-1392.

33. Song JK, Eskridge JM. Intracranial angioplasty and thrombolysis. Neurosurg Clin N Am. 2000;11:49-65, viii.

34. Mori T, Fukuoka M, Kazita K, Mori K. Follow-up study after intracranial percutaneous transluminal cerebral balloon angioplasty. Am J Neuroradiol. 1998;19:1525-1533.

35. Cruz-Flores S, Diamond AL. Angioplasty for intracranial artery stenosis. Cochrane Database Syst Rev. 2006;3:CD004133.

Less

The Honorable Kerry Weems
Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Room 445-G Hubert H. Humphrey Building
200 Independence Avenue, SW,
Washington, DC 20201

Date: 3/14/2008

Dear Mr. Weems:

The Society of Vascular and Interventional Neurology (SVIN) would like to provide you with our position on the consideration by the Centers for Medicare and Medicaid Services (CMS) regarding coverage for intracranial stenting for symptomatic intracranial stenosis with the Wingspan Intracranial stent system.

The proposal is "The CMS has reviewed the evidence for intracranial stenting and angioplasty for the patients with intracranial atherosclerotic disease (ICAD), who are medically refractory to therapy in intracranial vessels with ≥ 50% artery lumen stenosis that are accessible to the system. We propose to make no change to section 20.7.B.5 of the National Coverage Determination Manual titled "Percutaneous Transluminal Angioplasty" (PTA)."

We here provide review of the literature and scientific evidence and our recommendation on behalf of the SVIN.

Natural history of Intra-cranial stenosis:

Atherosclerotic stenosis of the major intracranial arteries is an important cause of stroke,^1-8 especially in African-Americans, Asians, and Hispanics.^1,2,6 Intracranial atherosclerotic disease (ICAD) is estimated to account for nearly 8-18% of all ischemic strokes.^1-2 (new 3)Of the 900,000 strokes or transient ischemic attacks that occur each year in the United States, approximately 70,000 to 90,000 are caused by intracranial arterial stenosis.⁶

Several studies have shown a high risk of recurrent strokes in patients with symptomatic ICAD ^3-5. In the Extracranial carotid-Intracranial carotid (EC-IC) bypass trial the risk of recurrent stroke in patients with symptomatic ICAD was 11.9% per year. ⁵ More recently, the Warfarin versus Aspirin for Intracranial Disease (WASID) trial demonstrated that the risk of stroke or vascular death in patients with symptomatic intracranial stenosis (degree of stenosis 50-99%) who were on best medical therapy namely antiplatelet therapy with aspirin or anti-thrombotic therapy with warfarin, was as high as 22.1% over a median follow-up of 1.8 years.⁶ In addition, several studies have identified sub-groups of patients who are at even higher risk.

Sub-populations that are at higher risk for stroke:

Patients with severe intracranial stenosis (≥70%) are at higher risk of stroke:

The WASID trial identified a high-risk group with an 18% risk of recurrent stroke in those with greater than or equal to 70% symptomatic intracranial stenosis at one year ^7-8. In addition, those who had their qualifying events within 30 days of enrollment in the trial and a ≥70% stenosis had a 23% risk of recurrent stroke at one year ^7-8.

Clearly, patients with symptomatic intracranial stenoses are a high risk population and medical therapy with aspirin or warfarin is not sufficient in preventing strokes in more than 1 in every 5 patients every year. There is a clear need for better treatments for symptomatic intracranial atherosclerotic disease.

Endovascular treatment options for Intracranial Stenosis:

Stenting and balloon angioplasty for severe symptomatic ICAD to prevent recurrent stroke has been performed with off-label use of balloons and stents. However, these devices were designed for the coronary circulation and therefore are not optimal for navigation and deployment in the intracranial vessels. In fact, authors have reported high rates of peri-procedural complications (as high as 50%) with suboptimal success rates. ^9-15

The Wingspan Intracranial Stent System (WIS) is a stent system specifically designed for use in the cerebral blood vessels. The device is approved by the FDA under HDE category in 2005, ¹⁶ Intracranial stenting with WIS can be performed with low procedural complications and with a high success rate. ^17-20 In particular, several retrospective and prospective case series have showed periprocedural complication rates of ≤6% with the WIS was with a procedural success rates of 97% ^17-20

Endovascular treatment for patients with intracranial stenosis refractory to medical therapy:

In 2005, several societies including the erstwhile American Society of Interventional and Therapeutic Neuroradiology (ASITN) (currently the Society of Neuro Interventional Surgery [SNIS]), the Society of Interventional Radiology (SIR), and the American Society of NeuroRadiology (ASNR) summarized the existing literature and published their position statement on the standards of care and practice with regard to intracranial angioplasty and stenting for cerebral atherosclerosis.²¹

"...The ASITN, SIR, and ASNR concur that sufficient evidence now exists to recommend that intracranial angioplasty with or without stenting should be offered to symptomatic patients with intracranial stenoses who have failed medical therapy..."

The results from the recent studies using the WIS suggest that despite the risks of stroke or death in patients who undergo intracranial angioplasty and stenting using the WIS, these risks are lower than the risks of current best medical therapy with anti-thrombotics as studied in the WASID trial.

Advances in "best medical therapy":

Existing studies on best medical therapy for intracranial stenosis have included single anti-platelet therapy with aspirin or anti-thrombotic therapy with warfarin. Recent studies on WIS have shown that the benefits of WIS use in patients with symptomatic ICAD far outweigh the risks when compared to the risks of these existing best medical therapy regimens..

The SAMMPRIS trial (Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis) is an NIH funded trial that is the first of its kind to test the efficacy of "intensive medical therapy" versus "intensive medical therapy" plus intracranial stenting using the WIS, a self expanding nitinol stent. "Best medical therapy" is defined in the trial as: double anti-platelet agents with aspirin 325mg po daily for the entire follow-up period and Clopidogrel 75mg po daily for 90 days plus aggressive risk factor management with blood pressure control < 130/80 mm Hg and low-density cholesterol levels of < 70 gm/dL.

The SVIN acknowledges the importance of multi-center randomized trials and strongly encourages the enrollment of patients in such trials. The results of the SAMMPRIS trial will help understand the importance of "intensive medical therapy" alone or in combination with WIS in patients with symptomatic ICAD. In addition, the SVIN recognizes the importance as well as fully supports the continued evaluations and improvements of pharmacological and catheter-based therapies for the treatment of symptomatic ICAD. However, not all patients will qualify for enrollment in the SAMMPRIS trial and therefore a high-risk patient population may not receive appropriate treatment if CMS does not cover treatment with WIS.

POSITION STATEMENT OF THE SVIN REGARDING THE CMS COVERAGE PROPOSAL FOR INTRACRANIAL STENTING WITH THE WINGSPAN SYSTEM:

1. For symptomatic patients with severe (>70%) intracranial stenosis who have failed "best medical therapy" (either single anti-platelet therapy such as aspirin or anti-thrombotic therapy such as warfarin), intracranial balloon angioplasty and stenting with devices designed specifically for the cerebral vasculature (e.g. Wingspan System) should be strongly considered as a treatment option and should be covered by CMS. Risk factor management for secondary stroke prevention should be encouraged in all patients.
2. For symptomatic patients with severe (>70%) intracranial stenosis who have failed "best medical therapy" (either single anti-platelet therapy such as aspirin or anti-thrombotic therapy such as warfarin), the role of "intensive medical therapy" (aspirin 325mg po daily for entire follow-up period and Clopidogrel 75mg po daily for 90 days plus aggressive risk factor management with blood pressure control < 130/80 mm Hg and low-density cholesterol levels of < 70 gm/dL) alone or in combination with intracranial balloon angioplasty and stenting needs to be further studied as part of a clinical trial. The SVIN encourages patients who meet the inclusion criteria for the SAMMPRIS trial to be enrolled in this NIH-funded trial.
3. For symptomatic patients with >50% and < 70% intracranial stenosis who have failed "best medical therapy" (either single anti-platelet therapy such as aspirin or anti-thrombotic therapy such as warfarin), intracranial balloon angioplasty and stenting with devices designed specifically for the cerebral vasculature (e.g. Wingspan System) should be strongly considered as a treatment option and should be covered by CMS. Risk factor management for secondary stroke prevention should be encouraged in all patients.
4. For symptomatic patients with >50% intracranial stenosis who have not been on "best medical therapy" (namely single anti-platelet therapy such as aspirin), there is insufficient evidence currently to make definitive recommendations regarding the role of intracranial balloon angioplasty with or without stenting. Patients should be counseled about the natural history of the disease and the risks of current medical and endovascular therapies. Risk factor management for secondary stroke prevention should be encouraged.
5. For asymptomatic patients with intracranial arterial stenosis, there is insufficient evidence currently to make definitive recommendations regarding the role of intracranial angioplasty with or without stenting. The SVIN encourages researchers to identify high risk groups for stroke among patients with asymptomatic intracranial atherosclerotic disease who might benefit from endovascular therapy. Patients should be counseled about the natural history of the disease and the risks of current medical and endovascular therapies. Best medical therapy including risk factor management for primary stroke prevention should be encouraged.
6. For all patients with intracranial atherosclerotic disease, it should be required by CMS that vascular neurology/neurology consults be obtained prior to treatment with intracranial angioplasty and stenting to ensure that the patient had a stroke or transient ischemic attack and meets the above criteria and is an appropriate candidate for treatment. A vascular neurologist/neurologist should also evaluate the patient following the procedure to objectively assess clinical outcomes to meet CMS quality measures.
7. For all patients with intracranial atherosclerotic disease treated with intracranial balloon angioplasty with or without stenting, hospitals should provide and maintain a local registry in a database accessible by the local IRB as well as CMS, of the intracranial angioplasty and stenting procedural indications, pre-procedure evaluations and post procedural independent neurological assessment of outcomes.
8. To ensure optimal patient outcomes all intracranial balloon angioplasty with or without stenting procedures should be performed by a neuro-interventionalist (Interventional Neurologist, Interventional Neuroradiologist, or Endovascular Neurosurgeon) with experience in cerebral micro-catheterization.
9. All intracranial angioplasty with or without stenting procedures should be performed at centers that have extensive experience with these procedures and that are also primary or comprehensive stroke centers.

In summary, the Society of Vascular and Interventional Neurology is strongly commited to improving patient outcomes and to improving the treatment options for patients with symptomatic >50% intracranial stenosis who have failed medical therapy.

We thank you for your consideration and decision to re-evaluate coverage for intracranial angioplasty and stenting.

Sincerely,

The Society of Vascular and Interventional Neurology
104 13th St.
Hudson, WI 54016
Ph. 715-381-3440

References:
1. 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
2. Sacco RL, Kargman DE, Gu Q, Zamanillo MC. Race-ethnicity and determinants of intracranial atherosclerotic cerebral infarction. The Northern Manhattan stroke study. Stroke. 1995;26:14-20
3. Zaidat OO, Zahuranec DB, Ubogu EE, Fernandes-Filho JA, Suarez JI, Sunshine JL, Tarr RW, Mirarchi S, Nour SG, Selman WR, Landis DM. Asymptomatic middle cerebral artery stenosis diagnosed by magnetic resonance angiography. Neuroradiology. 2004;46:49-53.
4. Qureshi AI, Ziai WC, Yahia AM, Mohammad Y, Sen S, Agarwal P, Zaidat OO, Suarez JI, Wityk RJ. Stroke-free survival and its determinants in patients with symptomatic vertebrobasilar stenosis: a multicenter study. Neurosurgery. 2003;52:1033-9; discussion 1039-40.
5. EC/IC Bypass Study Group: Failure of extracranial/intracranial arterial bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. N Engl J Med. 1985;313:1191-1200,
6. Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005;352:1305-1316
7. Kasner SE, Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Benesch CG, Sila CA, Jovin TG, Romano JG, Cloft HJ. Predictors of ischemic stroke in the territory of a symptomatic intracranial arterial stenosis. Circulation. 2006;113:555-563
8. Kasner SE, Lynn MJ, Chimowitz MI, Frankel MR, Howlett-Smith H, Hertzberg VS, Chaturvedi S, Levine SR, Stern BJ, Benesch CG, Jovin TG, Sila CA, Romano JG. Warfarin vs aspirin for symptomatic intracranial stenosis: Subgroup analyses from WASID. Neurology. 2006;67:1275-1278
9. Clark WM, Barnwell SL, Nesbit G, O''Neill OR, Wynn ML, Coull BM. Safety and efficacy of percutaneous transluminal angioplasty for intracranial atherosclerotic stenosis. Stroke. 1995;26:1200-1204
10. Escudero D, Muchart J, Sanchez-Ojanguren J, Millan M, Perendreu J. Angioplasty for intracranial internal carotid artery stenosis. Rev Neurol. 2000;31:538-541
11. Alazzaz A, Thornton J, Aletich VA, Debrun GM, Ausman JI, Charbel F. Intracranial percutaneous transluminal angioplasty for arteriosclerotic stenosis. Arch Neurol. 2000;57:1625-1630
12. Marks MP, Wojak JC, Al-Ali F, Jayaraman M, Marcellus ML, Connors JJ, Do HM. Angioplasty for symptomatic intracranial stenosis: Clinical outcome. Stroke. 2006;37:101
13. Cruz-Flores S, Diamond AL. Angioplasty for intracranial artery stenosis. Cochrane Database Syst Rev. 2006;3:CD004133
14. Abou-Chebl A, Bashir Q, Yadav JS. Drug-eluting stents for the treatment of intracranial atherosclerosis: Initial Experience and midterm angiographic follow-up. Stroke. 2005;36:e165-8
15. Gupta R, Schumacher HC, Mangla S, Meyers PM, Duong H. Urgent endovascular revascularization for symptomatic intracranial atherosclerotic stenosis. Neurology. 2003;61:1729-1735
16. FDA website: http://www.fda.gov/cdrh/pdf5/h050001b.pdf Summary of risk and probable benefit: Humanitarian Use Device Designation H050001. August 3, 2005.
17. Fiorella D, Levy EI, Turk AS, Albuquerque FC, Niemann DB, Aagaard-Kienitz B, Hanel RA, Woo H, Rasmussen PA, Hopkins LN, Masaryk TJ, McDougall CG. US multicenter experience with the wingspan stent system for the treatment of intracranial atheromatous disease: periprocedural results. Stroke. 2007;38:881-7
18. Samuels OB, Joseph GJ, Lynn MJ, Smith HA, Chimowitz MI. A standardized method for measuring intracranial arterial stenosis. AJNR Am J Neuroradiol. 2000;21:643-646
19. Bose A, Hartmann M, Henkes H, et al. A novel, self-expanding, nitinol stent in medically refractory intracranial atherosclerotic stenoses: the Wingspan study. Stroke. 2007;38:1531-7.
20. Zaidat OO, Klucznik R, Chaloupka JC, et al. An NIH funded multi-center registry on the use of the Wingspan intracranial stent (WIS) for high risk patients with symptomatic intracranial arterial stenosis (SIAS). Paper presented at: International Stroke Conference 2007, February 7¨C9, 2007; San Francisco, CA
21. Higashida RT, Meyers PM, Connors JJ, 3rd, Sacks D, Strother CM, Barr JD, Wojak JC, Duckwiler GR. Intracranial angioplasty & stenting for cerebral atherosclerosis: a position statement of the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, and the American Society of Neuroradiology. AJNR Am J Neuroradiol. 2005;26:2323-2327.
22. Xavier A, Nanjireddy RM, Manjila S, Jones M, Madhavan, R. High incidence of intracranial atherosclerosis in patients with acute ischemic stroke. Paper presented at the 60th Annual Meeting of the American Academy of Neurology 2008, April 12-19, Chicago, IL.

Less

Steve E. Phurrough, M.D., M.P.A.
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Blvd.
Baltimore, Maryland 21244-1850

Re: Proposed Decision Memorandum for Intracranial Stenting and Angioplasty (CAG00085R5)

Dear Dr. Phurrough:

On behalf of the Advanced Medical Technology Association (AdvaMed), I am pleased to provide comments in response to the Centers for Medicare and Medicaid Services (CMS) proposed decision memorandum for intracranial stenting and angioplasty (CAG-00085R5).

As you know, AdvaMed has a longstanding interest in matters related to the national coverage determination (NCD) process because of the impact that Medicare coverage decisions have on beneficiary access to state-of-the-art medical care. Our comments focus on two policy issues: coverage for humanitarian use devices and the application of “coverage with evidence development” (CED).

First, as we have articulated previously, AdvaMed believes that CMS should provide seniors and disabled Medicare beneficiaries coverage for medical technologies that have received a humanitarian device exemption (HDE) from the FDA. HDE technologies are FDA-approved for very limited patient populations for whom no other viable treatment modality exists. Through the HDE process, the FDA has promoted the development of technologies that treat orphan diseases. CMS can facilitate beneficiary access to HDEs by making the CED process an available pathway for coverage for those HDEs subject to national non-coverage determinations. In addition, for those few HDE devices subject to national non-coverage, we would support an expedited review process to address concerns regarding the lengthy timeframe of the NCD process. At the same time, CMS should maintain and encourage contractor discretion in determining coverage for HDEs in absence of a specific national coverage determination.

Second, AdvaMed is concerned by the rationale CMS uses for not applying CED in this case. The proposed decision memorandum states the following:

Additional non-IDE trials would provide useful evidence as well and, in previous NCDs we have covered research studies under the concept “Coverage with Evidence Development (CED).” However, as outlined in our Guidance Document on Coverage with Evidence Development, the Coverage with Study Participation (CSP) form of CED is applicable only for items and services where the medical evidence is not adequate for coverage under section 1862(a)(1)(A). In our existing NCD, 20.7.B.5, coverage exists under § 1862(a)(1)(A) for beneficiaries in certain IDE trials, section 1862(a)(1)(E).

AdvaMed notes that eligibility for coverage in an IDE clinical study should not prevent a technology from being eligible for CED. CMS can, and does, employ various approaches to coverage that involve evidence generation.

The Honorable Kerry Weems
Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Room 445-G
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

Re: February 14, 2008
Proposed Decision Memorandum for Intracranial Stenting and Angioplasty (CAG-00085R5)
On behalf of myself and my colleagues, Dr. Beverly Aagaard-Kienitz and Dr David Niemann, I want to stess the benefit that some patients with intracranial vascular diesease receive from intracranial angioplasty and stenting.
February 26, 2008

Dear Mr. Weems: On behalf of the Endovascular Surgery/Stroke service at the University of Wisconsin Madison, we strongly urge the Centers for Medicare and Medicaid Services (CMS) to reverse its proposal to not cover intracranial stenting and angioplasty within the context of an observational study.

Based on our extensive experience with the Wingspan stent system, we feel strongly that the availability of this device has greatly enhanced our abilities to care for patients with intracranial stenosis and occlusions. The availability of the stent has also improved our ability to use angioplasty alone since, it enhances our abilities to repair dissections that may occur as a consequence of an angioplasty. The proposed decision memorandum issued on February 14, 2008 directly affects our hospital’s financial ability to provide this endovascular treatment to these patients.

Intracranial stenting and angioplasty using the Wingspan® Stent System with Gateway® PTA Balloon Catheter is an FDA-approved treatment under the Humanitarian Device Exemption (HDE) for patients with intracranial atherosclerotic disease who are refractory to medical therapy in intracranial vessels > 50% artery lumen stenosis. By allowing coverage of this multi-year, multi-center prospective observational study, valuable clinical evidence to advance our scientific knowledge of both this disease state and innovative treatment could be obtained.

In its proposal, CMS cited the existence of Medicare coverage for Category B Investigational Device Exemption (IDE) trials as effectively restricting coverage under different statutory authorities. It is important to note that the observational study proposed by Boston Scientific would evaluate a separate and distinct patient population than those enrolled in the National Institutes of Health (NIH) randomized controlled IDE trial (SAMMPRIS). This important IDE clinical trial will compare the Wingspan Stent System with Gateway Balloon Catheter to medical therapy alone in patients with stenosis of 70% or greater, while the observational study would examine on-label medically refractory patients with stenosis of 50-69%. We strongly support the SAMMPRIS study and believe the observational study would complement SAMMPRIS trial findings, while permitting a treatment option for a vulnerable patient population with intracranial atherosclerotic disease (ICAD).

Disease Background
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. and it is the leading cause of long-term disability. The annual cost is about $65.5 billion 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. If medical therapy fails, there are no other treatment options, and these individuals are vulnerable to compromised quality of life.

There is now enough evidence available to warrant national Medicare coverage for a treatment that may benefit a population that has no other alternatives.

The interventional professional societies, the Society of Neurointerventional Surgery (SNIS) formerly known as (ASITN), the Society of Interventional Radiology (SIR), and the Society for Cardiovascular Angioplasty and Interventions (SCAI), favor coverage for the symptomatic medically refractory ICAD patient population. Given that these patients have no other treatment options and face an unacceptable risk of another stroke, the availability of endovascular treatment such as the Wingspan® Stent and Gateway® Balloon may be critical to patients’ long term prognosis, and CMS should provide coverage for this patient population.

To continue to provide these endovascular treatment options, we urge CMS to reverse its proposed non-coverage decision, and permit Medicare coverage of intracranial stenting and angioplasty for patients enrolled in any observational studies, including the proposed study that CMS reviewed as part of its proposed decision. This would help ensure that many patients who may benefit from an FDA-approved humanitarian use device could be treated, generating robust clinical evidence about this device.

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 608-262-1419

Sincerely,

Chares M. Strother, MD

CC:
Herb Kuhn - CMS Deputy Administrator
Kerry Weems - CMS Acting Administrator
Mike Reilly - Associate Deputy Secretary, HHS
Tom Barker - Counselor for Health Policy, Office of the Secretary, HHS
Ben Sasse - Asst Sec for Planning and Evaluation, HHS

Less

March 14, 2008

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Phurrough:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed national coverage decision (NCD), Intracranial Stenting and Angioplasty (CAG-00085R5). America’s Health Insurance Plans (AHIP) is the national association representing nearly 1,300 health insurance plans providing coverage to more than 200 million Americans. We are pleased to submit these comments on behalf of our members.

We concur with CMS that the rigor of the evidence available regarding the efficacy and safety of the procedure and the device is insufficient at this time to allow for coverage outside of a clinical trial. In particular, two of the three studies referenced to show effectiveness were case series type studies, where, as with all case series studies, there is a significant possibility of inherent biases due to the lack of control groups. This lack of a control group limits the ability to evaluate findings of clinical effectiveness. Additionally, the lack of long term follow-up in current studies adds to the uncertainty of being able to prove clinical benefit.

AHIP understands the statutory limitation that prevents CMS from expanding coverage of this procedure and device through the Coverage with Evidence Development (CED) mechanism. Nonetheless, we wish to highlight aspects of this procedure that we believe are general characteristics that CMS should use when identifying interventions that merit consideration for CED:

1. This procedure shows promise for the treatment of a serious condition with significant risk of associated morbidity and mortality and for which there are few or no effective therapies currently available.
2. Patient recruitment for clinical trials has been slow given the small number of patients with this condition and the relatively small number of sites where the procedure is performed. Without CED, therefore, it will be a difficult and lengthy process before there are adequate data on patient outcomes to be able to evaluate the procedure’s safety and effectiveness.

Thank you for the opportunity to comment on this important issue.

Less

March 14, 2008

The Honorable Kerry Weems
Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Room 445-G
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

Re: February 14, 2008 Proposed Decision Memorandum for Intracranial Stenting and Angioplasty (CAG-00085R5)

Dear Mr. Weems:

On behalf of Advocate Christ Medical Center and the Neurologic and Orthopedic Hospital of Chicago we strongly urge the Centers for Medicare and Medicaid Services (CMS) to reverse its proposal to not cover intracranial stenting and angioplasty within the context of an observational study.

As an interventional neuro-radiologist who specializes in endovascular treatment of neurovascular disease, I rely on the availability of devices that may be utilized in the treatment of intracranial atherosclerotic disease (ICAD) in patients that fail medical therapy. Our typical patient comes to us hopeless after failing medical therapy. Symptoms such as transient ischemic attacks (TIAs) or ‘mini-strokes’ are a terrifying part of their daily routine. Many patients also suffer side effects from high doses of “blood thinners” (e.g. gastric ulcers, bruising, bleeding problems). The treatment of ICAD with angioplasty and stenting has provided a new hope. The ability to control these symptoms and reduce their blood thinning medication is remarkable. I feel I made a difference in the lives of the patients I have treated with the Wingspan Stent and Gateway™ PTA Balloon Catheter. The proposed decision memorandum issued on February 14, 2008 directly affects our hospital’s financial ability to provide this endovascular treatment to these patients.

Intracranial stenting and angioplasty using the Wingspan® Stent System with Gateway® PTA Balloon Catheter is an FDA-approved treatment under the Humanitarian Device Exemption (HDE) for patients with intracranial atherosclerotic disease who are refractory to medical therapy in intracranial vessels ≥ 50% artery lumen stenosis. By allowing coverage of this multi-year, multi-center prospective observational study, valuable clinical evidence to advance our scientific knowledge of both this disease state and innovative treatment could be obtained.

In its proposal, CMS cited the existence of Medicare coverage for Category B Investigational Device Exemption (IDE) trials as effectively restricting coverage under different statutory authorities. It is important to note that the observational study proposed by Boston Scientific would evaluate a separate and distinct patient population than those enrolled in the National Institutes of Health (NIH) randomized controlled IDE trial (SAMMPRIS). This important IDE clinical trial will compare the Wingspan Stent System with Gateway Balloon Catheter to medical therapy alone in patients with stenosis of 70% or greater, while the observational study would examine on-label medically refractory patients with stenosis of 50-69%. We strongly support the SAMMPRIS study and believe the observational study would complement SAMMPRIS trial findings, while permitting a treatment option for a vulnerable patient population with ICAD.

Disease Background

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. and it is the leading cause of long-term disability.[1] The annual cost is about $65.5 billion 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. If medical therapy fails, there are no other treatment options, and these individuals are vulnerable to compromised quality of life.

There is now enough evidence available to warrant national Medicare coverage for a treatment that may benefit a population that has no other alternatives.

The interventional professional societies, the Society of Neurointerventional Surgery (SNIS) formerly known as (ASITN), the Society of Interventional Radiology (SIR), and the Society for Cardiovascular Angioplasty and Interventions (SCAI), favor coverage for the symptomatic medically refractory ICAD patient population. Given that these patients have no other treatment options and face an unacceptable risk of another stroke, the availability of endovascular treatment such as the Wingspan® Stent and Gateway® Balloon may be critical to patients’ long term prognosis, and CMS should provide coverage for this patient population.

To continue to provide these endovascular treatment options, we urge CMS to reverse its proposed non-coverage decision, and permit Medicare coverageof intracranial stenting and angioplasty for patients enrolled in any observational studies, including the proposed study that CMS reviewed as part of its proposed decision. This would help ensure that many patients who may benefit from an FDA-approved humanitarian use device could be treated, generating robust clinical evidence about this device.

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 312-315-9174.

[1]American Heart Association. Heart and Disease Stroke Statistics: 2008 Update. Page 17

Less

March 14, 2008

Re: February 14, 2008 Proposed Decision Memorandum for Intracranial Stenting and Angioplasty (CAG-00085R5)

Dear Mr. Weems:

On behalf of Rush University Medical Center and the Neurologic and Orthopedic Hospital of Chicago we strongly urge the Centers for Medicare and Medicaid Services (CMS) to reverse its proposal to not cover intracranial stenting and angioplasty within the context of an observational study.

As a neurosurgeon who specializes in endovascular treatment of neurovascular disease, I rely on the availability of devices that may be utilized in the treatment of intracranial atherosclerotic disease (ICAD) in patients that fail medical therapy. Our typical patient comes to us hopeless after failing medical therapy. Symptoms such as transient ischemic attacks (TIAs) or ‘mini-strokes’ are a terrifying part of their daily routine. Many patients also suffer side effects from high doses of “blood thinners” (e.g. gastric ulcers, bruising, bleeding problems). The treatment of ICAD with angioplasty and stenting has provided a new hope. The ability to control these symptoms and reduce their blood thinning medication is remarkable. I feel I made a difference in the lives of the patients I have treated with the Wingspan Stent and Gateway™ PTA Balloon Catheter. The proposed decision memorandum issued on February 14, 2008 directly affects our hospital’s financial ability to provide this endovascular treatment to these patients.

Intracranial stenting and angioplasty using the Wingspan® Stent System with Gateway® PTA Balloon Catheter is an FDA-approved treatment under the Humanitarian Device Exemption (HDE) for patients with intracranial atherosclerotic disease who are refractory to medical therapy in intracranial vessels ≥ 50% artery lumen stenosis. In the time since this device was approved by the FDA, I have utilized the treatment in approximately 45patients, all of whom have benefited from the procedure. By allowing coverage of this multi-year, multi-center prospective observational study, valuable clinical evidence to advance our scientific knowledge of both this disease state and innovative treatment could be obtained.

In its proposal, CMS cited the existence of Medicare coverage for Category B Investigational Device Exemption (IDE) trials as effectively restricting coverage under different statutory authorities. It is important to note that the observational study proposed by Boston Scientific would evaluate a separate and distinct patient population than those enrolled in the National Institutes of Health (NIH) randomized controlled IDE trial (SAMMPRIS). This important IDE clinical trial will compare the Wingspan Stent System with Gateway Balloon Catheter to medical therapy alone in patients with stenosis of 70% or greater, while the observational study would examine on-label medically refractory patients with stenosis of 50-69%. We strongly support the SAMMPRIS study and believe the observational study would complement SAMMPRIS trial findings, while permitting a treatment option for a vulnerable patient population with ICAD.

Disease Background

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. and it is the leading cause of long-term disability.[1] The annual cost is about $65.5 billion 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. If medical therapy fails, there are no other treatment options, and these individuals are vulnerable to compromised quality of life.

There is now enough evidence available to warrant national Medicare coverage for a treatment that may benefit a population that has no other alternatives.

The interventional professional societies, the Society of Neurointerventional Surgery (SNIS) formerly known as (ASITN), the Society of Interventional Radiology (SIR), and the Society for Cardiovascular Angioplasty and Interventions (SCAI), favor coverage for the symptomatic medically refractory ICAD patient population. Given that these patients have no other treatment options and face an unacceptable risk of another stroke, the availability of endovascular treatment such as the Wingspan® Stent and Gateway® Balloon may be critical to patients’ long term prognosis, and CMS should provide coverage for this patient population.

To continue to provide these endovascular treatment options, we urge CMS to reverse its proposed non-coverage decision, and permit Medicare coverageof intracranial stenting and angioplasty for patients enrolled in any observational studies, including the proposed study that CMS reviewed as part of its proposed decision. This would help ensure that many patients who may benefit from an FDA-approved humanitarian use device could be treated, generating robust clinical evidence about this device.

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 312-315-9174.

[1]American Heart Association. Heart and Disease Stroke Statistics: 2008 Update. Page 17

Less

On behalf of the Valley Neuroscience Institute, we strongly urge the Centers for Medicare and Medicaid Services (CMS) to reverse its proposal to not cover intracranial stenting and angioplasty within the context of an observational study.

Since implanting the first Wingspan device in California in 2006, our practice has used this device in many patients refractory to medical management. Several of these patients possessed nearly occlusive disease, for whom medical management would be expected to fair poorly. A sub-group of these patients possessed 50%-69% stenosis as well as poor collateral blood supply to the involved vascular territory. In these patients, disease progression on medical management would pose a higher likelihood of stroke prior to progressing to a 70% or higher lesion. Note that several publications have well documented the short term morbidity in symptomatic patients treated medically. Also, please note that under the current ruling, patients with 50%-69% stenosis who fail medical management would have no stent option. Half of these patients would be expected to fail a second time with a median time to failure of 36 days (Thijs and Albers. Neurology 2000;59: 490). The proposed decision memorandum issued on February 14, 2008 directly affects our hospital’s financial ability to provide this endovascular treatment to these patients.Intracranial stenting and angioplasty using the Wingspan® Stent System with Gateway® PTA Balloon Catheter is an FDA-approved treatment under the Humanitarian Device Exemption (HDE) for patients with intracranial atherosclerotic disease who are refractory to medical therapy in intracranial vessels > 50% artery lumen stenosis. By allowing coverage of this multi-year, multi-center prospective observational study, valuable clinical evidence to advance our scientific knowledge of both this disease state and innovative treatment could be obtained.

In its proposal, CMS cited the existence of Medicare coverage for Category B Investigational Device Exemption (IDE) trials as effectively restricting coverage under different statutory authorities. It is important to note that the observational study proposed by Boston Scientific would evaluate a separate and distinct patient population than those enrolled in the National Institutes of Health (NIH) randomized controlled IDE trial (SAMMPRIS). This important IDE clinical trial will compare the Wingspan Stent System with Gateway Balloon Catheter to medical therapy alone in patients with stenosis of 70% or greater, while the observational study would examine on-label medically refractory patients with stenosis of 50-69%. We strongly support the SAMMPRIS study and believe the observational study would complement SAMMPRIS trial findings, while permitting a treatment option for a vulnerable patient population with intracranial atherosclerotic disease (ICAD). There is now enough evidence available to warrant national Medicare coverage for a treatment that may benefit a population that has no other alternatives.

Sincerely,

George Rappard, MD

Less

I am a Physician Assistant working with a Neurointerventional Radiologist.

Many of the patients we see require stent-assisted endovascular coil embolization of cerebral aneurysms or have symptomatic intracerebral artery stenosis.It is frustrating as a medical provider to tell patients that Medicare will not pay for a procedure that will prevent them from having additional or worsening symptoms or from having an ischemic cerebrovascular accident.

These patients often choose not to proceed with treatment because Medicare will not reimburse the cost, even partially and the patients do not want to liquidate the last of their assets to pay for the intracerebral angioplasty and stenting.

Many of these patients have had failure of conservative medical antiplatelet therapy and continue to be symptomatic. The only option is to do nothing or perform the intracerebral angioplasty and stenting at the patient''''s expense.

It is ludicrous that Medicare and Medicaid pay the exorbitant expense for the patient''''s care once they have had a stroke but not for proven technology and procedures that reduce the risk of stroke.

Less

March 10, 2008

The Honorable Kerry Weems
Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Room 445-G
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

Re:February 14, 2008 Proposed Decision Memorandum for Intracranial Stenting and Angioplasty (CAG-00085R5)

Dear Mr. Weems:

On behalf of Fletcher Allen Health Care, we strongly urge the Centers for Medicare and Medicaid Services (CMS ) to reverse its proposal to not cover intracranial stenting and angioplasty within the context of an observational study.

In our experience, which is supported in the literature, medical therapy for symptomatic intracranial stenoses is inadequate. Our experience with the Wingspan® Stent System with Gateway® PTA Balloon Catheter has shown that intracranial stenoses can be safely and effectively treated. The proposed decision memorandum issued on February 14, 2008 directly affects our hospital’s ability to provide this endovascular treatment to these patients and to study to long termoutcomes of this treatment option.

Intracranial stenting and angioplasty using the Wingspan® Stent System with Gateway® PTA Balloon Catheter is an FDA-approved treatment under the Humanitarian Device Exemption (HDE) for patients with intracranial atherosclerotic disease who are refractory to medical therapy in intracranial vessels ≥ 50% artery lumen stenosis. By allowing coverage of this multi-year, multi-center prospective observational study, valuable clinical evidence to advance our scientific knowledge of both this disease state and innovative treatment could be obtained.

In its proposal, CMS cited the existence of Medicare coverage for Category B Investigational Device Exemption (IDE) trials as effectively restricting coverage under different statutory authorities. It is important to note that the observational study proposed by Boston Scientific would evaluate a separate and distinct patient population than those enrolled in the National Institutes of Health (NIH) randomized controlled IDE trial (SAMMPRIS). This important IDE clinical trial will compare the Wingspan Stent System with Gateway Balloon Catheter to medical therapy alone in patients with stenosis of 70% or greater, while the observational study would examine on-label medically refractory patients with stenosis of 50-69%. We strongly support the SAMMPRIS study and believe the observational study would complement SAMMPRIS trial findings, while permitting a treatment option for a vulnerable patient population with intracranial atherosclerotic disease (ICAD).

Disease Background

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. and it is the leading cause of long-term disability. The annual cost is about $65.5 billion 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. If medical therapy fails, there are no other treatment options, and these individuals are vulnerable to compromised quality of life.

There is now enough evidence available to warrant national Medicare coverage for a treatment that may benefit a population that has no other alternatives.

The interventional professional societies, the Society of Neurointerventional Surgery (SNIS) formerly known as (ASITN), the Society of Interventional Radiology (SIR), and the Society for Cardiovascular Angioplasty and Interventions (SCAI), favor coverage for the symptomatic medically refractory ICAD patient population. Given that these patients have no other treatment options and face an unacceptable risk of another stroke, the availability of endovascular treatment such as the Wingspan® Stent and Gateway® Balloon may be critical to patients’ long term prognosis, and CMS should provide coverage for this patient population.

To continue to provide these endovascular treatment options, we urge CMS to reverse its proposed non-coverage decision, and permit Medicare coverageof intracranial stenting and angioplasty for patients enrolled in any observational studies, including the proposed study that CMS reviewed as part of its proposed decision. This would help ensure that many patients who may benefit from an FDA-approved humanitarian use device could be treated, generating robust clinical evidence about this device.

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 802-881-8866 or grant.linnell@vtmednet.org.

Less

February 26, 2008

Re: February 14, 2008 Proposed Decision Memorandum for Intracranial Stenting and Angioplasty (CAG-00085R5)

Dear Mr. Weems:

I strongly urge the Centers for Medicare and Medicaid Services (CMS) to reverse its proposal to not cover intracranial stenting and angioplasty within the context of an observational study.

Intracranial atherosclerotic disease (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. and it is the leading cause of long-term disability.[1] The annual cost is about $65.5 billion in direct medical costs and indirect costs including losses in productivity.¹ The Wingspan Stent system is used in our patient population with intracranial stenosis that have continued transient ischemic attacks or stroke despite maximum medical therapy. These patients that continue to have symptoms have a very high risk of subsequent stroke. Therefore, if medical therapy fails, there are no other treatment options, and these individuals are vulnerable to compromised quality of life. The Wingspan Stent system is the only option for these patients. The proposed decision memorandum issued on February 14, 2008 directly affects our hospital’s financial ability to provide this endovascular treatment to these patients. By allowing coverage of this multi-year, multi-center prospective observational study, valuable clinical evidence to advance our scientific knowledge of both this disease state and innovative treatment could be obtained.

In its proposal, CMS cited the existence of Medicare coverage for Category B Investigational Device Exemption (IDE) trials as effectively restricting coverage under different statutory authorities. It is important to note that the observational study proposed by Boston Scientific would evaluate a separate and distinct patient population than those enrolled in the National Institutes of Health (NIH) randomized controlled IDE trial (SAMMPRIS). This important IDE clinical trial will compare the Wingspan Stent System with Gateway Balloon Catheter to medical therapy alone in patients with stenosis of 70% or greater, while the observational study would examine on-label medically refractory patients with stenosis of 50-69%. We strongly support the SAMMPRIS study and believe the observational study would complement SAMMPRIS trial findings, while permitting a treatment option for a vulnerable patient population with intracranial atherosclerotic disease.

The interventional professional societies, the Society of Neurointerventional Surgery (SNIS) formerly known as (ASITN), the Society of Interventional Radiology (SIR), and the Society for Cardiovascular Angioplasty and Interventions (SCAI), favor coverage for the symptomatic medically refractory ICAD patient population. Given that these patients have no other treatment options and face an unacceptable risk of another stroke, the availability of endovascular treatment such as the Wingspan Stent and Gateway Balloon may be critical to patients’ long term prognosis, and CMS should provide coverage for this patient population.

To continue to provide these endovascular treatment options, we urge CMS to reverse its proposed non-coverage decision, and permit Medicare coverageof intracranial stenting and angioplasty for patients enrolled in any observational studies, including the proposed study that CMS reviewed as part of its proposed decision. This would help ensure that many patients who may benefit from an FDA-approved humanitarian use device could be treated, generating robust clinical evidence about this device.

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 (310) 206-1527.

[1]American Heart Association. Heart and Disease Stroke Statistics: 2008 Update. Page 17

I am a physician who treats stroke patients and Ihave been treating patients with symptomaticintracranial stenosis for over ten years. Inpatients with symptomatic inttracranial stenosisthere is ample data from single and multicentertrials to include this as a covered service. I amfully supportive of broader randomized trials toevaluate this therapy, but I think it is wrong todeny symptomatic patients with intracraniallesions this therapy that is currently availableat specialized centers throughout the country. Itwill take at least ten years before the NIH trialwill be completed. In the meantime, what happensto the patients who don''t fit the inclusion andexclusion criteria for the trial or don''t want tobe randomized? We can''t just let them sufferrepeated strokes and die when we have thetechnology and skill to treat them.

In our experience, which we have published,intracranial intervention is safe andlife-changing, if not life-saving. This is adisease of the elderly, our most fragile citizens.To deny them this treatment based on a thirty yearold law made without an ounce of data is simplywrong. Please extend the coverage decision toinclude symptomatic intracranial stenoses at leastuntil the NIH trial is complete.

Less