National Coverage Analysis (NCA) View Public Comments

Transcatheter Aortic Valve Replacement (TAVR)

Public Comments

Commenter Comment Information
Driver, Steven Title: Interventional Cardiologist/Associate Med Director
Date: 04/25/2019
Comment:

We appreciate the opportunity to comment on the Proposed Decision Memo for Transcatheter Aortic Valve replacement. We support changes to surgical aortic valve replacement volumes for new TAVR programs. Similarly, we feel that quantity does not necessarily equate to quality when it comes to percutaneous coronary intervention (PCI) volumes. As such, we would suggest reducing the annual PCI requirements from 300 to 200 per year. Such an approach would avoid creating perverse incentives for

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Lewis, Alison Date: 04/25/2019
Comment:

Some people are told they are too young or too healthy for TAVR or even told you can handle open heart surgery. TAVR needs to be available as an option to patients and they need to be able to share in the decision making process. The following are focuses areas where I believe the overall process can be improved.

1) The two surgeon rule can caused significant confusion and stress

Confusion and stress results when being evaluated by an interventional cardiologist and

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Rekash, C Title: Patient Advocate
Date: 04/25/2019
Comment:

[PHI Redacted] it is paramount when being diagnosed with valve disease, that the patient feels empowered to exercise all treatment options available, whether surgically or via transcather. In addition, knowledge of being eligible to receive the highest standard of care is crucial and can impact a patient’s perspective about his or her diagnosis, treatment and recovery.

By ensuring equitable access, overall quality and full transparency for patients, collectively,

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Keegan, Patricia Title: Director
Organization: Emory Healthcare
Date: 04/25/2019
Comment:
I agree the proposed NCD is making a step forward by decreasing the surgeon assessment from two to one. However, this decision allows for two pathways of treatment for the same disease state. All patients being considered for treatment for aortic stenosis should be evaluated by a heart team to include a cardiothoracic surgeon as well as an interventional cardiologist who performs TAVR. There are no such requirements for patients seen in a center that does not provide TAVR. All patients

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Cozino, Carol Date: 04/25/2019
Comment:
[PHI Redacted] had an aortic valve replacement in July of 2013. [PHI Redacted] had heart valve replacement surgery in Dec of 2013. (not a fun year.) I cannot imagine what my life would be like if they had been unable to have this life saving surgery. Both at living a full and productive life. However, bot valves have a 10-15 year life span. Without Medicare insurance coverage they will die. I do not see how in the greatest country in the world we can even

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Hilmy, Shereef Title: Chief cardiology, Harlingen medical center
Organization: South Heart clinic
Date: 04/25/2019
Comment:

I am an interventional cardiologist with more than 30 years of experience. I have been involved in structuring multiple cardiac interventional programs and surgical programs. I have also been involved with and have performed approximately 900 thoracic and abdominal aneurysm endoluminal grafting. A large percentage of these procedures have been of a complex nature. I currently serve as an endoluminal graft instructor for Medtronic. Our hospital center has also been involved with high volume

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Leon, Martin Title: Mallah Family Professor of Medicine
Organization: Columbia University Medical Center
Date: 04/25/2019
Comment:

Overall, CMS should be congratulated for developing a thoughtful, balanced and well considered draft of the new NCD for TAVR, which respects all stakeholders and maintains a patient-centered focus. Several important points in this document are worthy to highlight and are the subject of constructive comments.

  • Introduction of flexibility regarding procedural volume requirements. The proposed minimum procedural requirements to open a new TAVR program or to maintain an existing TAVR

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  • Wood, Larry Title: Corporate Vice President, THV
    Organization: Edwards Lifesciences
    Date: 04/25/2019
    Comment:

    April 25, 2019

    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 Aortic Valve Replacement (TAVR) (CAG-00430R)

    Dear Ms. Syrek Jensen,

    Edwards Lifesciences (“Edwards”) appreciates the opportunity to comment on the proposed decision memo for TAVR (CAG-00430R). Edwards greatly

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    Peschin, MHS, Sue Title: President and CEO
    Organization: Alliance for Aging Research
    Date: 04/25/2019
    Comment:

    April 25, 2019

    Seema Verma
    Administrator
    Centers for Medicare & Medicaid Services
    7500 Security Blvd.
    Baltimore, MD 21244

    Dear Administrator Verma:

    The undersigned organizations are writing with our response to the Centers for Medicare & Medicaid Services’ (CMS) updated proposed decision on Medicare’s National Coverage Decision (NCD) for transcatheter aortic valve replacement (TAVR) (CAG-00430R). Collectively, we represent heart valve disease

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    Gleason, Thomas Title: Chief, Division of Cardiac Surgery
    Organization: UPMC
    Date: 04/25/2019
    Comment:

    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 Aortic Valve Replacement (TAVR) (CAG-00430R)

    Dear Ms. Syrek-Jensen:

    We write in response to the proposed decision memo for TAVR (TACMS VR) (CAG-00430R) on behalf of UPMC’S Heart and Vascular Institute, which is the Cardiovascular Service line for all

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    Berry, Kate Title: Senior Vice President for Strategic Planning
    Organization: America's Health Insurance Plans
    Date: 04/25/2019
    Comment:

    America’s Health Insurance Plans (AHIP) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) national coverage analysis for Transcatheter Aortic Valve Replacement (TAVR).

    We support CMS’ proposed decision to cover TAVR under a coverage of evidence development process, including the proposed safety mechanisms and additional monitoring guidelines.

    We recommend that CMS ensures that the registry includes a mechanism to track regulatory

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    Faller, Bernard Date: 04/25/2019
    Comment:
    [PHI Redacted] TAVR is far less invasive and, most importantly, the procedures is less of an insult to the brain. Replacing the pumping heart with a machine for an hour or two causes loss of cognitive function in many people. [PHI Redacted] In conclusion, the procedure is safer, likely cheaper at least in the long run [PHI Redacted]. Please factor these elements into your considerations. Thank you.
    Morrison, Janet Title: Patient Advocate
    Organization: Vision Resources,Inc.
    Date: 04/25/2019
    Comment:

    [PHI Redacted]. However, when I asked for their outcome data on TAVR patients with severe radiation induced aortic stenosis, I was told simply “we have done plenty”. I was then given national incidence percentages for adverse events like mortality, stroke, bleeding, etc. When I came back to that institution a few weeks later with a list of questions for the interventional cardiologist, I was given terse, one word responses. The contacts that I had with this large volume

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    Calvert, Barbara Title: Director, Government Affairs
    Organization: Abbott
    Date: 04/25/2019
    Comment:

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

    Re: Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R)

    Dear Ms. Syrek Jensen:

    Abbott welcomes the opportunity to comment on the Proposed Decision Memo for Transcatheter Aortic Valve

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    SPEIL, STEVEN Title: EVP
    Organization: FAH
    Date: 04/25/2019
    Comment:

    Charles N. Kahn III
    President and CEO

    April 25, 2019

    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 Aortic Valve Replacement

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    Acker, Michael Title: MD
    Organization: Penn Medicine
    Date: 04/25/2019
    Comment:

    Dear Centers for Medicare and Medicaid Services:

    This is a response to the proposed decision memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R) from the Penn Medicine Heart and Vascular Center (Penn HVC) which is the Cardiovascular Service Line for Penn Medicine in the Greater Philadelphia Region. The service line consists of 18 cardiac surgeons and 208 cardiologists in the Southeastern Pennsylvania and South Jersey region. The physicians represented by the Penn

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    McKenzie, Tabitha Title: Heart, Lung, & Vascular Service Line Director
    Organization: Genesis HealthCare System
    Date: 04/25/2019
    Comment:

    Genesis HealthCare System (GHS) welcomes the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposal to update its national coverage policy for Transcatheter Aortic Valve Replacement (TAVR). GHS appreciates your staff’s efforts to update the coverage criteria for hospitals and physicians to begin or maintain a TAVR program—thus potentially expanding patients’ access to TAVR. GHS hopes that its comments are helpful in this endeavor.

    GHS strongly supports

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    Prager, Richard Title: Interim Chair, Department of Cardiac Surgery
    Organization: University of Michigan, Michigan Medicine
    Date: 04/25/2019
    Comment:

    Centers for Medicare and Medicaid Services:

    This is a response to the proposed decision memo for TAVR (TAVR) (CAG-00430R) from the University of Michigan Frankel Cardiovascular Center (FCVC) which is the Cardiovascular Service line for Michigan Medicine. The service line consists of 9 adult cardiac surgeons and 133 cardiologists serving the state of Michigan. The physicians represented by the FCVC perform between 250-300 TAVRS annually and approximately 550-650 broadly defined

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    Weber, Mike Title: Assistant Regional Director
    Organization: The Mended Hearts, Inc.
    Date: 04/25/2019
    Comment:
    [PHI Redacted] I think procedures like TAVR are very important. It is much easier for the patients to tolerate and the recovery is much quicker. My hope is that the TAVR procedures will continue. I also visit patients in the hospital after surgery and I see a significant difference in patients that have had a TAVR as opposed to those who have had a sternotomy.
    Wallace, Mike Date: 04/25/2019
    Comment:

    I strongly urge you to continue coverage for the TAVR procedure. This less invasive procedure will continue to improve and reduce hospital stays and improve patient recovery time.

    [PHI Redacted]

    This procedure should become a first option for many patients. It is my hope that cardiologist and cardiac surgeons recommend this procedure more often in the future and open heart surgery becomes the last resort.

    Continued, and increased, coverage for

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    Handke, Bonnie Title: Vice President, Health Economics, Policy & Payment
    Organization: Medtronic Coronary and Structural Heart
    Date: 04/25/2019
    Comment:

    Dear Ms. Syrek Jensen:

    On behalf of Medtronic, I am pleased to respond to the Centers for Medicare & Medicaid Services’ (CMS’s) request for public comment on the proposed decision memo of the national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR).[1,2]

    Medtronic is the world’s leading medical technology company, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. As a global

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    Branham, Chandra Title: VP, Payment & Health Care Delivery Policy
    Organization: AdvaMed
    Date: 04/25/2019
    Comment:

    April 25, 2019

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

    RE: Proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R)

    Dear Ms. Syrek Jensen:

    The Advanced Medical Technology Association (AdvaMed) is pleased to

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    Health, Avalere Organization: Heart Valve Initiative
    Date: 04/25/2019
    Comment:

    Avalere Health and the Heart Valve Initiative appreciates CMS’ reference to the importance of shared decision-making (SDM) in a variety of clinical scenarios including transcatheter aortic valve replacement (TAVR). We understand that in the current environment, there are limited choices for an evidence-based decision aid or tool for this patient population.

    There is strong evidence to support that SDM increases a patient’s knowledge and accuracy of risk perceptions, and that

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    Poteet, James Date: 04/25/2019
    Comment:
    These proposed changes will certainly make it easier for patients who need a TAVR to have access to this lifesaving procedure.
    Walker, Michelle Title: Structural Heart Coordinator
    Organization: Henry Ford Allegiance Health
    Date: 04/25/2019
    Comment:

    April 24, 2019

    We appreciate the opportunity to submit in support of less stringent criteria for centers performing Surgical Aortic Valve Replacement (SAVR) to initiate a Transcatheter Aortic Valve (TAVR) program. The proposed volume requirements released on March 26th for the initiation and continuation of a TAVR center are inclusive to ensure innovative and therapeutic procedure can be offered to all patients equally, particularly in rural health systems like ours. Mandating

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    Tahil, Ghanshyam Title: Mr.
    Date: 04/25/2019
    Comment:

    [PHI Redacted]

    I urge you to make the TAVR option as widely available everywhere. Every one facing a heart operation should by law be informed of the TAVR option and where they can get it. It should be open heart surgery itself that should be minimized as much as possible. TAVR will be much less costly to Medicare, i.e. the nation, and to the patients themselves.

    We must not sacrifice the interests of the many for the sake of the few. The many being the

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    BJURLING, ELDEN Organization: WHEELEN SUPPLY CO INC
    Date: 04/25/2019
    Comment:
    [PHI Redacted] GREAT PROCEDURE WITH MINIMUM AFTER EFFECTS OR INFECTIONS.
    Kent, Amber Title: RN Valve Clinic Coordinator
    Date: 04/25/2019
    Comment:
    Our facility is 350 beds, and we serve a large region of rural communities. Our TAVR program has been running for almost 3 1/2 years, keeping our volume around 25 cases per year. Our SAVR volumes are around the same. Each year is a stress for our team as we strive to meet volume requirements for each. We have had great outcomes, with no in-hospital mortalities and a handful of complications. Our goal is to grow our program by doing outreach to have more providers refer their patients to us

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    Keochakian, Simon Organization: Eldercare Solutions, LLC
    Date: 04/25/2019
    Comment:
    [PHI Redacted] I urge CMS to expand TAVR availability to all people who need aortic valve replacement. The quick recovery, absence of pain, and the elimination of prolonged rehabilitation should make TAVR the treatment of choice for severe aortic stenosis. The available evidence indicates that TAVR is equally safe and effective as SAVR.
    Stewart, Maria Title: Vice President, Global HEMA
    Organization: Boston Scientific Corporation
    Date: 04/25/2019
    Comment:

    April 24, 2019

    Tamara Syrek Jensen, JD
    Director, Coverage & Analysis Group
    Office of Clinical Standards and Quality
    Centers for Medicare & Medicaid Services
    Mailstop C1-09-06
    7500 Security Blvd.
    Baltimore, MD 21244

    RE: National Coverage Analysis (NCA) Tracking Sheet for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R)

    Dear Ms. Syrek Jensen,

    Boston Scientific Corporation (BSC) appreciates the opportunity to comment on the

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    Coylewright, Megan Title: Mid-career academic heart team clinicians
    Organization: Columbia, Dartmouth, U of Washington, Yale
    Date: 04/25/2019
    Comment:

    Aortic stenosis (AS) is the most common valvular heart disease requiring intervention in the United States, and the past decade has witnessed a profound, rapid evolution in treatment paradigms. Based on an unprecedented clinical trial effort, transcatheter aortic valve replacement (TAVR) has been approved and rapidly adopted for the treatment of intermediate and higher surgical risk patients with symptomatic severe AS. (Leon MB et al. NEJM 2016; Reardon MJ et al. NEJM 2017) Indeed, by

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    Britting, Lorraine Title: Nurse Practitioner
    Date: 04/25/2019
    Comment:
    I agree to change to one surgeon. Having two surgeons see each patient is a waste of Medicare dollars.
    Higgins, Robert Title: President, STS
    Organization: Multi-Society Comments
    Date: 04/25/2019
    Comment:

    April 25, 2019

    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 Aortic Valve Replacement (TAVR) (CAG-00430R)

    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

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    Mack, Michael Title: Chair Cardiovascular Service Line
    Organization: Baylor Scott & White Health
    Date: 04/25/2019
    Comment:

    April 25, 2019

    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 Aortic Valve Replacement (“TAVR”) (CAG-00430R)

    Dear Ms. Syrek-Jensen:

    Baylor Scott & White Health (BSWH) is the largest not-for-profit healthcare system in Texas and one of the largest in the United States with over 1,000 access points. Our

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    Blount, wendy Date: 04/25/2019
    Comment:
    [PHI Redacted] Please push for this non invasive procedure to repair the aortic valve not only will it reduce recovery time, but it will reduce hospital inpatient expenses. Covering Transcatheter Aortic Valve Replacement can provide opportunity for those who need the procedure to be able to recover faster and reduce hospital stays which will save Medicare and medicaid money in the long run. After working so hard to survive, so we can be eligible for retirement and benefits it

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    Phillips, Kristine Title: Director Critical Care
    Organization: Mercy Health System
    Date: 04/25/2019
    Comment:

    I am reading with interest the discussion that is occurring regarding funding for TAVR procedures. [PHI Redacted] I also went through the experience of attending all pre-op appointments and listened to the decision making process when [PHI Redacted] needed an aortic valve replacement. [PHI Redacted] was initially scheduled to have a traditional AVR but due to a prior history of breast cancer and radiation treatments that left her sternum

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    Shaikh, Saeed Title: Director, Structural Heart Interventions
    Organization: Francian Health, Indianapolis
    Date: 04/25/2019
    Comment:
    Medium sized hospitals that provide care to vast majority of the country need to provide this essential service/procedure. Getting to 20 surgical AVRs over 2 yrs will be a daunting task for a new program, as TAVR approval for low risk patients is just around the corner. We expect that Surgical AVRs will be limited to patients with Endocarditis, Aortic root problems and Redo patients with indwelling Mechanical AVRs. It will be almost impossible to get 20 such case. Recommend the

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    Miller, Michael Title: Senior Policy Advisor
    Organization: HealthyWomen
    Date: 04/25/2019
    Comment:

    Below are the comments of our letter that HealthyWomen will also be submitting via email.

    April 25, 2019

    The Honorable Seema Verma
    Administrator
    Centers for Medicare and Medicaid Services
    Department of Health and Human Services
    Mail Stop C4-26-05
    7500 Security Boulevard
    Baltimore, MD 21244-1850

    Re: Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R)

    Dear Administrator Verma:

    HealthyWomen

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    Baeumler, Leonore Title: Transcatheter Aortic Valve Replacement (TAVR)
    Date: 04/25/2019
    Comment:

    I am writing this comment to support efforts that will allow the Medicare review board to discontinue (or at least minimize) restrictive directives which are currently in place to regulate access for the TAVR procedure that may have been necessary at the time of inception for initial review, but are no longer necessary. I am advocating that the quantifying hospital requirements give way to qualitative assessments that benefit all patients who are candidates for the

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    Johnston, Robert Date: 04/25/2019
    Comment:

    Getting good treatment and controlled TAVR surgery is paramount to success of such a wonderful procedure. I have witnessed 1st hand TAVR patient success that would be completely different if they did not receive quality TAVR surgery.

    I encourage CMS to expand access to TAVR and remove overly strict requirements Medicare has had in place for seven years for patients to get the procedure. Impactful people in my life that helped me [PHI Redacted] would not be alive

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    Mulukutla, Chalam Title: Adult / Pediatric Interventional Cardiologist
    Organization: El Paso Cardiology Associates
    Date: 04/25/2019
    Comment:

    Transcatheter aortic valve replacement is a life-saving procedure and limiting access to care is hurting patients.

    I live in El Paso, Texas and access to care is difficult and sometimes not possible due to our geographic isolation. I have had several patients die with aortic stenosis because they are unable to travel to large centers due to socio economic reasons, money, frailty, etc.

    Data clearly shows that low volume and high-volume centers have had similar outcomes.

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    Kessler, Carol Date: 04/25/2019
    Comment:
    Please protect/allow for patients to have access to TAVR. The prospect of better and faster recovery for the aging adults who usually are the ones who need this treatment is vital. [PHI Redacted]. [PHI Redacted] fully recovered from TAVR in 4 months. [PHI Redacted], who had his chest opened up, is 6 months out and still has pain and cannot perform as he wishes. The risks of his dying or serious consequences was also much greater than

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    Gambardella, Robert Title: Retired medical social worker
    Date: 04/24/2019
    Comment:

    [PHI Redacted] we are concerned about the current status of the decision making process for the TAVR. [PHI Redacted] had a surgical valve replacement with open heart surgery in September 2017 so she has been both a patient and a caregiver. The comparative differences in the procedure vs. the surgery are tremendous. Following the TAVR, [PHI Redacted] was out of the hospital in two days vs. 9 with the open heart surgery, and rehab

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    McKinney, Elizabeth Date: 04/24/2019
    Comment:
    I am writing to strongly urge revision in the proposed TAVR coverage documentation: [PHI Redacted] Aortic Valve replaced by open heart surgery. [PHI Redacted] The process of preventing a person chest being cracked open could make the process of getting back to normal like such as working and contributing to society quicker. [PHI Redacted] I feel with the advancements made in heart surgery in today's society that preventing patients from

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    Genereux, Philippe Title: MD
    Date: 04/24/2019
    Comment:

    Proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R)

    I am an Interventional Cardiologist and Co-Director of the Structural Heart Program at Morristown Medical Centre in New Jersey. I have served as the primary or co- investigator on more than 20 clinical trials and have been published more than 300 times in peer-reviewed cardiology journals. I have been active in research but in the clinical setting and have seen the evolution

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    Fabry, Victor Title: President
    Organization: Mended Hearts of Morris County
    Date: 04/24/2019
    Comment:
    Mended Hearts of Morris County is a all volunteer, non-profit support group for heart patients. Our accredited visiting members visit heart patients in-hospital before and after surgery to answer questions and support their recovery.
    Baeumler, Ruth Date: 04/24/2019
    Comment:

    Comments from a Caregiver:

    [PHI Redacted] was 88 when she had her TAVR procedure. She is now well on her way to 91. The year prior to her TAVR procedure I could see her slowing down, having a harder time doing things she loves. Her overall health was very good, but she kept needing to stop to catch her breath. The driveway was too long. I began to worry that she would need in-home care and other support[PHI Redacted]. [PHI Redacted]

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    Carothers, Frances Date: 04/24/2019
    Comment:
    [PHI Redacted] This procedure should be made available to all that need it. The cost is so much less and the recovery is so much easier that I can't understand why it is not given as a choice to all that need it.
    Kelley, Malcolm Date: 04/24/2019
    Comment:
    [PHI Redacted] I absolutely believe Medicare should cover TAVR nationally for all FDA approved indications. This possibility will be as important to any such patient as it was for [PHI Redacted]. [PHI Redacted] Finding information about the quality of the hospitals was very difficult and limited. I would like to see reporting of the performing hospitals made available to help patients make informed choices. I urge CMS to make these changes.
    Santos, Alfred Title: Director of Cardiovascular Services
    Organization: Swedish Covenant Hospital
    Date: 04/24/2019
    Comment:

    Thank you for considering comments regarding TAVR program qualifications. On behalf of Swedish Covenant Hospital’s cardiac patients we are in favor of the new proposed qualifications for TAVR program. Our hospital has provided high quality cardiac care for nearly 20 years. We have an excellent open heart surgery and interventional cardiology program that continuously produces great quality outcomes. Having the ability to offer TAVR at our facility would be a huge benefit to our community.

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    Ellegood, Cheryl Title: Vice President, Service Lines
    Organization: McLaren Health Care
    Date: 04/24/2019
    Comment:

    To whom it may concern,

    McLaren Health Care, a Michigan health care organization with four active TAVR sites, is responding to the CMS Decision Summary that outlines specific hospital infrastructure to provide treatment of symptomatic aortic valve stenosis. Our physicians who are active participants on the TAVR multidisciplinary teams at our four sites would like their comments considered in CMS’s final NCD decision. Their comments are as follows:

    1. We would like

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    Yadav, Neha Title: Cardiac cath lab director
    Organization: John Stroger Hospital of Cook County
    Date: 04/24/2019
    Comment:
    Partner 3 demonstrates that this technology should be accessible to all patients. Hopefully CMS makes it easier for hospitals that serve the community and safety net hospitals with established interventional cardiology programs and on site cardiac surgery to offer this life changing technology to their patients. We should try to avoid the mistakes of the "coronary stent" era where patients could not avail themselves of the benefits of medical progress unless you lived in a certain area or

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    Seffens, Martin Date: 04/24/2019
    Comment:

    One additional thought:

    In considering the pending NCD changes, CMS should give substantial weight to the studies based on information from the STS/ACC TVT Registry that report favorable patient outcomes of the TAVR procedure.

    Outcomes which were a legitimate concern and in doubt when the NCD was put in place, shouldn't be now.

    Smalling, Richard Title: Director, Interventional Cardiology
    Organization: UTHealth/McGovern Medical School/Memorial Hermann HVI
    Date: 04/24/2019
    Comment:

    The body of knowledge regarding the safety and efficacy of TAVR, especially with regard to SAVR, continues to increase at a rapid pace. I had the opportunity to participate, as one of the representatives from our healthcare system, at the Medicare Evidence Development and Coverage Advisory Committee - Procedural Volume Requirements for TAVR on July 25, 2018.

    It was clear, in that meeting, that there was a perception that the credentialing requirements for TAVR operators and

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    Malhotra, Saurabh Title: Asst Prof.of Medicine/Director of Cardiac Imaging
    Organization: Cook County Health
    Date: 04/24/2019
    Comment:
    TAVR is becoming standard of care given the data from new clinical trials. Community hospitals with established interventional and cardiac surgery programs should have access to this life saving therapy, specifically those programs that provide charity care and care for under served populations.
    Danforth, Melissa Title: Vice President of Health Care Ratings
    Organization: The Leapfrog Group
    Date: 04/24/2019
    Comment:

    The Leapfrog Group is writing in full support of CMS’ recent national coverage decision for transcatheter aortic valve replacement (TAVR).

    The Leapfrog Group, our Board of Directors, and members collectively comprise hundreds of the leading purchaser and employer organizations across the country. We are committed to improving the safety, quality and affordability of healthcare with meaningful metrics that inform consumer choice, payment and quality improvement. In 2001, developed

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    Doukky, Rami Title: Chair, Division of Cardiology
    Organization: Cook County Health
    Date: 04/24/2019
    Comment:
    The present data and state of TAVR technology clearly indicate that it is rapidly becoming the standard of care for treatment of aortic stenosis. Community programs with established interventional and open heart programs should have access to this technology. Special consideration should be given to public hospitals that provide charity care to a high proportion of their patients. Without access to TAVR therapies in such hospitals, many uninsured or under-insured patients would never have

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    Wright, Richard Title: Chairman
    Organization: Pacific Heart Institute
    Date: 04/24/2019
    Comment:

    To some, the proposed NCD is a reasonable compromise between assuring competency of TAVR services to Medicare beneficiaries and allowing access to such services.

    I suggest, however, that consideration be given to two salient unintended consequences of the proposed volume requirements of this NCD.

    1. It is completely unclear to me how percutaneous coronary intervention (PCI) was chosen as the most important surrogate for the annual hospital volume requirement. PCI

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    Jones, Stephanie Title: Manager Cardiology Services
    Organization: Hendrick Medical Center
    Date: 04/23/2019
    Comment:

    Hendrick Medical Center (HMC) is a West Texas Hospital ((564 Licensed bed facility) located in Abilene Texas with a service area that covers 24 counties, (400,000+ Population). We are interested in starting a TAVR program and meet all of the requirements of the National Coverage Determination (NCD) for TAVR (20.32) with the exception of the SAVR volume of the previous year.

    The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our

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    Guibone, Kimberly Title: Structural Heart Lead Nurse Practitioner
    Organization: Beth Israel Deaconess Medical Center
    Date: 04/23/2019
    Comment:
    This is in support of the proposed change to one-cardiac surgeon evaluation. The prior two-surgeon rule, though well intended, ultimately led to resource intensive work-arounds and a delay in care for this acute population.
    Donofrio, Kathy Title: VP, Cardiology and CNO
    Organization: SWEDISH COVENANT HOSPITAL
    Date: 04/23/2019
    Comment:

    Thank you for considering our comments on the proposed decision regarding TAVR program qualifications.

    For nearly 20 years our open heart program has provided our community with high quality, comprehensive care with over 40,000 cardiac patient visits each year. With open heart surgery mortality rates at or near 0%, our cardiac surgical team continues to perform, on average, 150 open heart surgeries per year. However, aortic valve surgery volume is just below the current required

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    Haffner, Lawrence Date: 04/23/2019
    Comment:

    [PHI Redacted]

    First of all, I am pleased that CMS finally decided to reconsider and revise the NCD for the TAVR process. I am also pleased that some significant changes have been made in this proposed draft.

    But I am just so disappointed that everything is seeming still volume based for doctors and hospital. This should NOT be about volume, but rather should be about quality of care and success. I know that many low volume institutions provide

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    Clegg, Stacey Title: MD
    Date: 04/23/2019
    Comment:
    This is a huge and beneficial step forward towards offering patients what is becoming standard of care. I think the guidelines should be even less strict regarding # of PCI per institution. PCI volumes are going down given the evidence supporting medical therapy for CAD and this is in no way a marker of a good institutional cardiac program. I would encourage the guidelines to be somewhere near 200 PCI per year. My academic institution does barely 300 PCI per year, we serve an underserved,

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    Pelikan, Peter Title: Medical Director, Coronary and Structural Interven
    Organization: Pacific Heart Institute
    Date: 04/23/2019
    Comment:

    VOLUME OUTCOMES RELATIONSHIP FOR TAVR:

    CLINICAL SIGNIFICANCE vs. STATISTICAL SIGNIFICANCE

    As the TAVR NCD proposed revision is considered, two articles1,2 with seemingly opposing findings have been published. The purpose of these comments is to review and compare these articles, so that the Medicare Coverage and Analysis Group (CAG) will not be misled by conflicting data. As such, it is my hope that the CAG will not be influenced to further restrict hospitals

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    Wolinsky, David Title: MD FACC
    Organization: Cleveland clinic Florida
    Date: 04/23/2019
    Comment:
    I agree with the proposed measures and fully support the change of requirements. With increased TAVR valve safety and results, and with expansion of indications to lower risk groups with results equal or superior to surgery (SAVR), expansion of access to care of patients by well trained operators will improve overall access and outcomes for the US population. Strongly support the Registry to monitor usage, safety and outcomes.
    Waksman, Ron Title: Associate Director, Cardiology
    Organization: MedStar Heart and Vascular Institute
    Date: 04/23/2019
    Comment:

    Proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R)

    As the associate director of the Division of Cardiology of Medstar Washington Hospital Center, I have seen the evolution of transcatheter aortic valve replacement (TAVR) since it was covered by Medicare with the first NCD in 2012. It has matured significantly, and it can be now be viewed as a proven technology that has been in use for the past 17 years. The amount of data

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    O'Mara, Jack Title: Mr
    Organization: retired
    Date: 04/23/2019
    Comment:

    [PHI Redacted]

    I am posting this because in the following 2 years I have met several folks that needed to have their aortic valve replaced and did not know about this extraordinary alternative to open heart surgery simply because their cardiologist didn’t mention or suggest it. In this day and age I think it is unconscionable that a cardiologist would not offer the TAVR procedure vs. open heart surgery. This is exacerbated by the fact that most valve patients i

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    Wilson, Laura Title: ACAGNP. AACC
    Date: 04/23/2019
    Comment:

    Living in the city of almost 1,000,000, we have small fractionated hospitals. Although the volume of the city meet the 2012 recommendations. The physicians although homogenous are unable to complete the volume requirement in one hospital related just to space. The geographical location and isolation of El Paso discourages our patients to leave to receive what is considered standard of care. And sadly they pass away without care they would receiving any other city the size. The

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    Siraj, Yaser Title: Medical Director
    Organization: SwedishAmerican Hospital
    Date: 04/23/2019
    Comment:
    CMS’ new proposed policy regarding TAVR requirements for new programs and maintenance of current programs is well thought out and appropriate. With TAVR continuing to show positive outcomes in trial after trial, it is imperative to increase patient access to this procedure nationally. The proposed new guidelines will enable hospitals in smaller communities to start and maintain TAVR programs. With team learning and approach to the procedure as is the current standard, I believe this procedure

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    Russo, Mark Title: Chief, Cardiac Surgery; Director SHD
    Organization: Rutgers-Robert Wood Johnson Medical School
    Date: 04/22/2019
    Comment:

    The initial TAVR NCD (2012) was a visionary document. In the setting of great uncertainty around a completely novel technology, providers, industry, and regulatory agencies worked together to develop a set of policies that not only created a pathway for the responsible adoption and diffusion of TAVR but also facilitated its evolution into a disruptive therapy. The rollout of TAVR should serve as a model for the introduction of novel device therapies.

    However, as TAVR has changed

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    Strong, Susan Date: 04/22/2019
    Comment:

    [PHI Redacted]

    Not everyone is so lucky. Some people are too sick to make a multi-hour trip, or they don’t have the resources to make multiple trips and overnight stays. Some people are told “you are too young/ too healthy for TAVR.” Today, TAVR is not provided at any facility in the state of Wyoming. Today, thousands of people who want TAVR are being told they do not qualify. Today, decisions can be made to improve patients’ access to TAVR.
    TAVR has been

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    Seffens, Martin Title: Medicare Recipient and Caregiver
    Organization: self
    Date: 04/22/2019
    Comment:

    In evaluating the TAVR coverage policy, I urge CMS to please ask the following questions about what we have learned from the 200,000 TAVR procedures completed over the past 7 years in the USA:

    1. Is the TAVR procedure still considered experimental by CMS?
    2. Have the best practices of the TAVR procedure been proven, documented, and widely distributed?
    3. Is the outcome of every TAVR procedure recorded in a registry available for analysis?
    4. How do these

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    Seffens, Brunhilde Organization: self
    Date: 04/22/2019
    Comment:

    [PHI Redacted]

    All patients deserve a fair chance to be informed of, evaluated for, and consider all appropriate treatment options, so they can choose the right one for their situation, values, and preferences.

    [PHI Redacted] I strongly recommend making TAVR accessible to all aortic stenosis patients who could benefit from it, regardless of risk profile or which hospital they go to, or which physician they consult.
    POP, Andrei Title: MD
    Date: 04/22/2019
    Comment:

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

    With regards to the Proposed National Coverage Decision Memo for Transcatheter Aortic Valve Replacement (CAG-00430R)

    Dear Ms. Syrken- Jensen:

    I have read carefully the document referenced above and I would like to offer the following comments:

    1. I applaud the proposal to require

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    Richardson, Marion Date: 04/22/2019
    Comment:

    [PHI Redacted]

    Medical decisions should be made, based on the best available research, by the patient and their doctor using the most appropriate methods, NOT dictated by bureaucrats!

    Zhang, Li Title: MD
    Organization: Cleveland Clinic
    Date: 04/22/2019
    Comment:
    I agree with the proposed measures and fully support the change of requirements. With increased TAVR valve safety and results, and with expansion of indications to lower risk groups with results equal or superior to surgery (SAVR), expansion of access to care of patients by well trained operators will improve overall access and outcomes for the US population. Strongly support the Registry to monitor usage, safety and outcomes.
    King, Terry Title: MD
    Organization: Cleveland Clinic Florida
    Date: 04/22/2019
    Comment:
    Comment: I agree with the proposed measures and fully support the change of requirements. With increased TAVR valve safety and results, and with expansion of indications to lower risk groups with results equal or superior to surgery (SAVR), expansion of access to care of patients by well trained operators will improve overall access and outcomes for the US population. Strongly support the Registry to monitor usage, safety and outcomes.
    KHEMANI, ANIL Title: MD
    Organization: MERCY HEALTH SYSTEM
    Date: 04/22/2019
    Comment:
    lower the PCI threshold to >200 interventions per year
    levin, thomas Title: MD
    Organization: Advocate MEdical Group
    Date: 04/22/2019
    Comment:

    Regarding qualifications to begin a program: the requirement for 60 BAVs seems excessive in the modern era in view of the fact that fewer BAVs are performed as isolated procedures and we're moving away from doing BAV at the time of TAVR implantation.

    Secondly, it seems reasonable to remove the requirement of having both a CV surgeon and interventional cardiologist physically at the table doing the procedure together in well established programs as long as there are two operators wit

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    Saini, Abhimanyu Title: MD
    Date: 04/22/2019
    Comment:
    I support the dissemination of the newer technologies like trans-cathetor aortic valve replacement to hospitals in the community with active robust surgical and interventional cardiology programs . These procedures should be made available to all out patients in the community and represent a paradigm shift in how we take care of these patients.
    Chilukuri, Karuna Date: 04/22/2019
    Comment:
    Please consider lowering the PCI threshold to >200 interventions per year
    Shifrin, Gary Title: MD, FACC
    Organization: Cleveland Clinic Florida
    Date: 04/22/2019
    Comment:
    Comment: I agree with the proposed measures and fully support the change of requirements. With increased TAVR valve safety and results, and with expansion of indications to lower risk groups with results equal or superior to surgery (SAVR), expansion of access to care of patients by well trained operators will improve overall access and outcomes for the US population. Strongly support the Registry to monitor usage, safety and outcomes.
    Patel, Vikas Organization: Riverside Medical Center
    Date: 04/21/2019
    Comment:
    Being a rural location with a large population to care more. It would be a great benefit for patient's to be able to get this care near their home. Many are unable to travel from their rural locations.
    Bush, Howard Title: Interventional Cardiologist
    Organization: Cleveland Clinic Florida
    Date: 04/21/2019
    Comment:
    I am in strong support of the proposed reduction in PCI volume (minimum of 300 PCI's/year, down from 400 PCI's/year) for the establishment of a TAVR program. I have been a practicing interventional cardiologist for over 30 years and have lived through the early years of this "sub-speciality". I don't believe would could have arrived at this point (percutaneous valve implantation) had we not "proceeded with caution" with each new therapy and device. I believe more important than actual case

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    Wien, Trudy Date: 04/21/2019
    Comment:
    Please allow anyone who needs this to have it. It has saved so many lives. [PHI Redacted] would be dead today if not for Tarv.
    Grove, Mark Title: M.D.
    Organization: Cleveland Clinic Florida.
    Date: 04/21/2019
    Comment:

    I agree with the proposed measures and fully support the change of requirements. With increased TAVR implementation and improved outcomes, with expansion of accepted indications to lower risk groups and by achieving results equal or superior to surgery (SAVR), expansion of access for patients to well- trained operators will improve overall access and outcomes for the US population with aortic valve disease. Continued efforts to monitor usage, safety and outcomes will be important going

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    Lopez, David Title: MD
    Organization: Cleveland Clinic Florida
    Date: 04/21/2019
    Comment:
    My comment is to express my support for the proposed TAVR institutional requirements. I also agree with the requirement for registry enrollment in order to understand the true clinical impact of TAVR as a day-to-day application.
    Kiernan, Francis Title: MD
    Organization: Hartford Hospital
    Date: 04/20/2019
    Comment:
    I would propose that an interventional cardiologist (qualified in TAVR) should also be able to evaluate a patient for the suitability of TAVR and this evaluation should be considered by the Heart Team and accepted by CMS
    Rubin, Arthur Date: 04/20/2019
    Comment:

    I'm writing to urge Medicare give full approval to the TAVR procedure. [PHI Redacted] many people my age and older aren't physically able to undergo it. That's why the TAVR is so miraculous for these people. [PHI Redacted]

    Thus, I urge you to give full, rather than restricted, approval for the TAVR procedure. Many people's aortic valve wears out in time, and living a healthy lifestyle doesn't prevent this. TAVR truly is a lifesaver for all of

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    Bramblett, Roderick Date: 04/20/2019
    Comment:

    I urge CMS to make the TAVR procedure more widely available. [PHI Redacted] Because [PHI Redacted] was considered at low risk for traditional surgery, [PHI Redacted] was only able to have the TAVR by entering a clinical trial. This restriction should be removed.

    I am sure that TAVR is far less expensive than traditional open-heart valve replacement and will result in much better patient outcomes.....[PHI

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    Bhansali, Hardik Title: Fellow, Cardiology
    Organization: Cleveland Clinic Florida
    Date: 04/20/2019
    Comment:
    I support the reduction of PCI numbers from 400 to 300, as a requirement for a center to be eligible for TAVR.
    Zeeshan, Ahmad Title: Cardiothoracic Surgeon
    Organization: Cleveland Clinic
    Date: 04/20/2019
    Comment:
    I believe by changing the required PCI volume from 400 to 300 PCIs with per year for an institution to become eligible to implant transcatheter aortic valves will benefit a large number of patient's. I urge the decision makers at CMS to please allow this to happen. This will help a lot of patients will need this life-saving therapy and are located far from large centers.
    Shreenivas, Satya Title: Interventional Cardiologist
    Organization: The Christ Hospital
    Date: 04/20/2019
    Comment:

    The TAVR NCD should be revised to focus on the treatment of aortic stenosis and not just on the performance of TAVR.

    We believe that the focus of reimbursement and certification programs should be on increasing quality, improving access, and facilitating patient-centered evidence based care within health care systems. To this end, reimbursement and quality initiatives should be designed around the comprehensive treatment of AS, and include both TAVR and SAVR. Rules directed

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    Dudley, Georgia Title: Mrs.
    Date: 04/20/2019
    Comment:

    Please rescind your strict rule against coverage for the TAVR procedure. [PHI Redacted] I would much prefer a safer and simpler procedure such as TAVR as would anyone facing heart surgery.

    Aortic valve replacement is most likely a concern that occurs later in life. As a senior, I am more concerned for my health chances surviving any surgery but most especially heart surgery.

    Please allow TAVR coverage by Medicare.

    Harris, George Title: Captain, U.S. Navy (Retired)
    Date: 04/19/2019
    Comment:

    I am writing to urge you to make the TAVR valve readily accessible for treatment of Aortic Va,ve Stenosis as well as Mitral Valve replacement. [PHI Redacted]

    I also want to make you aware of [PHI Redacted] THIRD open heart surgery for Mitral Valve replacement. When the surgeon had [PHI Redacted] heart open he discovered he could not replace the defective tissue valve since there was no tissue left to sew a new valve to. Instead he

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    Potts, Joanne Date: 04/19/2019
    Comment:
    Please continuing to cover TAVR. It can help treat so many in a simple procedure.
    Gladden, Robert Organization: aarp
    Date: 04/19/2019
    Comment:
    Please continue to cover this lifesaving procedure
    Knoepke, Christopher Organization: University of Colorado School of Medicine
    Date: 04/19/2019
    Comment:

    We are excited by CMS’ continued enthusiasm regarding the use of shared decision making (SDM) to promote high quality, person-centered care in the context of complex decisions such as the one to pursue TAVR, SAVR, or symptom-focused care for AS. We believe that CMS’s decision to mandate the documented use of evidence-based patient support tools to for primary prevention ICDs and LAAO were the correct ones, and we strongly urge CMS to consider including such a mandate in the NCD for TAVR.

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    Steinhorn, Jeffrey Title: Accredited Volunteer
    Organization: Mended Hearts
    Date: 04/19/2019
    Comment:
    As an accredited volunteer for Mended Hearts I have visited and talked with many TAVR patients at Suburban Hospital in Bethesda MD. I have observed very quick recovery times and single night stays in the unit compared to more stay time for open chest surgery for aortic valve replacement patients. Seems to me this lowered cost would be welcome by CMS and coverage allowed? Please make this happen.
    Schultz, Jason Title: Chief of Cardiology
    Organization: Essentia Health
    Date: 04/19/2019
    Comment:

    The need for 2 surgical opinions, particularly in light of new data, is redundant and subjects patients who often need to travel long distances to excessive clinic visits. I agree that this should be removed as a requirement.

    I strongly oppose the new recommendations for the criteria to start a new TAVR program. The volume requirements have loosened significantly, and there is too much vagueness regarding the experience required of an interventional cardiologist to perform such

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    Structural Interventionalist, Aaron Horne, Jr. Title: MD, MBA, MHS
    Organization: Heart and Vascular Specialist of North Hills; HCA Healthcare
    Date: 04/18/2019
    Comment:

    Thank you for the opportunity to submit comments to the proposed Medicare draft National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement. I commend CMS for drafting a policy that contains many elements that improve flexibility and reduce overall burden and will result in better access to care, and I appreciate the opportunity to provide additional suggestions to the draft below outside of those submitted on behalf of the Association of Black Cardiologists

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    Burr, Bob Date: 04/18/2019
    Comment:
    [PHI Redacted] doctors agree that TAVR is the path to follow. It is a proven procedure and is rapidly replacing open heart surgery in places that have trained physicians. Not providing reimbursement for a proven, non-maiming life saving procedure is beyond the pale. [PHI Redacted] TAVR MUST be covered by Medicare.
    Potempa, Debra Title: VP, CNO
    Organization: Mercyhealth
    Date: 04/18/2019
    Comment:
    I support in general the proposed memo, with a request to lower the PCI threshold to >200 interventions per year.
    Kostantakos, A Date: 04/18/2019
    Comment:
    Adjust PCI limit based on patient area served, (eg < 300)
    Wheeler, Megan Title: Structural Heart Coordinator
    Organization: Methodist Dallas Medical Center
    Date: 04/18/2019
    Comment:
    Reading through the proposed decision, the changes are amenable. My only comment is more of a grammatical correction. In reference to the heart team, "advanced patient practitioners" is not a recognized term. It should be "advanced practice providers." This will cover any APRN and PA. Thank you.
    Goldberg, Steven Title: Medical Director for Structural Heart Disease
    Organization: Tyler Heart Institute, Comm Hospital of the Monterey Peninsula
    Date: 04/17/2019
    Comment:

    The Proposed Decision Memo for Transcatheter Aortic Valve Replacement offers some creative solutions to the aortic valve replacements volume requirements at a hospital offering TAVR. CMS should be commended for this well considered advancement.

    However, there remain some points which were not completely addressed, and should be reconsidered. Most important is the requirement for 300 PCI’s per year. Although it is recognized that this is a decrease from the prior 400/year, this

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    Ahmad, Imran Date: 04/17/2019
    Comment:

    The TAVR evaluation process does not need two cardiac surgery consultations as a matter of requirement. Unless there is consideration for a surgical access, routine transfemoral TAVR cases could proceed safely without a formal cardiac surgery consultation. Other cases, could proceed safely with one cardiac surgeon consultation.

    TAVR volume requirements for maintenance of a TAVR program is a reasonable position. A volume of 30 TAVRs would be adequate.

    Lippert, Michele Title: VP
    Organization: Mercyhealth
    Date: 04/17/2019
    Comment:
    I support the new criteria for TAVR. This will be a good opportunity for programs that can offer this modality in a safe manner.
    Munoz, Oscar Title: MD
    Organization: Cardiology Care Consultants
    Date: 04/17/2019
    Comment:
    In a city like El Paso, Texas there is a big opportunity to improve the cardiovascular care ; implementing a TAVR program. Similar to many other intermediate size cities; we have many patients that die waiting for this procedure, because they can not travel to cities with available programs. Unfortunately the numbers of CV surgeries and interventions required up to now have been difficult to meet by a determinate hospital. However the doctors that’s do those procedures in town are the same and

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    Swanson, Julia Title: MD
    Organization: Providence Heart & Vascular Institute
    Date: 04/17/2019
    Comment:

    I support continued use of the Heart Team approach with participation by both a Cardiac Surgeon and an Interventional Cardiologist. Both need to be present and participate.

    As "low risk" patients are considered for TAVR, I believe greater emphasis should be placed on shared decision making as risks and benefits as well as multiple unknowns play a role in the decision between TAVR & SAVR.

    I do not support the ongoing use of the "second surgical opinion" as it is resource

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    Dorsey, John Title: MD-Chief medical Officer
    Organization: Mercyhealth, Rockford, Illinois
    Date: 04/17/2019
    Comment:
    Please lower the PCI criteria to 200/year. I believe this still demonstrates competency and makes sure that there is not a tendency to overtreat with stents to achieve the 300 number
    Naik, Hursh Title: Director of Cardiac Cath Lab and Structural Heart
    Organization: St Joseph Medical Center
    Date: 04/17/2019
    Comment:
    The recent data from the low risk patient population proved once again that TAVR is safer & better than surgery. To the point that it will change practice. The requirements for evaluation should change accordingly. It is not necessary to have more than one physician evaluate the patient (as long as he/she is part of the structural heart team). This can be either a CT surgeon or a cardiologist. But why both? The CT surgeon requirement was only present to calculate the risk for surgery. This

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    Wolnak, Kenneth Title: DO, MBA
    Organization: MercyHealth
    Date: 04/17/2019
    Comment:
    I support the proposed memo. As TAVR has become standardized with regard to devices, patient selection and imaging, the need to restrict access to only high volume centers has become less relevant. The smallest programs are still excluded by the levels in the memo. The threshold for PCI could safely be reduced to 200/year
    Cecil, MSN, APRN, ANP-C, Margaret Title: Director CV Service Line
    Organization: CHI St. Luke's Health The Woodlands Hospital
    Date: 04/17/2019
    Comment:
    I would like to applaud and strongly support the decision to move this new decision memo (March 26, 2019) in to the NCD/LCD for TAVR. This therapy has been proven safe and sustainable now for patients in many studies. Opening the ability for more facilities to perform TAVR while adhering to strict quality standards, is what is in the best interest of patients and will reduce the number of complications/ disability with larger procedures that open the chest. It also allows patients to receive

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    Parker, Lea Date: 04/17/2019
    Comment:

    [PHI Redacted]

    [PHI Redacted] I recently had a friend whose father was 90 years old and he was told he needed open heart surgery to replace his aortic valve. Can you imagine? [PHI Redacted] He was ready to do it because he didn’t know of any other options. Luckily, my friend called me and I told her to ask the surgeon about TAVR. He did end up choosing TAVR and this man was only in the hospital for a day or two and released

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    Keilen, Ruth Organization: Mended Hearts
    Date: 04/17/2019
    Comment:
    [PHI Redacted] I visit patients regularly as an accredited visitor with Mended Hearts. Whenever I have seen a TAVR patient I am amazed how well they are recuperating and how soon they are able to return to their home. I feel it is very important for this procedure to be available in all parts of the country - especially in areas that have more limited access and perform fewer procedures. Please eliminate the annual volume requirements as well as the other requirements that

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    kassas, safwan Title: intervntional cardiologist
    Organization: MCVI
    Date: 04/16/2019
    Comment:
    The heart team concept for TAVR has been beneficial and necessary, however requiring 2 surgeons has been very disruptive to the flow of care and resulted in treatment delay without necessarily any added benefit.
    AT this stage of TAVR progress, one surgeon requirement certainly will provide the expected benefit and will permit more efficient care.
    Once low risk criteria is approved in the future, I am hoping that the heart valve team will be similar to the heart team in the

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    Oakes, Bernard Title: Mr.
    Date: 04/16/2019
    Comment:

    [PHI Redacted]
    I am writing to strongly urge revision in the proposed TAVR coverage documentation: The current focus on Volume of cases a hospital performs - in order to conduct TAVR procedures, should be changed to Quality of the hospitals heart operations. Restrictions on a hospitals status and acceptability to perform TAVR procedures should be revised. Eliminate volume of procedures performed as a rule, to - quality of TAVR procedures performed. TAVR

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    Pitts, Andrew Title: Christian Hospital
    Organization: Heart Valve Program Coordinator
    Date: 04/16/2019
    Comment:

    I, my administration, and my heart team believe that the changes to the NCD are primarily positive but do have some comments and recommendations which echo many of my peers and physicians making comments.

    1. I would like to propose that TAVR can be done by one operator, either cardiac surgeon or IC, especially given the low incidence of conversion to open heart surgery and need to utilize cardio-pulmonary bypass. Continuing to require both in the room severely limits the

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    Richardson, Suzanne Date: 04/16/2019
    Comment:
    The two surgeon requirement is burdensome for patients and often delays their treatment due to the variety of negative social determinants that plague our rural population in South Carolina. Additionally, now that patients at intermediate surgical risk can undergo TAVR, it places undue scrutiny on a procedure that is approved for more than 50% of the applicable patient population. I strongly encourage CMS to review literature on the proficiency of implanters based on volumes. Anecdotally we

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    Guigures, Lindsey Title: Senior Heart Team Program Coordinator
    Organization: Bon Secours Mercy Health
    Date: 04/16/2019
    Comment:
    I would like to see the final NCD clarify the experience level of all independently operating (IC and Surgeon) providers v. stating that 'a' surgeon has 'X' experience. My concern is that the 'team' may include experienced clinicians for the decision making portion of a patients' care, but those with experience may not be actually operating thus compromising patient safety and outcomes.
    Ho, Andrew Title: MD
    Organization: Temecula Valley Hospital
    Date: 04/16/2019
    Comment:
    I think any movement to restrict access of programs/hospitals to TAVR is fundamentally flawed and outdated. The second surgical consultation is also outdated and should be phased out.
    Munoz, Eric Title: MD, MBA, Chairman Division of Surgery
    Organization: Wyoming Medical Center
    Date: 04/16/2019
    Comment:

    As you are aware, Wyoming is the only state in the country that does not have a TAVR center. We are excited by the fact that the newly proposed regulations are favorable for Wyoming Medical Center (WMC) to open a TAVR center which will become the hub for a structural heart program in our region. The original requirements precluded us from starting a TAVR center at WMC because of the volume requirements for SAVR. The number of aortic valve cases performed at our program were too low to meet

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    Kerwin, Peter Title: Medical Director, Structural Heart Program
    Organization: DuPage Medical Group
    Date: 04/15/2019
    Comment:
    I am writing in support of the current proposed revision (Decision memo 03/26/2019). I believe that it is a fair and balanced next step in providing access to TAVR for patients not currently able to access these procedures. The proposed requirements continue to support the concept of the heart team and suggest reasonable requirements that will allow new, high quality programs to develop. It is in the best interest of our patients and our community to move forward with this proposal. .
    Prentis, Stacey Title: Director of Cardiology
    Organization: Advocate Good Samaritan Hospital
    Date: 04/15/2019
    Comment:
    We support the recommended guidelines changes for New programs for TAVR. Our nearest hospital has 69% of the market share PSA. Our site actively does MitraClip and LAAO with some of the highest ranking quality outcomes in our region. It would be a disservice to our customers to not provide a comprehensive full program with superior clinical outcomes, due to decreasing SAVR volumes.
    Kimmel, Jocelyn Title: PA-C, Valve Clinic Coordinator
    Date: 04/15/2019
    Comment:
    I believe CMS should definitely drop the requirement for a 2nd surgical opinion. It adds no clinical benefit to the patient, especially since every patient is discussed in a heart team setting. It simply adds another visit for a procedure that already requires many tests and appointments.
    Lahsaei, Saba Title: Interventional cardiology
    Organization: Highland Hospital
    Date: 04/15/2019
    Comment:
    I agree to change the requirements. As someone who has trained for a whole year in structural heart but not being able to use it in a smaller programAnd having to transfer a patient to another hospital or refer I find this a great opportunity and in need for patient care to be able to perform in smaller programs. This is the same as when PCI had Started and I believe TAVR iS at a time of being ready to be more generalized and started in smaller programs.
    Cubeddu, Robert Title: Section Head, Structural Heart Disease
    Organization: Cleveland Clinic Florida
    Date: 04/14/2019
    Comment:

    Dear members of the CMS panel, I congratulate you for making the effort to revisit the NCD TAVR recommendations from 2012.

    As a busy and experienced implanter who has witnessed the spectacular evolution and impact of TAVR in patients with aortic stenosis, it astound me that after many years of robust clinical data with unprecedented clinical outcomes, we continue to restrict access to TAVR; a procedure that has become mainstream, that saves lives, improves quality of life, and

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    Kavinsky, Clifford Title: MD, PhD
    Organization: Rush University Medical Center
    Date: 04/13/2019
    Comment:

    I have carefully read the draft of the NCD and there are three areas of concern.

    1) Since there is either equipoise or superiority of TAVR compared to SAVR across all surgical risk subsets in the true spirit of patient centered care and shared decision making, patient preferences should be considered when deciding which form of aortic valve replacement should be offered. This should be clearly stated in the NCD

    2) Item number 4 states that the heart teams interventional

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    Villarreal, Ricky Date: 04/12/2019
    Comment:

    The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure.

    TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this

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    Yadav, Pradeep Title: MD
    Date: 04/11/2019
    Comment:
    1. Surgeon & IC must be present intra-procedure: is un-necessary requirement that delays patient care. TAVR is far more refined, planned, predictable procedure than many other things we do in cath lab or operating room. This is well evidenced by extremely low rate of "conversion to open surgery" in latest clinical trials. While co-participation of IC+surgeon intraprocedurally should be encouraged (case by case basis like MitraClip), mandating both is a waste of important resources and

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    Kim, Michael Title: Director, Structural Heart & Valve Disease Program
    Organization: Cardiovascular Institute of North Colorado/Banner Health
    Date: 04/11/2019
    Comment:

    I am writing this memo to comment on the CMS proposed decision memo for Transcatheter Aortic Valve Replacement (CAG-00430R). First, I would like to applaud those at CMS involved in drafting this updated National Coverage Decision for TAVR. This work represents an important update to the prior NCD, especially in the face of the significantly expanded indications for TAVR that have come to fruition since the original NCD was published many years ago.

    That being, said, I have some

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    mcdonald, jay Title: MD
    Date: 04/11/2019
    Comment:
    CMS should definitely cover TAVR for low risk patients.
    Pittman, Anna Title: COO/CNO
    Organization: Shannon Clinic
    Date: 04/10/2019
    Comment:
    TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality. Although nearly 500 TAVR programs exist throughout the United States, in some regions patients have little access or cannot travel to larger cities for their care.
    Doucette, Meaghan Title: Nurse Practitioner, Valve Clinic Coordinator
    Date: 04/10/2019
    Comment:

    Working for an organization that provides care for the undeserved population, I strongly believe that limiting TAVR access to high volume centers would negatively impact these patients. From personal experience, if we have had to refer to a high volume center, there has been a delay in access to care and patients have decompensated.

    It is unfair to patients who receive care at facility that is properly qualified to perform TAVR and has excellent outcome data to be sent to

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    Fathy, Maryam Title: Cardiovascular Nurse Practitioner-Structural Heart
    Organization: MemorialCare Saddleback Medical Center
    Date: 04/10/2019
    Comment:

    On behalf of our structural heart team, at a community hospital in Southern California, we find the required proposed NCD requirements a fair determination. We feel the cumulative volume requirements (SAVR and TAVR) are achievable by academic centers and community hospitals alike, without jeopardizing patient safety or closing a majority of 'low volume' quality TAVR programs across the country. We also feel there should be a stronger emphasis on engaging the heart team on outcomes, and

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    mohammed, khaja Title: MD, FACC
    Organization: Phoebe putney memorial hospital
    Date: 04/10/2019
    Comment:
    1. In addition to one cardiac surgeon, I propose to also include one interventional cardiologist to independently examine the patient face-to-face, evaluate the patient's suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy, and to document the rationale for the clinical judgment, and the rationale is available to the heart team.
    2. I propose that CMS should pay for a permanent pacemaker procedure post TAVR, if required, as it is a

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    Slocum, Nick Title: MD
    Date: 04/10/2019
    Comment:

    I agree that decrease to one surgeon is critical to access for our pts this is critical.
    I do not support lowering the volume to allow centers to start a TAVR program.

    An important part of TAVR vs SAVR is making sure that the patient's choices are involved in the decision making. This needs to be stressed.

    Reichert, Ileah Title: ACNP Structural Heart
    Date: 04/10/2019
    Comment:

    We have many patients that travel hours to come for evaluation for TAVR in our clinic. Many of them wait hours in our clinic waiting for their second CT surgeon opinion to save themselves another drive to our facility. We have a lot of trust in our entire heart team and open communication between all members (interventional cardiologists and cardiothoracic surgeons) and dialogue regarding the best option for our patients. At our facility, as I am sure as is similar to many others, the

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    Waggoner, Thomas E. Title: Structural Interventional Cardiology
    Organization: Pima Heart Physicians, Structural Interventional Cardiology & Endovascular Medicine
    Date: 04/10/2019
    Comment:

    To whom it may concern:

    As a practicing structural interventional cardiologist in a growing southern Arizona retirement community, we see many cases of aortic valves stenosis that is severe in an aging population. Our work up times for our TAVRs has been as high as six weeks. Which is unacceptable. The patient can have an open SAVR within a few days at the hospital with a Cardiothoracic surgeon whom, we all must point out, is not required to have a structural interventional

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    Schultz, M.D., Robert Title: Chief Medical Officer
    Organization: Shannon Clinic
    Date: 04/10/2019
    Comment:

    The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure. TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality.

    More

    Rios, Maribel Title: AVP, Ancillary Services
    Organization: Shannon Medical Center
    Date: 04/10/2019
    Comment:

    The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure.
    TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality.

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    Plymell, Shane Title: CEO & Presiden
    Organization: Shannon Medical Center & Shannon Clinic
    Date: 04/10/2019
    Comment:

    The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure.
    TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality.

    More

    Dolan, John Title: Associate CFO
    Organization: Shannon Clinics
    Date: 04/09/2019
    Comment:

    The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure. TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality.

    More

    barnett, james Title: MD
    Organization: Shannon Medical Center
    Date: 04/09/2019
    Comment:

    The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure. TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality.

    More

    Bradshaw, Pam Title: COO/CNO
    Organization: Shannon
    Date: 04/09/2019
    Comment:

    The TAVR (transcatheter aortic valve replacement) procedure could greatly benefit patients living in our area of Texas if CMS would lower its volume threshold to allow more hospitals to offer this procedure.
    TAVR has validated itself to be the new standard modality for treating aortic valve disease in high and medium risk patients and, most recently, in low risk patients. Unfortunately, due to geographical and transportation challenges, not all Americans have access to this modality.

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    Lotun, Kapildeo Title: Professor of Medicine
    Organization: Banner University Medical Center, University of Arizona
    Date: 04/05/2019
    Comment:
    1. The data is strongly in favor of TAVR compared to SAVR. The decision as to which procedure should a patient receive should not be only determinant on the CT surgeon evaluation. Rather it has to be a decision by both Interventional Cardiologist and CT Surgeon. The current proposed decision weighs heavily on the CT surgeon evaluation and literally gets the "gatekeeper" status.
    2. The TAVR procedure should be allowed to be performed by 1 or 2 Interventional Cardiologist OR

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    Hahn, Rebecca Organization: Dr.
    Date: 04/04/2019
    Comment:

    Comments:

    1. The requirement that a “cardiac surgeonhas independently examined the patient face-to-face” defeats the purpose of the Heart Team. Cardiac surgeons should be evaluating patient together WITH the interventionalist, imager and other members of the multi-disciplinary heart team.
    2. A cardiac surgeon is not required to perform this procedure (which not infrequently is performed under monitored anesthetic care) thus should not be required to “jointly

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    Kaneko, Tsuyoshi Title: Director of Aortic Surgery
    Organization: Brigham and Women's Hosptial
    Date: 04/04/2019
    Comment:

    I generally support the changes in the NCD proposed by the CMS, but I would like to emphasize several points for consideration.

    1. In the US, the byproduct of TAVR was the new concept of “Heart Team”. This concept is now embedded in the culture of Transcatheter therapies starting from the original TAVR RCTs and the subsequent CMS recommendation. What we learned is that the shared decision making not just with the patients, but also between the cardiac surgeons and the

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    NYPH-Columbia University Medical Center, Div of Cardiothoracic Surgery Organization: NYPH-Columbia University Medical Center
    Date: 04/03/2019
    Comment:

    I am writing on behalf of the Division of Cardiothoracic Surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center.

    We have embraced TAVR as an important therapy for patients with severe aortic stenosis and expect TAVR to become an integrated part of every cardiac surgeon’s clinical practice. The Centers for Medicare & Medicaid Services proposed changes to the National Coverage Decision regarding Transcatheter Aortic Valve Replacement (TAVR) are generally

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    Fluture, Adrian Title: MD, FACC, FSCAI
    Organization: Wyoming Medical Center and Wyoming Cardiopulmonary Services
    Date: 04/02/2019
    Comment:

    We have received with great joy the newly proposed regulations for Transcatheter Aortic Valve Replacement (TAVR) coverage by Centers for Medicare and Medicaid Services (CMS). We find these recommendations appropriate for our unique situation in Casper, WY. From our perspective we strongly advocate that these remain as such in the final version to come.

    Wyoming Medical Center is an important referral center situated in the middle of a very large state with a low population

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    Wiisanen, Matthew Title: Director of Structural Heart Disease
    Organization: Erlanger Health
    Date: 04/02/2019
    Comment:
    The proposed changes are an important step forward in the progression of therapy for severe aortic stenosis. I support these changes. Having worked in both a rural and an urban setting performing TAVR in the last 7 years, I appreciate these changes as not prohibiting some smaller volume centers from providing a valuable resource to geographically isolated patients.
    Pelikan, Peter Title: Medical Director, Coronary and Structural Heart
    Organization: Pacific Heart Institute
    Date: 04/01/2019
    Comment:

    RESPONSE TO THE PROPOSED DECISION MEMO FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) (CAG-00430R)

    Peter Pelikan, MD, FACC, FSCAI
    April 1, 2019

    The Proposed Decision Memo for the TAVR National Coverage Decision (NCD) was published on March 26, 2019. Following my request to the CMS Coverage and Analysis Group (CAG) to reconsider the TAVR NCD, there was a full day meeting at CMS in July, 2018, during which various parties expressed opinions on how the NCD should be

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    Tripp, Jennifer Date: 04/01/2019
    Comment:
    Second surgeon opinions should be removed. Our patients are already having to travel down from far distances, then for us to have to schedule a second opinion on another day can become tedious. Patient satisfaction if our number one priority and if we can remove a step to help ease of patients and get them scheduled for surgery sooner rather than later, than this is the way to go. Most of the time our surgeons agree with the first surgeon and we hardly ever have any disputes over it. If we can

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    Schreiner, Marylou Title: RN
    Organization: Cleveland Clinic
    Date: 04/01/2019
    Comment:
    I approve of this proposal
    George, Isaac Title: Assistant Professor of Surgery
    Organization: NYPH-Columbia University Medical Center
    Date: 04/01/2019
    Comment:

    Dear NCD:

    The proposed introduced is overall very strong and incorporates reasonable changes based on changing practices and current data.

    First, it is imperative that 1 surgeon and 1 cardiologist evaluate patients for TAVR specifically in order to provide a balanced, unbiased set of opinions to patients with aortic valve disease. Two surgeon evaluation is not needed, given that risk approval will likely be granted, TAVR has been shown to be safe in the short term, and

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    Saliba, Bassam Title: MD, FACC Director Cadio-Vascular services CCMH
    Organization: Comanche County Memorial Hospital
    Date: 03/31/2019
    Comment:

    Comanche County Memorial Hospital is located in Southwest Oklahoma. It has the only program with advanced cardiovascular services. We cover an area extending from North West Texas border to Ardmore, Chickasha, Carnegie, Hollis, Mangum and all the cities in between with the 2 biggest ones being Altus and Duncan. We do over 300 PCI a year and over 1000 diagnostic angiograms. We do an excess of 200 peripheral intervention a year. We have two cardiovascular surgeons with extensive

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    Zawacki, Kevin Title: MD
    Organization: Indiana University Health Bloomington
    Date: 03/31/2019
    Comment:
    I agree strongly that the requirements to begin and maintain a TAVR program need to be dramatically changed to a quality based model rather than solely a volume based one. The procedure has matured and the technology has improved to the point where TAVR is fast becoming the preferred modality for most AVR. I strongly support the proposed revised CMS guidelines for institution and maintenance of new and established TAVR programs. The prior "need" for 50 SAVR in the year before starting TAVR is

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    Nguyen, Tom C. Title: Co-Director of Structural Heart
    Organization: Memorial Hermann - University of Texas
    Date: 03/31/2019
    Comment:
    I have several comments:
    1) I applaud the CMS stipulation that TAVR is performed by surgeons and cardiologists. This has bred a truly multidisciplinary approach to the treatment of structural heart disease and is ultimately good for patient care. It is important to have the perspective of both cardiologists and surgeon in the cath/hybrid room during the procedure since both bring a unique vantage point to the problem.
    2) We are against any potential notion of TAVR being a single

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    Tang, Gilbert Title: Surgical Director, Structural Heart Program
    Organization: Mount Sinai Health System
    Date: 03/31/2019
    Comment:
    TAVR versus SAVR must be jointly assessed by a surgeon and interventional cardiologist experienced in TAVR who can truly assess the anatomical risk of TAVR vs SAVR once FDA approves TAVR for all comers, in the context of recent low risk randomized trial results. In addition, both a surgeon and interventional cardiologist must be present and participate in the TAVR procedure. TAVR is not a SINGLE OPERATOR procedure. Someone needs to position the catheter optimally to avoid the valve from

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    Zaidi, Syed Title: Director, Structural Heart Program
    Organization: University of Maryland Saint Joseph Medical Center
    Date: 03/30/2019
    Comment:

    I completely agree with the current CMS proposal.
    I strongly support the decision to restrict surgical evaluation for TAVR to only one surgeon. I would like to propose that we should also mandate an interventional cardiologist evaluation for SAVR.
    I would also propose to allow an interventional cardiologist to perform TAVR without surgeon in the room considering low procedural mortality in this group based on randomized trials and TVT registry. We are already performing high risk

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    Dube, Sandeep Title: MD
    Date: 03/29/2019
    Comment:
    Feel there is no need to have second surgeon for TAVR evaluation
    Bokhari, Syed Organization: Advanced Cardiovascular Care, Inc.
    Date: 03/28/2019
    Comment:

    I would suggest adding the same criteria for SAVR that all the patients suffering from severe aortic stenosis need to be seen by an interventional cardiologist in a face-to-face consultation, an independant examination and evaluation for best possible therapetic modality such as medical management, TAVR or SAVR with their rationale documented and available to the Heart Team.

    I am not sure with such an overwhelming data in favor of TAVR why do the patients still need to see both an

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    Sadler, Diego Title: MD FACC FACP
    Organization: Cleveland Clinic Florida
    Date: 03/28/2019
    Comment:
    I agree with the proposed measures and fully support the change of requirements.
    With increased TAVR valve safety and results, and with expansion of indications to lower risk groups with results equal or superior to surgery (SAVR), expansion of access to care of patients by well trained operators will improve overall access and outcomes for the US population. Strongly support the Registry to monitor usage, safety and outcomes.
    Kirsch, Jacobo Date: 03/28/2019
    Comment:
    This is the right decision for patients.
    Navia, Jose Luis Title: Chairman of Heart and Vascular Center
    Organization: Cleveland Clinic Florida
    Date: 03/28/2019
    Comment:
    I'm extremely support of the new proposed CMS recommendation call for a reduction in PCI volume from 400 to 300 in order to approve the TAVR program. In our institution we have large amount of patients that they will be benefit from TAVR indications. Thank you.
    Prasad, Sunil Title: Dr.
    Organization: University of Rochester
    Date: 03/27/2019
    Comment:

    The change in valve numbers to maintain a program are low. The idea that quality is able to be comprised for access goes against the idea of quailty care. Access should be to high quality centers. A joint commision like certification would standardize quality and accountable outcomes such as LVAD, Transplant, Hip, etc.

    That would be putting patient first by offering high quality access.

    Taylor, Travis Title: Interventional cardiologist
    Date: 03/27/2019
    Comment:
    Given the new data suggesting that TAVR is as good or perhaps even better than SAVR for low risk patients, all isolated aortic stenosis procedures should be evaluated by a surgeon and TAVR cardiologist. Informed consent is no longer obtainable unless the TAVR discussion has been done with the patient.
    Teirstein, Paul Title: Chief of Cardiology, Scripps Clinic
    Organization: Scripps Health
    Date: 03/27/2019
    Comment:

    The new Decision Memo is an improvement but I suggest two considerations:

    1) Add: FOR PATIENTS RECEIVING SAVR, ONE INTERVENTIONAL CARDIOLOGIST has independently examined the patient face-to-face, evaluated the patient's suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy, and has documented the rationale for their clinical judgment, and the rationale is available to the heart team.

    2) Physician scheduling is a huge challenge for

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    Timberlake, Anne Title: Structural Heart Program Coordinator/RN
    Organization: Salinas Valley Memorial Hospital
    Date: 03/27/2019
    Comment:

    We are a new TAVR program as of Jan 2019 based at a 269-bed community hospital located in a semi-rural region. Our team fully supports the proposed decision memo for TAVR. The proposed TAVR+SAVR and TAVR volume thresholds are realistic and appropriate for our setting. The requirement that one cardiac surgeon, rather than two, must evaluate suitability for TAVR is logical and help streamline the screening process.

    Our team fully supports the ACC recommendation that TAVR be made

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    Stiver, Kevin Date: 03/27/2019
    Comment:
    I believe that every patient being considered for TAVR requires an interventional cardiologist (IC) consult, and that a TAVR can be performed with the combination of IC/IC or surgeon/surgeon; and not just IC/surgeon
    Kressin, Jeanette Title: Reimbursement Specialist
    Organization: Bellin Memorial Hospital
    Date: 03/27/2019
    Comment:

    Currently, we bill TAVR as clinical trials to Medicare. With this new LCD/NCD, if patient has a Medicare Advantage plan, are we to bill their MA plan instead of Medicare? Therefore, will Medicare now deny as clinical trial (adding Q0 modifier) if patient has MA plan?

    Thank you,
    Jeanette
    Hansen, Rosemary Title: DNP
    Organization: Kaleida Health
    Date: 03/26/2019
    Comment:
    I agree with this Determination especially the reduction to one surgeon requirement that delays treatment. In my opinion ALL open Heart patients should be evaluated by a heart team and participate in a shared decision making process. all risk should be calculated including those tabulated by STS risk score calculator and OTHER criteria. This other criteria includes social, family and recovery concerns, ALL patients should have a choice between SAVR and TAVR based on informed decision based on

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    Iyer, Vijay Title: Medical Director/Assoc. Prof
    Organization: University at Buffalo
    Date: 03/26/2019
    Comment:
    The decision to require only one surgical opinion is long overdue.
    However to ensure that all patients have the opportunity to be evaluated by the heart team it is imperative that SAVR also rerequire an Interventional Cardiology opinion.
    Palafox, Brian Date: 03/26/2019
    Comment:
    CMS needs to be more diligent in monitoring programs that are doing TAVR. I am aware of programs that do not/did not make the basic requirements and have been able to start a program. If quality data is to be obtained I feel that the bare minimum requirements set forth should be at least adhered to.
    Szydlowski, Gary Title: Chief, Cardiac Surgery
    Organization: Bayhealth
    Date: 03/26/2019
    Comment:
    I applaud CMS for not taking the same position as proposed in the Multi-Society Consensus Document regarding TAVR. That proposal suggested prohibitive volume requirements which would clearly have restricted access to care for many patients.
    That said, I practice in a high quality cardiac program that has been in existence since 2004. We have performed TAVR since 2016. Since 2004 the annual volume of AVR cases has fluctuated around 50. While we would likely be fine with the current CMS

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    George, Jennifer Title: Valve Coordinator
    Organization: Delray Medical Center
    Date: 03/26/2019
    Comment:
    Yes I agree with no second surgical opinion. The results of the Tavr studies even for Low Risk are astounding. One surgeon is sufficient to deem a patient properly for tavr or savr.