National Coverage Analysis (NCA) View Public Comments

Transcatheter Mitral Valve Repair (TMVR)

Public Comments

Commenter Comment Information
Halim, Sharif Title: MD
Organization: Presbyterian Heart Group
Date: 07/30/2020
Comment:

Thank you for providing an update to the NCD for TMVR to include FMR.

FMR is common and carries significant risk of M&M to many patients. The results of COAPT prove proof of concept and provide a construct for which patients benefit from TMVR for FMR. Definitely need to provide this treatment as an option to our patients.

A few concerns I have are related to the need for CT surgery in person evaluation. These patients are complex and while a Heart Team discussion is

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Bapat, Vinnie Title: Chief of Cardiothoracic Surgery
Organization: Abbott Northwestern Hospital, Minneapolis
Date: 07/30/2020
Comment:

Surgical opinion is must as we already know from other trials that patients offered Mitraclip will be totally different than those included in the trial.
Trial took 6 years to complete enrolling patients at the lowest cadence ever but since then the use has tripled. This only indicates more liberal use and in the interest of patients it is must to have necessary checkpoints to prevent mis or over use

Burjonroppa, Sukesh Title: Interventional Cardiologist
Organization: Fort Worth Heart
Date: 07/30/2020
Comment:

1. The proposed requirement for new programs to have 40 mitral valve repair/surgery numbers is draconian and will deprive the community of much needed lifesaving therapy for patients who are vulnerable. This volume requirement measure will prevent access to care to large group of patients who are best taken care of in the local community. This is especially true when the program in question is an established structural heart program with a heart team which is doing high volume of structural

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park, James Title: Director of Heart and Vascular Program
Organization: Texas Health Presbyterian Dallas
Date: 07/30/2020
Comment:
As director of the heart and vascular program, I am concerned about the limitation of the coverage for trans catheter mitral valve repair for the patients who will most benefit from the therapy given the results of the trial looking at the patients with functional mitral regurgitation. The restriction of patients with concomitant other types of valvular disease would be too restricting for patients who are complex and need the most help in therapeutic options such at TMVR. Historically the

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Abbas, Samer Title: Director of Structural and Valve center
Organization: Community Health care System
Date: 07/30/2020
Comment:

Although we are in total support for the NCD proposal regarding reimbursement for FMR, I still have few questions and some reservations that I want to point out.

1. Mitral clip for FMR is part of Heart failure treatment. I am not sure the surgical volume of MR has anything to do with outcome of Mitral clip
2. Changing the requirement of MVR for 20 per year will take away patient access in many areas where patients can't travel far.
3. Many surgeons are trained in very busy

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Chauhan, Chirag Title: Structural/Interventional Cardiologist
Organization: Denver Heart
Date: 07/30/2020
Comment:

Thank you for the opportunity for me to provide my comments to the proposed NCD on TEER in functional MR (FMR). Given the data that has been evident from the COAPT clinical trial, this procedure is very powerful and will help patients who otherwise have minimal to no other options.

Data supports that these patients have improved outcomes if they are placed on optimal guideline-directed medical therapy and thus, the requirement should continue that these patients should be on

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Vavalle, John Title: MD, Int Card
Organization: Univ of NC
Date: 07/30/2020
Comment:
Outcomes associated with transcatheter mitral valve repair have never been shown to be linked to institutional volumes of surgical mitral valve replacement or repair. The requirements of surgical mitral valve surgery volumes to initiate or maintain a TEER program should be removed.
Thaden, Jeremy Date: 07/30/2020
Comment:
  • I wanted to thank CMS for recognizing that Interventional echocardiography is a needed and rapidly evolving medical specialty area.
  • I support the recognition by CMS in this NCD guidance that specialized expertise and training in interventional echocardiography is necessary for mitral valve edge to edge repairs. As these mitral procedures are currently performed with TEE echocardiography, anesthesiologists and cardiologists who are appropriately trained in TEE can guide this

    More

  • Quader, Nishath Title: MD
    Organization: American Society of Echocardiography
    Date: 07/30/2020
    Comment:
    I support the inclusion and identification of the essential role of the echocardiographer in this procedure as a key member of the heart team.
    Guirgues, Lindsey Parrish Title: Senior Heart Team Program Coordinator
    Organization: Bon Secours Mercy Health
    Date: 07/30/2020
    Comment:

    I agree with the new program/facility volume requirements. Mitraclip should not be offered/attempted my procedural teams/facilities that are unfamiliar with the nuances and complexities of mitral valve disorder management.

    I do not agree with the proposed exclusion criteria of other valve disorders as many pts with mitral valve disease often have dysfunction of other valves. This criteria would eliminate the potential of a staged approach to their structural heart disorders and even

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    Garnett, James Title: Interventional cardiologist
    Date: 07/30/2020
    Comment:

    It is absolutely critical for CMS to approve use of the MitraClip for use in patients with functional mitral regurgitation. The COAPT data is very compelling and these patients often remain symptomatic despite optical medical therapy and their treatment options are limited. The fact that there was a mortality benefit strongly supports coverage in these patients.

    Katinic, Jasmina Title: Structural Heart Director
    Date: 07/30/2020
    Comment:

    Dear MEDCAC Members,

    Please take into consideration below proposed changes to current volume requirements in the Proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R).

    Below listed changes would reflect the heart team concept and integration of comprehensive structural heart center’s experience with transcatheter based technologies.

    1. Qualifications to begin a mitral valve TEER program for hospitals without mitral valve TEER

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    Chung, Matthew Title: Structural Interventional Cardiologist
    Organization: Virginia Cardiovascular Specialists
    Date: 07/30/2020
    Comment:
    1. Excluding coverage of TEER for patients with coexisting aortic or tricuspid valve disease would prevent a large proportion of patients from receiving TEER — many patients with mitral regurgitation also have tricuspid regurgitation which can also be addressed with TEER or in a staged approach with catheter based devices designed for the tricuspid valve. There are ample publications that show success of TEER in patients with coexisting mitral regurgitation and tricuspid

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    Cornella, Lauren Title: MD
    Organization: Brigham and Women's Hospital
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

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    Chaudhary, Ashok Title: Structural Heart Cardiologist
    Organization: Rutgers Robert Wood Johnson Medical School, NJ
    Date: 07/30/2020
    Comment:

    I strongly support the decision to approve coverage for Transcatheter edge to edge repair (TEER) for functional MR (FMR) patients. Based on the results of the COAPT study, TEER should be the gold standard of treatment for FMR patients. As a structural heart cardiologist, actively involved in the care of this very common and serious valve disorder, I submit following comments to be considered for incorporation into the final decision.

    1. Surgery for FMR has not shown to have any

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    Astbury, Jeffrey Title: Physician
    Organization: Butler Health System
    Date: 07/30/2020
    Comment:

    Dear Central Medical Services (CMS) Staff,
    Thank you for recognizing that Interventional echocardiography is a needed and rapidly evolving medical specialty area.

    I support the recognition by CMS in this NCD guidance that specialized expertise and training in interventional echocardiography is necessary for mitral valve edge to edge repairs. As these mitral procedures are currently performed with TEE echocardiography, cardiac anesthesiologists and cardiologists who are

    More

    Fox, Amanda Title: Division Chief of Cardiothoracic Anesthesiology
    Organization: University of Texas Southwestern Medical Center
    Date: 07/30/2020
    Comment:

    Cardiothoracic anesthesiologists are extremely well trained to provide echo guidance for these procedures. We know a tremendous amount about mitral valve disease and are proficient with intraprocedural TEE and are immediately present for intraprocedural echo.

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral

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    Hickerson, Leigh Title: MD
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Guenther, Lauren Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Malik, Adnan Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Linganna, Regina Title: Cardiac anesthesiologist
    Organization: Thomas Jefferson University
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Nascimben, Luigino Title: MD, Ph.D
    Organization: Brigham And Womans Hospital
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Patel, Kinjal Organization: Cooper University Healthcare
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Calvert, Barbara Title: Director, Medical Products Reimbursement
    Organization: Abbott
    Date: 07/30/2020
    Comment:
    Please see comment letter submitted to CAGinquiries@cms.hhs.gov
    Razo Vazquez, Andres Oswaldo Title: MD
    Organization: Yale University
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Grocott, Hilary Title: adjunct professor of anesthesiology
    Organization: Uke University Medical Center
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Nyhan, Daniel Title: Professor of Cardiac Anesthesiology
    Organization: Johns Hopkins
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Shah, Tina Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Narula, Arvin Organization: San Diego Cardiac Center
    Date: 07/30/2020
    Comment:

    1. Face to Face: I would propose telehealth should be allowed for an evaluation by a second physician. Patient's should not have to travel hours to see two independent physicians as this can delay the appropriate therapy.
    2. TR in conjunction with FMR: The number one cause of TR in severe MR is the severe MR. TR can get better with therapy.
    3. Surgical Volume >40/year: Very few new programs will be able to reach these numbers to establish a program and can restrict access

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    Zovighian, Bernard Title: CVP, Transcatheter Mitral and Tricuspid Therapies
    Organization: Edwards Lifesciences
    Date: 07/30/2020
    Comment:

    July 30, 2020

    Tamara Syrek Jensen, J.D.
    Director, Coverage and Analysis Group
    Centers for Medicare & Medicaid Services
    7500 Security Boulevard
    Baltimore, MD 21244

    RE: National Coverage Analysis (NCA) for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R)

    Dear Ms. Syrek Jensen,

    Edwards Lifesciences (“Edwards”) thanks CMS for the opportunity to comment on the National Coverage Analysis (NCA) for Transcatheter Mitral Valve Repair

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    Hamilton Lopez, Marianne Title: Research Director
    Organization: Duke-Margolis Center for Health Policy
    Date: 07/30/2020
    Comment:

    Dear Director Syrek-Jensen,

    The Robert J. Margolis, MD Center for Health Policy at Duke University (Duke-Margolis) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) proposed national coverage determination (“Proposed NCD”) captioned above.

    The Duke-Margolis Center generates and analyzes across the spectrum of health policy and supports the triple aim of better care, better health, and lower cost. A core mission of the Center

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    Kahn, Ronald Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Ludmil, Mitrev Title: MD
    Organization: Cooper University Healthcare
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Makar, Moody Title: Interventional Echocardiographer
    Date: 07/30/2020
    Comment:

    1- Expanded coverage to FMR patients due to the COAPT results. While this is included in the draft decision, it is important that we reiterate the support to include coverage for this patient group. These patients had NO hope or treatment before, and it is important to emphasize that THERE is TREATMENT for these patients.

    2- Face to face evaluation of patients by a surgeon and interventional cardiologist: while this is acceptable for DMR, it is completely unacceptable for FMR. It

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    Sheu, Richard Title: MD, FASE
    Organization: University of Washington
    Date: 07/30/2020
    Comment:

    I would like to thank CMS for recognizing that Interventional echocardiography is a needed and rapidly evolving medical specialty area.

    I support the recognition by CMS in this NCD guidance that specialized expertise and training in interventional echocardiography is necessary for mitral valve edge to edge repairs. As these mitral procedures are currently performed with TEE echocardiography, cardiac anesthesiologists and cardiologists who are appropriately trained in TEE can and

    More

    Fischer, Matthew Title: Assistant Professor in Residence of Anesthesiology
    Organization: UCLA
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Kalarickal, Philip Title: Assistant Professor of Anesthesiology
    Organization: Emory University School of Medicine
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Makar, Moody Title: Interventional Echocardiographer
    Organization: Cedars Sinai Medical Center
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. I have been the main inerventional echocardigrapher, and our site has been the highest enroller in COAPT, with its excellent results. This NCD is not fair for all non TTE certified echocardiographers that has contributed to making the device available today for treating the patients. Anesthesiologists with the appropriate training and experience are qualified providers and

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    Kanmanthareddy, Arun Title: Assistant Professor of Medicine
    Organization: Creighton University School Of Medicine/ CHI Health Heart Institute
    Date: 07/30/2020
    Comment:

    The proposed coverage decision sets a very high bar for initiating and maintaining TEER/TMVRprograms. Although the idea of high volume centers to maintain good outcomes is reasonable but very impractical and Unreasonable.

    1. In the Midwestern states comprising largely rural population, people would have to travel extremely long distances to avail these therapies and most likely these patients with severe underlying comorbidities would decline this treatment option and would

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    Farmer, Blaine Title: MD
    Organization: Emory University School of Medicine
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Zhu, Qingbing Title: Assistant Professor of Clinical Anesthesia
    Organization: Yale University School of Medicine
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Lebow, Brandon Title: MD
    Organization: University of Rochester
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Rubenson, David Title: MD
    Organization: SCripps Health
    Date: 07/30/2020
    Comment:
    I wish to express my appreciation and support for your inclusion of interventional echocardiographers as essential members of the care team engaged in TEER/TMVR. As a participant in these procedures in recent years, I can attest to the essential role that echo guidance provides during the procedure itself.
    Schwartz, Jonathan Title: MD, FACC, FSCAI
    Organization: Sanger Heart & Vascular Institute
    Date: 07/30/2020
    Comment:

    I am a structural interventional cardiologist at a major tertiary and academic medical center, and have been involved in TMVR as an operator and investigator since 2013. I have participated in multiple clinical trials including COAPT.

    I fully support expanding coverage of TEER to patients with functional MR. Recent data supports its use in patients that have been managed on GDMT and continue to have symptoms. Surgical intervention has not been shown to have such benefits in this

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    Vullo, John Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Sarraf, Mohammad Title: Director of Structural Heart Program
    Organization: Princeton Hospital
    Date: 07/30/2020
    Comment:

    Thank you very much for allowing us to participate in this decision making. This is an excellent document as far as how the community of structural heart disease experts should manage their patients. However, there are a number of points that are worth further discussion.

    1. For FMR patients, the role of the surgeon in decision making for TEER is not quite clear. To this date, there is no convincing evidence, even in the most biased surgical literature review that surgery either

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    Naik, Hursh Title: Chief of Cardiology
    Organization: Dignity St. Joseph's Hospital and Medical Center
    Date: 07/30/2020
    Comment:

    I strongly support the expansion of coverage to patients with functional MR. COAPT demonstrated significant improvements in mortality, HF hospitalization, and QOL over optimized medical therapy alone. In my personal experience with TEER, these patients benefit remarkably from MitraClip therapy and the expansion of coverage will aid in patient access to a life saving therapy.

    While I support the role of the surgeon as a valuable member of the heart team, the requirement for a

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    Wang, Emily Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Stewart, Maria Title: VP, Global Health Economics and Market Access
    Organization: Boston Scientific
    Date: 07/30/2020
    Comment:

    July 30, 2020

    RE: National Coverage Analysis (NCA) Tracking Sheet for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R)

    Dear Ms. Syrek Jensen,

    Thank you for the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed National Coverage Determination (NCD) for mitral valve (MV) Transcatheter Edge-to-Edge Repair (TEER). 1 At Boston Scientific, we are dedicated to transforming lives through innovative medical

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    Mack, Michael Organization: Heart Valve Collaboratory
    Date: 07/30/2020
    Comment:

    July 30, 2020

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

    RE: Proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R)

    The Heart Valve Collaboratory (HVC) is a physician initiated, patient-centric consortium of multidisciplinary stakeholders established to identify and address knowledge gaps and foster initiatives in the

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    Basra, Sukhdeep Title: Interventional Cardiologist
    Date: 07/30/2020
    Comment:

    As an interventional and structural heart specialist practicing in a division of advanced heart failure, I see a large number of patients with severe functional mitral regurgitation. Given the extremely positive results noted in the COAPT study in the appropriately selected patients with functional mitral regurgitation after being treated with GDMT, revascularization as well as CRTD, I would recommend CMS approval for TMVRepair in these patients given the mortlity benefit, improvement in

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    Apostolakis, John Title: MD
    Organization: Cleveland Clinic
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Kinney, Daniel Title: MD
    Organization: Yale Department of Anesthesiology
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    stone, marc Title: MD; Professor of Anesthesiology
    Organization: Icahn School of Medicine at Mount Sinai
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer:

    Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Béïque, François Title: MD
    Organization: NBE
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    xu, zijian Title: md
    Organization: sutter medical center sacramento
    Date: 07/30/2020
    Comment:

    I support the CMS decision to expand coverage for TMVR. Our center has had a lot of experience with TMVR over the past several years, including patients with both functional and degenerative MR. It can be very effective in the correctly selected patients. I do have some concerns over the following issues.

    1) requirement of face-to-face evaluation by a cardiac surgeon is not consistent with the 2020 Focused Update of the 2017 ACC Expert Consensus Decision Pathway on the Management

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    Jelacic, Srdjan Title: Assistant Professor
    Organization: University of Washington
    Date: 07/30/2020
    Comment:

    Please consider using working such as this to support anesthesiologists in this role…:

    I would like to thank CMS for recognizing that Interventional echocardiography is a needed and rapidly evolving medical specialty area.
    I support the recognition by CMS in this NCD guidance that specialized expertise and training in interventional echocardiography is necessary for mitral valve edge to edge repairs. As these mitral procedures are currently performed with TEE

    More

    drilea, crystal Title: rn
    Organization: hca
    Date: 07/30/2020
    Comment:

    Thank you for allowing coverage for Secondary MR patients.

    We have concerns about the following:

    *NEW RESTRICTIONS FOR COEXISTING CONDITIONS
    (many of our patients have multiple comorbidities and they can still benefit from TEER. Many of our patients have severe TR, which could be resolved with TEER)

    *SURGEON AND IC REQUIRED FACE-TO-FACE EVALUATION FOR FUNCTIONAL MR
    (This should be removed, surgeons do not manage heart failure in the outpatient

    More

    Speil, Steven Title: EVP, Policy
    Organization: FAH
    Date: 07/30/2020
    Comment:

    Charles N. Kahn III
    President and CEO

    July 30, 2020

    VIA ELECTRONIC MAIL AND ELECTRONIC FILING

    Tamara Syrek Jensen, JD
    Director
    Coverage and Analysis Group
    Center for Clinical Standards and Quality
    Centers for Medicare & Medicaid Services
    7500 Security Boulevard S3-02-01
    Baltimore, MD 21244

    Re: Proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R)

    Dear Ms. Syrek

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    Banet, Melanie Title: RN
    Date: 07/30/2020
    Comment:

    Thank you for allowing coverage for Secondary MR patients.

    We have concerns about the following:

    *NEW RESTRICTIONS FOR COEXISTING CONDITIONS
    (many of our patients have multiple comorbidities and they can still benefit from TEER. Many of our patients have severe TR, which could be resolved with TEER)

    *SURGEON AND IC REQUIRED FACE-TO-FACE EVALUATION FOR FUNCTIONAL MR
    (This should be removed, surgeons do not manage heart failure in the outpatient

    More

    Lai, Cheuk Yin Title: Assistant Professor, Department of Anesthesiology
    Organization: Mount Sinai Hospital
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer.

    Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Suffredini, Giancarlo Title: Assistant Professor
    Organization: Johns Hopkins University School of Medicine
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Watt, Clifton Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Krei, Edward Organization: 1984
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    joffe, denise Title: Attending anesthesiologist
    Organization: University of Washington
    Date: 07/30/2020
    Comment:

    I would like to thank CMS for recognizing that Interventional echocardiography is a needed and rapidly evolving medical specialty area.
    I support the recognition by CMS in this NCD guidance that specialized expertise and training in interventional echocardiography is necessary for mitral valve edge to edge repairs. As these mitral procedures are currently performed with TEE echocardiography, cardiac anesthesiologists and cardiologists who are appropriately trained in TEE can and

    More

    Patel, Bhoumesh Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Hahn, Rebecca Title: Director of Interventional Echocardiography
    Organization: Columbia Unversity College of Physicians and Surgeons
    Date: 07/30/2020
    Comment:

    I wanted to thank CMS for:

    1) recognizing that the Interventional Echocardiographer is an essential part of the Heart Team,
    2) understanding that Interventional Echocardiograpers may be anesthesiologists and cardiologists and
    3) clearly stating that Interventional Echocardiographers require specialized training to acquire the expertise necessary for mitral valve edge to edge repairs.

    Stock, Eveline Title: MD
    Organization: Unviersity of California San Francisco
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Branham, Chandra Title: VP, Payment & Health Care Delivery Policy
    Organization: AdvaMed
    Date: 07/30/2020
    Comment:

    July 30, 2020

    Tamara Syrek Jensen, JD
    Director, Coverage & Analysis Group
    Center for Clinical Standards and Quality
    Centers for Medicare & Medicaid Services
    Mailstop S3-02-01
    7500 Security Blvd
    Baltimore MD 21244

    RE: Proposed National Coverage Analysis for Transcatheter Mitral Valve Repair (TMVR) Reopening (CAG-00438R)

    Dear Ms. Syrek Jensen:

    The Advanced Medical Technology Association (AdvaMed) is

    More

    Lewis, John Title: Executive Director
    Organization: Heart Valve Voice US
    Date: 07/30/2020
    Comment:

    July 30, 2020

    Ms. Seema Verma
    Administrator
    Centers for Medicare & Medicaid Services
    CC: Lead Analyst — Sarah Fulton, MHS
    sarah.fulton@cms.hhs.gov
    7500 Security Boulevard
    Baltimore, MD 21244

    Dear Administrator Verma,

    Heart Valve Voice US is a nonprofit patient advocacy organization that provides a united voice for people living with heart valve disease. We advocate for early detection, meaningful support, and

    More

    Arrigo, Robert Title: Cardiac Anesthesiologist
    Organization: Stanford University
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Fried, Eric Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Maynes, Vivian Title: APRN FNP
    Organization: HCA
    Date: 07/30/2020
    Comment:

    Thank you for allowing coverage for Secondary MR patients.

    We have concerns about the following:

    *NEW RESTRICTIONS FOR COEXISTING CONDITIONS

    (many of our patients have multiple comorbidities and they can still benefit from TEER. Many of our patients have severe TR, which could be resolved with TEER)

    *SURGEON AND IC REQUIRED FACE-TO-FACE EVALUATION FOR FUNCTIONAL MR

    (This should be removed, surgeons do not manage heart failure in the

    More

    Jung, Youn-Hoa Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    McHenry, Marie Title: Cardiac Anesthesiologist
    Organization: Stanford Hospital and Clinics
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Poppas, Athena Title: President
    Organization: American College of Cardiology
    Date: 07/30/2020
    Comment:

    July 30, 2020

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

    RE: Proposed Decision Memorandum for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R)

    Dear Ms. Syrek-Jensen:

    The Society of Thoracic Surgeons (STS), the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), and the Society for

    More

    Scamperle, Keely Title: Global Healthcare Policy and Advocacy Leader
    Organization: WL GORE and Associates
    Date: 07/30/2020
    Comment:

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

    RE: COMMENTS – Proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR) for Mitral Valve Regurgitation (CAG-00438R)

    Dear Ms. Syrek Jensen,

    W.L. Gore & Associates (GORE) is pleased to submit comments on the Centers for Medicare & Medicaid

    More

    Tsai, Albert Title: Clinical Assistant Professor
    Organization: Stanford Health Care
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Leepuengtham, Tosanath Title: MD
    Organization: Yale New Have
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    McStay, Frank Title: Senior Policy Advisor
    Organization: Baylor Scott & White Health
    Date: 07/30/2020
    Comment:

    Dear Ms. Syrek-Jensen,

    On behalf of Baylor Scott & White Health (BSWH), I appreciate this opportunity to provide feedback to the Centers for Medicare and Medicaid Services (CMS or the Agency) on its decision memo and national coverage determination (NCD) Transcatheter Mitral Valve Repair (TMVR); for clarity, we will use the term mitral valve Transcatheter Edge-to-Edge Repair (TEER) given CMS’ adoption to avoid confusion. As CMS notes in the document, 5.7 million people have

    More

    Ural, Nil Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Richter, Ellen Title: MD
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Vadlamudi, Ratna Title: MD, FASE, Associate Professor of Anesthesiology
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Weiner, Menachem Organization: Icahn School of Medicine at Mount Sinai
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Shanewise, Jack Title: MD
    Organization: Columbia University
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Rhee, Amanda Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Jolly, Neeraj Date: 07/30/2020
    Comment:
    There is no need for a cardiac surgeon to have a face to face meeting with a patient who is being considered for TEER for Functional MR. An IC and a HF physician is a more suitable combination.
    Sheinberg, Rosanne Organization: Johns Hopkins Hospital
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Levin, Matthew Title: Dr.
    Organization: Icahn School of Medicine at Mount Sinai
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Baron, Elvera Date: 07/30/2020
    Comment:

    Copy and paste into the Comments section:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are

    More

    Bush, Brian Title: Dr.
    Organization: Johns Hopkins University School of Medicine
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Glas, Kathryn Title: MD, Professor, Anesthesiology
    Organization: Emory University
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Trinh, Muoi Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    hakeem, abdul Date: 07/30/2020
    Comment:

    TMVR has revolutionized the care and consequently outcomes of patients with severe mitral regurgitation (both primary and secondary).

    The restrictions for coexisting medical conditions is very problematic as a lot of patient with FMR have co existing tricuspid regurgitation ( which is part and parcel of the disease process). Such restriction would exclude a large proportion of FMR patients who are proven to have robust clinical benefit including survival benefit. This should be

    More

    Alkhouli, Mohamad Adnan Organization: Mayo Clinic
    Date: 07/30/2020
    Comment:

    I would like to thank the CMS for putting together this detailed decision memo. Transcatheter mitral valve repair will offer substantial benefit to many heart failure patients with severe mitral regurgtiation who remain symptomatic despite maximal medical therapy. I have 2 main concerns about the proposed coverage decision:

    1. A large proportion of patients with severe MR also have severe TR, and might benefit from concomitant transcatheter repair. Although there is a dedicate

    More

    Linsky, MPA, MA, Norm Title: Private citizen, heart patient advocate
    Organization: Private citizen
    Date: 07/30/2020
    Comment:

    July 30, 2020

    Ms. Seema Verma
    Administrator
    Centers for Medicare & Medicaid Services
    CC: Lead Analyst — Sarah Fulton, MHS
    sarah.fulton@cms.hhs.gov
    7500 Security Boulevard
    Baltimore, MD 21244

    Dear Administrator Verma,

    Thank you for the opportunity to provide input on the proposed NCD for mitral valve Transcatheter Edge-to-Edge Repair (TEER). I am writing as a private citizen who has led, worked for, or

    More

    Carver, Ashley Title: Valve Clinic APRN
    Organization: HCA
    Date: 07/30/2020
    Comment:

    Thank you for allowing coverage for SMR patients. I have concerns about the following:

    - NEW RESTRICTIONS FOR COEXISTING CONDITIONS (many of our patients have multiple comorbidities and they can still benefit from TEER. Many of our patients have severe TR, which could be resolved with TEER)

    - SURGEON AND IC REQUIRED FACE-TO-FACE EVALUATION FOR FUNCTIONAL MR (This should be removed, surgeons do not manage heart failure in the outpatient setting. SMR patients don't do well

    More

    Cho, Brian Title: Doctor
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Van Assche, Lowie Title: MD
    Organization: My Cardiologist
    Date: 07/30/2020
    Comment:

    The new CMS coverage decision will greatly benefit our patients with moderate to severe or severe functional mitral regurgitation however there are a few points in the decision that could be altered to better reflect actual clinical practice. There is no proven effective surgical treatment for functional mitral regurgitation. Therefore, it is unclear why a surgeon needs to evaluate a patient for surgical appropriateness. The decision should be multidisciplinary however the team should

    More

    Brown, Charles Organization: Johns Hopkins University School of Medicine
    Date: 07/30/2020
    Comment:

    Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is far superior to transthoracic echocardiography in guiding this intervention,

    More

    Reich, David Title: President and Chief Operating Officer
    Organization: The Mount Sinai Hospital
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Rihal, Charanjit Title: MD
    Organization: Mayo Clinic
    Date: 07/30/2020
    Comment:
    Edge to edge mitral repair has become an invaluable component of the therapeutic options for patients with advanced valvular heart disease. Outcomes are improving year over year as is case selection and the incidence of adverse events. Since patients often present with mulitvalvular heart disease I would hope CMS recognizes the reality of that and allow simultaneous treatment if indicated of other heart valve disease such as aortic stenosis or tricuspid regurgitation. The determination of

    More

    Nyhan, Sinead Title: MD
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Brodt, Jessica Title: Clin. Assist. Professor, Stanford University
    Organization: Board of Directors, Society of Cardiovascular Anesthesiologists
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Nass, Omar Title: MD
    Organization: Nebraska Heart Hospital
    Date: 07/30/2020
    Comment:

    I am writing to comment on the proposed NCD by CMS on TEER, for the treatment of functional mitral regurgitation.

    I strongly support the decision to expand coverage for Mitraclip edge to edge mitral valve repair to include patients with functional regurgitation

    TEER is a procedure fully dependent on Echo guidance, the interventional echocardiographer doing the intra-op echo imaging should be considered key operator and included in the reimbursement as essential part

    More

    Mackensen, Georg Burkhard Title: Professor and Chief
    Organization: University of Washington
    Date: 07/30/2020
    Comment:

    As the Director of Interventional Echocardiography and the Chief of the Division of Cardiothoracic Anesthesiology at the UW Heart Institute in Seattle, I wanted to thank CMS for recognizing that Interventional echocardiography is a needed and rapidly evolving medical specialty area.

    I support the recognition by CMS in this NCD guidance that specialized expertise and training in interventional echocardiography is necessary for mitral valve edge to edge repairs. As these mitral

    More

    Nyman, Charles Title: Ass. Dir. of Interventional Cardiac Anesthesiology
    Organization: Brigham and Women's Hospital
    Date: 07/30/2020
    Comment:

    With respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic echocardiography. Transesophageal is

    More

    Sutherland, Lauren Title: Assistant Professor of Anesthesiology
    Organization: Columbia University
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Ward, Michael Title: Director of Public Policy
    Organization: Alliance for Aging Research
    Date: 07/30/2020
    Comment:

    July 30, 2020

    Ms. Seema Verma
    Administrator
    Centers for Medicare & Medicaid Services
    CC: Lead Analyst — Sarah Fulton, MHS
    sarah.fulton@cms.hhs.gov
    7500 Security Boulevard
    Baltimore, MD 21244

    Dear Administrator Verma,

    The undersigned organizations appreciate the opportunity to provide input on the proposed national coverage decision (NCD) memo for mitral valve Transcatheter Edge-to-Edge Repair (TEER), previously

    More

    Abernathy, James Title: MD, MPH
    Organization: Johns Hopkins University
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    garwood, susan Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Pretorius, Mias Title: Associate Professor in Anesthesiology
    Organization: Vanderbilt University Medical Center
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Schaff, Jake Title: MD
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Chan, June Title: Assistant Professor
    Organization: Weill Cornell Medicine
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Hernandez-Morgan, Marisa Title: Assistant Clinical Professor
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    HILL, STEVEN E Title: Professor of Anesthesiology and Pain Management
    Organization: UT Southwestern Medical Center
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Reddy, Yogesh Title: Assistant Professor,
    Organization: Mayo Clinic, Rochester
    Date: 07/30/2020
    Comment:

    I am in strong support of CMS approval for appropriate patients with secondary MR after maximal medical therapy. The mortality, symptom and hospitalization status benefits are clear from the results of COAPT, and the requirement for a HF specialist to titrate maximal medical therapy before clip consideration likely accounts for the benefit in COAPT and lack of benefit in MITRA FR. Therefore, requirement for a HF specialist on the heart team is an excellent requirement. However, since

    More

    Ho, Jonathan Title: Cardiovascular Laboratory Director of Operations
    Organization: UCLA Health
    Date: 07/30/2020
    Comment:

    As director of operations at the Ronald Reagan UCLA Medical Center, I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer.
    Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. They play a key role in providing clinical care to our patients, yet most anesthesiologists would be excluded from

    More

    Morrison, Janet Title: Community Outreach Consultant/Patient advocate
    Organization: Vision Resources, Imc
    Date: 07/30/2020
    Comment:
    Traveling to Centers that offer this procedure is often more than 100 miles from a patient’s home. This often places burdensome obstacles in a patient’s path to get approved for the TEER and other transcatheter procedures that could be dealt with through TELEHEALTH visits once the Heart CT & ECHO and Cath have confirmed need. It is a poor use of Medicare Funds to require in-person visits & a needless waste of a patient‘s financial resources for lodging, food, child care,etc. In view of

    More

    Hastie, Maya Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Mahmood, Feroze Title: Director Cardiac Anesthesia
    Organization: Beth Israel Deaconess Medical Center, Harvard Medical School
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Gudavalli, Anuradha Title: MD
    Organization: CPMG
    Date: 07/30/2020
    Comment:

    1) Strongly recommend expanded coverage to FMR (functional mitral regurgitation) patients
    2) There’s often coexisting Tricuspid regurgitation in pt’s with significant MR. studies have shown better outcomes when you treat both vs just the MR. Recommend including pt’s with concomitant Tricuspid valve disease as well.
    3) some Pt’s with acute/ subacute severe MR are too sick for surgery and do need mechanical /inotropic support. Some of them have benefited from mitraclip and

    More

    Agarwal, Anushree Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Boilson, Barry Title: Assistant Professor of Medicine
    Organization: Mayo Clinic
    Date: 07/30/2020
    Comment:

    This is a petition to support MitraClip approval by CMS in functional MR secondary to LV dysfunction. the COAPT data were favorable, showing both survival benefit and decreased hospitalizations. Anecdotally I have had several patients derive significant clinical benefit. I think in the long term, it will help many appropriately selected patients avoid repeated hospitalizations and improve survival.

    Stout, David Title: Chief of Cardiovascular Anesthesiology
    Organization: Swedish Heart and Vascular Institute
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Thompson, Annemarie Title: MD
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer.

    Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

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    Jasak, Robert Organization: Heart Failure Society of American (HFSA)
    Date: 07/30/2020
    Comment:

    July 30, 2020

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

    RE: Proposed Decision Memorandum for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R)

    Dear Ms. Syrek-Jensen:

    On behalf of the Heart Failure Society of America (HFSA), I am writing to provide input on the Agency’s proposed decision memorandum for national coverage of

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    Mehta, Sanjay Title: Interventional Cardiologist
    Organization: Carle Hospital
    Date: 07/30/2020
    Comment:

    I disagree with the limitation of patients with co-existing conditions. A great majority of our patients with severe MR also have tricuspid valve disease or COPD. These patients still see an improvement of symptoms and quality of life after TMVR despite co-existing conditions.

    The face to face visit with the Surgeon is not needed as there is no surgical option for Functional MR.

    Douglas, Aaron Title: Anesthesiologist and Intensivist
    Organization: Cleveland Clinic
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Greenwald, Andrew Title: Fellow
    Organization: Columbia University
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Brakke, Tara Title: MD
    Organization: University of Nebraska Medical Center
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Assaad, Sherif Title: M.D.
    Organization: Cleveland Clinic
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Alfirevic, Andrej Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Press, Marcella Title: Interventional Cardiologist
    Organization: Ronald Reagan UCLA Medical Center
    Date: 07/30/2020
    Comment:

    After reviewing the draft document for the National Coverage Decision for Mitraclip I would like to make the following comments.

    As Director of the UCLA Mitraclip Program and having performed the MitraClip procedure in over 100 patients I have personally been impressed with the clinical improvement that various patients experience both from degenerative and functional MR. As evidenced by the COAPT trial, I have witnessed particular benefit to my patients with heart failure who

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    Shaw, Andrew Title: President Elect
    Organization: Society of Cardiovascular Anesthesiologists
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Behfar, Atta Title: Cardiologist
    Organization: Mayo Clinic
    Date: 07/30/2020
    Comment:
    This comment is in strong support for the expansion of the national coverage policy for TEER of the mitral valve. As a physician that takes care of patients with functional MR, we have very limited options to improve quality of life and reduce repeat hospitalizations in this population. This procedure would afford a significant number of patients the ability to lead a much more productive life while dramatically reducing the cost of care for this population.
    Disque, Andrew Title: Assistant Clinical Professor
    Organization: UCLA Department of Anesthesiology
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Wu, Isaac Organization: Columbia University Irving Medical Center
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Markin, Nicholas Title: Dir of Periop Imaging, Associate Professor
    Organization: Dept of Anesthesiology, University of Nebraska Medical Center
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Spence, Brian Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Goergen, Katie Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Shillcutt, Sasha Title: Professor and Cardiac Anesthesiologist
    Organization: University of Nebraska Medical Center
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Khanna, Sandeep Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Karamnov, Sergey Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    klein, allan Title: MD
    Organization: Cleveland clinic
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Skubas, Nikolaos Title: MD
    Organization: Cleveland Clinic, Dpt of Cardiothoracic Anesthesiology
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Peterson, Mary Dale Title: President
    Organization: American Society of Anesthesiologists
    Date: 07/30/2020
    Comment:

    The American Society of Anesthesiologists (ASA) appreciates the opportunity to respond to the Centers for Medicare & Medicaid Services (CMS) proposed revision to current national coverage determination (NCD) 20.33 for patients with mitral regurgitation undergoing treatment with Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve.

    ASA’s comments are in respect to the qualifications of the interventional echocardiographer. The currently proposed language for

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    Shore-Lesserson, Linda Title: MD
    Organization: Northwell Health
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Methangkool, Emily Title: Assistant Clinical Professor
    Organization: UCLA
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Varelmann, Dirk Title: MD
    Organization: Brigham and Women's Hospital
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Abraham, Theodore Title: MD
    Organization: UCSF
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Shook, Douglas Title: Chief, Division of Cardiac Anesthesia
    Organization: Brigham and Women's Hospital
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer.

    Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Chehab, Bassem Title: MD
    Organization: Ascension Via Christi
    Date: 07/30/2020
    Comment:

    To: CMS

    Hi, my name is Bassem Chehab MD, I am and Interventional Cardiologist and Director of the Structural Heart Program at Via Christi in Wichita, KS. I am providing comments on behalf of the SH team at Via Christi.
    As of background we started our MitraClip/TMVr program in June of 2014. We have performed 266 procedures since our launch; over the last year we are averaging form 6-8 patients treated per month.
    As an investigative site for COAPT, we saw firsthand the

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    Mittnacht, Alexander Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Taylor, Mark Title: MD
    Organization: Cleveland Clinic
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Defede, Michael Date: 07/30/2020
    Comment:
    I believe CMS should expand the parmaters of coverage to include asymptomatic functional FMR. Being Proactive I believe would be more cost effective.
    Allyn, John Title: Immediate Past-President NBE (echo)
    Organization: Maine Medical Center
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Timimi, Farris Title: Program Director, AHFT Fellowship Program
    Organization: Mayo Clinic
    Date: 07/30/2020
    Comment:

    I support the FMR coverage but I have concerns around the language in the proposal. Specifically I am concerned about the exclusion of coverage in patients with co-existing tricuspid regurgitation. Moreover, I have concerns about requirement for a face to face visit with a surgeon, as I believe a Heart Failure Specialist requirement is more appropriate for titration of goal directed medical therapy.

    In addition, it will be critical to include more proper payment for the

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    Priest, Michele Title: Valve Clinic Coordinator
    Organization: Carle Hospital
    Date: 07/30/2020
    Comment:

    It is vital to our patients that the new restriction for coexisting conditions be removed. Many of our patients have severe symptomatic MR and also have Aortic and Tricuspid valve disease that could benefit from this transcatheter mitral valve repair and still may need future transcatheter therapies for the other valves.

    Also I feel that the face to face evaluation of surgeon for functional MR is not appropriate. There are not open surgical treatments for functional MR and this is

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    Kimmelstiel, Carey Organization: Tufts Medical Center
    Date: 07/30/2020
    Comment:

    Regarding expanded coverage for FMR patients:

    This is an extremely important group to be covered for percutaneous mitral repair. However face to face evaluation of patients by a surgeon and an interventional cardiologist is at odds with the expert consensus guideline statement and adds what I consider to be an unnecessary level of complexity.
    In addition, I am concerned that the coverage decision may exclude patients with coexistent tricuspid valve disease. This would likely

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    Troianos, Christopher Title: Anesthesiology Institute Chair
    Organization: Cleveland Clinic
    Date: 07/30/2020
    Comment:

    I wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in

    More

    Redfield, Margaret Title: MD
    Organization: Mayo Clinic Heart Failure Program
    Date: 07/30/2020
    Comment:

    I am a heart failure cardiologist and not an interventionalist.

    National CMS funding is urgently needed for TMVR in patients with heart failure and functional mitral regurgitation. The findings of the RCT were compelling and clear. This therapy can provide meaningful benefit in patients with HF and functional MR.

    Approval should be based on a heart failure specialist indicating that GDMT has been implemented and optimized - not on whether a surgeon thinks surgical

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    Chhatriwalla, Adnan Title: Medical Director, Structural Intervention
    Organization: Saint Luke's Mid America Heart Institute
    Date: 07/30/2020
    Comment:

    My name is Adnan Chhatriwalla MD, I am an Interventional Cardiologist and Director of the Structural Heart Program at Saint Luke’s Mid America Heart Institute in Kansas City, MO. I am providing comments on behalf of our Structural Heart team. Below are the names of the physicians & administrators who agree with and helped me draft this commentary.

    As background, we started our TEER program (using Mitraclip) in March of 2015. We have performed over 200 procedures since our

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    Elgin, Eric Title: MD
    Organization: Tower Health System
    Date: 07/30/2020
    Comment:

    1. The additional requirement for CT surgical consultation will add to the burden on the patient and does not add to the outcomes of the patient. For treatment of functional mitral regurgitation the surgical options remain lacking in efficacy relative to the effectiveness of the mitral clip as demonstrated in the COAPT trial. The presence and documentation of heart team collaborative case review should be sufficient.
    2. There has been no correlation between institutions mitral

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    Barker, Colin Title: Director, Interventional Cardiology and CCL
    Organization: VUMC
    Date: 07/30/2020
    Comment:

    Proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR)

    Thank you for the opportunity to comment on the proposed NCD for transcatheter mitral valve repair in the setting of functional mitral regurgitation (FMR). I wholeheartedly support the coverage for transcatheter mitral valve repair to treat patients suffering from FMR. However, I am concerned by the granularity, restrictions, and red tape outlined in the proposal.

    Functional Mitral Regurgitation is a

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    Eshcol, Jayasheel Title: MD
    Organization: HCA Midwest
    Date: 07/30/2020
    Comment:

    Thank you for expanding the coverage for functional MR patients. As the COAPT trial demonstrated Mitraclip can provide a profound benefit in patients who previously had no proven treatments.

    I am concerned that patients who are hemodynamically unstable patients maybe excluded. Multiple studies have shown that these patients can potentially benefit and unfortunately they often have no other suitable options. Please consider allowing the use of Mitraclip in these very challenging

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    Hasan, Syed Title: Interventional Cardiologist
    Organization: Advocate Sherman Hospital
    Date: 07/30/2020
    Comment:

    I have reviewed the proposed decision memo for transcatheter mitral valve repair. I agree with the decision to include coverage for patients with functional mitral regurgitation.

    However, I do not agree with excluding those patients with concomitant aortic or tricuspid valve disease, oxygen dependent COPD, or those who are anticipated to need cardiac surgery in the next 12 months. The transcatheter edge-to-edge repair (TEER) procedure will be of great benefit to patients

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    augoustides, yianni Date: 07/30/2020
    Comment:

    wish to provide the following comments with respect to the qualifications of the interventional echocardiographer. Anesthesiologists with the appropriate training and experience are qualified providers and are an integral part of many heart teams throughout the country performing these procedures daily. Yet most anesthesiologists would be excluded from providing this service with the language as currently proposed, because they are typically not board eligible or certified in transthoracic

    More

    Mikesell, Scott Date: 07/29/2020
    Comment:
    Regarding an institution’s minimal surgical MV volume, there is no correlation of TEER outcomes to surgical volume relative as research has demonstrated. Limiting potential an institution’s candidacy based upon surgical volume is not evidenced based and only limits patient’s access to state of the art care.
    Waxman, Sergio Title: Chief of Cardiology
    Organization: Newark Beth Israel Medical Center
    Date: 07/29/2020
    Comment:

    Re. New restrictions for coexisting conditions: Although expanding coverage for functional MR is a great step, the exclusion of coverage for patients with other valve disease, in particular tricuspid regurgitation, may be a dis-service to this patient population, as MR and TR commonly present together and may have common pathophysiologic mechanism. The pulmonary hypertension that is secondary to FMR and may be one of the contributing factors for TR would not be able to be properly managed

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    Kosova, Ethan Title: Physician
    Organization: DuPage Medical Group
    Date: 07/29/2020
    Comment:

    The NCD for the TEER will guide an important area of cardiac intervention for years to come.

    While overall an excellent document, there are a couple of points where improvements can be made.
    The restrictions for coexisting conditions are too restrictive. Treatment of functional MR with TEER is a life saving condition. There are a significant proportion of patients with coexisting functional tricuspid regurgitation. There is no data showing definitive clinical advantage to

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    Sorajja, Paul Date: 07/29/2020
    Comment:

    I have concerns about the requirement for both IC and CV surgery consultation. Certainly, either of these procedural specialities can perform MitraClip individually. However, there are many centers who do not have surgical mitral expertise to support the consultations needed to address the large number of patients. I believe it would be more fruitful to have a requirement for a HF consultation in conjunction with a proceduralist, whether that proceduralist is an IC or CV surgeon. Having a

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    Bullock, Carrie Title: Senior Director, Health Policy and Reimbursement
    Organization: Medtronic
    Date: 07/29/2020
    Comment:

    Medtronic appreciates the opportunity to comment on the proposed coverage decision memorandum regarding Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R). Our comments on the proposed decision memorandum are focused specifically on coverage with evidence development (CED) in the context of a national coverage determination (NCD).

    As the world's leading medical technology company, specializing in implantable and interventional therapies that alleviate pain, restore health,

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    Querijero, Michael Title: Director of Operations and Program Development
    Organization: NYU Langone Health
    Date: 07/29/2020
    Comment:

    The response to medical therapy with severe secondary mitral regurgitation is limited. The COAPT study has demonstrated patients with secondary MR did better with MV clip then medical therapy alone. Patients who have had the MV clip with GDMT had lower mortalities, less rehospitalizations and a better quality of life then guided medical therapy alone. There are a great number of patients who await for coverage for this life saving therapy. The Heart Valve Center at NYU is hoping that the

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    kipperman, robert Title: md
    Organization: atlantic health
    Date: 07/29/2020
    Comment:

    1. strongly agree with reimbursement based on strong clinical data and years of experience with device and therapy.
    2. No need for face to face evaluation CTS
    3. Would support coverage for patients with multiple valve disease and treatment should individualized, especially for patients with concomitant tricuspid disease as it often gets better after treatment of the mitral regurgitation
    4. Would also include payment for patient on an individualized basis who are on support

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    Cavalcante, João Title: Director, Structural CT and Cardiac MRI Labs
    Organization: Minneapolis Heart Institute
    Date: 07/29/2020
    Comment:

    It is great to see that CMS is considering the TMVR coverage to the large group of patients with secondary MR and cardiomyopathy. There are however some aspects that deserve further clarity and consideration:

    1) CMS proposes that local heart team must determine that mitral valve surgery will not be offered as a treatment option. Although in concept, it's valid, the need to have a CT surgeon to sign off on these patients is less than optimal given the current scenario which MV

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    Hogan, Peter Title: Cath Lab Manager
    Organization: Sharp Grossmont
    Date: 07/29/2020
    Comment:

    In regards to the proposed changes to the facility requirements, this would essentially exclude any hospital from ever meeting the criteria to start a TEER program, essentially ensuring a CMS partnership with only large facilities when it comes to structural heart procedures. Sharp Grossmont currently offers TAVRs and LAAO and services one of the largest catchment areas in Southern California. By drastically increasing the TMVR requirements, CMS is ensuring an under-served population will

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    McGinty, Joyce Title: Director, Heart and Vascular Services
    Organization: Sharp HealthCare
    Date: 07/29/2020
    Comment:

    We are happy to see an expansion in indications for Transcatheter Mitral Valve Repair.

    What we are NOT happy to see are the significant increases in volumes required to begin a program. This is not supported in the literature, in fact 2 recently publications show NO STATISTICALLY SIGNIFICANT relationship between Mitral Valve Surgical volume and Transcatheter Mitral Valve Repair outcomes. I believe the NCD should be based on evidence, and not driven by the desires of large centers.

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    Adler, David Title: Interventional Cardiologist
    Organization: Sentara Cardiology Specialists
    Date: 07/29/2020
    Comment:

    I strongly support CMS coverage of TEER for FMR patients. We have had a busy and successful Mitraclip program since 2014 at a large center with high surgical volumes and a busy transplant/heart failure program.

    Two comments:

    #1 While the cardiothoracic surgeon is clearly an invaluable member of the heart team, please reconsider whether a face-to-face visit is really necessary for all patients. Especially in the case of FMR, individual patients can usually be reviewed with

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    Lin, Frank Title: MD
    Organization: Foothill Cardiology
    Date: 07/29/2020
    Comment:

    I am writing out regarding the proposed guidelines for coverage for TMVr / TEER.

    Patients with functional MR who are being considered for mitral valve therapy typically do have some degree of co-existing tricuspid regurgitation. Many of these patients do not have the option for open heart surgery given high surgical risk and I am concerned that denying the option of therapy on the mitral valve, these patients will be without any other options and will continue to decline. There are

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    Alsidawi, Said Title: Cardiologist
    Date: 07/29/2020
    Comment:

    Concomitant TR should not be an exclusion criteria.

    Surgery visit should not be a requirement.

    Resor, Charles Date: 07/29/2020
    Comment:

    I appreciate the proposed coverage decision which is clearly based on a very thorough analysis of the existing FMR data.

    I would like to highlight two specific issues with the proposed coverage decision which I feel may impede the timely delivery of this life saving intervention to this high risk patient population.

    1)Independent face to face evaluation by a cardiac surgeon. As noted in the coverage decision analysis of existing data, none of the existing data from

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    Baden, Kristi Title: CCL Manager
    Organization: MU Health Care
    Date: 07/29/2020
    Comment:

    On behalf of Dr. Arun Kumar and our program: In efforts to build the program properly and get appropriate infrastructure in place, can we be held to the prior requirements. We meet the requirements detailed by CMS but the new requirements makes this more challenging. We feel we have patients in need who require this technology and would not want to lose the opportunity to care for these patients. Rather than rush through to get to our first case before the changes take effect, we would

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    Prejean, Shane Title: Cardiologist
    Organization: UAB Cardiology
    Date: 07/29/2020
    Comment:

    The new requirement for an increase in mitral surgeries is unnecessarily prohibitive. I agree with a heart team approach to seeing patients with mitral regurgitation (seeing both a surgeon and Cardiologist). However, even smaller programs may have proficiency in transcatheter mitral repair even if the hospitals surgical volume is <40. The requirement should stay at the previous number.

    This increase prohibits availability of transcatheter therapy for functional MR in smaller

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    Durairaj, Azhil Title: MD, Medical Director CV service line
    Organization: Huntington Hospitall
    Date: 07/29/2020
    Comment:

    1. I disagree with the exclusion of co-existing Tricuspid disease. Often times the TR improves after mitral valve therapy. Even if the TR doesn't improve the patient symptomatically improves following mitral valve therapy.

    2. I also disagree with restricting therapy to patients on inotropes or mechanical device support. As a referral center we often get critically ill patients and there is no option to medically stabilize them prior to Mitral valve therapy. Sometimes the

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    Schoch, Dana Title: Heart and Vascular Administrator
    Organization: Henry Ford Allegiance Health
    Date: 07/29/2020
    Comment:

    July 23, 2020

    We appreciate the opportunity to submit in support of less stringent criteria for the initiation of a Transcatheter Edge-to-Edge Repair (TEER) (CAG-00438R) program.

    Henry Ford Allegiance Health, is a 475-licensed bed regional hospital located in Jackson, Michigan. The hospital is part of the Henry Ford Health System, one of the nation’s leading comprehensive integrated health systems. The Henry Ford Structural Heart Disease (SHD) Program of Henry Ford Health

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    Kliger, Chad Title: Director of Structural Heart Disease
    Organization: Lenox Hill Hospital-Northwell Health
    Date: 07/29/2020
    Comment:

    Given the results of the COAPT trial and our experience in treating affected patients since the COAPT presentation/publication, we welcome the change in NCD for TMVr to now include FMR patients. Although an exclusion for COAPT trial was tricuspid valve disease requiring surgery or transcatheter intervention, including this new NCD exclusion may limit the application of this technology to symptomatic patients. There is data to support that one quarter of patients have tricuspid regurgitation

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    Chaudhry, Mohammad Sohail Title: MD
    Organization: Bon Secours Mercy Health System MRMC
    Date: 07/29/2020
    Comment:

    1. Proposed mitral valve repair and surgery numbers requirement will hinder busy community hospitals with establish structural heart program, such as ours, to bring this technology to vast number of patients in the community who cannot travel long distance. Would suggest to lower the bar for number requirements.

    2. With respect to restricting coverage to functional MR only in presence of no significant TR, will also make it impossible to take care of significant majority of these

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    Brown, Michael Title: Program Manager/ Cardiac Surgery/Structural Heart
    Organization: Mary Washington Healthcare
    Date: 07/29/2020
    Comment:

    The decision to increase the mitral valve surgery requirement to develop a mitral clip program (TMVR) will place a great constraint on the ability for hospitals to provide comprehensive cardiac care to residents in their service area. Many patients in our region will have to travel well outside the region to receive their care. Due to the complexity of the procedure, this will place a tremendous burden on the patient and their families to travel for physician visits, procedural visits and

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    Gupta, Amit Title: Interventional Cardiologist
    Organization: Baker and Gilmour Cardiovascular Institute
    Date: 07/29/2020
    Comment:

    COAPT has clearly shown benefit of Mitral clip in improving rate of readmission and mortality benefit in appropriately selected patients with functional MR. All surgical repairs never had shown any mortality benefit and expose patient to unnecessary procedure. Would strongly recommend adding consult in heart team from a heart failure physician or noninvasive cardiologist (from a different group if possible) with strong interest in valvular disease management as necessary prerequisite for

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    Abudayyeh, Islam Title: Associate Professor
    Organization: Loma Linda University
    Date: 07/29/2020
    Comment:

    We appreciate CMS's review of the Mitralclip and expanding the FMR indication. However, we feel strongly that there is a role for the device in patients with hemodynamic instability and compromised respiratory capacity. Over the last couple of years we had several episodes where patients could not be extubated with worsening condition. A clip procedure allowed each of those patients to revoker and were all discharged in stable condition.

    Pasala, Tilak Title: Interim Director, Structural Heart Center
    Organization: Hackensack University Medical Center
    Date: 07/29/2020
    Comment:

    I read with great interest the proposed changes of the NCD for TMVr. This is a welcome change. Having been involved in over 150 MitraClips, here are a few observations and comments.

    1. The need for face-to-face evaluation with the CT surgeon. While surgical evaluation is necessary and essential in determining the appropriateness of DMR patients. Current evidence does not support surgical intervention in FMR patients. In fact, TMVr is the first line of therapy in patients needing

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    Wu, Willis Title: Director of Structural Heart Program
    Organization: UNC REX Hospital
    Date: 07/29/2020
    Comment:

    We have a busy cardiovascular and particularly MitraClip program and treat thousands of heart failure patients each year at UNC REX hospital in Raleigh. We have a dedicated heart failure program here. I applaud the decision to cover functional mitral regurgitation patients as per the COAPT trial as this constitutes a large porportion of patients with CHF. However, I disagree with the decision not to include coverage for patients with co-existing tricuspid regurgitation. This is a common

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    Goldberg, Steven Title: Medical Director for Structural Heart Disease
    Organization: Tyler Heart Institute, CHOMP, Monterey, California
    Date: 07/29/2020
    Comment:

    CMS is to be commended by taking action to create a national coverage decision for the percutaneous management of functional MR (FMR), based upon the clinical beneifts that were seen in the COAPT study. This has the potential to deliver these benefits to the many patients who suffer from congestive heart failure despite adequate medical treatment, who have superimposed FMR. It does appear to be short-sighted that the NCD is not structured to accommodate future percutaneous therapies for

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    Kiss, Daniel Title: M.D.
    Organization: Jersey Shore University Medical Center
    Date: 07/28/2020
    Comment:

    1. I am concerned by the use of the terminology "heart failure specialist experienced in the care and treatment of mitral valve disease." Is this implying that the heart team must consist of a board certified, subspecialty trained heart failure specialist? While this was a requirement in the trial, the vast majority of heart failure care in this country is delivered by general cardiologists, interventional cardiologists with an interest in structural/valvular heart disease, and advanced

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    Cauchi, Matthew Title: DO, Intervevntional/Strctural Cardiology
    Organization: Sentara Rockingham Memorial Hospital
    Date: 07/28/2020
    Comment:

    In reference to recent proposed changes to CMS requirements for TMVr or TEER, a few thoughts come to mind:

    - Expanded coverage for FMR patients gives more options for patients, but we have definitely seen a more substantial improvement in those on true maximal medical therapy which is in line with the COAPT-cohort. Even those with atrial FMR or truly disproportionate LV cavity dilation on maximal medical therapy improved, but not to the same degree and it is more likely that other

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    Byrne, Timothy Title: Interventional cardiologist
    Organization: Abrazo Arizona Heart Hospital
    Date: 07/28/2020
    Comment:

    The CMS PROPOSAL TO LIMIT CMS REIMBURSEMENT FOR FMR AND CONCOMITANT TRICUSPID VALVE DISEASE IS NOT APPROPRIATE. PLEASE LET THE DATA DETERMINE OUTCOMES. THE TRILUMINATE TRIAL REQUIRES THAT PATIENT’s MITRAL VALVE DISEASE BE TREATED PRIOR TO ALLOWING CONSIDERATION FOR A TRICLIP THERAPY RANDOMIZATION. OUR GROUP WITH OTHERS HAVE ALSO SUBMITTED AN ABSTRACT TO TCT THAT SUGGESTS BOTH SAFETY AND EFFICACY OF MITRACLIP THERAPY IN PATIENT’s WITH HEMODYNAMICS INSTABILITY. PLEASE ALLOW A BROAD STROKE

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    Islam, Ashequl Title: MD
    Organization: Baystate Medical Center
    Date: 07/28/2020
    Comment:

    I strongly support the expanded coverage to functional mitral regargitation patients as per very positive results of the COAPT™ trial. This will help physicians and providers take care of these patients with better outcomes than currently available treatment options.

    I do not think that face to face evaluation of patients by a surgeon is necessary because of lack of any surgical interventions available for these patients. Also we will need a heart team approach which will

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    Saybolt, Matthew Title: MD
    Organization: Hackensack Meridian Jersey Shore University Medical Center
    Date: 07/28/2020
    Comment:

    It would be wrong to require that mitral valve surgery not be offered as a treatment option in order to quality for TEER. Mitral valve surgery has never shown a mortality benefit for secondary MR in the CHF population while mitraclip has a mortality benefit. Further patients should at least have a choice/say in the matter when there are two strategies (one of which has been proven), rather then for them to be forced into surgery and only mitraclip if surgery is not to be offered by the

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    Wang, Andrew Title: Professor of Medicine
    Organization: Duke University Hospital
    Date: 07/28/2020
    Comment:

    I strongly support the proposed NCD for TMVR using Mitraclip for patients who meet the COAPT clinical characteristics and inclusion criteria. The positive results of MitraClip for all primary and secondary endpoints in COAPT demonstrates the robust clinical effect. This therapy offers a beneficial treatment for heart failure patients who may not have other proven treatment options to reduce hospitalizations and reduce mortality.

    However, it may be more appropriate for a heart

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    Alvarez, Jorge Organization: South Texas Heart Valve Center
    Date: 07/28/2020
    Comment:

    As a group we have been treating multiple patient for both primary and secondary Mitral Regurgitation. Having the ability to offer this procedure for secondary MR has proven to be a very gratifying procedure. The number of patient that we have been able to help modify medication, decrease hospital admission and improve quality of life has been paramount. This procedure not only is great for the patient but physician and team as well.

    Hollingsworth, Paula Organization: Lexington Cardiology
    Date: 07/28/2020
    Comment:

    July 25. 2020

    Dear Committee Members,

    Thank you so much for proposing CMS coverage for MitraClip use in our functional mitral regurgitation patients. The COAPT trial was a great success with a lower rate of hospitalizations for heart failure and lower all cause mortality within 24 months compared with medical therapy.

    Our functional mitral regurgitant patients are very complex, more complex than those in the COAPT trial, and many are not good operative

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    Karha, Juhana Title: MD
    Organization: Austin Heart / Heart Hospital of Austin (Austin, TX)
    Date: 07/28/2020
    Comment:

    My comments re the national coverage determination for TEER are as follows :

    - a cardiac surgery evaluation should not be required for TEER for functional mitral regurgitation. Mitral valve surgery has not been established as an effective treatment for functional mitral regurgitation and thus requiring this evaluation is unnecessary and misguided.
    - comorbid tricuspid regurgitation should be allowed in the coverage for TEER, as it is current standard of care to treat many of

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    Mulukutla, Chalam Title: Pediatric and Adult Interventional Cardiology
    Organization: El Paso Cardiology Associates
    Date: 07/28/2020
    Comment:

    The proposed guideline changes are unfortunate as they will have limit access to care.

    1. There have been several documents that have shown there is no difference between mitral clip outcomes and surgical volume requirements. Increasing the requirements is going to have consequences in making it more difficult for patients to get appropriate therapy.

    2. In patients with functional mitral regurgitation, the trial was designed with mitral clip versus guideline directed

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    Kar, Biswajit Title: M.D , Chief of center for advanced heart Failure
    Organization: University of Texas, Houston
    Date: 07/28/2020
    Comment:

    I have four important points to submit for your kind consideration :

    1. The benefits of TEER in functional MR patients in the COAPT trial were consistent across numerous subgroups, including patients who had ischemic and nonischemic cardiomyopathy and those who were and were not at high risk for surgery-related complications or death, and the benefits were independent of the left ventricular volume and function at baseline. The prognosis among patients with heart failure and

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    Dhoble, Abhijeet Title: Director, Structural Heart Disease
    Organization: University of Texas Health Science Center, Houston
    Date: 07/28/2020
    Comment:

    Thanks for the opportunity to provide comments on this lifesaving procedure. It is clear from COAPT clinical trial that number needed to treat to prevent one death or hospitalization is 3.7. It is very rare to see such kind of powerful clinical impact in medical field.

    Currently there is NO Class I indication for mitral valve surgery due to lack of positive data. In patients undergoing surgical aortic valve replacement or CABG, it is considered class IIa indication to repair

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    Desai, Devang Title: Dir. of Cardiac Cath Lab
    Organization: Saint Mary's Regional Medical Center
    Date: 07/28/2020
    Comment:

    I am pleased to see that there will be CMS coverage for SMR patients soon. After reviewing CMS's proposed NCD I'd like to share some of my concerns. MR patients may require additional inotropic or mechanical support prior to, during or after TMVr therapy so I don't agree with excluding these patients from access to MitraClip therapy. Furthermore, I referred a patient with MR and TR to a program that offered tricuspid thearpy in a trial in addition to MitraClip. It was thought that the

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    Azam, Salman Title: Physician
    Date: 07/28/2020
    Comment:

    Some of the criteria listed for excluding patient undergoing evaluation for TEER in my opinion will leave numerous patients without any treatment options and essential lead them to the hospice pathway. For example, COPD patient being excluded for TEER are actually the same patients who are usually deemed high risk for cardiac surgery. With the new proposed criteria, they will have no invasive options to treat the MV/TV which is a disservice to the patients. Please do not include these

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    Gunasekaran, Prasad Title: Interventional Cardiologist
    Date: 07/28/2020
    Comment:

    1. Treatment of severe MR with Mitraclip results in tricuspid insufficiency improving in the magnitude of TR. Precluding repair of MR with MitraClip in patients with underlying severe TR effectively eliminates the only effective therapeutic option in non-surgical candidates who obtain the highest benefit with this procedure.

    2. Recurrence of functional MR in patients who undergo surgical mitral valve repair is close to 50-60% indicating poor efficacy of the open surgical

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    Shernan, Stanton Title: President
    Organization: Society of Cardiovascular Anesthesiologists
    Date: 07/28/2020
    Comment:

    The Society of Cardiovascular Anesthesiologists (SCA) wishes to respond with the following comments with respect to the Centers for Medicare & Medicaid Services proposed revision to current national coverage determination (NCD) 20.33 for patients with mitral regurgitation undergoing treatment with Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve. It is our understanding that CMS is proposing that coverage determinations under section 1862(a)(1)(A) of the Act for on-labeled uses

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    Arif, Imran Title: MD, Director Cardiac Cath Lab
    Organization: University of Cincinnati Medical Center
    Date: 07/28/2020
    Comment:

    To Whom It May Concern:

    We have been offering mitral clip therapy for high STS risk or prohibitive risk for mitral valve surgery. We have treated degenerative MR, functional MR with significant improvement in symptoms, quality of life. Being an advanced heart failure center, and transplant center, we do get referred a lot of patients with cardiogenic shock, that have no other options to treat mitral regurgitation except mitral clip therapy. So far we have performed mitral clip

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    Silva, Guilherme Title: Director, Structural Heart Disease
    Organization: Baylor College of Medicine
    Date: 07/28/2020
    Comment:

    The current Proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R) as it reads poses significant risk for harming a significant number of patients that would benefit from TMVR and have no other good therapeutic/surgical option.

    The lack of coverage for the treatment of functional MR with concurrent aortic or tricuspid valve disease would exclude a significant number of patients that would potentially benefit from the technology and avoid the high

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    Wyman, Janet Fredal Title: Administrative Director, Structural Heart Services
    Organization: Henry Ford Health System
    Date: 07/28/2020
    Comment:

    July 17,2020

    We appreciate the opportunity to comment on the Proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R).

    Henry Ford Hospital is an 877-licensed bed tertiary, quaternary care hospital, education and research center located in Detroit. The hospital is recognized for clinical excellence in the fields of cardiology and cardiovascular surgery, neurology and neurosurgery, orthopedics and sports medicine, transplant, and cancer. It is the

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    Brener, Sorin Title: MD
    Organization: NYP Brooklyn Methodist
    Date: 07/28/2020
    Comment:

    It is strange that surgical consultation is required for a condition for which surgery is not indicated

    Also tricuspid disease frequently improves after MR is corrected, thus precluding TEER because of significant TR may not be justified

    Bethea M.D., Brian Title: Vice Chief of Cardiac Surgery Medstar Union
    Organization: MedStar Heart and Vascular Institute
    Date: 07/28/2020
    Comment:

    I have read the comments of the other care providers thus far and agree with the interpretation of current data and echo their support to include FMR coverage.

    My concerns are mainly in excluding coverage in patients with concomitant valvular disease and dismantling the heart team. It would be an obvious disservice to apply strict study inclusion exclusion criteria to the general population thereby limiting access to a therapy with significant benefit to a large commercial

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    Patel, Mehul Title: Director of SHD
    Organization: MLH
    Date: 07/28/2020
    Comment:

    Please expand coverage to FMR patients due to the COAPT™ results.
    Please expand coverage for FMR patients with co-existing tricuspid valve disease requiring treatment.
    Please expand coverage for FMR patients with hemodynamic instability – those requiring inotropic support or mechanical heart assistance

    Loyalka, Pranav Title: Director of Heart Transplant/MCS/Structural HD
    Organization: HCA Gulfcoast
    Date: 07/28/2020
    Comment:

    A summary of this document:

    The ethical, educated cardiac surgeons and heart failure specialists should guide the unethical, uneducated structural interventionalist on the complexities of heart failure, echocardiography and mitral valve disease. This therefore necessitates the use of unprecedented restrictions on the procedure.

    Let me be more specific about my criticism of this NCD document.
    As always, the concern should be first and foremost patient

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    Stark, Randall Title: Interventional/ Structural Heart Cardiologist
    Organization: Metropolitan Heart and Vascular Institute
    Date: 07/27/2020
    Comment:

    1. FMR patient “ seen by a CV Surgeon”
    Why? They dont operate on these patients. Better to be seen by the Heart Failure team and insure maximal med therapy.

    2. Tricuspid Insufficiency- this should not be a reason alone to deny MitraClip. TI is complicated and can be interpreted with great variation in the same patient. Just because it was listed in the CoApt trial is not a reason to deny MitraClip

    3. FMR payment supoort for MitraClip is necessary and much

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    Iyengar, Srinivas Title: MD
    Organization: Boulder Community Health
    Date: 07/27/2020
    Comment:

    Given the amount of patients who have severe symptomatic MR, from both degenerative and functional causes, it is critical that we are allowed as clinicians treating these patients to utilize all current FDA approved tools.

    Oftentimes patients who have severe symptomatic MR from a functional etiology also have severely reduced LV function/associated co-morbid issues which would make them obvious surgically prohibitive patients. Streamlining the process for these patients to be seen

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    Coleman, Pat Title: Dir. of Cardiac Cath Lab
    Organization: Santa Rosa Memorial Hospital
    Date: 07/27/2020
    Comment:

    I agree with the proposed change to reimburse MitraClip for SMR. The coverage decision should not mimic the COAPT trial exclusively. There are many patient subgroups that would have been excluded from COAPT that have shown to benefit from MitraClip therapy. To exclude reimbursement for patients that require mechanical circulatory or inotropic support may limit the availability of a potentially life saving treatment option. Excluding reimbursement for patients with multi-valve disease

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    chen, chunguang Title: Cardiologist
    Organization: RWJ University Hospital
    Date: 07/27/2020
    Comment:

    1) Mitral clip therapy should not be excluded in patients with severe tricuspid regurgitation since tricuspid regurgitation may get better after mitral clip
    2) Mitral clip can be applied to some patients who are on intotropic support or mechanical support but at prohibitive risk of surgery and mitral clip is the only option to help patients survive and get out isotropic or mechanical support. Should not be a non coverage decision.

    Bell, Bethany Title: APRN, Structural Heart Program Coordinator
    Organization: Ascension St. Vincent's Cardiology
    Date: 07/27/2020
    Comment:

    Ascension St. Vincent’s Structural Heart Team Consensus Comment on Draft NCD that addresses coverage for the treatment of patients with secondary mitral regurgitation who are prohibitive surgical risk

    The structural heart team at Ascension St. Vincent’s in Jacksonville, Florida is pleased and supportive that CMS is proposing to cover this important population (the COAPT population) in need of Mitraclip TEER therapy. However, we would like to express some concerns regarding the

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    Long, Robert Title: Associate Professor of Medicine
    Organization: University of Mississippi Medical Center
    Date: 07/27/2020
    Comment:

    The volume requirements (baseline and ongoing) for cardiac surgeon mitral valve surgeries is excessive and will severely limit the availability/access to this therapy for patients. Also the in person evaluation by a cardiac surgeon seems that it is unnecessary and burdensome for the patient/institution. Chart review including imaging +/- telehealth visit should suffice for purposes of surgeon evaluation. Also the PCI numbers for interventional cardiology do not seem necessary as the skill

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    Tang, Gilbert Title: Surgical Director, Structural Heart Program
    Organization: Mount Sinai Health System
    Date: 07/26/2020
    Comment:

    Thank you for the opportunity for me to provide my comments to the proposed NCD on TEER in functional MR (FMR). As a cardiac surgeon practicing in a tertiary academic medical center and focused on structural heart disease including patients with FMR being evaluated for TEER, I read with interest my colleagues who have already raised many important points on this forum in their comments. I will highlight the ones from my viewpoint:

    1) Given the COVID19 pandemic and future public

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    Verma, Anil Title: Attending Physician
    Organization: Mercy Health
    Date: 07/26/2020
    Comment:

    Limiting TMVR to a few sites will have catastrophic effect on under privileged and undeserved population. Access to care will be a big problem. A requirement of over 25 mitral valve surgery for an institution is very harsh and will reduce number of sites who will qualify to perform TMVR despite presence of capable and skilled structural heart specialists. Patients will not travel far and physicians will not refer patients out of their institutions on a routine basis.

    Kim, Michael Title: Director, Structural Heart Services
    Organization: Penrose-St. Francis Health Services | Centura Health
    Date: 07/26/2020
    Comment:

    I am writing this memo to comment on the CMS proposed decision memo for Transcatheter Mitral Valve Repair (CAG-00438R). First, I would like to applaud those at CMS involved in drafting this updated National Coverage Decision for TMVR. This work represents an important update to the prior NCD, especially in the face of the additional data highlighting the benefits of TMVR that have come to fruition since the original NCD was published many years ago.

    With that being said, I have

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    Singh, Sunil Title: Interventional Cardiologist
    Organization: First Coast Heart & Vascular Center
    Date: 07/26/2020
    Comment:

    I have a few concerns about the proposed NCD that I would like to outline below:

    1. Mitral valve surgical volume requirements for TEER programs: There have been two recent studies (Barker et al and Vemulapalli et al) that both found no relation between a programs mitral valve surgery volume and TMVr/TEER outcomes. Therefore, why should mitral valve surgical volumes be used as a requirement for mitraclip programs?

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    Rinaldi, Michael Title: MD
    Organization: Sanger Heart and Vascular Institute, Atrium Health
    Date: 07/26/2020
    Comment:

    I have been involved in TMVR as an operator and investigator since 2005 and have contributed to a number of clinical trials in TEER including EVEREST 2, COAPT and CLASP.

    I strongly support expanding coverage of TEER to patients with functional MR. COAPT has shown substantial benefit of TEER for survival, prevention of HF hospitalization, and QOL. There are a substantial number of patients who may benefit from treatment and, after exhausting GDMT, there are no other treatment

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    Tierney, Renee Title: ACNP
    Organization: Bon Secours Mercy Health
    Date: 07/26/2020
    Comment:

    In reviewing the proposed recommendations for TMVr or TEER, I would like to submit the following comments.

         As a community hospital that serves a vast population of cardiovascular disease, we have found that in one year of opening a structural heart clinic, that our referrals are quite robust. We have had close to 100 referrals in that time frame, with about 15% being mitral valve in origin. The proposed change of 20 to 40 mitral valve procedures per

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    Daly, Dale Title: Medical Director, Structural Heart Program
    Organization: Memorial Health University medical Center
    Date: 07/26/2020
    Comment:

    Thank you for the opportunity to comment on the proposed guidelines for TEER for functional MR.

    1. While the importance of achieving maximally tolerated GDMT demonstrated in the COAPT Trial is fundamental to the care of these patients I don't feel that a heart failure physician is mandatory to achieve this outcome. Most programs, including ours do not have a cardiologist with formal advanced training in heart failure. As a cardiologist who happens to be an interventionist I am

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    Kaneko, Tsuyoshi Organization: Brigham and Women's Hospital
    Date: 07/26/2020
    Comment:

    When surgical mitral valve repair is considered for mitral regurgitation (MR), it is ubiquitous to see concomitant tricuspid regurgitation (TR). 15.7% of mitral valve surgeries require concomitant tricuspid repair from the STS database. Mitral regurgitation and tricuspid regurgitation are linked condition, but oftentimes MR is the cause of TR. It does not make sense to recommend treating TR first, when it is the consequence of MR. We understand that the COAPT trial did not include

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    Rogers, Jason Title: Professor, Cardiovascular Medicine
    Organization: University of California, Davis Medical Center
    Date: 07/26/2020
    Comment:

    I am glad to see that there will be CMS reimbursement for MitraClip therapy in secondary MR. I have some specific concerns that I would like to see modified in the final coverage decision.

    1. The CMS proposal for a face-to-face encounter with a heart surgeon seems unreasonable, since NO PATIENT IN THE COAPT TRIAL UNDERWENT MITRAL VALVE SURGERY AS AN INITIAL THERAPY, and approximately 1/3 of patients enrolled were not high surgical risk. MITRACLIP THERAPY (NOT SURGERY) IS NOW THE

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    Sullebarger, John Title: MD
    Organization: Florida Medical Clinic
    Date: 07/25/2020
    Comment:

    As an investigator in the COAPT trial I strongly support the decision to expand coverage for Mitraclip edge to edge mitral valve repair to include patients with functional regurgitation. I agree that the role of the cardiac surgeon and heart failure specialist is important in the evaluation of these patients before consideration for the procedure. We will continue to evaluate patients for optimal medical therapy pre procedure as we did in the trial. Our experience with high risk patients

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    Steinhoff, Jeff Title: MD, FACC
    Organization: The Heart Institute at Largo
    Date: 07/24/2020
    Comment:

    I agree with allowing patients access to TEER. I also agree with allowing patient;s like those in the COAPT trial. Our institution has used collaboration with Advanced Heart Failure as well, which was part of the COAPT protocol. I also agree with excluding patient’s with severe tricuspid regurgitation.

    Lim, Scott Title: Professor of Medicine
    Organization: University of Virginia
    Date: 07/24/2020
    Comment:

    I am writing to comment on the proposed NCD by CMS on TEER, for the treatment of functional mitral regurgitation. Since functional MR is inherently related to heart failure, I recommend the inclusion of the heart failure specialist as part of the independent examination of the patient and determination of maximally tolerated GDMT (section 1/c/iv/1), as well as part of the heart team involved in caring for the patient pre and post operatively. (section 2/a). The qualifications of the heart

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    Kiszka, Jessica Date: 07/24/2020
    Comment:
    We are in need of heart failure therapy, however the number of mitral valve surgeries proposed is high (40), concerning us about patient access to mitral therapy.
    Ali, Mir Title: Chief of Cardiothoracic Surgery
    Organization: Dignity Health St Bernardine Medical Center
    Date: 07/24/2020
    Comment:

    I had the chance to review the CMS draft decision and also reviewed the Recent joint ACC/STS consensus statement, as well as the article authored by Dr. Bonow in JACC.

    I also reviewed the comments from Dr. Price that have been publicly submitted and propagated, reportedly with his permission.

    I disagree with many of the comments regarding the value that a cardiac surgeon brings to the discussion involving the treatment of complex valvular heart problems. The fact that

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    Hodson, Robert Title: MD
    Organization: Providence Heart Institute, Providence Valve Center
    Date: 07/24/2020
    Comment:
    The NCD should not exclude functional MR patients with severe TR or requiring hemodynamic support. MitraClip has the potential tol save lives in these patients who would otherwise die at surgery or die on medical therapy. The NCD should allow for a reasoned heart team decision in these very ill patients.
    Pineda, Andres Title: MD
    Organization: University of Florida College of Medicine
    Date: 07/24/2020
    Comment:

    I would like to make the following comments in regards to the proposed TEER memo:

    1. The statement requiring a cardiac surgeon evaluation prior to TEER is not in line with the current knowledge on the subject and should be removed. Open mitral valve replacement or repair has not been shown to improve outcomes for patients with functional mitral regurgitation and therefore current guidelines appropriately give cardiac surgery only a class IIb recommendation. Heart surgery is not

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    Badheka, Dr. Apurva Title: Interventional Cardiologist
    Organization: Providence Everett Medical Center
    Date: 07/24/2020
    Comment:

    Functional MR patients should not require CT surgery evaluation prior to therapy since surgical rx is not standard of care for FMR nor is it part of the current FDA labeling for FMR Concomitant tricuspid intervention has shown to improve outcomes (mortality, functional status and CHF hospitalization). Operators / programs should not be penalized for double valve intervention.

    Atkins, Cameron Title: Administrative Director of Cardiovascular Services
    Organization: Bon Secours Mercy Health
    Date: 07/24/2020
    Comment:

    In reviewing the proposed decision memo for the Transcatheter Mitral Valve Repair (TMVR), I would like to submit the following observations which I hope will be taken into consideration:

  • 40 mitral valve surgeries in the previous year prior to program initiation, including at least 20 of which that must be mitral valve repairs, would seem to be an excessively high volume of cases that will prohibit many institutions from implementing TEER capabilities. I believe this will

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  • Posenau, John Title: MD
    Organization: VCS
    Date: 07/24/2020
    Comment:

    I believe coverage for TMVR with MitraClip should include patients with functional MR based on very positive results of COAPT Trial. Coverage should not be restricted for patients with concomitant tricuspid regurgitation as this is a common finding and therapies for TR are likely to continue to expand and evolve. Coverage should not be restricted for patients who are more ill and hospitalized, clinical judgement of the operators should determine if these patients are candidates for

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    Levitt, Robert Title: MD
    Organization: HCA Henrico Doctors Hospital
    Date: 07/24/2020
    Comment:

    I support coverage of TMVR for functional MR based on excellent supportive data and large patient need. This coverage is even greater needed for the patient group without any alternative therapies. This includes patients with COPD on home O2, on steroid use, on inotropic therapy, and patients with concomitant tricuspid regurgitation who benefit greatly from this therapy. Not supporting these patients groups could benefit possible life saving therapy.

    Jimenez, Javier Title: MD/Director Advanced Heart Failure and PAH
    Organization: Baptist Health South
    Date: 07/24/2020
    Comment:

    1-I support the decision to include FMR coverage

    2-Disagree with exclusion for coverage for FMR associated to TVR since this is a common occurrence and would exclude patients from a novel, rapidly growing and effective intervention. In turn we do not apply the same rules to patients that need mitral and concomitant tricuspid valve surgery.

    3-Disagree lack of coverage for FMR with hemodynamic instability. There are no studies that would ever include these patient in a

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    Soffer, Daniel Title: Director, Endovascular Cardiology
    Organization: UF Health, Jacksonville, Florida
    Date: 07/24/2020
    Comment:

    iv.The heart team cardiac surgeon and interventional cardiologist have:
    1.Independently examined the patient face-to-face, evaluated the patient’s suitability for surgical mitral valve repair, TEER, maximally tolerated GDMT, or palliative therapy; and
    2.Documented and made available to the other heart team members the rationale for their clinical judgment.
    Comment: For FMR patients, Interventional Cardiologist and heart failure cardiologist should be able to

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    Soffer, Daniel Title: Director, Endovascular Cardiology
    Organization: UF Health, Jacksonville
    Date: 07/24/2020
    Comment:
    The heart team must include:
    i.Cardiac surgeon: 1.With = 20 mitral valve surgeries in the previous year or = 40 in the 2 years prior to program initiation, 50% of which are mitral valve repairs; and
    Comment: There is no link between MV surgical volume and TMVr outcome
    Stark, Matthew Title: VP Clinical and Regulatory
    Organization: Cardiac Dimensions
    Date: 07/24/2020
    Comment:

    July 23, 2020
    Tamara Syrek Jensen, JD
    Director, Coverage & Analysis Group
    Center for Clinical Standards and Quality
    Centers for Medicare & Medicaid Services
    7500 Security Boulevard
    Baltimore, MD 21244

    RE: Proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R)

    Dear Ms. Syrek Jensen:

    Cardiac Dimensions Pty Ltd is pleased to submit comments regarding the Proposed Decision Memo for

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    Soffer, Daniel Title: director, Endovascular Cardiology
    Organization: UF Health, Jacksonville, Florida
    Date: 07/24/2020
    Comment:

    As a Structural Heart Interventionist I have concerns regarding the following statements:

    1. "TEER of the mitral valve for the treatment of functional MR is not covered for patients with any of the following conditions:

    i.Coexisting aortic or tricuspid valve disease requiring surgery or transcatheter intervention; or
    ii.COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use; or"
    iv.Estimated pulmonary artery systolic pressure

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    Birmingham, Brian Title: M.D.
    Organization: University Anesthesiologists
    Date: 07/24/2020
    Comment:
    The guidelines for interventional echocardiographer should include cardiac anesthesiologists. Cardiac anesthesiologists provide high-quality imaging and procedural guidance for this procedure in many high-volume centers. The current draft states that the interventional echocardiographic should be "board eligible or certified in transthoracic and transesophageal echocardiography with advanced training per the American Society of Echocardiography standards; " As the American Society of

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    Hung, Judy Title: MD, FASE, ASE President
    Organization: American Society of Echocardiography
    Date: 07/24/2020
    Comment:
    On behalf of the ASE, we appreciate and thank CMS for developing this NCD guidance. The NCD follows the 2019 ACC/AHA/ASE Advanced Training Statement on Echocardiography. Interventional echocardiography is a rapidly evolving area that requires specific training curriculum to maximize quality patient care. We support the recognition by CMS in this NCD guidance that specialized expertise and training in interventional echocardiography (both cardiologist and cardiac anesthesiologist) is

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    Lindman, Brian Title: Medical Director, Structural Heart and Valve Ctr
    Organization: Vanderbilt University Medical Center
    Date: 07/24/2020
    Comment:

    Name change. Replacing TMVR with TEER makes sense to most fittingly describe the therapy and type of repair.

    Requirements regarding candidacy for mitral valve surgery and face-to-face encounter with a surgeon. For patients with secondary MR, the only therapy that has been shown to be effective (in randomized trials) for improving survival and reducing hospitalizations is TEER. As such, these 2 requirements are unnecessary:
    (1) Section 1.b.v. “Local heart team has determined

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    Owen, Clarence Title: co-director, structural heart valve program
    Organization: Cone Health Heart and Vascular Center
    Date: 07/24/2020
    Comment:
    I applaud the proposed CMS guidelines with the only exception being that the presence of significant tricuspid regurgitation (TR) should not be considered a contraindication to TEER for patients with secondary MR. Many of these patients have significant TR that may improved after their MR has been treated
    Rapp, Jonathan Title: MD
    Organization: Mercy Health
    Date: 07/23/2020
    Comment:

    I think the current proposal for transcatheter edge-to-edge mitral valve is NOT in the best interest of patients for several reasons.

    1. There is data that suggests mitral open surgery volume is NOT predictive of procedural success for MitraClip. Increasing open surgical procedural requirements for centers would benefit high-volume surgical centers, likely in large urban cities, at the expense of patients who do not live close to these areas.
    2. There is data that describes how

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    Lubbe, Dr. Dieter Title: Interventional Cardiologist
    Organization: Sacred Heart Medical Center
    Date: 07/23/2020
    Comment:
    This is an invaluable treatment for my patients and I support your decision to reimburse for functional patients. However, I take issue with the recommendation that these functional patients need to be seen by surgeons as surgery is seldom a viable option for these functional patients.
    Huber, Phil Date: 07/23/2020
    Comment:
    Current clinical data strongly supports reimbursement for both functional and degenerative mitral regurgitation patients. With current structural heart teams, the need for a face-to-face visit with a cardiothoracic surgeon would not seem to always be necessary.
    Foerst, Jason Title: Medical Director of Structural Heart
    Organization: Carilion Clinic
    Date: 07/22/2020
    Comment:
    After careful review I find the proposed coverage for TEER too strict and requiring unnecessary surgical and heart failure physician interaction. The term heart failure expert is rather vague and many institutions do not have formal heart failure programs. There is no compelling surgical treatment for functional mitral regurgitation aside from revascularization when appropriate, therefore, I do not see the value in the added inconvenience, time and cost to a surgical consultation for FMR.

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    Fail, Peter Title: Director of the Structural Heart Team
    Organization: Cardiovascular Institute of the South
    Date: 07/22/2020
    Comment:

    In reviewing the NCD on TEERS there are several points that need to be addressed The hospital program must have the following:
    = 40 mitral valve surgeries in the previous year prior to program initiation, at least 20 of which are mitral valve repairs; from 2000 through 2009. Only 9% of hospitals performed more than 40 mitral operations per year. In 2019 a report noted in a study looking at mitral surgery Median annual procedural volume was 23 at the hospital level (11 for repairs only)

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    Levisay, Justin Title: MD
    Date: 07/22/2020
    Comment:
    I would like to voice my unequivocal support TMVR for the treatment of functional mitral regurgitation. The results off the COAPT trial are unambiguous and represent the strongest data of any modality to date for treatment of functional MR.
    I terms of the coverage decision I see no defensible rationale that patients be evaluated by a cardiothoracic surgeon in addition to a heart failure doctor and intrventional cardiologist. There are no "surgical" procedures which has been demonstrated

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    Kleiman, Neal Title: MD
    Organization: Houston Methodist DeBakey Heart and Vascular Center
    Date: 07/22/2020
    Comment:

    I wish to comment on the proposed Decision Memo for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R). My qualifications are as follows. I am a board certified interventional cardiologist and medical director of the Cardiac Catheterization Laboratory at the Houston Methodist Hospital, Houston TX. I have been involved in structural heart interventions since 2009 and am director of our structural interventional fellowship training program. I have been a principal investigator in

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    Gafoor, Sameer Organization: Swedish Medical Center
    Date: 07/22/2020
    Comment:
    Thank you for the opportunity to write on this document. After the COAPT trial, functional mitral regurgitation therapy with edge-to-edge repair is both safe and effective, and CMS should add this to the patient therapy options for this condition.
    Taylor, Travis Title: Interventional cardiologist
    Organization: Coastal Cardiology
    Date: 07/22/2020
    Comment:

    My primary concerns with the proposed NCD are predominantly related to how the restrictions listed below will limit patients’ access to care and May actually incentivize alternative inappropriate care

    1) the requirement for FMR patients to be seen by a surgeon may actually be harmful. Surgery for isolated secondary MR is not indicated by the Feb 2020 guideline update. Requiring a surgeon, who doesn’t necessarily do TEER, to see the patient may result in inappropriate surgeries.

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    Ramee, Stephen Title: MD
    Organization: Ochsner Heart Valve Center, New Orleans, LA
    Date: 07/22/2020
    Comment:

    I welcome this update to the CMS coverage decision for use of the Mitraclip. As a long tine user of this technology at a high volume center, I would request that you reconsider the exclusion criteria mentioned so that the Heart Team decides who this technology can be used in. Similar to valve surgery, the federal limitations should be narrow and the local heart valve team should be able to make final decisions about their patients.

    This is a life-saving technique in qualified

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    Smith, Cathy Title: RN
    Organization: Ascension Health
    Date: 07/22/2020
    Comment:
    It is very beneficial to continue entering the MitraClips into the national registry in order to track quality and outcomes. We utilize the quarterly data for process and improvements. It gives us the opportunity to look at the whole picture and not just case by case. I am the Structural Heart Coordinator for our program and have discussed this with our Heart Team and they are all in agreement with continuing to enter the MitraClip patients into the registry.
    Thank you,
    Garcia, Santiago Organization: Minneapolis Heart Institute
    Date: 07/21/2020
    Comment:
    Surgery is not the standard of care for patients with functional mitral regurgitation (IIb recommendation in guidelines). The requirement to meet a surgeon prior to trans-catheter edge to edge repair is hard to justify. A consult with a heart failure specialist to ensure medical therapies have been optimized seems more reasonable.
    McAdams, Kelly Title: NP
    Organization: Henrico Doctors' Hospital-HCA
    Date: 07/21/2020
    Comment:

    I have two comments regarding the exclusion list:

    1-It would be detrimental to many patients to exclude tricuspid disease. Many patients have both mitral and tricuspid disease and there is often a step wise treatment approach of treating the mitral valve and if the tricuspid disease does not improve, moving onto treat the tricuspid. Also, treating the mitral valve alone often improves the tricuspid disease.

    2-It seems arbitrary and harmful to exclude O2 dependent patients

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    Kini, Annapoorna Title: Director, Cardiac catheterization laboratory
    Organization: Mount Sinai Hospital
    Date: 07/21/2020
    Comment:

    I support the expanded coverage for FMR patients for TEER

    * CMS should align with the multi-society statement - IC with or without heart failure physician for evaluations of FMR patients. Face to face consultation with CTS team should not be a requirement for FMR cases as TEER is a percutaneous procedure and in most cases multi-specialty face to face consultations delay therapy for patients who need it the most.

    *CMS should consider striking specificity of

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    Aragon, Joseph Title: Director Structural Heart Disease, Director CCL
    Organization: Santa Barbara Cottage
    Date: 07/21/2020
    Comment:

    1. Non coverage for patients on circulatory support or ionotrops is paramount to putting a patent on hospice. Severe MR and Shock responds beautifully to the Mitraclip and is the treatment of choice. Our program has saved multiple lives with Mitraclip in this clinical scenario.

    2.The volume requirements for institutions that start new programs is appropriate

    3.Patients with co-existing valve conditions such as Tricuspid regurgitation or aortic disease will not improve

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    Altit, Roi Title: M.D.
    Date: 07/20/2020
    Comment:

    I just wanted to list several of my concerns - to be taken in to consideration to revising the currently proposed national coverage determination:

    1) Coverage deferred to MACS for degenerative MR: This therapy (TEER) has already been proven very effective to improve quality of life and reduce hospitalizations of CHF for degenerative MR. I am concerned if deferred to MACS, certain areas of the country will be able to get TEER for their patients, where others will not. We have seen

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    Sharma, Rahul Title: MD
    Organization: Carilion Clinic
    Date: 07/20/2020
    Comment:

    1) The use and success of MitraClip for appropriate FMR patients was recently shown in the COAPT trial. I want to reiterate the importance of this therapy remaining covered and being available for these important patients.
    2) Severe TR is associated with high mortality and is often present in patients with moderate-severe/severe MR. It is vital that we be able to percutaneously repair the MR in patients with concomitant severe TR, as our surgical colleagues would do in operable

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    Ambrosia, Alphonse Title: Interventional Cardiologist
    Organization: CardioVascular Associates of Mesa
    Date: 07/20/2020
    Comment:
    Having performed more than 30 TEER procedures and cared for patients with the Heart Team at Banner Heart hospital, the exclusion for coverage for TEER in patients with concomitant aortic and tricuspid disease and with oxygen requiring COPD will compromise the health of patients who have benefited from the procedure in my experience who have had reduced hospital admissions for heart failure and better quality of life. These patients are discussed in detail in the Heart team, and there are

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    Trachiotis, Gregory Title: Chief Cardiothoracic Surgery
    Organization: Vetrans Affairs Medical Center
    Date: 07/20/2020
    Comment:
    I would not excluded based on coexisting aortic and particular associative tricuspid valve disease. Many or most patients going for mitral clip are inoperable, and there will be clinical assessment to status of tricuspid valve disease after improvement of TEER; so to exclude for coverage is not appropriate, as the basis for future TV intervention cannot be determined.
    Price, Matthew Title: MD
    Organization: Scripps Clinic
    Date: 07/20/2020
    Comment:

    CMS proposes that the heart team must include a cardiac surgeon, and that the surgeon Independently examine the patient face-to-face, evaluate the patient’s suitability for surgical mitral valve repair, TEER, maximally tolerated GDMT, or palliative therapy. Furthermore, CMS proposes that local heart team must determine that mitral valve surgery will not be offered as a treatment option. Although this wording mimics the COAPT trial, the absolute requirement for a cardiac surgeon to be

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    Leonardi, Robert Date: 07/19/2020
    Comment:

    Dear Sir or Madam,

    Please take these comments into consideration as the National Coverage Decision for Transcatheter Mitral Valve Repair (TMVr) and Edge-to-Edge Repair (TEER) is finalized.

    Cardiac surgery has an extremely limited role in the treatment of functional mitral regurgitation (FMR). This is in stark contrast to the role of cardiac surgery in the treatment of degenerative mitral regurgitation (DMR), where surgery is first-line therapy. There are data to

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    Cubeddu, Robert Title: Chairman of Cardiology
    Organization: Cleveland Clinic Florida
    Date: 07/19/2020
    Comment:

    I. New proposal recommends IC and CV surgeon face-to-face evaluation for SMR (functional)??
    Response: This is not in line with the ACC which recommends an IC and Heart Failure physician for patients with MR and HF.

    II. New proposal call for exclusion of co-existing conditions such as: a) aortic and tricuspid valve disease requiring intervention, b) need for cardiac surgery within 12 months, c) copd requiring home oxygen.
    Response: TR severity should not be an

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    Verma, Div Title: MD MS
    Organization: Banner University Medical Center
    Date: 07/19/2020
    Comment:

    I want to express my full support for CMS coverage of MitraClip intervention for FMR patients. I have an extensive experience managing and co-managing these challenging patients along with my heart failure colleagues. I am convinced and have personally witnessed dramatic clinical improvement in these patients after MitrClip. I welcome this decision.

    For managing FMR patients and MitraClip procedure evaluation, I do understand need for optimal medical therapy, heart failure

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    Ricciardi, Mark Organization: NorthShore University Health System
    Date: 07/18/2020
    Comment:

    As one who cares for many patients with valvular heart disease, and as a COAPT investigator, I am happy to see CMS address coverage for transcatheter edge to edge repair for functional (secondary) MR. Thank you.

    While satisfied with the majority of the proposed memo, there is one area that I feel strongly should be altered; the section regarding pre op evaluation.

    MANDATING THAT 3 SEPARATE CV SPECIALISTS EVALUATE PATIENTS FOR CANDIDACY FOR A CARDIAC PROCEDURE IS

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    Romero, Steven Title: Cardiologist, Director of Procedural Imaging
    Organization: Scripps Clinic
    Date: 07/17/2020
    Comment:
    Thank you for your work on this important issue.
    I don't understand the need for a cardiac surgeon on the team for the following reasons:
    - surgery is a IIB indication & is not a consideration in this group of patients
    - requiring a surgical consultation will only work to delay patient scheduling & care
    Khan, Fawad Title: Cardiothoracic Surgeon
    Organization: Peninsula Regional Medical Center
    Date: 07/17/2020
    Comment:
    I am a cardiac surgeon at intermediate volume center ~ 300 open heart cases a year (25 open mitral cases per year). I believe that changes to the pre-requisite requirement for CMS coverage of Mitraclip cases will drastically limit patient access to this important therapy for sick patients that have no other alternative. The vast majority of our patients do not have the means (both physically and financially) or desire to travel very long distances to high volume centers to get Mitraclip

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    Patel, Amar Title: Co-Director, Structural Heart and Valve Program
    Organization: Wellstar Health System
    Date: 07/17/2020
    Comment:

    Two points:

    The statement made in the proposed document - "COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use" was listed as a criteria to disqualify a patient from Mitral TEER from an NCD perspective. This exclusionary clinical criteria needs to be considered in the setting of other clinical conditions (RV failure, dilated RV, PHTN with fixed pulmonary vascular resistance) that would suggest a more advanced pulmonary condition where MV

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    Choi, Calvin Title: Associate Professor of Medicine
    Organization: University of Florida
    Date: 07/16/2020
    Comment:
    • I support expanded coverage for FMR patients due to the COAPT™ results.
    • Please consider coverage for FMR patients with co-existing tricuspid valve disease requiring treatment. Combined tricuspid and mitral disease is not uncommon. Excluding these patients may not allow for a staged treatment approach and clinical trial consideration.
    • Please consider keeping volume requirement as before. There are two publications which have shown no link between

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    MacDonald, Lee Title: Cath lab director Swedish Medical Center
    Organization: South Denver Cardiology/Swedish Medical Center
    Date: 07/16/2020
    Comment:

    The COAPT trial used pts with severe functional MR, this subset has not done well with surgical MV repair or replacement. Surgical evaluation for this subset of patients is not practical and not useful, the addition of a HF specialist to make sure the patient is on appropriate goal directed medical therapy is the most important step. A confirmation that medical treatment has been optimized is a more important step than surgical evaluation.

    This surgical evaluation is a

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    John, Jooby Title: MD
    Organization: Cardiovascular Associates Inc
    Date: 07/16/2020
    Comment:
    There is clear and convincing data that transcatheter edge-to-edge mitral valve repair conclusively reduces mortality in secondary mitral regurgitation. There is no data that surgical mitral valve repair/replacement comes close to this. As such, there is no good basis for a surgeon to evaluate the patient first and percutaneous repair to be offered second, since the surgical procedure is not indicated at this point for this disease
    Dube, Sandeep Title: MD
    Organization: Community Heart and Vascular Hospital
    Date: 07/16/2020
    Comment:
    • I am glad CMS is considering expanded coverage to FMR patients due to the COAPT results. This is going to be beneficial to a large segment of patients.
    • Face to face evaluation of patients should be limited to the operator/interventional cardiologist. A surgeon should be part of multidisciplinary evaluation team but face to face with a surgeon should not be a requirement. This is a roadblock to efficient patient care.
    • There should be coverage for FMR patients

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    Diaz, Miguel Title: MD, FACC, FSCAI.
    Organization: Palmetto General Hospital
    Date: 07/15/2020
    Comment:

    Please consider that exclusion of coverage for patients requiring tricuspid valve treatment is not appropriate. TR often improves after transcatheter mitral valve repair and while it may be severe at the time trans catheter mitral valve is considered, it behooves us to treat the MR first and then re evaluate the TR at a later date, possibly saving the patient from a high morbidy and high mortality combined procedure.

    Additionally, this would effectively disqualify many patients

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    Hearne, Steven Title: Director, CV service line, PRMC hospital.
    Organization: Peninsula Regional Health System
    Date: 07/15/2020
    Comment:
    I don't think volume requirements should be increased from 25 to 40 open mitral procedures a year. There is no difference in outcomes in centers that do above 40 or 25 or above a year.
    Taussig, Andrew Title: MD
    Organization: AdventHealth Orlando
    Date: 07/15/2020
    Comment:
    Good afternoon. I commend the decision to recognize the important of the TMVR therapy and need to expand coverage. This is an incredibly valuable therapy to the patients in our community. The one objection I do have is the need for a face to face consultation with a CV surgeon. There is a large body of evidence supporting that these SMR patients are much better off with TMVR than conventional open surgery. Have a great day.
    Padgett, Richard Title: Excutive Medical Director
    Organization: Oregon Heart &Vascular Institute, PeaceHealth
    Date: 07/15/2020
    Comment:

    First, thank you very much for your inclusion of Functional MR in your coverage of Edge-Edge Mitral valve repair. This will help a tremendous number of patients with very limited treatment options.

    2nd While I total support the exclusion and treatment first of patients with AS, the exclusion of pts with TR does not seem appropriate. A major cause of TR is severe MR

    3rd I also have concerns with the exclusion of pts requiring inotropic or other forms of hemodynamic

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    Karanam, Ravindranath Title: Cardiothoracic surgeon
    Organization: Newark Beth Israel Medical Center
    Date: 07/14/2020
    Comment:
    Both competent cardiologists of all stripes duly trained and cardiac surgeons should be allowed to be co-primary operators Of “heart teams” in catheter based valve interventions. This will bring wealth of knowledge and skills and provide comprehensive, complete and safe care to the patients.
    Pick, Adam Title: Patient Advocate
    Organization: HeartValveSurgery.com
    Date: 07/14/2020
    Comment:

    To whom it may concern:

    My name is Adam Pick [PHI Redacted].

    In 2006, I founded HeartValveSurgery.com (HVS) with a mission to educate and to empower heart valve patients from diagnosis through recovery. Since then, the website has helped over 10 million people learn about the management and the treatment of heart valve disease.

    Thanks to HVS, I have been fortunate to see and to participate in the success stories of all different types of

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    Dobesh, David Title: MD
    Organization: RWJBH
    Date: 07/13/2020
    Comment:

    I believe this would be the ideal time to improve upon the " Heart Team Volume Requirements" I suggest adding "Electrophysiologist" to the list of patients who can be the primary or co-primary operator. The value of the knowledge of trans-septal and left atrial anatomy is more greatly appreciated that at the time of the NCD for degenerative MR. EP Cardiologists adept at complex LA ablation and LAA closure add expertise that allows them not only to assist but also to lead a TMVR

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    SUKHIJA, RISHI Date: 07/13/2020
    Comment:

    I do not agree with surgical number requirement for mitral clip
    This is not surgical procedure. You are depriving the needy patients who live in places that do not have surgical numbers but have cath lab with interventional procedures.
    The wait times at large centers, the inconvenience rendered to the patient and family members is not in interest of US population.
    I feel this number requirement might be due to lobbying by people who right these guidelines with vested

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    Condon, Erik Title: MD
    Organization: Providence Medical Group
    Date: 07/11/2020
    Comment:

    I support the expanded indications for trans catheter edge-to-edge mitral valve repair to include functional mitral regurgitation.

    I also would support a review of the policy that a cardiac anesthesiologist cannot bill for the 93355 (interventional TEE) code and provide anesthesia at the same time. In practice, many large heart centers use cardiac anesthesiologists to provide both the anesthetic (with or without a resident or CRNA) and provide intraoperative guidance with TEE

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    Eleid, Mackram Date: 07/10/2020
    Comment:

    There should be no penalty to helping patients and treating both mitral and tricuspid regurgitation in the same procedure. Many patients have both severe MR and TR and this group will be hurt by such a restriction. Current evidence supports treating concomitant tricuspid regurgitation to improve patient outcomes.

    There should not be a requirement to have face to face evaluation by surgeon for functional mitral regurgitation prior to MitraClip, given these patients are rarely

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    Smalling, Richard Title: Director, Interventional Cardiovascular Medicine
    Organization: Memorial Hermann Heart and Vascular Institute-TMC, Houston, TX
    Date: 07/10/2020
    Comment:

    Our Structural Heart Physicians have concerns regarding the following statements:

    1. “The mitral valve TEER must be furnished according to an FDA-approved indication and meet the following conditions:
    All requirements set forth in section 2a through 2c below; and The patient is under the care of a heart failure physician specialist experienced in the care and treatment of mitral valve disease; and The heart team also includes a heart failure physician specialist experienced

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    Goessl, Mario Date: 07/01/2020
    Comment:
    I applaud CMS' proposal for an update to its national coverage policy for edge-to-edge repair of the mitral valve to include FMR. Patients with FMR have limited treatment options, often too high risk for open heart surgery and - as the COAPT trial has shown - have a survival benefit from TEER compared to GDMT. This update is needed.