National Coverage Analysis (NCA) View Public Comments

Transcatheter Mitral Valve Repair (TMVR)

Public Comments

Commenter Comment Information
Gray, William Title: Associate Professor of Medicine
Organization: Columbia University
Date: 06/14/2014
Comment:

While the joint society guidelines emphasize the role of the multi-disciplinary local heart team in selecting and caring for TMVR patients due to the complexity of this procedure, they also clearly state that MitraClip may be performed as a single operator procedure. Specific to the draft coverage proposal, CMS would require that an interventional cardiologist and cardiac surgeon would have to “jointly participate in the intra-operative technical aspects of TMVR” both for FDA-approved

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Sweeney, Andrea Organization: Minneapolis Heart Institute at Abbott Northwestern Hospital
Date: 06/14/2014
Comment:

On behalf of the Minneapolis Heart Institute Center for Valve & Structural Heart Disease, a multi-disciplinary practice with extensive TAVR & MitraClip experience, we support CMS intention in development of a National Coverage Determination for MitraClip therapy. MHI has performed over 50 MitraClip procedures under research and commercial availability. We view MitraClip as a therapy option in a continuum of care for mitral valve disease and have protocols to ensure the patient is

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Kar, Saibal Title: Director of Interventional Cardiac Research
Organization: Heart Institute, Cedars Sinai Medical Center
Date: 06/14/2014
Comment:

Dated June 14, 2014
Ms. Tamara Syrek Jensen, JD
Acting Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: Comments on Proposed Decision Memorandum for Transcatheter Mitral Valve (TMV) Procedures (CAG-00438N)

Dear Ms. Syrek Jensen:

I am writing this letter as a faculty member of Cedars Sinai Medical Center, Los Angeles, CA. This letter is written in response

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Nakamura, Mamoo Date: 06/14/2014
Comment:

I am an interventional cardiologist and a faculty of heart institute, Cedars-Sinai Medical Center where is a nationwide leading center of MitraClip procedure under leadership of Dr. Saibal Kar. I was trained both MitraClip and transcatheter aortic valve replacement and is actively involved in both procedures. I am one of co-investigators of COAPT trial and I have had many opportunities to assist Dr. Saibal Kar for MitraClip as a primary assistant.

The MitraClip procedure provides

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Shaikh, Saeed Organization: Franciscan, St Francis health
Date: 06/14/2014
Comment:

MITRACLIP: I am an interventional cardiologist who performs structural heart procedures. I have following concerns:

  1. Mandatory presence of 2 operators, especially CT surgeon, is unnecessary during the procedure. CT surgeon has to find patient inoperable for a patient to eligible, mandating the surgeon to be in the hybrid lab for the duration of the procedure is impractical.
  2. Requirement of 50 structural heart procedure/yr/operator too high and

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Ivan, Eugen Date: 06/14/2014
Comment:

I am taking issue with the following part of the coverage decision:

"The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TMVR."

This provision is unnecessary for multiple reasons:

  1. It is clinically useless 2 operators are not needed for performance the procedure, therefore medical cost of the procedure would be increased without any benefit to the

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hermiller, James Title: Dr
Organization: St Vincent
Date: 06/13/2014
Comment:
The need for both an interventional cardiologist and a cardiovascular surgeon to be present during these procedures is unnecessary, impractical and wasteful. Unlike TAVR, where advanced surgical intervention (cardiopulmonary bypass, emergent open heart surgery, etc) is not uncommonly required, TMVR with the MitraClip is completely transcatheter, and emergent surgical intervention is essentially never required. Furthermore, procedural times for MitraClip are substantially longer than TAVR,

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mehrle, anderson Title: md
Organization: Jane Phillips medical center
Date: 06/13/2014
Comment:
Upon reviewing mitra clip I ask that you consider the millions of patients that can not currently tolerate mitral valve surgery but could benefit from the hemorrhagic changes that would occur by ccorrecting severe mitral regurgitation. Mitraclip has been thoroughly tested to be safe effective and technically easier and easier on the patient in repair mitral regurgitation. This would directly rreduce lv size and lower edp ultimately leading to fewer chf exacerbations and hospitalizations.

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May, Don Title: Executive Vice President
Organization: AdvaMed
Date: 06/13/2014
Comment:

June 13, 2014

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

RE: Proposed Medicare Coverage Decision Memorandum for Transcatheter Mitral Valve (TMV) Procedures (CAG-00438N)

Dear Ms. Syrek Jensen:

The Advanced Medical Technology Association is pleased

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Batchelor, Wayne Title: Co-Director of Strucutral Heart Program
Organization: Southern Medical Group and Tallahassee Memorial Hospital
Date: 06/13/2014
Comment:

I am interventional cardiologist in a 450 bed acute care teaching hospital in North Florida. We have had a structural heart program for transcatheter aortic valve replacement (TAVR) for nearly 2 years now. We have a well developed mitral valve surgery program and have been trained on the mitraclip procedure. We have performed mitraclip implants for both commercial use and within the COAPT study.

Thus far, although a very complex and difficult and time consuming procedure, I have

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Kander, Nathan Title: MD
Date: 06/13/2014
Comment:
I appreciate the opportunity to comment about the national coverage of mitral valve clip procedures. I'm an interventional cardiologist and have had the opportunity to implant these devices which clearly and markedly improve patient's shortness of breath if they suffer from severe mitral regurgitation. These have been placed in individuals who are too sick to have surgery and have marked benefit with improved quality of life. We work in a busy tertiary care hospital where we have been doing

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Badhwar, Vinay Title: Chief Cardiac Surgery
Organization: University of Pittsburgh Medical Center; Presbyterian
Date: 06/13/2014
Comment:

On November 18, 2013, the Centers for Medicare and Medicaid Services (CMS) opened a national coverage analysis for transcatheter mitral valve repair (TMVR) with MitraClip, referred to as simply ‘TMVR’ henceforth (CAG-00438N). The application for national coverage was jointly submitted to CMS by four national societies representing both cardiac surgeons and interventional cardiologists.

We have come together as leaders in cardiac surgery and cardiology to address issues associated

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Stone, Gregg Title: COAPT Principal Investigator
Organization: Physician Leadership from the COAPT Trial
Date: 06/13/2014
Comment:

June 13th,2014

Ms. Tamara Syrek Jensen, JD
Acting Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: Comments on Proposed Decision Memorandum for Transcatheter Mitral Valve (TMV)Procedures (CAG-00438N)

Dear Ms. Syrek Jensen:

On behalf of the physician investigators from the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for

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Calvert, Barbara Organization: Abbott
Date: 06/13/2014
Comment:

June 13, 2014

Ms. Tamara Syrek Jensen, JD
Acting Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: Comments on Proposed Decision Memorandum for Transcatheter Mitral Valve (TMV) Procedures (CAG-00438N)

Dear Ms. Syrek Jensen:

Abbott is pleased to submit comments on the proposed decision memorandum for transcatheter mitral valve repair (TMVR)

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Low, Reginald Title: Chief, Division of Cardiovascular Medicine,
Organization: University of California, Davis
Date: 06/13/2014
Comment:

I have been in the practice of interventional cardiology since 1980 and I was the Director of the Mercy Heart Institute in Sacramento from 1987 - 2000. This was the largest and most successful cardiac surgery program in California for many of those years. From 2001 to the present, I am Chief, Division of Cardiovascular Medicine and Director of the Heart Center at UC Davis. For the past 10 years, I have been focused on structural heart disease with emphasis on the research, development

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Jones, Thomas Title: Professor, Pediatrics and Internal Medicine
Organization: University of Washington School of Medicine
Date: 06/13/2014
Comment:
MitraClip represents a significant step forward in the less invasive, safer and effective treatment of patients with mitral valve disease. It is a new treatment paradigm that is fundimentally different from the traditional roles typically performed by cardiologists, surgeons and imaging specialists who are often cardiac anesthesiologists. I believe the current CMS document fails to adequately reimburse those performing this procedure and fails to recognize the vital role played by the highly

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Gualano, Sarah Title: Assistant Professor of Medicine
Organization: UT Southwestern Medical Center
Date: 06/13/2014
Comment:

The proposed CMS criteria for reimbursement related to MitraClip procedures have been made publically available and mirror that for transcatheter aortic valve replacement. While we acknowledge the vision of CMS to limit the rollout of MitraClip procedures to select centers, we believe the current volume criteria will predictably disadvantage qualified University Centers and limit this technology to many underserved patient populations. Our interventional practice at University of Texas

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Logan, Katie Organization: Piedmont Heart / Piedmont Atlanta Hospital
Date: 06/13/2014
Comment:

We do not agree that an interventional cardiologist and cardiac surgeon must participate together in key technical aspects of the procedure.

Worldwide experience shows that the procedure can be done safely with either one or two operators. Requiring both a cardiac surgeon and cardiologist would further limit the availability of this technology to patients due to resource constraints and cost effectiveness considerations.

Kiernan, Francis Title: Director, Cardiac Catheterization Lab
Organization: Hartford Hospital
Date: 06/13/2014
Comment:

This comment is written in strong support of the establishment by CMS of a national Medicare coverage for TMVR and MitraClip when furnished according to FDA approved indications.

I am a practicing interventional cardiologist at Hartford Hospital in Hartford CT. Our center treats a large number of patients with complex cardiovascular disease. We perform over 3000 cardiac catheterization procedures and over 1200 PCI procedures. We have a cardiac surgical program that performs nearly

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Hanzel, George Title: Director, Cardiac catheterization laboratory
Organization: William Beaumont Hospital
Date: 06/13/2014
Comment:
At William Beuamont Hospital we haev been part for the MitraCip program since 2008. We have performed > 30 MitraClip cases. In our experience, the MitraClip significantly improved dyspnea and CHF symptoms in the patients we have treated. We clearly support CMS proposal to provide national coverage for FDA approved indications for MitraClip. In our institution cardiac surgery has been instrumental in patient evaluaiton and screening but not in the procedural aspects of the MitraClip

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Foerst, Jason Title: Director of the Adult Structural Heart and Valve I
Organization: Carilion Clinic
Date: 06/13/2014
Comment:

Dear Sir/Madam,

I am the Director of the Adult Structural Heart and Valve Interventions Program at Carilion Clinic/Virginia Tech-Carilion School of Medicine and am very pleased to see CMS's interest in covering transcatheter mitral valve repair procedures. I personally have experience in this arena through a fellowship in Duesseldorf, Germany where we implanted many MitraClips. This procedure was performed with 2 interventional cardiologists after a multidisciplinary team

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Baran, David Title: Director, HF and Transplant Research
Organization: Newark Beth Israel Medical Center, NJ
Date: 06/13/2014
Comment:

I am a member of the heart failure and transplant team at Newark Beth Israel Medical Center in New Jersey and we see many patients with degenerative mitral regurgitation. Many of these are not surgical candidates due to severe left ventricular dysfunction. Only a select few are candidates for heart transplant or ventricular assist devices, leaving a large void of patients who we simply watch and treat medically which is not always effective. We have a skilled cardiac surgical team including

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O’Gara, MD, FACC, Patrick T. Title: President
Organization: The American College of Cardiology (ACC)
Date: 06/13/2014
Comment:

June 13, 2014

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

RE: Proposed Decision Memo for Transcatheter Mitral Valve (TMV) Procedures (CAG-00438N)

Dear Ms. Syrek Jensen:

Overview 

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

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McKay, Raymond Title: Director of Interventional Cardiology Research
Organization: Hartford Hospital, University of Connecticut
Date: 06/12/2014
Comment:

As an interventional cardiologist with over 35 years of experience, I strongly recommend that CMS provide appropriate coverage for reimbursement of Transcatheter Mitral Valve Procedures. I have thoroughly reviewed all published literature on use of the MitraClip as well as the enclosed CMS proposal, trained on the use of this new technology and performed 3 initial MitraClip procedures on patients with severe mitral regurgitation that were deferred from surgical repair. Without question,

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Kipperman, Robert Title: Director of Structural Heart Disease
Organization: Atlantic Health Systems
Date: 06/12/2014
Comment:

Comment re: Proposed NCD (CAG – 00438N)

Morristown Medical Center has provided TMVR with MitraClip procedures since 2009, initially as a clinical trial site and more recently as an early commercial site. To date, 42 patients have been treated with the MitraClip device at Morristown (and an additional 36 cases in Oklahoma by Dr. Kipperman). All procedures were performed by the undersigned physicians with support for a larger ‘Heart Team’. As ‘early adopters’ of the MitraClip

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Cash, Robert Title: Operations Officer
Organization: Intermountain Medical Center
Date: 06/12/2014
Comment:

Our hospital has been involved in clinical trials involving transcatheter mitral valve procedures. We have been pleased with the clinical outcomes and feel confident in the technology's benefit to our patients. These treaments meet an unmet need in the valve treatment community.

Proposed payment seems inconsisent with payment allowed for other procedures with similar complexity and cost. Failure to adequately price the procedures will prove a barrier to providing appropriate

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Cavendish, Jeffrey Date: 06/12/2014
Comment:
To mandate the cardiac surgeons be present and jointly perform the procedure is a waste of their time and hospital resources. The cardiac surgeons do not have the technical skills or training to be performing these procedures. They are a liability in the case as they do NOT possess expertise in catheter based interventions. If this stays in the policy then financially for CMS it is a loss as the cardiac surgeons will be getting re-imbursed for just standing around.
Moon, et al, Marc Title: Secretary
Organization: American Association for Thoracic Surgery
Date: 06/12/2014
Comment:

Transcatheter Therapies for Mitral Regurgitation: Perspectives of the American Association for Thoracic Surgery

RE: Proposed Decision Memo for Transcatheter Mitral Valve (TMV) Procedures (CAG-00438N)

The American Association for Thoracic Surgery (AATS)* would like to congratulate the Center for Medicare and Medicaid Services (CMS) for developing a thoughtful and complete proposal to cover transcatheter mitral valve procedures under Coverage with Evidence Development

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Babaliaros, Vasilis Title: Associate Professor
Organization: Emory University Hospitals
Date: 06/11/2014
Comment:
I am the Medical Director for the Emory Structural Heart and Valve Center. We have been using the Mitraclip device since 2003. It has been a valuable tool to treat patients with primary and functional mitral regurgitation. In cases without surgical options, it has been life saving and has significantly improved quality of life by preventing repeat hospitalizations. In Europe, this device has been used extensively and I believe that therapy should not be withheld in the US, particularly in

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Sanghvi, Kintur Title: Director of Transradial Program
Organization: Deborah Heart & Lung Center
Date: 06/11/2014
Comment:
Agree with the proposed conditions and support the decision to reimburse the TMV procedures
Shea, Richard Title: Codirector of Valvular Heart Disease
Organization: St Francis/Indiana Heart Physicians
Date: 06/11/2014
Comment:
It is not reasonable to require an interventional cardiologist to have 50 structural heart disease cases performed per year in order to be involved in TMVR - 20-25 per year is sufficienct to demonstrate competency. It also does not seem appropriate to have a surgeon in the room when the procedure is being performed - having a surgeon available, in the hospital on standby for emergencies should be sufficient.
Cohen, MD, Barry Title: Medical Director, Cardiac Cath Lab
Organization: Gagnon Cardiovascular Institute, Morristown Medical Center
Date: 06/11/2014
Comment:

Comment re: Proposed NCD (CAG – 00438N)
Morristown Medical Center has provided TMVR with MitraClip procedures since 2009, initially as a clinical trial site and more recently as an early commercial site. To date, 42 patients have been treated with the MitraClip device at Morristown (and an additional 36 cases in Oklahoma by Dr. Kipperman). All procedures were performed by the undersigned physicians with support for a larger ‘Heart Team’. As ‘early adopters’ of the MitraClip device,

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Smalling, Richard Title: Director of Interventional Cardiovascular Medicine
Organization: UT Medical School, Houston, TX
Date: 06/11/2014
Comment:

Comment on Medicare National Coverage Proposal for TMVR and Mitraclip

My name is Richard Smalling, MD, PhD and I am the Professor and Director of Interventional Cardiovascular Medicine and the James D Woods Distinguished Chair in Cardiovascular Medicine at the University of Texas Health Science Center at Houston and the Director of Interventional Cardiovascular Medicine at the Memorial Hermann Heart and Vascular Institute. Our institution has been involved in the percutaneous

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Brown, Diana Title: Manager of the Cardiac & Vascualar Labs
Organization: Franciscan St.Francis Health.
Date: 06/11/2014
Comment:
We have the infratructure to provided this service/treatment for our cardiac patient population. We have the trained physicians and staff ready to support the TMV procedure both intra and post-op care. The requirements to have a CT surgeon is not practical on for a 4hr procedure and should be removed, if you review the proposed guidelines by TMR it states the CT surgeon finds the patient but does not have to perform the procdure. I also feel 50 procedures is to steep and should be reduced to a

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Noel, Thomas Title: M.D.
Organization: Southern Medical Group
Date: 06/11/2014
Comment:

I am a structural heart cardiologist working in Tallahassee, Florida. We have performed TAVR, mitral clip, ASD and PFO closures. I applaud the decision by CMS to cover the mitral clip for patients with severe mitral regurgitation with degenerative valve disease in patients deemed high risk for surgery. I have personally found dramatic improvements in patients quality of life and readmissions for heart failure.

I strongly support the idea that a cardiothoracic surgeon needs to be

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St Goar, Frederick Title: Interventional Cardiologist
Organization: Advanced Cardiovascular Specialists / El Camino Hospital
Date: 06/11/2014
Comment:

As a physician pioneer of the mitraclip I have had the pleasure of being closely involved with the project since its inception in 1999. I have seen first hand cases performed around the world including the first human case 2003 and then have been involved in establishing a program at the hospital where I work, El Camino in Mountain View, Calif. We have successfully enrolled and treated patients in the REALISM trial and then the continued access protocol. Our results with the device have

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Helmer, Gregory Title: MD
Organization: University of Minnesota- Fairview
Date: 06/11/2014
Comment:
I am writing as an experienced interventionalist, structural heart cardiologist, and a cardiologist experienced in TAVR for comment upon policy decision for TMV procedures. I am in full agreement with the need for patient selection and care be provided by a team approach involving at its core a CV surgeon and Interventional cardiologist with expertise in MV procedures. I completely agree with the requirements of volume regarding total MV surgeries, caths, PCIs, and structural heart

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Caputo, Ronald Date: 06/10/2014
Comment:
As a practicing Cardiologist I feel it is crucial that we move forward with PMVR technologies within the clinical arena. Given the increased longevity of the US population and the burden of CHF which impacts both the quality of a patients life and the healthcare system as a whole this option for therapy is vitally important. PMVR is a tool that can keep high risk patients out of the hospital.
Slack, Michael Date: 06/10/2014
Comment:
The proposed reimbursement for the TMV procedure does not reflect the real workload, risk level and dedicated resourced required, not just to say the procedure was done, but to perform the procedure effectively to an optimal clinical outcome. Please stop trying to undercut reimbursements for procedures like this and others and start reimbursing hard working physicians and other healthcare workers for all their efforts rather than simply trying to reduce the cost of medical care on the backs

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Cohen, Mylan Date: 06/10/2014
Comment:

I write as a cardiologist/echocardiographer at MitraClip procedures at Maine Medical Center, Portland, ME. For the last 5 years we have participated in the Everest II Realism Registry. I am especially concerned about CMS' proposal that the MitraClip procedure be performed by a team comprised of an interventionlist cardiologist and cardiac surgeon. We have successfully performed this procedure in 22 Realism patients and 5 commercial patients using a team of 2 interventionist

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Bocchino, Carmella Title: Executive Vice President
Organization: America's Health Insurance Plans
Date: 06/10/2014
Comment:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) Proposed Decision Memo for Transcatheter Mitral Valve Procedures. America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong commitment to participation in public programs.

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George, Jon Title: Assistant Director, Cardiac Cath Lab
Organization: Deborah Heart and Lung Center
Date: 06/09/2014
Comment:
The MitraClip is a new valve therapy for patients with severe mitral regurgitation that have no other options when they are high risk for traditional surgery. The cost of the devices are prohibitive for the hospital to offer this therapy for patients that truly need it. Moreover, the cost of traditional surgery is much greater and does not justify a much lower payment for a procedure that is equivalent in patients unable to tolerate surgery. Finally, this is a therapy that would be offered

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Mumtaz, Mubashir Title: Chief of cardiovascular and thoracic surgery
Organization: Pinnacle health
Date: 06/09/2014
Comment:

Madam/Sir

I am a busy valve surgeon at Pinnacle health in Harrisburg Pennsylvania. Our center performs more than 550 open heart procedures per year. More than 50% of these procedures are valve related. I actively participate in transcatheter valve therapies as related to aortic valve and mitral valve diseases.

I strongly believe in heart team approach for valvular heart disease. I currently scrub in all mitraclip cases at our center and provide valuable expertise and support

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MAINI, BRIJESHWAR Title: MD
Organization: PINNACLEHEALTH CARDIOVASCULAR INSTITUTE
Date: 06/09/2014
Comment:
Congestive heart failure is a problem that is plaguing our country and one might even say that it is an epidemic. Mitral valve disease is a very important etiology of congestive heart failure and unfortunately, the treatment options are minimal to say the least. TMV procedures are an excellent treatment option for these sick patients and provide these patients with a fantastic quality of life to these patients.
Unfortunately, there is dismal reimbursement for this treatment modality and

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Yeung, Alan Title: Chief of Cardiovascular Medicine
Organization: Stanford University School of Medicine
Date: 06/09/2014
Comment:

I am the Medical Director of the Cardiovascular Service Line as well, overseeing the clinical practice of Cardiology, Cardiac Surgery and Vascular Surgery at Stanford University Medical Center. We started a TAVR program about 5 years ago and now in the process of starting a TMVR program. I am also the PI of the COAPT study using the MitraClip system. There is a clear unmet need for MR patient who are in extreme risk for cardiac surgery.

I support the CMS volume requirements for

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Qureshi, Wasif Title: Medical Director, Structural Heart Disease Program
Organization: Christiana Care Hospital Systems.
Date: 06/09/2014
Comment:
TMV procedures are critical to the development of treatment of mitral valve disorders. It is imperative a team approach is employed with and Interventional Cardiologist and a cardiac surgeon.Of what all is required to establish such a program and an important team approach also requires adequate reimbursement from CMS for this particular procedure. We will be spending time evaluating these very sick patients who cannot undergo open mitral valve procedures, taking care of them, speaking with

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Grayburn, Paul Title: Medical Director, Cardiology Research
Organization: Baylor University Medical Center, Baylor Scott and White Healthc
Date: 06/09/2014
Comment:

I am a cardiologist and a member of our multidisciplinary valve team at Baylor Heart and Vascular Hospital and the Heart Hospital Baylor Plano. We have extensive experience with TAVR and with MitraClip, both in selection of patients and performing the procedures. I strongly support the CMS proposal to extend coverage to MitraClip under the TAVR model of "Coverage with Evidence Development." I strongly support the framework of this coverage decision, including the requirement for a

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Flynn, Aidan Date: 06/09/2014
Comment:
TMVR is a reasonable and necessary procedure. Severe MR is a highly prevalent condition, with no effective therapeutic options for a large number of patients. Approximately 1.7 million people in the US have >3+ MR, and perhaps 50% of those are not surgical candidates due to frailty and other co-morbidities. Medical therapy is the only treatment modality for these patients in the US, and that has limited effectiveness. The European experience with TMVR demonstrates the effectiveness of this

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Slater, James Title: Director, Cardiac Cath Lab
Organization: NYU Langone Medical Center
Date: 06/09/2014
Comment:

I am choosing to comment publically on the proposed national coverage for TMVR with Mitraclip. I am the Director of the Cardiac Cath Lab at NYU Langone Medical Center in New York City. We have a very active mitral valve surgery program with several hundred mitral valve repairs, many done with miniimally invasive and also robotic approaches, each year. We have been involved with the mitraclip since being chosen as an investigative site in the EVEREST II trial and to date have performed 36

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Parker, Matthew Date: 06/09/2014
Comment:

Transcatheter mitral valve therapies are an important evolution in cardiovascular disease and an area where the United States is falling behind western Europe and other areas in the world in terms of treatment and innovation.

Clearly the current techniques have limitations. New technologies always do. We collectively need to start building valve centers of excellence as a foundation in transcatheter valve therapy, though, to be prepared for the next wave of technology and

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Tommaso, Carl Title: Director Cardiac Catheterization
Organization: Skokie Hospital
Date: 06/09/2014
Comment:

Dear Sirs:

I am writing to you concerning transcatheter mitral valve repair (TMVR), particularly the MitraClip, both in regard to the DRG placement of this procedure and in regard to the CMS specific requirements for facilities and operators.

I have been the chair of the writing committee which has published the operator and institutional requirements for TMVR as well as transcatheter aortic valve replacement (TAVR) . I do not perform these procedures, but am at an

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GLOWER, DONALD Title: PROFESSOR OF SURGERY
Organization: DUKE UNIVERSITY MEDICAL CENTER
Date: 06/09/2014
Comment:
Public Comments
RE: Proposed Decision Memo for Transcatheter Mitral Valve (TMV) Procedures (CAG-00438N)
FROM:
Dr. Donald D. Glower
Professor of Surgery
Duke University Medical Center

I am an adult cardiac surgeon at a leading academic center in the U.S. My institution performs 1800 cardiac surgical procedures per year along with a similar number of percutaneous interventions for cardiac disease. We perform about 350 mitral valve operations per year (mostly

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wudel, james Date: 06/09/2014
Comment:
I am a cardiac surgeon for 17 years and very active in transcatheter valve techniques and trials including PARTNER II and COAPT. Agree that cardiac surgeons must be intimately involved not only in selection of patients for these procedures but also actively participate in the implantation of the devices for therapy.
Petit, Janet Title: Clinical Program Administrator UM Heart Center
Organization: University of Maryland Medical Center
Date: 06/09/2014
Comment:
Medicare Coverage Comment on National Coverage:
The Heart Center at the University of Maryland is a robust multidisciplinary program including specialists from cardiac surgery and cardiovascular medicine. Surgeons in the division of cardiac surgery practice a specialization model to improve patient outcomes and care. We perform over 1400 cardiac surgical operations per year, and over 200 mitral valve operations per year, with a repair rate for degenerative disease > 95%. Cardiovascular

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Price, Matthew Title: Director, Cardiac Catheterization Laboratory
Organization: Scripps Clinic
Date: 06/08/2014
Comment:
This comment addresses the proposed requirement of both an interventional cardiologist AND a cardiac surgeon to participate in the transcatheter mitral valve repair procedure. I am a board-certified interventional cardiologist who performs other structural heart procedures (eg., ASD, PFO, transseptal punctures) and have performed 2 MitraClip procedures as part of the COAPT trial. All aspects of the MitraClip transcatheter mitral valve repair procedure required only a single operator (myself)

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Whisenant, Brian Organization: Intermountain Medical Center
Date: 06/08/2014
Comment:

At Intermountain Medical Center we have participated in the MitraClip trials since 2007 including Everest II, Realism,and COAPT and have also used the MitraClip in the commercial setting. Many of our patients who are at increased risk for surgery have derived marked symptomatic improvement following MitraClip placement as well as objective findings associated with improved survival including markedly diminished pulmonary hypertension.

Our MitraClip program is part of a highly

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rinaldi, michael Title: Interventional Cardiologist
Organization: Sanger Heart and Vascular Institute, Carolinas HealthCare System
Date: 06/08/2014
Comment:

I am writing to support a national coverage decision for percutaneous MV repair and specifically the MitraClip Repair Procedure. I am an interventional cardiologist and Director of Clinical Research for the Sanger Heart and Vascular Institute which is the cardiovascular Service Line for the Carolinas HealthCare System based in Charlotte, NC. I have extensive experience with MitraClip having participated in all US clinical trials to date and have performed nearly 70 MitraClip

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Kafer, Tim Title: Vice President
Organization: Maine Medical Center
Date: 06/08/2014
Comment:
As the Vice President for Cardiovascualr Services at Maine Medical Center in Portland Maine, I have been part of the growth of both the TAVR program and the Mitraclip program at MMC. I am concerned that the proposed NCD for the MitraClip requires a cardiac surgeon to be present during the procedure. We have two interventional cardiologists present as well as a cardiac imaging physician and an anesthesiologist. I am not sure a cardiac surgeon is required or adds additional value during the

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Burkey, M.D., David Date: 06/08/2014
Comment:

I am an Interventional Cardiologist. I have had the honor of being involved in the pMVR program at the Maine Medical Center using the Mitraclip. In the last couple of weeks we have completed the mandated five year follow up of our first three patients as part of the Realism registry. I can say categorically that this device has made a meaningful difference in the lives of these patients. In fact, it is unlikely that they would have survived these past five years without pMVR. In

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Berg, Claire Title: Valve Program Coordinator
Organization: Maine Medical Center
Date: 06/08/2014
Comment:

I write as Valve Program Coordinator for both TAVR and MitraClip procedures at Maine Medical Center, Portland, ME. For the last 5 years we have participated in the Everest II Realism Registry. I am especially concerned about CMS' proposal that the MitraClip procedure be performed by a team comprised of an interventionlist cardiologist and cardiac surgeon. We have successfully performed this procedure in 22 Realism patients and 5 commercial patients using a team of 2 interventionist

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Hodson MD, Robert Date: 06/07/2014
Comment:

As an interventional cardiologist and the medical director of The Providence Valve Center, I look forward to CMS coverage of transcatheter mitral valve repair. The Providence Valve Center is a high volume regional referral center located at Providence St. Vincent Medical Center, Portland Oregon. The heart team is composed of physicians, surgeons and staff from Providence St. Vincent and Providence Portland Medical Centers. Providence Health Systems has a long history of leadership and

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Rogers, Jason Title: Director, Intereventional Cardiology
Organization: University of California, Davis Medical Center
Date: 06/07/2014
Comment:

I wish to make an additional comment on the proposed CMS coverage decision.

Specifically, requirement that “The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TMVR” is my opinion inappropriate and unnecessary.

The cardiac surgeon and interventional cardiologist should work together for the screening and workup of the patient. However, the MitraClip procedure is and always has been a

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O'Neill, william Title: Medical Director Structural Heart Center
Organization: Henry Ford Hospital
Date: 06/07/2014
Comment:
The requirement for two operators is burdensome and unnecessary. This procedure can be performed by an interventional cardiologist and an assistant such as a fellow or scrub assistant.The cardiac surgeon becomes simply a bystander. Its as waste of time for a skilled mitral surgeon to hold wires while the IC does the work. The key parts of the procedure pertain to trans septal puncture and grasping the mitral leaflets which are done under echo guidance. A skilled echocardiographer with specifc

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Rammohan MD FACC, Chad Title: Director, Cardiac Catheterization Laboratory
Organization: El Camino Hospital
Date: 06/05/2014
Comment:

I am and interventional cardiologist and director of the cardiac catheterization lab at El Camino hospital in Mountain View California. We have been performing percutaneous transcatheter mitral valve repair with the mitral clip for 5 years As part of the research trial. We have treated over 40 patients. I strongly support the proposed national coverage for the FDA approved indications. I have seen this technology have impressive improvements in patients quality-of-life and rate of

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Talreja, Deepak Title: Asst Prof, EVMS/Sentara/CVAL
Organization: EVMS/SENTARA/CVAL
Date: 06/05/2014
Comment:
This technology represents a very important therapeutic advance for our patients with mitral valve disease. As a practicing cardiologist and coleader of our structural heart program in Norfolk Virginia I watched the tremendous results we have enjoyed with TAVR platforms and the lives we have helped change. Prior to this being approved in the US and adequately covered we had many patients who went overseas to receive care they could not in this country. On behalf of our patients, please help

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Korngold, Ethan Title: Co-Medical Director, Providence Valve Center
Organization: Providence Heart and Vascular Institute
Date: 06/03/2014
Comment:

I am an interventional cardiologist, and serve as Co-Medical Director of the Providence Valve Center at Providence St. Vincent Medical Center in Portland Oregon. Our center is the highest volume transcatheter valve program in Oregon, with over 135 TAVRs and 6 MitraClip cases at this time.

With our early MitraClip experience we have seen some dramatic results. The technical results have been excellent, with significant reductions in mitral regurgitation on echocardiogram. But the

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Nair, Deepu Date: 06/02/2014
Comment:

Dear CMS official,

I am a cardiologist involved in our local heart team, and I provide imaging support for various structural heart procedures in our busy community hospital. I have been responsible for transesophageal echocardiographic imaging for the nearly 40+ Mitraclip patients we have performed at our site. I have 2 comments:

a) I see no reason for a surgeon to be in the room for this procedure. There is no cut-down or surgical access, and the entire procedure is

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dobmeyer, david Organization: Heart Specialty Associates
Date: 06/02/2014
Comment:
I have been a physician practicing cardiology for over 20 years. During that time I have cared for many patients with severe mitral insufficiency who were not surgical candidates. It has been nothing short of heart breaking to watch these patients deteriorate and die for lack of any alternative therapy. I firmly believe that the Mitra Clip device will a safe and effective treatment for these patients.
Cain, Carolyn Title: RN
Organization: Mass General Hosp
Date: 05/29/2014
Comment:

Dear CMS,

Regarding requirement #4 - "The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TMVR." This appears to be a copy of the TAVR requirement and should not apply to the mitral clip procedure which does not involve cardiac surgery.

Also, we would ask that the proposed requirement #2, of "independent" and "face-to-face" evaluations of the MV cardiac surgeon and cardiologist be

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yakubov, steven Title: MD, System Director Advanced Str. Heart Dis.
Organization: OhioHealth - Riverside Methodist Hospital
Date: 05/28/2014
Comment:

I am an interventional cardiologist in Columbus Ohio at Riverside Methodist Hospital. I am the structural heart division leader. I have been involved in developing our TAVR program and performing this procedure. I have been leading our mitral valve therapy program along with our noninvasive cardiologists and heart failure specialists. Our site is an investigative site for the COAPT clinical trial randomizing optimal medical therapy vs. optimal medical therapy plus mitraClip for these

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Lee, Richard Title: Co-Director
Organization: Center for Comprehensive Cardiovascular Care, St. Louis U
Date: 05/28/2014
Comment:

I am currently a busy mitral valve surgeon and perform over 100 mitral surgeries a year. At my academic center, like most, we have seen a dramatic decline in coronary artery bypass and interventions. Since they are separate skill sets, I would recommend REMOVING all requirements for coronary catheterization and stenting. Especially at valve centers of excellence, there may be a much larger percentage of diagnostic catheterizations, and in fact, many of our younger patients do not need

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Ricciardi, Mark Date: 05/27/2014
Comment:

meet guideline based criteria for surgical treatment of severe symptomatic mitral regurgitation. In addition, we are participating in the COAPT Trial and are seeing more and more patients with different types of MR, CHF and complex non-cardiac disease.

Because many of the patients seen in our practice are not suitable for surgery, we were very happy to learn of the FDA’s October 2013 approval of the MitraClip device for severe, symptomatic degenerative MR in patients at prohibitive

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Malaisrie, Chris Date: 05/27/2014
Comment:
I am the cardiac surgeon participating in our institutions Heart team for transcatheter heart valve therapies. We have treated patient with MR under the COAPT trial using the Mitraclip. I support the CMS proposal for NCD. I agree with both the cardiac surgeon and interventional cardiologist must jointly participate in the intra-operative technical aspects of TMVR, which is consisted with NCD for TAVR.
Rihal, Chet Organization: Mayo Clinic
Date: 05/27/2014
Comment:

I strongly support CMS's move to support new options for patients with mitral regurgitation. TMVR is now an established therapeutic option and appropriate patients in the US should have access to it. Similarly, operators and hospitals should be able to provide this therapy in a financially prudent yet sustainable manner. I would urge a focus on value (quality / cost).

Mandating two staff level operators, one interventionalist and one surgeon, is clearly not necessary and not

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Patterson, David Title: Executive Director Cardiovasular Services
Organization: Sarasota Memorial Health Care System
Date: 05/27/2014
Comment:
I feel that involvement in new technology is a must for CMS to be involved with to ensure that people that would benefit is supported. In order to continue support hospitals must be reimbursed at a level that is not a loss to the institution or they will not be able to continue support of any new technology. With continued decrease in overall reimbursement from Medicare, hospitals will have to decide on whether or not to participate in procedures that have a negative reimbursement and thus

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Fensterle, Chris Date: 05/27/2014
Comment:
The minimally invasive nature of the device is deceiving. This is still a substantial procedure with substantial costs. The reimbursment for the procedure does not cover the cost, therefore the ability to effectily deploy the procedure becomes a financial burden on the facilties. I think that reimbursement should be at least cover the cost of the procedure, especially as the capabilites of this deveice/ procedure grows with improved patient quality of life.
Wang, Andrew Title: Professor of Medicine
Organization: Duke University Hospital
Date: 05/26/2014
Comment:
I am interventional cardiologist with over 8 years experience with MitraClip device in clinical trials. I agree with institutional and operator requirements in NCD, including evaluation of patients by cardiac surgery before procedure to assess surgical risk. However, it is unrealistic to have cardiac surgeons AND interventional cardiologist directly involved in the procedure. Unlike TAVR, there is not a need for additional operator and there is already an echocardiography cardiologist in

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Rose, Geoffrey Title: Chief, Division of Adult Cardiology
Organization: Sanger heart & Vascular Institute
Date: 05/26/2014
Comment:

Regarding CMS' proposed coverage decision CAG-00438N:

I am a cardiologist and imaging specialist with the Carolinas Healthcare System. Our institution (and I personally) have been involved w/ use of MitraClip technology for over 7 years principally through investigational access. We have found this technology to be truly life-saving, by providing access to mitral valve repair to patients who are not candidates for traditional surgery. Our first patient is now almost 8 years out

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Fail, Peter Title: Director of the Cardiac Cath Lab
Organization: Cardiovascular Institute of the South
Date: 05/26/2014
Comment:

The addition of the Mitral Clip to those patients that do no have a good surgical alternative, or NO surgical alternative has been nothing short of life saving. As an investigator in the EVEREST studies, I was able to witness first hand numerous patients that were able to gain a dramatic improvement in the NYHA status, preventing repeat hospitalizations for CHF. The reimbursement to the hospital has been a point of contention since the trial was finished and the continued access started.

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Daggubati, Ramesh Title: DIRECTOR OF INTERVENTIONAL CARDIOLOGY
Organization: EAST CAROLINA UNIVERSITY
Date: 05/25/2014
Comment:

We are in a unique practice at ECU with Dr. Randolph Chitwood heading our surgical mitral valve program. About 200 mitral valve surgeries are performed yearly at our institution.

I support the CMS proposal to provide national coverage for FDA approved indications of TMVR including MitraClip.

As part of research, we have gained great experience with MitraClip therapy. All our patients had improvement in their heart failure symptoms and

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Daniel, George Title: Interventional cardiologist
Organization: Daniel Heart and Vacsular Center
Date: 05/24/2014
Comment:

I am a structural and endovascular interventional cardiologist at a busy 500 bed tertiary referral hospital with full cardiac surgery and interventional program including structural interventions, and endovascular program, and a busy TAVR program. We see significant number of patients with mitral valve regurgitation, that require mitral vale surgery including repair and replacement. Also, we decline to operate on a significant number of patients with mitral regurgitation due to

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Barker, Colin Date: 05/22/2014
Comment:

I am an Interventional cardiologist in Houston, TX. I spend 75% of my time taking care of patients with structural heart disease, including heart valve disease. We have an established, multi-disciplinary valve program with a valve coordinator and a valve clinic. We are referred 5-6 cases per week of patients with severe, symptomatic mitral regurgitation. Complex cases are reviewed in a dedicated valve conference, and recommendations regarding treatment options are made.

I strongly

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Rogers, Jason Title: Director, Interventional Cardiology
Organization: University of California, Davis Medical Center
Date: 05/21/2014
Comment:

I am an interventional cardiologist who specializes in adult structural heart disease at a large tertiary care academic medical center. We are routinely referred patients with complex mitral valve disease for consultation and management with medical, surgical, or transcatheter approaches.

I strongly support the CMS proposal to provide national coverage for the FDA-approved indications for MitraClip and other transcatheter mitral valve repair procedures. The MitraClip procedure is

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