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

August 30, 2008

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

Dear Dr. Phurrough:

The American Association of Neurological Surgeons and the Congress of Neurological Surgeons support the proposed decision of CMS to make no changes to the national coverage determination (NCD) for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting (Medicare NCD Manual 20.7, CAG-00085R6) which was released on July 31, 2008.

However, for patients who meet the current conditions for coverage, we continue to support reimbursement for CAS performed without the use of an embolic protection device if safe use of the device is technically not feasible. In certain patients who meet current conditions of coverage, technical and anatomic considerations may prevent the safe deployment of an embolic protection device. Such circumstances may not be known before the procedure and should not preclude reimbursement for the procedure.

We believe that information resulting from the National Institute of Neurological Disorders and Stroke (NINDS) Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) should provide guidance regarding appropriate indications for carotid artery stenting. We recommend that coverage for this procedure not be expanded until the completion of the CREST trial and a thorough analysis of the data produced by it.

We have attached our comments from March 2, 2008, regarding this issue. Our position has not changed and we appreciate the comprehensive review the CMS Coverage Analysis Group has given to this issue.

Sincerely,

John A. Wilson, MD., FACS
Associate Professor Division of Surgical Sciences
Vice Chair and Residency Program Director
Department of Neurosurgery Wake Forest University
School Of Medicine
office: (336)716-4020
fax: (336) 716-3065

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August 30, 2008

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

RE: Proposed Coverage Decision for Carotid Artery Stenting CAG-00085R6

Dear Dr. Phurrough;

Representing over 2,400 physicians in the United States, the Society for Vascular Surgery (SVS) submits the following comment regarding the recent proposed coverage decision for percutaneous transluminal angioplasty of the carotid artery concurrent with stenting (CAG-00085R6, dated July 31, 2008). Once again, SVS appreciates the extensive effort expended by the CAG in developing and reappraising this important coverage policy. As noted in our earlier comments SVS is uniquely qualified to offer recommendations on this topic since our members perform carotid endarterectomy (CEA) and carotid artery stenting (CAS) in addition to providing medical treatment for large numbers of patients with carotid artery occlusive disease. Vascular surgeons are veterans in this field; we have been providing comprehensive longitudinal carotid disease care for five decades.

SVS reviewed all new scientific data published in the peer-reviewed literature since our last comment on this topic in March, 2008, and we believe there is insufficient evidence to alter our original position. In brief, SVS recommended and still recommends expansion of CAS coverage for patients with a tightly defined group of anatomic risk factors that would place them at high risk for open surgical CEA, as long as those patients also meet the additional coverage criteria which would include: 1) having suffered a lateralizing TIA or minor stroke and harboring an angiographically proven carotid artery stenosis of 50-69%; or 2) being without neurologic symptoms but proven to harbor a carotid artery stenosis > 80%. In addition, we believe that those who perform CAS in asymptomatic patients must document a 30-day stroke/death complication rate of <3.0% in that patient cohort in order to match the AHA recommendation for CEA providers.

Regarding refinement of the definition of anatomic high risk factors, SVS notes concordance in previously submitted recommendations by major professional societies in support of four anatomic high risk factors: 1) prior CEA with recurrent stenosis; 2) prior ablative neck surgery (e.g. radical neck dissection); 3) contralateral vocal chord palsy; and 4) presence of a tracheostomy stoma. SVS believes that concordance of society opinion would provide significant impetus for CMS to alter its coverage policy for these four specific high-risk anatomic indications. Additionally, SVS still recommends that two additional anatomic factors be considered appropriate for coverage; 1) history of ipsilateral neck radiation with permanent skin change; and 2) a common carotid stenosis below the clavicle. Finally, we continue to recommend that contralateral ICA occlusion, lesion above C2, immobile neck, and tandem carotid lesions are not high-risk anatomic factors that would result in CAS coverage.

SVS remains anxious for NCD consideration of our request, dated June 4, 2008, that CMS mandate the use of national society registries to serve as the CAS outcomes reporting mechanism, with simultaneous discontinuation of the current CMS CD-based data submission system. We believe this would assure collection of CAS data with sufficient pre- and post-procedural variables to allow scientifically valid and extremely valuable risk-adjusted CAS outcomes analysis.

Summary of SVS Recommendations, essentially as provided on 3/2/08:

SVS recommends refinement and limitation of the proposed “anatomic high-risk factors for CEA”. In the absence of published data comparing complications of CEA to those of CAS for any of the individual proposed “anatomic high-risk factors for CEA”, SVS strongly recommends that surgical input serve as the definitive word regarding factors that truly constitute anatomic high risk for CEA. In the following discussion, we suggest refinement and limitation of anatomic high-risk factors for CEA to six criteria based on the following justifications:

1. Previous CEA with recurrent stenosis. Based on the majority of studies that document an increase in cranial nerve injury after CEA, SVS believes this to be an appropriate anatomic high risk factor for CEA.

2. Prior ipsilateral radiation therapy to neck with permanent skin changes. Intensive radiation therapy to the neck may result in permanent “woody” skin changes. The lasting effects render surgical dissection difficult as tissue planes become less distinct. Wound healing problems are more common. SVS acknowledges this as an appropriate anatomic high risk factor for CEA. However, this does not include the side contralateral to radiation therapy, where skin and tissue planes are likely to be normal. Therefore, SVS recommends the terms “ipsilateral” and “with permanent skin changes” be added to this anatomic factor in the coverage decision.

3. Previous ablative neck surgery (e.g. radical neck dissection, laryngectomy). SVS agrees this is an appropriate anatomic high risk factor based on established increase in difficulty of dissection, potential for cranial nerve injury, and potential for difficult wound healing or infection following CEA.

4. Common carotid artery stenosis below the clavicle. This area is inaccessible to open surgery unless thoracotomy is performed. We base agreement on inclusion as an anatomic high risk for CEA on the assumption that stenting is likely less morbid than thoracotomy and open CCA endarterectomy or bypass graft in the chest.

5. Contralateral vocal cord paralysis. SVS agrees that this is a marker of anatomic high risk for CEA based on the low incidence but catastrophic nature of bilateral vocal cord paralysis, should the same complication accompany CEA on second side

6. Presence of tracheostomy stoma. SVS agrees that this is a marker of anatomic high risk for CEA based on propensity for an increased wound infection rate.

SVS recommends that four of the proposed “anatomic high-risk factors for CEA” be excluded for the following reasons:

1. Surgically inaccessible carotid lesion, located above cervical vertebra C2. It is extremely rare that cervical carotid bifurcation lesions are truly “inaccessible” for CEA. Extracranial carotid artery atherosclerosis occurs at the carotid bifurcation and is the disease under treatment by both CEA and CAS. Most often the bifurcation is easily accessible at mid-neck, but occasionally it can be higher. Techniques such as division of the digastric muscle or employment of nasotracheal rather than orotracheal intubation allow the surgeon to expose the “high” bifurcation without difficulty in almost all cases. In addition, determination that a lesion is "surgically inaccessible" is subjective depending on angulation of the imaging equipment. Finally, if atherosclerotic disease extends far beyond the carotid bifurcation it represents a potential problem for CAS as well as CEA. Gray et al noted a 9.7% stroke rate when multiple stents were required.¹ Overall, SVS believes that the inaccessible high lesion parameter lacks data to support an increased risk for CEA, is too subjective, and may also increase complexity for CAS. It should be excluded from the list of anatomic high-risk factors for CEA.

2. Contralateral internal carotid artery conclusion. The data suggesting that a contralateral ICA occlusion increases the stroke risk for a routine ipsilateral CEA are not conclusive. This parameter should be excluded from the list of anatomic high-risk for CEA.

3. Immobile neck. There are no published data we can identify indicating objective parameters of what constitutes an immobile neck. It is extremely unusual for a patient to have a neck so completely frozen as to render CEA impossible. This potential indicator for anatomic high-risk is impossible to define objectively and would be subject to wide variations in interpretation. SVS strongly recommends it be eliminated from the potential list of anatomic indicators of high surgical risk for CEA.

4. Severe tandem lesions. This purported marker for anatomic high CEA risk should never have been on the list to begin with, in our opinion. This issue has been studied and peer-reviewed articles demonstrate that the presence of an intracranial internal carotid artery stenosis does not increase the surgical risk of CEA. In fact, analysis of NASCET patients with tandem extracranial and intracranial disease suggested that CEA provided additional protection against stroke in presence of intracranial lesion.² SVS strongly recommends it be eliminated from the list of anatomic indicators of high surgical risk for CEA.

SVS recommends expansion of Medicare coverage for CAS with embolic protection to include patients with transient ischemic attack or minor stroke who are found to have a 50-69% ipsilateral carotid stenosis, and who also have one of the six anatomic markers, noted above, that establish high surgical risk for CEA. The specific anatomic markers, as described above, include and should be limited to:

The decision to not expand coverage of carotid stenting to patients with anatomic high risk features is flawed. In the conclusion, it is stated that "for CAS to be considered an alternative to CEA and improve health outcomes for asymptomatic patients with asymptomatic stenosis > 80%, the perioperative morbidity and mortality rates should be less than 3%. For symptomatic patients with stenosis >50%, the benchmark is less than 6% death and stroke within 30 days of the procedure. The body of randomized trials and post approval studies does not demonstrate that CAS can be performed at that level." Yet the 3%/6% benchmarks recommended for endarterectomy were established arbitrarily in 1989 in the absence of any prospective, randomized data: " The ad hoc committee recognizes there are insufficient data to define acceptable morbidity and mortality limits for carotid endarterectomy for various indications. Nevertheless, the committee believes the upper limits of morbidity and mortality that should prompt individual peer review can be defined. These recommendations are based on current data and are likely to change." (Beebe et al Circulation 1989;79:472-473). The benchmarks they set in 1989 for endarterectomy were:

Absence of symptoms < 3%
Transient ischemic attack <5%
Ischemic stroke <7%
Recurrent carotid disease in the same artery after endarterectomy < 10%

Beebe went on to say "The risk of carotid endarterectomy should properly influence the indication for surgery. If the risk of operating on a patient is low in relation to the risk of not operating, then the benefit of carotid endarterectomy as a least-risk strategy may be proportionately great and worthwhile. The converse is also true. If morbidity and mortality of carotid endarterectomy are excessive in proportion to the natural history of the untreated or nonoperatively treated lesion, surgery should be avoided."

In 1995, the AHA Council on Stroke published guidelines for endarterectomy (Stroke 1995;26:188-201) based on the opinions of 22 ad hoc committee members. That document references the Beebe publication as the basis for the assessment of surgical risk, even though Beebe established the benchmarks arbitrarily and not on the basis of surgical outcomes published in the literature. The ad hoc committee opinions were as follow:

"A list of 96 potential common indications was circulated to each conference participant. This list was based on symptomatic status, percent stenosis, plaque characteristic, status of opposite carotid artery, and various levels of surgical risk. The terms used are defined below. Each participant was asked to rank each surgical indication into one of four options: proven (score=1); acceptable but not proven (score=2); uncertain (score=3); and proven inappropriate (score=4). The scores were averaged for each of the 96 indications. Finally, the indications were aggregated again to make the presentation more manageable. Since many of the indications generated a range of scores, some participants rated a given indication higher (or lower) than other participants. For this reason, an average score was selected rather than attempting to find a unanimously acceptable score.

Definitions of Ranks for Surgical Indication for Carotid Endarterectomy
Four choices were available for each indication as a function of surgical risk. For asymptomatic patients, the options for surgical risk for combined stroke and death as a consequence of operation were < 3%, 3% to 5%, and 5% to 10%. For symptomatic patients, the surgical risk options were < 6% and 6% to 10%.

Surgical risk is based on a combined estimate of the patient''s general medical fitness to undergo surgery and the individual surgeon''s risk of morbidity and mortality for patients with a specific surgical indication.

A surgical indication that carries a high benefit-to-risk ratio would be acceptable in patients who were at higher surgical risk, whereas a surgical indication that had a lower benefit-to-risk ratio might be acceptable in only the best-risk patients.

Proven (Score=1)
This designation constitutes the strongest indication for carotid endarterectomy and strongly implies that to withhold surgery in the presence of this indication would be inappropriate under normal circumstances. Indications classified as proven are generally supported by data from contemporary, prospective, randomized clinical trials.

Acceptable but Not Proven (Score=2)There is general agreement that this represents a good indication for surgery, with the expectation that benefits outweigh the risks. This rank is supported by promising, but not scientifically certain, data. Indications in this category may be the subject of ongoing prospective randomized trials. In that case, it is expected that patients will be offered the opportunity to participate in the trial. However, when this is not possible, either by geography or patient preference, surgery would be an acceptable alternative at the present level of knowledge.

Uncertain (Score=3)
There are insufficient data to define the risk/benefit ratio. These potential indications should be evaluated in clinical trials.

Proven Inappropriate (Score=4
The current database is adequate to indicate that the stated risks of carotid endarterectomy outweigh the benefits. In general, the database includes contemporary, prospective, randomized clinical trials.

Definitions of Stroke Categories
Mild Stroke
The residual neurological symptoms and signs of a mild stroke cause no important functional impairment.

Moderate Stroke
The residual neurological symptoms and signs of a moderate stroke result in a loss of function that may be complete in one domain (eg, arm or leg function, speech loss) and incomplete in others, but the total functional loss still allows independent existence.

Severe Stroke
Residual neurological signs of a severe stroke are directly responsible for the patient''s loss of independence.

Current Indications for Carotid Endarterectomy

Asymptomatic Patients With CAD
For Patients With a Surgical Risk of < 3%

1. Proven indications: none*

2. Acceptable but not proven indications: ipsilateral carotid endarterectomy for stenosis 75% with or without ulceration, irrespective of contralateral artery status, ranging from no disease to total occlusion*

3. Uncertain indications

Stenosis < 50% with a "B" or "C" ulcer irrespective of contralateral internal carotid artery status

Unilateral carotid endarterectomy with CABG, coronary bypass graft required with bilateral asymptomatic stenosis >70%

Unilateral carotid stenosis >70%, CABG required, unilateral carotid endarterectomy with CABG

4. Proven inappropriate indications: none defined

For Patients With a Surgical Risk of 3% to 5%

1. Proven indications: none

2. Acceptable but not proven indications: ipsilateral carotid endarterectomy for stenosis 75% with or without ulceration but in the presence of contralateral internal carotid artery stenosis ranging from 75% to total occlusion

3. Uncertain indications

Ipsilateral carotid endarterectomy for stenosis 75% with or without ulceration irrespective of contralateral artery status, ranging from no stenosis to occlusion

Coronary bypass graft required, with bilateral asymptomatic stenosis >70%, unilateral carotid endarterectomy with CABG

Unilateral carotid stenosis >70%, CABG required, ipsilateral carotid endarterectomy with CABG

4. Proven inappropriate indications: none defined

For Patients With a Surgical Risk of 5% to 10%

1. Proven indications: none

2. Acceptable but not proven indications: none

3. Uncertain indications

Coronary bypass graft required with bilateral asymptomatic stenosis >70%, unilateral carotid endarterectomy with CABG

Unilateral carotid stenosis >70%, CABG required, ipsilateral carotid endarterectomy with CABG

4. Proven inappropriate indications

Ipsilateral carotid endarterectomy for stenosis 75% with or without ulceration irrespective of contralateral internal carotid artery status

Stenosis 50% with or without ulceration irrespective of contralateral carotid artery status

Symptomatic Patients With CAD
For Patients With a Surgical Risk of < 6%1. Proven indications

Single or multiple TIAs within a 6-month interval or crescendo TIAs in the presence of a stenosis 70%, with or without ulceration, with or without antiplatelet therapy

Mild stroke within a 6-month interval, in the presence of a stenosis 70%, with or without ulceration, with or without antiplatelet therapy

2. Acceptable but not proven indications

TIA (single, multiple, or recurrent) within a 6- month interval, in the presence of a stenosis 50%, with or without ulceration, with or without antiplatelet therapy

Crescendo TIAs in the presence of a stenosis >50%, with or without ulceration, with or without antiplatelet therapy

Progressive stroke in the presence of a stenosis 70%, with or without ulceration, with or without antiplatelet therapy

Mild stroke in the presence of a stenosis 50%, with or without ulceration, with or without antiplatelet therapy

Moderate stroke in the presence of a stenosis 50%, with or without ulceration, with or without antiplatelet therapy

Ipsilateral carotid endarterectomy combined with CABG in a patient experiencing TIAs, in the presence of unilateral or bilateral stenoses 70%, coronary bypass grafting needed

3. Uncertain indications

TIA (single, multiple, or recurrent) with stenosis < 50% with or without ulceration, with or without antiplatelet therapy

Crescendo TIAs, with or without ulceration, and a stenosis < 50%

TIAs in a patient who requires coronary bypass grafting and has a stenosis < 70%

Mild stroke with carotid stenosis < 50%, with or without ulceration, with or without antiplatelet therapy

Moderate stroke with carotid stenosis <69%, with or without ulceration, with or without antiplatelet therapy

Evolving stroke with carotid stenosis <69%, with or without ulceration, with or without antiplatelet therapy

Global ischemic symptoms with ipsilateral carotid stenosis >75% but contralateral stenosis <75%, with or without ulceration, with or without antiplatelet therapy

Acute dissection of internal carotid artery with persistent symptoms while on heparin

Acute carotid occlusion, diagnosed within 6 hours, producing transient ischemic events

Acute carotid occlusion, diagnosed within 6 hours, producing a mild stroke

4. Proven inappropriate indications

Moderate stroke with stenosis < 50%, not on aspirin

Evolving stroke with stenosis < 50%, not on aspirin

Acute internal carotid artery dissection, asymptomatic, on heparin

For Patients With a Surgical Risk of 6% to 10%

1. Proven indications: none

2. Acceptable but not proven indications

Single or multiple TIAs within a 6-month interval, in the presence of a carotid stenosis 70%, with or without ulceration, with or without antiplatelet therapy

Recurrent TIAs, while on antiplatelet drugs, for a carotid stenosis 50% in the presence of ulceration, or 70% with or without ulceration

Crescendo TIAs with a stenosis 50%, with or without ulceration, with or without antiplatelet therapy

Mild stroke in the presence of a stenosis >70%, with or without ulceration, with or without antiplatelet therapy

Moderate stroke with a stenosis >70%, with or without ulceration, with or without antiplatelet therapy

Evolving stroke in the presence of a >70% stenosis with large ulceration

3. Uncertain indications

Single TIA with stenosis < 70%, with or without ulceration, with or without antiplatelet therapy

Multiple TIAs within 6 months with stenosis < 70%, not on antiplatelet drugs, with or without ulceration

Recurrent TIAs while on antiplatelet drugs with stenosis < 70%, with or without ulceration

Crescendo TIAs for stenosis < 70%, with or without ulceration, with or without antiplatelet therapy.

Acute carotid occlusion with transient cerebral ischemia

Acute occlusion with mild stroke

Acute carotid artery dissection with continued symptoms while on heparin

Patient with transient cerebral ischemia secondary to a stenosis 70%, in need of CABG, with or without contralateral stenosis, use of combined operation

Mild stroke with stenosis < 70%, with or without ulceration, with or without antiplatelet therapy

Moderate stroke with stenosis < 70%, with or without ulceration, with or without antiplatelet therapy

Evolving stroke with stenosis < 70%, with or without ulceration, with or without antiplatelet therapy

Global ischemic symptoms with an ipsilateral stenosis >75%, with or without symptoms, irrespective of contralateral artery status, with lesions up to and including contralateral occlusion

4. Proven inappropriate indications

Single TIA, < 50% stenosis, with or without ulceration, not on aspirin

Multiple TIAs within 6 months, stenosis < 50%, not on aspirin

Mild stroke, stenosis < 50%, not on aspirin

Moderate stroke, stenosis < 50%, with or without ulceration, not on aspirin

Evolving stroke, stenosis < 50%, with or without ulceration, not on aspirin

Global ischemic symptoms with stenosis < 50%, with or without ulceration

Acute dissection of internal carotid artery, no symptoms while on heparin

Asymptomatic unilateral carotid stenosis 70% in patient undergoing CABG"

As you can see, many of the recommendations for treatment in increased risk categories are exactly those for which expanded coverage was requested for carotid stenting in the anatomic high risk patients.

In 1998, the AHA guidelines were revised after the publication of the ACAS trial of enarterectomy in asymptomatic patients, but only for good risk patients with an operative risk of < 3%. For asymptomatic good risk patients, the stroke/death rate of patients medically managed was extrapolated from Kaplan-Meier estimates to be 11% at five years with 2.7 years of follow-up in the ACAS trial in good surgical risk patients. Endarterectomy was estimated to reduce this risk to 5.1% at 5 years (a 53% reduction) in good surgical risk candidates. The guidelines were revised for good surgical risk candidates with less than a 3% operative stroke/death risk, but were not changed for higher risk patients with operative risks of >3%. "For patients with a surgical risk of 3% to 5% and for patients with a surgical risk of 5% to 10%, indications are unchanged from the original guidelines."

The 1995 AHA guidelines for endarterectomy with a >3% risk therefore still stand today. The published literature on carotid stenting has only been in increased surgical risk patients with a >3% risk, and in this population, carotid stenting has consistently shown 30-day stroke/death rates of 4-4.5% and three year stroke/death rates of 6-7%. Carotid stenting has therefore consistently met the benchmarks established for increased surgical risk patients for the increased risk indications established by the AHA Council on Stroke in 1995 and so carotid stenting should be a covered procedure by CMS for the anatomic increased surgical risk conditions as requested.

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Steve Phurrough, M.D., M.P.A.
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244

Re: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R6).

Dear Dr. Phurrough,

Abbott would like to provide comments on the proposed coverage decision for PTA of the carotid artery concurrent with stent placement in Medicare beneficiaries who are at high risk for CEA due to anatomic factors and who have symptomatic carotid artery stenosis of > 50% or asymptomatic carotid artery stenosis of > 80%.

Abbott is a global, broad-based health care company devoted to discovering new medicines, new technologies and new ways to manage health. Our products span the continuum of care, from nutritional products and laboratory diagnostics through medical devices and pharmaceutical therapies. The company employs 65,000 people and markets its products in more than 130 countries. Abbott is the leader in carotid stenting and related clinical research, with over 14,000 high surgical risk patients participating in Abbott's studies. Abbott is sponsoring or co-sponsoring two randomized clinical trials: CREST and ACT I.. These randomized trials of CEA vs. CAS are designed to understand the benefits of carotid stenting in normal surgical risk patients. While this patient population is not applicable for this coverage decision, Abbott is the only company studying this population in such detail and is committed to working with CMS to understand the outcomes of CAS across various patient populations.

Abbott continues to strongly support the request submitted by the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions (SCAI), the Society of Vascular and Interventional Neurology (SVIN) and the Society for Vascular Medicine (SVM) to expand coverage to patients who are at high risk for carotid endarterectomy (CEA) due to defined anatomic factors and who have either symptomatic carotid artery stenosis of 50-69% or asymptomatic carotid artery stenosis of ¡Ý80%. We disagree with the CMS proposal not to expand coverage for this population.

Patient Need for an Alternative Treatment to Surgery

Abbott believes that this expansion of coverage for the high-risk surgical population with anatomical risk factors is an appropriate step forward in assuring that Medicare beneficiaries with carotid artery disease who are at high risk for surgery are provided access to alternative treatments. These anatomic high surgical risk features, largely agreed to by most of the major societies involved in the care of these patients, represent either relative or absolute contra-indications for surgery. These beneficiaries require carotid stenting as an alternative intervention to surgery in cases where medical therapy alone is determined to be an inadequate means of stroke prevention. Absent of coverage for carotid stenting, these beneficiaries could face a high surgical risk, inadequate medical treatment or significant out of pocket expenses for carotid stenting.

Significant Support for Expanded Coverage

We note that the clinical community and patient advocates have expressed support for the expansion of coverage for high-risk beneficiaries with anatomical risk factors. At the stakeholder meeting convened by CMS in June 2007, there was an emerging consensus among numerous physician specialty societies that coverage should be expanded for this population given the clinical need. CMS subsequently actively encouraged stakeholders to submit a request for reconsideration of coverage for the anatomical risk factor group.

During the summer and fall of 2007 physician specialty societies held numerous meetings to attempt to reach agreement on the details of a request to expand coverage. These discussions resulted in a reconsideration request submitted by four specialty societies representing cardiologists and interventional neurologists. While The Society for Interventional Radiology (SIR) and the Society for Vascular Surgery (SVS) ultimately did not join the reconsideration request, comments submitted to CMS by these two societies nevertheless supported the expansion of coverage for beneficiaries with anatomical risk factors subject to certain conditions. In addition to the broad support for expansion of coverage expressed by the clinical community, the American Heart Association (AHA), the principal patient advocacy group for patients with heart disease, supported the proposed expansion of coverage. In fact, in the proposed decision memo, CMS indicates that of the 88 comment letters received, only 11 expressed opposition to expanded coverage. Clearly the physician community supports expansion of coverage for these approved products based on the clinical need and existing and emerging data.

Application of AHA Intervention Guidelines

In the proposed decision memo, CMS acknowledges the dispute surrounding the application of the AHA 3% and 6% intervention guidelines, developed from the NASCET and ACAS non-octogenarian normal risk CEA trials , to high-risk for CEA carotid stenting patients. CMS proposes these guidelines as a benchmark to determine whether coverage should be expanded for high-risk beneficiaries with anatomical risk factors. While it is reasonably argued these standards do not apply to the patient at high surgical risk, it is important to note that they have become the de facto comparator for this population based solely on the absence of any prospectively gathered multicenter neurologically controlled and adjudicated data on the outcomes of CEA or medical therapy

Evidence Focus on Anatomical Risk Factor Population

In the proposed decision memo, CMS focuses its literature search and analysis on articles that specifically address the subset of patients with anatomical risk factors. CMS concludes that little evidence is available on the outcomes for patients with the collective group of risk factors cited in the reconsideration request or on the individual risk factors. CMS further notes that the Abbott post market published data is insufficient because it does not provide outcomes by individual risk factor.

It is not at all surprising that there are few studies that focus specifically on patients with anatomical risk factors. These patients represent a small percentage of the high-risk population and as such have not represented a large enough population to study , except in the most recent analysis of CAS studies of ~7000 patients by Abbott and ~5000 patient by Johnson and Johnson. In the Abbott CAPTURE 2 and EXACT data (n=6685), a total of 431 subjects with anatomical risk factors are evaluated (431/6685= 6.4%). We do not, therefore, believe that it is reasonable to require extensive literature focusing on this population in order to expand coverage, given what appear to be compelling conclusions derived from these data sets.

Evidence Supporting the Expansion of Coverage

While there are only limited studies focusing specifically on the high-risk anatomical risk population, there is an extensive body of evidence on the outcomes for high-risk patients, including those with anatomical risk factors. In fact, data is now available for over 14,000 high-risk patients.

30-day Outcomes for Patients with Anatomical Risk Factors (Table 1)

Contemporary post market studies, such as CAPTURE 2 and EXACT, show overall improvement of outcomes, as physicians continue to gain experience with the procedure. In particular, outcomes in the non-octogenarian population in these large studies of over 6, 500 patients are within or approaching the AHA guidelines of 3% and 6% for asymptomatic and symptomatic patients, respectively.

CAPTURE 2 patients with anatomical risk factors for surgery have stroke and death rates of 2.4% and 2.2% for asymptomatic and symptomatic patients, respectively. For EXACT, these rates are 4.1% and 2.8% respectively.

In order to increase the sample size for these anatomic subgroups, Abbott combined CAPTURE 2 and EXACT. Combining these studies, the sample size of the anatomic sub-group is 431, comprised of 371 asymptomatic and 60 symptomatic patients. The stroke and death rates for this combined cohort are 2.7% and 1.7% for asymptomatic and symptomatic patients respectively.

In summary, 30-day stroke/death rates for high-risk patients with anatomical risk factors undergoing carotid stenting are lower than those in the overall high surgical risk population and within the AHA guidelines.

TABLE 1: Study Comparison of Safety Events ¡Ü 30 Days, Hierarchical Events (Data summary tables submitted to CMS as attachment)

Request for Published Data

In the proposed decision memo, CMS indicates that it believes the level of evidence for carotid stenting is generally poor and cites a lack of peer-reviewed literature. CMS suggests that it would need to see peer-reviewed published data before considering expanding coverage to the anatomical risk population.

We note that in the past CMS has considered unpublished data for the purpose of making a national coverage decision as long as the data is provided to CMS and made available to the public for review. Data from a number of Abbott sponsored and other carotid stenting studies were provided to CMS during the current reconsideration process that could have been made available for public review. Futhermore, most of these data are submitted to the FDA in bi-annual reports and are therefore 'locked' at those time points and virtually unalterable going forward. We recommend that CMS act now to expand coverage for high-risk beneficiaries with anatomical risk factors instead of waiting for more studies to be published, given the clinical need for an alternative intervention to surgery for these patients and the consistency of outcomes data across multiple studies.

Definition of Anatomical Risk Factors

In the proposed decision, CMS indicates that it continues to consider only those risk factors identified in previous coverage decisions as contraindications to surgery. These are: contralateral carotid occlusion, previous CEA, prior radiation treatment, lesion at C-2 or higher, lesion below clavicle, contralateral laryngeal nerve palsy and tracheostoma. CMS further indicates that there is a lack of society consensus on the definition of anatomical risk factors.

In fact, there is significant society consensus on the risk factor definitions. There is society consensus on all of the above factors except for lesion above C2, lesion below clavicle and contralateral occlusion. In addition, all societies support previous ablative neck surgery as a contraindication to surgery, a factor that CMS did not propose adding to the list of contraindications. We support, at a minimum, the expansion of coverage for beneficiaries with anatomical factors supported by all or almost all physician societies, namely previous CEA, prior radiation treatment, lesion above C2, lesion below clavicle, contralateral laryngeal nerve palsy, tracheostoma and previous ablative neck surgery

Randomized Controlled Trials vs. Registries and Medical Management Arm

In the proposed decision memo, CMS emphasizes the importance of randomized controlled trial (RCT) data and encourages future RCTs with a medical management arm. Given that high-risk populations rarely are studied in RCTs since equipoise in the minds of investigators is difficult to achieve, we believe it is reasonable that CMS base coverage for the high-risk anatomical risk population on the real-world, registry data before it now. Post Market Study data presented by Abbott have been generated in a prospective manner at several hundred US centers, neurologically-assessed at pre-specified intervals and independently adjudicated by a multispecialty Clinical Events Committee comprised of neurologists, surgeons, and interventionalists. We believe they are of the highest possible quality and serve as an appropriate basis for coverage expansion.

CMS suggests that RCT data including a medical management arm will be particularly important in evaluating the value of carotid stenting for normal risk patients. Data from RCTs for the normal risk population will be available within the next few years with the recent completion of the enrollment phase of CREST, and the ongoing enrollment in ACT I. The TACIT trial is still in development and proposes a medical arm comparator in the normal risk population. In addition, the 10-year follow-up from the ACST trial will be forthcoming by 2009-2010. We encourage CMS to be open to other options for obtaining additional evidence on the value of medical management versus carotid stenting.

Conclusion

Abbott appreciates the opportunity to comment on the proposed decision memo. We believe that there is a distinct clinical need for carotid stenting as an alternative to surgery for high-risk beneficiaries with anatomical risk factors. We also believe that the evidence supports the expansion of coverage. We urge CMS to expand coverage for carotid stenting to this population in the final coverage decision to assure patient access to a needed therapy. We look forward to continuing to work with CMS to assure appropriate access to carotid stenting for Medicare beneficiaries.

Sincerely,

Barbara J. Calvert
Director, Medical Products Reimbursement

cc: V Tobiason, Sr. Director, Corporate
Reimbursement

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August 29, 2008

Steve Phurrough, M.D., M.P.A.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21224

Dear Dr. Phurrough:

The Society for Cardiovascular Angiography and Interventions, the American College of Cardiology the Society for Vascular Medicine and the Society for Vascular and are responding to the CMS proposed decision memorandum (CAG-000885R6) denying our request for an expansion of coverage for carotid artery stenting (CAS) in patients who are at increased perioperative risk for carotid endarterectomy (CEA) complications due to defined anatomic factors and who have either symptomatic carotid artery stenosis of 50-69% or asymptomatic carotid artery stenosis of ¡Ý80%. Our request to CMS for expanding Medicare coverage to this population was motivated by an appreciation of the compelling scientific evidence that revascularization with CEA prevents stroke compared to medical therapy and that, in patients at high risk for CEA, revascularization with CAS is a safe and efficacious alternative. Without CMS approval of coverage for this unfortunate patient subset, only those Medicare beneficiaries who are able to pay out of pocket for this service will be allowed to avail themselves of this treatment.

HIGH SURGICAL RISK PATIENTS
In Section VII. A. of the memorandum, the evidence is discussed. We are concerned that CMS has misunderstood the issue of unfavorable anatomic features and erred in asking whether anatomic factors would make CEA contraindicated. It is not necessary that CEA be contraindicated in order to make the CEA procedure more difficult or higher in risk. High surgical risk CEA patients, of which the anatomic subgroup is a minority (20% to 40%) compared to the larger group with unfavorable medical comorbidities, provides one of the largest populations of vascular patients ever studied. There is compelling evidence in patients at increased CEA risk from a randomized controlled trial¹ and thousands of patients treated in highly structured FDA device approval trials and clinical registries^2-8 that have unequivocally shown that CAS is not inferior to CEA. In patients with predefined medical comorbidities and adverse anatomic features, CEA need not be contraindicated to warrant consideration of CAS as a reasonable therapeutic alternative. CMS should not require that CAS be superior to CEA to consider it a valid treatment option. The decision to proceed with CAS or CEA is a risk to benefit assessment to be considered by the patient, their family and their treating physician. A similar corollary is a patient who needs coronary revascularization, and is deemed to be at high risk for coronary artery bypass graft surgery (i.e., repeat coronary surgical revascularization, lack of suitable conduit, etc., severe obstructive lung disease). This patient is appropriately offered percutaneous coronary revascularization. Certainly, the data generated in support of carotid artery stent placement exceeds any similar data for coronary artery disease in quality and quantity. CMS asks if there is specific evidence that treatment with CAS for the subgroup of patients with high surgical risk anatomic factors improves health outcomes. Again, the anatomic high surgical risk group comprises a minority (20% to 30%) of all patients who are at increased surgical risk for carotid revascularization. There is absolutely no question, based upon the 1 and 3 year follow-up evidence of the randomized clinical trial and the FDA device approval trials that CAS, in patients at increased risk for perioperative surgical complications offers comparable, if not superior outcomes to those obtained with CEA ^{2, 3, 5-11}. The patient group most in need of coverage because of the lack of alternative therapiesthe anatomic high risk groupis too small to have served as the focus of any single clinical trial and this should not be cause for rejecting the reasonable request for coverage expansion. The purpose of limiting the requested expansion to the smaller subset of high risk anatomic features is reasonable and efficacious. While medical comorbidities certainly increase the risk of surgical procedures and make some patients unattractive surgical candidates, they do not prevent surgery in many cases. However, unfavorable anatomic features, a hostile neck, or a high cervical or low intrathoracic lesion, are much more difficult for the surgeon to overcome and may prevent needed carotid revascularization. It is specifically for this patient subset that the limited request for extending CMS coverage was made. Without expanded coverage for this subset, Medicare-covered patients who cannot afford to pay fee for service will be denied this safe and effective therapeutic option and may be denied any revascularization.

METHODLOGICAL CONCERNS
In Section VII.B.2. we take issue with the BlueCross BlueShield (BCBS) technology assessment and believe its findings are self-serving and biased against payment for new procedures. The BCBS's direct and major conflict of interest should make any governmental organization, but particularly CMS, wary of adopting the TEC findings. It is difficult for a reasonable person to read the body of literature that has been collected specifically for high surgical risk CEA patients and not conclude that CAS is a safe and effective option, if not the preferred treatment in suitable candidates. In the SAPPHIRE trial, in which independent adjudication of neurologic complications at 24 hours post procedure was assessed, the primary endpoint at one-year demonstrated that CAS was not inferior compared to CEA (ARR 7.9%, 95% CI -16.4% to 0.7%, P = 0.004 for non-inferiority)
1. Importantly, outcomes from the real-world post-FDA IDE post marketing studies continue to show more favorable outcomes⁹. These favorable outcomes have been confirmed in multiple with FDA-sponsored prospective multicenter trials, resulting in FDA device approvals based upon the safety and efficacy of CAS in high surgical risk patients. CMS creates confusion by mixing non-high risk trials, and by citing surgical trials with endpoints that have not been independently adjudicated. All the CAS trials cited and published have benefited form a robust methodology requiring independent assessment and adjudication of neurologic complications. Few CEA trials include the rigor of independent neurologic examination. When outcomes are compared, CEA has the advantage of potentially under-reporting outcomes, which is why the SAPPHIRE randomized data is so very important. SAPPHIRE is the only direct comparison, the only randomized trial, that has been performed in this population and it demonstrated non-inferiority of CAS compared to CEA. Multiple other non-randomized trials with independent neurologic adjudication of outcomes are consistent with SAPPHIRE's outcomes and strengthen our confidence in the favorable result for CAS. Isolated surgical reports suffer from excessive heterogeneity for outcome reporting, and therefore cannot be considered valid comparators¹².

COVERAGE OF OCTAGENARIANS
Regarding evidence on CAS in patients greater than 80 years, two manuscripts published this year, yet not considered in the CMS memorandum describe safe and effective CAS in the very elderly and report excellent outcomes for ¡Ý 80 year-old patients when properly selected and treated by experienced clinicians ^{13, 14}. In Section VII.B.5. the reference to the U.S. Preventive Services Task Force (USPTF) is irrelevant. The data discussed by USPTF does not apply to the population (high surgical risk) under consideration for the expansion of this NCD. This type of data-mixing raises concerns regarding CMS' capacity to provide balanced comparison of homogeneous patient subgroups in a non-biased fashion.

DATA REGISTRIES
We are also concerned that CMS's current data collection requirements are not sufficiently robust to afford CMS with valid evidence to inform the coverage determination process. CMS has previously defined the facility and reporting requirements, which must be in place at any hospital offering CAS as a condition for payment for procedures performed on Medicare patients. These requirements include, among other aspects, that facilities with operators performing CAS must provide proper imaging equipment, ongoing cardiovascular monitoring during CAS, a formal credentialing process, and ongoing quality assurance (QA). In addition, hospitals are required to collect basic data regarding every CAS case performed at the facility, and submit those cumulative data to CMS on bi-annual basis in order to re-qualify for reimbursement. Furthermore these are self-reported and are not associated with any validation effort which may compromise their accuracy.The data elements required for submission are mainly administrative; outcomes data are limited to the incidence of stroke and death, and there are no stipulations regarding objective/independent neurologic assessment or requirements (e.g. auditing) to confirm the completeness or accuracy of the reporting. Thus, the data are of very limited value in tracking the relevant outcomes from CAS at any given facility, and are even more limited when used to compare outcomes across facilities (e.g. for benchmarking performance and outcomes). We welcome the opportunity to discuss use of formal CAS registries by all facilities approved by CMS to perform CAS. At CMS's convenience, we would seek a meeting between agency staff and physicians representing the CAS registries to discuss these issues further and to explore new opportunities for agency use of these clinically relevant data elements.

FACILITY ACCREDITATION
We continue to be concerned by CMS's self accreditation option for facilities performing carotid stenting. An appropriate accreditation program could ensure that registry data is used effectively to improve the quality of care. Unfortunately, CMS's free self-accreditation process makes it untenable to establish a more robust and viable accreditation program. If CMS would truly like to encourage external accreditation program(s), SCAI, along with potential partners would welcome the opportunity to discuss developing such accreditation program(s).

CONCLUSION
We urge CMS to review the data carefully and to recognize that published studies demonstrate the safety and efficacy of CAS as a viable therapeutic option for patients at high risk for surgery due to anatomic factors. Allowing access to this technology for an important subset of Medicare patients is critical to their receiving optimal care. We look forward to the agency's final decision on this coverage determination. We also wish to acknowledge the efforts of Kenneth Rosenfield, M.D., FSCAI and Christopher White, M.D., FACC, FSCAI who are the primary authors of this communication.

Respectfully submitted,

Ziyad M. Hijazi, M.D., MPH, FSCAI
President
The Society for Cardiovascular Angiography and Interventions

Douglas Weaver, M.D., FACC
President
American College of Cardiology

J. Michael Bacharach, M.D., M.P.H.
President
Society for Vascular Medicine

cc: Marcel Salive, MD, MPH - marcel.salive@cms.hhs.gov
Lawrence Schott, MD, - Lawrence.Schott@cms.hhs.gov
Sarah McClain, MHS - sarah.mcclain@cms.hhs.gov

REFERENCES
1. Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med 2004;351(15):1493-501.
2. Gray WA, Yadav JS, Verta P, et al. The CAPTURE registry: results of carotid stenting with embolic protection in the post approval setting. Catheter Cardiovasc Interv 2007;69(3):341-8.
3. Gray WA, Yadav JS, Verta P, et al. The CAPTURE registry: Predictors of outcomes in carotid artery stenting with embolic protection for high surgical risk patients in the early post-approval setting. Catheterization and Cardiovascular Interventions 2007;70(7):1025-33.
4. Gray WA, Hopkins LN, Yadav S, et al. Protected carotid stenting in high-surgical-risk patients: the ARCHeR results. J Vasc Surg 2006;44(2):258-68.
5. Safian RD, Bresnahan JF, Jaff MR, et al. Protected carotid stenting in high-risk patients with severe carotid artery stenosis. J Am Coll Cardiol 2006;47(12):2384-9.
6. Hopkins LN, Myla S, Grube E, et al. Carotid artery revascularization in high surgical risk patients with the NexStent and the Filterwire EX/EZ: 1-year results in the CABERNET trial. Catheter Cardiovasc Interv 2008;71(7):950-60.
7. Katzen BT, Criado FJ, Ramee SR, et al. Carotid artery stenting with emboli protection surveillance study: thirty-day results of the CASES-PMS study. Catheter Cardiovasc Interv 2007;70(2):316-23.
8. White CJ, Iyer SS, Hopkins LN, Katzen BT, Russell ME. Carotid stenting with distal protection in high surgical risk patients: the BEACH trial 30 day results. Catheter Cardiovasc Interv 2006;67(4):503-12.
9. Gurm HS, Yadav JS, Fayad P, et al. Long-term results of carotid stenting versus endarterectomy in high-risk patients. N Engl J Med 2008;358(15):1572-9.
10. Gurm HS, Nallamothu BK, Yadav J. Safety of carotid artery stenting for symptomatic carotid artery disease: a meta-analysis. Eur Heart J 2007.
11. Iyer SS, White CJ, Hopkins LN, et al. Carotid artery revascularization in high-surgical-risk patients using the Carotid WALLSTENT and FilterWire EX/EZ: 1-year outcomes in the BEACH Pivotal Group. J Am Coll Cardiol 2008;51(4):427-34.
12. Rothwell PM, Slattery J, Warlow CP. A systematic review of the risks of stroke and death due to endarterectomy for symptomatic carotid stenosis. Stroke 1996;27(2):260-5.
13. Chiam P, Roubin G, Iyer S, et al. Carotid artery stenting in elderly patients: Importance of case selection. Catheterization and Cardiovascular Interventions 2008;72(3):318-24.
14. Velez CA, White CJ, Reilly JP, et al. Carotid artery stent placement is safe in the very elderly (ge80 years). Catheterization and Cardiovascular Interventions 2008;72(3):303-8.

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August 29, 2008

Dear Dr. Phurrough,

The Society of Interventional Radiology (SIR) is a physician association with over 4,300 members that represents the majority of practicing vascular and interventional radiologists in the United States.

We have reviewed the Proposed Coverage Decision Memorandum for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R6). We agree with the premises that the outcomes from carotid artery stenting (CAS) should meet the national benchmarks of 6% 30 day stroke/death for symptomatic patients and 3% for asymptomatic patients and that these benchmarks apply to those patients considered at high surgical risk for endarterectomy. We agree that evidence that CAS meets these benchmarks should either have been published or accepted for publication in peer reviewed professional journals.

The support of SIR for expanded reimbursement for patients at high surgical risk for endarterectomy for anatomic reasons (with anatomic criteria as outlined in the previous comments submitted by SIR to CMS) remains dependent on:

1. Peer reviewed data confirming acceptable CAS outcomes according to national benchmarks, and 2. A multispecialty facility accreditation process that requires facilities to meet national benchmarks for outcomes as a condition for accreditation and reimbursement by CMS for CAS procedures.

SIR appreciates the thorough analysis that CMS has performed in this proposed decision. We ask CMS to consider in its final decision data that may have been accepted for publication (although not yet formally published) since the writing of the proposed coverage decision.

Sincerely yours,
[endorsed copy submitted via email]
John Kaufman
President, Society of Interventional Radiology

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August 29, 2008

Lawrence Schott, MD, MS
Medicare Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard, Mail Stop C1-09-06
Baltimore, MD 21244

Re: Proposed Decision Memo for PercutaneousTransluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAS) (CAG- 00085R6)

Dear Dr. Schott:

Boston Scientific Corporation appreciates the opportunity to present these comments and policy recommendations to the Centers for Medicare and Medicaid Services (CMS) in response to its proposed decision memo for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting (CAS) (CAG-00085R6).

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices. For more than 25 years, Boston Scientific has advanced the practice of less-invasive medicine by providing a broad and deep portfolio of innovative products, technologies and services across a wide range of medical specialties. Boston Scientific has conducted or is conducting numerous studies of PTA and stenting of the carotid arteries, including the BEACH and CABERNET IDE studies, and the SONOMA post-approval study. Additional studies are planned for the near future.

Executive Summary
Boston Scientific appreciates CMS’ effort to evaluate coverage for CAS for beneficiaries at anatomic high risk for surgery. However, Boston Scientific is disappointed by CMS’ proposal not to expand coverage for carotid PTA and stenting for beneficiaries who are at high risk for carotid endarterectomy (CEA) due to defined anatomic risk factors, and who have either symptomatic carotid artery stenosis of 50-69% (or greater) or asymptomatic carotid artery stenosis of ≥80% (hereinafter referred to as “anatomic risk patients” or “anatomic high risk patients”). We urge CMS to reconsider its proposal.

CMS’s proposal not to expand coverage for beneficiaries at high risk for surgery seems to assume that medical therapy is an appropriate alternative to surgery for all high risk patients. Unfortunately, numerous studies, as well as published treatment guidelines, demonstrate that patients at risk for surgery are not always prescribed medical therapy, and, in fact, medical therapy is not always appropriate. Moreover, available data suggest that a significant number of Medicare beneficiaries undergo CEA despite their high risk status and that surgery in these patients is associated with higher adverse event rates. , In situations where physicians feel CAS (versus medical therapy) is warranted because of the high risk of stroke, they will very likely proceed with CEA despite the high risk. Thus, in many cases CMS’ proposal will force beneficiaries to forego CAS and undergo surgery, which places them at higher than necessary risk for major adverse events.

In addition, according to the recommendations of multiple professional societies, patient advocacy organizations, technology assessments and private payers, CAS should be covered for anatomic risk patients.

Finally, while a variety of factors certainly influenced CMS’ proposal, when evaluated individually, the great preponderance of data and information described below supports expanded coverage of CAS for anatomic high risk patients.

Requested Action
Boston Scientific urges CMS to reconsider its recommended coverage determination and provide beneficiaries who have anatomic risk for surgery with access to CAS. Specifically, Boston Scientific requests that CMS provide coverage for the following patient groups:

Dear Dr. Phurrough,

Cordis welcomes this opportunity to provide public comment with regards to this important coverage decision.

In contrast to the conclusions of the Proposed Decision Memorandum, we believe that the evidence strongly supports the modest expansion in coverage originally requested by the Society for Cardiovascular Angiography and Interventions, the Society of Vascular and Interventional Neuroradiology, the Society of Vascular Medicine and the American College of Cardiology. Specifically, to provide coverage for carotid artery stenting with emboli protection (CAS) for patients who possess defined, anatomic high risk factors for carotid endarterectomy (CEA) and who are symptomatic with a diameter stenosis >50% or asymptomatic with a diameter stenosis >80%.

We look forward to discussing such evidence in the body of this letter. For the most part, we believe that this is evidence that CMS has not considered in reaching the conclusions shared in the Proposed Decision Memorandum.

This evidence demonstrates that:

I agree with CMS not to expand the indications for carotid stenting until much stricter policing of liberal policies such as 50-69% lesions are much better defined and long term followup comparing surgey and stents is complete. As a vascular interventionist whom does both surgery and carotid stents I see a great potential for it''s abuse much like coronary stenting.Only a surgeon can say if one is not operable not a cardiologist or radiologist. If that is not placed as part of the equation to have a surgical evaluation first then just like multivessel stenting in the heart ,carotid stenting will be abused. Keep the critera strict,tight, and honest!

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- Dear Sir or Madam:I am writing to you to strongly voice my support of coverage for CAS for patients who are at anatomical high surgical risk for CEA and who are either symptomatic with 50%-69% stenosis or asymptomatic with greater than or equal to 80% stenosis. Expanding CAS coverage to patient groups for whom surgical intervention is not a recommended alternative would eliminate the requirement for these patients to be enrolled in an FDA-approved study in order to access CAS Medicare coverage. The physicians I work with are working very hard to help a population that otherwise would have to undergo a surgical procedure they physically are not suited for, for multiple reasons. If this coverage is not expanded, it causes continued hardship all around and continued expense for sponsors, hospitals and patients who must continue to conduct clinical trials. These patients are often quite elderly and it is a major hardship for them to return for repeated visits of evaluation. It goes without saying the hardship of extra cost and manpower that a clinical trial is to a sponsor and hospital. This expanded coverage would allow the patients to receive the intervention needed to prevent a first stroke or perhaps another stroke from recurring. I strongly encourage you to reconsider your decision.
Ann Dwyer, BSN, RN, CCRC
Cardiovascular Clinical Research Coordinator
The Wisconsin Heart Hospital
10000 West Blue Mound Avenue
Wauwatosa, WI 53226
Phone 414-778-7836
Fax 414-778-7555
Pager 414-590-2164
email adwyer@twhh.org

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To: CMS

Fr: Northwest Indiana Cardiovascular Physicians
2000 Roosevelt Road X Valparaiso, IN C 46383

Dr. Keith Atassi
Dr. Raghuram Dasari
Dr. Mark Dixon
Dr. John A. Forchetti
Dr. Fred J. Harris
Dr. Scott Kaufman
Dr. Akram Kholoki
Dr. Daniel Linert
Dr. Hector Marchand
Dr. M. Satya Rao
Dr. Sandeep Sehgal
Dr. Michael Wheat
Nancy George, B.S., M.P.A, Chief Executive Officer

Re: Proposed NCD for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R6)

Collectively, we thank you for the opportunity to submit public comments on the above.

To that end, our qualified cardiologists/interventionalists emphasize their support of coverage for CAS for patients who are at anatomical high surgical risk for CEA and who are either symptomatic with 50%-60% stenosis or asymptomatic with greater than or equal to 80% stenosis.

Coverage to patient groups for whom surgical intervention is not a recommended alternative would eliminate the requirement for these patients to be enrolled in an FDA-approved study in order to access CAS Medicare converge.

Our experiences associated with this have provided positive outcomes which warrant expansion of coverage. Two of our physicians have performed CAS on 18 patients with excellent results. All of these patients were at high risk for surgical intervention; therefore, CAS was an appropriate alternative therapy. The above mentioned patients are doing well and continue to benefit from the CAS procedure.

Our Cardiology practice participates in a variety of clinical trials, with extensive participation in Acute Coronary syndrome studies. However, we were not afforded the opportunity to participate in any CAS clinical trials. As one might expect, every cardiology practice would have relished the opportunity to participate in one of those trials.

Please consider our remarks and allow a greater base of patients the opportunity for this health enhancement.

Thank you.

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I fully support the CMS decision as it stands now. It is based on rational science and considers the patient''s best interest. As a taxpayer, I agree that CMS should not reimburse for procedures of with highly doubtful efficacy. The industry and physician proponents of expanded coverage for carotid artery angioplasty and stenting have a major financial conflict of interest and are not carefully considering the best interest of patients.

The use of carotid artery angioplasty and stenting in asymptomatic patients has not been shown to be beneficial to patients, and therefore this procedure should not be reimbursed. Keep up the good work.

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There can be no reasonable, non political way to justify the continued non coverage of this proceedure in the sub-population of asymptomatic patients at high risk for carotid endarterectomy. The body of literature supporting the coverage of asx. high risk CAS is huge, and of course there is no way to compare real world patients who are forced, cajoled or otherwise convinced to CEA, as there is no similar restriction on the surgical world(not even to inform them honestly about an equivalent or superior alternative). How many non endovascular surgeons are giving patients at high risk for CEA an alternative as part of informed consent?

I had the illusion that perhaps CMS had a altruistic, broader view that if they just put the brakes on for a short time, the furor would settle and perhaps even the motivated surgeons would catch on and acquire the skill set to perform the endovascular approach. That illusion would be unsupportable should this non expansion of coverage be upheld.Sufficient time has passed, and the mix of performing physicians has stablized. The only remaining logical conclusion is that the inevitable backroom politics associated with a controversial new proceedure has prevailed over the interests of medicare recipients.

I WOULD support a strong arm tactic on CMS''''s part to "suggest" to industry that they find a way to make this proven proceedure more cost effective, but NOT to continue the non coverage policy.

This non cverage policy puts patients in the middle of a debate between groups of physicians. That debate was carried out at the FDA level when this proceedure was approved for this group of patients. Continued non coverage is unsupportable, inexcusable and an embarassment to a body supposedly committed to providing care for its recipients. I continue to hope that wisdom will prevail here, but I must admit, my hope is fading. I think the CMS has asked the endovascular community in this country to "retrieve the witch''''s broom ". The community has responded by laying a stack of legitimate brooms at the wizzard''''s feet. Lets get this overwith. Approve it and let us ge on with the real mission -providing our patents with appropriate care, whichever techniqe happens to be best.

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To whom it may concern;

I am a vascular surgeon in Portland, Maine, who performs both open surgery and carotid stenting (CAS). As such, I am Primary Investigator in both the Capture II registry (at Maine Medical Center) and the SAPPHIRE World Wide registry (Mercy Hospital). My comments on carotid stenting follow, and are much in line with statements from the Society of Vascular Surgery (SVS);

CAS is not only an acceptable, but also sometimes the most desirable treatment option for patients with atherosclerotic occlusive disease of the carotid artery. I have found this method particularly useful in patients with recurrent stenosis after prior neck surgery (particularly after prior carotid endarterectomy), as well as in irradiated fields, or in patients with significant other cardiopulmonary morbidity. I will only treat symptomatic patients greater than 70% stenosis or asymptomatic patients in the 80-99% range. We have an excellent track record of outcomes at our institution, but have also highly selected our patients.

Although CAS is a very useful treatment method in some patients, I feel that it is overused by some. For example, patients greater than 80 years old have been clearly demonstrated to be at high risk for adverse events using carotid stenting. While I agree with the proposed list of what defines a patient high anatomic risk for open carotid operation[The list follows:

• Previous carotid endarterectomy (CEA) with recurrent stenosis,
• Prior radiation therapy to neck,
• Previous ablative neck surgery (e.g., radical neck dissection, laryngectomy),
• Surgically inaccessible carotid lesion located above cervical vertebra C2,
• Common carotid artery lesion below the clavicle,
• Contralateral vocal cord palsy,
• Presence of tracheostomy stoma,
• Contralateral internal carotid artery occlusion,
• Immobile neck, and
• Severe tandem lesions.]

I do not agree that presence of one or more of these criteria always makes carotid stenting a better option than open surgery (CEA or carotid bypass): There are good publications that support "redo" endarterectomy; Ablative neck surgery doesn't always preclude CEA; Common carotid lesions can be bypassed; CEA can be done safely in the presence of tracheostomy, tandem lesions, and sometimes even immobile neck. There are data to support the safety of CEA in octogenarians.

My concerns with widespread CMS approval of carotid stenting are:

Whereas carotid stenting was reaching major national publication status (Jay Yadav, MD and Gary Roubin, MD) over ten years ago, I have yet to see any five or ten year supportive data for patients who have received carotid stents. In stent restenosis and stroke have been a clearly identified problems in some of the longer term studies. And the elderly patients frequently survive for the long term.

Although the SAPPHIRE data appear to justify carotid stenting as equivalent or better than carotid endarterectomy in high risk patients...

The stroke rate in the carotid endarterectomy group is excessively high, and does not fall into the national norm. And there was no documentation of appropriate preoperative medical management (dosage and timing of aspirin, beta blocker, statin agents) in the carotid endarterectomy cohort.

In this study there was no cohort of patients enrolled in "best medical therapy", (which may be the best treatment option for these patients).

In patient groups "for which surgical intervention is not a recommended alternative," the decision will often be made by non-surgeons or non-vascular surgeons: "Either I could place a carotid stent through a groin puncture or I can send you to a surgeon who can cut your neck open", does not constitute an appropriate informed consent discussion for these patients. In fact, it is a scare tactic.

There are clearly anatomic risk factors for carotid stenting that need to be further assessed, and are, perhaps, contraindications to this procedure.

This procedure is being strongly advocated for widespread acceptance by both the cardiology specialty and by industry with very little data to support CAS over traditional open surgery (CEA). The old adage, "If your only tool is a hammer, then every problem becomes a nail" is appropriately applied here.

Thank you,

Sincerely,

Paul H.S. Bloch, MD, RVT, FACS

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As a practising interventional cardiologist who performs various percutaneous interventions including carotid stent implantation, I find the continued reticence of the CMS in approving this procedure for more widespread usage both perplexing and surprising. Carotid stent implantation in high risk patients for surgery is safe and obviously better. The forceful pushback from vascular surgeons who feel their "territory" being encroached upon, raises ethical and obvious financial concerns. As physicians we need to be considerate of the obvious. Any operator will know that a practised physician can perform a carotid stent procedure under ten minutes without general anesthesia. That this can somehow be a lot more dangerous than a half-to-one hour long surgery under anesthesia with routine postoperative hypertensive crises baffles the credulous. I make an earnest request of the Centers for Medicare and Medicaid Services to extend coverage for this life-saving procedure

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The issue of bias in these public comments must be considered. One sponsor has contacted physicians with the statement: "This is your only opportunity to publicly comment on this proposal and to provide support for expanded coverage for CAS, an important treatment option for patients who are at high surgical risk for CEA due to anatomical factors." This statement is, as CMS has noted, not justified based on any factual data. The many physicians receiving gifts and other support from this sponsor are more likely to respond to the sponsor''''s wishes and comment in support of the extension of CAS reimbursement.This should be considered in the analysis of public comment.

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I am writing to support expanded coverage of CAS with DP in patients with anatomic factors that increase the risk for CEA. Others have illustrated with evidence behind the safety of CAS in "high risk populations". I would like to point out that CMS currently covers CEA in this population. In fact CMS covers CEA in any patient regardless of risk. While the data supporting CEA in standard risk patients is strong there is little independant neurologist adjudicated data to support the use of CEA outside the patient populations in NASCET, ACST, ACAS, ECST. The data supporting CAS in higher risk populations is fairly strong in comparison with thousands of registry patient with independant neurologist outcome reported. While the SAPPHIRE study was small it is still the only independantly adjudicated RTC available for CAS with mandate DP vs. CEA.Some high risk patient populations are likely best left alone for medical therapy (functionally high risk)and these patients should likely be studied further by rescinding coverage for CEA in asymptomatic patients mandating a trial of med rx vs CEA vs CAS. High anatomic risk patients could be studied in the same way but these patients ussually have a better 5 year survival which makes them more representative of the ACAS population. Thus a head to head trial vs. medical therapy may be less necessary.Overall, there needs to be consistency in the CMS reimbursement policy that reflects attention to the data and not politics. Coverage should be approved for high anatomic risk patients for CAS or it should be rescinded for such patients for CEA. Waiting for the CREST results is not warrented. Regardless of the results of this study it should not have much influence on an anatomic high surgical risk population. This is a different patient population. Finally, in most high volume high quality centers CAS for asymptomatic patients with CEA restenosis has become the standard of care through use of ongoing registries. Eventually, these registries will end and care will be dictated by coverage and not by what is now generally accepted as stadard of care (even by most surgeons).Thank you for your attention
Michael Rinaldi, MD FACC FSCAI
Director, Peripheral Invasive Lab, Carolinas Medical Center
Director, Clinical Research, Carolinas Heart and Vascular Institute
The Sanger Clinic, Carolinas Medical Center

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Regarding extended coverage for carotid stenting:

The clinical evidence for the benefit and safety of carotid stenting has already been extensively reviewed and presented to CMS. The question of extending coverage to asymptomatic high risk patients is not a question of clinical data..but one of treatment access. At this time, patients fitting this criteria are only covered for carotid endarterectomy. That is to say that CMS has already reviewed and agreed to cover these operations for this particular group of patients.

It is therefore not a question of whether intervention is appropriate; but rather what type of intervention. There are certain situations such as high lesions that cannot be reached by surgical approaches, radiated necks, and contralateral vocal cord paralysis that absoulutely require carotid stenting. This is the patients only choice for treatment. For example, under the current guidelines, an asymptomatic patient with an 80% lesion that is inaccessible to surgery has NO TREATMENT OPTION beside medical management. This has already been proven to be inadequate and inappropriate care. To not provide coverage for a viable treatment option that appears to have the same safety profile as carotid endarterectomy would be a definite disservice to the American patient. I do think however, that "high risk" should be strictly defined and more importantly that only physicians with an intimate knowledge of the vascular bed be allowed to perform these procedures. On this note I strongly feel that a Board Certified vascular surgeon should always be consulted to review the case and ultimately decide whether or not the patient is a surgical candidate or if PTA/Stent is the only option.

Respectfully,

J Vasquez, MD

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I am an Interventional Radiologist here in Shreveport, La. and performed the first Carotid Stent Proceedure here in 1998 and aggressively preached from the beginning that CAS was of LIMITED use ONLY on NON-SURGICAL CANDIDATES...CEA is proven, safe surgery...knowing that those physicians with PROXIMAL CONTROL of the patients, i.e. Cardiology, etc. would OVERUSE the CAS proceedure for financial reasons, justifying their unnesessary proceedures on the innacurate and misleading literature you mentioned in your statement...CMS should NOT change it''s stand on reimbursement...as long as the Physician who has control of the patient can order and/or perform any proceedure he wants on the patient, then the "Wolf guarding the sheep" analogy applies...Andrew Marsala M.D....Shrevepert, Louisiana

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Expanded coverage of CAS for low grade symptomatic stenosis (50-69%)and high grade asymptomatic stenosis (>80%) would be a clinical mistake and a financial mistake. First, all patients requiring any form of vascular intervention should have maximal control of their risk factors before any intervention is performed. This should be mandated by CMS and no payment should go to the hospital or physician who intervene in an elective setting without having the patient''s risk factors under control. This is the most important aspect of care of the patient with atherosclerotic, obstructive vascular disease, including carotid stenosis, trumping even the hallowed interventions that everyone gets paid so much to perfrom. Second, the number needed to treat to prevent stroke in the low grade symptomatic lesions and the high grade asymptomatic lesions does not justify widespread use of carotid endarterectomy or CAS in either setting. By expanding the reimbursement for the performance of CAS, you are inviting patients to be subjected to unproven and unneeded interventions which may result in substantial harm to the patient. You must wait for the results of a newer trial such as TACIT which will accurately redefine the natural history of medical treatment of carotid stenosis in an era of dramatically improved medications for risk factor treatment and stabilization of plaque.This study has the potential to negate prior studies that showed benefit to endarterectomy and if it does there should be a sharp reduction in the performance of endarterectomy and CAS. As a board certified vascular surgeon with over twenty years of practice experience, I know firsthand that there are too many patient''s with carotid stenosis being subjected to intervention. Over the years I have followed thousands of asymptomatic patients who have all degrees of carotid artery stenosis greater than 50%. They have been followed with duplex ultrasound and the rate of plaque and stenosis progression is quite low and few if any patients become symptomatic with TIA or stroke. This has curtailed my enthusiasm for endarterectomy or CAS and allowed me to give realistic counsel to the patients about the low risk nature of their carotid stenosis and the lack of need for a procedural intervention i.e. endarterectomy or CAS. It would be a mistake to further expand payment coverage for a procedure which has marginal if any benefit. Furthermore, I would recommend the suspension of payment for CAS which is performed in a device manufacturer sponsored, non scientific registry. This is a horrible, non scientific hoax that allows unscrupulous or poorly informed operators to ply their trade on an unsuspecting public and as i see it protection of the public is one of the main goals of a government agency such as CMS. Thank you for your consideration.
Steve Powell MD
Professor and Chief, Vascular Surgery
Brody School of Medicine at East Carolina University
Greenville, NC 27834

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It is my view that CMS should expand coverage for CAS for asymptomatic high risk patients. Retrospective analysis of surgical databases showing no increased risk for high risk anatomic features are problematic because of selection bias and incompleteness of reporting. While high risk CEA in high volume centers with highly experienced surgical teams may have acceptable outcomes the majority of patients are treated in community hospitals where the levels of experience and volume are not that same as at New York Univeristy, for example.

I also believe that CMS coverage should be expanded to include patients with asymptomatic lesions (>80%) who required surgical coronary revascularization or valve surgery since the risk of stroke or MI with combined surgical procedures is extremely high. I believe that retrospective analysis by Rothman, et.al and others have repeatedly demonstrated high adverse event rates in these patient who undergo CEA.As it stand now these patients can only be treated as part of an approved post-marketing study. One suggestion would be expand post-marketing studies so that patients have options while at the same time we can collect more data.

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Thank you for the opportunity to comment on CAG-00085R6. The review of data on the CMS website was fairly comprehensive. Therefore I will not cite any references. Our site has implanted more than 1,000 carotid stents over 11 years, tracked the data carefully, and reported to CMS. Long-term MACE in our series is 2.5% with a median follow-up of more than 5 years. Included among our patients are those with anatomic high-risk criteria that makes carotid stenting the procedure of choice, but certainly not the only option. Very few patients are truly inoperable. Medical therapy remains an option, but not optimal, particularly for symptomatic patients with high-grade stenoses. Our outcomes in the anatomic subset are not statistically different from the overall cohort.

CMS would severely limit access for patients who need treatment, favoring academic centers and research hospitals. The non-coverage decision would actually favor our site (with access to clinical trials) compared to other area hospitals, but that decision would be unfair to skilled community physicians who do not do research.

I strongly urge CMS to expand coverage as requested by the societies that sponsored the proposal.

Respectfully, Malcolm Foster MD

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From a clinician who performs both CEA and CAS and a clinical scientist, I support the CMS decision to restrict expansion at this time. There are several factors for this opinion. First, the stroke-risk reduction benefit of both CEA and CAS versus modern medical therapy remains poorly defined, and both modalities may actually be over-applied in this setting.

Secondly, both physiological and anatomical high-risk indications have not been universally supported in the literature (please see Stoner MC. J Vasc Surg. 2006 Feb;43(2):285-295; Stoner MC. J Vasc Surg. 2005 Jun;41(6):942-9.).

Finally, caution must be advised if CMS is to broaden coverage for CMS, and therefore subject patients to a broad spectrum of providers, many of whom will lack the experience and judgement to preform such procedures. Market forces will increase the number of prviders if indications are to expand. Current NIS data analysis supports this statement, showing that "real-world" stroke-death rates with CAS are approximately 1.5 times higher than CEA.

Undoubtedly, many of these patients are anatomical high-risk, and have been turned down for CEA. This represents the subset of patients who would be covered by expanded indication. I am still a proponent of CAS in the correct setting, but feel that these procedures should still be done as a part of a trial, ideally one that has a medical and surgical arm (such as TACIT).

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As a vascular surgeon at one of the South''s busiest vascular institutions, I have seen repeated use of the term "high-risk" by non-surgical specialists in order to justify carotid stenting in patients who would be acceptable surgical risks otherwise. Furthermore, the patients are not provided objective, unbiased details regarding the options of carotid intervention. I believe there to be only one solution to this problem, namely, that carotid intervention be restricted to only those physicians who can provide to the patients both surgical and stent options.

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I have been involved in carotid revascularizationfor 30 yrs; published the first RCT comparing CEAand CAS in a community hospital, and engaged in CREST as a leading enroller, ARCHER, BEACH, VIVA,CAPTURE II, ETC.

I CONCUR that symptomatic stenosis be approved for CAS. The results of NASCETindicate only marginal benefit for CEA; to bringCAS to the table as an alternative is not properat this time, in my opinion.

I do NOT concur that asymptomatic stenosis > 80%in this population of patients should be also notapproved. I understand the issues of abuse yet todisaprove all intervention in asymptomatichigh-risk individuals who might benefit fromrevascularization seems inappropriate IF revascularization in asymptomatic individuals isconsidered of benefit in stroke prevention. Theproblems with ACAS notwithstanding, carotidintervention in individuals with >80% stenosis canreduce the risk of ipsilateral stroke. CAS shouldbe apart of that IN QUALIFIED HANDS/CENTERS. In my view, the real issues are center andinterventionalist certification. This is somethingCMS MUST tackle. Thanks for listening, WH Brooks, MD

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PTA with Filter wire protection of the carotid concurent with stenting is safe and effectve.It is noninferior to CEA in our experience.People with high risk anatomy,prior radation therapy,people deemed nonCEA candidates by experienced Vascular Surgeon''s,are good candidates for PTA (with filter wire and concurrent stenting).People with symptomatic carotid lesions > 50% are also good candidates for PTA (with Filter wire and concurrent stenting)i.e.,people with Drug eluting coronary stents less than 3 months prior who should not come off Plavix.

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Some of these indications can be significantly benefited by stenting over surgery. Although "challenging lesions" is subject to interpretation and can be readily abused !

Perhaps if performed and argued only by VASCULAR SURGEONS, it would be wise to accept the indications. The cardiologists would have a field day !

Although it will inconvenience my ability to adequately treat these small subset of patients....I understand its for the greater good of the public !!!!!

Vascular Surgeon. Cheers !

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I am a thoracic and vascular surgeon who has done roughly 300 carotid endarterectomies since 1992. I have been fortunate to never have a death or severe stroke following surgery. I have also never turned down a patient for surgery, as even most of the sickest patients can be operated upon safely under local anesthesia with a cervical block, if necessary. I don''t know the precise statistics for carotid stenting at our hospital, which has been done for the past 2-3 years, but I know they include at least two strokes and one death. In my opinion, carotid stenting would seem to have some value in the previously operated or irradiated neck, but little value otherwise, at least with the current generation of devices and widely variable level of experience with their use. I agree with the Medicare recommendation not to expand their use, and would go further to suggest that carotid stenting only be reimbursed if a surgeon has first seen the patient and agreed that stent placement is the best option for the patient. At the same time, I suspect this technology will continue to improve, and that, in time, carotid stenting may eventually supplant carotid endarterectomy, but I would wait for good clinical studies proving that improvement before recommending carotid stent placement for any patient I have met in the past or will meet in the foreseeable future.

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I very much support the current coverage decision. I perform both CAS and CEA and thus have no vested interest in the decision. However I am struck by the lack of quality data to support CAS. expanding the CAS indications would make it very difficult to enrole current or future registries and randomised trials. General expansion of indications would greatly increase the utilization of CAS and result in markedly increased health care costs with clear benefit.

However I would like to see future consideration given to increasing coverage for very high grade stenosis in high risk anatomic lesions. ie. re-op necks, radiation, etc. the high risk medical indications are very weak since nearly all carotid patients have some high risk medical situation and ost can be operated on quite safely.

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As a consumer, I am concerned with the lack of coverage expansion. I believe the discussions and decisions are based on the wrong criteria. Reimbursement should not be universally determined by patient status - it should be determined by physician training, credentials and CAS experience.

Physician Training & Experience is the critical point in this decision. Not all physicians should be allowed to expand their practice to this patient population. However, there are a number of experienced practitioners who perform more than 40 CAS procedures each year. For these practitioners, the expanded coverage and associated reimbursement should be allocated. Due to the current reimbursement standards, each procedure tends to be a learning curve for physicians because it is so difficult to find a patient to meet the requirements. This process causes these doctors to be cognizant of the procedure, the patient situation and the details.

If a physician only does 10-12 CAS each year - they should continue to focus on the current patient population and focus on the basics of the procedure. Do not expand the population for these practitioners. What you do no want is for these learning curve doctors to be faced with the masses and for your outcomes to decline due to the requirements being relaxed. Keep it strict for the low volume doctors and expand for those who are high volume and have the expertise to treat the masses appropriately.

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