National Coverage Analysis (NCA) View Public Comments

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

Public Comments

Commenter Comment Information
Katz, Daniel Date: 08/10/2023
Comment:

As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

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Mattos, Mark Title: Program Director, Vascular Surgery Fellowship
Organization: Michigan Vascular Center/Michigan State University
Date: 08/10/2023
Comment:

As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

More

Abbott, Anne Title: A/Prof
Organization: Global Expert Collaboration
Date: 08/10/2023
Comment:

It does not matter how many people outside, or inside, CMS support proposals to:

1. FUND FREE-FOR-ALL CAROTID ARTERY PROCEDURES (INCLUDING CAS which is more dangerous than CEA) on the most vulnerable Americans (older and/or disabled Americans and/or those with end-stage renal disease) who are labelled as having at least '50 or 70%' carotid stenosis

AND/OR TO

2. REMOVE CMS APPROVED PROCEDURAL STANDARDS.

Many, if not most or all, of these supporters

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The Multispecialty, Carotid Alliance Organization: The Multispecialty Carotid Alliance
Date: 08/10/2023
Comment:

August 10, 2023

Tamara Syrek Jensen, Director
Joseph Chin, Deputy Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, Maryland 21244

RE: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8)

Dear Ms. Syrek Jensen and Dr. Chin:

On behalf of the Multispecialty Carotid Alliance (MSCA or the Alliance), we are writing to

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Qureshi, Sheraz Title: Health System Clinician Vascular Surgery
Organization: Northwestern Medicine
Date: 08/10/2023
Comment:
I do not believe that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 will be good for patient safety particularly when removing facility requirements and standards.
Iyer, Adi Title: MD
Date: 08/10/2023
Comment:
I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision.
Abbott, Anne Title: A/Prof
Organization: Global Expert Collaboration
Date: 08/10/2023
Comment:

Regarding our earlier comments entitled:

'Why the United States Centers for Medicare & MedicAID Services (CMS) Should Still Not Extend Reimbursement Indications for Carotid Artery Angioplasty/Stenting or Other Carotid Artery ‘Revascularisation’ Procedures'.

We have 3 more expert collaborators who would like to be co-signatories with respect to the submission named above. These are:

Tim Stokes (Consumer Representative & Survivor of Stroke Misdiagnosis,

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Young, Michael Title: Dr.
Organization: Dartmouth-Hitchcock Medical Center
Date: 08/10/2023
Comment:
I am a physician who sees and refers patients for carotid artery revascularization. I would like to thank CMS for the detailed review of the data for carotid artery stenting. On review of this coverage analysis for carotid stenting, I would advocate the following considerations be included in the final decision: 1. Expansion of coverage for symptomatic patients with >50% carotid stenosis as well as asymptomatic patients with >70% stenosis. 2. Coverage without the requirement of clinical

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kabbani, loay Date: 08/10/2023
Comment:

To: Administrator Chiquita Brooks-LaSure
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Baltimore, MD

Date: August 10, 2023

Re: Feedback on the Proposed Decision Memo for PTA of the Carotid Artery with Stenting; CAG-00085R8

Dear Administrator Brooks-LaSure,

I am a vascular specialist and a member of the AHA, SVS, and Michigan society of vascular surgery an esteemed body dedicated to advancing vascular

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SArdar, M. Rizwan Title: Cheif of Cardiology, MMC, Lifepoint hospital.
Date: 08/10/2023
Comment:
Carotid artery stent is a proven method of revascularization in selected group of patients. CAS (carotid artery stent) has a long literature evidence of being effective with very low level of complications. I hope with new NCD, it will pave path for CAS to be first line for all comer patients with carotid artery disease like carotid endarterectomy. Patient should have choices of Carotid endarterectomy, and stents.
Garcia, Lou Date: 08/10/2023
Comment:

As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

More

Novakovic-White, Robin Title: MD
Organization: UT Southwestern
Date: 08/10/2023
Comment:
I fully support CMS updating the coverage policy for CAS in Medicare beneficiaries based on the available data from multiple randomized trials showing similar outcomes between CAS and CEA in the early and late follow-up windows. I specifically support: - covering PTA of the carotid artery concurrent with stenting for symptomatic greater than or equal to 50% stenosis and for asymptomatic greater than or equal to 70% stenosis. - covering CAS for standard surgical risk patients - covering CAS

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Spangler, Emily Title: MD, MS
Date: 08/10/2023
Comment:

As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

Current requirements for monitoring quality and safety of carotid stenting are critical in protecting patients, particularly in treatment of

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Parrack, Inkyong Title: MD
Organization: Sarasota Vascular Specialists, Florida State University
Date: 08/10/2023
Comment:

The proposed NCD reconsideration on carotid artery stenting (CAS) and the current decision to support this exposes many patients to a significant elevation in stroke risk. Although the request of NCD reconsideration is generalized for all carotid stenting, and the supporting evidence provided by the requesting group involves all forms of carotid artery stenting, the undeniable data on the risks of carotid artery stenting with respect to stroke is highly dependent on the modality of

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Gabriel, Yves Title: MD - Senior Vascular / Endovascular Surgeon
Date: 08/10/2023
Comment:

I am writing to you at this time to express my deepest concerns in regards to the proposed coverage expansion relating to NCD 20.7. I do think that there are several concerns as related to the proposed decision, which do need to be discussed and considered in the strongest sense.

#1 - The proposed decision to change the requirements for carotid artery intervention completely disregards years of meaningful data obtained through major trials such as NASCET, ACAS and CREST.

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Koenig, Mark Title: MD, FACC, FSCAI
Organization: Ascension Saint Thomas Hospital West
Date: 08/10/2023
Comment:

I would like to take this opportunity to thank you for your review of the current literature, evaluation and willingness to update the current guidelines regarding carotid stenting. I am a physician who performs carotid stenting and have seen the impact it has had in my patients lives, some of whom are alive and doing well 10 to 15 years after having undergone this procedure. I support this decision and ask that you finalize the proposal to expand coverage to asymptomatic patients with

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Lalani, Alykhan Title: Vascular surgeon
Organization: Vascular surgical associates
Date: 08/10/2023
Comment:
Approving transfemoral stenting based on the results of transcarotid stenting will create a huge problem. The risk of trans femoral stenting is increased peri operative stroke risk secondary to having to cross through a diseased arch this is avoided in trans carotid stenting. Therefore transfemoral stenting should be reserved for high risk patients that can not undergo endarterectomy or transcarotid stenting.
Gifford, Edward Title: MD
Organization: Hartford HealthCare
Date: 08/10/2023
Comment:

As a young vascular surgeon I feel this proposed decision does not do enough to monitor for the safety of patients after removing previous guardrails for carotid artery stunting. I feel that transfemoral stenting has a role in carotid stenosis. However, on the whole, our threshold to intervene on asymptomatic disease has only increased as medical therapy advances. In our own practice we target a threshold of >80% for asymptomatic patients for any intervention (CEA, CAS or TCAR). Why are we

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Castro, Yulanka Date: 08/10/2023
Comment:
This change in coverage is very well received.
Carotid stenting in well trained operators has proven to be safe and effective at stoke prevention. And it’s only fair for it to be reimbursed.
Kedora, John Title: MD
Date: 08/10/2023
Comment:

I appreciate the Centers for Medicare and Medicaid Services Coverage Advisory Group thoughtful analysis and proposal of expanded coverage for NCD20.7 percutaneous carotid artery stenting. As a vascular surgeon who performs all three treatment arms to treat carotid stenosis, I respectfully disagree with conclusions provided in the decision memo for the following reasons:

  • The CREST-2 trial (NCT02089217) is still underway and represents a major investment by NINDS. Its information

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  • Nejim, Besma Title: Vascular surgeon
    Date: 08/10/2023
    Comment:
    The CMS decision to expand transfemoral carotid artery stenting (CAS) indications is concerning. While the composite outcome was equivalent, The Crest trial showed a higher risk of stroke with transfemoral stenting compared to endarterectomy at 2 years. Other studies (RCTs, meta-analysis, and observational studies) consistently demonstrated that transfemoral stenting should be only considered for high-risk patients who can not tolerate the gold standard procedure (CEA). TCAR so far proved to

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    Sideman, Matthew Title: Professor and Interim Chief of Vascular Surgery
    Organization: UT Health San Antonio
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Bachinsky, William Title: Director, Cardiac and Vascular INT Program
    Organization: UPMC Central PA
    Date: 08/10/2023
    Comment:
    I’m writing in support of the approval of the proposed coverage of carotid artery PTA and Stenting (CAS) for standard indications used currently for CEA and TCAR. With over 8000 randomized pts in trials, and considering the most current CAS experience in the CREST 2 Registry of real world CAS (< 2 % procedure related stroke), the time come to accept CAS in many pts as a less invasive option when considering revascularization in pts with carotid artery disease.
    Oropallo, Alisha Organization: Northwell Health
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    The MSCA is not interdisciplinary and does not reflect the majority consensus represented by the Society of Vascular Surgery.

    Recommendation

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    Metzger, MD, D. Chris Title: System Chair Clinical Research Ballad Health
    Organization: Abbott Vascular
    Date: 08/10/2023
    Comment:

    First, I would like to commend CMS for their very thoughtful and thorough review of the extensive and rigorous data regarding carotid artery stenting in the National Coverage Decision determination. This subspecialty- agnostic, balanced review of data will be the best way to make the correct decision on the matter. This has been many, many years in the making.

    The opinions and thoughts that I express are those of a carotid stent operator and researcher with over 20 years of

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    LoGerfo, Frank Title: Professor of Surgery
    Organization: Harvard Medical School
    Date: 08/10/2023
    Comment:

    These are data from the original CREST trial:

    The 4-year rate of stroke or death was 6.4% with stenting and 4.7% with endarterectomy (hazard ratio, 1.50; P=0.03); the rates among symptomatic patients were 8.0% and 6.4% (hazard ratio, 1.37; P=0.14), and the rates among asymptomatic patients were 4.5% and 2.7% (hazard ratio, 1.86; P=0.07), respectively. Periprocedural rates of individual components of the end points differed between the stenting group and the endarterectomy group:

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    Vadlamudi, Venu Title: Neurointerventional Surgeon
    Date: 08/10/2023
    Comment:

    I am a practicing vascular/interventional radiologist and neurointerventional surgeon with training and experience in carotid revascularization including during acute stroke intervention.

    I support the decision to expand coverage for PTA with concurrent carotid artery stenting (CAS) to include individuals of standard surgical risk, patients with symptomatic carotid artery stenosis =50%, and patients with asymptomatic carotid artery stenosis =70%.

    Patients deserve the

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    Sakhuja, Rahul Title: MD
    Date: 08/10/2023
    Comment:

    I appreciate CMS for an incredibly thorough and critical review of the literature and data, and for a very well crafted/detailed proposed decision

    I ENDORSE the expansion of coverage to include standard surgical risk patients, including asymptomatic pts with >70% and symptomatic patients >50% stenosis

    We all look forward to results from the CREST 2 trial, which is still years away, but this is not relevant to the current decision and should not influence it.

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    Molnar, Robert Title: Vascular Surgeon
    Organization: Michigan Vascular Center
    Date: 08/10/2023
    Comment:

    I am extremely concerned regarding the potential adoption of NCD 20.7. Not only is it premature, given the pending CREST 2 trial which specifically will address the outcomes of TF CAS with best medical therapy, but it completely removes common sense safe guards needed to allow for all inclusive TF CAS. TF CAS is not a procedure that can be widely implemented without safeguards in place. The procedure is extremely complex, most notably in identifying potential complications and avoiding at

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    Lillemoe, Kaitlyn Organization: NYC H+H I Bellevue Hospital
    Date: 08/10/2023
    Comment:
    I strongly oppose CMS coverage of CAS in patients with asymptomatic carotid artery disease. CAS has increased periprocedural and longterm stroke risk compared to CAS, and its coverage would only increase morbidity in our older patients while greatly increasing healthcare costs. Feels premature to expand coverage without CREST-2 data, which should be available in a couple years.
    Brener, Bruce Title: Chief of Vascular Surgery
    Organization: RWJBarnabasHealth, The Cardiovascular Care Group
    Date: 08/10/2023
    Comment:

    I have been practicing vascular surgery for 50 years and have performed many cea, tfcas, and tcar for treatment of carotid artery disease. In my own experience and in observing others and reviewing the scientific literature as it develops, I have concluded that transfemoral stenting is the least safe of the three procedures. Yes, very experienced and talented individuals can perform tfcas safely. But the number of tfcas procedures in the seven hospitals in which our group practices has

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    White, Rodney Title: Medical Director, Vascular Surgery
    Organization: MEMORIALCARE LONG BEACH HEART & VASCULAR
    Date: 08/10/2023
    Comment:
    I strongly support the SVS recommendations regarding Decision Memo NCD 20.7. Continued credentialing processes and requirements are required to assure patient safety. Mandated utilization of a standardized decision making tool should be developed in collaboration with applicable medical specialty societies and other relevant stakeholders. Core competency standards should be developed and followed by all stakeholders.
    In summary, coverage expansion is premature, and compromises patient

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    Marsden, Brent Title: MD Vascular surgeon
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Sakhuja, Rahul Date: 08/10/2023
    Comment:

    I am Board Certified in Vascular Medicine and Endovascular intervention. I perform carotid stenting (CAS).

    When patients ask a for carotid artery stent over CEA, it is challenging - if not embarrassing- to admit that there is a less invasive procedure with equivalence to a surgical approach, CEA, but we cannot offer due to lack of reimbursement, not lack of science.

    Gulati, Deepak Date: 08/10/2023
    Comment:

    I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

      - Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.
    - Covering CAS for standard

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    Vollhaber, Daniel Title: MD
    Organization: MyMichigan Health
    Date: 08/10/2023
    Comment:
    Please expand the use of carotid artery stenting, as it benefits the patients, who are sworn to protect, with less risk than surgery.
    Redberg, Rita Title: Professor of Medicine
    Organization: University of California, San Francisco
    Date: 08/10/2023
    Comment:

    We strongly urge the Centers for Medicare & Medicaid Services to not implement the proposed changes to the coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting as they are dangerous for patients. There is no evidence on which to base changes such as: 1) allowing asymptomatic patients to receive the procedure outside of clinical trials at lower percentages of stenosis, 2) removing the requirements for high surgical risk and 3) removing all

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    Smith, W Date: 08/10/2023
    Comment:
    As a board certified vascular surgeon who performs both carotid angioplasty with stenting and carotid endarterectomy, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I trained in an era when carotid stenting was regaining popularity. After leaving fellowship I was amongst the first in my metropolitan area to offer all major treatment modalities for carotid

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    Hathidara, Mausaminben Title: Vascular Neurologist
    Organization: UPMC
    Date: 08/10/2023
    Comment:

    I support this proposed decision memo for stent to be as standard treatment option of 1) symptomatic carotid stenosis >50% stenosis 2) asymptomatic carotid stenosis > 70%

    Strongly agree with below
    Expanding coverage to individuals previously only eligible for coverage in clinical trials;
    Expanding coverage to standard surgical risk individuals by removing the limitation of coverage to only high surgical risk individuals;
    Removing facility standards and approval

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    Abbott, Anne Title: A/Prof
    Organization: Global Expert Collaboration
    Date: 08/10/2023
    Comment:

    Regarding our earlier comments entitled:

    'Why the United States Centers for Medicare & MedicAID Services (CMS) Should Still Not Extend Reimbursement Indications for Carotid Artery Angioplasty/Stenting or Other Carotid Artery ‘Revascularisation’ Procedures'.

    We have 4 more globally recognised experts in carotid arterial disease management and research who would like to be co-signatories with respect to the submission named above. These are:

    Henning Eckstein

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    Box, Elle Title: Chief Healthcare Compliance and Privacy Officer
    Organization: UConn Health
    Date: 08/10/2023
    Comment:

    August 10, 2023

    The Honorable Chiquita Brooks-LaSure
    Administrator
    Centers for Medicare & Medicaid Services
    Department of Health and Human Services
    7500 Security Boulevard
    Baltimore, MD 21244-1850

    Re: Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting; CAG-00085R8

    Dear Administrator Brooks-LaSure:

    The University of Connecticut Healthcare System has greater

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    moses, jeffrey Title: MD
    Organization: Columbia University
    Date: 08/10/2023
    Comment:
    To Whom it May Concern
    My name is Jeffrey Moses MD I am a cardiologist who refers patients for CAS. I am writing this in support of the proposal to expand coverage of patients with symptomatic carotid stenosis greater than or equal to 70% and asymptomatic of 50% as supported by current evidence without requiring participation in clinical trials.
    I support removal of facility standard and approval requirements and allowing MACs to determine coverage for other patients.
    I support

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    Min, Jiangyong Title: Medical Director of Comprehensive Stroke Center
    Organization: Corewell Health West
    Date: 08/10/2023
    Comment:

    Thank you for putting everything together. I fully support this action.

    Sincerely,

    John
    Jiangyong “John” Min
    Jaffer, Farouc Title: Dr
    Organization: MASS GENERAL HOSPITAL
    Date: 08/10/2023
    Comment:

    The outstanidng planned CMS changes below:

    "Expand coverage to include CAS for standard surgical risk patients"
    "Remove facility standards and approval requirements for CAS"
    "Implement a requirement for a formal shared decision-making (SDM) interaction with the patient prior to CAS"

    -Are vital for inclusive, patient-centered care of those patients with significant carotid disease. Carotid stenting has a clear role in managing a subset of carotid

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    Bokhari, Syed Title: Interventional Cardiologist
    Date: 08/10/2023
    Comment:

    I applaud CMS for a thorough and thoughtful analysis of the extensive body of clinical evidence and the public comments from healthcare professionals regarding carotid artery interventions. Also, the Society of Vascular Medicine (SVM) strongly supports CMS’s proposal to update the patient selection criteria in the National Coverage Determination (NCD) to mirror results from this clinical research and to parallel existing access to carotid endarterectomy (CEA) by expanding coverage to

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    Gharaibeh, Khaled Date: 08/10/2023
    Comment:
    Highly needed for better patient care
    Abdalkader, Mohamad Date: 08/10/2023
    Comment:
    Carotid stenting is equivalent to endarterectomy. I fully support the proposal to expand coverage for carotid by CMS, to the benefit of patients with carotid disease
    Beckman, Joshua Title: Immediate Past President
    Organization: The VIVA Foundation
    Date: 08/10/2023
    Comment:

    The Vascular InterVentional Advances (VIVA) Foundation is a not-for-profit, multidisciplinary organization dedicated to advancing the field of vascular medicine and intervention through education, research, advocacy, and collaboration. Our mission includes providing the premier education in vascular medicine and intervention to improve patient care within the peripheral vascular arena. We have a strong background in carotid artery disease and have held a Vascular Leaders Forum on Carotid

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    Teirstein, Paul Organization: Scripps Health
    Date: 08/10/2023
    Comment:
    It is terrific that CMS is doing a review of carotid artery stenting (CAS). I endorse expansion of CMS coverage to include standard surgical risk patients, including asymptomatic pts with >70% and symptomatic patients >50% stenosis. I also strongly believe these is no need to require “sign-off” from other physicians (e.g. different specialties, like a vasc surgeon) prior to performing CAS. I also want to stress that I do not believe CMS should require hospitals who perform CAS to participate

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    Scott, Kelly Date: 08/10/2023
    Comment:

    Multiple clinical trials have shown equivalence between Carotid artery stenting and endarterectomy

    Patients deserve the choice to choose between different revascularization options

    There should be a documented discussion of the specific risks and benefits and alternatives of any procedure or medical intervention

    Dombrowski, Danielle Title: Vascular Surgeon
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Samson, Russell Title: MD FACS DFSVS
    Organization: Mote Vascular Foundation inc
    Date: 08/10/2023
    Comment:
    We have all seen the recent publications in the lay press identifying the high volume of unnecessary Vascular procedures. Many of these have resulted in amputations. Opening up carotid stent will only increase unnecessary procedures but now we will see an increase in stroke and death. It is unconscionable!!
    Raz, Eytan Title: Professor
    Organization: NYU Langone Health
    Date: 08/10/2023
    Comment:
    There is an ongoing clinical trial to target this question. This is premature. We should wait for that.
    Repko, Brandon Date: 08/10/2023
    Comment:

    Carotid artery stenting is and has been a safe alternative to carotid endarterectomy. Outcomes are easily found in a number of randomized trials.

    TCAR (the surgical placement of a stent in the carotid artery) is actually quite more invasive and there is no good evidence to suggest it is safer or has better longterm outcomes. It actually requires riskier general anesthesia and requires two surgical incisions (one in the going and one in the neck) increasing risk of infection and

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    Miremadi, Brian Title: MD
    Organization: SLU Hospital
    Date: 08/10/2023
    Comment:
    - Patient centered practice of medicine indicates discussing with and offering to patients as many treatment options available.
    - Years of accumulated dara have shown equivalence between CEA and CAS.
    - Research support CAS in both symptomatic and asymptomatic patients.
    - There's no know way to make or validate a shared decision making tool. It should be sufficient to document that a thorough discussion occurred with the patient that all patient specific risks, benefits, and

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    Costanza, Michael Organization: SUNY Upstate Medical University
    Date: 08/10/2023
    Comment:

    I am a vascular surgeon in practicing at Upstate Medical University and the VA Medical Center in Syracuse, New York for the last 19 years. I am writing to express my support for the recommendations expressed in the memo from the Society for Vascular Surgery on the Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting; CAG-00085R8. There appears to be strong evidence that transfemoral carotid stenting has several drawbacks

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    Crayne, Chris Date: 08/10/2023
    Comment:
    I support this decision. PTA of the carotid artery is another effective tool in the prevention of and treatment of stroke. It allows even patients who are not candidates for CEA to receive high quality and effective treatment.
    Albrecht, Robert Title: MD
    Organization: Cape Fear Valley Health System
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Based upon the clearest of data out of the Crest trial, and other trials, there was clear data the reveals that carotid artery stenting is associated with

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    Bach, Richard Title: Professor of Medicine/Director, Cardiac ICU
    Organization: Washington University School of Medicine/Barnes-Jewish Hospital
    Date: 08/10/2023
    Comment:

    As a cardiologist who refers patients with carotid artery disease for appropriate management, I would like to express my support for this NCA proposal and convey that I am impressed by the careful review of the clinical trial evidence base on this topic. Based on my own review of the evidence, I would support the proposed expansion of coverage for CAS to include standard surgical risk patients, including asymptomatic carotid patients with >70% lesion stenosis and symptomatic patients

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    Frankel, David Title: Division Chief Vascular Surgery
    Organization: Scripps Clinic Medical Group
    Date: 08/10/2023
    Comment:
    I think that the CMS decision to approve TFCAS for standard risk carotid revascularization and for lower degrees of stenosis is misguided and not in line with the current available data. There is clear data to show there is a significantly higher risk of stroke with the trans femoral technique compared to TCAR and CEA. This along with widening the indication will lead to a large increase in the number of debilitating strokes amongst this population. In addition, patients who may not have

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    Schneider, Darren Title: Chief, Division of Vascular Surgery
    Organization: Perelman School of Medicine, University of Pennsylvania
    Date: 08/10/2023
    Comment:

    As a vascular specialist with formal fellowship training in both vascular surgery and interventional radiology with over 20 years of experience performing carotid endarterectomy (CEA), transfemoral carotid stenting (tfCAS), and TCAR I am deeply concerned that the Proposed National Coverage Determination for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting dated July 11, 2023 will result in inappropriate treatment and harm to Medicare patients with

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    Aziz, Yasmin Title: MD
    Organization: University of Cincinnati
    Date: 08/10/2023
    Comment:
    Carotid artery stenting is an important therapy in both symptomatic and asymptomatic carotid artery disease. Given that the data show benefit for this intervention, both patients and providers should have the option choosing carotid artery stenting instead of more invasive procedures.
    Scott, MD, Jordan Title: Vascular and Interventional Neurology
    Organization: SSM Health Saint Louis University Hospital
    Date: 08/10/2023
    Comment:

    Patients should be presented with all available treatment options as they have the right to make choices and decisions about the type and extent of medical care that they would want.

    Multiple RCTs have shown equivalence between CEA and CAS at 30-days, 1-year, 5-years, and 10-years. No randomized trial of TCAR has been performed to date.

    There is favorable data supporting CAS in patients who are symptomatic as well as asymptomatic.

    The patient and physician

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    Reddy, MD, Varun Date: 08/10/2023
    Comment:

    I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

      - Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.
    - Covering CAS for standard

    More

    Horton, Curtis Title: MD
    Organization: Sharp Rees Stealy
    Date: 08/10/2023
    Comment:

    The notion to approve funding for all types of carotid stenting is a horrible idea and will expose fragile patients to harm. The data is quite clear that transfemoral stenting, particularly when used in older patient populations, is fraught with hazard. By funding this, you will enable physicians, not well-versed in management of carotid artery disease to place stents.

    The potential for genuine harm is significant. Do not do this.

    Massop, MD, Doug Title: Vascular Surgeon
    Date: 08/10/2023
    Comment:
    Hershberger, Richard Title: MD, FACS, Vascular Surgeon
    Organization: Sarasota Vascular Specialists
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Wyers, Mark Title: Associate Professor
    Organization: BIDMC, Harvard Medical School
    Date: 08/10/2023
    Comment:

    I have been a vascular surgeon for over 20 years and perform tfCAS, TCAR and CEA with excellent results. In the past four years, TCAR has largely replaced transfemoral carotid stenting in my practice because of its better safety profile while still offering a less invasive option. Despite the trials of tfCAS which were carefully designed with only expert operators, well past their learning curve, there is very clear registry data (the real world) that clearly shows a higher procedural

    More

    Jung, Richard Title: Associate Director, Neuroendovascular Surgery
    Organization: Northwell Health, South Shore University Hospital
    Date: 08/10/2023
    Comment:

    I am a neurointerventionalist who performs carotid artery stenting. I am grateful to hear that CMS has reviewed the recent clinical literature about this procedure for an update to treatment.

    Neuroendovascular treatment of carotid stenosis has already been shown to be as safe and effective as carotid endarterectomy for symptomatic carotid disease. I support expansion of this coverage proposal for carotid stenting for >50% symptomatic stenosis and >70% asymptomatic stenosis as is

    More

    Azarbar, Sayena Title: MD
    Organization: HCA
    Date: 08/10/2023
    Comment:
    Wider access to percutaneous, trans luminal Angioplasty of the carotid. Bye Interventional Cardiovascular Disease would be extremely beneficial to a patient population, improving, timely, intervention on carotid, lesions and preventing, long-term complications of stroke and its associated repercussions. My interventional cardiology colleagues who have trained in this procedure are very competent and dedicated to the patient’s well-being and I urge this organization, to expedite the approval of

    More

    Guzman, Raul Date: 08/10/2023
    Comment:
    I believe that use of percutaneous transluminal angioplasty (PTA) of the carotid artery with stenting should be restricted to patients with high risk anatomic or medical conditions. This is because of the significantly increased risk of stroke associated with this procedure in comparison to standard carotid endarterectomy.
    Kirtane, Ajay Title: Professor of Medicine
    Organization: Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
    Date: 08/10/2023
    Comment:

    I am a physician who sees patients with carotid artery disease, and refers and performs carotid revascularization (carotid stent procedures). Thank you for your thoughtful review of the evidence in this field. Despite our enrollment in both CREST-2 and the CREST-2 registry, the situation regarding reimbursement of carotid stenting procedures has proven very challenging for my patients, and in this light in particular your decision to revisit the current reimbursement decisions is very

    More

    Judelson, Dejah Title: Assistant Professor of Surgery
    Organization: UMass Chan School of Medicine
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Fenton, Alexis Title: MD
    Date: 08/10/2023
    Comment:

    There is a role for carotid stenting instead of CEA in select patients, and it would be a service to our patients for the guidelines to reflect this.

    Respectfully,

    AMF

    Ortega Gutierrez, Santiago Title: MD, MSc
    Organization: University of Iowa
    Date: 08/10/2023
    Comment:

    I am a stroke neurologist that cares for patients with symptomatic carotid and asymptomatic carotid disease. Over the last few year, carotid stenting has become nearly the preferred choice for all symptomatic patients given its safety, feasibility and tolerability by our stroke patients. We perform nearly 100 patients per year with extremely low rate of complications in a very sick population. Those patient undergo this procedure in less than 45 minutes and under minimal local anesthesia

    More

    hingorani, anil Organization: Society of Vascular surgery
    Date: 08/10/2023
    Comment:

    Individual Comments Template:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the

    More

    DeMasi, Richard Title: MD
    Organization: Sentara Medical Group
    Date: 08/10/2023
    Comment:
    The difference between aggressive management of carotid disease and medical management of carotid disease in an asymptomatic, elderly patient is minuscule at best in the current era. To allow a large population of interventionalists with an unsophisticated understanding of cerebrovascular disease to perform carotid stenting with loose indications is a giant disservice to patients and will lead to many unnecessary procedures and bad outcomes. Please reconsider this decision.
    Dwyer, Trisha Title: Vascular Neurology Physician Assistant
    Organization: ProMedica
    Date: 08/10/2023
    Comment:
    CMS is considering an expansion of coverage based on new evidence from four RCTs. I am in full support of expanded coverage for CAS given the recent evidence that there are groups of patients who benefit from the procedure over CEA. I fully support the proposed amendments for expansion of CMS coverage for carotid artery stenting.
    May, Don Title: SVP for Policy
    Organization: Federation of American Hospitals
    Date: 08/10/2023
    Comment:

    August 10, 2023

    Via electronic submission at https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=311

    The Honorable Chiquita Brooks-LaSure
    Administrator
    Centers for Medicare & Medicaid Services
    U.S. Department of Health and Human Services
    Hubert H. Humphrey Building, Room 445-G
    200 Independence Avenue,

    More

    Calderon, Erick Title: MD, FACC, FSCAI
    Organization: Lakewood Cardiovascular COnsultants
    Date: 08/10/2023
    Comment:
    It is long overdue to get approval for carotid stenting. Performing it since 2006 with great results and lower risk of complications as compared to CEA
    Azizzadeh, Ali Title: Professor and Director of Vascular Surgery
    Organization: Cedars-Sinai Medical Center
    Date: 08/10/2023
    Comment:

    To: Centers for Medicare and Medicaid Services Coverage Advisory Group

    Re: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting Decision Memo, CAG-00085R8

    Regarding the reimbursement of carotid artery stenting, I would like to point out several comments:

    ? The CREST-1 trial had a detailed list of inclusion and exclusion criteria which makes the conclusions less generalizable for standard risk patients.
    ? Multiple

    More

    Sachar, Ravish Title: Physician-in-Chief, Heart and Vascular
    Organization: UNC-REX Healthcare
    Date: 08/10/2023
    Comment:

    As the Chief of Heart and Vascular Services at UNC-REX Hospital in Raleigh, NC, I strongly support the well thought out and well researched CMS proposed decision memo to expand reimbursement for carotid artery stenting. Our cardiovascular service-line at UNC-REX consists of cardiology, vascular surgery, and cardiothoracic surgery, all working together as one team to take care of our patients. We approach all patients in a multi-disciplinary manner and understand that no one specialty can

    More

    Wilentz, James Title: Associate Clinical Prof. of Medicine
    Organization: Mount Sinai School of Medicine
    Date: 08/10/2023
    Comment:

    Dear Madams and Sirs:

    I am an interventional cardiologist who has been active in performing carotid artery stenting and was involved in some of the early research on protection of the brain during these procedures. I would like to thank the CMS for its thoughtful review of the current state of CAS and the literature supporting its use. It has become very clear over the past years that the procedure is well-suited to treatment of carotid disease when patients are properly chosen

    More

    Kiviat, David Date: 08/10/2023
    Comment:
    TCAR holds promise for treating carotid disease with lower risk compared to first gen procedures and should be included in coverage
    Shanberg, David Title: MD, Vascular Surgeon
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Vavra, Ashley Organization: Northwestern University
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7. I agree in a mandated utilization of a standardized “Shared Decision Making” tool that would be designed in collaboration with applicable medical specialty

    More

    Copeland MD, MPH, Jessica Title: Senior Fellow
    Organization: National Center for Health Research
    Date: 08/10/2023
    Comment:

    National Center for Health Research Public Comment on Centers for Medicare & Medicaid Services Proposed Decision Memo: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting

    Decision No: CAG-00085R8

    The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective

    More

    Shawver, Julie Date: 08/10/2023
    Comment:

    I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

      - Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.
    - Covering CAS for standard

    More

    Faruqi, Rishad Title: Associate Prof (Affiliate)
    Organization: Stanford University
    Date: 08/10/2023
    Comment:

    As a vascular and endovascular surgeon, I am extremely concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is wrong-headed, premature and jeopardizes patient safety. The incidence of stroke in asymptomatic patients with carotid stenosis is extremely rare, especially when managed with appropriate medical therapy, and there is very little to justify expanding reimbursement for CAS, as suggested in this proposal.

    More

    Hajjar, Monica Title: Physician Assistant
    Date: 08/10/2023
    Comment:

    Hello, I'm reaching out to ask for your valuable support regarding a crucial decision being made by CMS concerning carotid stenting indications and coverage. In 2009, CMS assessed the National Coverage Decision (NCD), resulting in limited coverage for carotid stenting solely for high-risk patients, whether symptomatic or asymptomatic, who were at high risk for Carotid Endarterectomy (CEA). Presently, CMS is considering an expansion of coverage based on new evidence from four RCTs. The

    More

    Alhajala, Hisham Title: Neuroendovascular surgery fellow
    Organization: University Of Toledo Medical Center
    Date: 08/10/2023
    Comment:
    Based on the results of multiple clinical trials and long-term follow up that showed comparable efficacy and safety of percutaneous carotid artery stent, in comparison to Carotid and Door talk to me, I support the proposed amendment to expand CMS coverage for Carotid artery stenting.
    Timothy, Nypaver Title: Chief, Division of Vascular Surgery
    Organization: Henry Ford Health System
    Date: 08/10/2023
    Comment:

    As a practicing vascular surgeon and as chief of the Division of Vascular Surgery in a tertiary quaternary inner-city hospital, which cares for a large proportion of underserved patients, I am very concerned about the coverage expansion out in the CMS’ Proposed Decision Memo relating to NCD 20.7. The decision is premature, and has the potential to jeopardize patient safety, and erode the already fragile trust that the public has in the management of disease in the peripheral vasculature.

    More

    Ali, Ahsan Title: MD
    Organization: University of Toledo
    Date: 08/10/2023
    Comment:

    I appreciate CMS for proposing an updated coverage policy for CAS based on the available evidence.

    I fully support the specific elements proposed in this decision, including:

      - Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.
    - Covering CAS

    More

    Aranson, Nathan Title: Vascular Surgeon
    Organization: Vascular Care Group
    Date: 08/10/2023
    Comment:
    I will not reiterate the data that has been provided by others as clearly if the folks at CMS were influenced by data then this would not even be a consideration. This “wheels off” approach to patient care will most certainly cost the wellbeing of innumerable Medicare patients.
    I am a contemporary trained vascular surgeon who is a high volume carotid surgeon credentialed to perform the full spectrum of surgical interventions for carotid disease (CEA, TFCAS, TCAR). Despite this, I choose

    More

    Besse, Jennifer Title: Nurse Practitioner
    Organization: Ascension St Joseph Medical Center
    Date: 08/10/2023
    Comment:
    I support this decision, especially for patients that are high risk surgical and without having to be in a trial.
    Shah, Kavit Organization: Aurora St. Luke's Medical Center
    Date: 08/10/2023
    Comment:

    It is commendable for CMS to propose an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

      - Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.
    - Covering CAS for

    More

    Ayad, Micheal Title: MD
    Organization: Mount Sinai Medical Center
    Date: 08/10/2023
    Comment:
    I would like to express concern regarding this decision.
    The fact is medical therapy has become quite impressive in managing carotid disease. Providing an indication for stenting carotid disease at 70% or more in asymptomatic patient carries a risk of significantly increasing the number of patients who will get stenting when they can be managed medically. Also it will give the Interventionalist physicians a green light to potentially over-treat this patient population. Also these

    More

    Hussain, Ahmad Title: Vascular Surgeon
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    1) Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing process and

    More

    McGinigle, Katharine Title: Associate Professor
    Organization: University of North Carolina at Chapel Hill
    Date: 08/10/2023
    Comment:

    As a vascular surgeon and clinical researcher, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. It makes no sense to me that you would change the current coverage rules to encourage more transfemoral carotid stenting when there is no level 1 evidence that supports its use over carotid endarterectomy. The published literature is clear that the 30-day stroke

    More

    Bhatt, Nirav Title: Assistant Professor of Neurology
    Organization: University of Pittsburgh School of Medicine
    Date: 08/10/2023
    Comment:
    I support the decision of CMS in expanding the coverage for CAS in patients with carotid stenosis who fulfill the aforementioned criteria
    Sivapatham, Thinesh Organization: Christiana Care Health System
    Date: 08/10/2023
    Comment:

    As fellowship trained neurointerventional physicians, we collectively represent over 80 years of experience in treating patients with cerebrovascular disease, including carotid artery stenting. We are a comprehensive stroke center that serves 1.2 million people and admits over 1500 stroke patients and performs over 290 stroke interventions a year. Carotid artery stenting is a very important tool in the limited armamentarium we have to deal with atherosclerotic disease of the extracranial

    More

    Limaye, Kaustubh Title: Assistant Professor
    Organization: Indiana University
    Date: 08/10/2023
    Comment:

    Kudos to CMS for proposing an updated coverage policy for CAS based on the contemporary evidence. I support the specific elements proposed in this decision, including:

      - Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.
    - Covering CAS for standard

    More

    Deveshwar, Sanjeev Title: MD
    Organization: Moses Cone Hospital Greensboro NC
    Date: 08/10/2023
    Comment:
    There is ample of evidence after thousands of patients in multiple trials involving comparison of carotid stenting with protection and carotid endarterectomy that carotid stenting
    Is just as effective as carotid endarterectomy on preventing ischemic strokes of the brain when performed by fellowship trained physicians.
    Percutaneous treatment in general take shorter time, can be done without general anesthesia with only overnight stay most of the time.
    In my experience patients

    More

    Rizvi, Addi Title: Vascular Surgery MD
    Organization: Providence Vascular Institute
    Date: 08/10/2023
    Comment:
    Reconsider please
    Williams, Zachary Title: Assistant Professor f Surgery
    Organization: Duke University
    Date: 08/10/2023
    Comment:
    Transfemoral carotid artery stenting has a significantly higher stroke rate than both carotid endarterectomy and transcarotid artery stenting. It’s use should not be expanded.
    Linares, Guillermo Title: MD
    Organization: Saint Louis University
    Date: 08/10/2023
    Comment:
    Patients deserve the choice of treatment options. Multiple randomized trials with close to 8000 patients randomized show equivalence between CEA and CAS at 30 days, one year, 5 years, and 10 years. TCAR has not been evaluated in a randomized control trial. CAS has a track record in both symptomatic and asymptomatic patients. A comprehensive discussion occurred between the physician and patient regarding specific risks, benefits, aand a;ternatives including the options of all three types of

    More

    Grigoryan, Mikayel Date: 08/10/2023
    Comment:
    This policy update is long overdue. For great many years, the vascular surgical mafia used the obsolete trial data to their advantage to prevent patients from receiving endovascular treatment for CAS which according to modern evidence is equally safe and efficacious to CEA. I fully support the specific elements in the decision including lowering the stenosis %, CAS for low surgical risk patients, covering CAS without trial participation requirement, and requiring formal shared

    More

    Black, MD, James Title: Chief, Vascular Surgery and Endovascular Therapy
    Organization: Johns Hopkins Hospital
    Date: 08/10/2023
    Comment:
    The CREST-2 trial (NCT02089217) is still underway and represents a major investment by NINDS. Its information should provide improved Level 1 evidence to support treatment of asymptomatic carotid artery disease or management with optimal medical therapy (OMT). It would seem to be premature to expand the use of carotid artery stenting until this randomized trial comparing three treatment arms has reported its results. Second, I am concerned that when this new coverage rolls out, there will be

    More

    Hodgkiss-Harlow, Kelley Date: 08/10/2023
    Comment:

    To: Centers for Medicare and Medicaid Services Coverage Advisory Group

    Re: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting Decision Memo, CAG-00085R8

    Regarding the reimbursement of carotid artery stenting, I would like to point out several comments:

  • The CREST-1 trial had a detailed list of inclusion and exclusion criteria which makes the conclusions less generalizable for standard risk patients.
  • Multiple

    More

  • Stangenberg, Lars Title: MD PhD
    Organization: Beth Israel Deaconess Medical Center, Harvard Medical School
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Ross, Elsie Title: Associate Professor of Surgery
    Organization: UCSD
    Date: 08/10/2023
    Comment:

    Many of my colleagues have previously outlined the evidence that does not support the expansion of carotid stenting in individuals who are not considered high risk for surgery or other revascularization means (e.g. TCAR). I concur that expansion will only increase costs to CMS and ultimately harm patients. With the expansion we will likely see new outpatient "stroke prevention centers" whereby a number of specialists who can navigate to the carotid and place a stent will do so, without the

    More

    Thomas, Sneha Title: M.D.
    Date: 08/10/2023
    Comment:
    First of all, I would like to thank CMS for its thoughtful review of the clinical literature and current evidence. I am a physician who refers patients for CAS.
    I support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence. I also support coverage without requiring patients to participate in clinical trials and support removal of the facility

    More

    L Gillespie, David Title: Chief of Vascular Surgery , BIDMC - Brockton
    Organization: Brockton Hospital - BIDMC
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    DC, 100 Irving St Title: MD Director of cardiovascular research
    Organization: Medstar Health
    Date: 08/10/2023
    Comment:
    Thanks for considering reimbursement for carotid stenting
    Over the past decade, I have followed the literature that supported good outcomes with carotid stenting when performed in trained operators. The results are similar to carotid surgery. Patient's preference was always for a minimally invasive approach and they view this as an improvement in quality of life. It is imperative to grant to qualified physicians reimbursement to perform safe and effective procedures for carotid stenting

    More

    Ramee, Stephen Title: MD
    Organization: Ochsner Medical Center
    Date: 08/10/2023
    Comment:
    Thank you for your careful review of the carotid stenting and CEA literature. I'm an Interventional cardiologist with 30 yeras experience with carotid stnnting.and have personally done over 500 procedures. I have participated and PI or Co-investigator in at least 20 clinical trials. I believe that carotid stenting has been thoroughly studied and that patients with carotid artery disease deserve to be treated like all other vascular patients. Carotid stenting is safe and effective for

    More

    Exaire, Jose Title: MD
    Organization: Baylor Scott and White, Temple
    Date: 08/10/2023
    Comment:

    I am a physician that takes care of patients with carotid stenosis with percutaneous approach. First, I would like to thank CMS for its thoughtful review of the clinical literature and current evidence. I would like to ask CMS to finalize key components of the proposed decision including the expansion of the coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence. Also

    More

    Al-Nouri, Omar Title: Associate Professor, Surgery
    Organization: UCSD
    Date: 08/10/2023
    Comment:
    I urge the FDA to reconsider approving transfemoral carotid stenting for standard risk patients. We have had multiple large, randomized controlled trials, all showing that transfemoral carotid artery stenting has the highest risk of procedural stroke of any carotid intervention that we do. Periprocedural stroke can be debilitating and have significant financial affects to our patients with need for long term therapy and lost of work hours. The nature of transfemoral carotid stenting will

    More

    Lane, John Title: Professor of Surgery
    Organization: UCSD Vascular Surgery
    Date: 08/10/2023
    Comment:
    I am in strong opposition to the use of transfemoral Carotid stenting for the treatment of low risk, carotid artery disease. The results of clinical trials are poor and inferior to that of carotid endarterectomy and TCAR
    Nimjee, Shahid Title: Professor of Neurosurgery
    Organization: The Ohio State University Wexner Medical Center
    Date: 08/10/2023
    Comment:
    I am writing a letter in strong support of coverage of PTA of the carotid artery concurrent with stenting.
    There have been multiple clinical trials supporting PTA in conjunction with an FDA-approved embolic protection device and carotid stent with symptomatic carotid disease >50% or asymptomatic disease >70%. Coverage of this procedure will codify what has already been proven in the clinical literature and provide our patients afflicted with this disease with the best care available.
    Czap, Alexandra Title: Vascular Neurologist
    Date: 08/10/2023
    Comment:

    I commend CMS for proposing a coverage policy for CAS based on the current evidence. I fully support the specific elements proposed in this decision, including:  

    - Covering PTA of the carotid artery concurrent with stenting using a FDA-approved carotid stent and a FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.
    - Covering CAS for standard surgical risk

    More

    Barleben, Andrew Date: 08/10/2023
    Comment:

    As a practicing vascular surgeon who has taken part in the care of stroke and prevention of stroke for over 20 years, the decision to provide funding for transfemoral carotid stenting would be taking a step back in what we know, as far as efficacy and safety for our patients.

    Treatment trends go where funding goes and this change would not be supported by the data we have.

    Select patients still need carotid stents from a femoral approach but this is still higher risk by

    More

    Jha, Ruchira Date: 08/10/2023
    Comment:

    I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

      - Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.
    - Covering CAS for standard

    More

    Siegler, James Title: Stroke Director
    Organization: University of Chicago
    Date: 08/10/2023
    Comment:
    There is no compelling data to suggest one procedure (stenting or endarterectomy) is better than the other for recently symptomatic carotid atherostenotic disease. Modern medical management has HALVED the risk of recurrent stroke over the past 50 years (8% to 4%), so we ought to be considering less invasive procedures when caring for our patients, particularly if there is no clear difference with respect to efficacy.
    Berman, Scott Title: Director
    Organization: Southern Arizona Vascular Institute
    Date: 08/10/2023
    Comment:

    With regards to NCD 20.7., it is understood that CMS has an obligation to expand access to CAS to as broad a population of APPROPRIATE patients as possible. However, CMS also has an obligation to assure that beneficiaries are being treated safely, effectively and appropriately as CMS is the gate keeper of reimbursement. If the recent flurry of articles describing the abuse of peripheral atherectomy has taught us anything. it is that sadly physicians are not all driven by the tenants of

    More

    Stapleton, Christopher Title: MD
    Date: 08/10/2023
    Comment:
    I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including: - Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%. - Covering CAS for standard surgical risk

    More

    Saini, Vasu Title: MD
    Organization: Mt. Sinai Medical Center
    Date: 08/10/2023
    Comment:

    I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

      - Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.
    - Covering CAS for standard

    More

    Mokin, Maxim Title: Physician
    Organization: University of South Florida
    Date: 08/10/2023
    Comment:
    As a neurologist and neurointerventionaliat, I support covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%. Evidence from multiple studies suggests that both CEA and PTA with stenting are equally safe and effective.
    Cardella, Jonathan Title: Associate Professor, Program Director
    Organization: Yale University - Division of Vascular Surgery
    Date: 08/10/2023
    Comment:

    As a vascular surgeon I have significant concerns related to proposed CMS memo NCD 20.7. There is no data/evidence to support the expansion of CMS coverage for asymptomatic transfemoral stenting. Best evidence, true evidence, suggests a doubling of stroke rate for transferal scenting when compared to carotid endarterectomy, this is across numerous trials. Expanding these guidelines would result in harm to patients in the form of stroke.

    Furthermore, as a Program Director tasked

    More

    Grandowski, Colleen Title: Nurse practitioner
    Organization: Ascension
    Date: 08/10/2023
    Comment:
    Hey All,
    I support this decision in order to better care for our patients.
    - Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.
    - Covering CAS for standard surgical risk patients.
    - Covering CAS without requiring participation in clinical

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    Janssen, Claire Date: 08/10/2023
    Comment:
    I do not agree with the proposed changes in coverage generalizing carotid stent utilization in the community. The data that this change is based on is full of selection bias, and this has no regulation nor monitoring of outcomes. This will lead to patient harm in my opinion and should not be done.
    Moraff, Adrienne Title: Assistant Professor of Surgery
    Organization: Dartmouth Health
    Date: 08/10/2023
    Comment:
    As a dual-trained vascular neurosurgeon, I perform both carotid endarterectomy (CEA) and carotid artery stenting (CAS). I appreciate the attention that is being paid to this important question of CEA and CAS. The current framework of reimbursement for CAS repeatedly makes it difficult to provide patients with what is best for their individual case. The literature has evolved and I think reflects an increased role for CAS beyond what has been mandated by CMS. Our understanding of different

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    Mezo, Isaac Title: Neurologist
    Organization: Morris Hospital Neurology Specialists
    Date: 08/10/2023
    Comment:
    I support this decision as I have had excellent outcomes with my patients undergoing carotid stenting, which is less invasive than CEA.
    Kerschner, Matt Title: Director, Regulatory Affairs and policy
    Organization: American Academy of Neurology
    Date: 08/10/2023
    Comment:

    8.10.2023

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

    RE: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8)

    Dear Ms. Syrek Jensen,

    The American Academy of Neurology (AAN) is the world’s largest neurology specialty society

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    Shafii, Susan Date: 08/10/2023
    Comment:
    This will be detrimental to patients. The stroke rate will rise significantly due to unnecessary procedures likely to occur, increasing Medicare costs dramatically to care long term for the stroke victims from expanding the access.
    Ziayee, Habibulllah Title: MD
    Date: 08/10/2023
    Comment:
    I applaud CMS for suggesting a revised coverage policy for carotid artery stenting (CAS) grounded in the available evidence. Patients deserve the right to established treatment options with removal of barriers for CAS coverage. I also fully support covering PTA of the carotid artery with stenting for symptomatic stenosis =50% or asymptomatic stenosis =70%, covering CAS for standard surgical risk patients. I also endorse the inclusion of CAS without clinical trial participation and the

    More

    Hovorka, John Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Zaidat, Sam Title: Director of BSMH stroke Cente
    Organization: Bon Secours mercy health
    Date: 08/10/2023
    Comment:

    I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

      - Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.
    - Covering CAS for standard

    More

    Starr, Matthew Title: Assistant Professor of Neurology
    Organization: University of Pittsburgh Medical Center
    Date: 08/10/2023
    Comment:

    I am a vascular neurologist and have been in practice for the last 10 years. I work in an academic center with neurology and neurosurgery trained neuro-interventionalists. I refer patients for both carotid endarterectomy and carotid artery stenting. I am a neutral stakeholder. I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

    -Covering PTA of the carotid artery

    More

    Vora, Nirav Title: Interventional Neurology
    Date: 08/10/2023
    Comment:

    I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

      - Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.
    - Covering CAS for standard

    More

    Rao, Rahul Title: Neurointerventional Fellow
    Organization: University of Toledo/Promedica
    Date: 08/10/2023
    Comment:
    Thank you to the CMS for proposing these important changes to CAS coverage policy. I fully support the specific elements in this decision including but not limited to:
    - Coverage of PTA of a stenosed carotid artery (>50% is symptomatic or >75% if asymptomatic) along with carotid stenting using FDA approved devices
    - Coverage of CAS with an FDA-approved embolic protection device
    - Coverage of CAS without specific clinical trial participation
    - Allowing MACs to determine

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    Kenmuir, Cynthia Title: MD PhD
    Organization: UPMC Altoona
    Date: 08/10/2023
    Comment:

    I fully support CMS updating the coverage policy for CAS based on the available data from multiple randomized trials showing similar outcomes in early and late follow-up windows between CEA and CAS.

    I specifically support:
    - covering PTA of the carotid artery concurrent with stenting for symptomatic greater than or equal to 50% stenosis and for asymptomatic greater than or equal to 70% stenosis.
    - covering CAS for standard surgical risk patients
    - covering CAS without

    More

    Burke, Tara Title: VP, Payment & Healthcare Delivery Policy
    Organization: AdvaMed
    Date: 08/10/2023
    Comment:

    August 10, 2023

    Joseph Chin, MD
    Acting Director, Coverage and Analysis Group
    7500 Security Boulevard, Mailstop S3-02-01
    Baltimore, MD 21244

    RE: National Coverage Analysis – Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8) – Proposed

    To Joseph Chin, MD:

    On behalf of the Advanced Medical Technology Association (AdvaMed), we are writing to support CMS’ proposal for expansion of

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    Khatibi, Kasra Title: Assistant professor or Endovascular neurosurgery
    Organization: Usc
    Date: 08/10/2023
    Comment:
    Completely agree with the updated guidelines which is more representative of the current scientific evidence
    Chou, Daisy Title: MD
    Organization: Baylor Scott & White
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to

    More

    Jadhav, Ashutosh Title: Associate Professor of Neurosurgery
    Organization: Barrow Brain and Spine
    Date: 08/10/2023
    Comment:

    I commend CMS for proposing an updated coverage policy for CAS based on the available evidence. I fully support the specific elements proposed in this decision, including:

    - Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.
    - Covering CAS for standard

    More

    Tommaso, Carl Title: Cardiologist
    Organization: Baylor Scott and White
    Date: 08/10/2023
    Comment:

    I am a cardiologist who has referred patients for carotid artery stenting.

    Thank you for your thoughtful review of the clinical literature and current evidence.

    I support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.
    I support coverage without requiring patients to participate in clinical trials.
    I

    More

    Moore, Erin Title: Chief of Vascular Surgery
    Organization: CTVSA, Jacksonville, FL
    Date: 08/10/2023
    Comment:

    I would STRONGLY encourage CMS to consider the recommendations and concerns stated by the SVS. Carotid surgery of ANY kind carries significant consequences when bad outcomes arise. Stroke, debilitation, and death are all possible consequences and as such, the vascular community has worked tirelessly over the years to minimize these risks through education, qualification, and standardization. Oversight and careful scrutiny of those performing these procedures is needed to minimize risk and

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    Waldmann, Daniel Title: EVP, Health Policy & Reimbursement
    Organization: Medical Device Manufacturers Association
    Date: 08/10/2023
    Comment:

    The Medical Device Manufacturers Association (MDMA), a national trade association representing the innovative sector of the medical device market, is submitting this letter in response to the proposed coverage decision for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8). For nearly 30 years, MDMA has represented the medical device industry in Washington, DC, supporting policies that promote medical innovation and patient access to

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    Wong, Virginia Title: Vascular Surgeon (recently retired)
    Organization: (formerly) University Hospitals Cleveland Medical Center, Cleveland, OH
    Date: 08/10/2023
    Comment:

    I am a fellowship-trained Vascular Surgeon who just recently (July 2023) retired from clinical practice. I provided full-service Vascular Surgery care for patients with all types of vascular disease (arterial, venous, and hemodialysis access needs) at University Hospitals Cleveland Medical Center in Cleveland, OH for 18 years prior to closing my practice last month. I also served as Program Director for the Vascular Surgery Integrated Residency and Independent Fellowship training programs

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    Kim, Ryan Title: Vascular Surgeon
    Date: 08/10/2023
    Comment:
    I strongly disagree with this position. The only specialty that's on board with this decision and benefit is the Interventional Cardiologist, and not the patients. Every patient is different and deserves to know what's best for them. As someone who perform CEA, TCAR and TFCAS, this will only increase the number of TFCAS performed by the interventional cardiologist.
    Powell, Richard Title: Director of Heart and Vascular Center
    Organization: Dartmouth Hitchcock Medical Center
    Date: 08/10/2023
    Comment:

    Since 2000 I have performed over 600 tfCAS procedures and participated in the ADVANCE, VIVEXX, EMPIRE, SAPPHIRE, SCAFOLD, CREST, ACT-1, CREST-2 trials as a carotid interventionist. At our institution we have had a low stroke and death rate predominately through careful patient selection and avoiding high risk anatomy such as heavily calcified bifurcation, complex ICA lesions, free floating thrombus , severely tortuous carotid arteries, complex arch anatomy etc. all detected with pre-op CTA.

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    Pietrolungo, Joseph Title: Vice Chairman, Department of Cardiology
    Organization: Summa Health System
    Date: 08/10/2023
    Comment:

    I am a Vascular Cariologist with Summa Health System in Akron Ohio. I would like to thank CMS for their timely, much needed, and thoughtful review of the Carotid Stent literature. I would encourage CMS to finalize and support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence. In addition, I would like to see CMS:

    o Support coverage

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    Abedi, Nick Title: Vaacular Surgeon
    Organization: Fayette Surgical Associates
    Date: 08/10/2023
    Comment:
    As an experience vascular surgeon, involved in carotid stenting registries, I think it is disservice to the population to allow carotid stenting without oversight. Standard risk transfemoral stenting will result in undesirable outcomes and strokes in patients otherwise asymptomatic and not at high risk. I strongly appose the lack of restrictions in this field.
    Moliterno, David Title: Professor of Medicine
    Organization: University of Kentucky
    Date: 08/10/2023
    Comment:

    Dear CMS Committee Members:

    I have spent several decades of my career, both while at the Cleveland Clinic Foundation and at the University of Kentucky involved in the care of patients with carotid arterial disease. Likewise, as the editor-in-chief of the leading interventional cardiovascular medicine journal globally, JACC: Cardiovascular Interventions, I have closely followed the science as well as the clinical application of carotid artery stenting. I also serve as a Special

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    Robinson, Scott Title: Vascular Surgeon
    Organization: University of Florida/Malcom Randall Department of Veterans Affairs Medical Center
    Date: 08/10/2023
    Comment:

    I am a board-certified vascular surgeon and part of a large clinical practice with significant experience managing carotid disease. I am concerned with the coverage expansion outlined in this CMS proposal. The decision to change coverage is premature and jeopardizes patient safety. Numerous randomized control trials and retrospective analyses have demonstrated that transfemoral carotid stenting carries a significantly higher periprocedural stroke rate and should be reserved for a select

    More

    Brook, Allan Title: Professor
    Date: 08/10/2023
    Comment:
    Carotid stenting has been performed for decades in our institute
    It has been performed in the safest possible way.
    The literature supports its coverage strongly
    Aziz, Abdulrab Title: MD, President
    Organization: Specialists in Cardiovascular Medicine, PC
    Date: 08/10/2023
    Comment:

    I am an interventional cardiologist who performs carotid artery stenting (CAS). I would like to thank CMS for your thoughtful review of the clinical literature and current evidence. I kindly ask CMS to finalize these key components of the proposed decision:

    Support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.

  • Support

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  • Drachman, Douglas Title: MD
    Organization: Massachusetts General Hospital
    Date: 08/10/2023
    Comment:
    As a clinician who is deeply committed to providing care to patients with vascular disease, including carotid artery disease, and one who has been very engaged in the assessment of the evidence base regarding surgical and endovascular treatment strategies, I feel very strongly that it is imperative for our patients to have access to all available treatment approaches in order to receive the best possible care. This relies on the CMS decision to approve coverage for carotid artery stenting for

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    Luke, Jay Title: MD FACS
    Organization: Acadiana Vascular Center
    Date: 08/10/2023
    Comment:

    As a Vascular Surgeon in a practice that treats a high volume of carotid disease, I oppose the proposed CMS expanded coverage. In our current practice, we perform CEA, TCar, and TF CAS. TF CAS has become nearly obsolete secondary to the effectiveness of CEA and TCar. TF CAS has proven increased risk of stroke, and this was demonstrated in many previous studies with hand selected practitioners. With the proposed expanded coverage, there will assuredly be a steep spike of procedures

    More

    Collins, Laura Title: Physician Assistant
    Organization: MGH
    Date: 08/10/2023
    Comment:
    I have been a Physician Assistant in Interventional Vascular Medicine and Cardiology for nearly 25 years, caring for patients with carotid disease-many of which have received CAS. Most of the patients preferred this procedure over CEA or TCAR, and have had remarkable, long-term results. I have also cared for many other patients who would have preferred CAS but they could not get access given lack of coverage. It is clear that expansion of coverage for CAS is appropriate and important for

    More

    Mohan, Sathish Organization: Riverside Health System
    Date: 08/10/2023
    Comment:

    I am a practicing vascular surgeon. I perform carotid endarterectomy and TCAR. I am quite concerned about the CMS Proposed Decision Memo relating to NCD 20.7. The proposed ruling would open transfemoral carotid stenting to nearly all interventionalists that wish to do them, especially if the local hospital does not have adequate credentialing and/or proctoring programs in place. This would reduce standardization of care across the country. Currently, transfemoral carotid stenting is done at

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    Imsais, Joseph Title: MD
    Date: 08/10/2023
    Comment:

    I am a physician (interventional cardiologist) who performs CAS. I wish to thank CMS for its thoughtful review of the clinical literature and current evidence.
    I would like to encourage CMS to finalize key components of the proposed decision:

    Support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.
    Support coverage without

    More

    Brittenham, Gregory Title: DO
    Organization: UC Davis Medical Center
    Date: 08/10/2023
    Comment:

    I have significant concerns around CMS’ proposed decision memo that would provide broad coverage of TFCAS, independent of patient symptom status and risk stratification. This coverage is not contingent on data entry into societal registries which would have served to establish what the outcomes for this procedure are in all rather than selected patients by all rather than selected operators. Furthermore, there are no guard rails for credentialing or for establishing quality

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    Meyermann, Karol Title: MD
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7.

    I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety.

    Bowser, Andrew Title: Vascular Surgeon
    Date: 08/10/2023
    Comment:
    I believe CMS should reconsider expanding coverage for Carotid stenting as recently proposed. Patient should have care based on data that protects them from potential harm. The carotid interventions available (cea, transfemoral stenting. Tcar stenting) should not be considered equivalent and while each may have a place in care there is a higher risk for transfemoral stent procedures causing stroke the main endpoint the interventions are aimed at preventing. Cea and tcar stenting in real

    More

    Ascher, Enrico Title: CEO, Total Vascular Care
    Organization: Total Vascular Care
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    yamasaki, hiroshi Title: MD
    Organization: Eastside cardiovascular medicine
    Date: 08/10/2023
    Comment:
    I strongly support the expansion of coverage for carotid stenting for severe carotid stenosis.
    Patel, Akash Title: Physician
    Organization: Space Coast Vascular Interventional Radiology
    Date: 08/10/2023
    Comment:
    Right now only surgical procedures, such as endarterectomy and TCAR are approved for standard risk patients. There is strong data to support carotid stentting from multiple randomized trials. This procedure should be available for the Interventional Radiologists who are properly trained to do this.
    Williamson, Weldon Title: M.D.
    Organization: Carolina Vascular
    Date: 08/10/2023
    Comment:

    CMS

    Title: Vascular surgeon

    Date: August 2, 2023

    Comment:

    Dear CMS,

    I am grateful to have an opportunity to participate in public comment regarding proposed changes to National Coverage Determination (NCD) relative to percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting. In formulating these comments, I have had an opportunity to thoroughly review the best available medical evidence, comments from CMS,

    More

    Islam, Arsalla Title: Vascular Surgeon
    Organization: Wise Health System
    Date: 08/10/2023
    Comment:
    Patients and surgeons should have a choice in deciding the best treatment option in each individual case.
    Tomita, Tadaki Title: Assistant Professor of Surgery
    Organization: Northwestern University
    Date: 08/10/2023
    Comment:

    As a dedicated vascular surgeon, I'm alarmed by the coverage expansion proposed in CMS' Decision Memo for NCD 20.7. The proposed changes as written put patient safety at risk. I urge CMS to consider these concerns and recommendations prior to finalizing updates to NCD 20.7.

    To maintain patient safety, it is imperative to continue to collect real-time data and continue the credentialing process.

    Enforce a standardized "Shared Decision Making" tool, developed

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    Smolock, Christopher Title: Associate Professor of Vascular Surgery
    Organization: Icahn School Of Medicine At Mount Sinai
    Date: 08/10/2023
    Comment:
    In no study has transfemoral carotid artery stenting been showed to be superior to other carotid treatment. Carotid endarterectomy remains the gold standard.
    Additionally with the development of best medical therapy there is much debate over whether asymptomatic carotid disease needs to be treated at all. In many other countries it is not and stroke rates remain the same or better with best medical therapy. Opening up carotid disease, especially asymptomatic to transfemoral stenting in

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    Loh, Shang Title: Professor of Clinical Surgery
    Organization: University of Pennsylvania Perelman School of Medicine
    Date: 08/10/2023
    Comment:

    I am a Vascular Surgeon practicing at a large academic medical center. After reading the proposed recommendation, I have significant concerns regarding the proposal. Being at a quaternary referral center I have seen complications of carotid based procedures being performed throughout the community. I believe that in order to maintain the quality of treatment of carotid diseases and to ensure patient receive the best treatment for their disease process (and not just what is available at a

    More

    LaGraize, Chris Date: 08/10/2023
    Comment:
    I do not support transferable, stenting for standard risk carotid artery stenosis. There’s plenty of data showing that the stroke rate for transformer stenting is significantly higher than open CEA or TCAR. This is especially true in older adults. The current treatment paradigm is adequately taken care of our patients.
    Ching, YiMing Date: 08/10/2023
    Comment:

    Recent articles in pro publica and nyt, about aggressive and unethical treatment by non board certified Vascular Surgeons and non SVS members highlight the importance of quality control.

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before

    More

    Sadanandan, Saihari Title: MD, FACC, FSVM, FSCAI
    Organization: TAMPA CARDIOVASCULAR INTERVENTIONS AND RESEARCH
    Date: 08/10/2023
    Comment:
    Thank you for the review of CAS
    I support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.
    I support coverage without requiring patients to participate in clinical trials.
    I support removal of the facility standard and approval requirements.
    I support allowing Medicare Administrative Contractors (MACs) to determine whether to

    More

    Freeman, Michael Date: 08/10/2023
    Comment:
    Scientific data shows that carotid stent performed through the femoral artery route is associated with inferior outcomes compared to CEA and TCAR. Approval of carotid stenting across the board will only lead to more complications from a disease that already has a low risk benefit ratio. Strongly encourage that present guidelines continue to be left in place to protect an unsuspecting public that is not always informed of the treatment options and their associated risks.
    Singh, MD, Michael Title: Chief, Surgical Service UPMC Shadyside
    Organization: Univ of Pitt Medical Center
    Date: 08/10/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    McCollom, Vance Title: Neurointerventional Radiologist
    Organization: Integris Baptist Medical Center
    Date: 08/10/2023
    Comment:
    I believe that carotid angioplasty and stent placement is now as safe and effective as carotid endartectomy.
    Khurana, Neal Title: Physician
    Organization: Vascular & Interventional Specialists of Siouxland
    Date: 08/10/2023
    Comment:
    Life saving treatment, easily performed, cost savings compared to managing stroke is exponential.
    Conrad, Mark Title: MD
    Organization: Vascular and Endovascular Surgery Society
    Date: 08/10/2023
    Comment:

    The Vascular and Endovascular Surgery Society (VESS) would like to comment on the recent proposed decision memo for percutaneous transluminal angioplasty of the carotid artery concurrent with stenting by CMS. We are concerned that the proposed expansion of indication for transfemoral carotid stenting (CAS) to include asymptomatic standard risk patients while removing facility standards and approval requirements is unnecessary and will likely cause harm to patients with carotid disease.

    More

    Sewall, Luke Title: MD
    Organization: VIR Chicago
    Date: 08/10/2023
    Comment:

    As an interventional radiologist, I am concerned with the coverage expansion outlined in CMS' Proposed Decision Memo relating to NCD 20.7. I ask that CMS consider the following recommendations before finalizing updates to NCD 20.

    I would appreciate you clarifying the intended shared decision-making (SDM) tool more. Specifically, any tool used is subject to unintended bias in its evidence synthesis, thus warranting review and validation by the multiple medical specialty societies

    More

    Esses, Glenn Title: Md
    Organization: Vascular Center Of Mobile.
    Date: 08/10/2023
    Comment:

    Dear administrators

    How in the world we could even consider performing a less safe procedure is beyond me. The data done in several randomized perspective studies demonstrate considerably higher stroke, especially in women and especially in people over 80 years old. We have seen interventionalists do inappropriate balloons of renal arteries, lower extremity arteries for years.

    This is clearly being driven by people who only have a needle. There are currently two equally

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    Hummel, Michael Title: MD
    Organization: University of Iowa Hospitals and Clinics
    Date: 08/10/2023
    Comment:

    As an interventional radiologist, I am concerned with the coverage expansion outlined in CMS' Proposed Decision Memo relating to NCD 20.7. I ask that CMS consider the following recommendations before finalizing updates to NCD 20.

    I would appreciate you clarifying the intended shared decision-making (SDM) tool more. Specifically, any tool used is subject to unintended bias in its evidence synthesis, thus warranting review and validation by the multiple medical specialty societies

    More

    Lemmon, Gary Title: Associate Medical Director
    Organization: SVS PSO
    Date: 08/10/2023
    Comment:

    I would like to provide some financial perspective based on the overwhelming data offered about pros and cons for NCD 20.7 proposal.

    Facts:

    There are an estimated 3 million patients in the US over 65 who have asymptomatic carotid artery stenosis greater than 50%. VEITHsymposium Bulletin. June 2022: https://www.veithsymosium.org/pdf/articles/vei/61.pdf

    The estimated economic cost of a stroke per year in the US is $59,900. J Med Life 2021 Sep-Oct;14(5):606-619.

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    Malas, Mahmoud Title: Professor, Chief, Vascular & Endovascular Surgery
    Organization: UC San Diego
    Date: 08/10/2023
    Comment:

    To: Centers for Medicare and Medicaid Services Coverage Advisory Group

    Re: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting Decision Memo, CAG-00085R8

    Regarding the reimbursement of carotid artery stenting, I would like to point out several comments:

  • The CREST-1 trial had a detailed list of inclusion and exclusion criteria which makes the conclusions less generalizable for standard risk patients.
  • Multiple

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  • HASSANI, ASSADULLAH Title: doctor
    Organization: GMC
    Date: 08/10/2023
    Comment:
    i am dr assadullah hassani , invasive cardiologist
    i have done more than 100 CAS with a good result
    Budincevic, Hrvoje Title: MD, PhD. Neurologist
    Date: 08/10/2023
    Comment:

    I have some concerns regarding this issue, as a neurologist outside of the USA. Unfortunately, according to the current evidence-based medicine data CAS is still inferior to CEA, regarding efficacy and safety. CMS should support appropriate new research. Results from CREST-2 trial are expected in 2026. It is not applicable to remove procedural standards necessary in medicine. Key quality parameters concerning patients' treatments and outcomes should be included in quality monitoring. Since

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    Spinelli, Francesco Title: Full Professor of Vascular Surgery
    Organization: Campus Bio Medico University of Roma, Italy
    Date: 08/10/2023
    Comment:
    To Broaden the indication to Carotid Artery PTA and Stenting is a nonsense and leads to over treating Carotid Arterial Disease, giving more harm to patients. This has already happened in Italy, where despite a ten-fold increase in Carotid Procedures in the last two decades, there has not been a significant decrease in the amount of strokes due to Carotid Atherosclerosis. The whole Vascular Community believes that the indication to an invasive treatment of Carotid atheroma should be based on

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    AKRAM, MD.WASIM Date: 08/10/2023
    Comment:
    It's good.
    Hoel, Andrew Title: Associate Professor of Surgery
    Organization: Northwestern University Feinberg School of Medicine
    Date: 08/10/2023
    Comment:

    I am vascular surgeon and have been practice for 10 years. I perform a wide variety of surgical and endovascular procedures treating the full spectrum of vascular disease. This includes the use of transfemoral carotid artery stenting (TFCAS) and transcarotid artery stenting (TCAR) to treat carotid artery occlusive disease. From my experience as a vascular surgeon that treats carotid artery disease with medical management, surgery, and endovascular procedures, I am uniquely qualified to

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    Maximus, Steven Title: Assistant Professor, Director of Aortic Surgery
    Organization: UC Davis Medical Center
    Date: 08/10/2023
    Comment:

    There is absolutely zero data support expanding coverage for asymptomatic transfemoral stenting. There is no evidence to support this, and every single study that has been done in comparing transfemoral stenting vs. CEA or TCAR shows transfemoral to have at least double the stroke rate. If CMS should go down this route of expanding coverage for transfemoral stenting, then every patient undergoing a carotid procedure should be required to be evaluated by a physician who can perform both

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    Dmytriw, Adam Title: Neurovascular Practitioner
    Organization: Mass General Brigham
    Date: 08/10/2023
    Comment:

    Carotid standing, is demonstrably equal to carotid endarterectomy in most cases, with significantly lower risk of cranial nerve injury, and without disfiguring scar.

    The age of open surgery for the majority of patience for carotid disease is long over, and the only practitioners advocating for its persistence, are those who stand to personally benefit monetarily.

    You will note that the New York Times recently had to publish a damning investigation of unethical use of

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    DiLosa, Kathryn Title: Physician
    Organization: UC Davis Health
    Date: 08/10/2023
    Comment:

    I have significant concerns around CMS’ proposed decision memo that would provide broad coverage of TFCAS, independent of patient symptom status and risk stratification. This coverage is not contingent on data entry into societal registries which would have served to establish what the outcomes for this procedure are in all rather than selected patients by all rather than selected operators. Furthermore, there are no guard rails for credentialing or for establishing quality

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    Genova, Richard Title: Neurovascular Specialist
    Organization: Registered Vascular Tech Organization
    Date: 08/10/2023
    Comment:

    The CMS Proposed Decision Memo notes “that a standardized, nationwide registry – for all carotid artery procedures – would be helpful to monitor procedural safety, further evolve patient risk stratification, and to facilitate auditing and quality improvement, including comparison of local outcomes to national and other benchmarks. It would be helpful wherever possible that large-scale, data-collection enterprises (registries) collaborate, include all patients, and build off existing

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    Chu, Mabel Title: Vascular Surgeon
    Organization: Adventist Health
    Date: 08/09/2023
    Comment:
    IR have on clinical contact with patients. Lack clinical knowledge and judgement for the right set of patients where carotid stenting would be beneficial to patient.
    Cralle, Lauren Title: MD
    Organization: UC Davis Health
    Date: 08/09/2023
    Comment:

    I have significant concerns around CMS’ proposed decision memo that would provide broad coverage of TFCAS, independent of patient symptom status and risk stratification. This coverage is not contingent on data entry into societal registries which would have served to establish what the outcomes for this procedure are in all rather than selected patients by all rather than selected operators. Furthermore, there are no guard rails for credentialing or for establishing quality

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    Fishbein, Gary Title: Interventional Cardiologist
    Organization: Premier Cardiovascular Institute, Dayton, OH
    Date: 08/09/2023
    Comment:

    I am an interventional cardiologist who regularly evaluates patients with carotid disease and have been performing carotid stent procedures since 2003 . First of all, I would like to thank CMS both for their thoughtful and thorough review of the extensive amount of rigorous data that exists on this topic as well as allowing us the opportunity to advocate for our patients in this public forum.

    I take the treatment of extracranial carotid disease very seriously and tend to be

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    Jolly, Michael Title: Interventional Cardiologist
    Organization: OhioHealth Heart & Vascular
    Date: 08/09/2023
    Comment:

    I am an interventional cardiologist who regularly evaluates patients with carotid disease and performs carotid stent procedures. First of all, I would like to thank CMS both for their thoughtful and thorough review of the extensive amount of rigorous data that exists on this topic as well as allowing us the opportunity to advocate for our patients in this public forum.

    With this in mind, I would I strongly support the following proposed decisions:

    1. Proposal to expand

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    Goyal, Amit Title: MD
    Organization: Premier Health Specialists
    Date: 08/09/2023
    Comment:

    I am an interventional cardiologist who has been doing carotid stenting for over 10 years. I am extremely glad that after reviewing the state of the art literature and evidence on carotid stenting, CMS is considering expanding the indications for the procedure to include asymptomatic patients with lesions more than 70% and patients at normal risk for carotid surgery outside of the clinical trial setting. I am also supportive of the removal of facility standards and approval requirements

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    Gardener, Hannah Title: Assistant Professor
    Date: 08/09/2023
    Comment:

    I am an epidemiologist and I have been studying carotid disease and the prevention of vascular health outcomes for 16 years, with a particular focus on racial and ethnic disparities.

    My personal opinion is that US Medicare should reconsider proposals to fund any procedure known as 'carotid stenting' in anyone age 65 and older with at least 50% or 70% carotid stenosis as well as proposals to remove externally applied procedural standards. I am advocating for minority populations

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    Khan, Amid Title: Interventional cardiologist, Director , EV program
    Organization: Lankenau Medical center, Main Line Health
    Date: 08/09/2023
    Comment:

    Based on clinical data and multiple trials, approval of carotid artery stenting is overdue. This will advance patient care in a very positive way. Evolution of technology made this procedure safe and easily applicable in clinical practice. The patients will benefit the most . Therefore, my vote is to

    -Support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the

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    Crawford, Joel Title: Vascular Surgeon
    Date: 08/09/2023
    Comment:
    I'm against this decision. I think the risk of stroke from transfemoral intervention should be reserved for patients who are not surgical candidates and are symptomatic. It requires continued control to prevent inappropriate use such as has been seen in other procedures.
    Patel, Pratit Date: 08/09/2023
    Comment:
    As a practicing vascular and endovascular Neurologist, I support per cutaneous transluminal angioplasty of carotid artery with concurrent stenting. Clinical trials over last 10 years have established this treatment modality for carotid artery disease.
    Ramabadran, Ramanujam Date: 08/09/2023
    Comment:
    I support carotid stenting as this is less invasive.
    Verma, Anil Organization: Mercy Health Cincinnati Ohio
    Date: 08/09/2023
    Comment:

    I strongly support the expansion of CMS coverage for carotid artery stenting and offer this procedure to a wide group of patients regardless of their risk category. CMS needs to be congratulated and thanked for this bold decision. I have been doing transfemoral carotid artery stenting for about 12 years after graduating from a rigorous cardiovascular fellowship training program. The training program included complex stroke and carotid intervention. Carotid artery stenting is safe,

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    Trehan MD, Sanjeev Title: Cardiologist
    Organization: Baylor Heart Hospital Plano
    Date: 08/09/2023
    Comment:
    CMS should provide coverage for CAS for standard risk patient population. The technology has been available and safely used for more than 2 decades and has withstood the digits of multiple clinical trials
    We agree with Shared Decision making with patients for not only CAS but any form of interventional or surgical carotid therapy including discussion on medical therapy
    There is a need for validated SDM tool and perhaps the professional societies can be tasked with its development

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    Williams, Jessica Title: Vascular Surgeon
    Date: 08/09/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Strickman MD, Neil Title: Interventional and Vascular Cardiology
    Organization: Baylor College of Medicine Houston TX
    Date: 08/09/2023
    Comment:
    I started doing Carotid Artery stenting with medicare approval in the late 1990, having done well over 700 cases
    I was instrumental in the SAPPHIRE Trial as well
    I believe there are some corrections needed to medicares policy to be
    1-There is no need for an independent neurologist unless there is a major event. We had a neurologist see every patient in all the trials we entered. It only added time for the patient and family, parking fess and office visits. It was easier to have

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    Weinstock, Barry Title: MD
    Organization: Orlando Heart and Vascular Institute
    Date: 08/09/2023
    Comment:

    I have been performing carotid stent procedures since 1996 and have helped a large number of patients over the past several decades who chose to avoid surgery. My complication rate has been as low or lower than that seen with carotid surgery. I urge you to expand the indications for carotid stenting to make this well-studied procedure standard of care for appropriate patients when the procedure is performed by well trained, experienced interventionalists. Although the Shared Decision

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    Varghese, Joji Date: 08/09/2023
    Comment:

    I am an Interventional Cardiologist refers for CEA and has credentials to do Trans-femoral stenting.
    Appreciate CMA for the thoughtful review of the clinical literature and evidence.

    I support the proposal:
    1. To expand coverage to patients with symptomatic CAS > 50% and symptomatic CAS > 70%.
    2. To expand coverage without requiring patients to participate in clinical trials.
    3. Support removal of the facility standard and approval requirements.
    4. Support

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    Farkas, Nathan Date: 08/09/2023
    Comment:
    As a Vascular Neurologist the evidence behind stenting of the carotid artery as a valid revascularization strategy with unique benefits compared to carotid endarterectomy have been clear for many years. I have referred hundreds of patients for stenting evaluations and through careful discussion with the interventionalist we have been able to help revascularize and reduce recurrent stroke risks. It takes good training to interpret and manage the data that leads to a finalized plan to provide a

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    Goswami, Nilesh Title: MD
    Organization: Baylor Scott & White Hillcrest
    Date: 08/09/2023
    Comment:
    I have been an interventional cardiologist for 20 yrs. I have been doing carotid stenting during that time. I have participated in clinical trials using this approach. This is a great technology to address carotid artery disease. It has been extensively studied during this time. I agree that it should be available to our patients as an option to CEA. I like the multidisciplinary approach much like a heart team for structural cases.
    Williamson, Roz Title: Ms
    Date: 08/09/2023
    Comment:

    I am a Registered Nurse in Australia, and worked in Interventional Radiology. I am currently employed as a Lecturer in Nursing at Monash University - ranked 5 in the world on the Shanghai Ranking Of Academic Subjects I have seen countless patients who have presented with stroke who have been treated under best evidence based practice. The proposal to allow asymptomatic patients to have procedures that have a risk element, without evidence does not make sense. There is no evidence that

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    de Macedo Rodrigues, Katyucia Title: Carotid stenting
    Organization: Greensboro Radiology
    Date: 08/09/2023
    Comment:
    This is a much needed change expanding access to minimally invasive treatment to prevent stroke in the population served. Long term outcomes of carotid stenting have been to shown to be similar do endarterectomy, therefore, this must be available for medicare patients. Share decision making with explanation of options is always necessary.
    Sandhu, Divyajot Date: 08/09/2023
    Comment:
    I support expansion of criteria for carotid artery stent placement to include plaque morphology instead of just percentage stenosis. This is based on growing evidence that a significant number of cases of stroke previously classified as ESUS, are in fact because of atheromatous emboli from carotid plaques causing less than moderate stenosis.
    Altschul, David Title: Chief of Neurovascular Surgery
    Organization: Montefiore Medical Center
    Date: 08/09/2023
    Comment:

    To whom it may concern,

    As Chief of Neurovascular surgery i felt it important to comment to support the proposed coverage decision. I would like to thank CMS for its thoughtful review of the clinical literature and current evidence. I am in support of the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence. I support coverage without

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    Jacobs, Donald Title: Professor and Chief of Vascular Surgery
    Organization: University of Colorado
    Date: 08/09/2023
    Comment:

    I have been doing carotid stenting for 25 years. I have been involved in trials and registries and have seen the progression of outcome improvement with experience and device development. It iis not unreasonable to desire to open up access to TFCAS as the data from many studies show near equivalent results. However, the outcomes from carotid intervention either with CEA, TECAR and TFCAS depend on rigorous training and outcomes review. The restricted access imposed by the NCD has limited

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    dabus, guilherme Organization: Baptist Health South Florida
    Date: 08/09/2023
    Comment:
    As a practitioner who is involved in the treatment of carotid disease and stroke for the last 15 years, I strongly support the Proposed Decision Memo which undoubtfully will expand access to carotid disease treatment.
    Adelman, Mark Title: Professor and Chief of Vascular Surgery (ret.)
    Organization: NYULangone Medical Center
    Date: 08/09/2023
    Comment:

    Carotid artery stenting has not yet been proven safe and effective for the long-term management of asymptomatic carotid artery stenosis.

    Carotid artery disease poses a significant health concern due to its potential to cause stroke, a leading cause of morbidity and mortality. Three primary treatment options have emerged for carotid artery disease: carotid artery stenting (CAS), carotid endarterectomy (CEA), and best medical management consisting of a combination of antiplatelet

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    Sonig, Ashish Title: Assistant professor neurosurgery
    Organization: Rutgers university , state university of New Jersey
    Date: 08/09/2023
    Comment:
    I have experience with CAS for over 10 hrs . CAS had proved to be as durable and safe as CEA . I am glad the CMS has gone to the next step in its consideration, decision making . One must remember that cerebral aneurysm were traditionally treated with open vascular surgery ( craniotomy ) and now , predominantly by Endovascular route . The data of CAS is much more overwhelming in favor of the equipoise between CAS and CEA , and I completely support the CMS . At almost any center , when ever a

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    Lodha, Ankur Date: 08/09/2023
    Comment:
    I agree that indications for Trans femoral carotid stenting should be expanded. I am an interventional cardiologist and I have performed over 100 Transfemoral carotid artery stents and more than a 100 TCAR procedures and I feel that expanding the coverage for carotid stents will be beneficial for patients and a physician can chose the right treatment modality which includes CEA, TCAR or TF CAS. It allows the physicians to make a better informed choice for the patient.
    Data has been very

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    Pearce, Benjamin Title: MD
    Date: 08/09/2023
    Comment:

    The performance of stenting the carotid artery for asymptomatic disease is a very tight window for risk v. benefit. The absolute most critical step is avoidance of stroke intraoperatively.

    The largest Randomized control trials have demonstrated time after time that transferal carotid stenting carries at least DOUBLE the procedural stroke risk compared to CEA and TCAR, even when being performed by vetted providers. If these rule goes through, the entire medicare population

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    Hashem, Mustafa Title: MD, FACC
    Organization: Henryford health system
    Date: 08/09/2023
    Comment:
    Pts will benefit ftom expansion of criteria for carotid stents, it it is safe and equivalent to CAE and better in certain pts
    Pineda, Carlos Title: M.D.
    Date: 08/09/2023
    Comment:

    I am a board certified vascular surgeon and I do not support this change.

    Carotid stenting is one of three main procedures that deal with the management of carotid artery stenosis. Despite being a minimally invasive procedure, several trials have noted an increased stroke rate in patients when compared to traditional surgery (carotid endarterectomy). Furthermore, outcomes are quite worse in patients over the age of 70. As such, it has limited use in the modern management of

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    Jayaraman, MD, Mahesh Title: President
    Organization: Society of NeuroInterventional Surgery
    Date: 08/09/2023
    Comment:

    Tamara Syrek Jensen, Director
    Joseph Chin, Deputy Director
    Coverage and Analysis Group
    Centers for Medicare & Medicaid Services
    7500 Security Blvd.
    Baltimore, Maryland 21244

    RE: Comments on Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8) Proposed Decision Memo

    Dear Ms. Syrek Jensen and Dr. Chin:

    The Society of NeuroInterventional Surgery (SNIS) expresses its strong

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    Musicant, Scott Title: M.D.
    Organization: Vascular Associates of San Diego
    Date: 08/09/2023
    Comment:

    Good afternoon. I am a board certified vascular surgeon in San Diego. I have been in practice since 2006. I have been performing carotid stenting and carotid surgery since starting practice in 2006. Starting in 2017 I began to perform transcarotid artery revascularization/stenting (TCAR). I now perform both CEA and TCAR for appropriate patients with carotid disease. Based on evidence based research, I now rarely perform transfemoral carotid stenting as the rates of stroke have been

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    Costabile, Joseph Organization: Surgical Group of South Jersey
    Date: 08/09/2023
    Comment:
    The decision to change coverage criteria is premature and risks patient safety. I respectfully revise the proposed decision memo to include a definition for a qualified physician with demonstrated core competency standards relating to PTA of the carotid artery with stenting.
    Singh, Premranjan Title: MD, FACC, FSCAI
    Date: 08/09/2023
    Comment:
    I have been doing carotid stenting for all those high surgical risk patients for almost 10 years with great success and no complication. In my opinion carotid stent has become more safer due to advancement of wire, filter and stent system. In past we did not have much option when filter get filled with debris/clots but now penumbra aspiration has solved that problem. Patients satisfaction and recovery from procedure is far more better in stent arms. Its time to expand coverage for PTA and

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    Chen, Stephen Title: Associate Professor
    Organization: UT MD Anderson Cancer Center
    Date: 08/09/2023
    Comment:

    I am a Neurointerventional Radiologist that performs a high volume of CAS on patients with radiation related carotid disease. Thank you for your very thoughtful review of the literature.

    I support:
    1. Expanding coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.
    2. Expanding coverage to patients outside of clinical trials.
    3. Allowing Medicare

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    Crowl, Gabriel Title: M.D.
    Date: 08/09/2023
    Comment:

    I am a vascular surgeon in clinical practice in Portland, Oregon. I completed all of my medical training in the United States and I am board certified in vascular surgery by the American Board of Surgery. I write today to express my concerns about the proposed update to NCD 20.7 regarding angioplasty of the carotid artery with stenting.

    The current safety standards around coverage for carotid artery stenting are robust. This is necessary since the existing evidence around this

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    Gilani, MD, Syed Title: Associate Professor of Medicine,Cardiology
    Organization: UTMB Galveston TX
    Date: 08/09/2023
    Comment:
    I am interventional cardiology trained for carotid artery stent procedures. Appreciate CMS to consider modifying the current status based on clinical trial showing benefits of CAS. Please allow the physicians to discuss with their patients in SDM visit. There should be an option to consider carotid angiogram instead of CTA/MRA. Options is always a good idea instead of mandating certain imaging over other.
    Thankyou
    massop, douglas Title: MD
    Date: 08/09/2023
    Comment:
    /Users/douglasmassop/Desktop/RE- comment period NCD_MASSOP_SM.docx
    Schermerhorn, Marc Organization: BIDMC
    Date: 08/09/2023
    Comment:

    As a vascular surgeon who performs CEA, tfCAS, and TCAR I have substantial concerns about the proposed NCD changes.

    Those of us who made it through the process of credentialing for CREST and the registries understand the rigorous criteria employed, and that not all who applied were given access. This led to better outcomes than had been previously seen but cannot be assumed to be generalizable to the broad community. The CMS requirements for local credentialing committees and

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    Ingrassia, Joseph Date: 08/09/2023
    Comment:
    This will be helpful to expand treatment options.
    Mathews, Santhosh Title: MD
    Date: 08/09/2023
    Comment:

    I believe that the coverage decision is a welcome change and quite fair, allowing multiple options for treatment of patients without symptoms but significant disease. Depending on patient anatomy and operator skill/comfort, they can be treated with TCAR, transfemoral, or transradial carotid stenting. These approaches have similar outcomes in the modern era based on current data. Allowing for patient choice is important as well and broadening coverage allows for this. The shared decision

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    Aronow, Herb Title: President
    Organization: Society for Vascular Medicine
    Date: 08/09/2023
    Comment:

    The Society for Vascular Medicine (SVM) is a non-profit professional association with over 600 members representing the majority of practicing vascular specialties in the United States, including but not limited to vascular medicine, cardiovascular medicine, interventional cardiology, interventional radiology, and vascular surgery. Most of our members and member specialties manage patients with carotid artery disease. Several SVM members are considered thought leaders in the field of

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    Desai, Aken Title: Asst Prof of medicine
    Organization: University of Colorado
    Date: 08/09/2023
    Comment:

    I refer patients for CAS and I am thankful CMS reviewed this an agrees that carotid stenting is a procedure that is safe and efficacious and deserving of expansion of coverage to standard risk patients. I ask that CMS

  • Ask CMS to finalize key components of the proposed decision:

    o Support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical

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  • Stirling, Amanda Title: RE: CAG-00085R8, NCD 20.7
    Organization: American College of Cardiology and American Heart Association
    Date: 08/09/2023
    Comment:

    The American College of Cardiology and the American Heart Association appreciate the opportunity to provide comment on the National Coverage Determination (NCD) 20.7 for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting. There have been significant developments since the last consideration in 2009, and we strongly support updating NCD 20.7 to broaden the coverage indication to Medicare beneficiaries to reflect those developments.

    The

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    Hays, Katherine Title: MD
    Organization: Norman Regional
    Date: 08/09/2023
    Comment:
    Low risk
    Mills Sr., Joseph Title: Reid Professor, Chief of Vascular Surgery
    Organization: BAYLOR COLLEGE OF MEDICINE
    Date: 08/09/2023
    Comment:

    Re: Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting; CAG-00085R8

    The mission statement of CMS is: “The CMS seeks to strengthen and modernize the Nation’s health care system, to provide access to high quality care and improved health at lower costs.” The recent CMS proposed coverage expansion of percutaneous transluminal angioplasty and stenting (NCD 20.7) is at striking odds with its mission statement.

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    Curi, Michael Title: Director of Vascular & Endovascular Surgery
    Organization: New Jersey Medical School
    Date: 08/09/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Hadro, Neal Title: Chief Division of Vascular Surgery
    Organization: Baystate Health
    Date: 08/09/2023
    Comment:
    Since the mid-90’s our understanding of carotid disease, pervasive use of statins and improvements in diagnostic and interventional technology has resulted in fewer procedures annually and outstanding outcomes by high volume centers and providers . This current state should not be changed whereas unlike the loss of agency for vascular surgeons with exclusivity for the lower extremity, the indications for carotid surgery are far more exacting and the brain completely intolerant of casual and

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    Babrowski, Trissa Title: MD
    Organization: University of Chicago
    Date: 08/09/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Eagleton, Matthew Title: Chief, Division of Vascular & Endovascular Surgery
    Organization: Massachusetts General Hospital
    Date: 08/09/2023
    Comment:

    As President-Elect of the Society for Vascular Surgery, I disagree with CMS’ proposed decision relating to NCD 20.7 and expansion of coverage for carotid artery stenting. The expansion to include standard risk and asymptomatic patients should be delayed until the results of the CREST II study are available, as this would add valuable information to our decision-making process. The lack of this important data hinders our ability to formulate an appropriate “Shared Decision Making” tool among

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    Scali, Salvatore Title: Professor of Surgery
    Organization: University of Florida
    Date: 08/09/2023
    Comment:

    The overwhelming preponderance of peer reviewed evidence DOES NOT support use of trans-femoral carotid angioplasty and stenting (TF-CAS) for asymptomatic patients. A 2-3 fold higher perioperative stroke risk is evident in large database analyses and across various RCTs. Notably, the higher stroke rates occurred in controlled settings even when 'expert' stenters were doing these procedures. Accordingly, it would be irresponsible to allow coverage of TF-CAS for asymptomatic carotid artery

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    O'Shaughnessy, Charles Title: MD
    Organization: University Hospitals, Cleveland, Ohio
    Date: 08/09/2023
    Comment:

    To Whom It May Concern:

    I am a physician who performs carotid artery stenting. Thank you CMS for your thoughtful review of the clinical literature and current evidence of carotid artery stenting. I ask you to finalize key components of the proposed decision:

    -Support the proposal to expand coverage to patients with symptomatic carotid artery stenosis greater than or equal to 50% and patients with asymptomatic carotid artery stenosis greater than or

    More

    Milner, Ross Title: Chief of Vascular Surgery; Professor of Surgery
    Organization: University of Chicago Medicine
    Date: 08/09/2023
    Comment:
    Carotid disease needs to be managed with the lowest risk approach. Vascular surgeons are able to offer medical management; carotid endarterectomy; TCAR; and trans-femoral carotid stenting. In our practice, transfemoral stenting is the last approach that we would choose due to the data-supported evidence that is has the highest associated peri-procedural risk of a neurologic event. Transfemoral stenting should be restricted to very specific patients. This is especially true for asymptomatic

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    Short, Jody Date: 08/09/2023
    Comment:
    I support the changes to include the non high risk patients for CAS. This is probably long overdue and will give us more options to safety treat our patients. There is sufficient data to support this change.
    Livesay, Sarah Title: President
    Organization: Neurocritical Care Society
    Date: 08/09/2023
    Comment:

    August 9, 2023

    Tamara Syrek Jensen, Director
    Joseph Chin, Deputy Director
    Coverage and Analysis Group
    Centers for Medicare & Medicaid Services
    7500 Security Blvd.
    Baltimore, Maryland 21244

    RE: Comments on Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8) Proposed Decision Memo

    Ms. Syrek Jensen and Dr. Chin,

    The Neurocritical Care Society (NCS) appreciates the opportunity

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    Ali, Vaqar Title: MD
    Organization: HCA - memorial hospital JACKSONVILE Florida
    Date: 08/09/2023
    Comment:
    TF - CAS has multiple advantages over CEA and T CAR
    It is a minimally invasive procedure that takes less than 35 min to perform with < 2 % stroke and complications
    We have multiple studies with excellent results. I think it’s time we should approved this therapy as first line treatment for carotid disease
    FARHAT, NAIM Title: GIRECTIR HHVI EMC
    Organization: UNOVERSITY HOSPITALS
    Date: 08/09/2023
    Comment:
    I fully support covering Carotid tenting as an important procedure for patients care. This should not be restricted to clinical trial. It has proven over. Time the safety and efficacy of this procedure. Have not been involved in more than 400 cases I assure you it is a safe procedure with a great outcome and benefit patients who are at risk of surgical intervention. Follow-up of many years showed very low restenosis rate with low complication rate I hope we consider covering the procedure

    More

    Dayama, Anand Title: MD
    Organization: Sanford Health
    Date: 08/09/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Petrossian, George Title: MD
    Organization: Saint Francis
    Date: 08/09/2023
    Comment:

    I am an Interventional Cardiologist who has performed carotid stenting since 1997.

    I want to thank CMS for their review of the literature and current evidence.

    I support the proposal to expand coverage to those patients with symptomatic stenosis >50% and asymptomatic stenosis >70% , while also supporting coverage for patients without participating in clinical trials. I support the removal of faculty standards and approval requirements and support allowing MAC's to

    More

    Beach, Rebecca Title: RN
    Organization: Southeast Georgia Health System
    Date: 08/09/2023
    Comment:
    As a cardiovascular nurse with over 15 years of experience and a lifelong student of the medical literature I would like to voice my opinion against the proposed measure. The data is abundantly clear that the periprocedural stroke rate for transfemoral stenting is inferior to that of TCAR or CEA. Why would CMS open the floodgates for an inferior procedure? There should at least be some controlled quality measures that are followed like VQI. Patient safety is paramount!
    Dangas, MD, PhD, MSCAI, George Title: President
    Organization: The Society for Cardiovascular Angiography and Interventions
    Date: 08/09/2023
    Comment:

    The Society for Cardiovascular Angiography and Interventions (SCAI) has dedicated its work to advancing the profession and is the designated society for guidance, representation, professional recognition, education, and research opportunities for invasive and interventional cardiology professionals. For more than 40 years, SCAI has personified professional excellence and innovation globally, fostering a trusted community of more than 5000 members dedicated to medical advancement and

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    Buchbinder, Maurice Title: director
    Organization: foundation for cardiovascular medicine
    Date: 08/09/2023
    Comment:
    great idea regarding CAS for patients with severe >70 stenosis with or without surgical treatment accordingly !
    Pedersen, Christopher Title: Vascular surgeon
    Date: 08/09/2023
    Comment:

    As a vascular surgeon that recently completed a vascular surgery fellowship, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real time data,

    More

    Nguyen, Cuong Title: Interventional Neuroradiologist
    Organization: Novant
    Date: 08/09/2023
    Comment:
    I support coverage for percutaneous carotid angioplasty/stenting. This is a safe and effective alternative to CEA for patients who cannot safely undergo anesthesia.
    Alaswad, Khaldoon Title: MD
    Organization: Henry Ford Hospital
    Date: 08/09/2023
    Comment:

    I am writing in support of expanding coverage to Carotid Artery Stenting. Many patients go untreated because of the lack of Carotid Artery Stenting (CAS). The negative impact of the lack of coverage of CAS is mainly felt by minorities and people with low resources. Randomized clinical trials have demonstrated that CAS is equivalent to carotid artery endartectomy (CEA). CAS is safer for patient with advanced cardiovascular disease who cannot tolerate the surgical CEA.

    Thank you so

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    Brady, MD, FSIR, Paul Title: Chief of Neuro Interventional Radiology
    Organization: Einstein Heath Care Network Part of Jefferson Health
    Date: 08/09/2023
    Comment:

    I would like to thank CMS for its thoughtful review of the clinical literature and current evidence of Carotid artery stenting.

    As a dual fellowship trained physician in peripheral Endovascular and Endovascular Neurosurgery who has been treating cervical carotid disease for over 22 years. I respectfully support CMS in finalizing key components of the proposed decisions:

    I Support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and

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    Wildstein, Albert Title: MD
    Organization: metrovascularpc
    Date: 08/09/2023
    Comment:
    I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. It should be rescinded.
    Please reconsider how this decision which was apparently made without input from board certified vascular surgeons and their premier representative society will affect patient safety in an environment where flimflam procedures are common.
    Thanks
    Welch, Harold Title: Interim Chair, Division of Vascular Surgery
    Organization: Lahey Hospital and Medical Center, Burlington, MA
    Date: 08/09/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

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    Brown, Morry Title: Dr.
    Organization: Triad Radiology Associates
    Date: 08/09/2023
    Comment:
    I am in support of carotid artery stenting (CAS) for carotid artery stenosis. I believe there is sufficient data to support the approval of CAS. In addition, this will afford my patients another option for carotid artery stenosis.
    Martinez, Mesha Title: Assistant Professor
    Organization: Indiana University School of Medicine
    Date: 08/09/2023
    Comment:
    I strongly support access to carotid artery stenting (CAS) for patients who are symptomatic. In expert hands, patients will avoid stroke events. As a stroke and vascular expert, those who oppose this action do not understand the importance of preventing events when at all possible.
    If this was your mom, grandmother, father, grandfather, child, loved one or cherished friend, wouldn't you want the opportunity to prevent strokes in a minimally invasive way?
    Also I am opposed to the

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    Shapiro, Timothy Title: Director, Cardiac Catheterization Laboratory
    Organization: Main Line Health
    Date: 08/09/2023
    Comment:
    I support CMS coverage for carotid stenting. I believe that this therapy is effective and optimal for many patients with diseased carotid arteries. Please support services that help our patients.
    pucillo, anthony Title: md
    Organization: columbia university new york presbyerian hospit
    Date: 08/09/2023
    Comment:
    please proceed with approval for carotid artery stenting with distal protection for symptomatic and asymptomatic pts I have bee performing this procedure for over 25 yrs under all types clinical trials and registries and strongly feel we should expand to all patients who meet appropriate clinical criteria It is time thank you
    Ali, Aryan Title: Dr
    Organization: Hackensack University Medical Center
    Date: 08/09/2023
    Comment:
    CAS provides minimal and less serious wound related complications specially in patients with DAPT
    Kandzari, David Title: Chief, Piedmont Heart Institute
    Organization: Piedmont Heart Institute, Piedmont Healthcare
    Date: 08/09/2023
    Comment:
    The proposal to broaden reimbursement for transfemoral carotid stenting among Medicare patients at standard surgical risk addresses a long overdue unmet need. Following more than two decades of rigorous clinical trials, it is well time that clinicians are permitted to offer this therapy to indicated patients. Indeed, there are existing therapies with reimbursement with much less evidence than the evidence base supporting the procedural and late-term safety and effectiveness of this therapy. As

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    Memon, Muhammad Title: Assistant professor
    Organization: University of Texas medical branch
    Date: 08/09/2023
    Comment:

    For any who haven’t done it… here is a handy step by step

    1.I Support the CMS proposed decision, including expanded coverage for patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as the current clinical evidence supports.
    2.Support coverage without requiring patients to participate in clinical trials.
    3.Recommend that CMS not require providers to use a validated shared decision-making tool as a condition of

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    Matsumura, Jon Title: Professor Emeritus of Surgery
    Organization: University of Wisconsin School of Medicine and Public Health
    Date: 08/09/2023
    Comment:

    Thank you for the opportunity to comment on CMS’s Proposed Decision Memo relating to NCD 20.7:

    I am a vascular surgeon who has experience leading studies informing the treatment of carotid disease. Generally, I support the expansion of coverage for transfemoral carotid artery stenting in selected patients with asymptomatic severe carotid stenosis. There are excellent outcomes with long term follow up from randomized trials comparing transfemoral carotid artery stenting and carotid

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    Qahwash, Omar Title: Cerebrovascular/Endovascular Neurosurgeon
    Organization: Compass Health, Lansing Neurosurgery
    Date: 08/09/2023
    Comment:
    I am in support of CMS covering carotid angioplasty & stenting as a viable, safe, and effective treatment option for carotid stenosis.
    Ansel MD, FACC,FSCAI, Gary Title: Immediate Past System Medical Chief; Vascular
    Organization: OhioHealth
    Date: 08/09/2023
    Comment:

    My name is Dr. Gary Ansel MD, FACC, FSCAI

    I am the immediate past System Medical Chief, Vascular Services for OhioHealth which is a large and growing health system of14 hospitals and over 200 access points in 47 counties. The OhioHealth system has a long history of specialty collaboration in the treatment of patients with vascular disease in an integrated fashion utilizing the OhioHealth Vascular Institute (OHVI). The OHVI allows for collaboration and quality efforts for the

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    Rountree, Kaitlyn Title: Vascular Surgeon
    Organization: Henry Ford Vascular Surgery
    Date: 08/09/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Mohani, Amir Title: MD
    Organization: Baystate Medical Center
    Date: 08/09/2023
    Comment:
    CAS should be standard of care for standard surgical risk patient die to the equivalency of the procedure to surgical CEA.
    Papadakos, Stylianos Title: MD, Clinical Assistant Professor of Medicine
    Organization: NYU FGP
    Date: 08/09/2023
    Comment:
    It is time to correct one of the worst injustices to our medical system. Private insurance covering carotid stent procedure while Medicare provides a lot of hurdles. ACT I trial proved in Medicare patients, low risk asymptomatic there is no significant outcome difference between CEA and carotid stent. Even delayed, time to correct injustices to the Medicare patients and our seniors
    Duson, Sira Date: 08/09/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Mathew, Sunil Title: MD
    Organization: Norman Regional Hospital
    Date: 08/09/2023
    Comment:
    Interventional cardiologists should be able to utilize their expertise to intervene on hemodynamically significant carotid stenoses.
    Conway, R Gregory Title: Vascular Surgeon
    Date: 08/09/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Laufer MD, FACC, Nathan Title: Medical Director
    Organization: Heart & Vascular Center of Arizona
    Date: 08/09/2023
    Comment:

    Hello: I think the expanded indications for carotid stenting are excellent. I would not modify anything, I have been performing carotid stents for over 22 years within multiple research trials and find the results to be comparable to carotid endarterectomy. We have analyzed out data along with CEA data and find them equal with respect to all outcomes measured.

    CMS needs to separate financial gain and politics from the vascular surgeons, from what is most beneficial for

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    Salim, Muhammad Title: Cardiologist
    Organization: Norman regional
    Date: 08/09/2023
    Comment:
    Carotid stenting has a long proven record of safety and efficacy. It should be approved for all comers.
    Winston, Brion Title: Dr.
    Organization: Albany Medical Center
    Date: 08/09/2023
    Comment:
    We need expanded coverage for carotid artery stenting. Over the years my patients have benefited from carotid artery stenting. These are individuals who are at high risk for endarterectomy, or who simply expresses strong preference for stenting after we have a detailed discussion of risks, benefits, and alternatives. Invasive angiography must remain an acceptable diagnostic standard for determining anatomic suitability for carotid stenting.
    Zaitoun, Anwar Title: MD
    Organization: Covenant helathcare
    Date: 08/09/2023
    Comment:

    I would like to thank CMS for taking this step. I’m interventional cardiologist and I take care for carotid artery disease.

    I would like to truly thank CMS for its thoughtful review of the clinical literature and current evidence.

    I kindly request to expedite the key components of the proposed decision. I truly support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as

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    Janjua, Rashid Date: 08/09/2023
    Comment:
    Not supporting this is a futile effort. This is a highly effective treatment and if I had a stenosis, I’d prefer this.
    Shao, John Title: Director, Endovascular Medicine
    Organization: Newark Beth Israel Medical Center
    Date: 08/09/2023
    Comment:
    Carotid stenting is a legitimate option for patients. please approve the expanded indications.
    Trimm, James Title: mD
    Organization: Birmingham heart clinic
    Date: 08/09/2023
    Comment:
    I have been performing CAS since 2007 and have performed over 200 with 0.1% rate of neuro event , all have resolved . Shared decision making is a waste of time. The typical pcp especially if NP or PA knows very little regarding the high risk versus standard risk criteria or even the contraindications for CAS. Most surgeons do not believe in CAS so having them weigh in is counterproductive if including standard risk. CAS is being superseded by TCAR going forward and should be treatment of

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    Baweja, Gurpreet Title: Md
    Organization: Thpg
    Date: 08/09/2023
    Comment:
    I fully support expanding the CMS coverage for carotid stenting based on currently available randomized controlled trial data. It makes sense.
    Dua, Aashish Date: 08/09/2023
    Comment:
    Highly supportive of CAS expansion to standard risk patients and shared decision making with patients . Individual patients should have the option for surgical , interventional and medical treatment for carotid artery disease . Improvement in delivery systems and better peri procedural care during CAS has considerably improved outcomes and decreased the complication substantially.
    Romney, Wesley Title: Interventional Cardiologist
    Organization: Steward Melbourne
    Date: 08/09/2023
    Comment:
    I support the decision for Medicare and Medicaid to expand coverage of carotid artery stenting to include CAS for standard surgical risk patients given that these patients have a formal shared decision-making (SDM) interaction prior to CAS.
    Nourollahzadeh, Emad Title: Neuro-interventionalist
    Date: 08/09/2023
    Comment:

    Hello there,
    I'm a neurointerventionalist who performs CAS.
    First, I would like to thank CMS for its thoughtful review of the clinical literature and current evidence.

    I would like to voice my support for CMS to finalize the proposed decision, mainly on the following:

    * expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.
    *

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    Nair, Anil Organization: IGEA Brain and Spine
    Date: 08/09/2023
    Comment:

    As a neurosurgeon who performs both CEA and CAS, I see no reason why both options, particular now with TCAR and radial options, do not have the same indications. CAS is proven to be a safe and effective method of carotid revascularization. There is enough data to prove its effectiveness is similar to CEA. In fact, when there is restenosis of a previously treated CEA patient, most, if not all, of these patients are treated with CAS. In addition, a formal angiogram prior to revascularization

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    Patel, Parag Title: Professor of Radiology & Surgery
    Organization: Medical College of Wisconsin
    Date: 08/09/2023
    Comment:

    I am a Board Certified Interventional Radiologist as well as a Program Director of the IR Residency program at my institution. We have a multidisciplinary practice and training program. I perform CAs and train both IR and Vascular Surgery trainees in this procedure. I feel well equipped to comment the recent NCD.

    First I would like to thank CMS for their thoughtful review of the entirety of the clinical literature and current evidence.

    I support the proposal to expand

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    Werter, Christopher Title: MD, Vascular Surgeon
    Organization: P
    Date: 08/09/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. Multiple well performed randomized studies have demonstrated an increased risk of stroke when carotid artery stenting is performed from a transfemoral approach, as compared to a direct carotid approach with flow reversal or an open carotid endarterectomy.

    I respectfully request

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    Moussavian, Mehran Title: DO FACC
    Organization: Cardiovascular institute of San Diego
    Date: 08/09/2023
    Comment:
    We need to get coverage for carotid artery stenting. This is standard of care.
    Nguyen, Thanh Title: President-Elect
    Organization: Society of Vascular and Interventional Neurology
    Date: 08/09/2023
    Comment:

    I commend CMS for proposing an updated coverage policy for CAS based on the available evidence.

    I support the specific elements proposed in this decision, including:

    - Covering PTA of the carotid artery concurrent with stenting using an FDA-approved carotid stent and an FDA-approved or cleared embolic protection device for Medicare beneficiaries with symptomatic carotid artery stenosis =50% or with asymptomatic carotid artery stenosis =70%.
    - Covering CAS for

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    Edwards, Christopher Title: D.O.
    Organization: University of Rochester
    Date: 08/09/2023
    Comment:
    I support expanding coverage for TFCAS to match reimbursement for CEA and TCAR in select patients.
    Dattilo, Jeffery Title: Vascular Surgeon
    Date: 08/09/2023
    Comment:
    I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. I am concerned about interventionist prematurely placing stents in lesions in asymptomatic patients and the symptomatic patients not on maximal medical therapy. This proposal could open up the procedure to a number of practitioners who are not completely familiar with the carotid intervention data in its entirety

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    Thekkoott, Deepak Title: Medical Director
    Organization: Lane Regional Medical center
    Date: 08/09/2023
    Comment:
    Dears
    Current restrictions are prohibitive for patients especially in rural communities where I have successfully performed carotid artery stents for five years. No vascular surgery available in many communities.
    Please consider taking this into account on decision making.
    Spiotta, Alejandro Title: Professor Neurosurgery and Neuroendovascular Surge
    Date: 08/09/2023
    Comment:
    I deeply thank CMS for its comprehensive and thoughtful review of the literature and proposal to expand Medicare coverage. I support this evidence-based proposal: specifically expanding coverage for symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%. This expanded coverage will greatly help patients and reduce morbidity. We appreciate what you do.
    Trinidad, Magdiel Title: Vascular surgeon
    Date: 08/09/2023
    Comment:
    Removing all scrutiny and quality requirements would be a mistake. Simply take a look at the article in the New York Times about atherectomy. This would set up the arena for abuse of this type of treatment.
    Beach, Paul Title: MD
    Organization: Southeast Georgia Health System
    Date: 08/09/2023
    Comment:

    I find it horrifying that this is even being considered. Does CMS not even consider data anymore? I am a vascular surgeon with twenty years of experience and have been trained in all modalities, both endovascular and open. Transfemoral stenting has been proven to be inferior to CEA and TCAR. If this measure goes forward, the well controlled and monitored management of carotid disease will transition into the 'Wild West.' Many patients will be needlessly hurt.

    I beg you to

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    Phillips, John Title: System Director, OhioHealth Vascular Institute
    Date: 08/09/2023
    Comment:

    To Whom It May Concern:

    The physicians from the OhioHealth Vascular Institute comprise a multi-specialty group of thirty- five physicians consisting of vascular medicine doctors, vascular surgeons, interventional radiologists, and cardiologists.

    We, as a collective body, roundly support the proposed decision from CMS to expand coverage of carotid artery PTA and concurrent stenting with an FDA approved embolic protection device. We acknowledge that this decision stems

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    Botti Jr, Charles Title: System Chief for Vascular Disease (Ret 2023)
    Organization: OhioHealth (Ret 2023)
    Date: 08/09/2023
    Comment:

    I am an interventional cardiologist (semi-retired) and high volume peripheral vascular endovascular specialist who regularly evaluates patients with carotid disease and performed >500 carotid stent procedures (with < 1% adjudicated major or minor neurologic event rate), and was an enrolling investigator in >10 RCTs of TF carotid stenting, including both CREST and CREST2. I have stented many patients referred from vascular surgery, and also refer many patients for CEA. First of all, I would

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    Madsen, Kenneth Title: MD
    Organization: Society for Vascular Surgery
    Date: 08/09/2023
    Comment:
    I have performed carotid endarterectomy as well as TCAR and transfemoral carotid stenting. This disease should be respected for the nuances it presents. I have personally explanted stents in the carotid arteries due to acute, subacute and chronic failure issues. Some of these were due to poor patient selection while others were not. I appose green lighting transfemoral carotid stenting as proposed. I believe this will lead to worse patient outcomes and inappropriate care. Carotid procedures

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    Golla, Maheswara Satya Title: MD
    Organization: Camden Clark Medical center , WVU medicine
    Date: 08/09/2023
    Comment:
    I support CAS for asymptomatic >70% carotid disease and symptomatic >50% carotid disease.
    Berenji, Ashkan Title: Concerns regarding the expansion
    Date: 08/09/2023
    Comment:

    As an interventional radiologist, I am concerned with the coverage expansion outlined in CMS' Proposed Decision Memo relating to NCD 20.7. I ask that CMS consider the following recommendations before finalizing updates to NCD 20.

    I would appreciate you clarifying the intended shared decision-making (SDM) tool more. Specifically, any tool used is subject to unintended bias in its evidence synthesis, thus warranting review and validation by the multiple medical specialty societies

    More

    Mora, Ronald Title: MD
    Date: 08/09/2023
    Comment:

    As an interventional radiologist, I am concerned with the coverage expansion outlined in CMS' Proposed Decision Memo relating to NCD 20.7. I ask that CMS consider the following recommendations before finalizing updates to NCD 20.

    I would appreciate you clarifying the intended shared decision-making (SDM) tool more. Specifically, any tool used is subject to unintended bias in its evidence synthesis, thus warranting review and validation by the multiple medical specialty societies

    More

    Wong, Brian Date: 08/09/2023
    Comment:

    As an interventional radiologist, I am concerned with the coverage expansion outlined in CMS' Proposed Decision Memo relating to NCD 20.7. I ask that CMS consider the following recommendations before finalizing updates to NCD 20.

    I would appreciate you clarifying the intended shared decision-making (SDM) tool more. Specifically, any tool used is subject to unintended bias in its evidence synthesis, thus warranting review and validation by the multiple medical specialty societies

    More

    Caton, Michael Title: MD, Assistant Professor Neurosurgery
    Organization: Icahn School of Medicine at Mount Sinai
    Date: 08/09/2023
    Comment:

    I am an interventional neuroradiologist who routinely cares for patients with acute stroke and carotid artery disease on a daily basis.

    I work with a multidisciplinary group (neurosurgery, vascular neurology, neuroradiology) that performs the full array of open and endovascular cerebrovascular procedures, including CAS and CEA. Our group strongly and unanimously supports the new CMS recommendation on the basis of a comprehensive literature review and realistic assessment of

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    Gandhi, Ripal Title: Physician
    Organization: Baptist
    Date: 08/09/2023
    Comment:

    As an interventional radiologist and vascular medicine physician, I am concerned with the coverage expansion outlined in CMS' Proposed Decision Memo relating to NCD 20.7. I ask that CMS consider the following recommendations before finalizing updates to NCD 20.

    I would appreciate you clarifying the intended shared decision-making (SDM) tool more. Specifically, any tool used is subject to unintended bias in its evidence synthesis, thus warranting review and validation by the

    More

    Ibrahim, Osama Title: MD, FACC, FSCAI
    Date: 08/09/2023
    Comment:
    Completely support such changes to the current CAS PTA Requirements which has unfortunately substantially affected patient’s access to care.
    The requirement to be evaluated by Vascular surgery has hindered treatments and has resulted over the years in patients care being delayed with unnecessary patient associated morbidly.
    Psaty, Bruce Title: Professor of Medicine and Epidemiology
    Organization: University of Washington
    Date: 08/09/2023
    Comment:
    I urge the CMS to reconsider its proposed changes to the coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting. Removing the requirements for high surgical risk, allowing asymptomatic patients to receive the procedure outside of clinical trials, and removing all facility and operator requirements will expose beneficiaries to unnecessary risks.
    Petrella, Richard Title: MD
    Organization: East Georgia Regional Medical Center
    Date: 08/09/2023
    Comment:
    I have been performing TFCAS since 2002. I have been an investigator in multiple trials including CREST 2.
    My lifetime volume of TFCAS exceeds 1,100 cases with a in hospital MACE rate of 0.8%.
    It is unethical to restrict this 20 year old + procedure from our patients.
    matthews, thomas Title: MD - Vascular Surgeon
    Organization: Northside Vascular Surgery
    Date: 08/09/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Furey, Patricia Title: MD FACS MBA
    Organization: Catholic Medical Center
    Date: 08/09/2023
    Comment:

    Recent media articles (New York Times, ProPublica) have drawn attention to the actions of several endovascular interventionalists who have put profit over patient care with disastrous results. The current CMS initiative to expand the indications for carotid stenting via transfemoral approach will similarly put patients at risk. Open carotid surgery as well as trans carotid surgical stenting have proved highly successful in treating both asymptomatic and symptomatic patients. These

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    Hall, Heather Title: Vascular Surgeon
    Date: 08/09/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Rajagopal, Vivek Title: Dr
    Organization: Piedmont Heart Institute
    Date: 08/09/2023
    Comment:
    Dear CMS- as an interventional cardiologist who treats many patients suffering from diffuse vascular disease, severe carotid disease remains a significant cause of morbidity and mortality. Many of these patients are too sick, old, or frail to undergo CEA, and I believe it is critical for us to be able to offer carotid stenting in appropriate candidates.
    Lieb, Michael Title: Lead Physician Virtua Surgical Group Hainesport
    Organization: Virtua Health System
    Date: 08/09/2023
    Comment:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing

    More

    Abbott, Anne Title: A/Prof
    Organization: Global Expert Collaboration
    Date: 08/09/2023
    Comment:

    Regarding our earlier comments entitled:

    'Why the United States Centers for Medicare & Medicaid Services (CMS) Should Still Not Extend Reimbursement Indications for Carotid Artery Angioplasty/Stenting or Other Carotid Artery ‘Revascularisation’ Procedures'.

    We have 4 more experts in carotid arterial disease management and research from around the world who would like to be co-signatories with respect to the submission named above. They are:

    1. Kimberley Hammar (PhD

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    Azene, Ezana Title: MD, PhD
    Organization: Gundersen Health System
    Date: 08/09/2023
    Comment:

    As an interventional radiologist, I am concerned with the coverage expansion outlined in CMS' Proposed Decision Memo relating to NCD 20.7. I ask that CMS consider the following recommendations before finalizing updates to NCD 20.

    I would appreciate you clarifying the intended shared decision-making (SDM) tool more. Specifically, any tool used is subject to unintended bias in its evidence synthesis, thus warranting review and validation by the multiple medical specialty societies

    More

    Hook, Matthew Title: Physician/Interventional Cardiologist
    Organization: UNC-Johnston Health
    Date: 08/09/2023
    Comment:
    CMS should allow patients the choice of an endovascular approach with carotid artery stenting (with embolic protection). There is now two decades of documented clinical equivalency between these procedures. Both the safety and long-term beneficial outcome of both modalities has been documented in over 8000 randomized patients. It is a medical fact that carotid artery stenting performs as well as any available modality in both symptomatic and asymptomatic patients. It is relevant to the overall

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    Devireddy, Chandan Organization: Emory University
    Date: 08/09/2023
    Comment:
    I am writing in support of CMS’ proposal to update NCD 20.7 to broaden Medicare beneficiary access to carotid artery stenting (CAS) and to remove facility and operator requirements in regards to CAS. CMS has rightfully outlined that this proposal is based on a robust evidence base developed over the past two decades, including large level 1 prospective randomized controlled trials (CREST, ACT 1, ACST 2, and SPACE 2) demonstrating equivalence with surgical carotid endarterectomy (CEA). This

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    MacDonald, Joel Title: MD
    Organization: Centura Medical Group
    Date: 08/09/2023
    Comment:
    I am a neurosurgeon who refers patients for endovascular treatment of carotid artery stenosis. I am pleased to see that CMS has reviewed the pertinent literature and has decided to expand Medicare coverage. The literature has long established the benefits of treatment for patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%. Ideally, the final rules will permit coverage without requiring patients to participate in clinical trials

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    Heck, Don Title: MD
    Organization: Triad Radiology Associates
    Date: 08/09/2023
    Comment:

    I support the proposed NCD expanding coverage for carotid stenting. This important decision eliminates reimbursement as a factor in formulating treatment plans, and empowers physicians to offer the most appropriate method of carotid revascularization, if any, considering only the best interest and wishes of the patient.

    I support the development of a shared decision making tool, although as none exists, advise against requiring use of such a tool. The standard for almost all

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    Linfante, Italo Title: MD, FAHA
    Date: 08/09/2023
    Comment:

    I Strongly support the proposed changes in indication for ICA stenting !
    Long overdue!
    We owe it to our patients !
    Best regards

    Italo Linfante MD, FAHA
    Director
    Interventional Neuroradiology
    Clinical Professor
    Herbert Wertheim College of Medicine
    Florida International University
    Past President
    Society of Vascular and Interventional Neurology (SVIN)
    Miami Neuroscience Institute
    Baptist Hospital

    Goodney, Philip Title: MD, MS, Professor
    Organization: Dartmouth
    Date: 08/08/2023
    Comment:

    Dear Centers for Medicare and Medicaid Services Coverage Advisory Group,

    We appreciate consideration of expansion of reimbursement for endovascular carotid revascularization. However, for two reasons, we feel this is premature.

    1. First, the CREST-2 trial (NCT02089217) is still underway, and represents a major investment by NINDS. It would seem to be premature to expand the use of carotid artery stenting until this randomized trial has reported its

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    Yim, Benjamin Title: Neurosurgeon
    Organization: John Muir Health
    Date: 08/08/2023
    Comment:
    I support this change
    FARUQI, RISHAD Date: 08/08/2023
    Comment:

    I strongly object to this move to effectively declare "open season" on carotid stenting, for all comers with no oversight. This will result in enormous harm to the patients, who will be duped into believing that they are actually being helped by this procedure. There is overwhelming evidence that carotid stenting causes more strokes than carotid endarterectomy and that strokes in asymptomatic patients is exceedingly rare when treated with appropriate medical therapy. Consequently, by

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    Schiro, Brian Title: Vascular and Interventional Radiologist
    Organization: Miami Cardiac & Vascular Institute
    Date: 08/08/2023
    Comment:
    I support the NCD 20.7 proposed decision to remove restrictions on CAS. I would like to thank CMS for this thoughtful proposed decision. This decision will bring CAS into the armamentarium to treat patients with carotid disease, including optimal medical treatment, TCAR, and CEA. As an endovascular specialist caring for patients with carotid artery disease, I am against requirements of independent neurological assessment. It is well within my scope of practice to assess patients before and

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    Khatri, Jaikirshan Title: Director of Complex Coronary Intervention
    Organization: Cleveland Clinic
    Date: 08/08/2023
    Comment:

    I am a physician who performs transfemoral and transradial CAS. I also refer patients to my surgical colleagues for TCAR.

    I would like to thank CMS for its thoughtful review of the clinical literature and current evidence.

    In this regard, I would ask CMS to finalize key components of the proposed coverage decision:

    1. Support the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery

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    Ramchand, Preethi Title: Assistant Professor of Endovascular Neurosurgery
    Date: 08/08/2023
    Comment:
    I am a physician (Neurologist) who performs carotid artery stenting and would like to thank CMS for its thoughtful review of the clinical literature and current evidence. After review of the proposal, I am in favor of the following:
    1) expanded coverage for carotid artery stenting in patients with symptomatic carotid stenosis >/= 50% and those with asymptomatic carotid stenosis >/= 70%
    2) providing this support without requiring clinical trial participation
    3) removing facility

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    Marine, Joseph Title: Professor of Medicine
    Organization: Johns Hopkins University School of Medicine
    Date: 08/08/2023
    Comment:
    I am a practicing cardiologist with 22 years of experience writing on my own behalf and not any organization. I support this expansion of coverage for this service for properly qualified individuals using an appropriate shared decisionmaking process as outlined in the proposal. This is a mature technology which can benefit appropriate patients in the hand of properly trained clinicians.
    Chitturi, Kalyan Date: 08/08/2023
    Comment:
    Do not cut funding for this important and technically demanding procedure. Cutting funding is a disservice to the physicians who take on the risk to do this procedure and the patients that they serve.
    Anantha narayanan, Mahesh Title: Physician director cardiology, MD,FACC,FSCAI
    Organization: White River health i& University of Arkansas
    Date: 08/08/2023
    Comment:
    I perform a good number of carotid stent procedures and I think it’s very safe even in tight lessons to pass a filter to get good stent results. I have reviewed the data extensively and we have extensive evidence to support stents for carotid. Please get this procedure approved in asymptomatic patients as well, so they don’t have to go through an open incision procedure.
    Lichaa, Hady Title: MD
    Organization: Ascension Saint Thomas Heart
    Date: 08/08/2023
    Comment:
    Carotid stenting has been one of the most studied areas in vascular interventions and has a vast body of literature to support its safety and effectiveness, when done by well trained and experienced operators in appropriately selected patient populations. Our patients deserve a shared decision making discussion, with adequate equipoise, in order to make well informed medical decisions based on their personal goals and expectations.
    Aggarwal, Vikas Date: 08/08/2023
    Comment:
    I support reimbursement for carotid stenting and shared decision making for patients with carotid disease. As an interventional cardiologist, I believe evidence overwhelmingly supports carotid stenting and shared decision making.
    Bazan, MD DFSVS FACS, Hernan Title: John Ochsner Professor Surgery
    Organization: Ochsner Health
    Date: 08/08/2023
    Comment:

    Why the United States Centers for Medicare & Medicare Services (CMS) Should Still Not Extend Reimbursement Indications for Carotid Artery Angioplasty/Stenting or Other Carotid Artery ‘Revascularisation’ Procedures

    8th August 2023

    This analysis is based on a cut-down version of our updated evidence review and policy advice for US Medicare which was publicly posted in February 2023 (please see:

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    Self, Stephen Title: M.D.
    Organization: Norton Vascular Associates
    Date: 08/08/2023
    Comment:
    As a vascular surgeon who performs TFCAS, TCAR, and CEA I have great concern about the proposal to allow coverage for unrestricted TFCAS. I have personally experienced the steep learning curve involved and have seen the great potential for complications using this technique. I have abandoned TFCAR in my practice except in select circumstances after realizing the significant benefits of TCAR instead. Expanding coverage will lead to tremendous increase in the use of this technique by

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    Carstens, MD, MBA, FACC, Jeff Title: Service Line Medical Director, Cardiovascular
    Organization: UnityPoint Health
    Date: 08/08/2023
    Comment:

    UnityPoint Health appreciates this opportunity to provide comments on the Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting proposed decision memo (CAG-00085R8). UnityPoint Health is one of the nation’s most integrated health care systems. Through more than 32,000 employees and our relationships with more than 360 physician clinics, 36 hospitals in urban and rural communities and 14 home health agencies throughout our 8 regions, UnityPoint Health

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    Patterson, Robert Title: Clinical Professor of Surgery
    Organization: Alpert School of Medicine, Brown University
    Date: 08/08/2023
    Comment:

    As a vascular surgeon with 35 years of active practice in the management of carotid atherosclerosis in an attempt to reduce the risk of stroke, I have witnessed the significant evolution of management of this disease. Initially, somewhat misguided attempts at intervening with CEA, and now with percutaneous methods, on all asymptomatic patients with carotid atherosclerosis have been shown to be overly optimistic and in some cases harmful. Improvement in medical management of atherosclerosis

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    Sawchuk, Alan Title: MD
    Organization: Indiana University
    Date: 08/08/2023
    Comment:

    I do not think that CMS should widen the coverage for transferal carotid artery stenting. Transfemoral carotid stents have a higher incidence op peri procedural strokes than either transcervical carotid artery stenting or carotid endarterectomy. There is a strong belief among many vascular care givers that the number of carotid procedures in asymptomatic patients should be reduced, and that more of these patients should be medically managed. Many physicians are increasing the amount of

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    Abbott, Anne Title: A/Prof
    Date: 08/08/2023
    Comment:

    With respect to these proposals before US Medicare, it is hard to imagine how health policy in relation to carotid arterial disease could be designed to inflict more damage in terms of public health and the protection of precious healthcare resources. The science behind current best management of carotid arterial disease has been explained simply and comprehensively in our submissions below (by Abbott and Abbott with 76 others).

    As mentioned by us below, there are many supporters

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    Keyhani, Salomeh Title: Professor of Medicine
    Organization: UCSF
    Date: 08/08/2023
    Comment:

    I do not think CMS should consider coverage of carotid artery stenting (CAS) among patients with asymptomatic carotid artery stenosis. Stroke risk has declined among patients with asymptomatic carotid artery stenosis. There is a very real risk of 30-day stroke and death among older adults who undergo carotid procedures. Therefore, there may be no benefits from this surgery to patients but there may be real risks of harm. Coverage of CAS may increase risks to older patients, increase

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    Willey, Joshua Title: Associate Professor of Neurology
    Organization: Columbia University
    Date: 08/08/2023
    Comment:

    I find this proposal troubling. There is a well-known issue with stenting being done with the degree of stenosis not being greater than 70% when the patients are asymptomatic. Revascularizing asymptomatic carotid arteries remains controversial with stunting and the efficacy is currently being tested in the NIH funded CREST-2 study. The well-informed aspect of the proposal is also troublesome, and in my practice as a non-surgeon and as a vascular neurologist I have found that many patients

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    Kusyk, Dorian Date: 08/08/2023
    Comment:

    I am writing to express my support for the proposed decision regarding Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting. As a neurosurgery resident who treats patients for CAS, I would like to thank CMS for its thoughtful review of the literature and the expanded Medicare coverage proposal.

    I fully support the key components of the proposed decision, particularly the expanded coverage for patients with symptomatic carotid artery stenosis

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    Williams, Mary-Ann Date: 08/08/2023
    Comment:

    The US Medicare policy proposals are worrying [PHI Redacted]. The higher risk of stroke or death from CAS must be conveyed to patients. But how can I trust my doctor to tell me such things when there seems to be so much confusion and potential for conflict of interest among doctors? Surely all patients should receive current best practice non invasive care and we should work out if anyone now benefits from a carotid procedure as well.

    Mary-Ann Williams Consumer

    Khatri, Rakesh Date: 08/08/2023
    Comment:
    I enthusiastically support CMS’s proposal to expand coverage to patients at standard surgical risk, patients with symptomatic carotid artery stenosis =50%, and patients with asymptomatic carotid artery stenosis of =70%, without further evidence development.
    Wootton, Kim Date: 08/08/2023
    Comment:

    [PHI Redacted], I am concerned with the possible expansion outlined in CMS’ Proposed Direction Memo relating to NCD20.7. I am particularly concerned with comments relating to patients having the choice of treatment options. [PHI Redacted], I could not imagine having to discuss the options suggested here. It is overwhelming, especially when you are unwell, or your life is under immediate threat. I want my physician to choose the option that is best for me

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    Davis, Kathryn Title: MD
    Organization: Robley Rex VAMC Louisville, KY
    Date: 08/08/2023
    Comment:

    To Whom it May Concern:

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. Transfemoral carotid stenting is known to have a higher perioperative stroke risk than carotid endarterectomy or Trananscarotid artery revascularization (TCAR). Expanding coverage to allow insufficiently trained physicians to treat asymptomatic patients would inevitably lead to significant harm. Not only would individual

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    morrison, edward Title: md
    Date: 08/08/2023
    Comment:
    I do not believe this operation has an indication
    Mintz, Ari Title: DO
    Organization: Columbia University Medical Center
    Date: 08/08/2023
    Comment:

    To Whom It May Concern,

    Please accept this as endorsement of CMS’s proposal to update the patient selection criteria in the National Coverage Determination (NCD) to mirror results from this clinical research and to parallel existing access to carotid endarterectomy (CEA) by expanding coverage to include patients at standard surgical risk, patients with symptomatic carotid artery stenosis of at least 50%, and patients with asymptomatic carotid artery stenosis of at least 70%. SVM

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    Hasegawa, James Title: Sr. Director, Health Economics & Reimbursement
    Organization: Abbott
    Date: 08/08/2023
    Comment:

    Joseph Chin. MD, Acting Director
    Coverage and Analysis Group
    Centers for Medicare & Medicaid Services
    7500 Security Blvd.
    Baltimore, Maryland 21244

    Re: Proposed National Coverage Determination for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8)

    Dear Dr. Chin:

    We appreciate the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposed decision memo

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    Morrison, Justin Title: MD
    Organization: OhioHealth Riverside Methodist Hospital
    Date: 08/08/2023
    Comment:

    I am an interventional cardiologist who regularly evaluates patients with carotid vessel disease and performs carotid stent procedures (CAS). I would like to thank CMS for their thoughtful and thorough review of the extensive amount of rigorous data that exists on this topic.

    With this in mind, I strongly support the following proposed decisions:

    1. Proposal to expand coverage for CAS to patients with symptomatic carotid stenosis greater than or equal to 50% and

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    Martin, Kevin D Title: MD
    Organization: individual
    Date: 08/08/2023
    Comment:

    Thank you for allowing additional public comment on proposed changes to NCD 20.7 4. I am a retired vascular surgeon who has performed about a thousand CEAs, TF-CAS and some TCAR. I have been a long-time member of the Society for Vascular Surgery and was on the Medicare Carrier advisory committee for KY for 26 years. I am alarmed at the proposals to eliminate standards for facilities, expand carotid stenting to basically all patients with carotid disease, and mandating standardized "Shared

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    Handke, Bonnie Title: Vice President, Health Economics, Policy & Reimb.
    Organization: Medtronic LLC
    Date: 08/08/2023
    Comment:

    8200 Coral Sea St NE
    Mounds View, MN 55112
    Tel: 763-514-4111
    www.medtronic.com

    August 8, 2023

    SUBMITTED ELECTRONICALLY

    Sarah Fulton, MHS
    Joseph Hutter, MD
    Coverage & Analysis Group
    Centers for Medicare & Medicaid Services (CMS)
    7500 Security Blvd
    Baltimore MD 21244

    Re: National Coverage Analysis Proposed Decision Memo: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with

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    amuluru, krishna Title: MD
    Organization: Goodman Campbell Brain and Spine, Ascension St Vincent Medical Center
    Date: 08/08/2023
    Comment:

    I strongly urge CMS to finalize The Centers for Medicare & Medicaid Services’ (CMS) Proposed Decision Memo for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (“Proposed Decision Memo”).

    I enthusiastically support CMS’s proposal to expand coverage to patients at standard surgical risk, patients with symptomatic carotid artery stenosis =50%, and patients with asymptomatic carotid artery stenosis of =70%, without further evidence

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    Tapper, Scott Title: Vascular surgeon
    Organization: Symmetry Vascular Center
    Date: 08/08/2023
    Comment:

    Expansion of coverage for tf CAS = more Americans disabled by stroke.

    I recognize that there are well educated, skilled, and ethical physicians currently performing tf CAS with good outcomes. And the need for those skills is real. However, those good outcomes are occurring with appropriate guardrails in place. CMS must ensure that physicians have adequate training to understand the nuances of carotid artery disease. Expanding coverage of tf CAS (which has debatable indications)

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    Belkin, Michael Title: Vascular Surgeon
    Organization: BWH
    Date: 08/08/2023
    Comment:

    This proposed rule is bad for Medicare beneficiaries. Widespread use of transfemoral carotid stenting will lead to increased and unnecessary procedures. I strongly believe that it would lead to more neurovascular events and strokes than the natural history of carotid occlusive disease if these patients were treated with simple medical therapy.

    Michael Belkin, M.D.
    Chief of Vascular and Endovascular Surgery
    Brigham and Women's Hospital
    John Anthony Mannick Professor

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    Kayan, Yasha Title: MD
    Organization: Abbott Northwestern Hospital
    Date: 08/08/2023
    Comment:
    As a high volume neurointerventionalist who has been performing these procedure for over a decade, I strongly support expanded coverage for carotid stenting. Context matters, and those who perform these procedures in the setting of acute stroke will agree that carotid stenting is very routine, very safe, very effective, and often required in this setting, where it is "hidden" (from a coding perspective) as part of an acute stroke intervention. These same practitioners would also agree that our

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    Richardson, Albert Title: MD
    Organization: Southern Vascular Specialists
    Date: 08/08/2023
    Comment:
    As a private practice Vascular Surgeon for over 14 years, as a surgeon and CAS provider, I am extremely concerned regarding this proposed NCD. TF CAS is not akin to standard peripheral PTA and stenting. The studies clearly identify the risks, morbidity and mortality associated with TF CAS. The learning curve is very steep and the NCD to allow for any interventionalist to perform TF CAS without guardrails is extremely misguided. At the minimum, all TF CAS cases should be required to be entered

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    Hess, Connie Organization: University of Colorado
    Date: 08/08/2023
    Comment:

    I am an interventional cardiologist who sees patients with carotid artery stenosis in my clinic. I would like to thank CMS for a thoughtful review of the literature. I support finalization of key components of the proposed decision, specifically:

    1) Expanded coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.
    2) Coverage without requiring patients to

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    Luh, George Title: MD
    Organization: Dignity Health Neuro Inst Sacramento
    Date: 08/08/2023
    Comment:
    Carotid artery stenting CAS for average risk surgical patients should be covered by CMS. It is a viable alternative to carotid endarterectomy. Many patients prefer stenting over CEA. It has proven to be safe and effective for the treatment of carotid artery stenosis. There is no reason why it should not be covered. I have treated hundreds of patients with carotid artery stenting and it is definitely a worthwhile procedure. The patients are happy. And it is important for them to know that there

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    Khinikadze, Mirza Organization: EVEX
    Date: 08/08/2023
    Comment:
    I agree
    Chitale, Rohan Title: MD
    Organization: Vanderbilt University Medical Center
    Date: 08/08/2023
    Comment:

    I am a neurosurgeon with neurointerventional training who performs CEA and CAS.

    I support the following:

    - the proposal to expand coverage to patients with symptomatic carotid artery stenosis =50% and patients with asymptomatic carotid artery stenosis =70%, as supported by the current clinical evidence.
    - coverage without requiring patients to participate in clinical trials.
    - allowing Medicare Administrative Contractors (MACs) to determine whether to cover CAS

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    Johnston, Lily Date: 08/08/2023
    Comment:

    To whom it may concern,

    As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardizes patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.

    Recommendation 1. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the

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    Regenhardt, Robert Title: MD, PhD, Neurointerventionalist
    Organization: Society of Vascular and Interventional Neurology
    Date: 08/08/2023
    Comment:
    I enthusiastically support CMS’s proposed expansion of coverage. I believe this very important decision will improve the care of patient's with carotid stenosis.
    Pande, Ravi Title: MD
    Organization: HCA
    Date: 08/08/2023
    Comment:
    Percutaneous carotid angioplasty/stenting will benefit majority of my patients who are being subjected to TCAR and CEA due to regulatory and billing purposes. We have excellent data on trans femoral or trans radial carotid, stenting, being equally effective and less costly. Let’s make this rule, permanent and see in five years how much Medicare will save.
    Deiparine, Michael Title: Dr
    Organization: Midwest Aortic and Vascular Institute
    Date: 08/08/2023
    Comment:

    Dear Administrator Brooks-LaSure:

    I am a member of the Society for Vascular Surgery and also the program director for vascular surgery fellowship. I am writing to comment on the national coverage determination (NCD 20.7) for percutaneous transluminal angioplasty of the carotid artery concurrent with stenting (specifically TF-CAS).

    I and my vascular surgery group (MAVI) are opposed to expanding coverage for percutaneous transluminal angioplasty of the carotid artery with

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    Chandra, Ravi Title: Vascular surgeon
    Organization: Surgical specialists of ocala
    Date: 08/08/2023
    Comment:
    CAS is a high risk procedure that so far has been safeguarded against any misuse as was renal artery stenting, vascular surgeons have provided exemplary service in keeping the stroke rate to 2to 3% for all comers with carotid stenosis.
    This safety net will be lost and rise in complication rates may result by this proposed ruling.
    Sheth, Sunil Date: 08/08/2023
    Comment:
    The data on this topic are very clear. Carotid stenting is equivalent to CEA in asymptomatic and symptomatic carotid stenosis. Any misinformation implying otherwise is just that, and motivated by attempts from surgeons to misdirect care towards their control. CMS should not side with this misaligned view that is attempting to keep a safe and less invasive procedure from benefiting patients.
    Cronenwett, Jack Title: Medical Director, Emeritus
    Organization: Society for Vascular Surgery Patient Safety Organization
    Date: 08/08/2023
    Comment: